e424b5
CALCULATION OF REGISTRATION FEE
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Title of Each Class of |
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Amount |
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Offering Price |
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Aggregate |
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Amount of |
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Securities Registered |
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Registered |
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per Unit |
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Offering Price |
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Registration Fee(1) |
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9.00% Senior Subordinated Notes due 2016 |
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$ |
400,000,000 |
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96.865 |
% |
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$ |
387,460,000 |
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$ |
21,621 |
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Subsidiary Guarantees |
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(2) |
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(2) |
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(2) |
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(2) |
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(1) |
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Calculated in accordance with Rule 457(r) of the Securities Act of 1933. |
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(2) |
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Pursuant to Rule 457(n) under the Securities Act of 1933, no separate registration fee
is payable with regard to the guarantees. |
Filed
Pursuant to Rule 424(b)(5)
Registration File
No. 333-158542
PROSPECTUS
SUPPLEMENT
To
Prospectus dated May 1, 2009
$400,000,000
Inverness
Medical Innovations, Inc.
9.00% Senior
Subordinated Notes due 2016
We are offering $400,000,000 aggregate principal amount of our
9.00% Senior Subordinated Notes due 2016. The notes will
mature on May 15, 2016. Interest will be payable on
May 15 and November 15 of each year, beginning on
November 15, 2009.
We may redeem the notes in whole or in part on and after
May 15, 2013 at the redemption prices described herein plus
accrued and unpaid interest at the date of redemption. In
addition, we may redeem up to 35% of the notes before
May 15, 2012 with the proceeds of certain equity offerings.
Prior to May 15, 2013, we may also redeem the notes upon
payment of the make-whole premium described herein plus accrued
and unpaid interest at the date of redemption. If we sell
certain of our assets or experience specific kinds of changes in
control, we may be required to offer to repurchase the notes.
There is no sinking fund for the notes.
The notes are our senior subordinated unsecured obligations and
will be subordinated in right of payment to all our existing and
future senior debt. Subject to certain exceptions, our
obligations under the notes are or will be guaranteed on a
senior subordinated basis by our current and future domestic
subsidiaries that guarantee certain of our other indebtedness.
The notes will also be effectively subordinated to our and our
guarantor subsidiaries existing and future secured debt
and other secured obligations, to the extent of the value of the
assets securing such debt, and will be structurally subordinated
to all obligations of our subsidiaries that do not guarantee the
notes.
The notes have been authorized for listing on the New York Stock
Exchange, subject to notice of issuance. Currently, there is no
public market for the notes.
Investing in the notes involves substantial risk. See
Risk Factors beginning on page S-12.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities or determined if this prospectus supplement and the
accompanying prospectus are truthful or complete. Any
representation to the contrary is a criminal offense.
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Public
offering
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Underwriting
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Proceeds,
before
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price(1)
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discount
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expenses, to
us
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Per note
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96.865
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%
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2.000
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%
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94.865
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%
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Total
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$
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387,460,000
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$
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8,000,000
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$
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379,460,000
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(1) |
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Plus accrued interest from
May 12, 2009 to the date of delivery. |
We expect that delivery of the notes will be made to purchasers
in book-entry form through The Depository Trust Company on
or about May 12, 2009.
Joint
Book-Running Managers
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Banc
of America Securities LLC
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Co-Managers
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Canaccord
Adams |
Leerink Swann |
Stifel Nicolaus |
The
date of this prospectus supplement is May 7, 2009.
About this
prospectus supplement
This document is in two parts. The first part is this prospectus
supplement, which describes the specific terms of this offering.
The second part is the accompanying prospectus, which describes
more general information, some of which may not apply to this
offering. If the description of the offering varies between this
prospectus supplement and the accompanying prospectus, you
should rely on the information in this prospectus supplement.
In making your investment decision, you should rely only on the
information contained or incorporated by reference in this
prospectus supplement and the accompanying prospectus or any
issuer free writing prospectus. We have not, and the
underwriters have not, authorized any other person to provide
you with any other information. If anyone provides you with any
other information, you should not rely on it. You should assume
that the information appearing or incorporated by reference in
this prospectus supplement and the accompanying prospectus or
any issuer free writing prospectus is accurate as of the dates
on their respective covers. Our business, financial condition,
results of operations and prospects may have changed since those
dates. Neither the delivery of this prospectus supplement and
the accompanying prospectus or any issuer free writing
prospectus nor any sale made hereunder shall under any
circumstance imply that the information contained or
incorporated by reference in this prospectus supplement is
correct as of any date subsequent to the date on the cover of
this prospectus supplement or that the information contained or
incorporated by reference in the accompanying prospectus or any
issuer free writing prospectus is correct as of any date
subsequent to the dates on their respective covers.
We and the underwriters are offering to sell the notes only in
places where such offers and sales are permitted.
TABLE OF CONTENTS
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Prospectus
Supplement
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S-1
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S-12
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S-33
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S-34
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S-35
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S-36
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S-38
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S-40
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S-68
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S-80
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S-85
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S-88
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S-143
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S-147
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S-151
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Consolidated financial statements
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SF-1
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Prospectus
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1
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1
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2
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2
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4
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4
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7
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8
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10
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10
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13
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22
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24
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26
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28
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28
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29
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S-i
Summary
This summary highlights the information contained elsewhere
or incorporated by reference in this prospectus supplement.
Because this is only a summary, it does not contain all of the
information that may be important to you. For a more complete
understanding of this offering, we encourage you to read this
prospectus supplement, the accompanying prospectus and the
documents incorporated by reference in this prospectus
supplement and the accompanying prospectus. You should read the
following summary together with the more detailed information
and consolidated financial statements, including the
accompanying notes, included elsewhere or incorporated by
reference in this prospectus supplement and the accompanying
prospectus.
INVERNESS MEDICAL
INNOVATIONS, INC.
Inverness Medical Innovations, Inc. enables individuals to take
charge of improving their health and quality of life at home by
developing new capabilities in near-patient diagnosis,
monitoring and health management. Our global leading products
and services, as well as our new product development efforts,
focus on cardiology, womens health, infectious disease,
oncology and drugs of abuse. Our business is organized into four
major reportable segments: professional diagnostics, health
management, consumer diagnostics and vitamins and nutritional
supplements. Through our professional diagnostics segment, we
develop, manufacture and market an extensive array of innovative
rapid diagnostic test products and other in vitro
diagnostic tests to medical professionals and laboratories for
detection of infectious diseases, cardiac conditions, drugs of
abuse and pregnancy. Our health management segment provides
comprehensive, integrated programs and services focused on
wellness, disease and condition management, productivity
enhancement and informatics, all designed to reduce
health-related costs and enhance the health and quality of life
of the individuals we serve. Our consumer diagnostic segment
consists primarily of manufacturing operations related to our
role as the exclusive manufacturer of products for SPD Swiss
Precision Diagnostics, or SPD, our 50/50 joint venture with The
Procter & Gamble Company, or P&G. SPD holds a
leadership position in the worldwide over-the-counter pregnancy
and fertility/ovulation test market. We also manufacture and
market a variety of vitamins and nutritional supplements under
our brands and those of private label retailers primarily in the
U.S. consumer market. We have grown our businesses by
leveraging our strong intellectual property portfolio and making
selected strategic acquisitions. Our products are sold in
approximately 90 countries through our direct sales force and an
extensive network of independent global distributors.
ACON
ACQUISITION
On April 30, 2009, we completed our acquisition of certain
assets from ACON Laboratories, Inc. and certain related
entities, whom we refer to collectively as ACON, relating to
ACONs lateral flow immunoassay business. ACON is a
world-wide provider of diagnostic test kits in the consumer,
point-of-care and laboratory markets. In connection with our
March 2006 acquisition of the assets of ACONs business of
researching, developing, manufacturing, marketing and selling
lateral flow immunoassay and directly related products, which we
refer to as the ACON business, in the United States, Canada,
Europe (excluding Russia, the former Soviet Republics that are
not part of the European Union and Turkey), Israel, Australia,
Japan and New Zealand, which we refer to collectively as the
first territory, we entered into an agreement with ACON that
provided that in the event certain financial performance and
operating conditions were satisfied, we would agree to acquire,
and ACON would agree to sell, the ACON business for the
remainder of the world, which we refer to as the ACON second
territory business. The terms and conditions of our acquisition
of the ACON second territory business, which includes the ACON
business in China, Asia Pacific, Latin America, South America,
the Middle East, Africa, India, Pakistan, Russia and Eastern
Europe, are set forth in an agreement between ACON and us dated
March 16, 2009. ACON will retain its other worldwide
in-vitro diagnostics businesses including diabetes, clinical
chemistry and immunoassay products.
As agreed to in connection with the acquisition of the ACON
business in the first territory in March 2006, the aggregate
purchase price for the ACON second territory business will be
based on a multiple
S-1
of either the ACON second territory business revenue or
its pre-tax profits for calendar year 2008, subject to final
determination of ACONs financial results for calendar year
2008, as well as working capital and other customary
adjustments. We currently expect that the purchase price for the
ACON second territory business will be approximately
$200.0 million, subject to the foregoing determination and
adjustments.
At closing, we paid $80.0 million in cash toward the
purchase price. Not later than ten business days following the
closing of this offering, we expect to pay approximately an
additional $30.5 million in cash, based on the estimated
purchase price. On July 1, 2009, we must pay an amount
equal to approximately $59.5 million in shares of our
common stock or, at our election, cash, based on the estimated
purchase price. Such amount shall bear interest at the rate of
4% per annum from the closing date. The remainder of the
purchase price will be due in two installments, each comprising
7.5% of the total purchase price, or approximately
$15.0 million, based on the estimated purchase price, on
the dates that are 15 and 30 months after the closing.
These installment amounts do not bear interest and may be paid
in cash or a combination of cash (not less than approximately
71% of each payment) and shares of our common stock (not more
than approximately 29% of each payment).
The actual number of shares of our common stock to be issued
pursuant to the ACON acquisition agreement, if any, will be
determined by reference to a formula by which the value of the
common stock to be issued is divided by a price per share equal
to the volume weighted average price of our common stock during
the ten trading days immediately preceding the date of issuance.
In connection with the consummation of the acquisition of the
ACON second territory business, we also entered into various
other agreements with ACON, including an amended and restated
investor rights agreement, transitional supply and distribution
agreements, an amended and restated license agreement, a
transition services agreement, and other ordinary and customary
agreements.
We may use a portion of the proceeds of this offering to pay
some or all of the purchase price that remains outstanding.
S-2
RECENT FINANCIAL
RESULTS
We recently reported our preliminary unaudited financial results
for the first quarter of 2009. We have not yet filed with the
SEC our quarterly report on
Form 10-Q
for the first quarter of 2009, and our independent registered
public accounting firm has not completed the review of our
quarterly financial information required by Statement of
Auditing Standards No. 100, Interim Financial
Information.
In that quarter, we recorded net revenue of $443.9 million
compared to net revenue of $372.2 million in the first
quarter of 2008. The revenue increase was primarily due to
$76.9 million of incremental revenue provided by our health
management segment principally as a result of incremental
revenues from recently acquired businesses, along with
$10.2 million of incremental revenue contributed by our
other recently acquired businesses, offset in part by the
adverse impact of foreign currency translation, which reduced
reported revenues by $16.6 million. A relatively mild flu
season resulted in a reduction in sales of our influenza tests
in North America by $12.4 million from the first quarter of
2008.
The following tables provide certain of our preliminary
unaudited condensed consolidated financial data for the three
months ended March 31, 2009 and 2008 and as of
March 31, 2009.
For additional financial information relevant to our ability to
meet our debt service obligations, please see
Other Financial Information.
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For the three
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months ended
March 31,
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Statement of
operations data:
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2009
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2008
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(in thousands,
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except per share
data)
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(unaudited)
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Net product sales and services revenue
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$
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434,800
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$
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361,361
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License and royalty revenue
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9,060
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10,872
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Net revenue
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443,860
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372,233
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Cost of net revenue
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209,658
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191,843
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Gross profit
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234,202
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180,390
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Operating expenses:
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Research and development
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27,052
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30,925
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Selling, general and administrative
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178,996
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134,687
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Total operating expenses
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206,048
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165,612
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Operating income
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28,154
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14,778
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Interest and other income (expense), net
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(20,671
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(20,753
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Income tax provision (benefit)
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3,689
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(880
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Equity earnings of unconsolidated entities, net of tax
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2,497
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921
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Net income (loss)
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6,291
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(4,174
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Balance sheet
data:
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March 31,
2009
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(in
thousands)
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Cash and cash equivalents
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$
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205,181
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Working capital
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$
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514,134
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Total assets
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$
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5,902,506
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Total debt
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$
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1,516,032
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Total stockholders equity
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$
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3,257,677
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PRINCIPAL
EXECUTIVE OFFICES
Inverness Medical Innovations, Inc. is a Delaware corporation.
Our principal executive offices are located at 51 Sawyer Road,
Suite 200, Waltham, Massachusetts 02453 and our telephone
number is
(781) 647-3900.
Our website is www.invernessmedical.com. The information found
on our website is not part of this prospectus.
S-3
The offering
9.00% SENIOR
SUBORDINATED NOTES DUE 2016
The following summary describes the principal terms of the
notes. Some of the following description is subject to important
limitations and exceptions. The Description of Notes
section of this prospectus supplement contains a more detailed
description of the notes than this summary section.
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Issuer |
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Inverness Medical Innovations, Inc., a Delaware corporation. |
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Notes Offered |
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$400,000,000 aggregate principal amount of our 9.00% Senior
Subordinated Notes due 2016. |
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Maturity Date |
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May 15, 2016. |
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Interest |
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9.00% per annum, payable semi-annually on May 15 and
November 15 of each year, commencing November 15, 2009. |
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Optional Redemption |
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We may, at our option, redeem the notes, in whole or part, at
any time on or after May 15, 2013, at the redemption prices
described in Description of
NotesRedemptionOptional Redemption plus
accrued and unpaid interest to (but excluding) the redemption
date. |
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Optional Redemption After Certain Equity Offerings |
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At any time (which may be more than once) until May 15,
2012, we can choose to redeem up to 35% of the notes (including
any applicable notes issued after the issue date) with money
that we raise in certain equity offerings, so long as: |
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Ø we
pay 109.00% of the face amount of the notes, plus accrued and
unpaid interest to (but excluding) the redemption date;
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Ø we
redeem the notes within 90 days of completing such equity
offering; and
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at least 65% of the aggregate principal amount of the notes
(including any notes issued after the issue date) remains
outstanding afterwards. See Description of
NotesRedemptionRedemption with Proceeds from Equity
Offerings. |
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Make-Whole Redemption |
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Prior to May 15, 2013, we may redeem some or all of the
notes by the payment of a make-whole premium described under
Description of NotesRedemptionMake-whole
Redemption, plus accrued and unpaid interest to (but
excluding) the redemption date. |
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Change of Control |
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If a change of control occurs, subject to certain conditions, we
must give holders of the notes an opportunity to sell the notes
to us at a purchase price of 101% of the principal amount of the
notes, plus accrued and unpaid interest to (but excluding) the
date of the purchase. The credit agreements governing our
secured credit facilities prohibit us from repurchasing any of
the notes in connection with a change of control before the
repayment in full of all amounts outstanding under the secured
credit facilities. Therefore, if a change of control were to
occur, we may be unable to repurchase any of the notes due to
this or |
S-4
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similar prohibitions or because we do not have adequate funds.
See Description of NotesChange of Control. |
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Guarantees |
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The payment of the principal, premium and interest on the notes
is or will be fully and unconditionally guaranteed, jointly and
severally, on a senior subordinated basis by, subject to certain
exceptions, all of our current and future domestic subsidiaries
that guarantee certain other of our indebtedness. A guarantee
may be released if we dispose of the guarantor subsidiary or it
ceases to guarantee certain other indebtedness of ours or any of
our other subsidiaries. See Description of
NotesGuarantees of the Notes. |
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Ranking |
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The notes will be our general unsecured senior subordinated
obligations and will be: |
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Ø junior
in right of payment to all of our existing and future senior
indebtedness, including indebtedness arising under our secured
credit facilities; see Description of
NotesSubordination of the Notes;
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Ø pari
passu in right of payment with all of our existing and
future senior subordinated indebtedness, including indebtedness
arising under our outstanding senior subordinated convertible
notes;
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Ø senior
in right of payment to any of our existing or future
indebtedness that is, by its terms, subordinated in right of
payment to the notes;
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Ø unconditionally
guaranteed by the guarantor subsidiaries; see Description
of NotesGuarantees of the Notes;
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Ø effectively
subordinated to all of our existing and future secured
indebtedness, including indebtedness arising under our secured
credit facilities, to the extent of the assets securing such
indebtedness; and
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Ø structurally
subordinated to all of the existing and future obligations of
each of our subsidiaries that does not guarantee the notes; see
Description of NotesRanking of the Notes and the
Guarantees.
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The guarantees will be general unsecured obligations of the
guarantor subsidiaries and will be: |
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Ø junior
in right of payment to all existing and future senior
indebtedness of the guarantor subsidiaries, including
indebtedness arising under our secured credit facilities; see
Description of NotesSubordination of the Guarantees
of the Notes;
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Ø pari
passu in right of payment with any existing or future senior
subordinated indebtedness of the guarantor subsidiaries;
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Ø senior
in right of payment to any existing or future indebtedness of
guarantor subsidiaries that is, by its terms, subordinated to
the guarantees;
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S-5
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Ø effectively
subordinated to all existing and future secured indebtedness of
the guarantor subsidiaries, including the indebtedness arising
under our secured credit facilities, to the extent of the assets
securing such indebtedness; and
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Ø structurally
subordinated to all existing and future obligations of each of
our subsidiaries that is not also a guarantor subsidiary; see
Description of NotesRanking of the Notes and the
Guarantees.
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As of December 31, 2008, we had approximately
$1.37 billion in principal amount of senior debt
outstanding, including approximately $1.35 billion in
aggregate principal amount of debt outstanding under our secured
credit facilities. |
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Asset Sale Proceeds |
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If we or our subsidiaries engage in asset sales, we generally
must either invest the net cash proceeds from such sales in our
business within a period of time, prepay senior debt or make an
offer to purchase a principal amount of the notes equal to the
excess net cash proceeds, subject to certain exceptions. The
purchase price of the notes will be 100% of their principal
amount, plus accrued and unpaid interest. See Description
of NotesCertain CovenantsLimitations on Asset
Sales. |
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Certain Covenants |
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We will issue the notes under an indenture with U.S. Bank
National Association, as trustee. The indenture governing the
notes contains covenants that limit our ability and our
restricted subsidiaries ability to, among other things: |
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Ø incur
additional debt;
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Ø pay
dividends on our capital stock or redeem, repurchase or retire
our capital stock or subordinated debt;
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Ø make
certain investments;
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Ø create
liens on our assets;
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Ø transfer
or sell assets;
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Ø engage
in transactions with our affiliates;
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Ø create
restrictions on the ability of our subsidiaries to pay dividends
or make loans, asset transfers or other payments to us;
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Ø issue
capital stock of our subsidiaries;
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Ø engage
in any business, other than our existing businesses and related
businesses;
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Ø enter
into sale and leaseback transactions;
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Ø incur
layered indebtedness; and
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Ø consolidate,
merge or transfer all or substantially all of our assets and the
assets of our subsidiaries.
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|
|
These covenants are subject to important exceptions and
qualifications, which are described under the caption
Description of NotesCertain Covenants. |
S-6
|
|
|
Use of Proceeds |
|
We expect to use the net proceeds from this offering for working
capital and other general corporate purposes, including the
financing of potential acquisitions or other investments, if and
when suitable opportunities arise, and for capital expenditures,
in our sole discretion. We may use a portion of the net proceeds
from this offering to pay some or all of our remaining
obligations relating to our recently completed acquisition of
the second territory business from ACON. See Use of
Proceeds. |
|
Book-Entry Form |
|
Initially, the notes will be represented by one or more global
notes in definitive, fully registered form deposited with a
custodian for, and registered in the name of, a nominee of The
Depository Trust Company. |
|
No Prior Market |
|
The notes will be new securities for which there is currently no
market. Although the underwriters have informed us that they
intend to make a market in the notes, they are not obligated to
do so and they may discontinue market making activities at any
time without notice. Accordingly, we cannot assure you that a
liquid market for the notes will develop or be maintained. |
|
Listing |
|
The notes have been authorized for listing on the New York Stock
Exchange, subject to notice of issuance. |
RISK
FACTORS
You should carefully consider all information in this prospectus
supplement, the accompanying prospectus and the documents
incorporated by reference herein and therein. In particular, you
should evaluate the specific risk factors set forth in the
section entitled Risk Factors in this prospectus
supplement for a discussion of risks relating to our business
and an investment in the notes.
S-7
Summary consolidated
financial information
The following tables provide our summary consolidated financial
data as of the dates and for the periods shown. Our summary
consolidated statement of operations data for the years ended
December 31, 2006, 2007 and 2008 and our summary
consolidated balance sheet data as of December 31, 2007 and
2008 are derived from our audited consolidated financial
statements included elsewhere in this prospectus supplement,
which have been audited by BDO Seidman, LLP, our independent
registered public accounting firm, as indicated in their report.
Our summary consolidated balance sheet data as of
December 31, 2006 are derived from our audited consolidated
financial statements not included in this prospectus supplement,
which have been audited by BDO Seidman, LLP, our independent
registered public accounting firm. The summary consolidated
financial data should be read in conjunction with, and are
qualified in their entirety by reference to, our audited
consolidated financial statements, including the notes thereto,
included elsewhere in this prospectus supplement, Selected
Consolidated Financial Information and
Managements Discussion and Analysis of Financial
Condition and Results of Operations.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year
ended December 31,
|
|
Statement of
operations data:
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
(in thousands,
except per share data and ratios)
|
|
|
Net product sales and services revenue
|
|
$
|
1,645,600
|
|
|
$
|
817,561
|
|
|
$
|
552,130
|
|
License and royalty revenue
|
|
|
25,826
|
|
|
|
21,979
|
|
|
|
17,324
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue
|
|
|
1,671,426
|
|
|
|
839,540
|
|
|
|
569,454
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of net revenue
|
|
|
810,867
|
|
|
|
445,813
|
|
|
|
340,231
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
860,559
|
|
|
|
393,727
|
|
|
|
229,223
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
111,828
|
|
|
|
69,547
|
|
|
|
48,706
|
|
Purchase of in-process research and development
|
|
|
|
|
|
|
173,825
|
|
|
|
4,960
|
|
Selling, general and administrative
|
|
|
684,879
|
|
|
|
326,208
|
|
|
|
165,688
|
|
Loss on dispositions, net
|
|
|
|
|
|
|
|
|
|
|
3,498
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss)
|
|
|
63,852
|
|
|
|
(175,853
|
)
|
|
|
6,371
|
|
Interest expense and other expenses, net, including amortization
of original issue discounts and write-off of deferred financing
costs
|
|
|
(103,356
|
)
|
|
|
(74,251
|
)
|
|
|
(17,822
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before (benefit) provision for income taxes
|
|
|
(39,504
|
)
|
|
|
(250,104
|
)
|
|
|
(11,451
|
)
|
(Benefit) provision for income taxes
|
|
|
(16,686
|
)
|
|
|
(979
|
)
|
|
|
5,727
|
|
Equity earnings of unconsolidated entities, net of tax
|
|
|
1,050
|
|
|
|
4,372
|
|
|
|
336
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(21,768
|
)
|
|
|
(244,753
|
)
|
|
|
(16,842
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other financial
data(1)(2):
|
|
|
|
|
|
|
|
|
|
|
|
|
Ratio of earnings to fixed charges
|
|
|
0.7
|
x
|
|
|
|
|
|
|
0.6
|
x
|
Ratio of earnings to combined fixed charges and preference
dividends
|
|
|
0.5
|
x
|
|
|
|
|
|
|
0.6
|
x
|
|
(footnotes on following page)
|
S-8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
Balance sheet
data:
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
(in
thousands)
|
|
|
Cash and cash equivalents
|
|
$
|
141,324
|
|
|
$
|
414,732
|
|
|
$
|
71,104
|
|
Working capital
|
|
$
|
457,198
|
|
|
$
|
674,066
|
|
|
$
|
133,313
|
|
Total assets
|
|
$
|
5,955,360
|
|
|
$
|
4,880,759
|
|
|
$
|
1,085,771
|
|
Total debt
|
|
$
|
1,520,534
|
|
|
$
|
1,387,849
|
|
|
$
|
202,976
|
|
Total stockholders equity
|
|
$
|
3,278,838
|
|
|
$
|
2,586,667
|
|
|
$
|
714,138
|
|
|
|
|
(1) |
|
For the purpose of computing our ratio of earnings to fixed
charges, earnings consist of pre-tax income before
adjustment for income from equity investees plus fixed charges
(excluding capitalized interest). Fixed charges
consist of interest expensed and capitalized, amortized
premiums, discounts and capitalized expenses related to
indebtedness and an estimate of the interest within rental
expense. This ratio is adjusted to include preference dividends
in the ratio of earnings to combined fixed charges and
preference dividends. Preference dividends equal the
amount of pre-tax earnings that is required to pay the dividends
on outstanding preference securities. |
|
(2) |
|
Due to the net losses for the years ended December 31,
2008, 2007 and 2006, there were insufficient earnings of
$38.1 million, $248.9 million and $11.8 million,
respectively, to cover fixed charges and $61.4 million,
$248.9 million and $11.8 million, respectively, to
cover fixed charges and preference dividends. |
OTHER FINANCIAL
INFORMATION
This section presents additional financial information relevant
to our ability to meet our debt service obligations, including
our ratio of earnings to fixed charges, information from our
statement of cash flows, and a presentation of our
Adjusted EBITDA. EBITDA represents net income (loss)
before interest, income taxes, depreciation and amortization.
Our Adjusted EBITDA represents EBITDA plus:
|
|
Ø
|
non-cash stock-based compensation;
|
|
Ø
|
the amortization of inventory
write-ups
related to acquisitions;
|
|
Ø
|
net realized non-cash foreign exchange losses on the settlement
of certain inter-company transactions; and
|
|
Ø
|
charges for purchased in-process research and development.
|
For an explanation of these items, please see notes 17
(regarding stock-based compensation), 2(b) (regarding foreign
exchange losses) and 14 (regarding in-process research and
development) of the notes to our audited consolidated financial
statements included elsewhere in this prospectus supplement and
the discussion of inventory
write-ups
related to our acquisitions in Managements
Discussion and Analysis of Financial Condition and Results of
Operations.
Adjusted EBITDA is presented because we believe that it provides
useful information to investors relevant to our ability to meet
our requirements for debt service, capital expenditures and
working capital. We believe that EBITDA, with and without
adjustments, is widely used by investors, analysts and ratings
agencies in valuation, comparison, rating and investment
recommendations and decisions regarding companies in our
industry. Our management also evaluates the performance of our
businesses using Adjusted EBITDA measures. Adjusted EBITDA is
not a measurement of financial performance under GAAP and should
not be considered as an alternative to cash flow from operating
activities or net income, as a measure of liquidity or as an
indicator of operating performance or any measure of performance
derived in accordance with GAAP. Our calculation of Adjusted
EBITDA is different from the calculations that may be used by
other companies and, accordingly, comparability may be limited.
In addition, our calculation of Adjusted EBITDA is different
than that used in the covenants concerning our secured credit
facilities and the definition of consolidated cash flow used in
the indenture governing the notes.
S-9
Information for the twelve months ended March 31, 2009 was
prepared by subtracting information for the three months ended
March 31, 2008 from the information for the year ended
December 31, 2008 and by adding information for the three
months ended March 31, 2009, in accordance with GAAP.
This table does not present any information relating to our
recently completed acquisition of ACON, which is described in
more detail above.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve months
|
|
|
|
|
|
|
|
|
|
ended
|
|
|
|
Year ended
December 31,
|
|
|
March 31,
|
|
|
|
2007
|
|
|
2008
|
|
|
2009
|
|
|
|
|
|
|
|
(in thousands,
except ratios)
|
|
|
Net cash provided by operating activities
|
|
$
|
88,755
|
|
|
$
|
147,844
|
|
|
$
|
170,979
|
|
Net cash used in investing activities
|
|
$
|
(1,786,530
|
)
|
|
$
|
(713,332
|
)
|
|
$
|
(519,855
|
)
|
Net cash provided by financing activities
|
|
$
|
2,032,384
|
|
|
$
|
297,769
|
|
|
$
|
153,464
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Computation of Adjusted EBITDA:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss (GAAP)
|
|
$
|
(244,753
|
)
|
|
$
|
(21,768
|
)
|
|
$
|
(11,303
|
)
|
Income tax benefit
|
|
|
(979
|
)
|
|
|
(16,686
|
)
|
|
|
(12,117
|
)
|
Depreciation and amortization
|
|
|
92,886
|
|
|
|
266,855
|
|
|
|
286,553
|
|
Interest, net
|
|
|
71,539
|
|
|
|
94,426
|
|
|
|
90,173
|
|
Non-cash stock-based compensation
|
|
|
57,463
|
|
|
|
26,405
|
|
|
|
26,724
|
|
Amortization of inventory
write-up
related to acquisitions
|
|
|
8,227
|
|
|
|
2,021
|
|
|
|
313
|
|
Net realized non-cash foreign exchange loss
|
|
|
1,999
|
|
|
|
1,691
|
|
|
|
|
|
Charge for purchased in-process research and development
|
|
|
173,825
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted
EBITDA(1)(2)
|
|
$
|
160,207
|
|
|
$
|
352,944
|
|
|
$
|
380,343
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Net loss (GAAP) includes non-interest related restructuring
charges of $6.7 million, $43.7 million and
$34.7 million for the years ended December 31, 2007
and 2008 and the twelve months ended March 31, 2009,
respectively, which have not been added back for purposes of
computing Adjusted EBITDA. Net loss (GAAP) for the twelve months
ended March 31, 2009 also includes a charge of
$4.7 million associated with the expensing of certain
acquisition-related costs in connection with the adoption of
SFAS No. 141-R,
effective January 1, 2009, which also has not been added
back for purposes of computing Adjusted EBITDA. |
(footnotes continued on following page)
S-10
|
|
|
(2) |
|
The information in the foregoing table does not reflect any
information for Matria Healthcare, Inc., or Matria, prior
to the date of its acquisition on May 9, 2008. Matria is a
provider of comprehensive, integrated health management services
particularly in the areas of womens and childrens
health, cardiology and oncology. Adjusted EBITDA for Matria for
certain periods ending on or before May 8, 2008 is computed
as indicated in the following table. For the three months ended
March 31, 2008, Matrias net cash provided by
operating activities was $7.3 million, its net cash used in
investing activities was $3.4 million and its net cash used
in financing activities was $319,000. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period from
|
|
|
Period from
|
|
|
|
Three months
|
|
|
April 1,
2008
|
|
|
January 1,
2008
|
|
|
|
ended
March 31,
|
|
|
to May 8,
|
|
|
to May 8,
|
|
Matria financial
information:
|
|
2008
|
|
|
2008
|
|
|
2008
|
|
|
|
|
Matria net income from continuing operations (GAAP)
|
|
$
|
224
|
|
|
$
|
(22,334
|
)
|
|
$
|
(22,110
|
)
|
Income tax provision
|
|
|
162
|
|
|
|
(10,195
|
)
|
|
|
(10,033
|
)
|
Depreciation and amortization
|
|
|
5,387
|
|
|
|
2,304
|
|
|
|
7,691
|
|
Interest, net
|
|
|
4,883
|
|
|
|
15,321
|
|
|
|
20,204
|
|
Non-cash stock-based compensation
|
|
|
1,839
|
|
|
|
7,749
|
|
|
|
9,588
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Matria Adjusted
EBITDA(3)
|
|
$
|
12,495
|
|
|
$
|
(7,155
|
)
|
|
$
|
5,340
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3) |
|
Matria net income from continuing operations (GAAP) includes
restructuring charges and expenses related to our acquisition of
Matria of $3.5 million and $12.0 million for the three
months ended March 31, 2008 and the period from
April 1, 2008 to May 8, 2008, respectively, which have
not been added back for purposes of computing Adjusted EBITDA
for Matria. |
S-11
You should carefully consider the following risk factors as
well as the other information contained or incorporated by
reference in this prospectus supplement and the accompanying
prospectus before deciding to invest in the notes. The
occurrence of any of the events or actions described in the
following risk factors may have a material adverse effect on our
business or financial performance. This prospectus supplement
and the accompanying prospectus contain or incorporate
statements that constitute forward-looking statements regarding,
among other matters, our intentions, beliefs or current
expectations about our business. These forward-looking
statements are subject to risks, uncertainties and assumptions,
as further described in the section entitled Special Note
Regarding Forward-Looking Statements.
RISKS RELATED TO
OUR BUSINESS
Disruptions in
the capital and credit markets related to the current national
and worldwide financial crisis, which may continue indefinitely
or intensify, could adversely affect our results of operations,
cash flows and financial condition, or those of our customers
and suppliers.
The current disruptions in the capital and credit markets may
continue indefinitely or intensify, and adversely impact our
results of operations, cash flows and financial condition, or
those of our customers and suppliers. These disruptions could
adversely affect our ability to draw on our bank revolving
credit facility, which is dependent on the ability of the banks
that are parties to the facility to meet their funding
commitments. Those banks may not be able to meet their funding
commitments to us if they experience shortages of capital and
liquidity. Disruptions in the capital and credit markets as a
result of uncertainty, changing or increased regulation, reduced
alternatives or failures of significant financial institutions
could adversely affect our access to liquidity needed to conduct
or expand our businesses or conduct acquisitions or make other
discretionary investments, as well as our ability to effectively
hedge our currency or interest rate. Such disruptions may also
adversely impact the capital needs of our customers and
suppliers, which, in turn, could adversely affect our results of
operations, cash flows and financial condition.
Our business has
substantial indebtedness, which could, among other things, make
it more difficult for us to satisfy our debt obligations,
require us to use a large portion of our cash flow from
operations to repay and service our debt or otherwise create
liquidity problems, limit our flexibility to adjust to market
conditions, place us at a competitive disadvantage and expose us
to interest rate fluctuations.
We currently have, and will likely continue to have, a
substantial amount of indebtedness. The issuance of the notes
will add significantly to our indebtedness. As of
December 31, 2008, we had total debt outstanding of
approximately $1.5 billion, which included approximately
$1.1 billion in aggregate principal amount of indebtedness
outstanding under our senior secured credit facility,
$250.0 million in aggregate principal amount of
indebtedness outstanding under our junior secured credit
facility, which we refer to, together with the senior secured
credit facility, as our secured credit facilities, and
$150.0 million in indebtedness under our outstanding senior
subordinated convertible notes.
Our substantial indebtedness could affect our future operations
in important ways. For example, it could:
|
|
Ø
|
make it more difficult to satisfy our obligations under the
notes, the senior subordinated convertible notes, our secured
credit facilities and our other debt-related instruments;
|
|
Ø
|
require us to use a large portion of our cash flow from
operations to pay principal and interest on our indebtedness,
which would reduce the amount of cash available to finance our
operations and service obligations, to delay or reduce capital
expenditures or the introduction of new products
and/or
forego business opportunities, including acquisitions, research
and development projects or product design enhancements;
|
S-12
Risk
factors
|
|
Ø
|
limit our flexibility to adjust to market conditions, leaving us
vulnerable in a downturn in general economic conditions or in
our business and less able to plan for, or react to, changes in
our business and the industries in which we operate;
|
|
Ø
|
impair our ability to obtain additional financing;
|
|
Ø
|
place us at a competitive disadvantage compared to our
competitors that have less debt; and
|
|
Ø
|
expose us to fluctuations in the interest rate environment with
respect to our indebtedness that bears interest at variable
rates.
|
We expect to obtain the money to pay our expenses and to pay the
principal and interest on the notes, the senior subordinated
convertible notes, our secured credit facilities and our other
debt from cash flow from our operations and potentially from
other debt or equity offerings. Accordingly, our ability to meet
our obligations depends on our future performance, which will be
affected by financial, business, economic and other factors. We
will not be able to control many of these factors, such as
economic conditions in the markets in which we operate and
pressure from competitors. We cannot be certain that our cash
flow will be sufficient to allow us to pay principal and
interest on our debt, including the notes, and meet our other
obligations. If our cash flow and capital resources prove
inadequate, we could face substantial liquidity problems and
might be required to dispose of material assets or operations,
restructure or refinance our debt, including the notes, seek
additional equity capital or borrow more money. We cannot
guarantee that we will be able to do so on acceptable terms. In
addition, the terms of existing or future debt agreements,
including the indenture governing the notes, the credit
agreements governing our secured credit facilities and the
indenture governing the senior subordinated convertible notes,
may restrict us from adopting any of these alternatives.
The agreements
governing our indebtedness subject us to various restrictions
that may limit our ability to pursue business
opportunities.
The agreements governing our indebtedness, including the credit
agreements governing our secured credit facilities and the
indentures governing the notes and the senior subordinated
convertible notes, subject us to various restrictions on our
ability to engage in certain activities, including, among other
things, our ability to:
|
|
Ø
|
incur additional debt;
|
|
Ø
|
pay dividends or make distributions or repurchase or redeem our
stock or subordinated debt;
|
|
Ø
|
acquire other businesses;
|
|
Ø
|
make investments;
|
|
Ø
|
make loans to or extend credit for the benefit of third parties
or their subsidiaries;
|
|
Ø
|
prepay indebtedness;
|
|
Ø
|
enter into transactions with affiliates;
|
|
Ø
|
raise additional capital;
|
|
Ø
|
make capital or finance lease expenditures;
|
|
Ø
|
dispose of or encumber assets; and
|
|
Ø
|
consolidate, merge or sell all or substantially all of our
assets.
|
These restrictions may limit or restrict our cash flow and our
ability to pursue business opportunities or strategies that we
would otherwise consider to be in our best interests.
S-13
Risk
factors
Our secured
credit facilities contain certain financial covenants that we
may not satisfy, which, if not satisfied, could result in the
acceleration of the amounts due under our secured credit
facilities and the limitation of our ability to borrow
additional funds in the future.
The agreements governing our secured credit facilities subject
us to various financial and other restrictive covenants with
which we must comply on an on-going or periodic basis. These
include covenants pertaining to maximum consolidated leverage
ratios, minimum consolidated interest coverage ratios and limits
on capital expenditures. If we violate any of these covenants,
we may suffer a material adverse effect. Most notably, our
outstanding debt under our secured credit facilities could
become immediately due and payable, our lenders could proceed
against any collateral securing such indebtedness and our
ability to borrow additional funds in the future may be limited.
Alternatively, we could be forced to refinance or renegotiate
the terms and conditions of our secured credit facilities,
including the interest rates, financial and restrictive
covenants and security requirements of the secured credit
facilities, on terms that may be significantly less favorable to
us.
Our acquisitions
may not be profitable, and the integration of these businesses
may be costly and difficult and may cause disruption to our
business.
Since commencing activities in November 2001, we have acquired
and integrated into our operations numerous businesses. Since
the beginning of 2006, we have acquired and integrated, or are
in the process of integrating, the ACON second territory
business; the ACON first territory business; Instant
Technologies, Inc., or Instant; Biosite Incorporated, or
Biosite; Cholestech Corporation, or Cholestech; HemoSense, Inc.,
or HemoSense; Alere Medical, Inc., or Alere Medical; Redwood
Toxicology Laboratory, Inc., or Redwood; ParadigmHealth, Inc.,
or ParadigmHealth; Panbio Limited, or Panbio; BBI Holdings Plc,
or BBI; and Matria Healthcare, Inc., or Matria. We have also
made a number of smaller acquisitions. The ultimate success of
all of these acquisitions depends, in part, on our ability to
realize the anticipated synergies, cost savings and growth
opportunities from integrating these businesses or assets into
our existing businesses. However, the successful integration of
independent businesses or assets is a complex, costly and
time-consuming process. The difficulties of integrating
companies and acquired assets include, among others:
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consolidating manufacturing, research and development operations
and health management information technology platforms, where
appropriate;
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integrating newly-acquired businesses or product lines into a
uniform financial reporting system;
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coordinating sales, distribution and marketing functions and
strategies, including the integration of our current health
management products and services;
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establishing or expanding manufacturing, sales, distribution and
marketing functions in order to accommodate newly-acquired
businesses or product lines or rationalizing these functions to
take advantage of synergies;
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preserving the important licensing, research and development,
manufacturing and supply, distribution, marketing, customer and
other relationships;
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minimizing the diversion of managements attention from
on-going business concerns; and
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coordinating geographically separate organizations.
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We may not accomplish the integration of our acquisitions
smoothly or successfully. The diversion of the attention of our
management from current operations to integration efforts and
any difficulties encountered in combining operations could
prevent us from realizing the full benefits anticipated to
result from these acquisitions and adversely affect our other
businesses. Additionally, the costs associated with the
integration of our acquisitions may be substantial. To the
extent that we incur integration costs that are not anticipated
when we finance our acquisitions, these unexpected costs could
adversely impact our liquidity or force us to borrow additional
funds. Ultimately, the value of any business or asset that we
have acquired may not be greater than or equal to the purchase
price of that business or asset.
S-14
Risk
factors
If we choose to
acquire or invest in new and complementary businesses, products
or technologies rather than developing them internally, such
acquisitions or investments could disrupt our business and,
depending on how we finance these acquisitions or investments,
could result in the use of significant amounts of
cash.
Our success depends in part on our ability to continually
enhance and broaden our product offerings in response to
changing technologies, customer demands and competitive
pressures. Accordingly, from time to time, we may seek to
acquire or invest in businesses, products or technologies
instead of developing them internally. Acquisitions and
investments involve numerous risks, including:
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the inability to complete the acquisition or investment;
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disruption of our on-going businesses and diversion of
management attention;
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difficulties in integrating the acquired entities, products or
technologies;
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difficulties in operating the acquired business profitably;
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difficulties in transitioning key customer, distributor and
supplier relationships;
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risks associated with entering markets in which we have no, or
limited, prior experience; and
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unanticipated costs.
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In addition, any future acquisitions or investments may result
in:
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issuances of dilutive equity securities, which may be sold at a
discount to market price;
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use of significant amounts of cash;
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the incurrence of debt;
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the assumption of significant liabilities, including litigation;
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unfavorable financing terms;
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large one-time expenses; and
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the creation of intangible assets, including goodwill, the
write-down of which may result in significant charges to
earnings.
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Our joint venture
transaction with P&G may not realize all of its intended
benefits.
In connection with SPD, our 50/50 joint venture with P&G,
we may experience:
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difficulties in integrating our corporate culture and business
objectives with that of P&G into the joint venture;
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difficulties or delays in transitioning clinical studies;
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diversion of our managements time and attention from other
business concerns;
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higher than anticipated costs of integration at the joint
venture;
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difficulties in retaining key employees who are necessary to
manage the joint venture; or
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difficulties in working with an entity based in Switzerland and
thus remote or inconvenient to our Waltham, Massachusetts
headquarters.
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Moreover, because SPD is a 50/50 joint venture, we do not have
complete control over its operations, including business
decisions which may impact SPDs profitability.
S-15
Risk
factors
For any of these reasons, or as a result of other factors, we
may not realize the anticipated benefits of the joint venture
and cash flow or profits derived from our ownership interest in
SPD may be less than the cash flow or profits that could have
been derived had we retained the transferred assets and
continued to operate the consumer diagnostics business
ourselves. P&G retains an option to require us to purchase
P&Gs interest in SPD at fair market value during the
60-day
period beginning on May 17, 2011. Moreover, certain
subsidiaries of P&G have the right, at any time upon
certain material breaches by us or our subsidiaries of our
obligations under the joint venture documents, to acquire all of
our interest in the joint venture at fair market value less
damages.
We may not be
successful in conducting future joint venture
transactions.
In addition to SPD, our
50/50 joint
venture with P&G, we may enter into additional joint
venture transactions in the future. We may experience
unanticipated difficulties in connection with those joint
venture transactions. We cannot assure you that any such joint
venture transaction will be profitable or that we will receive
any of the intended benefits of such a transaction.
If goodwill
and/or other intangible assets that we have recorded in
connection with our acquisitions of other businesses become
impaired, we could have to take significant charges against
earnings.
In connection with the accounting for our acquisitions we have
recorded, or will record, a significant amount of goodwill and
other intangible assets. Under current accounting guidelines, we
must assess, at least annually and potentially more frequently,
whether the value of goodwill and other intangible assets has
been impaired. Any reduction or impairment of the value of
goodwill or other intangible assets will result in a charge
against earnings which could materially adversely affect our
reported results of operations in future periods.
We may experience
manufacturing problems or delays due to, among other reasons,
our volume, specialized processes or our Chinese operations,
which could result in decreased revenue or increased
costs.
Many of our manufacturing processes are complex and require
specialized and expensive equipment. Replacement parts for our
specialized equipment can be expensive and, in some cases, can
require lead times of up to a year to acquire. In addition, our
private label consumer diagnostics business, and our private
label and bulk nutritional supplements business in particular,
rely on operational efficiency to mass produce products at low
margins per unit. We also rely on numerous third parties to
supply production materials and, in some cases, there may not be
alternative sources immediately available.
In addition, during 2008, we began the process of closing the
manufacturing operations that we acquired with Cholestech, and
shifting the production of products from these facilities to our
San Diego campus. We also began the process of closing our
manufacturing facility in Bedford, England, and shifting the
production of units manufactured there to China and to other
lower-cost facilities. We have previously shifted the production
of other products to our manufacturing facilities in China.
Moving the production of products is difficult and involves
significant risk. Problems establishing relationships with local
materials suppliers; acquiring or adapting the new facility and
its equipment to the production of new products; hiring,
training and retaining personnel; and establishing and
maintaining compliance with governmental regulations and
industry standards can cause delays and inefficiencies which
could have a material negative impact on our financial
performance. We also currently rely on a number of significant
third-party manufacturers to produce certain of our professional
diagnostics. Any event which negatively impacts our
manufacturing facilities, our manufacturing systems or
equipment, or our contract manufacturers or suppliers,
including, among others, wars, terrorist activities, natural
disasters and outbreaks of infectious disease, could delay or
suspend shipments of products or the release of new products or
could result in the delivery of inferior products. Our revenues
from the affected products would decline or we could incur
losses until such time as it is able to restore its production
processes or put in place alternative contract manufacturers or
suppliers.
S-16
Risk
factors
Even though we carry business interruption insurance policies,
we may suffer losses as a result of business interruptions that
exceed the coverage available under our insurance policies.
We may experience
difficulties that may delay or prevent our development,
introduction or marketing of new or enhanced products or
services.
We intend to continue to invest in product and technology
development. The development of new or enhanced products or
services is a complex and uncertain process. We may experience
research and development, manufacturing, marketing and other
difficulties that could delay or prevent our development,
introduction or marketing of new products, services or
enhancements. We cannot be certain that:
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any of the products or services under development will prove to
be effective in clinical trials;
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any products or services under development will not infringe on
intellectual property rights of others;
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we will be able to obtain, in a timely manner or at all,
regulatory approval to market any of our products or services
that are in development or contemplated;
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the products and services we develop can be manufactured or
provided at acceptable cost and with appropriate quality; or
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these products and services, if and when approved, can be
successfully marketed.
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The factors listed above, as well as manufacturing or
distribution problems, or other factors beyond our control,
could delay new product or service launches. In addition, we
cannot assure you that the market will accept these products and
services. Accordingly, there is no assurance that our overall
revenue will increase if and when new products or services are
launched.
If the results of
clinical studies required to gain regulatory approval to sell
our products are not available when expected or do not
demonstrate the anticipated safety and effectiveness of those
potential products, we may not be able to sell future products
and our sales could be adversely affected.
Before we can sell certain of our products, we must conduct
clinical studies intended to demonstrate that our potential
products are safe, effective, and perform as expected. The
results of these clinical studies are used as the basis to
obtain regulatory approval from government authorities such as
the Food and Drug Administration, or FDA. Clinical studies are
experiments conducted using potential products and human
patients having the diseases or medical conditions that the
product is trying to evaluate or diagnose. Conducting clinical
studies is a complex, time-consuming and expensive process. In
some cases, we may spend several years completing certain
studies.
If we fail to adequately manage our clinical studies, those
clinical studies and corresponding regulatory approvals may be
delayed or we may fail to gain approval for our potential
product candidates altogether. Even if we successfully manage
our clinical studies, we may not obtain favorable results and
may not be able to obtain regulatory approval. If we are unable
to market and sell our new products or are unable to obtain
approvals in the timeframe needed to execute our product
strategies, our business and results of operations would be
materially and adversely affected.
If we are unable
to obtain required clearances or approvals for the
commercialization of our products in the United States, we may
not be able to sell future products and our sales could be
adversely affected.
Our future performance depends on, among other matters, our
estimates as to when and at what cost we will receive regulatory
approval for new products. Regulatory approval can be a lengthy,
expensive and uncertain process, making the timing, cost and
ability to obtain approvals difficult to predict. In addition,
regulatory processes are subject to change, and new or changed
regulations can result in increased costs and unanticipated
delays.
S-17
Risk
factors
In the United States, clearance or approval to commercially
distribute new medical devices is received from the FDA through
clearance of a Premarket Notification, or 510(k), or through
approval of a Premarket Approval, or PMA. To receive 510(k)
clearance, a new product must be substantially equivalent to a
medical device first marketed in interstate commerce prior to
May 1976. The FDA may determine that a new product is not
substantially equivalent to a device first marketed in
interstate commerce prior to May 1976 or that additional
information is needed before a substantial equivalence
determination can be made. A not substantially
equivalent determination, or a request for additional
information, could prevent or delay the market introduction of
new products that fall into this category. The 510(k) clearance
and PMA review processes can be expensive, uncertain and
lengthy. It generally takes from three to five months from
submission to obtain 510(k) clearance, and from six to eighteen
months from submission to obtain a PMA approval; however, it may
take longer, and 510(k) clearance or PMA approval may never be
obtained.
Modifications or enhancements that could significantly affect
safety or effectiveness, or constitute a major change in the
intended use of the device, require new 510(k) or PMA
submissions. We have made modifications to some of our products
since receipt of initial 510(k) clearance or PMA. With respect
to several of these modifications, we filed new 510(k)s
describing the modifications and received FDA 510(k) clearance.
We have made other modifications to some of our products that we
believe do not require the submission of new 510(k)s or PMAs.
The FDA may not agree with any of our determinations not to
submit a new 510(k) or PMA for any of these modifications made
to our products. If the FDA requires us to submit a new 510(k)
or PMA for any device modification, we may be prohibited from
marketing the modified products until the new submission is
cleared by the FDA.
We are also
subject to applicable regulatory approval requirements of the
foreign countries in which we sell products, which are costly
and may prevent or delay us from marketing our products in those
countries.
In addition to regulatory requirements in the United States, we
are subject to the regulatory approval requirements for each
foreign country to which we export our products. In the European
Union, regulatory compliance requires affixing the
CE mark to product labeling. Although our products
are currently eligible for CE marking through
self-certification, this process can be lengthy and expensive.
In Canada, as another example, our products require approval by
Health Canada prior to commercialization, along with
International Standards Organization, or ISO, 13485/CMDCAS
certification. It generally takes from three to six months from
submission to obtain a Canadian Device License. Any changes in
foreign approval requirements and processes may cause us to
incur additional costs or lengthen review times of our products.
We may not be able to obtain foreign regulatory approvals on a
timely basis, if at all, and any failure to do so may cause us
to incur additional costs or prevent us from marketing our
products in foreign countries, which may have a material adverse
effect on our business, financial condition and results of
operations.
Failure to comply
with on-going regulations applicable to our businesses may
result in significant costs or, in certain circumstances, the
suspension or withdrawal of previously obtained clearances or
approvals.
Our businesses are extensively regulated by the FDA and other
federal, state and foreign regulatory agencies. These
regulations impact many aspects of our operations, including
manufacturing, labeling, packaging, adverse event reporting,
storage, advertising, promotion and record keeping. For example,
our manufacturing facilities and those of our suppliers and
distributors are, or can be, subject to periodic regulatory
inspections. The FDA and foreign regulatory agencies may require
post-marketing testing and surveillance to monitor the effects
of approved products or place conditions on any product
approvals that could restrict the commercial applications of
those products. In addition, the subsequent discovery of
previously unknown problems with a product may result in
restrictions on the product, including withdrawal of the product
from the market. We are also subject to routine inspection by
the FDA and certain state agencies for compliance with the
Quality System Regulation and Medical Device Reporting
requirements in the United States and other applicable
S-18
Risk
factors
regulations worldwide, including but not limited to ISO
requirements. Certain portions of our health management business
are subject to unique licensing or permit requirements. For
example, we may be required to obtain certification to
participate in governmental payment programs, such as state
Medicaid programs, we may need an operating license in some
states, and some states have established Certificate of Need
programs regulating the expansion of healthcare operations. In
addition, we believe certain of our health management services
are educational in nature, do not constitute the practice of
medicine or provision of healthcare, and thus do not require
that we maintain federal or state licenses to provide such
services. However, it is possible that federal or state laws
regarding the provision of virtual or telephonic
medicine could be revised or interpreted to include our
services, or that other laws may be enacted which require
licensure or otherwise relate to our health management services.
In such event, we may incur significant costs to comply with
such laws and regulations. In addition, we are subject to
numerous federal, state and local laws relating to such matters
as privacy, healthcare kickbacks and false claims, safe working
conditions, manufacturing practices, environmental protection,
fire hazard control and disposal of hazardous or potentially
hazardous substances. We may incur significant costs to comply
with these laws and regulations. If we fail to comply with
applicable regulatory requirements, we may be subject to fines,
suspension or withdrawal of regulatory approvals, product
recalls, seizure of products or injunctions against our
distribution, termination of our service agreements by our
customers, disgorgement of money, operating restrictions and
criminal prosecution.
New federal or state laws may be enacted, or regulatory agencies
may also impose new or enhanced standards that would increase
our costs as well as the risks associated with non-compliance.
For example, our manufacturing facilities for nutritional
supplements will be subject to new Good Manufacturing Practices,
or GMP, standards starting mid-2009. While our manufacturing
facilities for nutritional supplements have been subjected to,
and passed, third-party inspections assessing GMP compliance,
the on-going compliance required in order to meet GMP standards
could involve additional costs and could present new risks
associated with any failure to comply with the regulations in
the future. In addition, the federal government recently enacted
the Genetic Information Non-discrimination Act of 2008 (GINA),
and we may incur additional costs in assisting our customers
with their efforts to comply with GINA while continuing to offer
certain of our services.
Healthcare reform
legislation could adversely affect our revenue and financial
condition.
In recent years, there have been numerous initiatives on the
federal and state levels for comprehensive reforms affecting the
payment for, the availability of and reimbursement for
healthcare services in the United States. These initiatives have
ranged from proposals to fundamentally change federal and state
healthcare reimbursement programs, including providing
comprehensive healthcare coverage to the public under
governmental funded programs, to minor modifications to existing
programs. In particular, federal legislation has reduced or
significantly altered Medicare and Medicaid reimbursements.
Legislative and regulatory bodies are likely to continue to
pursue healthcare reform initiatives and may continue to reduce
the funding of the Medicare and Medicaid programs, including
Medicare Advantage, in an effort to reduce overall federal
healthcare spending. The ultimate content or timing of any
future healthcare reform legislation, and its impact on us, is
impossible to predict. If significant reforms are made to the
healthcare system in the United States, or in other
jurisdictions, those reforms may have an adverse effect on our
financial condition and results of operations.
If we deliver
products with defects, our credibility may be harmed, market
acceptance of our products may decrease and we may be exposed to
liability in excess of our product liability insurance
coverage.
The manufacturing and marketing of professional and consumer
diagnostics involve an inherent risk of product liability
claims. For example, a defect in one of our diagnostic products
may cause the product to report inaccurate information, such as
a false positive result, a false negative result or an error
message. In addition, our product development and production are
extremely complex and could expose
S-19
Risk
factors
our products to defects. Any defects could harm our credibility
and decrease market acceptance of our products. In addition, our
marketing of monitoring services and vitamins and nutritional
supplements may cause us to be subjected to various product
liability claims, including, among others, claims that
inaccurate monitoring results lead to injury or death or that
the vitamins and nutritional supplements have inadequate
warnings concerning side effects and interactions with other
substances. Potential product liability claims may exceed the
amount of our insurance coverage or may be excluded from
coverage under the terms of the policy. In the event that we are
held liable for a claim for which we are not indemnified, or for
damages exceeding the limits of our insurance coverage, that
claim could materially damage our business and financial
condition.
The effect of
market saturation may negatively affect the sales of our
products, including our Triage BNP tests.
Our meter-based Triage BNP test, launched domestically in
January 2001, was the first blood test available to aid in the
detection of heart failure and benefited from a first-to-market
position until the entry of direct competition in June 2003. As
the acute care and initial diagnosis market segment for BNP
testing in the U.S. hospital setting becomes saturated,
unless we are able to successfully introduce new products into
the market and achieve market acceptance of those products in a
timely manner, we expect the growth rates of sales unit volume
for our Triage BNP tests in 2009 and future periods to be lower
than the growth rates experienced over the past several years.
In addition, as the market for BNP testing matures and more
competitive products become available, the average sales price
for the Triage BNP tests is likely to decline, which will
adversely impact our product sales, gross margins and our
overall financial results.
The health
management business is a relatively new component of the overall
healthcare industry.
The health management services provided by our Alere health
management business and our subsidiary Quality Assured Services,
Inc., or QAS, are relatively new components of the overall
healthcare industry. Accordingly, our health management
customers have not had significant experience in purchasing,
evaluating or monitoring such services, which can result in a
lengthy sales cycle. The success of our health management
business depends on a number of factors. These factors include:
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our ability to differentiate our health management services from
those of our competitors;
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the extent and timing of the acceptance of our services as a
replacement for, or supplement to, traditional managed care
offerings;
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the effectiveness of our sales and marketing and engagement
efforts with customers and their health plan participants;
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our ability to sell and implement new and additional services
beneficial to health plans and employers and their respective
participants or employees;
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our ability to achieve, measure and effectively communicate cost
savings for health plans and employers through the use of our
services; and
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our ability to retain health plan and employee accounts as
competition increases.
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Since the health management business is continually evolving, we
may not be able to anticipate and adapt to the developing
market. Moreover, we cannot predict with certainty the future
growth rate or the ultimate size of the market.
Increasing health
insurance premiums and co-pays may cause individuals to forgo
health insurance and avoid medical attention, either of which
may reduce demand for our products and services.
Health insurance premiums and co-pays have generally increased
in recent years. Increased premiums may cause individuals to
forgo health insurance, as well as medical attention. This may
reduce demand for our point-of-care diagnostic products and also
reduce the number of lives managed by our health management
S-20
Risk
factors
programs. Increased co-pays may cause insured individuals to
forgo medical attention thereby reducing demand for our
professional diagnostic tests, as well as revenues under certain
health management programs.
Our health
management business may be adversely affected by cost reduction
pressures among our customers.
Our customers continue to face cost reduction pressures that may
cause them to curtail their use of, or reimbursement for, health
management services, to negotiate reduced fees or other
concessions or to delay payment. In addition, the loss of jobs
due to the recent economic crisis may cause the number of lives
we manage to decrease. These financial pressures could have an
adverse impact on our business.
Rising
unemployment may negatively impact the collectibility of
uninsured accounts and patient due accounts and/or reduce total
health plan populations.
One of the primary collection risks of our health management
business accounts receivable relates to uninsured patient
accounts and patient accounts for which the primary insurance
carrier has paid the amounts covered by the applicable
agreement, but patient responsibility amounts (deductibles and
copayments) remain outstanding. As unemployment rates rise
nationally, these uninsured and patient due accounts could make
up a greater percentage of the health management business
accounts receivable. Deterioration in the collectibility of
these accounts could adversely affect the health management
business collection of accounts receivable, cash flows and
results of operations.
Additionally, certain of our health management contracts provide
reimbursement to us based on total relevant populations managed
by health plans. As unemployment rates rise, certain of our
revenues may be reduced under these contracts as managed lives
may decrease.
If we are unable
to retain and negotiate favorable contracts with managed care
plans, our revenues may be reduced.
The ability of our health management business to obtain
favorable contracts with health maintenance organizations,
preferred provider organizations and other managed care plans
significantly affects the revenues and operating results of our
health management business. The business future success
will depend, in part, on its ability to retain and renew its
managed care contracts and to enter into new managed care
contracts on terms favorable to us. If the health management
business is unable to retain and negotiate favorable contracts
with managed care plans, our revenues may be reduced.
A portion of our
health management fees are contingent upon
performance.
Some of our existing health management agreements contain
savings or other guarantees, which provide that our revenues, or
a portion of them, are contingent upon projected cost savings or
other quality performance measures related to our health
management programs. There is no guarantee that we will
accurately forecast cost savings and clinical outcome
improvements under our health management agreements or meet the
performance criteria necessary to recognize potential revenues
under the agreements. Additionally, untimely, incomplete or
inaccurate data from our customers, or flawed analysis of such
data, could have a material adverse impact on our ability to
recognize revenues.
If our costs of
providing health management services increase, we may not be
able to pass these cost increases on to our customers.
Many of our health management services are provided pursuant to
long-term contracts that we may not be able to re-negotiate. If
our costs increase, we may not be able to increase our prices,
which would adversely affect results of operations. Accordingly,
any increase in our costs could reduce our overall profit margin.
S-21
Risk
factors
Demands of
non-governmental payers may adversely affect our growth in
revenues.
Our ability to negotiate favorable contracts with
non-governmental payers, including managed care plans,
significantly affects the revenues and operating results of our
health management business. These non-governmental payers
increasingly are demanding discounted fee structures, and the
trend toward consolidation among non-governmental payers tends
to increase their bargaining power over fee structures.
Reductions in price increases or the amounts received from
managed care, commercial insurance or other payers could have a
material, adverse effect on the financial position and results
of operations of our health management business.
Our data
management and information technology systems are critical to
maintaining and growing our business.
Our businesses, and in particular our health management
business, are dependent on the effective use of information
technology and, consequently, technology failure or obsolescence
may negatively impact our businesses. In addition, data
acquisition, data quality control, data security, and data
analysis, which are a cornerstone of our health management
programs, are intense and complex processes subject to error.
Untimely, incomplete or inaccurate data, flawed analysis of such
data or our inability to properly integrate, implement and
update systems could have a material adverse impact on our
business and results of operations.
Our sales of
branded nutritional supplements have been trending downward
since 1998 due to the maturity of the market segments they serve
and the age of that product line, and we may experience further
declines in sales and/or profitability of those
products.
Our aggregate sales of all of our brand name nutritional
products, including, among others, Ferro-Sequels, Stresstabs,
Protegra, Posture, SoyCare, ALLBEE and Z-BEC, have declined each
year since 1998 through the year 2008, except in 2002 when they
increased slightly as compared to 2001. We believe that these
products have under-performed because they are, for the most
part, aging brands with limited brand recognition that face
increasing private label competition. The overall age of this
product line means that we are subject to future distribution
loss for under-performing brands, while its opportunities for
new distribution on the existing product lines are limited. As a
result, we do not expect significant sales growth of our
existing brand name nutritional products, and we may experience
further declines in overall sales of our brand name nutritional
products in the future.
Our sales of
specific vitamins and nutritional supplements could be
negatively affected by media attention or other news
developments that challenge the safety and effectiveness of
those specific vitamins and nutritional supplements.
Most growth in the vitamin and nutritional supplement industry
is attributed to new products that tend to generate greater
attention in the marketplace than do older products. Positive
media attention resulting from new scientific studies or
announcements can spur rapid growth in individual segments of
the market, and also affect individual brands. Conversely, news
that challenges individual segments or products can have a
negative impact on the industry overall, as well as on sales of
the challenged segments or products. Most of our vitamin and
nutritional supplement products serve well-established market
segments and, absent unforeseen new developments or trends, are
not expected to benefit from rapid growth. A few of our vitamin
and nutritional supplement products are newer products that are
more likely to be the subject of new scientific studies or
announcements, which could be either positive or negative. News
or other developments that challenge the safety or effectiveness
of these products could negatively affect the profitability of
our vitamin and nutritional supplements business.
S-22
Risk
factors
Because sales of
our private label nutritional supplements are generally made at
low margins, the profitability of these products may suffer
significantly as a result of relatively small increases in raw
material or other manufacturing costs.
Sales of our private label nutritional supplements, which for
the years ended December 31, 2008 and 2007 provided
approximately 6% and 7%, respectively, of our net product sales,
generate low profit margins. We rely on our ability to
efficiently mass produce nutritional supplements in order to
make meaningful profits from these products. Changes in raw
material or other manufacturing costs can drastically cut into
or eliminate the profits generated from the sale of a particular
product. For the most part, we do not have long-term supply
contracts for our required raw materials and, as a result, our
costs can increase with little notice. The private label
nutritional supplements business is also highly competitive,
such that our ability to raise prices as a result of increased
costs is limited. Customers generally purchase private label
products via purchase order, not through long-term contracts,
and they often purchase these products from the lowest bidder on
a product by product basis. The internet has enhanced price
competition among private label manufacturers through the advent
of on-line auctions, where customers will auction off the right
to manufacture a particular product to the lowest bidder.
Our financial
condition or results of operations may be adversely affected by
international business risks.
We generate a significant percentage of our net revenue from
outside the United States and a significant number of our
employees, including manufacturing, sales, support and research
and development personnel, are located in foreign countries,
including England, Scotland, Japan, China, Australia, Germany
and Israel. Conducting business outside the United States
subjects us to numerous risks, including:
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increased costs or reduced revenue as a result of movements in
foreign currency exchange rates;
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decreased liquidity resulting from longer accounts receivable
collection cycles typical of foreign countries;
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lower productivity resulting from difficulties managing sales,
support and research and development operations across many
countries;
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lost revenues resulting from difficulties associated with
enforcing agreements and collecting receivables through foreign
legal systems;
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lost revenues resulting from the imposition by foreign
governments of trade protection measures;
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higher cost of sales resulting from import or export licensing
requirements;
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lost revenues or other adverse effects as a result of economic
or political instability in or affecting foreign countries in
which we sell our products or operate; and
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adverse effects resulting from changes in foreign regulatory or
other laws affecting the sales of our products or our foreign
operations.
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Because our
business relies heavily on foreign operations and revenues,
changes in foreign currency exchange rates and our need to
convert currencies may negatively affect our financial condition
and results of operations.
Our business relies heavily on our foreign operations. Three of
our four largest manufacturing operations are conducted outside
the United States in Hangzhou and Shanghai, China; and Matsudo,
Japan, and we also have manufacturing operations in the United
Kingdom, Australia, South Africa and Israel. We also have
significant research and development operations in Jena, Germany
and Stirling, Scotland, as well as in the United Kingdom,
Australia and Israel. In addition, approximately 28% of our net
revenue was derived from sales outside the United States.
Because of our foreign operations and foreign sales, we face
exposure to movements in foreign currency exchange rates. Our
primary exposures are related to the operations of our European
and Asia Pacific subsidiaries and our manufacturing facilities
in China and Japan. These exposures
S-23
Risk
factors
may change over time as business practices evolve and could
result in increased costs or reduced revenue and could affect
our actual cash flow.
Intense
competition could reduce our market share or limit our ability
to increase market share, which could impair the sales of our
products and harm our financial performance.
The medical products industry is rapidly evolving, and
developments are expected to continue at a rapid pace.
Competition in this industry, which includes both our
professional diagnostics and consumer diagnostics businesses, is
intense and expected to increase as new products and
technologies become available and new competitors enter the
market. Our competitors in the United States and abroad are
numerous and include, among others, diagnostic testing and
medical products companies, universities and other research
institutions.
Our future success depends upon maintaining a competitive
position in the development of products and technologies in our
areas of focus. Our competitors may:
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develop technologies and products that are more effective than
our products or that render our technologies or products
obsolete or noncompetitive;
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obtain patent protection or other intellectual property rights
that would prevent us from developing potential products; or
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obtain regulatory approval for the commercialization of our
products more rapidly or effectively than we do.
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Also, the possibility of patent disputes with competitors
holding patent rights may limit or delay expansion possibilities
for our diagnostic businesses and new product launches. In
addition, many of our existing or potential competitors have or
may have substantially greater research and development
capabilities, clinical, manufacturing, regulatory and marketing
experience and financial and managerial resources.
The market for the sale of vitamins and nutritional supplements
is also highly competitive. This competition is based
principally upon price, quality of products, customer service
and marketing support. There are numerous companies in the
vitamins and nutritional supplements industry selling products
to retailers, such as mass merchandisers, drug store chains,
independent drug stores, supermarkets, groceries and health food
stores. As most of these companies are privately-held, we are
unable to obtain the information necessary to assess precisely
the size and success of these competitors. However, we believe
that a number of our competitors, particularly manufacturers of
nationally-advertised brand name products, are substantially
larger than we are and have greater financial resources.
We could suffer
monetary damages, incur substantial costs or be prevented from
using technologies important to our products as a result of a
number of pending legal proceedings.
We are involved in various legal proceedings arising out of our
businesses, including those matters discussed in the section
entitled BusinessLegal Proceedings. Because of
the nature of our business, we may be subject at any particular
time to commercial disputes, product liability claims,
negligence claims or various other lawsuits arising in the
ordinary course of our business, including infringement,
employment or investor matters, and we expect that this will
continue to be the case in the future. Such lawsuits generally
seek damages, sometimes in substantial amounts, for commercial
or personal injuries allegedly suffered and can include claims
for punitive or other special damages. An adverse ruling or
rulings in one or more such lawsuits could, individually or in
the aggregate, have a material adverse effect on our sales,
operations or financial performance. In addition, we
aggressively defend our patent and other intellectual property
rights. This often involves bringing infringement or other
commercial claims against third parties. These suits can be
expensive and result in counterclaims challenging the validity
of our patents and other rights. We cannot assure you that these
lawsuits or any future lawsuits relating to our business will
not have a material adverse effect on us.
S-24
Risk
factors
The rights we
rely upon to protect the intellectual property underlying our
products may not be adequate, which could enable third parties
to use our technology and would reduce our ability to compete in
the market.
Our success will depend in part on our ability to develop or
acquire commercially valuable patent rights and to protect our
intellectual property. Our patent position is generally
uncertain and involves complex legal and factual questions. The
degree of present and future protection for our proprietary
rights is uncertain.
The risks and uncertainties that we face with respect to our
patents and other proprietary rights include the following:
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the pending patent applications we have filed, or to which we
have exclusive rights, may not result in issued patents or may
take longer than we expect to result in issued patents;
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the claims of any patents which are issued may not provide
meaningful protection;
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we may not be able to develop additional proprietary
technologies that are patentable;
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the patents licensed or issued to us or our customers may not
provide a competitive advantage;
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other parties may challenge patents or patent applications
licensed or issued to us or our customers;
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patents issued to other companies may harm our ability to do
business; and
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other companies may design around technologies we have patented,
licensed or developed.
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In addition to patents, we rely on a combination of trade
secrets, non-disclosure agreements and other contractual
provisions and technical measures to protect our intellectual
property rights. Nevertheless, these measures may not be
adequate to safeguard the technology underlying our products. If
these measures do not protect our rights, third parties could
use our technology and our ability to compete in the market
would be reduced. In addition, employees, consultants and others
who participate in the development of our products may breach
their agreements with us regarding our intellectual property,
and we may not have adequate remedies for the breach. We also
may not be able to effectively protect our intellectual property
rights in some foreign countries. For a variety of reasons, we
may decide not to file for patent, copyright or trademark
protection or prosecute potential infringements of our patents.
Our trade secrets may also become known through other means not
currently foreseen by us. Despite our efforts to protect our
intellectual property, our competitors or customers may
independently develop similar or alternative technologies or
products that are equal or superior to our technology and
products without infringing on any of our intellectual property
rights, or design around our proprietary technologies.
Claims by others
that our products infringe on their proprietary rights could
adversely affect our ability to sell our products and services
and could increase our costs.
Substantial litigation over intellectual property rights exists
in both the professional and consumer diagnostics industries. We
expect that our products and services could be increasingly
subject to third-party infringement claims, as the number of
competitors grows and the functionality of products and
technology in different industry segments overlaps. Third
parties may currently have, or may eventually be issued, patents
which our products and services or technology may infringe. Any
of these third parties might make a claim of infringement
against us. Any litigation could result in the expenditure of
significant financial resources and the diversion of
managements time and resources. In addition, litigation in
which we are accused of infringement may cause negative
publicity, have an impact on prospective customers, cause
product delays, require us to develop non-infringing technology,
make substantial payments to third parties or enter into royalty
or license agreements, which may not be available on acceptable
terms, or at all. If a successful claim of infringement were
made against us and we could not develop non-infringing
technology or license the infringed or similar technology on a
timely and cost-effective basis, we may be forced to stop
selling current products or abandon new products under
development and we could be exposed to legal actions by our
customers.
S-25
Risk
factors
We have
initiated, and may need to further initiate, lawsuits to protect
or enforce our patents and other intellectual property rights,
which could be expensive and, if we lose, could cause us to lose
some of our intellectual property rights, which would reduce our
ability to compete in the market.
We rely on patents to protect a portion of our intellectual
property and our competitive position. In order to protect or
enforce our patent rights, we may initiate patent litigation
against third parties, such as infringement suits or
interference proceedings. Litigation may be necessary to:
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assert claims of infringement;
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enforce our patents;
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protect our trade secrets or know-how; or
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determine the enforceability, scope and validity of the
proprietary rights of others.
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Currently, we have initiated a number of lawsuits against
competitors whom we believe to be selling products that infringe
our proprietary rights. These current lawsuits and any other
lawsuits that we initiate could be expensive, take significant
time and divert managements attention from other business
concerns. Litigation also puts our patents at risk of being
invalidated or interpreted narrowly and our patent applications
at risk of not issuing. Additionally, we may provoke third
parties to assert claims against us.
Patent law relating to the scope of claims in the technology
fields in which we operate is still evolving and, consequently,
patent positions in our industry are generally uncertain. We may
not prevail in any of these suits and the damages or other
remedies awarded, if any, may not be commercially valuable.
During the course of these suits, there may be public
announcements of the results of hearings, motions and other
interim proceedings or developments in the litigation. If
securities analysts or investors perceive any of these results
to be negative, the trading price of the notes may decline.
Non-competition
obligations and other restrictions will limit our ability to
take full advantage of our management team, the technology we
own or license and our research and development
capabilities.
Members of our management team have had significant experience
in the diabetes field. In addition, technology we own or license
may have potential applications to this field and our research
and development capabilities could be applied to this field.
However, in conjunction with our split-off from Inverness
Medical Technology, Inc., or IMT, we agreed not to compete with
IMT and Johnson & Johnson in the field of diabetes
through 2011. In addition, our license agreement with IMT
prevents us from using any of the licensed technology in the
field of diabetes. As a result of these restrictions, we are
limited in our ability to pursue opportunities in the field of
diabetes at this time.
Our operating
results may fluctuate due to various factors and as a result
period-to-period comparisons of our results of operations will
not necessarily be meaningful.
Factors relating to our business make our future operating
results uncertain and may cause them to fluctuate from period to
period. Such factors include:
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the timing of new product announcements and introductions by us
and our competitors;
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market acceptance of new or enhanced versions of our products;
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the extent to which our current and future products rely on
rights belonging to third parties;
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changes in manufacturing costs or other expenses;
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competitive pricing pressures;
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changes in healthcare reimbursement policies and amounts;
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regulatory changes;
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S-26
Risk
factors
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the gain or loss of significant distribution outlets or
customers;
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increased research and development expenses;
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liabilities and costs associated with litigation;
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length of sales cycle and implementation process for new health
management customers;
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the costs and timing of any future acquisitions;
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general economic conditions; or
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general stock market conditions or other economic or external
factors.
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Because our operating results may fluctuate from quarter to
quarter, it may be difficult for us or our investors to predict
future performance by viewing historical operating results.
Period-to-period
comparisons of our operating results may not be meaningful due
to our acquisitions.
We have engaged in a number of acquisitions in recent years,
which makes it difficult to analyze our results and to compare
them from period to period. Significant acquisitions since 2006
include our acquisitions of the ACON business in the first
territory in March 2006, Instant in March 2007, Biosite in June
2007, Cholestech in September 2007 and Matria in May 2008.
Period-to-period comparisons of our results of operations may
not be meaningful due to these acquisitions and are not
indications of our future performance. Any future acquisitions
will also make our results difficult to compare from period to
period in the future.
The terms of the
Series B Preferred Stock may limit our ability to raise
additional capital through subsequent issuances of preferred
stock.
For so long as any shares of Series B Preferred Stock
remain outstanding, we are not permitted, without the
affirmative vote or written consent of the holders of at least
two-thirds of the Series B Preferred Stock then
outstanding, to authorize or designate any class or series of
capital stock having rights on liquidation or as to
distributions (including dividends) senior to the Series B
Preferred Stock. This restriction could limit our ability to
plan for or react to market conditions or meet extraordinary
capital needs, which could have a material adverse impact on our
business.
RISKS RELATED TO
THIS OFFERING
A default under
any of the agreements governing our indebtedness could result in
a default and acceleration of indebtedness under other
agreements.
The agreements governing our indebtedness, including the credit
agreements governing our secured credit facilities and the
indentures governing the notes and the senior subordinated
convertible notes, contain cross-default provisions whereby a
default under one agreement could result in a default and
acceleration of our repayment obligations under other
agreements. If a cross-default were to occur, we may not be able
to pay our debts or borrow sufficient funds to refinance them.
Even if new financing were available, it may not be on
commercially reasonable terms or acceptable terms. If some or
all of our indebtedness is in default for any reason, our
business, financial condition and results of operations could be
materially and adversely affected.
If we default on
our obligations to pay our indebtedness, we may not be able to
make payments on the notes.
Any default under the agreements governing our indebtedness,
including a default under our secured credit facilities, that is
not waived by the required lenders, and the remedies sought by
the holders of such indebtedness, could prevent us from paying
principal, premium, if any, and interest on the notes and
substantially decrease the market value of the notes. If we are
unable to generate sufficient cash flow and are
S-27
Risk
factors
otherwise unable to obtain funds necessary to meet required
payments of principal, premium, if any, and interest on our
indebtedness, or if we otherwise fail to comply with the various
covenants, including financial and operating covenants, in the
instruments governing our indebtedness (including covenants in
our secured credit facilities and the indenture governing the
notes offered hereby), we could be in default under the terms of
the agreements governing such indebtedness. In the event of such
default, the holders of such indebtedness could elect to declare
all the funds borrowed thereunder to be due and payable,
together with accrued and unpaid interest, the lenders under our
secured credit facilities could elect to terminate their
commitments thereunder, cease making further loans and institute
foreclosure proceedings against our assets, and we could be
forced into bankruptcy or liquidation. If our operating
performance declines, we may in the future need to obtain
waivers from the required lenders under our secured credit
facilities to avoid being in default. If we breach our covenants
under our secured credit facilities and seek a waiver, we may
not be able to obtain a waiver from the required lenders. If
this occurs, we would be in default under our secured credit
facilities, the lenders could exercise their rights, as
described above, and we could be forced into bankruptcy or
liquidation.
Your right to
receive payments on the notes and the related guarantees is
subordinated to our and our guarantor subsidiaries senior
debt.
The indebtedness evidenced by the notes and the related
guarantees are our senior subordinated obligations and those of
our guarantor subsidiaries. The payment of the principal of,
premium on, if any, and interest on the notes and the payment of
the related subsidiary guarantees are each subordinate in right
of payment, as set forth in the indenture governing the notes,
to the prior payment in full of all of our senior indebtedness
and obligations or the senior indebtedness and obligations of
our subsidiary guarantors, as the case may be, including our
obligations under, and the guarantee obligations of our
guarantor subsidiaries with respect to, our secured credit
facilities. Any future subsidiary guarantee of the notes will be
similarly subordinated to the senior indebtedness and
obligations of such guarantor subsidiary.
As of December 31, 2008, we had approximately
$1.37 billion of senior debt outstanding, including
approximately $1.35 billion of debt in aggregate principal
amount of indebtedness outstanding under our secured credit
facilities. Any additional borrowings pursuant to our existing
or future credit facilities would also be senior indebtedness if
incurred. Although the indenture governing the notes contains
limitations on the amount of additional indebtedness that we may
incur, under certain circumstances the amount of such
indebtedness could be substantial and, in any case, such
indebtedness may be senior indebtedness. See Description
of NotesCertain CovenantsLimitations on Additional
Indebtedness.
Because the notes are unsecured and because of the subordination
provisions of the notes, in the event of our bankruptcy,
liquidation or dissolution, or that of any subsidiary guarantor,
our assets and the assets of the subsidiary guarantors would be
available to pay obligations under the notes only after all
payments had been made on our and the subsidiary
guarantors senior indebtedness, including under our
secured credit facilities. We cannot assure you that, after all
these payments have been made, sufficient assets will remain to
make any payments on the notes, including payments of interest
when due. These subordination provisions may cause you to
recover less ratably than our other creditors in a bankruptcy,
liquidation or dissolution. In addition, all payments on the
notes and the related guarantees will be prohibited in the event
of a payment default on certain senior indebtedness as
designated under the indenture governing the notes, including
our secured credit facilities, and may be prohibited for up to
180 days in the event of non-payment defaults on certain of
our senior indebtedness, including the secured credit
facilities. See Description of NotesRanking of the
Notes and the Guarantees.
The notes are not
secured by our assets or those of our guarantor
subsidiaries.
The notes and the related guarantees are our and our guarantor
subsidiaries general unsecured obligations and are
effectively subordinated in right of payment to all of our and
our guarantor subsidiaries secured indebtedness and
obligations, including secured obligations that are otherwise
subordinated. Accordingly, our
S-28
Risk
factors
secured indebtedness and obligations, including secured
obligations that are otherwise subordinated, would effectively
be senior to the notes to the extent of the value of the
collateral securing that indebtedness.
Your right to
receive payment on the notes will be structurally subordinated
to the obligations of our non-guarantor subsidiaries.
Some of our existing and future domestic subsidiaries will
guarantee our obligations under the notes. However, our foreign
subsidiaries and our other domestic subsidiaries will not be
required by the indenture to guarantee the notes. Our
non-guarantor subsidiaries are separate and distinct legal
entities with no obligation to pay any amounts due pursuant to
the notes or the guarantees of the notes or to provide us or the
guarantors with funds for our payment obligations. Our cash flow
and our ability to service our debt, including the notes, depend
in part on the earnings of our non-guarantor subsidiaries and on
the distribution of earnings, loans or other payments to us by
these subsidiaries. For the fiscal year ended December 31,
2008, our subsidiaries that will not guarantee the notes (which
includes all of our foreign subsidiaries and certain of our
domestic subsidiaries) had net revenues of approximately
$499 million, or approximately 29.9% of our consolidated
2008 revenues, and operating income of approximately
$13.2 million, or approximately 20.7% of our consolidated
2008 operating income. As of December 31, 2008, our
subsidiaries that will not guarantee the notes had assets of
approximately $1,157 million, or approximately 19.4% of our
consolidated assets. Payments to us or a guarantor subsidiary by
these non-guarantor subsidiaries will be contingent upon their
earnings and their business considerations.
The notes will be structurally subordinated to all current and
future liabilities, including trade payables, of our
subsidiaries that do not guarantee the notes, and the claims of
creditors of those subsidiaries, including trade creditors, will
have priority as to the assets and cash flows of those
subsidiaries. In the event of a bankruptcy, liquidation,
dissolution or similar proceeding of any of the non-guarantor
subsidiaries, holders of their liabilities, including their
trade creditors, will generally be entitled to payment on their
claims from assets of those subsidiaries before any assets are
made available for distribution to us or our guarantor
subsidiaries. As of December 31, 2008, the non-guarantor
subsidiaries had approximately $467.8 million of total
indebtedness and other liabilities, including trade payables but
excluding intercompany liabilities.
The lenders under
our secured credit facilities will have the discretion to
release the guarantors under the secured credit facilities in a
variety of circumstances, which will cause those guarantors to
be released from their guarantees of the notes.
While any obligations under our secured credit facilities remain
outstanding, any guarantee of the notes may be released without
action by, or consent of, any holder of the notes or the trustee
under the indenture governing the notes offered hereby if the
related guarantor is no longer a guarantor of obligations under
the secured credit facilities or certain other indebtedness. See
Description of NotesGuarantees of the Notes.
The lenders under the secured credit facilities or such other
indebtedness will have the discretion to release the guarantees
under the secured credit facilities in a variety of
circumstances. You will not have a claim as a creditor against
any subsidiary that is no longer a guarantor of the notes.
If we undergo a
change of control, we may not have the ability to raise the
funds necessary to finance the change of control offer required
by the indenture governing the notes, which would violate the
terms of the notes.
Upon the occurrence of a change of control, as defined in the
indenture governing the notes, holders of the notes will have
the right to require us to purchase all or any part of such
holders notes at a price equal to
S-29
Risk
factors
101% of the principal amount thereof, plus accrued and unpaid
interest, if any, to (but excluding) the date of purchase. The
events that constitute a change of control under the indenture
may also constitute:
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a default under our secured credit facilities, which prohibit
the purchase of the notes by us in the event of certain changes
of control, unless and until our indebtedness under the secured
credit facilities is repaid in full; and
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a fundamental change under the indenture governing our senior
subordinated convertible notes, which would give the holders of
the senior subordinated convertible notes the right to require
us to purchase all or any part of such notes at a price equal to
100% of the principal amount thereof, plus accrued and unpaid
interest, if any, to the date of purchase.
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There can be no assurance that either we or our guarantor
subsidiaries would have sufficient financial resources available
to satisfy all of our or their obligations under the notes or
the related guarantees, our secured credit facilities or our
senior subordinated convertible notes in the event of a change
of control. Our failure to purchase the notes as required under
the indenture governing the notes would result in a default
under that indenture, the indenture governing the senior
subordinated convertible notes and under our secured credit
facilities, each of which could have material adverse
consequences for us and the holders of the notes. See
Description of NotesChange of Control.
The trading
prices of the notes will be directly affected by our ratings
with major credit rating agencies, the prevailing interest rates
being paid by companies similar to us, and the overall condition
of the financial and credit markets.
The trading prices of the notes in the secondary market will be
directly affected by our ratings with major credit rating
agencies, the prevailing interest rates being paid by companies
similar to us, and the overall condition of the financial and
credit markets. It is impossible to predict the prevailing
interest rates or the condition of the financial and credit
markets. Credit rating agencies continually revise their ratings
for companies that they follow, including us. Any ratings
downgrade could adversely affect the trading price of the notes
or the trading market for the notes, to the extent a trading
market for the notes develops. The condition of the financial
and credit markets and prevailing interest rates have fluctuated
in the past and are likely to fluctuate in the future.
A subsidiary
guarantee could be voided if it constitutes a fraudulent
transfer under U.S. bankruptcy or similar state law, which would
prevent the holders of the notes from relying on that subsidiary
to satisfy claims.
The notes will be guaranteed by some of our domestic
subsidiaries that are guarantors or borrowers under our secured
credit facilities. The guarantees may be subject to review under
U.S. federal bankruptcy law and comparable provisions of
state fraudulent conveyance laws if a bankruptcy or another
similar case or lawsuit is commenced by or on behalf of our or a
guarantor subsidiarys unpaid creditors or another
authorized party. Under these laws, if a court were to find
that, at the time any guarantor subsidiary issued a guarantee of
the notes, either it issued the guarantee to delay, hinder or
defraud present or future creditors, or it received less than
reasonably equivalent value or fair consideration for issuing
the guarantee and at the time:
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it was insolvent or rendered insolvent by reason of issuing the
guarantee;
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it was engaged, or about to engage, in a business or transaction
for which its remaining unencumbered assets constituted
unreasonably small capital to carry on its business;
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it intended to incur, or believed that it would incur, debts
beyond its ability to pay as they mature; or
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it was a defendant in an action for money damages, or had a
judgment for money damages docketed against it if, in either
case, after final judgment, the judgment is unsatisfied,
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then the court could void the obligations under the guarantee,
subordinate the guarantee of the notes to other debt or take
other action detrimental to holders of the notes.
S-30
Risk
factors
We cannot be sure as to the standard that a court would use to
determine whether a guarantor subsidiary was solvent at the
relevant time, or, regardless of the standard that the court
uses, that the issuance of the guarantees would not be voided or
that the guarantees would not be subordinated to other debt. If
such a case were to occur, the guarantee could also be subject
to the claim that, since the guarantee was incurred for our
benefit, and only indirectly for the benefit of the guarantor
subsidiary, the obligations of the applicable guarantor
subsidiary were incurred for less than fair consideration. A
court could thus void the obligations under the guarantee,
subordinate the guarantee to the applicable guarantor
subsidiarys other debt or take other action detrimental to
holders of the notes. If a court were to void a guarantee, you
would no longer have a claim against the guarantor subsidiary.
Sufficient funds to repay the notes may not be available from
other sources, including the remaining guarantor subsidiaries,
if any. In addition, the court might direct you to repay any
amounts that you already received from or are attributable to
the guarantor subsidiary.
Each subsidiary guarantee contains a provision intended to limit
the guarantor subsidiarys liability to the maximum amount
that it could incur without causing the incurrence of
obligations under its subsidiary guarantee to be a fraudulent
transfer. This provision may not be effective to protect the
subsidiary guarantees from being voided under fraudulent
transfer law.
If a bankruptcy
petition were filed by or against us, holders of notes may
receive a lesser amount for their claim than they would have
been entitled to receive under the indenture governing the
notes.
If a bankruptcy petition were filed by or against us under the
U.S. Bankruptcy Code after the issuance of the notes, the
claim by any holder of the notes for the principal amount of the
notes may be limited to an amount equal to the sum of:
|
|
Ø
|
the original issue price for the notes; and
|
|
Ø
|
that portion of the original issue discount that does not
constitute unmatured interest for purposes of the
U.S. Bankruptcy Code.
|
Any original issue discount that was not accreted as of the date
of the bankruptcy filing would constitute unmatured interest.
Accordingly, holders of the notes under these circumstances may
receive a lesser amount than they would be entitled to receive
under the terms of the indenture governing the notes, even if
sufficient funds are available.
Because the notes
will be issued with original issue discount, holders will be
required to pay tax on amounts included in gross income before
cash payments with respect to the original issue discount are
received.
The notes will be issued with original issue discount for
U.S. federal income tax purposes. Consequently,
U.S. holders will be required to include such original
issue discount in their gross income for U.S. federal
income tax purposes as it accrues, regardless of their method of
tax accounting. U.S. holders should be aware that the
amount of interest (including original issue discount) that a
U.S. holder is required to include in gross income for each
year for U.S. federal income tax purposes will exceed the
amount of cash interest that is received by the holder during
each such year. Special rules will apply to a holder that is not
a U.S. person for U.S. federal income tax purposes.
All holders should read the section entitled Material
U.S. Federal Income Tax Consequences regarding the
tax consequences of the purchase, ownership and disposition of
the notes.
Interest on the
notes may not be deductible by us for United States federal
income tax purposes.
The deductibility of interest is subject to many limitations
under the Internal Revenue Code. We may not be able to deduct,
in whole or in part, the interest on the notes. The availability
of an interest deduction on the notes was not determinative in
our issuance of the notes.
S-31
Risk
factors
Since we have
broad discretion in how we use the proceeds from this offering,
we may use the proceeds in ways with which you
disagree.
We intend to use a portion of the net proceeds from this
offering for general corporate purposes. Except as otherwise
described in Use of Proceeds, we have not allocated
specific amounts of the net proceeds from this offering for any
specific purpose. Accordingly, our management will have
significant flexibility in applying the net proceeds from this
offering. You will be relying on the judgment of our management
with regard to the use of these net proceeds, and you will not
have the opportunity as part of your investment decision to
assess whether the proceeds are being used appropriately. It is
possible that the net proceeds from this offering will be
invested in a way that does not yield a favorable, or any,
return for us. The failure of our management to use such funds
effectively could have a material adverse effect on our
business, financial condition, operating results and cash flow.
There may be no
active trading market for the notes.
The notes have been authorized for listing on the New York Stock
Exchange, subject to notice of issuance. The underwriters have
advised us that they intend to make a market for the notes, but
they are not obligated to do so and may cease their
market-making activities at any time. The liquidity of the
trading market in the notes, if any, and any market price quoted
for the notes, may be adversely affected by changes in the
overall market for high-yield securities and by changes in our
financial performance or prospects or in the financial
performance or prospects of companies in our industry generally.
As a result, no active trading market for the notes may develop
or be maintained. If an active market does not develop or is not
maintained, the market price and liquidity of the notes may be
adversely affected. Moreover, notes frequently trade in blocks
of large principal amounts, and retail and other small investors
may have limited liquidity for positions consisting of only a
small principal amount of notes.
Certain covenants
contained in the indenture will not be applicable during any
period in which the notes are rated investment grade.
The indenture governing the notes will provide that certain
covenants will not apply to us during any period in which the
notes are rated investment grade by both Standard &
Poors and Moodys and no default has otherwise
occurred and is continuing under the indenture. The covenants
that would be suspended include, among others, limitations on
our and our restricted subsidiaries ability to pay
dividends, incur additional indebtedness, sell certain assets
and enter into certain other transactions. Any actions that we
take while these covenants are not in force will be permitted
even if the notes are subsequently downgraded below investment
grade and such covenants are subsequently reinstated. There can
be no assurance that the notes will ever be rated investment
grade, or that if they are rated investment grade, the notes
will maintain such ratings. See Description of
Notes Certain Covenants Suspension of
Covenants.
S-32
Special
note regarding forward-looking statements
This prospectus supplement and the accompanying prospectus
contain forward-looking statements within the meaning of
Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as
amended. You can identify these statements by forward-looking
words such as may, could,
should, would, intend,
will, expect, anticipate,
believe, estimate, continue
or similar words. You should read statements that contain these
words carefully because they discuss our future expectations,
contain projections of our future results of operations or of
our financial condition or state other
forward-looking information. There may be events in
the future that we are unable to predict accurately or control
and that may cause our actual results to differ materially from
the expectations we describe in our forward-looking statements.
We caution investors that all forward-looking statements involve
risks and uncertainties, and actual results may differ
materially from those we discuss in this prospectus supplement
and the accompanying prospectus. These differences may be the
result of various factors, including the factors identified in
the section entitled Risk Factors in this prospectus
supplement, the factors identified in the section entitled
Risk Factors in our Annual Report on
Form 10-K/A
for the year ended December 31, 2008 and other factors
identified from time to time in our periodic filings with the
SEC. Some important factors that could cause our actual results
to differ materially from those projected in any such
forward-looking statements are as follows:
|
|
Ø
|
our inability to predict the effects of the current national and
worldwide financial and economic crisis, including disruptions
in the capital and credit markets;
|
|
Ø
|
our inability to predict the effects of anticipated United
States national healthcare reform legislation and similar
initiatives in other countries;
|
|
Ø
|
economic factors, including inflation and fluctuations in
interest rates and foreign currency exchange rates, and the
potential effect of such fluctuations on revenues, expenses and
resulting margins;
|
|
Ø
|
competitive factors, including technological advances achieved
and patents attained by competitors and general competition;
|
|
Ø
|
domestic and foreign healthcare changes resulting in pricing
pressures, including the continued consolidation among
healthcare providers, trends toward managed care and healthcare
cost containment and government laws and regulations relating to
sales and promotion, reimbursement and pricing generally;
|
|
Ø
|
government laws and regulations affecting domestic and foreign
operations, including those relating to trade, monetary and
fiscal policies, taxes, price controls, regulatory approval of
new products, licensing and environmental protection;
|
|
Ø
|
manufacturing interruptions, delays or capacity constraints or
lack of availability of alternative sources for components for
our products, including our ability to successfully maintain
relationships with suppliers, or to put in place alternative
suppliers on terms that are acceptable to us;
|
|
Ø
|
difficulties inherent in product development, including the
potential inability to successfully continue technological
innovation, complete clinical trials, obtain regulatory
approvals or clearances in the United States and abroad and the
possibility of encountering infringement claims by competitors
with respect to patent or other intellectual property rights
which can preclude or delay commercialization of a product;
|
|
Ø
|
significant litigation adverse to us including product liability
claims, patent infringement claims and antitrust claims;
|
|
Ø
|
product efficacy or safety concerns resulting in product recalls
or declining sales;
|
|
Ø
|
the impact of business combinations and organizational
restructurings consistent with evolving business strategies;
|
S-33
|
|
Ø
|
our ability to satisfy the financial covenants and other
conditions contained in the agreements governing our
indebtedness;
|
|
Ø
|
our ability to effectively manage the integration of our
acquisitions into our operations;
|
|
Ø
|
our ability to obtain required financing on terms that are
acceptable to us; and
|
|
Ø
|
the issuance of new or revised accounting standards by the
American Institute of Certified Public Accountants, the
Financial Accounting Standards Board, the Public Company
Accounting Oversight Board or the SEC.
|
The foregoing list provides many, but not all, of the factors
that could impact our ability to achieve the results described
in any forward-looking statement. Readers should not place undue
reliance on our forward-looking statements. Before you invest in
the notes, you should be aware that the occurrence of the events
described above and elsewhere in this prospectus supplement or
the accompanying prospectus could seriously harm our business,
prospects, operating results and financial condition. We do not
undertake any obligation to update any forward-looking statement
as a result of future events or developments.
Some of the market data and other statistical information used
throughout this prospectus supplement is based on independent
industry publications or other independent sources. Although we
believe these sources are reliable, we have not independently
verified the information and cannot guarantee its accuracy and
completeness. Some market and industry information is also based
on our good faith estimates, which are derived from our review
of internal data, as well as the independent sources.
S-34
Use of proceeds
We estimate that our net proceeds from the sale of the notes in
this offering will be approximately $378,460,000, after
deducting the underwriting discount and our estimated offering
expenses.
We intend to use our net proceeds from the sale of the notes for
working capital and other general corporate purposes, including
the financing of potential acquisitions or other investments, if
and when suitable opportunities arise, and for capital
expenditures, in our sole discretion. We currently have no
agreements or commitments to complete any material acquisition
that we intend to fund using the net proceeds from this
offering. We may use a portion of the net proceeds of this
offering to pay some or all of our remaining obligations
relating to our recently completed acquisition of the second
territory business from ACON.
Due to the rapidly changing nature of the markets in which we
operate, the amounts we actually spend on general corporate
purposes will depend on a number of factors, including revenue
growth, if any, and the amount of cash we generate from
operations. Until allocated for specific use, we intend to
invest our net proceeds from the sale of the notes in government
securities and other short-term, investment-grade securities.
S-35
Capitalization
The following table provides our cash and cash equivalents and
our capitalization as of December 31, 2008:
|
|
Ø
|
on an actual basis; and
|
|
Ø
|
on an as-adjusted basis to give effect to the receipt of the
estimated net proceeds of this offering, after deducting the
underwriting discount and our estimated offering expenses.
|
The following table does not give any effect to the closing of
our acquisition of the ACON second territory business on
April 30, 2009. The final purchase price for the
acquisition of the ACON second territory business will be based
on the audited financial statements of ACON, which are not yet
available. We currently expect that the purchase price for the
ACON second territory business will be approximately
$200.0 million, subject to adjustments, of which we paid
$80.0 million on April 30, 2009. Depending on the
results of the audit of ACONs financial statements, the
final purchase price could be materially larger or smaller than
our estimate. Not later than ten business days following the
closing of this offering, we expect to pay approximately an
additional $30.5 million in cash, based on the estimated
purchase price. On July 1, 2009, we must pay an amount
equal to approximately $59.5 million in shares of our
common stock or, at our election, cash, based on the estimated
purchase price. Such amount shall bear interest at the rate of
4% per annum from the closing date. The remainder of the
purchase price will be due in two installments, each comprising
7.5% of the total purchase price, or approximately
$15.0 million, based on the estimated purchase price, on
the dates that are 15 and 30 months after the closing.
These installment amounts do not bear interest, and we may pay
up to approximately 29% of each of these payments in shares of
our common stock.
The information in the table should be read in conjunction with,
and is qualified in its entirety by reference to, our audited
consolidated financial statements, including the notes thereto,
included elsewhere in this prospectus supplement and
Managements Discussion and Analysis of Financial
Condition and Results of Operations.
