10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934 |
For the quarterly period ended June 30, 2008
|
|
|
o |
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934 |
For the transition period from to
COMMISSION FILE NO. 0-26224
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
(EXACT NAME OF REGISTRANT AS SPECIFIED IN ITS CHARTER)
|
|
|
DELAWARE
|
|
51-0317849 |
(STATE OR OTHER JURISDICTION OF
INCORPORATION OR ORGANIZATION)
|
|
(I.R.S. EMPLOYER
IDENTIFICATION NO.) |
|
|
|
311 ENTERPRISE DRIVE
|
|
08536 |
PLAINSBORO, NEW JERSEY |
|
|
|
|
|
(ADDRESS OF PRINCIPAL
EXECUTIVE OFFICES)
|
|
(ZIP CODE) |
REGISTRANTS TELEPHONE NUMBER, INCLUDING AREA CODE: (609) 275-0500
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
a non-accelerated filer or a smaller reporting company. See the definitions of large accelerated
filer, accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act).
|
|
|
|
|
|
|
Large accelerated filer þ
|
|
Accelerated filer o
|
|
Non-accelerated filer o
|
|
Smaller reporting company o |
|
|
|
|
(Do not check if a smaller reporting company) |
|
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
The number of shares of the registrants Common Stock, $.01 par value, outstanding as of August 7,
2008 was 27,443,469.
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
INDEX
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Total Revenue |
|
$ |
157, 198 |
|
|
$ |
134,767 |
|
|
$ |
313,206 |
|
|
$ |
257,799 |
|
Costs and Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues |
|
|
58,159 |
|
|
|
52,808 |
|
|
|
120,371 |
|
|
|
101,385 |
|
Research and development |
|
|
7,793 |
|
|
|
6,239 |
|
|
|
15,591 |
|
|
|
12,299 |
|
Selling, general and administrative |
|
|
63,475 |
|
|
|
54,980 |
|
|
|
125,964 |
|
|
|
104,085 |
|
Intangible asset amortization |
|
|
2,973 |
|
|
|
3,845 |
|
|
|
5,946 |
|
|
|
6,632 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
132,400 |
|
|
|
117,872 |
|
|
|
267,872 |
|
|
|
224,401 |
|
Operating income |
|
|
24,798 |
|
|
|
16,895 |
|
|
|
45,334 |
|
|
|
33,398 |
|
Interest income |
|
|
444 |
|
|
|
636 |
|
|
|
1,131 |
|
|
|
860 |
|
Interest expense |
|
|
(4,261 |
) |
|
|
(3,273 |
) |
|
|
(8,476 |
) |
|
|
(6,033 |
) |
Other income (expense), net |
|
|
(451 |
) |
|
|
303 |
|
|
|
1,056 |
|
|
|
96 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income taxes |
|
|
20,530 |
|
|
|
14,561 |
|
|
|
39,045 |
|
|
|
28,321 |
|
Income tax expense |
|
|
6,716 |
|
|
|
5,220 |
|
|
|
13,666 |
|
|
|
9,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
13,814 |
|
|
$ |
9,341 |
|
|
$ |
25,379 |
|
|
$ |
18,416 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share |
|
$ |
0.50 |
|
|
$ |
0.33 |
|
|
$ |
0.93 |
|
|
$ |
0.65 |
|
Diluted net income per share |
|
$ |
0.48 |
|
|
$ |
0.31 |
|
|
$ |
0.90 |
|
|
$ |
0.61 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
27,662 |
|
|
|
28,156 |
|
|
|
27,276 |
|
|
|
28,371 |
|
Diluted |
|
|
28,580 |
|
|
|
30,169 |
|
|
|
28,170 |
|
|
|
30,189 |
|
The accompanying notes are an integral part of these condensed consolidated financial statements.
3
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(UNAUDITED)
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008 |
|
|
December 31, 2007 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
77,338 |
|
|
$ |
57,339 |
|
Trade accounts receivable, net of allowances of $7,947 and $7,816 |
|
|
108,126 |
|
|
|
103,539 |
|
Inventories, net |
|
|
149,345 |
|
|
|
144,535 |
|
Deferred tax assets |
|
|
21,214 |
|
|
|
22,254 |
|
Prepaid expenses and other current assets |
|
|
23,538 |
|
|
|
12,264 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
379,561 |
|
|
|
339,931 |
|
|
|
|
|
|
|
|
|
|
Property, plant and equipment, net |
|
|
63,437 |
|
|
|
61,730 |
|
|
|
|
|
|
|
|
|
|
Intangible assets, net |
|
|
188,130 |
|
|
|
195,766 |
|
Goodwill |
|
|
214,478 |
|
|
|
207,438 |
|
Other assets |
|
|
16,848 |
|
|
|
13,147 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
862,454 |
|
|
$ |
818,012 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Borrowings under senior credit facility |
|
$ |
120,000 |
|
|
$ |
|
|
Convertible securities |
|
|
|
|
|
|
119,962 |
|
Deferred revenue |
|
|
2,655 |
|
|
|
2,901 |
|
Accounts payable, trade |
|
|
26,029 |
|
|
|
23,232 |
|
Accrued expenses and other current liabilities |
|
|
40,551 |
|
|
|
45,576 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
189,235 |
|
|
|
191,671 |
|
|
|
|
|
|
|
|
|
|
Long-term convertible securities |
|
|
330,000 |
|
|
|
330,000 |
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities |
|
|
|
|
|
|
16,052 |
|
|
|
|
|
|
|
|
|
|
Other liabilities |
|
|
19,131 |
|
|
|
19,860 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
538,366 |
|
|
|
557,583 |
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity: |
|
|
|
|
|
|
|
|
Common stock; $.01 par value; 60,000 authorized shares; 33,735
and 32,252 issued at June 30, 2008 and December 31, 2007,
respectively |
|
|
337 |
|
|
|
323 |
|
Additional paid-in capital |
|
|
422,178 |
|
|
|
395,266 |
|
Treasury stock, at cost; 6,354 shares at June 30, 2008 and
December 31, 2007 |
|
|
(252,380 |
) |
|
|
(252,380 |
) |
Accumulated other comprehensive income (loss): |
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
32,006 |
|
|
|
19,768 |
|
Pension liability adjustment, net of tax |
|
|
(719 |
) |
|
|
(723 |
) |
Retained earnings |
|
|
122,666 |
|
|
|
98,175 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
324,088 |
|
|
|
260,429 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
862,454 |
|
|
$ |
818,012 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements
4
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net income |
|
$ |
25,379 |
|
|
$ |
18,416 |
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net income to net cash provided by
operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
14,044 |
|
|
|
13,196 |
|
Deferred income tax benefit |
|
|
(1,709 |
) |
|
|
(3,000 |
) |
Amortization of bond issuance costs |
|
|
1,218 |
|
|
|
237 |
|
Gain on sale of assets |
|
|
|
|
|
|
(133 |
) |
Share-based compensation |
|
|
7,078 |
|
|
|
7,182 |
|
Excess tax benefits from stock-based compensation arrangements |
|
|
(659 |
) |
|
|
(389 |
) |
Other, net |
|
|
18 |
|
|
|
228 |
|
Changes in assets and liabilities, net of business acquisitions: |
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(3,262 |
) |
|
|
(4,069 |
) |
Inventories |
|
|
(5,437 |
) |
|
|
(9,832 |
) |
Prepaid expenses and other current assets |
|
|
(13,387 |
) |
|
|
1,926 |
|
Other non-current assets |
|
|
(1,185 |
) |
|
|
4,198 |
|
Accounts payable, accrued expenses and other current liabilities |
|
|
(4,052 |
) |
|
|
1,466 |
|
Income taxes payable |
|
|
|
|
|
|
(878 |
) |
Deferred revenue |
|
|
(135 |
) |
|
|
(1,542 |
) |
Other liabilities |
|
|
460 |
|
|
|
(5,245 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
18,371 |
|
|
|
21,761 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash used in business acquisition, net of cash acquired |
|
|
(33 |
) |
|
|
(36,055 |
) |
Proceeds from sale of assets |
|
|
|
|
|
|
371 |
|
Purchases of property and equipment |
|
|
(6,103 |
) |
|
|
(11,066 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in investing activities |
|
|
(6,136 |
) |
|
|
(46,750 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Borrowings under senior credit facility |
|
|
120,000 |
|
|
|
75,000 |
|
Repayment of loans and credit facility |
|
|
(119,558 |
) |
|
|
(175,053 |
) |
Proceeds from issuance of convertible notes |
|
|
|
|
|
|
330,000 |
|
Proceeds from sale of stock purchase warrants |
|
|
|
|
|
|
21,662 |
|
Purchase option hedge on convertible notes |
|
|
|
|
|
|
(46,771 |
) |
Convertible note issuance costs |
|
|
|
|
|
|
(9,160 |
) |
Proceeds from exercised stock options |
|
|
3,628 |
|
|
|
11,837 |
|
Excess tax benefits from stock-based compensation arrangements |
|
|
659 |
|
|
|
389 |
|
Purchases of treasury stock |
|
|
|
|
|
|
(86,069 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
4,729 |
|
|
|
121,835 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents |
|
|
3,035 |
|
|
|
1,295 |
|
|
|
|
|
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
19,999 |
|
|
|
98,141 |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at beginning of period |
|
|
57,339 |
|
|
|
22,697 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
77,338 |
|
|
$ |
120,838 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed consolidated financial statements
5
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. BASIS OF PRESENTATION
General
The terms we, our, us, Company and Integra refer to Integra LifeSciences Holdings
Corporation, a Delaware corporation, and its subsidiaries unless the context suggests otherwise.
In the opinion of management, the June 30, 2008 unaudited condensed consolidated financial
statements contain all adjustments necessary for a fair statement of the financial position,
results of operations and cash flows of the Company. Certain information and footnote disclosures
normally included in financial statements prepared in accordance with generally accepted accounting
principles have been condensed or omitted in accordance with the instructions to Form 10-Q and Rule
10-01 of Regulation S-X. These unaudited condensed consolidated financial statements should be read
in conjunction with the Companys consolidated financial statements for the year ended December 31,
2007 included in the Companys Annual Report on Form 10-K. The December 31, 2007 condensed
consolidated balance sheet was derived from audited financial statements but does not include all
disclosures required by accounting principles generally accepted in the United States. Operating
results for the six-month period ended June 30, 2008 are not necessarily indicative of the results
to be expected for the entire year.
The preparation of consolidated financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates and assumptions that
affect the reported amount of assets and liabilities, the disclosure of contingent liabilities and
the reported amounts of revenues and expenses. Significant estimates affecting amounts reported or
disclosed in the consolidated financial statements include allowances for doubtful accounts
receivable and sales returns and allowances, net realizable value of inventories, estimates of
future cash flows associated with long-lived asset valuations, depreciation and amortization
periods for long-lived assets, fair value estimates of stock-based compensation awards, valuation
allowances recorded against deferred tax assets, estimates of amounts to be paid to employees and
other exit costs to be incurred in connection with the restructuring of our operations and loss
contingencies. These estimates are based on historical experience and on various other assumptions
that management believes to be reasonable under the current circumstances. Actual results could
differ from these estimates.
Certain reclassifications have been made to the prior year financial statements to conform to
the current year presentation.
Recently Adopted Accounting Standards
Effective January 1, 2008, the Company adopted Statement of Financial Accounting Standards No.
159 The Fair Value Option for Financial Assets and Financial Liabilities (SFAS 159). SFAS 159
provides companies an option to report certain financial assets and liabilities at fair value and
established presentation and disclosure requirements. The intent of SFAS 159 is to reduce the
complexity in accounting for financial instruments and the volatility in earnings caused by
measuring related assets and liabilities differently. The Company chose not to elect the fair value
option for its financial assets and liabilities existing at January 1, 2008, and did not elect the
fair value option on financial assets and liabilities transacted during the six months ended June
30, 2008. Therefore, the adoption of SFAS 159 had no impact on the Companys consolidated financial
statements.
Effective January 1, 2008, the Company adopted Statement of Financial Accounting Standards No.
157 Fair Value Measurements (SFAS 157) for our financial assets and liabilities that are
remeasured and reported at fair value at least annually. SFAS 157 defines fair value as the
exchange price that would be received for an asset or paid to transfer a liability (an exit price)
in the principal or most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. As of June 30, 2008, the Company does not have
any assets measured at fair value. The adoption of SFAS 157 to our financial assets and
liabilities and non-financial assets and liabilities that are remeasured and reported at fair value
at least annually did not have any impact on our financial results.
6
In accordance with the provisions of FSP No. FAS 157-2 Effective Date of Financial
Accounting Standards Statement No. 157, the Company has elected to defer implementation of SFAS 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 nonrecurring basis until January 1, 2009.
We are evaluating the impact, if any, SFAS 157 will have on our non-financial assets and
liabilities.
Recently Issued Accounting Standards
In May 2008, the Financial Accounting Standards Board (FASB) issued Staff Position No. APB
14-1, Accounting for Convertible Debt Instruments that May be Settled in Cash Upon Conversion (FSP
APB 14-1). FSP APB 14-1 requires that the liability and equity components of convertible debt
instruments that may be settled in cash upon conversion (including partial cash settlement) be
separately accounted for in a manner that reflects an issuers nonconvertible debt borrowing rate.
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, however, early adoption is not permitted. Retrospective application to all periods presented is required except for instruments that
were not outstanding during any of the periods that will be presented in the annual financial
statements for the period of adoption but were outstanding during an earlier period. We are
currently assessing the impact of adopting FSP APB 14-1, which we believe will be material to our
results of operations.
In March 2008, the FASB issued Statement No. 161, Disclosures about Derivative Instruments and
Hedging Activities (FAS 161), which is effective January 1, 2009. FAS 161 requires enhanced
disclosures about derivative instruments and hedging activities to allow for a better understanding
of their effects on an entitys financial position, financial performance, and cash flows. Among
other things, FAS 161 requires disclosure of the fair values of derivative instruments and
associated gains and losses in a tabular format. Since FAS 161 requires only additional disclosures
about our derivatives and hedging activities, the adoption of FAS 161 is not expected to affect our
financial position or results of operations.
In December 2007, the FASB issued Statement No. 141(R), Business Combinations (Statement
141(R)), a replacement of FASB Statement No. 141. Statement 141(R) is effective for fiscal years
beginning on or after December 15, 2008 and applies to all business combinations. Statement 141(R)
provides that, upon initially obtaining control of a target, an acquirer shall recognize 100% of
the fair values of acquired assets, including goodwill, and assumed liabilities, with only limited
exceptions, even if the acquirer has not acquired 100% of the target. Additionally, Statement
141(R) changes current practice, in part, as follows: (1) contingent consideration arrangements
will be fair valued at the acquisition date and included on that basis in the purchase price
consideration; (2) transaction costs will be expensed as incurred, rather than capitalized as part
of the purchase price; (3) pre-acquisition contingencies, such as legal issues, will generally have
to be accounted for in purchase accounting at fair value; and (4) in order to accrue for a
restructuring plan in purchase accounting, the requirements in FASB Statement No. 146, Accounting
for Costs Associated with Exit or Disposal Activities, would have to be met at the acquisition
date. While there is no expected material impact to our consolidated financial statements on the
accounting for acquisitions completed prior to December 31, 2008, the adoption of Statement 141(R)
on January 1, 2009 could materially change the accounting for business combinations consummated
subsequent to that date.
In April 2008, the FASB issued FASB Staff Position (FSP) FAS 142-3, Determination of the
Useful Life of Intangible Assets. This FSP 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 142, Goodwill and Other Intangible Assets. The intent of this FSP is
to improve the consistency between the useful life of a recognized intangible asset under SFAS 142
and the period of expected cash flows used to measure the fair value of the asset under SFAS 141R,
and other generally accepted accounting principles (GAAP). This FSP is effective for fiscal
years beginning after December 15, 2008. Early adoption is prohibited. The Company is required to
adopt FSP, FAS142-3 for the fiscal year beginning January 1, 2009. Management does not anticipate
that the adoption of this FSP will have a material impact on the Companys financial statements.
