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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the year ended December 31, 2006.
Or
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
Commission file number 0-18443
MEDICIS PHARMACEUTICAL CORPORATION
(Exact name of registrant as specified in its charter)
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Delaware
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52-1574808 |
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(State of other jurisdiction
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(I.R.S. Employer Identification No.) |
of incorporation or organization) |
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8125 North Hayden Road , Scottsdale, Arizona
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85258-2463 |
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(Address of principal executive office)
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(Zip Code) |
Registrants telephone number, including area code: (602) 808-8800
Securities registered pursuant to Section 12(b) of the Act:Class A common stock, $0.014 par value
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New York Stock Exchange
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Preference Share Purchase Rights |
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(Name of each exchange on which
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(Title of each Class) |
registered) |
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Securities registered pursuant to Section 12(g) of the Act: NONE
Indicate by check mark if the registrant is a well -known seasoned issuer, as defined in Rule 405 of the
Securities Act. Yes þ No o
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d)
of the Act. Yes o No þ
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 if disclosure of delinquent filers pursuant to
Item 405 of Regulation S-K is not contained herein, and will not be
contained, to the best of the registrants knowledge, in definitive proxy
or information statements incorporated by reference in Part III of this
Form or any amendment to this Form 10-K o.
Indicate by check mark whether the registrant is a large accelerated
filer, an accelerated filer, or a non -accelerated filer. See definition
of accelerated filer and large accelerated filer in Rule 12b-2 of the
Exchange Act. (Check one):
Large accelerated filer þ Accelerated filer o Non-accelerated filer o
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 aggregate market value of the voting stock held on June 30, 2006 by
non-affiliates of the registrant was $798,138,672 based on the closing
price of $24.00 per share as reported on the New York Stock Exchange on
June 30, 2006, the last business day of the registrants most recently
completed second fiscal quarter (calculated by excluding all shares held
by executive officers, directors and holders known to the registrant of
five percent or more of the voting power of the registrants common
stock, without conceding that such persons are affiliates of the
registrant for purposes of the federal securities laws). As of February
23, 2007, there were 55,602,652 outstanding shares of Class A common
stock.
Documents incorporated by reference:
Portions of the Proxy Statement for the registrants 2007 Annual Meeting of Shareholders (the Proxy
Statement) are incorporated herein by reference in Part III of this Form 10-K to the extent stated herein.
TABLE OF CONTENTS
PART I
Item 1. Business
Change in Fiscal Year
Effective December 31, 2005, Medicis Pharmaceutical Corporation (Medicis, the Company, or
as used in the context of we, us or our) changed its fiscal year end from June 30 to December
31. This change was made to align our fiscal year end with other companies within our industry.
This Form 10-K is intended to cover the audited calendar year January 1, 2006 to December 31, 2006,
which we refer to as 2006. Comparative financial information to 2006 is provided in this Form
10-K with respect to the calendar year January 1, 2005 to December 31, 2005, which is unaudited and
we refer to as 2005. Additional information is provided with respect to the transition period
July 1, 2005 through December 31, 2005 (the Transition Period), which is audited. We refer to
the period beginning July 1, 2004 and ending June 30, 2005 as fiscal 2005, and the period
beginning July 1, 2003 and ending June 30, 2004 as fiscal 2004.
The Company
Medicis Pharmaceutical Corporation, together with its wholly owned subsidiaries, is a leading
independent specialty pharmaceutical company focused primarily on helping patients attain a healthy
and youthful appearance and self-image through the development and marketing in the U.S. of
products for the treatment of dermatological, aesthetic and podiatric conditions. We also market
products in Canada for the treatment of dermatological and aesthetic conditions. We believe that
the U.S. market for dermatological pharmaceutical sales exceeds $5 billion annually. According to
the American Society for Aesthetic Plastic Surgery, a national not-for-profit organization for
education and research in cosmetic plastic surgery, nearly 11.5 million surgical and non-surgical
cosmetic procedures were performed in the United States during 2005, including approximately 9.3
million non-surgical cosmetic procedures.
We have built our business by executing a four-part growth strategy: promoting existing
brands, developing new products and important product line extensions, entering into strategic
collaborations, and acquiring complementary products, technologies and businesses. Our core
philosophy is to cultivate relationships of trust and confidence with the high prescribing
dermatologists and podiatrists and the leading plastic surgeons in the United States.
We offer a broad range of products addressing various conditions or aesthetic improvements,
including facial wrinkles, acne, fungal infections, rosacea, hyperpigmentation, photoaging,
psoriasis, skin and skin-structure infections, seborrheic dermatitis and cosmesis (improvement in
the texture and appearance of skin). We currently offer 17 branded products. Our primary brands
are OMNICEF® (cefdinir), RESTYLANE® (hyaluronic acid), SOLODYN®
(minocycline HCl, USP), TRIAZ® (benzoyl peroxide), VANOS (fluocinonide)
Cream 0.1%, and ZIANA (clindamycin phosphate 1.2% and tretinoin 0.025%) Gel. Many of
our primary brands currently enjoy branded market leadership in the segments in which they compete.
Because of the significance of these brands to our business, we concentrate our sales and
marketing efforts in promoting them to physicians in our target markets. We also sell a number of
other products that are considered less critical to our business.
We develop and obtain marketing and distribution rights to pharmaceutical agents in various
stages of development. For example, in 2006, we obtained the rights to develop, distribute and
commercialize RELOXIN® in the U.S., Canada and Japan. We have a variety of products
under development, ranging from new products to existing product line extensions and reformulations
of existing products. Our product development strategy involves the rapid evaluation and
formulation of new therapeutics by obtaining preclinical safety and efficacy data, when possible,
followed by rapid safety and efficacy testing in humans. As a result of our increasing financial
strength, we have begun adding long-term projects to our development pipeline. Historically, we
have supplemented our research and development efforts by entering into research and development
agreements with other pharmaceutical and biotechnology companies.
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Currently, we outsource our entire product manufacturing needs. The underlying cost to us for
manufacturing our products is established in our agreements with outside manufacturers. Because of
the short-term nature of these agreements, our expenses for manufacturing are not fixed and could
change from contract to contract.
OMNICEF® is a trademark of Fujisawa Pharmaceutical Co. Ltd. and is used under a
license from Abbott Laboratories, Inc. (Abbott). On April 1, 2005, Fujisawa Pharmaceutical Co.
Ltd. merged with Yamanouchi Pharmaceutical Co. Ltd., creating Astelles Pharma, Inc.
Our Products
We currently market 17 branded products. Our sales and marketing efforts are currently
focused on our primary brands. The following chart details certain important features of our
primary brands:
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Brand |
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Treatment |
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U.S. Market Impact |
OMNICEF®
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A patented oral cephalosporin for skin and
skin-structure infections
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Better pathogen eradication rates compared to most
frequently prescribed antibiotic for this indication |
RESTYLANE®
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Injectable gel for treatment of moderate
to severe facial wrinkles and folds,
such as nasolabial folds
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The leading worldwide injectable dermal filler |
SOLODYN®
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Once daily dosage in the treatment of
inflammatory lesions of non-nodular
moderate to severe acne vulgaris in
patients 12 and older
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Launched in July 2006 following U.S. Food and Drug Administration (FDA) approval on May 8, 2006 |
TRIAZ®
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Topical patented gel and cleanser and
patent-pending pad treatments for acne
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A leading branded prescription benzoyl peroxide product |
VANOS
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Super-high potency topical corticosteroid
indicated for the relief of the inflammatory
and pruritic manifestations of corticosteroid
responsive dermatoses in patients 12 years
of age or older
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Launched in April 2005 following FDA approval on February 11, 2005 |
ZIANA
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Once daily topical gel treatment for acne
vulgaris in patients 12 and older
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Approved by the FDA on November 7, 2006. First
commercial sales to wholesalers in December 2006
and launched in January 2007 |
Prescription Pharmaceuticals
Our principal branded prescription pharmaceutical products are described below:
OMNICEF® is indicated for the treatment of uncomplicated skin and skin-structure
infections. Studies show that OMNICEF® has superior pathogen eradication rates versus
Cephalexin, the most frequently prescribed antibiotic for uncomplicated skin and skin-structure
infections. OMNICEF® has been promoted to dermatologists and podiatrists since May 2001
pursuant to our exclusive co-promotion agreement with Abbott. In return, we receive commission
revenue from Abbott based on prescriptions generated in these categories. Our agreement with
Abbott expires in 2013.
SOLODYN®, launched to dermatologists in July 2006 after approval by the FDA on May
8, 2006, is the only oral minocycline approved for once daily dosage in the treatment of
inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age
and older. SOLODYN® is also the only approved minocycline in extended release tablet
form. SOLODYN® is lipid soluble, and its mode of action occurs in the skin and sebum.
SOLODYN® is not bioequivalent to any other minocycline products, and is in no way
interchangeable with other forms of minocycline. SOLODYN® is patented until 2018 by a
U.S. patent which covers SOLODYN®s unique dissolution rate. Other patents covering
SOLODYN® are to be filed or are pending. SOLODYN® is available by
prescription in 45mg, 90mg and 135mg extended release tablet dosages.
TRIAZ®, a topical therapy prescribed for the treatment of numerous forms and
varying degrees of acne, is available as a patented gel or cleanser or in a patent-pending pad in
three concentrations. TRIAZ® products are
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manufactured using the active ingredient
benzoyl peroxide in a patented vehicle containing glycolic acid and zinc lactate. Studies
conducted by third parties have shown that benzoyl peroxide is the most efficacious agent available
for eradicating the bacteria that cause acne with no reported resistance. We introduced the
TRIAZ® brand in fiscal 1996. In July 2003, we launched TRIAZ® Pads, the
first benzoyl peroxide pad available in the U.S. indicated for the topical treatment of acne
vulgaris. TRIAZ® is protected by a U.S. patent that expires in 2015.
VANOS Cream, launched to dermatologists in April 2005 after approval by the FDA on
February 11, 2005, is a super-high potency (Class I) topical corticosteroid indicated for the
relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in
patients 12 years of age or older. The active ingredient in VANOS is fluocinonide
0.1%, and is the only fluocinonide available in the Class I category of topical corticosteroids.
Physicians may already be familiar with the fluocinonide 0.05%, the active ingredient in another of
our products, the Class II corticosteroid LIDEX®. Two double blind clinical studies
have demonstrated the efficacy, safety and tolerability of VANOS. Its base was
formulated to have the cosmetic elegance of a cream, yet behave like an ointment on the skin. In
addition, physicians have the flexibility of prescribing VANOS either for once or twice
daily application. VANOS Cream is protected by a U.S. patent that expires in 2021.
ZIANA Gel, which contains clindamycin phosphate 1.2% and tretinoin 0.025%, was
approved by the FDA on November 7, 2006. Initial shipments of ZIANA to wholesalers
began in December 2006, with formal promotional launch to dermatologists occurring in January 2007.
ZIANA is the first and only combination of clindamycin and tretinoin approved for once
daily use for the topical treatment of acne vulgaris in patients 12 years and older.
ZIANA is also the first and only approved acne product to combine an antibiotic and a
retinoid. ZIANA is protected by a U.S. patent for both composition of matter and
method that expires in 2020. An additional patent covering composition of matter has been placed
before the U.S. Patent and Trademark Office to be reissued. Each of these patents cover aspects of
the unique vehicle which are used to deliver the active ingredients in ZIANA.
ZIANA is available by prescription in 30 gram and 60 gram tubes.
Dermal Restorative Products
Our principal branded dermal restorative products are described below:
RESTYLANE®, PERLANE®, RESTYLANE FINE LINESTM and
SubQTM are injectable, transparent, stabilized hyaluronic acid gels, which require no
patient sensitivity tests in advance of product administration. These products are the only
particle-based hyaluronic acid dermal fillers and offer patients a tissue tailored result based
on their particular skin type volume augmentation needs. In the United States, the FDA regulates
these products as medical devices. Medicis offers all four of these products in Canada, and began
offering RESTYLANE® in the United States on January 6, 2004. PERLANE®,
RESTYLANE FINE LINES TM and SubQTM have not yet been approved by the FDA for
use in the United States. We acquired the exclusive U.S. and Canadian rights to these dermal
restorative products from Q-Med AB, a Swedish biotechnology/medical device company and its
affiliates (collectively Q-Med) through license agreements.
Research and Development
We develop and obtain rights to pharmaceutical agents in various stages of development.
Currently, we have a variety of products under development, ranging from new products to existing
product line extensions and reformulations of existing products. Our product development strategy
involves the rapid evaluation and formulation of new therapeutics by obtaining preclinical safety
and efficacy data, when possible, followed by rapid safety and efficacy testing in humans. As a
result of our increasing financial strength, we have begun adding long-term projects to our
development pipeline. Historically, we have supplemented our research and development efforts by
entering into research and development agreements with other pharmaceutical and biotechnology
companies.
On September 26, 2002, we entered into an exclusive license and development agreement with Dow
Pharmaceutical Sciences, Inc. (Dow) for the development and commercialization of a patented
dermatologic product, ZIANA. Under terms of the agreement, as amended, we made an
initial payment of $5.4 million and a development milestone payment of $8.8 million to Dow during
fiscal 2003, a development milestone payment of $2.4 million to Dow during fiscal 2004 and
development milestone payments totaling $11.9 million to Dow during
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the Transition Period. These
payments were recorded as charges to research and development expense in the periods in which the
milestones were achieved. During the quarter ended December 31, 2006, ZIANA was
approved by the FDA and, in accordance with the agreement between the parties, we made an
additional payment of $1.0 million to Dow for the achievement of this milestone. The $1.0 million
payment was recorded as a long-lived asset in our consolidated balance sheets.
On July 15, 2004, we entered into an exclusive license agreement and other ancillary documents
with Q-Med to market, distribute and commercialize in the United States and Canada Q-Meds product
currently known as SubQ TM. Q-Med has the exclusive right to manufacture
SubQ TM for Medicis. SubQ TM is currently not approved for
use in the United States. Under the terms of the license agreement, Medicis Aesthetics Holdings
Inc., a wholly owned subsidiary of Medicis, licenses SubQ TM for approximately
$80.0 million, due as follows: approximately $30.0 million paid on July 15, 2004, which was
recorded as research and development expense during the first quarter of fiscal 2005; approximately
$10.0 million upon successful completion of certain clinical milestones; approximately $20.0
million upon the satisfaction of certain defined regulatory milestones; and approximately $20.0
million upon U.S. launch of SubQ TM. We also will make additional milestone
payments to Q-Med upon the achievement of certain commercial milestones.
SubQ TM is comprised of the same NASHA TM substance as
RESTYLANE®, PERLANE® and RESTYLANE FINE LINES TM with a
larger gel particle size and has patent protection until at least 2015 in the United States.
On December 13, 2004, we entered into an exclusive development and license agreement and other
ancillary agreements with Ansata Therapeutics, Inc. (Ansata). The development and license
agreement granted us the exclusive, worldwide rights to Ansatas early stage, proprietary
antimicrobial peptide technology. In accordance with the development and license agreement, we
paid $5.0 million upon signing of the contract, and would have been required to make additional
payments for the achievement of certain developmental milestones. In June 2006, the development
project was terminated. We have no current or future obligations related to this project. The
initial $5.0 million payment was recorded as a charge to research and development expense during
the second quarter of fiscal 2005.
On January 28, 2005, we amended our strategic alliance with AAIPharma, Inc. (AAIPharma)
previously initiated in June 2002 for the development, commercialization and license of a
dermatologic product, SOLODYN®. The consummation of the amendment did not affect the
timing of the development project. The amendment allowed for the immediate transfer of the work
product as defined under the agreement, as well as the products management and development, to us,
and provided that AAIPharma would continue to assist us with the development of SOLODYN®
on a fee for services basis. We had no financial obligations to pay AAIPharma on the attainment of
additional clinical milestones, but we incurred approximately $8.3 million as a charge to research
and development expense during the third quarter of fiscal 2005, as part of the amendment and the
assumption of all liabilities associated with the project. SOLODYN® was approved by the
FDA on May 8, 2006.
On March 17, 2006, we entered into a development and distribution agreement with Ipsen,
whereby Ipsen granted Aesthetica Ltd., our wholly-owned subsidiary, rights to develop, distribute
and commercialize Ipsens botulinum toxin type A product in the United States, Canada and Japan for
aesthetic use by physicians. The product is commonly referred to as RELOXIN® in the
U.S. aesthetic market and DYSPORT® in medical and aesthetic markets outside the U.S.
The product is not currently approved for use in the U.S., Canada or Japan. Upon execution of the
development and distribution agreement, we made an initial payment to Ipsen in the amount of $90.1
million in consideration for the exclusive distribution rights in the U.S., Canada and Japan. We
will pay Ipsen an additional $26.5 million upon successful completion of various clinical and
regulatory milestones, $75.0 million upon the products approval by the FDA and $2.0 million upon
regulatory approval of the product in Japan. Ipsen will manufacture and provide the product to us
for the term of the agreement, which extends to September 2019. Ipsen will receive a royalty based
on sales and a supply price, the total of which is equivalent to
approximately 30% of net sales as defined under the agreement. Under the terms of the
agreement, we are responsible for all remaining research and development costs associated with
obtaining the products approval in the U.S., Canada and Japan.
Additionally, Medicis and Ipsen agreed to negotiate and enter into an agreement relating to
the exclusive distribution and development rights of the product for the aesthetic market in
Europe, and subsequently in certain other markets. Under the terms of the U.S., Canada and Japan
agreement, we were obligated to make an additional
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$35.1 million payment, as amended, to Ipsen if
this agreement was not entered into by April 15, 2006. On April 13, 2006, Medicis and Ipsen agreed
to extend this deadline to July 15, 2006. In connection with this extension, we paid Ipsen
approximately $12.9 million in April 2006, which would be applied against the total obligation, in
the event an agreement was not entered into by the extended deadline. On July 17, 2006, Medicis
and Ipsen agreed that the two companies would not pursue an agreement for the commercialization of
the product outside of the U.S., Canada and Japan. On July 17, 2006, we made the additional $22.2
million payment to Ipsen, representing the remaining portion of the $35.1 million total obligation,
resulting from the discontinuance of negotiations for other territories.
The initial $90.1 million payment and the $35.1 million obligation was recognized as a charge
to research and development expense during 2006.
On June 19, 2006, we entered into an exclusive start-up development agreement with a company
for the development of a dermatologic product. Under terms of the agreement, we made an initial
payment of $1.0 million upon execution of the agreement, and are required to pay a milestone
payment of $3.0 million upon execution of a Development and License Agreement between the parties.
In addition, we will pay approximately $16.0 million upon successful completion of certain clinical
milestones and approximately $12.0 million upon the first commercial sales of the product in the
U.S. We also will make additional milestone payments upon the achievement of certain commercial
milestones. The $1.0 million payment was recognized as a charge to research and development
expense during 2006.
We incurred total research and development costs for all of our sponsored and unreimbursed
co-sponsored pharmaceutical projects for 2006, the Transition Period, the corresponding six-month
period of 2004, fiscal 2005, fiscal 2004 and fiscal 2003 of $161.3 million, $22.4 million, $45.1
million, $65.7 million and $16.5 million, respectively. Research and development costs for 2006
include $125.2 million paid to Ipsen pursuant to the RELOXIN® development agreements and
$1.0 million paid pursuant to the agreement discussed above. Research and development costs for
the Transition Period include $11.9 million paid to Dow pursuant to the development agreement.
Research and development costs for the corresponding six-month period of 2004 include $30.0 million
related to our license agreement with Q-Med related to the SubQTM product, and $5.0
million related to our development and license agreement with Ansata. Research and development
costs for fiscal 2005 include $30.0 million related to our license agreement with Q-Med related to
the SubQTM product, $5.0 million related to our development and license agreement with
Ansata, and $8.3 million related to our research and development collaboration with AAIPharma.
Research and development costs for fiscal 2004 include $2.4 million paid to Dow pursuant to the
development agreement.
Sales and Marketing
Our combined dedicated sales force, consisting of 167 employees as of December 31, 2006,
focuses on high patient volume dermatologists, plastic surgeons and podiatrists. Since a
relatively small number of physicians are responsible for writing a majority of dermatological and
podiatric prescriptions and performing dermal aesthetic procedures, we believe that the size of our
sales force, including its currently ongoing expansion, is appropriate to reach our target
physicians. Our therapeutic dermatology and podiatric sales forces consist of 95 employees who
regularly call on approximately 9,600 dermatologists and 1,100 podiatrists. Our dermal aesthetic
sales force consists of 72 employees who regularly call on leading plastic surgeons, facial plastic
surgeons, dermatologists and dermatologic surgeons. We also have seven national account managers
who regularly call on major drug wholesalers, managed care organizations, large retail chains,
formularies and related organizations.
We cultivate relationships of trust and confidence with the high prescribing dermatologists
and podiatrists and the leading plastic surgeons in the United States. We use a variety of
marketing techniques to promote our products including sampling, journal advertising, promotional
materials, specialty publications, coupons, money-back or product replacement guarantees,
educational conferences and informational websites.
We believe we have created an attractive incentive program for our sales force that is based
upon goals in prescription growth, market share achievement and customer service.
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Warehousing and Distribution
We utilize an independent national warehousing corporation to store and distribute our
products from primarily two regional warehouses in Nevada and Georgia, as well as additional
warehouses in Maryland and North Carolina. Upon the receipt of a purchase order through electronic
data input (EDI), phone, mail or facsimile, the order is processed through our inventory
management systems and is transmitted electronically to the appropriate warehouse for picking and
packing. Upon shipment, the warehouse sends back to us via EDI the necessary information to
automatically process the invoice in a timely manner.
Customers
Our customers include certain of the nations leading wholesale pharmaceutical distributors,
such as Cardinal Health, Inc. (Cardinal) and McKesson Corporation (McKesson) and other major
drug chains. During 2006, the Transition Period, the comparable six-month period in 2004, fiscal
2005 and fiscal 2004, these customers accounted for the following portions of our net revenues:
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Comparable |
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Six-Month |
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Transition |
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Period |
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2006 |
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Period |
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in 2004 |
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Fiscal 2005 |
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Fiscal 2004 |
McKesson |
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56.8 |
% |
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54.9 |
% |
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50.8 |
% |
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51.2 |
% |
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36.9 |
% |
Cardinal |
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19.3 |
% |
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18.9 |
% |
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19.7 |
% |
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21.8 |
% |
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23.8 |
% |
McKesson is our sole distributor of our RESTYLANE® products in the United States
and Canada. RESTYLANE® was our highest-selling product during 2006, the Transition
Period and fiscal 2005.
Seasonality
Our business, taken as a whole, is not materially affected by seasonal factors, although a
substantial portion of our prescription product revenues has been recognized in the last month of
each quarter and we schedule our inventory purchases to meet anticipated customer demand. As a
result, relatively small delays in the receipt of manufactured products by us could result in
revenues being deferred or lost.
Manufacturing
We currently outsource all of our manufacturing needs, and we are required by the FDA to
contract only with manufacturers who comply with current Good Manufacturing Practices (cGMP)
regulations and other applicable laws and regulations. Typically our manufacturing contracts are
short-term. We review our manufacturing arrangements on a regular basis and assess the viability
of alternative manufacturers if our current manufacturers are unable to fulfill our needs. If any
of our manufacturing partners are unable to perform their obligations under our manufacturing
agreements or if any of our manufacturing agreements are terminated, we may experience a disruption
in the manufacturing of the applicable product which would adversely affect our results of
operations.
Our TRIAZ® and ZIANA branded products are manufactured by Contract
Pharmaceuticals Limited pursuant to a manufacturing agreement that automatically renews on an
annual basis, unless terminated by either party.
Our OMNICEF® branded product, which we promote through a license agreement with
Abbott, is manufactured, warehoused and distributed by Abbott. The license agreement expires in
2013.
Our RESTYLANE® branded products in the U.S. and Canada are manufactured by Q-Med
pursuant to a long-term supply agreement that expires no earlier than 2013.
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Our SOLODYN® branded product is manufactured by AAIPharma pursuant to a long-term
supply agreement that expires in 2010, unless extended by mutual agreement. We are also in the
process of qualifying an alternative manufacturing facility for SOLODYN®.
Our VANOS branded product is manufactured by Patheon under a supply agreement that
automatically renews on an annual basis, unless terminated by either party.
Raw Materials
We and the manufacturers of our products rely on suppliers of raw materials used in the
production of our products. Some of these materials are available from only one source and others
may become available from only one source. Any disruption in the supply of raw materials or an
increase in the cost of raw materials to our manufacturers could have a significant effect on their
ability to supply us with our products.
License and Royalty Agreements
Pursuant to license agreements with third parties, we have acquired rights to manufacture, use
or market certain of our existing products, as well as many of our development products and
technologies. Such agreements typically contain provisions requiring us to use our best efforts or
otherwise exercise diligence in pursuing market development for such products in order to maintain
the rights granted under the agreements and may be canceled upon our failure to perform our payment
or other obligations. In addition, we have licensed certain rights to manufacture, use and sell
certain of our technologies outside the United States and Canada to various licensees.
Trademarks, Patents and Proprietary Rights
We believe that trademark protection is an important part of establishing product and brand
recognition. We own a number of registered trademarks and trademark applications. U.S. federal
registrations for trademarks remain in force for 10 years and may be renewed every 10 years after
issuance, provided the mark is still being used in commerce.
We have obtained and licensed a number of patents covering key aspects of our products,
including a U.S. patent expiring in October 2015 covering various formulations of
TRIAZ®, a U.S. patent expiring in October of 2015 covering RESTYLANE®, a U.S.
patent expiring in February of 2018 covering SOLODYN® tablets, five U.S. patents
expiring in June and August of 2020 covering the PLEXION® cleanser formulation and the
PLEXION® TS (topical suspension) and PLEXION® SCT formulations, two U.S.
patents expiring in February of 2015 and August of 2020 covering ZIANATM Gel, and a U.S.
patent expiring in December 2021 covering VANOSTM Cream. We have patent applications
pending relating to SOLODYN®, ZIANA Gel and our LOPROX® Shampoo
formulation. We are also pursuing several other U.S. and foreign patent applications.
We rely and expect to continue to rely upon unpatented proprietary know-how and technological
innovation in the development and manufacture of many of our principal products. Our policy is to
require all our employees, consultants and advisors to enter into confidentiality agreements with
us.
Our success with our products will depend, in part, on our ability to obtain, and successfully
defend if challenged, patent or other proprietary protection. However, the issuance of a patent is
not conclusive as to its validity or as to the enforceable scope of the claims of the patent.
Accordingly, our patents may not prevent other companies from developing similar or functionally
equivalent products or from successfully challenging the validity of our patents. As a result, if
our patent applications are not approved or, even if approved, such patents are circumvented or not
upheld in a legal proceeding, our ability to competitively exploit our patented products and
technologies may be significantly reduced. Also, such patents may or may not provide competitive
advantages for
their respective products or they may be challenged or circumvented by competitors, in which
case our ability to commercially exploit these products may be diminished.
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From time to time, we may need to obtain licenses to patents and other proprietary rights held
by third parties to develop, manufacture and market our products. If we are unable to timely obtain
these licenses on commercially reasonable terms, our ability to commercially exploit such products
may be inhibited or prevented.
Competition
The pharmaceutical and dermal aesthetics industries are characterized by intense competition,
rapid product development and technological change. Numerous companies are engaged in the
development, manufacture and marketing of health care products competitive with those that we
offer. As a result, competition is intense among manufacturers of prescription pharmaceuticals and
dermal injection products, such as for our primary brands.
Many of our competitors are large, well-established pharmaceutical, chemical, cosmetic or
health care companies with considerably greater financial, marketing, sales and technical resources
than those available to us. Additionally, many of our present and potential competitors have
research and development capabilities that may allow them to develop new or improved products that
may compete with our product lines. Our products could be rendered obsolete or made uneconomical
by the development of new products to treat the conditions addressed by our products, technological
advances affecting the cost of production, or marketing or pricing actions by one or more of our
competitors. Each of our products competes for a share of the existing market with numerous
products that have become standard treatments recommended or prescribed by dermatologists and
podiatrists and administered by plastic surgeons and aesthetic dermatologists. In addition to
product development, testing, approval and marketing, industry consolidation, product quality and
price, product technology, reputation, customer service and access to technical information are
other competitive factors affecting the pharmaceutical industry.
The largest competitors for our prescription dermatological products include Allergan,
Galderma, Johnson & Johnson, Sanofi-Aventis, Stiefel Laboratories, Warner Chilcott and others.
Several of our primary prescription brands compete or may compete in the near future with generic
(non-branded) pharmaceuticals, which claim to offer equivalent therapeutic benefits at a lower
cost. In some cases, insurers, third-party payors and pharmacies seek to encourage the use of
generic products, making branded products less attractive, from a cost perspective, to buyers.
Our facial aesthetics products compete against Allergan and others. On June 5, 2006, Allergan
announced that the FDA had approved its dermal filler product JuvédermTM. Allergan is a
larger company than Medicis, and has greater financial, marketing, sales and technical resources
than those available to us. Other dermal filler products, such as Artes Medicals
Artefill®, BioForm Medicals Radiesse®, and a cosmetic tissue augmentation
product developed by Anika Therapeutics, Inc. have also recently been approved by the FDA.
Patients may differentiate these products from RESTYLANE® based on price, efficacy
and/or duration, which may appeal to some patients. In addition, there are several dermal filler
products under development and/or in the FDA pipeline for approval which claim to offer equivalent
or greater facial aesthetic benefits to RESTYLANE® and, if approved, the companies
producing such products could charge less to doctors for their products.
Government Regulation
The manufacture and sale of biological products, drugs and medical devices are subject to
regulation principally by the FDA, but also by other federal agencies and state and local
authorities in the United States, and by comparable agencies in certain foreign countries. The
Federal Trade Commission (FTC), the FDA and state and local authorities regulate the advertising
of over-the-counter drugs and cosmetics. The Federal Food, Drug and Cosmetics Act and the
regulations promulgated thereunder, and other federal and state statutes and regulations, govern,
among other things, the testing, manufacture, safety, effectiveness, labeling, storage, record
keeping, approval, sale, distribution, advertising and promotion of our products.
Our RESTYLANE® dermal filler product is a medical device intended for human use and
is subject to regulation by the FDA in the United States. Unless an exemption applies, each
medical device in the U.S. must have a Premarket Approval Application (PMA) in accordance with
the Federal Food, Drug, and Cosmetic Act, as amended, or a 510(k) clearance (a demonstration that
the new device is substantially equivalent to a device already on the market).
RESTYLANE® and non-collagen dermal fillers are subject to PMA regulations that require
premarket review of clinical data on safety and effectiveness. FDA device regulations for PMAs
generally require
9
reasonable assurance of safety and effectiveness prior to marketing, including
safety and efficacy data obtained under clinical protocols approved under an Investigational Device
Exemption (IDE) and the manufacturing of the device requires compliance with quality systems
regulations (QSRs), as verified by detailed FDA investigations of manufacturing facilities.
These regulations also require post-approval reporting of alleged product defects, recalls and
certain adverse experiences to the FDA. Generally, FDA regulations divide medical devices into
three classes. Class I devices are subject to general controls that require compliance with device
establishment registration, product listing, labeling, QSRs and other general requirements that are
also applicable to all classes of medical devices but, at least currently, most are not subject to
pre-market review. Class II devices are subject to special controls in addition to general
controls and generally require the submission of a premarket notification (501(k) clearance) before
marketing is permitted. Class III devices are subject to the most comprehensive regulation and in
most cases, other than those remain grandfathered based on clinical use before 1976, require
submission to the FDA of a PMA application that includes biocompatibility, manufacturing and
clinical data supporting the safety and effectiveness of the device as well as compliance with the
same provisions applicable to all medical devices such as QSRs. Annual reports must be submitted
to the FDA, as well as descriptions of certain adverse events that are reported to the sponsor
within specified timeframes of receipt of such reports. RESTYLANE® is regulated as a
Class III PMA-required medical device. RESTYLANE® has been approved by the FDA under a
PMA.
In general, products falling within the FDAs definition of new drugs require premarket
approval by the FDA. Products falling within the FDAs definition of cosmetics or of drugs (if
they are not also new drugs) and that are generally recognized as safe and effective do not
require premarketing clearance although all drugs must comply with a host of post-market
regulations, including manufacture under cGMP and adverse experience reporting. The steps required
before a new drug may be marketed, shipped or sold in the United States include (i) preclinical
laboratory and animal testing of pharmacology and toxicology; (ii) manufacture under cGMP; (iii)
submission to the FDA of an Investigational New Drug (or IND) application, which must become
effective before clinical trials may commence; (iv) at least two adequate and well-controlled
clinical trials to establish the safety and efficacy of the drug (for some applications, the FDA
may accept one large clinical trial) beyond those human clinical trials necessary to establish a
safe dose and to identify the human absorption, distribution, metabolism and excretion of the
active ingredient as applicable; (v) submission to the FDA of a New Drug Application (or NDA);
and (vi) FDA approval of the NDA. In addition to obtaining FDA approval for each product, each
drug-manufacturing establishment must be registered with, and approved through a pre-approval
application (PAI) by, the FDA.
New drugs may also be approved by the agency pursuant to an ANDA for generic drugs if the same
active ingredient has previously been approved by the agency and the original sponsor of the NDA no
longer has patent protection or statutory marketing exclusivity. Approval of an ANDA does not
generally require the submission of clinical data on the safety and effectiveness of the drug
product if in an oral or parental dosage form. Clinical studies may be required for certain
topical ANDAs. However, even if no clinical studies are required, the applicant must provide
dissolution and/or metabolic studies to show that the active ingredient in an oral generic drug
sponsors application is comparably available to the patent as the original product in the NDA upon
which the ANDA is based.
Preclinical or biocompatibility testing is generally conducted on laboratory animals to
evaluate the potential safety and toxicity of a drug. The results of these studies are submitted to
the FDA as a part of an IND or IDE application, which must be approved before clinical trials in
humans can begin. Typically, clinical evaluation of new drugs involves a time consuming and costly
three-phase process. In Phase I, clinical trials are conducted with a small number of subjects to
determine the early safety profile, the relationship of safety to dose, and the
pattern of drug distribution and metabolism. In Phase II, one or more clinical trials are
conducted with groups of patients afflicted with a specific disease to determine preliminary
efficacy and expanded evidence of safety and to determine the degree of effect, if any, as compared
to the current treatment regimen. In Phase III, at least two large-scale, multi-center,
comparative trials are conducted with patients afflicted with a target disease to provide
sufficient confirmatory data to support the efficacy and safety required by the FDA. The FDA
closely monitors the progress of each of the three phases of clinical trials and may, at its
discretion, re-evaluate, alter, suspend or terminate the testing based upon the data that have been
accumulated to that point and its assessment of the risk/benefit ratio to the patient.
FDA approval is required before a new drug product may be marketed in the United States.
However, many historically over-the-counter (OTC) drugs are exempt from the FDAs premarket
approval requirements. In
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1972, the FDA instituted the ongoing OTC Drug Review to evaluate the
safety and effectiveness of all active ingredients and associated labeling (OTC drugs) that were
proven to be in the market before enactment of the Drug Amendments of 1962. Through this process,
the FDA issues monographs that set forth the specific active ingredients, dosages, indications and
labeling statements for OTC drugs that the FDA will consider generally recognized as safe and
effective and therefore not subject to premarket approval. Before issuance of a final OTC drug
monograph as a federal regulation, OTC drugs are classified by the FDA in one of three categories:
Category I ingredients and labeling which are deemed safe and effective for over-the-counter use;
Category II ingredients and labeling which are deemed not generally recognized as safe and
effective for over-the-counter use; and Category III ingredients and labeling which are deemed
possibly safe and effective with studies ongoing. Based upon the results of these ongoing
studies and pursuant to a court order, the FDA is required to reclassify all Category III
ingredients as either Category I or Category II before issuance of a final monograph through notice
and comment rule-making. For certain categories of OTC drugs not yet subject to a final monograph,
the FDA usually permits such drugs to continue to be marketed until a final monograph becomes
effective, unless the drug will pose a potential health hazard to consumers. Stated differently,
the FDA generally permits continued marketing only of any Category I products and those Category
III products that are safe but unknown efficacy products during the pendency of a final
monograph. Drugs subject to final monographs, as well as drugs that are subject only to proposed
monographs, are also and separately subject to various FDA regulations concerning, for example,
cGMP, general and specific OTC labeling requirements and prohibitions against promotion for
conditions other than those stated in the labeling. OTC drug manufacturing facilities are subject
to FDA inspection, and failure to comply with applicable regulatory requirements may lead to
administrative or judicially imposed penalties.
Each of the active ingredients in LOPROX® products and OMNICEF® products
have been approved by the FDA under an NDA. The active ingredient in DYNACIN® branded
products has been approved by the FDA under an ANDA. The active ingredient in the
TRIAZ® products has been classified as a Category III ingredient under a tentative final
FDA monograph for OTC use in treatment of labeled conditions. The FDA has requested, and a task
force of the Non-Prescription Drug Manufacturers Association (or NDMA), a trade association of
OTC drug manufacturers, has undertaken further studies to confirm that benzoyl peroxide, an active
ingredient in the TRIAZ® products, is not a tumor promoter when tested in conjunction
with UV light exposure. The TRIAZ® products, which we sell on a prescription basis,
have the same ingredients at the same dosage levels as the OTC products. When the FDA issues the
final monograph, one of several possible outcomes that may occur is that we may be required by the
FDA to discontinue sales of TRIAZ® products until and unless we file an NDA covering
such product. There can be no assurance as to the results of these studies or any FDA action to
reclassify benzoyl peroxide. In addition, there can be no assurance that adverse test results would
not result in withdrawal of TRIAZ® products from marketing. An adverse decision by the
FDA with respect to the safety of benzoyl peroxide could result in the assertion of product
liability claims against us and could have a material adverse effect on our business, financial
condition and results of operations.
Our TRIAZ® branded products must meet the composition and labeling requirements
established by the FDA for products containing their respective basic ingredients. We believe that
compliance with those established standards avoids the requirement for premarket clearance of these
products. There can be no assurance that the FDA will not take a contrary position in the future.
Our PLEXION® branded products, which contain the active
ingredients sodium sulfacetamide and sulfur, are marketed under the FDA compliance policy
entitled Marketed New Drugs without Approved NDAs or ANDAs.
We believe that certain of our products, as they are promoted and intended by us for use, are
exempt from being considered new drugs based upon the introduction date of their active
ingredients and therefore do not require premarket clearance. There can be no assurance that the
FDA will not take a contrary position in the future. If the FDA were to do so, we may be required
to seek FDA approval for these products, market these products as over-the-counter products or
withdraw such products from the market. We believe that these products are compliant with
applicable regulations governing product safety, use of ingredients, labeling, promotion and
manufacturing methods.
We also will be subject to foreign regulatory authorities governing clinical trials and
pharmaceutical sales for products we seek to market outside the United States. Whether or not FDA
approval has been obtained, approval of a product by the comparable regulatory authorities of
foreign countries must be obtained before marketing the
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product in those countries. The approval
process varies from country to country, the approval process time required may be longer or shorter
than that required for FDA approval, and any foreign regulatory agency may refuse to approve any
product we submit for review.
Our History
We filed our certificate of incorporation with the Secretary of State of Delaware on July 28,
1988. We completed our initial public offering during our fiscal year ended June 30, 1990, and
launched our initial pharmaceutical products during our fiscal year ended June 30, 1991. During
our fiscal year ended June 30, 2003, we acquired the exclusive U.S. and Canada license to the
RESTYLANE® family of products.
Financial Information About Segments
We operate in one significant business segment: Pharmaceuticals. Our current pharmaceutical
franchises are divided between the dermatological and non-dermatological fields. Information on
revenues, operating income, identifiable assets and supplemental revenue of our business franchises
appears in the consolidated financial statements included in Item 8 hereof.
Employees
At December 31, 2006, we had 391 full-time employees. No employees are subject to a
collective bargaining agreement. We believe our relationship with our employees is good.
Available Information
We make available free of charge on or through our Internet website, www.medicis.com, our
annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K, and all
amendments to those reports, if any, filed or furnished pursuant to Section 13(a) of 15(d) of the
Securities Exchange Act of 1934, as amended, as soon as reasonably practicable after they are
electronically filed with, or furnished to, the Securities and Exchange Commission. We also make
available free of charge on or through our website our Business Code of Conduct and Ethics,
Corporate Governance Guidelines, Nominating and Corporate Governance Committee Charter,
Compensation Committee Charter and Audit Committee Charter. The information contained on our
website is not intended to be incorporated into this annual report on Form 10-K.
Item 1A. Risk Factors
Our statements in this report, other reports that we file with the Securities and Exchange
Commission (SEC), our press releases and in public statements of our officers and corporate
spokespersons contain forward-looking statements within the meaning of Section 27A of the
Securities Act of 1933, as amended, Section 21 of the Securities Exchange Act of 1934, as amended,
and the Private Securities Litigation Reform Act of 1995. You can
identify these statements by the fact that they do not relate strictly to historical or current
events, and contain words such as anticipate, estimate, expect, project, intend, will,
plan, believe, should, outlook, could, target and other words of similar meaning in
connection with discussion of future operating or financial performance. These include statements
relating to future actions, prospective products or product approvals, future performance or
results of current and anticipated products, sales efforts, expenses, the outcome of contingencies
such as legal proceedings and financial results. These statements are based on certain assumptions
made by us based on our experience and perception of historical trends, current conditions,
expected future developments and other factors we believe are appropriate in the circumstances.
Such statements are subject to a number of assumptions, risks and uncertainties, many of which are
beyond our control. These forward-looking statements reflect the current views of senior
management with respect to future events and financial performance. No assurances can be given,
however, that these activities, events or developments will occur or that such results will be
achieved, and actual results may vary materially from those anticipated in any forward-looking
statement. Any such forward-looking statements, whether made in this report or elsewhere, should
be considered in context of the various disclosures made by us about our businesses including,
without limitation, the risk factors discussed below. We do not plan to
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update any such
forward-looking statements and expressly disclaim any duty to update the information contained in
this filing except as required by law.
We operate in a rapidly changing environment that involves a number of risks. The following
discussion highlights some of these risks and others are discussed elsewhere in this report. These
and other risks could materially and adversely affect our business, financial condition, prospects,
operating results or cash flows.
Risks Related To Our Business
We derive a majority of our sales from our primary products, and any factor adversely affecting
sales of these products would harm our business, financial condition and results of operations.
We believe that the prescription volume of our primary prescription products, in particular,
SOLODYN®, and sales of our dermal aesthetic product, RESTYLANE®, will
continue to constitute a significant portion of our sales for the foreseeable future. Accordingly,
any factor adversely affecting our sales related to these products, individually or collectively,
could harm our business, financial condition and results of operations. On June 5, 2006, Allergan
announced that the FDA had approved its JuvédermTM dermal filler family of products.
Allergan began marketing these products in January 2007. Other dermal filler products, such as
Artefill®, Radiesse®, and a cosmetic tissue augmentation product developed by
Anika Therapeutics, Inc. have also recently been approved by the FDA. Patients may differentiate
these products from RESTYLANE® based on price, efficacy and/or duration, which may
appeal to some patients. In addition, there are several dermal filler products under development
and/or in the FDA pipeline for approval which claim to offer equivalent or greater facial aesthetic
benefits to RESTYLANE® and, if approved, the companies producing such products could
charge less to doctors for their products. Many of our primary prescription products may be
subject to generic competition in the near future. Each of our primary products could be rendered
obsolete or uneconomical by competitive changes, including generic competition.
Sales related to our primary prescription products and RESTYLANE® could also be
adversely affected by other factors, including:
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manufacturing or supply interruptions; |
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the development of new competitive pharmaceuticals and technological advances to
treat the conditions addressed by our primary products, including the introduction of
new products into the marketplace; |
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generic competition; |
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marketing or pricing actions by one or more of our competitors; |
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regulatory action by the FDA and other government regulatory agencies; |
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importation of other dermal fillers; |
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changes in the prescribing or procedural practices of dermatologists, plastic
surgeons and/or podiatrists; |
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changes in the reimbursement or substitution policies of third-party payors or retail pharmacies; |
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product liability claims; |
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the outcome of disputes relating to trademarks, patents, license agreements and other rights; |
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changes in state and federal law that adversely affect our ability to market our
products to dermatologists, plastic surgeons and/or podiatrists; and |
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restrictions on travel affecting the ability of our sales force to market to
prescribing physicians and plastic surgeons in person. |
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Our operating results and financial condition may fluctuate.