S-36
Capitalization
|
|
|
|
|
|
|
|
|
|
|
December 31,
2008
|
|
|
|
Actual
|
|
|
As
adjusted
|
|
|
|
|
|
(In
thousands)
|
|
|
Cash and cash equivalents
|
|
$
|
141,324
|
|
|
$
|
519,784
|
|
|
|
|
|
|
|
|
|
|
Debt:
|
|
|
|
|
|
|
|
|
Revolving credit
facility(1)
|
|
$
|
142,000
|
|
|
$
|
142,000
|
|
First lien term loan
|
|
|
960,750
|
|
|
|
960,750
|
|
Second lien term loan
|
|
|
250,000
|
|
|
|
250,000
|
|
Capital lease obligations
|
|
|
919
|
|
|
|
919
|
|
Other secured indebtedness
|
|
|
16,865
|
|
|
|
16,865
|
|
|
|
|
|
|
|
|
|
|
Total secured debt
|
|
|
1,370,534
|
|
|
|
1,370,534
|
|
3% convertible senior subordinated notes
|
|
|
150,000
|
|
|
|
150,000
|
|
Notes offered hereby
|
|
|
|
|
|
|
387,460
|
|
|
|
|
|
|
|
|
|
|
Total debt
|
|
|
1,520,534
|
|
|
|
1,907,994
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Series B preferred stock, $0.001 par value
(liquidation preference, $751,479), 2,300 shares
authorized, 1,879 shares issued and outstanding
|
|
|
671,501
|
|
|
|
671,501
|
|
Common stock, $0.001 par value, 150,000 shares
authorized, 78,431 shares issued and outstanding
|
|
|
78
|
|
|
|
78
|
|
Additional paid-in capital
|
|
|
3,029,694
|
|
|
|
3,029,694
|
|
Accumulated deficit
|
|
|
(393,590
|
)
|
|
|
(393,590
|
)
|
Accumulated other comprehensive (loss) income
|
|
|
(28,845
|
)
|
|
|
(28,845
|
)
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
3,278,838
|
|
|
|
3,278,838
|
|
|
|
|
|
|
|
|
|
|
Total capitalization
|
|
$
|
4,799,372
|
|
|
$
|
5,186,832
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Our revolving credit facility provides for commitments of up
to $150.0 million. As of December 31, 2008, we had
outstanding borrowings under the revolving credit facility in
the aggregate principal amount of $142.0 million. |
S-37
Selected
consolidated financial information
The following tables provide our selected consolidated financial
data as of the dates and for the periods shown. Our selected
consolidated statement of operations data for the years ended
December 31, 2006, 2007 and 2008 and our selected
consolidated balance sheet data as of December 31, 2007 and
2008 are derived from our consolidated financial statements
included elsewhere in this prospectus supplement, which have
been audited by BDO Seidman, LLP, our independent registered
public accounting firm, as indicated in their report. Our
selected consolidated statement of operations data for the years
ended December 31, 2004 and 2005 and our selected
consolidated balance sheet data as of December 31, 2004,
2005 and 2006 are derived from our consolidated financial
statements not included in this prospectus supplement, which
have been audited by BDO Seidman, LLP, our independent
registered public accounting firm. The selected consolidated
financial data should be read in conjunction with, and are
qualified in their entirety by reference to, our audited
consolidated financial statements, including the notes thereto,
included elsewhere in this prospectus supplement and
Managements Discussion and Analysis of Financial
Condition and Results of Operations.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year
ended December 31,
|
|
Statement of
Operations Data:
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
|
|
|
(in thousands,
except per share data)
|
|
|
Net product sales
|
|
$
|
1,240,138
|
|
|
$
|
800,915
|
|
|
$
|
552,130
|
|
|
$
|
406,457
|
|
|
$
|
365,432
|
|
Services revenue
|
|
|
405,462
|
|
|
|
16,646
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales and services revenue
|
|
|
1,645,600
|
|
|
|
817,561
|
|
|
|
552,130
|
|
|
|
406,457
|
|
|
|
365,432
|
|
License and royalty revenue
|
|
|
25,826
|
|
|
|
21,979
|
|
|
|
17,324
|
|
|
|
15,393
|
|
|
|
8,559
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue
|
|
|
1,671,426
|
|
|
|
839,540
|
|
|
|
569,454
|
|
|
|
421,850
|
|
|
|
373,991
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of net product sales
|
|
|
624,654
|
|
|
|
431,403
|
|
|
|
334,799
|
|
|
|
264,999
|
|
|
|
223,669
|
|
Cost of services revenue
|
|
|
177,098
|
|
|
|
5,261
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of license and royalty revenue
|
|
|
9,115
|
|
|
|
9,149
|
|
|
|
5,432
|
|
|
|
4,539
|
|
|
|
3,318
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of net revenue
|
|
|
810,867
|
|
|
|
445,813
|
|
|
|
340,231
|
|
|
|
269,538
|
|
|
|
226,987
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
860,559
|
|
|
|
393,727
|
|
|
|
229,223
|
|
|
|
152,312
|
|
|
|
147,004
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
111,828
|
|
|
|
69,547
|
|
|
|
48,706
|
|
|
|
30,992
|
|
|
|
31,954
|
|
Purchase of in-process research and development
|
|
|
|
|
|
|
173,825
|
|
|
|
4,960
|
|
|
|
|
|
|
|
|
|
Sales and marketing
|
|
|
386,284
|
|
|
|
167,770
|
|
|
|
94,445
|
|
|
|
72,103
|
|
|
|
57,957
|
|
General and administrative
|
|
|
298,595
|
|
|
|
158,438
|
|
|
|
71,243
|
|
|
|
59,990
|
|
|
|
52,707
|
|
Loss on dispositions, net
|
|
|
|
|
|
|
|
|
|
|
3,498
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss)
|
|
|
63,852
|
|
|
|
(175,853
|
)
|
|
|
6,371
|
|
|
|
(10,773
|
)
|
|
|
4,386
|
|
Interest expense and other expenses, net, including amortization
of original issue discounts and write-off of deferred financing
costs
|
|
|
(103,356
|
)
|
|
|
(74,251
|
)
|
|
|
(17,822
|
)
|
|
|
(1,617
|
)
|
|
|
(18,707
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before (benefit) provision for income taxes
|
|
|
(39,504
|
)
|
|
|
(250,104
|
)
|
|
|
(11,451
|
)
|
|
|
(12,390
|
)
|
|
|
(14,321
|
)
|
(Benefit) provision for income taxes
|
|
|
(16,686
|
)
|
|
|
(979
|
)
|
|
|
5,727
|
|
|
|
6,819
|
|
|
|
2,275
|
|
Equity earnings of unconsolidated entities, net of tax
|
|
|
1,050
|
|
|
|
4,372
|
|
|
|
336
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(footnotes on following page)
|
S-38
Selected
consolidated financial information
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the year
ended December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
|
|
|
(in thousands,
except per share data and ratios)
|
|
|
Net loss
|
|
|
(21,768
|
)
|
|
|
(244,753
|
)
|
|
|
(16,842
|
)
|
|
|
(19,209
|
)
|
|
|
(16,596
|
)
|
Preferred stock dividends
|
|
|
(13,989
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(749
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common
stockholders(1)
|
|
$
|
(35,757
|
)
|
|
$
|
(244,753
|
)
|
|
$
|
(16,842
|
)
|
|
$
|
(19,209
|
)
|
|
$
|
(17,345
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common sharebasic and
diluted(1)
|
|
$
|
(0.46
|
)
|
|
$
|
(4.75
|
)
|
|
$
|
(0.49
|
)
|
|
$
|
(0.79
|
)
|
|
$
|
(0.87
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other financial data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ratio of earnings to fixed
charges(2)(3)
|
|
|
0.7
|
x
|
|
|
|
|
|
|
0.6
|
x
|
|
|
0.5
|
x
|
|
|
0.4
|
x
|
Ratio of earnings to combined fixed charges and preference
dividends(2)(3)
|
|
|
0.5
|
x
|
|
|
|
|
|
|
0.6
|
x
|
|
|
0.5
|
x
|
|
|
0.4
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
Balance Sheet
Data:
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
2005
|
|
|
2004
|
|
|
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
141,324
|
|
|
$
|
414,732
|
|
|
$
|
71,104
|
|
|
$
|
34,270
|
|
|
$
|
16,756
|
|
Working capital
|
|
$
|
457,198
|
|
|
$
|
674,066
|
|
|
$
|
133,313
|
|
|
$
|
84,523
|
|
|
$
|
62,615
|
|
Total assets
|
|
$
|
5,955,360
|
|
|
$
|
4,880,759
|
|
|
$
|
1,085,771
|
|
|
$
|
791,166
|
|
|
$
|
568,269
|
|
Total debt
|
|
$
|
1,520,534
|
|
|
$
|
1,387,849
|
|
|
$
|
202,976
|
|
|
$
|
262,504
|
|
|
$
|
191,224
|
|
Total stockholders equity
|
|
$
|
3,278,838
|
|
|
$
|
2,586,667
|
|
|
$
|
714,138
|
|
|
$
|
397,308
|
|
|
$
|
271,416
|
|
|
|
|
(1) |
|
Net loss available to common stockholders and basic and
diluted net loss per common share are computed as described in
Notes 2(n) and 15 of our consolidated financial statements
included elsewhere in this prospectus supplement. |
|
(2) |
|
For the purpose of computing our ratio of earnings to fixed
charges, earnings consist of pre-tax income before
adjustment for income from equity investees plus fixed charges
(excluding capitalized interest). Fixed charges
consist of interest expensed and capitalized, amortized
premiums, discounts and capitalized expenses related to
indebtedness and an estimate of the interest within rental
expense. This ratio is adjusted to include preference dividends
in the ratio of earnings to combined fixed charges and
preference dividends. Preference dividends equal the
amount of pre-tax earnings that is required to pay the dividends
on outstanding preference securities. |
|
(3) |
|
Due to the net losses for the years ended December 31,
2008, 2007, 2006, 2005 and 2004, there were insufficient
earnings of $38.1 million, $248.9 million,
$11.8 million, $12.4 million and $14.3 million,
respectively, to cover fixed charges, and $61.4 million,
$248.9 million, $11.8 million, $12.4 million and
$15.6 million, respectively, to cover fixed charges and
preference dividends. |
S-39
Managements
discussion and analysis of
financial condition and results of operations
You should read the following discussion in conjunction with
our consolidated financial statements and notes thereto
appearing elsewhere in this prospectus supplement. In addition
to historical consolidated financial information, the following
discussion and analysis contains forward-looking statements that
involve risks, uncertainties and assumptions. Our actual results
could differ materially from those anticipated by these
forward-looking statements as a result of many factors,
including those discussed under Risk Factors and
elsewhere in this prospectus supplement.
OVERVIEW
We enable individuals to take charge of improving their health
and quality of life at home by developing new capabilities in
near patient diagnosis, monitoring and health management. Our
global leading products and services, as well as our new product
development efforts, focus on cardiology, womens health,
infectious disease, oncology, and drugs of abuse. With our 2007
acquisitions of Biosite, Cholestech, and HemoSense, we
established our company as a leading supplier of cardiology
diagnostic products. Our acquisitions of Biosite, Instant and
Redwood during 2007 and Ameditech, Inc., or Ameditech, in 2008
enhanced our position in drugs of abuse testing. Additionally,
with our December 2007 acquisition of Matritech, Inc., or
Matritech, we also established a presence in oncology, by
acquiring the unique NMP-22 ELISA and rapid point-of-care tests
for the screening and monitoring of bladder cancer in
conjunction with standard diagnostic procedures. We expect to
continue to expand in all of these product categories through
focused research and development projects and further
development of our distribution capabilities.
During 2007 and 2008, we entered the growing health management
market with our acquisitions of Alere Medical, ParadigmHealth
and more recently, Matria. With the acquisition of Matria, we
are now a leader in this field offering a broad range of
services aimed at lowering costs for health plans, hospitals,
employers and patients. Our health management services are
focused in the areas of womens and childrens health,
cardiology and oncology. We are confident that our ability to
offer near patient monitoring tools combined with value-added
healthcare services will improve care and lower healthcare costs
for both providers and patients. During the third quarter of
2008, we began efforts to consolidate the health management
businesses under a single brand. Today, Matria, ParadigmHealth
and Alere Medical, each a leader in their respective areas, are
united as one business under the name Alere. Also, during the
third quarter of 2008, we acquired an overseas health management
business enabling us to establish a presence in the
newly-developing international health management market.
Our research and development programs have two general focuses.
We are developing new technology platforms that will facilitate
our primary objective of enabling individuals to take charge of
improving their health and quality of life by moving testing out
of the hospital and central laboratory, and into the
physicians office and ultimately the home. Additionally,
through our strong pipeline of novel proteins or combinations of
proteins that function as disease biomarkers, we are developing
new tests targeted towards all of our areas of focus.
We continue to advance toward our goal of establishing a
worldwide distribution network that will allow us to bring both
our current and future diagnostic products to the global
professional market. In addition, we continue to focus on
improving our margins through consolidation of certain of our
higher cost manufacturing operations into lower cost facilities,
including our 300,000 square foot manufacturing facility
located in Hangzhou, China, as well as our jointly-owned
facility in Shanghai, China, and we are already seeing improved
margins on some of our existing products that we have moved to
these facilities. Our business integration activities remain on
track and we have seen positive results from the integrations
completed to date and as we continue to aggressively integrate
acquired operations in order to achieve further synergies within
expected timelines. During the second half of 2007, we began
implementation of a plan to
S-40
Managements
discussion and analysis of financial condition and results of
operations
consolidate sales processing and certain other back-office
services from seven of our U.S. operations into a shared
services center, located in Orlando, Florida. This shared
services center commenced operations at the beginning of the
second quarter of 2008.
2008 FINANCIAL
HIGHLIGHTS
Net revenue in 2008 of $1.7 billion increased by
$831.9 million, or 99%, from $839.5 million in 2007.
Net revenue increased primarily as a result of our professional
diagnostics-related acquisitions which contributed
$397.8 million of the increase. Additionally, net revenue
increased as a result of our newly-formed health management
segment which provided $357.6 million of incremental
revenue and primarily included the activities of our recent
acquisitions of QAS, Alere Medical, ParadigmHealth and Matria.
Partially offsetting the increased revenue as a result of
acquisitions was the decrease in revenue associated with the
completion of our 50/50 joint venture (SPD) with P&G in May
2007 in which we transferred substantially all of the assets of
our consumer diagnostics business, other than our manufacturing
and core intellectual property assets. Upon completion of the
arrangement to form the joint venture, we ceased to consolidate
the operating results of our consumer diagnostics business
related to the joint venture and instead account for our 50%
interest in the results of the joint venture under the equity
method of accounting in accordance with Accounting Principles
Board, or APB, Opinion No. 18, The Equity Method of
Accounting for Investments in Common Stock. Organic growth,
particularly from our professional cardiology, infectious
disease and drugs of abuse products, also contributed to the
revenue growth, as well as higher license and royalty revenue.
Gross profit increased by $466.8 million, or 119%, to
$860.6 million in 2008 from $393.7 million in 2007,
principally as a result of gross profit earned on incremental
revenue from acquired businesses, primarily in our professional
diagnostics and health management businesses, as well as
increased license and royalty revenue. Offsetting these
increases was a decrease in our consumer diagnostics business
gross margin, principally as a result of the formation of our
50/50 joint venture with P&G in May 2007. During 2008,
gross profit was adversely impacted by a $17.9 million
restructuring charge related to the closure of various
manufacturing and operating facilities and a charge of
$2.0 million associated with the
write-up of
inventory acquired to fair value in connection with two of our
2008 acquisitions. Gross profit in 2007 was adversely impacted
by a $2.0 million charge associated with our various
restructuring plans and a charge of $8.2 million associated
with the
write-up of
inventory acquired to fair value in connection with three of our
2007 acquisitions.
We continue to invest aggressively in research and development
of new products and technologies as evidenced by our increased
research and development expense of $111.8 million in 2008,
from $69.5 million in 2007. Expenditures in 2007 are
reported net of $18.5 million arising from the
co-development funding arrangement that we entered into with ITI
Scotland Limited, or ITI, in February 2005. Research and
development expense before considering the co-development
funding was $88.0 million in 2007. The increase in spending
resulted principally from expenditures related to our cardiology
research programs. Offsetting these increases was the favorable
impact of the 50/50 joint venture with P&G. Our
co-development funding arrangement with ITI expired in the first
quarter of 2008. The final payment under this agreement was
received and earned in the fourth quarter of 2007, and as such,
no funding was earned in 2008.
RESULTS OF
OPERATIONS
Year ended
December 31, 2008 compared to year ended December 31,
2007
Net Product Sales. Net product sales increased
by $439.2 million, or 55%, to $1.2 billion in 2008
from $800.9 million in 2007. Excluding the unfavorable
impact of currency translation, net product sales in 2008 grew
by approximately $439.5 million, or 55%, over 2007. Of the
currency adjusted increase, revenue increased primarily as a
result of our professional diagnostic-related acquisitions which
contributed $363.8 million of the increase. Organic growth,
particularly from our professional infectious disease, drugs of
abuse products and vitamin and nutritional supplements, also
contributed to the growth.
S-41
Managements
discussion and analysis of financial condition and results of
operations
Net Product Sales by Business Segment. Net
product sales by business segment for 2008 and 2007 are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% increase
|
|
|
|
2008
|
|
|
2007
|
|
|
(decrease)
|
|
|
|
|
Professional diagnostics
|
|
$
|
1,000,190
|
|
|
$
|
565,265
|
|
|
|
77
|
%
|
Health management
|
|
|
18,632
|
|
|
|
9,210
|
|
|
|
102
|
%
|
Consumer diagnostics
|
|
|
132,443
|
|
|
|
153,616
|
|
|
|
(14
|
)%
|
Vitamins and nutritional supplements
|
|
|
88,873
|
|
|
|
72,824
|
|
|
|
22
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
$
|
1,240,138
|
|
|
$
|
800,915
|
|
|
|
55
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Professional
diagnostics
The increase in net product sales from our professional
diagnostics business segment was $434.9 million, or 77%,
resulting in $1.0 billion of net product sales in 2008. Of
the increase, revenue increased primarily as a result of our
acquisitions of: (i) Biosite, in June 2007, which
contributed additional product revenue of $161.7 million in
excess of those earned in the prior years comparative
period, (ii) Cholestech, in September 2007, which
contributed additional product revenue of $49.4 million in
excess of those earned in the prior years comparative
period, (iii) Bio-Stat Healthcare Group, or Bio-Stat, in
October 2007, which contributed additional product revenue of
$21.6 million in excess of those earned in the prior
years comparative period, (iv) HemoSense, in November
2007, which contributed additional product revenue of
$27.2 million in excess of those earned in the prior
years comparative period, (v) Redwood, in December
2007, which contributed additional product revenue of
$23.9 million in excess of those earned in the prior
years comparative period, (vi) BBI, in February 2008,
which contributed product revenue of $32.4 million and
(vii) various less significant acquisitions, which
contributed an aggregate of $47.6 million of such increase.
Organic growth, particularly from our professional infectious
disease products, also contributed to the growth. The currency
adjusted organic growth for our professional diagnostics net
product sales, excluding the impact of acquisitions, was 13%.
Health
management
Our health management net product sales increased
$9.4 million, or 102%, to $18.6 million in 2008. The
increase in net product sales represents additional sales
related to our acquisition of QAS in June 2007.
Consumer
diagnostics
The decrease in net product sales from our consumer diagnostics
business segment was $21.2 million, or 14%, resulting in
$132.4 million of net product sales for 2008. The decrease
was primarily driven by the completion of our 50/50 joint
venture with P&G in May 2007 in which we transferred
substantially all of the assets of our consumer diagnostics
business, other than our manufacturing and core intellectual
property assets. Upon completion of the arrangement to form the
joint venture, we ceased to consolidate the operating results of
our consumer diagnostics business related to the joint venture
and instead account for our 50% interest in the results of the
joint venture under the equity method of accounting. Net product
sales from our consumer diagnostics business segment for 2008
and 2007 included $103.0 million and $65.0 million,
respectively, of manufacturing revenue associated with our
manufacturing agreement with SPD, whereby we manufacture and
sell consumer diagnostics to the joint venture. Partially
offsetting the impact of the joint venture was an increase
$13.5 million of net product sales attributed to our
acquisitions of: (i) First Check Diagnostics LLC, or First
Check, in January 2007, which contributed additional product
revenue of $1.1 million in excess of those earned in the
prior years comparative period, (ii) Bio-Stat, in
October 2007, which contributed additional product revenue of
$4.6 million in excess of those earned in the prior
years comparative period and (iii) BBI, in February
2008, which contributed product revenue of $7.8 million.
S-42
Managements
discussion and analysis of financial condition and results of
operations
Vitamins and
nutritional supplements
Our vitamins and nutritional supplements net product sales
increased by $16.0 million, or 22%, to $88.9 million
in 2008. The increase is primarily a result of increased private
label nutritional sales to our existing and new customers.
Services Revenue. Services revenue was
$405.5 million in 2008, as compared to $16.6 million
in 2007. Services revenue is principally related to our
newly-formed health management business segment which primarily
includes our recent acquisitions of QAS, Alere Medical,
ParadigmHealth and Matria. In addition to the services revenue
generated by our health management businesses, services revenue
also includes revenue generated by our professional drugs of
abuse testing and screening business, along with revenue
associated with our long-term services agreement related to our
consumer diagnostics joint venture formed with P&G in May
2007, pursuant to which we provide certain operational support
services to the joint venture.
Services Revenue by Business Segment. Services
revenue by business segment for 2008 and 2007 are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Professional diagnostics
|
|
$
|
29,338
|
|
|
$
|
|
|
Health management
|
|
|
373,767
|
|
|
|
14,164
|
|
Consumer diagnostics
|
|
|
2,357
|
|
|
|
2,482
|
|
|
|
|
|
|
|
|
|
|
Total services revenue
|
|
$
|
405,462
|
|
|
$
|
16,646
|
|
|
|
|
|
|
|
|
|
|
Professional
diagnostics
Services revenue provided by our professional diagnostics
business segment of $29.3 million in 2008 represents
revenue related to the laboratory-based professional drugs of
abuse testing and screening business at Redwood, which was
acquired in December 2007.
Health
management
Services revenue provided by our newly-formed health management
business segment was $373.8 million in 2008, with Matria
contributing services revenue of $197.7 million, Alere
Medical contributing services revenue of $91.2 million,
ParadigmHealth contributing services revenue of
$71.3 million and QAS contributing services revenue of
$12.1 million.
Consumer
diagnostics
Services revenue provided by our consumer diagnostics business
segment decreased by $0.1 million, or 5%, to
$2.4 million in 2008. Services revenue provided by our
consumer diagnostics business segment represents revenue related
to our long-term services agreements with our 50/50 joint
venture with P&G formed in May 2007, pursuant to which
we provide certain operational support services to the joint
venture.
Net Product Sales and Services Revenue by Geographic
Location. Net product sales and services revenue
by geographic location for 2008 and 2007 are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% increase
|
|
|
|
2008
|
|
|
2007
|
|
|
(decrease)
|
|
|
|
|
United States
|
|
$
|
1,186,583
|
|
|
$
|
511,941
|
|
|
|
132
|
%
|
Europe
|
|
|
283,552
|
|
|
|
196,379
|
|
|
|
44
|
%
|
Other
|
|
|
175,465
|
|
|
|
109,241
|
|
|
|
61
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales and services revenue
|
|
$
|
1,645,600
|
|
|
$
|
817,561
|
|
|
|
101
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
S-43
Managements
discussion and analysis of financial condition and results of
operations
Net product sales and services revenue of $1.2 billion and
$511.9 million generated in the United States were
approximately 72% and 63%, respectively, of total net product
sales and services revenue for the year ended December 31,
2008 and 2007, respectively. The growth in net product sales and
services revenue in all geographic regions resulted from the
various acquisitions discussed above and organic growth,
partially offset by the decrease in revenue associated with the
formation of our 50/50 joint venture with P&G in May 2007.
License and Royalty Revenue. License and
royalty revenue represents license and royalty fees from
intellectual property license agreements with third parties.
License and royalty revenue increased by $3.8 million, or
18%, to $25.8 million in 2008, from $22.0 million in
2007. License and royalty revenue for 2008 increased primarily
as a result of our acquisition of Biosite in June 2007, which
contributed an additional $1.9 million of royalty revenue
in excess of those earned in 2007. Additionally, incremental
royalty revenue was derived from new royalty agreements entered
into during 2008, along with increases associated with certain
existing royalty agreements, partially offset by decreases in
other royalty agreements.
Gross Profit and Margin. Gross profit
increased by $466.8 million, or 119%, to
$860.6 million in 2008, from $393.7 million in 2007.
Gross profit during 2008 benefited from higher than average
margins earned on revenue from our recently acquired businesses
and from the favorable impact of our low cost manufacturing
facilities in China. Included in gross profit in 2008 were
restructuring charges totaling $17.9 million associated
with the closure of various manufacturing and operating
facilities, a $2.0 million charge related to the
write-up to
fair market value of inventory acquired in connection with our
first quarter acquisitions of BBI and Panbio, and
$1.5 million of stock-based compensation expense. Included
in gross profit in 2007 were restructuring charges totaling
$2.0 million associated with the closure of various
manufacturing and operating facilities, an $8.2 million
charge related to the
write-up to
fair market value of inventory acquired in connection with our
acquisitions of Biosite, Cholestech and HemoSense and
$0.6 million of stock-based compensation expense. Cost of
net revenue included amortization expense of $43.4 million
and $24.0 million in 2008 and 2007, respectively. Overall
gross margin was 52% in 2008, compared to 47% in 2007.
Gross Profit from Net Product Sales by Business
Segment. Gross profit from net product sales
represents total gross profit less gross profit associated with
services revenue and license and royalty revenue. Gross profit
from net product sales increased by $246.0 million to
$615.5 million in 2008, from $369.5 million in 2007.
Gross profit from net product sales by business segment for 2008
and 2007 is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% increase
|
|
|
|
2008
|
|
|
2007
|
|
|
(decrease)
|
|
|
|
|
Professional diagnostics
|
|
$
|
581,806
|
|
|
$
|
306,710
|
|
|
|
90
|
%
|
Health management
|
|
|
2,729
|
|
|
|
3,076
|
|
|
|
(11
|
)%
|
Consumer diagnostics
|
|
|
23,413
|
|
|
|
52,760
|
|
|
|
(56
|
)%
|
Vitamins and nutritional supplements
|
|
|
7,536
|
|
|
|
6,966
|
|
|
|
8
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit from net product sales
|
|
$
|
615,484
|
|
|
$
|
369,512
|
|
|
|
67
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Professional
diagnostics
Gross profit from our professional diagnostics net product sales
increased by $275.1 million, or 90%, comparing 2008 to
2007, principally as a result of gross profit earned on revenue
from acquired businesses, as discussed above, which contributed
higher than average gross profits. The higher than average
profits were partially offset by a $2.0 million charge
related to the
write-up to
fair market value of inventory acquired in connection with our
acquisitions of BBI and Panbio and $17.9 million in
restructuring charges. Reducing gross profit for 2007 was an
$8.2 million charge related to the
write-up to
fair market value of inventory acquired in connection with our
acquisitions of Biosite, Cholestech and HemoSense and
$0.5 million in restructuring charges.
S-44
Managements
discussion and analysis of financial condition and results of
operations
As a percentage of our professional diagnostics net product
sales, gross profit from our professional diagnostics business
was 58% in 2008, compared to 54% in 2007.
Health
management
Gross profit from our health management net product sales
decreased by $0.3 million, or 11%, to $2.7 million
during 2008, compared to $3.1 million during 2007.
As a percentage of our health management net product sales,
gross profit from our health management business was 15% in
2008, compared to 33% in 2007.
Consumer
diagnostics
Gross profit from our consumer diagnostics net product sales
decreased $29.3 million, or 56%, comparing 2008 to 2007.
The decrease is primarily a result of the formation of our 50/50
joint venture with P&G for our consumer diagnostics
business in May 2007, partially offset by the gross profit
earned on revenue from acquired businesses, primarily our BBI
acquisition and the manufacturing profit associated with
products sold under our manufacturing agreement with the joint
venture. Gross profit for 2007 was adversely impacted by
restructuring charges totaling $1.5 million related to the
formation of the joint venture.
As a percentage of our consumer diagnostics net product sales,
gross profit from our consumer diagnostics business was 18% for
2008, compared to 34% in 2007. The decrease in gross margin
percentage for 2008, as compared to 2007, is driven by the
formation of our 50/50 joint venture with P&G in May 2007.
As a result of the joint venture, our consumer diagnostics net
product sales consist of the manufacturing revenue associated
with our manufacturing agreement with the joint venture, whereby
we manufacture and sell consumer diagnostics to the joint
venture.
Vitamins and
nutritional supplements
Gross profit from our vitamins and nutritional supplements net
product sales increased $0.6 million, or 8%, comparing 2008
to 2007. The increase is primarily the result of higher private
label sales.
As a percentage of our vitamin and nutritional supplements net
product sales, gross profit from our vitamins and nutritional
supplements business was 9% in 2008, compared to 10% in 2007.
Gross Profit from Services Revenue. Gross
profit from services revenue primarily represents gross profit
related to our newly-formed health management business segment
which includes our recent acquisitions of QAS, Alere Medical,
ParadigmHealth and Matria. In addition to the gross profit from
services revenue generated by our health management businesses,
gross profit from services revenue also includes gross profit
generated by our professional drugs of abuse testing and
screening business, along with gross profit associated with our
long-term services agreement related to our consumer diagnostics
joint venture formed with P&G in May 2007, pursuant to
which we provide certain operational support services to the
joint venture. Our gross profit from services revenue was
$228.4 million in 2008 as compared to $11.4 million in
2007.
Gross Profit from Services Revenue by Business
Segment. Gross profit from services revenue was
$228.4 million and $11.4 million in 2008 and 2007,
respectively, and represents gross profit related to services
revenue associated with our newly-formed health management
business segment, which includes our recent acquisitions of QAS,
Alere Medical, ParadigmHealth and Matria, our professional drugs
of abuse testing and screening businesses, and our long-term
services agreement related to our consumer diagnostics
S-45
Managements
discussion and analysis of financial condition and results of
operations
joint venture formed with P&G in May 2007. Gross profit
from services revenue by segment for 2008 and 2007 is as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Professional diagnostics
|
|
$
|
14,380
|
|
|
$
|
|
|
Health management
|
|
|
211,627
|
|
|
|
8,903
|
|
Consumer diagnostics
|
|
|
2,357
|
|
|
|
2,482
|
|
|
|
|
|
|
|
|
|
|
Gross profit from services revenue
|
|
$
|
228,364
|
|
|
$
|
11,385
|
|
|
|
|
|
|
|
|
|
|
Professional
diagnostics
Gross profit from services revenue for our professional
diagnostics business segment was $14.4 million in 2008 and
represents gross profit related to the services provided by our
professional drugs of abuse testing and screening business,
Redwood, which was acquired in December 2007.
As a percentage of our professional diagnostics services
revenue, gross margin for 2008 was 49%.
Health
management
Gross profit from services revenue for our newly-formed health
management business segment was $211.6 million and
$8.9 million in 2008 and 2007, respectively, and represents
gross profit related to the services provided by our health
management businesses, primarily Alere Medical, ParadigmHealth,
QAS and Matria.
As a percentage of our health management services revenue, gross
margin for 2008 and 2007 was 57% and 63%, respectively.
Consumer
diagnostics
Gross profit from services revenue for our consumer diagnostics
business segment was $2.4 million and $2.5 million in
2008 and 2007, respectively, and represents gross profit from
services revenue related to our long-term services agreements
with the joint venture, pursuant to which we provide certain
operational support services to the joint venture. We presently
do not allocate any cost of goods sold to the services revenue
related to this long-term service agreement. All costs for this
segment are recorded in the gross profit from net product sales.
Research and Development Expense. Research and
development expense increased by $42.3 million, or 61%, to
$111.8 million in 2008 from $69.5 million in 2007. The
year over year increase in research and development expense is
primarily the result of increased spending related to our
cardiology research programs, partially offset by the transition
of our consumer-related research and development efforts into
our 50/50 joint venture with P&G. Additionally, our funding
relationship with ITI was complete as of December 31, 2007
and, as such, no funding was earned during 2008. This funding
relationship was reflected as an offset to research and
development expense totaling $18.5 million during 2007.
Also included in research and development expense is
$4.6 million of stock-based compensation expense,
representing an increase of approximately $2.4 million from
2007. Restructuring charges associated with our various
restructuring plans to integrate our newly-acquired businesses
totaling $7.2 million were included in research and
development expense during 2008, representing an increase of
approximately $4.7 million from 2007. Amortization expense
of $3.7 million and $2.9 million was included in
research and development expense for 2008 and 2007, respectively.
Research and development expense as a percentage of net revenue
decreased to 7% for 2008, from 8% for 2007.
S-46
Managements
discussion and analysis of financial condition and results of
operations
Purchase of In-Process Research and Development, or
IPR&D. In connection with two of our
acquisitions since 2007, we have acquired various IPR&D
projects. Substantial additional research and development will
be required prior to any of our acquired IPR&D programs and
technology platforms reaching technological feasibility. In
addition, once research is completed, each product candidate
acquired will need to complete a series of clinical trials and
receive FDA or other regulatory approvals prior to
commercialization. Our current estimates of the time and
investment required to develop these products and technologies
may change depending on the different applications that we may
choose to pursue. We cannot give assurances that these programs
will ever reach technological feasibility or develop into
products that can be marketed profitably. For example, we have
discontinued funding certain of the programs listed below. In
addition, we cannot guarantee that we will be able to develop
and commercialize products before our competitors develop and
commercialize products for the same indications. The following
table sets forth IPR&D projects for companies and certain
assets we have acquired since 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discount rate
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
used in
|
|
|
|
|
|
|
|
Company/
|
|
|
|
|
|
|
|
|
|
estimating
|
|
|
Year of
|
|
|
Estimated
|
|
year assets
|
|
Purchase
|
|
|
|
|
|
Programs
|
|
cash
|
|
|
expected
|
|
|
cost to
|
|
acquired
|
|
price
|
|
|
IPR&D(1)
|
|
|
acquired
|
|
flows(1)
|
|
|
launch
|
|
|
complete
|
|
|
|
|
Diamics/2007
|
|
$
|
4,000
|
|
|
$
|
682
|
|
|
PapMap (Pap Screening Methods)
|
|
|
63
|
%
|
|
|
2009-2010
|
|
|
|
|
|
|
|
|
|
|
|
|
1,049
|
|
|
C-Map (Automated Pap Screening)
|
|
|
63
|
%
|
|
|
2009-2010
|
|
|
|
|
|
|
|
|
|
|
|
|
3,094
|
|
|
POC (Point of Care Systems)
|
|
|
63
|
%
|
|
|
2009-2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
4,825
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
7,476
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Biosite/2007
|
|
$
|
1,800,000
|
|
|
$
|
13,000
|
|
|
Triage Sepsis Panel
|
|
|
15
|
%
|
|
|
2008-2010
|
|
|
|
|
|
|
|
|
|
|
|
|
156,000
|
|
|
Triage NGAL
|
|
|
15
|
%
|
|
|
2008-2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
169,000
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
6,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Management assumes responsibility for determining the
valuation of the acquired IPR&D projects. The fair value
assigned to IPR&D for each acquisition is estimated by
discounting, to present value, the cash flows expected once the
acquired projects have reached technological feasibility. The
cash flows are probability adjusted to reflect the risks of
advancement through the product approval process. In estimating
the future cash flows, we also considered the tangible and
intangible assets required for successful exploitation of the
technology resulting from the purchased IPR&D projects and
adjusted future cash flows for a charge reflecting the
contribution to value of these assets. |
Sales and Marketing Expense. Sales and
marketing expense increased by $218.5 million, or 130%, to
$386.3 million in 2008, from $167.8 million in 2007.
The increase in sales and marketing expense primarily relates to
additional spending related to newly-acquired businesses. Also
included in sales and marketing expense is $4.3 million of
stock-based compensation expense, representing an increase of
approximately $2.6 million from 2007. Partially offsetting
the increases was the favorable impact of the formation of our
50/50 joint venture with P&G. Restructuring charges
associated with our various restructuring plans to integrate our
newly-acquired businesses totaling $4.2 million were
included in sales and marketing expense during 2008,
representing an increase of approximately $3.4 million from
2007. Amortization expense of $148.6 million and
$34.5 million was included in sales and marketing expense
for 2008 and 2007, respectively.
Sales and marketing expense as a percentage of net revenue
increased to 23% for 2008, from 20% for 2007.
General and Administrative Expense. General
and administrative expense increased by $140.2 million, or
89%, to $298.6 million in 2008, from $158.4 million in
2007. The increase in general and administrative expense relates
primarily to additional spending related to newly-acquired
businesses. Legal spending increased by approximately
$9.4 million in 2008, as compared to 2007. Also included in
general and administrative expense is $16.0 million of
stock-based compensation expense, representing a decrease of
S-47
Managements
discussion and analysis of financial condition and results of
operations
approximately $36.9 million from 2007 which included a
charge of $45.2 million related to our acquisition of
Biosite. Partially offsetting the increases was the favorable
impact from the formation of our 50/50 joint venture with
P&G. Amortization expense of $18.4 million and
$0.3 million was included in general and administrative
expense for 2008 and 2007, respectively.
General and administrative expense as a percentage of net
revenue decreased to 18% for 2008, from 19% for 2007.
Interest Expense. Interest expense includes
interest charges and the amortization of deferred financing
costs associated with our debt issuances. Interest expense in
2007 also includes the write-off of deferred financing costs and
early termination fees associated with the repayment of
outstanding debt. Interest expense increased by
$18.1 million, or 22%, to $101.1 million in 2008, from
$83.0 million in 2007. The increase in interest expense in
2008 was due to higher average outstanding borrowing balances in
2008 and $6.6 million in interest expense related to the
accelerated present value accretion of our lease restoration
costs due to the early termination of our facility lease in
Bedford, England recorded in connection with our 2008
restructuring plans. Also contributing to the increase in 2008
was $0.8 million of interest expense recorded in connection
with a legal settlement with one of our distributors in June
2008. Interest expense for 2007 included the write-off of
$15.6 million of deferred financing costs and prepayment
premium related to the repayment of outstanding debt, in
conjunction with our financing arrangements related to our
Biosite acquisition.
Other Income (Expense), Net. Other income
(expense), net, includes interest income, realized and
unrealized foreign exchange gains and losses, and other income
and expense. The components and the respective amounts of other
income (expense), net, are summarized as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
Change
|
|
|
|
|
Interest income
|
|
$
|
6,718
|
|
|
$
|
11,486
|
|
|
$
|
(4,768
|
)
|
Foreign exchange gains (losses), net
|
|
|
(897
|
)
|
|
|
(1,609
|
)
|
|
|
712
|
|
Other
|
|
|
(8,033
|
)
|
|
|
(1,103
|
)
|
|
|
(6,930
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net
|
|
$
|
(2,212
|
)
|
|
$
|
8,774
|
|
|
$
|
(10,986
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net, for 2008 includes a
$12.5 million charge associated with an arbitration
decision, partially offset by $5.5 million of income
associated with settlements of prior years royalties
during 2008.
Other income (expense), net, for 2007 includes a foreign
exchange gain of $1.9 million realized on the settlement of
intercompany notes and $3.9 million in unrealized foreign
currency loss associated with a cash escrow established in
connection with the acquisition of BBI.
(Benefit) Provision for Income
Taxes. (Benefit) provision for income taxes
increased by $15.7 million, to a $16.7 million benefit
in 2008, from a $1.0 million benefit in 2007. The effective
tax rate in 2008 was 43%, compared to 0.4% in 2007. The increase
in the benefit for income taxes from 2007 to 2008 is primarily
related to the recognition of the benefit of losses in Germany,
Japan and the United Kingdom.
The primary components of the 2008 provision for income taxes
relates to U.S. federal and state income taxes, taxes on
foreign income and the recognition of benefit on German and U.K.
losses. The primary components of the 2007 provision for income
taxes relates to the recognition of benefit on U.S. and
U.K. losses, state income taxes and taxes on foreign income. We
recognized the benefit of U.S. net operating loss, or NOL,
carryforwards and other U.S. deferred tax assets due to the
U.S. non-current deferred tax liabilities recorded in
purchase accounting for 2007 acquisitions. During 2007, we
released approximately $83.0 million of valuation allowance
for these pre- acquisition U.S. deferred tax assets, which
was released to goodwill. Thereafter, we recognized a benefit or
recorded a provision, as appropriate, for the current year
U.S. losses.
S-48
Managements
discussion and analysis of financial condition and results of
operations
Net Loss. We incurred a net loss of
$21.8 million in 2008, while we incurred a net loss of
$244.8 million in 2007. Net loss per common share available
to common stockholders was $0.46 per basic and diluted common
share in 2008, as compared to net loss of $4.75 per basic and
diluted common share in 2007. The net loss in 2008 and 2007
resulted from the various factors as discussed above. See
Note 15 of our consolidated financial statements included
elsewhere in this prospectus supplement for the calculation of
net loss per common share.
Year ended
December 31, 2007 compared to year ended December 31,
2006
During 2007 and 2008, we entered the growing health management
market with our acquisitions of QAS, Alere Medical,
ParadigmHealth and more recently Matria. As a result of these
acquisitions, we formed our health management reporting unit in
2008. For presentation and comparative purposes certain amounts
for prior periods have been reclassified to conform to the
current period classification.
Net Product Sales. Net product sales increased
by $248.8 million, or 45%, to $800.9 million in 2007,
from $552.1 million in 2006. Excluding the favorable impact
of currency translation, net product sales in 2007 grew by
approximately $237.8 million, or 43%, over 2006. Of the
currency adjusted increase, revenue increased primarily as a
result of our acquisitions of: (i) First Check, in January
2007, which contributed revenue of $12.9 million,
(ii) Instant, in March 2007, which contributed revenue of
$22.8 million, (iii) Biosite, in June 2007, which
contributed revenue of $167.8 million,
(iv) Cholestech, in September 2007, which contributed
revenue of $24.1 million, (v) Bio-Stat, in October
2007, which contributed revenue of $8.1 million,
(vi) HemoSense, in November 2007, which contributed revenue
of $3.5 million and (vii) various less significant
acquisitions, which contributed an aggregate of
$19.4 million of such increase. Partially offsetting the
increased revenue as a result of acquisitions was the decrease
in revenue associated with the formation of our 50/50 joint
venture with P&G on May 17, 2007 in which we
transferred substantially all of the assets of our consumer
diagnostics business, other than our manufacturing and core
intellectual property assets. Upon completion of the transaction
to form the joint venture, we ceased to consolidate the
operating results of our consumer diagnostics business related
to the joint venture and instead account for our 50% interest in
the results of the joint venture under the equity method of
accounting. We recorded $76.1 million of net product sales
in 2007 (through the date the joint venture was formed), as
compared to $171.6 million of net product sales in 2006.
During 2007, we recorded $65.0 million of manufacturing
revenue associated with our manufacturing agreement with the
joint venture, whereby we manufacture and sell consumer
diagnostics to the joint venture. Organic growth, particularly
from our professional infectious disease and drugs of abuse
products, also contributed to the growth, as well as higher
license and royalty revenue.
Net Product Sales by Business Segment. Net
product sales by business segment for 2007 and 2006 are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% increase
|
|
|
|
2007
|
|
|
2006
|
|
|
(decrease)
|
|
|
|
|
Professional diagnostics
|
|
$
|
565,265
|
|
|
$
|
298,472
|
|
|
|
89
|
%
|
Health management
|
|
|
9,210
|
|
|
|
|
|
|
|
|
%
|
Consumer diagnostics
|
|
|
153,616
|
|
|
|
171,607
|
|
|
|
(11
|
)%
|
Vitamins and nutritional supplements
|
|
|
72,824
|
|
|
|
82,051
|
|
|
|
(11
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales
|
|
$
|
800,915
|
|
|
$
|
552,130
|
|
|
|
45
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Professional
diagnostics
The increase in net product sales from our professional
diagnostics business segment was $266.8 million, or 88%,
comparing 2007 to 2006. Revenue increased primarily as a result
of our acquisitions of: (i) Instant, in March 2007, which
contributed revenue of $22.8 million, (ii) Biosite, in
June 2007, which contributed revenue of $167.8 million,
(iii) Cholestech, in September 2007, which contributed
revenue of $24.1 million,
S-49
Managements
discussion and analysis of financial condition and results of
operations
(iv) Bio-Stat, in October 2007, which contributed revenue
of $8.1 million, (v) HemoSense, in November 2007,
which contributed revenue of $3.5 million and
(vi) various less significant acquisitions, which
contributed an aggregate of $17.2 million of such increase.
Organic growth, particularly from our professional infectious
disease and drugs of abuse products, also contributed to the
growth.
Health
management
Effective January 1, 2008, we formed our health management
business segment which includes the activities of our recent
acquisitions of QAS, which was acquired in June 2007; Alere
Medical, which was acquired in November 2007; and
ParadigmHealth, which was acquired in December 2007. Net product
sales associated with our recently acquired health management
businesses was $9.2 million during 2007.
Consumer
diagnostics
The decrease in net product sales from our consumer diagnostics
business segment was $18.0 million, or 11%, comparing 2007
to 2006. The decrease was primarily driven by the formation of
our 50/50
joint venture with P&G on May 17, 2007 in which we
transferred substantially all of the assets of our consumer
diagnostics business, other than our manufacturing and core
intellectual property assets. Upon completion of the transaction
to form the joint venture, we ceased to consolidate the
operating results of our consumer diagnostics business related
to the joint venture and instead account for our 50% interest in
the results of the joint venture under the equity method of
accounting. Net product sales of our consumer diagnostics for
2007 included $65.0 million of manufacturing revenue
associated with our manufacturing agreement with SPD, whereby we
manufacture and sell consumer diagnostics to the joint venture.
Partially offsetting the impact of the joint venture was
$12.9 million of net product sales from our First Check
consumer drugs of abuse product line which was acquired in
January 2007.
Vitamins and
nutritional supplements
Our vitamins and nutritional supplements net product sales
decreased by $9.2 million, or 11%, comparing 2007 to 2006.
The decrease was driven primarily by our private label business.
Services Revenue. Services revenue of
$16.6 million in 2007 represents revenue related to our
health management businesses, Alere Medical, ParadigmHealth and
QAS, all of which were acquired during 2007.
Net Product Sales and Services Revenue by Geographic
Location. Net product sales and services revenue
by geographic location for 2007 and 2006 are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% Increase
|
|
|
|
2007
|
|
|
2006
|
|
|
(decrease)
|
|
|
|
|
United States
|
|
$
|
511,941
|
|
|
$
|
323,046
|
|
|
|
58
|
%
|
Europe
|
|
|
196,379
|
|
|
|
134,528
|
|
|
|
46
|
%
|
Other
|
|
|
109,241
|
|
|
|
94,556
|
|
|
|
16
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales and services revenue
|
|
$
|
817,561
|
|
|
$
|
552,130
|
|
|
|
48
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales and services revenue of $511.9 million
and $323.0 million generated in the United States were
approximately 63% and 59%, respectively, of total net product
sales and services revenue for the year ended December 31,
2007 and 2006, respectively. The growth in net product sales and
services revenue in all geographic regions resulted from the
various acquisitions discussed above and organic growth,
partially offset by the decrease in revenue associated with the
formation of our
50/50 joint
venture with P&G in May 2007.
License and Royalty Revenue. License and
royalty revenue represents license and royalty fees from
intellectual property license agreements with third parties.
License and royalty revenue increased by $4.7 million, or
27%, to $22.0 million in 2007, from $17.3 million in
2006. The increase primarily relates to $3.9 million of
royalty revenue contributed by Biosite, which was acquired in
June 2007. Additionally,
S-50
Managements
discussion and analysis of financial condition and results of
operations
incremental royalty revenue was derived from new royalty
agreements entered into during 2007, along with increases
associated with certain existing royalty agreements, partially
offset by decreases in other royalty agreements.
Gross Profit and Margin. Gross profit
increased by $164.5 million, or 72%, to $393.7 million
in 2007, from $229.2 million in 2006. Gross profit during
2007 benefited from higher than average margins earned on
revenue from our recently acquired businesses and from the
favorable impact of our low cost manufacturing facilities in
China. Included in cost of net revenue in 2007 were
restructuring charges totaling $2.0 million associated with
our joint venture related restructuring plans, a charge of
$8.2 million associated with the
write-up of
inventory acquired to fair value in connection with our
acquisitions of Biosite, Cholestech and HemoSense, and
$0.6 million of stock-based compensation expense.
Additionally, gross profit in 2007 was unfavorably impacted by
the formation of our
50/50 joint
venture with P&G. Included in cost of net revenue during
2006 was a restructuring charge of $9.5 million related to
the closure of our ABI operation in San Diego, California,
along with the write-off of fixed assets at other facilities
impacted by our 2006 restructuring plans and the closure of
CDIL, our manufacturing facility in Galway, Ireland. Cost of net
revenue during 2006 also included a $0.4 million charge for
stock-based compensation expense. Cost of net revenue included
amortization expense of $24.0 million and
$11.2 million in 2007 and 2006, respectively.
Overall gross margin was 47% in 2007, compared to 40% in 2006.
Gross Profit from Net Product Sales by Business
Segment. Gross profit from net product sales
represents total gross profit less gross profit associated with
services revenue and license and royalty revenue. Gross profit
from net product sales increased by $152.2 million to
$369.5 million in 2007, from $217.3 million in 2006.
Gross profit from net product sales by business segment for 2007
and 2006 is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
% Increase
|
|
|
|
2007
|
|
|
2006
|
|
|
(decrease)
|
|
|
|
|
Professional diagnostics
|
|
$
|
306,710
|
|
|
$
|
129,636
|
|
|
|
137
|
%
|
Health management
|
|
|
3,076
|
|
|
|
|
|
|
|
|
%
|
Consumer diagnostics
|
|
|
52,760
|
|
|
|
82,658
|
|
|
|
(36
|
)%
|
Vitamins and nutritional supplements
|
|
|
6,966
|
|
|
|
5,037
|
|
|
|
38
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit from net product sales
|
|
$
|
369,512
|
|
|
$
|
217,331
|
|
|
|
70
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Professional
diagnostics
Gross profit from our professional diagnostics net product sales
increased by $177.1 million, or 137%, comparing 2007 to
2006, principally as a result of gross profit earned on revenue
from acquired businesses, as discussed above, which contributed
higher than average gross profits. The higher than average
profits were partially offset by an $8.2 million charge
associated with the
write-up of
inventory acquired to fair value in connection with our
acquisitions of Biosite, Cholestech and HemoSense,
$0.5 million in restructuring charges and $0.3 million
of stock-based compensation expense. Reducing gross profit for
2006 was a $7.2 million restructuring charge associated
with managements decision to close our ABI operations in
San Diego, California.
As a percentage of our professional diagnostics net product
sales, gross profit from our professional diagnostics business
was 54% in 2007, compared to 43% in 2006.
Health
management
Effective January 1, 2008, we formed our health management
business segment which includes the activities of our recent
acquisitions of QAS, which was acquired in June 2007; Alere
Medical, which was acquired in
S-51
Managements
discussion and analysis of financial condition and results of
operations
November 2007; and ParadigmHealth, which was acquired in
December 2007. Net product sales associated with our
recently-acquired health management businesses was
$3.1 million during 2007.
As a percentage of our health management net product sales,
gross margin for 2007 was 33%.
Consumer
diagnostics
Gross profit from our consumer diagnostics net product sales
decreased $29.9 million, or 36%, comparing 2007 to 2006.
The decrease is primarily a result of the formation of our 50/50
joint venture with P&G for our consumer diagnostics
business in May 2007, partially offset by the gross profit
earned on revenue from acquired businesses, primarily our First
Check acquisition, as discussed above; the 5%
mark-up on
products sold under our manufacturing agreement with the joint
venture, a restructuring charge of $1.5 million associated
with the decision to close facilities and the formation of our
joint venture with P&G and $0.3 million of stock-based
compensation expense. Gross profit for 2006 was adversely
impacted by restructuring charges totaling $2.2 million
related to the closure of our CDIL manufacturing facility and
$0.4 million of stock-based compensation expense.
As a percentage of our consumer diagnostics net product sales,
gross profit from our consumer diagnostics business was 34% for
2007, compared to 48% in 2006.
Vitamins and
nutritional supplements
Gross profit from our vitamins and nutritional supplements net
product sales increased $1.9 million, or 38%, comparing
2007 to 2006. The increase is primarily the result of improved
customer mix, improved factory utilization and our cost
reduction initiatives in our private label manufacturing
business.
As a percentage of our vitamins and nutritional supplements net
product sales, gross profit from our vitamins and nutritional
supplements business was 10% in 2007, compared to 6% in 2006.
Gross Profit from Services Revenue. Gross
profit from services revenue was $11.4 million in 2007, and
represents gross profit related to services revenue associated
with our newly-formed health management business segment, which
includes our recent acquisitions of QAS, Alere Medical,
ParadigmHealth and Matria, our professional drugs of abuse
testing and screening businesses, and our long-term services
agreement related to our consumer diagnostics joint venture
formed with P&G in May 2007.
Research and Development Expense. Research and
development expense increased by $20.8 million, or 43%, to
$69.5 million in 2007, from $48.7 million in 2006.
Research and development expense in 2007 and 2006 is reported
net of co-development funding of $18.5 million and
$16.6 million, respectively, arising from the
co-development funding arrangement that we entered into with ITI
in February 2005. The year over year increase in research and
development expense is primarily the result of increased
spending related to our cardiology research programs and
$21.5 million of spending related to our 2007 acquisitions,
partially offset by the transition of our consumer-related
research and development efforts into our 50/50 joint venture
with P&G in the second quarter of 2007. Also included in
research and development expense is $2.2 million of
stock-based compensation expense, representing an increase of
approximately $0.8 million from 2006. Restructuring charges
associated with the formation of our 50/50 joint venture and our
2007 restructuring plan to integrate our newly-acquired
businesses totaling $2.5 million were included in research
and development expense during 2007. Amortization expense of
$2.9 million and $3.3 million was included in research
and development expense for 2007 and 2006, respectively.
Research and development expense as a percentage of net product
revenue decreased to 9% for 2007, from 10% for 2006.
Purchase of In-Process Research and
Development. In connection with three of our
acquisitions since 2006, we have acquired various IPR&D
projects. Substantial additional research and development will
be required prior to any of our acquired IPR&D programs and
technology platforms reaching technological feasibility. In
S-52
Managements
discussion and analysis of financial condition and results of
operations
addition, once research is completed, each product candidate
acquired will need to complete a series of clinical trials and
receive FDA or other regulatory approvals prior to
commercialization. Our current estimates of the time and
investment required to develop these products and technologies
may change depending on the different applications that we may
choose to pursue. We cannot give assurances that these programs
will ever reach technological feasibility or develop into
products that can be marketed profitably. For example, we have
discontinued funding certain of the programs listed below. In
addition, we cannot guarantee that we will be able to develop
and commercialize products before our competitors develop and
commercialize products for the same indications. If products
based on our acquired IPR&D programs and technology
platforms do not become commercially viable, our results of
operations could be materially adversely affected. The following
table sets forth IPR&D projects for companies and certain
assets we have acquired since 2006 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discount rate
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
used in
|
|
|
|
|
|
|
|
Company/
|
|
|
|
|
|
|
|
|
|
estimating
|
|
|
Year of
|
|
|
Estimated
|
|
year assets
|
|
Purchase
|
|
|
|
|
|
|
|
cash
|
|
|
expected
|
|
|
cost to
|
|
acquired
|
|
price
|
|
|
IPR&D(1)
|
|
|
Programs
acquired
|
|
flows(1)
|
|
|
launch
|
|
|
complete
|
|
|
|
|
Diamics/2007
|
|
$
|
4,000
|
|
|
$
|
682
|
|
|
PapMap (Pap Screening Methods)
|
|
|
63
|
%
|
|
|
2009-2010
|
|
|
|
|
|
|
|
|
|
|
|
|
1,049
|
|
|
C-Map (Automated Pap Screening)
|
|
|
63
|
%
|
|
|
2009-2010
|
|
|
|
|
|
|
|
|
|
|
|
|
3,094
|
|
|
POC (Point of Care Systems)
|
|
|
63
|
%
|
|
|
2009-2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
4,825
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
7,476
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Biosite/2007
|
|
$
|
1,800,000
|
|
|
$
|
13,000
|
|
|
Triage Sepsis Panel
|
|
|
15
|
%
|
|
|
2008-2010
|
|
|
|
|
|
|
|
|
|
|
|
|
156,000
|
|
|
Triage NGAL
|
|
|
15
|
%
|
|
|
2008-2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
169,000
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
6,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clondiag/2006
|
|
$
|
24,000
|
|
|
$
|
1,800
|
|
|
CHF (Congestive Heart Failure)
|
|
|
37
|
%
|
|
|
2008-2009
|
|
|
|
|
|
|
|
|
|
|
|
|
2,500
|
|
|
ACS (Acute Coronary Syndrome)
|
|
|
37
|
%
|
|
|
2009-2010
|
|
|
|
|
|
|
|
|
|
|
|
|
660
|
|
|
HIV (Human Immuno-deficiency Virus)
|
|
|
37
|
%
|
|
|
2008-2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
4,960
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
9,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Management assumes responsibility for determining the
valuation of the acquired IPR&D projects. The fair value
assigned to IPR&D for each acquisition is estimated by
discounting, to present value, the cash flows expected once the
acquired projects have reached technological feasibility. The
cash flows are probability adjusted to reflect the risks of
advancement through the product approval process. In estimating
the future cash flows, we also considered the tangible and
intangible assets required for successful exploitation of the
technology resulting from the purchased IPR&D projects and
adjusted future cash flows for a charge reflecting the
contribution to value of these assets. |
Sales and Marketing Expense. Sales and
marketing expense increased by $73.3 million, or 78%, to
$167.8 million in 2007, from $94.4 million in 2006.
The increase in sales and marketing expense is primarily the
result of approximately $56.1 million of additional
spending related to newly-acquired businesses, primarily
Biosite, Instant, Cholestech and the various less significant
acquisitions. Also included in sales and marketing expense is
$1.7 million of stock-based compensation expense,
representing an increase of approximately $1.0 million from
2006. Partially offsetting the increases was the favorable
impact of the formation of our 50/50 joint venture with
P&G. Amortization expense of $36.9 million and
$6.8 million was included in sales and marketing expense
for 2007 and 2006, respectively.
Sales and marketing expense as a percentage of net product sales
and services revenue increased to 21% for 2007, from 17% for
2006.
General and Administrative Expense. General
and administrative expense increased by $87.2 million, or
122%, to $158.4 million in 2007, from $71.2 million in
2006. The increase in general and administrative
S-53
Managements
discussion and analysis of financial condition and results of
operations
expense is primarily the result of approximately
$26.9 million of additional spending related to
newly-acquired businesses, primarily Biosite, Instant,
Cholestech and the various less significant acquisitions. Also
included in general and administrative expense is
$53.0 million of stock-based compensation expense,
representing an increase of approximately $50.0 million
from 2006. The $53.0 million stock-based compensation
expense includes a one-time charge of $45.2 million
associated with the stock option acceleration and conversion in
connection with the acquisition of Biosite. Partially offsetting
the increases was the favorable impact of the formation of our
50/50 joint venture with P&G. Amortization expense of
$0.3 million and $0.4 million was included in general
and administrative expense for 2007 and 2006, respectively.
General and administrative expense as a percentage of net
product sales and services revenue increased to 19% for 2007,
from 13% for 2006.
Interest Expense. Interest expense in 2007
includes interest charges, amortization of deferred financing
costs, prepayment premiums and the amortization of non-cash
discounts associated with our debt issuances. Interest expense
for 2006 includes interest charges, the write-off and
amortization of deferred financing costs and the amortization of
non-cash discounts associated with our debt issuances in 2004.
Interest expense increased by $56.4 million, or 212%, to
$83.0 million in 2007, from $26.6 million in 2006.
Interest expense increased in 2007 as a result of higher debt
balances than in the prior period. Additionally, in 2007 we
recorded a write-off of $15.6 million of deferred financing
costs and prepayment premium related to the repayment of
outstanding debt, in conjunction with our financing arrangements
related to our Biosite acquisition. In 2006, we recorded a
charge of $1.3 million related to prepayment penalties and
the write-off of debt origination costs resulting from the early
repayment of our $20.0 million, 10% subordinated
promissory notes on September 8, 2006.
Other Income (Expense), Net. Other income
(expense), net, includes interest income, realized and
unrealized foreign exchange gains and losses, and other income
and expense. The components and the respective amounts of other
income (expense), net, are summarized as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007
|
|
|
2006
|
|
|
Change
|
|
|
|
|
Interest income
|
|
$
|
11,486
|
|
|
$
|
1,693
|
|
|
$
|
9,793
|
|
Foreign exchange gains (losses), net
|
|
|
(1,609
|
)
|
|
|
2,643
|
|
|
|
(4,252
|
)
|
Other
|
|
|
(1,103
|
)
|
|
|
4,412
|
|
|
|
(5,515
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net
|
|
$
|
8,774
|
|
|
$
|
8,748
|
|
|
$
|
26
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net, for 2007 includes a foreign
exchange gain of $1.9 million realized on the settlement of
intercompany notes and $3.9 million in unrealized foreign
currency loss associated with a cash escrow established in
connection with the acquisition of BBI.
Other income (expense), net, for 2006 includes a foreign
exchange gain of $4.3 million associated with the closure
of our Galway, Ireland manufacturing operation and
$4.7 million in other income, related to the portion of our
settlement with Vedalab S.A., relating to periods prior to 2006.
(Benefit) Provision for Income
Taxes. (Benefit) provision for income taxes
decreased by $6.7 million, to a $1.0 million benefit
in 2007, from a $5.7 million provision in 2006. The
effective tax rate in 2007 was 0.4%, compared to (52)% in 2006.
The decrease in the provision for income taxes from 2006 to 2007
is primarily related to the recognition of the benefit of
current year losses in the U.S. and the United Kingdom.
The primary components of the 2007 provision for income taxes
relates to the recognition of benefit on U.S. and U.K.
losses, state income taxes, and taxes on foreign income. We
recognized the benefit of U.S. NOL carryforwards and other
U.S. deferred tax assets due to the U.S. non-current
deferred tax liabilities recorded in purchase accounting for
2007 acquisitions. We released approximately $83.0 million
of valuation allowance for these U.S. deferred tax assets,
which was released to goodwill. Thereafter, we recognized a
benefit for the current year U.S. losses. The primary
components of the 2006 provision for income taxes are
S-54
Managements
discussion and analysis of financial condition and results of
operations
related to the recognition of U.S. deferred tax liabilities
for temporary differences between the book and tax bases of
goodwill and certain intangible assets with indefinite lives and
to taxes on foreign income.
Net Loss. We incurred a net loss of
$244.8 million in 2007, while we incurred a net loss of
$16.8 million in 2006. Net loss per common share available
to common stockholders was $4.75 per basic and diluted common
share in 2007, as compared to net loss of $0.49 per basic and
diluted common share in 2006. The net loss in 2007 and 2006
resulted from the various factors as discussed above. See
Note 15 of our consolidated financial statements included
elsewhere in this prospectus supplement for the calculation of
net loss per common share.
LIQUIDITY AND
CAPITAL RESOURCES
Based upon our current working capital position, current
operating plans and expected business conditions, we currently
expect to fund our short and long-term working capital needs and
other commitments primarily through our operating cash flow, and
we expect our working capital position to improve as we improve
our operating margins and grow our business through new product
introductions and by continuing to leverage our strong
intellectual property position. At this point in time, our
liquidity has not been materially impacted by the recent and
unprecedented disruption in the current capital and credit
markets and we do not expect that it will be materially impacted
in the near future. However, because of the unprecedented nature
and severity of the ongoing financial crisis in the capital and
credit markets, we cannot predict with certainty the ultimate
impact of these events on us. We will therefore continue to
closely monitor our liquidity and capital resources.
In addition, we may also utilize our revolving credit facility,
or other sources of financing, to fund a portion of our capital
needs and other future commitments, including future
acquisitions. If the capital and credit markets continue to
experience volatility and the availability of funds remains
limited, we may incur increased costs associated with issuing
commercial paper
and/or other
debt instruments. In addition, it is possible that our ability
to access the capital and credit markets may be limited by these
or other factors at a time when we would like, or need, to do
so, which could have an impact on our ability to refinance
maturing debt
and/or react
to changing economic and business conditions.
Our funding plans for our working capital needs and other
commitments may be adversely impacted by unexpected costs
associated with prosecuting and defending our existing lawsuits
and/or
unforeseen lawsuits against us, integrating the operations of
newly-acquired companies and executing our cost savings
strategies. We also cannot be certain that our underlying
assumed levels of revenues and expenses will be realized. In
addition, we intend to continue to make significant investments
in our research and development efforts related to the
substantial intellectual property portfolio we own. We may also
choose to further expand our research and development efforts
and may pursue the acquisition of new products and technologies
through licensing arrangements, business acquisitions, or
otherwise. We may also choose to make significant investment to
pursue legal remedies against potential infringers of our
intellectual property. If we decide to engage in such
activities, or if our operating results fail to meet our
expectations, we could be required to seek additional funding
through public or private financings or other arrangements. In
such event, adequate funds may not be available when needed, or,
may be available only on terms which could have a negative
impact on our business and results of operations. In addition,
if we raise additional funds by issuing equity or convertible
securities, dilution to then existing stockholders may result.
As of December 31, 2008, in addition to other indebtedness,
we had approximately $1.1 billion in aggregate principal
amount of indebtedness outstanding under our senior secured
credit facility, $250.0 million in aggregate principal
amount of indebtedness outstanding under our junior secured
credit facility, and $150.0 million in indebtedness under
our outstanding senior subordinated convertible notes. Included
in the secured credit facilities is a revolving line-of-credit
of $150.0 million, of which $142.0 million was
outstanding as of December 31, 2008.
S-55
Managements
discussion and analysis of financial condition and results of
operations
Interest accrues on indebtedness arising under the senior
secured credit facility as follows: (i) in the case of Base
Rate Loans, at a rate per annum equal to the sum of the Base
Rate and the Applicable Margin, each as in effect from time to
time, (ii) in the case of Eurodollar Rate Loans, at a rate
per annum equal to the sum of the Eurodollar Rate and the
Applicable Margin, each as in effect for the applicable Interest
Period, and (iii) in the case of other Obligations, at a
rate per annum equal to the sum of the Base Rate and the
Applicable Margin for Revolving Loans that are Base Rate Loans,
each as in effect from time to time. The Base Rate is a floating
rate which approximates the U.S. Prime rate and changes on
a periodic basis. The Eurodollar Rate is equal to the LIBOR rate
and is set for a period of one to three months at our election.
Applicable margin with respect to Base Rate Loans is 1.00% and
with respect to Eurodollar Rate Loans is 2.00%. Applicable
margin ranges for our revolving line-of-credit with respect to
Base Rate Loans is 0.75% to 1.25% and with respect to Eurodollar
Rate Loans is 1.75% to 2.25%.
The outstanding indebtedness under the junior secured credit
facility is a term loan in the amount of $250.0 million.
Interest on this term loan, as defined in the credit agreement,
is as follows: (i) in the case of Base Rate Loans, at a
rate per annum equal to the sum of the Base Rate and the
Applicable Margin, each as in effect from time to time,
(ii) in the case of Eurodollar Rate Loans, at a rate per
annum equal to the sum of the Eurodollar Rate and the Applicable
Margin, each as in effect for the applicable Interest Period,
and (iii) in the case of other Obligations, at a rate per
annum equal to the sum of the Base Rate and the Applicable
Margin for Base Rate Loans, as in effect from time to time.
Applicable margin with respect to Base Rate Loans is 3.25% and
with respect to Eurodollar Rate Loans is 4.25%.
For the year ended December 31, 2008, interest expense,
including amortization of deferred financing costs, under the
secured credit facilities was $85.2 million. As of
December 31, 2008, accrued interest related to the secured
credit facilities amounted to $3.4 million. As of
December 31, 2008, we were in compliance with all debt
covenants related to the above debt, which consisted principally
of maximum consolidated leverage and minimum interest coverage
requirements.
Interest expense related to our senior subordinated convertible
notes for the year ended December 31, 2008, including
amortization of deferred financing costs, was $5.0 million.
As of December 31, 2008, accrued interest related to the
senior subordinated convertible notes amounted to
$0.6 million.
In August 2007, we entered into interest rate swap contracts,
with an effective date of September 28, 2007, that have a
total notional value of $350.0 million and have a maturity
date of September 28, 2010. These interest rate swap
contracts pay us variable interest at the three-month LIBOR
rate, and we pay the counterparties a fixed rate of 4.85%. These
interest rate swap contracts were entered into to convert
$350.0 million of the $1.2 billion variable rate term
loan under the secured credit facility into fixed rate debt.
In January 2009, we entered into interest rate swap contracts,
with an effective date of January 14, 2009, that have a
total notional value of $500.0 million and have a maturity
date of January 5, 2011. These interest rate swap contracts
pay us variable interest at the one-month LIBOR rate, and we pay
the counterparties a fixed rate of 1.195%. These interest rate
swap contracts were entered into to convert $500.0 million
of the $1.2 billion variable rate term loan under the
secured credit facility into fixed rate debt.
As of December 31, 2008, we had 1.9 million shares of
our Series B preferred stock issued and outstanding. Upon a
conversion of these shares of Series B preferred stock, we
may, at our option and in our sole discretion, satisfy the
entire conversion obligation in cash, or through a combination
of cash and common stock, to the extent permitted under our
secured credit facilities and under Delaware law.
Summary of
changes in cash position
As of December 31, 2008, we had cash and cash equivalents
of $141.3 million, a $273.4 million decrease from
December 31, 2007. Our primary sources of cash during the
year ended December 31, 2008 included $147.8 million
generated by our operating activities, $20.7 million from
common stock issues under employee stock option and stock
purchase plans, $137.2 million from borrowing under our
existing credit facilities, and a decrease of
$139.2 million in restricted cash. Investing activities
during the year ended
S-56
Managements
discussion and analysis of financial condition and results of
operations
December 31, 2008 used a total of $713.3 million of
cash, net of cash acquired, primarily related to our acquisition
activities and capital expenditures. Our financing activities,
aside from the decrease in restricted cash, proceeds from
borrowings under our secured credit facilities and cash received
from common stock issues under employee stock option and stock
purchase plans, used $15.1 million of cash related to
repayments under our secured credit facilities and capital lease
obligations. Fluctuations in foreign currencies negatively
impacted our cash balance by $5.7 million during the year
ended December 31, 2008.
Operating cash
flows
Net cash provided by operating activities during the year ended
December 31, 2008 was $147.8 million, which resulted
from $287.0 million of non-cash items, offset by our net
loss of $21.8 million and $117.4 million of cash used
to meet net working capital requirements during the period. The
$287.0 million of non-cash items included
$267.9 million related to depreciation and amortization,
$24.2 million related to the impairment of assets,
$26.4 million related to non-cash stock-based compensation
expense and $5.9 million related to the amortization of
deferred financing costs, partially offset by a
$41.8 million decrease related to the recognition of a tax
benefit for current year losses and a $1.1 million decrease
related to equity investments in unconsolidated entities.
Investing cash
flows
Our investing activities during the year ended December 31,
2008 utilized $713.3 million of cash, including
$649.9 million used for acquisitions and
transaction-related costs, net of cash acquired,
$65.0 million of capital expenditures, net of proceeds from
sale of equipment, partially offset by a $1.6 million
decrease in investments and other assets, which included an
$11.2 million return of cash from our 50/50 joint venture
with P&G.
The acquisitions of Matria, BBI and Panbio during 2008 accounted
for approximately $576.5 million of the $649.9 million
of cash used for acquisitions.
Financing cash
flows
Net cash provided by financing activities during the year ended
December 31, 2008 was $297.8 million. During 2007, in
connection with our acquisition of BBI, a restricted cash
balance was created in the amount of approximately
$140.5 million. Subsequent to the acquisition of BBI in
February 2008, this cash balance became unrestricted and
available for future financing-related activities. Additionally,
financing activities provided $20.7 million from issuance of
common stock under employee stock option and stock purchase
plans, as well as $137.2 million from borrowings under
existing credit facilities.
As of December 31, 2008, we had an aggregate of
$1.0 million in outstanding capital lease obligations which
are payable through 2013.
Income
taxes
As of December 31, 2008, we had approximately
$256.6 million of domestic NOL carryforwards and
$15.9 million of foreign NOL carryforwards, respectively,
which either expire on various dates through 2027 or may be
carried forward indefinitely. These losses are available to
reduce federal, state and foreign taxable income, if any, in
future years. These losses are also subject to review and
possible adjustments by the applicable taxing authorities. In
addition, the domestic NOL carryforward amount at
December 31, 2008 included approximately
$199.2 million of pre-acquisition losses at Matria, Alere
Medical, Paradigm Health, Biosite, Cholestech, Diamics, Inc., or
Diamics, HemoSense, IMN, Ischemia and Ostex. Prior to adoption
of Statement of Financial Accounting Standards, or SFAS,
No. 141-R,
Business Combinations, these losses were applied first to
reduce to zero any goodwill and other non-current intangible
assets related to the acquisitions, prior to reducing our income
tax expense. Upon adoption of
SFAS No. 141-R
the reduction of a valuation allowance is generally recorded to
reduce our income tax expense. Also included in our domestic
S-57
Managements
discussion and analysis of financial condition and results of
operations
NOL carryforwards at December 31, 2008 is approximately
$17.5 million resulting from the exercise of employee stock
options, the tax benefit of which, when recognized, will be
accounted for as a credit to additional paid-in capital rather
than a reduction of income tax.
Furthermore, all domestic losses are subject to the Internal
Revenue Service Code Section 382 limitation and may be
limited in the event of certain cumulative changes in ownership
interests of significant shareholders over a three-year period
in excess of 50%. Section 382 imposes an annual limitation
on the use of these losses to an amount equal to the value of
the company at the time of the ownership change multiplied by
the long term tax exempt rate. We have recorded a valuation
allowance against a portion of the deferred tax assets related
to our NOLs and certain of our other deferred tax assets
to reflect uncertainties that might affect the realization of
such deferred tax assets, as these assets can only be realized
via profitable operations.
OFF-BALANCE SHEET
ARRANGEMENTS
We had no material off-balance sheet arrangements as of
December 31, 2008.
CONTRACTUAL
OBLIGATIONS
The following table summarizes our principal contractual
obligations as of December 31, 2008 and the effects such
obligations are expected to have on our liquidity and cash flow
in future periods (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments due by
period
|
|
Contractual
obligations
|
|
Total
|
|
|
2009
|
|
|
2010-2011
|
|
|
2012-2013
|
|
|
Thereafter
|
|
|
|
|
Long-term debt
obligations(1)
|
|
$
|
1,519,615
|
|
|
$
|
19,058
|
|
|
$
|
26,530
|
|
|
$
|
20,027
|
|
|
$
|
1,454,000
|
|
Capital lease
obligations(2)
|
|
|
973
|
|
|
|
495
|
|
|
|
446
|
|
|
|
32
|
|
|
|
|
|
Operating lease
obligations(3)
|
|
|
94,382
|
|
|
|
25,377
|
|
|
|
34,539
|
|
|
|
20,996
|
|
|
|
13,470
|
|
Long-term and other
liabilities(4)
|
|
|
3,403
|
|
|
|
469
|
|
|
|
938
|
|
|
|
938
|
|
|
|
1,058
|
|
Minimum royalty obligations
|
|
|
220
|
|
|
|
220
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquisition-related
obligations(5)
|
|
|
6,473
|
|
|
|
5,428
|
|
|
|
1,045
|
|
|
|
|
|
|
|
|
|
Purchase obligationscapital expenditure
|
|
|
17,492
|
|
|
|
17,492
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase
obligationsother(6)
|
|
|
69,763
|
|
|
|
68,996
|
|
|
|
767
|
|
|
|
|
|
|
|
|
|
Interest on
debt(7)
|
|
|
33,177
|
|
|
|
4,500
|
|
|
|
9,000
|
|
|
|
9,000
|
|
|
|
10,677
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$
|
1,745,498
|
|
|
$
|
142,035
|
|
|
$
|
73,265
|
|
|
$
|
50,993
|
|
|
$
|
1,479,205
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
See description of various financing arrangements in this
section and Note 6 of our consolidated financial statements
included elsewhere in this prospectus supplement. |
|
(2) |
|
See Note 8 of our consolidated financial statements
included elsewhere in this prospectus supplement. |
|
(3) |
|
See Note 11(a) of our consolidated financial statements
included elsewhere in this prospectus supplement. |
|
(4) |
|
Included in long-term and other liabilities are
$0.2 million in technology license payment obligations and
$3.4 million in pension obligations. Our liability
associated with Financial Accounting Standards Board, or FASB,
Interpretation No. 48, or FIN 48, Accounting for
Uncertainty in Income Taxesan interpretation of FASB
Statement 109, has not been included in the table above, as
we estimate payments annually. |
|
(5) |
|
Amounts represent obligations associated with our
acquisitions which are discussed in more detail below. |
|
(6) |
|
Other purchase obligations relate to inventory purchases and
other operating expense commitments. |
|
(7) |
|
Amounts are based on $150.0 million senior subordinated
notes. Amounts exclude interest on all other debt due to
variable interest rates. See Note 6 of our consolidated
financial statements included elsewhere in this prospectus
supplement. |
S-58
Managements
discussion and analysis of financial condition and results of
operations
We have contingent consideration contractual terms related to
our acquisitions of Alere Medical, Ameditech, Binax, Inc., or
Binax, Bio-Stat, CLONDIAG chip technologies GmbH, or Clondiag,
Diamics, First Check, Gabmed GmbH, or Gabmed, Global Diagnostics
CC, or Global, Matritech, Promesan S.r.l., or Promesan, Spectral
Diagnostics Private Limited and its affiliate Source Diagnostics
(India) Private Limited, or Spectral/Source, Vision Biotech Pty
Ltd, or Vision, and our most recently acquired healthcare
business. With the exception of Alere Medical, the contingent
considerations will be accounted for as increases in the
aggregate purchase prices if and when the contingencies occur.
With respect to Alere Medical, the terms of the acquisition
agreement provided for contingent consideration payable to each
Alere Medical stockholder who owned shares of our common stock
or retained the option to purchase shares of our common stock on
the six-month anniversary of the closing of the acquisition. The
contingent consideration, payable in cash or stock at our
election, was equal to the number of such shares of our common
stock or options to purchase our common stock held on the
six-month anniversary multiplied by the amount that $58.31
exceeded the greater of the average price of our common stock
for the ten business days preceding the six-month anniversary
date, or 75% of $58.31. Accordingly, based on the price of our
common stock for the ten business days preceding the six-month
anniversary of the closing of the acquisition, we issued
approximately 0.1 million shares of our common stock on
May 30, 2008 to the Alere Medical stockholders based on the
remaining outstanding shares at that time. Payment of this
contingent consideration did not impact the purchase price for
this acquisition.
With respect to Ameditech, the terms of the acquisition
agreement require us to pay an earn-out upon successfully
meeting certain revenue targets for the one-year period ending
on the first anniversary of the acquisition date and the
one-year period ending on the second anniversary of the
acquisition date. The maximum amount of incremental
consideration payable is $4.0 million.
With respect to Binax, the terms of the acquisition agreement
provide for $11.0 million of contingent cash consideration
payable to the Binax shareholders upon the successful completion
of certain new product developments during the five years
following the acquisition. As of December 31, 2008, the
remaining contingent consideration to be earned is approximately
$7.3 million.
With respect to Bio-Stat, the terms of the acquisition provided
for contingent consideration payable in the form of loan notes
to the Bio-Stat shareholders, if certain EBITDA (earnings before
interest, taxes, depreciation and amortization) milestones were
met for 2007. The EBITDA milestones were met in 2007 and loan
notes totaling £3.4 million ($6.2 million) were
issued during the third quarter of 2008. As of December 31,
2008, the loan notes remain outstanding with an approximate
value of $4.9 million.
With respect to Clondiag, the terms of the acquisition agreement
provided for $8.9 million of contingent consideration,
consisting of approximately 0.2 million shares of our
common stock and approximately $3.0 million of cash or
stock in the event that four specified products were developed
on Clondiags platform technology during the three years
following the acquisition date. Successful completion of the
second milestone occurred during the first quarter of 2008 for
which we made a payment for $0.9 million and issued
56,080 shares of our common stock during the first quarter
of 2008. Successful completion of the third and fourth
milestones occurred during the third quarter of 2008 for which
we made payment for $1.6 million and issued
0.1 million shares of our common stock during the fourth
quarter of 2008. No further milestones exist.
With respect to Diamics, the terms of the acquisition agreement
provide for contingent consideration payable upon the successful
completion of certain milestones, including development of
business plans and marketable products. As of December 31,
2008, the remaining contingent consideration to be earned is
approximately $2.3 million.
With respect to First Check, the terms of the acquisition
agreement required us to pay an earn-out to First Check equal to
the incremental revenue growth of the acquired products for 2007
and for the first nine months of 2008, as compared to the
immediately preceding comparable periods. The
2007 milestone, totaling
S-59
Managements
discussion and analysis of financial condition and results of
operations
$2.2 million, was met and accrued as of December 31,
2007 and was paid during the first quarter of 2008. The
2008 milestone, totaling $0.3 million, was met and
accrued during the third quarter of 2008 and was paid in the
fourth quarter of 2008. No further milestones exist.
With respect to Gabmed, the terms of the acquisition agreement
provide for contingent consideration totaling up to
750,000 payable in up to five annual amounts beginning in
2007, upon successfully meeting certain revenue and EBIT
(earnings before interest and taxes) milestones in each of the
respective annual periods. The 2007 milestone, totaling
0.1 million ($0.2 million), was met and accrued
as of June 30, 2008 and was paid during the third quarter
of 2008.
With respect to Global, the terms of the acquisition agreement
provided for contingent consideration payable upon successfully
meeting certain revenue targets in 2008. As of December 31,
2008, the 2008 revenue targets were met resulting in accrued
contingent consideration totaling $0.2 million. No further
milestones exist.
With respect to Matritech, the terms of the acquisition
agreement required us to pay an earn-out to the former Matritech
shareholders upon successfully meeting certain revenue targets
in 2008. As of December 31, 2008, the milestones were not
achieved. No further milestones exits.
With respect to Promesan, the terms of the acquisition agreement
provide for contingent consideration payable upon successfully
meeting certain annual revenue targets. Total contingent
consideration of up to 0.6 million is payable in
three equal annual amounts of 0.2 million beginning
in 2007 and ending in 2009. The 2007 milestone, totaling
0.2 million ($0.3 million), was met and accrued
as of December 31, 2007 and was paid during the first
quarter of 2008. The 2008 milestone, totaling
0.2 million ($0.3 million), was met and accrued
as of December 31, 2008.
With respect to Spectral/Source, the terms of the acquisition
agreement required us to pay an earn-out equal to two times the
consolidated revenue of Spectral/Source less $4.0 million,
if the consolidated profits before tax of Spectral/Source was at
least $0.9 million on the one year anniversary
(milestone period) following the acquisition date.
If consolidated profits before tax of Spectral/Source for the
milestone period were less than $0.9 million, then the
amount of the payment would be equal to seven times
Spectral/Sources consolidated profits before tax less
$4.0 million. The contingent consideration was payable 60%
in cash and 40% in stock. The revenue and profit milestones were
met and accrued during the fourth quarter of 2008 for which we
made payment for $1.6 million and issued 53,372 shares
of our common stock during the fourth quarter of 2008. No
further milestones exist.
With respect to Vision, the terms of the acquisition agreement
provide for incremental consideration payable to the former
Vision shareholders. The maximum amount of incremental
consideration payable is approximately $3.2 million, of
which $1.0 million is guaranteed and accrued as of
December 31, 2008. The remaining contingent consideration
is payable upon the completion of certain milestones and
successfully maintaining certain production levels and product
costs during each of the two years following the acquisition
date. As of December 31, 2008, no milestones have been met.
With respect to our most recently acquired healthcare business,
the terms of the acquisition agreement provide for contingent
consideration payable upon successfully meeting certain revenue
and EBITDA targets for the twelve months ending June 30,
2009 and December 31, 2010, respectively. We accrued a
liability in the amount of $3.8 million to avoid
recognition of negative goodwill, as a result of not recognizing
additional purchase price consideration that is contingent on
future events. As of December 31, 2008, the
$3.8 million liability remains accrued.
CRITICAL
ACCOUNTING POLICIES
The consolidated financial statements included elsewhere in this
prospectus supplement are prepared in accordance with accounting
principles generally accepted in the United States of America,
or GAAP. The accounting policies discussed below are considered
by our management and our audit committee to be critical
S-60
Managements
discussion and analysis of financial condition and results of
operations
to an understanding of our financial statements because their
application depends on managements judgment, with
financial reporting results relying on estimates and assumptions
about the effect of matters that are inherently uncertain.
Specific risks for these critical accounting policies are
described in the following paragraphs. For all of these
policies, management cautions that future events rarely develop
exactly as forecast and the best estimates routinely require
adjustment. In addition, the notes to our audited consolidated
financial statements for the year ended December 31, 2008
included elsewhere in this prospectus supplement include a
comprehensive summary of the significant accounting policies and
methods used in the preparation of our consolidated financial
statements.
Revenue
recognition
We primarily recognize revenue when the following four basic
criteria have been met: (1) persuasive evidence of an
arrangement exists, (2) delivery has occurred or services
rendered, (3) the fee is fixed and determinable and
(4) collection is reasonably assured.
The majority of our revenue is derived from product revenue. We
recognize revenue upon title transfer of the products to
third-party customers, less a reserve for estimated product
returns and allowances. Determination of the reserve for
estimated product returns and allowances is based on our
managements analyses and judgments regarding certain
conditions. Should future changes in conditions prove
managements conclusions and judgments on previous analyses
to be incorrect, revenue recognized for any reporting period
could be adversely affected.
Additionally, we generate services revenue in connection with
contracts with leading healthcare organizations whereby we
distribute clinical expertise through fee-based arrangements.
Revenue for fee-based arrangements is recognized over the period
in which the services are provided. Some contracts provide that
a portion of our fees are at risk if our customers do not
achieve certain financial cost savings over a period of time,
typically one year. Revenue subject to refund is not recognized
if (i) sufficient information is not available to calculate
performance measurements, or (ii) interim performance
measurements indicate that we are not meeting performance
targets. If either of these two conditions exists, we record the
amounts as other current liabilities in the consolidated balance
sheet, deferring recognition of the revenue until we establish
that we have met the performance criteria. If we do not meet the
performance targets at the end of the contractual period we are
obligated under the contract to refund some or all of the at
risk fees.
In connection with the acquisition of the Determine business in
June 2005 from Abbott Laboratories, we entered into a transition
services agreement with Abbott, whereby Abbott would continue to
distribute the acquired products until both parties agreed the
transition was completed. During the transition period, we
recognized revenue on sales of the products when title
transferred from Abbott to third party customers.
We also receive license and royalty revenue from agreements with
third-party licensees. Revenue from fixed fee license and
royalty agreements are recognized on a straight-line basis over
the obligation period of the related license agreements. License
and royalty fees that the licensees calculate based on their
sales, which we have the right to audit under most of our
agreements, are generally recognized upon receipt of the license
or royalty payments unless we are able to reasonably estimate
the fees as they are earned. License and royalty fees that are
determinable prior to the receipt thereof are recognized in the
period they are earned.
Use of estimates
for sales returns and other allowances and allowance for
doubtful accounts
Certain sales arrangements require us to accept product returns.
From time to time, we also enter into sales incentive
arrangements with our retail customers, which generally reduce
the sale prices of our products. As a result, we must establish
allowances for potential future product returns and claims
resulting from our sales incentive arrangements against product
revenue recognized in any reporting period. Calculation of these
allowances requires significant judgments and estimates. When
evaluating the adequacy of the sales returns and other
allowances, our management analyzes historical returns, current
economic trends, and changes in customer and consumer demand and
acceptance of our products. When such analysis is not available
and a
S-61
Managements
discussion and analysis of financial condition and results of
operations
right of return exists, we record revenue when the right of
return is no longer applicable. Material differences in the
amount and timing of our product revenue for any reporting
period may result if changes in conditions arise that would
require management to make different judgments or utilize
different estimates.
Our total provision for sales returns and other allowances
related to sales incentive arrangements amounted to
$48.0 million, $48.9 million and $52.8 million,
or 4%, 6% and 10%, respectively, of net product sales in 2008,
2007 and 2006, respectively, which have been recorded against
product sales to derive our net product sales.
Similarly, our management must make estimates regarding
uncollectible accounts receivable balances. When evaluating the
adequacy of the allowance for doubtful accounts, management
analyzes specific accounts receivable balances, historical bad
debts, customer concentrations, customer credit-worthiness,
current economic trends and changes in our customer payment
terms and patterns. Our accounts receivable balance was
$280.6 million and $163.4 million, net of allowances
for doubtful accounts of $12.8 million and
$12.2 million, as of December 31, 2008 and
December 31, 2007, respectively.
Additionally, we generate services revenue in connection with
contracts with leading healthcare organizations whereby we
distribute clinical expertise through fee-based arrangements.
Revenue for fee-based arrangements is recognized over the period
in which the services are provided. Some contracts provide that
a portion of our fees are at risk if our customers do not
achieve certain financial cost savings over a period of time,
typically one year. Revenue subject to refund is not recognized
if (i) sufficient information is not available to calculate
performance measurements, or (ii) interim performance
measurements indicate that we are not meeting performance
targets. If either of these two conditions exists, we record the
amounts as other current liabilities in the consolidated balance
sheet, deferring recognition of the revenue until we establish
that we have met the performance criteria. If we do not meet the
performance targets at the end of the contractual period we are
obligated under the contract to refund some or all of the at
risk fees. Our deferred revenue balance was $22.0 million
and $5.3 million, as of December 31, 2008 and
December 31, 2007, respectively.
Valuation of
inventories
We state our inventories at the lower of the actual cost to
purchase or manufacture the inventory or the estimated current
market value of the inventory. In addition, we periodically
review the inventory quantities on hand and record a provision
for excess and obsolete inventory. This provision reduces the
carrying value of our inventory and is calculated based
primarily upon factors such as forecasts of our customers
demands, shelf lives of our products in inventory, loss of
customers and manufacturing lead times. Evaluating these
factors, particularly forecasting our customers demands,
requires management to make assumptions and estimates. Actual
product and services revenue may prove our forecasts to be
inaccurate, in which case we may have underestimated or
overestimated the provision required for excess and obsolete
inventory. If, in future periods, our inventory is determined to
be overvalued, we would be required to recognize the excess
value as a charge to our cost of sales at the time of such
determination. Likewise, if, in future periods, our inventory is
determined to be undervalued, we would have over-reported our
cost of sales, or understated our earnings, at the time we
recorded the excess and obsolete provision. Our inventory
balance was $199.1 million and $148.2 million, net of
a provision for excess and obsolete inventory of
$10.8 million and $8.1 million, as of
December 31, 2008 and 2007, respectively.
Valuation of
goodwill and other long-lived and intangible assets
Our long-lived assets include (1) property, plant and
equipment, (2) goodwill and (3) other intangible
assets. As of December 31, 2008, the balances of property,
plant and equipment, goodwill and other intangible assets, net
of accumulated depreciation and amortization, were
$284.5 million, $3.0 billion and $1.7 billion,
respectively.
Goodwill and other intangible assets are initially created as a
result of business combinations or acquisitions of intellectual
property. The values we record for goodwill and other intangible
assets represent fair values
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Managements
discussion and analysis of financial condition and results of
operations
calculated by accepted valuation methods. Such valuations
require us to provide significant estimates and assumptions
which are derived from information obtained from the management
of the acquired businesses and our business plans for the
acquired businesses or intellectual property. Critical estimates
and assumptions used in the initial valuation of goodwill and
other intangible assets include, but are not limited to:
(1) future expected cash flows from product sales, customer
contracts and acquired developed technologies and patents,
(2) expected costs to complete any in-process research and
development projects and commercialize viable products and
estimated cash flows from sales of such products, (3) the
acquired companies brand awareness and market position,
(4) assumptions about the period of time over which we will
continue to use the acquired brand and (5) discount rates.
These estimates and assumptions may be incomplete or inaccurate
because unanticipated events and circumstances may occur. If
estimates and assumptions used to initially value goodwill and
intangible assets prove to be inaccurate, ongoing reviews of the
carrying values of such goodwill and intangible assets, as
discussed below, may indicate impairment which will require us
to record an impairment charge in the period in which we
identify the impairment.
Where we believe that property, plant and equipment and
intangible assets have finite lives, we depreciate and amortize
those assets over their estimated useful lives. For purposes of
determining whether there are any impairment losses, as further
discussed below, our management has historically examined the
carrying value of our identifiable long-lived tangible and
intangible assets and goodwill, including their useful lives
where we believe such assets have finite lives, when indicators
of impairment are present. In addition, SFAS No. 142,
Goodwill and Other Intangible Assets, requires that
impairment reviews be performed on the carrying values of all
goodwill on at least an annual basis. For all long-lived
tangible and intangible assets and goodwill, if an impairment
loss is identified based on the fair value of the asset, as
compared to the carrying value of the asset, such loss would be
charged to expense in the period we identify the impairment.
Furthermore, if our review of the carrying values of the
long-lived tangible and intangible assets with finite lives
indicates impairment of such assets, we may determine that
shorter estimated useful lives are more appropriate. In that
event, we will be required to record higher depreciation and
amortization in future periods, which will reduce our earnings.
Valuation of
goodwill
We perform an impairment review on the carrying value of
goodwill at least annually, or more frequently if events occur
or circumstances exist that indicate that a reporting
units carrying value exceeds its fair value. We performed
our annual impairment review as of September 30, 2008,
using the discounted cash flows approach and, based upon this
review, we do not believe that the goodwill related to our
professional diagnostics, health management and consumer
diagnostics reporting units was impaired. Because future cash
flows and operating results used in the impairment review are
based on managements projections and assumptions, future
events can cause such projections to differ from those used at
September 30, 2008, which could lead to significant
impairment charges of goodwill in the future. As of
December 31, 2008, we have goodwill balances related to our
professional diagnostics, health management and consumer
diagnostics reporting units, which amounted to
$1.7 billion, $1.3 billion and $52.7 million,
respectively.
Despite current economic conditions and the fluctuation in our
common stock price during the fourth quarter of 2008, we
determined that, based on our 2008 financial performance, our
unchanged expectations of future financial performance and the
improvement in our common stock price subsequent to year end, a
triggering event that would warrant further impairment testing
had not occurred and therefore no updated testing was performed
and no goodwill impairment was recorded during 2008. Should
economic conditions deteriorate further or remain depressed for
a prolonged period of time, estimates of future cash flows for
each reporting unit may be insufficient to support carrying
value and the goodwill assigned to it, requiring us to test for
impairment. Impairment charges, if any, may be material to our
results of operations and financial position.
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Managements
discussion and analysis of financial condition and results of
operations
Valuation of
other long-lived tangible and intangible assets
Factors we generally consider important which could trigger an
impairment review on the carrying value of other long-lived
tangible and intangible assets include the following:
(1) significant underperformance relative to expected
historical or projected future operating results;
(2) significant changes in the manner of our use of
acquired assets or the strategy for our overall business;
(3) underutilization of our tangible assets;
(4) discontinuance of product lines by ourselves or our
customers; (5) significant negative industry or economic
trends; (6) significant decline in our stock price for a
sustained period; (7) significant decline in our market
capitalization relative to net book value; and (8) goodwill
impairment identified during an impairment review under
SFAS No. 142. Although we believe that the carrying
value of our long-lived tangible and intangible assets was
realizable as of December 31, 2008, future events could
cause us to conclude otherwise.
Stock-based
compensation
We account for stock-based compensation in accordance with
SFAS No. 123-R,
Share-Based Payment. Under the fair value recognition
provisions of this statement, share-based compensation cost is
measured at the grant date based on the value of the award and
is recognized as expense over the vesting period. Determining
the fair value of share-based awards at the grant date requires
judgment, including estimating our stock price volatility and
employee stock option exercise behaviors. If actual results
differ significantly from these estimates, stock-based
compensation expense and our results of operations could be
materially impacted.
Our expected volatility is based upon the historical volatility
of our stock. The expected term is based on the assumption that
all outstanding options will exercise at the midpoint of the
vesting date and the full contractual term, including data on
experience to date. As stock-based compensation expense is
recognized in our consolidated statement of operations is based
on awards ultimately expected to vest, the amount of expense has
been reduced for estimated forfeitures.
SFAS No. 123-R
requires forfeitures to be estimated at the time of grant and
revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. Forfeitures were
estimated based on historical experience. If factors change and
we employ different assumptions in the application of
SFAS No. 123-R,
the compensation expense that we record in future periods may
differ significantly from what we have recorded in the current
period.
Accounting for
income taxes
As part of the process of preparing our consolidated financial
statements, we are required to estimate our income taxes in each
of the jurisdictions in which we operate. This process involves
us estimating our actual current tax exposure and assessing
temporary differences resulting from differing treatment of
items, such as reserves and accruals and lives assigned to
long-lived and intangible assets, for tax and accounting
purposes. These differences result in deferred tax assets and
liabilities. We must then assess the likelihood that our
deferred tax assets will be recovered through future taxable
income and, to the extent we believe that recovery is not more
likely than not, we must establish a valuation allowance. To the
extent we establish a valuation allowance or increase this
allowance in a period, we must include an expense within our tax
provision.
Significant management judgment is required in determining our
provision for income taxes, our deferred tax assets and
liabilities and any valuation allowance recorded against our net
deferred tax assets. We have recorded a valuation allowance of
$12.7 million as of December 31, 2008 due to
uncertainties related to the future benefits, if any, from our
deferred tax assets related primarily to our foreign businesses
and certain U.S. net operating losses and tax credits.
Included in this valuation allowance is $3.7 million for
deferred tax assets of acquired companies, the future benefits
of which will be generally applied to reduce our income tax
expense as required
SFAS No. 141-R,
Business Combinations. This is a reduction of
$6.2 million from the valuation allowance of
$18.9 million as of December 31, 2007, and resulted in
additional goodwill. The decrease is primarily related to the
recognition of foreign NOLs. The valuation allowance is
based on our
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Managements
discussion and analysis of financial condition and results of
operations
estimates of taxable income by jurisdiction in which we operate
and the period over which our deferred tax assets will be
recoverable. In the event that actual results differ from these
estimates or we adjust these estimates in future periods, we may
need to establish an additional valuation allowance or reduce
our current valuation allowance which could materially impact
our tax provision.
On January 1, 2007 we adopted FIN 48, Accounting
for Uncertainty in Income Taxesan Interpretation of FASB
Statement 109. In accordance with FIN 48, we
established reserves for tax uncertainties that reflect the use
of the comprehensive model for the recognition and measurement
of uncertain tax positions. We are currently undergoing routine
tax examinations by various state and foreign jurisdictions. Tax
authorities periodically challenge certain transactions and
deductions we reported on our income tax returns. We do not
expect the outcome of these examinations, either individually or
in the aggregate, to have a material adverse effect on our
financial position, results of operations, or cash flows.
Loss
contingencies
In the section of this prospectus supplement entitled
BusinessLegal Proceedings we have reported on
material legal proceedings. In addition, because of the nature
of our business, we may from time to time be subject to
commercial disputes, consumer product claims or various other
lawsuits arising in the ordinary course of our business,
including employment matters, and we expect this will continue
to be the case in the future. These lawsuits generally seek
damages, sometimes in substantial amounts, for commercial or
personal injuries allegedly suffered and can include claims for
punitive or other special damages. In addition, we aggressively
defend our patent and other intellectual property rights. This
often involves bringing infringement or other commercial claims
against third parties, which can be expensive and can result in
counterclaims against us.
We do not accrue for potential losses on legal proceedings where
our company is the defendant when we are not able to reasonably
estimate our potential liability, if any, due to uncertainty as
to the nature, extent and validity of the claims against us,
uncertainty as to the nature and extent of the damages or other
relief sought by the plaintiff and the complexity of the issues
involved. Our potential liability, if any, in a particular case
may become reasonably estimable and probable as the case
progresses, in which case we will begin accruing for the
expected loss.
RECENT ACCOUNTING
PRONOUNCEMENTS
Recently issued
standards
In June 2008, the FASB ratified Emerging Issue Task Force, or
EITF, Issue
No. 07-05,
Determining Whether an Instrument (or Embedded Feature) is
Indexed to an Entitys Own Stock, which addresses the
accounting for certain instruments as derivatives under
SFAS No. 133, Accounting for Derivative Instruments
and Hedging Activities. Under this new pronouncement, specific
guidance is provided regarding requirements for an entity to
consider embedded features as indexed to the entitys own
stock. This Issue is effective for fiscal years beginning after
December 15, 2008. We are currently in the process of
evaluating the impact of adopting this pronouncement.
In May 2008, the FASB issued FASB Staff Position, or FSP, APB
14-1,
Accounting for Convertible Debt Instruments That May Be
Settled In Cash upon Conversion (Including Partial Cash
Settlement). FSP APB
14-1
specifies that issuers of such instruments should separately
account for the liability and equity components in a manner that
will reflect the entitys nonconvertible debt borrowing
rate when interest cost is recognized in subsequent periods. FSP
APB 14-1 is
effective for financial statements issued for fiscal years
beginning after December 15, 2008 and interim periods
within those fiscal years. This FSP should be applied
retrospectively for all periods presented. We are currently in
the process of evaluating the impact of adopting this
pronouncement.
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discussion and analysis of financial condition and results of
operations
In April 2008, the FASB issued
FSP 142-3,
Determination of the Useful Life of Intangible Assets.
FSP 142-3
amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful
life of a recognized intangible asset under
SFAS No. 142, Goodwill and Other Intangible Assets.
FSP 142-3
is effective for financial statements issued for fiscal years
beginning after December 15, 2008, as well as interim
periods within those fiscal years. We are currently in the
process of evaluating the impact of adopting this pronouncement.
In March 2008, the FASB issued SFAS No. 161,
Disclosures about Derivative Instruments and Hedging
Activitiesan Amendment of FASB Statement No. 133.
This statement requires entities that utilize derivative
instruments to provide qualitative disclosures about their
objectives and strategies for using such instruments, as well as
any details of credit-risk-related contingent features contained
within derivatives. It also requires entities to disclose
additional information about the amounts and location of
derivatives located within the financial statements, how the
provisions of SFAS No. 133 have been applied and the
impact that hedges have on an entitys financial position,
financial performance and cash flows. This statement is
effective for fiscal years and interim periods beginning after
November 15, 2008, with early application encouraged. We
are currently in the process of evaluating the impact of
adopting this pronouncement.
In December 2007, the FASB ratified the consensus reached by the
EITF in EITF Issue
No. 07-01,
Accounting for Collaborative Arrangements Related to the
Development and Commercialization of Intellectual Property.
The EITF concluded that a collaborative arrangement is one in
which the participants are actively involved and are exposed to
significant risks and rewards that depend on the ultimate
commercial success of the endeavor. Revenues and costs incurred
with third parties in connection with collaborative arrangements
would be presented gross or net based on the criteria in EITF
Issue
No. 99-19,
Reporting Revenue Gross as a Principal versus Net as an Agent,
and other accounting literature. Payments to or from
collaborators would be evaluated and presented based on the
nature of the arrangement and its terms, the nature of the
entitys business, and whether those payments are within
the scope of other accounting literature. The nature and purpose
of collaborative arrangements are to be disclosed along with the
accounting policies and the classification and amounts of
significant financial statement amounts related to the
arrangements. Activities in the arrangement conducted in a
separate legal entity should be accounted for under other
accounting literature; however required disclosure under EITF
Issue
No. 07-01
applies to the entire collaborative agreement. This Issue is
effective for fiscal years beginning after December 15,
2008, and is to be applied retrospectively to all periods
presented for all collaborative arrangements existing as of the
effective date. We are currently in the process of evaluating
the impact of adopting this pronouncement.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interests in Consolidated Financial
Statementsan Amendment of Accounting Research Bulletin
(ARB) No. 51. This statement amends ARB No. 51 to
establish accounting and reporting standards for the
non-controlling interest in a subsidiary and for the
deconsolidation of a subsidiary. It clarifies that a
non-controlling interest in a subsidiary is an ownership
interest in the consolidated entity and should therefore be
reported as equity in the consolidated financial statements. The
statement also establishes standards for presentation and
disclosure of the non-controlling results on the consolidated
income statement. SFAS No. 160 is effective for fiscal
years beginning on or after December 15, 2008. We are
currently in the process of evaluating the impact of adopting
this pronouncement.
In December 2007, the FASB issued
SFAS No. 141-R,
Business Combinations. This statement replaces
SFAS No. 141, but retains the fundamental requirements
in SFAS No. 141 that the acquisition method of
accounting be used for all business combinations. This statement
requires an acquirer to recognize and measure the identifiable
assets acquired, the liabilities assumed, and any
non-controlling interest in the acquiree at their fair values as
of the acquisition date. The statement requires acquisition
costs and any restructuring costs associated with the business
combination to be recognized separately from the fair value of
the business combination.
SFAS No. 141-R
establishes requirements for recognizing and measuring goodwill
acquired in the business combination or a gain from a bargain
purchase as well as disclosure requirements designed to enable
users to better interpret the results of the business
combination.
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Managements
discussion and analysis of financial condition and results of
operations
SFAS No. 141-R
is effective for fiscal years beginning on or after
December 15, 2008. Given our history of acquisition
activity, we anticipate the adoption of
SFAS No. 141-R
to have a significant impact on our consolidated financial
statements. Early adoption of this statement is not permitted.
As of December 31, 2008 there were $3.8 million in
capitalized acquisition costs classified in other non-current
assets. The capitalized costs will be written off in January
2009 when this statement becomes effective.
Recently adopted
standards
Effective October 2008, we adopted
FSP 157-3,
Determining the Fair Value of a Financial Asset When the
Market for That Asset Is Not Active.