In May 2008, the FASB issued Statement of Financial Accounting Standards No. 162 (SFAS 162),
The Hierarchy of Generally Accepted Accounting Principles. SFAS 162 identifies the sources of
accounting principles and the framework for selecting the principles used in the
7
preparation of financial statements
of nongovernmental entities that are presented in conformity with GAAP in the United States. Any
effect of applying the provisions of SFAS 162 shall
be reported as a change in accounting principle in accordance with Statement of Financial Accounting Standards No. 154, Accounting Changes and
Error Corrections. SFAS 162 is effective 60 days following approval by the Securities and Exchange
Commission of the Public Company Accounting Oversight Board amendments to AU Section 411, The
Meaning of Present Fairly in Conformity with Generally Accepted
Accounting Principles. Management does not anticipate that the adoption of SFAS 162 will have a material impact on
the Companys financial statements.
In June 2008, the FASB issued Staff Position EITF 03-6-1, Determining Whether Instruments
Granted in Share-Based Payment Transactions Are Participating Securities (FSP EITF 03-6-1), which
is effective January 1, 2009. FSP EITF 03-6-1 clarifies that share-based payment awards that
entitle holders to receive nonforfeitable dividends before they vest will be considered
participating securities and included in the basic earnings per share calculation. The Company is
assessing the impact of adoption of FSP EITF 03-6-1 on its results of operations.
2. BUSINESS ACQUISITIONS
Precise Dental
In December 2007 we acquired all of the outstanding stock of the Precise Dental family of
companies (Precise) for $10.5 million in cash, subject to certain adjustments, and acquisition
expenses of $292,000. The Precise Dental family of companies develop, manufacture, procure, market
and sell endodontic materials and dental accessories, including the manufacture of absorbable paper
points, gutta percha and dental mirrors. Together these companies have procurement and distribution
operations in Canoga Park, California and manufacturing operations at multiple locations in Mexico.
The following summarizes the preliminary allocation of the purchase price based on fair value
of the assets acquired and liabilities assumed (in thousands):
|
|
|
|
|
|
|
Cash |
|
$ |
25 |
|
|
|
Inventory |
|
|
3,243 |
|
|
|
Accounts receivable |
|
|
820 |
|
|
|
Other current assets |
|
|
65 |
|
|
|
Property, plant and equipment |
|
|
603 |
|
|
|
Other assets |
|
|
10 |
|
|
|
Intangible assets: |
|
|
|
|
|
Wtd. Avg. Life |
Technology |
|
|
421 |
|
|
15 years |
Customer relationships |
|
|
2,971 |
|
|
15 years |
Noncompetition agreements |
|
|
100 |
|
|
5 years |
Trade name |
|
|
142 |
|
|
20 years |
Goodwill |
|
|
4,590 |
|
|
|
|
|
|
|
|
|
Total assets acquired |
|
|
12,990 |
|
|
|
|
|
|
|
|
|
Accounts payable and other current liabilities |
|
|
573 |
|
|
|
Deferred tax liability |
|
|
1,625 |
|
|
|
|
|
|
|
|
|
Total liabilities assumed |
|
|
2,198 |
|
|
|
|
|
|
|
|
|
Net assets acquired |
|
$ |
10,792 |
|
|
|
|
|
|
|
|
|
Management determined the preliminary fair value of assets acquired during the fourth quarter
2007. The goodwill recorded in connection with this acquisition is based on the benefits the
Company expects to generate from Precises future cash flows. Certain elements of the purchase
price allocation are considered preliminary, particularly as they relate to the final valuation of
certain identifiable intangible assets and deferred income taxes. Additional changes are not
expected to be significant as the allocations are finalized.
8
IsoTis, Inc.
In October 2007, we acquired all of the outstanding stock of IsoTis, Inc. and subsidiaries
(IsoTis) for $64.0 million in cash, subject to certain adjustments, and acquisition expenses of
$4.7 million. IsoTis is based in Irvine, California. IsoTis develops, manufactures and markets
proprietary products for the treatment of musculoskeletal diseases and disorders. IsoTis current
orthobiologics products are bone graft substitutes that promote the regeneration of bone and are
used to repair natural, trauma-related and surgically-created defects common in orthopedic
procedures, including spinal fusions.
The following summarizes the preliminary purchase price based on the fair value of the assets
acquired and liabilities assumed (in thousands):
|
|
|
|
|
|
|
Cash |
|
$ |
10,666 |
|
|
|
Inventory |
|
|
17,796 |
|
|
|
Other current assets |
|
|
10,502 |
|
|
|
Property and equipment, net |
|
|
3,841 |
|
|
|
Intangible assets: |
|
|
|
|
|
Wtd. Avg. Life |
Developed product technology Generation I |
|
|
3,400 |
|
|
10 years |
Developed product technology Generation II |
|
|
11,000 |
|
|
15 years |
In-process research and development |
|
|
4,600 |
|
|
Expensed immediately |
Goodwill |
|
|
27,848 |
|
|
|
Other assets |
|
|
500 |
|
|
|
|
|
|
|
|
|
Total assets acquired |
|
|
90,153 |
|
|
|
|
|
|
|
|
|
Current liabilities |
|
|
16,232 |
|
|
|
Deferred revenue and other liabilities |
|
|
5,256 |
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
21,488 |
|
|
|
|
|
|
|
|
|
Net assets acquired |
|
$ |
68,665 |
|
|
|
|
|
|
|
|
|
Management determined the preliminary fair value of assets acquired during the fourth quarter
2007. The in-process research and development has not yet reached technological feasibility and has
no alternative future use at the date of acquisition. The Company recorded an in-process research
and development charge of $4.6 million in the fourth quarter of 2007 in connection with this
acquisition, which was included in research and development expense. The goodwill recorded in
connection with this acquisition is based on the benefits the Company expects to generate from
IsoTis future cash flows. Certain elements of the purchase price allocation are considered
preliminary, particularly as they relate to the final valuation of certain identifiable intangible
assets, deferred taxes and final assessment of certain pre-acquisition tax and other contingencies.
Additional changes are not expected to be significant as the allocations are finalized.
Physician Industries
In May 2007, we acquired certain assets of the pain management business of Physician
Industries, Inc. (Physician Industries) for approximately $4.0 million in cash, subject to
certain adjustments, and acquisition expenses of $74,000. In addition, we may pay additional
amounts over the next four years depending on the performance of the business. Physician
Industries, located in Salt Lake City, Utah, assembles, markets, and sells a comprehensive line of
pain management products for acute and chronic pain, including customized trays for spinal,
epidural, nerve block, and biopsy procedures.
LXU Healthcare, Inc.
In May 2007, we acquired the shares of LXU Healthcare, Inc. (LXU) for $30.0 million in cash
paid at closing and $0.5 million of acquisition-related expenses. LXU is operated as part of our
surgical instruments business.
9
DenLite
On January 3, 2007, the Companys subsidiary Miltex, Inc. acquired the DenLite product line
from Welch Allyn in an asset purchase for $2.2 million in cash paid at closing and $35,000 of
acquisition-related expenses. This transaction was treated as a business combination. DenLite is a
lighted mouth mirror used in dental procedures.
The following unaudited pro forma financial information summarizes the results of operations
for the three months and six months ended June 30, 2007 as if the acquisitions completed by the
Company during 2007 had been completed as of the beginning of 2007. The pro forma results are based
upon certain assumptions and estimates, and they give effect to actual operating results prior to
the acquisitions and adjustments to reflect increased interest expense, depreciation expense,
intangible asset amortization, and income taxes at a rate consistent with the Companys statutory
rate. No effect has been given to cost reductions or operating synergies. As a result, these pro
forma results do not necessarily represent results that would have occurred if the acquisitions had
taken place on the basis assumed above, nor are they indicative of the results of future combined
operations.
|
|
|
|
|
|
|
|
|
|
|
Three Months |
|
Six Months |
|
|
Ended June 30, |
|
Ended June 30, |
(in thousands, except per share amounts) |
|
2007 |
|
2007 |
Total Revenue |
|
$ |
154,294 |
|
|
$ |
302,097 |
|
Net income |
|
$ |
8,689 |
|
|
$ |
11,693 |
|
Net income per share: Basic |
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.30 |
|
|
$ |
0.41 |
|
Diluted |
|
$ |
0.29 |
|
|
$ |
0.39 |
|
3. INVENTORIES
Inventories, net consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
June 30, 2008 |
|
|
December 31, 2007 |
|
|
|
(In thousands) |
|
Finished goods |
|
$ |
102,528 |
|
|
$ |
103,172 |
|
Work in process |
|
|
30,566 |
|
|
|
27,812 |
|
Raw materials |
|
|
41,350 |
|
|
|
37,639 |
|
Less reserves |
|
|
(25,099 |
) |
|
|
(24,088 |
) |
|
|
|
|
|
|
|
|
|
$ |
149,345 |
|
|
$ |
144,535 |
|
|
|
|
|
|
|
|
4. GOODWILL AND OTHER INTANGIBLE ASSETS
Changes in the carrying amount of goodwill for the six months ended June 30, 2008, were as
follows:
|
|
|
|
|
Balance at December 31, 2007 |
|
$ |
207,438 |
|
Purchase price allocation adjustments |
|
|
2,023 |
|
Foreign currency translation |
|
|
5,017 |
|
|
|
|
|
Balance at June 30, 2008 |
|
$ |
214,478 |
|
|
|
|
|
The Companys assessment of the recoverability of goodwill is based upon a comparison of the
carrying value of goodwill with its estimated fair value, determined using a discounted cash flow
methodology. This test was performed during the second quarter 2008 and resulted in no impairment
for any of the periods presented.
10
The components of the Companys identifiable intangible assets were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
June 30, 2008 |
|
|
December 31, 2007 |
|
|
|
Average |
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Life |
|
Cost |
|
|
Amortization |
|
|
Net |
|
|
Cost |
|
|
Amortization |
|
|
Net |
|
Completed technology |
|
13 years |
|
$ |
52,086 |
|
|
$ |
(14,008 |
) |
|
$ |
38,078 |
|
|
$ |
51,673 |
|
|
$ |
(11,663 |
) |
|
$ |
40,010 |
|
Customer relationships |
|
12 years |
|
|
76,110 |
|
|
|
(21,762 |
) |
|
|
54,348 |
|
|
|
75,719 |
|
|
|
(17,548 |
) |
|
|
58,171 |
|
Trademarks/brand names |
|
34 years |
|
|
36,082 |
|
|
|
(5,934 |
) |
|
|
30,148 |
|
|
|
36,069 |
|
|
|
(5,202 |
) |
|
|
30,867 |
|
Trademarks/brand names |
|
Indefinite |
|
|
36,300 |
|
|
|
|
|
|
|
36,300 |
|
|
|
36,300 |
|
|
|
|
|
|
|
36,300 |
|
Noncompetition agreement |
|
5 years |
|
|
6,559 |
|
|
|
(5,167 |
) |
|
|
1,392 |
|
|
|
6,504 |
|
|
|
(4,486 |
) |
|
|
2,018 |
|
Supplier relationships |
|
30 years |
|
|
29,300 |
|
|
|
(2,080 |
) |
|
|
27,220 |
|
|
|
29,300 |
|
|
|
(1,595 |
) |
|
|
27,705 |
|
All other |
|
15 years |
|
|
1,531 |
|
|
|
(887 |
) |
|
|
644 |
|
|
|
1,531 |
|
|
|
(836 |
) |
|
|
695 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
237,968 |
|
|
$ |
(49,838 |
) |
|
$ |
188,130 |
|
|
$ |
237,096 |
|
|
$ |
(41,330 |
) |
|
$ |
195,766 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Annual amortization expense is expected to approximate $16.6 million in 2008, $15.2 million in
2009, $13.4 million in 2010, $13.3 million in 2011, and $12.6 million in 2012. Identifiable
intangible assets are initially recorded at fair market value at the time of acquisition generally
using an income or cost approach.
5. RESTRUCTURING ACTIVITIES
In connection with the IsoTis acquisition, the Company announced plans to restructure the
Companys European operations. The restructuring plan includes closing the IsoTis facilities in
Lausanne, Switzerland and Bilthoven, Netherlands, eliminating various positions in Europe and
reducing various duplicative positions in Irvine, California.
In connection with the Precise acquisition the Company announced plans to restructure the
Companys procurement and distribution operations by closing the Precise facility in Canoga Park,
California. The Company will integrate the procurement and distribution operations into its York,
Pennsylvania dental operations.
In connection with these restructuring activities, the Company has recorded the following
charges during the three and six months ended June 30, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling |
|
|
|
|
|
|
|
|
Research and |
|
General and |
|
|
|
|
Cost of Sales |
|
Development |
|
Administrative |
|
Total |
Involuntary employee termination costs: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, 2008 |
|
$ |
|
|
|
$ |
|
|
|
$ |
12 |
|
|
$ |
12 |
|
Six months ended June 30, 2008 |
|
$ |
(47 |
) |
|
$ |
|
|
|
$ |
25 |
|
|
$ |
(22 |
) |
Facility exit costs: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, 2008 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Six months ended June 30, 2008 |
|
$ |
129 |
|
|
$ |
|
|
|
$ |
234 |
|
|
$ |
363 |
|
11
The Company recorded net reversals of previously recorded provisions based on the final
settlement of those obligations during the second quarter. Below is a reconciliation of the
restructuring accrual activity recorded through June 30, 2008 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee |
|
|
Facility |
|
|
|
|
|
|
Termination |
|
|
Exit |
|
|
|
|
|
|
Costs |
|
|
Costs |
|
|
Total |
|
Balance at December 31, 2007 |
|
$ |
615 |
|
|
$ |
625 |
|
|
$ |
1,240 |
|
Additions |
|
|
98 |
|
|
|
219 |
|
|
|
317 |
|
Change in estimate |
|
|
(120 |
) |
|
|
144 |
|
|
|
24 |
|
Payments |
|
|
(145 |
) |
|
|
(685 |
) |
|
|
(830 |
) |
Acquired through acquisitions |
|
|
|
|
|
|
|
|
|
|
|
|
Effects of foreign exchange |
|
|
6 |
|
|
|
|
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2008 |
|
$ |
454 |
|
|
$ |
303 |
|
|
$ |
757 |
|
|
|
|
|
|
|
|
|
|
|
The Company expects to pay all of the remaining employee termination costs by the end of 2008.
6. DEBT
2008 Contingent Convertible Subordinated
The Company was required to make interest payments on its $120 million contingent convertible
subordinated notes (the 2008 Notes) at an annual rate of 2.5% each September 15 and March 15. The
Company paid contingent interest on the 2008 Notes approximating $1.8 million during the quarter
ended March 31, 2008. The contingent interest paid was for each of the last three years the 2008
Notes remained outstanding in an amount equal to the greater of (1) 0.50% of the face amount of the
2008 Notes and (2) the amount of regular cash dividends paid during each such year on the number of
shares of common stock into which each 2008 Note was convertible. Holders of the 2008 Notes could
convert the 2008 Notes under certain circumstances, including when the market price of its common
stock on the previous trading day was more than $37.56 per share, based on an initial conversion
price of $34.15 per share. As of June 30, 2008, all of the 2008 Notes had been converted to common
stock or cash.
The 2008 Notes were general, unsecured obligations of the Company and were subordinate to any
senior indebtedness. The Company could not redeem the 2008 Notes prior to their maturity, and the
2008 Notes holders could have compelled the Company to repurchase the 2008 Notes upon a change of
control. On March 5, 2008 the Company borrowed $120 million under its senior secured revolving
credit facility. The Company used these funds to repay the 2008 Notes upon conversion or maturity.
As a result of the conversions, the Company issued 768,221 shares of the Companys common stock.
There were no financial covenants associated with the convertible 2008 Notes.
In conjunction with the 2008 Notes, the Company had previously recognized a deferred tax
liability related to the conversion feature of the debt. As a result of the repayment of the 2008
Notes, the Company reversed the remaining balance of the deferred tax liability which resulted in
the recognition of a $2.4 million valuation allowance on a deferred tax asset, a $4.8 million
increase to current income taxes payable and $11.4 million of additional paid-in capital for the
six months ended June 30, 2008.