Our operating results and financial condition may fluctuate from quarter to quarter and year
to year for a number of reasons. The following events or occurrences, among others, could cause
fluctuations in our financial performance from period to period:
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development of new competitive products or generics by others; |
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the timing and receipt of FDA approvals or lack of approvals; |
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changes in the amount we spend to develop, acquire or license new products,
technologies or businesses; |
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untimely contingent research and development payments under our third-party product
development agreements; |
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changes in the amount we spend to promote our products; |
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delays between our expenditures to acquire new products, technologies or businesses
and the generation of revenues from those acquired products, technologies or
businesses; |
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changes in treatment practices of physicians that currently prescribe our products; |
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changes in reimbursement policies of health plans and other similar health insurers,
including changes that affect newly developed or newly acquired products; |
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increases in the cost of raw materials used to manufacture our products; |
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manufacturing and supply interruptions, including failure to comply with
manufacturing specifications; |
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changes in prescription levels and the effect of economic changes in hurricane and
other natural disaster-affected areas; |
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the impact on our employees, customers, patients, manufacturers, suppliers, vendors,
and other companies we do business with and the resulting impact on the results of
operations associated with the possible mutation of the avian form of influenza from
birds or other animal species to humans, current human morbidity, and mortality levels
persist following such potential mutation; |
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the mix of products that we sell during any time period; |
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lower than expected demand for our products; |
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our responses to price competition; |
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expenditures as a result of legal actions; |
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market acceptance of our products; |
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the impairment and write-down of goodwill or other intangible assets; |
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implementation of new or revised accounting or tax rules or policies; |
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disposition of primary products, technologies and other rights; |
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termination or expiration of, or the outcome of disputes relating to, trademarks,
patents, license agreements and other rights; |
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increases in insurance rates for existing products and the cost of insurance for new
products; |
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general economic and industry conditions, including changes in interest rates
affecting returns on cash balances and investments that affect customer demand; |
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seasonality of demand for our products; |
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our level of research and development activities; |
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new accounting standards and/or changes to existing accounting standards that would
have a material effect on our consolidated financial position, results of operations or
cash flows; |
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costs and outcomes of any tax audits or any litigation involving intellectual
property, customers or other issues; and |
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timing of revenue recognition related to licensing agreements and/or strategic
collaborations. |
As a result, we believe that period-to-period comparisons of our results of operations are not
necessarily meaningful, and these comparisons should not be relied upon as an indication of future
performance. The above factors may cause our operating results to fluctuate and adversely affect
our financial condition and results of operations.
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We will be unable to meet our anticipated development and commercialization timelines if clinical
trials for our products are unsuccessful, delayed, or additional information is required by the
FDA.
The production and marketing of our products and our ongoing research and development,
pre-clinical testing and clinical trials activities are subject to extensive regulation and review
by numerous governmental authorities. Before obtaining regulatory approvals for the commercial
sale of any products, we and/or our partners must demonstrate through pre-clinical testing and
clinical trials that our products are safe and effective for use in humans. Conducting clinical
trials is a lengthy, time-consuming and expensive process. In addition to testing and approval
procedures, extensive regulations also govern marketing, manufacturing, distribution, labeling and
record-keeping procedures.
Completion of clinical trials may take several years or more. Our commencement and rate of
completion of clinical trials may be delayed by many factors, including:
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lack of efficacy during the clinical trials; |
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unforeseen safety issues; |
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slower than expected patient recruitment; |
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failure of Medicis, investigators, or other contractors to strictly adhere to
federal regulations governing the conduct and data collection procedures involved in
clinical trials; |
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development of issues that might delay or impede performance by a contractor; |
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errors in clinical documentation or at the clinical locations; |
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government or regulatory delays; and |
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unanticipated requests from the FDA for new or additional information. |
The results from pre-clinical testing and early clinical trials are often not predictive of
results obtained in later clinical trials. A number of new products have shown promising results
in clinical trials, but subsequently failed to establish sufficient safety and efficacy data to
obtain necessary regulatory approvals. Data obtained from pre-clinical and clinical activities are
susceptible to varying interpretations, which may delay, limit or prevent regulatory approval. In
addition, regulatory delays or rejections may be encountered as a result of many factors, including
perceived defects in the design of the clinical trials and changes in regulatory policy during the
period of product development. Any delays in, or termination of, our clinical trials could
materially and adversely affect our development and commercialization timelines, which could
adversely affect our financial condition, results of operations and cash flows.
If we are unable to secure and protect our intellectual property and proprietary rights, or if our
intellectual property rights are found to infringe upon the intellectual property rights of other
parties, our business could suffer.
Our success depends in part on our ability to obtain patents or rights to patents, protect
trade secrets, operate without infringing upon the proprietary rights of others, and prevent others
from infringing on our patents, trademarks, service marks and other intellectual property rights.
We believe that the protection of our trademarks and service marks is an important factor in
product recognition and in our ability to maintain or increase market share. If we do not
adequately protect our rights in our various trademarks and service marks from infringement, their
value to us could be lost or diminished. If the marks we use are found to infringe upon the
trademark or service mark of another company, we could be forced to stop using those marks and, as
a result, we could lose the value of those marks and could be liable for damages caused by an
infringement.
The patents and patent applications in which we have an interest may be challenged as to their
validity or enforceability. Challenges may result in potentially significant harm to our business.
The cost of responding to these challenges and the inherent costs to defend the validity of our
patents, including the prosecution of
infringements and the related litigation, could be substantial. Such litigation also could require
a substantial commitment of our managements time.
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We are pursuing several United States patent applications; although we cannot be sure that any
of these patents will ever be issued. We also have acquired rights under certain patents and
patent applications in connection with our licenses to distribute products and by assignment of
rights to patents and patent applications from certain of our consultants and officers. These
patents and patent applications may be subject to claims of rights by third parties. If there are
conflicting claims to the same patent or patent application, we may not prevail and, even if we do
have some rights in a patent or patent application, those rights may not be sufficient for the
marketing and distribution of products covered by the patent or patent application.
The ownership of a patent or an interest in a patent does not always provide significant
protection. Others may independently develop similar technologies or design around the patented
aspects of our technology. We only conduct patent searches to determine whether our products
infringe upon any existing patents when we think such searches are appropriate. As a result, the
products and technologies we currently market, and those we may market in the future, may infringe
on patents and other rights owned by others. If we are unsuccessful in any challenge to the
marketing and sale of our products or technologies, we may be required to license the disputed
rights, if the holder of those rights is willing to license such rights, otherwise we may be
required to cease marketing the challenged products, or to modify our products to avoid infringing
upon those rights. A claim or finding of infringement regarding one of our products could harm our
business, financial condition and results of operations. The costs of responding to infringement
claims could be substantial and could require a substantial commitment of our managements time.
The expiration of patents may expose our products to additional competition.
We also rely upon trade secrets, unpatented proprietary know-how and continuing technological
innovation in developing and manufacturing many of our primary products. It is our policy to
require all of our employees, consultants and advisors to enter into confidentiality agreements
prohibiting them from taking or disclosing our proprietary information and technology.
Nevertheless, these agreements may not provide meaningful protection for our trade secrets and
proprietary know-how if they are used or disclosed. Despite all of the precautions we may take,
people who are not parties to confidentiality agreements may obtain access to our trade secrets or
know-how. In addition, others may independently develop similar or equivalent trade secrets or
know-how.
If Q-Med is unable to protect its intellectual property and proprietary rights with respect to our
dermal filler products, our business could suffer.
RESTYLANE®, PERLANE®, RESTYLANE FINE LINESTM and
SubQTM currently have patent protection in the United States until 2015, and the
exclusivity period of the license granted to us by Q-Med will terminate on the later of (i) the
expiration of the last patent covering the products or (ii) upon the licensed know-how becoming
publicly known. If the validity or enforceability of these patents is successfully challenged, the
cost to us could be significant and our business may be harmed. For example, if any such
challenges are successful, Q-Med may be unable to supply products to us. As a result, we may be
unable to market, distribute and commercialize the products or it may no longer be profitable for
us to do so.
We may not be able to collect all scheduled license payments from BioMarin.
As part of our asset purchase agreement, license agreement and securities purchase agreement
with BioMarin Pharmaceutical Inc. (BioMarin) discussed in Note 8 to our consolidated financial
statements, BioMarin will make license payments to us of $1.75 million per quarter for the six
quarters beginning in January 2007 and $1.5 million per quarter for the subsequent four quarters
beginning in July 2008. While we did receive all scheduled quarterly license payments during 2006,
the Transition Period and during the fiscal year ending June 30, 2005, we cannot give any
assurances as to BioMarins continuing ability to make payments to us. Currently, our revenue
recognition of these payments is on a cash basis. In addition, we cannot give any assurances as to
BioMarins ability to make the $70.6 million payment to us in 2009 for the purchase of all of the
outstanding shares of Ascent Pediatrics. If BioMarin defaults on its obligations to make the
required payments, we may be
forced to incur indebtedness or otherwise reallocate our financial resources to cover the loss
of these expected cash payments.
16
We depend upon our key personnel and our ability to attract, train, and retain employees.
Our success depends significantly on the continued individual and collective contributions of
our senior management team, and Jonah Shacknai, our Chairman and Chief Executive Officer, in
particular. While we have entered into employment agreements with many members of our senior
management team, the loss of the services of any member of our senior management for any reason or
the inability to hire and retain experienced management personnel could adversely affect our
ability to execute our business plan and harm our operating results. In addition, our future
success depends on our ability to hire, train and retain skilled employees. Competition for these
employees is intense.
Our continued growth depends upon our ability to develop new products.
We have internally developed potential pharmaceutical compounds and agents. We also have
acquired the rights to certain potential compounds and agents in various stages of development. We
currently have a variety of new products in various stages of research and development and are
working on possible improvements, extensions and reformulations of some existing products. These
research and development activities, as well as the clinical testing and regulatory approval
process, which must be completed before commercial quantities of these developments can be sold,
will require significant commitments of personnel and financial resources. We cannot assure you
that we will be able to develop a product or technology in a timely manner, or at all. Delays in
the research, development, testing or approval processes will cause a corresponding delay in
revenue generation from those products. Regardless of whether they are ever released to the
market, the expense of such processes will have already been incurred.
We reevaluate our research and development efforts regularly to assess whether our efforts to
develop a particular product or technology are progressing at a rate that justifies our continued
expenditures. On the basis of these reevaluations, we have abandoned in the past, and may abandon
in the future, our efforts on a particular product or technology. Products that we research or
develop may not be successfully commercialized. If we fail to take a product or technology from
the development stage to market on a timely basis, we may incur significant expenses without a
near-term financial return.
We have in the past, and may in the future, supplement our internal research and development
by entering into research and development agreements with other pharmaceutical companies. We may,
upon entering into such agreements, be required to make significant up-front payments to fund the
projects. We cannot be sure, however, that we will be able to locate adequate research partners or
that supplemental research will be available on terms acceptable to us in the future. If we are
unable to enter into additional research partnership arrangements, we may incur additional costs to
continue research and development internally or abandon certain projects. Even if we are able to
enter into collaborations, we cannot assure you that these arrangements will result in successful
product development or commercialization.
There is also a risk that our products may not gain market acceptance among physicians,
patients and the medical community generally. The degree of market acceptance of any medical
device or other product that we develop will depend on a number of factors, including demonstrated
clinical efficacy and safety, cost-effectiveness, potential advantages over alternative products,
and our marketing and distribution capabilities. Physicians will not recommend our products until
clinical data or other factors demonstrate their safety and efficacy compared to other competing
products. Even if the clinical safety and efficacy of using our products is established,
physicians may elect to not recommend using them for any number of other reasons, including whether
our products best meet the particular needs of the individual patient.
We may acquire companies in the future and these acquisitions could disrupt our business. In
addition, we may not obtain the benefits that the acquisitions were intended to create.
As part of our business strategy, we regularly consider and, as appropriate, make acquisitions
of technologies, products and businesses that we believe are complementary to our business.
Acquisitions typically
entail many risks and could result in difficulties in integrating the operations, personnel,
technologies and products of
17
the companies acquired, some of which may result in significant
charges to earnings. If we are unable to successfully integrate our acquisitions with our existing
business, we may not obtain the advantages that the acquisitions were intended to create, which may
materially adversely affect our business, results of operations, financial condition and cash
flows, our ability to develop and introduce new products and the market price of our stock. In
addition, in connection with acquisitions, we could experience disruption in our business or
employee base, or key employees of companies that we acquire may seek employment elsewhere,
including with our competitors. Furthermore, the products of companies we acquire may overlap with
our products or those of our customers, creating conflicts with existing relationships or with
other commitments that are detrimental to the combined businesses.
We may not be able to identify and acquire products, technologies and businesses on acceptable
terms, if at all, which may constrain our growth.
Our strategy for continued growth includes the acquisition of products, technologies and
businesses. These acquisitions could involve acquiring other pharmaceutical companies assets,
products or technologies. In addition, we may seek to obtain licenses or other rights to develop,
manufacture and distribute products. We cannot be certain that we will be able to identify
suitable acquisition or licensing candidates, if they will be accretive in the near future, or if
any will be available on acceptable terms. Other pharmaceutical companies, with greater financial,
marketing and sales resources than we have, have also tried to grow through similar acquisition and
licensing strategies. Because of their greater resources, our competitors may be able to offer
better terms for an acquisition or license than we can offer, or they may be able to demonstrate a
greater ability to market licensed products. In addition, even if we identify potential
acquisitions and enter into definitive agreements relating to such acquisitions, we may not be able
to consummate planned acquisitions on the terms originally agreed upon or at all. For example, on
March 20, 2005, we entered into an agreement and plan of merger with Inamed, pursuant to which we
agreed to acquire Inamed. On December 13, 2005, we entered into a merger termination agreement
with Inamed following Allergan Inc.s exchange offer for all outstanding shares of Inamed, which
was commenced on November 21, 2005.
Our success depends on our ability to manage our growth.
We have experienced a period of rapid growth from both acquisitions and internal expansion of
our operations. This growth has placed significant demands on our human and financial resources.
We must continue to improve our operational, financial and management information controls and
systems and effectively motivate, train and manage our employees to properly manage this growth.
Even if these steps are taken, we cannot be sure that our acquisitions will be integrated
successfully into our business operations. If we are not able to successfully integrate our
acquisitions, we may not obtain the advantages that the acquisitions were intended to create. In
addition, if we do not manage this growth effectively, maintain the quality of our products despite
the demands on our resources and retain key personnel, our business could be harmed.
Implementation of our new enterprise resource planning system could cause business interruptions
and negatively affect our profitability and cash flows.
During 2007, we will be developing and will begin implementing a new enterprise resource
planning (ERP) system to help us integrate and improve the financial and operational aspects of
our business. The design and implementation of an ERP system involves risks such as cost overruns,
project delays and business interruption. A significant amount of our resources will be committed
to the ERP project, and we may experience challenges in designing and implementing the new ERP
system that could adversely affect our operations and our ability to timely and accurately process
and report key components of our financial position. If we experience a material business
interruption as a result of our design and implementation of our new ERP system, it could have a
material adverse effect on our business, results of operations and cash flows.
We depend on licenses from others, and any loss of such licenses could harm our business, market
share and profitability.
We have acquired the rights to manufacture, use and market certain products, including certain
of our primary products. We also expect to continue to obtain licenses for other products and
technologies in the future.
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Our license agreements generally require us to develop a market for
the licensed products. If we do not develop these markets within specified time frames, the
licensors may be entitled to terminate these license agreements.
We may fail to fulfill our obligations under any particular license agreement for various
reasons, including insufficient resources to adequately develop and market a product, and lack of
market development despite our diligence and lack of product acceptance. Our failure to fulfill
our obligations could result in the loss of our rights under a license agreement.
Our inability to continue the distribution of any particular licensed product could harm our
business, market share and profitability. Also, certain products we license are used in connection
with other products we own or license. A loss of a license in such circumstances could materially
harm our ability to market and distribute these other products.
We depend on a limited number of customers, and if we lose any of them, our business could be
harmed.
Our customers include some of the United States leading wholesale pharmaceutical
distributors, such as Cardinal, McKesson, and major drug chains. During 2006, McKesson and
Cardinal accounted for 56.8% and 19.3%, respectively, of our net revenues. During the Transition
Period, McKesson and Cardinal accounted for 54.9% and 18.9%, respectively, of our net revenues.
During fiscal 2005, McKesson and Cardinal accounted for 51.2%, and 21.8%, respectively, of our net
revenues. The loss of any of these customers accounts or a material reduction in their purchases
could harm our business, financial condition or results of operations. In addition, we may face
pricing pressure from our customers. McKesson is our sole distributor of our RESTYLANE®
products in the United States and Canada.
The consolidation of drug wholesalers could increase competition and pricing pressures throughout
the pharmaceutical industry.
We sell our pharmaceutical products primarily through major wholesalers. These customers
comprise a significant part of the distribution network for pharmaceutical products in the United
States. This distribution network is continuing to undergo significant consolidation marked by
mergers and acquisitions. As a result, a smaller number of large wholesale distributors control a
significant share of the market. In addition, the number of independent drug stores and small
chains has decreased as retail consolidation has occurred. Further consolidation among, or any
financial difficulties of, distributors or retailers could result in the combination or elimination
of warehouses which may result in product returns to our company, cause a reduction in the
inventory levels of distributors and retailers, result in reductions in purchases of our products,
increase competitive and pricing pressures on pharmaceutical manufacturers, any of which could harm
our business, financial condition and results of operations.
We rely on others to manufacture our products.
Currently, we outsource our entire product manufacturing needs. Typically, our manufacturing
contracts are short-term. We are dependent upon renewing agreements with our existing
manufacturers or finding replacement manufacturers to satisfy our requirements. As a result, we
cannot be certain that manufacturing sources will continue to be available or that we can continue
to outsource the manufacturing of our products on reasonable or acceptable terms.
The underlying cost to us for manufacturing our products is established in our agreements with
these outside manufacturers. Because of the short-term nature of these agreements, our expenses
for manufacturing are not fixed and could change from contract to contract. If the cost of
production increases, our gross margins could be negatively affected.
In addition, we rely on outside manufacturers to provide us with an adequate and reliable
supply of our products on a timely basis. Loss of a supplier or any difficulties that arise in the
supply chain could significantly affect our inventories and supply of products available for sale.
We do not have alternative sources of supply for all of our products. If a primary supplier of any
of our primary products is unable to fulfill our requirements for any
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reason, it could reduce our
sales, margins and market share, as well as harm our overall business and financial results. If we
are unable to supply sufficient amounts of our products on a timely basis, our revenues and market
share could decrease and, correspondingly, our profitability could decrease.
Under several exclusive supply agreements, with certain exceptions, we must purchase most of
our product supply from specific manufacturers. If any of these exclusive manufacturer or supplier
relationships were terminated, we would be forced to find a replacement manufacturer or supplier.
The FDA requires that all manufacturers used by pharmaceutical companies comply with the FDAs
regulations, including the cGMP regulations applicable to manufacturing processes. The cGMP
validation of a new facility and the approval of that manufacturer for a new drug product may take
a year or more before manufacture can begin at the facility. Delays in obtaining FDA validation of
a replacement manufacturing facility could cause an interruption in the supply of our products.
Although we have business interruption insurance covering the loss of income for up to 12 months,
which may mitigate the harm to us from the interruption of the manufacturing of our largest selling
products caused by certain events, the loss of a manufacturer could still cause a reduction in our
sales, margins and market share, as well as harm our overall business and financial results.
We and our third-party manufacturers rely on a limited number of suppliers of the raw materials of
our products. A disruption in supply of raw material would be disruptive to our inventory supply.
We and the manufacturers of our products rely on suppliers of raw materials used in the
production of our products. Some of these materials are available from only one source and others
may become available from only one source. We try to maintain inventory levels that are no greater
than necessary to meet our current projections, which could have the affect of exacerbating supply
problems. Any interruption in the supply of finished products could hinder our ability to timely
distribute finished products. If we are unable to obtain adequate product supplies to satisfy our
customers orders, we may lose those orders and our customers may cancel other orders and stock and
sell competing products. This, in turn, could cause a loss of our market share and reduce our
revenues. In addition, any disruption in the supply of raw materials or an increase in the cost of
raw materials to our manufacturers could have a significant effect on their ability to supply us
with our products, which would adversely affect our financial condition and results of operations.
We could experience difficulties in obtaining supplies of RESTYLANE
®
,PERLANE
®
, RESTYLANE FINE LINES
TM and SubQTM.
The manufacturing process to create bulk non-animal stabilized hyaluronic acid necessary to
produce RESTYLANE®, PERLANE®, RESTYLANE FINE LINESTM and
SubQTM products is technically complex and requires significant lead-time. Any failure
by us to accurately forecast demand for finished product could result in an interruption in the
supply of RESTYLANE®, PERLANE®, RESTYLANE FINE LINESTM and
SubQTM products and a resulting decrease in sales of the products.
We depend exclusively on Q-Med for our supply of RESTYLANE®, PERLANE®,
RESTYLANE FINE LINESTM and SubQTM products. There are currently no
alternative suppliers of these products. Q-Med has committed to supply RESTYLANE® to us
under a long-term license that is subject to customary conditions and our delivery of specified
milestone payments. Q-Med manufactures RESTYLANE®, PERLANE®, RESTYLANE FINE
LINESTM and SubQTM at its facility in Uppsala, Sweden. We cannot be certain
that Q-Med will be able to meet our current or future supply requirements. Any impairment of
Q-Meds manufacturing capacities could significantly affect our inventories and our supply of
products available for sale.
Supply interruptions may disrupt our inventory levels and the availability of our products.
Numerous factors could cause interruptions in the supply of our finished products, including:
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We estimate customer demand for our prescription products primarily through use of third party
syndicated data sources which track prescriptions written by health care providers and dispensed by
licensed pharmacies. The data represents extrapolations from information provided only by certain
pharmacies, and are estimates of historical demand levels. We estimate customer demand for our
non-prescription products primarily through internal data that we compile. We observe trends from
these data, and, coupled with certain proprietary information, prepare demand forecasts that are
the basis for purchase orders for finished and component inventory from our third party
manufacturers and suppliers. Our forecasts may fail to accurately anticipate ultimate customer
demand for products. Overestimates of demand may result in excessive inventory production and
underestimates may result in inadequate supply of our products in channels of distribution.
We sell our products primarily to major wholesalers and retail pharmacy chains. Approximately
75% of our gross revenues are derived from two major drug wholesale concerns. While we attempt to
estimate inventory levels of our products at our major wholesale customers by using historical
prescription information, historical purchase patterns, and limited inventory level information by
product type, this process is inherently imprecise. Rarely do wholesale customers provide us
complete inventory levels at regional distribution centers, or within their national distribution
systems. We rely wholly upon our wholesale and drug chain customers to effect the distribution
allocation of our products.
We periodically offer promotions to wholesale and chain drugstore customers to encourage
dispensing of our prescription products, consistent with prescriptions written by licensed health
care providers. Because many of our prescription products compete in multi-source markets, it is
important for us to ensure the licensed health care providers dispensing instructions are
fulfilled with our branded products and are not substituted with a generic product or another
therapeutic alternative product which may be contrary to the licensed health care providers
recommended prescribed Medicis brand. We believe that a critical component of our brand protection
program is maintenance of full product availability at drugstore and wholesale customers. We
believe such availability reduces the probability of local and regional product substitutions,
shortages and backorders, which could result in lost sales. We expect to continue providing
favorable terms to wholesale and retail drug chain customers as may be necessary to ensure the
fullest possible distribution of our branded products within the pharmaceutical chain of commerce.
We cannot control or influence greatly the purchasing patterns of our wholesale and retail
drug chain customers. They are highly sophisticated customers that purchase our products in a
manner consistent with their industry practices and, presumably, based upon their projected demand
levels. Purchases by any given customer, during any given period, may be above or below actual
prescription volumes of any of our products during the same period, resulting in fluctuations in
product inventory in the distribution channel. Any decision made by management to reduce wholesale
inventory levels will decrease our product revenue.
Fluctuations in demand for our products create inventory maintenance uncertainties.
As a result of customer buying patterns, a substantial portion of our prescription product
revenues has been recognized in the last month of each quarter, and we schedule our inventory
purchases to meet anticipated customer demand. As a result, miscalculation of customer demand or
relatively small delays in our receipt of manufactured products could result in revenues being
deferred or lost. Our operating expenses are based upon anticipated sales levels, and a high
percentage of our operating expenses are relatively fixed in the short term. Depending on the
customer, we recognize revenue at the time of shipment to the customer, or at the time of receipt
by the customer, net of estimated provisions. Consequently, variations in the timing of
revenue recognition could cause significant fluctuations in operating results from period to period
and may result in unanticipated periodic earnings shortfalls or losses.
21
We selectively outsource certain non-sales and non-marketing services, and cannot assure you that
we will be able to obtain adequate supplies of such services on acceptable terms.
To enable us to focus on our core marketing and sales activities, we selectively outsource
certain non-sales and non-marketing functions, such as laboratory research, manufacturing and
warehousing. As we expand our activities in these areas, additional financial resources are
expected to be utilized. We typically do not enter into long-term manufacturing contracts with
third party manufacturers. Whether or not such contracts exist, we cannot assure you that we will
be able to obtain adequate supplies of such services or products in a timely fashion, on acceptable
terms, or at all.
Importation of products from Canada and other countries into the United States may lower the prices
we receive for our products.
Our products are subject to competition from lower priced versions of our products and
competing products from Canada and other countries where government price controls or other market
dynamics result in lower prices. The ability of patients and other customers to obtain these lower
priced imports has grown significantly as a result of the Internet, an expansion of pharmacies in
Canada and elsewhere targeted to American purchasers, the increase in United States-based
businesses affiliated with Canadian pharmacies marketing to American purchasers, and other factors.
Most of these foreign imports are illegal under current United States law. However, the volume of
imports continues to rise due to the limited enforcement resources of the FDA and the United States
Customs Service, and there is increased political pressure to permit the imports as a mechanism for
expanding access to lower priced medicines.
In December 2003, Congress enacted the Medicare Prescription Drug, Improvement and
Modernization Act of 2003. This law contains provisions that may change United States import laws
and expand consumers ability to import lower priced versions of our and competing products from
Canada, where there are government price controls. These changes to United States import laws will
not take effect unless and until the Secretary of Health and Human Services certifies that the
changes will lead to substantial savings for consumers and will not create a public health safety
issue. The former Secretary of Health and Human Services did not make such a certification.
However, it is possible that the current Secretary or a subsequent Secretary could make the
certification in the future. As directed by Congress, a task force on drug importation recently
conducted a comprehensive study regarding the circumstances under which drug importation could be
safely conducted and the consequences of importation on the health, medical costs and development
of new medicines for United States consumers. The task force issued its report in December 2004,
finding that there are significant safety and economic issues that must be addressed before
importation of prescription drugs is permitted, and the current Secretary has not yet announced any
plans to make the required certification. In addition, federal legislative proposals have been made
to implement the changes to the United States import laws without any certification, and to broaden
permissible imports in other ways. Even if the changes to the United States import laws do not
take effect, and other changes are not enacted, imports from Canada and elsewhere may continue to
increase due to market and political forces, and the limited enforcement resources of the FDA, the
United States Customs Service and other government agencies.
The importation of foreign products adversely affects our profitability in the United States.
This impact could become more significant in the future, and the impact could be even greater if
there is a further change in the law or if state or local governments take further steps to
facilitate the importation of products from abroad.
If we become subject to product liability claims, our earnings and financial condition could
suffer.
We are exposed to risks of product liability claims from allegations that our products
resulted in adverse effects to the patient or others. These risks exist even with respect to those
products that are approved for commercial sale by the FDA and manufactured in facilities licensed
and regulated by the FDA.
In addition to our desire to reduce the scope of our potential exposure to these types of
claims, many of our customers require us to maintain product liability insurance as a condition of
conducting business with us. We currently carry product liability insurance in the amount of $50.0
million per claim and $50.0 million in the
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aggregate on a claims-made basis. Nevertheless, this
insurance may not be sufficient to cover all claims made against us. Insurance coverage is
expensive and may be difficult to obtain. As a result, we cannot be certain that our current
coverage will continue to be available in the future on reasonable terms, if at all. If we are
liable for any product liability claims in excess of our coverage or outside of our coverage, the
cost and expense of such liability could cause our earnings and financial condition to suffer.
Rising insurance costs could negatively impact profitability.
The cost of insurance, including workers compensation, product liability and general liability
insurance, have risen significantly in recent years and may increase in the future. In response,
we may increase deductibles and/or decrease certain coverages to mitigate these costs. These
increases, and our increased risk due to increased deductibles and reduced coverages, could have a
negative impact on our results of operations, financial condition and cash flows.
If we suffer negative publicity concerning the safety of our products, our sales may be harmed and
we may be forced to withdraw products.
Physicians and potential patients may have a number of concerns about the safety of our
products, whether or not such concerns have a basis in generally accepted science or peer-reviewed
scientific research. Negative publicity, whether accurate or inaccurate, concerning our products
could reduce market or governmental acceptance of our products and could result in decreased
product demand or product withdrawal. In addition, significant negative publicity could result in
an increased number of product liability claims, whether or not these claims are supported by
applicable law.
RESTYLANE
® is a consumer product and as such, it is susceptible to changes in popular
trends and applicable laws, which could adversely affect sales or product margins of RESTYLANE®.
RESTYLANE® is a consumer product. If we fail to anticipate, identify or react to
competitive products or if consumer preferences in the cosmetic marketplace shift to other
treatments for the treatment of fine lines, wrinkles and deep facial folds, we may experience a
decline in demand for RESTYLANE®. In addition, the popular media has at times in the
past produced, and may continue in the future to produce, negative reports regarding the efficacy,
safety or side effects of facial aesthetic products. Consumer perceptions of RESTYLANE®
may be negatively impacted by these reports and other reasons.
Demand for RESTYLANE® may be materially adversely affected by changing economic
conditions. Generally, the costs of cosmetic procedures are borne by individuals without
reimbursement from their medical insurance providers or government programs. Individuals may be
less willing to incur the costs of these procedures in weak or uncertain economic environments, and
demand for RESTYLANE® could be adversely affected.
We may not be able to repurchase the Old Notes and New Notes when required.
In June 2002, we sold Contingent Convertible Senior Notes, due in 2032 (the Old Notes), in
the amount of $400.0 million. In August 2003, we exchanged approximately $230.8 million in
principal of these Old Notes for approximately $283.9 million of our Contingent Convertible Senior
Notes due in 2033 (the New Notes).
On June 4, 2007, 2012 and 2017 and upon the occurrence of a change in control, holders of the
remaining Old Notes may require us to offer to repurchase their Old Notes for cash. On June 4,
2008, 2013 and 2018 and upon the occurrence of a change in control, holders of the New Notes may
require us to offer to repurchase their New Notes for cash. We may not have sufficient funds at
the time of any such events to make the required repurchases.
The source of funds for any repurchase required as a result of any such events will be our
available cash or cash generated from operating activities or other sources, including borrowings,
sales of assets, sales of equity or funds provided by a new controlling entity. We cannot assure
you, however, that sufficient funds will be available at the time of any such events to make any
required repurchases of the Notes tendered. Furthermore, the use of
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available cash to fund the
repurchase of the Old Notes or New Notes may impair our ability to obtain additional financing in
the future.
Our publicly-filed reports are reviewed by the SEC from time to time and any significant changes
required as a result of any such review may result in material liability to us, and have a material
adverse impact on the trading price of our common stock.
The reports of publicly-traded companies are subject to review by the SEC from time to time
for the purpose of assisting companies in complying with applicable disclosure requirements and to
enhance the overall effectiveness of companies public filings, and comprehensive reviews of such
reports are now required at least every three years under the Sarbanes-Oxley Act of 2002. SEC
reviews may be initiated at any time. While we believe that our previously filed SEC reports
comply, and we intend that all future reports will comply in all material respects with the
published rules and regulations of the SEC, we could be required to modify or reformulate
information contained in prior filings as a result of an SEC review. Any modification or
reformulation of information contained in such reports could be significant and result in material
liability to us and have a material adverse impact on the trading price of our common stock.
Unanticipated changes in our tax rates or exposure to additional income tax liabilities could
affect our profitability.
We are subject to income taxes in both the U.S. and other foreign jurisdictions. Our
effective tax rate could be adversely affected by changes in the mix of earnings in countries with
different statutory tax rates, changes in the valuation of deferred tax assets and liabilities,
changes in or interpretations of tax laws including pending tax law changes (such as the research
and development credit), changes in our manufacturing activities and changes in our future levels
of research and development spending. In addition, we are subject to the continuous examination of
our income tax returns by the Internal Revenue Service and other tax authorities. We regularly
assess the likelihood of outcomes resulting from these examinations to determine the adequacy of
our provision for income taxes. There can be no assurance that the outcomes from these continuous
examinations will not have an adverse effect on our provision for income taxes and estimated income
tax liabilities.
Risks Related to Our Industry
The growth of managed care organizations, other third-party reimbursement policies, state
regulatory agencies and retailer fulfillment policies may harm our pricing, which may reduce our
market share and margins.
Our operating results and business success depend in large part on the availability of
adequate third-party payor reimbursement to patients for our prescription-brand products. These
third-party payors include governmental entities such as Medicaid, private health insurers and
managed care organizations. Because of the size of the patient population covered by managed care
organizations, marketing of prescription drugs to them and the pharmacy benefit managers that serve
many of these organizations has become important to our business.
The trend toward managed healthcare in the United States and the growth of managed care
organizations could significantly influence the purchase of pharmaceutical products, resulting in
lower prices and a reduction in product demand. Managed care organizations and other third party
payors try to negotiate the pricing of medical services and products to control their costs.
Managed care organizations and pharmacy benefit managers typically develop formularies to reduce
their cost for medications. Formularies can be based on the prices and therapeutic benefits of the
available products. Due to their lower costs, generic products are often favored. The breadth of
the products covered by formularies varies considerably from one managed care organization to
another, and many formularies include alternative and competitive products for treatment of
particular medical conditions. Exclusion of a product from a formulary can lead to its sharply
reduced usage in the managed care organization patient
population. Payment or reimbursement of only a portion of the cost of our prescription
products could make our products less attractive, from a net-cost perspective, to patients,
suppliers and prescribing physicians. We cannot be certain that the reimbursement policies of these
entities will be adequate for our pharmaceutical products to compete on a price basis. If our
products are not included within an adequate number of formularies or adequate reimbursement levels
are not provided, or if those policies increasingly favor generic products, our market share and
gross margins could be harmed, as could our business, financial condition, results of operations
and cash flows.
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In addition, healthcare reform could affect our ability to sell our products and may have a
material adverse effect on our business, results of operations, financial condition and cash flows.
Some of our products are not of a type generally eligible for reimbursement. It is possible
that products manufactured by others could address the same effects as our products and be subject
to reimbursement. If this were the case, some of our products may be unable to compete on a price
basis. In addition, decisions by state regulatory agencies, including state pharmacy boards,
and/or retail pharmacies may require substitution of generic for branded products, may prefer
competitors products over our own, and may impair our pricing and thereby constrain our market
share and growth.
Managed care initiatives to control costs have influenced primary-care physicians to refer
fewer patients to dermatologists and other specialists. Further reductions in these referrals
could reduce the size of our potential market, and harm our business, financial condition, results
of operations and cash flows.
We are subject to extensive governmental regulation.
Pharmaceutical companies are subject to significant regulation by a number of national, state
and local governments and agencies. The FDA administers requirements covering testing,
manufacturing, safety, effectiveness, labeling, storage, record keeping, approval, sampling,
advertising and promotion of our products. Several states have also instituted laws and
regulations covering some of these same areas. In addition, the FTC and state and local
authorities regulate the advertising of over-the-counter drugs and cosmetics. Failure to comply
with applicable regulatory requirements could, among other things, result in:
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fines; |
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|
changes to advertising; |
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|
suspensions of regulatory approvals of products; |
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product recalls; |
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|
delays in product distribution, marketing and sale; and |
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civil or criminal sanctions. |
Our prescription and over-the-counter products receive FDA review regarding their safety and
effectiveness. However, the FDA is permitted to revisit and change its prior determinations. We
cannot be sure that the FDA will not change its position with regard to the safety or effectiveness
of our products. If the FDAs position changes, we may be required to change our labeling or
formulations or cease to manufacture and market the challenged products. Even prior to any formal
regulatory action, we could voluntarily decide to cease distribution and sale or recall any of our
products if concerns about their safety or effectiveness develop.
Before marketing any drug that is considered a new drug by the FDA, the FDA must provide its
approval of the product. All products which are considered drugs which are not new drugs and
that generally are recognized by the FDA as safe and effective for use do not require the FDAs
approval. We believe that some of our products, as they are promoted and intended for use, are
exempt from treatment as new drugs and are not subject to approval by the FDA. The FDA, however,
could take a contrary position, and we could be required to seek FDA approval of those products and
the marketing of those products. We could also be required to withdraw those products from the
market. For example, in the August 29, 2006 Federal Register, the FDA issued a notice of proposed
rulemaking to categorically establish that over-the-counter skin bleaching drug products are not
generally recognized as safe and effective and are misbranded. If the proposed rule is adopted,
all manufacturers of skin
bleaching products would be required to remove their products from the market and obtain FDA
approval prior to re-entering the U.S. market. The FDA has issued a Guidance document entitled Marketed Unapproved Drugs Compliance Policy
Guide. During a public workshop on January 9, 2007 concerning this Guidance, the FDA was reported
to have stated the intention to accelerate its evaluation of such
products. ESOTERICA® is an over-the-counter
product line that we sell that contains bleaching products that would be regulated by the proposed
rule and if that occurs we do not currently intend to invest in obtaining an approved NDA for this
product line. This product accounted for approximately $2.0 million in net revenues during 2006.
25
Sales representative activities may also be subject to the Voluntary Compliance Guidance
issued for pharmaceutical manufacturers by the Office of Inspector General (OIG) of the
Department of Health and Human Services, as well as state laws and regulations. We have
established compliance program policies and training programs for our sales force, which we believe
are appropriate. The OIG and/or state law enforcement entities, however, could take a contrary
position, and we could be required to modify our sales representative activities. See Item 3.
Legal Proceedings of this Form 10-K.
If we market products in a manner that violates health care fraud and abuse laws, we may be subject
to civil or criminal penalties.
Federal health care program anti-kickback statutes prohibit, among other things, knowingly and
willfully offering, paying, soliciting or receiving remuneration to induce, or in return for
purchasing, leasing, ordering or arranging for the purchase, lease or order of any health care item
or service reimbursable under Medicare, Medicaid, or other federally financed health care programs.
This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers on
one hand and prescribers, purchasers and formulary managers on the other. Although there are a
number of statutory exemptions and regulatory safe harbors protecting certain common activities
from prosecution, the exemptions and safe harbors are drawn narrowly, and practices that involve
remuneration intended to induce prescribing, purchasing, or recommending may be subject to scrutiny
if they do not qualify for an exemption or safe harbor. Although we believe that we are in
compliance, our practices may be determined to fail to meet all of the criteria for safe harbor
protection from anti-kickback liability.
Federal false claims laws prohibit any person from knowingly presenting, or causing to be
presented, a false claim for payment to the federal government, or knowingly making, or causing to
be made, a false statement to get a false claim paid. Pharmaceutical companies have been
prosecuted under these laws for a variety of alleged promotional and marketing activities, such as
allegedly providing free product to customers with the expectation that the customers would bill
federal programs for the product; reporting to pricing services inflated average wholesale prices
that were then used by federal programs to set reimbursement rates; engaging in off-label promotion
that caused claims to be submitted to Medicaid for non-covered off-label uses; and submitting
inflated best price information to the Medicaid Rebate Program. The majority of states also have
statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply
to items and services reimbursed under Medicaid and other state programs, or, in several states,
apply regardless of the payor. Sanctions under these federal and state laws may include civil
monetary penalties, exclusion of a manufacturers products from reimbursement under government
programs, criminal fines, and imprisonment. Because of the breadth of these laws and the
narrowness of the safe harbors, it is possible that some of our business activities could be
subject to challenge under one or more of such laws. The government notified us on December 14,
2004, that it is investigating claims that we violated the federal False Claims Act in connection
with the alleged off-label marketing and promotion of LOPROX® and LOPROX® TS
products to pediatricians during periods prior to our May 2004 disposition of our pediatric sales
division. On or around October 5, 2006, the parties agreed in principle to resolve all federal and
state civil claims against us for approximately $9.8 million. As
of December 31, 2006, we have accrued a loss contingency of
$10.2 million for this matter in connection with the possibility
of additional expenses related to the settlement amount. On or about October
12, 2006, the Company and the United States Attorneys Office for the District of Kansas entered
into a Nonprosecution Agreement wherein the government agreed not to prosecute the Company for any
alleged criminal violations relating to the alleged off-label marketing and promotion of
LOPROX®. In exchange for the governments agreement not to pursue any criminal charges
against us, we have agreed to continue cooperating with the government in its ongoing investigation
into whether our past and present employees and officers may have violated federal criminal law
regarding alleged off-label marketing and promotion of LOPROX® to pediatricians. No
individuals have been designated as targets of the investigation. Any such claims,
prosecutions or other proceedings, with respect to our past and present employees and officers, the
cost of their defense and fines and penalties resulting therefrom could have a material impact on
our reputation, business and financial condition. The Company also is engaged in discussions with
the Office of Inspector General of the Department of Health and Human Services (IG) to resolve
any potential administrative claims the IG may have arising out of the governments investigation
into the Companys marketing and promotion of LOPROX®. See Item 3. Legal Proceedings of
this Form 10-K
26
Obtaining FDA and other regulatory approvals is time consuming, expensive and uncertain.
The process of obtaining FDA and other regulatory approvals is time consuming and expensive.
Clinical trials are required and the marketing and manufacturing of pharmaceutical products are
subject to rigorous testing procedures. We may not be able to obtain FDA approval to conduct
clinical trials or to manufacture or market any of the products we develop, acquire or license on a
timely basis or at all. Moreover, the costs to obtain approvals could be considerable, and the
failure to obtain or delays in obtaining an approval could significantly harm our business
performance and financial results. Even if pre-marketing approval from the FDA is received, the FDA
is authorized to impose post-marketing requirements such as:
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testing and surveillance to monitor the product and its continued compliance with
regulatory requirements; |
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|
submitting products for inspection and, if any inspection reveals that the product
is not in compliance, prohibiting the sale of all products from the same lot; |
|
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|
suspending manufacturing; |
|
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|
|
switching status from prescription to over-the-counter drug; |
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|
recalling products; and |
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|
withdrawing marketing clearance. |
In their regulation of advertising, the FDA and FTC from time to time issue correspondence to
pharmaceutical companies alleging that some advertising or promotional practices are false,
misleading or deceptive. The FDA has the power to impose a wide array of sanctions on companies for
such advertising practices, and the receipt of correspondence from the FDA alleging these practices
could result in the following:
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|
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incurring substantial expenses, including fines, penalties, legal fees and costs to
comply with the FDAs requirements; |
|
|
|
|
changes in the methods of marketing and selling products; |
|
|
|
|
taking FDA-mandated corrective action, which may include placing advertisements or
sending letters to physicians rescinding previous advertisements or promotion; and |
|
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|
|
disruption in the distribution of products and loss of sales until compliance with
the FDAs position is obtained. |
In recent years, various legislative proposals have been offered in Congress and in some state
legislatures that include major changes in the health care system. These proposals have included
price or patient reimbursement constraints on medicines, restrictions on access to certain
products, reimportation of products from Canada or other sources and mandatory substitution of
generic for branded products. We cannot predict the outcome of such initiatives, and it is
difficult to predict the future impact of the broad and expanding legislative and regulatory
requirements affecting us.
We face significant competition within our industry.
The pharmaceutical and dermal aesthetics industries are highly competitive. Competition in our
industry occurs on a variety of fronts, including:
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developing and bringing new products to market before others; |
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|
developing new technologies to improve existing products; |
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|
developing new products to provide the same benefits as existing products at less cost; and |
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|
developing new products to provide benefits superior to those of existing products. |
The intensely competitive environment requires an ongoing, extensive search for technological
innovations and the ability to market products effectively. Consequently, we must continue to
develop and introduce products in a timely and cost-efficient manner to effectively compete in the
marketplace and maintain our revenue and gross margins.
27
Our competitors vary depending upon product categories. Many of our competitors are large,
well-established companies in the fields of pharmaceuticals, chemicals, cosmetics and health care.
Among our largest competitors are Allergan, Galderma, Johnson & Johnson, Sanofi-Aventis, Stiefel
Laboratories, Warner Chilcott and others.
Many of these companies have greater resources than we do to devote to marketing, sales,
research and development and acquisitions. As a result, they have a greater ability to undertake
more extensive research and development, marketing and pricing policy programs. It is possible
that our competitors may develop new or improved products to treat the same conditions as our
products or make technological advances reducing their cost of production so that they may engage
in price competition through aggressive pricing policies to secure a greater market share to our
detriment. These competitors also may develop products that make our current or future products
obsolete. Any of these events could significantly harm our business, financial condition and
results of operations, including reducing our market share, gross margins, and cash flows.
We sell and distribute prescription brands, medical devices and over-the-counter products.
Each of these products competes with products produced by others to treat the same conditions.