FSP 157-3
clarifies the application of SFAS No. 157 in an
inactive market. It demonstrated how the fair value of a
financial asset is determined when the market for that financial
asset is inactive. The adoption of these provisions did not have
a material impact on our consolidated financial statements.
Effective January 1, 2008, we adopted EITF Issue
No. 07-03,
Accounting for Nonrefundable Advance Payments for Goods or
Services to Be Used in Future Research and Development
Activities.
EITF 07-03
concludes that non-refundable advance payments for future
research and development activities should be deferred and
capitalized until the goods have been delivered or the related
services have been performed. If an entity does not expect the
goods to be delivered or services to be rendered, the
capitalized advance payment should be charged to expense. The
effect of applying this EITF is prospective for new contracts
entered into on or after the date of adoption. The adoption of
this EITF did not have a material impact on our consolidated
financial statements.
Effective January 1, 2008, we adopted
SFAS No. 159, The Fair Value Option for Financial
Assets and Financial LiabilitiesIncluding an Amendment of
FASB No. 115. This Statement provides companies with an
option to measure, at specified election dates, many financial
instruments and certain other items at fair value that are not
currently measured at fair value. The standard also establishes
presentation and disclosure requirements designed to facilitate
comparison between entities that choose different measurement
attributes for similar types of assets and liabilities. If the
fair value option is elected, the effect of the first
remeasurement to fair value is reported as a cumulative effect
adjustment to the opening balance of retained earnings. The
statement is to be applied prospectively upon adoption. The
adoption of these provisions did not have a material impact on
our consolidated financial statements.
Effective January 1, 2008, we adopted
SFAS No. 157, Fair Value Measurements, for all
financial instruments and non-financial instruments accounted
for at fair value on a recurring basis. SFAS No. 157
establishes a framework for measuring fair value in generally
accepted accounting principles, and expands disclosures about
fair value measurements. The standard applies whenever other
standards require, (or permit), assets or liabilities to be
measured at fair value. The standard does not expand the use of
fair value in any new circumstances. The FASB has provided a
one-year deferral for the implementation for other non-financial
assets and liabilities. The adoption of these provisions did not
have a material impact on our consolidated financial statements.
For further information about the adoption of the required
provisions of SFAS No. 157 see note 7 of the
notes to our consolidated financial statements included
elsewhere in this prospectus supplement.
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Business
Inverness Medical Innovations enables individuals to take charge
of improving their health and quality of life at home by
developing new capabilities in near-patient diagnosis,
monitoring and health management. Our global leading products
and services, as well as our new product development efforts,
focus on cardiology, womens health, infectious disease,
oncology and drugs of abuse. We are a Delaware corporation that
was formed to acquire the womens health, nutritional
supplements and professional diagnostics businesses of its
predecessor, Inverness Medical Technology, Inc., through a
split-off and merger transaction, which occurred in November
2001. We became an independent, publicly-traded company
immediately after the split-off and our common stock was listed
on the American Stock Exchange under the symbol IMA.
We are now listed on the New York Stock Exchange under the
symbol IMA. Since the split-off, we have grown our
businesses through strategic use of our superior intellectual
property portfolio and through strategic acquisitions. Our Alere
health management business, which represents the union of Matria
Healthcare, LLC, or Matria, acquired in 2008; Alere Medical,
Inc., or Alere Medical, and ParadigmHealth, Inc., or
ParadigmHealth, each acquired during 2007, is a leading provider
of health management services to insurers and employers and we
are confident that our unique ability to offer rapid diagnostic
tools combined with value-added healthcare services will improve
care and lower healthcare costs for both providers and patients.
SEGMENTS
Our major reportable operating segments are professional
diagnostics, health management, consumer diagnostics and
vitamins and nutritional supplements. Below are discussions of
each of these reportable segments. Financial information about
our reportable segments is provided in Note 20 of the
Notes to Consolidated Financial Statements included
elsewhere in this prospectus supplement.
PRODUCTS AND
SERVICES
Professional Diagnostics. Professional
diagnostics are generally designed to assist medical
professionals in both preventative and interventional medicine,
and includes testing or monitoring performed in hospitals and
doctors offices and, increasingly, testing or monitoring
done at home at the direction of the medical professional, or
through patient self-testing. Professional diagnostic products
provide for qualitative or quantitative analysis of a
patients body fluids or tissue for evidence of a specific
medical condition or disease state or to measure response to
therapy. Within professional diagnostics, we focus on
point-of-care, rapid diagnostic testing and the developing
patient self-testing market. We distinguish the point-of-care
and patient self-testing markets from clinical diagnostic
markets consisting of large, centralized laboratories offering a
wide range of highly-automated laboratory services in hospital
or related settings. The point-of-care market for rapid
diagnostic products consists primarily of small and medium size
laboratories and testing locations, such as physician office
laboratories, specialized mobile clinics, emergency rooms and
some rapid-response laboratories in larger medical centers.
In the market for rapid diagnostic products, the ability to
deliver faster, accurate results at reasonable prices generally
drives demand. This means that, while there is certainly demand
for faster, more efficient automated equipment from large
hospitals and major reference testing laboratories, there is
also growing demand by point-of-care facilities and smaller
laboratories for fast, high-quality, less expensive,
self-contained diagnostic kits. As the speed and accuracy of
such products improve, we believe that these products will play
an increasingly important role in achieving early diagnosis,
timely intervention and therapy monitoring outside of acute
medicine environments, especially where supplemented by the
support and management services that we also provide.
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Business
Our current professional diagnostic products test for over 100
disease states and conditions and include point-of-care and
laboratory tests in the following areas:
Cardiology. Cardiovascular disease encompasses
a spectrum of conditions and illnesses, including high blood
pressure, high cholesterol, metabolic syndrome, coronary artery
disease, heart attack, heart failure and stroke. It is estimated
that 80 million (one out of every three) American adults
alone have one or more types of cardiovascular disease. The
worldwide cardiology diagnostic market, including the markets
for heart failure diagnostics, coronary artery disease risk
assessment, coagulation testing and acute coronary syndrome,
exceeds $1.5 billion and, in the near-patient categories where
we focus, annual growth is estimated at 15% to 20%. Our Biosite
Triage, Cholestech LDX and HemoSense INRatio products, all
acquired through acquisitions in 2007, have established us as a
leader in this market. Our Triage system is used in
approximately 63% of U.S. hospitals and in over 50
countries worldwide. The Triage system consists of a portable
fluorometer that interprets consumable test devices for
cardiovascular conditions, as well as the detection of certain
drugs of abuse. The Biosite Triage cardiovascular tests include
the following:
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Triage BNP Test. An immunoassay that measures
B-type Natriuretic Peptide, or BNP, in whole blood or plasma,
used as an aid in the diagnosis and assessment of severity of
heart failure. The test is also used for the risk stratification
of patients with acute coronary syndrome and heart failure. We
also offer a version of the Triage BNP Test for use on Beckman
Coulter lab analyzers.
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Triage Cardiac Panel. An immunoassay for the
quantitative determination of CK-MB, myoglobin and troponin I in
whole blood or plasma, used as an aid in the diagnosis of acute
myocardial infarction.
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Triage CardioProfilER Panel. An immunoassay
for use as an aid in the diagnosis of acute myocardial
infarction, the diagnosis and assessment of severity of
congestive heart failure, risk stratification of patients with
acute coronary syndromes and risk stratification of patients
with heart failure. This panel combines troponin I, CK-MB,
myoglobin and BNP to provide rapid, accurate results in whole
blood and plasma.
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Triage Profiler Shortness of Breath (S.O.B.)
Panel. An immunoassay for use as an aid in the
diagnosis of myocardial infarction, the diagnosis and assessment
of severity of congestive heart failure, the assessment and
evaluation of patients suspected of having disseminated
intravascular coagulation and thromboembolic events, including
pulmonary embolism and deep vein thrombosis, and the risk
stratification of patients with acute coronary syndromes. This
panel combines troponin I, CK-MB, myoglobin, BNP and
d-dimer to provide rapid, accurate results in whole blood and
plasma.
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Triage D-Dimer Test. An immunoassay for use as
an aid in the assessment and evaluation of patients suspected of
having disseminated intravascular coagulation or thromboembolic
events, including pulmonary embolism and deep vein thrombosis.
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The Cholestech LDX System is a point-of-care monitor of blood
cholesterol and related lipids which is used to test patients at
risk of, or suffering from, heart disease and related
conditions. The Cholestech LDX System makes it possible to
provide a complete lipid profile with tests for total
cholesterol, or TC, HDL & LDL cholesterol,
triglycerides, and glucose (GLU), as well as tests for ALT and
AST (for liver enzyme monitoring), and high sensitivity
C-reactive protein, or hs-CRP. The Cholestech LDX System can
also provide coronary heart disease risk assessment from the
patients results as measured on the lipid profile
cassette. The Cholestech LDX System provides results in five
minutes per test cassette (seven minutes for CRP) and is
CLIA-waived, meaning that the United States Food and Drug
Administration, or FDA, has waived the more stringent
requirements for laboratory testing applicable to moderate or
high complexity laboratories based on the Cholestech LDX
Systems ease of use and accuracy. This allows the
Cholestech LDX System to be marketed to physicians
offices, rather than hospitals or larger laboratories, and it is
present in approximately 12% of U.S. CLIA-waived
physicians office laboratories with an installed base of
approximately 10,000 units in regular use.
The HemoSense INRatio System is an easy-to-use, hand-held blood
coagulation monitoring system for use by patients and healthcare
professionals in the management of warfarin, a commonly
prescribed medication used to prevent blood clots. The HemoSense
INRatio System measures PT/INR, which is the patients
blood
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Business
clotting time reported pursuant to an internationally normalized
ratio, to help ensure that patients with risk of blood clot
formation are maintained within the therapeutic range with the
proper dosage of oral anticoagulant therapy. The INRatio System
is 510(k) cleared by the FDA for use by healthcare
professionals, as well as for patient self-testing, and is also
CE marked in Europe. The INRatio System is targeted to both the
professional, or point-of-care market, as well as the patient
self-testing market. Recently we introduced the INRatio2 System,
which targets the patient self-testing market and offers
enhanced ease of use. Patient self-testing has gained
significant momentum since March 2008 when Centers for
Medicare & Medicaid Services expanded coverage of home
INR monitoring to include chronic atrial fibrillation and venous
thromboembolism patients on warfarin.
We also sell disposable, lateral flow rapid diagnostic tests for
d-dimer and troponin I under our Clearview brand. These tests
offer efficiency, as well as ease of use and accuracy, to
clinics, hospitals and laboratories around the world.
Womens Health. Since womens health
and general sexual health issues are a global health concern,
this remains a priority area for us. In the professional
marketplace, we are a global leader in pregnancy
fertility/ovulation testing and bone therapy (osteoporosis)
monitoring. Our professional pregnancy tests are generally
urine-based, CLIA-waived rapid tests in dipstick or cassette
format.
Our professional womens health products also target
diseases, such as rubella and Group B strep, which pose unique
threats to unborn or newborn babies and, in addition, we market
a portfolio of tests for sexually-transmitted diseases. Our
womens health products are sold under our Acceava,
Clearview, Sure-Step, Inverness Medical TestPack and Osteomark
brands.
Infectious Disease. We believe that the demand
for infectious disease diagnostic products is growing faster
than many other segments of the immunoassay market due to the
increasing incidence of certain diseases or groups of diseases,
including viral hepatitis, respiratory syncytial virus (RSV),
influenza, tuberculosis, acquired immunodeficiency syndrome, or
AIDS, herpes and other sexually-transmitted diseases. To meet
this demand, we have continued to expand our product offerings
and now offer one of the worlds largest infectious disease
test menus. We develop and market a wide variety of
point-of-care tests for Influenza A/B, strep throat, HIV, HSV-2,
malaria, C.difficile, infectious mononucleosis, lyme disease,
chlamydia, H.pylori, RSV, rubella and other infectious diseases.
Our tests for infectious disease are sold under brand names
which include Acceava, BinaxNOW, Clearview, Determine, Inverness
Medical TestPack, DoubleCheckGold, Panbio and
TECHLAB®.
In addition to point-of-care products, we also offer a line of
indirect fluorescent antibody, or IFA, assays for over 20 viral,
bacterial and autoimmune diseases, a full line of serology
diagnostic products covering a broad range of disease categories
and over 70 enzyme-linked immunosorbent assays, or ELISA, tests
for a wide variety of infectious and autoimmune diseases, as
well as a full line of automated instrumentation for processing
ELISA assays. We are the exclusive U.S. distributor of the
AtheNA
Multi-Lyte®
Test System, a multiplexed, fluorescent bead-based system
designed to simultaneously perform multiple assays from a single
sample using just one well. It offers a simple and streamlined
alternative to IFA and ELISA testing, providing improved
clinical sensitivity and comparable clinical specificity in a
labor-saving, automation-friendly format. Our IFA, serology and
ELISA products, which generally serve the clinical diagnostics
laboratory markets, are generally marketed under our Wampole
brand.
Demand for certain infectious disease tests, primarily Influenza
A/B, or flu, is significantly affected by the seasonal nature of
the cold and flu season. As a result, we typically experience
higher sales of our flu tests in the first and fourth quarters.
Sales of our flu products also vary from year to year based in
large part on the severity, length and timing of the onset of
the cold and flu season. While we believe that the severity,
length and timing of the onset of the cold and flu season will
continue to impact sales of certain of our infectious disease
products, there can be no assurance that our future sales of
these products will necessarily follow historical patterns.
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Oncology. Among chronic disease categories, we
are focused on oncology diagnostics as an area of significant
future opportunity. The Matritech NMP22 BladderChek Test is the
only in-office test approved by the FDA as an aid in the
diagnosis of bladder cancer. The NMP22 BladderChek Test is a
non-invasive assay, performed on a single urine sample, that
detects elevated levels of NMP22 protein. The test can be
performed in a physicians office with results delivered
during the patient visit, allowing a rapid, accurate and
cost-effective means of aiding the detection of bladder cancer
in patients at risk, when used in conjunction with standard
diagnostic procedures. We also offer the NMP22 Test Kit, a
quantitative ELISA also designed to detect elevated levels of
NMP22 protein.
Our Clearview FOB and Ultra FOB rapid tests aid in the early
detection of colorectal cancer, the third most common type of
cancer in men and women.
Drugs of Abuse. Drug abuse is a major global
health problem, as well as a social and economic burden. In
addition to being a primary cause of lost workforce
productivity, family conflict and drug-related crime, drug abuse
is linked to the spread of HIV/AIDS through contaminated
needles. Drug abuse is one of the most costly health problems in
the United States. As a result, employers, law enforcement
officials and others expend considerable effort to be sure their
employees and constituents are free of substance abuse, creating
a significant market for simple, reliable tests to detect the
most commonly abused substances. Urine-based screening tests for
drugs of abuse range from simple immunoassay tests to complex
analytical procedures. The speed and sensitivity of immunoassays
have made them the most widely-accepted method for screening
urine for drugs of abuse.
We offer one of the broadest and most comprehensive lines of
drugs of abuse tests available today. We offer tests to detect
alcohol, as well as the following illicit and prescription drugs
of abuse: amphetamines/methamphetamines, cocaine, opiates,
phencyclidine, tetrahydrocannabinol, acetaminophen,
barbiturates, benzodiazepines, methadone, propoxyphene and
tricyclic antidepressants, using both urine and saliva body
fluids.
Our rapid drugs of abuse tests are sold primarily under the
brands Triage, iScreen and SureStep. The TOX Drug Screen panel
sold for use with the Biosite Triage System detects the presence
of any illicit or prescription drugs listed above at the
point-of-care in approximately 15 minutes.
Through our subsidiary Redwood Toxicology Laboratories, or
Redwood, we also offer comprehensive, low-cost laboratory
testing services. Through its laboratory services, Redwood
offers its clients, including law enforcement agencies, penal
systems, insurers and employers, the certainty of science, the
dependability of proven processes and the assurance of legally
defensible results.
Health Management. We believe that by
utilizing both existing professional diagnostic devices and new
devices under development to enhance the delivery of health
management and other services to healthcare providers, we can
further facilitate cost containment and outcome-driven decision
making. Accordingly, during 2007, we entered the growing health
management marketplace with our acquisitions of Alere Medical
and ParadigmHealth, and in May 2008 we acquired Matria. Combined
as Alere, our health management business strives to empower
participants of our programs and physicians so that they can
work together towards better health. Our expert-designed
programs:
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Embrace the entire lifespan, from pre-cradle to end-of-life, and
targeted health states, from wellness to prevention to complex
care;
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Target high-cost chronic conditions with programs designed to
improve outcomes and reduce expenditures;
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Provide health coaches who engage and motivate participants
during teachable moments;
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Help participants improve their health by supporting their
individual health goals;
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Bring greater clarity to healthcare with empowering technologies
that lead to better outcomes;
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Offer 2,200+ healthcare professionals who share a passion for
excellence in everything we do.
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Our key health management programs are:
Care. The Alere Disease Management Program
provides technology-enabled, evidence-based solutions for
managing chronic and high-cost conditions, improving
productivity and reducing healthcare costs. The Alere Disease
Management Program assists individuals with chronic diseases or
conditions to better manage their care by increasing their
knowledge about their illnesses, potential complications and the
importance of medication and treatment plan compliance.
Aleres highly-trained clinicians proactively contact
participants to monitor their progress and ensure they are
following the plan of care set by their physician. They work
with participants to identify potential gaps in care, which
occur when individuals do not receive national standards of
care, or best practices, or when an individual fails to comply
with their treatment plan. Alere offers a personal health
support model of care. This model differs from providers of
traditional, total population health models in several ways,
including how individuals are selected, as well as a more
disciplined approach to defining who can benefit from what kinds
of touches and how these specific interactions are
best accomplished. A second key differentiator is the use of the
Alere DayLink Monitor for persons participating in higher risk
health management programs. The DayLink Monitor records a
participants weight
and/or
answers to questions regarding their symptoms. This information
is gathered daily and sent to Alere clinicians for review. The
Alere Disease Management Program currently assists individuals
with the following diseases or conditions: asthma, coronary
artery disease, chronic obstructive pulmonary disease, diabetes,
heart failure, pain, weight management and depression. In
addition, Alere also offers Complex Care Management and Chronic
Care Management for participants who require more attention and
care than a traditional disease management program provides.
What distinguishes our two programs is that Complex Care
provides
on-site
care, and the Chronic Complex program involves telephone contact
with Alere clinicians.
Womens & Childrens
Health. Aleres Womens and
Childrens Health division delivers a total spectrum of
obstetrical care services, ranging from a risk assessment to
identify women at risk for preterm birth to a neonatal program
for early infant care management. In between are home-based
obstetrical programs to manage and monitor pregnant women who
have medical or pregnancy-related problems that could harm the
health of the mother or baby. Alere delivers telephonic and
home-based nursing services that support physician and patient
goals. Alere has developed and refined these services over the
years to accommodate physician plans of care. We focus on
assessment of patient data and providing education. Our
high-risk pregnancy management program revenues tend to be
seasonal. Revenues tend to decrease with the onset of the
holiday season starting with Thanksgiving. As a result, first
and fourth quarter revenues of each year tend to be lower than
second and third quarter revenues.
Oncology. The Alere Oncology Program is the
most comprehensive, experienced and long-running cancer
management program in the nation, managing 122 cancer types,
covering more than eight million lives and effectively managing
more than 50,000 participants. Cancer continues to challenge
employers and health plans as they search for tools to
compassionately manage this condition among their population in
the most cost-effective manner. By incorporating best of
breed practices and coordinating with physicians and
participants, Alere provides an integrated solution to
proactively manage this expensive and debilitating disease.
Wellness. Wellness Solutions is a suite of
integrated wellness programs and resources designed to help
organizations reduce health risks and improve the health and
productivity of their employees while reducing
healthcare-related costs. Wellness programs include screening
for risk factors associated with diabetes, cardiovascular heart
disease, hypertension and obesity; screening for high-risk
pregnancies; assessments of health risks for broad populations;
programs that promote better health by encouraging sustainable
changes in behavior; and health coaching. In addition, the Alere
Health Portal provides employers and health plans with a
powerful front door to Aleres continuum of
healthcare services and the Alere Personal Health Record allows
individuals to create a completely confidential on-line record
of all of their personal healthcare data.
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Consumer Diagnostics. On May 17, 2007, we
and affiliates of P&G commenced a 50/50 joint venture for
the development, manufacturing, marketing and sale of existing
and to-be-developed consumer diagnostic products, outside the
cardiology, diabetes and oral care fields. As part of this
arrangement we transferred essentially all of the assets of our
consumer diagnostics business, other than our manufacturing and
core intellectual property assets, to the joint venture, and
P&G acquired its interest in the joint venture.
Accordingly, substantially all of the consumer diagnostics
business conducted by us prior to the joint venture, including
all of our products targeting the worldwide over-the-counter
pregnancy and fertility/ovulation test market, are now sold by
the joint venture, which is an unconsolidated entity operating
primarily under the name SPD Swiss Precision Diagnostics GmbH.
As part of the SPD joint venture with P&G, we entered into
a finished product purchase agreement, pursuant to which we
currently manufacture and sell to SPD substantially all of the
consumer diagnostic products which it sells. We also entered
into certain transition and long-term services agreements with
SPD, pursuant to which we provide certain operational support
services to the joint venture. Our consumer diagnostics segment
recognizes the revenue and costs arising from these arrangements.
Our other current consumer diagnostic products consist of our
market-leading First Check brand of over- the-counter drugs of
abuse tests for at-home testing for marijuana, cocaine,
methamphetamines and opiates, as well as First Check brand
over-the-counter tests for alcohol abuse, cholesterol monitoring
and colon cancer screening. Taking advantage of our leadership
in the field of womens health, we also sell Balance Activ
Vaginal Gel directly to consumers and health care professionals
alike for the effective treatment of bacterial vaginosis without
antibiotics.
Vitamins and Nutritional Supplements. We also
market a wide variety of vitamins and nutritional supplements
primarily within the United States. Most growth in this market
is attributed to new products that generate attention in the
marketplace. Well-established market segments, where competition
is greater and media commentary less frequent, are generally
stable. Slow overall growth in the industry has resulted in
retailers reducing shelf space for nutritional supplements and
has forced many under-performing items out of distribution,
including several broad product lines. Sales growth of private
label products has generally outpaced the overall industry
growth, as retailers continue to add to the number of private
label nutritional products on their shelves.
Our subsidiary, Inverness Medical Nutritionals Group, or IMN, is
a national supplier of private label vitamins and nutritional
products for major drug and food chains and also manufactures
bulk vitamins, minerals, nutritional supplements and
over-the-counter drug products under contract for unaffiliated
brand name distributors. IMN also manufactures an assortment of
vitamin, mineral and nutritional supplement products for sale
under Inverness Medical brand names.
Our Inverness Medical branded nutritional products are
high-quality products sold at moderate prices through national
and regional drug stores, groceries and mass merchandisers.
These branded products include Stresstabs, a B-complex vitamin
with added antioxidants; Ferro-Sequels, a time-release iron
supplement; and Posture-D, a calcium supplement.
METHODS OF
DISTRIBUTION AND CUSTOMERS
In the United States, Canada, the United Kingdom, Germany,
Italy, Spain, the Netherlands, France, Austria, India, Japan,
China, Australia, South Africa, Brazil, Colombia and Israel, we
distribute our professional diagnostic products to hospitals,
reference laboratories, physicians offices and other
point-of-care settings through our own sales forces and
distribution networks. In these countries, as well as in all
other major world markets, we also utilize third-party
distributors to sell our products. In the United States, we have
distribution relationships with all of the major distributors to
hospitals and reference laboratories, as well as with the major
distributors serving physicians offices and other
non-hospital, point-of-care settings. One of our distributors of
cardiology and other professional diagnostic products, Thermo
Fisher Scientific, accounted for 22% of our consolidated net
revenue in 2008. Our QAS subsidiary facilitates the distribution
of our
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HemoSense INRatio and INRatio2 coagulation monitors by
contacting targeted customers and facilitating the Medicare
reimbursement process for physicians and for patients monitoring
at home. Under the terms of our acquisition of our Determine
products from Abbott Laboratories in June 2005, Abbott
distributes a portion of our Determine products, which are sold
outside of the United States, in certain countries where we do
not currently have suitable distribution capabilities. We also
sell these products to Abbott as the exclusive supplier of its
global Access to HIV Care program, through which
Abbott provides free or low-cost testing products for HIV
testing in underdeveloped countries around the world.
We market our health management programs primarily to health
plans (both commercial and governmental) and self-insured
employers, and to a lesser extent to pharmaceutical companies
and physicians, through our employee sales force and channel
partners.
We market and sell our First Check consumer drug testing
products in the United States and Canada through retail drug
stores, drug wholesalers, groceries and mass merchandisers.
These products compete intensively with other brand name drug
testing products based on price, performance and brand
awareness, which is achieved through targeted print advertising.
We primarily market and sell our vitamins and nutritional
supplements in the United States through private label
arrangements with retail drug stores, groceries, mass
merchandisers and warehouse clubs who sell our products under
their store brands. We also sell a variety of branded products
to the retail drug stores, groceries and mass merchandisers.
MANUFACTURING
Our major manufacturing facilities are located in Hangzhou and
Shanghai, China; Matsudo, Japan; and San Diego, California.
We are in the process of closing another significant facility in
Bedford, England and transferring the manufacturing operations
located there to our low-cost production facilities mainly in
China. We also manufacture products at a number of other
facilities in the United States and in the United Kingdom, as
well as in Israel, Australia and South Africa. All of our
important manufacturing facilities are ISO certified and
registered with the FDA. We manufacture substantially all of our
consumable diagnostic products and nutritional products at these
facilities. We also manufacture the consumable diagnostic
devices containing the diagnostic chemistry or other proprietary
diagnostic technology which are used in conjunction with our
diagnostic or monitoring systems, including our Biosite Triage
system, our Cholestech LDX monitoring devices, our INRatio
monitoring devices and the digital pregnancy and ovulation
prediction tests and fertility monitors that we supply to the
SPD joint venture. We contract with third parties to supply the
electronic reader portion of these diagnostic or monitoring
systems and to supply various other products which we sell,
including our
Triage®
BNP Test for use on Beckman Coulter systems, a majority of our
IFA and ELISA tests and our
TECHLAB®
products.
We manufacture substantially all of our vitamin and nutritional
products at IMNs facilities in Freehold and Irvington, New
Jersey. IMN internally manufactures substantially all of its
softgel requirements at the Irvington facility. Both facilities
manufacture to the GMP standards.
RESEARCH AND
DEVELOPMENT
Our primary research and development centers are in Jena,
Germany; Stirling, Scotland; and San Diego, California. We
also conduct research and development in Bedford and Cambridge,
England; Hangzhou, China; Scarborough, Maine; Hayward,
California; Brisbane, Australia; and Yavne, Israel; and, to a
lesser extent, at certain of our other facilities. Our research
and development programs currently focus on the development of
cardiology, infectious disease, oncology, HIV and womens
health diagnostic products.
Our facility in Stirling, Scotland was formed in connection with
a February 2005 co-development agreement with ITI Scotland
Limited, or ITI, whereby ITI agreed to provide us with
approximately £30.0 million over three years to
partially fund research and development programs and we agreed
to invest at least
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£37.5 million in these programs over three years. The
funding arrangement with ITI, as well as our investment
commitments related thereto, expired during the first quarter of
2008.
Global
Operations
We are a global company. We have major manufacturing facilities
in San Diego, California; Hangzhou and Shanghai, China; and
Matsudo, Japan and significant research and development
operations in Jena, Germany and Stirling, Scotland. Our
distribution network supporting our professional diagnostics
business includes offices in the United States, Canada, England,
France, Spain, Germany, Italy, Switzerland, Austria, Australia,
New Zealand, Japan, South Africa, Israel, India, Brazil and
Colombia.
Our professional diagnostic products are sold throughout the
world. Our health management programs are offered almost
exclusively in the United States and our vitamins and
nutritional supplements are sold primarily in the United States
and, to a lesser extent, in Canada. During 2008 and 2007,
respectively, approximately 72% and 63% of our net revenues were
generated from the United States, approximately 17% and 24% of
our net revenues were generated from Europe, and approximately
11% and 13% of our net revenues were generated from customers
located elsewhere. Revenues from the United States increased
during 2008 due to the disproportionate impact of our
newly-established health management business and, in particular,
our acquisition of Matria in May 2008.
COMPETITION
Professional Diagnostics. The main competitors
for our professional rapid diagnostic products are Becton
Dickinson and Quidel. Some competitors in this market, such as
Becton Dickinson, are large companies with substantial
resources, while numerous smaller, yet aggressive companies are
also competitors. Some automated immunoassay systems can be
considered competitors when labor shortages force laboratories
to automate or when the costs of such systems are lower. Such
systems are provided by Abbott, Siemens AG, Beckman Coulter,
Johnson & Johnson, Roche Diagnostics and other large
diagnostic companies. In the infectious disease area, new
technologies utilizing amplification techniques for analyzing
molecular DNA gene sequences, from companies such as Abbott,
Roche Diagnostics, Cepheid and Gen-Probe, are making in-roads
into this market. Competition for rapid diagnostics is intense
and is primarily based on price, breadth of product line and
distribution capabilities.
Our competitors in the ELISA diagnostics market include the
large diagnostics companies named above, which manufacture
state-of-the-art automated immunoassay systems and a wide array
of diagnostic products designed for processing on those systems.
Other competitors in this market, DiaSorin and Diamedx, in
particular, are smaller companies who compete based on quality
and service. In the United States and Canada, we focus on
matching the instrumentation and product testing requirements of
our customers by offering a wide selection of diagnostic
products and test equipment.
The markets for our serology and our IFA and microbiology
products are mature and competition is based primarily on price
and customer service. Our main competitors in serology and
microbiology testing include Remel and Biokit. Our main
competitors in IFA testing are Bio-Rad Laboratories, INOVA
Diagnostics, Immuno Concepts, The Binding Site, Trinity Biotech,
Meridian Biosciences and DiaSorin. However, products in these
categories also compete to a large extent against rapid membrane
and ELISA products, which are often easier to perform and read
and can be more precise.
In cardiology, the majority of diagnostic immunoassays utilized
by physicians and other healthcare providers are performed by
independent clinical reference laboratories and hospital-based
laboratories using automated analyzers for batch testing. As a
result, the primary competitors of our Triage and LDX
point-of-care testing systems, which consist of rapid diagnostic
devices interpreted by portable electronic readers, are the
large diagnostic companies identified above who produce
automated immunoassay systems. We expect these large companies
to continue to compete vigorously to maintain their dominance of
the cardiology testing market. Although we offer our Triage BNP
test for use on Beckman Coulter Immunoassay Systems, our other
primary
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cardiology products are not currently designed for automated
batch testing. Our Triage products face strong competition from
Abbott Laboratories i-Stat handheld system and our LDX
system also faces direct competition from Abaxis Medical
Diagnostics, which markets its point-of-care blood laboratory
systems to physicians office laboratories and Polymer
Technology Systems, which sells a home cholesterol test system.
The primary competitors for our INRatio coagulation monitoring
system are Roche Diagnostics and International Technidyne
Corporation, a division of Thoratec, who together currently
account for over 75% of the domestic sales of PT/INR
point-of-care and patient self-testing devices.
In oncology, our Matritech NMP-22 diagnostic products aid in
diagnosing and monitoring bladder cancer patients, in
conjunction with standard diagnostic procedures, and are based
on our proprietary nuclear matrix protein technology. Our NMP-22
BladderChek Test is currently the only in-office test approved
by the FDA as an aid in the diagnosis of bladder cancer.
However, competition in the development and marketing of cancer
diagnostics and therapeutics, using a variety of other
technologies, is intense. Competing diagnostic products based on
other technologies may be introduced by other companies and
could adversely affect our competitive position. In a larger
sense, our tests also compete with more invasive or expensive
procedures, such as surgery, bone scans, magnetic resonance
imaging and other in vivo imaging techniques. In the market for
urine-based diagnostic tests, our NMP-22 tests also compete with
existing cellular-based tests, such as the microscopic
examination of suspicious cells and a test known as UroVysiontm,
which is a fluorescent in-situ hybridization test.
Generally, our professional diagnostic products
competitive positions may be based on, among other things, being
first to market with a novel product, product performance,
accuracy, convenience, cost-effectiveness, the strength of our
intellectual property and price, as well as on the effectiveness
of our sales force and our marketing and distribution partners.
Where we face competition from large diagnostic companies, these
competitors have greater resources than we do. In addition,
certain competitors may have more favorable competitive
positions than we do in markets outside of the United States.
We believe that our dedication to research and development and
our strong intellectual property portfolio, coupled with our
advanced manufacturing expertise, diversified product
positioning, global market presence and established distribution
networks, provide us with a competitive advantage in the
point-of-care markets in which we compete.
Health Management. Competition for our health
management services is also intense. Other health management
service providers include Health Dialog and Healthways. Our
competitors and potential competitors also include health plans,
self-insured employers, healthcare providers, pharmaceutical
companies, pharmacy benefit management companies, case
management companies and other organizations that provide
services to health plans and self-insured employers. Some of
these entities, health plans and self-insured employers in
particular, may be customers or potential customers and may own,
acquire or establish health management service providers or
capabilities for the purpose of providing health management
services in-house. Many of these competitors are considerably
larger than us, with access to greater resources. We believe
however that our ability to improve clinical and financial
outcomes and our highly-regarded technology platforms will
enable us to compete effectively.
Consumer Diagnostics. Our First Check tests
compete against over-the-counter diagnostic tests sold primarily
by Phamatech, Inc., but also by other smaller competitors.
Essentially all of our remaining consumer diagnostic product
sales are to SPD, our joint venture. These products are sold by
SPD in retail markets where competition is intense and based
primarily on brand recognition and price. Our revenues, as well
as our share of the profits from the sale of these products by
SPD, are dependent upon SPDs ability to effectively
compete in these markets.
Vitamins and Nutritional Supplements. The
market for private label vitamins and nutritional supplements is
extremely price sensitive, with quality, customer service and
marketing support also being important. Many of the companies
that mass market branded vitamins and nutritionals, including
U.S. Nutrition and Pharmavite, also sell to private label
customers and constitute our major competitors for private label
business. In addition, there are several companies, such as
Perrigo Company, that compete only in the private label business.
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In the branded nutritional supplements industry, competition is
based upon brand name recognition, price, quality, customer
service and marketing support. There are many companies, both
small and large, selling vitamin products to retailers. A number
of these companies, particularly manufacturers of nationally
advertised brand name products, are substantially larger than we
are and have greater financial resources. Among the major
competitors of our branded products that are sold through
groceries and other mass retailers are U.S. Nutrition,
Wyeth, Pharmavite and GlaxoSmithKline.
PATENTS AND
PROPRIETARY TECHNOLOGY; TRADEMARKS
We have built a strong intellectual property portfolio in the
area of lateral flow immunoassays, the technology which
underlies many rapid diagnostic test formats, including most
one-step home pregnancy and fertility/ovulation tests and most
of our rapid membrane products for the point-of-care
marketplaces that we serve. We believe that our intellectual
property rights in the major patent families in this area of
technology give us a distinct advantage and underpin our
continuing success in this area. In addition, our intellectual
property portfolio also includes an increasing number of other
patents, patent applications and licensed patents protecting our
vision of the technologies and products of the future. Our
intellectual property portfolio consists of patents that we own
and, in some cases, licenses to patents or other proprietary
rights of third parties which may be limited in terms of field
of use, transferability or may require royalty payments.
The medical products industry, including the diagnostic testing
industry, historically has been characterized by extensive
litigation regarding patents, licenses and other intellectual
property rights. As the fact of our pending litigation with
Healthways, Inc. and Robert Bosch North America Corp. and with
Health Hero Network Inc. suggests, litigation relating to
intellectual property rights is also prevalent in the health
management industry. For more information regarding these
pending matters see BusinessLegal Proceedings.
We believe that our history of successfully enforcing our
intellectual property rights in the United States and abroad
demonstrates our resolve in enforcing our intellectual property
rights, the strength of our intellectual property portfolio and
the competitive advantage that we have in this area. We have
incurred substantial costs, both in asserting infringement
claims against others and in defending ourselves against patent
infringement claims, and we expect to incur substantial
litigation costs as we continue to aggressively protect our
technology and defend our proprietary rights.
Finally, we believe that certain of our trademarks are valuable
assets that are important to the marketing of both our products
and services. Many of these trademarks have been registered with
the United States Patent and Trademark Office or
internationally, as appropriate.
The medical products industry, including the diagnostic testing
industry, and the health management industry place considerable
importance on obtaining and enforcing patent and trade secret
protection for new technologies, products, services and
processes. Trademark protection is an important factor in the
success of certain of our product lines and health management
programs. Our success therefore depends, in part, on our ability
to obtain and enforce the patents and trademark registrations
necessary to protect our products, to preserve our trade secrets
and to avoid or neutralize threats to our proprietary rights
from third parties. We cannot, however, guarantee our success in
enforcing or maintaining our patent rights; in obtaining future
patents or licensed patents in a timely manner or at all; or as
to the breadth or degree of protection that our patents or
trademark registrations or other intellectual property rights
might afford us. For more information regarding the risks
associated with our reliance on intellectual property rights see
Risk Factors.
GOVERNMENT
REGULATION
Our businesses are subject to extensive and frequently changing
federal, state and local regulations. Changes in applicable laws
or any failure to comply with existing or future laws,
regulations or standards could have a material adverse effect on
our results of operations, financial condition, business and
prospects. We believe our current arrangements and practices are
in material compliance with applicable laws and regulations.
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There can be no assurance that we are in compliance with all
applicable existing laws and regulations or that we will be able
to comply with new laws or regulations.
Our research, development and clinical programs, as well as our
manufacturing and marketing operations, are subject to extensive
regulation in the United States and other countries. Most
notably, all of our products sold in the United States are
subject to the Federal Food, Drug and Cosmetic Act, or the FDCA,
as implemented and enforced by the FDA. All of our diagnostic
products sold in the United States require FDA clearance to
market under Section 510(k) of the FDCA, which may require
pre-clinical and clinical trials. Foreign countries may require
similar or more onerous approvals to manufacture or market these
products. The marketing of our consumer diagnostic products is
also subject to regulation by the U.S. Federal Trade
Commission, or the FTC. In addition, we are required to meet
regulatory requirements in countries outside the United States,
which can change rapidly with relatively short notice.
The manufacturing, processing, formulation, packaging, labeling
and advertising of our nutritional supplements are subject to
regulation by one or more federal agencies, including the FDA,
the Drug Enforcement Administration, the Federal Trade
Commission, or FTC, and the Consumer Product Safety Commission.
These activities are also regulated by various agencies of the
states, localities and foreign countries in which our
nutritional supplements are now sold or may be sold in the
future. In particular, the FDA regulates the safety,
manufacturing, labeling and distribution of dietary supplements,
including vitamins, minerals and herbs, as well as food
additives, over-the-counter and prescription drugs and
cosmetics. The GMP standards promulgated by the FDA are
different for nutritional supplement, drug and device products.
In addition, the FTC has jurisdiction along with the FDA to
regulate the promotion and advertising of dietary supplements,
over-the-counter drugs, cosmetics and foods.
Certain of our clinicians, such as nurses, must comply with
individual licensing requirements. All of our clinicians who are
subject to licensing requirements are licensed in the state in
which they are physically present, such as the location of the
call center from which they operate. In the future, multiple
state licensing requirements for healthcare professionals who
provide services telephonically over state lines may require us
to license some of our clinicians in more than one state. New
judicial decisions, agency interpretations or federal or state
legislation or regulations could increase the requirement for
multi-state licensing of a greater number of our clinical staff,
which would increase our administrative costs.
Certain aspects of our health management business are subject to
unique licensing or permit requirements by state and local heath
agencies. In addition, our health management business is subject
to the security regulations of the Health Insurance Portability
and Accountability Act, or HIPAA. We may also be required to
obtain certification to participate in governmental payment
programs, such as state Medicaid programs. Some states have
established Certificate of Need, or CON, programs regulating the
expansion of healthcare operations. The failure to obtain, renew
or maintain any of the required licenses, certifications or CONs
could adversely affect our business.
EMPLOYEES
As of January 31, 2009, we had approximately
8,300 employees, including temporary and contract
employees, of which approximately 5,900 employees are
located in the United States. In addition, we utilize
consultants specializing in areas such as research and
development, risk management, regulatory compliance, strategic
planning and marketing.
LEGAL
PROCEEDINGS
On September 19, 2008, the Estate of Melissa Prince
Quisenberry filed a class action complaint in the Superior Court
of California against Alere Medical, Inc.; certain executive
officers, directors
and/or
significant shareholders of Alere Medical; and several
unaffiliated entities. On April 13, 2009, the plaintiff
amended the class action complaint, dismissing several of the
unaffiliated entities. The plaintiff and the class owned stock
in Alere Medical and allege that the defendants approved the
March 14, 2007 sale of Alere
S-78
Business
Medical to an unaffiliated entity at a price substantially lower
than the price at which Inverness bought Alere Medical in
November 2007, forcing plaintiff and the class either to tender
their stock or seek appraisal. The plaintiff also alleges that
the defendants failed to disclose material facts concerning the
valuation of Alere, misleading the plaintiff and the class to
tender their shares rather than seek appraisal. The plaintiff
alleges that, through the foregoing actions, the individual
defendants breached fiduciary duties of good faith, fair
dealing, loyalty and candor; and that Alere Medical and an
unaffiliated entity aided and abetted the breaches. We believe
that we have strong defenses to all of the allegations and we
intend to defend the claims vigorously. However, an outcome
against Alere Medical could potentially have a material adverse
impact on our sales, operations or financial performance.
Healthways, Inc. and Robert Bosch North America Corp. filed a
complaint in U.S. District Court in the Northern District
of Illinois on November 5, 2008 against Alere Medical
alleging infringement of 11 patents, licensed by Bosch from
Healthways. Alere Medical answered the complaint and filed
counterclaims seeking declarations that the patents are invalid
and not infringed. The plaintiffs subsequently filed an amended
complaint substituting Alere LLC, or Alere, our consolidated
health management subsidiary, as the defendant in place of Alere
Medical. We believe that we have strong defenses to
Healthways allegations and we intend to defend them
vigorously. However, a ruling against Alere could potentially
have a material adverse impact on our sales, operations or
financial performance or could limit our current or future
business opportunities.
We are not a party to any other pending legal proceedings that
we currently believe could have a material adverse impact on our
sales, operations or financial performance. However, because of
the nature of our business, we may be subject at any particular
time to commercial disputes, consumer product claims, negligence
claims or various other lawsuits arising in the ordinary course
of our business, including infringement, employment or investor
matters, and we expect that this will continue to be the case in
the future. Such lawsuits generally seek damages, sometimes in
substantial amounts.
As an example, as we have previously reported, in April 2008,
Pyramid Holdings Inc., a purchaser in our November 2007 public
offering of our common stock, filed a putative securities class
action against us, Ron Zwanziger, our chairman, chief executive
officer and president, and David Teitel, our chief financial
officer, in the United States District Court for the District of
Massachusetts, alleging that the prospectus supplement and
registration statement with respect to the November 2007 public
offering were inaccurate and misleading and omitted to state
material facts. The plaintiffs have subsequently filed their
amended class action complaint, adding as defendants each of our
then current directors, a former director, and a former chief
financial officer. We believe that the allegations are baseless,
and we intend to defend against them vigorously.
Also, our subsidiary Alere Medical continues to defend
infringement claims brought by Health Hero Network, Inc., a
subsidiary of Robert Bosch North America Corp., which alleges to
have patented certain processes related to home monitoring of
patients.
While we believe that we have strong defenses to the claims
brought by Pyramid Holdings and Health Hero and we intend to
defend them vigorously, these, or other claims, could
potentially have a negative impact on our sales, operations or
financial performance or could limit our existing or future
business opportunities.
In addition, we aggressively defend our patent and other
intellectual property rights. This often involves bringing
infringement or other commercial claims against third parties.
These suits can be expensive and result in counterclaims
challenging the validity of our patents and other rights.
Finally, we were recently notified by the SEC that its 2005
formal order of investigation in connection with the previously
disclosed revenue recognition matter at one of our diagnostic
divisions has been completed and that the SEC does not intend to
recommend any enforcement actions against us.
S-79
Management
The following biographical descriptions set forth certain
information with respect to our executive officers and directors.
|
|
|
|
|
|
|
Name
|
|
Age
|
|
Position
|
|
|
Ron Zwanziger
|
|
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55
|
|
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Chairman of the Board, Chief Executive Officer and President
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David Scott, Ph.D.
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|
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52
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|
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Director, Chief Scientific Officer
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Jerry McAleer, Ph.D.
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|
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53
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|
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Director, Vice President, Research and Development and Vice
President, Cardiology
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Hilde Eylenbosch, M.D.
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45
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Vice President, Marketing
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David Toohey
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52
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|
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President, Europe/Middle East
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John Yonkin
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|
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49
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|
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President, Inverness Medical Innovations North America, Inc.,
and President, Nutritionals
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John Bridgen, Ph.D.
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|
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62
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|
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Vice President, Strategic Business Development
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David Teitel
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|
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45
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Chief Financial Officer
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Jon Russell
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44
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Vice President, Finance
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Michael K. Bresson
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51
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Vice President, Mergers & Acquisitions
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Paul T. Hempel
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|
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60
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|
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Senior Vice President, Leadership Development and Special
Counsel and Secretary
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Ellen Chiniara
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50
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General Counsel and Assistant Secretary
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Ron Geraty, M.D.
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62
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Chief Executive Officer, Alere LLC
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Emanuel Hart
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59
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Vice President, International Business, LAmARCIS
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David Walton
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55
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Vice President, Asia Pacific
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Eli Y. Adashi, M.D.
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|
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64
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Director
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Carol R. Goldberg
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|
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78
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|
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Director
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Robert P. Khederian
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|
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57
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|
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Director
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John F. Levy
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|
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62
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|
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Director
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John A. Quelch
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|
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57
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Director
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James Roosevelt, Jr.
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63
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Director
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Peter Townsend
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74
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Director
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Ron Zwanziger has served as our Chairman, Chief
Executive Officer and President since our inception on
May 11, 2001. Mr. Zwanziger served as Chairman, Chief
Executive Officer and President of our predecessor company,
Inverness Medical Technology, from its inception in 1992 through
November 2001 when that company was acquired by
Johnson & Johnson. From 1981 to 1991, he was Chairman
and Chief Executive Officer of MediSense, a medical device
company. Mr. Zwanziger also serves as a director, as a
member of the Compensation Committee and as Chairperson of the
Nominating and Corporate Governance Committee of AMAG
Pharmaceuticals, Inc.
David Scott, Ph.D., has served on the Board since
July 31, 2001 and is our Chief Scientific Officer.
Dr. Scott served as Chairman of Inverness Medical Limited,
a subsidiary of our predecessor company, Inverness Medical
Technology, from July 1999 through November 2001, when that
company was acquired by Johnson & Johnson, and as a
managing director of Inverness Medical Limited from July 1995 to
July 1999. Dr. Scott served as Managing Director of Great
Alarm Limited, a consulting company, from October 1993 to April
1995. Between October 1984 and September 1993, he held several
positions at MediSense UK, serving most recently as Managing
Director where he was responsible for managing product
development, as well as the mass manufacture of one of its
principal products, ExacTech.
S-80
Management
Jerry McAleer, Ph.D., joined the Board on
March 10, 2003. Dr. McAleer has also served as our
Vice President, Research and Development since our inception in
May 2001 and has served as our Vice President, Cardiology since
early 2006. Dr. McAleer served as Vice President of
Research and Development of our predecessor company, Inverness
Medical Technology, from 1999 through November 2001, when that
company was acquired by Johnson & Johnson. From 1995
to 1999, Dr. McAleer served as Director of Development of
Inverness Medical Limited, Inverness Medical Technologys
primary research and development unit, where he headed the
development of Inverness Medical Technologys
electrochemical glucose strips. Prior to joining Inverness
Medical Technology, Dr. McAleer held senior research and
development positions at MediSense, a medical device company,
and Ecossensors, Inc., an environmental research company.
Hilde Eylenbosch, M.D., has served as our
Vice President of Marketing since April 1, 2009. Prior to
that, she served as Chief Executive Officer of SPD Swiss
Precision Diagnostics GmbH, our
50/50 joint
venture with P&G, since its inception on May 18, 2007.
Dr. Eylenbosch has also served as our President, Consumer
Diagnostics since June 2006. Prior to assuming that title she
served as Vice President, Consumer Diagnostics from July 2005 to
June 2006, Vice President, Consumer Marketing from October 2004
to July 2005 and Vice President of International Womens
Health from November 2001 to October 2004. Dr. Eylenbosch
served in the same capacity for our predecessor company,
Inverness Medical Technology, from August 2001 until that
company was acquired by Johnson & Johnson in November
2001. Prior to that, she held various positions at Inverness
Medical Technology, including Director of U.S. Womens
Health from September 1998 through October 2000. When she joined
Inverness Medical Technology in January 1995,
Dr. Eylenbosch was responsible for marketing that
companys womens health products in Europe. Before
joining Inverness Medical Technology, Dr. Eylenbosch was
employed by Synthelabo, a French pharmaceutical company, where
she held various marketing positions.
David Toohey was appointed President,
Europe/Middle East in January 2008. Prior to that, he served as
President, Professional Diagnostics from December 2005, as Vice
President, Professional Diagnostics from October 2002, as Vice
President, European Operations from February 2002, and as Vice
President, New Products from November 2001. He also served as
Managing Director of our Unipath Limited subsidiary from
December 2001 through October 2002. Mr. Toohey was employed
by our predecessor company, Inverness Medical Technology, as its
Vice President, New Products from May 2001 through November
2001, when that company was acquired by Johnson &
Johnson. Prior to joining Inverness Medical Technology,
Mr. Toohey served as Vice President of Operations at Boston
Scientific Corporations Galway, Ireland facility where he
oversaw its growth, from a
start-up to
Boston Scientific Corporations largest manufacturing
facility, between 1995 and 2001. Prior to that time he held
various executive positions at Bausch & Lomb, Inc.,
Digital Equipment Corp. and Mars, Inc.
John Yonkin was appointed President, Inverness
Medical Innovations North America, Inc. in January 2008. Prior
to that, he served as President, U.S. Point of Care from
June 2006. Mr. Yonkin also continues to serve as President,
Nutritionals, a role he has had since June 2006. Prior to that,
he served as our Vice President, Nutritionals from April 2005 to
June 2006 and Vice President, U.S. Sales and Marketing from
November 2001 to April 2005. Mr. Yonkin served as Vice
President of U.S. Sales of our predecessor company,
Inverness Medical Technology, from October 1998 through January
2000 and as its General Manager from January 2000 through
November 2001, when that company was acquired by
Johnson & Johnson. He also served as Manager of
Product Development for Inverness Medical Technology from
October 1997 until October 1998. From January 1995 to September
1997, Mr. Yonkin was Director of National Accounts for
Genzyme Genetics, a subsidiary of Genzyme, Inc., a leader in
genetic testing services for hospitals, physicians and managed
healthcare companies.
John Bridgen, Ph.D., joined our Company in
September 2002 upon our acquisition of Wampole Laboratories,
LLC. Dr. Bridgen served as President of Wampole from August
1984 until September 2005. He currently serves as our Vice
President, Strategic Business Development. Prior to joining
Wampole, Dr. Bridgen
S-81
Management
had global sales and marketing responsibility for the hematology
and immunology business units of Ortho Diagnostic Systems Inc.,
a Johnson & Johnson company.
David Teitel has served as our Chief Financial
Officer since December 2006. Mr. Teitel has over
20 years of public and private company finance experience,
including nine years of audit experience at Arthur Andersen and
senior financial positions with Thermo Electron, which is now
Thermo Fisher Scientific and Deknatel Snowden Pencer Inc.
Mr. Teitel joined the Company in December 2003 as Director
of Finance Operations and assumed the title Vice President,
Finance in December 2004.
Jon Russell has served as our Vice President,
Finance since December 2006. In this role, Mr. Russell
oversees financial systems management and integration and shares
responsibility for external communications with the Chief
Executive Officer. Previously, Mr. Russell was Chief
Financial Officer of Wampole Laboratories, LLC. He has
20 years of experience in finance and operations
management, including senior operational finance positions in
North America and Europe with Precision Castparts Corporation,
Vertex Interactive, Inc. and Genicom Corporation.
Mr. Russell began his career at Ernst & Young LLP.
Michael K. Bresson rejoined us as Vice President,
Mergers & Acquisitions, in January 2007 after serving
as President of LifeTrac Systems Incorporated from February 2006
to December 2006. Previously, Mr. Bresson served as our
Vice President, Business Development from May 2005 to February
2006. From 1998 until January 2005, he was employed at Apogent
Technologies Inc. (now part of Thermo Fisher Scientific Inc.),
last serving as Apogents Executive Vice
PresidentAdministration, General Counsel and Secretary.
Prior to joining Apogent in 1998, Mr. Bresson was a partner
at the law firm of Quarles & Brady LLP.
Paul T. Hempel served as our General Counsel and
Secretary since our inception on May 11, 2001. In April
2006, Mr. Hempel became Senior Vice President in charge of
Leadership Development, while retaining his role as Secretary
and oversight of legal affairs. Mr. Hempel served as
General Counsel and Assistant Secretary of our predecessor
company, Inverness Medical Technology, from October 2000 through
November 2001, when that company was acquired by
Johnson & Johnson. Prior to joining Inverness Medical
Technology, he was a founding stockholder and Managing Director
of Erickson Schaffer Peterson Hempel & Israel PC from
1996 to 2000. Prior to 1996, Mr. Hempel was a partner and
managed the business practice at Bowditch & Dewey LLP.
Ellen Chiniara serves as General Counsel and
Assistant Secretary and is responsible for managing legal
matters for our Company. Ms. Chiniara joined our Company in
October 2006 as General Counsel of the Professional Diagnostics
strategic business unit and became General Counsel of our
Company in May 2007. From 2002 to 2006, Ms. Chiniara was
Associate General Counsel, Neurology of Serono, Inc., a
biopharmaceutical company. Previously, she served as General
Counsel to a healthcare venture capital fund and a healthcare
management services organization, where she also was Chief
Operating Officer of its clinical trial site management
division. From 1994 to 1997, Ms. Chiniara was Assistant
General Counsel at Value Health, a specialty managed healthcare
company. Prior to 1994, Ms. Chiniara was a corporate
attorney in Boston with Hale and Dorr (now Wilmer Cutler
Pickering Hale and Dorr LLP).
Ron Geraty, M.D., serves as Chief Executive
Officer of Alere LLC, our health management subsidiary.
Dr. Geraty joined us when Alere Medical was purchased in
November 2007. Prior to our purchase of Alere Medical,
Dr. Geraty had served on the board and as Chief Executive
Officer of Alere Medical since late 2001. Prior to Alere
Medical, Dr. Geraty was Chief Executive Officer of American
Imaging Management, a radiology benefits management company,
from 1999 to 2000. In 1989, Dr. Geraty founded Assured
Health, Inc. (an employee assistance company) which was sold to
American Biodyne, Inc. where he was a board member and executive
through several company transitions until the company was sold
to a competitor in 1998. Dr. Geraty was a Fellow at the
Harvard School of Medicine School of Public Policy in 1998. In
1984, Dr. Geraty founded Monarch Health Corporation, which
was sold to Parkside Medical Corporation in 1986 where he served
as an executive.
S-82
Management
Emanuel Hart has served as Vice President for
International Business responsible for the Latin America,
Africa, Russia, ex-Soviet Union countries and Israel territories
(LAmARCIS) for all of our products since August 2007.
Mr. Hart has also served as Chief Executive Officer and
President of Orgenics Ltd., one of our subsidiaries, since 1997.
David Walton serves as Vice President, Asia
Pacific. Mr. Walton joined our Company in
December 2001 when we acquired the Unipath business from
Unilever, where he was previously International Director for the
Consumer and Professional Diagnostic business units. Prior to
this, Mr. Walton held various senior global sales and
marketing roles in the Diagnostics Division of Eli Lilly based
at Hybritech in San Diego, California and Liege, Belgium,
Biorad U.K. and Corning Medical U.K.
Eli Y. Adashi, M.D., M.S., F.A.C.O.G., joined the
Board on April 1, 2009. Dr. Adashi, a Professor of
Medical Science at The Warren Alpert Medical School of Brown
University since 2004, is a Physician-Scientist-Executive with
over 25 years of experience in Health Care and in the Life
Sciences. A member of the Institute of Medicine of the National
Academy of Sciences and of its Committees on Human Embryonic
Stem Cell Research and on Womens Health
Research, Dr. Adashi is the founder and former leader
of the multidisciplinary Ovarian Cancer Program of the
NCI-designated Huntsman Cancer Research Institute.
Dr. Adashi also served on sabbatical on the Quality
Improvement Group of the Office of Clinical Standards and
Quality, Centers for Medicare and Medicaid Services (CMS) and is
a current ad hoc member of the Reproductive Health Drugs
Advisory Committee of the U.S. Food & Drug
Administration. A fellow of the American Association for the
Advancement of Science and a member of the Association of
American Physicians, Dr. Adashi is the author or co-author
of over 250 peer-reviewed publications, over 120 book
chapters/reviews, and 13 books focusing on ovarian biology,
ovarian cancer and reproductive health. Dr. Adashi is a
member of the Boards Compensation Committee.
Carol R. Goldberg has served on the Board since
May 30, 2001. Ms. Goldberg served as a director of our
predecessor company, Inverness Medical Technology, from August
1992 through November 2001, when that company was acquired by
Johnson & Johnson. Since December 1989, she has served
as President of The AVCAR Group, Ltd., an investment and
management consulting firm in Boston, Massachusetts.
Ms. Goldberg is Chairperson of the Boards
Compensation Committee and a member of the Boards
Nominating and Corporate Governance Committee.
Robert P. Khederian has served on the Board since
July 31, 2001. Mr. Khederian is the Chairman of
Belmont Capital, a venture capital firm he founded in 1996, and
Provident Corporate Finance, an investment banking firm he
founded in 1998. From 1984 through 1996, he was founder and
Chairman of Medical Specialties Group, Inc., a nationwide
distributor of medical products which was acquired by Bain
Capital. Mr. Khederian is a member of the Boards
Audit Committee, Compensation Committee and Nominating and
Corporate Governance Committee.
John F. Levy has served on the Board since
May 30, 2001. Mr. Levy served as director of Inverness
Medical Technology from August 1996 through November 2001, when
that company was acquired by Johnson & Johnson. Since
1993, he has been an independent consultant. Mr. Levy
served as President and Chief Executive Officer of Waban, Inc.,
a warehouse merchandising company, from 1989 to 1993.
Mr. Levy is Chairperson of the Boards Audit Committee
and is a member of the Boards Compensation Committee and
Nominating and Corporate Governance Committee.
John A. Quelch joined the Board on March 10,
2003. Since June, 2001, Mr. Quelch has been a
professor and Senior Associate Dean at the Harvard Business
School. From July 1998 through June 2001, he was Dean of the
London Business School. Mr. Quelch also serves as a
director of WPP plc, one of the worlds largest
communications groups, Gentiva Health Services, Inc., as member
of the Compensation Committee of Pepsi Bottling Group and as
Chairman of the Massachusetts Port Authority. He is Chairperson
of the Boards Nominating and Corporate Governance
Committee.
S-83
Management
James Roosevelt, Jr. joined the Board on
February 6, 2009. Mr. Roosevelt has served as the
President and Chief Executive Officer of Tufts Health Plan since
2005. From 1999 to 2005, Mr. Roosevelt was Vice President
and General Counsel of Tufts Health Plan. Mr. Roosevelt
also serves as Co-Chair of the Rules and By-laws Committee of
the Democratic National Committee, Co-Chair of the Board of
Directors for the Tufts Health Care Institute, and member of the
Board of Directors at American Health Insurance Plans, Emmanuel
College and PointRight Inc. Mr. Roosevelt is a member of
The Boards Nominating and Corporate Governance Committee.
Peter Townsend has served on the Board since
May 30, 2001. Mr. Townsend served as a director of our
predecessor company, Inverness Medical Technology, from August
1996 through November 2001, when that company was acquired by
Johnson & Johnson. From 1991 to 1995, when he retired,
Mr. Townsend served as Chief Executive Officer and a
director of Enviromed plc, a medical products company.
Mr. Townsend is a member of the Boards Audit
Committee.
S-84
Description of other
indebtedness
SECURED CREDIT
FACILITIES
On June 26, 2007, in conjunction with our acquisition of
Biosite, Inc., we entered into a secured First Lien Credit
Agreement, which we refer to as our senior secured credit
facility, with certain lenders, General Electric Capital
Corporation as administrative agent and collateral agent, and
certain other agents and arrangers, a secured Second Lien Credit
Agreement, which we refer to as our junior secured credit
facility (and together with the senior secured credit facility,
as our secured credit facilities), with certain lenders, General
Electric Capital Corporation as administrative agent and
collateral agent, and certain other agents and arrangers, and
certain related guaranty and security agreements. On
November 15, 2007 we amended the senior secured credit
facility. As amended, the senior secured credit facility
provides for term loans in the aggregate amount of
$975.0 million and, subject to our continued compliance
with the senior secured credit facility, a $150.0 million
revolving line of credit. The junior secured credit facility
provides for term loans in the aggregate amount of
$250.0 million.
As of December 31, 2008, the term loans and the revolving
line of credit under the senior secured credit facility bore
interest at 3.89% and 3.64%, respectively, and the term loans
under the junior secured credit facility bore interest at 6.14%.
As of December 31, 2008, aggregate outstanding borrowings
under the secured credit facilities included $960.8 million
under the senior secured credit facility term loans,
$142.0 million under the senior secured credit facility
revolving line of credit and $250.0 million in borrowings
under the junior secured credit facility term loans. Interest
expense (including amortized deferred borrowing costs) related
to our secured credit facilities, which included the term loans
and revolving line of credit, for the year ended
December 31, 2008 was $85.2 million. As of
December 31, 2008, we were in compliance with all debt
covenants related to the secured credit facilities, which
consisted principally of maximum consolidated leverage and
minimum interest coverage requirements.
We must repay the senior secured credit facility term loans as
follows: (a) in two initial installments in the amount of
$2,250,000 each on September 30, 2007 and December 31,
2007 (each of which installment payment has been made),
(b) in twenty-five consecutive quarterly installments,
beginning on March 31, 2008 and continuing through
March 31, 2014, in the amount of $2,437,500 each (each of
which installment payments through March 31, 2009 has been
made) and (c) in a final installment on June 26, 2014
in an amount equal to the then outstanding principal balance of
the senior secured credit facility term loans. We may repay
borrowings under the senior secured credit facility revolving
line of credit at any time, but in no event later than
June 26, 2013. We must repay the entire junior credit
facility term loans on June 26, 2015.
In August 2007, we entered into interest rate swap contracts,
with an effective date of September 28, 2007, that fix our
floating rate interest obligations under the secured credit
facilities with respect to a total notional value of
$350.0 million and have a maturity date of
September 28, 2010. In January 2009, we entered into
additional interest rate swap contracts, with an effective date
of January 14, 2009, that fix our floating rate interest
obligations under the secured credit facilities with respect to
a total notional value of $500.0 million and have a
maturity date of January 5, 2011.
We are required to make mandatory prepayments of the term loans
and the revolving credit loans in various amounts under the
secured credit facilities if we make certain sales of assets
outside the ordinary course of business above certain
thresholds, if we suffer certain property loss events above
certain thresholds, if we issue certain types of debt, or if we
have excess cash flow, as that term is defined in the secured
credit facilities. We may make optional prepayments of the
senior secured credit facility term loan from time to time
without premium or penalty. If, after June 26, 2008 and on
or prior to June 26, 2009, we optionally prepay the junior
secured credit facility term loan or mandatorily prepay the
junior secured credit facility term loan as a result of our
issuing certain types of debt, we must pay a prepayment premium
equal to 1.0% of principal amount prepaid; after June 26,
2009, we may make optional prepayments of the second lien
S-85
Description of
other indebtedness
term loan from time to time without premium or penalty. Once
repaid in full or in part, no reborrowings of the term loans
under either secured credit facility may be made.
The senior secured credit facility term loans bear interest at a
rate per annum of, at our option, either (a) the base rate,
as defined in the secured credit facilities, plus 1.00%, or
(b) LIBOR plus 2.00%. The borrowings pursuant to the
revolving line of credit under the senior secured credit
facility bear interest at a rate per annum of, at our option,
either (a) the base rate plus an applicable margin, which
varies between 0.75% and 1.25% depending on our consolidated
leverage ratio, or (b) LIBOR plus an applicable margin,
which varies between 1.75% and 2.25% depending on our
consolidated leverage ratio. We are obligated to pay fees on the
unused portion of our revolving line of credit at a rate per
annum of 0.50%. The junior secured credit facility term loan
bears interest at a rate per annum of, at our option, either
(a) the base rate plus 3.25%, or (b) LIBOR plus 4.25%.
Under the secured credit facilities, we must comply with various
customary financial and non-financial covenants. The primary
financial covenants under the senior secured credit facility
consist of a maximum consolidated leverage ratio, a minimum
consolidated interest coverage ratio and a limit on capital
expenditures. The primary financial covenants under the junior
secured credit facility consist of a maximum consolidated
leverage ratio and a limit on capital expenditures. The primary
non-financial covenants under the secured credit facilities
limit our ability to pay dividends or other distributions on our
capital stock, to repurchase our capital stock, to conduct
mergers or acquisitions, to make investments and loans, to incur
future indebtedness, to place liens on assets, to prepay other
indebtedness, to alter our capital structure and to sell assets.
The non-financial covenants under both the senior secured credit
facility and the junior secured credit facility are
substantially similar, with the non-financial covenants under
the junior secured credit facility providing us some increased
flexibility in some respects.
The respective lender groups under the secured credit facilities
are entitled to accelerate repayment of the loans under the
respective secured credit facilities upon the occurrence of any
of various customary events of default, which include, among
other events, failure to pay when due any principal, interest or
other amounts in respect of the loans, breach of any of our
covenants (subject, in some cases, to certain grace periods) or
representations under the loan documents, default under any
other of our or our material subsidiaries significant
indebtedness agreements, a bankruptcy or insolvency event with
respect to us or any of our material subsidiaries, a significant
unsatisfied judgment against us or any of our material
subsidiaries, any exercise by Procter & Gamble of its
option to put its joint venture interest back to us if we are
not then in pro forma compliance with our financial covenants
under the secured credit facilities, or if we undergo a change
of control (including any fundamental change or
termination of trading event as defined under the
indenture governing our senior subordinated convertible notes).
Borrowings under the secured credit facilities are guaranteed by
us and substantially all of our United States subsidiaries and
are secured by the stock of substantially all of our United
States subsidiaries, portions of the stock of certain of our
foreign subsidiaries, substantially all of the intellectual
property rights of our United States subsidiaries and
substantially all of the other assets of our businesses in the
United States. Pursuant to the terms of an intercreditor
agreement entered into at the closing of the secured credit
facilities between the administrative agents for the respective
lender groups under the secured credit facilities, the liens
securing the loans and other obligations arising under senior
secured credit facility are senior to the liens securing the
loans and other obligations arising under the junior secured
credit facility.
3% CONVERTIBLE
SENIOR SUBORDINATED NOTES DUE 2016
On May 14, 2007, we sold $150.0 million in principal
amount of 3% convertible senior subordinated notes due
May 15, 2016, which we refer to as our senior subordinated
convertible notes, in a private placement to qualified
institutional buyers pursuant to the terms of Securities
Purchase Agreements dated May 9, 2007. The senior
subordinated convertible notes pay interest semiannually at a
rate of 3.00% per annum and were initially convertible into
shares of our common stock at a conversion price of
approximately $52.30 per
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Description of
other indebtedness
share. At the initial conversion price, the senior subordinated
convertible notes were convertible into an aggregate
2,868,120 shares of our common stock. On May 9, 2008,
pursuant to the terms of the indenture governing the terms of
the senior subordinated convertible notes, the conversion price
was adjusted to $43.98. At the adjusted conversion price, the
senior subordinated convertible notes are convertible into an
aggregate 3,410,641 shares of our common stock.
We may not redeem the senior subordinated convertible notes
prior to their stated maturity. In the event of certain
fundamental changes, as defined in the indenture governing the
senior subordinated convertible notes, we may be required to
repurchase the senior subordinated convertible notes for cash at
a price equal to 100% of the unconverted principal plus any
accrued but unpaid interest. The senior subordinated convertible
notes are equal in right of payment to the notes offered hereby
and subordinate in right of payment to the prior payment of our
senior indebtedness, including the secured credit facilities.
The senior subordinated convertible notes contain customary
events of default entitling the trustee or the holders thereof
to declare all amounts owed pursuant to the senior subordinated
convertible notes immediately payable if we violate certain of
our obligations.
As of December 31, 2008, $150.0 million in principal
amount of the senior subordinated convertible notes was
outstanding. Interest expense related to the senior subordinated
convertible notes for the year ended December 31, 2008,
including amortized deferred borrowing costs, was
$5.0 million.
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Description of notes
GENERAL
The terms of our 9.00% Senior Subordinated Notes due 2016,
which we refer to as the Notes, are described below.
Our debt securities are described generally in the accompanying
prospectus. The following description of the particular terms of
the Notes in this prospectus supplement overrides and supersedes
in its entirety the description of the general terms and
provisions of our debt securities included in the accompanying
prospectus.
The Notes will be issued under an indenture dated as of
May 12, 2009, between Inverness Medical Innovations, Inc.,
as issuer, and U.S. Bank National Association, as trustee
(the Base Indenture), as supplemented by a
supplemental indenture dated as of May 12, 2009, among
Inverness Medical Innovations, Inc., as issuer, the Guarantors
named therein, as guarantors, and U.S. Bank National
Association, as trustee (the Supplemental Indenture;
the Base Indenture as supplemented by the Supplemental
Indenture, the Indenture). The terms of the Notes
include those stated in the Indenture and those made part of the
Indenture by reference to the Trust Indenture Act of 1939,
as amended. The Notes are subject to all those terms, and you
should review the Indenture and the Trust Indenture Act for
a statement of the terms.
The following is a summary of the material provisions of the
Indenture. It does not purport to be complete and does not
restate the Indenture in its entirety. You are encouraged to
read the Indenture because it, and not this description, defines
your rights as holder of the Notes. A copy of the Indenture may
be obtained as described under Where You Can Find More
Information below.
You can find definitions of certain terms used in this
description under the heading Certain
Definitions. As used below in this Description of
Notes section, the Issuer means Inverness
Medical Innovations, Inc., a Delaware corporation, and its
successors, but not any of its subsidiaries, and
Notes means the Notes described in this prospectus
supplement that the Issuer will issue in this offering, along
with any additional Notes issued under the Indenture.
PRINCIPAL,
MATURITY AND INTEREST
The Notes will mature on May 15, 2016. The Notes will bear
interest at a rate of 9.00% per annum, payable semi-annually on
May 15 and November 15 of each year, or if any such
day is not a Business Day, on the next succeeding Business Day
(each an Interest Payment Date), commencing on
November 15, 2009, to holders of record at the close of
business on the May 1 or November 1, as the case may
be, immediately preceding the relevant interest payment date.
Interest on the Notes will be computed on the basis of a
360-day year
of twelve
30-day
months. The Issuer will be required to pay interest (including
post-petition interest in any proceeding under any Bankruptcy
Law) on overdue principal, premium and installments of interest,
if any, from time to time on demand to the extent lawful at the
interest rate applicable to the Notes.
The Notes will be issued in registered form, without coupons,
and in minimum denominations of $2,000 and integral multiples of
$1,000.
An aggregate principal amount of Notes equal to
$400.0 million is being issued in this offering. The Issuer
may issue additional Notes in an unlimited principal amount
having identical terms and conditions to the Notes being issued
in this offering, subject to compliance with the covenant
described under Certain CovenantsLimitations
on Additional Indebtedness. Any additional Notes will be
part of the same issue as the Notes being issued in this
offering and will be treated as a single class for all purposes
under the Indenture.
S-88
Description of
notes
METHODS OF
RECEIVING PAYMENTS ON THE NOTES
If a Holder has given wire transfer instructions to the Issuer
at least 10 Business Days prior to the applicable payment date,
the Issuer will make all payments on such Holders Notes by
wire transfer of immediately available funds to the account
specified in those instructions. Otherwise, payments on the
Notes will be made at the office or agency of the paying agent
(the Paying Agent) and registrar (the
Registrar) for the Notes within the City and State
of New York unless the Issuer elects to make interest payments
by check mailed to the Holders at their addresses set forth in
the register of Holders.
RANKING OF THE
NOTES AND THE GUARANTEES
The Notes will be:
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general unsecured senior subordinated obligations of the Issuer;
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junior in right of payment to all existing and future senior
indebtedness of the Issuer, including indebtedness arising under
the Credit Facilities; see Subordination of the
Notes below;
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pari passu in right of payment with all existing and
future senior subordinated indebtedness of the Issuer, including
indebtedness arising under the Issuers outstanding 2007
Convertible Notes and any indebtedness of the Issuer that ranks
pari passu in right of payment with the 2007 Convertible
Notes;
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senior in right of payment to any existing or future
indebtedness of the Issuer that is, by its terms, subordinated
in right of payment to the Notes;
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unconditionally guaranteed by the Guarantors; see
Guarantees of the Notes below;
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effectively subordinated to all existing and future secured
indebtedness of the Issuer, including indebtedness arising under
the secured Credit Facilities, to the extent of the assets
securing such indebtedness; and
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structurally subordinated to all existing and future obligations
of each of the Issuers Subsidiaries that is not a
Guarantor.
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Each Guarantee will be:
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a general unsecured senior subordinated obligation of the
Guarantor thereunder;
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junior in right of payment to all existing and future senior
indebtedness of that Guarantor, including indebtedness arising
under the Credit Facilities; see Subordination of
the Guarantees of the Notes below;
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pari passu in right of payment with any existing or
future senior subordinated indebtedness of that Guarantor;
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senior in right of payment to any existing or future
indebtedness of that Guarantor that is, by its terms,
subordinated in right of payment to the Guarantee of that
Guarantor;
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effectively subordinated to all existing and future secured
indebtedness of that Guarantor, including indebtedness arising
under the secured Credit Facilities, to the extent of the assets
securing such obligations; and
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structurally subordinated to all existing and future obligations
of each Subsidiary of that Guarantor that is not also a
Guarantor.
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SUBORDINATION OF
THE NOTES
The payment of all Obligations owing to the Holders in respect
of the Notes will be subordinated in right of payment to the
prior payment in full in cash of all Senior Debt (including all
Obligations under any Credit Facility (including any Credit
Agreement)), whether outstanding on the Issue Date or incurred
after that date.
The Notes shall in all respects rank pari passu in right
of payment with the 2007 Convertible Notes and any Indebtedness
of the Issuer that ranks pari passu in right of payment
with the 2007 Convertible Notes, and
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Description of
notes
only Indebtedness of the Issuer which is Senior Debt shall rank
senior to the Notes in accordance with the provisions of the
Indenture.
The holders of Senior Debt will be entitled to receive payment
in full in cash of all Obligations due on all Senior Debt
(including interest accruing after the commencement of any
bankruptcy or other like proceeding at the rate specified in any
Credit Facility (including any Credit Agreement), whether or not
such interest is an allowed claim in any such proceeding) before
the Holders of Notes will be entitled to receive any payment or
distribution of any kind or character made on account of any
Obligations on or relating to the Notes (other than Permitted
Junior Securities) in the event of any payment or distribution
of assets of the Issuer of any kind or character, whether in
cash, assets or securities, to creditors:
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in any total or partial liquidation, dissolution or
winding-up
of the Issuer;
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in a bankruptcy, reorganization, insolvency, receivership or
other similar proceeding relating to the Issuer or its assets
(whether voluntary or involuntary);
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in any assignment for the benefit of creditors; or
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in any marshalling of the Issuers assets and liabilities.
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In addition, the Issuer may not make any payment or distribution
of any kind or character with respect to any Obligations on or
relating to the Notes or acquire any of the Notes for cash or
assets or otherwise (other than, in either case, Permitted
Junior Securities) if:
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any payment default on any Designated Senior Debt occurs and is
continuing; or
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any other event of default occurs and is continuing on any
Designated Senior Debt that permits the holders of such
Designated Senior Debt to accelerate its maturity (a
non-payment default) and the Trustee receives a
notice of such default (a Payment Blockage Notice)
from the Representative of such Designated Senior Debt
(including, as applicable, the administrative agent under any
Credit Facility (including any Credit Agreement)).
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Payments on and distributions with respect to any Obligations on
or with respect to the Notes may and shall be resumed:
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in the case of a payment default, upon the date on which all
payment defaults are cured or waived (so long as no other event
of default exists); and
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in case of a non-payment default, on the earliest of
(1) the date on which all such non-payment defaults are
cured or waived, (2) 179 days after the date on which
the applicable Payment Blockage Notice is received or
(3) the date on which the Trustee receives notice from the
Representative for such Designated Senior Debt rescinding the
Payment Blockage Notice, unless in each case the maturity of any
Designated Senior Debt has been accelerated.
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No new Payment Blockage Notice may be delivered unless and until
360 days have elapsed since the effectiveness of the
immediately prior Payment Blockage Notice.
No non-payment default that existed or was continuing on the
date of delivery of any Payment Blockage Notice to the Trustee
shall be, or be made, the basis for a subsequent Payment
Blockage Notice, unless such non-payment default shall have been
cured or waived for a period of not less than 90 consecutive
days. Any subsequent action, or any breach of any financial
covenants for a period ending after the date of delivery of the
initial Payment Blockage Notice that, in either case, would give
rise to a non-payment default pursuant to any provisions under
which a non-payment default previously existed or was continuing
will constitute a new non-payment default for this purpose.
Notwithstanding anything to the contrary, payments and
distributions (i) of Permitted Junior Securities and
(ii) made from the trust established pursuant to the
provisions described under Legal Defeasance and
Covenant Defeasance will be permitted and will not be
subordinated so long as, with respect to clause (ii), the
payments into the trust were made in accordance with the
requirements described under Legal
S-90
Description of
notes
Defeasance and Covenant Defeasance and did not violate the
subordination provisions when they were made.
The Issuer must promptly notify the holders of Senior Debt and
Guarantor Senior Debt if payment of the Notes is accelerated
because of an Event of Default.
As a result of the subordination provisions described above, in
the event of a bankruptcy, liquidation or reorganization of the
Issuer, Holders of the Notes may recover less ratably than
creditors of the Issuer who are holders of Senior Debt. See
Risk FactorsRisks related to this offeringYour
right to receive payments on the notes and the related
guarantees is subordinated to our and our guarantor
subsidiaries senior debt.
As of December 31, 2008, the Issuer and its Restricted
Subsidiaries had approximately $1.37 billion in aggregate
principal amount of Senior Debt outstanding, including
approximately $1.35 billion in aggregate principal amount
of secured indebtedness outstanding under the Credit Facilities.
GUARANTEES OF THE
NOTES
The Issuers obligations under the Notes and the Indenture
will be jointly and severally guaranteed by each Restricted
Subsidiary that is a Domestic Subsidiary that guarantees any
Indebtedness or other Obligation under any Credit Agreement;
provided, however, that neither of the following
shall be a Guarantor unless the Issuer so elects:
(a) SPDH, Inc.; and
(b) Diamics, Inc., until such time, if ever, that it
becomes a Wholly-Owned Restricted Subsidiary.
Not all of our Subsidiaries will guarantee the Notes.
Unrestricted Subsidiaries, Foreign Subsidiaries, the
Subsidiaries named above, and Domestic Subsidiaries that do not
guarantee any Indebtedness or other Obligation under the Credit
Agreements will not be Guarantors. In the event of a bankruptcy,
liquidation or reorganization of any of these non-guarantor
Subsidiaries, these non-guarantor Subsidiaries will pay the
holders of their debts and their trade creditors before they
will be able to distribute any of their assets to us. For the
fiscal year ended December 31, 2008, our non-guarantor
Subsidiaries had net revenues of approximately
$499 million, or approximately 29.9% of our consolidated
2008 revenues, and operating income of approximately
$13.2 million, or approximately 20.7% of our consolidated
2008 operating income. As of December 31, 2008, our
non-guarantor Subsidiaries had assets of approximately
$1,157 million, or approximately 19.4% of our consolidated
assets. In addition, as of December 31, 2008, our
non-guarantor Subsidiaries had total indebtedness and other
liabilities of approximately $467.8 million, excluding
intercompany payable balances. For additional information, see
note 26 of the notes to our audited financial statements
included elsewhere in this prospectus supplement and Risk
FactorsRisks related to this offering under the
subheadings The notes are not secured by our assets
or those of our guarantor subsidiaries and
Your right to receive payment on the notes will be
structurally subordinated to the obligations of our
non-guarantor subsidiaries, respectively.
Under the circumstances described below under the subheading
Certain CovenantsLimitations on Designation of
Unrestricted Subsidiaries, the Issuer will be permitted to
designate some of our Subsidiaries as Unrestricted
Subsidiaries. On the Issue Date, no Subsidiary will be an
Unrestricted Subsidiary and all Subsidiaries of the Issuer will
be Restricted Subsidiaries. The effect of designating a
Subsidiary as an Unrestricted Subsidiary will be:
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an Unrestricted Subsidiary will not be subject to many of the
restrictive covenants in the Indenture;
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a Subsidiary that has previously been a Guarantor and that is
designated an Unrestricted Subsidiary will be released from its
Guarantee; and
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the assets, income, cash flow and other financial results of an
Unrestricted Subsidiary will not be consolidated with those of
the Issuer for purposes of calculating compliance with the
restrictive covenants
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Description of
notes
contained in the Indenture, except for income of the
Unrestricted Subsidiary to the extent any such income has
actually been received by the Issuer or any of its Wholly-Owned
Restricted Subsidiaries.
The Obligations of each Guarantor under its Guarantee will be
limited to the maximum amount as will, after giving effect to
all other contingent and fixed liabilities of such Guarantor
(including any guarantees under any Credit Facility (including
any Credit Agreement) permitted under clause (1) of
Certain CovenantsLimitations on Additional
Indebtedness) and after giving effect to any collections
from or payments made by or on behalf of any other Guarantor in
respect of the Obligations of such other Guarantor under its
Guarantee or pursuant to its contribution obligations under the
Indenture, result in the obligations of such Guarantor under its
Guarantee not constituting a fraudulent conveyance or fraudulent
transfer under federal or state law. Each Guarantor that makes a
payment for distribution under its Guarantee is entitled to a
contribution from each other Guarantor in a pro rata
amount based on adjusted net assets of each Guarantor.
A Guarantor shall be released from its obligations under its
Guarantee and the Indenture:
(1) in the event of a sale or other disposition of
all or substantially all of the assets of such Guarantor, by way
of merger, consolidation or otherwise, or a sale or other
disposition of all of the Equity Interests of such Guarantor
then held by the Issuer and the Restricted Subsidiaries;
(2) if such Guarantor is designated as an
Unrestricted Subsidiary or otherwise ceases to be a Restricted
Subsidiary, in each case in accordance with the provisions of
the Indenture, upon effectiveness of such designation or when it
first ceases to be a Restricted Subsidiary, respectively; or
(3) if such Guarantor does not guarantee any
Indebtedness or other Obligation under any Credit Agreement
(other than if such Guarantor no longer guarantees any
Indebtedness or other Obligation under such Credit Agreement as
a result of payment under any guarantee of any such Indebtedness
or other Obligation by such Guarantor); provided,
however, that a Guarantor shall not be permitted to be
released from its Guarantee if it is an obligor with respect to
any Indebtedness or other Obligation that would not, under
Certain CovenantsLimitations on Additional
Indebtedness, be permitted to be incurred by a Restricted
Subsidiary that is not a Guarantor.
SUBORDINATION OF
THE GUARANTEES OF THE NOTES
Each Guarantee will be subordinated to Guarantor Senior Debt on
the same basis as the Notes are subordinated to Senior Debt.
REDEMPTION
Optional
redemption
Except as set forth below, the Notes may not be redeemed at the
Issuers option prior to May 15, 2013. At any time on
or after May 15, 2013, the Issuer, at its option, may
redeem the Notes, in whole or in part, upon not less than 30 nor
more than 60 days notice, at the redemption prices
(expressed as percentages of principal amount) set forth below,
together with accrued and unpaid interest thereon, if any, to
but excluding the redemption date, if redeemed during the
12-month
period beginning May 15 of the years indicated:
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Optional
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Redemption
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Year
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Price
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2013
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104.500
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%
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2014
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102.250
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2015 and thereafter
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100.000
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S-92
Description of
notes
Redemption with
proceeds from equity offerings
At any time prior to May 15, 2012, the Issuer may redeem up
to 35% of the aggregate principal amount of the Notes with the
net cash proceeds of one or more Qualified Equity Offerings at a
redemption price equal to 109.00% of the principal amount of the
Notes to be redeemed, plus accrued and unpaid interest
thereon, if any, to but excluding the date of redemption;
provided, however, that (1) at least 65% of the
aggregate principal amount of Notes issued under the Indenture
remains outstanding immediately after the occurrence of such
redemption and (2) the redemption occurs within
90 days of the date of the closing of any such Qualified
Equity Offering.
Make-whole
redemption
At any time prior to May 15, 2013, the Issuer may redeem
all or a part of the Notes, upon not less than 30 nor more than
60 days notice, at a redemption price equal to 100%
of the principal amount (or portion thereof) of the Notes to be
redeemed plus the Applicable Premium as of, and accrued
and unpaid interest, if any, to but excluding, the date of
redemption.
Mandatory
redemption
The Issuer is not required to make mandatory redemption or
sinking fund payments with respect to the Notes.
Other
acquisitions of notes
The Issuer may acquire Notes by means other than a redemption,
whether pursuant to an issuer tender offer, open market purchase
or otherwise, in accordance with applicable securities laws, so
long as the acquisition does not otherwise violate the terms of
the Indenture.
SELECTION AND
NOTICE OF REDEMPTION
In the event that less than all of the Notes are to be redeemed
at any time pursuant to an optional redemption, a redemption
with proceeds from Qualified Equity Offerings or a make-whole
redemption, selection of the Notes for redemption will be made
by the Trustee in compliance with the requirements of the
principal national securities exchange, if any, on which the
Notes are listed or, if the Notes are not then listed on a
national security exchange, on a pro rata basis, by lot
or by such other method as the Trustee shall deem fair and
appropriate; provided, however, partial redemption
of Notes of any Holder may only be made of principal equal to
$1,000 or integral multiples thereof (provided, however,
that no Note will be purchased in part if such Note would
have a remaining principal amount of less than $2,000). In
addition, if a partial redemption is made pursuant to the
provisions described in RedemptionRedemption
with Proceeds from Equity Offerings, selection of the
Notes or portions thereof for redemption will be made by the
Trustee only on a pro rata basis or on as nearly a pro
rata basis as is practicable (subject to the procedures of
the Depository), unless that method is otherwise prohibited.
Notice of redemption will be mailed by first-class mail, postage
prepaid, at least 30 but not more than 60 days before the
date of redemption to each Holder of Notes to be redeemed at the
Holders registered address, except that redemption notices
may be mailed more than 60 days prior to a redemption date
if the notice is issued in connection with a satisfaction and
discharge of the Indenture. The notice, if given in the manner
provided above and in the Indenture, shall be conclusively
presumed to have been given, whether or not the Holder receives
such notice. If any Note is to be redeemed in part only, the
notice of redemption that relates to that Note will state the
portion of the principal amount of the Note to be redeemed. A
new Note in a principal amount equal to the unredeemed portion
of the Note will be issued in the name of the Holder of the Note
upon cancellation of the original Note. On and after the date of
redemption, interest will cease to accrue on Notes or portions
thereof called for redemption so long as the Issuer has
deposited with the paying
S-93
Description of
notes
agent for the Notes funds in satisfaction of the redemption
price (including accrued and unpaid interest, if any, on the
Notes to be redeemed) pursuant to the Indenture.
CHANGE OF
CONTROL
Upon the occurrence of any Change of Control, each Holder will
have the right to require that the Issuer purchase all or any
part (equal to $1,000 or an integral multiple thereof
(provided, however, that no Note will be purchased in
part if such Note would have a remaining principal amount of
less than $2,000)) of that Holders Notes for a cash price
(the Change of Control Purchase Price) equal to 101%
of the principal amount of the Notes to be purchased, plus
accrued and unpaid interest thereon, if any, to but
excluding the date of purchase.
Within 30 days following any Change of Control, the Issuer
will mail, or caused to be mailed, to the Holders a notice:
(1) describing the transaction or transactions that
constitute the Change of Control;
(2) offering to purchase, pursuant to the procedures
required by the Indenture and described in the notice (a
Change of Control Offer), on a date specified in the
notice (which shall be a Business Day not earlier than
30 days nor later than 60 days from the date the
notice is mailed) and for the Change of Control Purchase Price,
all Notes properly tendered by such Holder pursuant to such
Change of Control Offer; and
(3) describing the procedures that Holders must
follow to accept the Change of Control Offer.
The Change of Control Offer is required to remain open for at
least 20 Business Days or for such longer period as is required
by law.
The Issuer will publicly announce the results of the Change of
Control Offer on or as soon as practicable after the date of
purchase.
In the event that at the time of such Change of Control the
terms of the Indebtedness under any Credit Agreement restrict or
prohibit the purchasing of the Notes upon a Change of Control,
then prior to mailing the notice described above to the Holders,
but in any event within 30 days following any Change of
Control, the Issuer must either repay in full the Indebtedness
and terminate all commitments under the Credit Agreement that
contains the prohibition or obtain the requisite consent of the
applicable lenders to permit the purchase of Notes. The Issuer
shall first comply with the covenant in the immediately
preceding sentence before it shall be required to repurchase
Notes upon a Change of Control or to send the notice pursuant to
the provisions described above. The Issuers failure to
comply with the covenant described in the second preceding
sentence (and any failure to send the notice described above to
the Holders because the same is prohibited by the second
preceding sentence) may (with notice and lapse of time)
constitute an Event of Default described in clause (3) of
the definition of Event of Default below but shall
not constitute an Event of Default described in clause (2)
of the definition of Event of Default below.
Our existing Credit Agreements currently prohibit us from
purchasing any Notes, and also provide that some change of
control events with respect to us would constitute a default
under these Credit Agreements. Any future Credit Agreements or
other agreements relating to Senior Debt to which the Issuer
becomes a party may contain similar restrictions and provisions.
In the event a Change of Control occurs at a time when the
Issuer is prohibited from purchasing Notes, if the Issuer does
not obtain all required consents of our senior lenders to
purchase the Notes or repay or refinance the borrowings that
contain the prohibition, the Issuer will remain prohibited from
purchasing Notes. In that case, our failure to obtain such
consents or repay or refinance such borrowings so that we may
purchase the Notes would constitute an Event of Default under
the Indenture, which would, in turn, constitute a default under
the Credit Agreements and any such other Senior Debt. In these
circumstances, the subordination provisions in the Indenture
would likely restrict payments to the Holders of Notes.
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Description of
notes
The provisions described above that require us to make a Change
of Control Offer following a Change of Control will be
applicable regardless of whether any other provisions of the
Indenture are applicable. Except as described above with respect
to a Change of Control, the Indenture does not contain
provisions that permit the Holders to require that the Issuer
purchase or redeem the Notes in the event of a takeover,
recapitalization or similar transaction.
The Issuers obligation to make a Change of Control Offer
will be satisfied if a third party makes the Change of Control
Offer in the manner and at the times and otherwise in compliance
with the requirements applicable to a Change of Control Offer
made by the Issuer and purchases all Notes properly tendered and
not withdrawn under the Change of Control Offer.
The definition of Change of Control under the
Indenture contains important exceptions for certain types of
transactions. The occurrence of transactions within these
exceptions would not constitute a Change of Control
for purposes of the Indenture, and would therefore not trigger
the Holders right to require the Issuer to purchase Notes
as set forth above. The definition of Change of
Control is set forth below under Certain
Definitions.
With respect to any disposition of assets, the phrase all
or substantially all as used in the Indenture (including
as set forth under Certain
CovenantsLimitations on Mergers, Consolidations,
Etc. below) varies according to the facts and
circumstances of the subject transaction, has no clearly
established meaning under New York law (which governs the
Indenture) and is subject to judicial interpretation.
Accordingly, in certain circumstances there may be a degree of
uncertainty in ascertaining whether a particular transaction
would involve a disposition of all or substantially
all of the assets of the Issuer, and therefore it may be
unclear as to whether a Change of Control has occurred and
whether the Holders have the right to require the Issuer to
purchase Notes.
The Issuer will comply with applicable tender offer rules,
including the requirements of
Rule 14e-l
under the Exchange Act and any other applicable laws and
regulations in connection with the purchase of Notes pursuant to
a Change of Control Offer. To the extent that the provisions of
any securities laws or regulations conflict with the
Change of Control provisions of the Indenture, the
Issuer shall comply with the applicable securities laws and
regulations and will not be deemed to have breached its
obligations under the Change of Control provisions
of the Indenture by virtue of this compliance.
CERTAIN
COVENANTS
The Indenture contains, among others, the following covenants:
Limitations on
additional indebtedness
The Issuer will not, and will not permit any Restricted
Subsidiary to, directly or indirectly, incur any Indebtedness;
provided, however, that the Issuer or any
Restricted Subsidiary may incur additional Indebtedness, and the
Issuer or any Restricted Subsidiary may incur Acquired
Indebtedness, if, after giving effect thereto, the Consolidated
Interest Coverage Ratio would be at least 2.00 to 1.00 (the
Coverage Ratio Exception).
Notwithstanding the above, each of the following will be
permitted to be incurred (the Permitted
Indebtedness):
(1) Indebtedness of the Issuer or any Restricted
Subsidiary under any Credit Facility (including any Credit
Agreement) (including the issuance or creation of letters of
credit and bankers acceptances thereunder) so long as the
aggregate amount of all Indebtedness of the Issuer and its
Restricted Subsidiaries (without duplication) at any time
outstanding under all Credit Facilities (including all Credit
Agreements) (excluding Hedging Obligations related to the
Indebtedness thereunder) does not exceed the greater of
(x) $1.75 billion, less the aggregate amount of
Net Available Proceeds applied to repayments under the Credit
Agreements in accordance with the covenant described under
Limitations on Asset Sales, and (y) 85%
of the book value of the accounts receivable of the Issuer and
the Restricted Subsidiaries plus 65% of the book value of
inventory of the Issuer and the
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Restricted Subsidiaries, in each case calculated on a
consolidated basis and in accordance with GAAP as of the last
day of the last full fiscal quarter for which financial
statements are available;
(2) the Notes being issued on the Issue Date and the
related Guarantees;
(3) Indebtedness of the Issuer and the Restricted
Subsidiaries to the extent outstanding on the Issue Date (other
than Indebtedness referred to in clauses (1) and
(2) above);
(4) Indebtedness of the Issuer or any Restricted
Subsidiary under Hedging Obligations (i) entered into for
bona fide purposes of hedging against fluctuations in
interest rates with respect to Indebtedness under any Credit
Facility (including any Credit Agreement) or (ii) entered
into in the ordinary course of business for bona fide
hedging purposes and not for the purpose of speculation that
are designed to protect against fluctuations in interest rates,
foreign currency exchange rates and commodity prices, provided
that if, in the case of either (i) or (ii), such Hedging
Obligations are of the type described in clause (1) of the
definition thereof, (a) such Hedging Obligations relate to
payment obligations on Indebtedness otherwise permitted to be
incurred by this covenant, and (b) the notional principal
amount of such Hedging Obligations at the time incurred does not
exceed the principal amount of the Indebtedness to which such
Hedging Obligations relate;
(5) Indebtedness of the Issuer owed to a Restricted
Subsidiary and Indebtedness of any Restricted Subsidiary owed to
the Issuer or any other Restricted Subsidiary, provided that
upon any such Restricted Subsidiary ceasing to be a Restricted
Subsidiary or such Indebtedness being owed to any Person other
than the Issuer or a Restricted Subsidiary, the Issuer or such
Restricted Subsidiary, as applicable, shall be deemed to have
incurred Indebtedness not permitted by this clause (5);
(6)(i) Indebtedness in respect of bid, performance or
surety bonds issued for the account of the Issuer or any
Restricted Subsidiary in the ordinary course of business,
including guarantees or obligations of the Issuer or any
Restricted Subsidiary with respect to letters of credit
supporting such bid, performance or surety obligations (in each
case other than for an obligation for money borrowed), and (ii)
Indebtedness of the Issuer or any Restricted Subsidiary
consisting of reimbursement obligations with respect to
commercial letters of credit and letters of credit issued to
landlords, in each case in the ordinary course of business in an
aggregate face amount not to exceed $10.0 million at any time;
(7) Purchase Money Indebtedness incurred by the
Issuer or any Restricted Subsidiary, and Refinancing
Indebtedness with respect thereto, in an aggregate outstanding
amount not to exceed $50.0 million at any time;
(8) Indebtedness of the Issuer or any Restricted
Subsidiary arising from the honoring by a bank or other
financial institution of a check, draft or similar instrument
inadvertently (except in the case of daylight overdrafts) drawn
against insufficient funds in the ordinary course of business,
provided that such Indebtedness is extinguished within five
Business Days of incurrence;
(9) Indebtedness of the Issuer or any Restricted
Subsidiary arising in connection with endorsement of instruments
for deposit in the ordinary course of business;
(10) (i) Capitalized Lease Obligations arising
under Sale and Leaseback Transactions with respect to any of the
real property currently owned by Biosite Incorporated or any of
its Restricted Subsidiaries in San Diego, California or
San Clemente, California, and Refinancing Indebtedness with
respect thereto, in an aggregate outstanding amount for all such
transactions under this clause (i) not to exceed
$150.0 million at any time and (ii) Capitalized Lease
Obligations arising under any other Sale and Leaseback
Transactions, and Refinancing Indebtedness with respect thereto,
in an aggregate outstanding amount for all such transactions
under this clause (ii) not to exceed $50.0 million at
any time;
(11) guarantee Obligations of the Issuer or any of
its Restricted Subsidiaries with respect to Indebtedness of the
Issuer or any of its Restricted Subsidiaries;
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(12) (i) Indebtedness incurred by the Issuer or
any Restricted Subsidiary for the purpose of financing all or
any part of the cost of, or in order to consummate, the
acquisition of (x) Equity Interests of another Person
engaged in the Permitted Business that becomes a Restricted
Subsidiary, (y) all or substantially all of the assets of
such a Person or a line of business, division or business unit
within the Permitted Business by the Issuer or a Restricted
Subsidiary, or (z) any other Permitted Business assets by
the Issuer or a Restricted Subsidiary and (ii) Acquired
Indebtedness incurred by the Issuer or any Restricted Subsidiary
in connection with an acquisition by the Issuer or a Restricted
Subsidiary; provided, however, that, in each of the
foregoing cases, on the date of the incurrence of such
Indebtedness or Acquired Indebtedness, after giving effect to
the incurrence thereof and the use of any proceeds therefrom and
otherwise determined on a pro forma basis for such
transaction in accordance with the provisions set forth in the
definition of Consolidated Interest Coverage Ratio
in Certain Definitions below, either:
(a) the Issuer would be permitted to incur at least
$1.00 of additional Indebtedness pursuant to the Coverage Ratio
Exception, or
(b) the Consolidated Interest Coverage Ratio would be
greater than the Consolidated Interest Coverage Ratio
immediately prior to the incurrence of such Indebtedness;
(13) guarantees by the Issuer or any of its
Restricted Subsidiaries of the performance by any Restricted
Subsidiary of its obligations under the P&G JV Agreements
or the joint venture agreement or other related agreements,
instruments or documents relating to any other joint venture
entered into by the Issuer of any of its Restricted Subsidiaries
in compliance with the Indenture (for the avoidance of doubt
this clause shall not be read to allow guarantees of
Indebtedness of any joint venture or joint venture partner or
their Affiliates);
(14) Refinancing Indebtedness incurred by the Issuer
or any Restricted Subsidiary with respect to Indebtedness
incurred pursuant to the Coverage Ratio Exception or clause (2),
(3) or (12) or this clause (14) in this section;
(15) Indebtedness of any Foreign Restricted
Subsidiary or of any Domestic Subsidiary that is not a Guarantor
in an aggregate outstanding principal amount for all such
Indebtedness at any time not to exceed $50.0 million; and
(16) any other Indebtedness of the Issuer or any
Restricted Subsidiary in an aggregate outstanding principal
amount for all such Indebtedness not to exceed
$50.0 million at any time.
For purposes of determining compliance with this covenant, in
the event that an item of Indebtedness meets the criteria of
more than one of the categories of Permitted Indebtedness
described in clauses (1) through (16) above or is
entitled to be incurred pursuant to the Coverage Ratio
Exception, the Issuer shall, in its sole discretion, classify
such item of Indebtedness and may divide and classify (and may
later redivide and reclassify) such Indebtedness in more than
one of the types of Indebtedness described in this covenant in
any manner that complies with this covenant, except that
Indebtedness incurred under any Credit Agreement on the Issue
Date shall be deemed to have been incurred under clause (1)
above. Any item of Indebtedness entitled to be incurred pursuant
to the Coverage Ratio Exception and classified by the Issuer
within such type of Indebtedness shall retain such
classification (and the amount thereof shall not be counted in
the determination of the amount of Indebtedness under any of
clauses (1) through (16) of this covenant
notwithstanding that the Coverage Ratio Exception is not
available at any later time). In addition, for purposes of
determining any particular amount of Indebtedness under this
covenant or any category of Permitted Indebtedness, guarantees,
Liens, letter of credit obligations or other obligations
supporting Indebtedness otherwise included in the determination
of such particular amount shall not be included so long as
incurred by a Person that could have incurred such Indebtedness.
The accrual of interest, the accretion or amortization of
original issue discount, the payment of interest on any
Indebtedness in the form of additional Indebtedness with the
same terms and the payment of dividends
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on Disqualified Equity Interests of the Issuer in the form of
additional shares of the same class of Disqualified Equity
Interest (or in the form of Qualified Equity Interests) will not
be deemed to be an incurrence of Indebtedness for purposes of
this covenant.
Limitations on
layering indebtedness
The Issuer will not, and will not permit any Restricted
Subsidiary to, directly or indirectly, incur any Indebtedness
that by its terms (or by the terms of any agreement governing
such Indebtedness) is or purports to be senior in right of
payment to the Notes or the Guarantee, if any, of such
Restricted Subsidiary and subordinated in right of payment to
any other Indebtedness of the Issuer or of such Restricted
Subsidiary, as the case may be.
For purposes of the foregoing, no Indebtedness will be deemed to
be subordinated in right of payment to any other Indebtedness of
the Issuer or any Restricted Subsidiary solely by virtue of
being unsecured or by virtue of the fact that the holders of
such Indebtedness have entered into intercreditor agreements or
other arrangements giving one or more of such holders priority
over the other holders in the collateral held by them or by
virtue of structural subordination.