2010 and 2012 Senior Convertible Notes
On June 11, 2007, the Company issued $165 million aggregate principal amount of its 2.75%
Senior Convertible Notes due 2010 (the 2010 Notes) and $165 million aggregate principal amount of
its 2.375% Senior Convertible Notes due 2012 (the 2012 Notes and together with the 2010 Notes,
the Notes). The 2010 Notes and the 2012 Notes bear interest at a rate of 2.75% per annum and
2.375% per annum, respectively, in each case payable semi-annually in arrears on December 1 and
June 1 of each year. The fair value of the 2010 Notes and the 2012 Notes at June 30, 2008 was
approximately $164.8 million and $160.2 million, respectively. The Notes are senior, unsecured
obligations of the Company, and are convertible into cash and, if applicable, shares of its common
stock based on an initial conversion rate, subject to adjustment, of 15.0917 shares per $1,000
principal amount of notes for the 2010 Notes and 15.3935 shares per $1,000 principal amount of
12
notes for
the 2012 Notes (which represents an initial conversion price of approximately $66.26 per share and approximately
$64.96 per share for the 2010 Notes and the 2012 Notes, respectively.) The Company will satisfy any
conversion of the Notes with cash up to the principal amount of the applicable series of the Notes
pursuant to the net share settlement mechanism set forth in the applicable indenture and, with
respect to any excess conversion value, with shares of the Companys common stock. The Notes are
convertible only in the following circumstances: (1) if the closing sale price of the Companys
common stock exceeds 130% of the conversion price during a period as defined in the applicable
indenture; (2) if the average trading price per $1,000 principal amount of the Notes is less than
or equal to 97% of the average conversion value of the Notes during a period as defined in the
applicable indenture; (3) at any time on or after December 15, 2009 (with respect to the 2010
Notes) or anytime after December 15, 2011 (with respect to the 2012 Notes); or (4) if specified
corporate transactions occur. The issue price of the Notes was equal to their face amount, which is
also the amount holders are entitled to receive at maturity if the Notes are not converted. As of
June 30, 2008, none of these conditions existed and, as a result, the $330 million balance of the
2010 Notes and the 2012 Notes is classified as long-term.
Holders of the Notes, who convert their notes in connection with a qualifying fundamental
change, as defined in the applicable indenture, may be entitled to a make-whole premium in the form
of an increase in the conversion rate. Additionally, following the occurrence of a fundamental
change, holders may require that the Company repurchase some or all of the Notes for cash at a
repurchase price equal to 100% of the principal amount of the notes being repurchased, plus accrued
and unpaid interest, if any.
The Notes, under the terms of the private placement agreement, are guaranteed fully by Integra
LifeSciences Corporation, a subsidiary of the Company. The 2010 Notes rank equal in right of
payment to the 2012 Notes. The Notes will be the Companys direct senior unsecured obligations and
rank equal in right of payment to all of the Companys existing and future unsecured and
unsubordinated indebtedness.
In connection with the issuance of the Notes, the Company entered into call transactions and
warrant transactions, primarily with affiliates of the initial purchasers of the Notes (the hedge
participants). The cost of the call transactions to the Company was approximately $46.8 million.
The Company received approximately $21.7 million of proceeds from the warrant transactions. The
call transactions involve the Companys purchasing call options from the hedge participants, and
the warrant transactions involve the Companys selling call options to the hedge participants with
a higher strike price than the purchased call options.
The initial strike price of the call transactions is (1) for the 2010 Notes, approximately
$66.26 per share of Common Stock, and (2) for the 2012 Notes, approximately $64.96, in each case
subject to anti-dilution adjustments substantially similar to those in the Notes. The initial
strike price of the warrant transactions is (x) for the 2010 Notes, approximately $77.96 per share
of Common Stock and (y) for the 2012 Notes, approximately $90.95, in each case subject to customary
anti-dilution adjustments, substantially similar to those in the Notes.
Senior Secured Revolving Credit Facility
On March 5, 2008, the Company borrowed $120.0 million under its $300 million five-year senior
secured revolving credit facility and as of June 30, 2008 had $120.0 million of outstanding
borrowings under this credit facility. The outstanding borrowings have one-month interest periods.
The weighted average interest rate of the outstanding borrowings is approximately 3.46%. The
Company used a portion of these borrowings to repay approximately $3.3 million of related accrued
and contingent interest during the month of March 2008. The remaining proceeds from this borrowing
along with existing funds (for an aggregate amount of approximately $119.4 million) were used to
repay the 2008 Notes in the second quarter of 2008. The Company regularly borrows under the credit
facility and makes payments each month with respect thereto and considers such outstanding amounts
to be short-term in nature based on its current intent. If additional borrowings are made in
connection with, for instance, future acquisitions, this could impact the timing of when the
Company intends to repay amounts under this credit facility which runs through December 2011.
13
7. STOCK-BASED COMPENSATION
As of June 30, 2008, the Company had stock options, restricted stock awards, performance stock
awards, contract stock awards and restricted stock unit awards outstanding under seven plans: (i)
the 1993 Incentive Stock Option and Non-Qualified Stock Option Plan (the 1993 Plan), (ii) the
1996 Incentive Stock Option and Non-Qualified Stock Option Plan (the 1996 Plan), (iii) the 1998
Stock Option Plan (the 1998 Plan), (iv) the 1999 Stock Option Plan (the 1999 Plan), (v) the
2000 Equity Incentive Plan (the 2000 Plan), (vi) the 2001 Equity Incentive Plan (the 2001
Plan), and (vii) the 2003 Equity Incentive Plan (the 2003 Plan, and collectively, the Plans).
No awards may be granted under the 1993 Plan or the 1996 Plan.
Stock options issued under the Plans become exercisable over specified periods, generally
within four years from the date of grant for officers, employees and consultants, and generally
expire six years from the grant date. The transfer and non-forfeiture provisions of restricted
stock issued under the Plans lapse over specified periods, generally three years after the date of
grant.
Stock Options
The Company did not grant any stock options during the six months ended June 30, 2008 and June
30, 2007. As of June 30, 2008, there were approximately $9.2 million of total unrecognized
compensation costs related to unvested stock options. These costs were expected to be recognized
over a weighted-average period of approximately 2.2 years. The
Company was entitled to receive proceeds of $4.1
million and $11.8 million from stock option exercises for the six months ended June 30, 2008 and
2007, respectively.
During the three months ended June 30, 2008, the Company identified certain options that had
previously been granted to individuals who are not considered employees and had not been accounted
for under the guidance prescribed in EITF 96-18, Accounting for Equity Instruments That Are Issued
to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services. The
Company recorded an adjustment to revise retained earnings and additional paid-in-capital by
approximately $900,000 to reflect the impact of previously unrecognized compensation expense
associated with certain non-employee option grants between 1998 and 2004. This adjustment is
immaterial to the current period and each of the prior affected periods.
Awards of Restricted Stock, Performance Stock and Contract Stock
Performance stock awards have performance features associated with them. Performance stock,
restricted stock and contract stock awards generally have requisite service periods of three years.
The fair value of these awards is being expensed on a straight-line basis over the vesting period.
As of June 30, 2008, there were approximately $9.2 million of total unrecognized compensation costs
related to unvested awards. These costs were expected to be recognized over a weighted-average
period of approximately 1.8 years.
The Company has no formal policy related to the repurchase of shares for the purpose of
satisfying stock-based compensation obligations. Independent of these programs, the Company does
have a practice of repurchasing shares, from time to time, in the open market.
The Company also maintains an Employee Stock Purchase Plan (the ESPP), which provides
eligible employees of the Company with the opportunity to acquire shares of common stock at
periodic intervals by means of accumulated payroll deductions. The ESPP was amended in 2005 to
eliminate the look-back option and to reduce the discount available to participants to five
percent. Accordingly, the ESPP is a non-compensatory plan under FASB Statement No. 123(R),
Share-Based Payments.
14
8. RETIREMENT BENEFIT PLANS
The Company has pension plans covering certain former U.S. employees of Miltex, as well as
certain UK employees and former employees in Germany. Net periodic benefit costs for the Companys
defined benefit pension plans included the following amounts (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Service cost |
|
$ |
72 |
|
|
$ |
60 |
|
|
$ |
143 |
|
|
$ |
102 |
|
Interest cost |
|
|
361 |
|
|
|
231 |
|
|
|
721 |
|
|
|
394 |
|
Expected return on plan assets |
|
|
(307 |
) |
|
$ |
(199 |
) |
|
$ |
(612 |
) |
|
$ |
(340 |
) |
Recognized net actuarial loss |
|
|
6 |
|
|
|
99 |
|
|
|
11 |
|
|
|
169 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net period benefit cost |
|
$ |
132 |
|
|
$ |
191 |
|
|
$ |
263 |
|
|
$ |
325 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company made $255,000 and $190,000 of contributions to its defined benefit pension plans
for the six months ended June 30, 2008 and 2007, respectively.
9. COMPREHENSIVE INCOME
Comprehensive income was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Net Income |
|
$ |
13,814 |
|
|
$ |
9,341 |
|
|
$ |
25,379 |
|
|
$ |
18,416 |
|
Foreign currency translation adjustment |
|
|
2,108 |
|
|
|
2,700 |
|
|
|
12,238 |
|
|
|
4,248 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
$ |
15,922 |
|
|
$ |
12,041 |
|
|
$ |
37,617 |
|
|
$ |
22,664 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
15
10. NET INCOME PER SHARE
Basic and diluted net income per share was as follows (in thousands, except per share
amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Basic net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Income |
|
$ |
13,814 |
|
|
$ |
9,341 |
|
|
$ |
25,379 |
|
|
$ |
18,416 |
|
Weighted average common shares outstanding |
|
|
27,662 |
|
|
|
28,156 |
|
|
|
27,276 |
|
|
|
28,371 |
|
Basic net income per share |
|
$ |
0.50 |
|
|
$ |
0.33 |
|
|
$ |
0.93 |
|
|
$ |
0.65 |
|
Diluted net income per share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
13,814 |
|
|
$ |
9,341 |
|
|
$ |
25,379 |
|
|
$ |
18,416 |
|
Add back: Interest expense and other
income/(expense) related to convertible
notes payable, net of tax |
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income available to common stock |
|
$ |
13,814 |
|
|
$ |
9,343 |
|
|
$ |
25,379 |
|
|
$ |
18,421 |
|
Weighted average common shares
outstanding Basic |
|
|
27,662 |
|
|
|
28,156 |
|
|
|
27,276 |
|
|
|
28,371 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock options and restricted stock |
|
|
918 |
|
|
|
985 |
|
|
|
894 |
|
|
|
917 |
|
Shares issuable upon conversion of notes
payable |
|
|
|
|
|
|
1,028 |
|
|
|
|
|
|
|
901 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares for
diluted earnings per share |
|
|
28,580 |
|
|
|
30,169 |
|
|
|
28,170 |
|
|
|
30,189 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share |
|
$ |
0.48 |
|
|
$ |
0.31 |
|
|
$ |
0.90 |
|
|
$ |
0.61 |
|
Options outstanding to acquire approximately 0.5 million shares of common stock at each of
June 30, 2008 and 2007 were excluded from the computation of diluted net income per share for the
six months ended June 30, 2008 and 2007 because the effect would be anti-dilutive. There were no
options outstanding to acquire shares for the three months ended June 30, 2008 excluded from the
computation of diluted net income per share. Options outstanding at June 30, 2007 to acquire
approximately 0.3 million shares of common stock were excluded from the computation of diluted net
income per share for the three months ended June 30, 2007 because the effect would be
anti-dilutive.
11. SEGMENT AND GEOGRAPHIC INFORMATION
The Companys management reviews financial results and manages the business on an aggregate
basis. Accordingly, we report our financial results under a single
operating segment: the development, manufacturing and distribution of
medical devices.
16
The Company presents its revenues in two categories: Neurosurgical and Orthopedic Implants,
and Medical Surgical Equipment. The Companys revenues were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical surgical equipment and other |
|
$ |
89,496 |
|
|
$ |
85,359 |
|
|
$ |
177,904 |
|
|
$ |
161,304 |
|
Neurosurgical and orthopedic implants |
|
|
67,702 |
|
|
|
49,408 |
|
|
|
135,302 |
|
|
|
96,495 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Revenues |
|
$ |
157,198 |
|
|
$ |
134,767 |
|
|
$ |
313,206 |
|
|
$ |
257,799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Certain of the Companys products, including the DuraGen® and NeuraGen
product families and the INTEGRA® Dermal Regeneration Template and wound-dressing
products, contain material derived from bovine tissue. Products that contain materials derived from
animal sources, including food as well as pharmaceuticals and medical devices, are increasingly
subject to scrutiny from the press and regulatory authorities. These products constituted 22% and
25% of total revenues in each of the three-month periods ended June 30, 2008 and 2007,
respectively, and 22% and 25% of total revenues in each of the six-month periods ending June 30,
2008 and 2007, respectively. Accordingly, a widespread public controversy concerning collagen
products, new regulation, or a ban of the Companys products containing material derived from
bovine tissue could have a material adverse effect on the Companys current business or its ability
to expand its business.
Total revenues by major geographic area are summarized below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six
months ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
United States |
|
$ |
115,754 |
|
|
$ |
101,664 |
|
|
$ |
229,129 |
|
|
$ |
192,742 |
|
Europe |
|
|
25,937 |
|
|
|
23,552 |
|
|
|
52,599 |
|
|
|
44,721 |
|
Asia Pacific |
|
|
6,142 |
|
|
|
4,789 |
|
|
|
13,361 |
|
|
|
10,589 |
|
Other Foreign |
|
|
9,365 |
|
|
|
4,762 |
|
|
|
18,117 |
|
|
|
9,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
157,198 |
|
|
$ |
134,767 |
|
|
$ |
313,206 |
|
|
$ |
257,799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company classifies its revenue by major geographic area based on the customer location
receiving the product shipment.
12. COMMITMENTS AND CONTINGENCIES
In consideration for certain technology, manufacturing, distribution and selling rights, and
licenses granted to the Company, the Company has agreed to pay royalties on the sales of products
that are commercialized relative to the granted rights and licenses. Royalty payments under these
agreements by the Company were not significant for any of the periods presented.
Various lawsuits, claims and proceedings are pending or have been settled by the Company. The
most significant of those are described below.
In May 2006, Codman & Shurtleff, Inc., a division of Johnson & Johnson, commenced an action in
the United States District Court for the District of New Jersey for declaratory judgment against
the Company with respect to United States Patent No. 5,997,895 (the 895 Patent) held by the
Company. The Companys patent covers dural repair technology related to the Companys DuraGen®
family of duraplasty products.
The action seeks declaratory relief that Codmans DURAFORM® product does not infringe the
Companys patent and that the Companys patent is invalid. Codman does not seek either damages from
the Company or injunctive relief to prevent the Company from selling the DuraGen® Dural Graft
Matrix. The Company has filed a counterclaim against Codman, alleging that Codmans DURAFORM®
17
product
infringes the 895 Patent, seeking injunctive relief preventing the sale and use of DURAFORM®, and
seeking damages, including treble damages, for past infringement.
In addition to these matters, we are subject to various claims, lawsuits and proceedings in
the ordinary course of our business, including claims by current or former employees, distributors
and competitors and with respect to our products. In the opinion of management, such claims are
either adequately covered by insurance or otherwise indemnified, or are not expected, individually
or in the aggregate, to result in a material adverse effect on our financial condition. However, it
is possible that our results of operations, financial position and cash flows in a particular
period could be materially affected by these contingencies.
The Company accrues for loss contingencies in accordance with SFAS 5; that is, when it is
deemed probable that a loss has been incurred and that loss is estimable. The amounts accrued are
based on the full amount of the estimated loss before considering insurance proceeds, and do not
include an estimate for legal fees expected to be incurred in connection with the loss contingency.
The Company consistently accrues legal fees expected to be incurred in connection with loss
contingencies as those fees are incurred by outside counsel as a period cost, as permitted by EITF
Topic D-77.
13. SUBSEQUENT EVENTS
On August 1, 2008, the Company acquired Theken Spine, LLC, Theken Disc, LLC and Therics, LLC
(together Theken) for $75 million in cash at closing, subject to certain adjustments, and up to
$125 million in future payments based on the performance of the business after closing. The future
payments will be tied to revenues of the Theken business during a two-year period following the
closing.
On
July 28, 2008, the Company borrowed $80 million under our senior secured revolving credit facility
to fund the Theken acquisition and for other general corporate purposes. As a result of this
borrowing, the Company had $200 million of outstanding borrowings under our credit facility as of the date
of this filing.