Several of our prescription products compete with generic pharmaceuticals, which claim to offer
equivalent benefit at a lower cost. In some cases, insurers and other health care payment
organizations try to encourage the use of these less expensive generic brands through their
prescription benefits coverage and reimbursement policies. These organizations may make the generic
alternative more attractive to the patient by providing different amounts of reimbursement so that
the net cost of the generic product to the patient is less than the net cost of our prescription
brand product. Aggressive pricing policies by our generic product competitors and the prescription
benefits policies of third party payors could cause us to lose market share or force us to reduce
our gross margins in response.
There are several dermal filler products under development and/or in the FDA pipeline for
approval which claim to offer equivalent or greater facial aesthetic benefits to
RESTYLANE® and, if approved, the companies producing such products could charge less to
doctors for their products.
Item 1B. Unresolved Staff Comments
We have received no written comments regarding our periodic or current reports from the staff
of the SEC that were issued 180 days or more preceding the end of 2006 and that remain unresolved.
Item 2. Properties
Our office space in Scottsdale, Arizona has approximately 75,000 square feet under an amended
lease agreement that expires in December 2010. The average annual expense under the amended lease
agreement is approximately $2.1 million. The lease contains certain rent escalation clauses and,
upon expiration, can be renewed for two additional periods of five years each.
During July 2006, we executed a lease agreement for new headquarter office space to
accommodate our expected long-term growth. The first phase is for approximately 150,000 square
feet with the right to expand. Occupancy of the new headquarter office space, which is located
approximately one mile from our current headquarter office space in Scottsdale, Arizona, is
expected to occur in 2008. The term of the lease is twelve years.
During October 2006, we executed an interim lease agreement for additional headquarter office
space to accommodate our current needs and future growth. Approximately 21,000 square feet of
office space is being leased for a period of three years. Occupancy of the additional headquarter
office space, which is located approximately one mile from our current headquarter office space in
Scottsdale, Arizona, is expected to occur in 2007.
Medicis Aesthetics Canada Ltd., a wholly owned subsidiary, presently leases approximately
3,600 square feet of office space in Toronto, Ontario, Canada, under a lease agreement that expires
in February 2008.
Rent expense was approximately $2.2 million, $1.2 million, $1.1 million, $2.3 million and $2.1
million for 2006, the Transition Period, the comparable six-month period in 2004, fiscal 2005 and
fiscal 2004, respectively.
28
Item 3. Legal Proceedings
The government notified us on December 14, 2004, that it is investigating claims that we
violated the federal False Claims Act in connection with the alleged off-label marketing and
promotion of LOPROX® and LOPROX® TS products to pediatricians during periods
prior to our May 2004 disposition of our pediatric sales division. On or around October 5, 2006
the parties agreed in principle to resolve all federal and state civil claims against us for $9.8
million. As of December 31, 2006, we have accrued a
loss contingency of $10.2 million for this matter in connection
with the possibility of additional expenses related to the settlement
amount.
On or about October 12, 2006, we and the United States Attorneys Office for the District of
Kansas entered into a Nonprosecution Agreement wherein the government agreed not to prosecute us
for any alleged criminal violations relating to the alleged off-label marketing and promotion of
LOPROX®. In exchange for the governments agreement not to pursue any criminal charges
against us, we have agreed to continue cooperating with the government in its ongoing investigation
into whether past and present employees and officers may have violated federal criminal law
regarding alleged off-label marketing and promotion of LOPROX® to pediatricians. No individuals
have been designated as targets of the investigation. Any such claims, prosecutions or other
proceedings, with respect to our past and present employees and officers, the cost of their defense
and fines and penalties resulting therefrom could have a material impact on our reputation,
business and financial condition.
We are also engaged in discussions with the Office of Inspector General of the Department of
Health and Human Services (IG) to resolve any potential administrative claims the IG may have
arising out of the governments investigation into the Companys marketing and promotion of
LOPROX®.
On October 27, 2005, we filed suit against Upsher-Smith Laboratories, Inc. of Plymouth,
Minnesota and against Prasco Laboratories of Cincinnati, Ohio for infringement of Patent No.
6,905,675 entitled Sulfur Containing Dermatological Compositions and Methods for Reducing Malodors
in Dermatological Compositions covering our sodium sulfacetamide/sulfur technology. This
intellectual property is related to our PLEXION® Cleanser product. The suit was filed
in the U.S. District Court for the District of Arizona, and seeks an award of damages, as well as a
preliminary and a permanent injunction. A hearing on our preliminary injunction motion was heard
on March 8 and March 9, 2006. On May 2, 2006, an order
denying the motion for a preliminary injunction was received by
Medicis. The Court has entered an order staying this case until the
conclusion of a patent reexamination request submitted by Medicis.
On
June 22, 2006, Medicis and Aventis-Sanofi (the
manufacturer of
LOPROX®
Gel), filed a complaint in the U.S. District Court for the District
of Minnesota against Paddock Laboratories, asserting that Paddock's
proposed generic version of Medicis
LOPROX®
Gel product will infringe one or more claims of one of the
Companys patents on
LOPROX®
Gel. Paddock filed an answer and counterclaims and later amended
these filings, denying infringement and seeking fees and costs. On
December 7, 2006, plaintiffs served Paddock with a covenant not
to sue for infringement of the 656 patent based on the products
that are the subject of Paddocks current ANDA, and filed their
reply to Paddocks counterclaims, which included a denial of
Paddocks allegations that the 337 patent claims are
invalid, unenforceable and not infringed. On January 26, 2007,
the Court entered a stipulated Amended Pretrial Scheduling Order,
extending all pre-trial and discovery dates in the case by
30 days to allow the parties to engage in discussions.
29
In addition to the matters discussed above, we and certain of our subsidiaries are parties to
other actions and proceedings incident to our business, including litigation regarding our
intellectual property, challenges to the enforceability or validity of our intellectual property
and claims that our products infringe on the intellectual property rights of others. We record
contingent liabilities resulting from claims against us when it is probable (as that word is
defined in Statement of Financial Accounting Standards No. 5) that a liability has been incurred
and the amount of the loss is reasonably estimable. We disclose material contingent liabilities
when there is a reasonable possibility that the ultimate loss will exceed the recorded liability.
Estimating probable losses requires analysis of multiple factors, in some cases including judgments
about the potential actions of third-party claimants and courts. Therefore, actual losses in any
future period are inherently uncertain. In all of the cases noted where we are the defendant, we
believe we have meritorious defenses to the claims in these actions and resolution of these matters
will not have a material adverse effect on our business, financial condition, or results of
operation; however, the results of the proceedings are uncertain, and there can be no assurance to
that effect.
PART II
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Item 5. |
|
Market for Registrants Common Equity, Related Stockholder Matters and Issuer
Purchases of Equity Securities |
Description of Registrants Securities, Price Range of Common Stock and Dividends Declared
Medicis Class A common stock trades on the New York Stock Exchange under the symbol MRX.
The following table sets forth the high and low sale prices for our Class A common stock on the New
York Stock Exchange for the fiscal periods indicated:
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|
|
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|
|
DIVIDENDS |
|
|
HIGH |
|
LOW |
|
DECLARED |
FISCAL YEAR ENDED DECEMBER 31, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
34.40 |
|
|
$ |
28.20 |
|
|
$ |
0.03 |
|
Second Quarter |
|
|
34.90 |
|
|
|
23.54 |
|
|
|
0.03 |
|
Third Quarter |
|
|
32.46 |
|
|
|
22.57 |
|
|
|
0.03 |
|
Fourth Quarter |
|
|
40.31 |
|
|
|
32.08 |
|
|
|
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
TRANSITION PERIOD |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2005 |
|
$ |
35.45 |
|
|
$ |
31.08 |
|
|
$ |
0.03 |
|
Three Months Ended December 31, 2005 |
|
|
35.16 |
|
|
|
26.30 |
|
|
|
0.03 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FISCAL YEAR ENDED JUNE 30, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
40.65 |
|
|
$ |
32.85 |
|
|
$ |
0.03 |
|
Second Quarter |
|
|
41.00 |
|
|
|
34.64 |
|
|
|
0.03 |
|
Third Quarter |
|
|
37.67 |
|
|
|
28.69 |
|
|
|
0.03 |
|
Fourth Quarter |
|
|
31.97 |
|
|
|
26.80 |
|
|
|
0.03 |
|
On February 23, 2007, the last reported sale price on the New York Stock Exchange for
Medicis Class A common stock was $37.81 per share. As of such date, there were approximately 201
holders of record of Class A common stock.
30
Dividend Policy
We do not have a dividend policy. Since July 2003, we have paid quarterly cash dividends
aggregating approximately $21.8 million on our common stock. In addition, on December 14, 2006, we
declared a cash dividend of $0.03 per issued and outstanding share of common stock payable on
January 31, 2007 to our stockholders of record at the close of business on January 2, 2007. Prior
to these dividends, we had not paid a cash dividend on our common stock. Any future determinations
to pay cash dividends will be at the discretion of our Board of Directors and will be dependent
upon our financial condition, operating results, capital requirements and other factors that our
Board of Directors deems relevant.
Our 1.5% Contingent Convertible Senior Notes due 2033 require an adjustment to the conversion
price if the cumulative aggregate of all current and prior dividend increases above $0.025 per
share would result in at least a one percent (1%) increase in the conversion price. This threshold
has not been reached and no adjustment to the conversion price has been made.
Recent Sales of Unregistered Securities
None.
Equity Compensation Plan Information
Information required to be included about our equity compensation plan is incorporated by
reference to the material under the caption Equity Compensation Plan Information in the proxy
statement for our 2007 annual meeting of stockholders.
31
Item 6. Selected Financial Data
The following table sets forth selected consolidated financial data for the year ended
December 31, 2006 and 2005, the Transition Period, and the corresponding six-month period in 2004.
The data for December 31, 2006 and the Transition Period is derived from our audited consolidated
financial statements and accompanying notes, while the data for the year ended December 31, 2005
and the six-month period ended December 31, 2004 is derived from our unaudited consolidated
financial statements. The comparability of the periods presented is impacted by certain product
rights and business acquisitions and dispositions. Gross profit does not include amortization of
our intangible assets.
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|
|
|
|
|
|
Year |
|
|
Year |
|
|
|
|
|
|
Six Months |
|
|
|
Ended |
|
|
Ended |
|
|
Transition |
|
|
Ended |
|
|
|
Dec. 31, 2006 |
|
|
Dec. 31, 2005 |
|
|
Period |
|
|
Dec. 31, 2004 |
|
|
|
(in thousands, except per share amounts) |
|
Statements of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues |
|
$ |
333,625 |
|
|
$ |
313,684 |
|
|
$ |
155,569 |
|
|
$ |
146,999 |
|
Net contract revenues |
|
|
15,617 |
|
|
|
46,002 |
|
|
|
8,385 |
|
|
|
34,168 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
349,242 |
|
|
|
359,686 |
|
|
|
163,954 |
|
|
|
181,167 |
|
Gross profit (a) |
|
|
307,501 |
|
|
|
307,398 |
|
|
|
139,843 |
|
|
|
153,897 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
206,822 |
(b) |
|
|
149,607 |
(d) |
|
|
80,189 |
(g) |
|
|
65,736 |
(i) |
Impairment of long-lived assets |
|
|
52,586 |
|
|
|
9,171 |
|
|
|
9,171 |
|
|
|
|
|
Research and development |
|
|
161,837 |
(c) |
|
|
42,903 |
(e) |
|
|
22,367 |
(h) |
|
|
45,140 |
(j) |
Depreciation and amortization |
|
|
23,048 |
|
|
|
24,548 |
|
|
|
12,420 |
|
|
|
10,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
444,293 |
|
|
|
226,229 |
|
|
|
124,147 |
|
|
|
121,098 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
|
(136,792 |
) |
|
|
81,169 |
|
|
|
15,696 |
|
|
|
32,799 |
|
Other: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
|
|
|
|
59,801 |
(f) |
|
|
59,801 |
(f) |
|
|
|
|
Net interest income (expense) |
|
|
20,147 |
|
|
|
5,804 |
|
|
|
4,726 |
|
|
|
(248 |
) |
Income tax benefit (expense) |
|
|
40,796 |
|
|
|
(53,288 |
) |
|
|
(30,502 |
) |
|
|
(11,328 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(75,849 |
) |
|
$ |
93,486 |
|
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net (loss) income per share |
|
$ |
(1.39 |
) |
|
$ |
1.72 |
|
|
$ |
0.92 |
|
|
$ |
0.38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net (loss) income per share |
|
$ |
(1.39 |
) |
|
$ |
1.44 |
(k) |
|
$ |
0.76 |
|
|
$ |
0.34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share |
|
$ |
0.12 |
|
|
$ |
0.12 |
|
|
$ |
0.06 |
|
|
$ |
0.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic common shares outstanding |
|
|
54,688 |
|
|
|
54,290 |
|
|
|
54,323 |
|
|
|
55,972 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted common shares outstanding |
|
|
54,688 |
|
|
|
69,558 |
(k) |
|
|
69,772 |
|
|
|
72,160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Amounts exclude $20.0 million, $21.6 million, $10.9 million and $8.9 million of amortization
expense related to acquired intangible assets for the year ended December 31, 2006 and 2005,
the Transition Period, and the six months ended December 31,
2004, respectively. |
|
(b) |
|
Includes approximately $24.5 million of compensation expense related to stock options and
restricted stock, $10.2 million related to a loss contingency for a legal matter and $1.8
million related to a settlement of a dispute related to our merger with Ascent. |
|
(c) |
|
Includes approximately $125.2 million paid to Ipsen related to the RELOXIN®
development and distribution agreement and approximately $1.6 million of compensation expense
related to stock options and restricted stock. |
|
(d) |
|
Includes approximately $13.9 million of compensation expense related to stock options and
restricted stock recognized during the Transition Period and approximately $6.0 million of
integration planning costs incurred related to the proposed Inamed transaction during the
three months ended June 30, 2005 and three months ended September 30, 2005. |
32
|
|
|
(e) |
|
Includes approximately $8.3 million paid to AAIPharma related to a research and development
collaboration, $11.9 million related to a research and development collaboration with Dow and
approximately $1.0 million of compensation expense related to stock options and restricted
stock. |
|
(f) |
|
Represents a termination fee of $90.5 million received from Inamed upon the termination of
the proposed merger with Inamed, net of a termination fee paid to an investment banker and the
expensing of accumulated transactions costs of $27.0 million, and integration costs incurred
during the three months ended December 31, 2005 of $3.7 million. |
|
(g) |
|
Includes approximately $13.9 million of compensation expense related to stock options and
restricted stock recognized during the Transition Period and approximately $0.7 million of
integration planning costs incurred related to the proposed Inamed transaction during the
three months ended September 30, 2005. |
|
(h) |
|
Includes approximately $11.9 million related to a research and development collaboration with
Dow and approximately $1.0 million of compensation expense related to stock options and
restricted stock. |
|
(i) |
|
Includes approximately $1.3 million of professional fees related to research and development
collaborations with Ansata and Q-Med. |
|
(j) |
|
Includes $5.0 million paid to Ansata related to an exclusive development and license
agreement and $30.0 million paid to Q-Med related to an exclusive license agreement for the
development of SubQTM. |
|
(k) |
|
Diluted net income per common share for the unaudited year ended December 31, 2005 was
calculated by using the average of the periodic diluted common shares outstanding during the
year. For the period from January 1, 2005 to June 30, 2005, diluted common shares outstanding
was calculated using APB Opinion No. 25, while for the period from July 1, 2005 to December
31, 2005, diluted common shares outstanding was calculated using SFAS 123R. The Company
adopted SFAS No. 123R effective July 1, 2005. |
33
The cash flow data for the year ended December 31, 2005 and the six months ended December 31,
2004, is unaudited.
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2006 |
|
2005 |
|
|
(in thousands) |
Balance Sheet Data: |
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term
investments |
|
$ |
554,261 |
(a) |
|
$ |
742,532 |
|
Working capital |
|
|
550,022 |
|
|
|
692,453 |
|
Long-term investments |
|
|
130,290 |
|
|
|
|
|
Total assets |
|
|
1,069,286 |
|
|
|
1,145,954 |
|
Long-term debt |
|
|
453,065 |
|
|
|
453,065 |
|
Stockholders equity |
|
|
509,559 |
|
|
|
543,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
Year Ended |
|
Year Ended |
|
Transition |
|
Ended |
|
|
Dec. 31, 2006 |
|
Dec. 31, 2005 |
|
Period |
|
Dec. 31, 2004 |
|
|
(in thousands) |
Cash Flow Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by
operating activities |
|
$ |
(40,963 |
)(b) |
|
$ |
232,506 |
(c) |
|
$ |
147,990 |
(c) |
|
$ |
45,465 |
|
Net cash (used in) provided by
investing activities |
|
|
(216,915 |
) |
|
|
187,994 |
|
|
|
123,665 |
|
|
|
76,158 |
|
Net cash provided by (used in) by
financing activities |
|
|
14,278 |
|
|
|
(5,137 |
) |
|
|
(2,792 |
) |
|
|
(137,447 |
) |
|
|
|
(a) |
|
Decrease in cash, cash equivalents and short-term investments from December 31, 2005 to
December 31, 2006 primarily due to payments totaling $125.2 million made to Ipsen related
to a development and distribution agreement for the development of RELOXIN®,
payment of the $27.4 million contingent payment related to the merger with Ascent, and
payments totaling $35.7 million for income taxes during 2006. In addition, approximately
$130.3 million of our available-for-sale investments have been treated as long-term assets
as of December 31, 2006, based on their expected maturities. |
|
(b) |
|
Net cash used in operating activities for the year ended December 31, 2006 included
payments totaling $125.2 million made to Ipsen related to a development and distribution
agreement for the development of RELOXIN®. |
|
(c) |
|
Net cash provided by operating activities for the year ended December 31, 2005 and the
Transition Period included a $90.5 million termination received from Inamed related to the
termination of a proposed merger. |
34
The following selected consolidated financial data for the four-year period ended June 30,
2005 is derived from our audited consolidated financial statements and accompanying notes. The
comparability of the years presented is impacted by certain product rights and business
acquisitions and dispositions. All business acquisitions were accounted for under the purchase
method and accordingly, the results of operations reflect the financial results of each business
acquisition from the date of the acquisition. Certain business acquisitions resulted in the
write-off of in-process research and development resulting from an independent valuation. Gross
profit does not include amortization of the related intangible assets.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FISCAL YEAR ENDED JUNE 30, |
|
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
|
|
(in thousands, except per share amounts) |
|
Statements of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues |
|
$ |
305,114 |
|
|
$ |
291,607 |
|
|
$ |
241,909 |
|
|
$ |
211,248 |
|
Net contract revenues |
|
|
71,785 |
|
|
|
12,115 |
|
|
|
5,630 |
|
|
|
1,559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
376,899 |
|
|
|
303,722 |
|
|
|
247,539 |
|
|
|
212,807 |
|
Gross profit (a) |
|
|
321,452 |
|
|
|
257,116 |
|
|
|
209,279 |
|
|
|
177,042 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
135,154 |
(b) |
|
|
118,253 |
|
|
|
91,648 |
|
|
|
77,314 |
|
Research and development |
|
|
65,676 |
(c) |
|
|
16,494 |
(d) |
|
|
29,568 |
(e) |
|
|
15,132 |
(f) |
In-process research and development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,217 |
|
Depreciation and amortization |
|
|
22,350 |
|
|
|
16,794 |
|
|
|
10,125 |
|
|
|
7,928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
223,180 |
|
|
|
151,541 |
|
|
|
131,341 |
|
|
|
106,591 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
98,272 |
|
|
|
105,575 |
|
|
|
77,938 |
|
|
|
70,451 |
|
Other: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income (expense) |
|
|
830 |
|
|
|
(758 |
) |
|
|
(278 |
) |
|
|
8,533 |
|
Loss on early extinguishment of debt |
|
|
|
|
|
|
(58,660 |
) |
|
|
|
|
|
|
|
|
Income tax expense |
|
|
(34,112 |
) |
|
|
(15,317 |
) |
|
|
(26,404 |
) |
|
|
(28,960 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
64,990 |
|
|
$ |
30,840 |
|
|
$ |
51,256 |
|
|
$ |
50,024 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share |
|
$ |
1.18 |
|
|
$ |
0.55 |
|
|
$ |
0.94 |
|
|
$ |
0.83 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share |
|
$ |
1.01 |
|
|
$ |
0.52 |
|
|
$ |
0.84 |
|
|
$ |
0.79 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share |
|
$ |
0.12 |
|
|
$ |
0.10 |
|
|
$ |
0.025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic common shares outstanding |
|
|
55,196 |
|
|
|
55,618 |
|
|
|
54,376 |
|
|
|
60,536 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted common shares outstanding |
|
|
70,909 |
|
|
|
72,481 |
|
|
|
70,191 |
|
|
|
63,828 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Amounts exclude $19.6 million, $14.9 million, $9.2 million and $7.1 million for amortization
expense related to acquired intangible assets in fiscal 2005, 2004, 2003 and 2002,
respectively. |
|
(b) |
|
Includes approximately $5.3 million of business integration planning costs related to the
proposed merger with Inamed, and approximately $1.3 million of professional fees related to
research and development collaborations with AAIPharma, Ansata and Q-Med. |
|
(c) |
|
Includes approximately $8.3 million paid to AAIPharma related to a research and development
collaboration, $5.0 million paid to Ansata related to an exclusive development and license
agreement and $30.0 million paid to Q-Med related to an exclusive license agreement for the
development of SubQTM. |
|
(d) |
|
Includes approximately $2.4 million paid to Dow for a research and development collaboration. |
|
(e) |
|
Includes $14.2 million paid to Dow for a research and development collaboration and
approximately $6.0 million paid to AAIPharma for a research and development collaboration. |
|
(f) |
|
Includes $7.7 million paid to AAIPharma for a research and development collaboration. |
35
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
JUNE 30, |
|
|
2005 |
|
2004 |
|
2003 |
|
2002 |
|
|
(in thousands) |
Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, restricted cash
and short-term investments |
|
$ |
603,568 |
|
|
$ |
634,040 |
|
|
$ |
552,663 |
|
|
$ |
577,576 |
|
Working capital |
|
|
600,070 |
|
|
|
666,743 |
|
|
|
576,781 |
|
|
|
611,259 |
|
Total assets |
|
|
1,043,251 |
|
|
|
1,078,384 |
|
|
|
932,841 |
|
|
|
876,273 |
|
Long-term debt |
|
|
453,065 |
|
|
|
453,067 |
|
|
|
400,000 |
|
|
|
400,000 |
|
Stockholders equity |
|
|
486,346 |
|
|
|
555,303 |
|
|
|
461,121 |
|
|
|
429,059 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
FISCAL YEAR ENDED JUNE 30, |
|
|
2005 |
|
2004 |
|
2003 |
|
2002 |
|
|
(in thousands) |
Cash Flow Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
$ |
129,981 |
|
|
$ |
127,964 |
|
|
$ |
84,667 |
|
|
$ |
73,542 |
|
Net cash provided by (used in) investing
activities |
|
|
140,487 |
|
|
|
(166,341 |
) |
|
|
(113,709 |
) |
|
|
(341,660 |
) |
Net cash (used in) provided by financing
activities |
|
|
(139,793 |
) |
|
|
40,621 |
|
|
|
(23,343 |
) |
|
|
254,938 |
|
36
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following Managements Discussion and Analysis of Financial Condition and Results
of Operations (MD&A) summarizes the significant factors affecting our results of operations,
liquidity, capital resources and contractual obligations, as well as discusses our critical
accounting policies and estimates. You should read the following discussion and analysis
together with our consolidated financial statements, including the related notes, which are
included in this report on Form 10-K. Certain information contained in the discussion and
analysis set forth below and elsewhere in this report, including information with respect to
our plans and strategy for our business and related financing, includes forward-looking
statements that involve risks and uncertainties. See Risk Factors in Item 1A of this Form
10-K for a discussion of important factors that could cause actual results to differ
materially from the results described in or implied by the forward-looking statements in this
report. Our MD&A is composed of four major sections; Executive Summary, Results of
Operations, Liquidity and Capital Resources and Critical Accounting Policies and Estimates.
Change in Fiscal Year
Effective December 31, 2005, we changed our fiscal year end from June 30 to December 31. This
change was made to align our fiscal year end with other companies within our industry. This MD&A
is intended to cover the audited calendar year January 1, 2006 to December 31, 2006, which we refer
to as 2006. Comparative financial information to 2006 is provided in this Form 10-K with respect
to the calendar year January 1, 2005 to December 31, 2005, which is unaudited and we refer to as
2005. Additional information is provided with respect to the transition period July 1, 2005
through December 31, 2005 (the Transition Period), which is audited. We refer to the period
beginning July 1, 2004 and ending June 30, 2005 as fiscal 2005, and the period beginning July 1,
2003 and ending June 30, 2004 as fiscal 2004.
Executive Summary
We are a leading independent specialty pharmaceutical company focused primarily on helping
patients attain a healthy and youthful appearance and self-image through the development and
marketing in the U.S. of products for the treatment of dermatological, aesthetic and podiatric
conditions. We also market products in Canada for the treatment of dermatological and aesthetic
conditions. We offer a broad range of products addressing various conditions or aesthetics
improvements, including dermal fillers, acne, fungal infections, rosacea, hyperpigmentation,
photoaging, psoriasis, skin and skin-structure infections, seborrheic dermatitis and cosmesis
(improvement in the texture and appearance of skin).
Our current product lines are divided between the dermatological and non-dermatological
fields. Our dermatological field represents products for the treatment of acne and acne-related
dermatological conditions and non-acne dermatological conditions. Our non-dermatological field
represents products for the treatment of asthma (until May 2004), urea cycle disorder and contract
revenue. Our acne and acne-related dermatological product lines include DYNACIN®,
PLEXION®, SOLODYN®, TRIAZ® and ZIANATM. Our non-acne
dermatological product lines include LOPROX®, OMNICEF®, RESTYLANE®
and VANOSTM. Our non-dermatological product lines include AMMONUL®,
BUPHENYL® and ORAPRED®. ORAPRED® was licensed to BioMarin in May
2004. Our non-dermatological field also includes contract revenues associated with licensing
agreements and authorized generic agreements.
Key Aspects of Our Business
We derive a majority of our revenue from our primary products: OMNICEF®,
RESTYLANE®, SOLODYN®, TRIAZ®, VANOSTM and
ZIANATM. We believe that sales of our primary products and PERLANE®, which
is not currently approved for use by the FDA in the U.S., will constitute a significant portion of
our sales for the foreseeable future.
We have built our business by executing a four-part growth strategy: promoting existing
brands, developing new products and important product line extensions, entering into strategic
collaborations and acquiring complementary products, technologies and businesses. Our core philosophy is to
cultivate relationships of trust and
37
confidence with the high prescribing dermatologists and
podiatrists and the leading plastic surgeons in the United States.
As a result of customer buying patterns, a substantial portion of our product revenues has
been recognized in the last month of each quarter, and we schedule our inventory purchases to meet
anticipated customer demand. As a result, miscalculation of customer demand or relatively small
delays in our receipt of manufactured products could result in revenues being deferred or lost.
Our operating expenses are based upon anticipated sales levels, and a high percentage of our
operating expenses are relatively fixed in the short term. Depending on the customer, we recognize
revenue at the time of shipment to the customer, or at the time of receipt by the customer, net of
estimated provisions. Consequently, variations in the timing of revenue recognition could cause
significant fluctuations in operating results from period to period and may result in unanticipated
periodic earnings shortfalls or losses.
We estimate customer demand for our prescription products primarily through use of third party
syndicated data sources which track prescriptions written by health care providers and dispensed by
licensed pharmacies. The data represents extrapolations from information provided only by certain
pharmacies and are estimates of historical demand levels. We estimate customer demand for our
non-prescription products primarily through internal data that we compile. We observe trends from
these data and, coupled with certain proprietary information, prepare demand forecasts that are the
basis for our purchase orders for finished and component inventory from our third party
manufacturers and suppliers. Our forecasts may fail to accurately anticipate ultimate customer
demand for our products. Overestimates of demand may result in excessive inventory production and
underestimates may result in inadequate supply of our products in channels of distribution.
We sell our products primarily to major wholesalers and retail pharmacy chains. Approximately
75% of our gross revenues are derived from two major drug wholesale concerns. While we attempt to
estimate inventory levels of our products at our major wholesale customers by using historical
prescription information and historical purchase patterns, this process is inherently imprecise.
Rarely do wholesale customers provide us complete inventory levels at regional distribution
centers, or within their national distribution systems. We rely wholly upon our wholesale and drug
chain customers to effect the distribution allocation of substantially all of our products. Based
upon historically consistent purchasing patterns of our major wholesale customers, we believe our
estimates of trade inventory levels of our products are reasonable. We further believe that
inventories of our products among wholesale customers, taken as a whole, are similar to those of
other specialty pharmaceutical companies, and that our trade practices, which periodically involve
volume discounts and early payment discounts, are typical of the industry.
We periodically offer promotions to wholesale and chain drugstore customers to encourage
dispensing of our prescription products, consistent with prescriptions written by licensed health
care providers. Because many of our prescription products compete in multi-source markets, it is
important for us to ensure the licensed health care providers dispensing instructions are
fulfilled with our branded products and are not substituted with a generic product or another
therapeutic alternative product which may be contrary to the licensed health care providers
recommended and prescribed Medicis brand. We believe that a critical component of our brand
protection program is maintenance of full product availability at drugstore and wholesale
customers. We believe such availability reduces the probability of local and regional product
substitutions, shortages and backorders, which could result in lost sales. We expect to continue
providing favorable terms to wholesale and retail drug chain customers as may be necessary to
ensure the fullest possible distribution of our branded products within the pharmaceutical chain of
commerce.
We cannot control or significantly influence the purchasing patterns of our wholesale and
retail drug chain customers. They are highly sophisticated customers that purchase products in a
manner consistent with their industry practices and, presumably, based upon their projected demand
levels. Purchases by any given customer, during any given period, may be above or below actual
prescription volumes of any of our products during the same period, resulting in fluctuations of
product inventory in the distribution channel.
38
As described in more detail below, the following significant events and transactions occurred
during 2006, and affected our results of operations, our cash flows and our financial condition:
|
- |
|
Development and distribution agreement with Ipsen for rights to Ipsens
botulinum toxin type A product known as RELOXIN®; |
|
|
- |
|
FDA approval of SOLODYN®; |
|
|
- |
|
Loss contingency for a pending governmental investigation relating to our
marketing and promotion of LOPROX® products; |
|
|
- |
|
Write-down of long-lived assets due to impairment; and |
|
|
- |
|
FDA approval of ZIANATM. |
Development and Distribution Agreement With Ipsen for Rights to Ipsens Botulinum Toxin Type A
Product Known as RELOXIN
®
On March 17, 2006, we entered into a development and distribution agreement with Ipsen Ltd., a
wholly-owned subsidiary of Ipsen S.A. (Ipsen), whereby Ipsen granted Aesthetica Ltd., a
wholly-owned subsidiary of Medicis, rights to develop, distribute and commercialize Ipsens
botulinum toxin type A product in the United States, Canada and Japan for aesthetic use by
physicians. The product is commonly referred to as RELOXIN® in the U.S. aesthetic
market and DYSPORT® in medical and aesthetic markets outside the U.S. The product is
not currently approved for use in the U.S., Canada or Japan. Upon execution of the development and
distribution agreement, we made an initial payment to Ipsen in the amount of $90.1 million.
Additionally, we agreed to negotiate and enter into an agreement relating to the exclusive
distribution and development rights of the product for the aesthetic market in Europe, and
subsequently in certain other markets. Under the terms of the U.S., Canada and Japan agreement, we
were obligated to make an additional $35.1 million payment, as amended, to Ipsen if this agreement
was not entered into by April 15, 2006. On April 13, 2006, we agreed with Ipsen to extend this
deadline to July 15, 2006. In connection with this extension, we paid Ipsen approximately $12.9
million in April 2006, which would be applied against the total obligation, in the event an
agreement was not entered into by the extended deadline. On July 17, 2006, we reached a decision
with Ipsen to not pursue an agreement for the commercialization of the product outside of the U.S.,
Canada and Japan. On July 17, 2006, we made the additional $22.2 million payment to Ipsen,
representing the remaining portion of the $35.1 million total obligation, resulting from the
discontinuance of negotiations for other territories.
The initial $90.1 million payment was recognized as a charge to research and development
expense during the three months ended March 31, 2006, and the $35.1 million obligation was
recognized as a charge to research and development expense during the three months ended June 30,
2006.
We will pay an additional $26.5 million upon successful completion of various clinical and
regulatory milestones, $75.0 million upon the products approval by the FDA and $2.0 million upon
regulatory approval of the product in Japan. Ipsen will manufacture and provide the product to us
for the term of the agreement, which extends to September 2019. Ipsen will receive a royalty based
on sales and a supply price, the total of which is equivalent to approximately 30% of net sales as
defined under the agreement. Under the terms of the agreement, we are responsible for all
remaining research and development costs associated with obtaining the products approval in the
U.S., Canada and Japan. We expect to incur significant additional research and development
expenses related to the development of RELOXIN® each quarter throughout the development
process. It is our current expectation that we will file a Biologic License Application (BLA)
for RELOXIN® with the FDA during calendar 2007.
FDA approval of SOLODYN®
On May 8, 2006, the FDA approved our New Drug Application for our SOLODYN®
(minocycline HCl, USP) Extended Release Tablets. SOLODYN® is the only oral minocycline
approved for once daily dosage in the treatment of inflammatory lesions of non-nodular moderate to
severe acne vulgaris in patients 12 years of age and
older. SOLODYN® is also the only approved minocycline in extended release tablet form.
The first sales of SOLODYN® to our wholesale customers occurred during June 2006.
39
Loss contingency for a pending governmental investigation relating to our marketing and promotion
of LOPROX® products
The government notified us on December 14, 2004, that it is investigating claims that we
violated the federal False Claims Act in connection with the alleged off-label marketing and
promotion of LOPROX® and LOPROX® TS products to pediatricians during periods
prior to our May 2004 disposition of our pediatric sales division. In April 2006, we offered $6.0
million to resolve the governments civil claims contingent on the execution of appropriate
releases. The Justice Department countered with a demand of $12.8 million to resolve the civil
claims that the government is prepared to pursue. In May 2006, we countered with an offer of $8.0
million that was contingent on resolving other aspects of the governments investigation to our
satisfaction. In June 2006, the Justice Department countered with a $10.0 million offer for
settlement. On or about October 5, 2006 the parties agreed in principle to resolve all federal and
state civil claims against us for $9.8 million. As of
December 31, 2006, we have accrued a loss contingency of $10.2
million for this matter in connection with the possibility of
additional expenses related to the settlement amount. Of this amount, $6.0 million was recorded
during the three months ended March 31, 2006, $2.0 million was recorded during the three months
ended June 30, 2006 and $2.2 million was recorded during the three months ended September 30, 2006.
On or about October 12, 2006, we and the United States Attorneys Office for the District of
Kansas entered into a Nonprosecution Agreement wherein the government agreed not to prosecute us
for any alleged criminal violations relating to the alleged off-label marketing and promotion of
LOPROX®. In exchange for the governments agreement not to pursue any criminal charges
against us, we have agreed to continue cooperating with the government in its ongoing investigation
into whether past and present employees and officers may have violated federal criminal law
regarding alleged off-label marketing and promotion of LOPROX® to pediatricians. No
individuals have been designated as targets of the investigation. Any such claims, prosecutions or
other proceedings, with respect to our past and present employees and officers, the cost of their
defense and fines and penalties resulting therefrom could have a material impact on our reputation,
business and financial condition.
We are also engaged in discussions with the Office of Inspector General of the Department of
Health and Human Services (IG) to resolve any potential administrative claims the IG may have
arising out of the governments investigation into our marketing and promotion of
LOPROX®.
Write-down of Long-lived Assets Due to Impairment
We assess the potential impairment of long-lived assets on a periodic basis and when events or
changes in circumstances indicate that the carrying value of the assets may not be recoverable.
Factors that we consider in deciding when to perform an impairment review include significant
under-performance of a product line in relation to expectations, significant negative industry or
economic trends, and significant changes or planned changes in our use of the assets.
Recoverability of assets that will continue to be used in our operations is measured by comparing
the carrying amount of the asset grouping to our estimate of the related total future net cash
flows. If an asset carrying value is not recoverable through the related cash flows, the asset is
considered to be impaired. The impairment is measured by the difference between the asset
groupings carrying amount and its fair value, based on the best information available, including
market prices or discounted cash flow analysis.
During the quarter ended September 30, 2006, long-lived assets related to certain of our
products were determined to be impaired based on our analysis of the long-lived assets carrying
value and projected future cash flows. As a result of the impairment analysis, we recorded a
write-down of approximately $52.6 million related to these long-lived assets. This write-down
included the following (in thousands):
|
|
|
|
|
Long-lived asset related to LOPROX® products |
|
$ |
49,163 |
|
Long-lived asset related to ESOTERICA® products |
|
|
3,267 |
|
Other long-lived asset |
|
|
156 |
|
|
|
|
|
|
|
$ |
52,586 |
|
|
|
|
|
Factors affecting the future cash flows of the LOPROX® long-lived asset included
competitive pressures in the marketplace and the cancellation of the development plan to support
future forms of LOPROX®. Factors
40
affecting the future cash flows of the
ESOTERICA® long-lived asset included a notice of proposed rulemaking by the FDA for an
NDA to be required for continued marketing of hydroquinone products, such as ESOTERICA®.
ESOTERICA® is currently an over-the-counter product line, and we do not plan to invest
in obtaining an approved NDA for this product line if this proposed rule is made final without
change.
In addition, as a result of the impairment analysis, the remaining amortizable lives of the
long-lived assets related to LOPROX® and ESOTERICA® were reduced to fifteen
years and fifteen months, respectively. The long-lived asset related to LOPROX® will
become fully amortized on September 30, 2021, and the long-lived asset related to
ESOTERICA® will become fully amortized on December 31, 2007. The net impact on
amortization expense as a result of the write-down of the carrying value of the long-lived assets
and the reduction of their respective amortizable lives is a decrease in quarterly amortization
expense related to LOPROX® of $354,051 and an increase in quarterly amortization expense
related to ESOTERICA® of $48,077.
FDA approval of ZIANATM
On November 7, 2006, the FDA approved ZIANA (clindamycin phosphate 1.2% and
tretinoin 0.025%) Gel for once daily use for the topical treatment of acne vulgaris in patients 12
years or older. We began selling ZIANA to wholesale customers during the fourth
quarter of 2006. In accordance with the terms of a development and license agreement, as amended,
we paid Dow $1.0 million during the fourth quarter of 2006 as a result of the FDAs approval of
this product. The $1.0 million payment is classified as a long-lived asset in our consolidated
balance sheet.
41
Results of Operations
The following table sets forth certain data as a percentage of net revenues for the periods
indicated.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
(Unaudited) |
|
|
|
|
Year |
|
Year |
|
|
|
|
|
Six Months |
|
|
|
|
Ended |
|
Ended |
|
|
|
|
|
Ended |
|
|
|
|
Dec. 31, |
|
Dec. 31, |
|
Transition |
|
Dec. 31, |
|
Fiscal Year Ended |
|
|
2006(a) |
|
2005(b) |
|
Period(c) |
|
2004(d) |
|
2005(e) |
|
2004(f) |
Net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
Gross profit (g) |
|
|
88.0 |
|
|
|
85.5 |
|
|
|
85.3 |
|
|
|
84.9 |
|
|
|
85.3 |
|
|
|
84.7 |
|
Operating expenses |
|
|
127.2 |
|
|
|
62.9 |
|
|
|
75.7 |
|
|
|
66.8 |
|
|
|
59.2 |
|
|
|
49.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
|
(39.2 |
) |
|
|
22.6 |
|
|
|
9.6 |
|
|
|
18.1 |
|
|
|
26.1 |
|
|
|
34.8 |
|
Other income, net |
|
|
|
|
|
|
16.6 |
|
|
|
36.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and investment
income (expense), net |
|
|
5.8 |
|
|
|
1.6 |
|
|
|
2.9 |
|
|
|
(0.1 |
) |
|
|
0.2 |
|
|
|
(0.2 |
) |
Loss on early
extinguishment of debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(19.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before income
tax benefit (expense) |
|
|
(33.4 |
) |
|
|
40.8 |
|
|
|
49.0 |
|
|
|
18.0 |
|
|
|
26.3 |
|
|
|
15.3 |
|
Income tax benefit (expense) |
|
|
11.7 |
|
|
|
(14.8 |
) |
|
|
(18.7 |
) |
|
|
(6.3 |
) |
|
|
(9.1 |
) |
|
|
(5.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
|
(21.7 |
)% |
|
|
26.0 |
% |
|
|
30.3 |
% |
|
|
11.7 |
% |
|
|
17.2 |
% |
|
|
10.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Included in operating expenses is $125.2 million (35.8% of net revenues) related to our
development and distribution agreement with Ipsen for the development of RELOXIN®,
$52.6 million (15.1% of net revenues) for the write-down of long-lived assets, $26.1 million
(7.5% of net revenues) of share-based compensation expense,
$10.2 million (2.9% of net
revenues) related to a loss contingency for a legal matter and $1.8 million (0.5% of net
revenues) related to a settlement of a dispute related to our merger with Ascent. |
|
(b) |
|
Included in operating expenses is $11.9 million (3.3% of net revenues) related to a research
and development collaboration with Dow, $8.3 million (2.3% of net revenues) related to a
research and development collaboration with AAIPharma, $15.2 million (4.2% of net revenues) of
share-based compensation expense, $9.2 million (2.5% of net revenues) for the write-down of a
long-lived asset and $6.0 million (1.7% of net revenues) of business integration planning
costs related to the proposed (and subsequently terminated) merger with Inamed incurred during
the three months ended June 30, 2005 and three months ended September 30, 2005. Included in
other income, net, is $59.8 million (16.6% of net revenue) related to a termination fee of
$90.5 million received from Inamed upon the termination of the proposed merger with Inamed,
net of a fee paid to an investment banker and the expensing of accumulated transaction costs
of $27.0 million, and integration planning costs incurred during the three months ended
December 31, 2005 of $3.7 million. |
|
(c) |
|
Included in operating expenses is $14.9 million (9.1%) of net revenues) of share-based
compensation expense, a charge of approximately $9.2 million (5.6% of net revenues) for the
write-down of a long-lived asset, and $0.7 million (0.4% of net revenues) related to
integration planning costs incurred during the three months ended September 30, 2005 related
to the proposed merger with Inamed. Included in other income, net, is $59.8 million (36.5% of
net revenue) related to a termination fee of $90.5 million received from Inamed upon the
termination of the proposed merger with Inamed, net of a fee paid to an investment banker and
the expensing of accumulated transaction costs of $27.0 million, and integration planning
costs incurred during the three months ended December 31, 2005 of $3.7 million. |
|
(d) |
|
Included in operating expenses is $5.5 million (3.1% of net revenues) related to our
exclusive development and license agreement with
Ansata for proprietary technology and $30.7 million (17.0% of net revenues) related to our
exclusive license agreement with Q-Med for
the development of SubQTM. |
|
(e) |
|
Included in operating expenses is $5.3 million (1.4% of net revenues) of business
integration planning costs related to the proposed merger
with Inamed, $8.3 million (2.2% of net revenues) related to a research and development
collaboration with AAIPharma, $5.5 million
(1.5% of net revenues) related to our exclusive development and license agreement with Ansata
for proprietary technology and $30.7
million (8.2% of net revenues) related to our exclusive license agreement with Q-Med for the
development of SubQTM. |
|
(f) |
|
Included in operating expenses is a $2.4 million payment (0.8% of net revenues) to Dow for
a research and development collaboration. |
|
(g) |
|
Gross profit does not include amortization of the related intangibles as such expense is
included in operating expenses. |
42
Year Ended December 31, 2006 Compared to the Unaudited Year Ended December 31, 2005
Net Revenues
The following table sets forth the net revenues for the year ended December 31, 2006 and
2005, along with the percentage of net revenues and percentage point change for each of our product
categories (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
Net product revenues |
|
$ |
333.6 |
|
|
$ |
313.7 |
|
|
$ |
19.9 |
|
|
|
6.4 |
% |
Net contract revenues |
|
|
15.6 |
|
|
|
46.0 |
|
|
|
(30.4 |
) |
|
|
(66.1 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
349.2 |
|
|
$ |
359.7 |
|
|
$ |
(10.5 |
) |
|
|
(2.9 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
Point |
|
|
2006 |
|
2005 |
|
Change |
Acne and acne-related
dermatological products |
|
|
45.3 |
% |
|
|
27.2 |
% |
|
|
18.1 |
% |
Non-acne dermatological
products |
|
|
45.2 |
|
|
|
53.8 |
|
|
|
( 8.6 |
) |
Non-dermatological products |
|
|
9.5 |
|
|
|
19.0 |
|
|
|
( 9.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our total net revenues decreased during 2006 primarily due to a decrease in net contract
revenues associated with licensing agreements. Net contract revenues decreased primarily due to a
decrease in contract revenues during 2006 related to our outlicensing of the ORAPRED®
brand pursuant to the terms of our license agreement with BioMarin. Net revenues associated with
our acne and acne-related dermatological products increased as a percentage of net revenues, and
increased in net revenue dollars by 61.8% during 2006 as compared to 2005, primarily due to sales
of SOLODYN®, which was approved by the FDA during the second quarter of 2006, and sales
of ZIANA, which was approved by the FDA during the fourth quarter of 2006, partially
offset by decreases in sales of DYNACIN®, PLEXION® and TRIAZ®
products due to competitive pressures, including generic competition. Net revenues associated with
our non-acne dermatological products decreased as a percentage of net revenues, and decreased in
net revenue dollars by 18.4% during 2006, primarily due to decrease in sales of VANOS
and LOPROX® products, which was offset by an increase in sales of RESTYLANE®.