Limitations on
restricted payments
The Issuer will not, and will not permit any Restricted
Subsidiary to, directly or indirectly, make any Restricted
Payment if at the time of such Restricted Payment:
(1) a Default shall have occurred and be continuing
or shall occur as a consequence thereof;
(2) the Issuer cannot incur $1.00 of additional
Indebtedness pursuant to the Coverage Ratio Exception; or
(3) the amount of such Restricted Payment, when added
to the aggregate amount of all other Restricted Payments made
after the Issue Date (other than Restricted Payments made
pursuant to clauses (2) through (7), (8) (with respect to
non-cash dividends only), (10) and (11) of the next
paragraph), exceeds the sum (the Restricted Payments
Basket) of (without duplication):
(a) 50% of Consolidated Net Income for the period
(taken as one accounting period) commencing on the first day of
the first full fiscal quarter commencing after the Issue Date to
and including the last day of the fiscal quarter ended
immediately prior to the date of such calculation for which
consolidated financial statements are available (or, if such
Consolidated Net Income shall be a deficit, minus 100% of such
aggregate deficit), plus
(b) 100% of the aggregate net proceeds, including
cash and the Fair Market Value of the equity of a Person or of
assets used in or constituting a line of business, in each case
which becomes or becomes owned by a Restricted Subsidiary,
received by the Issuer from the issuance and sale of Qualified
Equity Interests after the Issue Date, other than any such
proceeds which are used to redeem Notes in accordance with the
second paragraph under RedemptionRedemption with
Proceeds from Equity Offerings, provided that the Issuer
delivers to the Trustee:
(x) with respect to any equity or assets with a Fair
Market Value in excess of $15.0 million, an Officers
Certificate setting forth such Fair Market Value and a
Secretarys Certificate which sets forth and authenticates
a resolution that has been adopted by a majority of the
Independent Directors approving such Fair Market Value; and
(y) with respect to any equity or assets with a Fair
Market Value in excess of $50.0 million, the certificates
described in the preceding clause (x) and a written opinion
as to the Fair Market Value of such equity or assets received by
the Issuer
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Description of
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from the issuance and sale of such Qualified Equity Interests to
the Issuer issued by an Independent Financial Advisor (which
opinion may be in the form of a fairness opinion with respect to
the transaction in which the equity or assets are acquired),
plus
(c) 100% of the aggregate net cash proceeds received
by the Issuer as contributions to the common or preferred equity
(other than Disqualified Equity Interests) of the Issuer after
the Issue Date, other than any such proceeds which are used to
redeem Notes in accordance with the second paragraph under
RedemptionRedemption with Proceeds from Equity
Offerings, plus
(d) the aggregate amount by which Indebtedness
incurred by the Issuer or any Restricted Subsidiary subsequent
to the Issue Date is reduced on the Issuers balance sheet
upon the conversion or exchange (other than by a Subsidiary of
the Issuer) of Indebtedness into Qualified Equity Interests
(less the amount of any cash, or the fair value of assets,
distributed by the Issuer or any Restricted Subsidiary upon such
conversion or exchange), plus
(e) in the case of the disposition or repayment of or
return on any Investment that was treated as a Restricted
Payment made after the Issue Date, an amount (to the extent not
included in the computation of Consolidated Net Income) equal to
the lesser of (i) the return of capital with respect to
such Investment and (ii) the amount of such Investment that
was treated as a Restricted Payment, in either case, less
the cost of the disposition of such Investment and net of
taxes, plus
(f) upon a Redesignation of an Unrestricted
Subsidiary as a Restricted Subsidiary, the lesser of
(i) the Fair Market Value of the Issuers
proportionate interest in such Subsidiary immediately following
such Redesignation, and (ii) the aggregate amount of the
Issuers Investments in such Subsidiary to the extent such
Investments reduced the Restricted Payments Basket and were not
previously repaid or otherwise reduced.
The foregoing provisions will not prohibit:
(1) the payment by the Issuer or any Restricted
Subsidiary of any dividend within 60 days after the date of
declaration thereof, if on the date of declaration the payment
would have complied with the provisions of the Indenture;
(2) the redemption of any Equity Interests of the
Issuer or any Restricted Subsidiary in exchange for, or out of
the proceeds of the substantially concurrent issuance and sale
of, Qualified Equity Interests (and any payment of cash in lieu
of delivering fractional shares in connection therewith);
(3) the redemption of Subordinated Indebtedness of
the Issuer or any Restricted Subsidiary (a) in exchange
for, or out of the proceeds of the substantially concurrent
issuance and sale of, Qualified Equity Interests (and any
payment of cash in lieu of delivering fractional shares in
connection therewith) or (b) in exchange for, or out of the
proceeds of the substantially concurrent incurrence of,
Refinancing Indebtedness permitted to be incurred under the
Limitations on Additional Indebtedness
covenant and the other terms of the Indenture;
(4) the redemption of Equity Interests of the Issuer
held by officers, directors or employees or former officers,
directors or employees (or their transferees, estates or
beneficiaries under their estates) upon their death, disability,
retirement, severance or termination of employment or service;
provided, however, that the aggregate cash
consideration paid for all such redemptions shall not exceed
$10.0 million during any calendar year;
(5) repurchases of Equity Interests deemed to occur
upon the exercise of stock options or warrants if the Equity
Interests represents a portion of the exercise price thereof;
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(6) the redemption of any Indebtedness of the Issuer
or any Restricted Subsidiary owing to any Restricted Subsidiary
or the Issuer;
(7) upon the occurrence of a Change of Control and
within 120 days after the completion of the offer to
repurchase the Notes pursuant to the provisions of the Indenture
described under Change of Control, any
redemption of Indebtedness of the Issuer required pursuant to
the terms thereof;
(8) the payment by the Issuer of any dividend on
shares of the Series B Preferred Stock, in accordance with
the terms thereof set forth in the Issuers certificate of
incorporation as in effect on the Issue Date (as may be modified
thereafter in a manner not adverse to the Holders), whether paid
in cash or Equity Interests (other than Disqualified Equity
Interests);
(9) payments of dividends on Disqualified Equity
Interests issued in compliance with the covenant described under
Limitations on Additional Indebtedness;
(10) payments made using any Net Proceeds Deficiency
(as such term is defined in Limitations on Asset
Sales below); or
(11) other Restricted Payments in an amount which,
when taken together with all other Restricted Payments made
pursuant to this clause (11), does not exceed $50.0 million
in the aggregate (with the amount of each Restricted Payment
being determined as of the date made and without regard to
subsequent changes in value);
provided, however, that (a) in the case of any
Restricted Payment pursuant to clause (3)(b), (10) or
(11) above, no Default shall have occurred and be
continuing or will occur as a consequence thereof and
(b) no issuance and sale of Qualified Equity Interests
pursuant to clause (2) or (3) above shall increase the
Restricted Payments Basket, except to the extent the proceeds
thereof exceed the amounts used to effect the transactions
described therein.
Limitations on
dividend and other restrictions affecting restricted
subsidiaries
The Issuer will not, and will not permit any Restricted
Subsidiary to, directly or indirectly, create or otherwise cause
or permit to exist or become effective any consensual
encumbrance or consensual restriction on the ability of any
Restricted Subsidiary to:
(a) pay dividends or make any other distributions on
or in respect of its Equity Interests;
(b) make loans or advances, or pay any Indebtedness
or other obligation owed, to the Issuer or any other Restricted
Subsidiary; or
(c) transfer any of its assets to the Issuer or any
other Restricted Subsidiary;
except for:
(1) encumbrances or restrictions existing under or by
reason of applicable law;
(2) encumbrances or restrictions existing under the
Indenture (including the Guarantees) and the Notes;
(3) non-assignment provisions or other restrictions
on transfer contained in any lease, license or other contract;
(4) encumbrances or restrictions existing under
agreements existing on the date of the Indenture (including any
Credit Facility or Credit Agreement) (with similar restrictions
under any such agreement applicable to future Restricted
Subsidiaries being permitted hereunder);
(5) encumbrances or restrictions under any Credit
Facility (including any Credit Agreement) (including with regard
to future Restricted Subsidiaries);
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(6) restrictions on the transfer of assets subject to
any Lien imposed by the holder of such Lien;
(7) restrictions on the transfer of assets imposed
under any agreement to sell such assets to any Person pending
the closing of such sale;
(8) encumbrances or restrictions under any instrument
governing Acquired Indebtedness that are not applicable to any
Person, or the properties or assets of any Person, other than
the Person or the properties or assets of the Person so acquired;
(9) encumbrances or restrictions under any other
agreement entered into after the Issue Date that are, in the
good faith judgment of the Issuer, not materially more
restrictive, taken as a whole, with respect to any Restricted
Subsidiary than those in effect on the Issue Date with respect
to that Restricted Subsidiary (or any future Restricted
Subsidiary) pursuant to agreements in effect on the Issue Date
(including the Indenture and the Credit Agreements);
(10) restrictions under customary provisions in
partnership agreements, limited liability company organizational
or governance documents, joint venture agreements, corporate
charters, stockholders agreements, and other similar
agreements and documents on the transfer of ownership interests
in such partnership, limited liability company, joint venture or
similar Person;
(11) encumbrances or restrictions imposed under
Purchase Money Indebtedness on the assets acquired that are of
the nature described in clause (c) above, provided such
Purchase Money Indebtedness is incurred in compliance with the
covenant described under Limitations on Additional
Indebtedness;
(12) restrictions of the nature described in
clause (c) above contained in any security agreement or
mortgage securing Indebtedness or other obligations of the
Issuer or any Restricted Subsidiary to the extent such
restrictions restrict the transfer of the property subject to
such security agreement or mortgage; and
(13) any encumbrances or restrictions imposed by any
amendments or refinancings of the contracts, instruments or
obligations referred to in clauses (1) through
(12) above; provided, however, that such
encumbrances or restrictions are, in the good faith judgment of
the Issuer, no more materially restrictive, taken as a whole,
than those in effect prior to such amendment or refinancing.
Limitations on
transactions with affiliates
The Issuer will not, and will not permit any Restricted
Subsidiary to, directly or indirectly, in one transaction or a
series of related transactions, sell, lease, transfer or
otherwise dispose of any of its assets to, or purchase any
assets from, or enter into any contract, agreement,
understanding, loan, advance or guarantee with, or for the
benefit of, any Affiliate (an Affiliate
Transaction), unless:
(1) such Affiliate Transaction is on terms that are
no less favorable to the Issuer or the relevant Restricted
Subsidiary than those that would have been obtained in a
comparable transaction at such time on an arms-length
basis by the Issuer or that Restricted Subsidiary from a Person
that is not an Affiliate of the Issuer or that Restricted
Subsidiary; and
(2) the Issuer delivers to the Trustee:
(a) with respect to any Affiliate Transaction
involving aggregate value expended by the Issuer or any
Restricted Subsidiary in a consecutive twelve-month period in
excess of $15.0 million, an Officers Certificate
certifying that such Affiliate Transaction complies with
clause (1) above and a Secretarys Certificate which
sets forth and authenticates a resolution that has been adopted
by a majority of the Independent Directors approving such
Affiliate Transaction; and
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(b) with respect to any Affiliate Transaction
involving aggregate value expended by the Issuer or any
Restricted Subsidiary in a consecutive twelve-month period of
$50.0 million or more, the certificates described in the
preceding clause (a) and a written opinion as to the
fairness of such Affiliate Transaction to the Issuer or such
Restricted Subsidiary from a financial point of view issued by
an Independent Financial Advisor.
The foregoing restrictions shall not apply to:
(1) transactions exclusively between or among
(a) the Issuer and one or more Restricted Subsidiaries or
(b) Restricted Subsidiaries, provided in each case, that no
Affiliate of the Issuer (other than another Restricted
Subsidiary) owns Equity Interests of any such Restricted
Subsidiary;
(2) director, officer and employee compensation
(including bonuses) and other benefits (including retirement,
health, stock option and other benefit plans) and
indemnification and insurance arrangements;
(3) the entering into of any tax sharing agreement,
or the making of payments pursuant to any such agreement,
between the Issuer
and/or one
or more Subsidiaries, on the one hand, and any other Person with
which the Issuer or such Subsidiaries are required or permitted
to file a consolidated tax return or with which the Issuer or
such Subsidiaries are part of a consolidated group for tax
purposes, on the other hand, which payments by the Issuer and
the Subsidiaries are not materially in excess of the tax
liabilities that would have been payable by them on a
stand-alone basis;
(4) any Permitted Investments;
(5) Restricted Payments which are made in accordance
with the covenant described above under Limitations
on Restricted Payments (including payments and
transactions that would constitute Restricted Payments but for
the exclusions in clauses (1) and (2) of the
definition thereof);
(6) any transaction with an Affiliate where the only
consideration paid by the Issuer or any Restricted Subsidiary is
Qualified Equity Interests (and any payments of cash in lieu of
delivering fractional shares in connection therewith);
(7) the sale to an Affiliate of the Issuer of Equity
Interests of the Issuer that do not constitute Disqualified
Equity Interests, and the sale to an Affiliate of the Issuer of
Indebtedness (including Disqualified Equity Interests) of the
Issuer in connection with an offering of such Indebtedness in a
market transaction and on terms substantially identical to those
of other purchasers in such market transaction who are not
Affiliates;
(8) any transaction with a joint venture in which the
Issuer or a Restricted Subsidiary is a joint venturer and no
other Affiliate is a joint venturer, or with any Subsidiary
thereof or other joint venturer therein, pursuant to the joint
venture agreement or related agreements for such joint venture,
including any transfers of any equity or ownership interests in
any such joint venture to any other joint venturer therein
pursuant to the performance or exercise of any rights or
obligations to make such transfer under the terms of the
agreements governing such joint venture; or
(9) without limiting clause (8) immediately
above, (a) any transaction with a P&G JV Company or
any Subsidiary or member thereof pursuant to the P&G JV
Agreements or (b) any other transactions with a P&G JV
Company or any Subsidiary or member thereof for the
manufacturing, packaging, supply or distribution of products or
materials, or the provision of other administrative or
operational services (whether on a transitional or ongoing
basis), solely with respect to the consumer diagnostic business,
so long as, with respect to this clause (b), the charges for
manufacturing such products are on a cost-plus basis.
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The foregoing restrictions in clause (2) of the first
paragraph of this covenant shall not apply to ordinary course
transactions between the Issuer or any Restricted Subsidiary and
an Unrestricted Subsidiary.
Limitations on
liens
The Issuer shall not, and shall not permit any Restricted
Subsidiary to, directly or indirectly, create, incur, assume or
permit or suffer to exist any Lien of any nature whatsoever
(other than Permitted Liens) against any assets of the Issuer or
any Restricted Subsidiary (including Equity Interests of a
Restricted Subsidiary), whether owned at the Issue Date or
thereafter acquired, or any proceeds therefrom, in each case
securing an obligation that ranks pari passu in right of
payment with, or that is subordinated in right of payment to,
the Notes or any Guarantee, unless contemporaneously therewith:
(1) in the case of any Lien securing an obligation
that ranks pari passu in right of payment with the Notes
or any Guarantee, effective provision is made to secure the
Notes or such Guarantee, as the case may be, at least equally
and ratably with or prior to such obligation with a Lien on the
same collateral; and
(2) in the case of any Lien securing an obligation
that is subordinated in right of payment to the Notes or a
Guarantee, effective provision is made to secure the Notes or
such Guarantee, as the case may be, with a Lien on the same
collateral that is prior to the Lien securing such subordinated
obligation,
in each case, for so long as such obligation is secured by such
Lien.
Limitations on
asset sales
The Issuer will not, and will not permit any Restricted
Subsidiary to, directly or indirectly, consummate any Asset Sale
unless:
(1) the Issuer or such Restricted Subsidiary receives
consideration at the time of such Asset Sale at least equal to
the Fair Market Value of the assets included in such Asset Sale;
and
(2) at least 75% (or, solely in the case of any Asset
Sale to create any Health Management Joint Venture, 50%) of the
total consideration received in such Asset Sale consists of cash
or Cash Equivalents.
For purposes of clause (2) (and not for purposes of determining
the Net Available Proceeds with respect to the application and
purchase offer provisions in this covenant), the following shall
be deemed to be cash:
(a) the amount (without duplication) of any
Indebtedness of the Issuer or such Restricted Subsidiary that is
expressly assumed by the transferee in such Asset Sale and with
respect to which the Issuer or such Restricted Subsidiary, as
the case may be, is released by the holder of such Indebtedness;
(b) the amount of any obligations received from such
transferee that are within 180 days converted by the Issuer
or such Restricted Subsidiary to cash (to the extent of the cash
actually so received);
(c) the Fair Market Value of (i) any assets
(other than securities) received by the Issuer or any Restricted
Subsidiary to be used by it in the Permitted Business,
(ii) Equity Interests in a Person that is a Restricted
Subsidiary or in a Person engaged in a Permitted Business that
shall become a Restricted Subsidiary immediately upon the
acquisition of such Person by the Issuer or (iii) a
combination of (i) and (ii); and
(d) the Fair Market Value of any Equity Interests for
which the Issuer or such Restricted Subsidiary has a contractual
right to require the registration of such Equity Interests under
the Securities Act or the applicable securities laws of the
jurisdiction in which such Securities are listed on a Major
Foreign Exchange (Designated Non-Cash
Consideration); provided, however, that no
consideration
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received in an Asset Sale will constitute Designated Non-Cash
Consideration if and to the extent that the classification of
such consideration as Designated Non-Cash Consideration would
cause the aggregate amount of all such Designated Non-Cash
Consideration outstanding at that time to exceed 2.5% of
Consolidated Total Assets (with the Fair Market Value of each
item of Designated Non-Cash Consideration being measured at the
time received and without giving effect to subsequent changes in
value).
If at any time any non-cash consideration (including any
Designated Non-Cash Consideration) received by the Issuer or any
Restricted Subsidiary of the Issuer, as the case may be, in
connection with any Asset Sale is repaid or converted into or
sold or otherwise disposed of for cash (other than interest
received with respect to any such non-cash consideration), then
the date of such repayment, conversion or disposition shall be
deemed to constitute the date of an Asset Sale hereunder and the
Net Available Proceeds thereof shall be applied in accordance
with this covenant.
If the Issuer or any Restricted Subsidiary engages in an Asset
Sale, the Issuer or such Restricted Subsidiary shall, no later
than 360 days following the consummation thereof, apply all
or any (or, in the Issuers discretion, none) of the Net
Available Proceeds therefrom to:
(1) repay Senior Debt or Guarantor Senior Debt, and
in the case of any such repayment under any revolving credit
facility, effect a permanent reduction in the availability under
such revolving credit facility, in each case if and to the
extent permitted under the terms of such Senior Debt or
Guarantor Senior Debt;
(2) repay any Indebtedness which was secured by the
assets sold in such Asset Sale; and/or
(3) (a) invest all or any part of the Net
Available Proceeds thereof in assets (other than securities),
including expenditures for research and development activities,
to be used by the Issuer or any Restricted Subsidiary in the
Permitted Business, (b) acquire Equity Interests in a
Person that is a Restricted Subsidiary or in a Person engaged in
a Permitted Business that shall become a Restricted Subsidiary
immediately upon the consummation of such acquisition or
(c) a combination of (a) and (b).
The amount of Net Available Proceeds not applied or invested as
provided in this paragraph will constitute Excess
Proceeds. The Issuer or such Restricted Subsidiary may
repay Senior Debt or Guarantor Senior Debt under a revolving
Credit Facility during the 360 days following the
consummation of such Asset Sale without effecting a permanent
reduction in the availability under such revolving credit
facility, pending application of such proceeds pursuant to
clause (1), (2) or (3) above or their use as Excess
Proceeds in accordance with the next paragraph, and such
repayment shall not be considered an application of Net
Available Proceeds for purposes of this paragraph;
provided, however, that, if such Net Available
Proceeds are not applied after 360 days for any purpose
other than the repayment of a revolving credit facility, a
permanent reduction in the availability under such revolving
credit facility shall then be required in order for such
repayment to be considered an application of Net Available
Proceeds for purposes of this paragraph.
When the aggregate amount of Excess Proceeds equals or exceeds
$50.0 million, the Issuer will be required to make an offer
to purchase from all Holders and, if applicable, redeem (or make
an offer to do so) any Pari Passu Indebtedness of the Issuer the
provisions of which require the Issuer to redeem such Pari Passu
Indebtedness with the proceeds from any Asset Sales (or offer to
do so), in an aggregate principal amount of Notes and such Pari
Passu Indebtedness equal to the amount of such Excess Proceeds
as follows:
(1) the Issuer will (a) make an offer to
purchase (a Net Proceeds Offer) to all Holders in
accordance with the procedures set forth in the Indenture, and
(b) redeem (or make an offer to do so) any such other Pari
Passu Indebtedness, on a pro rata basis (or on as nearly
a pro rata basis as is practicable) in proportion to the
respective principal amounts of the Notes and such other Pari
Passu Indebtedness required to be redeemed, the maximum
principal amount of Notes (in each case in whole in a principal
amount of $1,000 or integral multiples thereof; provided,
however, that no Note
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will be purchased in part if such Note would have a remaining
amount of less than $2,000) and Pari Passu Indebtedness that may
be redeemed out of the amount (the Payment Amount)
of such Excess Proceeds;
(2) the offer price for the Notes will be payable in
cash in an amount equal to 100% of the principal amount of the
Notes tendered pursuant to a Net Proceeds Offer, plus
accrued and unpaid interest thereon, if any, to the date
such Net Proceeds Offer is consummated (the Offered
Price), in accordance with the procedures set forth in the
Indenture and the redemption price for such Pari Passu
Indebtedness (the Pari Passu Indebtedness Price)
shall be as set forth in the related documentation governing
such Indebtedness;
(3) if the aggregate Offered Price of Notes validly
tendered and not withdrawn by Holders thereof exceeds the pro
rata portion of the Payment Amount allocable to the Notes,
Notes to be purchased will be selected on a pro rata
basis (or on as nearly a pro rata basis as is
practicable); and
(4) upon completion of such Net Proceeds Offer in
accordance with the foregoing provisions, the amount of Excess
Proceeds with respect to which such Net Proceeds Offer was made
shall be deemed to be zero.
To the extent that the sum of the aggregate Offered Price of
Notes tendered pursuant to a Net Proceeds Offer and the
aggregate Pari Passu Indebtedness Price paid to the holders of
such Pari Passu Indebtedness is less than the Payment Amount
relating thereto (such shortfall constituting a Net
Proceeds Deficiency), the Issuer may use the Net Proceeds
Deficiency, or a portion thereof, for general corporate
purposes, subject to the provisions of the Indenture, and the
amount of Excess Proceeds with respect to such Net Proceeds
Offer shall be deemed to be zero.
The Issuer will comply with applicable tender offer rules,
including the requirements of
Rule 14e-1
under the Exchange Act and any other applicable laws and
regulations in connection with the purchase of Notes pursuant to
a Net Proceeds Offer. To the extent that the provisions of any
securities laws or regulations conflict with the covenant
described under Limitations on Asset Sales,
the Issuer shall comply with the applicable securities laws and
regulations and will not be deemed to have breached its
obligations under the covenant described under
Limitations on Asset Sales by virtue of this
compliance.
Limitations on
designation of unrestricted subsidiaries
The Issuer may designate any Subsidiary of the Issuer (including
any newly acquired or newly formed Subsidiary) as an
Unrestricted Subsidiary under the Indenture (a
Designation) only if:
(1) no Default shall have occurred and be continuing
at the time of or after giving effect to such Designation; and
(2) the Issuer would be permitted to make, at the
time of such Designation, (a) a Permitted Investment or
(b) an Investment pursuant to the first paragraph of
Limitations on Restricted Payments above, in
either case, in an amount (the Designation Amount)
equal to the Fair Market Value of the Issuers
proportionate interest in such Subsidiary on such date
less, for this purpose, the amount of any intercompany
loan from the Issuer or any Restricted Subsidiary to such
Subsidiary that was treated as a Restricted Payment.
No Subsidiary shall be Designated as an Unrestricted
Subsidiary unless such Subsidiary:
(1) has no Indebtedness other than Non-Recourse Debt;
(2) is not party to any agreement, contract,
arrangement or understanding with the Issuer or any Restricted
Subsidiary unless the terms of the agreement, contract,
arrangement or understanding are no less favorable to the Issuer
or the Restricted Subsidiary than those that might be obtained
at the time from Persons who are not Affiliates;
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(3) is a Person with respect to which neither the
Issuer nor any Restricted Subsidiary has any direct or indirect
obligation (a) to subscribe for additional Equity Interests
or (b) to maintain or preserve the Persons financial
condition or to cause the Person to achieve any specified levels
of operating results; and
(4) has not guaranteed or otherwise directly or
indirectly provided credit support for any Indebtedness of the
Issuer or any Restricted Subsidiary in excess of
$25.0 million in the aggregate, except for any guarantee
given solely to support the pledge by the Issuer or any
Restricted Subsidiary of the Equity Interests of such
Unrestricted Subsidiary, which guarantee is not recourse to the
Issuer or any Restricted Subsidiary, and except to the extent
the amount thereof constitutes a Restricted Payment permitted
pursuant to the covenant described under Limitations
on Restricted Payments.
If, at any time, any Unrestricted Subsidiary fails to meet the
preceding requirements as an Unrestricted Subsidiary, it shall
thereafter cease to be an Unrestricted Subsidiary for purposes
of the Indenture and any Indebtedness of the Subsidiary and any
Liens on assets of such Subsidiary shall be deemed to be
incurred by a Restricted Subsidiary as of the date and, if the
Indebtedness is not permitted to be incurred under the covenant
described under Limitations on Additional
Indebtedness above, or the Lien is not permitted under the
covenant described under Limitations on Liens
above, the Issuer shall be in default of the applicable covenant.
The Issuer may redesignate an Unrestricted Subsidiary as a
Restricted Subsidiary (a Redesignation) only if:
(1) no Default shall have occurred and be continuing
at the time of and after giving effect to such Redesignation; and
(2) all Liens, Indebtedness and Investments of such
Unrestricted Subsidiary outstanding immediately following such
Redesignation would, if incurred or made at such time, have been
permitted to be incurred or made for all purposes of the
Indenture.
All Designations and Redesignations must be evidenced by
(1) resolutions of the Board of Directors of the Issuer,
and (2) an Officers Certificate certifying compliance
with the foregoing provisions, in each case delivered to the
Trustee.
Limitations on
sale and leaseback transactions
The Issuer will not, and will not permit any Restricted
Subsidiary to, directly or indirectly, enter into any Sale and
Leaseback Transaction; provided, however, that the
Issuer or any Restricted Subsidiary may enter into a Sale and
Leaseback Transaction if:
(1) the Issuer or such Restricted Subsidiary could
have (a) incurred the Indebtedness attributable to such
Sale and Leaseback Transaction pursuant to the covenant
described under Limitations on Additional
Indebtedness and (b) incurred a Lien to secure such
Indebtedness without equally and ratably securing the Notes
pursuant to the covenant described under Limitations
on Liens;
(2) the gross cash proceeds of such Sale and
Leaseback Transaction are at least equal to the Fair Market
Value of the asset that is the subject of such Sale and
Leaseback Transaction; and
(3) the transfer of assets in such Sale and Leaseback
Transaction is permitted by, and the Issuer or the applicable
Restricted Subsidiary applies the proceeds of such transaction
in accordance with, the covenant described under
Limitations on Asset Sales.
Limitations on
the issuance or sale of equity interests of restricted
subsidiaries
The Issuer will not, and will not permit any Restricted
Subsidiary to, directly or indirectly, sell or issue any shares
of Equity Interests of any Restricted Subsidiary except
(1) by any Wholly-Owned Restricted Subsidiary
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to the Issuer or any Restricted Subsidiary, (2) to the
Issuer, a Restricted Subsidiary or the minority stockholders of
any Restricted Subsidiary, on a pro rata basis, at Fair
Market Value, or (3) to the extent such shares represent
directors qualifying shares or shares required by
applicable law to be held by a Person other than the Issuer or a
Wholly-Owned Restricted Subsidiary. The sale of all the Equity
Interests of any Restricted Subsidiary is permitted by this
covenant but is subject to the covenant described under
Limitations on Asset Sales.
Limitations on
mergers, consolidations, etc.
The Issuer will not, directly or indirectly, in a single
transaction or a series of related transactions,
(a) consolidate or merge with or into any other Person
(other than a merger with a Wholly-Owned Restricted Subsidiary
solely for the purpose of changing the Issuers name or
jurisdiction of incorporation to another State of the United
States), or sell, lease, transfer, convey or otherwise dispose
of or assign all or substantially all of the assets of the
Issuer or the Issuer and the Restricted Subsidiaries (taken as a
whole) to any other Person or (b) effect a Plan of
Liquidation unless, in either case:
(1) either (x) the Issuer will be the surviving
or continuing Person or (y) the Person formed by or
surviving such consolidation or merger (if not the Issuer) or to
which such sale, lease, conveyance or other disposition shall be
made (or, in the case of a Plan of Liquidation, any Person to
which assets are transferred) (collectively, the
Successor) is a corporation organized and existing
under the laws of any State of the United States of America or
the District of Columbia, and the Successor expressly assumes,
by supplemental indenture in form and substance satisfactory to
the Trustee, all of the obligations of the Issuer under the
Notes and the Indenture;
(2) immediately after giving effect to such
transaction and the assumption of the obligations as set forth
in clause (1)(y) above, if applicable, and the incurrence of any
Indebtedness to be incurred in connection therewith, no Default
shall have occurred and be continuing; and
(3) except in the case of the consolidation or merger
of any Restricted Subsidiary with or into the Issuer,
immediately after giving effect to such transaction and the
assumption of the obligations set forth in clause (1)(y) above,
if applicable, and the incurrence of any Indebtedness to be
incurred in connection therewith, and the use of any net
proceeds therefrom on a pro forma basis, (a) the
Consolidated Net Worth of the Issuer or the Successor, as the
case may be, would be at least equal to the Consolidated Net
Worth of the Issuer immediately prior to such transaction and
(b) either (i) the Issuer or the Successor, as the
case may be, could incur $1.00 of additional Indebtedness
pursuant to the Coverage Ratio Exception or (ii) the
Consolidated Interest Coverage Ratio of the Issuer or the
Successor, as the case may be, determined on a pro forma
basis for such transaction, would not be lower than the
Consolidated Interest Coverage Ratio of the Issuer immediately
prior to such transaction.
For purposes of this covenant, any Indebtedness of the Successor
which was not Indebtedness of the Issuer immediately prior to
the transaction shall be deemed to have been incurred in
connection with such transaction.
Except as provided under the caption Guarantees of
the Notes, no Guarantor may consolidate with or merge with
or into (whether or not such Guarantor is the surviving Person)
another Person (other than the Issuer or another Guarantor),
whether or not affiliated with such Guarantor, unless:
(1) either:
(a) such Guarantor will be the surviving or
continuing Person; or
(b) the Person formed by or surviving any such
consolidation or merger assumes, by supplemental indenture in
the form of Exhibit B attached to the Indenture, all of the
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obligations of such Guarantor under the Guarantee of such
Guarantor and the Indenture; and
(2) immediately after giving effect to such
transaction, no Default shall have occurred and be continuing.
For purposes of this covenant, the sale, lease, transfer,
conveyance or other disposition or assignment of all or
substantially all of the assets of one or more Restricted
Subsidiaries, the Equity Interests of which constitute all or
substantially all of the assets of the Issuer, will be deemed to
be the transfer of all or substantially all of the assets of the
Issuer.
Except as provided under the caption Guarantees of
the Notes, upon any consolidation, combination or merger
of the Issuer or a Guarantor, or any sale, lease, transfer,
conveyance or other disposition or assignment of all or
substantially all of the assets of the Issuer in accordance with
the foregoing, in which the Issuer or such Guarantor is not the
continuing obligor or continuing guarantor, as the case may be,
under the Notes or its Guarantee, the surviving entity formed by
such consolidation or into which the Issuer or such Guarantor is
merged or the entity to which the sale, lease, transfer,
conveyance or other disposition or assignment is made will
succeed to, and be substituted for, and may exercise every right
and power of, the Issuer or such Guarantor under the Indenture,
the Notes and the Guarantee with the same effect as if such
surviving entity had been named therein as the Issuer or such
Guarantor, and, except in the case of a lease, the Issuer or
such Guarantor, as the case may be, will be released from the
obligation to pay the principal of and interest on the Notes or
in respect of its Guarantee, as the case may be, and all of the
Issuers or such Guarantors other obligations and
covenants under the Notes, the Indenture and its Guarantee, if
applicable.
Notwithstanding the foregoing, any Restricted Subsidiary may
merge into the Issuer or another Restricted Subsidiary.
Additional
guarantees
If, after the Issue Date, (a) the Issuer or any Restricted
Subsidiary acquires or creates a Domestic Subsidiary that
guarantees any Indebtedness or other Obligation under any Credit
Agreement (other than a Subsidiary that has been designated an
Unrestricted Subsidiary), (b) any Unrestricted Subsidiary
that is a Domestic Subsidiary that guarantees any Indebtedness
or other Obligation under any Credit Agreement is redesignated a
Restricted Subsidiary, or (c) if the proviso in the
definition of Domestic Subsidiary shall cease to
apply with respect to Inverness Medical Investments, LLC, BBI
Research, Inc. or Seravac USA Inc. such that any such Subsidiary
shall become a Domestic Subsidiary (and provided that such
Domestic Subsidiary is a Restricted Subsidiary and guarantees
any Indebtedness or other Obligations under any Credit
Agreement), then, in each such case, the Issuer shall cause such
Restricted Subsidiary to execute and deliver to the Trustee a
supplemental indenture in the form of Exhibit B attached to
the Indenture, pursuant to which such Restricted Subsidiary
shall unconditionally and irrevocably guarantee all of the
Issuers obligations under the Notes and the Indenture.
Thereafter, such Restricted Subsidiary shall be a Guarantor for
all purposes of the Indenture.
Conduct of
business
The Issuer will not, and will not permit any Restricted
Subsidiary to, engage in any business other than the Permitted
Business.
SEC
reports
Whether or not required by the SECs rules and regulations,
so long as any Notes are outstanding, the Issuer will furnish to
the Holders of Notes, cause the Trustee to furnish to the
Holders, or file electronically with the SEC through the
SECs Electronic Data Gathering, Analysis and Retrieval
System (or any successor system, including the Interactive Data
Electronic Applications System), within the time periods
(including any
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extensions thereof) applicable to (or that would be applicable
to) the Issuer under the SECs rules and regulations:
(1) all quarterly and annual financial information
that would be required to be contained in a filing with the SEC
on
Forms 10-Q
or 10-K (or
any successor forms), as the case may be, if the Issuer were
required to file these Forms, including a
Managements Discussion and Analysis of Financial
Condition and Results of Operations and, with respect to
the annual information only, a report on the annual financial
statements by the Issuers independent accountants; and
(2) all current reports that would be required to be
filed with the SEC on
Form 8-K
(or any successor form) if the Issuer were required to file
these reports.
In addition, whether or not required by the SECs rules and
regulations, the Issuer will file a copy of all of the
information and reports referred to in clauses (1) and
(2) above with the SEC for public availability within the
time periods applicable to the Issuer under Section 13(a)
or 15(d) of the Exchange Act (unless the SEC will not accept the
filing, in which case the Issuer shall make the information
available to securities analysts and prospective investors upon
request). The Issuer also shall comply with the other provisions
of Trust Indenture Act § 314(a).
Suspension of
covenants
If during any period of time following the issuance of the Notes
that (i) the Notes have a rating equal to or higher than
Baa3 (or the equivalent) by Moodys and BBB- (or the
equivalent) by S&P, or, if both will not make a rating on
the Notes publicly available, from a nationally recognized
statistical rating agency or agencies, as the case may be,
selected by the Issuer that will be substituted for Moodys
or S&P or both, as the case may be (Moodys, S&P
or such other agency or agencies, as the case may be, the
Rating Agencies), an equivalent rating by such other
agency or agencies, as the case may be (any such rating, an
Investment Grade Rating), and (ii) no Default
has occurred and is continuing under the Indenture (the
occurrence of the events described in the foregoing
clauses (i) and (ii) being collectively referred to as
a Covenant Suspension Event), the Issuer and the
Restricted Subsidiaries will not be subject to the covenants
described above under the following headings:
(1) Limitations on Additional
Indebtedness
(2) Limitations on Restricted
Payments
(3) Limitations on Dividend and other
Restrictions Affecting Restricted Subsidiaries
(4) Limitations on Transactions with
Affiliates
(5) Limitations on Asset Sales
(6) Limitations on Sale and Leaseback
Transactions and
(7) clause (3) under Limitations on
Mergers, Consolidations, Etc.
(collectively, the Suspended Covenants). Upon the
occurrence of a Covenant Suspension Event, the amount of Net
Available Proceeds with respect to any applicable Asset Sale
will be set at zero at such date (the Suspension
Date). In the event that the Issuer and the Restricted
Subsidiaries are not subject to the Suspended Covenants for any
period of time as a result of the foregoing, and on any
subsequent date (the Reversion Date) one or both of
the Rating Agencies withdraws its Investment Grade Rating or
downgrades the rating assigned to the Notes below an Investment
Grade Rating or a Default occurs and is continuing, then the
Issuer and the Restricted Subsidiaries will thereafter again be
subject to the Suspended Covenants, but only with respect to
events after the Reversion Date. The period of time between the
Suspension Date and the Reversion Date is referred to as the
Suspension Period. Notwithstanding that the
Suspended Covenants may be reinstated, no Default will be deemed
to have occurred as a result of a failure to comply with the
Suspended Covenants during the Suspension Period.
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On the Reversion Date, all Indebtedness incurred during the
Suspension Period will be subject to the covenant described
above under the caption Limitations on Additional
Indebtedness. To the extent such Indebtedness would not be
so permitted to be incurred pursuant to the covenant described
below under the caption Limitations on Additional
Indebtedness, such Indebtedness will be deemed to have
been outstanding on the Issue Date, so that it is classified as
permitted under clause (3) of the definition of
Permitted Indebtedness.
Calculations made after the Reversion Date of the amount
available to be made as Restricted Payments under the covenant
described above under the caption Limitations on
Restricted Payments will be made as though such covenant
had been in effect from the Issue Date and throughout the
Suspension Period. Accordingly, Restricted Payments made during
the Suspension Period will be deemed to have been permitted but
will reduce the amount available to be made as Restricted
Payments under the first paragraph of the covenant described
below under the caption Limitations on Restricted
Payments.
During a Suspension Period, the Issuer may not designate a
Subsidiary as an Unrestricted Subsidiary under the covenant
described under the caption Limitations on
Designation of Unrestricted Subsidiaries.
Notwithstanding the foregoing, neither (a) the continued
existence, after the Reversion Date, of facts and circumstances
or obligations that occurred, were incurred or otherwise came
into existence during a Suspension Period nor (b) the
performance of any such obligations, shall constitute a breach
of any Suspended Covenant set forth in the Indenture or cause a
Default thereunder, provided that (1) the Issuer and the
Restricted Subsidiaries did not incur or otherwise cause such
facts and circumstances or obligations to exist in anticipation
of a withdrawal or downgrade by the applicable Rating Agency
below an Investment Grade Rating and (2) the Issuer
reasonably believed that such incurrence or actions would not
result in such withdrawal or downgrade.
EVENTS OF
DEFAULT
Each of the following is an Event of Default:
(1) failure by the Issuer to pay interest on any of
the Notes when it becomes due and payable and the continuance of
any such failure for 30 consecutive days (whether or not such
payment is prohibited by the subordination provisions of the
Indenture);
(2) failure by the Issuer to pay the principal on any
of the Notes when it becomes due and payable, whether at stated
maturity, upon redemption, upon purchase, upon acceleration or
otherwise (including the failure to make a payment to purchase
Notes tendered pursuant to a Change of Control Offer or Net
Proceeds Offer on the date specified for such payment in the
applicable offer to purchase, if required) (whether or not such
payment is prohibited by the subordination provisions of the
Indenture);
(3) failure by the Issuer to comply with any other
agreement or covenant in the Indenture and the continuance of
any such failure for 60 consecutive days after notice of the
failure has been given to the Issuer by the Trustee or by the
Holders of at least 25% of the aggregate principal amount of the
Notes then outstanding (except in the case of a default with
respect to the covenant described under Limitations
on Mergers, Consolidations, Etc. which will constitute an
Event of Default with such notice requirement but without such
passage of time requirement);
(4) default under any mortgage, indenture or other
instrument or agreement under which there may be issued or by
which there may be secured or evidenced Indebtedness of the
Issuer or any Restricted Subsidiary, whether such Indebtedness
now exists or is incurred after the Issue Date, which default:
(a) is caused by a failure to pay at final maturity
(giving effect to any applicable grace periods and any
extensions thereof) principal on such Indebtedness, or
(b) results in the acceleration of such Indebtedness
prior to its express final maturity, and
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in each case, the principal amount of such Indebtedness,
together with any other Indebtedness with respect to which an
event described in clause (a) or (b) has occurred and
is continuing, aggregates $50.0 million or more;
(5) entry by a court or courts of competent
jurisdiction against the Issuer or any Restricted Subsidiary of
one or more final judgments or orders for the payment of money
that exceed $50.0 million in the aggregate (net of amounts
covered by insurance or bonded) and such judgments or orders
have not been satisfied, stayed, annulled or rescinded within
60 days of entry (or such longer period as may be permitted
for timely appeal under applicable law);
(6) the Issuer or any Significant Subsidiary pursuant
to or within the meaning of any Bankruptcy Law:
(a) commences a voluntary case,
(b) consents to the entry of an order for relief
against it in an involuntary case,
(c) consents to the appointment of a Custodian of it
or for all or substantially all of its assets, or
(d) makes a general assignment for the benefit of its
creditors;
(7) a court of competent jurisdiction enters an order
or decree under any Bankruptcy Law that:
(a) is for relief against the Issuer or any
Significant Subsidiary as debtor in an involuntary case,
(b) appoints a Custodian of the Issuer or any
Significant Subsidiary or a Custodian for all or substantially
all of the assets of the Issuer or any Significant Subsidiary, or
(c) orders the liquidation of the Issuer or any
Significant Subsidiary,
and the order or decree remains unstayed and in effect for
60 days; or
(8) (a) the Guarantee of any Significant
Subsidiary (i) ceases to be in full force and effect (other
than in accordance with the terms of the Indenture (including
such Guarantee)) or (ii) is declared null and void and
unenforceable or found to be invalid, and such circumstance or
event remains uncured for a period of 30 days, or
(b) any Guarantor denies its liability under its Guarantee
(other than by reason of release of a Guarantor from its
Guarantee in accordance with the terms of the Indenture
(including such Guarantee)).
If an Event of Default (other than an Event of Default specified
in clause (6) or (7) above with respect to the
Issuer), shall have occurred and be continuing under the
Indenture, the Trustee, by written notice to the Issuer, or the
Holders of at least 25% in aggregate principal amount of the
Notes then outstanding by written notice to the Issuer and the
Trustee, may declare all amounts owing under the Notes to be due
and payable, which notice shall specify each applicable Event of
Default and that it is a notice of acceleration (an
Acceleration Notice). Upon proper delivery of an
Acceleration Notice, the aggregate principal of and accrued and
unpaid interest on the outstanding Notes shall become due and
payable (a) if there is any Designated Senior Debt
outstanding at such time, with respect to any acceleration
arising out of any Event of Default other than a payment default
under clause (1) or (2) above, upon the earlier of
(x) the date which is 5 Business Days after receipt by the
Representatives of such Acceleration Notice or (y) the date
of acceleration of any Designated Senior Debt and (b) if
otherwise, immediately, but, in any case, only if one or more of
the Events of Default specified in such Acceleration Notice are
then continuing; provided, however, that after
such declaration of acceleration, but before a judgment or
decree based on acceleration, the Holders of at least a majority
in aggregate principal amount of such outstanding Notes may,
under certain circumstances and on behalf of all the Holders,
rescind and annul such declaration of acceleration and its
consequences if all existing Events of Default, other than the
nonpayment of accelerated principal and
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interest, have been cured or waived as provided in the
Indenture. If an Event of Default specified in clause (6)
or (7) with respect to the Issuer occurs, all outstanding
Notes shall become immediately due and payable without any
further action or notice.
The Trustee shall, within 30 days after the occurrence of
any Default with respect to the Notes or, if later, after a
responsible officer of the Trustee has knowledge of such
Default, give the Holders notice of all uncured Defaults
thereunder of which it received written notice; provided,
however, that, except in the case of a Default in payment
with respect to the Notes or a Default in complying with
Certain CovenantsLimitations on Mergers,
Consolidations, Etc., the Trustee will be protected in
withholding such notice if and so long as the board of
directors, the executive committee or a committee of its trust
officers in good faith determines that the withholding of such
notice is in the interest of the Holders.
No Holder will have any right to institute any proceeding with
respect to the Indenture or for any remedy thereunder, unless
the Trustee:
(1) has failed to act for a period of 60 consecutive
days after receiving written notice of a continuing Event of
Default from such Holder and a request to act by Holders of at
least 25% in aggregate principal amount of the outstanding Notes;
(2) has been offered indemnity satisfactory to it in
its reasonable judgment; and
(3) has not received from the Holders of a majority
in aggregate principal amount of the outstanding Notes a
direction inconsistent with such request.
However, such limitations do not apply to a suit instituted by a
Holder of any Note for enforcement of payment of the principal
of or interest on such Note on or after the due date therefor
(after giving effect to the grace period specified in
clause (1) of the first paragraph of this
Events of Default section).
The Issuer and each Guarantor (to the extent that such Guarantor
is so required under the Trust Indenture Act) is required
to deliver to the Trustee annually a statement regarding
compliance with the Indenture and, upon any Officer of the
Issuer becoming aware of any Default, a statement specifying
such Default and what action the Issuer is taking or proposes to
take with respect thereto.
LEGAL DEFEASANCE
AND COVENANT DEFEASANCE
The Issuer may, at its option and at any time, elect to have its
obligations and the obligations of the Guarantors discharged
with respect to the outstanding Notes and the Guarantees
(Legal Defeasance). Legal Defeasance means that the
Issuer and the Guarantors shall be deemed to have paid and
discharged the entire indebtedness represented by the Notes and
the Guarantees, and the Indenture shall cease to be of further
effect as to all outstanding Notes and the Guarantees, except as
to:
(1) the rights of Holders of outstanding Notes to
receive payments in respect of the principal of and interest on
the Notes when such payments are due from the trust funds
referred to below;
(2) the Issuers obligations with respect to the
Notes concerning issuing temporary Notes, registration of Notes,
mutilated, destroyed, lost or stolen Notes, and the maintenance
of an office or agency for payment and money for security
payments held in trust;
(3) the rights, powers, trust, duties, and immunities
of the Trustee under the Indenture and the Issuers
obligation in connection therewith; and
(4) the Legal Defeasance provisions of the Indenture.
In addition, the Issuer may, at its option and at any time,
elect to have its obligations and the obligations of each of the
Guarantors released with respect to most of the covenants under
the Indenture, except as described otherwise in the Indenture
(Covenant Defeasance), and thereafter any omission
to comply with such obligations shall not constitute a Default.
In the event Covenant Defeasance occurs, certain Events of
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Default (not including non-payment and, solely for a period of
91 days following the deposit referred to in
clause (1) of the next paragraph, bankruptcy, receivership,
rehabilitation and insolvency events) will no longer apply.
Covenant Defeasance will not be effective until such bankruptcy,
receivership, rehabilitation and insolvency events no longer
apply. The Issuer may exercise its Legal Defeasance option
regardless of whether it previously exercised Covenant
Defeasance.
In order to exercise either Legal Defeasance or Covenant
Defeasance:
(1) the Issuer must irrevocably deposit with the
Trustee, in trust, for the benefit of the Holders, funds in
Dollars or U.S. Government Obligations or a combination
thereof, in such amounts as will be sufficient (without
reinvestment) in the opinion of a nationally recognized firm of
independent public accountants selected by the Issuer, to pay
the principal of and interest on the outstanding Notes on the
stated date for payment thereof or on the applicable redemption
date, as the case may be, and the Issuer must specify to the
Trustee whether the Notes are being defeased to such stated date
for payment or to a particular redemption date, as the case may
be, and the Issuer must specify to the Trustee whether the Notes
are being defeased to such stated date for payment or particular
redemption date and the Holders must have a valid, perfected,
exclusive security interest in such trust;
(2) in the case of Legal Defeasance, the Issuer shall
have delivered to the Trustee an opinion of counsel in the
United States reasonably acceptable to the Trustee confirming
that:
(a) the Issuer has received from, or there has been
published by the Internal Revenue Service, a ruling, or
(b) since the date of the Indenture, there has been a
change in the applicable U.S. federal income tax law,
in either case to the effect that, and based thereon this
opinion of counsel shall confirm that, the Holders will not
recognize income, gain or loss for U.S. federal income tax
purposes as a result of the Legal Defeasance and will be subject
to U.S. federal income tax on the same amounts, in the same
manner and at the same times as would have been the case if such
Legal Defeasance had not occurred;
(3) in the case of Covenant Defeasance, the Issuer
shall have delivered to the Trustee an opinion of counsel in the
United States reasonably acceptable to the Trustee confirming
that the Holders will not recognize income, gain or loss for
U.S. federal income tax purposes as a result of such
Covenant Defeasance and will be subject to U.S. federal
income tax on the same amounts, in the same manner and at the
same times as would have been the case if the Covenant
Defeasance had not occurred;
(4) no Default shall have occurred and be continuing
on the date of such deposit (other than a Default resulting from
the borrowing of funds to be applied to such deposit and the
grant of any Lien securing such borrowing);
(5) the Legal Defeasance or Covenant Defeasance shall
not result in a breach or violation of, or constitute a default
under (other than a default resulting solely from the borrowing
of funds to be applied to such deposit and the grant of any Lien
on such deposit in favor of the Trustee
and/or the
Holders), any Credit Agreement or any other material agreement
or instrument to which the Issuer or any of its Subsidiaries is
a party or by which the Issuer or any of its Subsidiaries is
bound;
(6) the Issuer shall have delivered to the Trustee an
Officers Certificate stating that the deposit was not made
by the Issuer with the intent of preferring the Holders over any
other of its creditors or with the intent of defeating,
hindering, delaying or defrauding any other of its creditors or
others; and
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(7) the Issuer shall have delivered to the Trustee an
Officers Certificate and an opinion of counsel, stating,
in the case of the Officers Certificate, that the
conditions provided for in clauses (1) through (6) of
this paragraph have been complied with and stating, in the case
of the opinion of counsel, that clause (1) (with respect to the
validity and perfection of the security interest) and the
conditions provided for in clause (2) or (3), as
applicable, and clause (5) of this paragraph have been
complied with.
Notwithstanding anything to the contrary herein, the borrowing
of funds to be applied to any deposit, and the grant of any Lien
securing such borrowing, in order to effect any Legal Defeasance
or Covenant Defeasance will not constitute a Default under the
Indenture.
If the funds deposited with the Trustee to effect Covenant
Defeasance are insufficient to pay the principal of and interest
on the Notes when due, then the Issuers obligations and
the obligations of the Guarantors under the Indenture will be
revived and no such defeasance will be deemed to have occurred.
SATISFACTION AND
DISCHARGE
The Indenture and the Guarantees will be discharged and will
cease to be of further effect as to all outstanding Notes when
either:
(1) all the Notes that have been authenticated and
delivered (except lost, stolen or destroyed Notes that have been
replaced or paid and Notes for whose payment money has been
deposited in trust or segregated and held in trust by the Issuer
and thereafter repaid to the Issuer or discharged from this
trust) have been delivered to the Trustee for cancellation; or
(2) (a) all Notes that have not been delivered
to the Trustee for cancellation either (i) have become due
and payable by reason of the mailing of a notice of redemption
as described in Redemption or otherwise or
(ii) will become due and payable within one year, and in
each of the foregoing cases the Issuer has irrevocably deposited
or caused to be deposited with the Trustee as trust funds in
trust solely for the benefit of the Holders funds in Dollars or
U.S. Government Obligations in amounts sufficient (without
reinvestment) to pay and discharge the entire Indebtedness
(including all principal and accrued interest) on the Notes not
theretofore delivered to the Trustee for cancellation to the
date of maturity or redemption,
(b) the Issuer or any
Guarantor has paid or caused to be paid all other sums payable
by the Issuer under the Indenture,
(c) the Issuer has
delivered irrevocable instructions to the Trustee to apply the
deposited money toward the payment of the Notes at maturity or
on the date of redemption, as the case may be, and
(d) the Holders have a
valid, perfected, exclusive security interest in this trust.
In addition, the Issuer must deliver an Officers
Certificate and an opinion of counsel to the Trustee stating
that all conditions precedent to satisfaction and discharge have
been complied with.
TRANSFER AND
EXCHANGE
A Holder will be able to register the transfer of or exchange
Notes only in accordance with the provisions of the Indenture.
The Registrar may require a Holder, among other things, to
furnish appropriate endorsements and transfer documents and to
pay any taxes and fees required by law or permitted by the
Indenture. Without the prior consent of the Issuer, the
Registrar is not required (1) to register the transfer of
or exchange any Note for a period of 15 days before the
mailing of a notice of redemption of Notes to be redeemed,
(2) to register the transfer of or exchange any Note
selected for redemption or (3) to register the transfer or
exchange of a Note between a record date for the payment of
interest and the next succeeding interest payment date.
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The Notes will be issued in registered form and the registered
Holder will be treated as the owner of such Notes for all
purposes.
The Notes will be initially issued in the form of one or more
global notes in registered form and deposited with the Trustee
as custodian for the Depository.
AMENDMENT,
SUPPLEMENT AND WAIVER
Subject to certain exceptions, the Indenture (including the
Guarantees) or the Notes may be amended or supplemented with the
consent (which may include consents obtained in connection with
a tender offer or exchange offer for Notes) of the Holders of at
least a majority in aggregate principal amount of the Notes then
outstanding, and any existing Default under, or compliance with
any provision of, the Indenture may be waived (other than any
continuing Default in the payment of the principal or interest
on the Notes) with the consent (which may include consents
obtained in connection with a tender offer or exchange offer for
Notes) of the Holders of a majority in aggregate principal
amount of the Notes then outstanding; provided,
however, that without the consent of each Holder
affected, no amendment or waiver may:
(1) reduce the principal, or change the stated
maturity of any Note;
(2) reduce the rate or extend the time for payment of
interest on any Note;
(3) reduce any premium payable upon optional
redemption of the Notes, change the date on which any Notes are
subject to redemption or otherwise alter the provisions with
respect to the redemption of the Notes (other than provisions
relating to the purchase of Notes described above under
Change of Control and Certain
CovenantsLimitations on Asset Sales, except that if
a Change of Control has occurred, no amendment or other
modification of the obligation of the Issuer to make a Change of
Control Offer relating to such Change of Control shall be made
without the consent of each Holder of the Notes affected);
(4) make the principal of or interest, if any, on any
Note payable in money or currency other than that stated in the
Notes;
(5) modify or change any provision of the Indenture
or the related definitions affecting the subordination of the
Notes or the Guarantees in a manner that adversely affects the
Holders in any material respect;
(6) release any Guarantor which is a Significant
Subsidiary from any of its obligations under its guarantee or
Indenture other than as provided in the Indenture;
(7) waive a Default in the payment of principal of or
interest on any Notes (except a rescission of acceleration of
the Notes by the Holders of at least a majority in principal
amount of the outstanding Notes as provided in the Indenture and
a waiver of the payment Default that resulted from such
acceleration);
(8) impair the rights of Holders to receive payments
of principal of or interest on the Notes on or after the due
date therefor;
(9) reduce the principal amount of outstanding Notes
whose Holders must consent to an amendment, supplement or waiver
to or under the Indenture (including the Guarantees) or the
Notes; or
(10) make any change in (a) certain provisions
of the Indenture relating to the right of Holders to receive
payments when due or (b) these amendment or waiver
provisions.
Notwithstanding the foregoing, the Issuer, the Guarantors and
the Trustee, together, may amend or supplement the Indenture,
the Guarantees or the Notes without the consent of any Holder,
to cure any ambiguity, defect or inconsistency, to provide for
uncertificated Notes in addition to or in place of certificated
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Notes, to provide for the assumption of the Issuers or any
Guarantors obligations to the Holders in the case of a
merger, consolidation or sale of all or substantially all of the
Issuers assets, to add Guarantees with respect to the
Notes, to release any Guarantor from its Guarantee or any of its
other obligations under the Indenture (to the extent permitted
by the Indenture), to make any change that would provide any
additional rights or benefits to the Holders or that adds
covenants of the Issuer or any Guarantor for the benefit of the
Holders, to surrender any right or power conferred upon the
Issuer or any Guarantor, to make any change that does not
materially adversely affect the rights of any Holder, to
maintain the qualification of the Indenture under, or otherwise
comply with, the Trust Indenture Act, to conform the text
of the Indenture or the Notes to any provision of this
Description of Notes section of this prospectus
supplement to the extent that such provision in this
Description of Notes section was intended to be a
substantially verbatim recitation of a provision of the
Indenture or the Notes, or to evidence and provide for the
acceptance of appointment under the Indenture by a successor
Trustee with respect to the Notes and to add or change any of
the provisions of the Indenture as shall be necessary to provide
for or facilitate the administration of the trusts hereunder by
more than one Trustee.
No amendment of, or supplement or waiver to, the Indenture shall
adversely affect the rights of any holder of Senior Debt or
Guarantor Senior Debt under the subordination provisions of the
Indenture without the consent of such holder.
NO PERSONAL
LIABILITY OF DIRECTORS, OFFICERS, EMPLOYEES, STOCKHOLDERS,
MEMBERS OR MANAGERS
No director, officer, employee, incorporator, stockholder,
member or manager of the Issuer or any Guarantor will have any
liability for any obligations of the Issuer under the Notes or
the Indenture or of any Guarantor under its Guarantee or the
Indenture for any claim based on, in respect of, or by reason
of, such obligations or their creation. Each Holder by accepting
a Note waives and releases all such liability. The waiver and
release are part of the consideration for issuance of the Notes
and the Guarantees. The waiver may not be effective to waive
liabilities under the federal securities laws. It is the view of
the SEC that this type of waiver is against public policy.
CONCERNING THE
TRUSTEE
U.S. Bank National Association is the Trustee under the
Indenture and has been appointed by the Issuer as Registrar and
Paying Agent with regard to the Notes. The Indenture contains
certain limitations on the rights of the Trustee, should it
become a creditor of the Issuer, to obtain payment of claims in
certain cases, or to realize on certain assets received in
respect of any such claim as security or otherwise. The Trustee
will be permitted to engage in other transactions; however, if
it acquires any conflicting interest (as defined in the
Indenture), it must eliminate such conflict or resign.
The Holders of at least a majority in principal amount of the
then outstanding Notes will have the right to direct the time,
method and place of conducting any proceeding for exercising any
remedy available to the Trustee or exercising any trust or power
conferred on it, subject to certain exceptions. The Indenture
provides that, in case a Default occurs and is continuing, the
Trustee will be required, in the exercise of its power, to use
the degree of care of a prudent person in similar circumstances
in the conduct of his or her own affairs. Subject to such
provisions, the Trustee will be under no obligation to exercise
any of its rights or powers under the Indenture at the request
of any Holder, unless such Holder offers to the Trustee security
and indemnity satisfactory to the Trustee.
GOVERNING
LAW
The Indenture (including the Guarantees) and the Notes will be,
as the case may be, governed by, and construed in accordance
with, the laws of the State of New York, but without giving
effect to applicable
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principles of conflicts of laws to the extent that the
application of the laws of another jurisdiction would be
required thereby.
CERTAIN
DEFINITIONS
Set forth below is a summary of certain of the defined terms
used in the Indenture. Reference is made to the Indenture for
the full definition of all such terms.
2007 Convertible Notes means those
certain 3% convertible senior subordinated notes due 2016 in the
principal amount of $150.0 million issued by the Issuer to
certain holders thereof under that certain Indenture between the
Issuer and U.S. Bank Trust National Association, as
trustee, dated as of May 14, 2007.
Acquired Indebtedness means (1) with respect to
any Person that becomes a Restricted Subsidiary after the Issue
Date, Indebtedness of such Person and its Subsidiaries existing
at the time such Person becomes a Restricted Subsidiary that was
not incurred in connection with, or in contemplation of, such
Person becoming a Restricted Subsidiary and (2) with
respect to the Issuer or any Restricted Subsidiary, any
Indebtedness of a Person (other than the Issuer or a Restricted
Subsidiary) existing at the time such Person is merged with or
into, or consolidated with, the Issuer or a Restricted
Subsidiary, or Indebtedness expressly assumed by the Issuer or
any Restricted Subsidiary in connection with the acquisition of
any Person or any asset or assets from another Person, which
Indebtedness was not, in any case, incurred by such other Person
in connection with, or in contemplation of, such merger,
consolidation or acquisition.
Affiliate of any Person means any other Person which
directly or indirectly controls or is controlled by, or is under
direct or indirect common control with, the referent Person. For
purposes of the covenant described under Certain
CovenantsLimitations on Transactions with
Affiliates, Affiliates shall be deemed to include, with
respect to any Person, any other Person (1) which
beneficially owns or holds, directly or indirectly, 10% or more
of any class of the Voting Stock of the referent Person,
(2) of which 10% or more of the Voting Stock is
beneficially owned or held, directly or indirectly, by the
referenced Person or (3) with respect to an individual, any
immediate family member of such Person. For purposes of this
definition, control of a Person shall mean the power
to direct the management and policies of such Person, directly
or indirectly, whether through the ownership of voting
securities, by contract or otherwise, and
controlling, controlled by, and
under common control shall have correlative meanings.
amend means to amend, supplement, restate, amend and
restate or otherwise modify; and amendment shall
have a correlative meaning.
Applicable Premium means, with respect to the
principal amount of any Note to be redeemed on any redemption
date, the greater of:
(1) 1.0% of the principal amount (or portion thereof)
of such Note to be redeemed; and
(2) the excess, if any, of (a) the present value
at such redemption date of (i) the redemption price of such
Note (or portion of the principal amount thereof to be redeemed)
at May 15, 2013 (such redemption price being set forth in
the table appearing above in
RedemptionOptional Redemption), plus
(ii) all required interest payments due on such Note
(or portion of the principal amount thereof to be redeemed)
through May 15, 2013 (excluding accrued but unpaid interest
to the redemption date), computed using a discount rate equal to
the Treasury Rate as of such redemption date plus
50 basis points; over (b) the then outstanding
principal amount (or portion thereof) of such Note to be
redeemed.
asset means any asset or property.
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Asset Acquisition means:
(1) an Investment by the Issuer or any Restricted
Subsidiary of the Issuer in any other Person if, as a result of
such Investment, such Person shall become a Restricted
Subsidiary of the Issuer, or shall be merged with or into the
Issuer or any Restricted Subsidiary of the Issuer; or
(2) the acquisition by the Issuer or any Restricted
Subsidiary of the Issuer of all or substantially all of the
assets of any other Person or any division or line of business
of any other Person.
Asset Sale means any sale, conveyance, transfer,
lease, assignment, license or other disposition on or after the
Issue Date by the Issuer or any Restricted Subsidiary to any
Person other than the Issuer or any Restricted Subsidiary
(including by means of a Sale and Leaseback Transaction or a
merger or consolidation) (collectively, for purposes of this
definition, a transfer), in one transaction or a
series of related transactions, of any assets of the Issuer or
any of its Restricted Subsidiaries other than in the ordinary
course of business. For purposes of this definition, the term
Asset Sale shall not include:
(1) transfers of cash or Cash Equivalents;
(2) transfers of assets (including Equity Interests)
that are governed by, and made in accordance with, the covenant
described under Certain CovenantsLimitations
on Mergers, Consolidations, Etc.;
(3) Permitted Investments, Restricted Payments
permitted under the covenant described under Certain
CovenantsLimitations on Restricted Payments and
transfers that would constitute Restricted Payments but for the
exclusions in clauses (1) and (2) of the definition
thereof; provided, however, that any sale, conveyance,
contribution, transfer, lease, assignment, license or other
disposition of assets by the Issuer or any of its Restricted
Subsidiaries to any Health Management Joint Venture pursuant to
clause (13) of the definition of Permitted
Investments in connection with the creation thereof shall
be deemed to be an Asset Sale for purposes of this
definition;
(4) the creation or realization of any Permitted Lien;
(5) transfers of damaged, worn-out or obsolete
equipment or assets that, in the Issuers reasonable
judgment, are no longer used or useful in the business of the
Issuer or the Restricted Subsidiaries;
(6) any license of intellectual property not
otherwise in the ordinary course of business, other than the
license of all or substantially all of the rights associated
with any intellectual property owned or controlled by the Issuer
or any of the Restricted Subsidiaries if (i) such rights
are used or could be used in a line of business then being
conducted by the Issuer or any of the Restricted Subsidiaries
and such rights and line of business are material to the
business of the Issuer and the Restricted Subsidiaries taken as
a whole, as reasonably determined by the Issuer, (ii) such
license is for all or substantially all of the remaining
contractual or useful life of such intellectual property,
whichever is shorter, determined as of the date such license is
granted, and (iii) the Fair Market Value of such license,
together with that of any other such licenses meeting the
criteria in clauses (i) and (ii) (with the Fair Market
Value of any such license being determined at the time thereof
and without regard to subsequent changes in value), exceeds
$25.0 million in any fiscal year of the Issuer; and
(7) any transfer or series of related transfers that,
but for this clause, would be Asset Sales, if after giving
effect to such transfers, the aggregate Fair Market Value of the
assets transferred in such transaction or any such series of
related transactions does not exceed, in the aggregate with all
other such transactions or series of related transactions (with
the Fair Market Value of any such transaction being determined
at the time thereof and without regard to subsequent changes in
value), $25.0 million in any fiscal year of the Issuer.
Attributable Indebtedness, when used with respect to
any Sale and Leaseback Transaction, means, as at the time of
determination, the present value (discounted at a rate
equivalent to the Issuers then-current weighted
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average cost of funds for borrowed money as at the time of
determination, compounded on a semi-annual basis) of the total
obligations of the lessee for rental payments during the
remaining term of the lease included in any such Sale and
Leaseback Transaction.
Bankruptcy Law means Title 11 of the United
States Code, as amended, or any similar federal or state law for
the relief of debtors.
Board of Directors shall mean, with respect to any
Person, (i) in the case of any corporation, the board of
directors of such Person, (ii) in the case of any limited
liability company, the board of managers of such Person,
(iii) in the case of any partnership, the Board of
Directors of the general partner of such Person and (iv) in
any other case, the functional equivalent of the foregoing, or
any committee thereof duly authorized to act on behalf of such
Board.
Business Day means a day other than a Saturday,
Sunday or other day on which banking institutions in The City of
New York, New York are authorized or required by law to close.
Capitalized Lease means a lease required to be
capitalized for financial reporting purposes in accordance with
GAAP.
Capitalized Lease Obligations of any Person means
the obligations of such Person to pay rent or other amounts
under a Capitalized Lease, and the amount of such obligations
shall be the capitalized amount thereof determined in accordance
with GAAP.
Cash Equivalents means:
(1) marketable obligations with a maturity of one
year or less issued or directly and fully guaranteed or insured
by the United States of America or issued by any agency or
instrumentality thereof and the full faith and credit of the
United States of America is pledged in support thereof;
(2) any marketable direct obligations issued by any
other agency of the United States of America, any State of the
United States of America or the District of Columbia, or any
political subdivision of any such state or instrumentality
thereof, in each case having one of the two highest ratings
obtainable from either S&P or Moodys;
(3) demand and time deposits and certificates of
deposit or acceptances with a maturity of 180 days or less
of any financial institution that is a member of the Federal
Reserve System having combined capital and surplus and undivided
profits of not less than $500.0 million;
(4) commercial paper maturing no more than one year
from the date of creation thereof issued by a corporation that
is not the Issuer or an Affiliate of the Issuer, and is
organized under the laws of any State of the United States of
America or the District of Columbia and rated at least
A-1 by
S&P or at least
P-1 by
Moodys;
(5) repurchase obligations with a term of not more
than ten days for underlying securities of the types described
in clause (1) above entered into with any commercial bank
meeting the specifications of clause (3) above;
(6) investments in money market or other mutual funds
substantially all of whose assets comprise securities of the
types described in clauses (1) through (5) above; and
(7) other short-term investments utilized by any
Foreign Subsidiary in accordance with normal investment
practices for cash management, and other investments by Foreign
Subsidiaries in or with foreign obligors that, in the reasonable
judgment of the Issuer, are of a credit quality comparable to
those listed in clauses (1) through (6) above.
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Change of Control means the occurrence of any of the
following events:
(1) any person or group (as
such terms are used in Sections 13(d) and 14(d) of the Exchange
Act), is or becomes the beneficial owner (as defined
in
Rules 13d-3
and 13d-5
under the Exchange Act (except that for purposes of this clause
that person or group shall be deemed to have beneficial
ownership of all securities that any such person or group
has the right to acquire, whether such right is exercisable
immediately or only after the passage of time)), directly or
indirectly, of Voting Stock representing more than 50% of the
voting power of the total outstanding Voting Stock of the Issuer;
(2) during any period of two consecutive years,
individuals who at the beginning of such period constituted the
Issuers Board of Directors (together with any new
directors whose election to the Issuers Board of Directors
or whose nomination for election by the Issuers
stockholders was approved by a vote of at least a majority of
the directors of the Issuer then still in office either who were
directors of the Issuer at the beginning of such period or whose
election or nomination for election was previously so approved)
cease for any reason (other than death or disability) to
constitute a majority of the Issuers Board of Directors;
(3) consummation of (a) any share exchange,
consolidation or merger of the Issuer or series of such related
transactions (excluding a merger with a Wholly-Owned Restricted
Subsidiary solely for the purpose of changing the Issuers
name or jurisdiction of incorporation) or (b) any sale,
lease or other transfer, in one transaction or a series of
related transactions, of all or substantially all of the
consolidated assets of the Issuer and its Restricted
Subsidiaries, taken as a whole, to any person or
group within the meaning thereof in
Section 13(d) of the Exchange Act, other than one or more
of the Wholly-Owned Restricted Subsidiaries; provided,
however, that a transaction described in foregoing
clause (a) or (b) where the holders of Voting Stock
representing more than 50% of the voting power of the total
outstanding Voting Stock of the Issuer immediately prior to such
transaction own, directly or indirectly, Voting Stock
representing more than 50% of the voting power of the total
outstanding Voting Stock of the continuing, surviving or
resulting entity or the transferee immediately after such event
shall not be a Change of Control; or
(4) the Issuer shall adopt a Plan of Liquidation or
dissolution or any such plan shall be approved by the
stockholders of the Issuer.
Notwithstanding anything herein to the contrary, neither the
creation by the Issuer or any of its Subsidiaries of any Health
Management Joint Venture nor the sale, conveyance, contribution,
transfer, lease, assignment, license or other disposition by the
Issuer or any of its Subsidiaries of any Health Management
Business assets to any such Health Management Joint Venture in
connection with such creation shall constitute a Change of
Control for purposes of clause (3)(b) of this definition, so
long as (i) the holders of Voting Stock representing more
than 50% of the voting power of the total outstanding Voting
Stock of the Issuer immediately prior to such transaction own,
directly or indirectly, Voting Stock representing more than 50%
of the voting power of the total outstanding Voting Stock of the
Issuer immediately after such transaction and (ii) on the
date of such transaction, after giving effect to such
transaction, the Consolidated Total Leverage Ratio would be less
than or equal to 4.0 to 1.0.
Consolidated Amortization Expense for any period
means the amortization expense of the Issuer and the Restricted
Subsidiaries for such period, determined on a consolidated basis
in accordance with GAAP.
Consolidated Cash Flow for any period means, without
duplication, the sum of the amounts for such period of:
(1) Consolidated Net Income; plus
(2) in each case only to the extent (and in the same
proportion) deducted in determining Consolidated Net Income and
with respect to the portion of Consolidated Net Income
attributable to
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any Restricted Subsidiary only if a corresponding amount would
be permitted at the date of determination to be distributed to
the Issuer by such Restricted Subsidiary without prior approval
(that has not been obtained), pursuant to the terms of its
charter and all agreements, instruments, judgments, decrees,
orders, statutes, rules and governmental regulations applicable
to such Restricted Subsidiary or its stockholders,
(a) Consolidated Income Tax Expense,
(b) Consolidated Amortization Expense (but only to
the extent not included in Consolidated Interest Expense),
(c) Consolidated Depreciation Expense,
(d) Consolidated Interest Expense, and
(e) all other non-cash items reducing Consolidated
Net Income for such period, including any stock-based
compensation expense,
in each case determined on a consolidated basis in accordance
with GAAP; minus
(3) the aggregate amount of all non-cash items,
determined on a consolidated basis, to the extent such items
increased Consolidated Net Income (including the reversal of
accruals or reserves for charges that increased Consolidated Net
Income at any time during the Four-Quarter Period ending on the
Issue Date or thereafter) for such period; minus
(4) cash disbursements in respect of previously
accrued or reserved items increasing Consolidated Cash Flow in
that or prior periods.
Consolidated Depreciation Expense for any period
means the depreciation expense of the Issuer and the Restricted
Subsidiaries for such period, determined on a consolidated basis
in accordance with GAAP.
Consolidated Income Tax Expense for any period means
the provision for taxes of the Issuer and the Restricted
Subsidiaries, determined on a consolidated basis in accordance
with GAAP.
Consolidated Interest Coverage Ratio means the ratio
of (x) Consolidated Cash Flow during the Four-Quarter
Period ending on or prior to the date of the transaction giving
rise to the need to calculate the Consolidated Interest Coverage
Ratio (the Transaction Date) to
(y) Consolidated Interest Expense for such Four-Quarter
Period. For purposes of this definition, Consolidated Cash Flow
and Consolidated Interest Expense shall be calculated after
giving effect on a pro forma basis for the period of such
calculation to:
(1) the incurrence of any Indebtedness or the
issuance of any Preferred Stock of any Restricted Subsidiary
(and the application of the proceeds thereof) and any repayment
of other Indebtedness or the redemption of any Preferred Stock
of any Restricted Subsidiary (and the application of the
proceeds thereof), other than the incurrence or repayment of
Indebtedness in the ordinary course of business for working
capital purposes pursuant to any revolving credit arrangement,
occurring during the Four-Quarter Period or at any time
subsequent to the last day of the Four-Quarter Period and on or
prior to the Transaction Date, as if such incurrence, issuance,
redemption or repayment, as the case may be (and the application
of the proceeds thereof), occurred on the first (1st) day of the
Four-Quarter Period; and
(2) any Asset Sale or Asset Acquisition (including
any Asset Acquisition giving rise to the need to make such
calculation as a result of the Issuer or any Restricted
Subsidiary (including any Person who becomes a Restricted
Subsidiary as a result of such Asset Acquisition) incurring
Acquired Indebtedness and also including any Consolidated Cash
Flow (including any pro forma expense and cost reductions
calculated on a basis consistent with
Regulation S-X
under the Exchange Act) associated with any such Asset
Acquisition) occurring during the Four-Quarter Period or at any
time subsequent to the last day of the Four-Quarter Period and
on or prior to the Transaction Date, as if
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such Asset Sale or Asset Acquisition (including the incurrence
of, or assumption or liability for, any such Acquired
Indebtedness) occurred on the first (1st) day of the
Four-Quarter Period.
If the Issuer or any Restricted Subsidiary directly or
indirectly guarantees Indebtedness of a third Person, the
preceding sentence shall give effect to the incurrence of such
guaranteed Indebtedness as if the Issuer or such Restricted
Subsidiary had directly incurred or otherwise assumed such
guaranteed Indebtedness.
In calculating Consolidated Interest Expense for purposes of
determining the denominator (but not the numerator) of this
Consolidated Interest Coverage Ratio:
(1) interest on outstanding Indebtedness determined
on a fluctuating basis as of the Transaction Date and which will
continue to be so determined thereafter shall be deemed to have
accrued at a fixed rate per annum equal to the rate of
interest on such Indebtedness in effect on the Transaction Date;
(2) if interest on any Indebtedness actually incurred
on the Transaction Date may optionally be determined at an
interest rate based upon a factor of a prime or similar rate, a
eurocurrency interbank offered rate, or other rates, then the
interest rate in effect on the Transaction Date will be deemed
to have been in effect during the Four-Quarter Period; and
(3) notwithstanding clause (1) or
(2) above, interest on Indebtedness determined on a
fluctuating basis, to the extent such interest is covered by
agreements relating to Hedging Obligations, shall be deemed to
accrue at the rate per annum resulting after giving
effect to the operation of these agreements.
Consolidated Interest Expense for any period means
the sum, without duplication, of the total interest expense of
the Issuer and the Restricted Subsidiaries for such period,
determined on a consolidated basis in accordance with GAAP and
including without duplication:
(1) imputed interest on Capitalized Lease Obligations
and Attributable Indebtedness;
(2) commissions, discounts and other fees and charges
owed with respect to letters of credit securing financial
obligations, bankers acceptance financing and receivables
financings;
(3) the net costs associated with Hedging Obligations;
(4) amortization of debt issuance costs, debt
discount or premium and other financing fees and expenses (other
than the write-off of deferred debt issuance costs resulting
from the initial offering of the Notes);
(5) the interest portion of any deferred payment
obligations;
(6) all other non-cash interest expense;
(7) capitalized interest;
(8) the product of (a) all dividend payments on
any series of Disqualified Equity Interests of the Issuer or any
Preferred Stock of any Restricted Subsidiary (other than any
such Disqualified Equity Interests or any Preferred Stock held
by the Issuer or a Wholly-Owned Restricted Subsidiary or to the
extent paid in Qualified Equity Interests), multiplied by
(b) a fraction, the numerator of which is one and the
denominator of which is one minus the then current combined
federal, state and local statutory tax rate of the Issuer and
the Restricted Subsidiaries, expressed as a decimal;
(9) all interest payable with respect to discontinued
operations; and
(10) all interest on any Indebtedness of any other
Person guaranteed by the Issuer or any Restricted Subsidiary.
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Consolidated Interest Expense shall be calculated after giving
effect to Hedging Obligations (including associated costs)
described in clause (1) of the definition of Hedging
Obligations, but excluding unrealized gains and losses
with respect to Hedging Obligations.
Consolidated Net Income for any period means the net
income (or loss) of the Issuer and the Restricted Subsidiaries
for such period determined on a consolidated basis in accordance
with GAAP; provided, however, that there shall be
excluded from such net income (to the extent otherwise included
therein), without duplication:
(1) the net income (or loss) of any Person (other
than a Restricted Subsidiary) in which any Person other than the
Issuer and the Restricted Subsidiaries has an ownership
interest, except to the extent that cash in an amount equal to
any such income has actually been received by the Issuer or any
of its Wholly-Owned Restricted Subsidiaries during such period;
(2) except to the extent includible in the
consolidated net income of the Issuer pursuant to the foregoing
clause (1), the net income (or loss) of any Person that accrued
prior to the date that (a) such Person becomes a Restricted
Subsidiary or is merged into or consolidated with the Issuer or
any Restricted Subsidiary or (b) the assets of such Person
are acquired by the Issuer or any Restricted Subsidiary;
(3) the net income of any Restricted Subsidiary
during such period to the extent that the declaration or payment
of dividends or similar distributions by such Restricted
Subsidiary of that income is not permitted by operation of the
terms of its charter or any agreement, instrument, judgment,
decree, order, statute, rule or governmental regulation
applicable to that Subsidiary during such period, except that
the Issuers equity in a net loss of any such Restricted
Subsidiary for such period shall be included in determining
Consolidated Net Income;
(4) for the purposes of calculating the Restricted
Payments Basket only, in the case of a successor to the Issuer
by consolidation, merger or transfer of its assets, any income
(or loss) of the successor prior to such merger, consolidation
or transfer of assets;
(5) other than for purposes of calculating the
Restricted Payments Basket, any gain (or loss), together with
any related provisions for taxes on any such gain (or the tax
effect of any such loss), realized during such period by the
Issuer or any Restricted Subsidiary upon (a) the
acquisition of any securities, or the extinguishment of any
Indebtedness, of the Issuer or any Restricted Subsidiary or
(b) any Asset Sale by the Issuer or any Restricted
Subsidiary;
(6) any gains and losses due solely to fluctuations
in currency values and the related tax effects according to GAAP;
(7) any unrealized gains and losses with respect to
Hedging Obligations;
(8) any extraordinary, unusual or nonrecurring gain,
charges and losses (including all restructuring costs,
facilities relocation costs, acquisition integration costs and
fees, including cash severance payments made in connection with
acquisitions, and any expense or charge related to the
repurchase of Equity Interests or warrants or options to
purchase Equity Interests), and the related tax effects
according to GAAP;
(9) any acquisition-related expenses expensed in
accordance with Statement of Financial Accounting Standards
No. 141(R) promulgated by the Financial Accounting
Standards Board (SFAS 141(R)) and any gains or
losses on any earn-out payments, contingent consideration or
deferred purchase price in conjunction with any Asset
Acquisition determined in accordance with SFAS 141(R);
(10) any impairment charge or asset write-off, in
each case pursuant to GAAP, and the amortization of intangibles
arising pursuant to GAAP;
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(11) any non-cash compensation charges and deferred
compensation charges, including any arising from existing stock
options resulting from any merger or recapitalization
transaction; provided, however, that Consolidated
Net Income for any period shall be reduced by any cash payments
made during such period by the Issuer or any Restricted
Subsidiary in connection with any such deferred compensation,
whether or not such reduction is in accordance with GAAP; and
(12) inventory purchase accounting adjustments and
amortization and impairment charges resulting from other
purchase accounting adjustments in connection with acquisition
transactions.
In addition, any return of capital with respect to an Investment
that increased the Restricted Payments Basket pursuant to clause
(3)(e) of the first paragraph under Certain
CovenantsLimitations on Restricted Payments or
decreased the amount of Investments outstanding pursuant to
clause (15) of the definition of Permitted
Investments shall be excluded from Consolidated Net Income
for purposes of calculating the Restricted Payments Basket.
Consolidated Net Worth means, with respect to any
Person as of any date, the consolidated stockholders
equity of such Person, determined on a consolidated basis in
accordance with GAAP, less (without duplication) (1) any
amounts thereof attributable to Disqualified Equity Interests of
such Person or its Subsidiaries or any amount attributable to
Unrestricted Subsidiaries and (2) all
write-ups
(other than
write-ups
resulting from foreign currency translations and
write-ups of
tangible assets of a going concern business made within twelve
months after the acquisition of such business) subsequent to the
Issue Date in the book value of any asset owned by such Person
or a Subsidiary of such Person.
Consolidated Total Assets means, at any time of
determination, the consolidated total assets of the Issuer and
the Restricted Subsidiaries determined on a consolidated basis
in accordance with GAAP as of the most recent date for which
financial statements of the Issuer are then available.
Consolidated Total Debt means all Indebtedness of a
type described in clause (1), (2), (3), (4)(i), (6), (7), or
(9) of the definition thereof and all guarantee Obligations
with respect to any such Indebtedness of another Person, in each
case of the Issuer and its Restricted Subsidiaries determined on
a consolidated basis in accordance with GAAP.
Consolidated Total Leverage Ratio means the ratio of
(x) Consolidated Total Debt as of the last day of the most
recent fiscal quarter of the Issuer for which financial
statements are available ending on or prior to the date of the
Health Management Joint Venture transaction giving rise to the
need to calculate the Consolidated Total Leverage Ratio (the
HMJV Transaction Date) to (y) Consolidated Cash
Flow for the Four-Quarter Period ending on or prior to the HMJV
Transaction Date. In addition to and without limitation of the
foregoing, for purposes of this definition, (i) there shall
deducted from Consolidated Total Debt in the
calculation thereof the amount of all cash and Cash Equivalents
received by the Issuer or any of its Restricted Subsidiaries as
consideration in connection with the relevant Health Management
Joint Venture transaction and not applied by the Issuer or any
of its Restricted Subsidiaries on the HMJV Transaction Date to
repay Indebtedness of the Issuer or any of its Restricted
Subsidiaries of any type included within the definition of
Consolidated Total Debt, and
(ii) Consolidated Total Debt and
Consolidated Cash Flow shall be calculated after
giving effect on a pro forma basis for the period of such
calculation to:
(1) the incurrence of any Indebtedness or the
issuance of any Preferred Stock of any Restricted Subsidiary
(and the application of the proceeds thereof) and any repayment
of other Indebtedness or the redemption of any Preferred Stock
of any Restricted Subsidiary (and the application of the
proceeds thereof), other than the incurrence or repayment of
Indebtedness in the ordinary course of business for working
capital purposes pursuant to any revolving credit arrangement,
occurring during the Four-Quarter Period or at any time
subsequent to the last day of the Four-Quarter Period and on or
prior to the HMJV Transaction Date, as if such incurrence,
issuance, redemption or repayment, as the case may be (and the
application of the proceeds thereof), occurred on the first day
of the Four-Quarter Period; and
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(2) any Asset Sale or Asset Acquisition (including
any Asset Sale constituting a Health Management Joint Venture
transaction described in the last paragraph of the definition of
Change of Control above giving rise to the need to
make such calculation, also including any Asset Acquisition
resulting in the Issuer or any Restricted Subsidiary incurring
any Acquired Indebtedness, and also including any Consolidated
Cash Flow (including any pro forma expense and cost reductions
calculated on a basis consistent with
Regulation S-X
under the Exchange Act) associated with or attributable to any
such Asset Sale or Asset Acquisition or the assets which are the
subject of any such Asset Sale or Asset Acquisition) occurring
during the Four-Quarter Period or at any time subsequent to the
last day of the Four-Quarter Period and on or prior to the HMJV
Transaction Date, as if such Asset Sale or Asset Acquisition
(including the incurrence of, or assumption or liability for,
any such Acquired Indebtedness) occurred on the first (1st) day
of the Four-Quarter Period.
If the Issuer or any Restricted Subsidiary directly or
indirectly guarantees Indebtedness of a third Person, the
preceding sentence shall give effect to the incurrence of such
guaranteed Indebtedness as if the Issuer or such Restricted
Subsidiary had directly incurred or otherwise assumed such
guaranteed Indebtedness.
Coverage Ratio Exception has the meaning set forth
in the proviso in the first paragraph of the covenant described
under Certain CovenantsLimitations on
Additional Indebtedness.
Credit Agreements means the First Lien Credit
Agreement and the Second Lien Credit Agreement, and Credit
Agreement means the First Lien Credit Agreement or the
Second Lien Credit Agreement.
Credit Facilities means, with respect to the Issuer
or any Subsidiary, one or more debt facilities (including any
Credit Agreement) or commercial paper facilities with banks or
institutional or other similar lenders providing for revolving
credit loans, term loans, receivables financing (including
through the sale of receivables to such lenders or to special
purpose entities formed to borrow from such lenders against such
receivables), letters of credit or other similar debt financing
arrangements, in each case, as amended, restated, supplemented,
modified, extended, renewed, refunded, replaced, refinanced or
otherwise restructured (including any increase in the amount of
borrowings or other Indebtedness outstanding or available to be
borrowed thereunder) in whole or in part from time to time.
Custodian means any receiver, trustee, assignee,
liquidator or similar official under any Bankruptcy Law.
Default means (1) any Event of Default or
(2) any event, act or condition that, after notice or the
passage of time or both, would be an Event of Default.
Depository means The Depository Trust Company,
New York, New York, or a successor thereto that is a clearing
agency registered under the Exchange Act or other applicable
statute or regulation.
Designated Senior Debt means (1) Senior Debt
under or in respect of any Credit Facility (including any Credit
Agreement), and (2) any other Indebtedness constituting
Senior Debt that, in the case of clause (2), at the time of
determination, (x) has an aggregate principal amount of at
least $25.0 million and (y) is specifically designated
in the instrument evidencing such Senior Debt as
Designated Senior Debt for purposes of the Indenture.
Designation has the meaning given to this term in
the covenant described under Certain
CovenantsLimitations on Designation of Unrestricted
Subsidiaries.
Designation Amount has the meaning given to this
term in the covenant described under Certain
CovenantsLimitations on Designation of Unrestricted
Subsidiaries.
Disqualified Equity Interests of any Person means
any class of Equity Interests of such Person that, by its terms,
or by the terms of any related agreement or of any security into
which it is convertible, puttable or exchangeable, is, or upon
the happening of any event or the passage of time would be,
required to be redeemed by such Person, whether or not at the
option of the holder thereof (but excluding redemption at the
option of such Person), or matures or is mandatorily redeemable,
pursuant to a sinking fund obligation or
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otherwise, in whole or in part, on or prior to the date which is
91 days after the final maturity date of the Notes;
provided, however, that any class of Equity Interests of
such Person that, by its terms, authorizes such Person to
satisfy in full its obligations with respect to the payment of
dividends or upon maturity, redemption (pursuant to a sinking
fund or otherwise) or repurchase thereof or otherwise by the
delivery of Equity Interests that are not Disqualified Equity
Interests (other than the payment of cash in lieu of delivery of
fractional shares of Equity Interests), and that is not
convertible, puttable or exchangeable for Disqualified Equity
Interests or Indebtedness, will not be deemed to be Disqualified
Equity Interests so long as such Person satisfies its
obligations with respect thereto solely by the delivery of
Equity Interests that are not Disqualified Equity Interests
(other than the payment of cash in lieu of delivery of
fractional shares of Equity Interests); provided further,
however, that any Equity Interests that would not
constitute Disqualified Equity Interests but for provisions
thereof giving holders thereof (or the holders of any security
into or for which such Equity Interests is convertible,
exchangeable or exercisable) the right to require the Issuer to
redeem such Equity Interests upon the occurrence of a change of
control or an asset disposition occurring prior to the final
maturity date of the Notes shall not constitute Disqualified
Equity Interests if the change in control or asset disposition
provisions applicable to such Equity Interests are no more
favorable to such holders than the provisions described under
Change of Control and Certain
CovenantsLimitations on Asset Sales, respectively,
and such Equity Interests specifically provide that the Issuer
will not redeem any such Equity Interests pursuant to such
provisions prior to the Issuers purchase of the Notes as
required pursuant to the provisions described under
Change of Control and Certain
CovenantsLimitations on Asset Sales, respectively;
provided further, however, in no event shall the
Series B Preferred Stock on the terms thereof existing on
the Issue Date (or any other Preferred Stock issued by the
Issuer on substantially similar terms with regard to the
foregoing matters in this definition) be deemed to be
Disqualified Equity Interests.
Dollars and $ means the currency of The
United States of America.
Domestic Subsidiary means any Subsidiary of the
Issuer that is not a Foreign Subsidiary; provided,
however, that (without limiting the definition of
Foreign Subsidiary below) each of Inverness Medical
Investments, LLC, BBI Research, Inc. and Seravac USA Inc.,
respectively, shall not be a Domestic Subsidiary for so long as
it is a Subsidiary of a Foreign Subsidiary.
Equity Interests of any Person means (1) any
and all shares or other equity interests (including common
stock, preferred stock, limited liability company interests and
partnership interests) in such Person and (2) all rights to
purchase, warrants or options (whether or not currently
exercisable), participations or other equivalents of or
interests in (however designated) such shares or other interests
in such Person; provided, however, that no
Indebtedness under the 2007 Convertible Notes or any other
Indebtedness of the Issuer or any Subsidiary of the Issuer that
is convertible into Equity Interests of such Person shall be
deemed to be Equity Interests of such Person prior to conversion
thereof into such Equity Interests.
Exchange Act means the U.S. Securities Exchange
Act of 1934, as amended.
Fair Market Value means, with respect to any asset,
the price (after taking into account any liabilities relating to
such assets) that would be negotiated in an arms-length
transaction for cash between a willing seller and a willing and
able buyer, neither of which is under any compulsion to complete
the transaction, as such price is determined in good faith by
the Board of Directors of the Issuer or a duly authorized
committee thereof, as evidenced by a resolution of such Board of
Directors or committee.
First Lien Credit Agreement means that certain First
Lien Credit Agreement dated as of June 26, 2007 among,
inter alia, the Issuer, the lenders party thereto and
General Electric Capital Corporation as administrative agent,
including any notes, guarantees, collateral and security
documents, instruments and agreements executed in connection
therewith (including Hedging Obligations related to the
Indebtedness incurred thereunder), and in each case as amended,
restated, supplemented or otherwise modified from time to time
before, on or after the date of the Indenture, including any
agreement extending the maturity of, refinancing, refunding,
replacing or otherwise restructuring (including increasing the
amount of borrowings or other Indebtedness outstanding or
available to be borrowed thereunder) all or any portion of the
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Indebtedness under such agreement, and any successor or
replacement agreement or agreements with the same or any other
agent or agents, creditor, lender or group of creditors or
lenders.
Foreign Subsidiary means, with respect to any
Person, any Subsidiary of such Person that is not organized or
existing under the laws of the United States, any state thereof,
the District of Columbia, or any territory thereof and any
Subsidiary of such Foreign Subsidiary.
Four-Quarter Period means the most recent four
consecutive full fiscal quarters of the Issuer for which
financial statements are available.
GAAP means generally accepted accounting principles
set forth in the opinions and pronouncements of the Accounting
Principles Board of the American Institute of Certified Public
Accountants and statements and pronouncements of the Financial
Accounting Standards Board or in such other statements by such
other entity as may be approved by a significant segment of the
accounting profession of the United States, as in effect on the
Issue Date.
guarantee means a direct or indirect guarantee by
any Person of any Indebtedness of any other Person and includes
any obligation, direct or indirect, contingent or otherwise, of
such Person: (1) to purchase or pay (or advance or supply
funds for the purchase or payment of) Indebtedness of such other
Person (whether arising by virtue of partnership arrangements,
or by agreements to keep-well, to purchase assets, goods,
securities or services (unless such purchase arrangements are on
arms-length terms and are entered into in the ordinary
course of business), to take-or-pay, or to maintain financial
statement conditions or otherwise); or (2) entered into for
purposes of assuring in any other manner the obligee of such
Indebtedness of the payment thereof or to protect such obligee
against loss in respect thereof (in whole or in part), and
guarantee, when used as a verb, and
guaranteed have correlative meanings.
Guarantee means the senior subordinated guarantee by
each of the Guarantors of the Issuers obligations under
the Indenture and the Notes as provided under the section of the
Indenture described under Guarantees of the
Notes.
Guarantor Senior Debt means, with respect to any
Guarantor, the principal of, premium, if any, and interest
(including any interest accruing subsequent to the filing of a
petition of bankruptcy at the rate provided for in the
documentation with respect thereto, whether or not such interest
is an allowed claim under applicable law) on any Indebtedness of
such Guarantor, whether outstanding on the Issue Date or
thereafter created, incurred or assumed, unless, in the case of
any particular Indebtedness, the instrument creating or
evidencing the same or pursuant to which the same is outstanding
expressly provides that such Indebtedness shall not be senior in
right of payment to the Guarantees and the Notes.
Without limiting the generality of the foregoing,
Guarantor Senior Debt shall also include the
principal of, premium, if any, interest (including any interest
accruing subsequent to the filing of a petition of bankruptcy at
the rate provided for in the documentation with respect thereto,
whether or not such interest is an allowed claim under
applicable law) on, and all other amounts owing in respect of:
(1) all obligations of every nature of such Guarantor
under, or with respect to, any Credit Facility (including any
Credit Agreement), including obligations to pay principal and
interest, reimbursement obligations under letters of credit,
fees, expenses and indemnities (and guarantees thereof), and
including all obligations of each Guarantor under guarantees
under or with respect to any of the foregoing or otherwise under
or with respect to any Credit Facility (including any Credit
Agreement); and
(2) all obligations of every nature of such Guarantor
under or with respect to any Hedging Obligations in respect of
any Credit Facility (including any Credit Agreement) (and
guarantees thereof);
in each case whether outstanding on the Issue Date or thereafter
incurred.
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Description of
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Notwithstanding the foregoing, Guarantor Senior Debt
shall not include:
(1) any Indebtedness of such Guarantor to the Issuer
or any of its Subsidiaries;
(2) Indebtedness to, or guaranteed on behalf of, any
director, officer or employee of the Issuer or any of its
Subsidiaries (including amounts owed for compensation);
(3) obligations to trade creditors and other amounts
incurred (but not under any Credit Facility (including any
Credit Agreement)) in connection with obtaining goods, materials
or services;
(4) Indebtedness represented by Disqualified Equity
Interests;
(5) any liability for taxes owed or owing by such
Guarantor;
(6) that portion of any Indebtedness incurred in
violation of the Indenture (but, as to any such obligation, no
such violation shall be deemed to exist for purposes of this
clause (6) if the holder(s) of such obligation or their
representative shall have received an Officers Certificate
(and/or representation or warranty) of such Guarantor (any such
Officers Certificate, notwithstanding the definition of
such term, to be executed by analogous officers of the Guarantor
rather than the Issuer) to the effect that the incurrence of
such Indebtedness does not (or, in the case of revolving credit
indebtedness, the incurrence of the entire committed amount
thereof at the date on which the initial borrowing thereunder is
made would not) violate the provisions of the Indenture);
(7) Indebtedness which, when incurred and without
respect to any election under Section 1111(b) of
Title 11, United States Code, is without recourse to such
Guarantor; and
(8) any Indebtedness (including any Pari Passu
Indebtedness or Subordinated Indebtedness) which is, by its
express terms, subordinated in right of payment to any other
Indebtedness of such Guarantor.
Guarantors means (1) each party named as such
on the signature pages of the Indenture, which (subject to the
proviso below), collectively, consist of each Domestic
Subsidiary on the Issue Date that guarantees any Indebtedness or
other Obligation under any Credit Agreement, and (2) each
other Person that is required to, or at the election of the
Issuer does, become a Guarantor by the terms of the Indenture
after the Issue Date, in each case, until such Person is
released from its Guarantee in accordance with the terms of the
Indenture; provided, however, in each case, that
in any event neither of the following Subsidiaries of the Issuer
shall be a Guarantor unless the Issuer so elects by notice to
the Trustee delivered in accordance with the Indenture (in which
case such Subsidiary shall become a Guarantor as provided in the
section of the Indenture described under Certain
CovenantsAdditional Guarantees):
(a) SPDH, Inc.; and
(b) Diamics, Inc., until such time, if ever, that it
becomes a Wholly-Owned Restricted Subsidiary of the Issuer.
Health Management Joint Venture means a single joint
venture (which may be conducted through more than one joint
venture entity) created by the Issuer or any of its Restricted
Subsidiaries, on the one hand, and any joint venture partner or
partners who are not Affiliates of the Issuer, on the other
hand, for the purpose of developing or conducting any business
within the fields of business described or otherwise included in
the definition of Health Management Business below.
Health Management Business means the businesses
engaged in by the Issuer and its Subsidiaries on the Issue Date
focused on wellness, disease and condition management,
productivity enhancement or informatics, any businesses that are
otherwise within any of such business fields (whether or not
engaged in by the Issuer on the Issue Date), and any businesses
that are a reasonable extension, development or expansion of,
any of the foregoing (whether or not engaged in by the Issuer on
the Issue Date).
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Description of
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Hedging Obligations of any Person means the
obligations of such Person pursuant to (1) any interest
rate swap agreement, interest rate collar agreement or other
similar agreement or arrangement designed to alter the risks to
that Person arising from fluctuations in interest rates,
(2) agreements or arrangements designed to alter the risks
to that Person arising from fluctuations in foreign currency
exchange rates in the conduct of its operations, or (3) any
forward contract, commodity swap agreement, commodity option
agreement or other similar agreement or arrangement designed to
protect such Person against fluctuations in commodity prices, in
each case entered into in the ordinary course of business for
bona fide hedging purposes and not for the purpose of
speculation.
Holder means any registered holder, from time to
time, of the Notes.
incur means, with respect to any Indebtedness or
Obligation, incur, create, issue, assume, guarantee or otherwise
become directly or indirectly liable, contingently or otherwise,
with respect to such Indebtedness or Obligation; provided,
however, that (1) the Indebtedness of a Person existing
at the time such Person became a Restricted Subsidiary shall be
deemed to have been incurred by such Restricted Subsidiary at
such time and (2) neither the accrual of interest nor the
accretion of original issue discount shall be deemed to be an
incurrence of Indebtedness.
Indebtedness of any Person at any date means,
without duplication:
(1) all liabilities, contingent or otherwise, of such
Person for borrowed money (whether or not the recourse of the
lender is to the whole of the assets of such Person or only to a
portion thereof);
(2) all obligations of such Person evidenced by
bonds, debentures, notes or other similar instruments;
(3) all reimbursement obligations of such Person in
respect of letters of credit, letters of guaranty, bankers
acceptances and similar credit transactions;
(4) (i) all obligations of such Person to pay
the deferred and unpaid purchase price of property or services,
and (ii) all obligations of such Person under conditional
sale or other title retention agreements relating to the assets
purchased by such Person; provided, however, that in no
event shall the following constitute Indebtedness
under the Indenture: (x) trade payables and other accrued
liabilities incurred by such Person in the ordinary course of
business and (y) customary adjustments of purchase price,
contingent payments, earnout payments or similar obligations of
such Person arising under any of the documents pertaining to any
acquisition of any Person or assets or Equity Interests of any
Person or any sale, transfer or other disposition of assets to
any Person, in each case to the extent not yet determined, due
and payable;
(5) the maximum fixed involuntary redemption or
repurchase price of all Disqualified Equity Interests of such
Person;
(6) all Capitalized Lease Obligations of such Person;
(7) all Indebtedness of others secured by a Lien on
any asset of such Person, whether or not such Indebtedness is
assumed by such Person;
(8) all Indebtedness of others guaranteed by such
Person to the extent of such guarantee; provided, however,
that Indebtedness of the Issuer or its Subsidiaries that is
guaranteed by the Issuer or the Issuers Subsidiaries shall
only be counted once in the calculation of the amount of
Indebtedness of the Issuer and its Subsidiaries on a
consolidated basis;
(9) all Attributable Indebtedness; and
(10) to the extent not otherwise included in this
definition, Hedging Obligations of such Person, determined as
the net amount of all payments that would be required to be made
in respect thereof in the event of a termination (including an
early termination) on the date of determination.
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Description of
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The amount of any Indebtedness which is incurred at a discount
to the principal amount at maturity thereof as of any date shall
be deemed to have been incurred at the accreted value thereof as
of such date. The amount of Indebtedness of any Person at any
date shall be the outstanding balance at such date of all
unconditional obligations as described above, the maximum
liability of such Person for any such contingent obligations at
such date and, in the case of clause (7), the lesser of
(a) the Fair Market Value of any asset subject to a Lien
securing the Indebtedness of others on the date that the Lien
attaches and (b) the amount of the Indebtedness secured.
For purposes of clause (5), the maximum fixed involuntary
redemption or repurchase price of any Disqualified Equity
Interests that do not have a fixed involuntary redemption or
repurchase price shall be calculated in accordance with the
terms of such Disqualified Equity Interests as if such
Disqualified Equity Interests were redeemed or repurchased on
any date on which an amount of Indebtedness outstanding shall be
required to be determined pursuant to the Indenture.