On August 6, 2008, the Company and Stuart M. Essig entered into Amendment 2008-2 (the
Amendment) to Mr. Essigs Second Amended and Restated Employment Agreement with the Company,
dated as of July 27, 2004. The Amendment extends the term of Mr. Essigs employment until December
31, 2011 and provides for automatic one-year extensions thereafter. The Amendment also provides
that Mr. Essig will receive (i) a grant of 375,000 restricted stock units (RSUs) on the effective
date of the Amendment; (ii) a non-qualified stock option to purchase 125,000 shares of Company
common stock to be granted on the first day on which the Company trading window opens following the
effective date of the Amendment and (iii) annual grants during the term, commencing in December
2008, of between 75,000 and 100,000 RSUs or performance shares. As the 375,000 RSUs vest at the
grant date, a charge of approximately $18.0 million is to be recognized upon issuance.
18
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations
should be read in conjunction with our condensed consolidated financial statements and the related
notes thereto appearing elsewhere in this report and our consolidated financial statements for the
year ended December 31, 2007 included in our Annual Report on Form 10-K.
We have made statements in this report which constitute forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act
of 1934. These forward-looking statements are subject to a number of risks, uncertainties and
assumptions about the Company. Our actual results may differ materially from those anticipated in
these forward-looking statements as a result of many factors, including but not limited to those
set forth above under the heading Risk Factors in our Annual Report on Form 10-K for the year
ended December 31, 2007 and in subsequent Quarterly Reports on Form 10-Q.
You can identify these forward-looking statements by forward-looking words such as believe,
may, could, will, estimate, continue, anticipate, intend, seek, plan, expect,
should, would and similar expressions in this report.
GENERAL
Integra is a market-leading, innovative medical device company focused on helping the medical
professional enhance the standard of care for patients. Integra provides customers with clinically
relevant, innovative and cost-effective products that improve the quality of life for patients. We
focus on cranial and spinal procedures, small bone and joint injuries, the repair and
reconstruction of soft tissue, and instruments for surgery.
Our distribution channels include three main sales organizations (Integra NeuroSpine, Integra
Extremity Reconstruction, and Integra Medical Instruments) and strategic alliances. We have
direct sales forces and dealer networks managed by a direct sales organization in the United
States. Outside of the United States, we sell our products directly through sales representatives
in major European markets and through stocking distributors elsewhere. We generally invest
substantial resources and management effort to develop our sales organizations, and we believe that
we compete very effectively in this aspect of our business.
We present revenues in two categories: Neurosurgical and Orthopedic Implants, and Medical
Surgical Equipment. Our Neurosurgical and Orthopedic Implants product group includes the following:
dural grafts that are indicated for the repair of the dural matter; bone graft substitutes that
promote the regeneration of bone; dermal regeneration and engineered wound dressings; implants used
in small bone and joint fixation and repair of peripheral nerves; hydrocephalus management; and
implants used in bone regeneration and in guided tissue regeneration in periodontal surgery. Our
Medical Surgical Equipment product group includes the following: ultrasonic surgery systems for
tissue ablation; cranial stabilization and brain retraction systems; instrumentation used in
general, neurosurgical, spinal, plastic and reconstructive surgery and dental procedures; systems
for the measurement of various brain parameters; specialty surgical lighting systems; and devices
used to gain access to the cranial cavity and to drain excess cerebrospinal fluid from the
ventricle of the brain.
We manage these product groups and distribution channels on a centralized basis. Accordingly,
we report our financial results under a single operating segment: the development, manufacturing
and distribution of medical devices.
We manufacture many of our products in various plants located in the United States, Puerto
Rico, France, Germany, Ireland, the United Kingdom and Mexico. We also source most of our hand-held
surgical instruments and orthopedic implants through specialized third-party vendors.
We believe that we have a particular advantage in the development, manufacture and sale of
specialty tissue repair products derived from bovine collagen. Products that contain materials
derived from animal sources, including food as well as pharmaceuticals and medical devices, are
increasingly subject to scrutiny from the media and regulatory authorities. These products
comprised 22% and 25% of total revenues in each of the six-month
periods ended June 30, 2008 and June 30, 2007, respectively. Accordingly, widespread public
controversy concerning
19
collagen products, new regulation, or a ban of our products containing
material derived from bovine tissue, could have a material adverse effect on our current business
and our ability to expand our business.
Our objective is to continue to build a customer-focused and profitable medical device company
by developing or acquiring innovative medical devices and other products to sell through our sales
channels. Our strategy therefore entails substantial growth in revenues through both internal means
through launching new and innovative products and selling existing products more intensively
and by acquiring existing businesses or already successful product lines.
We aim to achieve this growth in revenues while maintaining strong financial results. While we
pay attention to any meaningful trend in our financial results, we pay particular attention to
measurements that are indicative of long-term profitable growth. These measurements include revenue
growth (derived through acquisitions and products developed internally), gross margins on total
revenues, operating margins (which we aim to continually expand on as we leverage our existing
infrastructure), and earnings per diluted share of common stock.
ACQUISITIONS
Our strategy for growing our business includes the acquisition of complementary product lines
and companies. Our recent acquisitions of businesses, assets and product lines may make our
financial results for the six months ended June 30, 2008 not directly comparable to those of the
corresponding prior-year period. See Note 2 to the unaudited condensed consolidated financial
statements for a further discussion.
RESULTS OF OPERATIONS
Net income for the three months ended June 30, 2008 was $13.8 million, or $0.48 per diluted
share, as compared with net income of $9.3 million, or $0.31 per diluted share, for the three
months ended June 30, 2007.
Net income for the six months ended June 30, 2008 was $25.4 million, or $0.90 per diluted
share, as compared with net income of $18.4 million, or $0.61 per diluted share, for the six months
ended June 30, 2007.
Executive Summary
The increase in net income for the three months ended June 30, 2008 over the prior year period
resulted primarily from a 17% increase in revenues, an improvement in gross margin percentage from
60.8% in the 2007 period to 63.0% in 2008, reductions in each of general and administrative
expenses and amortization expense as a percentage of revenue, and a reduction in the effective tax
rate as a percentage of income before taxes from 35.8% during the 2007 period to 32.7% in the
second quarter of 2008.
The increase in net income for the six months ended June 30, 2008 over the prior year period
resulted primarily from a 21% increase in revenues, an improvement in gross margin percentage from
60.6% in the 2007 period to 61.6% in 2008 and a reduction in amortization expense as a percentage
of revenue.
20
Our costs and expenses include the following charges (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Acquisition-related charges |
|
$ |
453 |
|
|
$ |
1,631 |
|
|
$ |
3,661 |
|
|
$ |
1,631 |
|
Facility consolidation, manufacturing
transfer and
System integration charges |
|
|
201 |
|
|
|
186 |
|
|
|
565 |
|
|
|
685 |
|
Employee termination and related costs |
|
|
|
|
|
|
(228 |
) |
|
|
|
|
|
|
(159 |
) |
Charges associated with discontinued or
withdrawn
product lines |
|
|
|
|
|
|
956 |
|
|
|
|
|
|
|
1,456 |
|
Intangible asset impairments |
|
|
|
|
|
|
1,014 |
|
|
|
|
|
|
|
1,014 |
|
Charges related to restructuring European
subsidiaries |
|
|
|
|
|
|
335 |
|
|
|
|
|
|
|
335 |
|
Incremental professional and bank fees
related to the delayed 10-K filing |
|
|
493 |
|
|
|
|
|
|
|
1,041 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
1,147 |
|
|
$ |
3,894 |
|
|
$ |
5,267 |
|
|
$ |
4,962 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Of these amounts, $4.1 million and $3.5 million were charged to cost of product revenues in the
six-month periods ended June 30, 2008 and 2007, respectively. The remaining amounts, except for
intangible asset amortization, were charged to selling, general and administrative expenses.
Employee termination and related costs for the 2007 periods reflect the reversal of previously
recorded accruals for anticipated terminations as a result of changes in estimates during the
second quarter 2007. Charges associated with discontinued or withdrawn product lines reflect the
discontinuation of certain dural repair products. Intangible asset impairments include termination
of various trademarks for various products, which will now be re-branded as part of Integra Pain
Management, and the impairment of certain other technology and trademarks based on business and
operating decisions during the second quarter.
We believe that, given our strategy of seeking new acquisitions and integrating recent
acquisitions, our current focus on rationalizing our existing manufacturing and distribution
infrastructure, our recent review of various product lines in relation to our current business
strategy, and a renewed focus on enterprise business systems integrations, charges similar to those
discussed above could recur with similar materiality in the future. We believe that the delineation
of these costs provides useful information to measure the comparative performance of our business
operations across reporting periods.
21
Revenues and Gross Margin on Product Revenues
Our revenues and gross margin on product revenues were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Medical Surgical Equipment and other |
|
$ |
89,496 |
|
|
$ |
85,359 |
|
|
$ |
177,904 |
|
|
$ |
161,304 |
|
Neurosurgical and Orthopedic Implants |
|
|
67,702 |
|
|
|
49,408 |
|
|
|
135,302 |
|
|
|
96,495 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenue |
|
|
157,198 |
|
|
|
134,767 |
|
|
|
313,206 |
|
|
|
257,799 |
|
Cost of product revenues |
|
|
58,159 |
|
|
|
52,808 |
|
|
|
120,371 |
|
|
|
101,385 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin on total revenues |
|
$ |
99,039 |
|
|
$ |
81.959 |
|
|
$ |
192,835 |
|
|
$ |
156,414 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross margin as a percentage of total revenues |
|
|
63 |
% |
|
|
61 |
% |
|
|
62 |
% |
|
|
61 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
THREE MONTHS ENDED JUNE 30, 2008 AS COMPARED TO THREE MONTHS ENDED JUNE 30, 2007
Revenues and Gross Margin
For the three months ended June 30, 2008, total revenues increased by $22.4 million, or 17%,
to $157.2 million from $134.8 million for the same period during 2007. Domestic revenues increased
by $14.1 million to $115.8 million, or 74% of total revenues, for the three months ended June 30,
2008 from $101.7 million, or 75% of total revenues, for the three months ended June 30, 2007.
International revenues increased to $41.4 million from $33.1 million in the prior-year period, an
increase of 25%.
In the Neurosurgical and Orthopedic Implants category, sales of our DuraGen® family of
products, extremity reconstruction implants, private label infection control products and bone
growth products led the revenue growth. Growth in dermal repair products and sales of products for
the foot and ankle accounted for much of the increase in implant product revenues. IsoTis products
contributed $10.1 million of revenues in the second quarter of 2008.
In the Medical Surgical Equipment category, acquired products and neurosurgical systems
provided most of the year-over-year growth. LXU Healthcare products, Physician Industries products
and Precise Dental products (all acquired in 2007) contributed $11.2 million of sales in the second
quarter of 2008, compared to $7.5 million for the same period in 2007.
Included in revenues are royalties of $3.1 million and $5.8 million, respectively, for the
three and six months ended June 30, 2008 and $2.9 million and $5.1 million for the three and six
months ended June 30, 2007.
We have generated our product revenue growth through acquisitions, new product launches and
increased direct sales and marketing efforts both domestically and in Europe. We expect that our
expanded domestic sales force, the continued implementation of our direct sales strategy in Europe
and sales of internally developed and acquired products will drive our future revenue growth. We
also intend to continue to acquire businesses that complement our existing businesses and products.
Many of our recent acquisitions involve businesses or product lines that overlap in some way with
our existing products. Our sales and marketing departments are integrating these acquisitions, and,
as a result, there has been, and we expect there will continue to be, some negative effect on sales
of our existing products that will affect our internal growth.
22
Gross margin increased by $17.0 million to $99.0 million for the three months ended June 30,
2008, from $82.0 million for the same period last year. Gross margin as a percentage of total
revenue is 63% for the second quarter 2008, compared to 61% for second quarter 2007.
Other Operating Expenses
The following is a summary of other operating expenses as a percent of total revenues (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
2008 |
|
2007 |
Research and development |
|
|
5 |
% |
|
|
4 |
% |
Selling, general and administrative |
|
|
40 |
% |
|
|
41 |
% |
Intangible asset amortization |
|
|
2 |
% |
|
|
3 |
% |
Total other operating expenses |
|
|
47 |
% |
|
|
48 |
% |
Total other operating expenses, which consist of research and development expenses, selling,
general and administrative expenses, and amortization expenses, increased $9.1 million, or 14%, to
$74.2 million in the second quarter of 2008, compared to $65.1 million in the second quarter of
2007. Research and development expenses in the second quarter of 2008
increased by $1.6 million to
$7.8 million, compared to $6.2 million in the same period last year. In 2008, we increased spending
on our biomaterial development programs.
In 2008, we expect our research and development expenses to increase as we increase
expenditures on research and clinical activities. These activities will be directed toward
expanding the indications for use of our absorbable implant technology products, including a
multi-center clinical trial in connection with a proposed application to the FDA for approval of
our DuraGen Plus® Adhesion Barrier Matrix product in the United States.
Selling, general and administrative expenses in the second quarter of 2008 increased by $8.5
million to $63.5 million, or 40% of revenue, compared to $55.0 million, or 41% of revenue, in the
same period last year. The increase in selling, general and administrative expenses over the prior
year was due primarily to substantial increases in the size of our selling organizations,
particularly for spine and extremity reconstruction, and higher expenses for corporate staff and
consulting. As we gain more leverage from our larger selling organizations, we expect selling,
general and administrative expenses to decrease to between 38% and 40% of revenue over the
remainder of 2008 and into 2009.
We intend to continue to expand our direct sales and marketing organizations in our selling
platforms, increase corporate staff to support the recent growth in our business, integrate
acquired businesses, and improve the internal controls over financial reporting. Additionally, we
have incurred higher operating costs in connection with our recent investments in our
infrastructure, including the continued implementation of an enterprise business system and the
expansion of our finance and accounting staff. We expect to incur costs related to these activities
in 2008 and 2009 as we complete these on-going activities.
Amortization expenses in the second quarter of 2008 decreased by $0.8 million to $3.0 million,
compared to $3.8 million in the same period last year. During the second quarter of 2007, the
Company recorded $1.7 million of impairments to intangible assets, of which $0.9 million was
related to technology-based intangible assets and recorded in cost of product revenues and the
remaining $0.8 million relates to other intangible assets, principally a trade name that was
discontinued following managements decision to re-brand the related product line, and was recorded
in intangible asset amortization.
23
Non-Operating Income and Expenses
The following is a summary of non-operating income and expenses (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
June 30, |
|
|
2008 |
|
2007 |
Interest income |
|
$ |
444 |
|
|
$ |
636 |
|
Interest expense |
|
|
(4,261 |
) |
|
|
(3,273 |
) |
Other income (expense) |
|
|
(451 |
) |
|
|
303 |
|
Interest Income
Interest income decreased in the three months ended June 30, 2008 compared to the same period
last year, primarily as a result of lower average cash and investment balances.
Interest Expense
Interest expense increased in the three months ended June 30, 2008 compared to the same period
last year, primarily due to the issuance of $330 million of senior convertible notes in June 2007,
which was offset in part by lower borrowing costs on our credit facility. On March 4, 2008, we
entered into a waiver agreement with the lenders on our credit facility primarily related to the
late filing of our Annual Report on Form 10-K for the year ended December 31, 2007. We paid
$220,068 with respect to this waiver which is treated as interest expense.
Our reported interest expense for the three-month period ended June 30, 2008 and 2007,
includes $3.4 million and $1.7 million, respectively, of cash interest expense on convertible
notes and the senior credit facility. We incurred approximately $9.8 million of costs in connection with the issuance of our 2010
Notes and 2012 Notes, each as defined below, in the second quarter of 2007, which are being
amortized over the term of the notes. Interest expense for the three months ended June 30, 2008
includes $0.6 million of non-cash amortization of debt issuance costs as compared to $0.2 million
in the same period last year.
On March 15, 2008, our 2008 Notes, as defined below, matured and in accordance with the terms
of the 2008 Notes we paid approximately $119.4 million and issued approximately 756,000 shares of
our common stock in April 2008. We borrowed $120 million under our credit facility in March 2008 in
order to repay the 2008 Notes, which were entirely repaid by April 15, 2008.
Other Income
Other income decreased in the three months ended June 30, 2008 compared to the same period
last year, primarily as a result of $0.6 million of foreign currency exchange recognized in the
second quarter of 2008.