Net revenues associated with our non-dermatological products decreased as a percentage of net
revenues, and decreased in net revenue dollars by 51.6% during 2006, primarily due to the decrease
in ORAPRED® contract revenues discussed above.
Gross Profit
Gross profit represents our net revenues less our cost of product revenue. Our cost of
product revenue includes our acquisition cost for the products we purchase from our third party
manufacturers and royalty payments made to third parties. Amortization of intangible assets
related to products sold is not included in gross profit. Amortization expense related to these
intangibles for 2006 and 2005 was approximately $20.0 million and $21.6 million, respectively.
Product mix plays a significant role in our quarterly and annual gross profit as a percentage of
net revenues. Different products generate different gross profit margins, and the relative mix of
higher gross profit products and lower gross profit products can affect our total gross profit.
43
The following table sets forth our gross profit for 2006 and 2005, along with the percentage
of net revenues represented by such gross profit (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
$ Change |
|
% Change |
Gross profit |
|
$ |
307.5 |
|
|
$ |
307.4 |
|
|
$ |
0.1 |
|
|
|
0.0 |
% |
% of net revenues |
|
|
88.0 |
% |
|
|
85.5 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit as a percentage of net revenues was primarily due to the
different mix of high gross margin products sold during 2006 as compared to 2005. The launch of
SOLODYN® during the second quarter of 2006, a higher margin product, was the primary
change in the mix of products sold during the comparable periods that affected gross profit as a
percentage of net revenues.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for 2006 and
2005, along with the percentage of net revenues represented by selling, general and administrative
expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
$Change |
|
% Change |
Selling, general and administrative |
|
$ |
206.8 |
|
|
$ |
149.6 |
|
|
$ |
57.2 |
|
|
|
38.2 |
% |
% of net revenues |
|
|
59.2 |
% |
|
|
41.6 |
% |
|
|
|
|
|
|
|
|
Inamed business integration planning
costs included in selling,
general and administrative |
|
$ |
|
|
|
$ |
6.0 |
|
|
$ |
(6.0 |
) |
|
|
(100.0 |
)% |
Share-based compensation expense
included in selling, general and
administrative |
|
$ |
24.5 |
|
|
$ |
14.2 |
|
|
$ |
10.3 |
|
|
|
72.1 |
% |
The increase in selling, general and administrative expenses during 2006 from 2005 was
attributable to approximately $10.3 million of additional share-based compensation expense
recognized in accordance with SFAS No. 123R (twelve months of expense was recognized during 2006 as
compared to six months of expense recognized during 2005 as SFAS No. 123R was adopted as of July 1,
2005), $10.2 million related to a loss contingency for a legal matter related to our marketing of
LOPROX® to pediatricians (see Part II, Item 3, Legal Proceedings), approximately $11.2
million of increased promotional expense, primarily related to the promotion of
RESTYLANE®, the launches of SOLODYN® and ZIANA and pre-launch
costs for PERLANE®, $11.2 million of increased personnel costs due to increased
headcount and the effect of the annual salary increase that occurred during August 2005 and the
partial-year salary increase that occurred during February 2006, $1.8 million related to a
settlement of a dispute related to our merger with Ascent, and $18.5 million of other additional
selling, general and administrative expenses incurred during 2006, which was partially offset by
$6.0 million of business integration planning costs related to the proposed (and subsequently
terminated) merger with Inamed incurred during 2005.
Impairment of Long-lived Assets
During the third quarter of 2006, long-lived assets related to certain of our products were
determined to be impaired based on our analysis of the long-lived assets carrying value and
projected future cash flows. As a result of the impairment analysis, we recorded a write-down of
approximately $52.6 million related to these long-lived assets. This write-down included the
following (in thousands):
|
|
|
|
|
Long-lived asset related to LOPROX® products |
|
$ |
49,163 |
|
Long-lived asset related to ESOTERICA® products |
|
|
3,267 |
|
Other long-lived asset |
|
|
156 |
|
|
|
|
|
|
|
$ |
52,586 |
|
|
|
|
|
Factors affecting the future cash flows of the LOPROX® long-lived asset included
competitive pressures in the marketplace and the cancellation of the development plan to support
future forms of LOPROX®. Factors
affecting the future cash flows of the ESOTERICA® long-lived asset included a
notice of proposed rulemaking by the FDA for an NDA to be required for continued marketing of
hydroquinone products, such as ESOTERICA®.
44
ESOTERICA® is currently an
over-the-counter product line, and we do not plan to invest in obtaining an approved NDA for this
product line if this proposed rule is made final without change.
During the fourth quarter of 2005, a long-lived asset related to our DYNACIN®
capsule products was determined to be impaired based on our analysis of the long-lived assets
carrying value and projected future cash flows. Factors affecting the long-lived assets future
cash flows included our promotional focus on our DYNACIN® tablet products, and
competitive pressures in the marketplace. As a result of the impairment analysis, we recorded a
write-down of approximately $9.2 million related to this long-lived asset.
Research and Development Expenses
The following table sets forth our research and development expenses for 2006 and 2005 (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
$ Change |
|
% Change |
Research and development |
|
$ |
161.8 |
|
|
$ |
42.9 |
|
|
$ |
118.9 |
|
|
|
277.2 |
% |
Charges included in research
and development |
|
$ |
125.2 |
|
|
$ |
20.2 |
|
|
$ |
105.0 |
|
|
|
518.8 |
% |
Share-based compensation
expense included in
research and development |
|
$ |
1.6 |
|
|
$ |
1.0 |
|
|
$ |
0.6 |
|
|
|
62.7 |
% |
Included in research and development expenses for 2006 was $125.2 million related to the
development and distribution agreement with Ipsen for the development of RELOXIN® and
approximately $1.6 million of share-based compensation expense. Included in research and
development expense for 2005 was approximately $11.9 million related to research and development of
ZIANATM, $8.3 million related to a research and development of SOLODYN® and
approximately $1.0 million of share-based compensation expense. In addition to these increases in
development milestone charges and share-based compensation expense, research and development
expenses increased due to costs related to the development of RELOXIN® incurred during
2006. We expect research and development expenses to continue to fluctuate from quarter to quarter
based on the timing of the achievement of development milestones under license and development
agreements, as well as the timing of other development projects and the funds available to support
these projects. We expect to incur significant research and development expenses related to the
development of RELOXIN® each quarter throughout the development process.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during 2006 decreased $1.5 million, or 6.1%, to $23.0
million from $24.5 million during 2005. This decrease was primarily due to a decrease in the
amount of intangible assets being amortized during 2006 as compared to 2005, due to the write-down
of a long-lived asset due to impairment during the three months ended December 31, 2005. This
long-lived asset had a cost basis of approximately $15.4 million and was being amortized at a rate
of approximately $0.3 million per quarter.
Interest and Investment Income
Interest and investment income during 2006 increased $14.3 million, or 87.1%, to $30.8 million
from $16.5 million during 2005, due to an increase in the funds available for investment and an
increase in the interest rates achieved by our invested funds during 2006.
Interest Expense
Interest expense during 2006 remained consistent with 2005, at $10.6 million. Our interest
expense during 2006 and 2005 consisted of interest expense on our Old Notes, which accrue interest
at 2.5% per annum,
our New Notes, which accrue interest at 1.5% per annum, and amortization of fees and other
origination costs related to the issuance of the Old Notes and New Notes. See Note 13 in our
accompanying consolidated financial statements for further discussion on the Old Notes and New
Notes.
45
Income Tax Expense
The following table sets forth our income tax expense and the resulting effective tax rate
stated as a percentage of pre-tax income for 2006 and 2005 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
$ Change |
|
% Change |
Income tax (benefit) expense |
|
$ |
(40.8 |
) |
|
$ |
53.3 |
|
|
$ |
(94.1 |
) |
|
|
(176.6 |
)% |
Effective tax rate |
|
|
(35.0 |
)% |
|
|
36.3 |
% |
|
|
|
|
|
|
|
|
Income taxes are determined using an annual effective tax rate, which generally differs from
the U.S. Federal statutory rate, primarily because of state and local income taxes, charitable
contribution deductions, tax credits available in the U.S., the treatment of certain share-based
payments under SFAS 123R that are not designed to normally result in tax deductions, various
expenses that are non-deductible for tax purposes, and differences in tax rates in certain non-U.S.
jurisdictions. Our effective tax rate may be subject to fluctuations during the year as new
information is obtained which may affect the assumptions we use to estimate our annual effective
tax rate, including factors such as our mix of pre-tax earnings in the various tax jurisdictions in
which we operate, changes in valuation allowances against deferred tax assets, reserves for tax
audit issues and settlements, utilization of tax credits and changes in tax laws in jurisdictions
where we conduct operations. We recognize deferred tax assets and liabilities for temporary
differences between the financial reporting basis and the tax basis of our assets and liabilities,
along with net operating losses and credit carryforwards. We record valuation allowances against
our deferred tax assets to reduce the net carrying values to amounts that management believes is
more likely than not to be realized.
Income taxes during 2006 was a benefit of $40.8 million, due to our pre-tax loss recognized
during 2006, compared to income tax expense of $53.3 million during 2005. The effective tax rate
for 2006 of 35.0% includes a $5.1 million tax benefit recorded during the second quarter of 2006
relating to resolutions of income tax examinations through years ended June 30, 2004. The
effective tax rate for 2006 absent this $5.1 million benefit is (30.8)%.
Six Months Ended December 31, 2005 Compared To Unaudited Six Months Ended December 31, 2004
Net Revenues
The following table sets forth the net revenues for the Transition Period and December 31,
2004 (the comparable 2004 six months), along with the percentage of net revenues for each of our
product categories (amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable |
|
|
|
|
|
|
|
|
|
Transition |
|
|
2004 |
|
|
|
|
|
|
|
|
|
Period |
|
|
Six Months |
|
|
$ Change |
|
|
%Change |
|
Net product revenues |
|
$ |
155.6 |
|
|
$ |
147.0 |
|
|
$ |
8.6 |
|
|
|
5.8 |
% |
Net contract revenues |
|
|
8.4 |
|
|
|
34.2 |
|
|
|
(25.8 |
) |
|
|
(75.5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
164.0 |
|
|
$ |
181.2 |
|
|
$ |
(17.2 |
) |
|
|
(9.5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable |
|
Percentage |
|
|
Transition |
|
2004 |
|
Point |
|
|
Period |
|
Six Months |
|
Change |
Acne and acne-related
dermatological products |
|
|
28.1 |
% |
|
|
32.8 |
% |
|
|
(4.7 |
)% |
Non-acne dermatological
products |
|
|
58.9 |
% |
|
|
44.4 |
% |
|
|
14.5 |
% |
Non-dermatological products |
|
|
13.0 |
% |
|
|
22.8 |
% |
|
|
(9.8 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our total net revenues decreased during the Transition Period compared to the comparable 2004
six months primarily as a result of a decrease in net contract revenues associated with licensing
agreements and authorized generic agreements. Net contract revenues decreased primarily due to a
decrease in contract revenues during the Transition
46
Period related to our outlicensing of the
ORAPRED® brand pursuant to the terms of our license agreement with BioMarin. Net
revenues associated with our acne and acne-related dermatological products decreased as a
percentage of net revenues and decreased in net dollars by 22.6% during the Transition Period as
compared to the comparable 2004 six months, primarily due to generic competition with our
DYNACIN® brand of products. Net revenues associated with our non-acne dermatological
products increased as a percentage of net revenues, and increased in net dollars by 20.0% during
the Transition Period, primarily due to the launch of VANOS in April 2005, and an
increase in sales of RESTYLANE®. Net revenues associated with our non-dermatological
products decreased as a percentage of net revenues and decreased in net dollars by 48.1% during the
Transition Period, primarily due to the decrease in ORAPRED® contract revenues discussed
above.
Gross Profit
Gross profit represents our net revenues less our cost of product revenue. Our cost of
product revenue includes our acquisition cost for the products we purchase from our third party
manufacturers and royalty payments made to third parties. Amortization of intangible assets
related to products sold is not included in gross profit. Amortization expense related to these
intangibles for the Transition Period and the comparable 2004 six months was approximately $10.9
million and $8.9 million, respectively. Product mix plays a significant role in our quarterly and
annual gross profit as a percentage of net revenues. Different products generate different gross
profit margins, and the relative mix of higher gross profit products and lower gross profit
products can affect our total gross profit.
The following table sets forth our gross profit for the Transition Period and comparable 2004
six months, along with the percentage of net revenues represented by such gross profit (amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable |
|
|
|
|
|
|
Transition |
|
2004 |
|
|
|
|
|
|
Period |
|
Six Months |
|
$ Change |
|
% Change |
Gross profit |
|
$ |
139.8 |
|
|
$ |
153.9 |
|
|
$ |
(14.1 |
) |
|
|
(9.1 |
)% |
% of net revenues |
|
|
85.3 |
% |
|
|
84.9 |
% |
|
|
|
|
|
|
|
|
The decrease in gross profit during the Transition Period as compared to the comparable 2004
six months was due to the decrease in our net revenues, while the increase in gross profit as a
percentage of net revenues was primarily due to the different mix of products sold during the
Transition Period as compared to the comparable 2004 six months.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for the
Transition Period and comparable 2004 six months, along with the percentage of net revenues
represented by selling, general and administrative expenses (amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable |
|
|
|
|
|
|
Transition |
|
2004 |
|
|
|
|
|
|
Period |
|
Six Months |
|
$ Change |
|
% Change |
Selling, general and administrative |
|
$ |
80.2 |
|
|
$ |
65.7 |
|
|
$ |
14.5 |
|
|
|
22.0 |
% |
% of net revenues |
|
|
48.9 |
% |
|
|
36.3 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense
included in selling, general and
administrative |
|
$ |
13.9 |
|
|
$ |
0.3 |
|
|
$ |
13.6 |
|
|
|
5,416.1 |
% |
The increase in selling, general and administrative expenses during the Transition Period from
the comparable 2004 six months was attributable to $13.6 million of additional share-based
compensation expense recognized upon our adoption of SFAS No. 123R, $0.7 million of integration
costs related to the proposed merger with Inamed incurred during the three months ended September
30, 2005, and $1.5 million of additional selling, general and administrative expenses incurred
during the Transition Period, partially offset by approximately $1.3 million of professional fees
related to a research and development agreements with Q-Med (for the development of
SubQTM) and Ansata incurred during the comparable 2004 six months.
47
Impairment of Long-lived Assets
During the three months ended December 31, 2005, a long-lived asset related to our
DYNACIN® capsule products was determined to be impaired based on our analysis of the
long-lived assets carrying value and projected future cash flows. Factors affecting the
long-lived assets future cash flows included our promotional focus on our DYNACIN®
tablet products, and competitive pressures in the marketplace. As a result of the impairment
analysis, we recorded a write-down of approximately $9.2 million related to this long-lived asset.
Research and Development Expenses
The following table sets forth our research and development expenses for the Transition Period
and comparable 2004 six months (amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable |
|
|
|
|
|
|
Transition |
|
2004 |
|
|
|
|
|
|
Period |
|
Six Months |
|
$ Change |
|
% Change |
Research and development |
|
$ |
22.4 |
|
|
$ |
45.1 |
|
|
$ |
(22.7 |
) |
|
|
(50.4 |
)% |
Charges included in research and development |
|
|
11.9 |
|
|
|
35.0 |
|
|
|
(23.1 |
) |
|
|
(65.9 |
)% |
Share-based compensation
expense included in
research and development |
|
|
1.0 |
|
|
|
|
|
|
|
1.0 |
|
|
|
100.0 |
% |
Included in research and development expenses for the Transition Period was approximately
$11.9 million of milestone payments related to the license and development agreement with Dow for
ZIANATM and approximately $1.0 million of share-based compensation expense stock
recognized upon our adoption of SFAS No. 123R. Included in research and development expenses for
the comparable 2004 six months was approximately $30.0 million related to the SubQTM
license agreement and $5.0 million related to the Ansata development and license agreement.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during the Transition Period increased $2.2 million, or
21.5%, to $12.4 million from $10.2 million during the comparable 2004 six months. This increase
was primarily due to increased amortization that began during the third quarter of fiscal 2005
related to certain intangible assets whose useful lives were determined to be shorter than
originally estimated.
Other Income, net
Other income, net, during the Transition Period represented a termination fee received from
Inamed as a result of the termination of the proposed merger, net of the expensing of accumulated
transaction costs related to the transaction and integration planning costs incurred during the
three months ended December 31, 2005. The net amount of these items is summarized as follows (in
millions):
|
|
|
|
|
Termination fee received from Inamed, including
expense reimbursement fees |
|
$ |
90.5 |
|
Less: |
|
|
|
|
Transaction costs expensed, including legal and
advisory fees |
|
|
27.0 |
|
Integration planning costs incurred during the
three months ended December 31, 2005 |
|
|
3.7 |
|
|
|
|
|
|
|
$ |
59.8 |
|
|
|
|
|
48
Interest and Investment Income
Interest and investment income during the Transition Period increased $5.0 million, or 98.2%,
to $10.1 million from $5.1 million during the comparable 2004 six months, primarily due to an
increase in funds available for investment and an increase in the interest rates achieved by our
invested funds during the Transition Period. The increase in interest rates achieved was partially
due to a shift from non-taxable to taxable investments, which yield higher rates.
Interest Expense
Interest expense during the Transition Period remained consistent with the comparable 2004 six
months, at $5.3 million. Our interest expense during the Transition Period and the comparable 2004
six months consisted of interest expense on our Old Notes, which accrue interest at 2.5% per annum,
our New Notes, which accrue interest at 1.5% per annum, and amortization of fees and other
origination costs related to the issuance of the Old Notes and New Notes. See Note 13 in our
accompanying consolidated financial statements for further discussion on the Old Notes and New
Notes.
Income Tax Expense
The following table sets forth our income tax expense and the resulting effective tax rate
stated as a percentage of pre-tax income for the Transition Period and comparable 2004 six months
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable |
|
|
|
|
|
|
Transition |
|
2004 |
|
|
|
|
|
|
Period |
|
Six Months |
|
$ Change |
|
% Change |
Income tax expense |
|
$ |
30.5 |
|
|
$ |
11.3 |
|
|
$ |
19.2 |
|
|
|
169.3 |
% |
Effective tax rate |
|
|
38.0 |
% |
|
|
34.8 |
% |
|
|
|
|
|
|
|
|
Income taxes are determined using an annual effective tax rate, which generally differs from
the U.S. Federal statutory rate, primarily because of state and local income taxes, charitable
contribution deductions, tax deductions available in the U.S., the treatment of certain share-based
payments under SFAS 123R that are not designed to normally result in tax deductions, tax-exempt
interest in applicable periods, various expenses that are non-deductible for tax purposes, and
difference in tax rates in certain non-U.S. jurisdictions. Our effective tax rate may be subject
to fluctuations during the fiscal year as new information is obtained which may affect the
assumptions we use to estimate our annual effective tax rate, including factors such as our mix of
pre-tax earnings in the various tax jurisdictions in which we operate, changes in valuation
allowances against deferred tax assets, reserves for tax audit issues and settlements, utilization
of research and development tax credits and changes in tax laws in jurisdictions where we conduct
operations. We recognize deferred tax assets and liabilities for temporary differences between the
financial reporting basis and the tax basis of our assets and liabilities. We record valuation
allowances against our deferred tax assets to reduce the net carrying values to amounts that
management believes is more likely than not to be realized.
Income tax expense during the Transition Period increased 169.3%, or $19.2 million, to $30.5
million, from $11.3 million in the comparable 2004 six months. The increase in income tax expense
was primarily due to the increase in our pre-tax income for the same period. The increase in our
Transition Period effective tax rate from the comparable 2004 six months effective tax rate was
primarily due to: (i) an increase in the relative weighting of interest income in our mix of
taxable and tax-exempt investments and (ii) the adoption of SFAS No. 123R which precludes the
recognition of tax benefits relating to the expensing of share-based awards that are not ordinarily
designed to result in a tax deduction.
49
Fiscal Year Ended June 30, 2005 Compared To Fiscal Year Ended June 30, 2004
Net Revenues
The following table sets forth the net revenues for the fiscal years ended June 30, 2005 and
June 30, 2004, along with the percentage of net revenues for each of our product categories (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2005 |
|
|
Fiscal 2004 |
|
|
$ Change |
|
|
% Change |
|
Net product revenues |
|
$ |
305.1 |
|
|
$ |
291.6 |
|
|
$ |
13.5 |
|
|
|
4.6 |
% |
Net contract revenues |
|
|
71.8 |
|
|
|
12.1 |
|
|
|
59.7 |
|
|
|
492.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
$ |
376.9 |
|
|
$ |
303.7 |
|
|
$ |
73.2 |
|
|
|
24.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
Point |
|
|
Fiscal 2005 |
|
Fiscal 2004 |
|
Change |
Acne and acne-related
dermatological products |
|
|
29.5 |
% |
|
|
30.5 |
% |
|
|
(1.0 |
)% |
Non-acne dermatological
products |
|
|
47.1 |
% |
|
|
50.9 |
% |
|
|
(3.8 |
)% |
Non-dermatological products |
|
|
23.4 |
% |
|
|
18.6 |
% |
|
|
4.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our total net revenues increased during fiscal 2005 primarily as a result of growth in sales
of the PLEXION®, RESTYLANE® and VANOSTM products and an increase
in contract revenue. Net revenues associated with our Acne and acne-related dermatological
products decreased as a percentage of net revenues, but increased in net dollars by 20.0% primarily
due to an increase in PLEXION® net revenues due to the launch of PLEXION®
Cleansing Cloths during the first quarter of fiscal 2005. Net revenues associated with our
Non-acne dermatological products decreased as a percentage of net revenues, but increased in net
dollars by 14.8% during fiscal 2005, primarily due to the launch of RESTYLANE® in the
United States in January 2004 and the launch of VANOSTM in April 2005, partially offset
by a decrease in LOPROX® net revenues due to increased competition from generic products
launched during fiscal 2005. Net revenues associated with our Non-dermatological products increased
as a percentage of net revenues primarily due to the increase in contract revenues associated with
the outlicensing of the ORAPRED® and LUSTRA® brands, which was greater than
the revenues generated by those products for the comparable period during fiscal 2004. Contract
revenue during fiscal 2005 included fees derived from authorized generics launched on our behalf.
Gross Profit
Gross profit represents our net revenues less our cost of product revenue. Our cost of
product revenue includes our acquisition cost for the products we purchase from our third party
manufacturers and royalty payments made to third parties. Amortization of intangible assets
related to acquired products is not included in gross profit. Amortization expense related to
these intangibles for fiscal 2005 and fiscal 2004 was approximately $19.6 million and $14.9
million, respectively. Product mix plays a significant role in our quarterly and annual gross
profit as a percentage of net revenues. Different products generate different gross profit
margins, and the relative mix of higher gross profit products and lower gross profit products can
affect our total gross profit.
50
The following table sets forth our gross profit for fiscal 2005 and fiscal 2004, along with
the percentage of net revenues represented by such gross profit (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2005 |
|
Fiscal 2004 |
|
$ Change |
|
% Change |
Gross profit |
|
$ |
321.5 |
|
|
$ |
257.1 |
|
|
$ |
64.4 |
|
|
|
25.0 |
% |
% of net revenues |
|
|
85.3 |
% |
|
|
84.7 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit during fiscal 2005 as compared to fiscal 2004 was due to the
increase in our net revenues, while the increase in gross profit as a percentage of net revenues
was primarily due to the different mix of products sold during fiscal 2005 as compared to during
fiscal 2004, and an increase in contract revenue during fiscal 2005 as compared to fiscal 2004.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for fiscal
2005 and fiscal 2004, along with the percentage of net revenues represented by selling, general and
administrative expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2005 |
|
Fiscal 2004 |
|
$ Change |
|
% Change |
Selling, general and administrative |
|
$ |
135.2 |
|
|
$ |
118.3 |
|
|
$ |
16.9 |
|
|
|
14.3 |
% |
% of net revenues |
|
|
35.9 |
% |
|
|
38.9 |
% |
|
|
|
|
|
|
|
|
The increase in selling, general and administrative expenses from fiscal 2004 as compared to
fiscal 2005 was primarily attributable to incremental costs associated with RESTYLANE®,
$5.3 million of business integration planning costs related to the proposed merger with Inamed and
approximately $1.3 million of professional fees related to research and development collaborations.
The decrease in selling, general and administrative expenses as a percentage of net revenues from
fiscal 2004 to fiscal 2005 was due to net revenues during fiscal 2005, which exceeded the increase
in selling, general and administrative spending. A pre-market approval application for
RESTYLANE® was approved by the FDA on December 12, 2003, followed by the product launch
and first U.S. commercial sales of RESTYLANE® on January 6, 2004. During fiscal 2004,
we incurred incremental costs associated with the establishment of a sales and marketing strategy
for RESTYLANE®, prior to the commercial launch of the product.
Research and Development Expenses
The following table sets forth our research and development expenses for fiscal 2005 and
fiscal 2004 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2005 |
|
Fiscal 2004 |
|
$ Change |
|
% Change |
Research and development |
|
$ |
65.7 |
|
|
$ |
16.5 |
|
|
$ |
49.2 |
|
|
|
298.2 |
% |
Charges included in research
and development associated
with research and development
transactions |
|
|
43.3 |
|
|
|
2.4 |
|
|
|
40.9 |
|
|
|
1,686.2 |
% |
Included in research and development expenses for fiscal 2005 was approximately $8.3 million
related to the AAIPharma research and development collaboration, $30.0 million related to the
SubQTM license agreement and $5.0 million related to the Ansata development and license
agreement. Included in research and development expenses for fiscal 2004 was a $2.4 million
milestone payment under a license and development agreement with Dow for ZIANATM.
51
Depreciation and Amortization Expenses
Depreciation and amortization expenses during fiscal 2005 increased $5.5 million, or 33.1%, to
$22.3 million from $16.8 million during fiscal 2004. This increase was primarily due to the
amortization of expenses related to the $53.3 million and $19.4 million milestone payments made to
Q-Med in December 2003 and May 2004, respectively, which are being amortized over the period from
the date of payment through January 2018 and increased amortization related to certain intangible
assets whose useful lives were determined to be shorter than originally estimated.
Interest and Investment Income
Interest and investment income during fiscal 2005 increased $1.5 million, or 14.1%, to $11.5
million from $10.0 million during fiscal 2004, primarily due to an increase in the rates achieved
by our invested funds during fiscal 2005.
Interest Expense
Interest expense during fiscal 2005 decreased $0.2 million, or 1.6%, to $10.6 million from
$10.8 million during fiscal 2004. This decrease was due to the August 2003 exchange of a portion
of our Old Notes, which accrue interest at 2.5% per annum, for our New Notes, which accrue interest
at 1.5% per annum.
Income Tax Expense
The following table sets forth our income tax expense and the resulting effective tax rate
stated as a percentage of pre-tax income for fiscal 2005 and fiscal 2004 (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2005 |
|
Fiscal 2004 |
|
$ Change |
|
% Change |
Income tax expense |
|
$ |
34.1 |
|
|
$ |
15.3 |
|
|
$ |
18.8 |
|
|
|
122.7 |
% |
Effective tax rate |
|
|
34.4 |
% |
|
|
33.2 |
% |
|
|
|
|
|
|
|
|
The increase in income tax expense from fiscal 2004 to fiscal 2005 was primarily due to the
increase in pretax earnings over the same period. Excluding the loss on early extinguishment of
debt in fiscal 2004, our adjusted effective tax rate for fiscal 2004 was 35%. The effective rate
is lower than the expected combined federal and state income tax rates due primarily to tax-exempt
interest income and contributions to charitable programs that receive favorable tax treatment. Our
full year effective tax rate may increase in fiscal 2006 compared to our effective tax rate in
fiscal 2005 due to expected changes in the mix of earnings, the adoption of Financial Accounting
Standards Board (FASB) Statement No. 123R, Share-Based Payment (SFAS No. 123R), and the
expiration of the U.S. research and development tax credit, the latter of which is currently
expected to sunset on December 31, 2005.
52
Liquidity and Capital Resources
Overview
The following table highlights selected cash flow components for the year ended December 31,
2006 and the unaudited year ended December 31, 2005, and selected balance sheet components as of
December 31, 2006 and 2005 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
2005 |
|
$ Change |
|
% Change |
Cash (used in) provided by: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
(41.0 |
) |
|
$ |
232.5 |
|
|
$ |
(273.5 |
) |
|
|
(117.6 |
)% |
Investing activities |
|
|
(216.9 |
) |
|
|
188.0 |
|
|
|
(404.9 |
) |
|
|
(215.4 |
)% |
Financing activities |
|
|
14.3 |
|
|
|
(5.1 |
) |
|
|
19.4 |
|
|
|
(377.9 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dec. 31, 2006 |
|
Dec. 31, 2005 |
|
$ Change |
|
% Change |
Cash, cash equivalents and
short-term investments |
|
$ |
554.3 |
|
|
$ |
742.5 |
|
|
$ |
(188.2 |
) |
|
|
(25.4 |
)% |
Working capital |
|
|
550.0 |
|
|
|
692.5 |
|
|
|
(142.5 |
) |
|
|
(20.6 |
)% |
Long-term investments |
|
|
130.3 |
|
|
|
|
|
|
|
130.3 |
|
|
|
100.0 |
% |
2.5% contingent convertible senior
notes due 2032 |
|
|
169.2 |
|
|
|
169.2 |
|
|
|
|
|
|
|
|
|
1.5% contingent convertible senior
notes due 2033 |
|
|
283.9 |
|
|
|
283.9 |
|
|
|
|
|
|
|
|
|
The following table highlights selected cash flow components for the Transition Period and the
unaudited comparable 2004 six months, and selected balance sheet components as of December 31, 2005
and June 30, 2005 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable |
|
|
|
|
|
|
Transition |
|
2004 |
|
|
|
|
|
|
Period |
|
Six Months |
|
$ Change |
|
% Change |
Cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
148.0 |
|
|
$ |
45.5 |
|
|
$ |
102.5 |
|
|
|
225.5 |
% |
Investing activities |
|
|
123.7 |
|
|
|
76.2 |
|
|
|
47.5 |
|
|
|
62.4 |
% |
Financing activities |
|
|
(2.8 |
) |
|
|
(137.4 |
) |
|
|
134.6 |
|
|
|
(98.0 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dec. 31, 2005 |
|
June 30, 2005 |
|
$ Change |
|
% Change |
|
|
|
|
Cash, cash equivalents and
short-term investments |
|
$ |
742.5 |
|
|
$ |
603.6 |
|
|
$ |
138.9 |
|
|
|
23.0 |
% |
|
|
|
|
Working capital |
|
|
692.5 |
|
|
|
600.1 |
|
|
|
92.4 |
|
|
|
15.4 |
% |
|
|
|
|
2.5% contingent convertible senior
notes due 2032 |
|
|
169.2 |
|
|
|
169.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
1.5% contingent convertible senior
notes due 2033 |
|
|
283.9 |
|
|
|
283.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
53
The following table highlights selected cash flow components for fiscal 2005 and fiscal 2004,
and selected balance sheet components as of June 30, 2005 and 2004 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal 2005 |
|
Fiscal 2004 |
|
$ Change |
|
% Change |
Cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
130.0 |
|
|
$ |
128.0 |
|
|
$ |
2.0 |
|
|
|
1.6 |
% |
Investing activities |
|
|
140.5 |
|
|
|
(166.3 |
) |
|
|
306.8 |
|
|
|
184.5 |
% |
Financing activities |
|
|
(139.8 |
) |
|
|
40.6 |
|
|
|
(180.4 |
) |
|
|
(444.1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2005 |
|
June 30, 2004 |
|
$ Change |
|
% Change |
Cash, cash equivalents and
short-term investments |
|
$ |
603.6 |
|
|
$ |
634.0 |
|
|
$ |
(30.4 |
) |
|
|
(4.8 |
)% |
Working capital |
|
|
600.1 |
|
|
|
666.7 |
|
|
|
(66.6 |
) |
|
|
(10.0 |
)% |
2.5% contingent convertible senior
notes due 2032 |
|
|
169.2 |
|
|
|
169.2 |
|
|
|
|
|
|
|
|
|
1.5% contingent convertible senior
notes due 2033 |
|
|
283.9 |
|
|
|
283.9 |
|
|
|
|
|
|
|
|
|
Working Capital
Working capital as of December 31, 2006 and 2005 consisted of the following (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dec. 31, 2006 |
|
|
Dec. 31, 2005 |
|
|
$ Change |
|
|
% Change |
|
Cash, cash equivalents and
short-term investments |
|
$ |
554.3 |
|
|
$ |
742.5 |
|
|
$ |
(188.2 |
) |
|
|
(25.4 |
)% |
Accounts receivable, net |
|
|
36.4 |
|
|
|
46.7 |
|
|
|
(10.3 |
) |
|
|
(22.1 |
)% |
Inventories, net |
|
|
27.0 |
|
|
|
19.1 |
|
|
|
7.9 |
|
|
|
41.6 |
% |
Deferred tax assets, net |
|
|
23.0 |
|
|
|
12.7 |
|
|
|
10.3 |
|
|
|
80.9 |
% |
Other current assets |
|
|
16.0 |
|
|
|
12.3 |
|
|
|
3.7 |
|
|
|
30.6 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
656.7 |
|
|
|
833.3 |
|
|
|
(176.6 |
) |
|
|
(21.1 |
)% |
|
Accounts payable |
|
|
47.5 |
|
|
|
57.7 |
|
|
|
(10.2 |
) |
|
|
(17.7 |
)% |
Short-term contract obligation |
|
|
|
|
|
|
27.4 |
|
|
|
(27.4 |
) |
|
|
(100.0 |
)% |
Income taxes payable |
|
|
11.3 |
|
|
|
31.5 |
|
|
|
(20.2 |
) |
|
|
(64.0 |
)% |
Other current liabilities |
|
|
47.9 |
|
|
|
24.2 |
|
|
|
23.7 |
|
|
|
(97.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
106.7 |
|
|
|
140.8 |
|
|
|
(34.1 |
) |
|
|
(24.3 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital |
|
$ |
550.0 |
|
|
$ |
692.5 |
|
|
$ |
(142.5 |
) |
|
|
(20.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We had cash, cash equivalents and short-term investments of $554.3 million and working capital
of $550.0 million at December 31, 2006, as compared to $742.5 million and $692.5 million,
respectively, at December 31, 2005. The decreases were primarily due to payments totaling $125.2
million made to Ipsen related to a development and distribution agreement related to
RELOXIN®, payment of the $27.4 million contingent payment related to the merger with
Ascent, and payments totaling $35.7 million for income taxes during 2006. In addition, $130.3
million of our available-for-sale investments have been treated as long-term assets as of December
31, 2006, based on their expected maturities.
54
Working capital as of December 31, 2005 and June 30, 2005 consisted of the following (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dec. 31, 2005 |
|
|
June 30, 2005 |
|
|
$ Change |
|
|
% Change |
|
Cash, cash equivalents and
short-term investments |
|
$ |
742.5 |
|
|
$ |
603.6 |
|
|
$ |
138.9 |
|
|
|
23.0 |
% |
Accounts receivable, net |
|
|
46.7 |
|
|
|
47.2 |
|
|
|
(0.5 |
) |
|
|
(1.1 |
)% |
Inventories, net |
|
|
19.1 |
|
|
|
20.7 |
|
|
|
(1.6 |
) |
|
|
(7.9 |
)% |
Deferred tax assets, net |
|
|
12.7 |
|
|
|
11.0 |
|
|
|
1.7 |
|
|
|
15.8 |
% |
Other current assets |
|
|
12.3 |
|
|
|
16.4 |
|
|
|
(4.1 |
) |
|
|
(25.5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
833.3 |
|
|
|
698.9 |
|
|
|
134.4 |
|
|
|
19.2 |
% |
|
Accounts payable |
|
|
57.7 |
|
|
|
30.8 |
|
|
|
26.9 |
|
|
|
87.2 |
% |
Short-term contract obligation |
|
|
27.4 |
|
|
|
27.4 |
|
|
|
|
|
|
|
|
% |
Income taxes payable |
|
|
31.5 |
|
|
|
10.2 |
|
|
|
21.3 |
|
|
|
207.9 |
% |
Other current liabilities |
|
|
24.2 |
|
|
|
30.4 |
|
|
|
(6.2 |
) |
|
|
(20.4 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
140.8 |
|
|
|
98.8 |
|
|
|
42.0 |
|
|
|
42.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital |
|
$ |
692.5 |
|
|
$ |
600.1 |
|
|
$ |
92.4 |
|
|
|
15.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We had cash, cash equivalents and short-term investments of $742.5 million and working capital
of $692.5 million at December 31, 2005, as compared to $603.6 million and $600.1 million,
respectively, at June 30, 2005. The increases were primarily due to the $90.5 million termination
fee received from Inamed due to the termination of the proposed merger (before expenses), and other
operating cash flows generated during the Transition Period.
Working capital as of June 30, 2005 and 2004 consisted of the following (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2005 |
|
|
June 30, 2004 |
|
|
$ Change |
|
|
% Change |
|
Cash, cash equivalents and
short-term investments |
|
$ |
603.6 |
|
|
$ |
634.0 |
|
|
$ |
(30.4 |
) |
|
|
(4.8 |
)% |
Accounts receivable, net |
|
|
47.2 |
|
|
|
47.9 |
|
|
|
(0.7 |
) |
|
|
(1.3 |
)% |
Inventories, net |
|
|
20.7 |
|
|
|
19.5 |
|
|
|
1.2 |
|
|
|
5.9 |
% |
Deferred tax assets, net |
|
|
11.0 |
|
|
|
14.1 |
|
|
|
(3.1 |
) |
|
|
(22.0 |
)% |
Other current assets |
|
|
16.4 |
|
|
|
18.3 |
|
|
|
(1.9 |
) |
|
|
(10.3 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
698.9 |
|
|
|
733.8 |
|
|
|
(34.9 |
) |
|
|
(4.8 |
)% |
|
Accounts payable |
|
|
30.8 |
|
|
|
13.9 |
|
|
|
16.9 |
|
|
|
121.6 |
% |
Short-term contract obligation |
|
|
27.4 |
|
|
|
17.9 |
|
|
|
9.5 |
|
|
|
53.2 |
% |
Income taxes payable |
|
|
10.2 |
|
|
|
0.7 |
|
|
|
9.5 |
|
|
|
1,337.3 |
% |
Other current liabilities |
|
|
30.4 |
|
|
|
34.6 |
|
|
|
(4.2 |
) |
|
|
(12.2 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
98.8 |
|
|
|
67.1 |
|
|
|
31.7 |
|
|
|
47.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital |
|
$ |
600.1 |
|
|
$ |
666.7 |
|
|
$ |
(66.6 |
) |
|
|
(10.0 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We had cash, cash equivalents and short-term investments of $603.6 million and working capital
of $600.1 million at June 30, 2005, as compared to $634.0 million and $666.7 million, respectively,
at June 30, 2004. The decreases were primarily due to $150.0 million of repurchases of our Class A
common stock, $30.7 million paid in respect of the SubQTM license agreement during the
first quarter of fiscal 2005 (including $0.7 million of related professional fees), $5.5 million
paid in respect of the Ansata development and license agreement during the second quarter of fiscal
2005 (including $0.5 million of related professional fees) and $8.3 million paid in respect of the
research and development collaboration with AAIPharma during the third quarter of fiscal 2005,
partially offset by operating cash flow generated during fiscal 2005 and proceeds from the exercise
of stock options received during fiscal 2005.
Management believes existing cash and short-term investments, together with funds generated
from operations, should be sufficient to meet operating requirements for the foreseeable future.
Our cash and short-term
55
investments are available for strategic investments, mergers and
acquisitions, and other potential large-scale needs. In addition, we may consider incurring
additional indebtedness and issuing additional debt or equity securities in the future to fund
potential acquisitions or investments, to refinance existing debt or for general corporate
purposes. If a material acquisition or investment is completed, our operating results and
financial condition could change materially in future periods. However, no assurance can be given
that additional funds will be available on satisfactory terms, or at all, to fund such activities.
During July 2006, we executed a lease agreement for new headquarter office space to
accommodate our expected long-term growth. The first phase is for approximately 150,000 square
feet with the right to expand. Occupancy of the new headquarter office space, which is located
approximately one mile from our current headquarter office space in Scottsdale, Arizona, is
expected to occur in 2008.
During October 2006, we executed a lease agreement for additional headquarter office space to
accommodate our current needs and future growth. Approximately 21,000 square feet of office space
is being leased for a period of three years. Occupancy of the additional headquarter office space,
which is located approximately one mile from our current headquarter office space in Scottsdale,
Arizona, is expected to occur in 2007.
During 2007 and 2008, we will be designing and implementing a new ERP system to integrate and
improve the financial and operational aspects of our business. We are committed to having the
information technology system in place that will allow us to better operate and manage all aspects
of our operations. We have dedicated approximately 50 of our employees to various aspects of the
project, along with third party consultants. We expect this project will require an aggregate
investment of approximately $10 $12 million during 2007 and 2008.
Operating Activities
Net cash used in operating activities during the year ended December 31, 2006 was
approximately $41.0 million, compared to cash provided by operating activities of approximately
$232.5 million during the unaudited year ended December 31, 2005. The following is a summary of
the primary components of cash (used in) provided by operating activities during the year ended
December 31, 2006 and 2005 (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
2006 |
|
|
2005 |
|
Payments made to Ipsen related to development of RELOXIN® |
|
$ |
(125.2 |
) |
|
$ |
|
|
Termination fee received from Inamed related to termination
of proposed merger |
|
|
|
|
|
|
90.5 |
|
Payment made to AAIPharma related to a research and
development collaboration |
|
|
|
|
|
|
(8.3 |
) |
Payments made to Dow related to a research and
development collaboration |
|
|
(3.9 |
) |
|
|
(8.0 |
) |
Payment of professional fees related to termination of proposed
merger with Inamed |
|
|
(16.7 |
) |
|
|
|
|
Income taxes paid |
|
|
(35.7 |
) |
|
|
(22.4 |
) |
Other cash provided by operating activities |
|
|
140.5 |
|
|
|
180.7 |
|
|
|
|
|
|
|
|
Cash (used in) provided by operating activities |
|
$ |
(41.0 |
) |
|
$ |
232.5 |
|
|
|
|
|
|
|
|
Net cash provided by operating activities during the Transition Period increased 225.5%, or
$102.5 million, to $148.0 million from $45.5 million during the comparable 2004 six months. Our
operating cash flow for the Transition Period was generated principally by our net earnings,
(including the $90.5 million termination
fee received from Inamed related to the termination of the proposed merger, before expenses),
adjusted for non-cash charges including depreciation and amortization.
Net cash provided by operating activities during fiscal 2005 increased 1.6%, or $2.0 million,
to $130.0 million from $128.0 million during fiscal 2004. Our operating cash flow for fiscal 2005
was generated principally by our net earnings, adjusted for non-cash charges including depreciation
and amortization.
56
Investing Activities
Net cash used in investing activities during the year ended December 31, 2006 was
approximately $216.9 million, compared to net cash provided by investing activities during the
unaudited year ended December 31, 2005 of $188.0 million. The change was primarily due to the net
purchases or sales of our short-term and long-term investments during the respective periods. In
addition, approximately $27.4 million was paid during the first quarter of 2006 for Contingent
Payments related to our 2001 merger with Ascent.
Net cash provided by investing activities during the Transition Period was $123.7 million, as
compared to $76.2 million during the comparable 2004 six months. Net cash provided by investing
activities during the Transition Period included net dispositions and maturities of
available-for-sale investments of approximately $130.7 million, as compared to approximately $81.2
million during the comparable 2004 six months.
Net cash provided by investing activities during fiscal 2005 was $140.5 million, as compared
to net cash used in investing activities during fiscal 2004 of $166.3 million. Net cash provided
by investing activities during fiscal 2005 included net sales of available-for-sale investments of
approximately $154.1 million, as compared to net purchases of available-for-sale investments of
approximately $143.1 million during fiscal 2004. Net cash used in investing activities during
fiscal 2004 included $84.1 million in payments for the purchase of product rights, including $72.7
million in milestone payments to Q-Med, as compared to $3.3 million in payments for the purchase of
product rights during fiscal 2005.