Independent Director means a director of the Issuer
who:
(1) is independent with respect to the transaction at
issue;
(2) does not have any material financial interest in
the Issuer or any of its Affiliates (other than as a result of
holding securities of the Issuer); and
(3) has not and whose Affiliates or affiliated firm
has not, at any time during the twelve months prior to the
taking of any action hereunder, directly or indirectly,
received, or entered into any understanding or agreement to
receive, any compensation, payment or other benefit, of any type
or form, from the Issuer or any of its Affiliates, other than
customary directors fees for serving on the Board of
Directors of the Issuer or any Affiliate and reimbursement of
out-of-pocket expenses for attendance at the Issuers or
Affiliates board and board committee meetings.
Independent Financial Advisor means an accounting,
appraisal or investment banking firm of recognized standing that
is, in the reasonable judgment of the Issuers Board of
Directors, qualified to perform the task for which it has been
engaged and disinterested and independent with respect to the
Issuer and its Affiliates.
Investments of any Person means:
(1) all direct or indirect investments by such Person
in any other Person in the form of loans, advances or capital
contributions or other credit extensions constituting
Indebtedness of such other Person, and any guarantee of
Indebtedness of any other Person;
(2) all purchases (or other acquisitions for
consideration) by such Person of Indebtedness, Equity Interests
or other securities of any other Person (other than any such
purchase that constitutes a Restricted Payment of the type
described in clause (2) of the definition thereof);
(3) all other items that would be classified as
investments (including purchases of assets outside the ordinary
course of business) on a balance sheet of such Person prepared
in accordance with GAAP; and
(4) the Designation after the Issue Date of any
Subsidiary as an Unrestricted Subsidiary.
Except as otherwise expressly specified in this definition, the
amount of any Investment (other than an Investment made in cash)
shall be the Fair Market Value thereof on the date such
Investment is made. The amount of any Investment pursuant to
clause (4) shall be the Designation Amount determined in
accordance with the covenant described under Certain
CovenantsLimitations on Designation of Unrestricted
Subsidiaries. Notwithstanding the foregoing, neither
(a) purchases or redemptions of Equity Interests of the
Issuer nor (b) acquisitions of assets by any Person shall
be deemed to be Investments.
Issue Date means the date on which the Notes being
issued in this offering are originally issued.
Lien means, with respect to any asset, any mortgage,
deed of trust, lien (statutory or other), pledge, lease,
easement, restriction, charge, security interest or other
similar encumbrance of any kind or nature in respect
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Description of
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of such asset, whether or not filed, recorded or otherwise
perfected under applicable law, including any conditional sale
or other title retention agreement, and any lease in the nature
thereof.
Major Foreign Exchange means an exchange which is
the primary
non-U.S. trading
location for one or more stocks included in the Morgan Stanley
Capital International Europe, Australasia and Far East Index (or
if such index does not exist a comparable then existing index).
Moodys means Moodys Investors Service,
Inc., and its successors.
Net Available Proceeds means, with respect to any
Asset Sale, the proceeds thereof in the form of cash or Cash
Equivalents, net of:
(1) brokerage commissions and other fees and expenses
(including fees and expenses of legal counsel, accountants and
investment banks) incurred in connection with such Asset Sale;
(2) provisions for taxes payable as a result of such
Asset Sale (after taking into account any available tax credits
or deductions and any tax sharing arrangements);
(3) amounts required to be paid to any Person (other
than the Issuer or any Restricted Subsidiary) owning a
beneficial interest in the assets subject to the Asset Sale or
having a Lien thereon;
(4) payments of unassumed liabilities (not
constituting Indebtedness) relating to the assets sold at the
time of, or within 180 days after the date of, such Asset
Sale; and
(5) appropriate amounts to be provided by the Issuer
or any Restricted Subsidiary, as the case may be, as a reserve
required in accordance with GAAP against any adjustment in the
sale price of such asset or assets or liabilities associated
with such Asset Sale and retained by the Issuer or any
Restricted Subsidiary, as the case may be, after such Asset
Sale, including pensions and other post-employment benefit
liabilities, liabilities related to environmental matters and
liabilities under any indemnification obligations associated
with such Asset Sale, all as reflected in an Officers
Certificate delivered to the Trustee; provided,
however, that any amounts remaining after adjustments,
revaluations or liquidations of such reserves shall constitute
Net Available Proceeds.
Non-Recourse Debt means Indebtedness of an
Unrestricted Subsidiary:
(1) as to which neither the Issuer nor any Restricted
Subsidiary (a) provides credit support of any kind
(including any undertaking, agreement or instrument that would
constitute Indebtedness), (b) is directly or indirectly
liable as a guarantor or otherwise, or (c) constitutes the
lender; provided, however, that an intercompany
loan from the Issuer or any Restricted Subsidiary to an
Unrestricted Subsidiary shall be deemed Non-Recourse Debt if
such loan at the time such Subsidiary is designated an
Unrestricted Subsidiary or if made later, at the time such
intercompany loan is made, was permitted under and made in
compliance with the covenant described under Certain
CovenantsLimitations on Restricted Payments; and
(2) no default with respect to which (including any
rights that the holders thereof may have to take enforcement
action against an Unrestricted Subsidiary) would permit upon
notice, lapse of time or both any holder or holders of any other
Indebtedness (other than the Notes) of the Issuer or any
Restricted Subsidiary in an aggregate principal amount of
$50.0 million or more to declare a default on the other
Indebtedness or cause the payment thereof to be accelerated or
payable prior to its stated maturity.
Obligation means any principal, interest, penalties,
fees, indemnification, reimbursements, costs, expenses, damages
and other liabilities payable under the documentation governing
any Indebtedness.
Officer means any of the following of the Issuer:
the Chairman of the Board of Directors, the Chief Executive
Officer, the President, any Vice President, the Chief Financial
Officer, the Treasurer, any Assistant Treasurer, the Secretary
or any Assistant Secretary.
Officers Certificate means a certificate
signed by two Officers.
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Description of
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Pari Passu Indebtedness means any Indebtedness of
the Issuer or any Guarantor that ranks pari passu in
right of payment with the Notes or the Guarantees, as
applicable, including the 2007 Convertible Notes and any
Indebtedness of the Issuer that ranks pari passu in right
of payment with the 2007 Convertible Notes.
Permitted Business means the businesses engaged in
by the Issuer and its Subsidiaries on the Issue Date as
described in this prospectus supplement, businesses that are
otherwise within the healthcare, life sciences or diagnostic
industries, and businesses that are reasonably similar,
ancillary or related to, or that are a reasonable extension,
development or expansion of, any of the foregoing.
Permitted Indebtedness has the meaning given to such
term in the second paragraph of the covenant described under
Certain Covenants Limitations on
Additional Indebtedness.
Permitted Investments means:
(1) Investments by the Issuer or any Restricted
Subsidiary (a) in any Restricted Subsidiary or
(b) including the purchase price paid for and reasonable
transaction costs related thereto, in any Person that is or will
become immediately after or substantially concurrent with such
Investment a Restricted Subsidiary or that will merge or
consolidate into the Issuer or a Restricted Subsidiary
(including the exercise or performance of any rights or
obligations to acquire any equity or ownership interest in any
joint venture under the terms of the agreements governing such
joint venture);
(2) Investments in the Issuer by any Restricted
Subsidiary;
(3) loans and advances to directors, employees and
officers of the Issuer and the Restricted Subsidiaries for
(a) bona fide business purposes and (b) to
purchase Equity Interests of the Issuer not in excess of
$5.0 million at any one time outstanding, in each case, in
addition to any such loans outstanding on the Issue Date;
(4) Hedging Obligations incurred pursuant to
clause (4) of the second paragraph under the covenant
described under Certain CovenantsLimitations
on Additional Indebtedness;
(5) cash and Cash Equivalents;
(6) receivables owing to the Issuer or any Restricted
Subsidiary and payable or dischargeable in accordance with
customary trade terms; provided, however, that such trade
terms may include such concessionary trade terms as the Issuer
or any such Restricted Subsidiary deems reasonable under the
circumstances;
(7) Investments in securities of trade creditors or
customers received pursuant to any plan of reorganization or
similar arrangement upon the bankruptcy or insolvency of such
trade creditors or customers;
(8) Investments made by the Issuer or any Restricted
Subsidiary in compliance with the covenant described under
Certain CovenantsLimitations on Asset
Sales using consideration received in connection with an
Asset Sale;
(9) lease, utility and other similar deposits in the
ordinary course of business;
(10) Investments made by the Issuer or a Restricted
Subsidiary for consideration consisting only of Qualified Equity
Interests of the Issuer;
(11) stock, obligations or securities received in
settlement of debts created in the ordinary course of business
and owing to the Issuer or any Restricted Subsidiary or in
satisfaction of judgments;
(12) Investments existing on the Issue Date;
(13) non-cash and non-Cash Equivalents Investments by
the Issuer or any Restricted Subsidiary in a single Health
Management Joint Venture (which may be conducted through more
than one joint venture entity) in connection with the creation
thereof;
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Description of
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(14) acquisitions (including the purchase price paid
for and reasonable transaction costs related thereto) by the
Issuer or any Restricted Subsidiary of (i) Equity Interests
of another Person engaged in the Permitted Business and who will
thereafter become a Restricted Subsidiary (including the
exercise or performance of any rights or obligations to acquire
any equity or ownership interest in any joint venture under the
terms of the agreements governing such joint venture),
(ii) all or a substantial portion of the assets of a Person
engaged in or of a line of business, in each case, within the
Permitted Business, or (iii) any other assets within the
Permitted Business; and
(15) other Investments having an aggregate Fair
Market Value at any one time outstanding not to exceed 3.0% of
Consolidated Total Assets (with the Fair Market Value of each
Investment being determined as of the date made and without
regard to subsequent changes in value) (it being understood that
any Investment permitted under this clause (15) shall
remain so permitted notwithstanding any decrease in Consolidated
Total Assets). (For avoidance of doubt, in determining the
amount of any Investments made and outstanding under this
clause (15) in any joint venture in connection with any
contribution, transfer or other disposition of assets by the
Issuer or any of its Restricted Subsidiaries to such joint
venture, the aggregate amount of cash and Cash Equivalents
received by the Issuer and its Restricted Subsidiaries in
consideration for such contribution, transfer or disposition
shall be netted against the Fair Market Value of the assets so
contributed, transferred or disposed of.)
The amount of Investments outstanding at any time pursuant to
clause (15) above shall be deemed to be reduced:
(a) upon the disposition or repayment of or return on
any Investment made pursuant to clause (15) above, by an
amount equal to the return of capital with respect to such
Investment to the Issuer or any Restricted Subsidiary (to the
extent not included in the computation of Consolidated Net
Income), less the cost of the disposition of such Investment and
net of taxes; and
(b) upon a Redesignation of an Unrestricted
Subsidiary as a Restricted Subsidiary, by an amount equal to the
lesser of (x) the Fair Market Value of the Issuers
proportionate interest in such Subsidiary immediately following
such Redesignation, and (y) the aggregate amount of
Investments in such Subsidiary that increased (and did not
previously decrease) the amount of Investments outstanding
pursuant to clause (15) above.
Permitted Junior Securities means:
(1) Equity Interests in the Issuer or any Guarantor;
and
(2) debt securities,
in the case of each of clauses (1) and (2), provided for by
a plan of reorganization or readjustment and that are
subordinated to (a) all Senior Debt and Guarantor Senior
Debt and (b) any securities issued in exchange for Senior
Debt, in each case, to substantially the same extent as, or to a
greater extent than, the Notes and the Guarantees are
subordinated to Senior Debt and Guarantor Senior Debt under the
Indenture.
Permitted Liens means the following types of Liens:
(1) Liens for taxes, assessments or governmental
charges or claims either (a) not delinquent or payable
without penalty or (b) contested in good faith by
appropriate proceedings and as to which the Issuer or the
Restricted Subsidiaries shall have set aside on its books such
reserves as may be required pursuant to GAAP;
(2) statutory, contractual or common law Liens of
landlords and mortgagees of landlords and Liens of carriers,
warehousemen, mechanics, suppliers, materialmen, repairmen or
workmen and other Liens imposed by law or arising in the
ordinary course of business for sums not yet delinquent or
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Description of
notes
being contested in good faith, if such reserve or other
appropriate provision, if any, as shall be required by GAAP
shall have been made in respect thereof;
(3) Liens arising or pledges or deposits made in the
ordinary course of business in connection with workers
compensation, unemployment insurance, social security or other
types of government insurance benefits, or made in lieu of, or
to secure the performance of tenders, statutory obligations,
surety, customs, reclamation, performance or appeal bonds, bids,
leases, government, sales or other trade contracts, performance
and return-of-money bonds and other similar obligations
(exclusive of obligations for the payment of borrowed money);
(4) Liens upon specific items of inventory, equipment
or other goods and proceeds of any Person securing such
Persons obligations in respect of bankers
acceptances issued or created for the account of such Person to
facilitate the purchase, shipment or storage of such inventory
or other goods;
(5) attachment or judgment Liens not giving rise to a
Default so long as any appropriate legal proceedings which may
have been duly initiated for the review of such judgment have
not been finally terminated or the period within which the
proceedings may be initiated has not expired, and pledges or
cash deposits made in lieu of, or to secure the performance of,
judgment or appeal bonds in connection with the foregoing;
(6) easements, rights-of-way, zoning restrictions and
other similar charges, restrictions, licenses, reservations,
covenants, encroachments or other similar encumbrances in
respect of real property or immaterial imperfections of title
which are customary or do not, in the aggregate, impair in any
material respect the ordinary conduct of the business of the
Issuer and the Restricted Subsidiaries taken as a whole;
(7) (i) Liens securing reimbursement obligations
with respect to commercial letters of credit which encumber
documents, goods covered thereby, and other assets relating to
such letters of credit and products and proceeds thereof and
(ii) Liens securing reimbursement obligations with respect
to letters of credit issued to landlords in an aggregate face
amount not exceeding $10.0 million at any time;
(8) Liens encumbering deposits made to secure
obligations arising from statutory, regulatory, contractual or
warranty requirements of the Issuer or any Restricted
Subsidiary, including rights of offset and setoff;
(9) bankers Liens, rights of setoff and other
similar Liens existing solely with respect to cash and Cash
Equivalents on deposit in one or more of accounts maintained by
the Issuer or any Restricted Subsidiary, in each case granted in
the ordinary course of business in favor of the bank or banks
with which such accounts are maintained, securing amounts owing
to such bank with respect to cash management and operating
account arrangements, including those involving pooled accounts
and netting arrangements (including any Liens securing Permitted
Indebtedness incurred in reliance on clause (8) of the
definition thereof in the covenant described under
Certain CovenantsLimitations on Additional
Indebtedness above); provided, however, that in no
case shall any such Liens secure (either directly or indirectly)
the repayment of any Indebtedness (except such Permitted
Indebtedness expressly referenced above);
(10) leases or subleases (or any Liens on the
property related thereto) granted to others that do not
materially interfere with the ordinary course of business of the
Issuer or any Restricted Subsidiary;
(11) licenses and sublicenses of intellectual
property granted to third parties in the ordinary course of
business;
(12) Liens arising from filing Uniform Commercial
Code financing statements regarding leases or other transactions
that are not secured transactions;
(13) Liens securing all of the Notes and Liens
securing any Guarantee;
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Description of
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(14) (i) Liens securing Senior Debt or Guarantor
Senior Debt (including, in each case, Indebtedness under any
Credit Facility or Credit Agreement (including with respect to
letters of credit or bankers acceptances issued
thereunder)); and (ii) Liens securing Hedging Obligations
permitted under clause (4)(i) in Certain
CovenantsLimitations on Additional Indebtedness with
respect to Indebtedness under any Credit Facility or Credit
Agreement, which Liens in this clause (ii) extend only to assets
securing such Indebtedness under such Credit Facility or Credit
Agreement;
(15) Liens securing Indebtedness of any Domestic
Subsidiary that is not a Guarantor (other than Indebtedness that
is Subordinated Indebtedness or that ranks pari passu in
right of payment with the Notes or any Guarantee), provided that
such Liens do not extend to the assets of a Person who is not
liable for such Indebtedness, whether as a borrower, a guarantor
or otherwise;
(16) Liens securing Indebtedness of Foreign
Subsidiaries that relate solely to the Equity Interests or
assets of Foreign Subsidiaries;
(17) Liens existing on the Issue Date securing
Indebtedness outstanding on the Issue Date;
(18) Liens in favor of the Issuer or a Restricted
Subsidiary;
(19) Liens securing Purchase Money Indebtedness;
(20) Liens securing Acquired Indebtedness permitted
to be incurred under the Indenture; provided,
however, that the Liens do not extend to assets not
subject to such Lien at the time of acquisition (other than
improvements thereon) and are no more favorable to the
lienholders than those securing such Acquired Indebtedness prior
to the incurrence of such Acquired Indebtedness by the Issuer or
a Restricted Subsidiary;
(21) Liens on assets of a Person existing at the time
such Person is acquired or merged with or into or consolidated
with the Issuer or any such Restricted Subsidiary (and not
created in anticipation or contemplation thereof);
(22) Liens to secure Refinancing Indebtedness of
Indebtedness secured by Liens referred to in the foregoing
clauses (17), (20) and (21) and this clause (22);
provided, however, that in each case such Liens do not
extend to any additional assets (other than improvements thereon
and replacements thereof);
(23) Liens to secure Attributable Indebtedness
and/or that
are incurred pursuant to the covenant described under
Certain CovenantsLimitations on Sale and
Leaseback Transactions; provided, however,
that any such Lien shall not extend to or cover any assets of
the Issuer or any Restricted Subsidiary other than the assets
which are the subject of the Sale and Leaseback Transaction in
which the Attributable Indebtedness is incurred;
(24) Liens in favor of customs and revenue
authorities arising as a matter of law to secure payment of
customs duties in connection with the importation of goods;
(25) Liens securing Permitted Indebtedness incurred
in reliance on clause (16) in the Limitations
on Additional Indebtedness covenant; provided,
however, that this clause (25) shall not permit
Liens on the assets of any Domestic Subsidiary to secure
Indebtedness of any Foreign Subsidiary; and
(26) Liens incurred in the ordinary course of
business of the Issuer or any Restricted Subsidiary with respect
to obligations (other than Indebtedness) that do not in the
aggregate exceed $25.0 million at any one time outstanding.
Person means any individual, corporation,
partnership, limited liability company, joint venture,
incorporated or unincorporated association, joint-stock company,
trust, unincorporated organization or government or other agency
or political subdivision thereof or other entity of any kind.
P&G Joint Venture means the joint venture
between the Issuer and The Proctor & Gamble Company
conducted through the P&G JV Companies pursuant to the
P&G JV Agreements for the purpose of
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Description of
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developing, acquiring and marketing consumer diagnostic and
monitoring products (excluding products in the cardiology,
diabetes and oral care fields).
P&G JV Agreements means the various joint
venture, limited liability company, asset transfer and
contribution agreements dated on or about May 17, 2007
among the Issuer and certain of its Subsidiaries and
Procter & Gamble RHD, Inc., Proctor & Gamble
International Operations, SA and certain of their Affiliates,
and the other agreements, instruments and documents executed or
delivered in connection therewith on or after such date.
P&G JV Companies means US CD LLC, a Delaware
limited liability company, and SPD Swiss Precision Diagnostics
GmbH, a company organized under the laws of Switzerland, and any
subsidiaries of either of them.
Plan of Liquidation with respect to any Person,
means a plan that provides for, contemplates or the effectuation
of which is preceded or accompanied by (whether or not
substantially contemporaneously, in phases or otherwise):
(1) the sale, lease, conveyance or other disposition of all
or substantially all of the assets of such Person otherwise than
as an entirety or substantially as an entirety; and (2) the
distribution of all or substantially all of the proceeds of such
sale, lease, conveyance or other disposition of all or
substantially all of the remaining assets of such Person to
holders of Equity Interests of such Person.
Preferred Stock means, with respect to any Person,
any and all preferred or preference stock or other equity
interests (however designated) of such Person whether now
outstanding or issued after the Issue Date.
principal of a Note means the principal of the Note
plus, when appropriate, the premium, if any, on the Note.
Purchase Money Indebtedness means Indebtedness,
including Capitalized Lease Obligations, of the Issuer or any
Restricted Subsidiary incurred for the purpose of financing all
or any part of the purchase price of property, plant or
equipment used in the business of the Issuer or any Restricted
Subsidiary or the cost of installation, construction or
improvement thereof; provided, however, that (1) the
amount of such Indebtedness shall not exceed such purchase price
or cost, (2) such Indebtedness shall not be secured by any
asset other than the specified asset being financed or, in the
case of real property or fixtures, including additions and
improvements, the real property to which such asset is attached
and (3) such Indebtedness shall be incurred within
180 days before or after such acquisition of such asset by
the Issuer or such Restricted Subsidiary or such installation,
construction or improvement.
Qualified Equity Interests means Equity Interests of
the Issuer other than Disqualified Equity Interests.
Qualified Equity Offering means the issuance and
sale of Qualified Equity Interests of the Issuer.
redeem means to redeem, repurchase, purchase,
defease, discharge or otherwise acquire or retire for value, and
redemption has a correlative meaning; provided,
however, that this definition shall not apply for purposes
of the provisions described
under RedemptionOptional Redemption.
Redesignation has the meaning given to such term in
the covenant described under Certain
CovenantsLimitations on Designation of Unrestricted
Subsidiaries.
refinance means to refinance, repay, prepay,
replace, renew or refund.
Refinancing Indebtedness means Indebtedness of the
Issuer or a Restricted Subsidiary issued in exchange for, or the
proceeds from the issuance and sale or disbursement of which are
used substantially concurrently to redeem or refinance in whole
or in part, or constituting an amendment of, any Indebtedness of
the Issuer or any Restricted Subsidiary (the Refinanced
Indebtedness); provided, however, that:
(1) the principal amount (or accreted value, in the
case of Indebtedness issued at a discount) of the Refinancing
Indebtedness does not exceed the principal amount (or accreted
value, as the case may be) of the Refinanced Indebtedness
plus the amount of accrued and unpaid interest on the
S-136
Description of
notes
Refinanced Indebtedness, any premium paid to the holders of the
Refinanced Indebtedness and reasonable expenses incurred in
connection with the incurrence of the Refinancing Indebtedness;
(2) the Refinancing Indebtedness is the obligation of
the same Person as that of the Refinanced Indebtedness;
(3) if the Refinanced Indebtedness was subordinated
to the Notes or the Guarantees, as the case may be, then such
Refinancing Indebtedness, by its terms, is subordinate in right
of payment to the Notes or the Guarantees, as the case may be,
at least to the same extent as the Refinanced Indebtedness, and
if the Refinanced Indebtedness was pari passu with the
Notes or the Guarantees, as the case may be, then the
Refinancing Indebtedness ranks pari passu with, or is
subordinated to, the Notes or the Guarantees, as the case may be;
(4) the Refinancing Indebtedness is scheduled to
mature either (a) no earlier than the Refinanced
Indebtedness being repaid or amended or (b) after the
maturity date of the Notes;
(5) the portion, if any, of the Refinancing
Indebtedness that is scheduled to mature on or prior to the
maturity date of the Notes has a Weighted Average Life to
Maturity at the time such Refinancing Indebtedness is incurred
that is equal to or greater than the Weighted Average Life to
Maturity of the portion of the Refinanced Indebtedness being
repaid that is scheduled to mature on or prior to the maturity
date of the Notes; and
(6) the Refinancing Indebtedness is secured only to
the extent, if at all, and by the assets, that the Refinanced
Indebtedness being repaid or amended is secured.
Representative means any agent or representative in
respect of any Designated Senior Debt; provided, however,
that if, and for so long as, any Designated Senior Debt
lacks such representative, then the Representative for such
Designated Senior Debt shall at all times constitute the holders
of a majority in outstanding principal amount of such Designated
Senior Debt.
Restricted Payment means any of the following:
(1) the declaration or payment of any dividend or any
other distribution on Equity Interests of the Issuer or any
Restricted Subsidiary or any payment made to the direct or
indirect holders (in their capacities as such) of Equity
Interests of the Issuer or any Restricted Subsidiary (in respect
of such Equity Interests) by the Issuer or any Restricted
Subsidiary, including any payment in connection with any merger
or consolidation involving the Issuer, but excluding
(a) dividends, distributions or payments payable or paid
solely in Qualified Equity Interests (and payments of cash in
lieu of delivering fractional shares in connection therewith)
and (b) in the case of Restricted Subsidiaries, dividends,
distributions or payments payable or paid to the Issuer or to a
Restricted Subsidiary and pro rata dividends or
distributions payable to minority stockholders of any Restricted
Subsidiary;
(2) the redemption of any Equity Interests of the
Issuer or any Restricted Subsidiary, including any payment by
the Issuer or any Restricted Subsidiary in connection with any
merger or consolidation involving the Issuer, but excluding
(i) any such Equity Interests held by the Issuer or any
Restricted Subsidiary and (ii) any redemptions to the
extent payable or paid in Equity Interests of the Issuer or of
an acquiror of the Issuer (and payments of cash in lieu of
delivering fractional shares in connection therewith), in either
case in this clause (ii) other than Disqualified Equity
Interests;
(3) any Investment other than a Permitted Investment;
or
(4) any redemption prior to the scheduled maturity or
prior to any scheduled repayment of principal or sinking fund
payment, as the case may be, in respect of Subordinated
Indebtedness, but excluding (i) any redemptions to the
extent payable or paid in Qualified Equity Interests (and
payments of cash in lieu of delivering fractional shares in
connection therewith), (ii) any redemptions of any
Indebtedness the incurrence of which is permitted pursuant to
clause (5) of the definition of
S-137
Description of
notes
Permitted Indebtedness, or (iii) any redemption of
Indebtedness of the Issuer or any Restricted Subsidiary
purchased in anticipation of satisfying a sinking fund
obligation, principal installment or final maturity, in each
case due within one year of such redemption.
Restricted Payments Basket has the meaning given to
such term in the first paragraph of the covenant described under
Certain CovenantsLimitations on Restricted
Payments.
Restricted Subsidiary means any Subsidiary of the
Issuer other than an Unrestricted Subsidiary.
S&P means Standard & Poors
Ratings Services, a division of The McGraw-Hill Companies, Inc.,
and its successors.
Sale and Leaseback Transactions means with respect
to any Person an arrangement with any bank, insurance company or
other lender or investor or to which such lender or investor is
a party, providing for the leasing by such Person of any asset
of such Person which has been or is being sold or transferred by
such Person to such lender or investor or to any Person to whom
funds have been or are to be advanced by such lender or investor
on the security of such asset.
SEC means the U.S. Securities and Exchange
Commission.
Secretarys Certificate means a certificate
signed by the Secretary or Assistant Secretary of the Issuer.
Second Lien Credit Agreement means that certain
Second Lien Credit Agreement dated as of June 26, 2007
among, inter alia, the Issuer, the lenders party thereto
and General Electric Capital Corporation as administrative
agent, including any notes, guarantees, collateral and security
documents, instruments and agreements executed in connection
therewith (including Hedging Obligations related to the
Indebtedness incurred thereunder), and in each case as amended,
restated, supplemented or otherwise modified from time to time
before, on or after the date of the Indenture, including any
agreement extending the maturity of, refinancing, refunding,
replacing or otherwise restructuring (including increasing the
amount of borrowings or other Indebtedness outstanding or
available to be borrowed thereunder) all or any portion of the
Indebtedness under such agreement, and any successor or
replacement agreement or agreements with the same or any other
agent or agents, creditor, lender or group of creditors or
lenders.
Securities Act means the U.S. Securities Act of
1933, as amended.
Senior Debt means the principal of, premium, if any,
and interest (including any interest accruing subsequent to the
filing of a petition of bankruptcy at the rate provided for in
the documentation with respect thereto, whether or not such
interest is an allowed claim under applicable law) on any
Indebtedness of the Issuer, whether outstanding on the Issue
Date or thereafter created, incurred or assumed, unless, in the
case of any particular Indebtedness, the instrument creating or
evidencing the same or pursuant to which the same is outstanding
expressly provides that such Indebtedness shall not be senior in
right of payment to the Notes.
Without limiting the generality of the foregoing, Senior
Debt shall also include the principal of, premium, if any,
interest (including any interest accruing subsequent to the
filing of a petition of bankruptcy at the rate provided for in
the documentation with respect thereto, whether or not such
interest is an allowed claim under applicable law) on, and all
other amounts owing in respect of:
(1) all obligations of every nature of the Issuer
under, or with respect to, any Credit Facility (including any
Credit Agreement), including obligations to pay principal and
interest, reimbursement obligations under letters of credit,
fees, expenses and indemnities (and guarantees thereof), and
including all obligations under guarantees of the Issuer under
or with respect to any of the foregoing or otherwise under or
with respect to any Credit Facility (including any Credit
Agreement); and
(2) all obligations of every nature of the Issuer
under, or with respect to, any Hedging Obligations in respect of
any Credit Facility (including any Credit Agreement);
S-138
Description of
notes
in each case whether outstanding on the Issue Date or thereafter
incurred.
Notwithstanding the foregoing, Senior Debt shall not
include:
(1) any Indebtedness of the Issuer to any of its
Subsidiaries;
(2) Indebtedness to, or guaranteed on behalf of, any
director, officer or employee of the Issuer or any of its
Subsidiaries (including amounts owed for compensation);
(3) obligations to trade creditors and other amounts
incurred (but not under any Credit Facility (including any
Credit Agreement)) in connection with obtaining goods, materials
or services;
(4) Indebtedness represented by Disqualified Equity
Interests;
(5) any liability for taxes owed or owing by the
Issuer;
(6) that portion of any Indebtedness incurred in
violation of the Indenture (but, as to any such obligation, no
such violation shall be deemed to exist for purposes of this
clause (6) if the holder(s) of such obligation or their
representative shall have received an Officers Certificate
(and/or representation or warranty) of the Issuer to the effect
that the incurrence of such Indebtedness does not (or, in the
case of revolving credit indebtedness, the incurrence of the
entire committed amount thereof at the date on which the initial
borrowing thereunder is made would not) violate the provisions
of the Indenture);
(7) Indebtedness which, when incurred and without
respect to any election under Section 1111(b) of
Title 11, United States Code, is without recourse to the
Issuer;
(8) Indebtedness under or evidenced by the 2007
Convertible Notes and any Indebtedness that expressly provides
that it ranks pari passu in right of payment to the 2007
Convertible Notes; and
(9) any Indebtedness (including any Pari Passu
Indebtedness or Subordinated Indebtedness) which is, by its
express terms, subordinated in right of payment to any other
Indebtedness of the Issuer.
Series B Preferred Stock means the
Series B Convertible Perpetual Preferred Stock, par value
$0.001 per share, of the Issuer.
Significant Subsidiary means (1) any Restricted
Subsidiary that would be a significant subsidiary as
defined in
Regulation S-X
promulgated pursuant to the Securities Act as such Regulation is
in effect on the Issue Date and (2) any Restricted
Subsidiary that, when aggregated with all other Restricted
Subsidiaries that are not otherwise Significant Subsidiaries and
as to which any event described in clause (6) or
(7) under Events of Default has occurred
and is continuing, would constitute a Significant Subsidiary
under clause (1) of this definition.
Subordinated Indebtedness means Indebtedness of the
Issuer or any Restricted Subsidiary that is subordinated in
right of payment to the Notes or the Guarantees, respectively.
Subsidiary means, with respect to any Person:
(1) any corporation, limited liability company,
association or other business entity of which more than 50% of
the total voting power of the Equity Interests entitled (without
regard to the occurrence of any contingency) to vote in the
election of the Board of Directors thereof are at the time owned
or controlled, directly or indirectly, by such Person or one or
more of the other Subsidiaries of that Person (or a combination
thereof); and
(2) any partnership (a) the sole general partner
or the managing general partner of which is such Person or a
Subsidiary of such Person or (b) the only general partners
of which are such Person or of one or more Subsidiaries of such
Person (or any combination thereof).
S-139
Description of
notes
Unless otherwise specified, Subsidiary refers to a
Subsidiary of the Issuer. Based on the capital structure and
ownership of the P&G JV Companies as of the Issue Date, the
P&G JV Companies are not Subsidiaries of the Issuer.
Treasury Rate means, as of any redemption date, the
yield to maturity as of such redemption date of United States
Treasury securities with a constant maturity (as compiled and
published in the most recent Federal Reserve Statistical Release
H.15 (519) that has become publicly available at least two
Business Days prior to the redemption date (or, if such
Statistical Release is no longer published, any publicly
available source of similar market data)) most nearly equal to
the period from the redemption date to May 15, 2013;
provided, however, that if the period from the
redemption date to May 15, 2013 is less than one year, the
weekly average yield on actually traded United States Treasury
securities adjusted to a constant maturity of one year will be
used.
Trust Indenture Act means the
Trust Indenture Act of 1939, as amended.
Trustee means U.S. Bank National Association
until a successor Trustee shall have become such pursuant to the
applicable provisions of the Indenture, and thereafter
Trustee shall mean such Person who is then a Trustee
under the Indenture.
Unrestricted Subsidiary means, (1) any
Subsidiary that at the time of determination shall be designated
an Unrestricted Subsidiary by the Board of Directors of the
Issuer in accordance with the covenant described under
Certain CovenantsLimitations on Designation of
Unrestricted Subsidiaries and (2) any Subsidiary of
an Unrestricted Subsidiary. As of the Issue Date, no Subsidiary
has been designated by the Board of Directors of the Issuer as
an Unrestricted Subsidiary.
U.S. Government Obligations means direct
non-callable obligations of, or obligations guaranteed by, the
United States of America, and the payment for which the United
States pledges its full faith and credit.
Voting Stock with respect to any Person, means
securities of any class of Equity Interests of such Person
entitling the holders thereof (whether at all times or only so
long as no senior class of stock or other relevant equity
interest has voting power by reason of any contingency) to vote
in the election of members of the Board of Directors of such
Person.
Weighted Average Life to Maturity when applied to
any Indebtedness at any date, means the number of years obtained
by dividing (1) the sum of the products obtained by
multiplying (a) the amount of each then remaining
installment, sinking fund, serial maturity or other required
payment of principal, including payment at final maturity, in
respect thereof by (b) the number of years (calculated to
the nearest one-twelfth) that will elapse between such date and
the making of such payment by (2) the then outstanding
principal amount of such Indebtedness.
Wholly-Owned Restricted Subsidiary means a
Restricted Subsidiary of which 100% of the Equity Interests
(except for directors qualifying shares or certain
minority interests owned by other Persons solely due to local
law requirements that there be more than one stockholder, but
which interest is not in excess of what is required for such
purpose) are owned directly by the Issuer or through one or more
Wholly-Owned Restricted Subsidiaries.
BOOK-ENTRY,
DELIVERY AND FORM OF SECURITIES
The Notes will be represented by one or more global notes (the
Global Notes) in definitive form. The Global Notes
will be deposited on the Issue Date with, or on behalf of, the
Depository Trust Company, or DTC, and registered in the
name of Cede & Co., as nominee of DTC (such nominee
being referred to herein as the Global Note Holder).
DTC will maintain the Notes in minimum denominations of $2,000
and integral multiples of $1,000 through its book-entry
facilities.
S-140
Description of
notes
DTC has advised the Issuer as follows:
DTC is a limited-purpose trust company that was created to hold
securities for its participating organizations, including
Euroclear and Clearstream (collectively, the
Participants or the Depositorys
Participants), and to facilitate the clearance and
settlement of transactions in these securities between
Participants through electronic book-entry changes in accounts
of its Participants. The Depositorys Participants include
securities brokers and dealers (including the initial
purchasers), banks and trust companies, clearing corporations
and certain other organizations. Access to DTCs system is
also available to other entities such as banks, brokers, dealers
and trust companies (collectively, the Indirect
Participants or the Depositorys Indirect
Participants) that clear through or maintain a custodial
relationship with a Participant, either directly or indirectly.
Persons who are not Participants may beneficially own securities
held by or on behalf of DTC only through the Depositorys
Participants or the Depositorys Indirect Participants.
Pursuant to procedures established by DTC, ownership of the
Notes will be shown on, and the transfer of ownership thereof
will be effected only through, records maintained by DTC (with
respect to the interests of the Depositorys Participants)
and the records of the Depositorys Participants (with
respect to the interests of the Depositorys Indirect
Participants).
The laws of some states require that certain persons take
physical delivery in definitive form of securities that they
own. Consequently, the ability to transfer the Notes will be
limited to such extent.
So long as the Global Note Holder is the registered owner of any
Notes, the Global Note Holder will be considered the sole Holder
of outstanding Notes represented by such Global Notes under the
Indenture. Except as provided below, owners of Notes will not be
entitled to have Notes registered in their names and will not be
considered the owners or holders thereof under the Indenture for
any purpose, including with respect to the giving of any
directions, instructions, or approvals to the Trustee
thereunder. None of the Issuer, the Guarantors or the Trustee
will have any responsibility or liability for any aspect of the
records relating to or payments made on account of Notes by DTC,
or for maintaining, supervising or reviewing any records of DTC
relating to such Notes.
Payments in respect of the principal of, premium, if any, and
interest on any Notes registered in the name of a Global Note
Holder on the applicable record date will be payable by the
Trustee to or at the direction of such Global Note Holder in its
capacity as the registered holder under the Indenture. Under the
terms of the Indenture, the Issuer and the Trustee may treat the
persons in whose names any Notes, including the Global Notes,
are registered as the owners thereof for the purpose of
receiving such payments and for any and all other purposes
whatsoever. Consequently, neither the Issuer or the Trustee has
or will have any responsibility or liability for the payment of
such amounts to beneficial owners of Notes (including principal,
premium, if any, and interest). The Issuer believes, however,
that it is currently the policy of DTC to immediately credit the
accounts of the relevant Participants with such payments, in
amounts proportionate to their respective beneficial interests
in the relevant security as shown on the records of DTC.
Payments by the Depositorys Participants and the
Depositorys Indirect Participants to the beneficial owners
of Notes will be governed by standing instructions and customary
practice and will be the responsibility of the Depositorys
Participants or the Depositorys Indirect Participants.
Subject to certain conditions, any person having a beneficial
interest in the Global Notes may, upon request to the Trustee
and confirmation of such beneficial interest by the Depository
or its Participants or Indirect Participants, exchange such
beneficial interest for Notes in definitive form. Upon any such
issuance, the Trustee is required to register such Notes in the
name of and cause the same to be delivered to, such person or
persons (or the nominee of any thereof). In addition, if the
Depository notifies the Issuer in writing that DTC is no longer
willing or able to act as a depositary and the Issuer is unable
to locate a qualified successor within 90 days, then, upon
surrender by the relevant Global Note Holder of its Global Note,
Notes in such form will be issued to each person that such
Global Note Holder and DTC identifies as being the beneficial
owner of the related Notes.
S-141
Description of
notes
Neither the Issuer nor the Trustee will be liable for any delay
by the Global Note Holder or DTC in identifying the beneficial
owners of Notes and the Issuer and the Trustee may conclusively
rely on, and will be protected in relying on, instructions from
the Global Note Holder or DTC for all purposes.
S-142
Underwriting
We and the underwriters named in the following table have
entered into an underwriting agreement with respect to the
notes. Subject to the terms and conditions of the underwriting
agreement, each underwriter has severally agreed to purchase the
principal amount of notes indicated in the following table.
|
|
|
|
|
|
|
Principal
|
|
|
|
amount
|
|
Underwriters
|
|
of
notes
|
|
|
|
|
UBS Securities LLC
|
|
$
|
122,511,000
|
|
Goldman, Sachs & Co.
|
|
|
118,011,000
|
|
Banc of America Securities LLC
|
|
|
78,674,000
|
|
Canaccord Adams Inc.
|
|
|
26,225,000
|
|
Leerink Swann LLC
|
|
|
26,290,000
|
|
Stifel, Nicolaus & Company, Incorporated
|
|
|
28,289,000
|
|
|
|
|
|
|
Total
|
|
$
|
400,000,000
|
|
|
|
|
|
|
The underwriters are committed to take and pay for all of the
notes being offered, if any are taken.
The notes sold by the underwriters to the public will initially
be offered at the initial public offering price set forth on the
cover of this prospectus supplement. If all the notes are not
sold at the initial offering price, the underwriters may change
the offering price and the other selling terms.
The following table shows the underwriting discounts and
commissions that we are to pay to the underwriters in connection
with this offering.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Public
offering
|
|
|
Underwriting
|
|
|
Proceeds,
before
|
|
|
|
price(1)
|
|
|
discount
|
|
|
expenses, to
us
|
|
|
|
|
Per note
|
|
|
96.865
|
%
|
|
|
2.000
|
%
|
|
|
94.865
|
%
|
Total
|
|
$
|
387,460,000
|
|
|
$
|
8,000,000
|
|
|
$
|
379,460,000
|
|
|
|
|
(1) |
|
Plus accrued interest from May 12, 2009 to the date of
delivery. |
We estimate that our share of the total expenses related to the
offering of the notes, excluding underwriting discounts, will be
approximately $1.0 million.
The notes are a new issue of securities with no established
trading market. The notes have been authorized for listing on
the New York Stock Exchange, subject to notice of issuance. We
have been advised by the underwriters that certain of the
underwriters intend to make a market in the notes, but they are
not obligated to do so and may discontinue market making at any
time without notice. No assurance can be given as to the
liquidity of the trading market for the notes or that an active
public market for the notes will develop. If any active public
trading market for the notes does not develop, the market price
and liquidity of the notes may be adversely affected. See
Risk FactorsThere may be no active trading market
for the notes.
In connection with the offering of the notes, the underwriters
may purchase and sell notes in the open market. These
transactions may include short sales, stabilizing transactions
and purchases to cover positions created by short sales. Short
sales involve the sale by the underwriters of a greater number
of notes than they are required to purchase in the offering of
the notes. Stabilizing transactions consist of certain bids or
purchases made for the purpose of preventing or retarding a
decline in the market price of the notes while the offering of
the notes is in progress.
S-143
Underwriting
The underwriters also may impose a penalty bid. This occurs when
a particular underwriter repays to the underwriters a portion of
the underwriting discount received by it because a
representative of the underwriters has repurchased notes sold by
or for the account of such underwriter in stabilizing or short
covering transactions.
These activities by the underwriters may stabilize, maintain or
otherwise affect the market price of the notes. As a result, the
price of the notes may be higher than the price that otherwise
might exist in the open market. If these activities are
commenced, they may be discontinued by the underwriters at any
time. These transactions may be effected on the New York Stock
Exchange, in the over-the-counter market or otherwise.
Each underwriter intends to comply with all applicable laws and
regulations in each jurisdiction in which it acquires, offers,
sells or delivers the notes or has in its possession or
distributes the prospectus supplement.
In relation to each Member State of the European Economic Area
(namely, the European Union, Iceland, Norway and Liechtenstein)
which has implemented the Prospectus Directive (each, a Relevant
Member State), each underwriter has represented and agreed that
with effect from and including the date on which the Prospectus
Directive is implemented in that Relevant Member State (the
Relevant Implementation Date) it has not made and will not make
an offer of notes to the public in that Relevant Member State
prior to the publication of a prospectus in relation to the
notes which has been approved by the competent authority in that
Relevant Member State or, where appropriate, approved in another
Relevant Member State and notified to the competent authority in
that Relevant Member State, all in accordance with the
Prospectus Directive, except that it may, with effect from and
including the Relevant Implementation Date, make an offer of
notes to the public in that Relevant Member State at any time:
|
|
Ø
|
to legal entities which are authorized or regulated to operate
in the financial markets or, if not so authorized or regulated,
whose corporate purpose is solely to invest in securities;
|
|
Ø
|
to any legal entity which has two or more of (1) an average
of at least 250 employees during the last financial year;
(2) a total balance sheet of more than 43,000,000 and
(3) an annual net turnover of more than 50,000,000,
as shown in its last annual or consolidated accounts;
|
|
Ø
|
to fewer than 100 natural or legal persons (other than qualified
investors as defined in the Prospectus Directive); or
|
|
Ø
|
in any other circumstances which do not require the publication
by the issuer of a prospectus pursuant to Article 3 of the
Prospectus Directive.
|
For the purposes of this provision, the expression an
offer of notes to the public in relation to any
notes in any Relevant Member State means the communication in
any form and by any means of sufficient information on the terms
of the offer and the notes to be offered so as to enable an
investor to decide to purchase or subscribe for the notes, as
the same may be varied in that Member State by any measure
implementing the Prospectus Directive in that Member State, and
the expression Prospectus Directive means Directive
2003/71/EC and includes any relevant implementing measure in
each Relevant Member State.
Each underwriter has represented and agreed that:
|
|
Ø
|
it has only communicated or caused to be communicated and will
only communicate or cause to be communicated an invitation or
inducement to engage in investment activity (within the meaning
of Section 21 of the Financial Services and Markets Act, or
FSMA) received by it in connection with the issue or sale of the
notes in circumstances in which Section 21(1) of the FSMA
does not apply to the issuer; and
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Ø
|
it has complied and will comply with all applicable provisions
of the FSMA with respect to anything done by it in relation to
the notes in, from or otherwise involving the United Kingdom.
|
S-144
Underwriting
The notes may not be offered or sold by means of any document
other than (i) in circumstances which do not constitute an
offer to the public within the meaning of the Companies
Ordinance (Cap.32, Laws of Hong Kong), or (ii) to
professional investors within the meaning of the
Securities and Futures Ordinance (Cap.571, Laws of Hong Kong)
and any rules made thereunder, or (iii) in other
circumstances which do not result in the document being a
prospectus within the meaning of the Companies
Ordinance (Cap.32, Laws of Hong Kong), and no advertisement,
invitation or document relating to the notes may be issued or
may be in the possession of any person for the purpose of issue
(in each case whether in Hong Kong or elsewhere), which is
directed at, or the contents of which are likely to be accessed
or read by, the public in Hong Kong (except if permitted to do
so under the laws of Hong Kong) other than with respect to notes
which are or are intended to be disposed of only to persons
outside Hong Kong or only to professional investors
within the meaning of the Securities and Futures Ordinance (Cap.
571, Laws of Hong Kong) and any rules made thereunder.
The notes have not been and will not be registered under the
Financial Instruments and Exchange Law of Japan (the Financial
Instruments and Exchange Law) and each underwriter has agreed
that it will not offer or sell any notes, directly or
indirectly, in Japan or to, or for the benefit of, any resident
of Japan (which term as used herein means any person resident in
Japan, including any corporation or other entity organized under
the laws of Japan), or to others for re-offering or resale,
directly or indirectly, in Japan or to a resident of Japan,
except pursuant to an exemption from the registration
requirements of, and otherwise in compliance with, the Financial
Instruments and Exchange Law and any other applicable laws,
regulations and ministerial guidelines of Japan.
This prospectus supplement has not been registered as a
prospectus with the Monetary Authority of Singapore.
Accordingly, this prospectus supplement and any other document
or material in connection with the offer or sale, or invitation
for subscription or purchase, of the notes may not be circulated
or distributed, nor may the notes be offered or sold, or be made
the subject of an invitation for subscription or purchase,
whether directly or indirectly, to persons in Singapore other
than (i) to an institutional investor under
Section 274 of the Securities and Futures Act,
Chapter 289 of Singapore (the SFA),
(ii) to a relevant person, or any person pursuant to
Section 275(1A), and in accordance with the conditions,
specified in Section 275 of the SFA or (iii) otherwise
pursuant to, and in accordance with the conditions of, any other
applicable provision of the SFA.
Where the notes are subscribed or purchased under
Section 275 by a relevant person which is: (a) a
corporation (which is not an accredited investor) the sole
business of which is to hold investments and the entire share
capital of which is owned by one or more individuals, each of
whom is an accredited investor; or (b) a trust (where the
trustee is not an accredited investor) whose sole purpose is to
hold investments and each beneficiary is an accredited investor,
shares, debentures and units of shares and debentures of that
corporation or the beneficiaries rights and interest in
that trust shall not be transferable for 6 months after
that corporation or that trust has acquired the notes under
Section 275 except: (1) to an institutional investor
under Section 274 of the SFA or to a relevant person, or
any person pursuant to Section 275(1A), and in accordance
with the conditions, specified in Section 275 of the SFA;
(2) where no consideration is given for the transfer; or
(3) by operation of law.
We have agreed to indemnify the underwriters and certain of
their affiliates against certain liabilities, including
liabilities under the Securities Act of 1933, as amended, or to
contribute to payments they may be required to make in respect
of those liabilities.
Certain of the underwriters and their respective affiliates
have, from time to time, performed and may in the future
perform, various commercial banking, financial advisory,
investment banking and other services for us and our affiliates,
for which they received or will receive customary fees and
expenses. Certain of the underwriters or their respective
affiliates are lenders and/or agents under our secured credit
facilities, for which they receive customary payments and fees.
In addition, from time to time, the underwriters and their
S-145
Underwriting
affiliates may effect transactions for their own account or the
account of customers, and hold on behalf of themselves or their
customers, long or short positions in our debt or equity
securities or loans, and may do so in the future.
S-146
Material United
States federal income tax consequences
The following is a discussion of the material U.S. federal
income tax consequences of the purchase, ownership and
disposition of the notes.
This discussion is based on currently existing provisions of the
Internal Revenue Code of 1986, as amended, which we refer to as
the Code, the final, temporary and proposed Treasury regulations
promulgated under the Code, and administrative and judicial
interpretations thereof, all as in effect on the date of this
prospectus supplement and all of which are subject to change,
possibly with retroactive effect, or different interpretations.
There can be no assurance that the Internal Revenue Service, or
IRS, will not take a different position concerning the tax
consequences of the purchase, ownership or disposition of the
notes or that any such position would not be sustained.
This discussion does not address the U.S. federal income
tax consequences to subsequent purchasers of notes and is
limited to holders who both purchase the notes pursuant to this
offering at the public offering price set forth on the cover
page of this prospectus supplement and hold the notes as capital
assets within the meaning of section 1221 of the Code.
Moreover, this discussion is for general information only and
does not address all of the tax consequences that may be
relevant to particular holders in light of their specific
circumstances or to certain types of holders subject to special
treatment under U.S. federal tax laws (such as
U.S. holders having a functional currency other than the
U.S. dollar, taxpayers holding the notes through a
partnership or similar pass-through entity, persons subject to
special rules applicable to former citizens and residents of the
United States, persons subject to the alternative minimum tax,
grantor trusts, real estate investment trusts, certain financial
institutions, insurance companies, tax-exempt entities, dealers
in securities or currencies, persons holding the notes in
connection with a hedging transaction, straddle, conversion or
other integrated transaction, controlled foreign corporations,
passive foreign investment companies or
non-U.S. holders
that are owned or controlled by U.S. holders).
If a partnership holds notes, the tax treatment of a partner
will generally depend upon the status of the partner and upon
the activities of the partnership. We suggest that partners of a
partnership holding notes consult their tax advisors.
Prospective holders should consult their own tax advisors as to
the particular tax consequences to them of their participation
in the offering and their ownership and disposition of the
notes, including the applicability of any U.S. income,
estate, gift or other federal tax laws and any state, local or
foreign tax laws or any treaty, and any changes (or proposed
changes) in applicable tax laws or interpretations thereof.
Under certain circumstances, we may be required to pay holders
amounts in excess of the stated interest and principal payable
on the notes. We have determined (and this discussion assumes)
that as of the date of issuance of the notes, the possibility
that amounts will be paid in such circumstances is a
remote or incidental contingency within
the meaning of applicable Treasury regulations. Based on this
determination, we do not intend to treat the possibility of such
payments as either affecting the determination of the yield to
maturity of (or OID on) the notes or resulting in the notes
being treated as contingent payment debt instruments under the
applicable Treasury regulations. Our determination that such
possibility is a remote or incidental contingency is binding on
you unless you explicitly disclose on a statement attached to
your timely filed income tax return that your determination is
different. However, the IRS may take a different position, in
which case the tax consequences to a holder could differ
materially and adversely from those described below. Prospective
holders are urged to consult their own tax advisors regarding
the potential effect, if any, of these matters on their
particular situation.
S-147
Material United
States federal income tax consequences
U.S.
HOLDERS
As used in this section, the term U.S. holder
means a beneficial owner of a note that is, for
U.S. federal income tax purposes:
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Ø
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an individual citizen or resident of the United States;
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Ø
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a corporation (or any other entity treated as a corporation for
U.S. federal income tax purposes) created or organized in
or under the laws of the United States, any state thereof or the
District of Columbia;
|
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Ø
|
an estate the income of which is includible in gross income for
U.S. federal income tax purposes, regardless of its source;
or
|
|
Ø
|
a trust if a U.S. court is able to exercise primary
supervision over the administration of the trust and one or more
U.S. persons have the authority to control all substantial
decisions of the trust, or that has a valid election in effect
under applicable Treasury regulations to be treated as a
U.S. person.
|
Stated
interest
The stated interest on the notes will be included in income by a
U.S. holder in accordance with such U.S. holders
usual method of accounting for U.S. federal income tax
purposes. Interest income generally is taxed as ordinary income.
Original issue
discount
The notes will be treated as issued with original issue
discount, or OID, for U.S. federal income tax purposes in
an amount equal to the excess of the stated redemption
price at maturity of the notes over their issue
price. The stated redemption price at maturity
of a debt instrument is the sum of all payments to be made under
the debt instrument other than qualified stated
interest. Qualified stated interest means
stated interest that is unconditionally payable in cash or
property (other than debt instruments issued by us) at least
annually at a single fixed rate or at certain floating rates
that properly take into account the length of the interval
between stated interest payments. All of the stated interest
with respect to the notes will be qualified stated interest, and
thus the stated redemption price at maturity will equal the
stated principal amount of the notes. The issue
price of the notes will be the first price at which a
substantial amount of the notes is sold for cash (excluding
sales to bond houses, brokers or similar persons or
organizations acting in the capacity of underwriters, placement
agents or wholesalers).
A U.S. holder of a note generally must include OID in
income as it accrues, based on a constant yield method (which
includes at least annual compounding) and regardless of the
U.S. holders regular method of tax accounting. Thus,
U.S. holders generally will be taxed on OID income in
advance of the receipt of cash attributable to that income (but
will not be taxed again when such cash is received).
A U.S. holder generally may elect to treat all interest on
a note as OID and calculate the amount includible in gross
income under the constant yield method described above.
U.S. holders should consult their own tax advisors about
this election.
Sale, exchange,
redemption or other disposition
Unless a nonrecognition provision applies, the sale, exchange,
redemption or other disposition of a note will be a taxable
event for U.S. federal income tax purposes. In such event,
a U.S. holder generally will recognize gain or loss equal
to the difference between (a) the sum of cash plus the fair
market value of all other property received on such disposition
(except to the extent such cash or property is attributable to
accrued but unpaid stated interest, which will be taxable as
ordinary income to the extent not previously included in income)
and (b) such U.S. holders adjusted tax basis in
the note. A U.S. holders adjusted tax basis in a note
generally will equal the price paid for the note by such
U.S. holder, increased by any OID previously included in
income with respect to such note (including OID accrued to such
U.S. holder in the year of the disposition)
S-148
Material United
States federal income tax consequences
and decreased by the amount of any cash payments previously
received with respect to the note (other than payments of
qualified stated interest). Gain or loss recognized on the
disposition of a note generally will be capital gain or loss and
will be long-term capital gain or loss if, at the time of such
disposition, the U.S. holders holding period for the
note is more than one year. For non-corporate taxpayers, net
long-term capital gains are generally subject to tax at
preferential rates. The deductibility of capital losses is
subject to limitations.
NON-U.S.
HOLDERS
As used in this section, the term
non-U.S. holder
means a beneficial owner of a note that is an individual,
corporation, trust or estate for U.S. federal income tax
purposes and is not a U.S. holder.
Interest on
notes
Generally, any interest (including OID) paid to a
non-U.S. holder
of a note that is not effectively connected with a
U.S. trade or business will not be subject to
U.S. federal income (including withholding) tax if the
interest qualifies as portfolio interest. Interest
on the notes generally will qualify as portfolio interest if
(a) the
non-U.S. holder
does not actually or constructively own 10% or more of the total
voting power of all our voting stock, (b) such holder is
not a controlled foreign corporation with respect to
which we are a related person within the meaning of
the Code, (c) either the beneficial owner, under penalties
of perjury, certifies that the beneficial owner is not a
U.S. person and such certificate provides the beneficial
owners name and address, or a securities clearing
organization, bank or other financial institution that holds
customers securities in the ordinary course of its trade
or business and holds the notes certifies, under penalties of
perjury, that such statement has been received from the
beneficial owner by it or by a financial institution between it
and the beneficial owner, and (d) the
non-U.S. holder
is not a bank receiving interest on the extension of credit made
pursuant to a loan agreement made in the ordinary course of its
trade or business.
The gross amount of payments to a
non-U.S. holder
of interest (including OID) that is not effectively connected
with a U.S. trade or business and that does not qualify for
the portfolio interest exemption will be subject to
U.S. withholding tax at the rate of 30%, unless a
U.S. income tax treaty applies to reduce or eliminate such
withholding tax.
Payments of interest (including OID) that are effectively
connected with the conduct of a U.S. trade or business by a
non-U.S. holder
and, to the extent an applicable treaty so provides, are
attributable to a permanent establishment (or, in the case of an
individual, a fixed base) in the United States will be taxed on
a net basis at regular U.S. rates in the same manner as
such payments to U.S. holders. In the case of a
non-U.S. holder
that is a corporation, such effectively connected income may
also be subject to the branch profits tax (which is generally
imposed on a foreign corporation on the actual or deemed
repatriation from the United States of earnings and profits
attributable to U.S. trade or business income) at a 30%
rate. The branch profits tax may not apply (or may apply at a
reduced rate) if a recipient is a qualified resident of certain
countries with which the United States has an income tax treaty.
If payments of interest (including OID) are effectively
connected with a
non-U.S. holders
conduct of a U.S. trade or business (whether or not a
treaty applies), the 30% withholding tax discussed above will
not apply provided the appropriate certification discussed below
is provided.
To claim the benefit of a tax treaty or to claim exemption from
withholding because the income is effectively connected with a
non-U.S. holders
conduct of a U.S. trade or business, the
non-U.S. holder
must provide a properly executed IRS
Form W-8BEN
or W-8ECI
(or such successor forms as the IRS designates), as applicable,
prior to the payment of interest. These forms must be
periodically updated. A
non-U.S. holder
who is claiming the benefits of a treaty may be required in
certain instances to obtain a U.S. taxpayer identification
number and to provide certain documentary evidence issued by
foreign governmental authorities to prove residence in the
foreign country.
S-149
Material United
States federal income tax consequences
Sale, exchange,
redemption or other disposition
A
non-U.S. holder
generally will not be subject to U.S. federal income tax
with respect to any gain realized on the sale, exchange,
redemption or other disposition of a note unless:
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Ø
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the
non-U.S. holder
is a nonresident alien individual who is present in the United
States for a period or periods aggregating 183 or more days in
the taxable year of the disposition and certain other conditions
are met, in which case the
non-U.S. Holder
will be subject to a flat 30% U.S. federal income tax on
any gain recognized (except to the extent otherwise provided by
an applicable income tax treaty), which may be offset by certain
U.S. losses; or
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|
Ø
|
such gain is effectively connected with the conduct of a
U.S. trade or business by a
non-U.S. holder
and, to the extent an applicable treaty so provides, is
attributable to a permanent establishment (or, in the case of an
individual, a fixed base) in the United States, in which case
such gain will be taxable in the same manner as effectively
connected interest as discussed above.
|
BACKUP
WITHHOLDING AND INFORMATION REPORTING
Information returns may be filed with the IRS in connection with
payments on the notes and the proceeds from a sale or other
disposition of the notes. A U.S. holder may be subject to
U.S. backup withholding tax on these payments if it fails
to provide its correct taxpayer identification number to the
paying agent and comply with certification procedures or
otherwise establish an exemption from backup withholding. A
non-U.S. holder
may be subject to U.S. backup withholding tax on these
payments unless the
non-U.S. holder
complies with certification procedures to establish that it is
not a U.S. person. The certification procedures required of
non-U.S. holders
to claim the exemption from withholding tax on certain payments
on the notes, described above, will satisfy the certification
requirements necessary to avoid the backup withholding tax as
well. The amount of any backup withholding from a payment will
be allowed as a credit against the holders
U.S. federal income tax liability and may entitle the
holder to a refund, provided that the required information is
timely furnished to the IRS.
S-150
Legal matters
Our legal counsel, Foley Hoag
llp, Boston,
Massachusetts, will pass upon certain legal matters in
connection with the offered securities. Certain legal matters in
connection with the offering will be passed upon for the
underwriters by Cahill Gordon & Reindel
llp, New York, New
York.
S-151
Inverness Medical
Innovations, Inc. and subsidiaries
Consolidated
financial statements
TABLE OF
CONTENTS
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Page
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SF-2
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SF-3
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SF-4
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SF-5
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SF-8
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SF-9
|
SF-1
Inverness Medical
Innovations, Inc. and subsidiaries
Report of
independent registered public accounting firm
The Board of Directors and Stockholders of
Inverness Medical Innovations, Inc.:
We have audited the accompanying consolidated balance sheets of
Inverness Medical Innovations, Inc. and Subsidiaries (the
Company) as of December 31, 2008 and 2007, and
the related consolidated statements of operations,
stockholders equity and comprehensive loss, and cash flows
for each of the three years in the period ended
December 31, 2008. These consolidated financial statements
are the responsibility of the Companys management. Our
responsibility is to express an opinion on these consolidated
financial statements based on our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements, assessing the accounting principles
used and significant estimates made by management, as well as
evaluating the overall financial statement presentation. We
believe that our audits provide a reasonable basis for our
opinion.
In our opinion, the consolidated financial statements referred
to above present fairly, in all material respects, the
consolidated financial position of Inverness Medical
Innovations, Inc. and Subsidiaries at December 31, 2008 and
2007, and the consolidated results of their operations and their
cash flows for each of the three years in the period ended
December 31, 2008, in conformity with accounting principles
generally accepted in the United States of America.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
Companys internal control over financial reporting as of
December 31, 2008, based on criteria established in
Internal ControlIntegrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission
(COSO) and our report dated February 27, 2009,
expressed an unqualified opinion thereon.
/s/ BDO Seidman, LLP
Boston, Massachusetts
February 27, 2009
(Except for Note 26, which is dated April 10, 2009)
SF-2
Inverness Medical
Innovations, Inc. and subsidiaries
Consolidated
statements of operations
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2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
(in thousands,
except per share amounts)
|
|
|
Net product sales
|
|
$
|
1,240,138
|
|
|
$
|
800,915
|
|
|
$
|
552,130
|
|
Services revenue
|
|
|
405,462
|
|
|
|
16,646
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales and services revenue
|
|
|
1,645,600
|
|
|
|
817,561
|
|
|
|
552,130
|
|
License and royalty revenue
|
|
|
25,826
|
|
|
|
21,979
|
|
|
|
17,324
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue
|
|
|
1,671,426
|
|
|
|
839,540
|
|
|
|
569,454
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of net product sales
|
|
|
624,654
|
|
|
|
431,403
|
|
|
|
334,799
|
|
Cost of services revenue
|
|
|
177,098
|
|
|
|
5,261
|
|
|
|
|
|
Cost of license and royalty revenue
|
|
|
9,115
|
|
|
|
9,149
|
|
|
|
5,432
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of net revenue
|
|
|
810,867
|
|
|
|
445,813
|
|
|
|
340,231
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
860,559
|
|
|
|
393,727
|
|
|
|
229,223
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
111,828
|
|
|
|
69,547
|
|
|
|
48,706
|
|
Purchase of in-process research and development
|
|
|
|
|
|
|
173,825
|
|
|
|
4,960
|
|
Sales and marketing
|
|
|
386,284
|
|
|
|
167,770
|
|
|
|
94,445
|
|
General and administrative
|
|
|
298,595
|
|
|
|
158,438
|
|
|
|
71,243
|
|
Loss on dispositions, net
|
|
|
|
|
|
|
|
|
|
|
3,498
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss)
|
|
|
63,852
|
|
|
|
(175,853
|
)
|
|
|
6,371
|
|
Interest expense, including amortization of original issue
discounts and write-off of deferred financing costs
|
|
|
(101,144
|
)
|
|
|
(83,025
|
)
|
|
|
(26,570
|
)
|
Other (expense) income, net
|
|
|
(2,212
|
)
|
|
|
8,774
|
|
|
|
8,748
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before (benefit) provision for income taxes
|
|
|
(39,504
|
)
|
|
|
(250,104
|
)
|
|
|
(11,451
|
)
|
(Benefit) provision for income taxes
|
|
|
(16,686
|
)
|
|
|
(979
|
)
|
|
|
5,727
|
|
Equity earnings of unconsolidated entities, net of tax
|
|
|
1,050
|
|
|
|
4,372
|
|
|
|
336
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
(21,768
|
)
|
|
|
(244,753
|
)
|
|
|
(16,842
|
)
|
Preferred stock dividends
|
|
|
(13,989
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss available to common stockholders
|
|
$
|
(35,757
|
)
|
|
$
|
(244,753
|
)
|
|
$
|
(16,842
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per common sharebasic and diluted
|
|
$
|
(0.46
|
)
|
|
$
|
(4.75
|
)
|
|
$
|
(0.49
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average sharesbasic and diluted
|
|
|
77,778
|
|
|
|
51,510
|
|
|
|
34,109
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
SF-3
Inverness Medical
Innovations, Inc. and subsidiaries
Consolidated balance
sheets
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
(in thousands,
except par value amounts)
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
141,324
|
|
|
$
|
414,732
|
|
Restricted cash
|
|
|
2,748
|
|
|
|
141,869
|
|
Marketable securities
|
|
|
1,763
|
|
|
|
2,551
|
|
Accounts receivable, net of allowances of $12,835 and $12,167 at
December 31, 2008 and 2007, respectively
|
|
|
280,608
|
|
|
|
163,380
|
|
Inventories, net
|
|
|
199,131
|
|
|
|
148,231
|
|
Deferred tax assets
|
|
|
104,311
|
|
|
|
18,170
|
|
Income tax receivable
|
|
|
6,406
|
|
|
|
5,256
|
|
Receivable from joint venture, net
|
|
|
12,018
|
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
74,234
|
|
|
|
58,785
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
822,543
|
|
|
|
952,974
|
|
Property, plant and equipment, net
|
|
|
284,483
|
|
|
|
267,880
|
|
Goodwill
|
|
|
3,046,083
|
|
|
|
2,148,850
|
|
Other intangible assets with indefinite lives
|
|
|
42,984
|
|
|
|
43,097
|
|
Core technology and patents, net
|
|
|
459,307
|
|
|
|
432,583
|
|
Other intangible assets, net
|
|
|
1,169,330
|
|
|
|
869,644
|
|
Deferred financing costs, net, and other non-current assets
|
|
|
46,884
|
|
|
|
51,747
|
|
Investments in unconsolidated entities
|
|
|
68,832
|
|
|
|
77,753
|
|
Marketable securities
|
|
|
591
|
|
|
|
20,432
|
|
Deferred tax assets
|
|
|
14,323
|
|
|
|
15,799
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
5,955,360
|
|
|
$
|
4,880,759
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
Current portion of long-term debt
|
|
$
|
19,058
|
|
|
$
|
20,320
|
|
Current portion of capital lease obligations
|
|
|
451
|
|
|
|
776
|
|
Accounts payable
|
|
|
112,704
|
|
|
|
72,061
|
|
Accrued expenses and other current liabilities
|
|
|
233,132
|
|
|
|
174,935
|
|
Payable to joint venture, net
|
|
|
|
|
|
|
10,816
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
365,345
|
|
|
|
278,908
|
|
|
|
|
|
|
|
|
|
|
Long-term liabilities:
|
|
|
|
|
|
|
|
|
Long-term debt, net of current portion
|
|
|
1,500,557
|
|
|
|
1,366,395
|
|
Capital lease obligations, net of current portion
|
|
|
468
|
|
|
|
358
|
|
Deferred tax liabilities
|
|
|
462,787
|
|
|
|
326,128
|
|
Deferred gain on joint venture
|
|
|
287,030
|
|
|
|
293,078
|
|
Other long-term liabilities
|
|
|
60,335
|
|
|
|
29,225
|
|
|
|
|
|
|
|
|
|
|
Total long-term liabilities
|
|
|
2,311,177
|
|
|
|
2,015,184
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies (Notes 8, 9 and 11)
|
|
|
|
|
|
|
|
|
Stockholders equity:
|
|
|
|
|
|
|
|
|
Series B preferred stock, $0.001 par value
(liquidation preference, $751,479)
|
|
|
|
|
|
|
|
|
Authorized: 2,300 shares
|
|
|
|
|
|
|
|
|
Issued and outstanding: 1,879 shares
|
|
|
671,501
|
|
|
|
|
|
Common stock, $0.001 par value
|
|
|
|
|
|
|
|
|
Authorized: 150,000 shares
|
|
|
|
|
|
|
|
|
Issued and outstanding: 78,431 shares at December 31,
2008 and 76,789 shares at December 31, 2007
|
|
|
78
|
|
|
|
77
|
|
Additional paid-in capital
|
|
|
3,029,694
|
|
|
|
2,937,143
|
|
Accumulated deficit
|
|
|
(393,590
|
)
|
|
|
(371,822
|
)
|
Accumulated other comprehensive (loss) income
|
|
|
(28,845
|
)
|
|
|
21,269
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
3,278,838
|
|
|
|
2,586,667
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
5,955,360
|
|
|
$
|
4,880,759
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
SF-4
Inverness Medical
Innovations, Inc. and subsidiaries
Consolidated
statements of stockholders equity and comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
Common
stock
|
|
|
|
|
|
Notes
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.001
|
|
|
|
|
|
$0.001
|
|
|
Additional
|
|
|
receivable
|
|
|
|
|
|
other
|
|
|
Total
|
|
|
Total
|
|
|
|
Number of
|
|
|
par
|
|
|
Number of
|
|
|
par
|
|
|
paid-in
|
|
|
from
|
|
|
Accumulated
|
|
|
comprehensive
|
|
|
stockholders
|
|
|
comprehensive
|
|
|
|
shares
|
|
|
value
|
|
|
shares
|
|
|
value
|
|
|
capital
|
|
|
stockholders
|
|
|
deficit
|
|
|
income
|
|
|
equity
|
|
|
loss
|
|
|
|
|
|
(in thousands,
except par value amounts)
|
|
Balance, December 31, 2005
|
|
|
|
|
|
$
|
|
|
|
|
27,497
|
|
|
$
|
27
|
|
|
$
|
515,147
|
|
|
$
|
(14,691
|
)
|
|
$
|
(110,227
|
)
|
|
$
|
7,052
|
|
|
$
|
397,308
|
|
|
|
|
|
Issuance of common stock in connection with acquisitions and
equity offering, net of issuance costs of $9,617
|
|
|
|
|
|
|
|
|
|
|
10,893
|
|
|
|
11
|
|
|
|
295,488
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
295,499
|
|
|
|
|
|
Exercise of common stock options and warrants and shares issued
under employee stock purchase plan
|
|
|
|
|
|
|
|
|
|
|
825
|
|
|
|
1
|
|
|
|
10,330
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,331
|
|
|
|
|
|
Stock-based compensation related to grants of common stock
options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,455
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,455
|
|
|
|
|
|
Stock option income tax benefits
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
567
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
567
|
|
|
|
|
|
Repayment of notes receivable from stockholder options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,691
|
|
|
|
|
|
|
|
|
|
|
|
14,691
|
|
|
|
|
|
Effect of adoption of SFAS No. 158
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,738
|
)
|
|
|
(3,738
|
)
|
|
|
|
|
Changes in cumulative translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,823
|
|
|
|
10,823
|
|
|
$
|
10,823
|
|
Unrealized gain on available-for-sale securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
44
|
|
|
|
44
|
|
|
|
44
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(16,842
|
)
|
|
|
|
|
|
|
(16,842
|
)
|
|
|
(16,842
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(5,975
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2006
|
|
|
|
|
|
$
|
|
|
|
|
39,215
|
|
|
$
|
39
|
|
|
$
|
826,987
|
|
|
$
|
|
|
|
$
|
(127,069
|
)
|
|
$
|
14,181
|
|
|
$
|
714,138
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
SF-5
Inverness Medical
Innovations, Inc. and subsidiaries
Consolidated
statements of stockholders equity and comprehensive loss
(continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
Common
stock
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
|
|
|
$0.001
|
|
|
|
|
|
$0.001
|
|
|
Additional
|
|
|
|
|
|
other
|
|
|
Total
|
|
|
Total
|
|
|
|
Number of
|
|
|
par
|
|
|
Number of
|
|
|
par
|
|
|
paid-in
|
|
|
Accumulated
|
|
|
comprehensive
|
|
|
stockholders
|
|
|
comprehensive
|
|
|
|
shares
|
|
|
value
|
|
|
shares
|
|
|
value
|
|
|
capital
|
|
|
deficit
|
|
|
income
|
|
|
equity
|
|
|
loss
|
|
|
|
|
|
(in thousands,
except par value amounts)
|
|
|
Balance, December 31, 2006
|
|
|
|
|
|
$
|
|
|
|
|
39,215
|
|
|
$
|
39
|
|
|
$
|
826,987
|
|
|
$
|
(127,069
|
)
|
|
$
|
14,181
|
|
|
$
|
714,138
|
|
|
|
|
|
Issuance of common stock in connection with acquisitions and
equity offerings, net of issuance costs of $44,204
|
|
|
|
|
|
|
|
|
|
|
35,204
|
|
|
|
35
|
|
|
|
1,859,985
|
|
|
|
|
|
|
|
|
|
|
|
1,860,020
|
|
|
|
|
|
Exercise of common stock options and warrants and shares issued
under employee stock purchase plan
|
|
|
|
|
|
|
|
|
|
|
2,370
|
|
|
|
3
|
|
|
|
55,095
|
|
|
|
|
|
|
|
|
|
|
|
55,098
|
|
|
|
|
|
Stock-based compensation related to grants of common stock
options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
57,480
|
|
|
|
|
|
|
|
|
|
|
|
57,480
|
|
|
|
|
|
Fair value associated with options exchanged in acquisitions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
135,022
|
|
|
|
|
|
|
|
|
|
|
|
135,022
|
|
|
|
|
|
Stock option income tax benefits
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,574
|
|
|
|
|
|
|
|
|
|
|
|
2,574
|
|
|
|
|
|
Minimum pension liability adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
341
|
|
|
|
341
|
|
|
$
|
341
|
|
Changes in cumulative translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,758
|
|
|
|
12,758
|
|
|
|
12,758
|
|
Unrealized loss on interest rate swap (Note 10)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(9,518
|
)
|
|
|
(9,518
|
)
|
|
|
(9,518
|
)
|
Unrealized gain on available-for-sale securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,507
|
|
|
|
3,507
|
|
|
|
3,507
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(244,753
|
)
|
|
|
|
|
|
|
(244,753
|
)
|
|
|
(244,753
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(237,665
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2007
|
|
|
|
|
|
$
|
|
|
|
|
76,789
|
|
|
$
|
77
|
|
|
$
|
2,937,143
|
|
|
$
|
(371,822
|
)
|
|
$
|
21,269
|
|
|
$
|
2,586,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
SF-6
Inverness Medical
Innovations, Inc. and subsidiaries
Consolidated
statements of stockholders equity and comprehensive loss
(continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common
stock
|
|
|
|
|
|
|
|
|
Accumulated
|
|
|
|
|
|
|
|
|
|
Preferred
stock
|
|
|
|
|
|
$0.001
|
|
|
Additional
|
|
|
|
|
|
other
|
|
|
Total
|
|
|
Total
|
|
|
|
Number of
|
|
|
|
|
|
Number of
|
|
|
par
|
|
|
paid-in
|
|
|
Accumulated
|
|
|
comprehensive
|
|
|
stockholders
|
|
|
comprehensive
|
|
|
|
shares
|
|
|
Amount
|
|
|
shares
|
|
|
value
|
|
|
capital
|
|
|
deficit
|
|
|
income
(loss)
|
|
|
equity
|
|
|
loss
|
|
|
|
|
|
(in thousands,
except par value amounts)
|
|
Balance, December 31, 2007
|
|
|
|
|
|
$
|
|
|
|
|
76,789
|
|
|
$
|
77
|
|
|
$
|
2,937,143
|
|
|
$
|
(371,822
|
)
|
|
$
|
21,269
|
|
|
$
|
2,586,667
|
|
|
|
|
|
Issuance of Series B preferred stock in connection with
acquisition of Matria Healthcare, Inc., net of issuance costs of
$350
|
|
|
1,788
|
|
|
|
657,573
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
657,573
|
|
|
|
|
|
Issuance of common stock in connection with acquisitions, net of
issuance costs of $219
|
|
|
|
|
|
|
|
|
|
|
580
|
|
|
|
|
|
|
|
20,945
|
|
|
|
|
|
|
|
|
|
|
|
20,945
|
|
|
|
|
|
Exercise of common stock options and warrants and shares issued
under employee stock purchase plan
|
|
|
|
|
|
|
|
|
|
|
1,062
|
|
|
|
1
|
|
|
|
20,712
|
|
|
|
|
|
|
|
|
|
|
|
20,713
|
|
|
|
|
|
Preferred stock dividends (Note 16)
|
|
|
91
|
|
|
|
13,928
|
|
|
|
|
|
|
|
|
|
|
|
(14,026
|
)
|
|
|
|
|
|
|
|
|
|
|
(98
|
)
|
|
|
|
|
Fair value associated with options exchanged in acquisitions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,973
|
|
|
|
|
|
|
|
|
|
|
|
20,973
|
|
|
|
|
|
Stock-based compensation related to grants of common stock
options
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26,405
|
|
|
|
|
|
|
|
|
|
|
|
26,405
|
|
|
|
|
|
Stock option income tax benefits
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,542
|
|
|
|
|
|
|
|
|
|
|
|
17,542
|
|
|
|
|
|
Minimum pension liability adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(562
|
)
|
|
|
(562
|
)
|
|
$
|
(562
|
)
|
Changes in cumulative translation adjustment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(32,889
|
)
|
|
|
(32,889
|
)
|
|
|
(32,889
|
)
|
Unrealized loss on interest rate swap (Note 10)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11,614
|
)
|
|
|
(11,614
|
)
|
|
|
(11,614
|
)
|
Unrealized loss on available-for-sale securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,049
|
)
|
|
|
(5,049
|
)
|
|
|
(5,049
|
)
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,768
|
)
|
|
|
|
|
|
|
(21,768
|
)
|
|
|
(21,768
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(71,882
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2008
|
|
|
1,879
|
|
|
$
|
671,501
|
|
|
|
78,431
|
|
|
$
|
78
|
|
|
$
|
3,029,694
|
|
|
$
|
(393,590
|
)
|
|
$
|
(28,845
|
)
|
|
$
|
3,278,838
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
SF-7
Inverness Medical
Innovations, Inc. and subsidiaries
Consolidated
statement of cash flows
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
(in
thousands)
|
|
|
Cash Flows from Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(21,768
|
)
|
|
$
|
(244,753
|
)
|
|
$
|
(16,842
|
)
|
Adjustments to reconcile net loss to net cash provided by
operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense related to amortization of original issue
discounts and write-off of deferred financing costs
|
|
|
5,930
|
|
|
|
10,963
|
|
|
|
4,158
|
|
Non-cash income related to currency hedge
|
|
|
|
|
|
|
|
|
|
|
(217
|
)
|
Non-cash stock-based compensation expense
|
|
|
26,405
|
|
|
|
52,210
|
|
|
|
5,455
|
|
Charge for in-process research and development
|
|
|
|
|
|
|
173,825
|
|
|
|
4,960
|
|
Impairment of inventory
|
|
|
4,193
|
|
|
|
|
|
|
|
707
|
|
Impairment of long-lived assets
|
|
|
20,031
|
|
|
|
3,872
|
|
|
|
8,866
|
|
Loss (gain) on sale of fixed assets
|
|
|
777
|
|
|
|
59
|
|
|
|
(1,528
|
)
|
Equity earnings of unconsolidated entities
|
|
|
(1,050
|
)
|
|
|
(4,372
|
)
|
|
|
(336
|
)
|
Interest in minority investments
|
|
|
167
|
|
|
|
1,401
|
|
|
|
(299
|
)
|
Depreciation and amortization
|
|
|
267,927
|
|
|
|
101,113
|
|
|
|
39,362
|
|
Deferred and other non-cash income taxes
|
|
|
(41,756
|
)
|
|
|
(27,892
|
)
|
|
|
(409
|
)
|
Other non-cash items
|
|
|
4,378
|
|
|
|
197
|
|
|
|
714
|
|
Changes in assets and liabilities, net of acquisitions:
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
(48,650
|
)
|
|
|
47,018
|
|
|
|
(13,846
|
)
|
Inventories, net
|
|
|
(49,226
|
)
|
|
|
(1,463
|
)
|
|
|
167
|
|
Prepaid expenses and other current assets
|
|
|
(7,373
|
)
|
|
|
15,432
|
|
|
|
(86
|
)
|
Accounts payable
|
|
|
16,467
|
|
|
|
(6,745
|
)
|
|
|
210
|
|
Accrued expenses and other current liabilities
|
|
|
(32,008
|
)
|
|
|
(33,893
|
)
|
|
|
3,294
|
|
Other non-current liabilities
|
|
|
3,400
|
|
|
|
1,783
|
|
|
|
(60
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities
|
|
|
147,844
|
|
|
|
88,755
|
|
|
|
34,270
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment
|
|
|
(66,061
|
)
|
|
|
(36,398
|
)
|
|
|
(19,717
|
)
|
Proceeds from sale of property, plant and equipment
|
|
|
1,070
|
|
|
|
264
|
|
|
|
2,244
|
|
Cash paid for acquisitions and transactional costs, net of cash
acquired
|
|
|
(649,899
|
)
|
|
|
(2,036,116
|
)
|
|
|
(131,465
|
)
|
Cash received, net of cash paid, from formation of joint venture
|
|
|
|
|
|
|
324,170
|
|
|
|
|
|
Cash received from (paid for) investments in minority interests
and marketable securities
|
|
|
12,133
|
|
|
|
(10,177
|
)
|
|
|
(25,817
|
)
|
Increase in other assets
|
|
|
(10,575
|
)
|
|
|
(28,273
|
)
|
|
|
(4,077
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(713,332
|
)
|
|
|
(1,786,530
|
)
|
|
|
(178,832
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in restricted cash
|
|
|
139,204
|
|
|
|
(141,869
|
)
|
|
|
|
|
Issuance costs associated with preferred stock
|
|
|
(350
|
)
|
|
|
|
|
|
|
|
|
Cash paid for financing costs
|
|
|
(1,401
|
)
|
|
|
(40,675
|
)
|
|
|
(2,787
|
)
|
Dividends to preferred stockholders
|
|
|
(56
|
)
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock, net of issuance costs
|
|
|
20,675
|
|
|
|
1,122,852
|
|
|
|
234,961
|
|
Net repayments on long-term debt
|
|
|
(13,787
|
)
|
|
|
(22,326
|
)
|
|
|
(20,000
|
)
|
Net proceeds (repayments) from revolving lines-of-credit
|
|
|
137,242
|
|
|
|
1,114,171
|
|
|
|
(47,879
|
)
|
Repayments of notes receivable
|
|
|
|
|
|
|
|
|
|
|
14,691
|
|
Tax benefit on exercised stock options
|
|
|
17,542
|
|
|
|
867
|
|
|
|
567
|
|
Principal payments of capital lease obligations
|
|
|
(1,300
|
)
|
|
|
(636
|
)
|
|
|
(546
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities
|
|
|
297,769
|
|
|
|
2,032,384
|
|
|
|
179,007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange effect on cash and cash equivalents
|
|
|
(5,689
|
)
|
|
|
9,019
|
|
|
|
2,389
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(273,408
|
)
|
|
|
343,628
|
|
|
|
36,834
|
|
Cash and cash equivalents, beginning of period
|
|
|
414,732
|
|
|
|
71,104
|
|
|
|
34,270
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
|
$
|
141,324
|
|
|
$
|
414,732
|
|
|
$
|
71,104
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated financial statements.
SF-8
Inverness Medical
Innovations, Inc. and subsidiaries
Notes to
consolidated financial statements
|
|
1.
|
DESCRIPTION OF
BUSINESS AND BASIS OF PRESENTATION
|
By developing new capabilities in near-patient diagnosis,
monitoring and health management, Inverness Medical Innovations,
Inc. and subsidiaries enable individuals to take charge of
improving their health and quality of life at home. Our products
and services, as well as our new product development efforts,
focus on infectious disease, cardiology, oncology, drugs of
abuse and womens health. In addition, we manufacture a
variety of vitamins and nutritional supplements that we market
under our brands and those of private label retailers in the
consumer market primarily in the United States.
Our business is organized into four primary operating segments:
(i) professional diagnostics, (ii) health management,
(iii) consumer diagnostics and (iv) vitamins and
nutritional supplements. The professional diagnostics segment
includes an array of innovative rapid diagnostic test products
and other in vitro diagnostic tests marketed to medical
professionals and laboratories for detection of infectious
diseases, cardiac conditions, oncology, drugs of abuse and
pregnancy. The health management segment provides comprehensive,
integrated programs and services focused on wellness, disease
and condition management, productivity enhancement and
informatics, all designed to reduce health-related costs and
enhance the health and quality of life of the individuals we
serve. The consumer diagnostics segment consists primarily of
manufacturing operations related to our role as the exclusive
manufacturer of products for SPD Swiss Precision Diagnostics, or
SPD, our 50/50 joint venture with The Procter & Gamble
Company, or P&G. SPD has significant operations in the
worldwide over-the-counter pregnancy and fertility/ovulation
test market. The vitamins and nutritional supplements segment
includes branded and private label vitamins and nutritional
supplements that are sold over-the-counter.
Acquisitions are an important part of our growth strategy. When
we acquire businesses, we seek to complement existing products
and services, enhance or expand our product lines
and/or
expand our customer base. We determine what we are willing to
pay for each acquisition partially based on our expectation that
we can cost effectively integrate the products and services of
the acquired companies into our existing infrastructure. In
addition, we utilize existing infrastructure of the acquired
companies to cost effectively introduce our products to new
geographic areas. All these factors contributed to the
acquisition prices of acquired businesses that were in excess of
the fair value of net assets acquired and the resultant goodwill
(Note 4).
Following the completion of our 50/50 joint venture with
P&G on May 17, 2007 (Note 13), we ceased to consolidate the
operating results of our consumer diagnostics business, which
represented $76.1 million of net product sales in 2007
(through the date the joint venture was formed) and
$171.6 million of net product sales in 2006, and instead
account for our 50% interest in the results of the joint venture
under the equity method of accounting. In our capacity as the
manufacturer of products for the joint venture, we supply
product to the joint venture and record revenue on those sales.
No gain on the proceeds that we received from P&G through
the formation of our joint venture will be recognized in our
financial statements until P&Gs option to require us
to purchase its interest in the joint venture at market value
expires after the fourth anniversary of the closing.
The consolidated financial statements include the accounts of
Inverness Medical Innovations, Inc. and its subsidiaries.
Intercompany transactions and balances are eliminated and net
earnings are reduced by the portion of the net earnings of
subsidiaries applicable to minority interests. Equity
investments in which we exercise significant influence but do
not control and are not the primary beneficiary are accounted
for using the equity method. Investments in which we are not
able to exercise significant influence over the investee and
which do not have readily determinable fair values are accounted
for under the cost method. Certain amounts for prior periods
have been reclassified to conform to the current period
classification.
SF-9
Notes to
consolidated financial statements
|
|
2.
|
SUMMARY OF
SIGNIFICANT ACCOUNTING POLICIES
|
a. Use
of estimates
To prepare our financial statements in conformity with
accounting principles generally accepted in the United States of
America, our management must make estimates and assumptions that
affect the reported amounts of assets and liabilities,
disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenue and
expenses during the reporting period. Actual results could
differ significantly from such estimates.
b. Foreign
currencies
We follow the provisions of Statement of Financial Accounting
Standards (SFAS) No. 52, Foreign Currency
Translation. In general, the functional currencies of our
foreign subsidiaries are the local currencies. For purpose of
consolidating the financial statements of our foreign
subsidiaries, all assets and liabilities of the foreign
subsidiaries are translated into U.S. dollars using the
exchange rate at each balance sheet date while the
stockholders equity accounts are translated at historical
exchange rates. Translation gains and losses that result from
the conversion of the balance sheets of the foreign subsidiaries
into U.S. dollars are recorded to cumulative translation
adjustment which is a component of accumulated other
comprehensive income within stockholders equity
(Note 18).
The revenue and expenses of our foreign subsidiaries are
translated using the average rates of exchange in effect during
each fiscal month during the year. Net realized and unrealized
foreign currency exchange transaction losses of
$0.9 million during 2008, losses of $1.6 million
during 2007 and gains of $2.6 million during 2006, are
included as a component of other income (expense), net in the
accompanying consolidated statements of operations.
c. Cash
and cash equivalents
We consider all highly liquid investments purchased with
original maturities of three months or less at the date of
acquisition to be cash equivalents. Cash equivalents consisted
of money market funds at December 31, 2008 and 2007.
d. Restricted
cash
We have restricted cash of $2.7 million and
$141.9 million as of December 31, 2008 and 2007,
respectively. Of the $141.9 million, $139.7 million
represented a cash escrow established in connection with our
February 2008 acquisition of BBI Holdings Plc, or BBI
(Note 4).
e. Marketable
securities
We account for our investment in marketable securities in
accordance with SFAS No. 115, Accounting for
Certain Investments in Debt and Equity Securities.
Securities classified as available-for-sale or trading are
carried at estimated fair value, as determined by quoted market
prices at the balance sheet date. Realized gains and losses on
securities are included in earnings and are determined using the
specific identification method. Unrealized holding gains and
losses (except for other than temporary impairments) on
securities classified as available for sale, are excluded from
earnings and are reported in accumulated other comprehensive
income, net of related tax effects. Unrealized gains and losses
on actively-traded securities are included in earnings.
Marketable securities that are held indefinitely are classified
in our accompanying balance sheet as long-term marketable
securities.
SF-10
Notes to
consolidated financial statements
f. Inventories
Inventories are stated at the lower of cost
(first-in,
first-out) or market and made up of raw material,
work-in-process
and finished goods. The cost elements of
work-in-process
and finished goods inventory consist of raw material, direct
labor and manufacturing overhead. Where finished goods inventory
is purchased from third-party manufacturers, the costs of such
finished goods inventory represent the costs to acquire such
inventory.
g. Property,
plant and equipment
We record property, plant and equipment at historical cost or,
in the case of a business combination, at fair value on the date
of the business combination. Depreciation and amortization are
computed using the straight-line method based on the following
estimated useful lives of the related assets: machinery,
laboratory equipment and tooling, 2-21 years; buildings,
20-50 years;
leasehold improvements, lesser of remaining term of lease or
estimated useful life of asset; computer software and equipment,
1-6 years and furniture and fixtures,
2-15 years.
Land is not depreciated. Depreciation and amortization expense
related to property, plant and equipment amounted to
$51.8 million, $28.3 million and $17.6 million in
2008, 2007 and 2006, respectively. Expenditures for repairs and
maintenance are expensed as incurred.
h. Goodwill
and other intangible assets with indefinite lives
We account for goodwill and other intangible assets with
indefinite lives in accordance with SFAS No. 142,
Goodwill and Other Intangible Assets, which establishes
financial accounting and reporting standards for acquired
goodwill and other intangible assets. Under the provisions of
SFAS No. 142, goodwill and indefinite-lived intangible
assets are required to be tested for impairment annually, in
lieu of being amortized, using a fair value approach at the
reporting unit level. Furthermore, testing for impairment is
required on an interim basis if an event or circumstance
indicates that it is more likely than not an impairment loss has
been incurred. An impairment loss shall be recognized to the
extent that the carrying amount of goodwill or any
indefinite-lived intangible asset exceeds its implied fair
value. Impairment losses shall be recognized in operating
results.
Our valuation methodology for assessing impairment, using the
discounted cash flows approach, requires management to make
judgments and assumptions based on historical experience and
projections of future operating performance. If these
assumptions differ materially from future results, we may record
impairment charges in the future. Our annual impairment review
performed on September 30, 2008 did not indicate that
goodwill or other indefinite-lived intangible assets related to
our professional diagnostics, health management or our consumer
diagnostics reporting units were impaired.
Despite current economic conditions and the fluctuation in our
common stock price during the fourth quarter of 2008, we
determined that, based on our 2008 financial performance, our
unchanged expectations of future financial performance as used
in our fair value analysis and the improvement in our common
stock price subsequent to year end, a triggering event that
would warrant further impairment testing had not occurred and
therefore no updated testing was performed and no goodwill
impairment was recorded during 2008. Should economic conditions
deteriorate further or remain depressed for a prolonged period
of time, estimates of future cash flows for each reporting unit
may be insufficient to support carrying value and the goodwill
assigned to it, requiring us to test for impairment. Impairment
charges, if any, may be material to our results of operations
and financial position.
i. Impairment
of other long-lived tangible and intangible assets
In accordance with SFAS No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, we evaluate
long-lived tangible and intangible assets whenever events or
changes in circumstances indicate that the carrying amount of an
asset may not be recoverable. If indicators of impairment are
present with respect
SF-11
Notes to
consolidated financial statements
to long-lived tangible and intangible assets used in operations
and undiscounted future cash flows are not expected to be
sufficient to recover the assets carrying amount,
additional analysis is performed as appropriate and the carrying
value of the long-lived asset is reduced to the estimated fair
value, if this is lower, and an impairment loss would be charged
to expense in the period the impairment is identified. We
believe that the carrying values of our other long-lived
tangible and intangible assets were realizable as of
December 31, 2008.
j. Business
acquisitions
We account for acquired businesses using the purchase method of
accounting as prescribed by SFAS No. 141, Business
Combinations. Under the purchase method, the operating
results of an acquired business are included in our consolidated
financial statements starting from the consummation date of the
acquisition. In addition, the assets acquired and liabilities
assumed must be recorded at the date of acquisition at their
respective estimated fair values, with any excess of the
purchase price over the estimated fair values of the net assets
acquired recorded as goodwill.
Significant judgment is required in estimating the fair value of
intangible assets and in assigning their respective useful
lives. The fair value estimates are based on available
historical information and on future expectations and
assumptions deemed reasonable by management, but are inherently
uncertain.
We generally employ the income method to estimate the fair value
of intangible assets, which is based on forecasts of the
expected future cash flows attributable to the respective
assets. Significant estimates and assumptions inherent in the
valuations reflect a consideration of other marketplace
participants, and include the amount and timing of future cash
flows (including expected growth rates and profitability), the
underlying product life cycles, economic barriers to entry, a
brands relative market position and the discount rate
applied to the cash flows. Unanticipated market or macroeconomic
events and circumstances may occur, which could affect the
accuracy or validity of the estimates and assumptions.
Other significant estimates associated with the accounting for
acquisitions include exit costs. We have undertaken certain
restructurings of the acquired businesses to realize
efficiencies and potential cost savings. Our restructuring
activities include the elimination of duplicate facilities,
reductions in staffing levels, and other costs associated with
exiting certain activities of the businesses we acquire.
Provided certain criteria are met, the estimated costs
associated with these restructuring activities are treated as
assumed liabilities, consistent with the guidance of Emerging
Issue Task Force (EITF) Issue
No. 95-3,
Recognition of Liabilities in Connection with a Purchase
Business Combination. Our estimates and assumptions
associated with these restructuring activities may change as we
execute approved plans. Decreases to the estimated costs are
generally recorded as an adjustment to goodwill. Increases to
the estimates are generally recorded as an adjustment to
goodwill during the purchase price allocation period (generally
within one year of the acquisition date) and as operating
expenses thereafter.
Any common stock issued in connection with our acquisitions is
determined based on the average market price of our common stock
pursuant to EITF Issue
No. 99-12,
Determination of the Measurement Date for the Market Price of
Acquirer Securities Issued in a Purchase Business
Combination.
Some of our acquisitions have involved an exchange of employee
stock options and restricted stock awards. Accordingly, we have
accounted for these exchanges within a purchase business
combination under the guidance of
SFAS No. 123-R,
Share-Based Payments. In general, to the extent that the
fair value of our awards approximate the fair value of the
acquired-company awards, the fair value of the awards has been
recognized as a component of the purchase price. The fair value
of unvested or partially-vested awards is allocated between the
vested and unvested portions of the awards. The fair value of
the unvested portion is deducted from the purchase price and
recognized as compensation cost as that portion vests.
SF-12
Notes to
consolidated financial statements
k. Income
taxes
We follow the provisions of SFAS No. 109,
Accounting for Income Taxes, under which deferred tax
assets and liabilities are determined based on differences
between financial reporting and tax bases of assets and
liabilities. Deferred tax assets and liabilities are measured
using the enacted tax rates and laws that are expected to be in
effect when the differences are expected to reverse. The
provisions of SFAS No. 109 also require the
recognition of future tax benefits such as net operating loss,
or NOL, carryforwards, to the extent that the realization of
such benefits is more likely than not. To the extent that it is
not more likely than not that we will realize such benefits, we
must establish a valuation allowance against the related
deferred tax assets (Note 19).
We follow the provisions of Financial Accounting Standards Board
(FASB) Interpretation No. 48, Accounting for
Uncertainty in Income Taxesan Interpretation of FASB
Statement No. 109, (FIN 48). In
accordance with FIN 48, we recognize some or all of the
benefit of a tax position, if that position is more likely than
not of being sustained on audit, based on the technical merits
of the position (Note 19).
l. Revenue
recognition
We primarily recognize revenue when the following four basic
criteria have been met: (1) persuasive evidence of an
arrangement exists, (2) delivery has occurred or services
rendered, (3) the fee is fixed and determinable and
(4) collection is reasonably assured.
The majority of our revenue is derived from product revenue. We
recognize revenue upon title transfer of the products to
third-party customers, less a reserve for estimated product
returns and allowances. Determination of the reserve for
estimated product returns and allowances is based on our
managements analyses and judgments regarding certain
conditions. Should future changes in conditions prove
managements conclusions and judgments on previous analyses
to be incorrect, revenue recognized for any reporting period
could be adversely affected.
Additionally, we generate services revenue in connection with
contracts with leading healthcare organizations whereby we
distribute clinical expertise through fee-based arrangements.
Revenue for fee-based arrangements is recognized over the period
in which the services are provided. Some contracts provide that
a portion of our fees are at risk if our customers do not
achieve certain financial cost savings over a period of time,
typically one year. Revenue subject to refund is not recognized
if (i) sufficient information is not available to calculate
performance measurements, or (ii) interim performance
measurements indicate that we are not meeting performance
targets. If either of these two conditions exists, we record the
amounts as other current liabilities in the consolidated balance
sheet, deferring recognition of the revenue until we establish
that we have met the performance criteria. If we do not meet the
performance targets at the end of the contractual period we are
obligated under the contract to refund some or all of the at
risk fees.
In connection with the acquisition of the Determine business in
June 2005 from Abbott Laboratories, we entered into a transition
services agreement with Abbott, whereby Abbott would continue to
distribute the acquired products until both parties agreed the
transition was completed. During the transition period, we
recognized revenue on sales of the products when title
transferred from Abbott to third party customers.
We also receive license and royalty revenue from agreements with
third-party licensees. Revenue from fixed fee license and
royalty agreements are recognized on a straight-line basis over
the obligation period of the related license agreements. License
and royalty fees that the licensees calculate based on their
sales, which we have the right to audit under most of our
agreements, are generally recognized upon receipt of the license
or royalty payments unless we are able to reasonably estimate
the fees as they are earned. License and royalty fees that are
determinable prior to the receipt thereof are recognized in the
period they are earned.
SF-13
Notes to
consolidated financial statements
m. Employee
stock-based compensation arrangements
Effective January 1, 2006, we began recording compensation
expense associated with stock options and other forms of equity
compensation in accordance with
SFAS No. 123-R,
Share-Based Payment, as interpreted by SEC Staff
Accounting Bulletin (SAB) No. 107. We adopted
the modified prospective transition method provided for under
SFAS No. 123-R,
and consequently have not retroactively adjusted results from
prior periods. Under this transition method, compensation cost
associated with stock options now includes:
(i) amortization related to the remaining unvested portion
of all stock option awards granted prior to January 1,
2006, based on the grant-date fair value estimated in accordance
with the original provisions of SFAS No. 123, and
(ii) amortization related to all stock option awards
granted subsequent to January 1, 2006, based on the
grant-date fair value estimated in accordance with the
provisions of
SFAS No. 123-R.
In addition, we record expense over the offering period in
connection with shares issued under our employee stock purchase
plan. The compensation expense for stock-based compensation
awards includes an estimate for forfeitures and is recognized
over the expected term of the options using the straight-line
method.
Our stock option plans provide for grants of options to
employees to purchase common stock at the fair market value of
such shares on the grant date of the award. The options
generally vest over a four-year period, beginning on the date of
grant, with a graded vesting schedule of 25% at the end of each
of the four years. The fair value of each option grant is
estimated on the date of grant using a Black-Scholes
option-pricing method. We use historical data to estimate the
expected price volatility and the expected forfeiture rate. The
contractual term of our stock option awards is ten years. The
risk-free rate is based on the U.S. Treasury yield curve in
effect at the time of grant with a remaining term equal to the
expected term of the option. We have not made any dividend
payments nor do we have plans to pay dividends in the
foreseeable future.
n. Net
(loss) income per common share
Net (loss) income per common share, computed in accordance with
SFAS No. 128, Earnings per Share, is based upon
the weighted average number of outstanding common shares and the
dilutive effect of common share equivalents, such as options and
warrants to purchase common stock, convertible preferred stock
and convertible notes, if applicable, that are outstanding each
year (Note 15).
o. Other
operating expenses
We expense advertising costs as incurred. In 2008, 2007 and
2006, advertising costs amounted to $15.7 million,
$16.3 million and $23.0 million, respectively, and are
included in sales and marketing expenses in the accompanying
consolidated statements of operations.
Shipping and handling costs are included in cost of net revenue
in the accompanying consolidated statements of operations.
Additionally, to the extent that we charge our customers for
shipping and handling costs, these costs are recorded as product
revenues.
p. Concentration
of credit risk, off-balance sheet risks and other risks and
uncertainties
Financial instruments that potentially subject us to
concentration of credit risk primarily consist of cash and cash
equivalents and accounts receivable. We invest our excess cash
primarily in high quality securities and limit the amount of our
credit exposure to any one financial institution. We do not
require collateral or other securities to support customer
receivables; however, we perform on-going credit evaluations of
our customers and maintain allowances for potential credit
losses.
At December 31, 2008 and 2007, we had one individual
customer account receivable balance outstanding that represented
14% and 12% of the gross account receivable balance,
respectively. During 2008 and 2007, we had one customer that
represented 22% and 17% of our net revenue, respectively, and
purchased our
SF-14
Notes to
consolidated financial statements
professional diagnostics products. During 2006, no customer
represented greater than 10% of our net revenue.