Income Taxes
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
June 30, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
Income before income taxes |
|
$ |
20,530 |
|
|
$ |
14,561 |
|
Income tax expense |
|
|
6,716 |
|
|
|
5,220 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
13,814 |
|
|
$ |
9,341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate |
|
|
32.7 |
% |
|
|
35.8 |
% |
24
Our effective income tax rate for the three months ended June 30, 2008 and 2007 was 32.7% and
35.8%, respectively. The decrease in the effective income tax rate year-over-year was primarily the
result of changes in the geographic mix of taxable income attributable to recently acquired
businesses and the changes in valuation allowances.
Our effective tax rate may vary from period to period depending on, among other factors, the
geographic and business mix of taxable earnings and losses. We consider these factors and others,
including our history of generating taxable earnings, in assessing our ability to realize deferred
tax assets.
SIX MONTHS ENDED JUNE 30, 2008 AS COMPARED TO SIX MONTHS ENDED JUNE 30, 2007
Revenues and Gross Margin
For the six-month period ended June 30, 2008, total revenues increased 21% to $313.2 million
from $257.8 million during the prior-year period. Domestic revenues increased by $36.4 million to
$229.1 million and were 73% of total revenues, as compared to 75% of revenues in the six months
ended June 30, 2007. International revenues increased $19.0 million to $84.1 million, an increase
of 29% compared to the same period in 2007.
The Neurosurgical and Orthopedic Implants category grew 40% over the prior year. Sales of our
DuraGen® family of products, extremity reconstruction implants and bone repair products
led the revenue growth. IsoTis products, principally demineralized bone matrix, contributed $20.6
million of sales in the first two quarters of 2008. The Medical Surgical Equipment category grew
10% over the prior year. Acquired products provided most of the year-over-year growth in Medical
Surgical Equipment.
Gross margin increased by $36.4 million to $192.8 million for the six-month period ended June
30, 2008, from $156.4 million for the same period last year. Gross margin as a percentage of total
revenue was 62% for the first two quarters of 2008, compared to 61% for this same period during
2007.
Other Operating Expenses
The following is a summary of other operating expenses as a percent of total revenues (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
June 30, |
|
|
2008 |
|
2007 |
Research and development |
|
|
5 |
% |
|
|
5 |
% |
Selling, general and administrative |
|
|
40 |
% |
|
|
40 |
% |
Intangible asset amortization |
|
|
2 |
% |
|
|
3 |
% |
Total other operating expenses |
|
|
47 |
% |
|
|
48 |
% |
Total other operating expenses, which consist of research and development expenses, selling,
general and administrative expenses and amortization expenses, increased $24.5 million, or 20%, to
$147.5 million in the first half of 2008, compared to $123.0 million in the same period last year.
Research and development expenses in the first half of 2008 increased by $3.3 million to $15.6
million, compared to $12.3 million in the same period last year. IsoTis accounted for $1.3 million
of the increase. These increases relate to expanding the indications for use of our absorbable
implant technology products, including a multi-center clinical trial in connection with a proposed
application to the FDA for approval of our DuraGen Plus® Adhesion Barrier Matrix product
in the United States.
In 2008, we expect our research and development expenses to increase as we increase
expenditures on research and clinical activities. These activities will be directed toward
expanding the indications for use of our absorbable implant technology products, including a
multi-center clinical trial in connection with a proposed application to the FDA for approval of
our DuraGen Plus® Adhesion Barrier Matrix product in the United States.
25
Selling, general and administrative expenses in the six-month period ended June 30, 2008
increased by $21.9 million to $126.0 million, compared to $104.1 million in the same period last
year. Selling expenses increased by $10.2 million primarily due to the accelerated ramp-up in our
extremities reconstructive, intensive care unit, specialist and spine sales forces, and the impact
of acquisitions. General and administrative expenses increased by $11.7 million in the first half
of 2008 compared to the same period last year primarily because of the impact of acquisitions and
increases in headcount, compensation and consulting services charged to corporate operations.
We intend to continue to expand our direct sales and marketing organizations in our selling
platforms, increase corporate staff to support the recent growth in our business, integrate
acquired businesses, and improve the internal controls over financial reporting. Additionally, we
have incurred higher operating costs in connection with our recent investments in our
infrastructure, including the continued implementation of an enterprise business system and the
expansion of our finance and accounting staff. We expect to incur costs related to these activities
in 2008 and 2009.
Amortization expense in the first six months of 2008 decreased by $0.7 million to $5.9
million, compared to $6.6 million in the same period last year.
Non-Operating Income and Expenses
The following is a summary of non-operating income and expenses (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
June 30, |
|
|
2008 |
|
2007 |
Interest income |
|
$ |
1,131 |
|
|
$ |
860 |
|
Interest expense |
|
|
(8,476 |
) |
|
|
(6,033 |
) |
Other income (expense) |
|
|
1,056 |
|
|
|
96 |
|
Interest Income
Interest income increased in the six-month period ended June 30, 2008, compared to the same
period last year, primarily as a result of higher average cash and investment balances.
Interest Expense
Interest expense increased in the six-month period ended June 30, 2008 compared to the same
period last year, primarily as a result of the issuance of $330 million of senior convertible notes
in June 2007, which was offset in part by lower borrowing costs on our credit facility. On March 4,
2008, we entered into a waiver agreement with the lenders on our credit facility primarily related
to the late filing of our 10-K. We paid $537,568 with respect to this waiver which is treated as
interest expense.
Our reported interest expense for the six-month periods ended June 30, 2008 and 2007 includes
$6.6 million and $4.0 million, respectively, of cash interest expense on the convertible notes and
the senior credit facility. We incurred approximately $9.8 million of costs in connection with the
issuance of our 2010 and 2012 Notes, as defined below, in the second quarter of 2007, which are
being amortized over the term of the notes. Interest expense for the six-month period ended June
30, 2008 includes $1.2 million of non-cash amortization of debt issuance costs as compared to $0.1
million in the same period last year.
On March 17, 2008, our 2008 Notes matured and we paid $1.8 million of contingent interest
because our common stock price was greater than $37.56 at thirty days prior to the maturity date.
The value of this contingent interest obligation was marked to its fair value at each balance sheet
date, with changes in the fair value recorded to interest expense. The changes in the estimated
fair value of the contingent interest obligation increased interest expense by $25,000 and $192,000
for the six months ended June 31, 2008 and 2007, respectively.
26
In accordance with the terms of the 2008 Notes, we paid approximately $119.6 million and
issued 768,221 shares of our common stock in connection with the repayment of these notes. We
borrowed $120 million under our credit facility in March 2008 in order to repay the 2008 Notes,
which were entirely repaid by April 15, 2008.
Other Income
Other income increased in the six-month period ended June 30, 2008, compared to the same
period last year, primarily as a result of $0.9 million of foreign currency exchange gains realized
in the six months ended June 30, 2008.
Income Taxes
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
Income before income taxes |
|
$ |
39,045 |
|
|
$ |
28,321 |
|
Income tax expense |
|
|
13,666 |
|
|
|
9,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
25,379 |
|
|
$ |
18,416 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective tax rate |
|
|
35.0 |
% |
|
|
35.0 |
% |
Our effective income tax rate for the six months ended June 30, 2008 and 2007 was 35.0%. Our
effective tax rate may vary from period to period depending on, among other factors, the geographic
and business mix of taxable earnings and losses. We consider these factors and others, including
our history of generating taxable earnings, in assessing our ability to realize deferred tax
assets.
GEOGRAPHIC
PRODUCT REVENUES AND OPERATIONS
Product revenues by major geographic area are summarized below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30, |
|
|
Six months ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
United States |
|
$ |
115,754 |
|
|
$ |
101,664 |
|
|
$ |
229,129 |
|
|
$ |
192,742 |
|
Europe |
|
|
25,937 |
|
|
|
23,552 |
|
|
|
52,599 |
|
|
|
44,721 |
|
Asia Pacific |
|
|
6,142 |
|
|
|
4,789 |
|
|
|
13,361 |
|
|
|
10,589 |
|
Other Foreign |
|
|
9,365 |
|
|
|
4,762 |
|
|
|
18,117 |
|
|
|
9,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
157,198 |
|
|
$ |
134,767 |
|
|
$ |
313,206 |
|
|
$ |
257,799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the
three months ended June 30, 2008, revenues from customers outside the United States
totaled $41.4 million, or 26% of total revenues, of which approximately 63% were to European
customers. Foreign
exchange positively affected revenues by $3.7 million. Revenues from customers
outside the United States included $30.1 million of revenues generated in foreign currencies.
In the three months ended June 30, 2007, revenues from customers outside the United States
totaled $33.1 million, or 25% of total revenues, of which approximately 71% were from European
customers. Foreign exchange positively affected revenues by $1.4 million. Revenues
from customers outside the United States included $21.5 million of revenues generated in foreign
currencies.
For the six months ended June 30, 2008, revenues from customers outside the United States
totaled $84.1 million, or 27% of total revenues, of which approximately 63% were to European
customers. Foreign exchange positively affected revenues by $7.3 million. Revenues from
customers outside the United States included $60.4 million of revenues generated in foreign
currencies.
27
In the six months ended June 30, 2007, revenues from customers outside the United States
totaled $65.1 million, or 25% of total revenues, of which approximately 69% were from European
customers. Foreign exchange positively affected revenues by $3.0 million. Revenues from customers outside the United States included $40.4 million of revenues
generated in foreign currencies.
Additionally, we generate significant revenues outside the United States, a portion of which
are U.S. dollar-denominated transactions conducted with customers who generate revenue in
currencies other than the U.S. dollar. As a result, currency fluctuations between the U.S. dollar
and the currencies in which those customers do business may have an impact on the demand for our
products from these customers.
Because we have operations based in Europe and we generate revenues and incur operating
expenses in Euros and British pounds, we experience currency exchange risk with respect to those
foreign currency denominated revenues or expenses. A weakening of the dollar against the Euro and
the British pound could positively affect future revenues and negatively affect future gross
margins and operating margins, while a strengthening of the dollar against the Euro and the British
pound could negatively affect future revenues and positively affect future gross margins and
operating margins. We are exposed to various market risks, including changes in foreign currency
exchange rates and interest rates that could adversely affect our results of operations and
financial condition. We do not hold or issue derivative instruments for trading or other
speculative purposes. As the volume of our business transacted in foreign currencies increases, we
will continue to assess the potential effects that changes in foreign currency exchange rates could
have on our business. If we believe this potential impact presents a significant risk to our
business, we may enter into additional derivative financial instruments to mitigate this risk.
Our sales into markets outside the United States may be affected by various factors, including
one or more of the following: local economic conditions, regulatory or political considerations,
the effectiveness of our sales representatives and distributors, local competition and changes in
local medical practice.
Relationships with customers and effective terms of sale frequently vary by country, often
with longer-term receivables than are typical in the United States.
LIQUIDITY AND CAPITAL RESOURCES
Cash and Marketable Securities
We had cash and cash equivalents totaling approximately $77.3 million and $57.3 million at
June 30, 2008 and December 31, 2007, respectively.
Cash Flows
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
2008 |
|
|
2007 |
|
|
|
(in thousands) |
|
Net cash provided by operating activities |
|
$ |
18,371 |
|
|
$ |
21,761 |
|
Net cash used in investing activities |
|
|
(6,136 |
) |
|
|
(46,750 |
) |
Net cash provided by financing activities |
|
|
4,729 |
|
|
|
121,835 |
|
Effect of exchange rate fluctuations on cash |
|
|
3,035 |
|
|
|
1,295 |
|
|
|
|
|
|
|
|
Net increase in cash and cash equivalents |
|
$ |
19,999 |
|
|
$ |
98,141 |
|
|
|
|
|
|
|
|
Cash Flows Provided by Operating Activities
We have generated positive operating cash flows on an annual basis, including $47.0 million
for the year ended December 31, 2007 and $18.4 million for the six months ended June 30, 2008,
resulting from net income and non-cash add-backs, partially offset by deferred tax benefit and
changes in working capital items.
28
Cash provided by operations has recently been, and is expected to continue to be our primary
means of funding existing operations and capital expenditures. Despite higher net income for the
six months ended June 30, 2008 compared to June 30, 2007, operating cash flows decreased as a
result of payments totaling $26.2 million for tax liabilities and estimated taxes.
Cash Flows (Used in) Provided by Investing and Financing Activities
Our principal use of funds during the six months ended June 30, 2008 was $6.1 million in
capital expenditures. We received $3.6 million from the issuance of common stock through the
exercise of stock options during the period. We also borrowed $120 million under our senior credit
facility in March 2008 in order to repay the 2008 Notes of $119.6 million, which were entirely
repaid by April 15, 2008.
Working Capital
At June 30, 2008 and December 31, 2007, working capital was $190.3 million and $148.3 million,
respectively. The increase in working capital is primarily related to the increase in cash and cash
equivalents of $20.0 million and $13.4 million in prepaid
expenses, which includes income taxes.
Convertible Debt
We pay interest each June 1 and December 1 on our $165 million senior convertible notes due
June 2010 (2010 Notes) at an annual rate of 2.75% and on our $165 million senior convertible
notes due June 2012 (2012 Notes and, collectively with the 2010 Notes, the Notes) at an
annual rate of 2.375%. In 2008, we paid an additional amount to holders of the Notes as liquidated
damages for failure to maintain the effectiveness of the registration statements that permit resale
of the common stock issuable upon conversion of the Notes, which failure was caused by our
inability to timely file our Annual Report on Form 10-K for the quarter ended June 30, 2008.
Pursuant to the registration rights agreements, dated June 11, 2007, related to the Notes, the
liquidated damages amount is calculated at an annualized rate of 0.25% of the outstanding principal
amount of the Notes beginning on May 1, 2008 until the earlier of the date on which a qualifying
shelf registration statement becomes effective or June 11, 2008. The aggregate payments made for
the period from May 1, 2008 to May 31, 2008 were approximately $70,000. Additional payments to be
made in December 2008 for the period from June 1, 2008 to June 10, 2008 total approximately $23,000
in the aggregate. Payments of the liquidated damages amount were and will be made at the same time
that ordinary interest payments are made to the holders of the Notes.
The Notes are senior, unsecured obligations of Integra, and are convertible into cash and, if
applicable, shares of our common stock based on an initial conversion rate, subject to adjustment,
of 15.0917 shares per $1,000 principal amount of notes for the 2010 Notes and 15.3935 shares per
$1,000 principal amount of notes for the 2012 Notes (which represents an initial conversion price
of approximately $66.26 per share and approximately $64.96 per share for the 2010 Notes and the
2012 Notes, respectively). We expect to satisfy any conversion of the Notes with cash up to the
principal amount of the applicable series of Notes pursuant to the net share settlement mechanism
set forth in the applicable indenture and, with respect to any excess conversion value, with shares
of our common stock. The Notes are convertible only in the following circumstances: (1) if the
closing sale price of our common stock exceeds 130% of the conversion price during a period as
defined in the applicable indenture; (2) if the average trading price per $1,000 principal amount
of the Notes is less than or equal to 97% of the average conversion value of the Notes during a
period as defined in the applicable indenture; (3) at any time on or after December 15, 2009 (in
connection with the 2010 Notes) or anytime after December 15, 2011 (in connection with the 2012
Notes); or (4) if specified corporate transactions occur. The issue price of the Notes was equal to
their face amount, which is also the amount holders are entitled to receive at maturity if the
Notes are not converted. As of June 30, 2008, none of these conditions existed and, as a result,
the $330 million balance of the 2010 Notes and the 2012 Notes is classified as long-term.
The Notes, under the terms of the private placement agreement, are guaranteed fully by Integra
LifeSciences Corporation, a subsidiary of Integra. The 2010 Notes will rank equal in right of
payment to the 2012 Notes. The Notes will be Integras direct senior unsecured obligations and will
rank equal in right of payment to all of our existing and future unsecured and unsubordinated
indebtedness.
29
In connection with the issuance of the Notes, we entered into call transactions and warrant
transactions, primarily with affiliates of the initial purchasers of the Notes (the hedge
participants). The cost of the call transactions to us was approximately $46.8 million. We
received approximately $21.7 million of proceeds from the warrant transactions. The call
transactions involved our purchasing call options from the hedge participants, and the warrant
transactions involved us selling call options to the hedge participants with a higher strike price
than the purchased call options.