On December 12, 2003, the FDA approved RESTYLANE® for use in the United States, and
a payment of $53.3 million was made to Q-Med upon the occurrence of this milestone. In May 2004,
we paid $19.4 million to Q-Med as a result of certain cumulative commercial milestones being
achieved. We will pay Q-Med approximately $29.1 million upon FDA approval of PERLANE®.
Financing Activities
Net cash provided by financing activities during the year ended December 31, 2006 was $14.3
million, compared to net cash used in financing activities of $5.1 million during the unaudited
year ended December 31, 2005. Proceeds from the exercise of stock options were $18.7 million
during 2006 compared to $1.3 million during 2005. Dividends paid during 2006 was $6.6 million
compared to $6.5 million during 2005.
Net cash used in financing activities during the Transition Period was $2.8 million compared
to $137.4 million during the comparable 2004 six months. The change is primarily attributable to
the purchase of $150.0 million of our common stock during the comparable 2004 six months while no
cash was used to purchase our common stock during the Transition Period, as well as $15.7 million
of proceeds from the exercise of stock options received during the comparable 2004 six months, as
compared to $0.4 million received during the Transition Period.
Net cash used in financing activities during fiscal 2005 was $139.8 million compared to net
cash provided by financing activities of $40.6 million during fiscal 2004. The change is primarily
attributable to the purchase of $150.0 million of our common stock during fiscal 2005 while no cash
was used to purchase our common stock during fiscal 2004, as well as $16.6 million of proceeds from
the exercise of stock options received during fiscal 2005, as compared to $51.4 million received
during fiscal 2004.
Contingent Convertible Senior Notes and Other Long-Term Commitments
On August 14, 2003, we exchanged $230.8 million in principal amount of our Old Notes for
$283.9 million in principal amount of our New Notes. Holders of Old Notes that accepted the
Companys exchange offer received $1,230 in principal amount of New Notes for each $1,000 in
principal amount of Old Notes. The terms of the New Notes are similar to the terms of the Old
Notes, but have a different interest rate, conversion rate and
maturity date. Holders of Old Notes that did not exchange will continue to be subject to the terms
of the Old Notes. See Note 13 of Notes to Consolidated Financial Statements for further
discussion.
57
The New Notes and the Old Notes are unsecured and do not contain any restrictions on the
incurrence of additional indebtedness or the repurchase of our securities, and do not contain any
financial covenants. The Old Notes do not contain any restrictions on the payment of dividends.
The New Notes require an adjustment to the conversion price if the cumulative aggregate of all
current and prior dividend increases above $0.025 per share would result in at least a one percent
(1%) increase in the conversion price. This threshold has not been reached and no adjustment to
the conversion price has been made.
Except for the Old Notes, the New Notes and deferred tax liabilities, we have no long-term
liabilities and had only $106.7 million of current liabilities at December 31, 2006. Our other
commitments and planned expenditures consist principally of payments we will make in connection
with strategic collaborations and research and development expenditures, and we will continue to
invest in sales and marketing infrastructure. In addition, we will be implementing a new ERP
system during 2007 and 2008, which will require financial expenditures to complete.
We have made available to BioMarin the ability to draw down on a Convertible Note up to $25.0
million beginning July 1, 2005 (the Convertible Note). The Convertible Note is convertible based
on certain terms and conditions including a change of control provision. Money advanced under the
Convertible Note is convertible into BioMarin shares at a strike price equal to the BioMarin
average closing price for the 20 trading days prior to such advance. The Convertible Note matures
on the option purchase date in 2009 as defined in the Securities Purchase Agreement entered into on
May 18, 2004 (the Securities Purchase Agreement) but may be repaid by BioMarin at any time prior
to the option purchase date. As of February 28, 2007, BioMarin has not requested any monies to be
advanced under the Convertible Note, and no amounts are outstanding.
Repurchases of Common Stock
In May 2003, our Board of Directors approved a new repurchase program that authorized the
repurchase of up to $75.0 million of our common stock. This program provided for the repurchase of
Class A common stock at such times as management determined. As of June 30, 2004, we had not
repurchased any shares of our Class A common stock under this program. In August 2004, our Board
of Directors approved a new program that replaced the May 2003 program, which authorized the
repurchase of up to $150.0 million of our Class A common stock. During the first two quarters of
fiscal 2005, we purchased a total of 3,921,086 shares of our Class A common stock in the open
market at an average price of $38.25 per share, for an aggregate purchase price of approximately
$150.0 million. As the purchase limit had been reached, the plan was terminated during the second
quarter of fiscal 2005.
Dividends
We do not have a dividend policy. Since July 2003, we have paid quarterly cash dividends
aggregating approximately $21.8 million on our common stock. In addition, on December 14, 2006, we
declared a cash dividend of $0.03 per issued and outstanding share of common stock payable on
January 31, 2007 to our stockholders of record at the close of business on January 2, 2007. Prior
to these dividends, we had not paid a cash dividend on our common stock. Any future determinations
to pay cash dividends will be at the discretion of our Board of Directors and will be dependent
upon our financial condition, operating results, capital requirements and other factors that our
Board of Directors deems relevant.
Off-Balance Sheet Arrangements
As of December 31, 2006, we are not involved in any off-balance sheet arrangements, as defined
in Item 3(a)(4)(ii) of SEC Regulation S-K.
58
Contractual Obligations
The following table summarizes our significant contractual obligations at December 31, 2006,
and the effect such obligations are expected to have on our liquidity and cash flows in future
periods. This table excludes amounts already recorded on our balance sheet as current liabilities
at December 31, 2006 or certain other purchase obligations as discussed below (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due By Period |
|
|
|
|
|
|
|
|
|
|
|
More Than |
|
|
More Than |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1 Year and |
|
|
3 Years and |
|
|
|
|
|
|
|
|
|
|
Less Than |
|
|
Less Than |
|
|
Less Than |
|
|
More Than |
|
|
|
Total |
|
|
1 Year |
|
|
3 Years |
|
|
5 Years |
|
|
5 Years |
|
Long-term debt |
|
$ |
453,065 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
453,065 |
|
Interest on long-term debt |
|
|
220,691 |
|
|
|
8,488 |
|
|
|
16,975 |
|
|
|
16,975 |
|
|
|
178,253 |
|
Operating leases |
|
|
55,860 |
|
|
|
2,371 |
|
|
|
6,866 |
|
|
|
10,507 |
|
|
|
36,116 |
|
Other purchase obligations
and commitments |
|
|
867 |
|
|
|
173 |
|
|
|
347 |
|
|
|
347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
730,483 |
|
|
$ |
11,032 |
|
|
$ |
24,188 |
|
|
$ |
27,829 |
|
|
$ |
667,434 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The long-term debt consists of the Companys Old Notes and New Notes. The table above
reflects the maturity date of debt. However, the Company may redeem some or all of the Old Notes
and New Notes at any time on or after June 11, 2007 and June 11, 2008, respectively, at a
redemption price, payable in cash, of 100% of the principal amount, plus accrued and unpaid
interest, including contingent interest, if any. Holders of the Old Notes and New Notes may
require the Company to repurchase all or a portion of their Old Notes on June 4, 2007, 2012 and
2017 and New Notes on June 4, 2008, 2013 and 2018, or upon a change in control, as defined in the
indenture agreements governing the Old Notes and New Notes, at 100% of the principal amount of the
Old Notes and New Notes, plus accrued and unpaid interest to the date of the repurchase, payable in
cash.
Interest on long-term debt includes interest payable on our Old Notes and New Notes, assuming
the Old Notes and New Notes will not have any redemptions or conversions into shares of our Class A
common stock until their respective maturities in 2032 and 2033, but does not include any
contingent interest. The amount of interest ultimately paid in future years could change if any of
the Old Notes or New Notes are converted or redeemed and/or if contingent interest becomes payable
if certain future criteria are met.
Other purchase obligations and commitments include payments due under research and development
and consulting contracts.
We have committed to make potential future milestone payments to third-parties as part of
certain product development and license agreements. Payments under these agreements generally
become due and payable only upon achievement of certain developmental, regulatory and/or commercial
milestones. Because the achievement and timing of these milestones are not fixed or reasonably
determinable, such contingencies have not been recorded on our consolidated balance sheets and are
not included in the above table. The total amount of potential future milestone payments related
to development and license agreements is approximately $213.7 million.
Purchase orders for raw materials, finished goods and other goods and services are not
included in the above table. We are not able to determine the aggregate amount of such purchase
orders that represent contractual obligations, as purchase orders may represent authorizations to
purchase rather than binding agreements. For the purpose of this table, contractual obligations
for purchase of goods or services are defined as agreements that are enforceable and legally
binding on us and that specify all significant terms, including: fixed or minimum quantities to be
purchased; fixed, minimum or variable price provisions; and the approximate timing of the
transaction. Our
purchase orders are based on our current manufacturing needs and are fulfilled by our vendors
with relatively short timetables. We do not have significant agreements for the purchase of raw
materials or finished goods specifying
59
minimum quantities or set prices that exceed our short-term
expected requirements. We also enter into contracts for outsourced services; however, the
obligations under these contracts were not significant and the contracts generally contain clauses
allowing for cancellation without significant penalty.
The expected timing of payment of the obligations discussed above is estimated based on
current information. Timing of payments and actual amounts paid may be different depending on the
time of receipt of goods or services or changes to agreed-upon amounts for some obligations.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based
upon our consolidated financial statements, which have been prepared in conformity with U.S.
generally accepted accounting principles. The preparation of the consolidated financial statements
requires us to make estimates and assumptions that affect the amounts reported in the consolidated
financial statements and accompanying notes. On an ongoing basis, we evaluate our estimates
related to sales allowances, chargebacks, rebates, returns and other pricing adjustments,
depreciation and amortization and other contingencies and litigation. We base our estimates on
historical experience and various other factors related to each circumstance. Actual results could
differ from those estimates based upon future events, which could include, among other risks,
changes in the regulations governing the manner in which we sell our products, changes in the
health care environment and managed care consumption patterns. Our significant accounting policies
are described in Note 2 to the consolidated financial statements included in this report. We
believe the following critical accounting policies affect our most significant estimates and
assumptions used in the preparation of our consolidated financial statements and are important in
understanding our financial condition and results of operations.
Revenue Recognition
Revenue from our product sales is recognized pursuant to Staff Accounting Bulletin No. 104
(SAB 104), Revenue Recognition in Financial Statements. Accordingly, revenue is recognized when
all four of the following criteria are met: (i) persuasive evidence that an arrangement exists;
(ii) delivery of the products has occurred; (iii) the selling price is both fixed and determinable;
and (iv) collectibility is reasonably assured. Our customers consist primarily of large
pharmaceutical wholesalers who sell directly into the retail channel.
We do not provide any material forms of price protection to our wholesale customers and permit
product returns if the product is damaged, or, depending on the customer, if it is returned within
six months prior to expiration or up to 12 months after expiration. Our customers consist
principally of financially viable wholesalers, and depending on the customer, revenue is recognized
based upon shipment (FOB shipping point) or receipt (FOB destination), net of estimated
provisions. As a general practice, we do not ship product that has less than 15 months until its
expiration date. We also authorize returns for damaged products and credits for expired products
in accordance with our returned goods policy and procedures. The shelf life associated with our
products is up to 36 months depending on the product. The majority of our products have
a shelf life of approximately 18-24 months.
We enter into licensing arrangements with other parties whereby we receive contract revenue
based on the terms of the agreement. The timing of revenue recognition is dependent on the level
of our continuing involvement in the manufacture and delivery of licensed products. If we have
continuing involvement, the revenue is deferred and recognized on a straight-line basis over the
period of continuing involvement. In addition, if our licensing arrangements require no continuing
involvement and payments are merely based on the passage of time, we assess such payments for
revenue recognition under the collectibility criteria of SAB 104.
Items Deducted From Gross Revenue
Provisions for estimates for product returns and exchanges, sales discounts, chargebacks,
managed care and Medicaid rebates and other adjustments are established as a reduction of product
sales revenues at the time such revenues are recognized. These deductions from gross revenue are
established by us as our best estimate at the time of sale based on historical experience adjusted
to reflect known changes in the factors that impact such reserves.
60
These deductions from gross
revenue are generally reflected either as a direct reduction to accounts receivable through an
allowance, or as an addition to accrued expenses if the payment is due to a party other than the
wholesale or retail customer.
Our accounting policies for revenue recognition have a significant impact on our reported
results and rely on certain estimates that require complex and subjective judgment on the part of
our management. If the levels of product returns and exchanges, cash discounts, chargebacks,
managed care and Medicaid rebates and other adjustments fluctuate significantly and/or if our
estimates do not adequately reserve for these reductions of gross product revenues, our reported
net product revenues could be negatively affected.
Product Returns
We account for returns of product by establishing an allowance based on our estimate of
revenues recorded for which the related products are expected to be returned in the future. We
estimate the rate of future product returns based on our historical experience, the relative risk
of return based on expiration date, and other qualitative factors that could impact the level of
future product returns, such as competitive developments, product discontinuations and our
introduction of new products. Historical experience and the other qualitative factors are assessed
on a product-specific basis as part of our compilation of our estimate of future product returns.
We also monitor inventories held by our distributors, as well as prescription trends to help us
assess the rate of return. Changes due to our competitors price movements have not adversely
affected us. We do not provide incentives to our distributors to assume additional inventory
levels beyond what is customary in their ordinary course of business.
Returns
for new products are more difficult to estimate than returns for
established products. We determine our estimates of the sales return accrual for new products
primarily based on our historical product returns experience of similar products, products that
have similar characteristics at various stages of their life cycle, and other available information
pertinent to the intended use and marketing of the new product.
Our actual experience and the qualitative factors that we use to determine the necessary
accrual for future product returns are susceptible to change based on unforeseen events and
uncertainties. We assess the trends that could affect our estimates and make changes to the
accrual quarterly.
Sales Discounts
We offer cash discounts to our customers as an incentive for prompt payment, generally
approximately 2% of the sales price. We account for cash discounts by establishing an allowance
reducing accounts receivable by the full amount of the discounts expected to be taken by the
customers. We consider payment performance and adjust the allowance to reflect actual experience
and our current expectations about future activity.
Contract Chargebacks
We have agreements for contract pricing with several entities, whereby pricing on products is
extended below wholesaler list price. These parties purchase products through wholesalers at the
lower contract price, and the wholesalers charge the difference between their acquisition cost and
the lower contract price back to us. We account for chargebacks by establishing an allowance
reducing accounts receivable based on our estimate of chargeback claims attributable to a sale. We
determine our estimate of chargebacks based on historical experience and changes to current
contract prices. We also consider our claim processing lag time, and adjust the allowance
periodically throughout each quarter to reflect actual experience. Although we record an allowance
for estimated
chargebacks at the time we record the sale (typically when we ship the product), the actual
chargeback related to that sale is not processed until the entities purchase the product from the
wholesaler. We estimate the rate of chargebacks based on our historical experience and changes to
current contract prices.
61
Managed Care and Medicaid Rebates
Rebates are contractual discounts offered to government programs and private health plans that
are eligible for such discounts at the time prescriptions are dispensed, subject to various
conditions. We record provisions for rebates by estimating these liabilities as products are sold,
based on factors such as timing and terms of plans under contract, time to process rebates, product
pricing, sales volumes, amount of inventory in the distribution channel, and prescription trends.
Other
In addition to the significant items deducted from gross revenue described above, we deduct
other items from gross revenue. For example, we offer consumer rebates on many of our products and
a consumer loyalty program for our RESTYLANE® dermal filler product. We generally
account for these other items deducted from gross revenue by establishing an accrual based on our
estimate of the adjustments attributable to a sale. We generally base our estimates for the
accrual of these items deducted from gross sales on historical experience and other relevant
factors. We adjust our accruals periodically throughout each quarter based on actual experience
and changes in other factors, if any.
Use of Information from External Sources
We use information from external sources to estimate our significant items deducted from gross
revenues. Our estimates of inventory in the distribution channel are based on historical shipment
and return information from our accounting records and data on prescriptions filled, which we
purchase from IMS Health, Inc., one of the leading providers of prescription-based information. We
also utilize projected prescription demand for our products, as well as, written and oral
information obtained from certain wholesalers with respect to their inventory levels and our
internal information. We use the information from IMS Health, Inc. to project the prescription
demand for our products. Our estimates are subject to inherent limitations pertaining to reliance
on third-party information, as certain third-party information is itself in the form of estimates.
Use of Estimates in Reserves
We believe that our allowances and accruals for items that are deducted from gross revenues
are reasonable and appropriate based on current facts and circumstances. It is possible, however,
that other parties applying reasonable judgment to the same facts and circumstances could develop
different allowance and accrual amounts for items that are deducted from gross revenues.
Additionally, changes in actual experience or changes in other qualitative factors could cause our
allowances and accruals to fluctuate, particularly with newly launched products. We review the
rates and amounts in our allowance and accrual estimates on a quarterly basis. If future estimated
rates and amounts are significantly greater than those reflected in our recorded reserves, the
resulting adjustments to those reserves would decrease our reported net revenues; conversely, if
actual returns, rebates and chargebacks are significantly less than those reflected in our recorded
reserves, the resulting adjustments to those reserves would increase our reported net revenues. If
we changed our assumptions and estimates, our related reserves would change, which would impact the
net revenues we report. For example, if the 2006 prescription data
used to estimate inventory in the distribution channel changed by
1.0 percent and our historical returns reserve percent were to
change by 1.0 percentage point our sales returns reserve could be
impacted
by approximately $1.1 million and corresponding revenue could be
impacted by the same amount.
During the three months ended December 31, 2006, we experienced a decline in demand for
certain of our products, primarily VANOS. As a result, we increased the sales returns
reserves by approximately $8.9 million during the three months
ended December 31, 2006, specifically related to
VANOS. We will continue to monitor demand for this product and will adjust our sales
reserves accordingly in the future. The effect of this change on the net loss for 2006 was to
increase the net loss by approximately $5.8 million or $0.11 per common share.
62
Share-Based Compensation
As part of our adoption of SFAS No. 123R as of July 1, 2005, we were required to recognize the
fair value of share-based compensation awards as an expense. Determining the appropriate
fair-value model and calculating the fair value of share-based awards at the date of grant requires
judgment. We use the Black-Scholes option pricing model to estimate the fair value of employee
stock options. Option pricing models, including the Black-Scholes model, also require the use of
input assumptions, including expected volatility, expected life, expected dividend rate, and
expected risk-free rate of return. We use a blend of historical and implied volatility based on
options freely traded in the open market as we believe this is more reflective of market conditions
and a better indicator of expected volatility than using purely historical volatility. Increasing
the weighted average volatility by 2.5 percent (from 0.36 percent to 0.385 percent) would have
increased the fair value of stock options granted in 2006 to $15.08 per share. Conversely,
decreasing the weighted average volatility by 2.5 percent (from 0.36 percent to 0.335 percent)
would have decreased the fair value of stock options granted in 2006 to $13.85 per share. The
expected life of the awards is based on historical and other economic data trended into the future.
Stock option awards granted during 2006 have a stated term of 7 years, and the weighted average
expected life of the awards was determined to be 7 years. Decreasing the weighted average expected
life by 0.5 years (from 7.0 years to 6.5 years) would have decreased the fair value of stock
options granted in 2006 to $13.96 per share. The risk-free interest rate assumption is based on
observed interest rates appropriate for the terms of our awards. The dividend yield assumption is
based on our history and expectation of future dividend payouts.
The fair value of our restricted stock grants is based on the fair market value of our common
stock on the date of grant discounted for expected future dividends.
SFAS No. 123R requires us to develop an estimate of the number of share-based awards which
will be forfeited due to employee turnover. Quarterly changes in the estimated forfeiture rate may
have a significant effect on share-based compensation, as the effect of adjusting the rate for all
expense amortization after July 1, 2005 is recognized in the period the forfeiture estimate is
changed. If the actual forfeiture rate is higher than the estimated forfeiture rate, then an
adjustment is made to increase the estimated forfeiture rate, which will result in a decrease to
the expense recognized in the financial statements. If the actual forfeiture rate is lower than
the estimated forfeiture rate, then an adjustment is made to decrease the estimated forfeiture
rate, which will result in an increase to the expense recognized in the financial statements. The
effect of forfeiture adjustments in the first quarter of fiscal 2007 was immaterial.
We evaluate the assumptions used to value our awards on a quarterly basis. If factors change
and we employ different assumptions, stock-based compensation expense may differ significantly from
what was recorded in the past. If there are any modifications or cancellations of the underlying
unvested securities, we may be required to accelerate, increase or cancel any remaining unearned
stock-based compensation expense. Future stock-based compensation expense and unearned stock-based
compensation will increase to the extent that we grant additional equity awards to employees or we
assume unvested equity awards in connection with acquisitions.
Our estimates of these important assumptions are based on historical data and judgment
regarding market trends and factors. If actual results are not consistent with our assumptions and
judgments used in estimating these factors, we may be required to record additional stock-based
compensation expense or income tax expense, which could be material to our results of operations.
Inventory
Inventory costs associated with products that have not yet received regulatory approval are
capitalized if we believe there is probable future commercial use and future economic benefit. If
future commercial use and future economic benefit are not considered probable, then costs
associated with pre-launch inventory that has not yet received regulatory approval are expensed as
research and development expense during the period the costs are incurred. We could be required to
expense previously capitalized costs related to pre-approval inventory if the probability of future
commercial use and future economic benefit changes due to denial or delay of regulatory
approval, a delay in commercialization, or other factors. Conversely, our gross margins could be
favorably impacted
63
if previously expensed pre-approval inventory becomes available and is used for
commercial sale. As of December 31, 2006, there no costs capitalized into inventory for products
that have not yet received regulatory approval.
Long-lived Assets
We assess the impairment of long-lived assets when events or changes in circumstances indicate
that the carrying value of the assets may not be recoverable. Factors that we consider in deciding
when to perform an impairment review include significant under-performance of a product line in
relation to expectations, significant negative industry or economic trends, and significant changes
or planned changes in our use of the assets. Recoverability of assets that will continue to be used
in our operations is measured by comparing the carrying amount of the asset grouping to our
estimate of the related total future net cash flows. If an asset carrying value is not recoverable
through the related cash flows, the asset is considered to be impaired. The impairment is measured
by the difference between the asset groupings carrying amount and its fair value, based on the
best information available, including market prices or discounted cash flow analysis.
When we determine that the useful lives of assets are shorter than we had originally
estimated, and there are sufficient cash flows to support the carrying value of the assets, we
accelerate the rate of amortization charges in order to fully amortize the assets over their new
shorter useful lives.
During 2006 and the Transition Period, an impairment charge of $52.6 million and $9.2 million,
respectively, was recognized related to our review of long-lived assets. During 2006, the
remaining useful lives of two of the long-lived assets that were deemed to be impaired were
reduced, while no acceleration of amortization was recorded during the Transition Period. This
process requires the use of estimates and assumptions, which are subject to a high degree of
judgment. If these assumptions change in the future, we may be required to record additional
impairment charges for, and/or accelerate amortization of, long-lived assets.
Income Taxes
Income taxes are determined using an annual effective tax rate, which generally differs from
the U.S. Federal statutory rate because of state and local income taxes, tax-exempt interest,
charitable contribution deductions, nondeductible expenses and research and development tax credits
available in the U.S. Our effective tax rate may be subject to fluctuations during the year as
new information is obtained which may affect the assumptions we use to estimate our annual
effective tax rate, including factors such as our mix of pre-tax earnings in the various tax
jurisdictions in which we operate, valuation allowances against deferred tax assets, reserves for
tax audit issues and settlements, utilization of research and development tax credits and changes
in tax laws in jurisdictions where we conduct operations. We recognize deferred tax assets and
liabilities for temporary differences between the financial reporting basis and the tax basis of
our assets and liabilities. We record valuation allowances against our deferred tax assets to
reduce the net carrying value to an amount that management believes is more likely than not to be
realized.
Based on the Companys historical pre-tax earnings, management believes it is more likely than
not that the Company will realize the benefit of the existing net deferred tax assets at December
31, 2006. Management believes the existing net deductible temporary differences will reverse
during periods in which the Company generates net taxable income; however, there can be no
assurance that the Company will generate any earnings or any specific level of continuing earnings
in future years. Certain tax planning or other strategies could be implemented, if necessary, to
supplement income from operations to fully realize recorded tax benefits.
Research and Development Costs and Accounting for Strategic Collaborations
All research and development costs, including payments related to products under development
and research consulting agreements, are expensed as incurred. We may continue to make
non-refundable payments to
third parties for new technologies and for research and development work that has been completed.
These payments may be expensed at the time of payment depending on the nature of the payment made.
64
Our policy on accounting for costs of strategic collaborations determines the timing of our
recognition of certain development costs. In addition, this policy determines whether the cost is
classified as development expense or capitalized as an asset. We are required to form judgments
with respect to the commercial status of such products in determining whether development costs
meet the criteria for immediate expense or capitalization. For example, when we acquire certain
products for which there is already an ANDA or NDA approval related directly to the product, and
there is net realizable value based on projected sales for these products, we capitalize the amount
paid as an intangible asset. In addition, if we acquire product rights which are in the
development phase and as to which we have no assurance that the third party will successfully
complete its development milestones or that the product will gain regulatory approval, we expense
such payments.
Legal Contingencies
We record contingent liabilities resulting from asserted and unasserted claims against
us, when it is probable that a liability has been incurred and the amount of the loss is reasonably
estimable. We disclose material contingent liabilities, when there is a reasonable possibility,
that the ultimate loss will exceed the recorded liability. Estimating probable losses requires
analysis of multiple factors, in some cases including judgments about the potential actions of
third-party claimants and courts. Therefore, actual losses in any future period are inherently
uncertain. We currently are involved in certain legal proceedings and we have accrued a loss
contingency of $10.2 million as of December 31, 2006, related to one matter. This loss contingency
is included in other current liabilities as of December 31, 2006 in the accompanying consolidated
balance sheets, and is included in selling, general and administrative expenses for the year ended
December 31, 2006 in the accompanying consolidated statements of
income. In addition to the matters disclosed in "Item 3. Legal
Proceedings," we are party to ordinary and routine litigation
incidental to our
business. We do not expect the outcome of any pending litigation,
other than those specified in "Item 3. Legal Proceedings," to
have a material adverse effect on our consolidated financial position
or results of operations. It is possible, however, that future results of operations
for any particular quarterly or annual period could be materially affected by changes in our
assumptions or the effectiveness of our strategies related to these proceedings.
Recent Accounting Pronouncements
In June 2006, the FASB issued Interpretation No. 48 (FIN 48) Accounting for Uncertainty in
Income Taxes, which clarifies the accounting for uncertainty in income taxes recognized in an
enterprises financial statements in accordance with FASB Statement No. 109, Accounting for Income
Taxes. FIN 48 prescribes a recognition threshold and measurement attribute for the financial
statement recognition and measurement of a tax position taken or expected to be taken in a tax
return. FIN 48 also provides guidance on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure, and transition. FIN 48 is effective for fiscal years
beginning after December 15, 2006. We are currently evaluating FIN 48 but do not expect it to have
a material impact on our consolidated results of operations and financial condition.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, which clarifies the
definition of fair value, establishes a framework for measuring fair value, and expands the
disclosures about fair value measurements. SFAS No. 157 is effective for fiscal years beginning
after November 15, 2007. We are currently evaluating SFAS No. 157 and its impact, if any, on our
consolidated results of operations and financial condition.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Statements
and Financial Liabilities, which provides companies with an option to report selected financial
assets and liabilities at fair value. SFAS No. 159 requires companies to provide additional
information that will help investors and other users of financial statements to more easily
understand the effect of the companys choice to use fair value on its earnings. It also requires
entities to display the fair value of those assets and liabilities for which the company has chosen
to use fair value on the face of the balance sheet. The new Statement does not eliminate
disclosure requirements included in other accounting standards, including requirements for
disclosures about fair value measurements included in FASB Statements No. 157, Fair Value
Measurements, and No. 107, Disclosures about
Fair Value of Financial Instruments. We are currently evaluating SFAS No. 159 and its impact,
if any, on our consolidated results of operations and financial condition.
65
Item 7A. Quantitative and Qualitative Disclosure About Market Risk
At December 31, 2006, $198.1 million of our cash equivalent investments are in money market
securities that are reflected as cash equivalents, because all maturities are within 90 days.
Included in money market securities are commercial paper, Federal agency discount notes and money
market funds. Our interest rate risk with respect to these investments is limited due to the
short-term duration of these arrangements and the yields earned, which approximate current interest
rates.
Our investment portfolio, consisting of fixed income securities that we hold on an
available-for-sale basis, was approximately $481.2 million as of December 31, 2006, $295.5 million
as of December 31, 2005, $425.8 million as of June 30, 2005, and $587.4 million as of June 30,
2004. These securities, like all fixed income instruments, are subject to interest rate risk and
will decline in value if market interest rates increase. We have the ability to hold our fixed
income investments until maturity and, therefore, we would not expect to recognize any material
adverse impact in income or cash flows if market interest rates increase. The following table
provides information about our available-for-sale securities that are sensitive to changes in
interest rates. We have aggregated our available-for-sale securities for presentation purposes
since they are all very similar in nature (dollar amounts in thousands):
Interest Rate Sensitivity
Principal Amount by Expected Maturity as of December 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial instruments mature during year ended December 31, |
|
|
2007 |
|
2008 |
|
2009 |
|
2010 |
|
2011 |
|
Thereafter |
Available-for-sale securities |
|
$ |
158,153 |
|
|
$ |
217,707 |
|
|
$ |
35,570 |
|
|
$ |
22,612 |
|
|
$ |
5,353 |
|
|
$ |
41,837 |
|
Weighted-average yield rate |
|
|
5.27 |
% |
|
|
5.17 |
% |
|
|
5.56 |
% |
|
|
5.36 |
% |
|
|
5.06 |
% |
|
|
5.36 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent convertible
senior notes due 2032 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
169,155 |
|
Interest rate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.5 |
% |
Contingent convertible
senior notes due 2033 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
283,910 |
|
Interest rate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.5 |
% |
Changes in interest rates do not affect interest expense incurred on our Contingent
Convertible Senior Notes as the interest rates are fixed. We have not entered into derivative
financial instruments. We have minimal operations outside of the United States and, accordingly,
we have not been susceptible to significant risk from changes in foreign currencies.
During the normal course of business we could be subjected to a variety of market risks,
examples of which include, but are not limited to, interest rate movements and foreign currency
fluctuations, as we discussed above, and collectibility of accounts receivable. We continuously
assess these risks and have established policies and procedures to protect against the adverse
effects of these and other potential exposures. Although we do not anticipate any material losses
in these risk areas, no assurance can be made that material losses will not be incurred in these
areas in the future.
Item 8. Financial Statements and Supplementary Data
Our financial statements and related financial statement schedule and the Independent
Registered Public Accounting Firms Reports are incorporated herein by reference to the financial
statements set forth in Item 15 of Part IV of this report.
66
Item 9. Changes in and Disagreements with Accountants and Financial Disclosure
None.
Item 9A. Controls and Procedures
We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and
15d-15(e) of the Exchange Act) that are designed to ensure that information required to be
disclosed in reports filed by us under the Exchange Act is recorded, processed, summarized and
reported within the time periods specified in the SECs rules and forms and that such information
is accumulated and communicated to management, including our Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow for timely decisions regarding required disclosure.
Our Chief Executive Officer and Chief Financial Officer, with the participation of other members of
management, evaluated the effectiveness of our disclosure controls and procedures as of the end of
the period covered by this Annual Report on Form 10-K. Based on this evaluation, our Chief
Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures
were effective to ensure that the information we are required to disclose in reports that we file
or submit under the Exchange Act is recorded, processed, summarized and reported within the time
periods specified ion the SECs rules and forms.
Although the management of our Company, including the Chief Executive Officer and the Chief
Financial Officer, believes that our disclosure controls and internal controls currently provide
reasonable assurance that our desired control objectives have been met, management does not expect
that our disclosure controls or internal controls will prevent all error and all 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 are met. Further, the design of a control
system must reflect the fact that there are resource constraints, and the benefits of controls must
be considered relative to their costs. Because of the inherent limitations in all control systems,
no evaluation of controls can provide absolute assurance that all control issues and instances of
fraud, if any, within our Company have been detected. These inherent limitations include the
realities that judgments in decision-making can be faulty, and that breakdowns can occur because of
simple error or mistake. Additionally, controls can be circumvented by the individual acts of some
persons, by collusion of two or more people, or by management override of the controls. The design
of any system of controls is also based in part upon certain assumptions about the likelihood of
future events, and there can be no assurance that any design will succeed in achieving its stated
goals under all potential future conditions.
There were no significant changes in our internal controls over financial reporting identified
in connection with this evaluation that occurred during our last fiscal quarter that have
materially affected, or are reasonably likely to materially affect, Medicis internal controls over
financial reporting.
Managements Report on Internal Control over Financial Reporting
The management of Medicis Pharmaceutical Corporation is responsible for establishing and
maintaining adequate internal control over financial reporting as such term is defined in Exchange
Act Rules 13a-15(f) and 15d-15(f). Our internal control over financial reporting is designed to
provide reasonable assurance regarding the reliability of financial reporting and the preparation
of financial statements for external purposes in accordance with accounting principles generally
accepted in the United States of America.
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. Also, projections of any evaluation of effectiveness to future periods
are subject to the risk that controls may become inadequate because of changes in conditions, or
that the degree of compliance with the policies or procedures may deteriorate.
Under the supervision and with the participation of the Chief Executive Officer and Chief
Financial Officer, management conducted an evaluation of the effectiveness of its internal control
over financial reporting as of December 31, 2006. The framework on which such evaluation was based
is contained in the report entitled
Internal Control Integrated Framework issued by the Committee of Sponsoring Organizations
of the Treadway
67
Commission (the COSO Report). Based on that evaluation and the criteria set
forth in the COSO Report, management concluded that its internal control over financial reporting
was effective as of December 31, 2006.
Our independent registered public accounting firm, Ernst & Young LLP, who also audited our
consolidated financial statements, audited managements assessment and independently assessed the
effectiveness of our internal control over financial reporting. Ernst & Young LLP has issued their
attestation report, which is included in Item 15 of this Form 10-K.
Item 9B. Other Information
None.
68
PART III
Item 10. Directors and Executive Officers of the Registrant
The Company has adopted a written code of ethics, Medicis Pharmaceutical Corporation Code of
Business Conduct and Ethics, which is applicable to all directors, officers and employees of the
Company, including the Companys principal executive officer, principal financial officer,
principal accounting officer or controller and other executive officers identified pursuant to this
Item 10 who perform similar functions (collectively, the Selected Officers). In accordance with
the rules and regulations of the SEC, a copy of the code is available on the Companys website.
The Company will disclose any changes in or waivers from its code of ethics applicable to any
Selected Officer on its website at http://www.medicis.com or by filing a Form 8-K.
The Company has filed, as exhibits to this Annual Report on Form 10-K for the year ended
December 31, 2006, the certifications of its Chief Executive Officer and Chief Financial Officer
required pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
On June 20, 2006, the Company submitted to the New York Stock Exchange the Annual CEO
Certification required pursuant to Section 303A.12(a) of the New York Stock Exchange Listed Company
Manual.
The information in the section entitled Section 16(a) Beneficial Ownership Reporting
Compliance, Directors, Director Nominees and Executive Officers and Committee Meetings in the
Proxy Statement is incorporated herein by reference.
Item 11. Executive Compensation
The information to be included in the sections entitled Executive Compensation,
Compensation of Directors, and Stock Option and Compensation Committee Report in the Proxy
Statement is incorporated herein by reference.
Item 12. Security Ownership of Certain Beneficial Owners and Management
The information to be included in the section entitled Security Ownership of Director and
Executive Officers and Certain Beneficial Owners in the Proxy Statement is incorporated herein by
reference.
Item 13. Certain Relationships and Related Transactions
The information to be included in the sections entitled Certain Relationships and Related
Transactions and Compensation Committee Interlocks and Insider Participation in the Proxy
Statement is incorporated herein by reference.
Item 14. Principal Accountant Fees and Services
The information to be included in the section entitled Independent Registered Public
Accounting Firm Fees in the Proxy Statement is incorporated herein by reference.
69
PART IV
Item 15. Exhibits, Financial Statement Schedules
|
|
|
|
|
|
|
Page |
(a) Documents filed as a part of this Report |
|
|
|
|
(1) Financial Statements: |
|
|
|
|
Index to consolidated financial statements |
|
|
F-1 |
|
Reports of Independent Registered Public Accounting Firm |
|
|
F-2 |
|
Consolidated balance sheets as of December 31, 2006 and 2005 |
|
|
F-4 |
|
Consolidated statements of income for the year ended December 31,
2006, the six months ended December 31, 2005 and 2004 (unaudited)
and the fiscal years ended June 30, 2005 and 2004 |
|
|
F-6 |
|
Consolidated statements of stockholders equity for the year ended
December 31, 2006, the six months ended December 31, 2005 and
the fiscal years ended June 30, 2005 and 2004 |
|
|
F-7 |
|
Consolidated statements of cash flows for the year ended
December 31, 2006, the six months ended December 31, 2005 and
2004 (unaudited) and the fiscal years ended June 30, 2005 and
2004 |
|
|
F-11 |
|
Notes to consolidated financial statements |
|
|
F-12 |
|
(2) Financial Statement Schedule: |
|
|
|
|
Schedule II Valuation and Qualifying Accounts |
|
|
S-1 |
|
This financial statement schedule should be read in conjunction with
the consolidated financial statements. Financial statement schedules
not included in this Annual Report on Form 10-K have been omitted
because they are not applicable or the required information is shown
in the financial statements or notes thereto. |
|
|
|
|
(3) Exhibits filed as part of this Report: |
|
|
|
|
|
|
|
|
|
Exhibit No. |
|
|
|
Description |
2.1
|
|
|
|
Agreement of Merger by and between the Company, Medicis Acquisition Corporation and GenDerm
Corporation, dated November 28, 1997 (11) |
|
|
|
|
|
2.2
|
|
|
|
Agreement of Plan of Merger, dated as of October 1, 2001, by and among the Company, MPC
Merger Corp. and Ascent Pediatrics, Inc. (17) |
|
|
|
|
|
3.1
|
|
|
|
Certificate of Incorporation of the Company, as amended (23) |
|
|
|
|
|
3.2
|
|
|
|
Amended and Restated By-Laws of the Company (13) |
|
|
|
|
|
4.1
|
|
|
|
Amended and Restated Rights Agreement, dated as of August 17, 2005, between the Company and
Wells Fargo Bank, N.A., as Rights Agent(26) |
|
|
|
|
|
4.2
|
|
|
|
Indenture, dated as of August 19, 2003, by and between the Company, as issuer, and Deutsche
Bank Trust Company Americas, as trustee (23) |
|
|
|
|
|
4.3
|
|
|
|
Indenture, dated as of June 4, 2002, by and between the Company, as issuer, and Deutsche Bank
Trust Company Americas, as trustee. (19) |
|
|
|
|
|
4.4
|
|
|
|
Supplemental Indenture dated as of February 1, 2005 to Indenture dated as of August 19, 2003
between the Company and Deutsche Bank Trust Company Americas as Trustee (25) |
|
|
|
|
|
4.5
|
|
|
|
Registration Rights Agreement, dated as of June 4, 2002, by and between the Company and
Deutsche Bank Securities Inc. (19) |
|
|
|
|
|
4.6
|
|
|
|
Form of specimen certificate representing Class A common stock (1) |
|
|
|
|
|
10.1
|
|
|
|
Asset Purchase Agreement among the Company, Ascent Pediatrics, Inc., BioMarin Pharmaceutical
Inc., and BioMarin Pediatrics Inc., dated April 20, 2004 (23) |
|
|
|
|
|
10.2
|
|
|
|
Merger Termination Agreement, dated as of December 13, 2005, by and among the Company,
Masterpiece Acquisition Corp., and Inamed Corporation(31) |
|
|
|
|
|
10.3
|
|
|
|
Securities Purchase Agreement among the Company, Ascent Pediatrics, Inc., BioMarin
Pharmaceutical Inc. and BioMarin Pediatrics Inc., dated May 18, 2004 (23) |
|
|
|
|
|
10.4
|
|
|
|
Termination Agreement dated October 19, 2005 between the Company and Michael A.