We rely on a number of third parties to manufacture certain of
our products. If any of our third-party manufacturers cannot, or
will not, manufacture our products in the required volumes, on a
cost-effective basis, in a timely manner, or at all, we will
have to secure additional manufacturing capacity. Any
interruption or delay in manufacturing could have a material
adverse effect on our business and operating results.
q. Financial
instruments and fair value of financial instruments
Our primary financial instruments at December 31, 2008 and
2007 consisted of cash equivalents, marketable securities,
accounts receivable, accounts payable, debt and our interest
rate swap contract. The estimated fair value of these financial
instruments approximates their carrying values at
December 31, 2008 and 2007. The estimated fair values have
been determined through information obtained from market
sources. We account for our derivative instruments in accordance
with SFAS No. 133, Accounting for Derivative
Instruments and Hedging Activities, and related amendments,
including SFAS No. 149, Amendment of Statement 133
on Derivative Instruments and Hedging Activities.
r. Recent
accounting pronouncements
Recently issued
standards
In June 2008, the FASB ratified EITF Issue
No. 07-05,
Determining Whether an Instrument (or Embedded Feature) is
Indexed to an Entitys Own Stock, which addresses the
accounting for certain instruments as derivatives under
SFAS No. 133, Accounting for Derivative Instruments
and Hedging Activities. Under this new pronouncement, specific
guidance is provided regarding requirements for an entity to
consider embedded features as indexed to the entitys own
stock. This Issue is effective for fiscal years beginning after
December 15, 2008. We are currently in the process of
evaluating the impact of adopting this pronouncement.
In May 2008, the FASB issued FASB Staff Position
(FSP) Accounting Principles Board (APB)
14-1,
Accounting for Convertible Debt Instruments That May Be
Settled In Cash upon Conversion (Including Partial Cash
Settlement). FSP APB
14-1
specifies that issuers of such instruments should separately
account for the liability and equity components in a manner that
will reflect the entitys nonconvertible debt borrowing
rate when interest cost is recognized in subsequent periods. FSP
APB 14-1 is
effective for financial statements issued for fiscal years
beginning after December 15, 2008 and interim periods
within those fiscal years. This FSP should be applied
retrospectively for all periods presented. We are currently in
the process of evaluating the impact of adopting this
pronouncement.
In April 2008, the FASB issued
FSP 142-3,
Determination of the Useful Life of Intangible Assets.
FSP 142-3
amends the factors that should be considered in developing
renewal or extension assumptions used to determine the useful
life of a recognized intangible asset under
SFAS No. 142, Goodwill and Other Intangible Assets.
FSP 142-3
is effective for financial statements issued for fiscal years
beginning after December 15, 2008, as well as interim
periods within those fiscal years. We are currently in the
process of evaluating the impact of adopting this pronouncement.
In March 2008, the FASB issued SFAS No. 161,
Disclosures about Derivative Instruments and Hedging
Activitiesan Amendment of FASB Statement No. 133.
This statement requires entities that utilize derivative
instruments to provide qualitative disclosures about their
objectives and strategies for using such instruments, as well as
any details of credit-risk-related contingent features contained
within derivatives. It also requires entities to disclose
additional information about the amounts and location of
derivatives located within the financial statements, how the
provisions of SFAS No. 133 have been applied and the
impact that hedges have on an entitys financial position,
financial performance and cash flows. This statement is
effective for fiscal
SF-15
Notes to
consolidated financial statements
years and interim periods beginning after November 15,
2008, with early application encouraged. We are currently in the
process of evaluating the impact of adopting this pronouncement.
In December 2007, the FASB ratified the consensus reached by the
EITF in EITF Issue
No. 07-01,
Accounting for Collaborative Arrangements Related to the
Development and Commercialization of Intellectual Property.
The EITF concluded that a collaborative arrangement is one in
which the participants are actively involved and are exposed to
significant risks and rewards that depend on the ultimate
commercial success of the endeavor. Revenues and costs incurred
with third parties in connection with collaborative arrangements
would be presented gross or net based on the criteria in EITF
Issue
No. 99-19,
Reporting Revenue Gross as a Principal versus Net as an Agent,
and other accounting literature. Payments to or from
collaborators would be evaluated and presented based on the
nature of the arrangement and its terms, the nature of the
entitys business, and whether those payments are within
the scope of other accounting literature. The nature and purpose
of collaborative arrangements are to be disclosed along with the
accounting policies and the classification and amounts of
significant financial statement amounts related to the
arrangements. Activities in the arrangement conducted in a
separate legal entity should be accounted for under other
accounting literature; however required disclosure under EITF
Issue
No. 07-01
applies to the entire collaborative agreement. This Issue is
effective for fiscal years beginning after December 15,
2008, and is to be applied retrospectively to all periods
presented for all collaborative arrangements existing as of the
effective date. We are currently in the process of evaluating
the impact of adopting this pronouncement.
In December 2007, the FASB issued SFAS No. 160,
Noncontrolling Interests in Consolidated Financial
Statementsan Amendment of Accounting Research Bulletin
(ARB) No. 51. This statement amends ARB No. 51 to
establish accounting and reporting standards for the
non-controlling interest in a subsidiary and for the
deconsolidation of a subsidiary. It clarifies that a
non-controlling interest in a subsidiary is an ownership
interest in the consolidated entity and should therefore be
reported as equity in the consolidated financial statements. The
statement also establishes standards for presentation and
disclosure of the non-controlling results on the consolidated
income statement. SFAS No. 160 is effective for fiscal
years beginning on or after December 15, 2008. We are
currently in the process of evaluating the impact of adopting
this pronouncement.
In December 2007, the FASB issued
SFAS No. 141-R,
Business Combinations. This statement replaces
SFAS No. 141, but retains the fundamental requirements
in SFAS No. 141 that the acquisition method of
accounting be used for all business combinations. This statement
requires an acquirer to recognize and measure the identifiable
assets acquired, the liabilities assumed, and any
non-controlling interest in the acquiree at their fair values as
of the acquisition date. The statement requires acquisition
costs and any restructuring costs associated with the business
combination to be recognized separately from the fair value of
the business combination.
SFAS No. 141-R
establishes requirements for recognizing and measuring goodwill
acquired in the business combination or a gain from a bargain
purchase as well as disclosure requirements designed to enable
users to better interpret the results of the business
combination.
SFAS No. 141-R
is effective for fiscal years beginning on or after
December 15, 2008. Given our history of acquisition
activity, we anticipate the adoption of
SFAS No. 141-R
to have a significant impact on our consolidated financial
statements. Early adoption of this statement is not permitted.
As of December, 31, 2008 there were $3.8 million in
capitalized acquisition costs classified in other non-current
assets. The capitalized costs will be written off in January
2009 when this statement becomes effective.
Recently adopted
standards
Effective October 2008, we adopted
FSP 157-3,
Determining the Fair Value of a Financial Asset When the
Market for That Asset Is Not Active.
FSP 157-3
clarifies the application of SFAS No. 157 in an
inactive market. It demonstrated how the fair value of a
financial asset is determined when the market for that financial
asset is inactive. The adoption of these provisions did not have
a material impact on our consolidated financial statements.
SF-16
Notes to
consolidated financial statements
Effective January 1, 2008, we adopted EITF Issue
No. 07-03,
Accounting for Nonrefundable Advance Payments for Goods or
Services to Be Used in Future Research and Development
Activities.
EITF 07-03
concludes that non-refundable advance payments for future
research and development activities should be deferred and
capitalized until the goods have been delivered or the related
services have been performed. If an entity does not expect the
goods to be delivered or services to be rendered, the
capitalized advance payment should be charged to expense. The
effect of applying this EITF is prospective for new contracts
entered into on or after the date of adoption. The adoption of
this EITF did not have a material impact on our consolidated
financial statements.
Effective January 1, 2008, we adopted
SFAS No. 159, The Fair Value Option for Financial
Assets and Financial LiabilitiesIncluding an Amendment of
FASB No. 115. This Statement provides companies with an
option to measure, at specified election dates, many financial
instruments and certain other items at fair value that are not
currently measured at fair value. The standard also establishes
presentation and disclosure requirements designed to facilitate
comparison between entities that choose different measurement
attributes for similar types of assets and liabilities. If the
fair value option is elected, the effect of the first
remeasurement to fair value is reported as a cumulative effect
adjustment to the opening balance of retained earnings. The
statement is to be applied prospectively upon adoption. The
adoption of these provisions did not have a material impact on
our consolidated financial statements.
Effective January 1, 2008, we adopted
SFAS No. 157, Fair Value Measurements, for all
financial instruments and non-financial instruments accounted
for at fair value on a recurring basis. SFAS No. 157
establishes a framework for measuring fair value in generally
accepted accounting principles, and expands disclosures about
fair value measurements. The standard applies whenever other
standards require, (or permit), assets or liabilities to be
measured at fair value. The standard does not expand the use of
fair value in any new circumstances. The FASB has provided a
one-year deferral for the implementation for other non-financial
assets and liabilities. The adoption of these provisions did not
have a material impact on our consolidated financial statements.
For further information about the adoption of the required
provisions of SFAS No. 157 see Note 7.
SF-17
Notes to
consolidated financial statements
|
|
3.
|
OTHER BALANCE
SHEET INFORMATION
|
Components of selected captions in the consolidated balance
sheets consist of (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Inventories, net:
|
|
|
|
|
|
|
|
|
Raw materials
|
|
$
|
45,161
|
|
|
$
|
45,111
|
|
Work-in-process
|
|
|
41,651
|
|
|
|
40,184
|
|
Finished goods
|
|
|
112,319
|
|
|
|
62,936
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
199,131
|
|
|
$
|
148,231
|
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net:
|
|
|
|
|
|
|
|
|
Machinery, laboratory equipment and tooling
|
|
$
|
152,760
|
|
|
$
|
134,776
|
|
Land and buildings
|
|
|
139,186
|
|
|
|
132,512
|
|
Leasehold improvements
|
|
|
22,158
|
|
|
|
29,032
|
|
Computer software and equipment
|
|
|
60,135
|
|
|
|
34,857
|
|
Furniture and fixtures
|
|
|
15,449
|
|
|
|
16,301
|
|
|
|
|
|
|
|
|
|
|
|
|
|
389,688
|
|
|
|
347,478
|
|
Less: Accumulated depreciation and amortization
|
|
|
(105,205
|
)
|
|
|
(79,598
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
284,483
|
|
|
$
|
267,880
|
|
|
|
|
|
|
|
|
|
|
Accrued expenses and other current liabilities:
|
|
|
|
|
|
|
|
|
Compensation and compensation-related
|
|
$
|
60,495
|
|
|
$
|
55,397
|
|
Advertising and marketing
|
|
|
7,433
|
|
|
|
6,308
|
|
Professional fees
|
|
|
8,517
|
|
|
|
23,436
|
|
Interest payable
|
|
|
4,459
|
|
|
|
2,436
|
|
Royalty obligations
|
|
|
13,821
|
|
|
|
8,221
|
|
Deferred revenue
|
|
|
21,977
|
|
|
|
5,337
|
|
Taxes payable
|
|
|
47,658
|
|
|
|
39,778
|
|
Acquisition-related obligations
|
|
|
29,107
|
|
|
|
22,375
|
|
Other
|
|
|
39,665
|
|
|
|
11,647
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
233,132
|
|
|
$
|
174,935
|
|
|
|
|
|
|
|
|
|
|
a. Acquisitions
in 2008
i. Acquisition
of Matria
On May 9, 2008, we acquired Matria Healthcare Inc., or
Matria, a national provider of health improvement, disease
management and high-risk pregnancy management programs and
services. The preliminary aggregate purchase price was
$834.6 million, which consisted of $141.3 million in
cash, Series B convertible preferred stock with a fair
value of approximately $657.9 million, $17.3 million
of fair value associated with Matria employee stock options
exchanged as part of the transaction and $18.0 million for
direct acquisition costs. In addition, we assumed and
immediately repaid debt totaling approximately
$279.2 million. The operating results of Matria are
included in our health management reporting unit and business
segment.
SF-18
Notes to
consolidated financial statements
A summary of the preliminary purchase price allocation for this
acquisition is as follows (in thousands):
|
|
|
|
|
Current assets
|
|
$
|
109,106
|
|
Property, plant and equipment
|
|
|
24,460
|
|
Goodwill
|
|
|
836,178
|
|
Intangible assets
|
|
|
325,385
|
|
Other non-current assets
|
|
|
27,184
|
|
|
|
|
|
|
Total assets acquired
|
|
|
1,322,313
|
|
|
|
|
|
|
Current liabilities
|
|
|
358,270
|
|
Non-current liabilities
|
|
|
129,486
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
487,756
|
|
|
|
|
|
|
Net assets acquired
|
|
|
834,557
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
17,961
|
|
Fair value of Series B convertible preferred stock issued
(1,787,834 shares)
|
|
|
657,923
|
|
Fair value of stock options exchanged (1,490,655 options)
|
|
|
17,334
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
141,339
|
|
|
|
|
|
|
We expect that all of the amount allocated to goodwill will not
be deductible for tax purposes.
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Core technology
|
|
$
|
31,000
|
|
|
|
3 years
|
|
Database
|
|
|
25,000
|
|
|
|
10 years
|
|
Trade names
|
|
|
1,185
|
|
|
|
5 months
|
|
Customer relationships
|
|
|
253,000
|
|
|
|
13 years
|
|
Non-compete agreements
|
|
|
15,200
|
|
|
|
0.75-3 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
325,385
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ii. Acquisition
of BBI
On February 12, 2008, we acquired BBI Holdings Plc, or BBI,
a publicly-traded company headquartered in the United Kingdom
that specializes in the development and manufacture of
non-invasive lateral flow tests and gold reagents. The
preliminary aggregate purchase price was $163.2 million,
which consisted of $138.6 million in cash, including
$14.7 million of cash paid for shares of BBI common stock
which we owned prior to the acquisition date, common stock with
an aggregate fair value of $14.4 million, $6.6 million
for direct acquisition costs and $3.6 million of fair value
associated with BBI employee stock options exchanged as part of
the transaction. The operating results of BBI are included in
our professional and consumer diagnostics reporting units and
business segments.
SF-19
Notes to
consolidated financial statements
A summary of the preliminary purchase price allocation for this
acquisition is as follows (in thousands):
|
|
|
|
|
Current assets
|
|
$
|
22,421
|
|
Property, plant and equipment
|
|
|
7,603
|
|
Goodwill
|
|
|
87,713
|
|
Intangible assets
|
|
|
90,201
|
|
Other non-current assets
|
|
|
3,001
|
|
|
|
|
|
|
Total assets acquired
|
|
|
210,939
|
|
|
|
|
|
|
Current liabilities
|
|
|
15,587
|
|
Non-current liabilities
|
|
|
32,141
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
47,728
|
|
|
|
|
|
|
Net assets acquired
|
|
|
163,211
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
6,581
|
|
Fair value of common stock issued (251,085 shares)
|
|
|
14,397
|
|
Fair value of stock options/awards exchanged (329,612
options/25,626 awards)
|
|
|
3,639
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
138,594
|
|
|
|
|
|
|
We expect that all of the amount allocated to goodwill will not
be deductible for tax purposes.
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Core technology
|
|
$
|
28,043
|
|
|
|
15-20 years
|
|
Trade names and other intangible assets
|
|
|
16,180
|
|
|
|
10-25 years
|
|
Customer relationships
|
|
|
45,978
|
|
|
|
7-25 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
90,201
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
iii. Acquisition
of Panbio
On January 7, 2008, we acquired Panbio Limited, or Panbio,
an Australian publicly-traded company headquartered in Brisbane,
Australia, that develops and manufactures diagnostic tests for
use in the diagnosis of a broad range of infectious diseases.
The preliminary aggregate purchase price was $36.5 million,
which consisted of $35.9 million in cash and
$0.6 million for direct acquisition costs. In June 2008, we
sold certain assets totaling $1.8 million related to a
particular product line. The sale of these assets, at their
acquisition date fair values, is reflected in the preliminary
purchase price allocation. The operating results of Panbio are
included in our professional diagnostics reporting unit and
business segment.
SF-20
Notes to
consolidated financial statements
A summary of the preliminary purchase price allocation for this
acquisition is as follows (in thousands):
|
|
|
|
|
Current assets
|
|
$
|
12,835
|
|
Property, plant and equipment
|
|
|
2,080
|
|
Goodwill
|
|
|
13,556
|
|
Intangible assets
|
|
|
17,717
|
|
Other non-current assets
|
|
|
246
|
|
|
|
|
|
|
Total assets acquired
|
|
|
46,434
|
|
|
|
|
|
|
Current liabilities
|
|
|
3,115
|
|
Non-current liabilities
|
|
|
6,810
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
9,925
|
|
|
|
|
|
|
Net assets acquired
|
|
|
36,509
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
566
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
35,943
|
|
|
|
|
|
|
We expect that all of the amount allocated to goodwill will not
be deductible for tax purposes.
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Core technology
|
|
$
|
4,154
|
|
|
|
5-7 years
|
|
Trade name
|
|
|
2,382
|
|
|
|
10 years
|
|
Customer relationships
|
|
|
11,181
|
|
|
|
17-25 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
17,717
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
iv.
|
Other
acquisitions in 2008
|
During 2008, we acquired the following assets and businesses for
an aggregate preliminary purchase price of $49.2 million,
in which we paid $42.0 million in cash, $1.7 million
in direct acquisition costs, and accrued contingent
consideration and milestone payments totaling $5.5 million:
|
|
Ø
|
Certain assets from Mochida Pharmaceutical Co., Ltd, or Mochida.
As part of the acquisition of certain assets, Mochida
transferred the exclusive distribution rights in Japan for
certain Osteomark products (Acquired April 2008)
|
|
Ø
|
Privately-owned provider of care and health management services
(Acquired July 2008)
|
|
Ø
|
Vision Biotech Pty Ltd, or Vision, located in Cape Town, South
Africa, a privately-owned distributor of rapid diagnostic
products predominantly to the South African marketplace
(Acquired September 2008)
|
|
Ø
|
Global Diagnostics CC, or Global, located in Johannesburg, South
Africa, a privately-owned contract manufacturer and distributor
of high quality rapid diagnostic tests predominantly to the
South African marketplace (Acquired September 2008)
|
|
Ø
|
DiaTeam Diagnostika und Arzneimittel Großhandel GmbH, or
DiaTeam, located in Linz, Austria, a privately-owned distributor
of high quality rapid diagnostic tests predominantly to the
Austrian marketplace (Acquired September 2008)
|
|
Ø
|
Prodimol Biotecnologia S.A., or Prodimol, located in Brazil, a
privately-owned distributor of high quality rapid diagnostic
tests predominantly to the Brazilian marketplace (Acquired
October 2008)
|
SF-21
Notes to
consolidated financial statements
|
|
Ø |
Ameditech, Inc., or Ameditech, located in San Diego,
California, a leading manufacturer of high quality drugs of
abuse diagnostic tests (Acquired December 2008)
|
A summary of the preliminary purchase price allocation for these
acquisitions is as follows (in thousands):
|
|
|
|
|
Current assets
|
|
$
|
10,966
|
|
Property, plant and equipment
|
|
|
655
|
|
Goodwill
|
|
|
16,238
|
|
Other non-current assets
|
|
|
173
|
|
Intangible assets
|
|
|
36,938
|
|
|
|
|
|
|
Total assets acquired
|
|
|
64,970
|
|
|
|
|
|
|
Current liabilities
|
|
|
5,838
|
|
Non-current liabilities
|
|
|
9,955
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
15,793
|
|
|
|
|
|
|
Net assets acquired
|
|
|
49,177
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
1,725
|
|
Accrued earned milestone and contingent consideration
|
|
|
5,466
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
41,986
|
|
|
|
|
|
|
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Core technology
|
|
$
|
2,866
|
|
|
|
6-10 years
|
|
Trade names
|
|
|
2,690
|
|
|
|
10 years
|
|
Customer relationships
|
|
|
29,477
|
|
|
|
3.5-14 years
|
|
Non-compete agreements
|
|
|
1,063
|
|
|
|
2-5 years
|
|
Manufacturing know-how
|
|
|
842
|
|
|
|
5 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets
|
|
$
|
36,938
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mochida, Vision, Global, DiaTeam, Prodimol and Ameditech are
included in our professional diagnostics reporting unit and
business segment; and the healthcare acquisition is included in
our health management reporting unit and business segment.
Goodwill has been recognized in the Vision, Global, DiaTeam,
Prodimol and Ameditech transactions and amounted to
approximately $16.2 million. Goodwill related to these
acquisitions, excluding Ameditech, is not deductible for tax
purposes.
b. Acquisitions
in 2007
i. Acquisition
of ParadigmHealth
On December 21, 2007, we acquired ParadigmHealth, Inc., or
ParadigmHealth, a privately-owned leading provider of precise
medical management to provide optimal health outcomes for
acutely ill and clinically complex patients. The aggregate
purchase price was $236.8 million, which consisted of
$236.0 million in cash and $0.8 million for direct
acquisition costs. The operating results of ParadigmHealth are
included in our health management reporting unit and business
segment.
SF-22
Notes to
consolidated financial statements
A summary of the purchase price allocation for this acquisition
is as follows (in thousands):
|
|
|
|
|
Current assets
|
|
$
|
34,498
|
|
Property, plant and equipment
|
|
|
2,163
|
|
Goodwill
|
|
|
168,172
|
|
Intangible assets
|
|
|
61,449
|
|
|
|
|
|
|
Total assets acquired
|
|
|
266,282
|
|
|
|
|
|
|
Current liabilities
|
|
|
1,094
|
|
Non-current liabilities
|
|
|
28,397
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
29,491
|
|
|
|
|
|
|
Net assets acquired
|
|
|
236,791
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
844
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
235,947
|
|
|
|
|
|
|
We expect that substantially all of the amount allocated to
goodwill will not be deductible for tax purposes.
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Core technology
|
|
$
|
6,900
|
|
|
|
5-10 years
|
|
Trademarks
|
|
|
249
|
|
|
|
9 months
|
|
Software
|
|
|
5,100
|
|
|
|
8 years
|
|
Non-compete agreements
|
|
|
2,700
|
|
|
|
2 years
|
|
Customer relationships
|
|
|
46,500
|
|
|
|
6-21 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
61,449
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ii. Acquisition
of Redwood
On December 20, 2007, we acquired Redwood Toxicology
Laboratories, Inc., or Redwood, a privately-owned drugs of abuse
diagnostics and testing company. The aggregate purchase price
was $53.8 million, which consisted of $53.3 million in
cash and $0.5 million for direct acquisition costs. In
addition, we assumed and paid debt of $47.7 million. The
operating results of Redwood are included in our professional
diagnostics reporting unit and business segment.
SF-23
Notes to
consolidated financial statements
A summary of the purchase price allocation for this acquisition
is as follows (in thousands):
|
|
|
|
|
Current assets
|
|
$
|
11,234
|
|
Property, plant and equipment
|
|
|
5,653
|
|
Goodwill
|
|
|
21,471
|
|
Intangible assets
|
|
|
66,020
|
|
Other non-current assets
|
|
|
84
|
|
|
|
|
|
|
Total assets acquired
|
|
|
104,462
|
|
|
|
|
|
|
Current liabilities
|
|
|
2,947
|
|
Non-current liabilities
|
|
|
47,708
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
50,655
|
|
|
|
|
|
|
Net assets acquired
|
|
|
53,807
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
546
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
53,261
|
|
|
|
|
|
|
We expect that substantially all of the amount allocated to
goodwill will not be deductible for tax purposes.
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Trademarks
|
|
$
|
5,970
|
|
|
|
10 years
|
|
Non-compete agreements
|
|
|
2,800
|
|
|
|
2-5 years
|
|
Customer relationships
|
|
|
57,250
|
|
|
|
11-12.5 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
66,020
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
iii. Acquisition
of Alere
On November 16, 2007, we acquired Alere Medical, Inc., or
Alere Medical, a privately-held leading provider of care and
health management services. The aggregate purchase price was
$311.3 million, which consisted of $128.6 million in
cash, common stock with an aggregate fair value of
$161.1 million, $1.0 million for direct acquisition
costs and $20.6 million of fair value associated with Alere
Medical employee stock options which were exchanged as part of
the transaction. The operating results of Alere Medical are
included in our health management reporting unit and business
segment.
With respect to Alere Medical, the terms of the acquisition
agreement provided for contingent consideration payable to each
Alere Medical stockholder who owned shares of our common stock
or retained the option to purchase shares of our common stock on
the six-month anniversary of the closing of the acquisition. The
contingent consideration, payable in cash or stock at our
election, was equal to the number of such shares of our common
stock or options to purchase our common stock held on the
six-month anniversary multiplied by the amount that $58.31
exceeded the greater of the average price of our common stock
for the ten business days preceding the six-month anniversary
date, or 75% of $58.31. Accordingly, based on the price of our
common stock for the ten business days preceding the six-month
anniversary of the closing of the acquisition, we issued
approximately 0.1 million shares of our common stock on
May 30, 2008 to the Alere Medical stockholders based on the
remaining outstanding shares at that time. Payment of this
contingent consideration did not impact the purchase price for
this acquisition.
SF-24
Notes to
consolidated financial statements
A summary of the purchase price allocation for this acquisition
is as follows (dollars in thousands):
|
|
|
|
|
Current assets
|
|
$
|
13,332
|
|
Property, plant and equipment
|
|
|
8,897
|
|
Goodwill
|
|
|
262,565
|
|
Intangible assets
|
|
|
55,500
|
|
Other non-current assets
|
|
|
5,523
|
|
|
|
|
|
|
Total assets acquired
|
|
|
345,817
|
|
|
|
|
|
|
Current liabilities
|
|
|
10,651
|
|
Non-current liabilities
|
|
|
23,880
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
34,531
|
|
|
|
|
|
|
Net assets acquired
|
|
|
311,286
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
959
|
|
Fair value of common stock issued (2,762,182 shares)
|
|
|
161,086
|
|
Fair value of stock options exchanged (380,894 options)
|
|
|
20,614
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
128,627
|
|
|
|
|
|
|
We expect that substantially all of the amount allocated to
goodwill will not be deductible for tax purposes.
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Core technology
|
|
$
|
6,100
|
|
|
|
3-6 years
|
|
Trademarks
|
|
|
1,500
|
|
|
|
10 years
|
|
Customer relationships
|
|
|
46,300
|
|
|
|
9 years
|
|
Non-compete agreements
|
|
|
1,600
|
|
|
|
0.5-1 year
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
55,500
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
iv. Acquisition
of HemoSense
On November 6, 2007, we acquired HemoSense, Inc., or
HemoSense, a publicly-traded developer and marketer of
point-of-care testing products for therapeutic drug monitoring.
The aggregate purchase price was $244.0 million, which
consisted of common stock with an aggregate fair value of
$226.4 million, $0.9 million for direct acquisition
costs and $16.7 million of fair value associated with
HemoSense employee stock options which were exchanged as part of
the transaction. The operating results of HemoSense are included
in our professional diagnostics reporting unit and business
segment.
SF-25
Notes to
consolidated financial statements
A summary of the purchase price allocation for this acquisition
is as follows (dollars in thousands):
|
|
|
|
|
Current assets
|
|
$
|
23,399
|
|
Property, plant and equipment
|
|
|
1,936
|
|
Goodwill
|
|
|
137,791
|
|
Intangible assets
|
|
|
100,670
|
|
Other non-current assets
|
|
|
232
|
|
|
|
|
|
|
Total assets acquired
|
|
|
264,028
|
|
|
|
|
|
|
Current liabilities
|
|
|
15,232
|
|
Non-current liabilities
|
|
|
4,747
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
19,979
|
|
|
|
|
|
|
Net assets acquired
|
|
|
244,049
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
939
|
|
Fair value of common stock issued (3,691,369 shares)
|
|
|
226,415
|
|
Fair value of stock options exchanged (380,732 options)
|
|
|
16,695
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
|
|
|
|
|
|
|
We expect that substantially all of the amount allocated to
goodwill will not be deductible for tax purposes.
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Core technology
|
|
$
|
24,130
|
|
|
|
1-10 years
|
|
Trademarks
|
|
|
7,100
|
|
|
|
10 years
|
|
Customer relationships
|
|
|
69,100
|
|
|
|
20 years
|
|
Non-compete agreements
|
|
|
300
|
|
|
|
1 year
|
|
Internally-developed software
|
|
|
40
|
|
|
|
10 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
100,670
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
v. Acquisition
of Cholestech
On September 12, 2007, we acquired Cholestech Corporation,
or Cholestech, a publicly-traded leading provider of diagnostic
tools and information for immediate risk assessment and
therapeutic monitoring of heart disease and inflammatory
disorders. The aggregate purchase price was $354.7 million,
which consisted of common stock with an aggregate fair value of
$329.8 million, $4.6 million for direct acquisition
costs and $20.3 million of fair value associated with the
Cholestech employee stock options and restricted stock awards
which were exchanged as part of the transaction. The operating
results of Cholestech are included in our cardiology reporting
unit of our professional diagnostics business segment.
SF-26
Notes to
consolidated financial statements
A summary of the purchase price allocation for this acquisition
is as follows (dollars in thousands):
|
|
|
|
|
Current assets
|
|
$
|
83,377
|
|
Property, plant and equipment
|
|
|
6,643
|
|
Goodwill
|
|
|
143,611
|
|
Intangible assets
|
|
|
209,078
|
|
Other non-current assets
|
|
|
669
|
|
|
|
|
|
|
Total assets acquired
|
|
|
443,378
|
|
|
|
|
|
|
Current liabilities
|
|
|
17,685
|
|
Non-current liabilities
|
|
|
71,032
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
88,717
|
|
|
|
|
|
|
Net assets acquired
|
|
|
354,661
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
4,556
|
|
Fair value of common stock issued (6,840,361 shares)
|
|
|
329,774
|
|
Fair value of stock options/awards exchanged (733,077
options/awards)
|
|
|
20,331
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
|
|
|
|
|
|
|
We expect that substantially all of the amount allocated to
goodwill will not be deductible for tax purposes.
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Core technology
|
|
$
|
83,833
|
|
|
|
13 years
|
|
Trademarks
|
|
|
20,590
|
|
|
|
10 years
|
|
Customer relationships
|
|
|
99,060
|
|
|
|
26 years
|
|
License agreement
|
|
|
355
|
|
|
|
7 years
|
|
Non-compete agreements
|
|
|
5,040
|
|
|
|
1.5-2 years
|
|
Internally-developed software
|
|
|
200
|
|
|
|
7 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
209,078
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
vi. Acquisition
of Biosite
On June 29, 2007, we completed our acquisition of Biosite
Incorporated, or Biosite, a publicly-traded global medical
diagnostic company utilizing a biotechnology approach to create
products for the diagnosis of critical diseases and conditions.
The aggregate purchase price was $1.8 billion, which
consisted of $1.6 billion in cash, $68.9 million in
estimated direct acquisition costs and $77.4 million of
fair value associated with Biosite employee stock options which
were exchanged as part of the transaction. In connection with
our acquisition of Biosite, we also recorded $45.2 million
of compensation expense associated with unvested stock options.
The operating results of Biosite are included in our cardiology
reporting unit of our professional diagnostics business segment.
SF-27
Notes to
consolidated financial statements
A summary of the purchase price allocation for this acquisition
is as follows (dollars in thousands):
|
|
|
|
|
Current assets
|
|
$
|
325,804
|
|
Property, plant and equipment
|
|
|
145,144
|
|
Goodwill
|
|
|
778,734
|
|
Intangible assets
|
|
|
663,891
|
|
In-process research and development
|
|
|
169,000
|
|
Other non-current assets
|
|
|
102,343
|
|
|
|
|
|
|
Total assets acquired
|
|
|
2,184,916
|
|
|
|
|
|
|
Current liabilities
|
|
|
128,971
|
|
Non-current liabilities
|
|
|
266,621
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
395,592
|
|
|
|
|
|
|
Net assets acquired
|
|
|
1,789,324
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
68,897
|
|
Cash settlement of vested stock options
|
|
|
51,503
|
|
Non-cash income tax benefits on stock options
|
|
|
2,574
|
|
Fair value of stock options exchanged (753,863 options)
|
|
|
25,879
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
1,640,471
|
|
|
|
|
|
|
As part of the purchase price allocation, IPR&D projects
have been valued at $169.0 million. These are projects that
have not yet achieved technological feasibility as of the date
of our acquisition of Biosite.
We expect that substantially all of the amount allocated to
goodwill will not be deductible for tax purposes.
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their and respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Core technology
|
|
$
|
237,691
|
|
|
|
5-19.5 years
|
|
Trademarks
|
|
|
78,100
|
|
|
|
10.5 years
|
|
Customer relationships
|
|
|
348,100
|
|
|
|
1.5-22.5 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
663,891
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
vii. Acquisition
of Instant
On March 12, 2007, we acquired 75% of the issued and
outstanding capital stock of Instant Technologies, Inc., or
Instant, a privately-owned distributor of rapid drugs of abuse
diagnostic products used in the workplace, criminal justice and
other testing markets. On December 28, 2007, we acquired
the remaining 25% interest, bringing the aggregate purchase
price to $60.8 million, which consisted of
$38.9 million in cash, common stock with an aggregate fair
value of $21.5 million and $0.3 million in direct
acquisition costs. In addition, we assumed and paid debt of
$4.9 million. The operating results of Instant are included
in our professional diagnostics reporting unit and business
segment.
SF-28
Notes to
consolidated financial statements
A summary of the purchase price allocation for this acquisition
is as follows (dollars in thousands):
|
|
|
|
|
Current assets
|
|
$
|
9,012
|
|
Property, plant and equipment
|
|
|
141
|
|
Goodwill
|
|
|
43,708
|
|
Intangible assets
|
|
|
28,520
|
|
|
|
|
|
|
Total assets acquired
|
|
|
81,381
|
|
|
|
|
|
|
Current liabilities
|
|
|
4,273
|
|
Non-current liabilities
|
|
|
16,334
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
20,607
|
|
|
|
|
|
|
Net assets acquired
|
|
|
60,774
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
348
|
|
Fair value of common stock issued (463,399 shares)
|
|
|
21,530
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
38,896
|
|
|
|
|
|
|
We expect that the amount allocated to goodwill will not be
deductible for tax purposes.
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Trademarks
|
|
$
|
3,170
|
|
|
|
5 years
|
|
Customer relationships
|
|
|
25,350
|
|
|
|
12 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
28,520
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
viii. Other
acquisitions in 2007
During the year ended December 31, 2007, we acquired the
following businesses for an aggregate purchase price of
$184.5 million, in which we paid $116.0 million in
cash, issued 1.0 million shares of our common stock with an
aggregate fair value of $54.1 million, issued notes payable
totaling $9.6 million, incurred $4.5 million in direct
acquisition costs and accrued milestone payments totaling
$0.3 million:
|
|
Ø
|
Matritech, Inc., or Matritech, located in Newton, Massachusetts
and Freiburg, Germany, a biotechnology company principally
engaged in the development, manufacturing, marketing,
distribution and licensing of cancer diagnostic technologies and
products (Acquired December 2007)
|
|
Ø
|
Aska Diagnostic, Inc., or Aska, located in Tokyo, Japan, a
distributor of professional diagnostics in Japan (Acquired
December 2007)
|
|
Ø
|
90.91% share in Biosystems S.A., or Biosystems, located in Cali
and Bogota, Colombia, a distributor of diagnostics tests,
instruments and reagents throughout Colombia (Acquired December
2007). In October 2008, we acquired the remaining 9.09% interest
in Biosystems
|
|
Ø
|
the assets of Akubio, a research company located in Cambridge,
England (Acquired October 2007)
|
|
Ø
|
Bio-Stat Healthcare Group, or Bio-Stat, located in Cheshire,
United Kingdom, a privately-owned distributor of core laboratory
and point-of-care diagnostic testing products to the U.K.
marketplace (Acquired October 2007)
|
SF-29
Notes to
consolidated financial statements
Ø Spectral
Diagnostics Private Limited and its affiliate Source Diagnostics
(India) Private Limited, or Spectral/Source, located in New
Delhi and Shimla, India, distributes professional diagnostics in
India (Acquired July 2007)
|
|
Ø
|
52.45% share in Diamics, Inc., or Diamics, located in Novato,
California, a developer of molecular-based cancer screening and
diagnostic systems (Acquired July 2007)
|
|
Ø
|
Quality Assured Services, Inc., or QAS, located in Orlando,
Florida, a privately-owned provider of diagnostic home tests and
services in the U.S. marketplace (Acquired June 2007)
|
|
Ø
|
Orange Medical, or Orange, located in Tilburg, The Netherlands,
a manufacturer and marketer of rapid diagnostic products to the
Benelux marketplace (Acquired May 2007)
|
|
Ø
|
Promesan S.r.l., or Promesan, located in Milan, Italy, a
distributor of point-of-care diagnostic testing products to the
Italian marketplace (Acquired January 2007)
|
|
Ø
|
First Check Diagnostics LLC, or First Check, located in Lake
Forrest, California, a privately-held diagnostics company in the
field of home testing for drugs of abuse, including marijuana,
cocaine, methamphetamines and opiates (Acquired January 2007)
|
|
Ø
|
the assets of Nihon Schering K.K., or NSKK, located in Japan, a
diagnostic distribution business (Acquired January 2007)
|
|
Ø
|
Gabmed GmbH, or Gabmed, located in Nettetal, Germany, a
distributor of point-of-care diagnostic testing products in the
German marketplace (Acquired January 2007)
|
|
Ø
|
Med-Ox Chemicals Limited, or Med-Ox, located in Ottawa, Canada,
a distributor of professional diagnostic testing products in the
Canadian marketplace (Acquired January 2007)
|
A summary of the purchase price allocation for these
acquisitions is as follows (in thousands):
|
|
|
|
|
Current assets
|
|
$
|
38,518
|
|
Property, plant and equipment
|
|
|
4,145
|
|
Goodwill
|
|
|
110,255
|
|
Intangible assets
|
|
|
74,557
|
|
In-process research and development
|
|
|
4,826
|
|
Other non-current assets
|
|
|
838
|
|
|
|
|
|
|
Total assets acquired
|
|
|
233,139
|
|
|
|
|
|
|
Current liabilities
|
|
|
29,100
|
|
Non-current liabilities
|
|
|
19,584
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
48,684
|
|
|
|
|
|
|
Net assets acquired
|
|
|
184,455
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
4,488
|
|
Notes payable
|
|
|
9,551
|
|
Accrued earned milestones
|
|
|
259
|
|
Fair value of common stock issued (1,017,244 shares)
|
|
|
54,111
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
116,046
|
|
|
|
|
|
|
NSKK and Promesan are included in our professional and consumer
diagnostics reporting units and business segments; Matritech,
Aska, Biosystems, Bio-Stat, Akubio, Spectral/Source, Orange,
Gabmed and Med-Ox are included in our professional diagnostics
reporting unit and business segment; QAS is included in our
health management reporting unit and business segment; and First
Check is included in our consumer diagnostics reporting unit and
business segment. Diamics is consolidated and included in our
professional diagnostics reporting unit and business segment.
Goodwill has been recognized in the Matritech, Aska, Biosystems,
SF-30
Notes to
consolidated financial statements
Bio-Stat,
Spectral/Source, Diamics, QAS, Orange, Gabmed, Promesan, First
Check and Med-Ox transactions and amounted to approximately
$110.3 million. Goodwill related to these acquisitions,
with the exception of Matritech and First Check, is not
deductible for tax purposes.
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Core technology
|
|
$
|
4,234
|
|
|
|
7.0-13.5 years
|
|
Supplier relationships
|
|
|
3,882
|
|
|
|
15 years
|
|
Trademarks
|
|
|
9,278
|
|
|
|
2-10 years
|
|
License agreements
|
|
|
920
|
|
|
|
15 years
|
|
Customer relationships
|
|
|
53,294
|
|
|
|
10-20 years
|
|
Non-compete agreements
|
|
|
801
|
|
|
|
3-4 years
|
|
Internally-developed software
|
|
|
1,910
|
|
|
|
7 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
|
74,319
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trademark
|
|
|
238
|
|
|
|
N/A
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with indefinite lives
|
|
|
238
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets
|
|
$
|
74,557
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
c. Acquisitions
in 2006
i. Acquisition
of the Innovacon business, including the ABON facility
On March 31, 2006, we acquired the assets of ACON
Laboratories business of researching, developing,
manufacturing, marketing and selling lateral flow immunoassay
and directly-related products in the United States, Canada,
Europe (excluding Russia, the former Soviet Republics that are
not part of the European Union and Turkey), Israel, Australia,
Japan and New Zealand, or the Innovacon business. The
preliminary aggregate purchase price was approximately
$97.7 million which consisted of $55.1 million in
cash, common stock with an aggregate fair value of
$19.7 million, $12.9 million in estimated direct
acquisition costs and an additional liability of
$10.0 million which was paid in 2007, pursuant to the
purchase agreement.
On May 15, 2006, as part of the Innovacon business we
acquired a newly-constructed manufacturing facility in Hangzhou,
China, pursuant to the terms of our acquisition agreement with
ACON Laboratories, Inc. and its affiliates. In connection with
the acquisition of the new facility, we acquired ABON BioPharm
(Hangzhou) Co., Ltd, or ABON, the direct owner of the new
factory and now our subsidiary. The preliminary aggregate
purchase price was approximately $20.8 million which
consisted of $8.8 million in cash and common stock with an
aggregate fair value of $12.0 million. In addition,
pursuant to the acquisition agreement, we made an additional
payment of $4.1 million in cash as a result of the amount
of cash acquired, net of indebtedness assumed, which increased
the preliminary aggregate purchase price to $24.9 million.
This acquisition also had contingent payments due if the
attainment of certain milestones were met. These milestones were
achieved in 2008 resulting in an additional $6.0 million
cash paid. We have made cash payments totaling
$49.0 million and issued common stock with an aggregate
fair value of $21.3 million as various milestones were
achieved. This brings the aggregate purchase price for the
Innovacon business, including the ABON facility to a total of
$192.9 million. The operating results of the Innovacon
business are included in our professional and consumer
diagnostics reporting units and business segments.
SF-31
Notes to
consolidated financial statements
A summary of the purchase price allocation for this acquisition
including the ABON facility discussed above is as follows
(dollars in thousands):
|
|
|
|
|
Current assets
|
|
$
|
25,914
|
|
Property, plant and equipment
|
|
|
10,274
|
|
Goodwill
|
|
|
120,920
|
|
Intangible assets
|
|
|
48,000
|
|
|
|
|
|
|
Total assets acquired
|
|
|
205,108
|
|
|
|
|
|
|
Current liabilities
|
|
|
4,081
|
|
Non-current liabilities
|
|
|
8,125
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
12,206
|
|
|
|
|
|
|
Net assets acquired
|
|
|
192,902
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
12,962
|
|
Fair value of common stock issued (1,871,250 shares)
|
|
|
53,052
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
126,888
|
|
|
|
|
|
|
We expect that substantially all of the amount allocated to
goodwill will not be deductible for tax purposes.
Customer relationships are amortized based on patterns in which
the economic benefits of customer relationships are expected to
be utilized. Other finite-lived identifiable assets are
amortized on a straight-line basis. The following are the
intangible assets acquired and their respective amortizable
lives (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Core technology
|
|
$
|
16,200
|
|
|
|
7 years
|
|
Supplier relationships
|
|
|
3,300
|
|
|
|
1.8 years
|
|
Trademarks
|
|
|
800
|
|
|
|
10 years
|
|
Customer relationships
|
|
|
27,700
|
|
|
|
16.8-17.8 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
48,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additionally, in connection with the acquisition of the
Innovacon business, we entered into an agreement for the
purchase of ACON Laboratories lateral flow immunoassay
sales and distribution business in all territories not included
within the territories acquired in connection with our
March 31, 2006 acquisition described above. Under the terms
of this agreement, in the event that this business achieves a
specified level of profitability, we will acquire this business
in 2009 for a formulaic price based on the revenues and earnings
of the business. Alternatively, we may elect not to complete the
acquisition of the business in exchange for a payment equal to
15% of the purchase price that would have been due had we
elected to complete the acquisition.
ii. Acquisition
of Clondiag
On February 28, 2006, we acquired 67.45% of CLONDIAG chip
technologies GmbH, or Clondiag, a privately-held company located
in Jena in Germany which is developing a multiplexing technology
for nucleic acid and immunoassay-based diagnostics. Pursuant to
the acquisition agreement, we purchased the remaining 32.55% on
August 31, 2006. The aggregate purchase price was
$23.1 million, which consisted of an initial cash payment
of $11.9 million, common stock with an aggregate fair value
of $5.8 million, a $5.3 million cash payment to
acquire the remaining 32.55% stock ownership and
$0.1 million in direct acquisition costs. Additionally,
pursuant to the terms of the acquisition agreement, we have an
obligation to settle existing employee bonus arrangements with
the Clondiag employees totaling 1.1 million
($1.3 million). In
SF-32
Notes to
consolidated financial statements
connection with this obligation, we issued common stock with a
fair value of $0.7 million to the employees of Clondiag and
a cash payment of $0.5 million. As of December 31,
2008, our remaining obligation was $0.1 million. This
obligation increased our aggregate purchase price to
$24.4 million as of December 31, 2006 and resulted in
additional goodwill.
In addition, the terms of the acquisition agreement provided for
contingent consideration in the event that four specified
products were developed on Clondiags platform technology
during the three years following the acquisition date. This
contingent consideration has been accounted for as an increase
in the aggregate purchase price when the milestones are
achieved. During 2007, we paid cash of $0.9 million and
issued 56,079 shares of our common stock with a fair value
of $1.5 million, in conjunction with Clondiag meeting one
of the milestones mentioned above. During 2008, we paid cash of
$2.6 million and issued 0.2 million shares of our
common stock with a fair value of $4.5 million in conjunction
with Clondiag meeting the final three milestones. Upon
settlement of the third and fourth milestones, we recognized a
$0.2 million foreign currency exchange gain which was
included in the aggregate purchase price. The payments of the
contingent consideration have increased our aggregate purchase
price to $34.1 million. The operating expenses of Clondiag,
which consist principally of research and development
activities, have been included in our corporate and other
business segment in 2006 and in our professional diagnostics
segment in 2008 and 2007.
A summary of the purchase price allocation for this acquisition
is as follows (dollars in thousands):
|
|
|
|
|
Current assets
|
|
$
|
1,191
|
|
Property, plant and equipment
|
|
|
1,783
|
|
Goodwill
|
|
|
16,937
|
|
Intangible assets
|
|
|
11,310
|
|
In-process research and development
|
|
|
4,960
|
|
Other non-current assets
|
|
|
20
|
|
|
|
|
|
|
Total assets acquired
|
|
|
36,201
|
|
|
|
|
|
|
Current liabilities
|
|
|
1,296
|
|
Non-current liabilities
|
|
|
850
|
|
|
|
|
|
|
Total liabilities assumed
|
|
|
2,146
|
|
|
|
|
|
|
Net assets acquired
|
|
|
34,055
|
|
Less:
|
|
|
|
|
Acquisition costs
|
|
|
92
|
|
Realized foreign currency exchange gain
|
|
|
221
|
|
Accrued obligation cost
|
|
|
55
|
|
Fair value of common stock issued (467,415 shares)
|
|
|
12,457
|
|
|
|
|
|
|
Cash consideration
|
|
$
|
21,230
|
|
|
|
|
|
|
We also evaluated certain in-process research and development
projects and have expensed, as in-process research and
development, those projects that have not yet attained technical
feasibility. The amount expensed during the year ended
December 31, 2006 was $5.0 million.
We expect that substantially all of the amount allocated to
goodwill will not be deductible for tax purposes.
Other finite-lived identifiable assets are amortized on a
straight-line basis. The following are the intangible assets
acquired and their respective amortizable lives (dollars in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Amount
|
|
|
Amortizable
life
|
|
|
|
|
Core technology
|
|
$
|
11,310
|
|
|
|
20 years
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
11,310
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SF-33
Notes to
consolidated financial statements
d. Restructuring
plans related to business combinations
In connection with several of our acquisitions, we initiated
integration plans to consolidate and restructure certain
functions and operations, including the relocation and
termination of certain personnel of these acquired entities and
the closure of certain of the acquired entities leased
facilities. These costs have been recognized as liabilities
assumed, in connection with the acquisition of these entities in
accordance with EITF Issue
No. 95-3,
and are subject to potential adjustments as certain exit
activities are confirmed or refined. The following table
summarizes the liabilities established for exit activities
related to these acquisitions (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Severance
|
|
|
Facility
|
|
|
Total exit
|
|
|
|
related
|
|
|
and
other
|
|
|
activities
|
|
|
|
|
Balance at December 31, 2005
|
|
$
|
1,489
|
|
|
$
|
939
|
|
|
$
|
2,428
|
|
Payments
|
|
|
(172
|
)
|
|
|
(150
|
)
|
|
|
(322
|
)
|
Currency adjustments
|
|
|
177
|
|
|
|
|
|
|
|
177
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
1,494
|
|
|
|
789
|
|
|
|
2,283
|
|
Acquisitions
|
|
|
19,823
|
|
|
|
1,327
|
|
|
|
21,150
|
|
Payments
|
|
|
(6,763
|
)
|
|
|
(218
|
)
|
|
|
(6,981
|
)
|
Currency adjustments
|
|
|
25
|
|
|
|
|
|
|
|
25
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007
|
|
|
14,579
|
|
|
|
1,898
|
|
|
|
16,477
|
|
Acquisitions
|
|
|
19,561
|
|
|
|
3,897
|
|
|
|
23,458
|
|
Payments
|
|
|
(23,407
|
)
|
|
|
(854
|
)
|
|
|
(24,261
|
)
|
Currency adjustments
|
|
|
(385
|
)
|
|
|
(15
|
)
|
|
|
(400
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008
|
|
$
|
10,348
|
|
|
$
|
4,926
|
|
|
$
|
15,274
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
i. 2008
acquisitions
In connection with our acquisition of Matria, we implemented an
integration plan to improve operating efficiencies and eliminate
redundant costs resulting from the acquisition. The
restructuring plan impacted all cost centers within the Matria
organization, as activities were combined with our existing
business operations. We recorded $15.2 million in exit
costs, all of which relates to change in control and severance
costs to involuntarily terminate employees. As of
December 31, 2008, $4.0 million in severance costs
remain unpaid.
In conjunction with our acquisition of Panbio, we formulated a
restructuring plan to realize efficiencies and cost savings. In
February 2008, we agreed upon a plan to close Panbios
facility located in Columbia, Maryland. The manufacturing
operation at the Maryland-based facility has been transferred to
a third-party manufacturer and the sales and distribution of the
products at this facility has been transferred to our
newly-formed shared services center in Orlando, Florida. We
recorded $0.6 million in exit costs, including
$0.4 million related to facility and other exit costs and
$0.2 million related to severance costs. As of
December 31, 2008, $0.3 million in exit costs remain
unpaid. See Note 23 for additional restructuring charges
related to the Panbio facility closure and integration.
Although we believe our plan and estimated exit costs for our
2008 acquisitions are reasonable, actual spending for exit
activities may differ from current estimated exit costs.
ii. 2007
acquisitions
In conjunction with our acquisition of Biosite, we implemented
an integration plan to improve efficiencies and eliminate
redundant costs resulting from the acquisition. The
restructuring plan impacted all cost centers within the Biosite
organization, as activities were combined with our existing
business operations. Since the inception of the plan, we
recorded $15.4 million in exit costs, of which
$15.1 million relates to change in
SF-34
Notes to
consolidated financial statements
control and severance costs to involuntarily terminate employees
and $0.3 million relates to facility and other exit costs.
As of December 31, 2008, $1.3 million in exit costs
remain unpaid.
During 2007, we formulated restructuring plans in connection
with our acquisition of Cholestech, consistent with our
acquisition strategy to realize operating efficiencies and cost
savings. Additionally, in March 2008, we announced plans to
close the Cholestech facility in Hayward, California. We are
transitioning the manufacturing of the related products to our
Biosite facility in San Diego, California and have
transitioned the sales and distribution of the products to our
newly-formed shared services center in Orlando, Florida. Since
inception of the plans, we recorded $9.2 million in exit
costs, of which $6.5 million relates to executive change in
control agreements and severance costs to involuntarily
terminate employees and $2.7 million relates to facility
exit costs. As of December 31, 2008, $6.7 million in
exit costs remain unpaid.
In conjunction with our acquisition of HemoSense, we formulated
restructuring plans during 2007 to realize operating
efficiencies and cost savings. Additionally, in March 2008, we
announced plans to close the HemoSense facility in
San Jose, California. We are transitioning the
manufacturing of the related products to our Biosite facility in
San Diego, California and have transitioned the sales and
distribution of the products to our newly-formed shared services
center in Orlando, Florida. Since inception of the plans, we
recorded $1.5 million in exit costs, of which
$1.3 million relates to severance costs to terminate
employees and $0.2 million relates to facility and other
exit costs. As of December 31, 2008, $0.5 million in
exit costs remain unpaid.
See Note 23 for additional restructuring charges related to
the Cholestech and HemoSense facility closures and integration.
In conjunction with our acquisition of Matritech, we formulated
a plan to exit the leased facility of Matritech in Newton,
Massachusetts and recorded $1.5 million in facility exit
costs. As of December 31, 2008, $1.1 million of the
facility exit costs remain unpaid.
In conjunction with our acquisition of Alere Medical and
ParadigmHealth, we recorded $2.2 million related to
executive change in control agreements and severance costs to
involuntarily terminate employees. As of December 31, 2008,
$0.9 million remains unpaid.
Although we believe our plans and estimated exit costs for our
2007 acquisitions are reasonable, actual spending for exit
activities may differ from current estimated exit costs.
iii. Other
acquisitions
As a result of our acquisition of Ostex in 2003, we established
a restructuring plan whereby we exited the facilities of Ostex
in Seattle, Washington, and combined the activities of Ostex
with our existing manufacturing and distribution facilities.
Total severance costs associated with involuntarily terminated
employees were $1.6 million, all of which has been paid as
of December 31, 2006. Facility exit costs, including costs
to vacate the Ostex facilities and lease commitments, were
$2.4 million, of which $0.4 million remains unpaid as
of December 31, 2008.
e. Pro
forma financial information
The following table presents selected unaudited financial
information, including the assets of Instant, Biosite,
Cholestech and Matria, as if the acquisitions of these entities
had occurred on January 1, 2007. Pro forma results also
reflect the impact of the formation of our consumer diagnostics
business joint venture with P&G (Note 13(a)(i)) as if
the joint venture had been formed on January 1, 2007. Pro
forma results exclude
SF-35
Notes to
consolidated financial statements
adjustments for various other less significant acquisitions
completed since January 1, 2007, as these acquisitions did
not materially affect our results of operations.
The pro forma results are derived from the historical financial
results of the acquired businesses for all periods presented and
are not necessarily indicative of the results that would have
occurred had the acquisitions been consummated on
January 1, 2007 (in thousands, except pet share amount).
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
|
(unaudited)
|
|
|
Pro forma net revenue
|
|
$
|
1,783,801
|
|
|
$
|
1,362,196
|
|
|
|
|
|
|
|
|
|
|
Pro forma net loss available to common shareholders
|
|
$
|
(47,793
|
)
|
|
$
|
(131,732
|
)
|
|
|
|
|
|
|
|
|
|
Pro forma net loss per common sharebasic and
diluted(1)
|
|
$
|
(0.61
|
)
|
|
$
|
(2.34
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Net loss per common share amounts are computed as described
in Note 15. |
|
|
5.
|
GOODWILL AND
OTHER INTANGIBLE ASSETS
|
The following is a summary of goodwill and other intangible
assets as of December 31, 2008 (in thousands, except useful
life):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
|
|
|
Net
|
|
|
|
|
|
|
carrying
|
|
|
Accumulated
|
|
|
carrying
|
|
|
|
|
|
|
amount
|
|
|
amortization
|
|
|
value
|
|
|
Useful
life
|
|
|
|
|
Amortized intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Core technology and patents
|
|
$
|
547,816
|
|
|
$
|
88,509
|
|
|
$
|
459,307
|
|
|
|
1-20 years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplier relationships
|
|
|
17,167
|
|
|
|
10,477
|
|
|
|
6,690
|
|
|
|
1.8-15 years
|
|
Trademarks and trade names
|
|
|
151,245
|
|
|
|
27,612
|
|
|
|
123,633
|
|
|
|
2-25 years
|
|
License agreements
|
|
|
10,445
|
|
|
|
9,655
|
|
|
|
790
|
|
|
|
5-8.5 years
|
|
Customer relationships
|
|
|
1,151,893
|
|
|
|
175,150
|
|
|
|
976,743
|
|
|
|
1.5-26 years
|
|
Manufacturing know-how
|
|
|
7,208
|
|
|
|
3,825
|
|
|
|
3,383
|
|
|
|
5-15 years
|
|
Other
|
|
|
78,469
|
|
|
|
20,378
|
|
|
|
58,091
|
|
|
|
0.5-11 years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other intangible assets
|
|
|
1,416,427
|
|
|
|
247,097
|
|
|
|
1,169,330
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
1,964,243
|
|
|
$
|
335,606
|
|
|
$
|
1,628,637
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets with indefinite lives:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
$
|
3,046,083
|
|
|
$
|
|
|
|
$
|
3,046,083
|
|
|
|
|
|
Other intangible assets
|
|
|
42,984
|
|
|
|
|
|
|
|
42,984
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with indefinite lives
|
|
$
|
3,089,067
|
|
|
$
|
|
|
|
$
|
3,089,067
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SF-36
Notes to
consolidated financial statements
The following is a summary of goodwill and other intangible
assets as of December 31, 2007 (in thousands, except useful
life):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
|
|
|
|
|
|
Net
|
|
|
|
|
|
|
carrying
|
|
|
Accumulated
|
|
|
carrying
|
|
|
|
|
|
|
amount
|
|
|
amortization
|
|
|
value
|
|
|
Useful
life
|
|
|
|
|
Amortized intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Core technology and patents
|
|
$
|
476,609
|
|
|
$
|
44,026
|
|
|
$
|
432,583
|
|
|
|
1-20 years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplier relationships
|
|
|
18,307
|
|
|
|
9,101
|
|
|
|
9,206
|
|
|
|
1.8-15 years
|
|
Trademarks and trade names
|
|
|
137,352
|
|
|
|
11,964
|
|
|
|
125,388
|
|
|
|
5-25 years
|
|
License agreements
|
|
|
10,105
|
|
|
|
8,167
|
|
|
|
1,938
|
|
|
|
5-8.5 years
|
|
Customer relationships
|
|
|
770,230
|
|
|
|
46,516
|
|
|
|
723,714
|
|
|
|
1.5-26 years
|
|
Manufacturing know-how
|
|
|
3,616
|
|
|
|
3,558
|
|
|
|
58
|
|
|
|
1-15 years
|
|
Other
|
|
|
10,938
|
|
|
|
1,598
|
|
|
|
9,340
|
|
|
|
0.5-10 years
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other intangible assets
|
|
|
950,548
|
|
|
|
80,904
|
|
|
|
869,644
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with finite lives
|
|
$
|
1,427,157
|
|
|
$
|
124,930
|
|
|
$
|
1,302,227
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets with indefinite lives:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill
|
|
$
|
2,148,850
|
|
|
$
|
|
|
|
$
|
2,148,850
|
|
|
|
|
|
Other intangible assets
|
|
|
43,097
|
|
|
|
|
|
|
|
43,097
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets with indefinite lives
|
|
$
|
2,191,947
|
|
|
$
|
|
|
|
$
|
2,191,947
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We amortize intangible assets with finite lives using primarily
the straight-line method over the above estimated useful lives
of the respective intangible asset. We believe that the
straight-line method is appropriate, as it approximates the
pattern in which economic benefits are consumed in circumstances
where such patterns can be reliably determined. In certain
circumstances, such as certain customer relationship assets,
accelerated amortization is recognized which reflect estimate of
the cash flows. Amortization expense of intangible assets, which
in the aggregate amounted to $214.1 million,
$64.6 million and $21.8 million in 2008, 2007 and
2006, respectively, is included in cost of net revenue, research
and development, sales and marketing and general and
administrative in the accompanying consolidated statements of
operations. During 2006, there was no amortization expense
included in general and administrative on the accompanying
consolidated statement of operations. The allocation of
amortization expense to the expense categories is based on the
intended usage and the expected benefits of the intangible
assets in relation to the expense categories.
The following is a summary of estimated aggregate amortization
expense of intangible assets for each of the five succeeding
fiscal years as of December 31, 2008 (in thousands):
|
|
|
|
|
2009
|
|
$
|
233,399
|
|
2010
|
|
$
|
207,012
|
|
2011
|
|
$
|
182,741
|
|
2012
|
|
$
|
159,117
|
|
2013
|
|
$
|
139,607
|
|
In accordance with SFAS No. 142, we perform annual
impairment tests of the carrying value of our goodwill by
reporting unit. Our annual impairment review on
September 30, 2008 did not indicate that goodwill related
to our professional diagnostics, health management and consumer
diagnostics reporting units were impaired. For further
discussion see Note 2(h).
We allocate goodwill by reporting unit based on the relative
percentage of estimated future revenues generated for the
respective reporting unit as of the acquisition date. Goodwill
amounts allocated to our
SF-37
Notes to
consolidated financial statements
professional diagnostics, health management and consumer
diagnostics reporting units are summarized as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Professional
|
|
|
Health
|
|
|
Consumer
|
|
|
|
|
|
|
diagnostics
|
|
|
management
|
|
|
diagnostics
|
|
|
Total
|
|
|
|
|
Goodwill at December 31, 2006
|
|
$
|
353,361
|
|
|
$
|
|
|
|
$
|
86,008
|
|
|
$
|
439,369
|
|
Acquisitions(1)
|
|
|
1,267,985
|
|
|
|
463,066
|
|
|
|
8,940
|
|
|
|
1,739,991
|
|
Other(2)(3)
|
|
|
13,254
|
|
|
|
|
|
|
|
(43,764
|
)
|
|
|
(30,510
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill at December 31, 2007
|
|
|
1,634,600
|
|
|
|
463,066
|
|
|
|
51,184
|
|
|
|
2,148,850
|
|
Acquisitions(1)
|
|
|
93,473
|
|
|
|
817,113
|
|
|
|
1,497
|
|
|
|
912,083
|
|
Other(2)
|
|
|
(14,850
|
)
|
|
|
|
|
|
|
|
|
|
|
(14,850
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill at December 31, 2008
|
|
$
|
1,713,223
|
|
|
$
|
1,280,179
|
|
|
$
|
52,681
|
|
|
$
|
3,046,083
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes purchase accounting adjustments recorded to the
acquired entities opening balance sheet and additional
payments made for earn-outs and milestones achieved. |
|
(2) |
|
These amounts relate primarily to adjustments resulting from
fluctuations in foreign currency exchange rates. |
|
(3) |
|
Includes amounts written off in connection with the formation
of our 50/50 joint venture with P&G. |
We generally expense costs incurred to internally-develop
intangible assets, except for costs that are incurred to
establish patents and trademarks, such as legal fees for
initiating, filing and obtaining the patents and trademarks. As
of December 31, 2008, we had approximately
$7.8 million of costs capitalized, net of amortization, in
connection with establishing patents and trademarks which are
included in other intangible assets, net, in the accompanying
consolidated balance sheets. Upon the successful registration of
the patents and trademarks, we commence amortization of such
intangible assets over their estimated useful lives. Costs
incurred to maintain the patents and trademarks are expensed as
incurred.
We had the following long-term debt balances outstanding (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31,
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
First Lien Credit AgreementTerm loan
|
|
$
|
960,750
|
|
|
$
|
970,500
|
|
First Lien Credit AgreementRevolving line-of-credit
|
|
|
142,000
|
|
|
|
|
|
Second Lien Credit Agreement
|
|
|
250,000
|
|
|
|
250,000
|
|
3% Senior subordinated convertible notes
|
|
|
150,000
|
|
|
|
150,000
|
|
Lines-of-credit
|
|
|
3,503
|
|
|
|
3,730
|
|
Other
|
|
|
13,362
|
|
|
|
12,485
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,519,615
|
|
|
|
1,386,715
|
|
Less: Current portion
|
|
|
(19,058
|
)
|
|
|
(20,320
|
)
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,500,557
|
|
|
$
|
1,366,395
|
|
|
|
|
|
|
|
|
|
|
The following describes each of the above listed debt
instruments:
a. First
lien credit agreement and second lien credit agreement
On June 26, 2007, in conjunction with our acquisition of
Biosite, we entered into a First Lien Credit Agreement, or
senior secured credit facility, and a Second Lien Credit
Agreement, or junior secured credit facility, collectively,
secured credit facility, with certain lenders, General Electric
Capital Corporation as
SF-38
Notes to
consolidated financial statements
administrative agent and collateral agent, and certain other
agents and arrangers, and certain related guaranty and security
agreements. The senior secured credit facility initially
provided for term loans in the aggregate amount of
$900.0 million and, subject to our continued compliance
with the senior secured credit facility, a $150.0 million
revolving line-of-credit. The junior secured credit facility
provides for term loans in the aggregate amount of
$250.0 million. We may repay any future borrowings under
the senior secured credit facility revolving line-of-credit at
any time, but in no event later than June 26, 2013. We must
repay the entire junior facility term loan on June 26,
2015. As of December 31, 2008, the term loans and the
revolving line-of-credit under the senior secured credit
facility bore interest at 3.89% and 3.64%, respectively. The
term loan under the junior secured credit facility bore interest
at 6.14%.
On November 15, 2007, we amended the senior secured credit
facility, increasing the total amount of credit available to us
to $1,125,000,000 resulting from the increase in the term loans
to the aggregate amount of $975.0 million. Additionally,
under the amendment, we must repay the senior secured credit
facility term loans as follows: (a) in two initial
installments in the amount of $2,250,000 each on
September 30, 2007 and December 31, 2007 (each of
which installment payment has been made), (b) in
twenty-five consecutive quarterly installments, beginning on
March 31, 2008 and continuing through March 31, 2014,
in the amount of $2,437,500 each and (c) in a final
installment on June 26, 2014 in an amount equal to the then
outstanding principal balance of the senior secured credit
facility term loans.
As of December 31, 2008, aggregate borrowings amounted to
$142.0 million under the senior secured credit facility
revolving line-of-credit and $1.2 billion under the term
loans. Interest expense related to the secured credit facility
for the year ended December 31, 2008, including amortized
deferred financing costs, was $85.2 million. As of
December 31, 2008, accrued interest related to the credit
facilities amounted to $3.4 million. As of
December 31, 2008, we were in compliance with all debt
covenants related to the above debt, which consisted principally
of maximum consolidated leverage and minimum interest coverage
requirements.
In August 2007, we entered into interest rate swap contracts,
with an effective date of September 28, 2007, that have a
total notional value of $350.0 million and have a maturity
date of September 28, 2010. These interest rate swap
contracts pay us variable interest at the three-month LIBOR
rate, and we pay the counterparties a fixed rate of 4.85%. These
interest rate swap contracts were entered into to convert
$350.0 million of the $1.2 billion variable rate term
loan under the senior credit facility into fixed rate debt.
Based on the terms of the interest rate swap contracts and the
underlying debt, these interest rate swap contracts were
determined to be effective, and thus qualify as a cash flow
hedge under SFAS No. 133. As such, any changes in the
fair market value of these interest rate swaps are recorded in
accumulated other comprehensive income on the accompanying
consolidated balance sheet until earnings are affected by the
variability of cash flows. As of December 31, 2008 and
2007, we recorded cumulative changes of $21.1 million and
$9.5 million, respectively, in accumulated other
comprehensive income on the accompanying balance sheets.
In January 2009, we entered into interest rate swap contracts,
with an effective date of January 14, 2009, that have a
total notional value of $500.0 million and have a maturity
date of January 5, 2011. These interest rate swap contracts
pay us variable interest at the one-month LIBOR rate, and we pay
the counterparties a fixed rate of 1.195%. These interest rate
swap contracts were entered into to convert $500.0 million
of the $1.2 billion variable rate term loan under the
secured credit facility into fixed rate debt.
|
|
b.
|
3% Senior
subordinated convertible notes, principal amount
$150.0 million
|
On May 14, 2007, we sold $150.0 million principal
amount of 3% senior subordinated convertible notes due 2016
(the Convertible Notes) in a private placement to
qualified institutional buyers. At the initial conversion price
of $52.30, the Convertible Notes were convertible into an
aggregate 2,868,120 shares of our common stock. The
conversion price was subject to adjustment one year from the
date of sale. Based upon the daily volume-weighted price per
share of our common stock for the thirty consecutive trading
days ending May 9, 2008, the conversion price decreased
from $52.30 to $43.98 in May 2008. The decrease in
SF-39
Notes to
consolidated financial statements
conversion price resulted in additional shares of our common
stock becoming issuable upon conversion of our senior
subordinated convertible notes. The senior subordinated
convertible notes are now convertible into 3.4 million
shares of our common stock at a conversion price of $43.98.
Interest accrues at 3% per annum, compounded daily, on the
outstanding principal amount and is payable in arrears on
May 15th and November 15th, which started on
November 15, 2007. Interest expense for the year ended
December 31, 2008 and 2007, including amortized deferred
costs, was $5.0 million and $3.1 million, respectively.
We evaluated the Convertible Notes agreement for potential
embedded derivatives under SFAS No. 133 and related
applicable accounting literature, including EITF Issue
No. 00-19,
Accounting for Derivative Financial Instruments Indexed
to, and Potentially Settled in, a Companys Own
Stock, and EITF Issue
No. 05-4,
The Effect of a Liquidated Damages Clause on a
Freestanding Financial Instrument Subject to Issue
No. 00-19.
The conversion feature and the make-whole provision were
determined to not meet the embedded derivative criteria as set
forth by SFAS No. 133. Therefore, no fair value has
been recorded for these items.
|
|
c.
|
Prior senior
credit facility
|
As of December 31, 2006, $44.8 million of borrowings
were outstanding under our then senior credit facility dated
June 30, 2005. On February 1, 2007, using a portion of
the proceeds from our January 2007 sale of 6.9 million
shares of common stock (Note 16), we paid the remaining
principal balance outstanding and accrued interest under the
June 2005 senior credit facility. We terminated our June 2005
senior credit facility in conjunction with our refinancing
activities discussed above. We had no outstanding loans under
the June 2005 senior credit facility at the time it was
terminated.
Borrowings under the revolving lines-of-credit and term loan
bore interest at either (i) the London Interbank Offered
Rate (LIBOR), as defined in the agreement, plus
applicable margins or, at our option or (ii) a floating
Index Rate, as defined in the agreement, plus applicable
margins. For the year ended December 31, 2007, interest
expense, including amortization of deferred financing costs,
under this senior credit facility was $4.7 million.
Included in interest expense is the write-off of
$2.6 million, in unamortized deferred financing costs.
For the year ended December 31, 2006, we recorded interest
expense, including amortization of deferred financing costs,
under these senior credit facilities in the aggregate amount of
$8.9 million.
|
|
d.
|
Senior
subordinated notes, 8.75%, principal amount
$150.0 million
|
On June 26, 2007, we fully repaid our 8.75% senior
subordinated notes due 2012 (the Notes). The total
amount repaid, including principal of $150.0 million and a
prepayment premium of $9.3 million, was
$159.3 million. Accrued interest of $4.8 million was
also paid as part of the final settlement of these Notes and
unamortized deferred financing costs of $3.7 million were
written off as a result of the repayment.
Some of our subsidiaries maintain a local line-of-credit for
short-term advances. At December 31, 2008, a total of
$3.5 million was borrowed against these local
lines-of-credit.
Included in other above, for the year ended December 31,
2008, are borrowings by certain of our subsidiaries from various
financial institutions. The borrowed funds are used to fund
capital expenditure and working capital requirements. Interest
expense on these borrowings was $1.4 million for the year
ended December 31, 2008.
SF-40
Notes to
consolidated financial statements
|
|
g.
|
Maturities of
long-term debt
|
The following is a summary of the maturities of long-term debt
outstanding on December 31, 2008 (in thousands):
|
|
|
|
|
2009
|
|
$
|
19,058
|
|
2010
|
|
|
15,372
|
|
2011
|
|
|
11,158
|
|
2012
|
|
|
10,177
|
|
2013
|
|
|
9,850
|
|
Thereafter
|
|
|
1,454,000
|
|
|
|
|
|
|
|
|
$
|
1,519,615
|
|
|
|
|
|
|
|
|
7.
|
FAIR VALUE
MEASUREMENTS
|
Effective January 1, 2008, we implemented
SFAS No. 157, Fair Value Measurement, for our
financial assets and liabilities that are re-measured and
reported at fair value at each reporting period-end date, and
non-financial assets and liabilities that are re-measured and
reported at fair value at least annually. In accordance with the
provisions of FASB Staff Position
No. FAS 157-2,
Effective Date of FASB Statement No. 157, we have
elected to defer implementation of SFAS No. 157 as it
relates to our non-financial assets and non-financial
liabilities that are recognized and disclosed at fair value in
the financial statements on a non-recurring basis until
January 1, 2009. We are evaluating the impact, if any, this
Standard will have on our non-financial assets and liabilities.
The adoption of SFAS No. 157 to our financial assets
and liabilities and non-financial assets and liabilities that
are re-measured and reported at fair value at least annually did
not have an impact on our financial results.
Financial assets and liabilities recorded on the accompanying
condensed consolidated balance sheets are categorized based on
the inputs to the valuation techniques as follows:
Level 1Financial assets and liabilities whose
values are based on unadjusted quoted prices for identical
assets or liabilities in an active market that the company has
the ability to access at the measurement date (examples include
active exchange-traded equity securities, listed derivatives and
most U.S. Government and agency securities).
Level 2Financial assets and liabilities whose
values are based on quoted prices in markets where trading
occurs infrequently or whose values are based on quoted prices
of instruments with similar attributes in active markets.
Level 2 inputs include the following:
|
|
Ø
|
Quoted prices for identical or similar assets or liabilities in
non-active markets (examples include corporate and municipal
bonds which trade infrequently);
|
|
Ø
|
Inputs other than quoted prices that are observable for
substantially the full term of the asset or liability (examples
include interest rate and currency swaps); and
|
|
Ø
|
Inputs that are derived principally from or corroborated by
observable market data for substantially the full term of the
asset or liability (examples include certain securities and
derivatives).
|
Level 3Financial assets and liabilities whose
values are based on prices or valuation techniques that require
inputs that are both unobservable and significant to the overall
fair value measurement. These inputs reflect managements
own assumptions about the assumptions a market participant would
use in pricing the asset or liability. We currently do not have
any Level 3 financial assets or liabilities.
SF-41
Notes to
consolidated financial statements
The following table presents information about our assets and
liabilities that are measured at fair value on a recurring basis
as of December 31, 2008, and indicates the fair value
hierarchy of the valuation techniques we utilized to determine
such fair value (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quoted prices
in
|
|
|
Significant
other
|
|
|
|
December 31,
|
|
|
active markets
|
|
|
observable
inputs
|
|
Description
|
|
2008
|
|
|
(Level 1)
|
|
|
(Level 2)
|
|
|
|
|
Assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
Marketable securities
|
|
$
|
2,354
|
|
|
$
|
2,354
|
|
|
$
|
|
|
Strategic
investments(1)
|
|
|
229
|
|
|
|
229
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
2,583
|
|
|
$
|
2,583
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest rate swap
liability(2)
|
|
$
|
21,132
|
|
|
$
|
|
|
|
$
|
21,132
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities
|
|
$
|
21,132
|
|
|
$
|
|
|
|
$
|
21,132
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Represents our investment in StatSure which is included in
investments in unconsolidated entities on our accompanying
consolidated balance sheets. |
|
(2) |
|
Included in other long-term liabilities in our accompanying
consolidated balances sheets. |
The following is a schedule of the future minimum lease payments
under the capital leases, together with the present value of
such payments as of December 31, 2008 (in thousands):
|
|
|
|
|
2009
|
|
$
|
495
|
|
2010
|
|
|
362
|
|
2011
|
|
|
84
|
|
2012
|
|
|
10
|
|
2013
|
|
|
22
|
|
|
|
|
|
|
Total future minimum lease payments
|
|
|
973
|
|
Less: Imputed interest
|
|
|
(54
|
)
|
|
|
|
|
|
Present value of future minimum lease payments
|
|
|
919
|
|
Less: Current portion
|
|
|
(451
|
)
|
|
|
|
|
|
|
|
$
|
468
|
|
|
|
|
|
|
At December 31, 2008, the capitalized amounts of the
building, machinery and equipment and computer equipment under
capital leases were as follows (in thousands):
|
|
|
|
|
Machinery, laboratory equipment and tooling
|
|
$
|
1,077
|
|
Computer equipment
|
|
|
269
|
|
Furniture and fixtures
|
|
|
141
|
|
|
|
|
|
|
|
|
|
1,487
|
|
Less: Accumulated amortization
|
|
|
(514
|
)
|
|
|
|
|
|
|
|
$
|
973
|
|
|
|
|
|
|
The amortization expense of assets recorded under capital leases
is included in depreciation and amortization expense of
property, plant and equipment.
SF-42
Notes to
consolidated financial statements
|
|
9.
|
POSTRETIREMENT
BENEFIT PLANS
|
a. Employee
savings plans
Our company and several of our
U.S.-based
subsidiaries sponsor various 401(k) savings plans, to which
eligible domestic employees may voluntarily contribute a portion
of their income, subject to statutory limitations. In addition
to the participants own contributions to these 401(k)
savings plans, we match such contributions up to a designated
level. Total matching contributions related to employee savings
plans were $4.6 million, $1.5 million and
$0.8 million in 2008, 2007 and 2006, respectively.
b. U.K.
pension plans
Changes in benefit obligations, plan assets, funded status and
amounts recognized on the balance sheet as of and for the years
ended December 31, 2008 and 2007, for our Defined Benefit
Plan, were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Change in projected benefit obligation
|
|
|
|
|
|
|
|
|
Benefit obligation at beginning of year
|
|
$
|
12,627
|
|
|
$
|
12,370
|
|
Interest cost
|
|
|
677
|
|
|
|
660
|
|
Actuarial loss (gain)
|
|
|
534
|
|
|
|
(470
|
)
|
Benefits paid
|
|
|
(182
|
)
|
|
|
(140
|
)
|
Curtailment gain
|
|
|
(1,113
|
)
|
|
|
|
|
Foreign exchange impact
|
|
|
(3,465
|
)
|
|
|
207
|
|
|
|
|
|
|
|
|
|
|
Benefit obligation at end of year
|
|
$
|
9,078
|
|
|
$
|
12,627
|
|
|
|
|
|
|
|
|
|
|
Change in accumulated benefit obligation
|
|
|
|
|
|
|
|
|
Benefit obligation at beginning of year
|
|
$
|
9,159
|
|
|
$
|
8,959
|
|
Interest cost
|
|
|
677
|
|
|
|
660
|
|
Actuarial loss (gain)
|
|
|
534
|
|
|
|
(470
|
)
|
Benefits paid
|
|
|
(182
|
)
|
|
|
(140
|
)
|
Curtailment gain
|
|
|
(1,113
|
)
|
|
|
|
|
Foreign exchange impact
|
|
|
(2,508
|
)
|
|
|
150
|
|
|
|
|
|
|
|
|
|
|
Benefit obligation at end of year
|
|
$
|
6,567
|
|
|
$
|
9,159
|
|
|
|
|
|
|
|
|
|
|
Change in plan assets
|
|
|
|
|
|
|
|
|
Fair value of plan assets at beginning of year
|
|
$
|
9,143
|
|
|
$
|
8,189
|
|
Actual return on plan assets
|
|
|
(1,543
|
)
|
|
|
220
|
|
Employer contribution
|
|
|
835
|
|
|
|
750
|
|
Benefits paid
|
|
|
(182
|
)
|
|
|
(150
|
)
|
Foreign exchange impact
|
|
|
(2,325
|
)
|
|
|
134
|
|
|
|
|
|
|
|
|
|
|
Fair value of plan assets at end of year
|
|
$
|
5,928
|
|
|
$
|
9,143
|
|
|
|
|
|
|
|
|
|
|
Funded status at end of year
|
|
$
|
(3,150
|
)
|
|
$
|
(3,484
|
)
|
|
|
|
|
|
|
|
|
|
The net amounts recognized in the accompanying consolidated
balance sheets are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Accrued benefit asset (liability)
|
|
$
|
(603
|
)
|
|
$
|
34
|
|
Long-term benefit liability
|
|
|
(5,498
|
)
|
|
|
(4,594
|
)
|
Intangible asset
|
|
|
2,951
|
|
|
|
1,076
|
|
|
|
|
|
|
|
|
|
|
Net amount recognized
|
|
$
|
(3,150
|
)
|
|
$
|
(3,484
|
)
|
|
|
|
|
|
|
|
|
|
SF-43
Notes to
consolidated financial statements
The measurement date used to determine plan assets and benefit
obligations for the Defined Benefit Plan was December 31,
2008 and 2007.
The following table provides the weighted-average actuarial
assumptions:
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Assumptions used to determine benefit obligations:
|
|
|
|
|
|
|
|
|
Discount rate
|
|
|
6.10%
|
|
|
|
5.80%
|
|
Rate of compensation increase
|
|
|
3.85%
|
|
|
|
4.15%
|
|
Assumptions used to determine net periodic benefit cost:
|
|
|
|
|
|
|
|
|
Discount rate
|
|
|
5.80%
|
|
|
|
5.25%
|
|
Expected return on plan assets
|
|
|
7.20%
|
|
|
|
7.30%
|
|
Rate of compensation increase
|
|
|
4.15%
|
|
|
|
3.80%
|
|
The actuarial assumptions are reviewed on an annual basis. The
overall expected long-term rate of return on plan assets
assumption was determined based on historical investment return
rates on portfolios with a high proportion of equity securities.
The annual cost of the Defined Benefit Plan is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
Interest cost
|
|
$
|
677
|
|
|
$
|
660
|
|
|
$
|
586
|
|
Expected return on plan assets
|
|
|
(634
|
)
|
|
|
(620
|
)
|
|
|
(461
|
)
|
Amortization of net loss
|
|
|
(80
|
)
|
|
|
(90
|
)
|
|
|
(26
|
)
|
Curtailment gain
|
|
|
(1,113
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net periodic benefit cost (benefit)
|
|
$
|
(1,150
|
)
|
|
$
|
(50
|
)
|
|
$
|
99
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The plan assets of the Defined Benefit Plan comprise of a mix of
stocks and fixed income securities and other investments. At
December 31, 2008, these stocks and fixed income securities
represented 63% and 37%, respectively, of the market value of
the pension assets. We expect to contribute approximately
0.5 million British Pounds Sterling (or $0.6 million
at December 31, 2008) to the Defined Benefit Plan in
2009. We expect benefits to be paid to plan participants of
approximately $0.2 million per year for each of the next
five years and for benefits totaling $0.2 million to be
paid annually for the five years thereafter.
Unipath Limited, or Unipath contributed $1.0 million in
2008 and $1.2 million in 2007 and 2006 to a Defined
Contribution Plan, which was recognized as an expense in the
accompanying consolidated statement of operations.
|
|
10.
|
DERIVATIVE
FINANCIAL INSTRUMENTS
|
We use derivative financial instruments (interest rate swap
contracts) in the management of our interest rate exposure
related to our senior credit facilities. We do not hold or issue
derivative financial instruments for speculative purposes.
In August 2007, we entered into interest rate swap contracts,
with an effective date of September 28, 2007, that have a
total notional value of $350.0 million and have a maturity
date of September 28, 2010. These interest rate swap
contracts pay us variable interest at the three-month LIBOR
rate, and we pay the counterparties a fixed rate of 4.85%. These
interest rate swap contracts were entered into to convert
$350.0 million of the $1.2 billion variable rate term
loan under the senior credit facility into fixed rate debt.
Based on the terms of the interest rate swap contracts and the
underlying debt, these interest rate swap contracts were
determined to be effective, and thus qualify as a cash flow
hedge under SFAS No. 133, Accounting for Derivative
Instruments and Hedging Activities. As such, any changes in
the fair value of these interest rate swaps are recorded in
other comprehensive income on the accompanying consolidated
balance
SF-44
Notes to
consolidated financial statements
sheet until earnings are affected by the variability of cash
flows. As of December 31, 2008 and 2007, we recorded
cumulative changes of $21.1 million and $9.5 million,
respectively, in accumulated other comprehensive income on the
accompanying balance sheets in connection with our interest rate
swap contracts.
See Note 13(b) regarding our Chembio Diagnostics, Inc., or
Chembio, warrants and Note 13(d) regarding StatSure
Diagnostic Systems, Inc., or StatSure, warrants which are
accounted for as derivative instruments.
|
|
11.
|
COMMITMENTS AND
CONTINGENCIES
|
a. Operating
leases
We have operating lease commitments for certain of our
facilities and equipment that expire on various dates through
2021. The following schedule outlines future minimum annual
rental payments under these leases at December 31, 2008 (in
thousands):
|
|
|
|
|
2009
|
|
$
|
25,377
|
|
2010
|
|
|
19,159
|
|
2011
|
|
|
15,380
|
|
2012
|
|
|
11,011
|
|
2013
|
|
|
9,985
|
|
Thereafter
|
|
|
13,470
|
|
|
|
|
|
|
|
|
$
|
94,382
|
|
|
|
|
|
|
Rent expense relating to operating leases was approximately
$35.4 million, $17.4 million and $11.8 million
during 2008, 2007 and 2006, respectively.
b. Capital
expenditure commitments
At December 31, 2008, we had total outstanding
non-cancelable equipment purchase commitments of
$17.5 million.
c. Contingent
consideration obligations
We have contingent consideration contractual terms related to
our acquisitions of Alere Medical, Ameditech, Binax, Inc., or
Binax, Bio-Stat, Clondiag, Diamics, First Check, Gabmed, Global,
Matritech, Promesan, Spectral/Source, Vision and our most
recently acquired healthcare business. With the exception of
Alere Medical, the contingent considerations will be accounted
for as increases in the aggregate purchase prices if and when
the contingencies occur.
With respect to Alere Medical, the terms of the acquisition
agreement provided for contingent consideration payable to each
Alere Medical stockholder who owned shares of our common stock
or retained the option to purchase shares of our common stock on
the six-month anniversary of the closing of the acquisition. The
contingent consideration, payable in cash or stock at our
election, was equal to the number of such shares of our common
stock or options to purchase our common stock held on the
six-month anniversary multiplied by the amount that $58.31
exceeded the greater of the average price of our common stock
for the ten business days preceding the six-month anniversary
date, or 75% of $58.31. Accordingly, based on the price of our
common stock for the ten business days preceding the six-month
anniversary of the closing of the acquisition, we issued
approximately 0.1 million shares of our common stock on
May 30, 2008 to the Alere Medical stockholders based on the
remaining outstanding shares at that time. Payment of this
contingent consideration did not impact the purchase price for
this acquisition.
With respect to Ameditech, the terms of the acquisition
agreement require us to pay an earn-out upon successfully
meeting certain revenue targets for the one year period ending
on the first anniversary of the
SF-45
Notes to
consolidated financial statements
acquisition date and the one year period ending on the second
anniversary of the acquisition date. The maximum amount of
incremental consideration payable is $4.0 million.
With respect to Binax, the terms of the acquisition agreement
provide for $11.0 million of contingent cash consideration
payable to the Binax shareholders upon the successful completion
of certain new product developments during the five years
following the acquisition. As of December 31, 2008, the
remaining contingent consideration to be earned is approximately
$7.3 million.
With respect to Bio-Stat, the terms of the acquisition provided
for contingent consideration payable in the form of loan notes
to the Bio-Stat shareholders, if certain EBITDA (earnings before
interest, taxes, depreciation and amortization) milestones were
met for 2007. The EBITDA milestones were met in 2007 and loan
notes totaling £3.4 million ($6.2 million) were
issued during the third quarter of 2008. As of December 31,
2008, the loan notes remain outstanding with an approximate
value of $4.9 million.
With respect to Clondiag, the terms of the acquisition agreement
provided for $8.9 million of contingent consideration,
consisting of approximately 0.2 million shares of our
common stock and approximately $3.0 million of cash or
stock in the event that four specified products were developed
on Clondiags platform technology during the three years
following the acquisition date. Successful completion of the
second milestone occurred during the first quarter of 2008 for
which we made a payment for $0.9 million and issued
56,080 shares of our common stock during the first quarter
of 2008. Successful completion of the third and fourth
milestones occurred during the third quarter of 2008 for which
we made payment for $1.6 million and issued
0.1 million shares of our common stock during the fourth
quarter of 2008. No further milestones exist.
With respect to Diamics, the terms of the acquisition agreement
provide for contingent consideration payable upon the successful
completion of certain milestones, including development of
business plans and marketable products. As of December 31,
2008, the remaining contingent consideration to be earned is
approximately $2.3 million.
With respect to First Check, the terms of the acquisition
agreement required us to pay an earn-out to First Check equal to
the incremental revenue growth of the acquired products for 2007
and for the first nine months of 2008, as compared to the
immediately preceding comparable periods. The
2007 milestone, totaling $2.2 million, was met and
accrued as of December 31, 2007 and was paid during the
first quarter of 2008. The 2008 milestone, totaling
$0.3 million, was met and accrued during the third quarter
of 2008 and was paid in the fourth quarter of 2008. No further
milestones exist.
With respect to Gabmed, the terms of the acquisition agreement
provide for contingent consideration totaling up to
750,000 payable in up to five annual amounts beginning in
2007, upon successfully meeting certain revenue and EBIT
(earnings before interest and taxes) milestones in each of the
respective annual periods. The 2007 milestone, totaling
0.1 million ($0.2 million), was met and accrued
as of June 30, 2008 and was paid during the third quarter
of 2008.
With respect to Global, the terms of the acquisition agreement
provided for contingent consideration payable upon successfully
meeting certain revenue targets in 2008. As of December 31,
2008, the 2008 revenue targets were met resulting in accrued
contingent consideration totaling $0.2 million. No further
milestones exist.
With respect to Matritech, the terms of the acquisition
agreement required us to pay an earn-out to the former Matritech
shareholders upon successfully meeting certain revenue targets
in 2008. As of December 31, 2008, the milestones were not
achieved. No further milestones exits.
With respect to Promesan, the terms of the acquisition agreement
provide for contingent consideration payable upon successfully
meeting certain annual revenue targets. Total contingent
consideration of up to 0.6 million is payable in
three equal annual amounts of 0.2 million beginning
in 2007 and ending in 2009. The 2007 milestone, totaling
0.2 million ($0.3 million), was met and accrued
as of December 31, 2007 and
SF-46
Notes to
consolidated financial statements
was paid during the first quarter of 2008. The
2008 milestone, totaling 0.2 million
($0.3 million), was met and accrued as of December 31,
2008.
With respect to Spectral/Source, the terms of the acquisition
agreement required us to pay an earn-out equal to two times the
consolidated revenue of Spectral/Source less $4.0 million,
if the consolidated profits before tax of Spectral/Source was at
least $0.9 million on the one year anniversary
(milestone period) following the acquisition date.
If consolidated profits before tax of Spectral/Source for the
milestone period were less than $0.9 million, then the
amount of the payment would be equal to seven times
Spectral/Sources consolidated profits before tax less
$4.0 million. The contingent consideration was payable 60%
in cash and 40% in stock. The revenue and profit milestones were
met and accrued during the fourth quarter of 2008 for which we
made payment for $1.6 million and issued 53,372 shares
of our common stock during the fourth quarter of 2008. No
further milestones exist.
With respect to Vision, the terms of the acquisition agreement
provide for incremental consideration payable to the former
Vision shareholders. The maximum amount of incremental
consideration payable is approximately $3.2 million, of
which $1.0 million is guaranteed and accrued as of
December 31, 2008. The remaining contingent consideration
is payable upon the completion of certain milestones and
successfully maintaining certain production levels and product
costs during each of the two years following the acquisition
date. As of December 31, 2008, no milestones have been met.
With respect to our most recently-acquired healthcare business,
the terms of the acquisition agreement provide for contingent
consideration payable upon successfully meeting certain revenue
and EBITDA targets for the twelve months ending June 30,
2009 and December 31, 2010, respectively. We accrued a
liability in the amount of $3.8 million to avoid
recognition of negative goodwill, as a result of not recognizing
additional purchase price consideration that is contingent on
future events. As of December 31, 2008, the
$3.8 million liability remains accrued.
d. Legal
proceedings
Estate of Melissa
Prince Quisenberry v. Alere Medical, Inc., TA Associates,
Inc., Covington Associates, et al.
On September 19, 2008, the Estate of Melissa Prince
Quisenberry filed a class action complaint in the Superior Court
of California on behalf of herself and others similarly situated
against Alere Medical Inc., or Alere Medical, and Agora Parent,
Inc., both of which are wholly owned subsidiaries; Ronald D.
Geraty, MD, chief executive officer of Alere Medical and certain
other individuals who were executive officers, directors
and/or
significant shareholders of Alere Medical; as well as certain
other unaffiliated entities. Plaintiff and class owned common
and/or
preferred stock in Alere Medical and allege that the defendants
forced them to tender their stock in connection with the
March 14, 2007 sale of Alere Medical to an unaffiliated
entity at a price which was substantially lower than the price
at which we bought Alere Medical on October 24, 2007.
Plaintiff also alleges that the individual defendants breached
fiduciary duties of good faith, fair dealing, loyalty and
candor; and that Alere Medical and certain unaffiliated entities
aided, abetted and substantially participated in the breach of
fiduciary duty. We believe that we have strong defenses to all
of the allegations made by the class and we intend to defend the
claims vigorously. However, an outcome against Alere Medical
could potentially have a material adverse impact on our sales,
operations or financial performance.
Healthways, Inc.
and Robert Bosch North America Corp, v. Alere Medical,
Inc.
Healthways, Inc. and Robert Bosch North America Corp. filed a
complaint in U.S. District Court in the Northern District
of Illinois on November 5, 2008 against Alere Medical, Inc.
alleging infringement of 11 patents, licensed by Bosch from
Healthways. Alere Medical answered the complaint and filed
counterclaims seeking declarations that the patents are invalid
and not infringed. The plaintiffs subsequently filed an amended
complaint substituting Alere LLC, or Alere, our consolidated
health management
SF-47
Notes to
consolidated financial statements
subsidiary, as the defendant in place of Alere Medical. We
believe that we have strong defenses to Healthways
allegations and we intend to defend them vigorously. However, a
ruling against Alere could potentially have a material adverse
impact on our sales, operations or financial performance or
could limit our current or future business opportunities.
Claims in the
ordinary course and other matters
We are not a party to any other pending legal proceedings that
we currently believe could have a material adverse impact on our
sales, operations or financial performance. However, because of
the nature of our business, we may be subject at any particular
time to commercial disputes, consumer product claims, negligence
claims or various other lawsuits arising in the ordinary course
of our business, including infringement, employment or investor
matters, and we expect that this will continue to be the case in
the future. Such lawsuits generally seek damages, sometimes in
substantial amounts.
As an example, as we have previously reported, in April 2008,
Pyramid Holdings Inc., a purchaser in our November 2007 public
offering of our common stock, filed a putative securities class
action against us, Ron Zwanziger, our chairman, chief
executive officer and president, and David Teitel, our chief
financial officer, in the United States District Court for the
District of Massachusetts, alleging that the prospectus
supplement and registration statement with respect to the
November 2007 public offering were inaccurate and misleading and
omitted to state material facts. The plaintiffs have
subsequently filed their amended class action complaint, adding
as defendants each of our then current directors, a former
director, and a former chief financial officer. We believe that
the allegations are baseless, and we intend to defend against
them vigorously.
Also, our subsidiary Alere Medical continues to defend
infringement claims brought by Health Hero Network, Inc., which
alleges to have patented certain processes related to home
monitoring of patients.
While we believe that we have strong defenses to the claims
brought by Pyramid Holdings and Health Hero and we intend to
defend them vigorously, these, or other claims, could
potentially have a negative impact on our sales, operations or
financial performance or could limit our existing or future
business opportunities.
In addition, we aggressively defend our patent and other
intellectual property rights. This often involves bringing
infringement or other commercial claims against third parties.
These suits can be expensive and result in counterclaims
challenging the validity of our patents and other rights.
12. CO-DEVELOPMENT
AGREEMENT WITH ITI SCOTLAND LIMITED
On February 25, 2005, we entered into a co-development
agreement with ITI Scotland Limited, or ITI, whereby ITI agreed
to provide us with £30.0 million over three years to
partially fund research and development programs focused on
identifying novel biomarkers and near-patient and home-use tests
for cardiovascular and other diseases (the
programs). We agreed to invest £37.5 million in
the programs over three years from the date of the agreement.
Through our subsidiary, Stirling Medical Innovations Limited, or
Stirling, we established a new research center in Stirling,
Scotland, where we consolidated many of our existing cardiology
programs and will ultimately commercialize products arising from
the programs. ITI and Stirling will have exclusive rights to the
developed technology in their respective fields of use. As
qualified expenditures were made under the co-development
arrangement, we recognized the fee earned during the period as a
reduction of our related expenses, subject to certain
limitations. As of December 31, 2007, we had earned full
funding under this arrangement in the amount of
£30.0 million ($56.0 million) and as such, no
funding was earned in 2008. For the fiscal years ended
December 31, 2007 and 2006, we recognized
$20.0 million and $18.4 million of reimbursements,
respectively, of which $18.5 million and
$16.6 million, respectively, offset our research and
development spending and $1.5 million and
$1.8 million, respectively, reduced our general,
administrative and marketing spending incurred by Stirling.
Though the funding
SF-48
Notes to
consolidated financial statements
arrangement has completed, Stirling continues to support ITI in
exploiting the developed technology into their fields of
interest.
|
|
13.
|
INVESTMENT IN
UNCONSOLIDATED ENTITIES AND MARKETABLE SECURITIES
|
a. Equity
method investments
i. Joint
venture with P&G
In May 2007, we completed our 50/50 joint venture with P&G
for the development, manufacturing, marketing and sale of
existing and to-be-developed consumer diagnostics, outside the
cardiology, diabetes and oral care fields. At the closing, we
transferred our related consumer diagnostics assets totaling
$63.6 million, other than our manufacturing and core
intellectual property assets, to the joint venture, and P&G
acquired its interest in the joint venture for a cash payment of
approximately $325.0 million.
We also entered into an option agreement with P&G, pursuant
to which P&G has the right, for a period of 60 days
commencing on the fourth anniversary date of the agreement, to
require us to acquire all of P&Gs interest in the
joint venture at fair market value, and P&G has the right,
upon certain material breaches by us of our obligations to the
joint venture, to acquire all of our interest in the joint
venture at fair market value. No gain on the proceeds that we
received from P&G through the formation of the joint
venture will be recognized in our financial statements until
P&Gs option to require us to purchase its interest in
the joint venture expires. The deferred gain recorded on our
accompanying consolidated balance sheets as of December 31,
2008 and 2007 was $287.0 million and $293.1 million,
respectively.
We also entered into a manufacturing agreement with P&G,
whereby we will manufacture consumer diagnostics and sell these
products to the joint venture entity. In our capacity as the
manufacturer of products for the joint venture, we recorded
$103.0 million and $65.0 million in manufacturing
revenue for the year ended December 31, 2008 and 2007,
respectively, which is included in net product sales in our
accompanying consolidated statements of operations.
Furthermore, we entered into certain transition and long-term
services agreements with the joint venture, pursuant to which we
will provide certain operational support services to the joint
venture. Revenue related to these service agreements for the
year ended December 31, 2008 and 2007 was $2.4 million
and $2.5 million, respectively, and is included in our
services revenue on our consolidated statements of operations.
Customer receivables associated with this revenue has been
classified as other receivables within prepaid and other current
assets on our accompanying consolidated balance sheets in the
amount of $16.2 million and $29.5 million as of
December 31, 2008 and 2007, respectively. In connection
with the joint venture arrangement, the joint venture bears the
collection risk associated with these receivables.
Upon completion of the arrangement to form the joint venture, we
ceased to consolidate the operating results of our consumer
diagnostics business related to the joint venture and instead
account for our 50% interest in the results of the joint venture
under the equity method of accounting in accordance with APB
Opinion No. 18, The Equity Method of Accounting for
Investments in Common Stock. For the year ended
December 31, 2008 and 2007, we recorded a loss of
$0.9 million and earnings of $3.0 million,
respectively, in equity earnings of unconsolidated entities, net
of tax, in our accompanying consolidated statements of
operations, which represented our share of the joint
ventures net income for the respective periods including
restructuring related expenses. During 2008, the joint venture
paid $11.2 million in cash to both of the parent companies,
equally reducing the respective investments in the joint venture.
ii. Vedalab
S.A.
In November 2006, we acquired 40% of Vedalab S.A., or Vedalab, a
French manufacturer and supplier of rapid diagnostic tests in
the professional markets. The aggregate purchase price was
$9.7 million which consisted of $7.6 million in cash,
49,787 shares of our common stock with an aggregate fair
value of
SF-49
Notes to
consolidated financial statements
$2.0 million and $0.1 million in estimated direct
acquisition costs. On the same date, we settled an on-going
patent infringement claim with Vedalab. Under the terms of the
settlement, Vedalab paid us $5.1 million and agreed to pay
us royalties on future sales ranging from 5% to 10%, depending
on the products being sold in exchange for a license under
certain patents to manufacture its current products at its
facility in Alencon, France. The payment of $5.1 million
has been included as income in our financial results for the
year ended December 31, 2006, of which $4.6 million
relates to periods prior to 2006 and has been included in other
income (expense), net and the remaining $0.5 million has
been recorded as license and royalty revenue. We account for our
40% investment in Vedalab under the equity method of accounting
in accordance with APB Opinion No. 18, The Equity Method
of Accounting for Investments in Common Stock. In January
2007, we received $0.7 million from Vedalab in the form of
a dividend distribution. This was accounted for as a reduction
in the value of our investment in accordance with APB Opinion
No. 18. For the year ended December 31, 2008 and 2007,
we recorded $0.5 million and $0.3 million,
respectively, in equity earnings of unconsolidated entities, net
of tax, in our accompanying consolidated statement of
operations, which represented our minority share of
Vedalabs net income for the respective period.
iii. TechLab,
Inc.
In May 2006, we acquired 49% of TechLab, Inc., or TechLab, a
privately-held developer, manufacturer and distributor of rapid
non-invasive intestinal diagnostics tests in the areas of
intestinal inflammation, antibiotic associated diarrhea and
parasitology. The aggregate purchase price was $8.8 million
which consisted of 303,417 shares of our common stock with
an aggregate fair value of $8.6 million and
$0.2 million in estimated direct acquisition costs. We
account for our 49% investment in TechLab under the equity
method of accounting, in accordance with APB Opinion
No. 18. In 2008 and 2007, we received $1.4 million and
$0.6 million, respectively, from TechLab in the form of
dividend distributions. These were accounted for as a reduction
in the value of our investment in accordance with APB Opinion
No. 18. For the year ended December 31, 2008, 2007 and
2006, we recorded $1.5 million, $1.1 million and
$0.6 million, respectively, in equity earnings of
unconsolidated entities, net of tax, in our accompanying
consolidated statement of operations, which represented our
minority share of TechLabs net income for the respective
period.
b. Investment
in Chembio
In September 2006, we acquired 5% of Chembio, a developer and
manufacturer of rapid diagnostic tests for infectious diseases,
through the purchase of 40 shares of their preferred stock.