The initial strike price of the call transactions is (1) for the 2010 Notes, approximately
$66.26 per share of Common Stock, and (2) for the 2012 Notes, approximately $64.96, in each case
subject to anti-dilution adjustments substantially similar to those in the Notes. The initial
strike price of the warrant transactions is (i) for the 2010 Notes, approximately $77.96 per share
of Common Stock and (ii) for the 2012 Notes, approximately $90.95, in each case subject to
customary anti-dilution adjustments.
On March 5, 2008, we borrowed $120.0 million under our senior secured revolving credit
facility, and as a result of this borrowing, we currently have $120.0 million of outstanding
borrowings under this credit facility. We used the proceeds along with existing funds to repay our
2.5% Contingent Convertible Subordinated Notes due 2008 (the 2008 Notes) upon conversion or
maturity, approximating $119.6 million, and related accrued and contingent interest approximating
an additional $3.3 million. On March 4, 2008 we entered into a waiver agreement with the lenders
under the credit facility waiving the requirement that tax recapture payments made by the Company
in connection with the repayment of the 2008 Notes up to but not exceeding $23 million, be included
in consolidated cash taxes for purposes of calculating the consolidated fixed charge ratio under
the credit agreement.
We made our final interest payment on the 2008 Notes at an annual rate of 2.5% on March 15. On
March 17, 2008, we also paid $1.8 million of contingent interest on the 2008 Notes at maturity.
There were no financial covenants associated with the 2008 Notes. We repaid the 2008 Notes upon
conversion or maturity in March and April 2008 in accordance with the terms of the 2008 Notes and
issued 768,221 shares of our common stock.
In conjunction with the 2008 Notes, the Company had previously recognized a deferred tax
liability related to the conversion feature of the debt. Due to the repayment of the 2008 Notes,
the Company reversed the remaining balance of the deferred tax liability which resulted in the
recognition of a $2.4 million valuation allowance on a deferred tax asset, a $4.8 million increase
to current income taxes payable and $11.4 million of additional paid-in capital.
Senior Secured Revolving Credit Facility
In March and April 2008 we received waivers from the lenders under our credit facility related
to the late completion of our audited financial statements for the year ended December 31, 2007. We
included such financial statements in our Annual Report on Form 10-K filed on May 16, 2008. We also
received an extension of the delivery date under the credit facility of our financial statements
for the quarter ended March 31, 2008. We included such financial statements in our Quarterly Report
on Form 10-Q filed on June 4, 2008. In addition, we obtained a waiver regarding a representation
and warranty in the credit agreement relating to material weaknesses in our internal controls
through November 15, 2008. If, however, we have not eliminated our material weaknesses by November
15, 2008 and if there has been no intervening further amendment extending such date, the sole
consequence prior to February 28, 2009 will be that we could not make further borrowings under the
credit facility. On or before February 28, 2009 (or such later date as we may be required to
deliver audited financial statements for the year ended December 31, 2008), we will be required to
deliver a compliance certificate that includes a representation that we do not have a material
weakness in our internal controls.
On July 28, 2008, we borrowed $80 million under our senior secured revolving credit facility
to fund the acquisition of Theken Spine, LLC, Theken Disc, LLC and Therics, LLC, and for other
general corporate purposes. As a result of this borrowing, we had $200 million of outstanding
borrowings under our credit facility as of the date of this filing.
The outstanding borrowings have one-month interest periods. The weighted average interest rate
of the outstanding borrowings is approximately 3.46%.
30
Share Repurchase Plan
In October 2007, our Board of Directors adopted a new program that authorized us to repurchase
shares of our common stock for an aggregate purchase price not to exceed $75 million through
December 31, 2008. Shares may be repurchased either in the open market or in privately negotiated
transactions. As of June 30, 2008, there remained $54.5 million available for share repurchases
under this authorization.
Dividend Policy
We have not paid any cash dividends on our common stock since our formation. Our credit
facility limits the amount of dividends that we may pay. Any future determinations to pay cash
dividends on our common stock will be at the discretion of our Board of Directors and will depend
upon our financial condition, results of operations, cash flows and other factors deemed relevant
by the Board of Directors.
Capital Resources
We believe that our cash and borrowings under the senior secured revolving credit facility are
sufficient to finance our operations and capital expenditures in the
near term based on our current intent. We regularly borrow
under the credit facility and make payments with respect thereto and consider the outstanding
amounts to be short-term in nature. See Convertible Debt and Senior Secured Revolving Credit
Facility for a description of the material terms of our credit facility.
31
Contractual Obligations and Commitments
As of June 30, 2008, we were obligated to pay the following amounts under various agreements:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1-3 |
|
|
|
|
|
|
More |
|
|
|
|
|
|
|
Less than |
|
|
Years |
|
|
3-5 |
|
|
than |
|
|
|
Total |
|
|
1 Year |
|
|
(in millions) |
|
|
Years |
|
|
5 years |
|
Convertible Securities Long Term |
|
$ |
330.0 |
|
|
$ |
|
|
|
$ |
165.0 |
|
|
$ |
165.0 |
|
|
$ |
|
|
Revolving Credit Facility* |
|
|
120.0 |
|
|
|
120.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest on Convertible Securities |
|
|
28.4 |
|
|
|
7.8 |
|
|
|
14.7 |
|
|
|
5.9 |
|
|
|
|
|
Operating Leases |
|
|
18.5 |
|
|
|
4.1 |
|
|
|
6.4 |
|
|
|
2.2 |
|
|
|
5.8 |
|
Purchase Obligations |
|
|
9.2 |
|
|
|
3.7 |
|
|
|
0.7 |
|
|
|
4.8 |
|
|
|
|
|
Warranty Obligations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pension Contributions |
|
|
0.2 |
|
|
|
|
|
|
|
|
|
|
|
0.1 |
|
|
|
0.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
506.3 |
|
|
$ |
135.6 |
|
|
$ |
186.8 |
|
|
$ |
178.0 |
|
|
$ |
5.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
The Company regularly borrows under the credit facility and makes payments with respect
thereto and considers the outstanding amounts to be short-term in nature based on its current
intent. If additional borrowings are made in connection with, for instance, future
acquisitions, this could impact the timing of when the Company intends to repay amounts under
this credit facility which runs through December 2011. |
|
|
|
On July 28, 2008, we borrowed $80 million under our senior secured revolving credit facility to
fund the acquisition of Theken Spine, LLC, Theken Disc, LLC and Therics, LLC, and for other
general corporate purposes. As a result of this borrowing, we have $200 million of outstanding
borrowings under our credit facility as of the date of this filing. |
Excluded from the contractual obligations table is the liability for unrecognized tax benefits
totaling $11.4 million. This liability for unrecognized tax benefits has been excluded because
we cannot make a reliable estimate of the period in which the unrecognized tax benefits will be
realized.
In addition, the terms of the purchase agreements executed in connection with certain
acquisitions we closed in the last several years, including the August 1, 2008 Theken
acquisition, require us to make payments to the sellers of those businesses based on the
performance of such businesses after the acquisition.
OTHER MATTERS
Critical Accounting Estimates
The critical accounting estimates included in our Annual Report on Form 10-K for the fiscal
year ended December 31, 2007 have not materially changed.
Recently Issued Accounting Standards
In May 2008, the FASB issued Staff Position No. APB 14-1, Accounting for Convertible Debt
Instruments that May be Settled in Cash Upon Conversion (FSP APB 14-1). FSP APB 14-1 requires
that the liability and equity components of convertible debt instruments that may be settled in
cash upon conversion (including partial cash settlement) be separately accounted for in a manner
that reflects an issuers nonconvertible debt borrowing rate. 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, however, early adoption is not permitted.
32
Retrospective application to all periods presented is required except for instruments that
were not outstanding during any of the periods that will be presented in the annual financial
statements for the period of adoption but were outstanding during an earlier period. We are
currently assessing the impact of adopting FSP APB 14-1, which we believe may be material to our
financial condition and results of operations.
In March 2008, the FASB issued Statement No. 161, Disclosures about Derivative Instruments and
Hedging Activities (FAS 161), which is effective January 1, 2009. FAS 161 requires enhanced
disclosures about derivative instruments and hedging activities to allow for a better understanding
of their effects on an entitys financial position, financial performance, and cash flows. Among
other things, FAS 161 requires disclosure of the fair values of derivative instruments and
associated gains and losses in a tabular format. Since FAS 161 requires only additional disclosures
about our derivatives and hedging activities, the adoption of FAS 161 is not expected to affect our
financial position or results of operations.
In December 2007, the FASB issued Statement No. 141(R), Business Combinations (Statement
141(R)), a replacement of FASB Statement No. 141. Statement 141(R) is effective for fiscal years
beginning on or after December 15, 2008 and applies to all business combinations. Statement 141(R)
provides that, upon initially obtaining control of a target, an acquirer shall recognize 100% of
the fair values of acquired assets, including goodwill, and assumed liabilities, with only limited
exceptions, even if the acquirer has not acquired 100% of the target. Additionally, Statement
141(R) changes current practice, in part, as follows: (1) contingent consideration arrangements
will be fair valued at the acquisition date and included on that basis in the purchase price
consideration; (2) transaction costs will be expensed as incurred, rather than capitalized as part
of the purchase price; (3) pre-acquisition contingencies, such as legal issues, will generally have
to be accounted for in purchase accounting at fair value; and (4) in order to accrue for a
restructuring plan in purchase accounting, the requirements in FASB Statement No. 146, Accounting
for Costs Associated with Exit or Disposal Activities, would have to be met at the acquisition
date. While there is no expected material impact to our consolidated financial statements on the
accounting for acquisitions completed prior to December 31, 2008, the adoption of Statement 141(R)
on January 1, 2009 could materially change the accounting for business combinations consummated
subsequent to that date.
In April 2008, the FASB issued FASB Staff Position (FSP) FAS 142-3, Determination of the
Useful Life of Intangible Assets. This FSP 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 142, Goodwill and Other Intangible Assets. The intent of this FSP is
to improve the consistency between the useful life of a recognized intangible asset under SFAS 142
and the period of expected cash flows used to measure the fair value of the asset under SFAS 141R,
and other generally accepted accounting principles (GAAP). This FSP is effective for fiscal
years beginning after December 15, 2008. Early adoption is prohibited. The Company is required to
adopt FSP, FAS142-3 for the fiscal year beginning January 1, 2009. Management does not anticipate
that the adoption of this FSP will have a material impact on the Companys financial statements.
In May 2008, the FASB issued Statement of Financial Accounting Standards No. 162 (SFAS 162),
The Hierarchy of Generally Accepted Accounting Principles. SFAS 162 identifies the sources of
accounting principles and the framework for selecting the principles used in the preparation of
financial statements of nongovernmental entities that are presented in conformity with GAAP in the
United States. Any effect of applying the provisions of SFAS 162 shall be reported as a change in accounting principle in accordance with
Statement of Financial Accounting
Standards No. 154, Accounting Changes and Error Corrections. SFAS 162 is effective 60 days following approval by
the Securities and Exchange Commission of the Public Company Accounting Oversight Board amendments
to AU Section 411, The Meaning of Present Fairly in Conformity with Generally Accepted Accounting
Principles. Management does not anticipate that the adoption of SFAS 162 will have a material impact on
the Companys financial statements.
In June 2008, the FASB issued Staff Position EITF 03-6-1, Determining Whether Instruments
Granted in Share-Based Payment Transactions Are Participating Securities (FSP EITF 03-6-1), which
is effective January 1, 2009. FSP EITF 03-6-1 clarifies that share-based payment awards that
entitle holders to receive nonforfeitable dividends before they vest will be considered
participating securities and included in the basic earnings per share calculation. The Company is
assessing the impact of adoption of FSP EITF 03-6-1 on its results of operations.
33
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to various market risks, including changes in foreign currency exchange rates
and interest rates that could adversely affect our results of operations and financial condition.
To manage the volatility relating to these typical business exposures, we may enter into various
derivative transactions when appropriate. We do not hold or issue derivative instruments for
trading or other speculative purposes.
Foreign Currency Exchange Rate Risk
A discussion of foreign currency exchange risks is provided under the caption Geographic
Product Revenues and Operations under Managements Discussion and Analysis of Financial Condition
and Results of Operations.
Interest Rate Risk Senior Secured Credit Facility
We are exposed to the risk of interest rate fluctuations on the interest paid under the terms
of our senior secured credit facility. Based on our outstanding borrowings as of June 30, 2008, a
hypothetical 100 basis point movement in interest rates applicable to this credit facility would
increase or decrease interest expense by approximately $1.2 million on an annual basis.
34
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to ensure that information
required to be disclosed in our periodic filings is recorded, processed, summarized and reported
within the time periods specified in the Securities and Exchange Commissions rules and forms, and
that such information is accumulated and communicated to our management, including our chief
executive officer and chief financial officer, as appropriate, to allow for timely decisions
regarding required disclosure. Disclosure controls and procedures, no matter how well designed and
operated, can provide only reasonable assurance of achieving the desired control objectives, and
management is required to apply its judgment in evaluating the cost-benefit relationship of
possible controls and procedures. Management has designed our disclosure controls and procedures to
provide reasonable assurance of achieving the desired control objectives.
As required by Rule 13a-15(b) of the Securities Exchange Act of 1934, as amended (the
Exchange Act), we have carried out an evaluation, under the supervision and with the
participation of our management, including our principal executive officer and principal financial
officer, of the effectiveness of the design and operation of our disclosure controls and procedures
as of the end of the period covered by this report. Based upon this evaluation, our principal
executive officer and principal financial officer concluded that our disclosure controls and
procedures were not effective as of June 30, 2008 because of the material weaknesses discussed
below. Notwithstanding the material weaknesses discussed below, our management has concluded that
the condensed consolidated financial statements included in this Quarterly Report on Form 10-Q
fairly present in all material respects our financial condition, results of operations and cash
flows for the periods presented therein in conformity with generally accepted accounting
principles.
Changes in Internal Control Over Financial Reporting
There were no material changes in our internal control over financial reporting (as defined in
Rule 13a-15(f) under the Exchange Act) that occurred during the quarter ended June 30, 2008 that
have materially affected, or are reasonably likely to materially affect, our internal control over
financial reporting.
Description of Material Weaknesses
A material weakness is a control deficiency, or combination of control deficiencies, that
results in more than a remote likelihood that a material misstatement of the annual or interim
financial statements will not be prevented or detected. In our Form 10-K for the year ended
December 31, 2007, management noted it had identified material weaknesses in our internal control
over financial reporting with respect to the following.
1. The Company did not maintain a sufficient complement of personnel with the appropriate
skills, training and experience to identify and address the application of generally accepted
accounting principles and effective controls with respect to locations undergoing change or
experiencing staff turnover. Specifically, the Company did not maintain a sufficient complement of
personnel to completely and accurately record and review the inventory, accrued liabilities,
intercompany accounts, account receivable and income taxes accounts as of and for the year ended
December 31, 2007. Further, effective communication was not designed and in place for sharing of
information within and between our finance department and other operating departments. This control
deficiency contributed to the following control deficiencies which are individually considered to
be material weaknesses.
2. The Company did not maintain effective controls over certain financial statement accounts
reconciliation. Specifically, accounts reconciliation involving inventory, accrued liabilities,
intercompany accounts, account receivable and income taxes were not designed for proper preparation
and timely review and reconciling items were not timely resolved and adjusted. This control
deficiency resulted in audit adjustments to the aforementioned accounts and disclosures in the
Companys consolidated financial statements as of and for the year ended December 31, 2007.
3. The Company did not maintain effective controls over the recording and elimination of
intercompany transactions. Specifically, controls were not appropriately designed for completeness
and accuracy of intercompany accounts and to reconcile and review intercompany
35
transactions between the Companys
subsidiaries on a timely basis. This control deficiency resulted in improper intercompany profit
eliminations and audit adjustments to intercompany sales and cost of goods sold for the year ended
December 31, 2007.
4. The Company did not maintain effective controls over the completeness and accuracy of its
income tax provision. Specifically, controls were not appropriately designed to ensure its income
tax provision and related income taxes payable and deferred income tax assets and liabilities were
properly calculated. This control deficiency resulted in audit adjustments to the aforementioned
accounts and disclosures in the Companys consolidated financial statements as of and for the year
ended December 31, 2007.