Pietrangelo(28) |
|
|
|
|
|
10.5
|
|
|
|
License Agreement among the Company, Ascent Pediatrics, Inc. and BioMarin Pediatrics Inc.,
dated May 18, 2004 (23) |
70
|
|
|
|
|
Exhibit No. |
|
|
|
Description |
10.6
|
|
|
|
Medicis Pharmaceutical Corporation 1995 Stock Option Plan (incorporated by
reference to Exhibit C to the definitive Proxy Statement for the 1995 Annual
Meeting of Shareholders previously filed with the SEC, File No. 0-18443) |
|
|
|
|
|
10.7(a)
|
|
|
|
Employment Agreement between the Company and Jonah Shacknai, dated
July 24, 1996 (8) |
|
|
|
|
|
10.7(b)
|
|
|
|
Amendment to Employment Agreement by and between the Company and
Jonah Shacknai, dated April 1, 1999 (15) |
|
|
|
|
|
10.7(c)
|
|
|
|
Amendment to Employment Agreement by and between the Company and
Jonah Shacknai, dated February 21, 2001 (15) |
|
|
|
|
|
10.7(d)
|
|
|
|
Third Amendment, dated December 30, 2005, to Employment Agreement between the Company and
Jonah Shacknai(32) |
|
|
|
|
|
10.8
|
|
|
|
Medicis Pharmaceutical Corporation 2001 Senior Executive Restricted Stock Plan(30) |
|
|
|
|
|
10.9(a)
|
|
|
|
Medicis Pharmaceutical Corporation 2002 Stock Option Plan (20) |
|
|
|
|
|
10.9(b)
|
|
|
|
Amendment No. 1 to the Medicis Pharmaceutical Corporation 2002 Stock Option Plan, dated
August 1, 2005(29) |
|
|
|
|
|
10.10(a)
|
|
|
|
Medicis Pharmaceutical Corporation 2004 Stock Incentive Plan(27) |
|
|
|
|
|
10.10(b)
|
|
|
|
Amendment No. 1 to the Medicis Pharmaceutical Corporation 2004 Stock Option Plan, dated
August 1, 2005(29) |
|
|
|
|
|
10.11(a)
|
|
|
|
Medicis Pharmaceutical Corporation 1998 Stock Option Plan(33) |
|
|
|
|
|
10.11(b)
|
|
|
|
Amendment No. 1 to the Medicis Pharmaceutical Corporation 1998 Stock Option Plan, dated
August 1, 2005(29) |
|
|
|
|
|
10.11(c)
|
|
|
|
Amendment No. 2 to the Medicis Pharmaceutical Corporation 1998 Stock Option Plan, dated
September 30, 2005(29) |
|
|
|
|
|
10.12(a)
|
|
|
|
Medicis Pharmaceutical Corporation 1996 Stock Option Plan(34) |
|
|
|
|
|
10.12(b)
|
|
|
|
Amendment No. 1 to the Medicis Pharmaceutical Corporation 1996 Stock Option Plan, dated
August 1, 2005(29) |
|
|
|
|
|
10.13
|
|
|
|
Waiver Letter dated March 18, 2005 between the Company and Q-Med AB(27) |
|
|
|
|
|
10.14
|
|
|
|
Supply Agreement, dated October 21, 1992, between Schein Pharmaceutical and the Company
(2) |
|
|
|
|
|
10.15
|
|
|
|
Amendment to Manufacturing and Supply Agreement, dated March 2, 1993, between
Schein Pharmaceutical and the Company (3) |
|
|
|
|
|
10.16(a)
|
|
|
|
Credit and Security Agreement, dated August 3, 1995, between the Company and
Norwest Business Credit, Inc. (5) |
|
|
|
|
|
10.16(b)
|
|
|
|
First Amendment to Credit and Security Agreement, dated May 29, 1996,
between the Company and Norwest Bank Arizona, N.A. (8) |
|
|
|
|
|
10.16(c)
|
|
|
|
Second Amendment to Credit and Security Agreement, dated November 22, 1996,
by and between the Company and Norwest Bank Arizona, N.A. as successor-in-interest
to Norwest Business Credit, Inc. (10) |
|
|
|
|
|
10.16(d)
|
|
|
|
Third Amendment to Credit and Security Agreement, dated November 22, 1998, by
and between the Company and Norwest Bank Arizona, N.A., as successor-in-interest
to Norwest Business Credit, Inc. (12) |
|
|
|
|
|
10.16(e)
|
|
|
|
Fourth Amendment to Credit and Security Agreement, dated November 22, 2000,
by and between the Company and Wells Fargo Bank Arizona, N.A., formerly
known as Norwest Bank Arizona, N.A., as successor-in-interest to Norwest Business
Credit, Inc. (16) |
|
|
|
|
|
10.16(f)
|
|
|
|
Fifth Amendment to Credit and Security Agreement, dated November 22, 2002, by and between the
Company and Wells Fargo Bank Arizona, N.A., formerly known as Norwest Bank Arizona, N.A., as
successor-in-interest to Norwest Business Credit, Inc. (23) |
|
|
|
|
|
10.17(a)
|
|
|
|
Patent Collateral Assignment and Security Agreement, dated August 3, 1995, by
the Company to Norwest Business Credit, Inc. (6) |
|
|
|
|
|
10.17(b)
|
|
|
|
First Amendment to Patent Collateral Assignment and Security Agreement, dated
May 29, 1996, by the Company to Norwest Bank Arizona, N.A. (8) |
|
|
|
|
|
10.17(c)
|
|
|
|
Amended and Restated Patent Collateral Assignment and Security Agreement, dated
November 22, 1998, by the Company to Norwest Bank Arizona, N.A. (12) |
|
|
|
|
|
10.18(a)
|
|
|
|
Trademark Collateral Assignment and Security Agreement, dated August 3, 1995,
by the Company to Norwest Business Credit, Inc. (7) |
|
|
|
|
|
10.18(b)
|
|
|
|
First Amendment to Trademark Collateral Assignment and Security Agreement, dated
May 29, 1996, by the Company to Norwest Bank Arizona, N.A. (8) |
|
|
|
|
|
10.18(c)
|
|
|
|
Amended and Restated Trademark,
Tradename, and Service Mark Collateral Assignment and Security Agreement, dated November 22, 1998, by the Company
to Norwest Bank Arizona, N.A. (12) |
71
|
|
|
|
|
Exhibit No. |
|
|
|
Description |
10.19
|
|
|
|
Assignment and Assumption of Loan Documents, dated May 29, 1996, from
Norwest Business Credit, Inc., to and by Norwest Bank Arizona, N.A. (8) |
|
|
|
|
|
10.20
|
|
|
|
Multiple Advance Note, dated May 29, 1996, from the Company to Norwest Bank
Arizona, N.A. (8) |
|
|
|
|
|
10.21
|
|
|
|
Asset Purchase Agreement dated November 15, 1998, by and among the Company and
Hoechst Marion Roussel, Inc., Hoechst Marion Roussel Deutschland GMHB and
Hoechst Marion Roussel, S.A. (12) |
|
|
|
|
|
10.22
|
|
|
|
License and Option Agreement dated November 15, 1998, by and among the Company
and Hoechst Marion Roussel, Inc., Hoechst Marion Roussel Deutschland GMBH and
Hoechst Marion Roussel, S.A. (12) |
|
|
|
|
|
10.23
|
|
|
|
Loprox Lotion Supply Agreement dated November 15, 1998, by and between the
Company and Hoechst Marion Roussel, Inc. (12) |
|
|
|
|
|
10.24
|
|
|
|
Supply Agreement dated November 15, 1998, by and between the Company and
Hoechst Marion Roussel Deutschland GMBH (12) |
|
|
|
|
|
10.25
|
|
|
|
Asset Purchase Agreement effective January 31, 1999, between the Company and
Bioglan Pharma Plc (14) |
|
|
|
|
|
10.26
|
|
|
|
Stock Purchase Agreement by and among the Company, Ucyclyd Pharma, Inc. and
Syed E. Abidi, William Brusilow, Susan E. Brusilow and Norbert L. Wiech, dated
April 19, 1999 (14) |
|
|
|
|
|
10.27
|
|
|
|
Asset Purchase Agreement by and between the Company and Bioglan Pharma Plc,
dated June 29, 1999 (14) |
|
|
|
|
|
10.28
|
|
|
|
Asset Purchase Agreement by and among The Exorex Company, LLC, Bioglan
Pharma Plc, the Company and IMX Pharmaceuticals, Inc., dated June 29, 1999 (16) |
|
|
|
|
|
10.29
|
|
|
|
Medicis Pharmaceutical Corporation Executive Retention Plan (14) |
|
|
|
|
|
10.30
|
|
|
|
Asset Purchase Agreement between Warner Chilcott, plc and the Company, dated
September 14, 1999(14) |
|
|
|
|
|
10.31(a)
|
|
|
|
Share Purchase Agreement between Q-Med International B.V. and Startskottet 21914
AB (under proposed change of name to Medicis Sweden Holdings AB), dated
February 10, 2003(21) |
|
|
|
|
|
10.31(b)
|
|
|
|
Amendment No. 1 to Share Purchase Agreement between Q-Med International
B.V. and Startskottet 21914 AB (under proposed change of name to Medicis Sweden
Holdings AB), dated March 7, 2003(21) |
|
|
|
|
|
10.32
|
|
|
|
Supply Agreement between Q-Med AB and the Company,
dated March 7, 2003(21) |
|
|
|
|
|
10.33
|
|
|
|
Amended and Restated Intellectual Property Agreement between Q-Med AB and HA
North American Sales AB, dated March 7, 2003(21) |
|
|
|
|
|
10.34
|
|
|
|
Supply Agreement between Medicis Aesthetics Holdings Inc., a wholly owned subsidiary of the
Company, and Q-Med AB, dated July 15, 2004 (23) Portions of this exhibit
(indicated by asterisks) have been omitted pursuant to a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934. |
|
|
|
|
|
10.35
|
|
|
|
Intellectual Property License Agreement between Q-Med AB and Medicis Aesthetics Holdings
Inc., dated July 15, 2004 (23) Portions of this exhibit (indicated by asterisks)
have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2
under the Securities Exchange Act of 1934. |
|
|
|
|
|
10.36
|
|
|
|
Note Agreement, dated as of October 1, 2001, by and among Ascent Pediatrics, Inc., the
Company, Furman Selz Investors II L.P., FS Employee Investors LLC, FS Ascent Investments LLC,
FS Parallel Fund L.P., BancBoston Ventures Inc. and Flynn Partners (17) |
|
|
|
|
|
10.37
|
|
|
|
Voting Agreement, dated as of October 1, 2001, by and among the Company, MPC Merger Corp., FS
Private Investments LLC, Furman Selz Investors II L.P., FS Employee Investors LLC, FS Ascent
Investments LLC and FS Parallel Fund L.P. (17) |
|
|
|
|
|
10.38
|
|
|
|
Exclusive Remedy Agreement, dated as of October 1, 2001, by and among the Company, Ascent
Pediatrics, Inc., FS Private Investments LLC, Furman Selz Investors II L.P., FS Employee
Investors LLC, FS Ascent Investments LLC and FS Parallel Fund L.P., BancBoston Ventures Inc.,
Flynn Partners, Raymond F. Baddour, Sc.D., Robert E. Baldini, Medical Science Partners L.P.
and Emmett Clemente, Ph.D. (17) |
|
|
|
|
|
10.39
|
|
|
|
Medicis Pharmaceutical Corporation 1992 Stock Option Plan(35) |
72
|
|
|
|
|
Exhibit No. |
|
|
|
Description |
10.40
|
|
|
|
Form of Stock Option Agreement for Medicis Pharmaceutical Corporation 2004 Stock Incentive
Plan(36) |
|
|
|
|
|
10.41
|
|
|
|
Form of Restricted Stock Agreement for Medicis Pharmaceutical Corporation 2004 Stock
Incentive Plan(36) |
|
|
|
|
|
10.42
|
|
|
|
Letter Agreement dated as of March 13, 2006 among Medicis Pharmaceutical Corporation,
Aesthetica Ltd., Medicis Aesthetics Holdings Inc., Ipsen S.A. and Ipsen Ltd. (37) |
|
|
|
|
|
10.43
|
|
|
|
Development and Distribution Agreement by and between Aesthetica, Ltd. and Ipsen, Ltd.
(38) |
|
|
|
|
|
10.44
|
|
|
|
Trademark License Agreement by and between Aesthetica, Ltd. and Ipsen, Ltd. (38) |
|
|
|
|
|
10.45
|
|
|
|
Trademark Assignment Agreement by and between Aesthetica, Ltd. and Ipsen, Ltd. (38) |
|
|
|
|
|
10.46(a)
|
|
|
|
Medicis 2006 Incentive Award Plan(39) |
|
|
|
|
|
10.46(b)
|
|
|
|
Amendment to the Medicis 2006 Incentive Award Plan, dated July 10, 2006(41) |
|
|
|
|
|
10.47
|
|
|
|
Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical Corporation and
Mark A. Prygocki, Sr. (40) |
|
|
|
|
|
10.48
|
|
|
|
Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical Corporation and
Mitchell S. Wortzman, Ph.D. (40) |
|
|
|
|
|
10.49
|
|
|
|
Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical Corporation and
Richard J. Havens (40) |
|
|
|
|
|
10.50
|
|
|
|
Employment Agreement, dated July 27, 2006, between Medicis Pharmaceutical Corporation and
Jason D. Hanson (40) |
|
|
|
|
|
10.51
|
|
|
|
Office Sublease by and between Apex 7720 North Dobson, L.L.C., an Arizona limited liability
company, and Medicis Pharmaceutical Corporation, dated as of July 26, 2006(42) |
|
|
|
|
|
12
|
|
+
|
|
Computation of Ratios of Earnings to Fixed Charges |
|
|
|
|
|
21.1
|
|
+
|
|
Subsidiaries |
|
|
|
|
|
23.1
|
|
+
|
|
Consent of Independent Registered Public Accounting Firm |
|
|
|
|
|
24.1
|
|
|
|
Power of Attorney See signature page |
|
|
|
|
|
31.1
|
|
+
|
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted |
|
|
|
|
|
31.2
|
|
+
|
|
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the
Securities Exchange Act, as amended
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the
Securities Exchange Act, as amended pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
32.1
|
|
+
|
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted |
|
|
|
|
|
32.2
|
|
+
|
|
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
+ |
|
Filed herewith |
|
(1) |
|
Incorporated by reference to the Registration Statement on Form S-1 of the Registrant,
File No. 33-32918, filed with the SEC on January 16, 1990 |
|
(2) |
|
Incorporated by reference to the Registration Statement on Form S-1 of the Company, File
No. 33-54276, filed with the SEC on June 11, 1993 |
|
(3) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 1993, File No. 0-18443, filed with the SEC on October 13, 1993 |
|
(4) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 1995, File No. 0-18443, previously filed with the SEC (the 1994 Form 10-K) |
|
(5) |
|
Incorporated by reference to the Companys 1995 Form 10-K |
|
(6) |
|
Incorporated by reference to the Companys 1995 Form 10-K |
|
(7) |
|
Incorporated by reference to the Companys 1995 Form 10-K |
|
(8) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 1996, File No. 0-18443, previously filed with the SEC |
|
(9) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended March 31, 1997, File No. 0-18443, previously filed with the SEC |
|
(10) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended December 31, 1996, File No. 0-18443, previously filed with the SEC |
|
(11) |
|
Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC
on December 15, 1997 |
|
(12) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended December 31, 1998, File No. 0-18443, previously filed with the SEC |
73
|
|
|
(13) |
|
Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC
on July 13, 2006 |
|
(14) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 1999, File No. 0-18443, previously filed with the SEC |
|
(15) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended March 31, 2001, File No. 0-18443, previously filed with the SEC |
|
(16) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 2001, File No. 0-18443, previously filed with the SEC |
|
(17) |
|
Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC
on October 2, 2001 |
|
(18) |
|
Incorporated by reference to the Companys registration statement on Form 8-A12B/A filed
with the SEC
on June 4, 2002 |
|
(19) |
|
Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC
on
June 6, 2002 |
|
(20) |
|
Incorporated by reference to the Companys Annual Report on Form
10-K for the fiscal year ended June 30, 2002, File No. 0-18443, previously filed with the
SEC |
|
(21) |
|
Incorporated by reference to the Companys Current Report on Form
8-K filed with the SEC on March 10, 2003 |
|
(22) |
|
Incorporated by reference to the Companys Quarterly Report on
Form 10-Q for the quarter ended December 31, 2003, File No. 0-18443, previously filed with
the SEC |
|
(23) |
|
Incorporated by reference to the Companys Annual Report on Form
10-K for the fiscal year ended June 30, 2004, File No. 0-18443, previously filed with the
SEC |
|
(24) |
|
Incorporated by reference to the Companys Current Report on Form
8-K filed with the SEC on March 21, 2005 |
|
(25) |
|
Incorporated by reference to the Companys Quarterly Report on
Form 10-Q for the quarter ended March 31, 2005, File No. 0-18443, previously filed with the
SEC |
|
(26) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on August 18, 2005 |
|
(27) |
|
Incorporated by reference to the Companys Annual Report on
Form 10-K for the fiscal year ended June 30, 2005, File No. 0-18443, previously filed with
the SEC |
|
(28) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on October 20, 2005 |
|
(29) |
|
Incorporated by reference to the Companys Annual Report on
Form 10-K/A for the fiscal year ended June 30, 2005, File No. 0-18443, previously filed with
the SEC on October 28, 2005 |
|
(30) |
|
Incorporated by reference to the Companys Quarterly Report on
Form 10-Q for the quarter ended September 30, 2005, File No. 0-18443, previously filed with
the SEC |
|
(31) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on December 13, 2005 |
|
(32) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on January 3, 2006 |
|
(33) |
|
Incorporated by reference to Appendix 1 to the Companys definitive Proxy Statement for
the 1998 Annual
Meeting of Stockholders filed with the SEC on December 2, 1998 |
|
(34) |
|
Incorporated by reference to Appendix 2 to the Companys definitive Proxy Statement for
the 1996 Annual
Meeting of Stockholders filed with the SEC on October 23, 1996 |
|
(35) |
|
Incorporated by reference to Exhibit B to the Companys definitive Proxy Statement for
the 1992 Annual
Meeting of Stockholders previously filed with the SEC |
|
(36) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K/T for the six month
transition
period ended December 31, 2005, File No. 0-18443, previously filed with the SEC on March 16,
2006 |
|
(37) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on March 16, 2006 |
|
(38) |
|
Incorporated by reference to the Companys Quarterly Report on
Form 10-Q for the quarter ended March 31, 2006, File No. 0-18443, previously filed with the
SEC |
|
(39) |
|
Incorporated by reference to Appendix A to the Companys Definitive Proxy Statement for
the 2006
Annual Meeting of Stockholders filed with the SEC on April 13, 2006 |
74
|
|
|
(40) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on July 31, 2006 |
|
(41) |
|
Incorporated by reference to the Companys Quarterly Report on
Form 10-Q for the quarter ended June 30, 2006, File No. 0-18443, previously filed with
the SEC |
|
(42) |
|
Incorporated by reference to the Companys Quarterly Report on
Form 10-Q for the quarter ended September 30, 2006, File No. 0-18443, previously filed
with the SEC |
|
(b) |
|
The exhibits to this Form 10-K follow the Companys Financial Statement Schedule included in
this Form 10-K. |
|
(c) |
|
The Financial Statement Schedule to this Form 10-K appears on page S-1 of this Form 10-K. |
75
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) 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.
Date: March 1, 2007
|
|
|
|
|
|
MEDICIS PHARMACEUTICAL CORPORATION
|
|
|
By: |
/s/ JONAH SHACKNAI
|
|
|
|
Jonah Shacknai |
|
|
|
Chairman of the Board and Chief Executive Officer |
|
|
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature appears below constitutes and
appoints Jonah Shacknai and Mark A. Prygocki, Sr., or either of them, as his true and lawful
attorneys-in-fact and agents, with full power of substitution and resubstitution, for him and in
his name, place and stead, in any and all capacities, to sign any and all amendments to this Annual
Report on Form 10-K and any documents related to this report and filed pursuant to the Securities
Exchange Act of 1934, and to file the same, with all exhibits thereto, and other documents in
connection therewith, with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and agents, full power and authority to do and perform each and every act and
thing requisite and necessary to be done in connection therewith as fully to all intents and
purposes as he might or could do in person, hereby ratifying and confirming all that said
attorneys-in-fact and agents, or their substitute or substitutes may lawfully do or cause to be
done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the Registrant in the capacities and on the
dates indicated.
|
|
|
|
|
SIGNATURE |
|
TITLE |
|
DATE |
|
|
|
|
|
/s/ JONAH SHACKNAI
|
|
Chairman of the Board of Directors and
Chief Executive Officer
|
|
March 1, 2007 |
|
|
(Principal Executive Officer) |
|
|
|
|
|
|
|
/s/ MARK A. PRYGOCKI, SR.
|
|
Executive Vice President, Chief
Financial Officer, and
Treasurer
|
|
March 1, 2007 |
|
|
(Principal Financial and Accounting Officer) |
|
|
|
|
|
|
|
/s/ ARTHUR G. ALTSCHUL, JR.
|
|
Director
|
|
March 1, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ SPENCER DAVIDSON
|
|
Director
|
|
March 1, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ STUART DIAMOND
|
|
Director
|
|
March 1, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ PETER S. KNIGHT, ESQ.
|
|
Director
|
|
March 1, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ MICHAEL A. PIETRANGELO
|
|
Director
|
|
March 1, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ PHILIP S. SCHEIN, M.D.
|
|
Director
|
|
March 1, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ LOTTIE SHACKELFORD
|
|
Director
|
|
March 1, 2007 |
|
|
|
|
|
76
MEDICIS PHARMACEUTICAL CORPORATION
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
|
|
PAGE |
Reports of Independent Registered Public Accounting Firm |
|
|
F-2 |
|
|
|
|
|
|
Consolidated Balance Sheets as of December 31, 2006 and 2005. |
|
|
F-4 |
|
|
|
|
|
|
Consolidated Statements of Income for the year ended
December 31, 2006, the six months ended December 31, 2005
and December 31, 2004 (unaudited), and the fiscal years
ended June 30, 2005 and 2004 |
|
|
F-6 |
|
|
|
|
|
|
Consolidated Statements of Stockholders Equity for the year
ended December 31, 2006, the six months ended December 31,
2005, and the fiscal years ended June 30, 2005 and 2004 |
|
|
F-7 |
|
|
|
|
|
|
Consolidated Statements of Cash Flows for the year ended
December 31, 2006, the six months ended December 31, 2005
and December 31, 2004 (unaudited) and the fiscal years ended
June 30, 2005 and 2004 |
|
|
F-11 |
|
|
|
|
|
|
Notes to Consolidated Financial Statements |
|
|
F-12 |
|
F-1
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Medicis Pharmaceutical Corporation
We have audited the accompanying consolidated balance sheets of Medicis Pharmaceutical
Corporation and subsidiaries (the Company) as of December 31, 2006 and 2005, and the related
consolidated statements of income, stockholders equity, and cash flows for the year ended
December 31, 2006, the six months ended December 31, 2005 and each of the two years in the
period ended June 30, 2005. Our audits also included the financial statement schedule
listed in Item 15(a)(2). These financial statements and schedule are the responsibility of
the Companys management. Our responsibility is to express an opinion on these financial
statements and schedule based upon our audits.
We conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a test basis, evidence
supporting the amounts and disclosures in the financial statements. An audit also includes
assessing the accounting principles used and significant estimates made by management, as
well as evaluating the overall financial statement presentation. We believe that our audits
provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in all
material respects, the consolidated financial position of Medicis Pharmaceutical Corporation
and subsidiaries at December 31, 2006 and 2005 and the consolidated results of their
operations and their cash flows for the year ended December 31, 2006, the six months ended
December 31, 2005 and each of the two years in the period ended June 30, 2005, in conformity
with U.S. generally accepted accounting principles. Also, in our opinion, the related
financial statement schedule, when considered in relation to the basic financial statements
taken as a whole, presents fairly in all material respects the information set forth
therein.
We also have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the effectiveness of Medicis Pharmaceutical Corporations
internal control over financial reporting as of December 31, 2006, based on criteria
established in Internal ControlIntegrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission and our report dated February 26, 2007 expressed an
unqualified opinion thereon.
Phoenix, Arizona
February 26, 2007
F-2
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Medicis Pharmaceutical Corporation
We have audited managements assessment, included in the accompanying Managements
Report on Internal Control over Financial Reporting, that Medicis Pharmaceutical Corporation
and subsidiaries (the Company) maintained effective internal control over financial
reporting as of December 31, 2006, based on criteria established in Internal
ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (the COSO criteria). Medicis Pharmaceutical Corporations management is
responsible for maintaining effective internal control over financial reporting and for its
assessment of the effectiveness of internal control over financial reporting. Our
responsibility is to express an opinion on managements assessment and an opinion on the
effectiveness of the Companys internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan and perform
the audit to obtain reasonable assurance about whether effective internal control over
financial reporting was maintained in all material respects. Our audit included obtaining an
understanding of internal control over financial reporting, evaluating managements
assessment, testing and evaluating the design and operating effectiveness of internal
control, and performing such other procedures as we considered necessary in the
circumstances. We believe that our audit provides a reasonable basis for our opinion.
A companys internal control over financial reporting is a process designed to provide
reasonable assurance regarding the reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with generally accepted accounting
principles. A companys internal control over financial reporting includes those policies
and procedures that (1) pertain to the maintenance of records that, in reasonable detail,
accurately and fairly reflect the transactions and dispositions of the assets of the
company; (2) provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company are being made only in
accordance with authorizations of management and directors of the company; and (3) provide
reasonable assurance regarding prevention or timely detection of unauthorized acquisition,
use, or disposition of the companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Also, projections of any evaluation of effectiveness to
future periods are subject to the risk that controls may become inadequate because of
changes in conditions, or that the degree of compliance with the policies or procedures may
deteriorate.
In our opinion, managements assessment that Medicis Pharmaceutical Corporation
maintained effective internal control over financial reporting as of December 31, 2006, is
fairly stated, in all material respects, based on the COSO criteria. Also, in our opinion,
Medicis Pharmaceutical Corporation maintained, in all material respects, effective internal
control over financial reporting as of December 31, 2006, based on the COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the December 31, 2006 consolidated financial statements of
Medicis Pharmaceutical Corporation and subsidiaries and our report dated February 26, 2007
expressed an unqualified opinion thereon.
Phoenix, Arizona
February 26, 2007
F-3
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED BALANCE SHEETS
(in thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2006 |
|
|
2005 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
203,319 |
|
|
$ |
446,997 |
|
Short-term investments |
|
|
350,942 |
|
|
|
295,535 |
|
Accounts receivable, less allowances: |
|
|
|
|
|
|
|
|
December 31, 2006 and
2005: $37,443 and $18,160, respectively |
|
|
36,370 |
|
|
|
46,697 |
|
Inventories, net |
|
|
27,016 |
|
|
|
19,076 |
|
Deferred tax assets, net |
|
|
23,047 |
|
|
|
12,738 |
|
Other current assets |
|
|
15,990 |
|
|
|
12,241 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
656,684 |
|
|
|
833,284 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
6,576 |
|
|
|
5,416 |
|
Intangible assets: |
|
|
|
|
|
|
|
|
Intangible assets related to product line
acquisitions and business combinations |
|
|
239,396 |
|
|
|
311,406 |
|
Other intangible assets |
|
|
6,052 |
|
|
|
4,888 |
|
|
|
|
|
|
|
|
|
|
|
245,448 |
|
|
|
316,294 |
|
Less: accumulated amortization |
|
|
76,241 |
|
|
|
76,458 |
|
|
|
|
|
|
|
|
Net intangible assets |
|
|
169,207 |
|
|
|
239,836 |
|
Goodwill |
|
|
63,107 |
|
|
|
63,094 |
|
Deferred tax assets, net |
|
|
41,241 |
|
|
|
|
|
Long-term investments |
|
|
130,290 |
|
|
|
|
|
Deferred financing costs, net |
|
|
2,181 |
|
|
|
4,325 |
|
|
|
|
|
|
|
|
|
|
$ |
1,069,286 |
|
|
$ |
1,145,955 |
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-4
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED BALANCE SHEETS, Continued
(in thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2006 |
|
|
2005 |
|
Liabilities |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
47,513 |
|
|
$ |
57,708 |
|
Short-term contract obligation |
|
|
|
|
|
|
27,407 |
|
Income taxes payable |
|
|
11,346 |
|
|
|
31,521 |
|
Other current liabilities |
|
|
47,803 |
|
|
|
24,195 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
106,662 |
|
|
|
140,831 |
|
|
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Contingent convertible senior notes |
|
|
453,065 |
|
|
|
453,065 |
|
Deferred tax liability, net |
|
|
|
|
|
|
8,572 |
|
|
|
|
|
|
|
|
|
|
Commitments and Contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders Equity |
|
|
|
|
|
|
|
|
Preferred stock, $0.01 par value; shares authorized: 5,000,000;
no shares issued |
|
|
|
|
|
|
|
|
Class A
common stock, $0.014 par value; shares authorized: 150,000,000; issued and
outstanding: 68,044,363, and 67,052,326 at
December 31, 2006 and 2005, respectively |
|
|
952 |
|
|
|
938 |
|
Class B
common stock, $0.014 par value; shares authorized: 1,000,000; issued and outstanding: no shares issued |
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
598,435 |
|
|
|
550,006 |
|
Accumulated other comprehensive income |
|
|
537 |
|
|
|
379 |
|
Accumulated earnings |
|
|
252,431 |
|
|
|
334,894 |
|
Less: Treasury stock, 12,650,233 and 12,647,554 shares at cost at
December 31, 2006 and 2005, respectively |
|
|
(342,796 |
) |
|
|
(342,730 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
509,559 |
|
|
|
543,487 |
|
|
|
|
|
|
|
|
|
|
$ |
1,069,286 |
|
|
$ |
1,145,955 |
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-5
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF INCOME
(in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEAR ENDED |
|
|
SIX MONTHS ENDED |
|
|
|
|
|
|
DECEMBER 31, |
|
|
DECEMBER 31, |
|
|
YEAR ENDED JUNE 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
|
|
(UNAUDITED) |
|
Net product revenues |
|
$ |
333,625 |
|
|
$ |
155,569 |
|
|
$ |
146,999 |
|
|
$ |
305,114 |
|
|
$ |
291,607 |
|
Net contract revenues |
|
|
15,617 |
|
|
|
8,385 |
|
|
|
34,168 |
|
|
|
71,785 |
|
|
|
12,115 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
349,242 |
|
|
|
163,954 |
|
|
|
181,167 |
|
|
|
376,899 |
|
|
|
303,722 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue (1) |
|
|
41,741 |
|
|
|
24,111 |
|
|
|
27,270 |
|
|
|
55,447 |
|
|
|
46,606 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
307,501 |
|
|
|
139,843 |
|
|
|
153,897 |
|
|
|
321,452 |
|
|
|
257,116 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (2) |
|
|
206,822 |
|
|
|
80,189 |
|
|
|
65,736 |
|
|
|
135,154 |
|
|
|
118,253 |
|
Impairment of long-lived assets |
|
|
52,586 |
|
|
|
9,171 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development (3) |
|
|
161,837 |
|
|
|
22,367 |
|
|
|
45,140 |
|
|
|
65,676 |
|
|
|
16,494 |
|
Depreciation and amortization |
|
|
23,048 |
|
|
|
12,420 |
|
|
|
10,222 |
|
|
|
22,350 |
|
|
|
16,794 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating (loss) income |
|
|
(136,792 |
) |
|
|
15,696 |
|
|
|
32,799 |
|
|
|
98,272 |
|
|
|
105,575 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
|
|
|
|
59,801 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and investment income |
|
|
30,787 |
|
|
|
10,059 |
|
|
|
5,076 |
|
|
|
11,470 |
|
|
|
10,050 |
|
Interest expense |
|
|
(10,640 |
) |
|
|
(5,333 |
) |
|
|
(5,324 |
) |
|
|
(10,640 |
) |
|
|
(10,808 |
) |
Loss on early extinguishment of debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(58,660 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) income before income tax |
|
|
(116,645 |
) |
|
|
80,223 |
|
|
|
32,551 |
|
|
|
99,102 |
|
|
|
46,157 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax (benefit) expense |
|
|
(40,796 |
) |
|
|
30,502 |
|
|
|
11,328 |
|
|
|
34,112 |
|
|
|
15,317 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(75,849 |
) |
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
$ |
30,840 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net (loss) income per share |
|
$ |
(1.39 |
) |
|
$ |
0.92 |
|
|
$ |
0.38 |
|
|
$ |
1.18 |
|
|
$ |
0.55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net (loss) income per share |
|
$ |
(1.39 |
) |
|
$ |
0.76 |
|
|
$ |
0.34 |
|
|
$ |
1.01 |
|
|
$ |
0.52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share |
|
$ |
0.12 |
|
|
$ |
0.06 |
|
|
$ |
0.06 |
|
|
$ |
0.12 |
|
|
$ |
0.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic common shares outstanding |
|
|
54,688 |
|
|
|
54,323 |
|
|
|
55,972 |
|
|
|
55,196 |
|
|
|
55,618 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted common shares outstanding |
|
|
54,688 |
|
|
|
69,772 |
|
|
|
72,160 |
|
|
|
70,909 |
|
|
|
72,481 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) amounts exclude
amortization of intangible assets
related
to acquired products |
|
$ |
20,017 |
|
|
$ |
10,899 |
|
|
$ |
8,933 |
|
|
$ |
19,620 |
|
|
$ |
14,891 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2) amounts include share-based
compensation expense |
|
$ |
24,453 |
|
|
$ |
13,947 |
|
|
$ |
258 |
|
|
$ |
515 |
|
|
$ |
515 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3) amounts include share-based
compensation expense |
|
$ |
1,626 |
|
|
$ |
1,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-6
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class A |
|
|
Class B |
|
|
|
Common Stock |
|
|
Common Stock |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
Balance at June 30, 2003 |
|
|
62,510 |
|
|
$ |
876 |
|
|
|
758 |
|
|
$ |
10 |
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains on available-for-sale
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized losses on foreign currency
translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of contingent convertible senior notes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation, net of award
reacquisitions |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
2,909 |
|
|
|
40 |
|
|
|
|
|
|
|
|
|
Tax effect of stock options exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2004 |
|
|
65,419 |
|
|
|
916 |
|
|
|
758 |
|
|
|
10 |
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains on available-for-sale
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains on foreign currency
translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of Class B common stock to Class A
common stock |
|
|
758 |
|
|
|
10 |
|
|
|
(758 |
) |
|
|
(10 |
) |
Conversion of contingent convertible senior
notes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted shares issued for deferred
compensation, net
of award reacquisitions |
|
|
18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation, net of award
reacquisitions |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
812 |
|
|
|
12 |
|
|
|
|
|
|
|
|
|
Tax effect of stock options exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of treasury stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2005 |
|
|
67,007 |
|
|
|
938 |
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-7
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Other |
|
|
|
|
|
|
|
|
|
|
Treasury |
|
|
|
|
|
|
Paid-In |
|
|
Comprehensive |
|
|
Deferred |
|
|
Accumulated |
|
|
Stock |
|
|
|
|
|
|
Capital |
|
|
Income (Loss) |
|
|
Compensation |
|
|
Earnings |
|
|
Shares |
|
|
Amount |
|
|
Total |
|
|
|
$ |
445,653 |
|
|
$ |
2,400 |
|
|
$ |
(1,727 |
) |
|
$ |
204,817 |
|
|
|
(8,682 |
) |
|
$ |
(190,908 |
) |
|
$ |
461,121 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30,840 |
|
|
|
|
|
|
|
|
|
|
|
30,840 |
|
|
|
|
|
|
|
|
(3,452 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,452 |
) |
|
|
|
|
|
|
|
32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,420 |
|
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,608 |
) |
|
|
|
|
|
|
|
|
|
|
(5,608 |
) |
|
|
|
|
|
|
|
|
|
|
|
515 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
515 |
|
|
|
|
51,393 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51,433 |
|
|
|
|
20,416 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,416 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
517,468 |
|
|
|
(1,020 |
) |
|
|
(1,212 |
) |
|
|
230,049 |
|
|
|
(8,682 |
) |
|
|
(190,908 |
) |
|
|
555,303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
64,990 |
|
|
|
|
|
|
|
|
|
|
|
64,990 |
|
|
|
|
|
|
|
|
(75 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(75 |
) |
|
|
|
|
|
|
|
489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65,404 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,565 |
) |
|
|
|
|
|
|
|
|
|
|
(6,565 |
) |
|
|
|
298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18 |
) |
|
|
(298 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
515 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
515 |
|
|
|
|
16,571 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,583 |
|
|
|
|
5,104 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,104 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,920 |
) |
|
|
(150,000 |
) |
|
|
(150,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
539,443 |
|
|
|
(606 |
) |
|
|
(697 |
) |
|
|
288,474 |
|
|
|
(12,620 |
) |
|
|
(341,206 |
) |
|
|
486,346 |
|
F-8
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class A |
|
|
Class B |
|
|
|
Common Stock |
|
|
Common Stock |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
Balance at June 30, 2005 |
|
|
67,007 |
|
|
$ |
938 |
|
|
|
|
|
|
$ |
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains on available-for-sale
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains on foreign currency
translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustment for adoption of SFAS No.
123(R) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted shares issued for deferred
compensation |
|
|
27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax effect of stock options
exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005 |
|
|
67,052 |
|
|
|
938 |
|
|
|
|
|
|
|
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains on available-for-sale
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized losses on foreign currency
translation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted shares issued for deferred
compensation |
|
|
24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted shares held in lieu of
employee taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
968 |
|
|
|
14 |
|
|
|
|
|
|
|
|
|
Tax effect of stock options
exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
68,044 |
|
|
$ |
952 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-9
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Other |
|
|
|
|
|
|
|
|
|
|
Treasury |
|
|
|
|
|
|
Paid-In |
|
|
Comprehensive |
|
|
Deferred |
|
|
Accumulated |
|
|
Stock |
|
|
|
|
|
|
Capital |
|
|
Income (Loss) |
|
|
Compensation |
|
|
Earnings |
|
|
Shares |
|
|
Amount |
|
|
Total |
|
|
|
$ |
539,443 |
|
|
$ |
(606 |
) |
|
$ |
(697 |
) |
|
$ |
288,474 |
|
|
|
(12,620 |
) |
|
$ |
(341,206 |
) |
|
$ |
486,346 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
49,721 |
|
|
|
|
|
|
|
|
|
|
|
49,721 |
|
|
|
|
|
|
|
|
636 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
636 |
|
|
|
|
|
|
|
|
349 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
349 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50,706 |
|
|
|
|
|
|
|
|
827 |
|
|
|
|
|
|
|
697 |
|
|
|
|
|
|
|
|
|
|
|
(1,524 |
) |
|
|
|
|
|
|
|
14,947 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,947 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,301 |
) |
|
|
|
|
|
|
|
|
|
|
(3,301 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(27 |
) |
|
|
|
|
|
|
|
|
|
|
|
430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
430 |
|
|
|
|
(5,641 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,641 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
550,006 |
|
|
|
379 |
|
|
|
|
|
|
|
334,894 |
|
|
|
(12,647 |
) |
|
|
(342,730 |
) |
|
|
543,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(75,849 |
) |
|
|
|
|
|
|
|
|
|
|
(75,849 |
) |
|
|
|
|
|
|
|
236 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
236 |
|
|
|
|
|
|
|
|
(78 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(78 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(75,691 |
) |
|
|
|
26,078 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
26,078 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,614 |
) |
|
|
|
|
|
|
|
|
|
|
(6,614 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3 |
) |
|
|
(66 |
) |
|
|
(66 |
) |
|
|
|
18,430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
18,444 |
|
|
|
|
3,921 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,921 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
598,435 |
|
|
$ |
537 |
|
|
$ |
|
|
|
$ |
252,431 |
|
|
|
(12,650 |
) |
|
$ |
(342,796 |
) |
|
$ |
509,559 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-10
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEAR ENDED |
|
|
SIX MONTHS ENDED |
|
|
|
|
|
|
DECEMBER 31, |
|
|
DECEMBER 31, |
|
|
YEAR ENDED JUNE 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
|
|
|
|
|
|
|
(UNAUDITED) |
|
|
|
|
|
|
|
|
|
Operating Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(75,849 |
) |
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
$ |
30,840 |
|
Adjustments to reconcile net (loss) income to net
cash (used in) provided by operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
23,048 |
|
|
|
12,420 |
|
|
|
10,222 |
|
|
|
22,350 |
|
|
|
16,794 |
|
Amortization of deferred financing fees |
|
|
2,144 |
|
|
|
1,072 |
|
|
|
1,072 |
|
|
|
2,143 |
|
|
|
2,144 |
|
Impairment of long-lived assets |
|
|
52,586 |
|
|
|
9,171 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss (gain) on disposal of property and
equipment |
|
|
449 |
|
|
|
34 |
|
|
|
39 |
|
|
|
52 |
|
|
|
(4 |
) |
Loss on sale of product rights |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32 |
|
(Gain) loss on sale of
available-for-sale investments |
|
|
(421 |
) |
|
|
599 |
|
|
|
103 |
|
|
|
882 |
|
|
|
(599 |
) |
Write-off of Inamed transaction costs......... |
|
|
|
|
|
|
14,042 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense............ |
|
|
26,079 |
|
|
|
14,947 |
|
|
|
258 |
|
|
|
515 |
|
|
|
515 |
|
Deferred income tax expense (benefit) |
|
|
(60,122 |
) |
|
|
1,849 |
|
|
|
(3,060 |
) |
|
|
5,369 |
|
|
|
(3,634 |
) |
Tax benefit from exercise of stock options |
|
|
3,921 |
|
|
|
|
|
|
|
5,058 |
|
|
|
5,104 |
|
|
|
20,416 |
|
Excess tax benefits from share-based
payment arrangements |
|
|
(2,166 |
) |
|
|
(73 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Provision for doubtful accounts and returns |
|
|
19,282 |
|
|
|
(913 |
) |
|
|
3,100 |
|
|
|
3,118 |
|
|
|
1,050 |
|
(Amortization) accretion of (discount)/premium
on investments |
|
|
(2,159 |
) |
|
|
(418 |
) |
|
|
5,010 |
|
|
|
6,528 |
|
|
|
7,284 |
|
Loss on early extinguishment of debt |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
58,660 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(8,955 |
) |
|
|
1,436 |
|
|
|
(957 |
) |
|
|
(2,480 |
) |
|
|
2,753 |
|
Inventories |
|
|
(7,940 |
) |
|
|
1,625 |
|
|
|
2,621 |
|
|
|
(1,160 |
) |
|
|
(5,535 |
) |
Other current assets |
|
|
(3,749 |
) |
|
|
4,194 |
|
|
|
(1,942 |
) |
|
|
1,886 |
|
|
|
(1,472 |
) |
Accounts payable |
|
|
(10,195 |
) |
|
|
27,220 |
|
|
|
4,557 |
|
|
|
15,580 |
|
|
|
(4,655 |
) |
Income taxes payable |
|
|
(20,175 |
) |
|
|
17,255 |
|
|
|
5,974 |
|
|
|
9,524 |
|
|
|
232 |
|
Other current liabilities |
|
|
23,259 |
|
|
|
(6,191 |
) |
|
|
(7,813 |
) |
|
|
(4,420 |
) |
|
|
3,143 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by
operating activities |
|
|
(40,963 |
) |
|
|
147,990 |
|
|
|
45,465 |
|
|
|
129,981 |
|
|
|
127,964 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(4,450 |
) |
|
|
(748 |
) |
|
|
(1,829 |
) |
|
|
(2,913 |
) |
|
|
(4,594 |
) |
Proceeds from sale of property and equipment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
131 |
|
Payment of direct merger costs |
|
|
(27,420 |
) |
|
|
(5,811 |
) |
|
|
(129 |
) |
|
|
(7,454 |
) |
|
|
(633 |
) |
Payments for purchase of product rights |
|
|
(2,164 |
) |
|
|
(481 |
) |
|
|
(3,085 |
) |
|
|
(3,296 |
) |
|
|
(84,116 |
) |
Proceeds from sale of product rights |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,100 |
|
Purchase of available-for-sale investments |
|
|
(822,512 |
) |
|
|
(203,247 |
) |
|
|
(440,602 |
) |
|
|
(762,561 |
) |
|
|
(888,152 |
) |
Sale of available-for-sale investments |
|
|
349,034 |
|
|
|
159,597 |
|
|
|
489,352 |
|
|
|
846,143 |
|
|
|
622,006 |
|
Maturity of available-for-sale investments |
|
|
290,597 |
|
|
|
174,355 |
|
|
|
32,451 |
|
|
|
70,568 |
|
|
|
123,072 |
|
Decrease in restricted cash |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
53,837 |
|
Change in other assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by
investing activities Activities |
|
|
(216,915 |
) |
|
|
123,665 |
|
|
|
76,158 |
|
|
|
140,487 |
|
|
|
(166,341 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment of financing costs |
|
|
|
|
|
|
|
|
|
|
(6 |
) |
|
|
(6 |
) |
|
|
(5,276 |
) |
Payment of dividends |
|
|
(6,581 |
) |
|
|
(3,295 |
) |
|
|
(3,115 |
) |
|
|
(6,370 |
) |
|
|
(5,536 |
) |
Purchase of treasury stock |
|
|
|
|
|
|
|
|
|
|
(150,000 |
) |
|
|
(150,000 |
) |
|
|
|
|
Excess tax benefits from share-based
payment arrangements |
|
|
2,166 |
|
|
|
73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from the exercise of stock options |
|
|
18,693 |
|
|
|
430 |
|
|
|
15,674 |
|
|
|
16,583 |
|
|
|
51,433 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in)
financing activities |
|
|
14,278 |
|
|
|
(2,792 |
) |
|
|
(137,447 |
) |
|
|
(139,793 |
) |
|
|
40,621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate on cash and
cash equivalents |
|
|
(78 |
) |
|
|
349 |
|
|
|
724 |
|
|
|
489 |
|
|
|
31 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash
equivalents |
|
|
(243,678 |
) |
|
|
269,212 |
|
|
|
(15,100 |
) |
|
|
131,164 |
|
|
|
2,275 |
|
Cash and cash equivalents at beginning
of period |
|
|
446,997 |
|
|
|
177,785 |
|
|
|
46,621 |
|
|
|
46,621 |
|
|
|
44,346 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
203,319 |
|
|
$ |
446,997 |
|
|
$ |
31,521 |
|
|
$ |
177,785 |
|
|
$ |
46,621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-11
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
NOTE 1. THE COMPANY AND BASIS OF PRESENTATION
The Company
Medicis Pharmaceutical Corporation (Medicis or the Company) is a leading specialty
pharmaceutical company focusing primarily on the development and marketing of products in
the United States (U.S.) for the treatment of dermatological, aesthetic and podiatric
conditions. Medicis also markets products in Canada for the treatment of dermatological and
aesthetic conditions.
The Company offers a broad range of products addressing various conditions or aesthetic
improvements including facial wrinkles, acne, fungal infections, rosacea, hyperpigmentation,
photoaging, psoriasis, skin and skin-structure infections, seborrheic dermatitis and
cosmesis (improvement in the texture and appearance of skin). Medicis currently offers 17
branded products. Its primary brands are OMNICEF®, RESTYLANE®,
SOLODYN®, TRIAZ®, VANOS Cream, and ZIANA Gel.
On March 17, 2006, Medicis entered into a development and distribution agreement with
Ipsen Ltd., a wholly-owned subsidiary of Ipsen S.A. (Ipsen), whereby Ipsen granted
Aesthetica Ltd., a wholly-owned subsidiary of Medicis, rights to develop, distribute and
commercialize Ipsens botulinum toxin type A product in the U.S., Canada and Japan for
aesthetic use by physicians. The product is commonly referred to as RELOXIN® in
the U.S. aesthetic market and DYSPORT® for medical and aesthetic markets outside
the U.S. The product is not currently approved for use in the U.S., Canada or Japan.
The consolidated financial statements include the accounts of Medicis and its wholly
owned subsidiaries. The Company does not have any subsidiaries in which it does not own
100% of the outstanding stock. All of the Companys subsidiaries are included in the
consolidated financial statements. All significant intercompany accounts and transactions
have been eliminated in consolidation.
Basis of Presentation
Effective December 31, 2005, the Company changed its fiscal year end from June 30 to
December 31. This change was made in order to align the Companys fiscal year end with
other companies within the industry. The audited calendar year January 1, 2006 to December
31, 2006, is referred to as 2006. The resulting six-month period ended December 31, 2005
may be referred to herein as the Transition Period. The six-month period ended December
31, 2004 is unaudited and may be referred to herein as the comparable 2004 six months.
The Company refers to the period beginning July 1, 2004 and ending June 30, 2005 as fiscal
2005 and the period beginning July 1, 2003 and ending June 30, 2004 as fiscal 2004.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Cash and Cash Equivalents
At December 31, 2006, cash and cash equivalents included highly liquid investments
invested in money market accounts consisting of government securities and high-grade
commercial paper. These investments are stated at cost, which approximates fair value. The
Company considers all highly liquid investments purchased with a remaining maturity of three
months or less to be cash equivalents.