The preferred stock pays a dividend of 7%, payable in cash or
common stock. The aggregate purchase price of $2.0 million
was paid in cash. In addition to the preferred stock, we
received a warrant to purchase 625,000 shares of
Chembios common stock at $0.80 per share. Chembios
stock is publicly-traded. The warrant, accounted for as a
derivative instrument, had a fair value of approximately
$0.4 million at the date of issuance. The fair value of
this warrant was estimated at the time of issuance using the
Black-Scholes pricing model and assuming no dividend yield,
expected volatility of 116%, risk-free rate of 4.9% and a
contractual term of five years. In December 2007, we exercised
our warrant and purchased 625,000 shares of Chembios
common stock and recorded a $0.3 million loss in connection
with our mark-to- market of this warrant, which we have included
in other income (expense), net in our accompanying consolidated
statement of operations for the year ended December 31,
2007. Furthermore, we converted our 40 shares of their
preferred stock into common stock. At December 31, 2008 and
2007, we owned 5.4 million shares of common stock in
Chembio with a fair market value of approximately
$0.6 million and $1.3 million, respectively, and which
are classified as marketable securities, non-current on our
accompanying consolidated balance sheets. We recorded an
unrealized holding loss of approximately $1.4 million and
$0.6 million in accumulated other comprehensive income
within stockholders equity on our accompanying
consolidated balance sheets as of December 31, 2008 and
2007, respectively.
SF-50
Notes to
consolidated financial statements
c. Investment
in BBI
Our investment in BBI consisted of marketable equity securities
purchased in May 2007. On receipt, the shares were recorded at
their market value. At December 31, 2007, the fair market
value of these securities, which have been included in
marketable securities, long-term, on our accompanying
consolidated balance sheet, was approximately
$19.0 million, representing an unrealized holding gain of
approximately $4.3 million which was recorded in
accumulated other comprehensive income within stockholders
equity on our accompanying consolidated balance sheets as of
December 31, 2007. We acquired BBI in February 2008, at
which time we recorded the original cost of this investment as
part of our preliminary purchase price and reversed the
$4.3 million unrealized holding gain from accumulated other
comprehensive income.
d. Investment
in StatSure
In October 2007, we acquired 5% of StatSure, a developer and
marketer of oral fluid collection devices for the drugs of abuse
market, through the purchase of 1.4 million shares of their
common stock. The aggregate purchase price of $0.5 million
was paid in cash. In addition to the common stock, we received a
warrant to purchase 1.1 million shares of StatSures
common stock at $0.35 per share. StatSures stock is
publicly-traded. The warrant, accounted for as a derivative
instrument, in accordance with SFAS No. 133,
Accounting for Derivative Instruments and Hedging
Activities, had a fair value of approximately
$0.3 million at the date of issuance. The fair value of
this warrant was estimated at the time of issuance using the
Black-Scholes pricing model and assuming no dividend yield,
expected volatility of 150%, a risk-free rate of 3.9% and a
contractual term of five years. We marked-to-market the warrant
over the contractual term and recorded an unrealized loss of
$0.3 million and an unrealized gain of $0.1 million in
other income (expense), net in our accompanying consolidated
statement of operations for the year ended December 31,
2008 and 2007, respectively. As of December 31, 2008, the
warrant was valued at approximately $25,000.
14. IN-PROCESS
RESEARCH AND DEVELOPMENT
In connection with three of our acquisitions since 2006, we have
acquired various IPR&D projects. Substantial additional
research and development will be required prior to any of our
acquired IPR&D programs and technology platforms reaching
technological feasibility. In addition, once research is
completed, each product candidate acquired will need to complete
a series of clinical trials and receive FDA or other regulatory
approvals prior to commercialization. Our current estimates of
the time and investment required to develop these products and
technologies may change depending on the different applications
that we may choose to pursue. We cannot give assurances that
these programs will ever reach technological feasibility or
develop into products that can be marketed profitably. For
example, we have discontinued funding certain of the programs
listed below. In addition, we cannot guarantee that we will be
able to develop and commercialize products before our
competitors develop and commercialize products for the same
indications.
SF-51
Notes to
consolidated financial statements
The following table sets forth IPR&D projects for companies
and certain assets we have acquired since 2006 (in thousands):
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Discount Rate
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Company/
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Used in
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Year of
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Year Assets
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Estimating
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Expected
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Acquired
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Purchase
Price
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IPR&D(1)
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Programs
Acquired
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Cash
Flows(1)
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Launch
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Diamics/2007
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$
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4,000
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$
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682
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PapMap (Pap Screening Methods)
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63%
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2009-2010
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1,049
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C-Map (Automated Pap Screening)
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63%
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2009-2010
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3,094
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POC (Point of Care Systems)
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63%
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2009-2010
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$
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4,825
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Biosite/2007
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$
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1,800,000
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$
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13,000
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Triage Sepsis Panel
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15%
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2008-2010
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156,000
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Triage NGAL
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15%
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2008-2010
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$
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169,000
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Clondiag/2006
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$
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24,000
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$
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1,800
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CHF (Congestive Heart Failure)
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37%
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2008-2009
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2,500
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ACS (Acute Coronary Syndrome)
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37%
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2009-2010
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660
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HIV (Human Immuno-deficiency Virus)
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37%
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2008-2009
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$
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4,960
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(1) |
|
Management assumes responsibility for determining the
valuation of the acquired IPR&D projects. The fair value
assigned to IPR&D for each acquisition is estimated by
discounting, to present value, the cash flows expected once the
acquired projects have reached technological feasibility. The
cash flows are probability adjusted to reflect the risks of
advancement through the product approval process. In estimating
the future cash flows, we also considered the tangible and
intangible assets required for successful exploitation of the
technology resulting from the purchased IPR&D projects and
adjusted future cash flows for a charge reflecting the
contribution to value of these assets. |
15. NET
LOSS PER COMMON SHARE
The following table sets forth the computation of basic and
diluted net loss per common share (in thousands, except per
share amounts):
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2008
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2007
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2006
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Net loss per common sharebasic and diluted:
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Numerator:
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Net loss
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$
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(21,768
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)
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$
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(244,753
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)
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$
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(16,842
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)
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Less: Preferred stock dividends
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(13,989
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)
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Net loss available to common stockholders
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$
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(35,757
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)
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$
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(244,753
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)
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$
|
(16,842
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)
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Denominator:
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Weighted average shares outstanding
|
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77,778
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|
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51,510
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34,109
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Net loss per common sharebasic and diluted
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$
|
(0.46
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)
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$
|
(4.75
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)
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$
|
(0.49
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)
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We had the following potential dilutive securities outstanding
on December 31, 2008: (a) options and warrants to
purchase an aggregate of 10.6 million shares of our common
stock at a weighted average exercise price of $32.15 per share,
(b) 3.4 million shares related to the issuance of our
$150.0 million, 3% senior subordinated convertible
notes and (c) 1.9 million shares of our Series B
convertible preferred stock, convertible under certain
circumstances at $69.32 per share into 10.8 million shares
of our common stock. Potential dilutive securities were not
included in the computation of diluted net loss per common share
in 2008 because the inclusion thereof would be antidilutive.
SF-52
Notes to
consolidated financial statements
We had the following potential dilutive securities outstanding
on December 31, 2007: (a) options and warrants to
purchase an aggregate of 8.3 million shares of our common
stock at a weighted average exercise price of $30.82 per share
and (b) 1.8 million shares related to the issuance of
our $150.0 million, 3% senior subordinated convertible
notes. Potential dilutive securities were not included in the
computation of diluted loss per common share in 2007 because the
inclusion thereof would be antidilutive.
We had the following potential dilutive securities outstanding
on December 31, 2006: options and warrants to purchase an
aggregate of 4.1 million shares of our common stock at a
weighted average exercise price of $20.75 per share. Potential
dilutive securities were not included in the computation of
diluted loss per common share in 2006 because the inclusion
thereof would be antidilutive.
16. STOCKHOLDERS
EQUITY
a. Common
stock
As of December 31, 2008, we had 150.0 million shares
of common stock, $0.001 par value, authorized, of which
approximately 78.4 million shares were issued and
outstanding, 11.1 million shares were reserved for issuance
upon grant and exercise of stock options under current stock
option plans, 0.5 million shares were reserved for issuance
under our employee stock purchase plan and 0.5 million
shares were reserved for issuance upon exercise of outstanding
warrants. In addition, we have potential dilutive securities
consisting of our $150 million, 3% senior subordinated
convertible notes, convertible into 3.4 million shares of
our common stock (Note 6(b)) and 1.9 million shares of
our Seried B convertible preferred stock, convertible under
certain circumstances at $69.32 per share into 10.8 million
shares of our common stock (Note 16(b)).
In November 2007, we sold an aggregate 13.6 million shares
of our common stock at $61.49 per share through an underwritten
public offering. Certain of our officers also sold a total of
165,698 shares of common stock in the offering. Proceeds to
us from the offering were approximately $806.9 million, net
of issuance costs of $31.8 million, which includes
deductions for underwriting discounts and commissions and takes
into effect the reimbursement by the underwriters of a portion
of our offering expenses. The net proceeds were used to fund
certain acquisitions with the remainder of the net proceeds
retained for working capital and other general corporate
purposes.
In January 2007, we sold an aggregate 6.9 million shares of
our common stock at $39.65 per share through an underwritten
public offering, inclusive of 0.9 million shares associated
with the exercise of our underwriter option to purchase
additional shares to cover over-allotments. Proceeds from the
offering were approximately $261.3 million, net of issuance
costs of $12.3 million, which included deductions for
underwriting discounts and commissions and takes into effect the
reimbursement by the underwriters of a portion of our offering
expenses. Of this amount, we used $44.9 million to repay
principal outstanding and accrued interest on our term loan
under our senior credit facility, with the remainder of the net
proceeds retained for working capital and other general
corporate purposes.
b. Preferred
stock
As of December 31, 2008, we had 5.0 million shares of
preferred stock, $0.001 par value, authorized, of which
2.3 million shares were designated as Series B
Convertible Perpetual Preferred Stock, or Series B
preferred stock. On May 8, 2008, in connection with our
acquisition of Matria we issued 1.8 million shares of the
Series B preferred stock with a fair value of approximately
$657.9 million (Note 4(a)(i)).
Each share of Series B preferred stock, which has a
liquidation preference of $400.00 per share, is convertible, at
the option of the holder and only upon certain circumstances,
into 5.7703 shares of our common stock, plus cash in lieu
of fractional shares. The initial conversion price is $69.32 per
share, subject to adjustment upon the occurrence of certain
events, but will not be adjusted for accumulated and unpaid
dividends. Upon a conversion of shares of the Series B
preferred stock, we may, at our option, satisfy the
SF-53
Notes to
consolidated financial statements
entire conversion obligation in cash or through a combination of
cash and common stock. There were no conversions as of
December 31, 2008.
Generally, the shares of Series B preferred stock are
convertible, at the option of the holder, if during any calendar
quarter beginning with the second calendar quarter after the
issuance date of the Series B preferred stock, if the
closing sale price of our common stock for each of 20 or more
trading days within any period of 30 consecutive trading days
ending on the last trading day of the immediately preceding
calendar quarter exceeds 130% of the conversion price per share
of common stock in effect on the last trading day of the
immediately preceding calendar quarter. In addition, the shares
of Series B preferred stock are convertible, at the option
of the holder, in certain other circumstances, including those
relating to the trading price of the Series B preferred
stock and upon the occurrence of certain fundamental changes or
major corporate transactions. We also have the right, under
certain circumstances relating to the trading price of our
common stock, to force conversion of the Series B preferred
stock. Depending on the timing of any such forced conversion, we
may have to make certain payments relating to foregone
dividends, which payments we can make, at our option, in the
form of cash, shares of our common stock, or a combination of
cash and shares of our common stock.
Each share of Series B preferred stock accrues dividends at
$12.00, or 3%, per annum, payable quarterly on January 15,
April 15, July 15 and October 15 of each year, commencing
following the first full calendar quarter after the issuance
date. Dividends on the Series B preferred stock are
cumulative from the date of issuance. For the year ended
December 31, 2008, Series B preferred stock dividends
amounted to $14.0 million, which reduced earnings available
to common stockholders for purposes of calculating net loss per
common share in 2008 (Note 15). Accrued dividends are
payable only if declared by our board of directors and, upon
conversion by the Series B preferred stockholder, holders
will not receive any cash payment representing accumulated
dividends. If our board of directors declares a dividend
payable, we have the right to pay the dividends in cash, shares
of common stock, additional shares of Series B preferred
stock or a similar convertible preferred stock or any
combination thereof.
On September 15, 2008, the board of directors declared a
dividend of $4.77 per share on the Series B preferred
stock. The dividend was paid in shares of Series B
preferred stock in an amount per share of Series B
preferred stock equal to the quotient of (a) $4.77 divided
by (b) 97% of the average of the volume-weighted average
price per share of the Series B preferred stock on the
American Stock Exchange for each of the five consecutive trading
days ending on the second trading day immediately prior to the
record date of the dividend. We paid cash in lieu of any
fractional shares resulting from the dividend. The dividend
totaling $8.5 million was paid on October 15, 2008 to
holders of record of Series B preferred stock at the close
of business on October 1, 2008. This was the first dividend
declared and paid on the Series B preferred stock, and such
payment covered the amount of all dividends accrued from
May 9, 2008, the original issuance date of the
Series B preferred stock, through September 30, 2008.
On December 10, 2008, the board of directors declared a
dividend of $3.00 per share on the Series B preferred
stock. The dividend was paid in shares of Series B
preferred stock in an amount per share of Series B
preferred stock equal to the quotient of (a) $3.00 divided
by (b) 97% of the average of the volume-weighted average
price per share of the Series B preferred stock on the
American Stock Exchange for each of the five consecutive trading
days ending on the second trading day immediately prior to the
record date of the dividend. We paid cash in lieu of any
fractional shares resulting from the dividend. The dividend
totaling $5.5 million was paid on January 15, 2009 to
holders of record of Series B preferred stock at the close
of business on January 2, 2009. Such payment covered the
amount of all dividends accrued from October 1, 2008
through December 31, 2008. As of December 31, 2008,
1.9 million shares of Series B preferred stock are
issued and outstanding.
The holders of Series B preferred stock have liquidation
preferences over the holders of the Companys common stock
and other classes of stock, if any, outstanding at the time of
liquidation. Upon liquidation, the holders of outstanding
Series B preferred stock would receive an amount equal to
$400.00 per share of
SF-54
Notes to
consolidated financial statements
Series B preferred stock, plus any accumulated and unpaid
dividends. As of December 31, 2008, the liquidation
preference of the outstanding Series B preferred stock was
$751.5 million. The holders of the Series B preferred
stock have no voting rights, except with respect to matters
affecting the Series B preferred stock (including the
creation of a senior preferred stock).
We evaluated the terms and provisions of our Series B
preferred stock to determine if it qualified for derivative
accounting treatment under SFAS No. 133, Accounting
for Derivative Instruments and Hedging Activities. Based on
our evaluation, these securities do not qualify for derivative
accounting under SFAS No. 133.
c. Stock
options and awards
In 2001, we adopted the 2001 Stock Option and Incentive Plan (as
amended, the 2001 Plan) which currently allows for
the issuance of up to 11.1 million shares of common stock
and other awards. The 2001 Plan is administered by the
Compensation Committee of the Board of Directors in order to
select the individuals eligible to receive awards, determine or
modify the terms and conditions of the awards granted,
accelerate the vesting schedule of any award and generally
administer and interpret the 2001 Plan. The key terms of the
2001 Plan permit the granting of incentive or nonqualified stock
options with a term of up to ten years and the granting of stock
appreciation rights, restricted stock awards, unrestricted stock
awards, performance share awards and dividend equivalent rights.
The 2001 Plan also provides for option grants to non-employee
directors and automatic vesting acceleration of all options and
stock appreciation rights upon a change in control, as defined
by the 2001 Plan. As of December 31, 2008 and 2007, there
were 0.8 million and 2.3 million, respectively, shares
available for future grant under the 2001 plan.
In August 2001, we sold to our chief executive officer
1.2 million shares of restricted common stock at a price of
$9.13 per share. Two-thirds of the restricted stock, or
0.8 million shares, vested ratably over 36 months; the
remaining one-third, or 0.4 million shares, vested ratably
over 48 months. Except for the par value of the common
stock, which was paid in cash, the chief executive officer
purchased the restricted stock with a five-year promissory note,
which, for accounting purposes, was treated as a non-recourse
note. The total interest under the promissory note was fully
recourse to our chief executive officer. The note was due and
payable on August 16, 2006 and bore interest at an annual
rate of 4.99%. Interest income recorded under this note amounted
to $0.3 million for the year ended December 31, 2006.
In August, 2006 the note and accrued interest were paid in full
(Note 21).
In August 2001, we granted two non-qualified stock options to
purchase an aggregate of 0.8 million shares of common stock
at an exercise price of $6.20 per share to two other key
executive officers. These options were set to expire on
January 31, 2002. In December 2001, the executive officers
exercised these options (one fully; one partially) by paying
cash in the amount of par value and delivering promissory notes
for the difference, as permitted pursuant to the terms of the
original grant. For accounting purposes, the promissory notes
were treated as non-recourse notes. The notes were due and
payable in December 2006 and bore interest at an annual rate of
3.97%, the applicable federal rate for a five-year note in
effect during the month of exercise. The notes and accrued
interest were paid in full in December 2006 (Note 21).
Interest income recorded under these notes amounted to
$0.2 million for the year ended December 31, 2006.
SF-55
Notes to
consolidated financial statements
The following summarizes all stock option activity during the
year ended December 31 (in thousands, except exercise price):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
average
|
|
|
|
|
|
average
|
|
|
|
|
|
average
|
|
|
|
Options
|
|
|
exercise
price
|
|
|
Options
|
|
|
exercise
price
|
|
|
Options
|
|
|
exercise
price
|
|
|
|
|
Outstanding at January 1
|
|
|
7,836
|
|
|
$
|
31.42
|
|
|
|
3,775
|
|
|
$
|
21.11
|
|
|
|
3,902
|
|
|
$
|
18.82
|
|
Exchanged
|
|
|
1,820
|
|
|
$
|
30.52
|
|
|
|
3,606
|
|
|
$
|
23.48
|
|
|
|
|
|
|
$
|
|
|
Granted
|
|
|
1,787
|
|
|
$
|
34.13
|
|
|
|
2,807
|
|
|
$
|
49.53
|
|
|
|
666
|
|
|
$
|
31.88
|
|
Exercised
|
|
|
(836
|
)
|
|
$
|
16.84
|
|
|
|
(2,204
|
)
|
|
$
|
23.70
|
|
|
|
(510
|
)
|
|
$
|
17.30
|
|
Canceled/expired/forfeited
|
|
|
(452
|
)
|
|
$
|
37.75
|
|
|
|
(148
|
)
|
|
$
|
33.33
|
|
|
|
(283
|
)
|
|
$
|
21.81
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31
|
|
|
10,155
|
|
|
$
|
32.65
|
|
|
|
7,836
|
|
|
$
|
31.42
|
|
|
|
3,775
|
|
|
$
|
21.11
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31
|
|
|
5,866
|
|
|
$
|
27.08
|
|
|
|
3,887
|
|
|
$
|
20.03
|
|
|
|
2,408
|
|
|
$
|
17.16
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The aggregate intrinsic value of the options outstanding at
December 31, 2008 was $9.7 million. The aggregate
intrinsic value of the options exercisable at December 31,
2008 was $9.6 million. The aggregate intrinsic value of
stock options exercised during 2008, 2007 and 2006 was
$18.2 million, $62.5 million and $7.4 million,
respectively. Based on equity awards outstanding as of
December 31, 2008, there was $62.6 million of
unrecognized compensation costs related to unvested share-based
compensation arrangements that are expected to vest. Such costs
are expected to be recognized over a weighted average period of
1.5 years.
d. Warrants
The following is a summary of all warrant activity during the
three years ended December 31:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
|
|
|
|
Number of
|
|
|
|
|
|
average
|
|
|
|
shares
|
|
|
Exercise
price
|
|
|
exercise
price
|
|
|
|
|
|
(in
thousands)
|
|
|
|
|
|
|
|
|
Warrants outstanding and exercisable, December 31, 2005
|
|
|
758
|
|
|
$
|
3.81-$24.00
|
|
|
$
|
16.47
|
|
Exercised
|
|
|
(452
|
)
|
|
$
|
3.88-$18.12
|
|
|
$
|
16.51
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants outstanding and exercisable, December 31, 2006
|
|
|
306
|
|
|
$
|
3.81-$24.00
|
|
|
$
|
16.42
|
|
Exchanged
|
|
|
285
|
|
|
$
|
14.52-$29.78
|
|
|
$
|
28.98
|
|
Exercised
|
|
|
(122
|
)
|
|
$
|
13.54-$29.78
|
|
|
$
|
19.31
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants outstanding and exercisable, December 31, 2007
|
|
|
469
|
|
|
$
|
3.81-$29.78
|
|
|
$
|
20.80
|
|
Exercised
|
|
|
(12
|
)
|
|
$
|
13.54-$20.06
|
|
|
$
|
19.64
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants outstanding and exercisable, December 31, 2008
|
|
|
457
|
|
|
$
|
3.81-$29.78
|
|
|
$
|
20.83
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SF-56
Notes to
consolidated financial statements
The following represents additional information related to
warrants outstanding and exercisable at December 31, 2008:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding and
exercisable
|
|
|
|
|
|
|
Weighted
|
|
|
|
|
|
|
|
|
|
average
|
|
|
Weighted
|
|
|
|
Number of
|
|
|
remaining
|
|
|
average
|
|
Exercise
Price
|
|
shares
|
|
|
contract
life
|
|
|
exercise
price
|
|
|
|
|
|
(in
thousands)
|
|
|
(in
years)
|
|
|
|
|
|
$3.81-$3.93
|
|
|
4
|
|
|
|
1.48
|
|
|
$
|
3.87
|
|
$4.48-$4.57
|
|
|
1
|
|
|
|
1.54
|
|
|
$
|
4.54
|
|
$5.44-$5.57
|
|
|
4
|
|
|
|
1.58
|
|
|
$
|
5.53
|
|
$7.37-$7.55
|
|
|
2
|
|
|
|
1.66
|
|
|
$
|
7.48
|
|
$13.54-$18.12
|
|
|
219
|
|
|
|
2.97-3.72
|
|
|
$
|
14.41
|
|
$20.06-$29.78
|
|
|
152
|
|
|
|
6.78
|
|
|
$
|
29.66
|
|
$24.00
|
|
|
75
|
|
|
|
6.25
|
|
|
$
|
24.00
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
457
|
|
|
|
5.03
|
|
|
$
|
20.83
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The majority of the warrants included in the table above were
issued in connection with debt and equity financings, or
amendments thereto, of which warrants to purchase an aggregate
of 0.3 million shares of our common stock were issued to
officers and directors of our company or entities controlled by
these officers and directors and were outstanding at
December 31, 2008. The value of warrants issued in
connection with debt financings yielded original issue discounts
and additional interest expense of $0.5 million in 2006. No
such expense was incurred during 2008 and 2007. All outstanding
warrants have been classified in equity, pursuant to provision
EITF
No. 00-19.
e. Employee
stock purchase plan
In 2001, we adopted the 2001 Employee Stock Purchase Plan under
which eligible employees are allowed to purchase shares of our
common stock at a discount through periodic payroll deductions.
Purchases may occur at the end of every six month offering
period at a purchase price equal to 85% of the market value of
our common stock at either the beginning or end of the offering
period, whichever is lower. We may issue up to 1.0 million
shares of common stock under this plan. At December 31,
2008, 0.5 million shares had been issued under this plan.
|
|
17.
|
STOCK-BASED
COMPENSATION
|
In accordance with
SFAS No. 123-R,
our results of operations for the year ended December 31,
2008, 2007 and 2006 reflected compensation expense for new stock
options granted since January 1, 2006, and vested under our
stock incentive plan and employee stock purchase plan and the
unvested portion of previous stock option grants which vested
during the years ended December 31, 2008, 2007 and 2006.
Stock-based compensation expense in the amount of
$26.4 million ($20.7 million, net of tax),
$57.5 million ($52.7 million, net of tax) and
$5.5 million ($4.9 million, net of tax), was reflected
in our consolidated
SF-57
Notes to
consolidated financial statements
statements of operations for the year ended December 31,
2008, 2007 and 2006, respectively, as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
Cost of net revenue
|
|
$
|
1,504
|
|
|
$
|
608
|
|
|
$
|
391
|
|
Research and development
|
|
|
4,627
|
|
|
|
2,215
|
|
|
|
1,390
|
|
Sales and marketing
|
|
|
4,264
|
|
|
|
1,699
|
|
|
|
682
|
|
General and administrative
|
|
|
16,010
|
|
|
|
52,958
|
|
|
|
2,992
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
26,405
|
|
|
$
|
57,480
|
|
|
$
|
5,455
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Included in the amount above for general and administrative
expense for the year ended December 31, 2007, is
$45.2 million related to our assumption of Biosite options.
The expense relates to the acceleration of unvested Biosite
employee options. See Note 4(b) regarding our acquisition
of Biosite.
In accordance with
SFAS No. 123-R,
for the year ended December 31, 2008, 2007 and 2006, the
presentation of our cash flows reports the excess tax benefits
from the exercise of stock options as financing cash flows. For
the year ended December 31, 2008, 2007 and 2006, excess tax
benefits generated from option exercises amounted to
$17.5 million, $0.9 million and $0.6 million,
respectively.
The following assumptions were used to estimate the fair value
of options granted during the year ended December 31, 2008,
2007 and 2006 using the Black-Scholes option-pricing model:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
Risk-free interest rate
|
|
|
2.39-3.14
|
%
|
|
|
3.15-5.00
|
%
|
|
|
4.00-4.67
|
%
|
Expected dividend yield
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected life
|
|
|
5.19 years
|
|
|
|
6.25 years
|
|
|
|
6.25 years
|
|
Expected volatility
|
|
|
37-43
|
%
|
|
|
44
|
%
|
|
|
41
|
%
|
The weighted average fair value under the Black-Scholes option
pricing model of options granted to employees during 2008, 2007
and 2006 was $10.66, $24.05 and $15.29, respectively. All
options granted during these periods were granted at fair market
value on date of grants.
For the year ended December 31, 2008, in accordance with
SFAS 123-R,
we recorded compensation expense of $2.8 million related to
our Employee Stock Purchase Plan. The fair value of the option
component of the Employee Stock Purchase Plan shares was
estimated at the date of grant using the Black-Scholes pricing
model and assumed an expected volatility of 43.31% to 53.87%, a
risk-free interest rate range of 2.13% to 3.32% and an expected
life of 181 and 184 days. The charge is included in general
and administrative in the table above.
For the year ended December 31, 2007, in accordance with
SFAS 123-R,
we recorded compensation expense of $1.5 million related to
our Employee Stock Purchase Plan. The fair value of the option
component of the Employee Stock Purchase Plan shares was
estimated at the date of grant using the Black-Scholes pricing
model and assumed an expected volatility of 32.64% to 69.49%, a
risk-free interest rate range of 4.17% to 4.94% and an expected
life of 181 and 184 days. The charge is included in general
and administrative in the table above.
For the year ended December 31, 2006, in accordance with
SFAS 123-R,
we recorded compensation expense of $0.3 million related to
our Employee Stock Purchase Plan. The fair value of the option
component of the Employee Stock Purchase Plan shares were
estimated at the date of grant using the Black-Scholes pricing
model and assumed an expected volatility of 33%, a risk-free
interest rate range of 4.55% to 4.99% and an expected life of
0.5 years. The charge is included in general and
administrative in the table above.
SF-58
Notes to
consolidated financial statements
18. OTHER
COMPREHENSIVE INCOME
SFAS No. 130, Reporting Comprehensive Income,
establishes standards for the reporting and display of
comprehensive income. In general, comprehensive income combines
net income and other changes in equity during the year from
non-owner sources. Accumulated other comprehensive income is
recorded as a component of stockholders equity. The
following is a summary of the components of and changes in
accumulated other comprehensive income as of December 31,
2008 and in each of the three years then ended (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cumulative
|
|
|
Pension
|
|
|
|
|
|
Accumulated
|
|
|
|
translation
|
|
|
liability
|
|
|
|
|
|
other
|
|
|
|
adjustment
|
|
|
adjustment
|
|
|
|
|
|
comprehensive
|
|
|
|
(note
2(b))
|
|
|
(note
9(b))
|
|
|
Other(1)
|
|
|
income
(loss)(2)
|
|
|
|
|
Balance at December 31, 2005
|
|
$
|
7,052
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
7,052
|
|
Period change
|
|
|
10,823
|
|
|
|
(3,738
|
)
|
|
|
44
|
|
|
|
7,129
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006
|
|
|
17,875
|
|
|
|
(3,738
|
)
|
|
|
44
|
|
|
|
14,181
|
|
Period change
|
|
|
12,758
|
|
|
|
341
|
|
|
|
(6,011
|
)
|
|
|
7,088
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007
|
|
|
30,633
|
|
|
|
(3,397
|
)
|
|
|
(5,967
|
)
|
|
|
21,269
|
|
Period change
|
|
|
(32,889
|
)
|
|
|
(562
|
)
|
|
|
(16,663
|
)
|
|
|
(50,114
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008
|
|
$
|
(2,256
|
)
|
|
$
|
(3,959
|
)
|
|
$
|
(22,630
|
)
|
|
$
|
(28,845
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Other represents (realization of) unrealized gains on
available-for-sale securities and interest rate swap. |
|
(2) |
|
All of the components of accumulated other comprehensive
income relate to our foreign subsidiaries, except item
(1) above. No adjustments for income taxes were recorded
against other comprehensive income, as we intend to permanently
invest in our foreign subsidiaries in the foreseeable future. |
19. INCOME
TAXES
Our income tax (benefit) provision in 2008, 2007 and 2006 mainly
represents those recorded by us and certain of our
U.S. subsidiaries and by our foreign subsidiaries Unipath
in the United Kingdom, Inverness Medical France, and Inverness
Medical Switzerland. Loss before (benefit) provision for income
taxes consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
United States
|
|
$
|
(52,935
|
)
|
|
$
|
(235,862
|
)
|
|
$
|
(5,089
|
)
|
Foreign
|
|
|
13,431
|
|
|
|
(14,242
|
)
|
|
|
(6,362
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
(39,504
|
)
|
|
$
|
(250,104
|
)
|
|
$
|
(11,451
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our primary temporary differences that give rise to the deferred
tax asset and liability are NOL carryforwards, nondeductible
reserves, accruals and differences in bases of the tangible and
intangible assets, and the gain on the joint venture
transaction. The income tax effects of these temporary
differences are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
NOL and capital loss carryforwards
|
|
$
|
102,484
|
|
|
$
|
141,620
|
|
Tax credit carryforwards
|
|
|
15,884
|
|
|
|
18,236
|
|
Nondeductible reserves
|
|
|
9,488
|
|
|
|
5,327
|
|
Nondeductible accruals
|
|
|
67,142
|
|
|
|
41,318
|
|
Difference between book and tax bases of tangible assets
|
|
|
3,133
|
|
|
|
2,328
|
|
Difference between book and tax bases of intangible assets
|
|
|
35,986
|
|
|
|
35,042
|
|
SF-59
Notes to
consolidated financial statements
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Gain on joint venture
|
|
$
|
33,264
|
|
|
$
|
37,300
|
|
All other
|
|
|
1,162
|
|
|
|
26
|
|
|
|
|
|
|
|
|
|
|
Gross deferred tax asset
|
|
|
268,543
|
|
|
|
281,197
|
|
Less: Valuation allowance
|
|
|
(12,740
|
)
|
|
|
(18,899
|
)
|
|
|
|
|
|
|
|
|
|
Total deferred tax assets
|
|
|
255,803
|
|
|
|
262,298
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
Difference between book and tax bases of tangible assets
|
|
|
10,824
|
|
|
|
6,249
|
|
Difference between book and tax bases of intangible assets
|
|
|
588,766
|
|
|
|
524,603
|
|
Other
|
|
|
366
|
|
|
|
23,973
|
|
|
|
|
|
|
|
|
|
|
Total deferred tax liability
|
|
|
599,956
|
|
|
|
554,825
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax liability
|
|
$
|
344,153
|
|
|
$
|
292,527
|
|
|
|
|
|
|
|
|
|
|
Reported as:
|
|
|
|
|
|
|
|
|
Deferred tax assets, current portion
|
|
$
|
104,311
|
|
|
$
|
18,170
|
|
Deferred tax assets, long-term
|
|
|
14,323
|
|
|
|
15,799
|
|
Deferred tax liabilities, current portion
|
|
|
|
|
|
|
(368
|
)
|
Deferred tax liabilities, long-term
|
|
|
(462,787
|
)
|
|
|
(326,128
|
)
|
|
|
|
|
|
|
|
|
|
Net deferred tax liability
|
|
$
|
(344,153
|
)
|
|
$
|
(292,527
|
)
|
|
|
|
|
|
|
|
|
|
As of December 31, 2008, we had approximately
$256.6 million of domestic NOL carryforwards and
$15.9 million of foreign NOL and foreign capital loss
carryforwards, which either expire on various dates through 2027
or can be carried forward indefinitely. These loss carryforwards
are available to reduce future federal and foreign taxable
income, if any. These loss carryforwards are subject to review
and possible adjustment by the appropriate taxing authorities.
The domestic NOL carryforwards include approximately
$199.2 million of pre-acquisition losses at Matria, Alere
Medical, ParadigmHealth, Biosite, Cholestech, Diamics,
HemoSense, IMN, Ischemia and Ostex. Also included in our
domestic NOL carryforwards at December 31, 2008 was
approximately $17.5 million resulting from the exercise of
employee stock options, the tax benefit of which was recognized
as a credit to additional paid-in capital rather than a
reduction of income tax. Our domestic NOLs are subject to
the Internal Revenue Service Code Section 382 limitation.
Section 382 imposes an annual limitation on the use of
these losses to an amount equal to the value of the company at
the time of the ownership change multiplied by the long-term tax
exempt rate. The Section 382 limited amount for 2009 is
approximately $167.0 million.
We have recorded a valuation allowance of $12.7 million as
of December 31, 2008 due to uncertainties related to the
future benefits, if any, from our deferred tax assets related
primarily to our foreign businesses and certain U.S. net
operating losses and tax credits. This is a reduction of
$6.2 million from the valuation allowance of
$18.9 million as of December 31, 2007. The decrease is
primarily related to the recognition of foreign NOLs. The
valuation allowance is based on our estimates of taxable income
by jurisdiction in which we operate and the period over which
our deferred tax assets will be recoverable. In the event that
actual results differ from these estimates or we adjust these
estimates in future periods, we may need to establish an
additional valuation allowance or reduce our current valuation
allowance which could materially impact our tax provision.
In accordance with SFAS No. 109, the accounting for
the tax benefits of acquired deductible temporary differences
and NOL carryforwards, which are not recognized at the
acquisition date because a valuation allowance is established
and which are recognized subsequent to the acquisitions, will be
applied first to reduce to zero any goodwill and other
non-current intangible assets related to the acquisitions. Any
remaining benefits would be recognized as a reduction of income
tax expense. As of December 31, 2008,
SF-60
Notes to
consolidated financial statements
$3.7 million of deferred tax assets with a valuation
allowance pertains to acquired companies, the future benefits of
which will be applied to reduce our income tax expense as
required under
SFAS No. 141-R,
Business Combinations, adopted January 1, 2009.
Our China-based manufacturing subsidiaries qualify for a reduced
income tax rate in 2008 and an income tax holiday for 2007. The
general income tax rate is 25%. The income tax rate for ABON is
12.5% for 2008, 2009 and 2010, and for IM Shanghai it is 9% for
2008, 10% for 2009, 11% for 2010 and 24% for 2011. The reduced
rates for 2008, 2009, 2010 and 2011 are grandfathered in the
China Tax Reform Act. A tax rate of 15% or 25% will apply to
2011 and future years. The tax rate of 15% applies to companies
with high technology status. We are in the process of applying
for high technology status. The reduced tax rate produced a tax
expense of approximately $1.0 million. In the absence of
the reduced tax rate for 2008 a tax rate of 25% would apply
which would have resulted in a tax expense of approximately
$2.0 million in 2008. The earnings per common share effect
of the reduced tax rate is $0.01 for 2008. The tax holiday
provided an income tax rate of 0% in 2007. In the absence of the
tax holiday, a tax rate of 33% would apply, which would have
resulted in a tax expense of approximately $3.8 million in
2007. The earnings per share common effect of the tax holiday is
$0.07 for 2007.
The estimated amount of undistributed earnings of our foreign
subsidiaries is $86.1 million at December 31, 2008. No
amount for U.S. income tax has been provided on
undistributed earnings of our foreign subsidiaries because we
consider such earnings to be indefinitely reinvested. In the
event of distribution of those earnings in the form of dividends
or otherwise, we would be subject to both U.S. income
taxes, subject to an adjustment, if any, for foreign tax
credits, and foreign withholding taxes payable to certain
foreign tax authorities. Determination of the amount of
U.S. income tax liability that would be incurred is not
practicable because of the complexities associated with this
hypothetical calculation, however, unrecognized foreign tax
credit carryforwards may be available to reduce some portion of
the U.S. tax liability, if any.
The following table presents the components of our (benefit)
provision for income taxes (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
Current:
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$
|
7,433
|
|
|
$
|
2,434
|
|
|
$
|
|
|
State
|
|
|
7,250
|
|
|
|
2,073
|
|
|
|
423
|
|
Foreign
|
|
|
10,387
|
|
|
|
22,406
|
|
|
|
5,315
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
25,070
|
|
|
|
26,913
|
|
|
|
5,738
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred:
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
|
(5,897
|
)
|
|
|
(4,961
|
)
|
|
|
3,152
|
|
State
|
|
|
(4,237
|
)
|
|
|
(1,523
|
)
|
|
|
289
|
|
Foreign
|
|
|
(31,622
|
)
|
|
|
(21,408
|
)
|
|
|
(3,452
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(41,756
|
)
|
|
|
(27,892
|
)
|
|
|
(11
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total tax (benefit) provision
|
|
$
|
(16,686
|
)
|
|
$
|
(979
|
)
|
|
$
|
5,727
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SF-61
Notes to
consolidated financial statements
The following table presents a reconciliation from the
U.S. statutory tax rate to our effective tax rate:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
Statutory rate
|
|
|
35
|
%
|
|
|
35
|
%
|
|
|
35
|
%
|
Effect of Biosite in-process R&D write-off
|
|
|
|
|
|
|
(24
|
)
|
|
|
|
|
Effect of Diamics in-process R&D write-off
|
|
|
|
|
|
|
(1
|
)
|
|
|
|
|
Effect of Biosite compensation charges and other non-cash
compensation
|
|
|
|
|
|
|
(6
|
)
|
|
|
|
|
Effect of losses and expenses not benefited
|
|
|
|
|
|
|
|
|
|
|
(28
|
)
|
Stock-based compensation
|
|
|
(10
|
)
|
|
|
|
|
|
|
|
|
Rate differential on foreign earnings
|
|
|
3
|
|
|
|
|
|
|
|
(2
|
)
|
Research and development benefit
|
|
|
6
|
|
|
|
1
|
|
|
|
14
|
|
State income taxes, net of federal benefit
|
|
|
2
|
|
|
|
(1
|
)
|
|
|
(4
|
)
|
Deferred tax on indefinite-lived assets
|
|
|
|
|
|
|
|
|
|
|
(31
|
)
|
Accrual to return reconciliation
|
|
|
|
|
|
|
|
|
|
|
(9
|
)
|
Other permanent items and FIN 48
|
|
|
(4
|
)
|
|
|
1
|
|
|
|
|
|
Change in valuation allowance
|
|
|
11
|
|
|
|
(4
|
)
|
|
|
(27
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate
|
|
|
43
|
%
|
|
|
1
|
%
|
|
|
(52
|
)%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We adopted FIN 48, Accounting for Uncertainty in Income
Taxesan Interpretation of FASB Statement 109 on
January 1, 2007. During the year ended December 31,
2008, we increased the liability for income taxes associated
with uncertain tax positions by $2.4 million for a total of
$11.1 million at December 31, 2008. The primary reason
for the increase is due to our acquisitions of Clondiag and
Matria, where we increased the liability for income taxes
associated with uncertain tax positions by $1.8 million.
Any future recognition of the Clondiag or Matria tax benefit is
generally recorded to income due to the adoption of
SFAS No. 141-R,
Business Combinations, effective January 1, 2009. In
addition, consistent with the provisions of FIN 48, we
classified $11.1 million of income tax liabilities as
non-current income tax liabilities because a payment of cash is
not anticipated within one year of the balance sheet date. These
non-current income tax liabilities are recorded in other
long-term liabilities in our consolidated balance sheet at
December 31, 2008. We anticipate an increase every quarter
to the total amount of unrecognized tax benefits. We do not
anticipate a significant increase or decrease of the total
amount of unrecognized tax benefits within twelve months of the
reporting date.
A reconciliation of the beginning and ending amount of
unrecognized tax benefits is as follows (in thousands):
|
|
|
|
|
|
|
Amount
|
|
|
|
|
Balances as of January 1, 2007
|
|
$
|
2,248
|
|
Additions for tax positions taken during prior years
|
|
|
53
|
|
Additions for tax positions in current year acquisitions
|
|
|
6,229
|
|
Additions for tax positions taken during current year
|
|
|
235
|
|
Expiration of statutes of limitations or closure of tax audits
|
|
|
|
|
|
|
|
|
|
Balances as of December 31, 2007
|
|
|
8,765
|
|
Additions for tax positions taken during prior years
|
|
|
63
|
|
Additions for tax positions in current and prior year
acquisitions
|
|
|
2,296
|
|
Additions for tax positions taken during current year
|
|
|
143
|
|
Expiration of statutes of limitations or closure of tax audits
|
|
|
(134
|
)
|
|
|
|
|
|
Balance as of December 31, 2008
|
|
$
|
11,133
|
|
|
|
|
|
|
SF-62
Notes to
consolidated financial statements
Interest and penalties related to income tax liabilities are
included in income tax expense. The interest and penalties
recorded in 2008 amounted to $0.4 million. The balance of
accrued interest and penalties recorded on the consolidated
balance sheet at December 31, 2008 was $0.8 million.
With limited exceptions, we are subject to U.S. federal,
state and local or
non-U.S. income
tax audits by tax authorities for 2002 through 2007. We are
currently under income tax examination by the IRS and a number
of state and foreign tax authorities and anticipate these audits
will be completed by the end of 2009. We cannot currently
estimate the impact of these audits due to the uncertainties
associated with tax examinations.
|
|
20.
|
FINANCIAL
INFORMATION BY SEGMENT
|
Under SFAS No. 131, Disclosures about Segments of
an Enterprise and Related Information, operating segments
are defined as components of an enterprise about which separate
financial information is available that is evaluated regularly
by the chief operating decision maker, or decision-making group,
in deciding how to allocate resources and in assessing
performance. Our chief operating decision-making group is
composed of the chief executive officer and members of senior
management. Our reportable operating segments are Professional
Diagnostics, Health Management, Consumer Diagnostics, Vitamins
and Nutritional Supplements, and Corporate and Other. Our
operating results include license and royalty revenue which are
allocated to Professional Diagnostics and Consumer Diagnostics
on the basis of the original license or royalty agreement.
Included in the operating results of Professional Diagnostics in
2008 are expenses related to our research and development
activities in the area of cardiology, as a result of our recent
cardiology-related acquisitions, which amounted to
$37.0 million.
Included in the operating results of Professional Diagnostics in
2007 are expenses related to our research and development
activities in the area of cardiology, as a result of our 2007
cardiology-related acquisitions, which amounted to
$26.5 million, net of $18.5 million of reimbursements
received from ITI as part of the co-development arrangement that
we entered into in February 2005.
Included in the operating results of Corporate and Other in 2006
are expenses related to our research and development activities
in the area of cardiology, which amounted to $30.2 million,
net of $16.6 million of reimbursements received from ITI as
part of the co-development arrangement mentioned above.
Operating loss of $250.7 million for the year ended
December 31, 2007 in our Corporate and Other segment
includes the write-off of $173.8 million of IPR&D
incurred in connection with our acquisitions of Biosite and
Diamics and $45.2 million of stock-based compensation
related to employee stock options assumed in the acquisition of
Biosite. Total assets related to our cardiology research
operations in Scotland and Germany, which are included in
Professional Diagnostics in 2008 and 2007 and included in
Corporate and Other in 2006 in the tables below, amounted to
$37.9 million at December 31, 2008, $39.4 million
at December 31, 2007 and $18.4 million at
December 31, 2006.
The accounting policies of the segments are the same as those
described in the summary of significant accounting policies. We
evaluate performance of our operating segments based on revenue
and operating
SF-63
Notes to
consolidated financial statements
income (loss). Revenues are attributed to geographic areas based
on where the customer is located. Segment information for 2008,
2007 and 2006 are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vitamins and
|
|
|
Corporate
|
|
|
|
|
|
|
Professional
|
|
|
Health
|
|
|
Consumer
|
|
|
nutritional
|
|
|
and
|
|
|
|
|
2008
|
|
diagnostics
|
|
|
management
|
|
|
diagnostics
|
|
|
supplements
|
|
|
other
|
|
|
Total
|
|
|
|
|
Net revenue to external customers
|
|
$
|
1,051,301
|
|
|
$
|
392,399
|
|
|
$
|
138,853
|
|
|
$
|
88,873
|
|
|
$
|
|
|
|
$
|
1,671,426
|
|
Operating income (loss)
|
|
$
|
97,994
|
|
|
$
|
11,241
|
|
|
$
|
9,505
|
|
|
$
|
(840
|
)
|
|
$
|
(54,048
|
)
|
|
$
|
63,852
|
|
Depreciation and amortization
|
|
$
|
171,980
|
|
|
$
|
85,990
|
|
|
$
|
6,809
|
|
|
$
|
2,286
|
|
|
$
|
862
|
|
|
$
|
267,927
|
|
Restructuring charge
|
|
$
|
36,196
|
|
|
$
|
|
|
|
$
|
238
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
36,434
|
|
Stock-based compensation
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
26,405
|
|
|
$
|
26,405
|
|
Assets
|
|
$
|
3,687,685
|
|
|
$
|
1,850,236
|
|
|
$
|
223,383
|
|
|
$
|
65.263
|
|
|
$
|
128,793
|
|
|
$
|
5,955,360
|
|
Expenditures for property, plant and equipment
|
|
$
|
46,859
|
|
|
$
|
7,935
|
|
|
$
|
1,917
|
|
|
$
|
362
|
|
|
$
|
8,988
|
|
|
$
|
66,061
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vitamins and
|
|
|
Corporate
|
|
|
|
|
|
|
Professional
|
|
|
Health
|
|
|
Consumer
|
|
|
nutritional
|
|
|
and
|
|
|
|
|
2007
|
|
diagnostics
|
|
|
management
|
|
|
diagnostics
|
|
|
supplements
|
|
|
other
|
|
|
Total
|
|
|
|
|
Net revenue to external customers
|
|
$
|
582,250
|
|
|
$
|
23,374
|
|
|
$
|
161,092
|
|
|
$
|
72,824
|
|
|
$
|
|
|
|
$
|
839,540
|
|
Operating income (loss)
|
|
$
|
61,067
|
|
|
$
|
(498
|
)
|
|
$
|
15,332
|
|
|
$
|
(1,061
|
)
|
|
$
|
(250,693
|
)
|
|
$
|
(175,853
|
)
|
Depreciation and amortization
|
|
$
|
82,797
|
|
|
$
|
4,487
|
|
|
$
|
9,106
|
|
|
$
|
2,917
|
|
|
$
|
1,806
|
|
|
$
|
101,113
|
|
Restructuring charge
|
|
$
|
3,965
|
|
|
$
|
|
|
|
$
|
2,737
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
6,702
|
|
Stock-based compensation
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
57,480
|
|
|
$
|
57,480
|
|
Assets
|
|
$
|
3,748,931
|
|
|
$
|
635,415
|
|
|
$
|
309,175
|
|
|
$
|
49,655
|
|
|
$
|
137,583
|
|
|
$
|
4,880,759
|
|
Expenditures for property, plant and equipment
|
|
$
|
30,581
|
|
|
$
|
2,257
|
|
|
$
|
1,366
|
|
|
$
|
872
|
|
|
$
|
1,559
|
|
|
$
|
36,635
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vitamins and
|
|
|
Corporate
|
|
|
|
|
|
|
Professional
|
|
|
Health
|
|
|
Consumer
|
|
|
nutritional
|
|
|
and
|
|
|
|
|
2006
|
|
diagnostics
|
|
|
management
|
|
|
diagnostics
|
|
|
supplements
|
|
|
other
|
|
|
Total
|
|
|
|
|
Net revenue to external customers
|
|
$
|
310,632
|
|
|
$
|
|
|
|
$
|
176,771
|
|
|
$
|
82,051
|
|
|
$
|
|
|
|
$
|
569,454
|
|
Operating income (loss)
|
|
$
|
42,554
|
|
|
$
|
|
|
|
$
|
26,975
|
|
|
$
|
(3,013
|
)
|
|
$
|
(60,145
|
)
|
|
$
|
6,371
|
|
Depreciation and amortization
|
|
$
|
27,030
|
|
|
$
|
|
|
|
$
|
5,062
|
|
|
$
|
3,270
|
|
|
$
|
4,000
|
|
|
$
|
39,362
|
|
Restructuring charge
|
|
$
|
7,625
|
|
|
$
|
|
|
|
$
|
2,921
|
|
|
$
|
|
|
|
$
|
2,587
|
|
|
$
|
13,133
|
|
Stock-based compensation
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
|
|
|
$
|
5,455
|
|
|
$
|
5,455
|
|
Assets
|
|
$
|
625,560
|
|
|
$
|
|
|
|
$
|
314,815
|
|
|
$
|
49,896
|
|
|
$
|
95,500
|
|
|
$
|
1,085,771
|
|
Expenditures for property, plant and equipment
|
|
$
|
9,905
|
|
|
$
|
|
|
|
$
|
1,807
|
|
|
$
|
475
|
|
|
$
|
7,530
|
|
|
$
|
19,717
|
|
SF-64
Notes to
consolidated financial statements
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
Revenue by Geographic Area:
|
|
|
|
|
|
|
|
|
|
|
|
|
United States
|
|
$
|
1,209,166
|
|
|
$
|
529,870
|
|
|
$
|
335,405
|
|
Europe
|
|
|
285,696
|
|
|
|
198,525
|
|
|
|
136,971
|
|
Other
|
|
|
176,564
|
|
|
|
111,145
|
|
|
|
97,078
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
1,671,426
|
|
|
$
|
839,540
|
|
|
$
|
569,454
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
|
|
Long-lived Tangible Assets by Geographic Area:
|
|
|
|
|
|
|
|
|
United States
|
|
$
|
222,450
|
|
|
$
|
198,225
|
|
United Kingdom
|
|
|
12,113
|
|
|
|
36,204
|
|
China
|
|
|
19,491
|
|
|
|
17,975
|
|
Other
|
|
|
30,429
|
|
|
|
15,476
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
284,483
|
|
|
$
|
267,880
|
|
|
|
|
|
|
|
|
|
|
|
|
21.
|
RELATED PARTY
TRANSACTIONS
|
In November 2008, the Zwanziger Family Trust, a trust
established for the benefit of the children of
Ron Zwanziger, our Chairman, Chief Executive Officer and
President, and the trustee of which is Mr. Zwanzigers
sister, purchased certain of our securities from third parties
in market transactions. The purchase consisted of approximately
$1.0 million of each of the following securities: our
common stock, our Series B Preferred Stock, our Convertible
Notes, interests in our First Lien Credit Agreement and
interests in our Second Lien Credit Agreement. To the extent we
make principal and interest payments under the Convertible Notes
and the credit facilities in accordance with their terms, the
Zwanziger Family Trust, as a holder of Convertible Notes and as
a lender under the credit facilities, will receive its
proportionate share. In connection with its purchases of
interests under our First Lien Credit Agreement and Second Lien
Credit Agreement, the Trust agreed that, whenever the consent or
vote of the lenders is required under the credit facilities, it
will vote the outstanding principal amount of its holdings in
the same proportion as the votes cast by the other lenders under
these credit facilities.
In May 2007, we completed our 50/50 joint venture with P&G
for the development, manufacturing, marketing and sale of
existing and to-be-developed consumer diagnostics, outside the
cardiology, diabetes and oral care fields. At December 31,
2008 and 2007, we had a net receivable from the joint venture of
$12.0 million and a net payable to the joint venture of
$10.8 million, respectively. Additionally, customer
receivables associated with revenue earned after the joint
venture was completed have been classified as other receivables
within prepaid and other current assets on our accompanying
consolidated balance sheets in the amount of $16.2 million
and $29.5 million as of December 31, 2008 and 2007,
respectively. In connection with the joint venture arrangement,
the joint venture bears the collection risk associated with
these receivables. Sales to the joint venture under our
manufacturing agreement totaled $103.0 million and
$65.0 million during the year ended December 31, 2008
and 2007, respectively, and are included in net product sales in
our accompanying statements of operations. Under the terms of
our product supply agreement, SPD purchases products from our
manufacturing facilities in the U.K. and China. SPD in turn
sells a portion of those tests back to Inverness for final
assembly and packaging. Once packaged, the tests are sold to
P&G for distribution to third party customers in North
America. As a result of these related transactions we have
recorded $15.6 million of trade receivables which are
included in accounts receivable on our consolidated balance
sheet as of December 31, 2008 and $18.9 million of
trade accounts payable which are included in accounts payable on
our consolidated balance sheet as of December 31, 2008.
During 2008,
SF-65
Notes to
consolidated financial statements
the joint venture paid $11.2 million in cash to both of the
parent companies, equally reducing the respective investments in
the joint venture.
On March 22, 2007, we entered into a convertible loan
agreement with BBI whereby we loaned them £7.5 million
($14.7 million as of the transaction date). Under the terms
of the agreement, the loan amount would simultaneously convert
into shares of BBI common stock per the prescribed conversion
formula defined in the loan agreement, in the event the BBI
consummated a specific target acquisition on or before
September 30, 2007. On May 15, 2007, BBI consummated a
specific target acquisition and the loan converted into
5,208,333 shares of BBIs common stock which is
included in investments in unconsolidated entities on our
accompanying consolidated balance sheet at December 31,
2007. In February 2008, we acquired the remaining outstanding
shares of BBI common stock in connection with our acquisition of
BBI (Note 4).
In December 2006, one of our key executive officers, paid us
$1,606,831 in full satisfaction of his obligations to us,
including principal and accrued interest, under a previously
disclosed, five-year promissory note dated August 16, 2001.
The promissory note was provided to us in connection with his
purchase of 250,000 shares of our common stock in August,
2001 (Note 16).
In December 2006, one of our key executive officers, paid us
$2,571,320 in full satisfaction of his obligations to us,
including principal and accrued interest, under a previously
disclosed, five-year promissory note dated August 16, 2001.
The promissory note was provided to us in connection with his
purchase of 399,381 shares of our common stock in August,
2001 (Note 16).
In August 2006, our Chairman, Chief Executive Officer and
President, paid us $11,197,096 in full satisfaction of his
obligations to us, including principal and accrued interest,
under a previously disclosed, five-year promissory note dated
August 16, 2001. The promissory note was provided to us in
connection with his purchase of 1,168,191 shares of our
common stock in August, 2001 (Note 16).
In June 2006, we issued 25,000 shares of our common stock
as consideration for the acquisition of all of the capital stock
of Innovative Medical Devices BVBA. The seller of the capital
stock of Innovative Medical Devices BVBA is the spouse of the
Chief Executive Officer, SPD Swiss Precision Diagnostics, our
50/50 joint venture with P&G.
|
|
22.
|
VALUATION AND
QUALIFYING ACCOUNTS
|
We have established reserves against accounts receivable for
doubtful accounts, product returns, discounts and other
allowances. The activity in the table below includes all
accounts receivable reserves. Provisions for doubtful accounts
are recorded as a component of general and administrative
expenses. Provisions for returns, discounts and other allowances
are charged against net product sales. The following table sets
forth activities in our accounts receivable reserve accounts (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts
|
|
|
|
|
|
|
Balance at
|
|
|
|
|
|
charged
|
|
|
Balance at
|
|
|
|
beginning of
|
|
|
|
|
|
against
|
|
|
end of
|
|
|
|
period
|
|
|
Provision
|
|
|
reserves
|
|
|
period
|
|
|
|
|
Year ended December 31, 2006
|
|
$
|
9,748
|
|
|
$
|
22,914
|
|
|
$
|
(24,261
|
)
|
|
$
|
8,401
|
|
Year ended December 31, 2007
|
|
$
|
8,401
|
|
|
$
|
28,352
|
|
|
$
|
(24,586
|
)
|
|
$
|
12,167
|
|
Year ended December 31, 2008
|
|
$
|
12,167
|
|
|
$
|
20,810
|
|
|
$
|
(20,142
|
)
|
|
$
|
12,835
|
|
We have established reserves against obsolete and slow-moving
inventories. The activity in the table below includes all
inventory reserves. Provisions for obsolete and slow-moving
inventories are recorded as a
SF-66
Notes to
consolidated financial statements
component of cost of net product sales. The following table sets
forth activities in our inventory reserve accounts (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts
|
|
|
|
|
|
|
Balance at
|
|
|
|
|
|
charged
|
|
|
Balance at
|
|
|
|
beginning of
|
|
|
|
|
|
against
|
|
|
end of
|
|
|
|
period
|
|
|
Provision
|
|
|
reserves
|
|
|
period
|
|
|
|
|
Year ended December 31, 2006
|
|
$
|
7,742
|
|
|
$
|
6,661
|
|
|
$
|
(6,184
|
)
|
|
$
|
8,219
|
|
Year ended December 31, 2007
|
|
$
|
8,219
|
|
|
$
|
8,067
|
|
|
$
|
(8,164
|
)
|
|
$
|
8,122
|
|
Year ended December 31, 2008
|
|
$
|
8,122
|
|
|
$
|
9,194
|
|
|
$
|
(6,478
|
)
|
|
$
|
10,838
|
|
|
|
23.
|
RESTRUCTURING
ACTIVITIES
|
The following table sets forth the aggregate charges associated
with restructuring plans recorded in operating income (loss) for
the years ended December 31, (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008
|
|
|
2007
|
|
|
2006
|
|
|
|
|
Fixed asset and inventory write-off
|
|
$
|
18,837
|
|
|
$
|
3,870
|
|
|
$
|
6,989
|
|
Severance
|
|
|
8,357
|
|
|
|
1,989
|
|
|
|
2,886
|
|
Intangible asset write-off
|
|
|
5,103
|
|
|
|
|
|
|
|
2,722
|
|
Facility and other exit costs
|
|
|
4,137
|
|
|
|
843
|
|
|
|
536
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$
|
36,434
|
|
|
$
|
6,702
|
|
|
$
|
13,133
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
a. 2008
Restructuring plans
In May 2008, we decided to close our facility located in
Bedford, England, and initiated steps to cease operations at
this facility and transition the manufacturing operations
principally to our manufacturing facilities in Shanghai and
Hangzhou, China. Based upon this decision, we recorded
$12.6 million in restructuring charges during the year
ended December 31, 2008, including $6.9 million
related to the acceleration of facility restoration costs,
$4.8 million of fixed asset impairments, $1.1 million
in severance costs, $0.7 million in early termination lease
penalties and $0.9 million related to a pension plan
curtailment gain associated with the Bedford employees being
terminated. Of these restructuring charges, $5.7 million
was charged to our professional diagnostics business segment as
follows: $3.5 million to cost of net product sales,
$0.2 million to research and development expense,
$0.2 million to sales and marketing expense and
$1.8 million to general and administrative expense. We also
recorded $6.7 million related to the accelerated present
value accretion of our lease restoration costs due to the early
termination of our facility lease to interest expense.
In addition to the restructuring charges discussed above,
$14.5 million of charges associated with the Bedford
facility closure were borne by SPD our consumer diagnostics
joint venture with P&G, during the year ended
December 31, 2008. Included in these charges were
$8.4 million of fixed asset impairments, $3.2 million
in early termination lease penalties, $2.6 million in
severance and retention costs, $0.2 million facility exit
costs and $0.1 million related to the acceleration of
facility restoration costs. Of these restructuring charges, 50%,
or $7.2 million, has been included in equity earnings of
unconsolidated entities, net of tax, in our consolidated
statements of operations for the year ended December 31,
2008. Of the total exit costs incurred by SPD and us under this
plan, including severance related costs, lease penalties and
restoration costs, $10.1 million remains unpaid as of
December 31, 2008. We anticipate incurring additional costs
of approximately $30.1 million related to the closure of
this facility, including, but not limited to, severance and
retention costs, rent obligations and incremental interest
expense associated with our lease obligations which will
terminate the end of 2011. Of these additional anticipated
costs, approximately $20.5 million will be
SF-67
Notes to
consolidated financial statements
borne by SPD and $9.6 million will be borne by us. We
expect the majority of these costs to be incurred by the end of
2009, which is our anticipated facility closure date.
In February 2008, we decided to cease research and development
activities for one of the products in development at our
Bedford, England facility, based upon comparison of the product
under development with existing products acquired in the
HemoSense acquisition. During the year ended December 31,
2008, we recorded restructuring charges of $9.4 million, of
which $6.8 million related to the impairment of fixed
assets, $1.9 million related to the write-off of inventory,
$0.5 million related to contractual obligations with
suppliers and $0.2 million related to severance costs to
involuntarily terminate employees working on the development of
this product. The $9.4 million was included in our
professional diagnostics business segment and included
$6.0 million charged to cost of net product sales,
$3.3 million charged to research and development expense
and $0.1 million charged to sales and marketing expense. Of
the $0.7 million in contractual obligations and severance
costs, all has been paid as of December 31, 2008. We do not
expect to incur significant additional charges under this plan.
In April 2008, we initiated cost reduction efforts at our
facilities in Stirling, Scotland, consolidating our business
activities into one facility and with our Biosite operations. As
a result of these efforts, we recorded $3.3 million in
restructuring charges for the year ended December 31, 2008,
consisting of $2.0 million in fixed asset impairments,
$1.0 million in severance costs and $0.3 million in
facility exit costs. These charges are included in our
professional diagnostics business segment as follows:
$3.2 million to research and development expense and
$0.1 million to general and administrative expense. Of the
$1.3 million in severance and facility exit costs,
$0.1 million remains unpaid at December 31, 2008. We
do not expect to incur significant additional charges under this
plan.
On March 18, 2008, we announced our plans to close our
BioStar Inc., or BioStar, facility in Louisville, Colorado, and
exit production of the BioStar OIA product line, along with our
plans to close two of our newly-acquired facilities in the
San Francisco, California area, relating to Cholestech and
HemoSense and one of our newly-acquired facility in Columbia,
Maryland, relating to Panbio. The Cholestech operation, which
was acquired in September 2007 and manufactures and distributes
the Cholestech LDX system, a point-of-care monitor of blood
cholesterol and related lipids used to test patients at risk of,
or suffering from, heart disease and related conditions, will
move to our Biosite facility in San Diego, California by
the middle of 2009. The HemoSense operation, which was acquired
in November 2007 and manufactures and distributes the INRatio
System, an easy-to-use, hand-held blood coagulation monitoring
system for use by patients and healthcare professionals in the
management of warfarin, a commonly prescribed medication used to
prevent blood clots, has substantially moved to our Biosite
facility as of December 31, 2008. The Panbio distribution
facility, which was acquired in January 2008, has been
transferred to our distribution center in Freehold, New Jersey
as of December 31, 2008.
BioStar manufacturing ceased at the end of June 2008, with
BioStar OIA products available for purchase through the end of
the first quarter of 2009. During the year ended
December 31, 2008, we incurred $10.6 million in
restructuring charges related to this plan, which consisted of
$5.1 million of intangible assets impairment,
$1.4 million in severance-related costs, $0.6 million
in fixed asset impairments, $1.2 million in facility exit
costs and $2.3 million related to the write-off of
inventory. Of the $10.6 million, which is included in our
professional diagnostics business segment, $7.1 million was
charged to cost of net product sales, $2.0 million was
charged to sales and marketing expense and $1.5 million was
charged to general and administrative. We expect to incur an
additional $0.1 million in charges under this plan during
the first half of 2009, primarily related to severance and
facility exit costs. As of December 31, 2008,
$0.4 million in severance and facility exit costs remain
unpaid.
As a result of our plans to transition the businesses of
Cholestech and HemoSense to Biosite and Panbio to Orlando,
Florida and close these facilities, we incurred
$3.8 million in restructuring charges during the year ended
December 31, 2008, of which $2.7 million relates to
severance and retention costs, $0.4 million in fixed asset
impairments, $0.5 million in transition costs and
$0.2 million in present value accretion of facility
SF-68
Notes to
consolidated financial statements
lease costs related to these plans. Of the $3.8 million
included in our professional diagnostics business segment,
$1.2 million was charged to cost of net product sales,
$0.5 million was charged to research and development
expense, $0.3 million was charged to sales and marketing
expense and $1.6 million was charged to general and
administrative expense. We also recorded $0.2 million
related to the present value accretion of our facility lease
costs due to the early termination of our facility lease to
interest expense. Of the $3.4 million in exit costs,
$2.5 million remains unpaid as of December 31, 2008.
We anticipate incurring an additional $2.3 million in
restructuring charges under our Cholestech and HemoSense plans,
primarily related to severance, retention and outplacement
benefits, along with other costs to transition the Cholestech
and HemoSense operations to our Biosite facility. See
Note 4(d) for further information and costs related to
these plans.
In addition to transitioning the businesses of Cholestech and
HemoSense to Biosite, we also made the decision to close our
Innovacon facility in San Diego, California and move the
operating activities to Biosite; the Innovacon business is the
rapid diagnostics business that we acquired from ACON
Laboratories, Inc. During the year ended December 31, 2008,
we recorded $0.6 million in restructuring charges, of which
$0.5 million relates to facility lease and exit costs and
$0.1 million relates to impairment of fixed assets. These
charges are included in our professional diagnostics business
segment and were charged to general and administrative. As of
December 31, 2008, $0.2 million in restructuring costs
remain unpaid. We vacated the facility in August 2008 and do not
anticipate incurring additional costs under this plan.
b. 2007
restructuring plans
During 2007, we committed to several plans to restructure and
integrate our world-wide sales, marketing, order management and
fulfillment operations, as well as evaluate certain research and
development projects. The objectives of the plans were to
eliminate redundant costs, improve customer responsiveness and
improve efficiencies in operations. As a result of these
restructuring plans, we recorded $3.0 million in
restructuring charges during the year ended December 31,
2008. The $3.0 million charge included $2.6 million
related to severance charges and outplacement services and
$0.4 million related to facility exit costs. These
restructuring charges consisted of $0.1 million charged to
cost of net revenue, $1.6 million charged to sales and
marketing expenses and $1.3 million charged to general and
administrative expenses, all of which were included in our
professional diagnostics business segments. Since inception of
the plan we have recorded $8.2 million in restructuring
charges, including $3.8 million related to severance
charges and outplacement services, $0.4 million related to
facility exit costs and $4.0 million related to impairment
charges on fixed assets. Of the $8.2 million recorded,
$1.8 million and $6.4 million were included in our
consumer diagnostics and professional diagnostics business
segment, respectively. As of December 31, 2008,
$1.2 million of severance-related charges and facility exit
costs remain unpaid. We do not anticipate incurring additional
charges related to this plan.
In addition, we recorded restructuring charges associated with
the formation of our joint venture with P&G. In connection
with the joint venture, we committed to a plan to close one of
our sales offices in Germany and in Sweden, as well as evaluate
redundancies in all departments of the consumer diagnostics
business segment that are impacted by the formation of the joint
venture. For the year ended December 31, 2008, we recorded
$0.2 million in severance costs related to this plan, which
was primarily charged to general and administrative expenses. We
have recorded $1.4 million in restructuring charges since
inception of the plan, of which $1.0 million relates to
severance costs and $0.4 million relates to facility and
other exit costs. Of the total $1.4 million in severance
and exit costs, $0.1 million remains unpaid as of
December 31, 2008. We do not anticipate incurring
additional charges related to this plan.
c. 2006
restructuring plans
In May 2006, we committed to a plan to cease operations at our
ABI manufacturing facility in San Diego, California and to
write off certain excess manufacturing equipment at other
impacted facilities. Additionally,
SF-69
Notes to
consolidated financial statements
in June 2006, we committed to a plan to reorganize the sales and
marketing and customer service functions in certain of our
U.S. professional diagnostics companies. For the year ended
December 31, 2007, we recorded $0.4 million in net
restructuring charges under these plans, which primarily relates
to $0.6 million in facility exit costs, offset by a
$0.2 million adjustment due to the finalization of fixed
asset write-offs. Of the $0.4 million net charge, the
$0.2 million adjustment was recorded to cost of net
revenue, and was included in our consumer diagnostics segment,
and $0.6 million was charged to general and administrative
expense, and was included in our professional diagnostics
business segment.
Net restructuring charges since the commitment date consist of
$6.7 million related to impairment of fixed assets and
inventory, $2.7 million related to an impairment charge on
an intangible asset, $2.5 million related to severance, and
$0.6 million related to facility closing costs. Of the
$12.5 million recorded in operating income,
$8.2 million, $1.7 million and $2.6 million were
included in our professional diagnostics, consumer diagnostics,
and corporate and other business segments, respectively. As of
December 31, 2008, $0.1 million of the severance
related charges remains unpaid.
d. 2005
restructuring plan
In May 2005, we committed to a plan to cease operations at our
facility in Galway, Ireland. During the year ended
December 31, 2006, we recorded a net restructuring gain of
$3.2 million, of which $0.4 million related to charges
for severance, early retirement and outplacement services,
$0.1 million related to an impairment charge of fixed
assets, $0.6 million related to facility closing costs and
$4.3 million related to foreign exchange gains as a result
of recording a cumulative translation adjustment to other income
relating primarily to this plan of termination. The charges for
the year ended December 31, 2006 consisted of
$0.7 million charged to cost of goods sold,
$0.4 million charged to general and administrative and
$4.3 million in gains recorded to other expense. Of the net
restructuring gain of $3.2 million included in our net loss
for the year ended December 31, 2006, the $1.1 million
loss and the $4.3 million gain were included in our
consumer diagnostics and corporate and other business segments,
respectively. Additionally, during the year ended
December 31, 2006, we recorded a $1.4 million gain on
the sale of our CDIL facility in Ireland which has been recorded
in loss on dispositions, net in our consolidated statements of
operations and was included in our corporate and other business
segment for these periods (Note 25).
Net restructuring charges since the commitment date consist of
$2.6 million related to severance, early retirement and
outplacement services, $2.4 million related to impairment
of fixed assets and inventory and $1.2 million related to
facility closing costs, offset by $4.3 million related to
net foreign exchange gains relating primarily to this plan of
termination and a $1.4 million gain on the sale of the
manufacturing facility. Of the total $6.2 million
restructuring charges recorded in operating income,
$0.3 million and $5.9 million were included in our
professional diagnostics and consumer diagnostics business
segments, respectively. The $4.3 million and
$1.4 million gains were included in our corporate and other
business segment. The plan of termination was substantially
complete as of December 31, 2006 and all costs related to
severance, early retirement, outplacement services and facility
closing costs have been paid as of December 31, 2006.
SF-70
Notes to
consolidated financial statements
e. Restructuring
reserves
The following table summarizes our liabilities related to the
restructuring activities associated with the plans discussed
above (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at
|
|
|
Additions
|
|
|
|
|
|
|
|
|
Balance at
|
|
|
|
beginning
|
|
|
to the
|
|
|
Amounts
|
|
|
|
|
|
end of
|
|
|
|
of
period
|
|
|
reserve
|
|
|
paid
|
|
|
Other
(1)
|
|
|
period
|
|
|
|
|
Year ended December 31, 2006
|
|
$
|
949
|
|
|
$
|
3,422
|
|
|
$
|
(2,820
|
)
|
|
$
|
14
|
|
|
$
|
1,565
|
|
Year ended December 31, 2007
|
|
$
|
1,565
|
|
|
$
|
2,828
|
|
|
$
|
(3,264
|
)
|
|
$
|
(6
|
)
|
|
$
|
1,123
|
|
Year ended December 31, 2008
|
|
$
|
1,123
|
|
|
$
|
25,642
|
|
|
$
|
(9,148
|
)
|
|
$
|
(2,823
|
)
|
|
$
|
14,794
|
|
|
|
|
(1) |
|
Represents foreign currency translation adjustment. |
|
|
24
|
SUPPLEMENTAL CASH
FLOW INFORMATION
|
Cash paid for
interest and income taxes:
During fiscal 2008, 2007 and 2006, we made cash payments for
interest totaling $88.6 million, $65.0 million and
$22.7 million, respectively.
During fiscal 2008, 2007 and 2006, total net cash paid
(received) for income taxes was $5.5 million,
$(31.5) million and $8.8 million, respectively.
Non-cash
investing activities:
During fiscal 2008, 2007 and 2006, we issued shares of our
common stock and exchanged employee stock options in connection
with several of our acquisitions (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee stock
options/
|
|
|
|
|
|
|
|
|
restricted stock
awards
|
|
|
|
|
|
Common stock
issued
|
|
|
exchanged
|
|
|
|
|
|
Number of
|
|
|
Fair value of
|
|
|
Number of
|
|
|
Fair value of
|
|
Company
acquired
|
|
Date of
acquisition
|
|
shares
|
|
|
shares
|
|
|
shares
|
|
|
shares
|
|
|
|
|
Matria Healthcare, Inc.
|
|
May 9, 2008
|
|
|
|
|
|
$
|
|
|
|
|
1,490,655
|
|
|
$
|
17,334
|
|
BBI Holdings Plc
|
|
February 12, 2008
|
|
|
251,085
|
|
|
$
|
14,397
|
|
|
|
355,238
|
|
|
$
|
3,639
|
|
Matritech, Inc.
|
|
December 12, 2007
|
|
|
616,671
|
|
|
$
|
35,592
|
|
|
|
|
|
|
$
|
|
|
Biosystems S.A.
|
|
December 11, 2007
|
|
|
33,373
|
|
|
$
|
1,948
|
|
|
|
|
|
|
$
|
|
|
Alere Medical, Inc.
|
|
November 16, 2007
|
|
|
2,762,182
|
|
|
$
|
161,086
|
|
|
|
380,894
|
|
|
$
|
20,614
|
|
HemoSense, Inc.
|
|
November 6, 2007
|
|
|
3,691,369
|
|
|
$
|
226,415
|
|
|
|
380,732
|
|
|
$
|
16,695
|
|
Cholestech Corporation
|
|
September 12, 2007
|
|
|
6,840,361
|
|
|
$
|
329,774
|
|
|
|
733,077
|
|
|
$
|
20,331
|
|
Spectral Diagnostics Private
Limited(1)
|
|
July 27, 2007
|
|
|
93,558
|
|
|
$
|
3,737
|
|
|
|
|
|
|
$
|
|
|
Biosite
Incorporated(2)
|
|
June 29, 2007
|
|
|
|
|
|
$
|
|
|
|
|
753,863
|
|
|
$
|
28,453
|
|
Quality Assured Services, Inc.
|
|
June 7, 2007
|
|
|
273,642
|
|
|
$
|
12,834
|
|
|
|
|
|
|
$
|
|
|
Instant Technologies, Inc.
|
|
December 28, 2007
|
|
|
463,399
|
|
|
$
|
21,530
|
|
|
|
|
|
|
$
|
|
|
ABON BioPharm (Hangzhou) Co. Ltd. and ACON Laboratories
|
|
May 15, 2006
|
|
|
1,871,250
|
|
|
$
|
53,052
|
|
|
|
|
|
|
$
|
|
|
CLONDIAG chip technologies GmbH
|
|
February 28, 2006
|
|
|
467,715
|
|
|
$
|
12,457
|
|
|
|
|
|
|
$
|
|
|
SF-71
Notes to
consolidated financial statements
|
|
|
(1) |
|
The acquisition of Spectral Diagnostics Private Limited also
included its affiliate Source Diagnostics (India) Private
Limited. |
|
(2) |
|
The value includes $2.6 million associated with net
operating loss, or NOL, carryforwards related to stock options
issued to Biosite Incorporated employees. |
Non-cash
financing activities:
During 2008 and 2007, we recorded non-cash charges to
accumulated other comprehensive income of $11.6 million and
$9.5 million, respectively, representing the change in fair
market value of our interest rate swap agreement.
|
|
25.
|
LOSS ON
DISPOSITIONS, NET
|
During 2006, we recorded a net loss on dispositions of
$3.5 million. Included in this net loss is a
$4.9 million charge associated with managements
decision to dispose of our Scandinavian Micro Biodevices ApS, or
SMB, research operation, which was part of our professional
diagnostics and corporate and other business segments, of which
$2.0 million is related to impaired assets, primarily
goodwill associated with SMB, and a $2.9 million loss on
the sale of SMB. The sale of this operation was completed in the
fourth quarter of 2006. The net loss on dispositions also
includes an offsetting $1.4 million gain on the sale of an
idle manufacturing facility in Galway, Ireland, as a result of
our 2005 restructuring plan. This facility was associated with
our consumer diagnostics business segment.
26. GUARANTOR
FINANCIAL INFORMATION
The Company intends to file a universal shelf registration
statement on
Form S-3
(the Shelf Registration Statement) pursuant to which
it may offer or sell, on a delayed or continuous basis pursuant
to Rule 415, as amended, under the Securities Act of 1933,
securities, including debt securities guaranteed by certain of
its consolidated subsidiaries (the Guarantor
Subsidiaries). The guarantees would be full and
unconditional and joint and several. The following supplemental
financial information sets forth, on a consolidating basis,
audited balance sheets as of December 31, 2008, and 2007,
and the related audited statements of operations and cash flows
for each of the three years in the period ended
December 31, 2008 for the Company (the Issuer),
the Guarantor Subsidiaries and the Companys other
subsidiaries (the Non-Guarantor Subsidiaries). The
supplemental financial information reflects the investments of
the Company and the Guarantor Subsidiaries in the Guarantor and
Non-Guarantor Subsidiaries using the equity method of
accounting. There can be no assurance that the Company will
offer or sell debt securities under the Shelf Registration
Statement.
The Company has extensive transactions and relationships between
various members of the consolidated group. These transactions
and relationships include intercompany pricing agreements,
intellectual property royalty agreements and general and
administrative and research and development cost-sharing
agreements. Because of these relationships, it is possible that
the terms of these transactions are not the same as those that
would result from transactions among wholly unrelated parties.
SF-72
Notes to
consolidated financial statements
Consolidating
statement of operations
For the year
ended December 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor
|
|
|
Non-guarantor
|
|
|
|
|
|
|
|
|
|
Issuer
|
|
|
subsidiaries
|
|
|
subsidiaries
|
|
|
Eliminations
|
|
|
Consolidated
|
|
|
|
|
|
(in
thousands)
|
|
|
Net product sales
|
|
$
|
|
|
|
$
|
869,774
|
|
|
$
|
486,275
|
|
|
$
|
(115,911
|
)
|
|
$
|
1,240,138
|
|
Services revenue
|
|
|
|
|
|
|
402,758
|
|
|
|
2,704
|
|
|
|
|
|
|
|
405,462
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales and services revenue
|
|
|
|
|
|
|
1,272,532
|
|
|
|
488,979
|
|
|
|
(115,911
|
)
|
|
|
1,645,600
|
|
License and royalty revenue
|
|
|
|
|
|
|
15,536
|
|
|
|
10,290
|
|
|
|
|
|
|
|
25,826
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue
|
|
|
|
|
|
|
1,288,068
|
|
|
|
499,269
|
|
|
|
(115,911
|
)
|
|
|
1,671,426
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of net product sales
|
|
|
2,541
|
|
|
|
447,914
|
|
|
|
286,739
|
|
|
|
(112,540
|
)
|
|
|
624,654
|
|
Cost of services revenue
|
|
|
77
|
|
|
|
176,421
|
|
|
|
600
|
|
|
|
|
|
|
|
177,098
|
|
Cost of license and royalty revenue
|
|
|
|
|
|
|
4,978
|
|
|
|
6,438
|
|
|
|
(2,301
|
)
|
|
|
9,115
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of net revenue
|
|
|
2,618
|
|
|
|
629,313
|
|
|
|
293,777
|
|
|
|
(114,841
|
)
|
|
|
810,867
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
(2,618
|
)
|
|
|
658,755
|
|
|
|
205,492
|
|
|
|
(1,070
|
)
|
|
|
860,559
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
27,709
|
|
|
|
50,631
|
|
|
|
33,488
|
|
|
|
|
|
|
|
111,828
|
|
Sales and marketing
|
|
|
37,183
|
|
|
|
258,580
|
|
|
|
90,389
|
|
|
|
132
|
|
|
|
386,284
|
|
General and administrative
|
|
|
59,784
|
|
|
|
170,401
|
|
|
|
68,410
|
|
|
|
|
|
|
|
298,595
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
124,676
|
|
|
|
479,612
|
|
|
|
192,287
|
|
|
|
132
|
|
|
|
796,707
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income
|
|
|
(127,294
|
)
|
|
|
179,143
|
|
|
|
13,205
|
|
|
|
(1,202
|
)
|
|
|
63,852
|
|
Interest expense, including amortization of deferred financing
costs
|
|
|
(90,328
|
)
|
|
|
(72,447
|
)
|
|
|
(15,986
|
)
|
|
|
77,617
|
|
|
|
(101,144
|
)
|
Other income (expense), net
|
|
|
78,604
|
|
|
|
(15,854
|
)
|
|
|
12,655
|
|
|
|
(77,617
|
)
|
|
|
(2,212
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before (benefit) provision for income taxes
|
|
|
(139,018
|
)
|
|
|
90,842
|
|
|
|
9,874
|
|
|
|
(1,202
|
)
|
|
|
(39,504
|
)
|
(Benefit) provision for income taxes
|
|
|
(63,152
|
)
|
|
|
46,759
|
|
|
|
(293
|
)
|
|
|
|
|
|
|
(16,686
|
)
|
Equity in earnings of subsidiaries, net of tax
|
|
|
52,576
|
|
|
|
|
|
|
|
|
|
|
|
(52,576
|
)
|
|
|
|
|
Equity earnings of unconsolidated entities, net of tax
|
|
|
1,522
|
|
|
|
(23
|
)
|
|
|
(379
|
)
|
|
|
(70
|
)
|
|
|
1,050
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
|
(21,768
|
)
|
|
|
44,060
|
|
|
|
9,788
|
|
|
|
(53,848
|
)
|
|
|
(21,768
|
)
|
Preferred stock dividends
|
|
|
(13,989
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(13,989
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income available to common stockholders
|
|
$
|
(35,757
|
)
|
|
$
|
44,060
|
|
|
$
|
9,788
|
|
|
$
|
(53,848
|
)
|
|
$
|
(35,757
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SF-73
Notes to
consolidated financial statements
Consolidating
statement of operations
For the year
ended December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor
|
|
|
Non-guarantor
|
|
|
|
|
|
|
|
|
|
Issuer
|
|
|
subsidiaries
|
|
|
subsidiaries
|
|
|
Eliminations
|
|
|
Consolidated
|
|
|
|
|
|
(in
thousands)
|
|
|
Net product sales
|
|
$
|
10,494
|
|
|
$
|
552,754
|
|
|
$
|
320,831
|
|
|
$
|
(83,164
|
)
|
|
$
|
800,915
|
|
Services revenue
|
|
|
|
|
|
|
14,164
|
|
|
|
2,482
|
|
|
|
|
|
|
|
16,646
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales and services revenue
|
|
|
10,494
|
|
|
|
566,918
|
|
|
|
323,313
|
|
|
|
(83,164
|
)
|
|
|
817,561
|
|
License and royalty revenue
|
|
|
|
|
|
|
14,047
|
|
|
|
17,962
|
|
|
|
(10,030
|
)
|
|
|
21,979
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue
|
|
|
10,494
|
|
|
|
580,965
|
|
|
|
341,275
|
|
|
|
(93,194
|
)
|
|
|
839,540
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of net product sales
|
|
|
27,208
|
|
|
|
294,317
|
|
|
|
203,196
|
|
|
|
(93,318
|
)
|
|
|
431,403
|
|
Cost of services revenue
|
|
|
|
|
|
|
5,261
|
|
|
|
|
|
|
|
|
|
|
|
5,261
|
|
Cost of license and royalty revenue
|
|
|
|
|
|
|
1,380
|
|
|
|
7,769
|
|
|
|
|
|
|
|
9,149
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of net revenue
|
|
|
27,208
|
|
|
|
300,958
|
|
|
|
210,965
|
|
|
|
(93,318
|
)
|
|
|
445,813
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
(16,714
|
)
|
|
|
280,007
|
|
|
|
130,310
|
|
|
|
124
|
|
|
|
393,727
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
6,614
|
|
|
|
27,910
|
|
|
|
35,023
|
|
|
|
|
|
|
|
69,547
|
|
Purchase of in-process research and development
|
|
|
169,000
|
|
|
|
|
|
|
|
4,825
|
|
|
|
|
|
|
|
173,825
|
|
Sales and marketing
|
|
|
25,395
|
|
|
|
98,116
|
|
|
|
44,259
|
|
|
|
|
|
|
|
167,770
|
|
General and administrative
|
|
|
78,499
|
|
|
|
42,518
|
|
|
|
37,421
|
|
|
|
|
|
|
|
158,438
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
279,508
|
|
|
|
168,544
|
|
|
|
121,528
|
|
|
|
|
|
|
|
569,580
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income
|
|
|
(296,222
|
)
|
|
|
111,463
|
|
|
|
8,782
|
|
|
|
124
|
|
|
|
(175,853
|
)
|
Interest expense, including amortization and write-off of
deferred financing costs
|
|
|
(77,201
|
)
|
|
|
(49,960
|
)
|
|
|
(21,069
|
)
|
|
|
65,205
|
|
|
|
(83,025
|
)
|
Other income (expense), net
|
|
|
71,426
|
|
|
|
4,461
|
|
|
|
(695
|
)
|
|
|
(66,418
|
)
|
|
|
8,774
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before (benefit) provision for income taxes
|
|
|
(301,997
|
)
|
|
|
65,964
|
|
|
|
(12,982
|
)
|
|
|
(1,089
|
)
|
|
|
(250,104
|
)
|
(Benefit) provision for income taxes
|
|
|
(12,949
|
)
|
|
|
9,701
|
|
|
|
2,269
|
|
|
|
|
|
|
|
(979
|
)
|
Equity in earnings of subsidiaries, net of tax
|
|
|
43,226
|
|
|
|
|
|
|
|
|
|
|
|
(43,226
|
)
|
|
|
|
|
Equity earnings of unconsolidated entities, net of tax
|
|
|
1,069
|
|
|
|
|
|
|
|
3,348
|
|
|
|
(45
|
)
|
|
|
4,372
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(244,753
|
)
|
|
$
|
56,263
|
|
|
$
|
(11,903
|
)
|
|
$
|
(44,360
|
)
|
|
$
|
(244,753
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SF-74
Notes to
consolidated financial statements
Consolidating
statement of operations
For the year
ended December 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor
|
|
|
Non-guarantor
|
|
|
|
|
|
|
|
|
|
Issuer
|
|
|
subsidiaries
|
|
|
subsidiaries
|
|
|
Eliminations
|
|
|
Consolidated
|
|
|
|
|
|
(in
thousands)
|
|
|
Net product sales
|
|
$
|
23,100
|
|
|
$
|
334,471
|
|
|
$
|
272,028
|
|
|
$
|
(77,469
|
)
|
|
$
|
552,130
|
|
Services revenue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product sales and services revenue
|
|
|
23,100
|
|
|
|
334,471
|
|
|
|
272,028
|
|
|
|
(77,469
|
)
|
|
|
552,130
|
|
License and royalty revenue
|
|
|
|
|
|
|
306
|
|
|
|
17,018
|
|
|
|
|
|
|
|
17,324
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenue
|
|
|
23,100
|
|
|
|
334,777
|
|
|
|
289,046
|
|
|
|
(77,469
|
)
|
|
|
569,454
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of net product sales
|
|
|
22,395
|
|
|
|
231,948
|
|
|
|
160,564
|
|
|
|
(80,108
|
)
|
|
|
334,799
|
|
Cost of license and royalty revenue
|
|
|
|
|
|
|
481
|
|
|
|
4,951
|
|
|
|
|
|
|
|
5,432
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of net revenue
|
|
|
22,395
|
|
|
|
232,429
|
|
|
|
165,515
|
|
|
|
(80,108
|
)
|
|
|
340,231
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
705
|
|
|
|
102,348
|
|
|
|
123,531
|
|
|
|
2,639
|
|
|
|
229,223
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
1,750
|
|
|
|
7,705
|
|
|
|
39,251
|
|
|
|
|
|
|
|
48,706
|
|
Purchase of in-process research and development
|
|
|
|
|
|
|
|
|
|
|
4,960
|
|
|
|
|
|
|
|
4,960
|
|
Sales and marketing
|
|
|
4,096
|
|
|
|
48,684
|
|
|
|
41,665
|
|
|
|
|
|
|
|
94,445
|
|
General and administrative
|
|
|
21,345
|
|
|
|
18,999
|
|
|
|
30,899
|
|
|
|
|
|
|
|
71,243
|
|
Loss on dispositions, net
|
|
|
|
|
|
|
|
|
|
|
3,498
|
|
|
|
|
|
|
|
3,498
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income
|
|
|
(26,486
|
)
|
|
|
26,960
|
|
|
|
3,258
|
|
|
|
2,639
|
|
|
|
6,371
|
|
Interest expense, including amortization of original issue
discounts and write-off of deferred financing costs
|
|
|
(16,895
|
)
|
|
|
(6,206
|
)
|
|
|
(20,461
|
)
|
|
|
16,992
|
|
|
|
(26,570
|
)
|
Other income (expense), net
|
|
|
12,852
|
|
|
|
4,686
|
|
|
|
8,323
|
|
|
|
(17,113
|
)
|
|
|
8,748
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before provision for income taxes
|
|
|
(30,529
|
)
|
|
|
25,440
|
|
|
|
(8,880
|
)
|
|
|
2,518
|
|
|
|
(11,451
|
)
|
Provision for income taxes
|
|
|
1,390
|
|
|
|
2,012
|
|
|
|
1,935
|
|
|
|
390
|
|
|
|
5,727
|
|
Equity in earnings of subsidiaries, net of tax
|
|
|
14,716
|
|
|
|
|
|
|
|
|
|
|
|
(14,716
|
)
|
|
|
|
|
Equity earnings of unconsolidated entities, net of tax
|
|
|
361
|
|
|
|
|
|
|
|
(25
|
)
|
|
|
|
|
|
|
336
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(16,842
|
)
|
|
$
|
23,428
|
|
|
$
|
(10,840
|
)
|
|
$
|
(12,588
|
)
|
|
$
|
(16,842
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SF-75
Notes to
consolidated financial statements
Consolidating
balance sheet
December 31,
2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor
|
|
|
Non-guarantor
|
|
|
|
|
|
|
|
|
|
Issuer
|
|
|
subsidiaries
|
|
|
subsidiaries
|
|
|
Eliminations
|
|
|
Consolidated
|
|
|
|
|
|
(in
thousands)
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
1,743
|
|
|
$
|
69,798
|
|
|
$
|
69,783
|
|
|
$
|
|
|
|
$
|
141,324
|
|
Restricted cash
|
|
|
|
|
|
|
1,160
|
|
|
|
1,588
|
|
|
|
|
|
|
|
2,748
|
|
Marketable securities
|
|
|
|
|
|
|
1,347
|
|
|
|
416
|
|
|
|
|
|
|
|
1,763
|
|
Accounts receivable, net of allowances
|
|
|
|
|
|
|
199,385
|
|
|
|
97,459
|
|
|
|
(16,236
|
)
|
|
|
280,608
|
|
Inventories, net
|
|
|
|
|
|
|
131,918
|
|
|
|
71,478
|
|
|
|
(4,265
|
)
|
|
|
199,131
|
|
Deferred tax assets
|
|
|
80,926
|
|
|
|
22,334
|
|
|
|
1,051
|
|
|
|
|
|
|
|
104,311
|
|
Income tax receivable
|
|
|
|
|
|
|
2,792
|
|
|
|
3,614
|
|
|
|
|
|
|
|
6,406
|
|
Receivable from joint venture, net
|
|
|
|
|
|
|
|
|
|
|
15,227
|
|
|
|
(3,209
|
)
|
|
|
12,018
|
|
Prepaid expenses and other current assets
|
|
|
10,887
|
|
|
|
20,181
|
|
|
|
26,930
|
|
|
|
16,236
|
|
|
|
74,234
|
|
Intercompany receivables
|
|
|
455,746
|
|
|
|
248,177
|
|
|
|
75,686
|
|
|
|
(779,609
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
549,302
|
|
|
|
697,092
|
|
|
|
363,232
|
|
|
|
(787,083
|
)
|
|
|
822,543
|
|
Property, plant and equipment, net
|
|
|
2,395
|
|
|
|
221,345
|
|
|
|
62,422
|
|
|
|
(1,679
|
)
|
|
|
284,483
|
|
Goodwill
|
|
|
2,020,528
|
|
|
|
599,517
|
|
|
|
427,251
|
|
|
|
(1,213
|
)
|
|
|
3,046,083
|
|
Other intangible assets with indefinite lives
|
|
|
|
|
|
|
21,195
|
|
|
|
21,789
|
|
|
|
|
|
|
|
42,984
|
|
Core technology and patents, net
|
|
|
43,700
|
|
|
|
331,892
|
|
|
|
83,715
|
|
|
|
|
|
|
|
459,307
|
|
Other intangible assets, net
|
|
|
277,389
|
|
|
|
772,457
|
|
|
|
119,484
|
|
|
|
|
|
|
|
1,169,330
|
|
Deferred financing costs, net, and other non-current assets
|
|
|
36,876
|
|
|
|
6,872
|
|
|
|
3,136
|
|
|
|
|
|
|
|
46,884
|
|
Investments in unconsolidated entities
|
|
|
872,848
|
|
|
|
751
|
|
|
|
57,681
|
|
|
|
(862,448
|
)
|
|
|
68,832
|
|
Marketable securities
|
|
|
591
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
591
|
|
Deferred tax assets
|
|
|
(1,742
|
)
|
|
|
|
|
|
|
16,065
|
|
|
|
|
|
|
|
14,323
|
|
Intercompany notes receivable
|
|
|
1,633,174
|
|
|
|
(50,660
|
)
|
|
|
2,454
|
|
|
|
(1,584,968
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
5,435,061
|
|
|
$
|
2,600,461
|
|
|
$
|
1,157,229
|
|
|
$
|
(3,237,391
|
)
|
|
$
|
5,955,360
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current portion of long-term debt
|
|
$
|
9,750
|
|
|
$
|
2,870
|
|
|
$
|
6,438
|
|
|
$
|
|
|
|
$
|
19,058
|
|
Current portion of capital lease obligations
|
|
|
|
|
|
|
265
|
|
|
|
186
|
|
|
|
|
|
|
|
451
|
|
Accounts payable
|
|
|
4,173
|
|
|
|
72,627
|
|
|
|
35,904
|
|
|
|
|
|
|
|
112,704
|
|
Accrued expenses and other current liabilities
|
|
|
(120,656
|
)
|
|
|
263,380
|
|
|
|
93,617
|
|
|
|
(3,209
|
)
|
|
|
233,132
|
|
Intercompany payables
|
|
|
155,443
|
|
|
|
198,939
|
|
|
|
425,229
|
|
|
|
(779,611
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
48,710
|
|
|
|
538,081
|
|
|
|
561,374
|
|
|
|
(782,820
|
)
|
|
|
365,345
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt, net of current portion
|
|
|
1,493,000
|
|
|
|
2,302
|
|
|
|
5,255
|
|
|
|
|
|
|
|
1,500,557
|
|
Capital lease obligations, net of current portion
|
|
|
|
|
|
|
66
|
|
|
|
402
|
|
|
|
|
|
|
|
468
|
|
Deferred tax liabilities
|
|
|
(36,399
|
)
|
|
|
459,501
|
|
|
|
39,685
|
|
|
|
|
|
|
|
462,787
|
|
Deferred gain on joint venture
|
|
|
16,310
|
|
|
|
|
|
|
|
270,720
|
|
|
|
|
|
|
|
287,030
|
|
Other long-term liabilities
|
|
|
26,830
|
|
|
|
17,864
|
|
|
|
15,641
|
|
|
|
|
|
|
|
60,335
|
|
Intercompany notes payable
|
|
|
607,772
|
|
|
|
853,470
|
|
|
|
119,594
|
|
|
|
(1,580,836
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term liabilities
|
|
|
2,107,513
|
|
|
|
1,333,203
|
|
|
|
451,297
|
|
|
|
(1,580,836
|
)
|
|
|
2,311,177
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity
|
|
|
3,278,838
|
|
|
|
729,177
|
|
|
|
144,558
|
|
|
|
(873,735
|
)
|
|
|
3,278,838
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
5,435,061
|
|
|
$
|
2,600,461
|
|
|
$
|
1,157,229
|
|
|
$
|
(3,237,391
|
)
|
|
$
|
5,955,360
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SF-76
Notes to
consolidated financial statements
Consolidating
balance sheet
December 31,
2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor
|
|
|
Non-guarantor
|
|
|
|
|
|
|
|
|
|
Issuer
|
|
|
subsidiaries
|
|
|
subsidiaries
|
|
|
Eliminations
|
|
|
Consolidated
|
|
|
|
|
|
(in
thousands)
|
|
|
ASSETS
|
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$
|
228,178
|
|
|
$
|
127,626
|
|
|
$
|
58,928
|
|
|
$
|
|
|
|
$
|
414,732
|
|
Restricted cash
|
|
|
|
|
|
|
15
|
|
|
|
141,854
|
|
|
|
|
|
|
|
141,869
|
|
Marketable securities
|
|
|
|
|
|
|
2,551
|
|
|
|
|
|
|
|
|
|
|
|
2,551
|
|
Accounts receivable, net of allowances
|
|
|
|
|
|
|
123,951
|
|
|
|
68,880
|
|
|
|
(29,451
|
)
|
|
|
163,380
|
|
Inventories, net
|
|
|
59
|
|
|
|
96,046
|
|
|
|
55,629
|
|
|
|
(3,503
|
)
|
|
|
148,231
|
|
Deferred tax assets
|
|
|
7,725
|
|
|
|
4,496
|
|
|
|
5,949
|
|
|
|
|
|
|
|
18,170
|
|
Income tax receivable
|
|
|
|
|
|
|
2,302
|
|
|
|
2,954
|
|
|
|
|
|
|
|
5,256
|
|
Receivable from joint venture, net
|
|
|
|
|
|
|
|
|
|
|
1,856
|
|
|
|
(1,856
|
)
|
|
|
|
|
Prepaid expenses and other current assets
|
|
|
4,864
|
|
|
|
11,046
|
|
|
|
13,424
|
|
|
|
29,451
|
|
|
|
58,785
|
|
Intercompany receivables
|
|
|
170,353
|
|
|
|
22,815
|
|
|
|
64,500
|
|
|
|
(257,668
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
411,179
|
|
|
|
390,848
|
|
|
|
413,974
|
|
|
|
(263,027
|
)
|
|
|
952,974
|
|
Property, plant and equipment, net
|
|
|
2,028
|
|
|
|
197,237
|
|
|
|
68,615
|
|
|
|
|
|
|
|
267,880
|
|
Goodwill
|
|
|
1,721,706
|
|
|
|
132,849
|
|
|
|
298,943
|
|
|
|
(4,648
|
)
|
|
|
2,148,850
|
|
Other intangible assets with indefinite lives
|
|
|
|
|
|
|
21,120
|
|
|
|
21,977
|
|
|
|
|
|
|
|
43,097
|
|
Core technology and patents, net
|
|
|
356,355
|
|
|
|
19,531
|
|
|
|
56,697
|
|
|
|
|
|
|
|
432,583
|
|
Other intangible assets, net
|
|
|
747,300
|
|
|
|
63,211
|
|
|
|
59,133
|
|
|
|
|
|
|
|
869,644
|
|
Deferred financing costs, net, and other non-current assets
|
|
|
40,111
|
|
|
|
6,850
|
|
|
|
4,786
|
|
|
|
|
|
|
|
51,747
|
|
Investments in unconsolidated entities
|
|
|
(327,854
|
)
|
|
|
(615
|
)
|
|
|
53,070
|
|
|
|
353,152
|
|
|
|
77,753
|
|
Marketable securities
|
|
|
1,389
|
|
|
|
|
|
|
|
19,043
|
|
|
|
|
|
|
|
20,432
|
|
Deferred tax assets
|
|
|
509
|
|
|
|
(546
|
)
|
|
|
15,836
|
|
|
|
|
|
|
|
15,799
|
|
Intercompany notes receivable
|
|
|
2,096,757
|
|
|
|
(286,692
|
)
|
|
|
|
|
|
|
(1,810,065
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets
|
|
$
|
5,049,480
|
|
|
$
|
543,793
|
|
|
$
|
1,012,074
|
|
|
$
|
(1,724,588
|
)
|
|
$
|
4,880,759
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY
|
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current portion of long-term debt
|
|
$
|
9,750
|
|
|
$
|
6,526
|
|
|
$
|
4,044
|
|
|
$
|
|
|
|
$
|
20,320
|
|
Current portion of capital lease obligations
|
|
|
|
|
|
|
680
|
|
|
|
96
|
|
|
|
|
|
|
|
776
|
|
Accounts payable
|
|
|
4,257
|
|
|
|
33,316
|
|
|
|
31,991
|
|
|
|
2,497
|
|
|
|
72,061
|
|
Accrued expenses and other current liabilities
|
|
|
37,196
|
|
|
|
74,455
|
|
|
|
65,781
|
|
|
|
(2,497
|
)
|
|
|
174,935
|
|
Payable to joint venture, net
|
|
|
|
|
|
|
6,476
|
|
|
|
6,196
|
|
|
|
(1,856
|
)
|
|
|
10,816
|
|
Intercompany payables
|
|
|
46,647
|
|
|
|
82,455
|
|
|
|
128,567
|
|
|
|
(257,669
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
97,850
|
|
|
|
203,908
|
|
|
|
236,675
|
|
|
|
(259,525
|
)
|
|
|
278,908
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt, net of current portion
|
|
|
1,360,750
|
|
|
|
5,175
|
|
|
|
470
|
|
|
|
|
|
|
|
1,366,395
|
|
Capital lease obligations, net of current portion
|
|
|
|
|
|
|
184
|
|
|
|
174
|
|
|
|
|
|
|
|
358
|
|
Deferred tax liabilities
|
|
|
287,015
|
|
|
|
23,524
|
|
|
|
15,589
|
|
|
|
|
|
|
|
326,128
|
|
Deferred gain on joint venture
|
|
|
16,311
|
|
|
|
|
|
|
|
276,767
|
|
|
|
|
|
|
|
293,078
|
|
Other long-term liabilities
|
|
|
10,057
|
|
|
|
6,439
|
|
|
|
12,729
|
|
|
|
|
|
|
|
29,225
|
|
Intercompany notes payable
|
|
|
690,830
|
|
|
|
794,968
|
|
|
|
324,264
|
|
|
|
(1,810,062
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total long-term liabilities
|
|
|
2,364,963
|
|
|
|
830,290
|
|
|
|
629,993
|
|
|
|
(1,810,062
|
)
|
|
|
2,015,184
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity
|
|
|
2,586,667
|
|
|
|
(490,405
|
)
|
|
|
145,406
|
|
|
|
344,999
|
|
|
|
2,586,667
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity
|
|
$
|
5,049,480
|
|
|
$
|
543,793
|
|
|
$
|
1,012,074
|
|
|
$
|
(1,724,588
|
)
|
|
$
|
4,880,759
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SF-77
Notes to
consolidated financial statements
Consolidating
statement of cash flows
For the year
ended December 31, 2008
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor
|
|
|
Non-guarantor
|
|
|
|
|
|
|
|
|
|
Issuer
|
|
|
subsidiaries
|
|
|
subsidiaries
|
|
|
Eliminations
|
|
|
Consolidated
|
|
|
|
|
|
(in
thousands)
|
|
|
Cash Flows from Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(21,768
|
)
|
|
$
|
89,569
|
|
|
$
|
9,755
|
|
|
$
|
(99,324
|
)
|
|
$
|
(21,768
|
)
|
Adjustments to reconcile net (loss) income to net cash provided
by (used in) operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings of subsidiaries, net of tax
|
|
|
(53,576
|
)
|
|
|
|
|
|
|
|
|
|
|
53,576
|
|
|
|
|
|
Interest expense related to amortization of deferred financing
costs
|
|
|
5,930
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,930
|
|
Non-cash stock-based compensation expense
|
|
|
26,405
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26,405
|
|
Impairment of inventory
|
|
|
|
|
|
|
2,300
|
|
|
|
1,893
|
|
|
|
|
|
|
|
4,193
|
|
Impairment of long-lived assets
|
|
|
|
|
|
|
6,117
|
|
|
|
13,914
|
|
|
|
|
|
|
|
20,031
|
|
(Gain) loss on sale of fixed assets
|
|
|
(1
|
)
|
|
|
255
|
|
|
|
523
|
|
|
|
|
|
|
|
777
|
|
Equity earnings of unconsolidated entities, net of tax
|
|
|
(1,522
|
)
|
|
|
23
|
|
|
|
379
|
|
|
|
70
|
|
|
|
(1,050
|
)
|
Interest in minority investments
|
|
|
|
|
|
|
|
|
|
|
167
|
|
|
|
|
|
|
|
167
|
|
Depreciation and amortization
|
|
|
48,754
|
|
|
|
176,236
|
|
|
|
42,937
|
|
|
|
|
|
|
|
267,927
|
|
Deferred and other non-cash income taxes
|
|
|
(957
|
)
|
|
|
(25,497
|
)
|
|
|
(15,302
|
)
|
|
|
|
|
|
|
(41,756
|
)
|
Other non-cash items
|
|
|
2,714
|
|
|
|
1,680
|
|
|
|
(16
|
)
|
|
|
|
|
|
|
4,378
|
|
Changes in assets and liabilities, net of acquisitions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
1,000
|
|
|
|
(37,182
|
)
|
|
|
(12,468
|
)
|
|
|
|
|
|
|
(48,650
|
)
|
Inventories, net
|
|
|
|
|
|
|
(80,371
|
)
|
|
|
(12,854
|
)
|
|
|
43,999
|
|
|
|
(49,226
|
)
|
Prepaid expenses and other current assets
|
|
|
616
|
|
|
|
11,659
|
|
|
|
(24,759
|
)
|
|
|
5,111
|
|
|
|
(7,373
|
)
|
Accounts payable
|
|
|
(84
|
)
|
|
|
18,958
|
|
|
|
(2,407
|
)
|
|
|
|
|
|
|
16,467
|
|
Accrued expenses and other current liabilities
|
|
|
(154,680
|
)
|
|
|
112,386
|
|
|
|
15,397
|
|
|
|
(5,111
|
)
|
|
|
(32,008
|
)
|
Other non-current liabilities
|
|
|
(1,104
|
)
|
|
|
139
|
|
|
|
4,365
|
|
|
|
|
|
|
|
3,400
|
|
Intercompany payable (receivable)
|
|
|
224,207
|
|
|
|
(282,185
|
)
|
|
|
54,037
|
|
|
|
3,941
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities
|
|
|
75,934
|
|
|
|
(5,913
|
)
|
|
|
75,561
|
|
|
|
2,262
|
|
|
|
147,844
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment
|
|
|
(1,009
|
)
|
|
|
(42,511
|
)
|
|
|
(24,220
|
)
|
|
|
1,679
|
|
|
|
(66,061
|
)
|
Proceeds from sale of property, plant and equipment
|
|
|
|
|
|
|
96
|
|
|
|
974
|
|
|
|
|
|
|
|
1,070
|
|
Cash paid for acquisitions and transactional costs, net of cash
acquired
|
|
|
(470,393
|
)
|
|
|
10,185
|
|
|
|
(189,691
|
)
|
|
|
|
|
|
|
(649,899
|
)
|
Cash received from (paid for) investments in minority interests
and marketable securities
|
|
|
1,372
|
|
|
|
(1,113
|
)
|
|
|
11,874
|
|
|
|
|
|
|
|
12,133
|
|
Increase in other assets
|
|
|
(1,000
|
)
|
|
|
(5,007
|
)
|
|
|
(4,568
|
)
|
|
|
|
|
|
|
(10,575
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities
|
|
|
(471,030
|
)
|
|
|
(38,350
|
)
|
|
|
(205,631
|
)
|
|
|
1,679
|
|
|
|
(713,332
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Increase) decrease in restricted cash
|
|
|
|
|
|
|
(1,145
|
)
|
|
|
140,349
|
|
|
|
|
|
|
|
139,204
|
|
Issuance costs associated with preferred stock
|
|
|
(350
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(350
|
)
|
Cash paid for financing costs
|
|
|
(1,401
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,401
|
)
|
Dividends to preferred stockholders
|
|
|
(56
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(56
|
)
|
Proceeds from issuance of common stock, net of issuance costs
|
|
|
20,675
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,675
|
|
Net repayments on long-term debt
|
|
|
(9,750
|
)
|
|
|
(4,037
|
)
|
|
|
|
|
|
|
|
|
|
|
(13,787
|
)
|
Net proceeds (repayments) from revolving
lines-of-credit
|
|
|
142,000
|
|
|
|
(2,320
|
)
|
|
|
(2,438
|
)
|
|
|
|
|
|
|
137,242
|
|
Tax benefit on exercised stock options
|
|
|
17,542
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,542
|
|
Principal payments of capital lease obligations
|
|
|
|
|
|
|
(704
|
)
|
|
|
(596
|
)
|
|
|
|
|
|
|
(1,300
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities
|
|
|
168,660
|
|
|
|
(8,206
|
)
|
|
|
137,315
|
|
|
|
|
|
|
|
297,769
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange effect on cash and cash equivalents
|
|
|
|
|
|
|
(866
|
)
|
|
|
(882
|
)
|
|
|
(3,941
|
)
|
|
|
(5,689
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash equivalents
|
|
|
(226,436
|
)
|
|
|
(53,335
|
)
|
|
|
6,363
|
|
|
|
|
|
|
|
(273,408
|
)
|
Cash and cash equivalents, beginning of period
|
|
|
228,178
|
|
|
|
123,133
|
|
|
|
63,421
|
|
|
|
|
|
|
|
414,732
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
|
$
|
1,742
|
|
|
$
|
69,798
|
|
|
$
|
69,784
|
|
|
$
|
|
|
|
$
|
141,324
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SF-78
Notes to
consolidated financial statements
Consolidating
statement of cash flows
For the year
ended December 31, 2007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor
|
|
|
Non-guarantor
|
|
|
|
|
|
|
|
|
|
Issuer
|
|
|
subsidiaries
|
|
|
subsidiaries
|
|
|
Eliminations
|
|
|
Consolidated
|
|
|
|
|
|
(in
thousands)
|
|
|
Cash Flows from Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(244,753
|
)
|
|
$
|
58,237
|
|
|
$
|
(12,222
|
)
|
|
$
|
(46,015
|
)
|
|
$
|
(244,753
|
)
|
Adjustments to reconcile net (loss) income to net cash provided
by (used in) operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings of subsidiaries, net of tax
|
|
|
(44,881
|
)
|
|
|
|
|
|
|
|
|
|
|
44,881
|
|
|
|
|
|
Interest expense related to amortization and write-off of
deferred financing costs
|
|
|
6,884
|
|
|
|
2,122
|
|
|
|
1,957
|
|
|
|
|
|
|
|
10,963
|
|
Non-cash stock-based compensation expense
|
|
|
52,210
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52,210
|
|
Charge for in-process research and development
|
|
|
4,825
|
|
|
|
169,000
|
|
|
|
|
|
|
|
|
|
|
|
173,825
|
|
Impairment of long-lived assets
|
|
|
|
|
|
|
108
|
|
|
|
3,764
|
|
|
|
|
|
|
|
3,872
|
|
Loss (gain) on sale of fixed assets
|
|
|
|
|
|
|
116
|
|
|
|
(57
|
)
|
|
|
|
|
|
|
59
|
|
Equity earnings of unconsolidated entities, net of tax
|
|
|
(1,069
|
)
|
|
|
|
|
|
|
(3,348
|
)
|
|
|
45
|
|
|
|
(4,372
|
)
|
Interest in minority investments
|
|
|
(243
|
)
|
|
|
|
|
|
|
476
|
|
|
|
1,168
|
|
|
|
1,401
|
|
Depreciation and amortization
|
|
|
43,718
|
|
|
|
31,305
|
|
|
|
26,090
|
|
|
|
|
|
|
|
101,113
|
|
Deferred and other non-cash income taxes
|
|
|
(34,636
|
)
|
|
|
3,050
|
|
|
|
3,694
|
|
|
|
|
|
|
|
(27,892
|
)
|
Other non-cash items
|
|
|
197
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
197
|
|
Changes in assets and liabilities, net of acquisitions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
|
|
|
|
23,988
|
|
|
|
(6,421
|
)
|
|
|
29,451
|
|
|
|
47,018
|
|
Inventories, net
|
|
|
|
|
|
|
7,588
|
|
|
|
(8,972
|
)
|
|
|
(79
|
)
|
|
|
(1,463
|
)
|
Prepaid expenses and other current assets
|
|
|
(2,669
|
)
|
|
|
45,520
|
|
|
|
176
|
|
|
|
(27,595
|
)
|
|
|
15,432
|
|
Accounts payable
|
|
|
2,198
|
|
|
|
(13,290
|
)
|
|
|
4,347
|
|
|
|
|
|
|
|
(6,745
|
)
|
Accrued expenses and other current liabilities
|
|
|
16,714
|
|
|
|
(34,805
|
)
|
|
|
(13,946
|
)
|
|
|
(1,856
|
)
|
|
|
(33,893
|
)
|
Other non-current liabilities
|
|
|
407
|
|
|
|
220
|
|
|
|
1,156
|
|
|
|
|
|
|
|
1,783
|
|
Intercompany payable (receivable)
|
|
|
1,385,254
|
|
|
|
(1,385,378
|
)
|
|
|
5,391
|
|
|
|
(5,267
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities
|
|
|
1,184,156
|
|
|
|
(1,092,219
|
)
|
|
|
2,085
|
|
|
|
(5,267
|
)
|
|
|
88,755
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment
|
|
|
(1,538
|
)
|
|
|
(12,845
|
)
|
|
|
(22,015
|
)
|
|
|
|
|
|
|
(36,398
|
)
|
Proceeds from sale of property, plant and equipment
|
|
|
|
|
|
|
171
|
|
|
|
93
|
|
|
|
|
|
|
|
264
|
|
Cash paid for acquisitions and transactional costs, net of cash
acquired
|
|
|
(2,147,492
|
)
|
|
|
179,154
|
|
|
|
(67,778
|
)
|
|
|
|
|
|
|
(2,036,116
|
)
|
Cash received, net of cash paid, from formation of joint venture
|
|
|
30,881
|
|
|
|
|
|
|
|
293,289
|
|
|
|
|
|
|
|
324,170
|
|
Cash (paid for) received from investments in minority interests
and marketable securities
|
|
|
(1,471
|
)
|
|
|
1,550
|
|
|
|
(10,256
|
)
|
|
|
|
|
|
|
(10,177
|
)
|
(Increase) decrease in other assets
|
|
|
(26,362
|
)
|
|
|
3,416
|
|
|
|
(5,327
|
)
|
|
|
|
|
|
|
(28,273
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities
|
|
|
(2,145,982
|
)
|
|
|
171,446
|
|
|
|
188,006
|
|
|
|
|
|
|
|
(1,786,530
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase in restricted cash
|
|
|
|
|
|
|
(15
|
)
|
|
|
(141,854
|
)
|
|
|
|
|
|
|
(141,869
|
)
|
Cash paid for financing costs
|
|
|
(40,347
|
)
|
|
|
(164
|
)
|
|
|
(164
|
)
|
|
|
|
|
|
|
(40,675
|
)
|
Proceeds from issuance of common stock, net of issuance costs
|
|
|
1,122,852
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,122,852
|
|
Net repayments on long-term debt
|
|
|
|
|
|
|
|
|
|
|
(22,326
|
)
|
|
|
|
|
|
|
(22,326
|
)
|
Net proceeds (repayments) from revolving
lines-of-credit
|
|
|
1,166,601
|
|
|
|
(47,703
|
)
|
|
|
(4,727
|
)
|
|
|
|
|
|
|
1,114,171
|
|
Tax benefit on exercised stock options
|
|
|
867
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
867
|
|
Principal payments of capital lease obligations
|
|
|
|
|
|
|
(554
|
)
|
|
|
(82
|
)
|
|
|
|
|
|
|
(636
|
)
|
Intercompany notes (receivable) payable
|
|
|
(1,245,000
|
)
|
|
|
1,245,000
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities
|
|
|
1,004,973
|
|
|
|
1,196,564
|
|
|
|
(169,153
|
)
|
|
|
|
|
|
|
2,032,384
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange effect on cash and cash equivalents
|
|
|
|
|
|
|
761
|
|
|
|
2,991
|
|
|
|
5,267
|
|
|
|
9,019
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
43,147
|
|
|
|
276,552
|
|
|
|
23,929
|
|
|
|
|
|
|
|
343,628
|
|
Cash and cash equivalents, beginning of period
|
|
|
16,031
|
|
|
|
20,074
|
|
|
|
34,999
|
|
|
|
|
|
|
|
71,104
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
|
$
|
59,178
|
|
|
$
|
296,626
|
|
|
$
|
58,928
|
|
|
$
|
|
|
|
$
|
414,732
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SF-79
Notes to
consolidated financial statements
Consolidating
statement of cash flows
For the year
ended December 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guarantor
|
|
|
Non-guarantor
|
|
|
|
|
|
|
|
|
|
Issuer
|
|
|
subsidiaries
|
|
|
subsidiaries
|
|
|
Eliminations
|
|
|
Consolidated
|
|
|
|
|
|
(in
thousands)
|
|
|
Cash Flows from Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
$
|
(16,842
|
)
|
|
$
|
23,428
|
|
|
$
|
(10,840
|
)
|
|
$
|
(12,588
|
)
|
|
$
|
(16,842
|
)
|
Adjustments to reconcile net (loss) income to net cash (used in)
provided by operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Equity in earnings of subsidiaries, net of tax
|
|
|
(14,716
|
)
|
|
|
|
|
|
|
|
|
|
|
14,716
|
|
|
|
|
|
Interest expense related to amortization of original issue
discounts and write-off of deferred financing costs
|
|
|
1,937
|
|
|
|
1,213
|
|
|
|
1,008
|
|
|
|
|
|
|
|
4,158
|
|
Non-cash income related to currency hedge
|
|
|
(217
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(217
|
)
|
Non-cash stock-based compensation expense
|
|
|
5,455
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,455
|
|
Charge for in-process research and development
|
|
|
|
|
|
|
|
|
|
|
4,960
|
|
|
|
|
|
|
|
4,960
|
|
Impairment of inventory
|
|
|
|
|
|
|
707
|
|
|
|
|
|
|
|
|
|
|
|
707
|
|
Impairment of long-lived assets
|
|
|
|
|
|
|
4,939
|
|
|
|
3,927
|
|
|
|
|
|
|
|
8,866
|
|
Loss (gain) on sale of fixed assets
|
|
|
|
|
|
|
9
|
|
|
|
(1,537
|
)
|
|
|
|
|
|
|
(1,528
|
)
|
Equity earnings of unconsolidated entities, net of tax
|
|
|
(361
|
)
|
|
|
|
|
|
|
25
|
|
|
|
|
|
|
|
(336
|
)
|
Interest in minority investments
|
|
|
(274
|
)
|
|
|
|
|
|
|
(25
|
)
|
|
|
|
|
|
|
(299
|
)
|
Depreciation and amortization
|
|
|
4,989
|
|
|
|
13,378
|
|
|
|
20,995
|
|
|
|
|
|
|
|
39,362
|
|
Deferred and other non-cash income taxes
|
|
|
84
|
|
|
|
2,186
|
|
|
|
(2,551
|
)
|
|
|
(128
|
)
|
|
|
(409
|
)
|
Other non-cash items
|
|
|
159
|
|
|
|
|
|
|
|
555
|
|
|
|
|
|
|
|
714
|
|
Changes in assets and liabilities, net of acquisitions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net
|
|
|
(194
|
)
|
|
|
(8,931
|
)
|
|
|
(4,721
|
)
|
|
|
|
|
|
|
(13,846
|
)
|
Inventories, net
|
|
|
1,534
|
|
|
|
5,533
|
|
|
|
(4,382
|
)
|
|
|
(2,518
|
)
|
|
|
167
|
|
Prepaid expenses and other current assets
|
|
|
(10
|
)
|
|
|
740
|
|
|
|
(816
|
)
|
|
|
|
|
|
|
(86
|
)
|
Accounts payable
|
|
|
3,757
|
|
|
|
(5,652
|
)
|
|
|
2,105
|
|
|
|
|
|
|
|
210
|
|
Accrued expenses and other current liabilities
|
|
|
2,510
|
|
|
|
(4,962
|
)
|
|
|
5,228
|
|
|
|
518
|
|
|
|
3,294
|
|
Other non-current liabilities
|
|
|
|
|
|
|
28
|
|
|
|
(88
|
)
|
|
|
|
|
|
|
(60
|
)
|
Intercompany (receivable) payable
|
|
|
(12,998
|
)
|
|
|
(15,288
|
)
|
|
|
28,409
|
|
|
|
(123
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by operating activities
|
|
|
(25,187
|
)
|
|
|
17,328
|
|
|
|
42,252
|
|
|
|
(123
|
)
|
|
|
34,270
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchases of property, plant and equipment
|
|
|
(558
|
)
|
|
|
(3,332
|
)
|
|
|
(15,827
|
)
|
|
|
|
|
|
|
(19,717
|
)
|
Proceeds from sale of property, plant and equipment
|
|
|
|
|
|
|
15
|
|
|
|
2,229
|
|
|
|
|
|
|
|
2,244
|
|
Cash paid for acquisitions and transactional costs, net of cash
acquired
|
|
|
(70,603
|
)
|
|
|
(109
|
)
|
|
|
(60,753
|
)
|
|
|
|
|
|
|
(131,465
|
)
|
Cash paid for investments in minority interests and marketable
securities
|
|
|
(14,455
|
)
|
|
|
|
|
|
|
(11,362
|
)
|
|
|
|
|
|
|
(25,817
|
)
|
Increase in other assets
|
|
|
(933
|
)
|
|
|
(133
|
)
|
|
|
(3,011
|
)
|
|
|
|
|
|
|
(4,077
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities
|
|
|
(86,549
|
)
|
|
|
(3,559
|
)
|
|
|
(88,724
|
)
|
|
|
|
|
|
|
(178,832
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash paid for financing costs
|
|
|
(79
|
)
|
|
|
(1,358
|
)
|
|
|
(1,350
|
)
|
|
|
|
|
|
|
(2,787
|
)
|
Proceeds from issuance of common stock, net of issuance costs
|
|
|
234,961
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
234,961
|
|
Net repayments on long-term debt
|
|
|
(20,000
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(20,000
|
)
|
Net repayments from revolving
lines-of-credit
|
|
|
|
|
|
|
(15,225
|
)
|
|
|
(32,654
|
)
|
|
|
|
|
|
|
(47,879
|
)
|
Repayments of notes receivable
|
|
|
14,691
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,691
|
|
Tax benefit on exercised stock options
|
|
|
567
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
567
|
|
Principal payments of capital lease obligations
|
|
|
|
|
|
|
(511
|
)
|
|
|
(35
|
)
|
|
|
|
|
|
|
(546
|
)
|
Intercompany notes (receivable) payable
|
|
|
(103,247
|
)
|
|
|
15,000
|
|
|
|
88,247
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities
|
|
|
126,893
|
|
|
|
(2,094
|
)
|
|
|
54,208
|
|
|
|
|
|
|
|
179,007
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign exchange effect on cash and cash equivalents
|
|
|
(3
|
)
|
|
|
|
|
|
|
2,269
|
|
|
|
123
|
|
|
|
2,389
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents
|
|
|
15,154
|
|
|
|
11,675
|
|
|
|
10,005
|
|
|
|
|
|
|
|
36,834
|
|
Cash and cash equivalents, beginning of period
|
|
|
1,196
|
|
|
|
8,080
|
|
|
|
24,994
|
|
|
|
|
|
|
|
34,270
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents, end of period
|
|
$
|
16,350
|
|
|
$
|
19,755
|
|
|
$
|
34,999
|
|
|
$
|
|
|
|
$
|
71,104
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SF-80
Prospectus
Common
Stock
Preferred Stock
Warrants
Stock Purchase Contracts
Depositary Shares
Debt Securities
Subsidiary Guarantees of Debt Securities
Units
This prospectus provides you with a general description of
securities that we may offer and sell from time to time. Each
time we sell securities we will provide a prospectus supplement
that will contain specific information about the terms of that
sale and may add to or update the information in this
prospectus. You should read this prospectus and any applicable
prospectus supplement carefully before you invest in our
securities.