5. The Company did not maintain effective controls over the system configuration, segregation
of duties and access to key financial reporting systems, particularly with respect to locations
undergoing systems implementations. Specifically, key financial reporting systems were not
appropriately configured to ensure that certain transactions were properly processed, to segregate
duties amongst personnel and to ensure that unauthorized individuals did not have access to add,
change or delete key financial data. Further, the Company lacked adequate internal access security
policies and procedures.
Because of these material weaknesses, management concluded that our internal control over
financial reporting was not effective as of December 31, 2007. Remediation of these weaknesses has
not yet been fully completed and, therefore, these material weaknesses continued to exist as of
June 30, 2008. These control deficiencies could result in misstatements of financial statement
accounts and disclosures that would result in a material misstatement of the consolidated financial
statements that would not be prevented or detected.
Management Action Plan and Progress to Date
In response to the material weaknesses, we have taken certain actions and will continue to
take further steps to strengthen our control processes and procedures in order to remediate such
material weaknesses. We will continue to evaluate the effectiveness of our internal controls and
procedures on an ongoing basis and will take further action as appropriate. These actions include
an assessment of intercompany accounts and the reconciliation process with the assistance of
outside consultants. This was helpful not only in connection with previous quarterly closes, but
also identified a number of process improvements which will be implemented in future monthly and
quarterly closes.
Additionally, we have taken and are taking the following actions to remediate the material
weaknesses identified above:
|
|
|
On September 6, 2007, we accepted the resignation of our Chief Financial Officer. |
|
|
|
|
Reassigned our former corporate controller from the business development department to
the finance organization to assist with the quarterly close and process improvements. |
|
|
|
|
We are reorganizing the financial functions in Europe, and have assigned an
experienced executive to develop the European organization, and have hired additional
qualified personnel to keep the accounts for our European operations. |
|
|
|
|
Recruited additional accounting, internal audit, financial analysis, business systems
and tax professionals who can provide the adequate experience and knowledge to improve the
timeliness and effectiveness of our account reconciliations and ultimately the financial
reporting processes. Management continues to recruit additional personnel. We have utilized
our internal audit group and outside consultants as needed to assist with executing the
preparation and/or reviews of reconciliations under our direction. We have significantly
increased training, both formal and on the job, for new personnel. We also have developed
a group that is solely dedicated to developing and administrating training materials to
departmental personnel as well as enhancing communication channels among departments and
organizations within the company. |
|
|
|
|
Enhancements to the reconciliation process were made during the 2007 fiscal year.
Reconciliations are being reviewed by several levels of management prior to finalization.
In addition, during the first quarter of 2008, management developed reconciliation policies
and procedures and in the second quarter of 2008 those policies and
procedures were implemented by the accounting department at all |
36
|
|
|
significant
sites. Additional training for all site controllers is scheduled for the third quarter of
2008. |
|
|
|
Management continues to address the control weaknesses around intercompany accounting
transactions. Detailed intercompany reconciliations are being prepared each period and
analyzed by several levels of management. Process changes are being identified and
implemented, which enforce compliance with existing and revised processes for intercompany
transactions and allow for easier accounting and monitoring of such transactions. Process
improvements are still being analyzed and addressed by management. |
|
|
|
|
We have hired qualified professionals in the tax department, and we have engaged
outside consultants to assist us in the preparation of the quarterly tax provision. These
new employees and consultants have been working on assessing the current tax structure and
reviewing the transactions in the tax accounts. Management will continue working on
addressing the control weaknesses as it relates to assessing and recording tax
transactions. |
|
|
|
|
The Company performed a detailed study related to its controls associated with the use
of its primary financial reporting system and has a working group in place focused on
implementing the key findings from that assessment. The Business Process Management team
was established and has been recruiting IT and project management professionals with the
necessary knowledge and experience to continue the optimization efforts around the
Companys Enterprise Resource Planning system (ERP) and supporting business processes. The
team continues its planning around additional phases of ERP rollouts in international
locations and the integration of acquired businesses. We expect the remediation in this
area to continue for a number of months. |
|
|
|
|
We are implementing a system tool to identify conflicts between duties that ought to
remain segregated and are developing procedures to control access to systems. |
The effectiveness of any system of controls and procedures is subject to certain limitations,
and, as a result, there can be no assurance that our controls and procedures will detect all errors
or fraud. A control system, no matter how well conceived and operated, can provide only reasonable,
not absolute, assurance that the objectives of the control system will be attained.
We will continue to develop new policies and procedures as well as educate and train our
financial reporting department regarding our existing policies and procedures in a continual effort
to improve our internal control over financial reporting, and will be taking further actions as
appropriate. We view this as an ongoing effort to which we will devote significant resources.
We believe that the foregoing actions have improved and will continue to improve our internal
control over financial reporting, as well as our disclosure controls and procedures.
37
PART II. OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Various lawsuits, claims and proceedings are pending or have been settled by the Company. The
most significant of those are described below.
In May 2006, Codman & Shurtleff, Inc., a division of Johnson & Johnson, commenced an action in
the United States District Court for the District of New Jersey for declaratory judgment against
the Company with respect to United States Patent No. 5,997,895 (the 895 Patent) held by the
Company. The Companys patent covers dural repair technology related to the Companys DuraGen®
family of duraplasty products.
The action seeks declaratory relief that Codmans DURAFORM® product does not infringe the
Companys patent and that the Companys patent is invalid. Codman does not seek either damages from
the Company or injunctive relief to prevent the Company from selling the DuraGen® Dural Graft
Matrix. The Company has filed a counterclaim against Codman, alleging that Codmans DURAFORM®
product infringes the 895 Patent, seeking injunctive relief preventing the sale and use of
DURAFORM®, and seeking damages, including treble damages, for past infringement.
In addition to these matters, we are subject to various claims, lawsuits and proceedings in
the ordinary course of our business, including claims by current or former employees, distributors
and competitors and with respect to our products. In the opinion of management, such claims are
either adequately covered by insurance or otherwise indemnified, or are not expected, individually
or in the aggregate, to result in a material adverse effect on our financial condition. However, it
is possible that our results of operations, financial position and cash flows in a particular
period could be materially affected by these contingencies.
38
ITEM 1A. RISK FACTORS
The Risk Factors included in the Companys Annual Report on Form 10-K for the fiscal year
ended December 31, 2007 (as modified by the subsequent Quarterly Report on Form 10-Q for the period
ended March 31, 2008) have not materially changed other than the modifications to the risk factors
as set forth below.
To market our products under development we will first need to obtain regulatory approval. Further,
if we fail to comply with the extensive governmental regulations that affect our business, we could
be subject to penalties and could be precluded from marketing our products.
As a manufacturer and marketer of medical devices, we are subject to extensive regulation by
the FDA and the Center for Medicare Services (CMS) of the U.S. Department of Health and Human
Services and other federal governmental agencies and, in some jurisdictions, by state and foreign
governmental authorities. These regulations govern the introduction of new medical devices, the
observance of certain standards with respect to the design, manufacture, testing, labeling,
promotion and sales of the devices, the maintenance of certain records, the ability to track
devices, the reporting of potential product defects, the import and export of devices and other
matters. We are facing an increasing amount of scrutiny and compliance costs as more states are
implementing regulations governing medical devices, pharmaceuticals and/or biologics which affect
many of our products. As a result, we are implementing additional procedures, controls and tracking
and reporting processes, as well as paying additional permit and license fees, where required.
Our products under development are subject to FDA approval or clearance prior to marketing for
commercial use. The process of obtaining necessary FDA approvals or clearances can take years and
is expensive and uncertain. Our inability to obtain required regulatory approval on a timely or
acceptable basis could harm our business. Further, approval or clearance may place substantial
restrictions on the indications for which the product may be marketed or to whom it may be
marketed, warnings that may be required to accompany the product or additional restrictions placed
on the sale and/or use of the product. Further studies, including clinical trials and FDA
approvals, may be required to gain approval for the use of a product for clinical indications other
than those for which the product was initially approved or cleared or for significant changes to
the product. These studies could take years to complete and could be expensive, and there is no
guarantee that the results will convince the FDA to approve or clear the additional indication. Any
negative outcome in our clinical trials could adversely impact our ability to compete against
alternative products or technologies, which could impact our sales. In addition, for products with
an approved Pre-Market Approval (PMA), the FDA requires annual reports and may require
post-approval surveillance programs and/or studies to monitor the products safety and
effectiveness. Results of post-approval programs may limit or expand the further marketing of the
product.
Another risk of application to the FDA relates to the regulatory classification of new
products or proposed new uses for existing products. In the filing of each application, we make a
judgment about the appropriate form and content of the application. If the FDA disagrees with our
judgment in any particular case and, for example, requires us to file a PMA application rather than
allowing us to market for approved uses while we seek broader approvals or requires extensive
additional clinical data, the time and expense required to obtain the required approval might be
significantly increased or approval might not be granted.
Approved products are subject to continuing FDA requirements relating to quality control and
quality assurance, maintenance of records, reporting of adverse events and product recalls,
documentation, and labeling and promotion of medical devices. For example, our orthobiologics
products, acquired in connection with the IsoTis transaction, are subject to FDA and certain state
regulations regarding human cells, tissues, and cellular or tissue-based products, which include
requirements for establishment registration and listing, donor eligibility, current good tissue
practices, labeling, adverse-event reporting, and inspection and enforcement. Some states have
their own tissue banking regulation. We are licensed or have permits as a tissue bank in
California, Florida, New York and Maryland. In addition, tissue banks may undergo voluntary
accreditation by the American Association of Tissue Banks, or the AATB. The AATB has issued
operating standards for tissue banking. Compliance with these standards is a requirement in order
to become a licensed tissue bank.
The FDA and foreign regulatory authorities require that our products be manufactured according
to rigorous standards. These and future regulatory requirements could significantly increase our
production or purchasing costs and could even prevent us from making or
39
obtaining our products in amounts
sufficient to meet market demand. If we or a third-party manufacturer change our approved
manufacturing process, the FDA may require a new approval before that process may be used. Failure
to develop our manufacturing capability could mean that, even if we were to develop promising new
products, we might not be able to produce them profitably, as a result of delays and additional
capital investment costs. Manufacturing facilities, both international and domestic, are also
subject to inspections by or under the authority of the FDA. In addition, failure to comply with
applicable regulatory requirements could subject us to enforcement action, including product
seizures, recalls, withdrawal of clearances or approvals, restrictions on or injunctions against
marketing our product or products based on our technology, cessation of operations and civil and
criminal penalties.
We are also subject to the regulatory requirements of countries outside the United States
where we do business. For example, under the European Union Medical Device Directive, all medical
devices must meet the Medical Device Directive standards and receive CE Mark Certification prior to
marketing in the European Union. CE Mark Certification requires a comprehensive Quality System
program, comprehensive technical documentation and data on the product, which a Notified Body in
Europe reviews. In addition, we must be certified to the ISO 13485:2003 Quality System standards
and maintain this certification in order to market our products in the European Union, Canada,
Latin America, Asia-Pacific and most other countries outside the United States. As a result of an
amendment to Japans Pharmaceutical Affairs Law that went into effect on April 1, 2005, new
regulations and requirements exist for obtaining approval of medical devices, including new
requirements governing the conduct of clinical trials, the manufacturing of products and the
distribution of products in Japan. Significant resources may be needed to comply with the extensive
auditing of and requests for documentation relating to all manufacturing facilities of our company
and our vendors by the Pharmaceutical Medical Device Agency and the Ministry of Health, Labor and
Welfare in Japan to comply with the amendment to the Pharmaceutical Affairs Law. These new
regulations may affect our ability to obtain approvals of new products for sale in Japan.
Additionally, there are many countries outside the United States that have new medical device
regulations that require extensive documentation as well as may require audits of our manufacturing
facilities. There are also associated fees with these new regulations. These regulations are
required for all new products and re-registration of our medical devices.
Our products that contain human derived tissue, including those containing DBM, are not
medical devices in the European Union as defined in the Medical Device Directive (93/42/EC). They
are also not medicinal products as defined in Directive 2001/83/EC. Today, regulations, if
applicable, are different from one EU member state to the next. Due to the absence of a harmonized
regulatory framework and the proposed regulation for advanced therapy medicinal products in the EU,
as well as for other countries, the approval process for human derived cell or tissue based medical
products may be extensive, lengthy, expensive, and unpredictable.
Certain of our products contain materials derived from animal sources and may become subject
to additional regulation.
Certain of our products, including our dermal regeneration products, duraplasty products,
biomaterial products for the spine, nerve and tendon repair products and certain other products,
contain material derived from bovine tissue. Products that contain materials derived from animal
sources, including food, pharmaceuticals and medical devices, are increasingly subject to scrutiny
in the media and by regulatory authorities. Regulatory authorities are concerned about the
potential for the transmission of disease from animals to humans via those materials. This public
scrutiny has been particularly acute in Japan and Western Europe with respect to products derived
from animal sources, because of concern that materials infected with the agent that causes bovine
spongiform encephalopathy, otherwise known as BSE or mad cow disease, may, if ingested or
implanted, cause a variant of the human Creutzfeldt-Jakob Disease, an ultimately fatal disease with
no known cure. Cases of BSE in cattle discovered in Canada and the United States have increased
awareness of the issue in North America.
We take great care to provide that our products are safe and free of agents that can cause
disease. In particular, we are qualifying sources of collagen from countries outside the United
States that are considered BSE-free. The World Health Organization classifies different types of
cattle tissue for relative risk of BSE transmission. Deep flexor tendon is in the lowest-risk
categories for BSE transmission (the same category as milk, for example), and are therefore
considered to have a negligible risk of containing the agent that causes BSE (an improperly folded
protein known as a prion). Nevertheless, products that contain materials derived from animals,
including our products, may become subject to additional regulation, or even be banned in certain
countries, because of concern over the potential for prion transmission. Significant
40
new regulation, or a ban of our
products, could have a material adverse effect on our current business or our ability to expand our
business.
Certain countries, such as Japan, China, Taiwan and Argentina, have issued regulations that
require our collagen products be processed from bovine tendon sourced from countries where no cases
of BSE have occurred and the European Union has requested that our dural replacement products be
sourced from bovine tendon sourced from a country where no cases of BSE have occurred. In addition,
Japan has issued new regulations regarding medical devices that contain tissue of animal origin.
Among other regulations, Japan requires that the tendon used in the manufacture of medical devices
sold in Japan originate in a country that has never had a case of BSE. Currently, we purchase our
tendon from the United States and New Zealand. We received approval in Japan for the use of New
Zealand-sourced tendon in the manufacturing of our products sold in Japan. If we cannot continue to
use or qualify a source of tendon from New Zealand or another country that has never had a case of
BSE, we will not be permitted to sell our collagen hemostatic agents and products for oral surgery
in Japan. We do not currently sell our dural or dermal repair products in Japan.
Our success will depend partly on our ability to operate without infringing or misappropriating the
proprietary rights of others.
We may be sued for infringing the intellectual property rights of others. In addition, we may
find it necessary, if threatened, to initiate a lawsuit seeking a declaration from a court that we
do not infringe the proprietary rights of others or that their rights are invalid or unenforceable.
If we do not prevail in any litigation, in addition to any damages we might have to pay, we would
be required to stop the infringing activity or obtain a license for the proprietary rights
involved. Any required license may be unavailable to us on acceptable terms, if at all. In
addition, some licenses may be nonexclusive and allow our competitors to access the same technology
we license.
If we fail to obtain a required license or are unable to design our product so as not to
infringe on the proprietary rights of others, we may be unable to sell some of our products, and
this potential inability could have a material adverse effect on our revenues and profitability.
We have material weaknesses in our internal control over financial reporting and cannot assure you
that additional material weaknesses will not be identified in the future.
Management identified material weaknesses in our internal controls over financial reporting
related to (1) the complement of its personnel; (2) accounts reconciliation; (3) intercompany
transactions; (4) income tax accounts; and (5) the configuration, segregation of duties and access
to key financial reporting applications. Remediation of these weaknesses had not yet been
completed, and therefore, these material weaknesses continued to exist as of June 30, 2008. In
response to the material weaknesses identified, we have taken certain actions and will continue to
take further steps in an attempt to strengthen our control processes and procedures in order to
remediate such material weaknesses.