F-12
Short-Term and Long-Term Investments
The Companys short-term and long-term investments are classified as
available-for-sale. Available-for-sale securities are carried at fair value with the
unrealized gains and losses reported in stockholders equity. Realized gains and losses and
declines in value judged to be other-than-temporary, if any, are included in operations. On
an ongoing basis, the Company evaluates its available-for-sale securities to determine if a
decline in value is other-than-temporary. A decline in market value of any
available-for-sale security below cost that is determined to be other-than-temporary,
results in an impairment in the fair value of the investment. The impairment is charged to
earnings and a new cost basis for the security is established. Premiums and discounts are
amortized or accreted over the life of the related available-for-sale security. Dividends
and interest income are recognized when earned. Realized gains and losses and interest and
dividends on securities are included in interest and investment income. The cost of
securities sold is calculated using the specific identification method.
Inventories
The Company utilizes third parties to manufacture and package inventories held for
sale, takes title to certain inventories once manufactured, and warehouses such goods until
packaged for final distribution and sale. Inventories consist of salable products held at
the Companys warehouses, as well as raw materials and components at the manufacturers
facilities, and are valued at the lower of cost or market using the first-in, first-out
method. The Company provides valuation reserves for estimated obsolescence or unmarketable
inventory in an amount equal to the difference between the cost of inventory and the
estimated market value based upon assumptions about future demand and market conditions.
Inventory costs associated with products that have not yet received regulatory approval
are capitalized if, in the view of the Companys management, there is probable future
commercial use and future economic benefit. If future commercial use and future economic
benefit are not considered probable, then costs associated with pre-launch inventory that
has not yet received regulatory approval are expensed as research and development expense
during the period the costs are incurred. As of December 31, 2006 and 2005, there are no
costs capitalized into inventory for products that have not yet received regulatory
approval.
Inventories are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2006 |
|
|
2005 |
|
Raw materials |
|
$ |
8,637 |
|
|
$ |
6,436 |
|
Finished goods |
|
|
19,709 |
|
|
|
13,925 |
|
Valuation reserve |
|
|
(1,330 |
) |
|
|
(1,285 |
) |
|
|
|
|
|
|
|
Total inventories |
|
$ |
27,016 |
|
|
$ |
19,076 |
|
|
|
|
|
|
|
|
Property and Equipment
Property and equipment are stated at cost. Depreciation is calculated on a
straight-line basis over the estimated useful lives of property and equipment (three to five
years). Leasehold improvements are amortized over the shorter of their estimated useful
lives or the remaining lease term. Property and equipment consist of the following (amounts
in thousands):
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2006 |
|
|
2005 |
|
Furniture, fixtures and equipment |
|
$ |
12,330 |
|
|
$ |
10,064 |
|
Leasehold improvements |
|
|
2,203 |
|
|
|
1,994 |
|
|
|
|
|
|
|
|
|
|
|
14,533 |
|
|
|
12,058 |
|
Less: accumulated depreciation |
|
|
(7,957 |
) |
|
|
(6,642 |
) |
|
|
|
|
|
|
|
|
|
$ |
6,576 |
|
|
$ |
5,416 |
|
|
|
|
|
|
|
|
Total depreciation expense for property and equipment was approximately $2.8 million,
$1.4 million, $1.2 million (unaudited), $2.6 million and $1.7 million for 2006, the
Transition Period, the comparable 2004 six months, fiscal 2005 and fiscal 2004,
respectively.
F-13
Goodwill
Goodwill is recorded when the purchase price paid for an acquisition exceeds the
estimated fair value of the net identified tangible and intangible assets acquired. The
Company is required to perform an annual impairment review, and more frequently under
certain circumstances. The goodwill is subjected to this annual impairment test typically
during the last quarter of the Companys fiscal year. The impairment review process
compares the fair value of the reporting unit to its carrying value. If the Company
determines through the impairment process that goodwill has been impaired, the Company will
record the impairment charge in the statement of income. As of December 31, 2006, there was
no impairment charge related to goodwill. There can be no assurance that future goodwill
impairment tests will not result in a charge to earnings.
Intangible Assets
The Company has in the past made acquisitions of license agreements, product rights,
and other identifiable intangible assets. Intangible assets subject to amortization were
approximately $169.2 million and $239.8 million as of December 31, 2006 and 2005,
respectively. The Company amortizes intangible assets over their expected useful lives,
which range between five and 25 years. Total intangible assets as of December 31, 2006 and
2005 were as follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
December 31, 2005 |
|
|
|
Weighted |
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Average Life |
|
|
Gross |
|
|
Amortization |
|
|
Net |
|
|
Gross |
|
|
Amortization |
|
|
Net |
|
Related to product line
acquisitions |
|
|
15.7 |
|
|
$ |
234,314 |
|
|
$ |
(72,299 |
) |
|
$ |
162,015 |
|
|
$ |
306,324 |
|
|
$ |
(73,879 |
) |
|
$ |
232,445 |
|
Related to business
combinations |
|
|
7.5 |
|
|
|
5,082 |
|
|
|
(2,996 |
) |
|
|
2,086 |
|
|
|
5,082 |
|
|
|
(1,824 |
) |
|
|
3,258 |
|
Patents and trademarks |
|
|
18.5 |
|
|
|
6,052 |
|
|
|
(946 |
) |
|
|
5,106 |
|
|
|
4,888 |
|
|
|
(755 |
) |
|
|
4,133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets |
|
|
|
|
|
$ |
245,448 |
|
|
$ |
(76,241 |
) |
|
$ |
169,207 |
|
|
$ |
316,294 |
|
|
$ |
(76,458 |
) |
|
$ |
239,836 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total amortization expense was approximately $20.2 million, $11.0 million, $9.0
million (unaudited), $19.8 million and $15.1 million for 2006, the Transition Period, the
comparable 2004 six months, fiscal 2005 and fiscal 2004, respectively. Based on the
intangible assets recorded at December 31, 2006, and assuming no subsequent impairment of
the underlying assets, the annual amortization expense for each period, is expected to be as
follows: approximately $19.4 million for the year ended December 31, 2007, approximately
$19.0 million for the year ended December 31, 2008, approximately $16.5 million for the year
ended December 31, 2009, and approximately $13.9 million for the years ended December 31,
2010 and December 31, 2011.
Impairment of Long-Lived Assets
The Company assesses the potential impairment of long-lived assets on a periodic basis
and when events or changes in circumstances indicate that the carrying value of the assets
may not be recoverable. Factors that the Company considers in deciding when to perform an
impairment review include significant under-performance of a product line in relation to
expectations, significant negative industry or economic trends, and significant changes or
planned changes in the Companys use of the assets. Recoverability of assets that will
continue to be used in the Companys operations is measured by comparing the carrying amount
of the asset grouping to the Companys estimate of the related total future net cash flows.
If an asset carrying value is not recoverable through the related cash flows, the asset is
considered to be impaired. The impairment is measured by the difference between the asset
groupings carrying amount and its fair value, based on the best information available,
including market prices or discounted cash flow analysis. If the assets determined to be
impaired are to be held and used, the Company recognizes an impairment loss through a charge
to operating results to the extent the present value of anticipated net cash flows
attributable to the asset are less than the assets carrying value. When it is determined
that the useful lives of assets are shorter than originally estimated, and there are
sufficient cash flows to support the carrying value of the assets, the Company will
accelerate the rate of amortization charges in order to fully amortize the assets over their
new shorter useful lives (See Note 3).
This process requires the use of estimates and assumptions, which are subject to a high
degree of judgment. If these assumptions change in the future, the Company may be required
to record impairment charges for these assets.
F-14
During the quarter ended September 30, 2006, long-lived assets related to certain of
the Companys products were determined to be impaired based on the Companys analysis of the
long-lived assets carrying value and projected future cash flows. As a result of the
impairment analysis, the Company recorded a write-down of approximately $52.6 million
related to these long-lived assets. This write-down included the following (in thousands):
|
|
|
|
|
Long-lived asset related to LOPROX® products |
|
$ |
49,163 |
|
Long-lived asset related to ESOTERICA® products |
|
|
3,267 |
|
Other long-lived asset |
|
|
156 |
|
|
|
|
|
|
|
$ |
52,586 |
|
|
|
|
|
Factors affecting the future cash flows of the LOPROX® long-lived asset
included competitive pressures in the marketplace and the cancellation of the development
plan to support future forms of LOPROX®. Factors affecting the future cash flows
of the ESOTERICA® long-lived asset included a notice of proposed rulemaking by
the FDA for an NDA to be required for continued marketing of hydroquinone products, such as
ESOTERICA®. ESOTERICA® is currently an over-the-counter product line,
and the Company does not plan to invest in obtaining an approved NDA for this product line
if this proposed rule is made final without change.
In addition, as a result of the impairment analysis, the remaining amortizable lives of
the long-lived assets related to LOPROX® and ESOTERICA® were reduced
to fifteen years and fifteen months, respectively. The long-lived asset related to
LOPROX® will become fully amortized on September 30, 2021, and the long-lived
asset related to ESOTERICA® will become fully amortized on December 31, 2007.
The net impact on amortization expense as a result of the write-down of the carrying value
of the long-lived assets and the reduction of their respective amortizable lives is a
decrease in quarterly amortization expense related to LOPROX® of $354,051 and an
increase in quarterly amortization expense related to ESOTERICA® of $48,077.
During the quarter ended December 31, 2005, a long-lived asset related to the Companys
DYNACIN® capsule products was determined to be impaired based on the Companys
analysis of the long-lived assets carrying value and projected future cash flows. Factors
affecting the long-lived assets future cash flows included the Companys promotional focus
on its DYNACIN® tablet products, and competitive pressures in the marketplace.
As a result of the impairment analysis, the Company recorded a write-down of approximately
$9.2 million related to this long-lived asset.
Deferred Financing Costs
Deferred financing costs represent fees and other costs incurred in connection with the
June 2002 issuance of the 2.5% Contingent Convertible Senior Notes Due 2032 and the August
2003 issuance of the 1.5% Contingent Convertible Senior Notes Due 2033. These costs are
being amortized as interest expense on a basis that approximates the effective interest
method over the five-year period that ends on the initial Put date of the Notes.
Accumulated amortization amounted to approximately $8.5 million as of December 31, 2006.
Managed Care and Medicaid Reserves
Rebates are contractual discounts offered to government programs and private health
plans that are eligible for such discounts at the time prescriptions are dispensed, subject
to various conditions. The Company records provisions for rebates by estimating these
liabilities as products are sold, based on factors such as timing and terms of plans under
contract, time to process rebates, product pricing, sales volumes, amount of inventory in
the distribution channel, and prescription trends.
F-15
Other Current Liabilities
Other current liabilities are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2006 |
|
|
2005 |
|
Accrued incentives |
|
$ |
13,479 |
|
|
$ |
6,506 |
|
Managed care and Medicaid
reserves |
|
|
7,111 |
|
|
|
6,081 |
|
Legal reserves |
|
|
10,500 |
|
|
|
351 |
|
Other accrued expenses |
|
|
16,713 |
|
|
|
11,257 |
|
|
|
|
|
|
|
|
|
|
$ |
47,803 |
|
|
$ |
24,195 |
|
|
|
|
|
|
|
|
Revenue Recognition
Revenue from product sales is recognized pursuant to Staff Accounting Bulletin No. 104
(SAB 104), Revenue Recognition in Financial Statements. Accordingly, revenue is
recognized when all four of the following criteria are met: (i) persuasive evidence that an
arrangement exists; (ii) delivery of the products has occurred; (iii) the selling price is
both fixed and determinable; and (iv) collectibility is reasonably assured. The Companys
customers consist primarily of large pharmaceutical wholesalers who sell directly into the
retail channel. Provisions for product returns and exchanges, sales discounts, chargebacks,
managed care and Medicaid rebates and other adjustments are established as a reduction of
product sales revenues at the time such revenues are recognized. These deductions from
gross revenue are established by the Companys management as its best estimate at the time
of sale based on historical experience adjusted to reflect known changes in the factors that
impact such reserves. These deductions from gross revenue are generally reflected either as
a direct reduction to accounts receivable through an allowance, or as an addition to accrued
expenses if the payment is due to a party other than the wholesale or retail customer.
The Company enters into licensing arrangements with other parties whereby the Company
receives contract revenue based on the terms of the agreement. The timing of revenue
recognition is dependent on the level of the Companys continuing involvement in the
manufacture and delivery of licensed products. If the Company has continuing involvement,
the revenue is deferred and recognized on a straight-line basis over the period of
continuing involvement. In addition, if the licensing arrangements require no continuing
involvement and payments are merely based on the passage of time, the Company assesses such
payments for revenue recognition under the collectibility criteria of SAB 104. Direct costs
related to contract acquisition and origination of licensing agreements are expensed as
incurred.
The Company does not provide any material forms of price protection to its wholesale
customers and permits product returns if the product is damaged, or, depending on the
customer, if it is returned within six months prior to expiration or up to 12 months after
expiration. The Companys customers consist principally of financially viable wholesalers,
and depending on the customer, revenue is based upon shipment (FOB shipping point) or
receipt (FOB destination), net of estimated provisions. As a general practice, the
Company does not ship product that has less than 15 months until its expiration date. The
Company also authorizes returns for damaged products and credits for expired products in
accordance with its returned goods policy and procedures. The shelf life associated with
the Companys products is up to 36 months depending on the product. The majority of the
Companys products have a shelf life of approximately 18-24 months.
Advertising
The Company expenses advertising as incurred. Advertising expenses for 2006, the
Transition Period, the comparable 2004 six months, fiscal 2005 and fiscal 2004 were
approximately $34.6 million, $12.9 million, $13.3 million (unaudited), $24.2 million and
$22.5 million, respectively. Advertising expenses include samples of the Companys products
given to physicians for marketing to their patients.
Share-Based Compensation
At December 31, 2006, the Company had seven active share-based employee compensation
plans. Of these seven share-based compensation plans, only the 2006 Incentive Award Plan is
eligible for the granting of future awards. Stock option awards granted from these plans
are granted at the fair market value on the date of grant. The
F-16
option awards vest over a
period determined at the time the options are granted, ranging from one to five years, and
generally have a maximum term of ten years. Certain options provide for accelerated vesting
if there is a change in control (as defined in the plans). When options are exercised, new
shares of the Companys Class A common stock are issued. Effective July 1, 2005, the
Company adopted SFAS No. 123R using the modified prospective method. Other than restricted
stock, no share-based employee compensation cost has been reflected in net income prior to
the adoption of SFAS No. 123R. Results for prior periods have not been restated.
The
effect of SFAS No. 123R increased the net loss before income tax benefit for 2006
by approximately $26.1 million, and increased the net loss for 2006 by approximately $19.0
million. As a result, the net loss per common share for 2006 was increased $0.35.
The total value of the stock options awards is expensed ratably over the service period
of the employees receiving the awards. As of December 31, 2006, total unrecognized
compensation cost related to stock option awards, to be recognized as expense subsequent to
December 31, 2006, was approximately $39.6 million and the related weighted-average period
over which it is expected to be recognized is approximately 2.3 years.
Prior to the adoption of SFAS No. 123R, the Company presented all tax benefits of
deductions resulting from the exercise of stock options as operating cash flows in the
consolidated statements of cash flows. SFAS No. 123R requires the cash flows resulting from
the tax benefits resulting from tax deductions in excess of the compensation cost recognized
for those options (excess tax benefits) to be classified as financing cash flows.
Approximately $2.2 million of excess tax benefits were recognized during 2006.
A summary of stock option activity within the Companys stock-based compensation plans
and changes for 2006 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
of Shares |
|
Price |
|
Term |
|
Value |
Balance at December 31, 2005 |
|
|
14,379,336 |
|
|
$ |
27.21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
91,125 |
|
|
$ |
31.38 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(999,831 |
) |
|
$ |
20.43 |
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
(481,619 |
) |
|
$ |
30.60 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
12,989,011 |
|
|
$ |
27.63 |
|
|
|
5.56 |
|
|
$ |
105,812,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The intrinsic value of options exercised during 2006 was $13,258,954. Options
exercisable under the Companys share-based compensation plans at December 31, 2006 were
8,555,147, with an average exercise price of $25.45, an average remaining contractual term
of 4.9 years, and an aggregate intrinsic value of $85,433,979.
A summary of fully vested stock options and stock options expected to vest, based on
historical forfeiture rates, as of December 31, 2006, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
of Shares |
|
Price |
|
Term |
|
Value |
Outstanding |
|
|
12,528,566 |
|
|
$ |
27.61 |
|
|
|
5.6 |
|
|
$ |
102,360,180 |
|
Exercisable |
|
|
8,293,843 |
|
|
$ |
25.44 |
|
|
|
4.9 |
|
|
$ |
82,922,424 |
|
F-17
The fair value of each stock option award is estimated on the date of the grant using
the Black-Scholes option pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve Months Ended |
|
Six Months Ended |
|
Six Months Ended |
|
|
December 31, 2006 |
|
December 31, 2005 |
|
December 31, 2004 |
|
|
|
|
|
|
|
|
|
|
(UNAUDITED) |
Expected dividend yield |
|
|
0.4 |
% |
|
|
0.4% |
|
|
|
0.3 |
% |
Expected stock price volatility |
|
|
0.36 |
|
|
|
0.36 |
|
|
|
0.44 |
|
Risk-free interest rate |
|
4.5% to 4.6% |
|
4.1% to 4.2% |
|
|
3.6 |
% |
Expected life of options |
|
7 Years |
|
|
6 to 8 Years |
|
|
5 Years |
|
|
|
|
|
|
|
|
|
|
|
Twelve Months Ended |
|
Twelve Months Ended |
|
|
June 30, 2005 |
|
June 30, 2004 |
Expected dividend yield |
|
|
0.3 |
% |
|
|
0.3 |
% |
Expected stock price volatility |
|
|
0.44 |
|
|
|
0.49 |
|
Risk-free interest rate |
|
|
3.6 |
% |
|
|
3.3 |
% |
Expected life of options |
|
5 Years |
|
5 Years |
The expected dividend yield is based on expected annual dividend to be paid by the
Company as a percentage of the market value of the Companys stock as of the date of grant.
The Company determined that a blend of implied volatility and historical volatility is more
reflective of market conditions and a better indicator of expected volatility than using
purely historical volatility. The risk-free interest rate is based on the U.S. treasury
security rate in effect as of the date of grant. The expected lives of options are based on
historical data of the Company.
The weighted average fair value of stock options granted during 2006, the Transition
Period, the comparable 2004 six months, fiscal 2005 and fiscal 2004 was $14.00, $14.15,
$16.08 (unaudited), $11.66 and $10.17, respectively.
The following table illustrates the effect on net income and net income per common
share as if the Company had applied the fair value recognition provisions of SFAS No. 123 to
all outstanding stock option awards for periods presented prior to the Companys adoption of
SFAS No. 123R (amounts in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6 Months |
|
|
12 Months |
|
|
12 Months |
|
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
|
December 31, 2004 |
|
|
June 30,2005 |
|
|
June 30, 2004 |
|
|
|
(UNAUDITED) |
|
|
|
|
|
|
|
|
|
Net income, as reported |
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
$ |
30,840 |
|
Deduct: Total stock-based employee
compensation expense determined under
fair value based method for all awards,
net of related tax effects |
|
|
10,195 |
|
|
|
21,813 |
|
|
|
17,078 |
|
|
|
|
|
|
|
|
|
|
|
Pro-forma net income |
|
$ |
11,028 |
|
|
$ |
43,177 |
|
|
$ |
13,762 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic, as reported |
|
$ |
0.38 |
|
|
$ |
1.18 |
|
|
$ |
0.55 |
|
Basic, pro forma |
|
$ |
0.20 |
|
|
$ |
0.78 |
|
|
$ |
0.25 |
|
Diluted, as reported |
|
$ |
0.34 |
|
|
$ |
1.01 |
|
|
$ |
0.52 |
|
Diluted, pro forma |
|
$ |
0.20 |
|
|
$ |
0.70 |
|
|
$ |
0.23 |
|
The Company also grants restricted stock awards to certain employees. Restricted stock
awards are valued at the closing market value of the Companys Class A common stock on the
date of grant, and the total value of the award is expensed ratably over the service period
of the employees receiving the grants. During 2006, 163,025 shares of restricted stock were
granted to certain employees. Share-based compensation expense related to all
restricted stock awards outstanding during 2006, the Transition Period, the comparable
2004 six months, fiscal 2005 and fiscal 2004 was approximately $2.0 million, $0.7 million,
$0.3 million (unaudited), $0.5 million and $0.5
F-18
million, respectively. As of December 31,
2006, the total amount of unrecognized compensation cost related to nonvested restricted
stock awards, to be recognized as expense subsequent to December 31, 2006, was approximately
$7.3 million, and the related weighted-average period over which it is expected to be
recognized is approximately 4.2 years.
A summary of restricted stock activity within the Companys share-based compensation
plans and changes for 2006 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Grant-Date |
Nonvested Shares |
|
Shares |
|
Fair Value |
Nonvested at December 31, 2005 |
|
|
212,260 |
|
|
$ |
29.65 |
|
|
Granted |
|
|
163,025 |
|
|
$ |
28.83 |
|
Vested |
|
|
(69,456 |
) |
|
$ |
26.07 |
|
Forfeited |
|
|
(10,250 |
) |
|
$ |
31.43 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2006 |
|
|
295,579 |
|
|
$ |
29.98 |
|
|
|
|
|
|
|
|
|
|
The total fair value of restricted shares vested during 2006, the Transition Period,
the comparable 2004 six months and fiscal 2005 was $1.8 million, $0.6 million, $0.4 million
(unaudited) and $0.4 million, respectively. No restricted shares vested during fiscal 2004.
See Note 18 for further discussion of the Companys share-based employee compensation
plans.
Shipping and Handling Costs
Substantially all costs of shipping and handling of products to customers are included
in selling, general and administrative expense. Shipping and handling costs for 2006, the
Transition Period, the comparable 2004 six months, fiscal 2005 and fiscal 2004 were
approximately $2.4 million, $1.4 million, $1.6 million (unaudited), $3.1 million and $3.1
million, respectively.
Research and Development Costs and Accounting for Strategic Collaborations
All research and development costs, including payments related to products under
development and research consulting agreements, are expensed as incurred. The Company may
continue to make non-refundable payments to third parties for new technologies and for
research and development work that has been completed. These payments may be expensed at
the time of payment depending on the nature of the payment made.
The Companys policy on accounting for costs of strategic collaborations determines the
timing of the recognition of certain development costs. In addition, this policy determines
whether the cost is classified as development expense or capitalized as an asset.
Management is required to form judgments with respect to the commercial status of such
products in determining whether development costs meet the criteria for immediate expense or
capitalization. For example, when the Company acquires certain products for which there is
already an Abbreviated New Drug Application (ANDA) or a New Drug Application (NDA)
approval related directly to the product, and there is net realizable value based on
projected sales for these products, the Company capitalizes the amount paid as an intangible
asset. In addition, if the Company acquires product rights which are in the development
phase and to which the Company has no assurance that the third party will successfully
complete its development milestones or that the product will gain regulatory approval, the
Company expenses such payments.
Income Taxes
Income taxes are determined using an annual effective tax rate, which generally differs
from the U.S. Federal statutory rate because of state and local taxes, tax-exempt interest,
charitable contribution deductions, nondeductible expenses and research and development tax
credits available in the U.S. The Companys effective tax rate may be subject to
fluctuations during the year as new information is obtained which may affect the assumptions
F-19
it uses to estimate its annual effective tax rate, including factors such as its mix of
pre-tax earnings in the various tax jurisdictions in which it operates, valuation allowances
against deferred tax assets, reserves for tax audit issues and settlements, utilization of
research and development tax credits and changes in tax laws in jurisdictions where the
Company conducts operations. The Company recognizes deferred tax assets and liabilities for
temporary differences between the financial reporting basis and the tax basis of its assets
and liabilities. The Company records valuation allowances against its deferred tax assets to
reduce the net carrying value to an amount that management believes is more likely than not
to be realized.
Legal Contingencies
In the ordinary course of business, the Company is involved in legal proceedings
involving regulatory inquiries, contractual and employment relationships, product liability
claims, patent rights, and a variety of other matters. The Company records contingent
liabilities resulting from asserted and unasserted claims against it, when it is probable
that a liability has been incurred and the amount of the loss is reasonably estimable. The
Company discloses contingent liabilities when there is a reasonable possibility that the
ultimate loss will exceed the recorded liability. Estimating probable losses requires
analysis of multiple factors, in some cases including judgments about the potential actions
of third-party claimants and courts. Therefore, actual losses in any future period are
inherently uncertain. Currently, the Company does not believe any of its pending legal
proceedings or claims, beyond what the Company has already accrued for, will have a material
adverse effect on its results of operations or financial condition. See Note 14 for further
discussion.
Foreign Currency Translations
The financial statements of foreign subsidiaries have been translated into U.S. Dollars
in accordance with SFAS No. 52, Foreign Currency Translation. All balance sheet accounts
have been translated using the exchange rates in effect at the balance sheet date. Income
statement amounts have been translated using the average exchange rate for the year. The
gains and losses resulting from the changes in exchange rates from year to year have been
reported in other comprehensive income. The effect on the consolidated statements of
operations of transaction gains and losses is not material for all years presented.
Earnings Per Common Share
Basic and diluted earnings per common share are calculated in accordance with the
requirements of Statement of Financial Accounting Standards No. 128, Earnings Per Share.
Because the Company has Contingently Convertible Debt (see Note 13), diluted net income per
common share must be calculated using the if-converted method in accordance with EITF
04-8, Effect of Contingently Convertible Debt on Diluted Earnings per Share. Diluted net
income per common share is calculated by adjusting net income for tax-effected net interest
and issue costs on the Contingent Convertible Debt, divided by the weighted average number
of common shares outstanding assuming conversion. The Company adopted EITF 04-8 during
fiscal 2005, and all earnings per share amounts reflect the adoption of EITF 04-8.
Use of Estimates and Risks and Uncertainties
The preparation of the consolidated financial statements in conformity with U.S.
generally accepted accounting principles requires management to make estimates and
assumptions that affect the amounts reported in the consolidated financial statements and
accompanying notes. The accounting estimates that require managements most significant,
difficult and subjective judgments include the assessment of recoverability of long-lived
assets; the recognition and measurement of current and deferred income tax assets and
liabilities; and the reductions to revenue recorded at the time of sale for sales returns.
The actual results experienced by the company may differ from managements estimates.
The Company purchases its inventory from third party manufacturers, many of whom are
the sole source of products for the Company. The failure of such manufacturers to provide
an uninterrupted supply of products could adversely impact the Companys ability to sell
such products.
Fair Value of Financial Instruments
The carrying amount of cash and cash equivalents, short-term investments, accounts
receivable, accounts payable and accrued liabilities reported in the consolidated balance
sheets approximates fair value because of the
F-20
immediate or short-term maturity of these
financial instruments. The fair market value of the Companys long-term debt is estimated
based on market quotations at year-end. The fair market value approximates $508.5 million
at December 31, 2006.
Supplemental Disclosure of Cash Flow Information
During 2006, the Transition Period, the comparable 2004 six months, fiscal 2005 and
fiscal 2004, the Company made interest payments of $8.5 million, $4.2 million, $4.2 million
(unaudited), $8.5 million and $8.8 million, respectively.
Reclassifications
Certain prior year amounts have been reclassified to conform with the current year
presentation.
Recent Accounting Pronouncements
In June 2006, the FASB issued Interpretation No. 48 (FIN 48) Accounting for
Uncertainty in Income Taxes, which clarifies the accounting for uncertainty in income taxes
recognized in an enterprises financial statements in accordance with FASB Statement No.
109, Accounting for Income Taxes. FIN 48 prescribes a recognition threshold and measurement
attribute for the financial statement recognition and measurement of a tax position taken or
expected to be taken in a tax return. FIN 48 also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods, disclosure, and
transition. FIN 48 is effective for fiscal years beginning after December 15, 2006. The
Company is currently evaluating FIN 48 but does not expect it to have a material impact on
the Companys consolidated results of operations and financial condition.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements, which
clarifies the definition of fair value, establishes a framework for measuring fair value,
and expands the disclosures about fair value measurements. SFAS No. 157 is effective for
fiscal years beginning after November 15, 2007. The Company is currently evaluating SFAS
No. 157 and its impact, if any, on the Companys consolidated results of operations and
financial condition.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial
Statements and Financial Liabilities, which provides companies with an option to report
selected financial assets and liabilities at fair value. SFAS No. 159 requires companies to
provide additional information that will help investors and other users of financial
statements to more easily understand the effect of the companys choice to use fair value on
its earnings. It also requires entities to display the fair value of those assets and
liabilities for which the company has chosen to use fair value on the face of the balance
sheet. The new Statement does not eliminate disclosure requirements included in other
accounting standards, including requirements for disclosures about fair value measurements
included in FASB Statements No. 157, Fair Value Measurements, and No. 107, Disclosures about
Fair Value of Financial Instruments. The Company is currently evaluating SFAS No. 159 and
its impact, if any, on the Companys consolidated results of operations and financial
condition.
NOTE 3. CHANGE IN ESTIMATE
During the three months ended December 31, 2006, the Company experienced a decline in
demand for certain of its products, primarily VANOS. As a result, the Company
increased the sales returns reserves by approximately $8.9 million during the three months
ended December 31, 2006, specifically related to VANOS. The Company will continue to monitor
demand for this product and will adjust its sales reserves accordingly in the future. The
effect of this change on the net loss for 2006 was to increase the net loss by approximately
$5.8 million or $0.11 per common share.
Effective January 1, 2005, the Company changed the estimated useful life for certain
intangible assets related to its merger with Ascent, based on managements determination
that these intangible assets appear to have shorter useful
lives than originally estimated. There is no cumulative effect for this change. The
effect of this change on net income for fiscal 2005 was to decrease net income by
approximately $1.1 million or $0.02 per diluted common share.
F-21
NOTE 4. SEGMENT AND PRODUCT INFORMATION
The Company operates in one significant business segment: Pharmaceuticals. The
Companys current pharmaceutical franchises are divided between the dermatological and
non-dermatological fields. The dermatological field represents products for the treatment
of acne and acne-related dermatological conditions and non-acne dermatological conditions.
The non-dermatological field represents products for the treatment of urea cycle disorder
and contract revenue. The acne and acne-related dermatological product lines include
DYNACIN®, PLEXION® SOLODYN®, TRIAZ® and
ZIANA. The non-acne dermatological product lines include LOPROX®,
OMNICEF®, RESTYLANE® and VANOS. The non-dermatological
product lines include AMMONUL®, and BUPHENYL®. The non-dermatological
field also includes contract revenues associated with licensing agreements and authorized
generics. ORAPRED® was one of the Companys non-dermatological product lines
until it was licensed to BioMarin Pharmaceutical Inc. (BioMarin) in May 2004 (see Note 8).
The Companys pharmaceutical products, with the exception of AMMONUL® and
BUPHENYL®, are promoted to dermatologists, podiatrists and plastic surgeons.
Such products are often prescribed by physicians outside these three specialties; including
family practitioners, general practitioners, primary-care physicians and OB/GYNs, as well as
hospitals, government agencies and others. Currently, all products are sold primarily to
wholesalers and retail chain drug stores. Prior to October 2006, BUPHENYL® was
primarily sold directly to hospitals and pharmacies. Prior to the Companys licensing of
ORAPRED® to BioMarin in May 2004, the Company also promoted its pharmaceutical
products to pediatricians. During 2006, the Transition Period, the comparable 2004 six
months, fiscal 2005 and fiscal 2004, two wholesalers accounted for the following portions of
the Companys net revenues:
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SIX MONTHS ENDED |
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DECEMBER 31, |
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2006 |
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2005 |
|
2004 |
|
FISCAL 2005 |
|
FISCAL 2004 |
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|
(Unaudited) |
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McKesson |
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56.8 |
% |
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54.9 |
% |
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50.8 |
% |
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51.2 |
% |
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36.9 |
% |
Cardinal |
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|
19.3 |
% |
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18.9 |
% |
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19.7 |
% |
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21.8 |
% |
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|
23.8 |
% |
McKesson is the sole distributor for the Companys RESTYLANE® products in
the U.S. and Canada. RESTYLANE®, the Companys highest-selling product during
2006, the Transition Period and fiscal 2005, was launched in the U.S. in January 2004.
The percentage of net revenues for each of the product categories is as follows:
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SIX MONTHS ENDED |
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DECEMBER 31, |
|
FISCAL |
|
FISCAL |
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2006 |
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2005 |
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2004 |
|
2005 |
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2004 |
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(Unaudited) |
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Acne and acne-related
dermatological products |
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45 |
% |
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28 |
% |
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33 |
% |
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|
30 |
% |
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|
30 |
% |
Non-acne dermatological
products |
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45 |
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59 |
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44 |
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47 |
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51 |
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Non-dermatological products |
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10 |
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13 |
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23 |
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23 |
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19 |
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Total net revenues |
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100 |
% |
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100 |
% |
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100 |
% |
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100 |
% |
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100 |
% |
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NOTE 5. STRATEGIC COLLABORATIONS
On June 19, 2006, Medicis entered into an exclusive start-up development agreement with
a German company for the development of a dermatologic product. Under terms of the
agreement, Medicis made an initial payment of $1.0 million upon signing of the contract.
Medicis will be required to pay a milestone payment of $3.0 million upon execution of a
Development and License Agreement between the parties. In addition, Medicis will pay
approximately $16.0 million upon successful completion of certain clinical milestones and
approximately $12.0 million upon the first commercial sales of the product in the U.S. The
Company will also make additional milestone payments upon the achievement of certain
commercial milestones. The $1.0 million payment was recognized as a charge to research and
development expense during 2006.
F-22
On September 26, 2002, Medicis entered into an exclusive license and development
agreement with Dow Pharmaceutical Sciences, Inc. (Dow) for the development and
commercialization of a patented dermatologic product. Under terms of the agreement, as
amended, Medicis made an initial payment of $5.4 million and a development milestone payment
of $8.8 million to Dow during fiscal 2003, a development milestone payment of $2.4 million
to Dow during fiscal 2004, and development milestone payments totaling $11.9 million during
the Transition Period. These payments were recorded as charges to research and development
expense in the periods in which the milestones were achieved. During the quarter ended
December 31, 2006, the product, ZIANA, was approved by the FDA, and in
accordance with the agreement between the parties, Medicis made an additional payment of
$1.0 million to Dow for the achievement of this milestone. The $1.0 million payment was
recorded as a long-lived asset in the Companys consolidated balance sheets.
On June 26, 2002, Medicis entered into an exclusive strategic alliance with AAIPharma,
Inc. (AAIPharma) for the development, commercialization and license of a key dermatologic
product. Medicis made an initial payment of $7.7 million to AAIPharma during fiscal 2002, a
development milestone payment of $6.0 million during fiscal 2003, and had potential
additional payments to be made to AAIPharma upon the successful completion of various
development milestones. The $7.7 million initial payment and the $6.0 million development
milestone payment were recorded as charges to research and development expense during fiscal
2002 and fiscal 2003, respectively. On January 28, 2005, the Company amended its strategic
alliance with AAIPharma. The consummation of the amendment did not affect the timing of the
development project. The amendment allowed for the immediate transfer of the work product
as defined under the agreement, as well as the products management and development, to
Medicis, and provided that AAIPharma would continue to assist Medicis with the development
of the product on a fee for services basis. Medicis had no financial obligations to pay
AAIPharma on the attainment of additional clinical milestones, but incurred approximately
$8.3 million as a charge to research and development expense during the third quarter of
fiscal 2005, as part of the amendment and the assumption of all liabilities associated with
the project. The product, SOLODYN®, was approved by the FDA on May 8, 2006.
In addition to the amendment, Medicis entered into a supply agreement with AAIPharma
for the eventual manufacture of the product by AAIPharma under certain conditions. Medicis
has the right to qualify an alternate manufacturing facility, and AAIPharma agreed to assist
Medicis in obtaining these qualifications. Upon the approval of the alternate facility and
approval of the product, Medicis will pay AAIPharma approximately $1 million.
On December 13, 2004, the Company entered into an exclusive development and license
agreement and other ancillary agreements with Ansata Therapeutics, Inc. (Ansata). The
development and license agreement granted Medicis the exclusive, worldwide rights to
Ansatas early stage, proprietary antimicrobial peptide technology. In accordance with the
development and license agreement, Medicis paid $5 million upon signing of the contract, and
would have been required to make additional payments for the achievement of certain
development milestones. In June 2006, the development project was terminated. Medicis has
no current or future obligations related to this project. The initial $5 million payment
was recorded as a charge to research and development expense during the second quarter of
fiscal 2005. The Company also incurred approximately $0.5 million of professional fees
related to the completion of the agreements, which was included in selling, general and
administrative expenses during the second quarter of fiscal 2005.
On July 15, 2004, the Company entered into an exclusive license agreement and other
ancillary documents with Q-Med to market, distribute, sell and commercialize in the United
States and Canada Q-Meds product currently known as SubQTM. Q-Med has the
exclusive right to manufacture SubQTM for Medicis. SubQTM is
currently not approved for use in the United States. Under terms of the license agreement,
Medicis Aesthetics Holdings Inc., a wholly owned subsidiary of Medicis, licenses
SubQTM for approximately $80 million, due as follows: approximately $30 million
on July 15, 2004, which was recorded as a charge to research and development expense during
the first quarter of fiscal 2005; approximately $10 million upon completion of certain
clinical milestones; approximately $20 million upon satisfaction of certain defined
regulatory milestones; and approximately $20 million upon U.S. launch of SubQTM.
In addition, the Company incurred approximately $0.7 million of professional fees related to
the completion of the agreements during the first quarter of fiscal 2005, which was included
in selling, general and administrative expenses. The Company also will make additional
milestone payments to Q-Med upon the achievement of certain commercial milestones.
F-23
NOTE 6. DEVELOPMENT AND DISTRIBUTION AGREEMENT WITH IPSEN FOR RIGHTS TO
IPSENS BOTULINUM TOXIN TYPE A PRODUCT KNOWN AS RELOXIN®
On March 17, 2006, the Company entered into a development and distribution agreement
with Ipsen, whereby Ipsen granted Aesthetica Ltd., a wholly-owned subsidiary of Medicis,
rights to develop, distribute and commercialize Ipsens botulinum toxin type A product in
the United States, Canada and Japan for aesthetic use by physicians. The product is
commonly referred to as RELOXIN® in the U.S. aesthetic market and
DYSPORT® in medical and aesthetic markets outside the U.S. The product is not
currently approved for use in the U.S., Canada or Japan. Upon execution of the development
and distribution agreement, Medicis made an initial payment to Ipsen in the amount of $90.1
million in consideration for the exclusive distribution rights in the U.S., Canada and
Japan.
Additionally, Medicis and Ipsen agreed to negotiate and enter into an agreement
relating to the exclusive distribution and development rights of the product for the
aesthetic market in Europe, and subsequently in certain other markets. Under the terms of
the U.S., Canada and Japan agreement, Medicis was obligated to make an additional $35.1
million payment, as amended, to Ipsen if this agreement was not entered into by April 15,
2006. On April 13, 2006, Medicis and Ipsen agreed to extend this deadline to July 15, 2006.
In connection with this extension, Medicis paid Ipsen approximately $12.9 million in April
2006, which would be applied against the total obligation, in the event an agreement was not
entered into by the extended deadline. On July 17, 2006, Medicis and Ipsen agreed that the
two companies would not pursue an agreement for the commercialization of the product outside
of the U.S., Canada and Japan. On July 17, 2006, Medicis made the additional $22.2 million
payment to Ipsen, representing the remaining portion of the $35.1 million total obligation,
resulting from the discontinuance of negotiations for other territories.
The initial $90.1 million payment was recognized as a charge to research and
development expense during the three months ended March 31, 2006, and the $35.1 million
obligation was recognized as a charge to research and development expense during the three
months ended June 30, 2006.
Medicis will pay an additional $26.5 million upon successful completion of various
clinical and regulatory milestones, $75.0 million upon the products approval by the FDA and
$2.0 million upon regulatory approval of the product in Japan. Ipsen will manufacture and
provide the product to Medicis for the term of the agreement, which extends to September
2019. Ipsen will receive a royalty based on sales and a supply price, the total of which is
equivalent to approximately 30% of net sales as defined under the agreement. Under the
terms of the agreement, Medicis is responsible for all remaining research and development
costs associated with obtaining the products approval in the U.S., Canada and Japan.
NOTE 7. TERMINATION OF DEFINITIVE MERGER AGREEMENT WITH INAMED CORPORATION
On March 20, 2005, Medicis and Inamed Corporation (Inamed) entered into an Agreement
and Plan of Merger (the Agreement). Inamed is a global healthcare company that develops,
manufactures, and markets breast implants for aesthetic augmentation and reconstructive
surgery following a mastectomy, a range of dermal products to correct facial wrinkles, the
BioEnterics® LAP-BAND® System designed to treat severe and morbid
obesity, and the BioEnterics® Intragastric Balloon (BIB®) system for
the treatment of obesity. Under the terms of the Agreement, Inamed was to merge with and
into a subsidiary of Medicis and each share of Inamed common stock would have been converted
into the right to receive 1.4205 shares of Medicis common stock and $30.00 in cash. The
completion of the transaction was subject to several customary conditions, including the
receipt of applicable approvals from Medicis and Inameds stockholders, the absence of any
material adverse effect on either partys business and the receipt of regulatory approvals.
On December 13, 2005, the Company entered into a merger termination agreement with
Inamed following Allergan Inc.s exchange offer for all outstanding shares of Inamed, which
was commenced on November 21, 2005, pursuant to which Medicis and Inamed agreed to terminate
the Agreement. In accordance with the terms of the Agreement and the merger termination
agreement, Inamed paid Medicis a termination fee of $90.0 million, plus $0.5 million in
expense reimbursement fees on December 13, 2005.
From the inception of the proposed transaction with Inamed through the termination of
the Agreement, the Company had incurred approximately $14.0 million of professional and
other costs related to the transaction.
These costs, which were maintained in other long-term assets in our consolidated
balance sheet during the transaction approval process, were expensed upon termination of the
Agreement. As a result of the termination, the Company
F-24
was required to pay Deutsche Bank
Trust Company Americas (Deutsche Bank) a fee pursuant to a provision in Deutsche Banks
merger engagement letter whereby Deutsche Bank was entitled to a portion of the termination
fee. This fee was included in accounts payable in the Companys consolidated balance sheets
as of December 31, 2005. The Company also incurred business integration costs related to
the transaction, including the planning for and implementation of integration activities.
These costs were expensed as incurred. During the Transition Period, the Company incurred
approximately $4.4 million of business integration planning costs. These costs were
primarily consulting and other professional fees.
During the Transition Period, the Company recognized a net benefit related to the above
items of approximately $59.1 million. This is summarized as follows (in millions):
|
|
|
|
|
Termination fee received from Inamed, including
expense reimbursement fees |
|
$ |
90.5 |
|
Less: |
|
|
|
|
Transaction costs expensed, including legal and
advisory fees |
|
|
27.0 |
|
Integration planning costs |
|
|
4.4 |
|
|
|
|
|
|
|
$ |
59.1 |
|
|
|
|
|
Approximately $0.7 million of the integration planning costs, incurred during the three
months ended September 30, 2005, were classified as selling, general and administrative
expenses during the Transition Period. Approximately $59.8 million of the net benefit
related to the above items, including $3.7 million of integration planning costs incurred
during the three months ended December 31, 2005, was classified as other income, net, during
the Transition Period.
The total net benefit recognized by the Company from the inception of the proposed
transaction through the termination of the Agreement was approximately $53.8 million. This
includes the $59.1 million benefit recognized during the Transition Period, partially offset
by approximately $5.3 million of integration planning costs incurred during the three months
ended June 30, 2005.
NOTE 8. LICENSE OF ORAPRED® TO BIOMARIN
On May 18, 2004, the Company closed an asset purchase agreement and license agreement
and executed a securities purchase agreement with BioMarin. The asset purchase agreement
involves BioMarins purchase of assets related to ORAPRED®, including assets
concerning the Ascent field sales force. ORAPRED® and related pediatric
intellectual property is owned by Ascent, a wholly owned subsidiary of Medicis. The license
agreement granted BioMarin, among other things, the exclusive worldwide rights to
ORAPRED®. The securities purchase agreement granted BioMarin the option to
purchase all outstanding shares of common stock of Ascent, based on certain conditions. As
part of the transaction, the name of Ascent Pediatrics, Inc. was changed to Medicis
Pediatrics, Inc.