The securities may be offered directly by us or by any selling
security holder, through agents designated from time to time by
us or to or through underwriters or dealers. If any agents,
underwriters or dealers are involved in the sale of any of the
securities, their names and any applicable purchase price, fee,
commission or discount arrangement between or among them will be
set forth, or will be calculable from the information set forth,
in the applicable prospectus supplement. See the sections
entitled About This Prospectus and Plan of
Distribution for more information. No securities may be
sold without delivery of this prospectus and the applicable
prospectus supplement describing the method and terms of the
offering of such securities.
Our common stock is listed on the New York Stock Exchange under
the symbol IMA. On April 9, 2009 the last
reported sale price of our common stock on the New York Stock
Exchange was $28.56.
Investing in our securities involves various risks. In our
filings with the Securities and Exchange Commission, which are
incorporated by reference in this prospectus, we identify and
discuss risk factors that you should consider before investing
in our securities.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved of these
securities, or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The date of this prospectus is May 1, 2009.
Table of
Contents
|
|
|
|
|
|
|
Page
|
|
|
|
|
1
|
|
|
|
|
1
|
|
|
|
|
2
|
|
|
|
|
2
|
|
|
|
|
4
|
|
|
|
|
4
|
|
|
|
|
7
|
|
|
|
|
8
|
|
|
|
|
10
|
|
|
|
|
10
|
|
|
|
|
13
|
|
|
|
|
22
|
|
|
|
|
24
|
|
|
|
|
26
|
|
|
|
|
28
|
|
|
|
|
28
|
|
|
|
|
29
|
|
ABOUT
THIS PROSPECTUS
This document is called a prospectus, and it
provides you with a general description of the securities we may
offer. Each time we sell securities, we will provide a
prospectus supplement containing specific information about the
terms of the securities being offered. That prospectus
supplement may include a discussion of any risk factors or other
special considerations that apply to those securities. The
prospectus supplement may also add, update or change the
information in this prospectus. If there is any inconsistency
between the information in this prospectus and in a prospectus
supplement, you should rely on the information in that
prospectus supplement. You should read both this prospectus and
any prospectus supplement together with additional information
described under the heading Where You Can Find More
Information.
We have filed a registration statement with the Securities and
Exchange Commission, or the SEC, using a shelf
registration process. Under this shelf registration process, we
may offer and sell any combination of the securities described
in this prospectus in one or more offerings.
Our SEC registration statement containing this prospectus,
including exhibits, provides additional information about us and
the securities offered under this prospectus. The registration
statement can be read at the SECs website or at the
SECs offices. The SECs website and street address
are provided under the heading Where You Can Find More
Information.
When acquiring securities, you should rely only on the
information provided in this prospectus and in the related
prospectus supplement, including any information incorporated by
reference. No one is authorized to provide you with information
different from that which is contained, or deemed to be
contained, in the prospectus and related prospectus supplement.
We are not offering the securities in any state where the offer
is prohibited. You should not assume that the information in
this prospectus, any prospectus supplement or any document
incorporated by reference is truthful or complete as of any date
other than the date indicated on the cover page of the relevant
document.
This prospectus contains forward-looking statements. You should
read the explanation of the qualifications and limitations on
such forward-looking statements on page 4 of this
prospectus. You should also carefully consider the various risk
factors incorporated by reference into this prospectus from our
SEC filings, which risk factors may cause our actual results to
differ materially from those indicated by such forward-looking
statements. You should not place undue reliance on our
forward-looking statements.
Unless otherwise stated or unless the context otherwise
requires, all references to we, us,
our, our Company or the
Company in this prospectus refer collectively to Inverness
Medical Innovations, Inc., a Delaware corporation, and its
subsidiaries, and their respective predecessor entities for the
applicable periods, considered as a single enterprise.
Unless otherwise stated, currency amounts in this prospectus and
any prospectus supplement are stated in United States dollars.
ABOUT
INVERNESS MEDICAL INNOVATIONS, INC.
Inverness Medical Innovations enables individuals to take charge
of improving their health and quality of life at home by
developing new capabilities in near-patient diagnosis,
monitoring and health management. Our global leading products
and services, as well as our new product development efforts,
focus on cardiology, womens health, infectious disease,
oncology and drugs of abuse. Our business is organized into four
major reportable segments: professional diagnostics, health
management, consumer diagnostics and vitamins and nutritional
supplements. Through our professional diagnostics segment, we
develop, manufacture and market an extensive array of innovative
rapid diagnostic test products and other in vitro
diagnostic tests to medical professionals and laboratories for
detection of infectious diseases, cardiac conditions, drugs of
abuse and pregnancy. Our health management segment provides
comprehensive, integrated programs and services focused on
wellness, disease and condition
1
management, productivity enhancement and informatics, all
designed to reduce health-related costs and enhance the health
and quality of life of the individuals we serve. Our consumer
diagnostic segment consists primarily of manufacturing
operations related to our role as the exclusive manufacturer of
products for SPD Swiss Precision Diagnostics, or Swiss
Precision, our 50/50 joint venture with The Procter &
Gamble Company. Swiss Precision holds a leadership position in
the worldwide over-the-counter pregnancy and fertility/ovulation
test market. We also manufacture and market a variety of
vitamins and nutritional supplements under our brands and those
of private label retailers primarily in the U.S. consumer
market. We have grown our businesses by leveraging our strong
intellectual property portfolio and making selected strategic
acquisitions. Our products are sold in approximately 90
countries through our direct sales force and an extensive
network of independent global distributors.
Inverness Medical Innovations, Inc. is a Delaware corporation.
Our principal executive offices are located at 51 Sawyer Road,
Suite 200, Waltham, Massachusetts 02453 and our telephone
number is
(781) 647-3900.
Our website is www.invernessmedical.com. The information found
on our website is not part of this prospectus.
RATIO OF
EARNINGS TO FIXED CHARGES AND RELATED MATTERS
The following table presents our ratio of earnings to fixed
charges and our ratio of earnings to combined fixed charges and
preference dividends for the periods indicated. For this
purpose, earnings consist of
pre-tax
income before adjustment for income from equity investees plus
fixed charges (excluding capitalized interest). Fixed
charges consist of interest expensed and capitalized,
amortized premiums, discounts and capitalized expenses related
to indebtedness and an estimate of the interest within rental
expense. Preference dividends equal the amount of
pre-tax earnings that is required to pay the dividends on
outstanding preference securities. Due to the net losses for the
years ended December 31, 2008, 2007, 2006, 2005 and 2004,
there were insufficient earnings of $38.1 million,
$248.9 million, $11.8 million, $12.4 million and
$14.3 million, respectively, to cover fixed charges, and
$61.4 million, $248.9 million, $11.8 million,
$12.4 million and $15.6 million, respectively, to
cover fixed charges and preference dividends.
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Year Ended December 31,
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2008
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2007
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2006
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2005
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2004
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Ratio of earnings to fixed charges
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0.7
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x
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0.6
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x
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0.5
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x
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0.4
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x
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Ratio of earnings to combined fixed charges and preference
dividends
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0.5
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x
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0.6
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x
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0.5
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x
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0.4
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x
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SPECIAL
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of
1934, as amended. You can identify these statements by
forward-looking words such as may,
could, should, would,
intend, will, expect,
anticipate, believe,
estimate, continue or similar words. You
should read statements that contain these words carefully
because they discuss our future expectations, contain
projections of our future results of operations or of our
financial condition or state other forward-looking
information. There may be events in the future that we are
unable to predict accurately or control and that may cause our
actual results to differ materially from the expectations we
describe in our forward-looking statements. We caution investors
that all forward-looking statements involve risks and
uncertainties, and actual results may differ materially from
those we discuss in this prospectus. These differences may be
the result of various factors, including those factors
identified from time to time in our periodic filings with the
SEC or in a prospectus supplement. Some important factors that
could cause our actual results to differ materially from those
projected in any such forward-looking statements are as follows:
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our inability to predict the effects of the current national and
worldwide financial and economic crisis, including disruptions
in the capital and credit markets;
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our inability to predict the effects of anticipated United
States national healthcare reform legislation and similar
initiatives in other countries;
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economic factors, including inflation and fluctuations in
interest rates and foreign currency exchange rates, and the
potential effect of such fluctuations on revenues, expenses and
resulting margins;
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competitive factors, including technological advances achieved
and patents attained by competitors and general competition;
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domestic and foreign healthcare changes resulting in pricing
pressures, including the continued consolidation among
healthcare providers, trends toward managed care and healthcare
cost containment and government laws and regulations relating to
sales and promotion, reimbursement and pricing generally;
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government laws and regulations affecting domestic and foreign
operations, including those relating to trade, monetary and
fiscal policies, taxes, price controls, regulatory approval of
new products and licensing;
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manufacturing interruptions, delays or capacity constraints or
lack of availability of alternative sources for components for
our products, including our ability to successfully maintain
relationships with suppliers, or to put in place alternative
suppliers on terms that are acceptable to us;
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difficulties inherent in product development, including the
potential inability to successfully continue technological
innovation, complete clinical trials, obtain regulatory
approvals or clearances in the United States and abroad and the
possibility of encountering infringement claims by competitors
with respect to patent or other intellectual property rights
that can preclude or delay commercialization of a product;
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significant litigation adverse to us including product liability
claims, patent infringement claims and antitrust claims;
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product efficacy or safety concerns resulting in product recalls
or declining sales;
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the impact of business combinations and organizational
restructurings consistent with evolving business strategies;
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our ability to satisfy the financial covenants and other
conditions contained in the agreements governing our
indebtedness;
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our ability to effectively manage the integration of our
acquisitions into our operations;
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our ability to obtain required financing on terms that are
acceptable to us; and
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the issuance of new or revised accounting standards by the
American Institute of Certified Public Accountants, the
Financial Accounting Standards Board, the Public Company
Accounting Oversight Board or the SEC.
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The foregoing list provides many, but not all, of the factors
that could impact our ability to achieve the results described
in any forward-looking statement. Readers should not place undue
reliance on our forward-looking statements. Before you invest in
our securities, you should be aware that the occurrence of the
events described above and elsewhere in this prospectus could
seriously harm our business, prospects, operating results and
financial condition. We do not undertake any obligation to
update any forward-looking statement as a result of future
events or developments.
3
HOW WE
INTEND TO USE THE PROCEEDS
We currently intend to use the net proceeds from the sale of any
securities under this prospectus for general corporate purposes,
which may include:
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the repayment of debt;
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the repurchase of our capital stock;
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the financing of potential acquisitions and investments;
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working capital; and
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other purposes described in any prospectus supplement.
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Pending such use, we may temporarily invest the net proceeds.
The precise amounts and timing of the application of proceeds
will depend upon our funding requirements and the availability
of other funds. Except as described in any prospectus
supplement, specific allocations of the proceeds to such
purposes will not have been made at the date of that prospectus
supplement.
Based upon our historical and anticipated future growth and our
financial needs, we may engage in additional financings of a
character and amount that we determine as the need arises.
DESCRIPTION
OF COMMON STOCK WE MAY OFFER
Please note that in the sections entitled Description
of Common Stock We May Offer, Description of
Preferred Stock We May Offer, Description of
Warrants We May Offer, Description of Stock Purchase
Contracts We May Offer, Description of Depositary
Shares We May Offer, Description of Debt Securities
and Subsidiary Guarantees We May Offer, and
Description of Units We May Offer, references to
we, our and us refer only to
Inverness Medical Innovations, Inc. and not to any of its
consolidated subsidiaries.
The following summary description of our common stock is
based on the provisions of our Restated Certificate of
Incorporation, as amended, which we refer to as our certificate
of incorporation, and amended and restated by-laws, which we
refer to as our by-laws, and the applicable provisions of the
Delaware General Corporation Law, which we refer to as the DGCL.
This description may not contain all of the information that is
important to you and is subject to, and is qualified in its
entirety by reference to our certificate of incorporation, our
by-laws and the applicable provisions of the DGCL. For
information on how to obtain copies of our certificate of
incorporation and by-laws, see Where You Can Find More
Information.
We may offer common stock. We may also offer common stock
issuable upon the conversion of debt securities or preferred
stock, the exercise of warrants and pursuant to stock purchase
contracts.
Authorized
and Outstanding Capital Stock
Our authorized capital stock consists of 150,000,000 shares
of common stock, par value $0.001 per share, and
5,000,000 shares of preferred stock, par value $0.001 per
share, of which 2,300,000 shares have been designated as
Series B Convertible Perpetual Preferred Stock, or
Series B preferred stock. As of April 9, 2009, we had
78,716,338 shares of common stock and 1,878,731 shares
of Series B preferred stock issued and outstanding.
Common
Stock
Voting Rights. The holders of our common stock
have one vote per share. Holders of our common stock are not
entitled to vote cumulatively for the election of directors.
Generally, all matters to be voted on by stockholders must be
approved by a majority, or, in the case of the election of
directors, by a plurality, of the votes cast at a meeting at
which a quorum is present, voting together as a single class,
subject to any voting rights granted to holders of any then
outstanding preferred stock.
4
Dividends. Holders of common stock will share
ratably in any dividends declared by our board of directors,
subject to the preferential rights of any preferred stock then
outstanding. We may pay dividends consisting of shares of common
stock to holders of shares of common stock.
Other Rights. Upon the liquidation,
dissolution or winding up of our Company, all holders of common
stock are entitled to share ratably in any assets available for
distribution to holders of shares of common stock, subject to
the preferential rights of any preferred stock then outstanding.
No shares of common stock are subject to redemption or have
preemptive rights to purchase additional shares of common stock.
Preferred
Stock
Our certificate of incorporation provides that we may issue
shares of preferred stock from time to time in one or more
series. Our board of directors is authorized to fix the voting
rights, if any, designations, powers, preferences,
qualifications, limitations and restrictions thereof, applicable
to the shares of each series. Our board of directors may,
without stockholder approval, issue preferred stock with voting
and other rights that could adversely affect the voting power
and other rights of the holders of the common stock and could
have anti-takeover effects, including preferred stock or rights
to acquire preferred stock in connection with implementing a
shareholder rights plan. The ability of our board of directors
to issue preferred stock without stockholder approval could have
the effect of delaying, deferring or preventing a change of
control of our company or the removal of existing management.
Our board of directors has designated 2,300,000 shares of
preferred stock as Series B preferred stock.
Indemnification
Matters
Our certificate of incorporation contains a provision permitted
by Delaware law that generally eliminates the personal liability
of directors for monetary damages for breaches of their
fiduciary duty, including breaches involving negligence or gross
negligence in business combinations, unless the director has
breached his or her duty of loyalty, failed to act in good
faith, engaged in intentional misconduct or a knowing violation
of law, paid a dividend or approved a stock repurchase in
violation of the DGCL or obtained an improper personal benefit.
This provision does not alter a directors liability under
the federal securities laws and does not affect the availability
of equitable remedies, such as an injunction or rescission, for
breach of fiduciary duty. Our by-laws provide that directors and
officers shall be, and in the discretion of our board of
directors, non-officer employees may be, indemnified by us to
the fullest extent authorized by Delaware law, as it now exists
or may in the future be amended, against all expenses and
liabilities reasonably incurred in connection with service for
us or on our behalf. Our by-laws also provide for the
advancement of expenses to directors and, in the discretion of
our board of directors, officers and non-officer employees. In
addition, our by-laws provide that the right of directors and
officers to indemnification shall be a contractual right and
shall not be exclusive of any other right now possessed or
hereafter acquired under any by-law, agreement, vote of
stockholders or otherwise. We also have directors and
officers insurance against certain liabilities. We believe
that the limitation of liability and indemnification provisions
of our certificate of incorporation and by-laws and
directors and officers insurance will assist us in
attracting and retaining qualified individuals to serve as our
directors and officers.
Insofar as indemnification for liabilities arising under the
Securities Act of 1933 may be provided to our directors or
officers, or persons controlling our Company as described above,
we have been advised that in the opinion of the Securities and
Exchange Commission such indemnification is against public
policy as expressed in the Securities Act and is therefore
unenforceable.
Provisions
of Our Certificate of Incorporation and By-laws That May Have
Anti-Takeover Effects
Certain provisions of our certificate of incorporation and
by-laws described below, as well as the ability of our board of
directors to issue shares of preferred stock and to set the
voting rights, preferences and other terms thereof, may be
deemed to have an anti-takeover effect and may discourage
5
takeover attempts not first approved by our board of directors,
including takeovers that stockholders may believe to be in their
best interests.
These provisions also could have the effect of discouraging open
market purchases of our common stock because these provisions
may be considered disadvantageous by a stockholder who desires
subsequent to such purchases to participate in a business
combination transaction with us or elect a new director to our
board.
Classified Board of Directors. Our board of
directors is divided into three classes serving staggered
three-year terms, with one-third of the board being elected each
year. Our classified board, together with certain other
provisions of our certificate of incorporation authorizing the
board of directors to fill vacant directorships or increase the
size of the board, may prevent a stockholder from removing, or
delay the removal of, incumbent directors and simultaneously
gaining control of the board of directors by filling vacancies
created by such removal with its own nominees.
Director Vacancies and Removal. Our
certificate of incorporation provides that the affirmative vote
of a majority of the remaining directors is necessary to fill
vacancies in our board of directors, except for any directorship
that is to be filled exclusively by holders of preferred stock.
Our certificate of incorporation provides that directors, other
than those elected exclusively by the holders of preferred
stock, may be removed from office only with cause and only by
the affirmative vote of holders of at least seventy-five percent
of the shares then entitled to vote in an election of directors.
No Common Stockholder Action by Written
Consent. Our certificate of incorporation
provides that any action required or permitted to be taken by
the holders of our common stock at an annual or special meeting
of stockholders must be effected at a duly called meeting and
may not be taken or effected by a written consent of
stockholders.
Special Meetings of Stockholders. Our
certificate of incorporation and by-laws provide that only our
board of directors may call a special meeting of stockholders.
Our by-laws provide that only those matters included in the
notice of the special meeting may be considered or acted upon at
that special meeting unless otherwise provided by law.
Advance Notice of Director Nominations and Stockholder
Proposals. Our by-laws include advance notice
and informational requirements and time limitations on any
director nomination or any new proposal which a stockholder
wishes to make at an annual meeting of stockholders. A
stockholders notice of a director nomination or proposal
will be timely if delivered to our corporate secretary at our
principal executive offices not later than the close of business
on the 90th day nor earlier than the close of business on
the 120th day prior to the first anniversary of the
preceding years annual meeting.
Amendment of the Certificate of
Incorporation. As required by Delaware law, any
amendment to our certificate of incorporation must first be
approved by a majority of our board of directors and, if
required by law, thereafter approved by a majority of the
outstanding shares entitled to vote with respect to such
amendment, except that any amendment to the provisions relating
to common stockholder action by written consent, directors
(other than those provisions contained in any certificate of
designation relating to preferred stock), limitation of
liability and the amendment of our certificate of incorporation
must be approved by not less than seventy-five percent of the
outstanding shares entitled to vote with respect to such
amendment.
Amendment of By-laws. Our certificate of
incorporation and by-laws provide that our by-laws may be
amended or repealed by our board of directors or by the
stockholders. Such action by the board of directors requires the
affirmative vote of a majority of the directors then in office.
Such action by the stockholders requires the affirmative vote of
at least seventy-five percent of the shares present in person or
represented by proxy at an annual meeting of stockholders or a
special meeting called for such purpose unless our board of
directors recommends that the stockholders approve such
amendment or repeal at such meeting, in which case such
amendment or repeal only requires the affirmative vote of a
majority of the shares present in person or represented by proxy
at the meeting.
6
Statutory
Business Combination Provision
We are subject to Section 203 of the DGCL, which prohibits
a publicly-held Delaware corporation from completing a
business combination, except under certain
circumstances, with an interested stockholder for a
period of three years after the date such person became an
interested stockholder unless:
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before such person became an interested stockholder, the board
of directors of the corporation approved the transaction in
which the interested stockholder became an interested
stockholder or approved the business combination;
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upon the closing of the transaction that resulted in the
interested stockholder becoming such, the interested stockholder
owned at least 85% of the voting stock of the corporation
outstanding at the time the transaction commenced, excluding
shares held by directors who are also officers of the
corporation and shares held by employee stock plans; or
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following the transaction in which such person became an
interested stockholder, the business combination is approved by
the board of directors of the corporation and authorized at a
meeting of stockholders by the affirmative vote of the holders
of at least two-thirds of the outstanding voting stock of the
corporation not owned by the interested stockholder.
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The term interested stockholder generally is defined
as a person who, together with affiliates and associates, owns,
or, within the prior three years, owned, 15% or more of a
corporations outstanding voting stock.
The term business combination includes mergers,
consolidations, asset sales involving 10% or more of a
corporations assets and other similar transactions
resulting in a financial benefit to an interested stockholder.
Section 203 makes it more difficult for an interested
stockholder to effect various business combinations with a
corporation for a three-year period. A Delaware corporation may
opt out of Section 203 with an express
provision in its original certificate of incorporation or an
express provision in its certificate of incorporation or by-laws
resulting from an amendment approved by holders of at least a
majority of the outstanding voting stock. Neither our
certificate of incorporation nor our by-laws contain any such
exclusion.
Trading
on the New York Stock Exchange
Our common stock is listed on the New York Stock Exchange under
the symbol IMA.
Transfer
Agent and Registrar
The transfer agent and registrar for our common stock is
Computershare Trust Company, N.A.
DESCRIPTION
OF PREFERRED STOCK WE MAY OFFER
This section outlines some of the provisions of the preferred
stock we may offer. This description may not contain all of the
information that is important to you and is subject to, and is
qualified in its entirety by reference to our certificate of
incorporation, by-laws and the applicable provisions of the
DGCL. The specific terms of any series of preferred stock will
be described in the applicable prospectus supplement. Any series
of preferred stock we issue will be governed by our certificate
of incorporation (as amended and in effect as of the date of
such issuance) and by the certificate of amendment related to
that series. We will file the certificate of amendment with the
SEC and incorporate it by reference as an exhibit to our
registration statement at or before the time we issue any
preferred stock of that series of authorized preferred stock.
7
Authorized
Preferred Stock
Our certificate of incorporation provides that we may issue up
to 5,000,000 shares of preferred stock from time to time in
one or more series. Our board of directors is authorized to fix
the voting rights, if any, designations, powers, preferences,
qualifications, limitations and restrictions thereof, applicable
to the shares of each series. We have designated
2,300,000 shares of preferred stock as Series B
preferred stock, of which 1,878,731 shares were outstanding
as of April 9, 2009.
The prospectus supplement relating to any series of preferred
stock that we may offer will contain the specific terms of the
preferred stock.
DESCRIPTION
OF WARRANTS WE MAY OFFER
This section outlines some of the provisions of each warrant
agreement pursuant to which warrants may be issued, the warrants
or rights of warrant holders, and any warrant certificates. This
description may not contain all of the information that is
important to you and is qualified in its entirety by reference
to any warrant agreement with respect to the warrants of any
particular series. The specific terms of any series of warrants
will be described in the applicable prospectus supplement. If so
described in the prospectus supplement, the terms of that series
of warrants may differ from the general description of terms
presented below.
We may issue warrants. We may issue these securities in such
amounts or in as many distinct series as we wish. This section
summarizes the terms of these securities that apply generally.
Most of the financial and other specific terms of any such
series of securities will be described in the applicable
prospectus supplement. Those terms may vary from the terms
described here.
When we refer to a series of securities in this section, we mean
all securities issued as part of the same series under any
applicable indenture, agreement or other instrument. When we
refer to the applicable prospectus supplement, we mean the
prospectus supplement describing the specific terms of the
security you purchase. The terms used in the applicable
prospectus supplement generally will have the meanings described
in this prospectus, unless otherwise specified in the applicable
prospectus supplement.
Warrants
We may issue warrants, options or similar instruments for the
purchase of our common stock, preferred stock, depositary
shares, debt securities or units. We refer to these collectively
as warrants. Warrants may be issued independently or
together with common stock, preferred stock, depositary shares,
debt securities or units, and may be attached to or separate
from those securities.
Agreements
Each series of warrants may be evidenced by certificates and may
be issued under a separate indenture, agreement or other
instrument to be entered into between us and a bank, trust
company or other institution that we select as agent with
respect to such series. The warrant agent will act as our agent
in connection with the warrant agreement or any warrant
certificates and will not assume any obligation or relationship
of agency or trust for or with any warrant holders. Copies of
the forms of agreements and the forms of certificates
representing the warrants will be filed with the SEC near the
date of filing of the applicable prospectus supplement with the
SEC. Because the following is a summary of certain provisions of
the forms of agreements and certificates, it does not contain
all information that may be important to you. You should read
all the provisions of the agreements and the certificates once
they are available.
No warrant agreement will be qualified as an indenture, and no
warrant agent will be required to qualify as a trustee, under
the Trust Indenture Act. Therefore, holders of warrants
issued under warrant agreements will not have the protections of
the Trust Indenture Act with respect to their warrants.
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General
Terms of Warrants
The prospectus supplement relating to a series of warrants will
identify the name and address of the warrant agent, if any. The
prospectus supplement will describe the terms of the series of
warrants in respect of which this prospectus is being delivered,
including:
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the offering price;
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the designation and terms of any securities with which the
warrants are issued and in that event the number of warrants
issued with each security or each principal amount of security;
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the dates on which the right to exercise the warrants will
commence and expire, and the price at which the warrants are
exercisable;
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the amount of warrants then outstanding;
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material U.S. federal income tax consequences of holding or
exercising these securities; and
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any other terms of the warrants.
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Warrant certificates may be exchanged for new certificates of
different denominations and may be presented for transfer of
registration and, if exercisable for other securities or other
property, may be exercised at the warrant agents corporate
trust office or any other office indicated in the prospectus
supplement. If the warrants are not separately transferable from
any securities with which they were issued, an exchange may take
place only if the certificates representing the related
securities are also exchanged. Prior to exercise of any warrant
exercisable for other securities or other property, warrant
holders will not have any rights as holders of the underlying
securities, including the right to receive any principal,
premium, interest, dividends, or payments upon our liquidation,
dissolution or winding up or to exercise any voting rights.
Modification Without Consent. We and the
applicable warrant agent may amend any warrant or warrant
agreement without the consent of any holder to:
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cure any ambiguity;
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correct or supplement any defective or inconsistent
provision; or
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make any other change that we believe is necessary or desirable
and will not adversely affect the interests of the affected
holders in any material respect.
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We do not need any approval to make changes that affect only
warrants to be issued after the changes take effect. We may also
make changes that do not adversely affect a particular warrant
in any material respect, even if they adversely affect other
warrants in a material respect. In those cases, we do not need
to obtain the approval of the holder of the unaffected warrant;
we need only obtain any required approvals from the holders of
the affected warrants.
Modification With Consent. We and any agent
for any series of warrants may also amend any agreement and the
related warrants by a supplemental agreement with the consent of
the holders of a majority of the warrants of any series affected
by such amendment. However, no such amendment that:
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increases the exercise price of such warrant;
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shortens the time period during which any such warrant may be
exercised;
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reduces the number of securities the consent of holders of which
is required for amending the agreement or the related
warrants; or
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otherwise adversely affects the exercise rights of warrant
holders in any material respect;
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may be made without the consent of each holder affected by that
amendment.
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DESCRIPTION
OF STOCK PURCHASE CONTRACTS WE MAY OFFER
This section outlines some of the provisions of the stock
purchase contracts, the stock purchase contract agreement and
the pledge agreement. This description may not contain all of
the information that is important to you and is qualified in its
entirety by reference to the stock purchase contract agreement
and pledge agreement with respect to the stock purchase
contracts of any particular series. The specific terms of any
series of stock purchase contracts will be described in the
applicable prospectus supplement. If so described in a
prospectus supplement, the specific terms of any series of stock
purchase contracts may differ from the general description of
terms presented below.
Unless otherwise specified in the applicable prospectus
supplement, we may issue stock purchase contracts, including
contracts obligating holders to purchase from us and us to sell
to the holders, a specified number of shares of common stock,
preferred stock, depositary shares or other security or property
at a future date or dates. Alternatively, the stock purchase
contracts may obligate us to purchase from holders, and obligate
holders to sell to us, a specified or varying number of shares
of common stock, preferred stock, depositary shares or other
security or property. The consideration per share of common
stock or preferred stock or per depositary share or other
security or property may be fixed at the time the stock purchase
contracts are issued or may be determined by a specific
reference to a formula set forth in the stock purchase
contracts. The stock purchase contracts may provide for
settlement by delivery by us or on our behalf of shares of the
underlying security or property or they may provide for
settlement by reference or linkage to the value, performance or
trading price of the underlying security or property. The stock
purchase contracts may be issued separately or as part of stock
purchase units consisting of a stock purchase contract and debt
securities, preferred stock or debt obligations of third
parties, including U.S. treasury securities, other stock
purchase contracts or common stock, or other securities or
property, securing the holders obligations to purchase or
sell, as the case may be, the common stock, preferred stock,
depositary shares or other security or property under the stock
purchase contracts. The stock purchase contracts may require us
to make periodic payments to the holders of the stock purchase
units or vice versa, and such payments may be unsecured or
prefunded on some basis and may be paid on a current or on a
deferred basis. The stock purchase contracts may require holders
to secure their obligations thereunder in a specified manner and
may provide for the prepayment of all or part of the
consideration payable by holders in connection with the purchase
of the underlying security or other property pursuant to the
stock purchase contracts.
The securities related to the stock purchase contracts may be
pledged to a collateral agent for our benefit pursuant to a
pledge agreement to secure the obligations of holders of stock
purchase contracts to purchase the underlying security or
property under the related stock purchase contracts. The rights
of holders of stock purchase contracts to the related pledged
securities will be subject to our security interest therein
created by the pledge agreement. No holder of stock purchase
contracts will be permitted to withdraw the pledged securities
related to such stock purchase contracts from the pledge
arrangement except upon the termination or early settlement of
the related stock purchase contracts or in the event other
securities, cash or property is made subject to the pledge
agreement in lieu of the pledged securities, if permitted by the
pledge agreement, or as otherwise provided in the pledge
agreement. Subject to such security interest and the terms of
the stock purchase contract agreement and the pledge agreement,
each holder of a stock purchase contract will retain full
beneficial ownership of the related pledged securities.
Except as described in the applicable prospectus supplement, the
collateral agent will, upon receipt of distributions on the
pledged securities, distribute such payments to us or the stock
purchase contract agent, as provided in the pledge agreement.
The purchase agent will in turn distribute payments it receives
as provided in the stock purchase contract agreement.
DESCRIPTION
OF DEPOSITARY SHARES WE MAY OFFER
This section outlines some of the provisions of the deposit
agreement to govern any depositary shares, the depositary shares
themselves and the depositary receipts. This description may not
contain
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all of the information that is important to you and is
qualified in its entirety by reference to the relevant deposit
agreement and depositary receipts with respect to the depositary
shares related to any particular series of preferred stock. The
specific terms of any series of depositary shares will be
described in the applicable prospectus supplement. If so
described in the prospectus supplement, the terms of that series
of depositary shares may differ from the general description of
terms presented below.
Interest
in a Fractional Share, or Multiple Shares, of Preferred
Stock
We may, at our option, elect to offer depositary shares, each of
which would represent an interest in a fractional share, or
multiple shares, of our preferred stock instead of whole shares
of preferred stock. If so, we will allow a depositary to issue
to the public depositary shares, each of which will represent an
interest in a fractional share, or multiple shares, of preferred
stock as described in the prospectus supplement.
Deposit
Agreement
The shares of the preferred stock underlying any depositary
shares will be deposited under a separate deposit agreement
between us and a bank, trust company or other institution acting
as depositary with respect to those shares of preferred stock.
The prospectus supplement relating to a series of depositary
shares will specify the name and address of the depositary.
Under the deposit agreement, each owner of a depositary share
will be entitled, in proportion to its interest in a fractional
share, or multiple shares, of the preferred stock underlying
that depositary share, to all the rights and preferences of that
preferred stock, including dividend, voting, redemption,
conversion, exchange and liquidation rights.
Depositary shares will be evidenced by one or more depositary
receipts issued under the deposit agreement. We will distribute
depositary receipts to those persons purchasing such depositary
shares in accordance with the terms of the offering made by the
related prospectus supplement.
No depositary agreement will be qualified as an indenture, and
no depositary will be required to qualify as a trustee, under
the Trust Indenture Act. Therefore, holders of depositary
shares issued under depositary agreements will not have the
protections of the Trust Indenture Act with respect to
their depositary shares.
Dividends
and Other Distributions
The depositary will distribute all cash dividends or other cash
distributions in respect of the preferred stock underlying the
depositary shares to each record depositary shareholder based on
the number of depositary shares owned by that holder on the
relevant record date. The depositary will distribute only that
amount which can be distributed without attributing to any
depositary shareholders a fraction of one cent, and any balance
not so distributed will be added to and treated as part of the
next sum received by the depositary for distribution to record
depositary shareholders.
If there is a distribution other than in cash, the depositary
will distribute property to the entitled record depositary
shareholders, unless the depositary determines that it is not
feasible to make that distribution. In that case the depositary
may, with our approval, adopt the method it deems equitable and
practicable for making that distribution, including any sale of
property and the distribution of the net proceeds from the sale
to the concerned holders.
Each deposit agreement will also contain provisions relating to
the manner in which any subscription or similar rights we offer
to holders of the relevant series of preferred stock will be
made available to depositary shareholders.
The amount distributed in all of the foregoing cases will be
reduced by any amounts required to be withheld by us or the
depositary on account of taxes and governmental charges.
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Withdrawal
of Stock
Upon surrender of depositary receipts at the office of the
depositary and upon payment of the charges provided in the
deposit agreement and subject to the terms thereof, a holder of
depositary receipts is entitled to have the depositary deliver
to such holder the applicable number of shares of preferred
stock underlying the depositary shares evidenced by the
surrendered depositary receipts. There may be no market,
however, for the underlying preferred stock and once the
underlying preferred stock is withdrawn from the depositary, it
may not be redeposited.
Redemption
and Liquidation
The terms on which the depositary shares relating to the
preferred stock of any series may be redeemed, and any amounts
distributable upon our liquidation, dissolution or winding up,
will be described in the applicable prospectus supplement.
Voting
Upon receiving notice of any meeting at which preferred
stockholders of any series are entitled to vote, the depositary
will mail the information contained in that notice to the record
depositary shareholders relating to those series of preferred
stock. Each depositary shareholder on the record date will be
entitled to instruct the depositary on how to vote the shares of
preferred stock underlying that holders depositary shares.
The depositary will vote the shares of preferred stock
underlying those depositary shares according to those
instructions, and we will take reasonably necessary actions to
enable the depositary to do so. If the depositary does not
receive specific instructions from the depositary shareholders
relating to that preferred stock, it will abstain from voting
those shares of preferred stock, unless otherwise discussed in
the prospectus supplement.
Amendment
and Termination of Deposit Agreement
We and the depositary may amend the depositary receipt form
evidencing the depositary shares and the related deposit
agreement. However, any amendment that significantly affects the
rights of the depositary shareholders will not be effective
unless holders of a majority of the outstanding depositary
shares approve that amendment. No amendment, however, may impair
the right of any depositary shareholder to receive any money or
other property to which he may be entitled under the terms of
the deposit agreement at the times and in the manner and amount
provided for therein. We or the depositary may terminate a
deposit agreement only if:
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we redeemed or reacquired all outstanding depositary shares
relating to the deposit agreement;
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all outstanding depositary shares have been converted (if
convertible) into shares of common stock or another series of
preferred stock; or
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there has been a final distribution in respect of the preferred
stock of any series in connection with our liquidation,
dissolution or winding up and such distribution has been made to
the related depositary shareholders.
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Charges
of Depositary
We will pay all transfer and other taxes and governmental
charges arising solely from the existence of the depositary
arrangements. We will also pay all charges of each depositary in
connection with the initial deposit and any redemption of the
preferred stock. Depositary shareholders will be required to pay
any other transfer and other taxes and governmental charges and
any other charges expressly provided in the deposit agreement to
be for their accounts.
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Miscellaneous
Each depositary will forward to the relevant depositary
shareholders all our reports and communications that we are
required to furnish to preferred stockholders of any series.
The deposit agreement will contain provisions relating to
adjustments in the fraction of a share of preferred stock
represented by a depositary share in the event of a change in
par value,
split-up,
combination or other reclassification of the preferred stock or
upon any recapitalization, merger or sale of substantially all
of our assets.
Neither the depositary nor our company will be liable if it is
prevented or delayed by law or any circumstance beyond its
control in performing its obligations under any deposit
agreement, or subject to any liability under the deposit
agreement to holders of depositary receipts other than for the
relevant partys gross negligence or willful misconduct.
The obligations of each depositary under any deposit agreement
will be limited to performance in good faith of their duties
under that agreement, and they will not be obligated to
prosecute or defend any legal proceeding in respect of any
depositary shares or preferred stock unless they are provided
with satisfactory indemnity. They may rely upon written advice
of counsel or accountants, or information provided by persons
presenting preferred stock for deposit, depositary shareholders
or other persons believed to be competent and on documents
believed to be genuine.
Resignation
and Removal of Depositary
A depositary may resign at any time by issuing us a notice of
resignation, and we may remove any depositary at any time by
issuing it a notice of removal. Resignation or removal will take
effect upon the appointment of a successor depositary and its
acceptance of appointment. That successor depositary must be
appointed within 60 days after delivery of the notice of
resignation or removal.
DESCRIPTION
OF DEBT SECURITIES AND SUBSIDIARY GUARANTEES WE MAY
OFFER
This section outlines some of the provisions of the debt
securities and any related subsidiary guarantees we may issue
and the indenture and supplemental indentures pursuant to which
they may be issued. This description may not contain all of the
information that is important to you and is qualified in its
entirety by reference to the form of indenture and the
applicable supplemental indenture with respect to the debt
securities of any particular series and any related subsidiary
guarantees. The specific terms of any series of debt securities
and any related subsidiary guarantees will be described in the
applicable prospectus supplement. If so described in a
particular supplement, the specific terms of any series of debt
securities and any related subsidiary guarantees may differ from
the general description of terms presented below.
We may issue secured or unsecured debt securities. Our debt
securities and any related subsidiary guarantees will be issued
under an indenture to be entered into between us and a trustee
to be designated by us, a form of which is filed as an exhibit
to the registration statement of which this prospectus forms a
part. Our debt securities may be convertible into our common
stock or other of our securities.
When we offer to sell a particular series of debt securities, we
will describe the specific terms of the series in a supplement
to this prospectus. We will also indicate in the prospectus
supplement whether the general terms and provisions described in
this prospectus apply to a particular series of debt securities.
To the extent the information contained in the prospectus
supplement differs from this summary description, you should
rely on the information in the prospectus supplement.
Unless otherwise specified in a supplement to this prospectus,
the debt securities and any related subsidiary guarantees will
be the direct, unsecured obligations of the issuers thereof and
will rank equally with all of the issuers other unsecured
and unsubordinated indebtedness. The holders of our debt
securities will be structurally subordinated to holders of any
indebtedness (including trade
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payables) of any of our subsidiaries, except to the extent our
subsidiaries guarantee our obligations under that series of debt
securities.
The debt securities may be fully and unconditionally guaranteed
on a secured or unsecured, senior or subordinated basis, jointly
and severally, by some or all of our direct and indirect wholly
owned domestic subsidiaries. The obligations of each subsidiary
guarantor, if any, under its guarantee, if any, will be limited
as necessary to prevent that guarantee from constituting a
fraudulent conveyance under applicable law. In the event that
any series of debt securities and any related subsidiary
guarantees will be subordinated to other indebtedness that we or
our subsidiary guarantors have outstanding or may incur, the
terms of the subordination will be set forth in the prospectus
supplement relating to such debt securities and related
subsidiary guarantees.
We have described select portions of the indenture below. This
description may not contain all of the information that is
important to you. The form of indenture has been included as an
exhibit to the registration statement of which this prospectus
is a part, and you should read the indenture for provisions that
may be important to you. In the summary below, we have included
references to the section numbers of the indenture so that you
can easily locate these provisions.
General
The terms of each series of debt securities and any related
subsidiary guarantees will be established by or pursuant to a
resolution of our board of directors and set forth or determined
in the manner provided in a resolution of our board of
directors, in an officers certificate or by a supplemental
indenture. (Section 2.02)
We may issue an unlimited amount of debt securities under the
indenture that may be in one or more series with the same or
various maturities, at par, at a premium, or at a discount. When
we offer a particular series of debt securities, we will
identify the title of the debt securities, the trustee or
trustees (to which we refer in this description collectively as
the trustee), any subsidiary guarantors and the aggregate
principal amount of the debt securities we are offering, and we
will describe the following terms of the debt securities, if
applicable:
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the price or prices (expressed as a percentage of the principal
amount) at which we will issue the debt securities;
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any limit on the aggregate principal amount of the debt
securities;
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the date or dates on which we will pay the principal on the debt
securities;
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the rate or rates (which may be fixed or variable) per annum or,
if applicable, the method used to determine the rate or rates
(including any rate or rates determined by reference to any
commodity, commodity index, stock exchange index or financial
index) at which the debt securities will bear interest, the date
or dates from which interest will accrue, the date or dates on
which interest will commence and be payable and any regular
record date for the interest payable on any interest payment
date;
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the place or places where principal of and interest on the debt
securities will be payable, where the debt securities may be
surrendered for registration of transfer or exchange and where
notices and demands to or upon us in respect of the debt
securities and the indenture may be served, and the method of
such payment, if by wire transfer, mail or other means;
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the terms and conditions on which we may redeem the debt
securities;
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any obligations we have to redeem or purchase the debt
securities pursuant to any sinking fund or analogous provisions
or at the option of a holder of debt securities and the date or
dates on which or period or periods within which, the price or
prices at which and the other detailed terms and provisions upon
which the debt securities will be redeemed or purchased pursuant
to such obligations;
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the denominations in which the debt securities will be issued,
if other than denominations of $1,000 and integral multiples
thereof;
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whether the debt securities will be issued as bearer or fully
registered securities and, if they are to be issued as fully
registered securities, whether they will be in the form of
certificated debt securities or global debt securities;
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the portion of principal amount of the debt securities payable
upon acceleration or declaration of acceleration of the maturity
date, if other than the principal amount;
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the currency of denomination of the debt securities;
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the designation of the currency, currencies or currency units in
which payment of principal of and interest on the debt
securities will be made;
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if payments of principal of or interest on the debt securities
will be made in one or more currencies or currency units other
than that or those in which the debt securities are denominated,
the manner in which the exchange rate with respect to these
payments will be determined;
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the terms, if any, of subordination of the debt securities;
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the terms, if any, of any guarantee of the payment of principal
of and interest on the debt securities by any of our
subsidiaries (including the identity of any guarantor), whether
any such guarantee shall be made on a senior or subordinated
basis and, if applicable, a description of the subordination
terms of any such guarantee;
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any provisions relating to any security provided for the debt
securities or any subsidiary guarantees (including any security
to be provided by any subsidiary guarantor);
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any addition to or change in the events of default described in
this prospectus or in the indenture with respect to the debt
securities and any change in the acceleration provisions
described in this prospectus or in the indenture with respect to
the debt securities;
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any addition to or change in the covenants described in this
prospectus or in the indenture with respect to the debt
securities;
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any provisions relating to conversion of any debt securities
into equity interests, including the conversion price and the
conversion period, whether conversion will be mandatory, at the
option of the holders of the debt securities or at our option,
events requiring an adjustment of the conversion price, and
provisions affecting conversion if the debt securities are
redeemed;
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any exchange features of the debt securities;
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whether any underwriter(s) will act as market maker(s) for the
debt securities;
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the extent to which a secondary market for the debt securities
is expected to develop;
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any addition to or change in the provisions relating to
satisfaction and discharge of the indenture described in this
prospectus with respect to the debt securities, or in the
provisions relating to legal defeasance or covenant defeasance
under the indenture described in this prospectus with respect to
the debt securities;
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any addition to or change in the provisions relating to
modification of the indenture both with and without the consent
of holders of debt securities issued under the indenture;
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any other terms or provisions of the debt securities, which may
supplement, modify or delete any provision of the indenture as
it applies to that series; and
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any registrars, paying agents, service agents, depositaries,
interest rate calculation agents, exchange rate calculation
agents or other agents with respect to the debt securities.
(Section 2.02)
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We will provide you with information on the material United
States federal income tax considerations and other special
considerations applicable to any series of debt securities in
the applicable prospectus supplement.
The indenture does not limit our ability to issue convertible or
subordinated debt securities. Any conversion or subordination
provisions of a particular series of debt securities will be set
forth in the resolution of our board of directors, the
officers certificate or supplemental indenture related to
that series of debt securities and will be described in the
relevant prospectus supplement.
We may issue debt securities that provide for an amount less
than their stated principal amount to be due and payable upon
declaration of acceleration of their maturity pursuant to the
terms of the indenture.
One or more series of debt securities may be sold at a discount
to their stated principal amount or may bear no interest or
interest at a rate which at the time of issuance is below market
rates. One or more series of debt securities may be variable
rate debt securities that may be exchanged for fixed rate debt
securities.
Debt securities may be issued where the amount of principal
and/or
interest payable is determined by reference to one or more
currency exchange rates, commodity prices, commodity indices,
stock exchange indices, financial indices, equity indices or
other factors. Holders of such securities may receive a
principal amount or a payment of interest that is greater than
or less than the amount of principal or interest otherwise
payable on such dates, depending upon the value of the
applicable currencies, commodities, commodity indices, stock
exchange indices, financial indices, equity indices or other
factors. Information as to the methods for determining the
amount of principal or interest, if any, payable on any date,
the currencies, commodities, commodity indices, stock exchange
indices, financial indices, equity indices or other factors to
which the amount payable on such date is linked and certain
additional United States federal income tax considerations will
be set forth in the applicable prospectus supplement.
If we denominate the purchase price of any of the debt
securities in a foreign currency or currencies or a foreign
currency unit or units, or if the principal of and interest on
any series of debt securities is payable in a foreign currency
or currencies or a foreign currency unit or units, we will
provide you with information on the restrictions, elections,
general United States federal tax considerations, specific terms
and other information with respect to that issue of debt
securities and such foreign currency or currencies or foreign
currency unit or units in the applicable prospectus supplement.
When we determine to issue debt securities, we will instruct the
trustee to authenticate for issuance such debt securities in a
principal amount that we will provide in a resolution of our
board of directors, in an officers certificate or by a
supplemental indenture. Our instructions may authorize the
trustee to authenticate and deliver such debt securities upon
our oral instructions or the oral instructions of our authorized
agent or agents. (Section 2.03)
Transfer
and Exchange
We expect most debt securities to be issued in denominations of
$1,000 and integral multiples thereof. Each debt security will
be represented by either one or more global securities deposited
with and registered in the name of a depositary to be designated
by us in the applicable prospectus supplement, or a nominee (we
refer to any debt security represented by a global security as a
book-entry debt security), or by a certificate
issued in definitive registered or bearer form (we refer to any
fully registered debt security represented by a certificate as a
registered certificated debt security), as set forth
in the applicable prospectus supplement. Except as set forth
under the heading Global Securities below,
book-entry debt securities will not be issuable in certificated
form.
You may transfer or exchange registered certificated debt
securities at any office we maintain for this purpose in
accordance with the terms of the indenture. No service charge
will be made for any transfer or exchange of registered
certificated debt securities, but we may require payment of a
sum
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sufficient to cover any tax or other governmental charge payable
in connection with a transfer or exchange. (Section 2.07)
You may effect the transfer of registered certificated debt
securities, and the right to receive the principal of and
interest on those registered certificated debt securities, only
by surrendering the certificate representing those registered
certificated debt securities and the issuance by us or the
trustee of a certificate to the new holder. (Section 2.07)
Global
Securities
The debt securities of a series may be issued in whole or in
part in the form of one or more global securities that will be
deposited with, or on behalf of, a depositary (the
depositary) identified in the prospectus supplement.
Global securities will be issued to the depositary in registered
certificated form and in either temporary or definitive form.
Unless and until it is exchanged in whole or in part for the
individual debt securities, a global security may not be
transferred except as a whole by the depositary for such global
security to a nominee of such depositary or by a nominee of such
depositary to such depositary or another nominee of such
depositary or by such depositary or any such nominee to a
successor of such depositary or a nominee of such successor. The
specific terms of the depositary arrangement with respect to any
debt securities of a series and the rights of and limitations
upon owners of beneficial interests in a global security will be
described in the applicable prospectus supplement.
(Section 2.14)
No
Protection in the Event of a Change of Control or a Highly
Leveraged Transaction
Unless we state otherwise in the applicable prospectus
supplement, the debt securities will not contain any provisions
which may afford holders of the debt securities protection in
the event we have a change in control or in the event of a
highly leveraged transaction (whether or not such transaction
results in a change in control) that could adversely affect
holders of debt securities.
Covenants
We will set forth in the applicable prospectus supplement any
restrictive covenants applicable to the particular debt
securities being issued.
Subordination
Debt securities of a series, and any related subsidiary
guarantees, may be subordinated, which we refer to as
subordinated debt securities, to senior indebtedness (as will be
defined in the applicable prospectus supplement) to the extent
set forth in the applicable prospectus supplement.
Consolidation,
Merger and Sale of Assets
We may not consolidate with or merge with or into, or sell,
lease, transfer, convey, or otherwise dispose of or assign all
or substantially all of our properties and assets to, any entity
or enter into a plan of liquidation unless:
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we are the resulting or surviving corporation in such
consolidation or merger or the successor entity in the
transaction (if other than us)(or, in the case of a plan of
liquidation, any entity to which our properties or assets are
transferred), is a corporation organized and validly existing
under the laws of any U.S. domestic jurisdiction and
expressly assumes, by supplemental indenture, our obligations on
the debt securities and under the indenture; and
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immediately after giving effect to the transaction, no event of
default under the indenture, and no event which, after notice or
lapse of time, or both, would become an event of default under
the indenture, shall have occurred and be continuing.
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Notwithstanding the above, any of our subsidiaries may
consolidate with, merge into or transfer all or part of its
properties and assets to us or any of our other subsidiaries.
(Section 5.01)
Events of
Default
An event of default means, with respect to any
series of debt securities, any of the following:
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default in the payment of any interest upon any debt security of
that series when it becomes due and payable, and continuance of
that default for a period of 30 consecutive days;
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default in the payment of principal of any debt security of that
series when and as due and payable;
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default on any obligation to deposit any sinking fund payment
when and due and payable in respect of any debt security of that
series;
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default in the performance or breach of any other covenant or
warranty by us in the indenture or any debt security (other than
a covenant or warranty that has been included in the indenture
solely for the benefit of a series of debt securities other than
that series), which default continues uncured for a period of
60 days after we receive written notice from the trustee or
we and the trustee receive written notice from the holders of
not less than 25% in principal amount of the outstanding debt
securities of that series as provided in the indenture;
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certain events of bankruptcy, insolvency or reorganization with
respect to us; and
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any other event of default provided with respect to debt
securities of that series that is described in the applicable
prospectus supplement. (Section 6.01)
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No event of default with respect to a particular series of debt
securities (except as to certain events of bankruptcy,
insolvency or reorganization) necessarily constitutes an event
of default with respect to any other series of debt securities.
The occurrence of certain events of default or an acceleration
under the indenture may constitute a default under certain of
our other indebtedness outstanding from time to time, as may be
provided in the terms governing that other indebtedness.
If an event of default with respect to debt securities of any
series at the time outstanding occurs and is continuing, then
the trustee or the holders of not less than 25% in principal
amount of the outstanding debt securities of that series may, by
a notice in writing to us (and to the trustee if given by the
holders), declare to be due and payable immediately the
principal of (or, if the debt securities of that series are
discount securities, that portion of the principal amount as may
be specified in the terms of that series) and accrued and unpaid
interest, if any, on all debt securities of that series. In the
case of an event of default resulting from certain events of
bankruptcy, insolvency or reorganization, the principal (or such
specified amount) of and accrued and unpaid interest, if any, on
all outstanding debt securities will become and be immediately
due and payable without any declaration or other act on the part
of the trustee or any holder of outstanding debt securities.
(Section 6.02)
At any time after a declaration of acceleration with respect to
debt securities of any series has been made, but before a
judgment or decree based on the acceleration has been obtained,
the holders of a majority in principal amount of the outstanding
debt securities of that series may rescind and annul the
acceleration if all events of default, other than the
non-payment of accelerated principal and interest, if any, with
respect to debt securities of that series, have been cured or
waived (and certain other conditions have been satisfied) as
provided in the indenture. (Section 6.02) We refer you to
the prospectus supplement relating to any series of debt
securities that are discount securities for the particular
provisions relating to acceleration of a portion of the
principal amount of such discount securities upon the occurrence
of an event of default.
The indenture provides that the trustee will be under no
obligation to exercise any of its rights or powers under the
indenture unless the trustee receives reasonable security or
indemnity satisfactory to it against any cost, expense or
liability. (Section 7.02(f)) Subject to certain rights of
the trustee, the holders
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of a majority in principal amount of the outstanding debt
securities of any series will have the right to direct the time,
method and place of conducting any proceeding for any remedy
available to the trustee or exercising any trust or power
conferred on the trustee with respect to the debt securities of
that series. (Section 6.05)
No holder of any debt security of any series will have any right
to institute any proceeding, judicial or otherwise, with respect
to the indenture or such debt securities for any remedy under
the indenture, unless the trustee for such debt securities:
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has failed to act for a period of 60 days after receiving
notice of a continuing event of default with respect to such
debt securities from such holder and a request to act by holders
of not less than 25% in principal amount of the outstanding debt
securities of that series;
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has been offered indemnity satisfactory to it in its reasonable
judgment; and
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has not received from the holders of a majority in principal
amount of the outstanding debt securities of that series a
direction inconsistent with that request. (Section 6.06)
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Notwithstanding the foregoing, the holder of any debt security
will have an absolute and unconditional right to receive payment
of the principal of and any interest on that debt security on or
after the due dates expressed in that debt security and to
institute suit for the enforcement of payment.
(Section 6.07)
The indenture requires us, within 120 days after the end of
our fiscal year, to furnish to the trustee an officers
certificate as to compliance with the indenture.
(Section 4.04) The indenture provides that the trustee may
withhold notice to the holders of debt securities of any series
of any default (except in payment of the principal of or
interest on any debt securities of that series) with respect to
debt securities of that series if it in good faith determines
that withholding notice is in the interest of the holders of
those debt securities. (Section 7.05)
Modification
and Waiver
Generally, we may amend the indenture with the consent of, and
our compliance with provisions of the indenture may be waved by,
the holders of a majority in principal amount of the outstanding
debt securities of each series affected by the amendment or
waiver. However, we may not make any or amendment without the
consent of, and our compliance with provisions of the indenture
requires the waiver of, each holder of the affected debt
securities if that amendment or waiver would:
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reduce the principal of or change the fixed maturity of any debt
security or reduce the amount of, or postpone the date fixed
for, the payment of any sinking fund or analogous obligation
with respect to any series of debt securities;
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reduce the rate of or extend the time for payment of interest
(including default interest) on any debt security;
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reduce the principal amount of discount securities payable upon
acceleration of maturity;
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waive a redemption payment, or change any of the other
redemption provisions, with respect to any debt security, except
as specifically set forth in the applicable resolution of our
board of directors, the officers certificate or the
supplemental indenture establishing the terms and conditions of
such debt securities;
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make the principal of or interest on any debt security payable
in a currency other than that stated in the debt security;
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waive a default in the payment of the principal of or interest
on any debt security (except a rescission of acceleration of the
debt securities of any series by the holders of a majority in
aggregate principal amount of the then outstanding debt
securities of that series and a waiver of the payment default
that resulted from such acceleration);
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make any change to certain provisions of the indenture relating
to, among other things, the right of holders of debt securities
to receive payment of the principal of and interest on those
debt securities and to institute suit for the enforcement of any
such payment, and certain waivers or amendments;
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if the debt securities of that series are entitled to the
benefit of any guarantee, release any guarantor of such series
other than as provided in the indenture or modify the guarantee
in any manner adverse to the holders; or
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reduce the amount of debt securities whose holders must consent
to an amendment, supplement or waiver. (Section 9.02)
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In addition, the indenture permits us and the trustee to make
certain routine amendments to the indenture without the consent
of any holder of debt securities. (Section 9.01)
Discharge
Our obligations under the indenture will be discharged as to a
series of debt securities when all of the debt securities of
that series have been delivered to the trustee for cancellation
or, alternatively, when the following conditions are met:
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all of the debt securities of that series that have not been
delivered for cancellation have become due and payable, whether
by reason of the mailing of a notice of redemption or otherwise,
or will become due and payable within one year;
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we have deposited with the trustee in trust for the benefit of
the holders of such debt securities funds in an amount
sufficient to pay all of our indebtedness owing on such debt
securities; and
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we or any guarantor of such debt securities have paid all other
amounts due and payable by us under the indenture;
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we have instructed the trustee to apply the deposited money
toward the payment of such debt securities at maturity or on the
date of redemption, as the case may be. (Section 8.01)
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Legal
Defeasance and Covenant Defeasance
The indenture provides that, upon the satisfaction of certain
conditions specified in the indenture:
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we and each guarantor, if any, may be discharged from any and
all obligations in respect of the debt securities of any series
(except for certain obligations to register the transfer or
exchange of debt securities of such series, to replace stolen,
lost or mutilated debt securities of such series, and to
maintain paying agencies and certain provisions relating to the
treatment of funds held by paying agents) (we refer to this
below as legal defeasance); or
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we and each guarantor, if any, may omit to comply with the
covenants set forth in the indenture, as well as any additional
covenants which may be set forth in the applicable prospectus
supplement, and any omission to comply with those covenants will
not constitute a default with respect to the debt securities of
that series (we refer to this below as covenant
defeasance). (Section 8.02)
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The conditions to the legal defeasance or covenant defeasance of
a series of debt securities as described above include:
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depositing with the trustee money
and/or
non-callable obligations guaranteed by the U.S. government
(which we refer to below as U.S. government
obligations) that, through the payment of interest and
principal in accordance with their terms, will provide money in
an amount sufficient in the opinion of a nationally recognized
firm of independent public accountants to pay and discharge each
installment of principal of and interest on, and any mandatory
sinking fund payments in respect of, the debt securities of that
series on the stated
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maturity of those payments in accordance with the terms of the
indenture and those debt securities;
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in the case of legal defeasance, delivering to the trustee an
opinion of counsel confirming that we have received an Internal
Revenue Service tax ruling or that there has been a change in
applicable United States federal income tax law, in either case
to the effect that, and based thereon, the holders of the debt
securities of that series will not recognize income, gain or
loss for United States federal income tax purposes as a result
of the deposit and related legal defeasance and will be subject
to United States federal income tax on the same amounts and in
the same manner and at the same times as would have been in the
case if the deposit and related legal defeasance had not
occurred;
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in the case of covenant defeasance, delivering to the trustee an
opinion of counsel to the effect that the holders of the debt
securities of that series will not recognize income, gain or
loss for United States federal income tax purposes as a result
of the deposit and related covenant defeasance and will be
subject to United States federal income tax on the same amounts
and in the same manner and at the same times as would have been
the case if the deposit and related covenant defeasance had not
occurred;
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there being no continuing default with respect to the debt
securities of that series on the date of deposit of the money
and/or
U.S. government obligations referred to above (other than a
default resulting from the borrowing of funds to be applied to
that deposit);
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the defeasance not resulting in a breach or violation of, or
default under, any of our or our subsidiaries material
agreements (other than any such default resulting solely from
the borrowing of funds to be applied to the deposit referred to
above and the grant of any lien on that deposit in favor of the
trustee
and/or the
holders of the debt securities of that series); and
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delivering to the trustee a certificate stating that the deposit
was not made with the intent of preferring the holders of the
debt securities of that series over any other of our creditors
or with the intent of defeating, hindering, delaying or
defrauding any other of our creditors. (Section 8.03)
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Regarding
the Trustee
The indenture provides that, except during the continuance of an
event of default or any event, act or condition that, after
notice or the passage of time or both, would be an event of
default, the trustee will perform only such duties as are
specifically set forth in the indenture. During the continuance
of an event of default or any event, act or condition that,
after notice or the passage of time or both, would be an event
of default, the trustee will exercise such rights and powers
vested in it under the indenture and use the same degree of care
and skill in its exercise as a prudent person would exercise or
use under the circumstances in the conduct of such persons
own affairs. (Section 7.01)
The indenture and provisions of the Trust Indenture Act
that are incorporated by reference in the indenture contain
limitations on the rights of the trustee, should it become one
of our creditors, to obtain payment of claims in certain cases
or to realize on certain property received by it in respect of
any such claim as security or otherwise. The trustee is
permitted to engage in other transactions with us or any of our
affiliates; provided, however, that if it acquires any
conflicting interest (as defined in the indenture or in the
Trust Indenture Act), it must eliminate such conflict or
resign. (Section 7.10)
Governing
Law
The indenture, the debt securities and any subsidiary guarantees
will be governed by and construed in accordance with the
internal laws of the State of New York. (Section 10.08)
21
DESCRIPTION
OF UNITS WE MAY OFFER
This section outlines some of the provisions of the units and
the unit agreements. This description may not contain all of the
information that is important to you and is qualified in its
entirety by reference to the unit agreement with respect to the
units of any particular series. The specific terms of any series
of units will be described in the applicable prospectus
supplement. If so described in a particular supplement, the
specific terms of any series of units may differ from the
general description of terms presented below.
We may issue units comprised of shares of common stock, shares
of preferred stock, warrants, stock purchase contracts, debt
securities, subsidiary guarantees of debt securities and other
securities in any combination. Each unit will be issued so that
the holder of the unit is also the holder of each security
included in the unit. Thus, the holder of a unit will have the
rights and obligations of a holder of each included security.
The unit agreement under which a unit is issued may provide that
the securities included in the unit may not be held or
transferred separately, at any time or for specified periods.
The applicable prospectus supplement may describe:
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the designation and terms of the units and of the securities
comprising the units, including whether and under what
circumstances those securities may be held or transferred
separately;
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any provisions of the governing unit agreement;
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the price or prices at which such units will be issued;
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the applicable U.S. federal income tax considerations
relating to the units;
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any provisions for the issuance, payment, settlement, transfer
or exchange of the units or of the securities comprising the
units; and
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any other terms of the units and of the securities comprising
the units.
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The provisions described in this section, as well as those
described under Description of Common Stock We May
Offer, Description of Preferred Stock We May
Offer, Description of Warrants We May Offer,
Description of Stock Purchase Contracts We May Offer
and Description of Debt Securities and Subsidiary
Guarantees We May Offer will apply to the securities
included in each unit, to the extent relevant.
Issuance
in Series
We may issue units in such amounts and in as many distinct
series as we wish. This section summarizes terms of the units
that apply generally to all series. Most of the financial and
other specific terms of your series will be described in the
applicable prospectus supplement.
Unit
Agreements
We will issue the units under one or more unit agreements to be
entered into between us and a bank, trust company or other
institution, as unit agent. We may add, replace or terminate
unit agents from time to time. We will identify the unit
agreement under which each series of units will be issued and
the unit agent under that agreement in the applicable prospectus
supplement.
The following provisions will generally apply to all unit
agreements unless otherwise stated in the applicable prospectus
supplement.
Modification Without Consent. We and the
applicable unit agent may amend any unit or unit agreement
without the consent of any holder:
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to cure any ambiguity; any provisions of the governing unit
agreement that differ from those described below;
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to correct or supplement any defective or inconsistent
provision; or
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to make any other change that we believe is necessary or
desirable and will not adversely affect the interests of the
affected holders in any material respect.
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We do not need any approval to make changes that affect only
units to be issued after the changes take effect. We may also
make changes that do not adversely affect a particular unit in
any material respect, even if they adversely affect other units
in a material respect. In those cases, we do not need to obtain
the approval of the holder of the unaffected unit; we need only
obtain any required approvals from the holders of the affected
units.
Modification With Consent. We may not amend
any particular unit or a unit agreement with respect to any
particular unit unless we obtain the consent of the holder of
that unit, if the amendment would:
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impair any right of the holder to exercise or enforce any right
under a security included in the unit if the terms of that
security require the consent of the holder to any changes that
would impair the exercise or enforcement of that right; or
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reduce the percentage of outstanding units or any series or
class the consent of whose holders is required to amend that
series or class, or the applicable unit agreement with respect
to that series or class, as described below.
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Any other change to a particular unit agreement and the units
issued under that agreement would require the following approval:
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If the change affects only the units of a particular series
issued under that agreement, the change must be approved by the
holders of a majority of the outstanding units of that
series; or
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If the change affects the units of more than one series issued
under that agreement, it must be approved by the holders of a
majority of all outstanding units of all series affected by the
change, with the units of all the affected series voting
together as one class for this purpose.
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These provisions regarding changes with majority approval also
apply to changes affecting any securities issued under a unit
agreement, as the governing document.
In each case, the required approval must be given by written
consent.
Unit Agreements Will Not Be Qualified Under
Trust Indenture Act. No unit agreement will
be qualified as an indenture, and no unit agent will be required
to qualify as a trustee, under the Trust Indenture Act.
Therefore, holders of units issued under unit agreements will
not have the protections of the Trust Indenture Act with
respect to their units.
Mergers
and Similar Transactions Permitted; No Restrictive Covenants or
Events of Default
The unit agreements will not restrict our ability to merge or
consolidate with, or sell our assets to, another corporation or
other entity or to engage in any other transactions. If at any
time we merge or consolidate with, or sell our assets
substantially as an entirety to, another corporation or other
entity, the successor entity will succeed to and assume our
obligations under the unit agreements. We will then be relieved
of any further obligation under these agreements.
The unit agreements will not include any restrictions on our
ability to put liens on our assets, including our interests in
our subsidiaries, nor will they restrict our ability to sell our
assets. The unit agreements also will not provide for any events
of default or remedies upon the occurrence of any events of
default.
Form,
Exchange and Transfer
We will issue each unit in global i.e.,
book-entry form only. Units in book-entry form will
be represented by a global security registered in the name of a
depositary, which will be the holder of all
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the units represented by the global security. Those who own
beneficial interests in a unit will do so through participants
in the depositarys system, and the rights of these
indirect owners will be governed solely by the applicable
procedures of the depositary and its participants. We will
describe book-entry securities and other terms regarding the
issuance and registration of the units in the applicable
prospectus supplement.
Each unit and all securities comprising the unit will be issued
in the same form.
If we issue any units in registered, non-global form, the
following will apply to them:
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The units will be issued in the denominations stated in the
applicable prospectus supplement. Holders may exchange their
units for units of smaller denominations or combined into fewer
units of larger denominations, as long as the total amount is
not changed.
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Holders may exchange or transfer their units at the office of
the unit agent. Holders may also replace lost, stolen, destroyed
or mutilated units at that office. We may appoint another entity
to perform these functions or perform them ourselves.
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Holders will not be required to pay a service charge to transfer
or exchange their units, but they may be required to pay for any
tax or other governmental charge associated with the transfer or
exchange. The transfer or exchange, and any replacement, will be
made only if our transfer agent is satisfied with the
holders proof of legal ownership. The transfer agent may
also require an indemnity before replacing any units.
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If we have the right to redeem, accelerate or settle any units
before their maturity, and we exercise our right as to less than
all those units or other securities, we may block the exchange
or transfer of those units during the period beginning
15 days before the day we mail the notice of exercise and
ending on the day of that mailing, in order to freeze the list
of holders to prepare the mailing. We may also refuse to
register transfers of or exchange any unit selected for early
settlement, except that we will continue to permit transfers and
exchanges of the unsettled portion of any unit being partially
settled. We may also block the transfer or exchange of any unit
in this manner if the unit includes securities that are or may
be selected for early settlement.
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Only the depositary will be entitled to transfer or exchange a
unit in global form, since it will be the sole holder of the
unit.
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Payments
and Notices
In making payments and giving notices with respect to our units,
we will follow the procedures as described in the applicable
prospectus supplement.
HOW WE
PLAN TO OFFER AND SELL THE SECURITIES
We may sell the securities in any one or more of the following
ways:
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directly to investors;
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to investors through agents;
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to dealers;
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through a special offering, an exchange distribution or a
secondary distribution in accordance with applicable New York
Stock Exchange or other stock exchange rules;
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through underwriting syndicates led by one or more managing
underwriters; and
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through one or more underwriters acting alone.
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Any underwritten offering may be on a best efforts or a firm
commitment basis. We may also make direct sales through
subscription rights distributed to our stockholders on a pro
rata basis, which may
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or may not be transferable. In any distribution of subscription
rights to stockholders, if all of the underlying securities are
not subscribed for, we may then sell the unsubscribed securities
directly to third parties or may engage the services of one or
more underwriters, dealers or agents, including standby
underwriters, to sell the unsubscribed securities to third
parties.
The distribution of the securities may be effected from time to
time in one or more transactions:
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at a fixed price or prices, which may be changed;
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at market prices prevailing at the time of sale;
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at prices related to such prevailing market prices; or
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at negotiated prices.
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Any of the prices may represent a discount from the prevailing
market prices.
In the sale of the securities, underwriters or agents may
receive compensation from us or from purchasers of the
securities, for whom they may act as agents, in the form of
discounts, concessions or commissions. Underwriters may sell the
securities to or through dealers, and such dealers may receive
compensation in the form of discounts, concessions or
commissions from the underwriters
and/or
commissions from the purchasers for whom they may act as agents.
Underwriters, dealers and agents that participate in the
distribution of the securities may be deemed to be underwriters
under the Securities Act of 1933, and any discounts or
commissions they receive from us and any profit on the resale of
securities they realize may be deemed to be underwriting
discounts and commissions under the Securities Act of 1933. The
applicable prospectus supplement will, where applicable:
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identify any such underwriter or agent;
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describe any compensation in the form of discounts, concessions,
commissions or otherwise received from us by each such
underwriter or agent and in the aggregate to all underwriters
and agents;
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identify the amounts underwritten;
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identify the nature of the underwriters obligation to take
the securities;
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and any other material terms of the offering, including any
over-allotment option.
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Unless otherwise specified in the related prospectus supplement,
each series of securities will be a new issue with no
established trading market, other than the common stock and the
Series B preferred stock, which are listed on the New York
Stock Exchange. Common stock and Series B preferred stock
sold pursuant to a prospectus supplement will be listed on the
New York Stock Exchange, subject to the New York Stock
Exchanges approval of the listing of the additional
shares. We may elect to list other securities on an exchange,
but we are not obligated to do so. It is possible that one or
more underwriters may make a market in a series of securities,
but such underwriters will not be obligated to do so and may
discontinue any market making at any time without notice.
Therefore, no assurance can be given as to the liquidity of, or
the trading market for, any series of securities.
Until the distribution of the securities is completed, rules of
the Securities and Exchange Commission may limit the ability of
any underwriters and selling group members to bid for and
purchase the securities. As an exception to these rules,
underwriters are permitted to engage in some transactions that
stabilize the price of the securities. Such transactions consist
of bids or purchases for the purpose of pegging, fixing or
maintaining the price of the securities.
If any underwriters create a short position in the securities in
an offering in which they sell more securities than are set
forth on the cover page of the applicable prospectus supplement,
the underwriters may reduce that short position by purchasing
the securities in the open market.
The lead underwriters may also impose a penalty bid on other
underwriters and selling group members participating in an
offering. This means that if the lead underwriters purchase
securities in the
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open market to reduce the underwriters short position or
to stabilize the price of the securities, they may reclaim the
amount of any selling concession from the underwriters and
selling group members who sold those securities as part of the
offering.
In general, purchases of a security for the purpose of
stabilization or to reduce a short position could cause the
price of the security to be higher than it might be in the
absence of such purchases. The imposition of a penalty bid might
also have an effect on the price of a security to the extent
that it discourages resales of the security before the
distribution is completed.
We do not make any representation or prediction as to the
direction or magnitude of any effect that the transactions
described above might have on the price of the securities. In
addition, we do not make any representation that underwriters
will engage in such transactions or that such transactions, once
commenced, will not be discontinued without notice.
Under agreements into which we may enter, underwriters, dealers
and agents who participate in the distribution of the securities
may be entitled to indemnification by us against some
liabilities, including liabilities under the Securities Act, or
to contribution from us with respect to such liabilities.
Underwriters, dealers and agents may engage in transactions with
us, perform services for us or be our customers in the ordinary
course of business.
If indicated in the applicable prospectus supplement, we will
authorize underwriters or other persons acting as our agents to
solicit offers by particular institutions to purchase securities
from us at the public offering price set forth in such
prospectus supplement pursuant to delayed delivery contracts
providing for payment and delivery on the date or dates stated
in such prospectus supplement. Each delayed delivery contract
will be for an amount no less than, and the aggregate principal
amounts of securities sold under delayed delivery contracts
shall be not less nor more than, the respective amounts stated
in the applicable prospectus supplement. Institutions with which
such contracts, when authorized, may be made include commercial
and savings banks, insurance companies, pension funds,
investment companies, educational and charitable institutions
and others, but will in all cases be subject to our approval.
The obligations of any purchaser under any such contract will be
subject to the conditions that (a) the purchase of the
securities shall not at the time of delivery be prohibited under
the laws of any jurisdiction in the United States to which the
purchaser is subject, and (b) if the securities are being
sold to underwriters, we shall have sold to the underwriters the
total principal amount of the securities less the principal
amount thereof covered by the contracts. The underwriters and
such other agents will not have any responsibility in respect of
the validity or performance of such contracts.
To comply with applicable state securities laws, the securities
offered by this prospectus will be sold, if necessary, in such
jurisdictions only through registered or licensed brokers or
dealers. In addition, securities may not be sold in some states
unless they have been registered or qualified for sale in the
applicable state or an exemption from the registration or
qualification requirement is available and is complied with.
INCORPORATION
OF DOCUMENTS BY REFERENCE
The Securities and Exchange Commission allows us to
incorporate by reference information into this
prospectus. This means that we can disclose important
information to you by referring you to another document filed
separately with the SEC. The information incorporated by
reference is considered to be a part of this prospectus, except
for any information that is superseded by information that is
included directly in this prospectus or incorporated by
reference subsequent to the date of this prospectus. We do not
incorporate the contents of our website into this prospectus.
This prospectus incorporates by reference the documents listed
below that we have previously filed with the SEC. They
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contain important information about us and our financial
condition. The following documents are incorporated by reference
into this prospectus:
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Our annual report on
Form 10-K/A
for the fiscal year ended December 31, 2008, filed with the
SEC on April 10, 2009;
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Our current report on
Form 8-K
dated February 6, 2009, filed with the SEC on
February 9, 2009;
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Our current report on
Form 8-K
dated March 16, 2009, filed with the SEC on March 20,
2009;
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Our current report on
Form 8-K
dated April 1, 2009, filed with the SEC on April 1,
2009;
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Our current report on
Form 8-K
dated April 30, 2009, filed with the SEC on April 30,
2009;
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Our definitive proxy statement filed with the SEC on
April 30, 2009;
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The description of our common stock contained in the
Registration Statement on Form
8-A, which
was filed on January 5, 2009, and all amendments and
reports updating such description; and
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The description of our Series B convertible perpetual
preferred stock contained in the Registration Statement on
Form 8-A,
which was filed on January 5, 2009, and all amendments and
reports updating such description.
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The following historical audited financial statements of Matria
included in Matrias annual report on
Form 10-K
filed on March 3, 2008, and as amended, are hereby
incorporated by reference:
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Reports of independent registered public accounting firm on
consolidated financial statements dated February 29, 2008;
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Consolidated balance sheet as of December 31, 2007;
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Consolidated statement of operations for the year ended
December 31, 2007;
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Consolidated statement of shareholders equity and
comprehensive earnings (loss) for the year ended
December 31, 2007;
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Consolidated statement of cash flows for the year ended
December 31, 2007; and
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Notes to consolidated financial statements.
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The following historical unaudited financial statements of
Matria included in Matrias quarterly report on
Form 10-Q
filed on May 6, 2008 are hereby incorporated by reference:
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Consolidated condensed balance sheets as of March 31, 2008
and December 31, 2007;
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Consolidated condensed statements of operations for the three
months ended March 31, 2008 and 2007;
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Consolidated condensed statements of cash flows for the three
months ended March 31, 2008 and 2007; and
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Notes to consolidated condensed financial statements.
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The following historical audited financial statements of Biosite
included in Biosites annual report on
Form 10-K
filed on February 26, 2007 are hereby incorporated by
reference:
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Report of independent registered public accounting firm dated
February 23, 2007;
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Consolidated balance sheets as of December 31, 2006 and
2005;
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Consolidated statements of income for the years ended
December 31, 2006, 2005 and 2004;
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27
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Consolidated statements of stockholders equity for the
years ended December 31, 2006, 2005 and 2004;
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Consolidated statements of cash flows for the years ended
December 31, 2006, 2005 and 2004; and
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Notes to consolidated financial statements.
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The following historical unaudited financial statements of
Biosite included in Biosites quarterly report on
Form 10-Q
filed on May 9, 2007 are hereby incorporated by reference:
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Condensed consolidated balance sheets as of March 31, 2007
and December 31, 2006;
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Condensed consolidated statements of income for the three months
ended March 31, 2007 and 2006;
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Condensed consolidated statements of cash flows for the three
months ended March 31, 2007 and 2006; and
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Notes to condensed consolidated financial statements.
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In addition, we incorporate by reference all documents that we
may file with the SEC pursuant to Sections 13(a), 13(c), 14
or 15(d) of the Securities Exchange Act of 1934, as amended, on
or after the date of this prospectus. These documents include
periodic reports, such as annual reports on
Form 10-K,
quarterly reports on
Form 10-Q
and current reports on
Form 8-K
(excluding (a) any information furnished pursuant to
Item 2.02 or Item 7.01, (b) exhibits furnished
pursuant to Item 9.01 in connection with disclosures made
pursuant to Item 2.02 or Item 7.01, and (c) any
information furnished pursuant to Item 8.01 solely for
purposes of satisfying the requirements of Regulation FD
under the Securities Exchange Act of 1934, as amended), as well
as proxy statements. These documents will become a part of this
prospectus from the date that the documents are filed with the
SEC.
Upon oral or written request and at no cost to the requester, we
will provide to each person, including any beneficial owner, to
whom a prospectus is delivered, a copy of any or all of the
information that has been incorporated by reference in this
prospectus but not delivered with this prospectus. All requests
should be made to: Inverness Medical Innovations, Inc., 51
Sawyer Road, Suite 200, Waltham, Massachusetts 02453, Attn:
Corporate Secretary. Telephone requests may be directed to the
Corporate Secretary at
(781) 647-3900.
WHERE YOU
CAN FIND MORE INFORMATION
We are subject to the informational requirements of the
Securities Exchange Act of 1934, as amended, and we are required
to file reports and proxy statements and other information with
the SEC. You may read and copy these reports, proxy statements
and information at the SECs Public Reference Room at
100 F Street, N.E., Washington, D.C. 20549. You
may obtain information on the operation of the Public Reference
Room by calling the SEC at
1-800-SEC-0330.
The SEC maintains a web site that contains reports, proxy and
information statements and other information regarding
registrants, including Inverness Medical Innovations, Inc., that
file electronically with the SEC. You may access the SECs
website at
http://www.sec.gov.
EXPERTS
The consolidated financial statements of our company as of
December 31, 2007 and 2008, and for each of the three years
in the period ended December 31, 2008, and
managements assessment of the effectiveness of internal
control over financial reporting as of December 31, 2008,
incorporated by reference in the prospectus constituting a part
of this registration statement on
Form S-3
have been audited by BDO Seidman, LLP, our independent
registered public accounting firm, to the extent and for the
periods set forth in its report incorporated herein by
reference, and are incorporated herein in reliance upon such
report given upon the authority of said firm as experts in
auditing and accounting.
28
The consolidated financial statements of Biosite Incorporated as
of December 31, 2005 and 2006, and for each of the three
years in the period ended December 31, 2006, incorporated
by reference in the Current Report on
Form 8-K
filed with the SEC on July 2, 2007, as amended on
July 20, 2007, that is referenced in the prospectus
constituting a part of this registration statement on
Form S-3,
have been audited by Ernst & Young LLP, Biosite
Incorporateds independent registered public accounting
firm, as set forth in its report incorporated herein by
reference, and are incorporated herein in reliance upon such
report given on the authority of such firm as experts in
accounting and auditing.
The consolidated financial statements and schedule of Matria
Healthcare, Inc. as of December 31, 2007 and 2006, and for
each of the years in the three-year period ended
December 31, 2007 have been incorporated by reference
herein in reliance upon the reports of KPMG LLP, independent
registered public accounting firm, incorporated by reference
herein, and upon the authority of said firm as experts in
accounting and auditing.
LEGAL
MATTERS
Certain legal matters relating to this prospectus will be passed
upon for us by Foley Hoag LLP.
29
Inverness
Medical Innovations, Inc.
9.00%
Senior Subordinated Notes due 2016
May 7, 2009
Joint
Book-Running Managers
UBS Investment Bank
Goldman, Sachs &
Co.
Banc of America Securities
LLC
Canaccord Adams
Leerink Swann
Stifel Nicolaus