While we aim to work diligently to ensure a robust accounting system that is devoid of
significant deficiencies and material weaknesses, given the growth of our business through
acquisitions and the complexity of the accounting rules, we may, in the future, identify additional
significant deficiencies or material weaknesses in our disclosure controls and procedures and
internal control over financial reporting. Any failure to maintain or implement required new or
improved controls, or any difficulties we encounter in their implementation, could result in
additional significant deficiencies or material weaknesses, cause us to fail to meet our periodic
reporting obligations or result in material misstatements in our financial statements. Any such
failure could also adversely affect the results of periodic management evaluations and annual
auditor attestation reports regarding the effectiveness of our internal control over financial
reporting required under Section 404 of the Sarbanes-Oxley Act of 2002 and the rules promulgated
under Section 404. The existence of a material weakness could result in errors in our financial
statements that could result in a restatement of financial statements, cause us to fail to meet our
reporting obligations and cause investors to lose confidence in our reported financial information,
leading to a decline in our stock price. See Part I. Item 4 Controls and Procedures for a further
discussion of our assessment of our internal controls over financial reporting.
41
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
In October 2007, our Board of Directors adopted a new program that authorized us to repurchase
shares of our common stock for an aggregate purchase price not to exceed $75 million through
December 31, 2008. Shares may be repurchased either in the open market or in privately negotiated
transactions.
The following table summarizes our repurchases of our common stock during the quarter ended
June 30, 2008 under this program:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Number of |
|
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
Approximate |
|
|
|
|
|
|
|
|
|
|
Purchased as |
|
Dollar Value of |
|
|
Total Number |
|
|
|
|
|
Part of Publicly |
|
Shares that May Yet |
|
|
of Shares |
|
Average price paid |
|
Announced |
|
be Purchased |
Period |
|
Purchased |
|
per Share |
|
Program |
|
Under the Program |
April 1, 2008 April 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
54,533,276 |
|
May 1, 2008 May 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
54,533,276 |
|
June 1, 2008 June 30, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
54,533,276 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
54,533,276 |
|
|
|
|
42
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The Companys Annual Meeting of Stockholders was held on July 9, 2008 and in connection
therewith, management solicited proxies pursuant to Regulation 14A under the Exchange Act. An
aggregate of 27,307,058 shares of the Companys common stock were outstanding and entitled to a
vote at the meeting. At the meeting the following matters (not including ordinary procedural
matters) were submitted to a vote of the holders of the common stock, with the results indicated
below:
1. Election of directors to serve until the 2009 Annual Meeting. The following persons were
elected. All were managements nominees for election, and all were serving as directors. There was
no solicitation in opposition to such nominees. The tabulation of votes was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Nominee |
|
|
For |
|
Against |
|
|
Abstain |
|
Thomas J. Baltimore, Jr. |
|
|
23,111,865 |
|
|
|
217,454 |
|
|
|
20,462 |
|
Keith Bradley |
|
|
20,282,501 |
|
|
|
3,054,283 |
|
|
|
12,996 |
|
Richard E. Caruso |
|
|
14,681,732 |
|
|
|
8,655,401 |
|
|
|
12,647 |
|
Stuart M. Essig |
|
|
23,085,012 |
|
|
|
253,952 |
|
|
|
10,819 |
|
Neal Moszkowski |
|
|
23,032,806 |
|
|
|
305,217 |
|
|
|
11,756 |
|
Christian S. Schade |
|
|
23,147,863 |
|
|
|
182,691 |
|
|
|
19,227 |
|
James M. Sullivan |
|
|
22,990,088 |
|
|
|
340,391 |
|
|
|
19,303 |
|
Anne M. VanLent |
|
|
20,460,800 |
|
|
|
2,877,541 |
|
|
|
11,440 |
|
2. Ratification of independent registered public accounting firm. The appointment of
PricewaterhouseCoopers LLP as the Companys independent registered public accounting firm for the
2008 fiscal year was ratified. The tabulation of votes was as follows:
|
|
|
|
|
|
|
|
|
For |
|
Against |
|
|
Abstentions |
|
23,299,830 |
|
|
39,927 |
|
|
|
10,028 |
|
3. Approval of Amended and Restated 2003 Equity Incentive Plan. The terms of the Amended and
Restated 2003 Equity Incentive Plan were approved. The tabulation of votes was as follows:
|
|
|
|
|
|
|
|
|
For |
|
Against |
|
|
Abstentions |
|
21,198,287 |
|
|
394,857 |
|
|
|
21,666 |
|
4. Approval of Amendment to Amended and Restated 2003 Equity Incentive Plan to increase
shares. The amendment to the 2003 Equity Incentive Plan to increase the number of shares that may
be issued or awarded under the plan was approved, the tabulation of votes was as follows:
|
|
|
|
|
|
|
|
|
For |
|
Against |
|
|
Abstentions |
|
14,524,329 |
|
|
7,071,176 |
|
|
|
19,305 |
|
43
ITEM 5. OTHER INFORMATION
AMENDMENT TO ESSIG EMPLOYMENT AGREEMENT
On August 6, 2008, the Company and Stuart M. Essig, entered into Amendment 2008-2 (the
Amendment) to Mr. Essigs Second Amended and Restated Employment Agreement with the Company,
dated as of July 27, 2004 (the Employment Agreement). The Amendment was approved by the
Compensation Committee of the Board of Directors (the Board) of the Company on August 6, 2008.
The Amendment extends the term of Mr. Essigs employment, as President and Chief Executive Officer,
until December 31, 2011 and provides for automatic one-year extensions thereafter. The Amendment
also provides that Mr. Essig will receive grants of (i) 375,000 restricted stock units (RSUs) on
the effective date of the Amendment (the Initial RSU Award); (ii) a non-qualified stock option
(the Option) to purchase 125,000 shares of Company common stock (the Shares) to be granted on
the first day on which the Company trading window opens following the effective date of the
Amendment (the Option Grant Date) and (iii) annual grants during the term, commencing in December
2008, of between 75,000 and 100,000 RSUs or performance shares (the Annual Award).
The per share exercise price of the Option will be equal to the quoted closing trading price
of a share of the Companys common stock on the effective date of grant (determined in accordance
with the Companys 2003 Equity Incentive Plan, as amended). Subject to Mr. Essigs continued
service with the Company, the Option will vest as follows: 25% of the Shares vest on the first
anniversary of the Option Grant Date and the remaining Shares vest monthly thereafter over the
subsequent 36 months. In addition, the Option will vest in full upon the occurrence of any of the
following: (i) termination of Mr. Essigs employment by the Company without Cause or by Mr. Essig
for Good Reason, (ii) a Change in Control of the Company, (iii) a Disability Termination,
each as defined in the Employment Agreement, (iv) a termination of Mr. Essigs employment upon
non-renewal of the employment term by either party, or (v) Mr. Essigs death (each, an
Acceleration Event). The Option will have a ten-year term.
The Initial RSU Award vests in full on the effective date of the grant, and the underlying
shares will be deferred and delivered to Mr. Essig within the 30 day period immediately following
the six month anniversary of his separation from service, from the Company, within the meaning of
Section 409A of the Internal Revenue Code.
Pursuant to the Amendment, the Annual Award will take the form of either (i) RSUs for between
75,000 and 100,000 (inclusive) shares of the Companys common stock, or (ii) performance stock for
between 75,000 and 100,000 (inclusive) shares of the Companys common stock. The form of the
Annual Award will be determined by the Compensation Committee of the Board in its sole discretion.
Any Annual Award of RSUs will, subject to Mr. Essigs continued service with the Company, vest
in three equal annual installments on the first three anniversaries of the grant date and will be
subject to accelerated vesting upon the occurrence of an Acceleration Event. The shares underlying
the vested RSUs covered by the Annual Award will be deferred and delivered to Mr. Essig within the
30 day period immediately following the six month anniversary of his separation from service with
the Company.
Any Annual Award of performance shares will be subject to both (A) annual time-based vesting
through December 31, 2011, and (B) performance-based vesting in the event that the Companys sales
in any calendar year during the 3-year performance period exceed sales in the calendar year prior
to such 3-year performance period. The performance shares will only vest to the extent that both
the time-based and performance-based conditions are satisfied (except in the event of a Change in
Control of the Company). The time-based vesting condition will deemed satisfied in full upon a
termination of Mr. Essigs employment by the Company without Cause, by Mr. Essig for Good Reason,
by reason of a Disability Termination or Mr. Essigs death, or upon a nonrenewal of the employment
term by either party. In addition, the performance shares will vest in full upon a Change in
Control of the Company that occurs during the performance period and prior to Mr. Essigs
termination of service. The vested performance shares will be delivered to Mr. Essig upon or
within thirty days after vesting.
Each of the RSU grants and performance stock grants will also include certain dividend
equivalent rights.
44
The foregoing description of the Amendment is qualified in its entirety by reference to the
copy of the Amendment which is attached as Exhibit 10.7 to this Quarterly Report on Form 10-Q and
is incorporated by reference herein. In all other respects not amended, the Employment Agreement
remains in full force and effect.
MORGAN LANE LEASE
In May 2008, Integra LifeSciences Corporation entered into a Lease Agreement with 109 Morgan
Lane, LLC (the Lease) for the expansion of the Companys headquarters in Plainsboro, New Jersey.
The Lease was signed simultaneously with Morgan Lane, LLCs purchase of the building, land and
premises from Provestco, Inc. The Company is initially leasing approximately 26,750 square feet
located at 109 Morgan Lane, Plainsboro, New Jersey (the Initial Space) for general office, lab
and warehouse purposes. If Morgan Lane, LLC completes certain improvements to the building,
parking lot and surrounding premises, then the Company has the right to lease an additional
approximately 31,261 square feet in the building beginning on April 1, 2009 (the Remaining
Space). The rent for the Initial Space ranges from approximately $240,000 per year in the
beginning stages of the term to approximately $340,000 per year at the end of the term. The rent
for the Remaining Space is approximately $330,000 per year, subject to adjustments. Additional
rent is also required for, among other things, operating expenses and taxes. The initial term of
the Lease expires on May 31, 2018 with an option for the Company to extend the term for an
additional five years.
The foregoing description of the Lease is only a summary, does not purport to be complete and
is qualified in its entirety by reference to, and should be read in conjunction with, the complete
text of the Lease, which is filed as Exhibit 10.10 to this Quarterly Report and is incorporated
herein by reference.
45
ITEM 6. EXHIBITS
|
|
|
10.1
|
|
Theken Spine Unit Purchase Agreement, dated as of July 23,
2008, by and among Integra LifeSciences Holdings Corporation,
Theken Spine, LLC, Randall R. Theken and the other members of
the Theken Spine, LLC (Incorporated by reference to Exhibit
10.1 to the Companys Current Report on Form 8-K filed on July
24, 2008) |
|
|
|
10.2
|
|
Form of Option Agreement for John B. Henneman, III
(Incorporated by reference to Exhibit 10.1 to the Companys
Current Report on Form 8-K filed on June 6, 2008) |
|
|
|
10.3
|
|
Compensation of Directors of the Company (Incorporated by
reference to Exhibit 10.1 to the Companys Current Report on
Form 8-K filed on July 11, 2008) |
|
|
|
*10.4
|
|
Form of Restricted Stock Agreement for Non-Employee Directors
under the Integra LifeSciences Holdings Corporation Equity
Incentive Plan |
|
|
|
10.5
|
|
Integra LifeSciences Holdings Corporation Amended and Restated
2003 Equity Incentive Plan (Incorporated by reference to
Exhibit 10.2 to the Companys Current Report on Form 8-K filed
on July 11, 2008) |
|
|
|
10.6
|
|
Amendment to the Integra LifeSciences Holdings Corporation
2003 Equity Incentive Plan (Incorporated by reference to
Exhibit 10.3 to the Companys Current Report on Form 8-K filed
on July 11, 2008) |
|
|
|
*10.7
|
|
Amendment 2008-2, dated as of August 6, 2008, to the Second
Amended and Restated Employment Agreement, between Integra
LifeSciences Holdings Corporation and Stuart M. Essig, which
is filed as Exhibit 10.1 to the Companys Quarterly Report on
Form 10-Q for the quarter ended September 30, 2004 and
previously amended by Amendment 2006-1, filed as Exhibit 10.1
to the Companys Current Report on Form 8-K filed on December
22, 2006 and Amendment 2008-1, filed as Exhibit 10.12(c) to
the Companys Annual Report on Form 10-K for the year ended
December 31, 2007 filed on May 16, 2008 |
|
|
|
*10.8
|
|
Form of Contract Stock/Restricted Units Agreement for Mr. Essig |
|
|
|
*10.9
|
|
Form of Performance Stock Agreement for Mr. Essig |
|
|
|
*10.10
|
|
Lease Agreement between 109 Morgan Lane, LLC and Integra
LifeSciences Corporation, dated May 15, 2008 |
|
|
|
*31.1
|
|
Certification of Principal Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
*31.2
|
|
Certification of Principal Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
*32.1
|
|
Certification of Principal Executive Officer Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
*32.2
|
|
Certification of Principal Financial Officer Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 |
46
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
|
INTEGRA LIFESCIENCES HOLDINGS
CORPORATION |
|
|
|
|
|
|
|
Date: August 11, 2008
|
|
/s/ Stuart M. Essig
Stuart M. Essig
|
|
|
|
|
President and Chief Executive Officer |
|
|
|
|
|
|
|
Date: August 11, 2008
|
|
/s/ John B. Henneman, III
John B. Henneman, III
|
|
|
|
|
Executive Vice President, |
|
|
|
|
Finance and Administration, and |
|
|
|
|
Chief Financial Officer |
|
|
47
Exhibits
|
|
|
10.1
|
|
Theken Spine Unit Purchase Agreement, dated as of July 23,
2008, by and among Integra LifeSciences Holdings Corporation,
Theken Spine, LLC, Randall R. Theken and the other members of
the Theken Spine, LLC (Incorporated by reference to Exhibit
10.1 to the Companys Current Report on Form 8-K filed on July
24, 2008) |
|
|
|
10.2
|
|
Form of Option Agreement for John B. Henneman, III
(Incorporated by reference to Exhibit 10.1 to the Companys
Current Report on Form 8-K filed on June 6, 2008) |
|
|
|
10.3
|
|
Compensation of Directors of the Company (Incorporated by
reference to Exhibit 10.1 to the Companys Current Report on
Form 8-K filed on July 11, 2008) |
|
|
|
*10.4
|
|
Form of Restricted Stock Agreement for Non-Employee Directors
under the Integra LifeSciences Holdings Corporation Equity
Incentive Plan |
|
|
|
10.5
|
|
Integra LifeSciences Holdings Corporation Amended and Restated
2003 Equity Incentive Plan (Incorporated by reference to
Exhibit 10.2 to the Companys Current Report on Form 8-K filed
on July 11, 2008) |
|
|
|
10.6
|
|
Amendment to the Integra LifeSciences Holdings Corporation
2003 Equity Incentive Plan (Incorporated by reference to
Exhibit 10.3 to the Companys Current Report on Form 8-K filed
on July 11, 2008) |
|
|
|
*10.7
|
|
Amendment 2008-2, dated as of August 6, 2008, to the Second
Amended and Restated Employment Agreement, between Integra
LifeSciences Holdings Corporation and Stuart M. Essig, which
is filed as Exhibit 10.1 to the Companys Quarterly Report on
Form 10-Q for the quarter ended September 30, 2004 and
previously amended by Amendment 2006-1, filed as Exhibit 10.1
to the Companys Current Report on Form 8-K filed on December
22, 2006 and Amendment 2008-1, filed as Exhibit 10.12(c) to
the Companys Annual Report on Form 10-K for the year ended
December 31, 2007 filed on May 16, 2008 |
|
|
|
*10.8
|
|
Form of Contract Stock/Restricted Units Agreement for Mr. Essig |
|
|
|
*10.9
|
|
Form of Performance Stock Agreement for Mr. Essig |
|
|
|
*10.10
|
|
Lease Agreement between 109 Morgan Lane, LLC and Integra
LifeSciences Corporation, dated May 15, 2008 |
|
|
|
*31.1
|
|
Certification of Principal Executive Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
*31.2
|
|
Certification of Principal Financial Officer Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
*32.1
|
|
Certification of Principal Executive Officer Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
*32.2
|
|
Certification of Principal Financial Officer Pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 |
48