Under terms of the original agreements, BioMarin was to make license payments to Ascent
of approximately $93 million payable over a five-year period as follows: approximately $10
million as of the date of the transaction; approximately $12.5 million per quarter for four
quarters beginning in July 2004; approximately $2.5 million per quarter for the subsequent
four quarters beginning in July 2005; approximately $2 million per quarter for the
subsequent eight quarters beginning in July 2006; and approximately $1.75 million per
quarter for the last four quarters of the five-year period beginning in July 2008. BioMarin
was also to make payments of $2.5 million per quarter for six quarters beginning in July
2004 for reimbursement of certain contingent payments as discussed in Note 10. The license
agreement will terminate in July 2009. At that time, based on certain conditions, BioMarin
would have the option to purchase all outstanding shares of Ascent for approximately $82
million. The payment was to consist of $62 million in cash and $20 million in BioMarin
common stock, based on the fair value of the stock at that time. The Company was responsible
for the manufacture and delivery of finished goods inventory to BioMarin, and BioMarin was
responsible for paying the Company for finished goods inventory delivered through June 30,
2005. As a result, the Company was required to recognize the first $60 million of license
payments ratably through June 30, 2005. The license payments received after June 30, 2005
and the reimbursement of contingent payments will be recognized as revenue when all four
criteria of SAB 104 have been met.
As of the closing date of the transaction, BioMarin is responsible for all marketing
and promotional efforts regarding the sale of ORAPRED®. As a result, Medicis no
longer advertises and promotes any oral liquid prednisolone sodium phosphate solution
product or any related line extension. During the term of the license
F-25
agreement, Medicis
will maintain ownership of the intellectual property and, consequently, will continue to
amortize the related intangible assets. Payments received from BioMarin under the license
agreement will be treated as contract revenue, which is included in net revenues in the
consolidated statements of income.
On January 12, 2005, BioMarin and the Company entered into amendments to the Securities
Purchase Agreement and License Agreement entered into on May 18, 2004, a Convertible
Promissory Note (the Convertible Note) and a Settlement and Mutual Release Agreement
(collectively the Agreements). Under the terms of the Agreements, transaction payments
from BioMarin to Medicis previously totaling $175 million were reduced to $159 million.
Beginning with license payments relating to ORAPRED® to be made by BioMarin after
July 2005, license payments totaling $93 million were reduced pro rata to $88.4 million.
Consideration to be received by Medicis from BioMarin in 2009 for the option relating to the
purchase of all outstanding shares of Ascent Pediatrics were reduced from $82 million to
$70.6 million. Medicis took full financial responsibility for contingent payments due to
former Ascent Pediatric shareholders without the $5 million in offset payments that would
have been paid by BioMarin to Medicis after July 1, 2005. Contingent payments are due to
former Ascent Pediatric shareholders from Medicis only if revenue from Ascent Pediatric
products exceeds certain thresholds. In addition, Medicis reimbursed BioMarin for actual
returns, up to certain agreed-upon limits, of ORAPRED® finished goods received by
BioMarin during the quarters ended December 31, 2004, March 31, 2005 and June 30, 2005.
Additionally, per the terms of the Agreements, Medicis has made available to BioMarin
the ability to draw down on a Convertible Note up to $25 million beginning July 1, 2005.
The Convertible Note is convertible based on certain terms and conditions including a change
of control provision. Money advanced under the Convertible Note is convertible into
BioMarin shares at a strike price equal to the BioMarin average closing price for the 20
trading days prior to such advance. The Convertible Note matures on the option purchase
date in 2009 as defined in the Securities Purchase Agreement but may be repaid by BioMarin
at any time prior to the option purchase date. No monies have been advanced to-date. In
conjunction with the Agreements, BioMarin and Medicis entered into a settlement and Mutual
Release Agreement to forever discharge each other from any and all claims, demands, damages,
debts, liabilities, actions and causes of action relating to the transaction consummated by
the parties other than certain continuing obligations in accordance with the terms of the
parties agreements. As of December 31, 2006, BioMarin had paid $81.9 million to Medicis
under the license agreement, which represents all scheduled payments due through that date
under the license agreement.
NOTE 9. ACQUISITION OF DERMAL AESTHETIC ENHANCEMENT PRODUCTS FROM THE Q-MED GROUP
On March 10, 2003, Medicis acquired all outstanding shares of HA North American Sales
AB from Q-Med AB, a Swedish biotechnology/medical device company and its affiliates,
collectively Q-Med. HA North American Sales AB holds a license for the exclusive U.S. and
Canadian rights to market, distribute and commercialize the dermal restorative product lines
known as RESTYLANE®, PERLANE® and RESTYLANE FINE LINES.
RESTYLANE® has been approved by the FDA for use in the U.S.
RESTYLANE®, PERLANE® and RESTYLANE FINE LINES have been
approved for use in Canada. Under terms of the agreements, a wholly owned subsidiary of
Medicis acquired all outstanding shares of HA North American Sales AB for total
consideration of approximately $160.0 million, payable upon the successful completion of
certain milestones or events. Medicis paid $58.2 million upon closing of the transaction,
$53.3 million in December 2003 upon FDA approval of RESTYLANE®, $19.4 million in
May 2004 upon certain cumulative commercial milestones being achieved and will pay
approximately $29.1 million upon FDA approval of PERLANE®. Payments and costs
related to this acquisition are capitalized as a long-lived asset and are amortized over 15
years beginning in March 2003.
NOTE 10. LICENSE AND SALE OF PRODUCTS TO TARO PHARMACEUTICAL INDUSTRIES, LTD.
On July 27, 2004, the Company entered into an exclusive license and optional purchase
agreement with Taro Pharmaceutical Industries, Inc. (Taro) pursuant to which Taro will
market, distribute and sell the LUSTRA® family of products and two development
stage products in the U.S., Canada and Puerto Rico. The LUSTRA® family of
products are topical therapies prescribed for the treatment of ultraviolet-induced skin
discolorations and hyperpigmentation usually associated with the use of oral
contraceptives, pregnancy, hormone replacement therapy, sun damage and superficial trauma.
The license agreement extends through July 1, 2007, after which Taro may purchase the
product lines.
On January 14, 2003, Taro licensed with an option to purchase from Medicis four branded
prescription product lines for sale in the U.S. and Puerto Rico. The license agreement was
effective on January 14, 2003 and extended
F-26
through June 1, 2004, after which Taro had the
option to purchase the product lines. Medicis received quarterly license payments from Taro
during the term of the agreement. Under terms of the agreement, Taro licensed from Medicis
the following four brands: TOPICORT® (desoximetasone), a topical corticosteroid
used for inflammatory skin diseases; A/T/S® (erythromycin), a topical antibiotic
used in the treatment of acne; OVIDE® (malathion), a pediculicide used in the
treatment of head lice; and PRIMSOL® (trimethoprim HCI), an antibiotic oral
solution for children with acute otitis media, or middle ear infections. Taro purchased the
product lines at the end of the term of the agreement for $12.1 million. The carrying value
of the long-lived assets related to these products was written off as of the sale date, and
a loss of approximately $32,000 was recognized during fiscal 2004 and is included in
selling, general and administrative expenses in the accompanying consolidated statements of
income. The Company additionally incurred approximately $350,000 of professional fees
related to the transaction.
NOTE 11. MERGER OF ASCENT PEDIATRICS, INC.
As part of its merger with Ascent completed in November 2001, the Company may have been
required to make contingent purchase price payments (Contingent Payments) for each of the
first five years following closing based upon reaching certain sales threshold milestones on
the Ascent products for each twelve month period through November 30, 2006, subject to
certain deductions and set-offs. During the five-year period, the Company from time to time
assessed the probability and likelihood of payment in the coming respective November period
based on current sales trends. A total of approximately $27.4 million was included in
short-term contract obligation in the Companys consolidated balance sheets as of December
31, 2005, representing the first four years Contingent Payments. Pursuant to the merger
agreement, payment of the contingent portion of the purchase price was withheld pending the
final outcome of certain pending litigation. The Company distributed the accumulated $27.4
million in Contingent Payments to the former shareholders of Ascent during the three months
ended March 31, 2006, as the pending litigation matter was settled in Medicis favor. In
addition, the Company settled an additional dispute during May 2006, which was initiated in
March 2006, relating to the concluded lawsuit. A $1.8 million settlement was recognized as
a charge to selling, general and administrative expense during the three months ended March
31, 2006. For the fifth and final twelve month period ended November 30, 2006, sales
threshold milestones were not met and no additional Contingent Payment became payable.
NOTE 12. SHORT-TERM AND LONG-TERM INVESTMENTS
The Companys short-term and long-term investments are intended to establish a
high-quality portfolio that preserves principal, meets liquidity needs, avoids inappropriate
concentrations and delivers an appropriate yield in relationship to the Companys investment
guidelines and market conditions. Short-term and long-term investments consist of corporate
and various government agency and municipal debt securities. Management classifies the
Companys short-term and long-term investments as available-for-sale. Available-for-sale
securities are carried at fair value with unrealized gains and losses reported in
stockholders equity. Realized gains and losses and declines in value judged to be other
than temporary, if any, are included in operations. A decline in the market value of any
available-for-sale security below cost that is deemed to be other than temporary, results in
an impairment in the fair value of the investment. The impairment is charged to earnings
and a new cost basis for the security is established. Premiums and discounts are amortized
or accreted over the life of the related available-for-sale security. Dividends and
interest income are recognized when earned. The cost of securities sold is calculated using
the specific identification method. At December 31, 2006, the Company has recorded the
estimated fair value in available-for-sale securities for short-term and long-term
investments of approximately $350.9 million and $130.3 million, respectively.
F-27
The following is a summary of available-for-sale securities (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, 2006 |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
U.S. corporate securities |
|
$ |
224,547 |
|
|
$ |
59 |
|
|
$ |
206 |
|
|
$ |
224,400 |
|
Other debt securities |
|
|
256,917 |
|
|
|
50 |
|
|
|
135 |
|
|
|
256,832 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
481,464 |
|
|
$ |
109 |
|
|
$ |
341 |
|
|
$ |
481,232 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, 2005 |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
U.S. corporate securities |
|
$ |
73,398 |
|
|
$ |
92 |
|
|
$ |
274 |
|
|
$ |
73,216 |
|
Other debt securities |
|
|
222,736 |
|
|
|
2 |
|
|
|
419 |
|
|
|
222,319 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
296,134 |
|
|
$ |
94 |
|
|
$ |
693 |
|
|
$ |
295,535 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During 2006, the Transition Period, the comparable six month period in 2004,
fiscal 2005 and fiscal 2004, the gross realized gains on sales of available-for-sale
securities totaled $430,122, $658, $217,361 (unaudited), $231,766 and $1,360,154,
respectively, and the gross realized losses totaled $8,547, $599,200, $320,382 (unaudited),
$1,117,366 and $236,427, respectively. Such amounts of gains and losses are determined
based on the specific identification method and are included in interest and investment
income. The net adjustment to unrealized gains during 2006, the Transition Period, the
comparable six month period in 2004, fiscal 2005 and fiscal 2004 on available-for-sale
securities included in stockholders equity totaled $235,718, $636,777, $(107,204)
(unaudited), $(75,721) and $(3,451,343), respectively. The amortized cost and estimated
fair value of the available-for-sale securities at December 31, 2006, by maturity, are shown
below (amounts in thousands).
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, 2006 |
|
|
|
|
|
|
|
Estimated |
|
|
|
Cost |
|
|
Fair Value |
|
Available-for-sale |
|
|
|
|
|
|
|
|
Due in one year or less |
|
$ |
158,167 |
|
|
$ |
158,153 |
|
Due after one year through five years |
|
|
281,461 |
|
|
|
281,242 |
|
Due after five years through 10 years |
|
|
|
|
|
|
|
|
Due after 10 years |
|
|
41,836 |
|
|
|
41,837 |
|
|
|
|
|
|
|
|
|
|
$ |
481,464 |
|
|
$ |
481,232 |
|
|
|
|
|
|
|
|
At December 31, 2006, approximately $192.8 million of the $323.1 million in
estimated fair value expected to mature greater than one year has been classified as
short-term investments since these investments are in an unrealized gain position. Expected
maturities will differ from contractual maturities because the issuers of the securities may
have the right to prepay obligations without prepayment penalties, and the Company views its
available-for-sale securities as available for current operations.
The following table shows the gross unrealized losses and fair value of the Companys
investments with unrealized losses that are not deemed to be other-than-temporarily
impaired, aggregated by investment category and length of time that individual securities
have been in a continuous unrealized loss position at December 31, 2006 (amounts in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than 12 Months |
|
|
Greater Than 12 Months |
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
Fair |
|
|
Unrealized |
|
|
Fair |
|
|
Unrealized |
|
|
|
Value |
|
|
Loss |
|
|
Value |
|
|
Loss |
|
U.S. corporate securities |
|
$ |
150,268 |
|
|
$ |
172 |
|
|
$ |
11,720 |
|
|
$ |
36 |
|
Other debt securities |
|
|
82,344 |
|
|
|
133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
232,612 |
|
|
$ |
305 |
|
|
$ |
11,720 |
|
|
$ |
36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-28
The unrealized losses on the Companys investments were caused primarily by interest
rate increases. It is expected that the investments will not be settled at a price less
than the amortized cost. Because the Company has the ability to and intent to hold these
investments until a recovery of fair value, which may be maturity, the Company does not
consider these investments to be other than temporarily impaired at December 31, 2006.
NOTE 13. CONTINGENT CONVERTIBLE SENIOR NOTES
In June 2002, the Company sold $400.0 million aggregate principal amount of its 2.5%
Contingent Convertible Notes Due 2032 (the Old Notes) in private transactions. As
discussed below, approximately $230.8 million in principal amount of the Old Notes was
exchanged for New Notes on August 14, 2003. The Old Notes bear interest at a rate of 2.5%
per annum, which is payable on June 4 and December 4 of each year, beginning on December 4,
2002. The Company also agreed to pay contingent interest at a rate equal to 0.5% per annum
during any six-month period, with the initial six-month period commencing June 4, 2007, if
the average trading price of the Old Notes reaches certain thresholds. The Old Notes will
mature on June 4, 2032.
The Company may redeem some or all of the Old Notes at any time on or after June 11,
2007, at a redemption price, payable in cash, of 100% of the principal amount of the Old
Notes, plus accrued and unpaid interest, including contingent interest, if any. Holders of
the Old Notes may require the Company to repurchase all or a portion of their Old Notes on
June 4, 2007, 2012 and 2017, or upon a change in control, as defined in the indenture
governing the Old Notes, at 100% of the principal amount of the Old Notes, plus accrued and
unpaid interest to the date of the repurchase, payable in cash.
The Old Notes are convertible, at the holders option, prior to the maturity date into
shares of the Companys Class A common stock in the following circumstances:
|
|
|
during any quarter commencing after June 30, 2002, if the closing price of
the Companys Class A common stock over a specified number of trading days
during the previous quarter, including the last trading day of such quarter, is
more than 110% of the conversion price of the Old Notes, or $31.96. The Old
Notes are initially convertible at a conversion price of $29.05 per share, which
is equal to a conversion rate of approximately 34.4234 shares per $1,000
principal amount of Old Notes, subject to adjustment; |
|
|
|
|
if the Company has called the Old Notes for redemption; |
|
|
|
|
during the five trading day period immediately following any nine consecutive
day trading period in which the trading price of the Old Notes per $1,000
principal amount for each day of such period was less than 95% of the product of
the closing sale price of the Companys Class A common stock on that day
multiplied by the number of shares of the Companys Class A common stock
issuable upon conversion of $1,000 principal amount of the Old Notes; or |
|
|
|
|
upon the occurrence of specified corporate transactions. |
The Old Notes, which are unsecured, do not contain any restrictions on the payment of
dividends, the incurrence of additional indebtedness or the repurchase of the Companys
securities and do not contain any financial covenants.
The Company incurred $12.6 million of fees and other origination costs related to the
issuance of the Old Notes. The Company is amortizing these costs over the five-year Put
period, which runs through May 2007. The Put period runs from the date the Old Notes were
issued to the date the Company may redeem some or all of the Old Notes.
On August 14, 2003, the Company exchanged approximately $230.8 million in principal
amount of its Old Notes for approximately $283.9 million in principal amount of its 1.5%
Contingent Convertible Senior Notes Due 2033 (the New Notes). Holders of Old Notes that
accepted the Companys exchange offer received $1,230 in principal amount of New Notes for
each $1,000 in principal amount of Old Notes. The terms of the New Notes are similar to the
terms of the Old Notes, but have a different interest rate, conversion rate and maturity
date. Holders of Old Notes that chose not to exchange continue to be subject to the terms
of the Old Notes.
The New Notes bear interest at a rate of 1.5% per annum, which is payable on June 4 and
December 4 of each year, beginning December 4, 2003. The Company will also pay contingent
interest at a rate of 0.5% per annum
F-29
during any six-month period, with the initial six-month
period commencing June 4, 2008, if the average trading price of the New Notes reaches
certain thresholds. The New Notes mature on June 4, 2033.
The Company may redeem some or all of the New Notes at any time on or after June 11,
2008, at a redemption price, payable in cash, of 100% of the principal amount of the New
Notes, plus accrued and unpaid interest, including contingent interest, if any. Holders of
the New Notes may require the Company to repurchase all or a portion of their New Notes on
June 4, 2008, 2013 and 2018, or upon a change in control, as defined in the indenture
governing the New Notes, at 100% of the principal amount of the New Notes, plus accrued and
unpaid interest to the date of the repurchase, payable in cash.
The New Notes are convertible, at the holders option, prior to the maturity date into
shares of the Companys Class A common stock in the following circumstances:
|
|
|
during any quarter commencing after September 30, 2003, if the closing price
of the Companys Class A common stock over a specified number of trading days
during the previous quarter, including the last trading day of such quarter, is
more than 120% of the conversion price of the New Notes, or $46.51. The Notes
are initially convertible at a conversion price of $38.76 per share, which is
equal to a conversion rate of approximately 25.7998 shares per $1,000 principal
amount of New Notes, subject to adjustment; |
|
|
|
|
if the Company has called the New Notes for redemption; |
|
|
|
|
during the five trading day period immediately following any nine consecutive
day trading period in which the trading price of the New Notes per $1,000
principal amount for each day of such period was less than 95% of the product of
the closing sale price of the Companys Class A common stock on that day
multiplied by the number of shares of the Companys Class A common stock
issuable upon conversion of $1,000 principal amount of the New Notes; or |
|
|
|
|
upon the occurrence of specified corporate transactions. |
The New Notes, which are unsecured, do not contain any restrictions on the incurrence
of additional indebtedness or the repurchase of the Companys securities and do not contain
any financial covenants. The New Notes require an adjustment to the conversion price if the
cumulative aggregate of all current and prior dividend increases above $0.025 per share
would result in at least a one percent (1%) increase in the conversion price. This
threshold has not been reached and no adjustment to the conversion price has been made.
As a result of the exchange, the outstanding principal amounts of the Old Notes and the
New Notes were $169.2 million and $283.9 million, respectively. Both the New Notes and Old
Notes are reported in aggregate on the Companys consolidated balance sheets. The Company
incurred approximately $5.1 million of fees and other origination costs related to the
issuance of the New Notes. The Company is amortizing these costs over the five-year Put
period, which runs through August 2008. The Put period runs from the date the New Notes
were issued to the date the Company may redeem some or all of the New Notes.
During the quarters ended December 31, 2006, December 31, 2005, September 30, 2005,
December 31, 2004, September 30, 2004, June 30, 2004, March 31, 2004 and December 31, 2003,
the Old Notes met the criteria for the right of conversion into shares of the Companys
Class A common stock. This right of conversion of the holders of Old Notes was triggered by
the stock closing above $31.96 on 20 of the last 30 trading days and the last trading day of
the quarters ended December 31, 2006, December 31, 2005, September 30, 2005, December 31,
2004, September 30, 2004, June 30, 2004, March 31, 2004 and December 31, 2003. The holders
of Old Notes have this conversion right only until March 31, 2007. During the quarters
ended September 30, 2006, June 30, 2006, March 31, 2006, June 30, 2005 and March 31, 2005,
the Old Notes did not meet the criteria for the right of conversion. At the end of all
future quarters, the conversion rights will be reassessed in accordance with the bond
indenture agreement to determine if the conversion trigger rights have been achieved.
During the three months ended September 30, 2004 and March 31, 2004, outstanding principal
amounts of $2,000 and $6,000 of Old Notes, respectively, were converted into shares of the
Companys Class A common stock. During the two months ended February 28, 2007, outstanding
principal in the amount of $5,000 of Old Notes was converted into shares of the Companys
Class A common stock.
F-30
NOTE 14. COMMITMENTS AND CONTINGENCIES
Occupancy Arrangements
The Company presently occupies approximately 75,000 square feet of office space in
Scottsdale, Arizona, at an average annual expense of approximately $2.1 million, under an
amended lease agreement that expires in December 2010. The lease contains certain rent
escalation clauses and, upon expiration, can be renewed for two additional periods of five
years each. Rent expense was approximately $2.2 million, $1.2 million, $1.1 million
(unaudited), $2.3 million and $2.1 million for 2006, the Transition Period, the comparable
2004 six months, fiscal 2005 and fiscal 2004, respectively. Medicis Aesthetics Canada Ltd.,
a wholly owned subsidiary, presently leases approximately 3,600 square feet of office space
in Toronto, Ontario, Canada, under a lease agreement that expires in February 2008.
During July 2006, the Company executed a lease agreement for new headquarter office
space. The first phase is for 150,000 square feet with the right to expand. The term of
the lease is twelve years. Occupancy of the new headquarter office space, which is located
approximately one mile from the Companys current headquarter office space in Scottsdale,
Arizona, is expected to occur in 2008.
During October 2006, the Company executed a lease agreement for additional headquarter
office space to accommodate its current needs and future growth. Approximately 21,000
square feet of office space is being leased for a period of three years. Occupancy of the
additional headquarter office space, which is located approximately one mile from the
Companys current headquarter office space in Scottsdale, Arizona, is expected to occur in
2007.
At December 31, 2006, approximate future lease payments under the Companys operating
leases are as follows (amounts in thousands):
|
|
|
|
|
YEAR ENDING DECEMBER 31, |
|
|
|
|
2007 |
|
$ |
2,371 |
|
2008 |
|
|
2,537 |
|
2009 |
|
|
4,329 |
|
2010 |
|
|
6,174 |
|
2011 |
|
|
4,333 |
|
Thereafter |
|
|
36,116 |
|
|
|
|
|
|
|
$ |
55,860 |
|
|
|
|
|
Research and Development and Consulting Contracts
The Company has various consulting agreements with certain scientists in exchange for
the assignment of certain rights and consulting services. At December 31, 2006, the Company
had approximately $867,300 of commitments (solely attributable to the Chairman of the
Central Research Committee of the Company) payable over the remaining five years under an
agreement that is cancelable by either party under certain conditions.
Litigation
The government notified the Company on December 14, 2004, that it is investigating
claims that the Company violated the federal False Claims Act in connection with the alleged
off-label marketing and promotion of LOPROX® and LOPROX® TS products
(LOPROX®) to pediatricians during periods prior to the Companys May 2004
disposition of the Companys pediatric sales division. In April 2006, the Company offered
$6.0 million to resolve the governments civil claims contingent on the execution of
appropriate releases. The Justice Department countered with a demand of $12.8 million to
resolve the civil claims that the government is prepared to pursue. In May 2006, the
Company countered with an offer of $8.0 million that was contingent on resolving other
aspects of the governments investigation to the satisfaction of the Company. In June 2006,
the Justice Department countered with a $10.0 million offer for settlement. On or around
October 5, 2006 the parties agreed in principle to resolve all federal and state civil
claims against the Company for $9.8 million. As of
December 31, 2006, the Company has accrued a loss contingency of
$10.2 million for this matter in connection with the possibility
of additional expenses related to the settlement amount. Of this
amount, $6.0 million was recorded during the three months ended March 31, 2006, $2.0 million
was recorded during the three months ended June 30, 2006, and
$2.2 million was recorded
during the three months ended September 30, 2006. This loss contingency is included in
other current liabilities as of December 31, 2006 in the accompanying consolidated balance
sheets, and is
F-31
included in selling, general and administrative expenses for the year ended
December 31, 2006 in the accompanying consolidated statements of income.
On or about October 12, 2006, the Company and the United States Attorneys Office for
the District of Kansas entered into a Nonprosecution Agreement wherein the government agreed
not to prosecute the Company for any alleged criminal violations relating to the alleged
off-label marketing and promotion of LOPROX®. In exchange for the governments
agreement not to pursue any criminal charges against the Company, the Company has agreed to
continue cooperating with the government in its ongoing investigation into whether past and
present employees and officers may have violated federal criminal law regarding alleged
off-label marketing and promotion of LOPROX® to pediatricians. No individuals
have been designated as targets of the investigation. Any such claims, prosecutions or
other proceedings, with respect to the Companys past and present employees and officers,
the cost of their defense and fines and penalties resulting therefrom could have a material
impact on the Companys reputation, business and financial condition.
The Company also is engaged in discussions with the Office of Inspector General of the
Department of Health and Human Services (IG) to resolve any potential administrative
claims the IG may have arising out of the governments investigation into the Companys
marketing and promotion of LOPROX®.
In addition to the matters discussed above, in the ordinary course of business, the
Company is involved in a number of legal actions, both as plaintiff and defendant, and could
incur uninsured liability in any one or more of them. Although the outcome of these actions
is not presently determinable, it is the opinion of the Companys management, based upon the
information available at this time, that the expected outcome of these matters, individually
or in the aggregate, will not have a material adverse effect on the results of operations or
financial condition of the Company.
NOTE 15. INCOME TAXES
The provision for income taxes consists of the following (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEAR ENDED |
|
|
SIX MONTHS ENDED |
|
|
YEAR ENDED |
|
|
|
DECEMBER 31, |
|
|
DECEMBER 31, |
|
|
JUNE 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
Current |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
14,172 |
|
|
$ |
26,780 |
|
|
$ |
13,392 |
|
|
$ |
27,516 |
|
|
$ |
15,831 |
|
State |
|
|
1,415 |
|
|
|
1,543 |
|
|
|
822 |
|
|
|
1,215 |
|
|
|
861 |
|
Foreign |
|
|
3,870 |
|
|
|
750 |
|
|
|
110 |
|
|
|
156 |
|
|
|
109 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,457 |
|
|
|
29,073 |
|
|
|
14,324 |
|
|
|
28,887 |
|
|
|
16,801 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
(58,068 |
) |
|
|
1,366 |
|
|
|
(2,854 |
) |
|
|
4,456 |
|
|
|
(1,404 |
) |
State |
|
|
(2,185 |
) |
|
|
45 |
|
|
|
(142 |
) |
|
|
787 |
|
|
|
(80 |
) |
Foreign |
|
|
|
|
|
|
18 |
|
|
|
|
|
|
|
(18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(60,253 |
) |
|
|
1,429 |
|
|
|
(2,996 |
) |
|
|
5,225 |
|
|
|
(1,484 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
(40,796 |
) |
|
$ |
30,502 |
|
|
$ |
11,328 |
|
|
$ |
34,112 |
|
|
$ |
15,317 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current income tax expense does not reflect benefit of $3.9 million,. $0.1 million,
$5.1 million (unaudited), $5.1 million and $20.4 million for 2006, the Transition Period,
the comparable 2004 six months, fiscal 2005 and fiscal 2004, respectively, related to the
vesting of restricted stock and exercise of employee stock options recorded directly to
Additional paid-in-capital in the Companys consolidated statements of stockholders
equity. During the Transition Period, the Company reduced Additional paid-in-capital by
$5.7 million to properly record the amount of excess tax benefits attributable to the prior
fiscal years.
F-32
The reconciliations of the U.S. federal statutory rate to the combined effective tax
rate used to determine income tax expense (benefit) are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEAR ENDED |
|
SIX MONTHS ENDED |
|
YEAR ENDED |
|
|
DECEMBER 31, |
|
DECEMBER 31, |
|
JUNE 30, |
|
|
2006 |
|
2005 |
|
2004 |
|
2005 |
|
2004 |
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
Statutory federal income tax rate |
|
|
(35.0 |
)% |
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
State tax rate, net of federal benefit |
|
|
(1.1 |
) |
|
|
1.3 |
|
|
|
1.4 |
|
|
|
1.4 |
|
|
|
1.8 |
|
Share-based payments |
|
|
1.9 |
|
|
|
1.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign taxes |
|
|
2.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax exposures reserve |
|
|
(4.2 |
) |
|
|
1.4 |
|
|
|
|
|
|
|
0.1 |
|
|
|
0.7 |
|
Non-deductible items |
|
|
3.2 |
|
|
|
0.6 |
|
|
|
|
|
|
|
1.2 |
|
|
|
3.0 |
|
Tax-exempt interest |
|
|
|
|
|
|
|
|
|
|
(2.4 |
) |
|
|
(1.0 |
) |
|
|
(4.0 |
) |
Credits and other |
|
|
(2.2 |
) |
|
|
(1.9 |
) |
|
|
0.8 |
|
|
|
(2.3 |
) |
|
|
(3.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35.0 |
)% |
|
|
38.0 |
% |
|
|
34.8 |
% |
|
|
34.4 |
% |
|
|
33.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred income taxes reflect the net tax effects of temporary differences between the
carrying amounts of assets and liabilities for financial reporting purposes and the amounts
used for income tax purposes. Significant components of the Companys deferred tax assets
and liabilities are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2006 |
|
|
2005 |
|
|
|
Current |
|
|
Long-term |
|
|
Current |
|
|
Long-term |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net operating loss
carryforwards |
|
$ |
|
|
|
$ |
5,340 |
|
|
$ |
|
|
|
$ |
6,315 |
|
Reserves and liabilities |
|
|
22,963 |
|
|
|
|
|
|
|
11,810 |
|
|
|
|
|
Unrealized losses on securities |
|
|
84 |
|
|
|
|
|
|
|
215 |
|
|
|
|
|
Excess of net book value over
tax basis of intangible assets |
|
|
|
|
|
|
68,105 |
|
|
|
|
|
|
|
8,885 |
|
Share-based payment awards |
|
|
|
|
|
|
10,199 |
|
|
|
|
|
|
|
4,200 |
|
Foreign tax credit |
|
|
|
|
|
|
|
|
|
|
713 |
|
|
|
|
|
Depreciation on property and equipment |
|
|
|
|
|
|
38 |
|
|
|
|
|
|
|
|
|
Capital loss carryover |
|
|
|
|
|
|
426 |
|
|
|
|
|
|
|
892 |
|
Charitable contributions, other |
|
|
|
|
|
|
1,783 |
|
|
|
|
|
|
|
824 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
23,047 |
|
|
|
85,891 |
|
|
|
12,738 |
|
|
|
21,116 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation on property and
equipment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(455 |
) |
Bond interest |
|
|
|
|
|
|
(44,650 |
) |
|
|
|
|
|
|
29,233 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets
(liabilities) |
|
$ |
23,047 |
|
|
$ |
41,241 |
|
|
$ |
12,738 |
|
|
$ |
(8,572 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2006, the Company has a federal net operating loss carryforward of
approximately $15.3 million that begins expiring in varying amounts in the years 2008
through 2020 if not previously utilized. The net operating loss carryforward was acquired
in connection with the Companys merger with Ascent during fiscal 2002. As a result of the
merger and related ownership change for Ascent, the annual utilization of the net operating
loss carryforward is limited under Internal Revenue Code Section 382. The federal net
operating loss of $15.3 million is net of the Section 382 limitation, thus, representing the
Companys estimate of the net operating loss carryforward that will be realized. The
deferred tax assets and liabilities and valuation allowance at December 31, 2005 have been
reclassified to conform to the December 31, 2006 presentation.
At December 31, 2006, the Company had a charitable contribution carryover of
approximately $4.9 million. The charitable contribution carryover will begin to expire in
2008 if not previously utilized. Additionally, the Company has a capital loss carryover of
$1.2 million of which $0.2 million has been realized for tax purposes and will begin to
expire in 2008 if not previously utilized. The remaining $1.0 million of the capital loss
is subject to a five-year carryover period that will commence once the capital loss is
realized for tax purposes.
The Company recorded a deferred tax asset of approximately $84,000, $215,000, $617,000
(unaudited), $586,000 and $555,000 for 2006, the Transition Period, the comparable 2004 six
months, fiscal 2005 and fiscal 2004, respectively, relating to unrealized losses on
available-for-sale securities presented in other comprehensive income in stockholders
equity.
F-33
During 2006, the Transition Period, the comparable 2004 six months and fiscal 2005, the
Company made net tax payments of $35.7 million, $11.8 million, $3.1 million (unaudited) and
$13.9 million, respectively. The Company received net tax refunds of $3.7 million during
fiscal 2004.
The Company operates in multiple tax jurisdictions and is periodically subject to audit
in these jurisdictions. These audits can involve complex issues that may require an extended
period of time to resolve and may cover multiple years. The Company and its domestic
subsidiaries file a consolidated U.S. federal income tax return. Such returns have either
been audited or settled through statute expiration through fiscal 2004. The Company and its
consolidated subsidiaries received a final notice of proposed assessment in January 2007
from the Arizona Department of Revenue for fiscal years ended 2001 through 2004. The
Company has filed a protest of the final assessment from the Arizona Department of Revenue.
The Company does not believe that an unfavorable resolution to the matters under protest
will have a material effect on the financial position of the Company. The Company
continually assesses its tax filing positions and believes that an adequate provision for
taxes has been made for all open years that may be subject to audit.
NOTE 16. STOCK TRANSACTIONS
Class A common stock has one vote per share. During September 2004, all 758,032
outstanding shares of the Companys Class B common stock were exchanged for 758,032 shares
of the Companys Class A common stock. As of December 31, 2005, there were no shares of
Class B common stock outstanding.
During the three months ended December 31, 2004 and September 30, 2004, Medicis
purchased 2,177,286 and 1,743,800 shares of its Class A common stock in the open market at
an average price of $38.65 and $37.76 per share, respectively. These stock purchases were
made in accordance with a stock repurchase program that was approved by the Companys Board
of Directors in August 2004. This program provided for the repurchase of up to $150.0
million of Class A common stock at such times as management determined. As of December 31,
2005, the Company had repurchased a total of approximately $150.0 million of Class A common
stock pursuant to this program, all during the six months ended December 31, 2004. As the
purchase limit had been reached, the plan was terminated. During 2006 and the Transition
Period, Medicis did not purchase any of its shares of Class A common stock. The timing and
amount of any future payments will depend on market conditions and corporate considerations.
NOTE 17. DIVIDENDS DECLARED ON COMMON STOCK
During 2006, the Transition Period, the comparable 2004 six months, fiscal 2005 and
fiscal 2004, the Company paid quarterly cash dividends aggregating $6.6 million, $3.3
million, $3.1 million (unaudited), $6.4 million, $5.5 million, respectively, on its common
stock. In addition, on December 14, 2006, the Company declared a cash dividend of $0.03 per
issued and outstanding share of common stock payable on January 31, 2007 to stockholders of
record at the close of business on January 2, 2007. The $1.7 million dividend was recorded
as a reduction of accumulated earnings and is included in other current liabilities in the
accompanying consolidated balance sheets as of December 31, 2006. Prior to these dividends,
the Company had not paid a cash dividend on our common stock. The Company has not adopted a
dividend policy.
F-34
NOTE 18. STOCK OPTION PLANS
As of December 31, 2006, the Company has seven active Stock Option Plans (the 2006,
2004, 2002, 1998, 1996, 1995 and 1992 Plans or, collectively, the Plans). Of these seven
Plans, only the 2006 Incentive Award Plan is eligible for the granting of future awards. As
of December 31, 2006, the 2006, 2004, 2002, 1998, 1996, 1995 and 1992 Plans had the
following options outstanding: 52,500, 360,325, 4,822,137, 4,868,656, 1,101,041, 1,248,904,
and 535,448, respectively. Except for the 2002 Stock Option Plan, which only includes
non-qualified incentive options, the Plans allow the Company to designate options as
qualified incentive or non-qualified on an as-needed basis. Qualified and non-qualified
stock options vest over a period determined at the time the options are granted, ranging
from one to five years, and generally have a maximum term of ten years. Options are granted
at the fair market value on the grant date. Options outstanding at December 31, 2006 vary
in price from $7.80 to $39.04, with a weighted average exercise price of $27.63 as is set
forth in the following chart:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Weighted |
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
Average |
|
|
Average |
|
|
|
|
|
|
Average |
|
Range of |
|
Number |
|
|
Contractual |
|
|
Exercise |
|
|
Number |
|
|
Exercise |
|
Exercise Prices |
|
Outstanding |
|
|
Life |
|
|
Price |
|
|
Exercisable |
|
|
Price |
|
$7.80 - $15.30 |
|
|
1,010,349 |
|
|
|
2.23 |
|
|
$ |
11.49 |
|
|
|
1,010,349 |
|
|
$ |
11.49 |
|
$15.42 - $18.33 |
|
|
1,792,567 |
|
|
|
5.44 |
|
|
$ |
18.28 |
|
|
|
1,242,125 |
|
|
$ |
18.25 |
|
$18.57 - $23.16 |
|
|
266,610 |
|
|
|
5.37 |
|
|
$ |
21.63 |
|
|
|
184,830 |
|
|
$ |
21.14 |
|
$23.29 - $26.95 |
|
|
1,888,448 |
|
|
|
4.61 |
|
|
$ |
26.72 |
|
|
|
1,834,268 |
|
|
$ |
26.76 |
|
$26.98 - $27.63 |
|
|
1,818,832 |
|
|
|
3.60 |
|
|
$ |
27.63 |
|
|
|
1,806,232 |
|
|
$ |
27.63 |
|
$27.70 - $29.13 |
|
|
127,110 |
|
|
|
5.97 |
|
|
$ |
28.35 |
|
|
|
71,100 |
|
|
$ |
28.24 |
|
$29.20 - $29.20 |
|
|
2,196,510 |
|
|
|
6.58 |
|
|
$ |
29.20 |
|
|
|
1,044,114 |
|
|
$ |
29.20 |
|
$29.25 - $32.56 |
|
|
1,304,855 |
|
|
|
6.80 |
|
|
$ |
31.61 |
|
|
|
565,279 |
|
|
$ |
30.93 |
|
$32.81 - $36.06 |
|
|
74,000 |
|
|
|
6.27 |
|
|
$ |
33.80 |
|
|
|
36,160 |
|
|
$ |
33.87 |
|
$38.45 - $39.04 |
|
|
2,509,730 |
|
|
|
7.55 |
|
|
$ |
38.48 |
|
|
|
760,690 |
|
|
$ |
38.56 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,989,011 |
|
|
|
5.56 |
|
|
$ |
27.63 |
|
|
|
8,555,147 |
|
|
$ |
25.45 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A summary of stock options granted within the Plans and related information for 2006,
the Transition Period, fiscal 2005 and fiscal 2004 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Qualified |
|
Non-Qualified |
|
Total |
|
Price |
Balance at June 30, 2003 |
|
|
3,206,462 |
|
|
|
9,575,130 |
|
|
|
12,781,592 |
|
|
$ |
21.11 |
|
|
Granted |
|
|
10,272 |
|
|
|
3,403,248 |
|
|
|
3,413,520 |
|
|
$ |
29.32 |
|
Exercised |
|
|
(1,383,395 |
) |
|
|
(1,526,179 |
) |
|
|
(2,909,574 |
) |
|
$ |
17.68 |
|
Terminated/expired |
|
|
(275,772 |
) |
|
|
(985,822 |
) |
|
|
(1,261,594 |
) |
|
$ |
25.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2004 |
|
|
1,557,567 |
|
|
|
10,466,377 |
|
|
|
12,023,944 |
|
|
$ |
23.82 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
2,795,890 |
|
|
|
2,795,890 |
|
|
$ |
38.48 |
|
Exercised |
|
|
(269,554 |
) |
|
|
(542,216 |
) |
|
|
(811,770 |
) |
|
$ |
20.43 |
|
Terminated/expired |
|
|
(62,896 |
) |
|
|
(296,790 |
) |
|
|
(359,686 |
) |
|
$ |
28.82 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2005 |
|
|
1,225,117 |
|
|
|
12,423,261 |
|
|
|
13,648,378 |
|
|
$ |
26.89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
843,550 |
|
|
|
843,550 |
|
|
$ |
32.43 |
|
Exercised |
|
|
(9,552 |
) |
|
|
(8,444 |
) |
|
|
(17,996 |
) |
|
$ |
23.87 |
|
Terminated/expired |
|
|
(10,626 |
) |
|
|
(83,970 |
) |
|
|
(94,596 |
) |
|
$ |
28.85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005 |
|
|
1,204,939 |
|
|
|
13,174,397 |
|
|
|
14,379,336 |
|
|
$ |
27.21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
91,125 |
|
|
|
91,125 |
|
|
$ |
31.38 |
|
Exercised |
|
|
(260,756 |
) |
|
|
(739,075 |
) |
|
|
(999,831 |
) |
|
$ |
20.43 |
|
Terminated/expired |
|
|
(18,394 |
) |
|
|
(463,225 |
) |
|
|
(481,619 |
) |
|
$ |
30.60 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
925,789 |
|
|
|
12,063,222 |
|
|
|
12,989,011 |
|
|
$ |
27.63 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-35
NOTE 19. NET (LOSS) INCOME PER COMMON SHARE
The following table sets forth the computation of basic and diluted net (loss) income per
common share (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEAR ENDED |
|
|
SIX MONTHS ENDED |
|
|
YEAR ENDED |
|
|
|
DECEMBER 31, |
|
|
DECEMBER 31, |
|
|
JUNE 30, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
2004 |
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
BASIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(75,849 |
) |
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
$ |
30,840 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares outstanding |
|
|
54,688 |
|
|
|
54,323 |
|
|
|
55,972 |
|
|
|
55,196 |
|
|
|
55,618 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net (loss) income per
common share |
|
$ |
(1.39 |
) |
|
$ |
0.92 |
|
|
$ |
0.38 |
|
|
$ |
1.18 |
|
|
$ |
0.55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income |
|
$ |
(75,849 |
) |
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
$ |
30,840 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax-effected interest expense and
issue costs related to Old Notes |
|
|
|
|
|
|
1,677 |
|
|
|
1,675 |
|
|
|
3,347 |
|
|
|
3,884 |
|
Tax-effected interest expense and
issue costs related to New Notes |
|
|
|
|
|
|
1,677 |
|
|
|
1,677 |
|
|
|
3,353 |
|
|
|
2,925 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income assuming dilution |
|
$ |
(75,849 |
) |
|
$ |
53,075 |
|
|
$ |
24,575 |
|
|
$ |
71,690 |
|
|
$ |
37,649 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares outstanding |
|
|
54,688 |
|
|
|
54,323 |
|
|
|
55,972 |
|
|
|
55,196 |
|
|
|
55,618 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Old Notes |
|
|
|
|
|
|
5,823 |
|
|
|
5,823 |
|
|
|
5,823 |
|
|
|
6,777 |
|
New Notes |
|
|
|
|
|
|
7,325 |
|
|
|
7,325 |
|
|
|
7,325 |
|
|
|
6,446 |
|
Stock options and restricted stock |
|
|
|
|
|
|
2,301 |
|
|
|
3,040 |
|
|
|
2,565 |
|
|
|
3,640 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
common shares assuming dilution |
|
|
54,688 |
|
|
|
69,772 |
|
|
|
72,160 |
|
|
|
70,909 |
|
|
|
72,481 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net (loss) income per
common share |
|
$ |
(1.39 |
) |
|
$ |
0.76 |
|
|
$ |
0.34 |
|
|
$ |
1.01 |
|
|
$ |
0.52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net (loss) income per common share must be calculated using the
if-converted method in accordance with EITF 04-8, Effect of Contingently Convertible Debt
on Diluted Earnings per Share. Diluted net (loss) income per share is calculated by
adjusting net (loss) income for tax-effected net interest and issue costs on the Old Notes
and New Notes, divided by the weighted average number of common shares outstanding assuming
conversion. All earnings per share amounts presented reflect the adoption of EITF 04-8.
Due to the Companys net loss during 2006, a calculation of diluted earnings per share
is not required. For 2006, potentially dilutive securities consisted of restricted stock
and stock options convertible into 2,228,059 shares in the aggregate, and 5,822,894 and
7,324,819 shares of common stock, issuable upon conversion of the Old Notes and New Notes,
respectively.
The diluted net income per common share computation for the Transition Period excludes
6,120,755 shares of stock that represented outstanding stock options that were
anti-dilutive.
F-36
The diluted net income per common share computation for the six months ended December
31, 2004 excludes 2,459,862 (unaudited) shares of stock that represented outstanding stock
options whose exercise price were greater than the average market price of the common shares
during the period and were anti-dilutive.
The dilutive net income per common share computation for fiscal 2005 and fiscal 2004
excludes 2,734,600 and 5,393 shares of stock, respectively, which represented outstanding
stock options whose exercise prices were greater than the average market price of the common
shares during the respective fiscal years and were anti-dilutive.
NOTE 20. FINANCIAL INSTRUMENTS CONCENTRATIONS OF CREDIT AND OTHER RISKS
Financial instruments that potentially subject the Company to significant
concentrations of credit risk consist principally of cash, cash equivalents, short-term and
long-term investments and accounts receivable.
The Company maintains cash, cash equivalents and short-term and long-term investments
primarily with two financial institutions that invest funds in short-term, interest-bearing,
investment-grade, marketable securities. Financial instruments that potentially subject the
Company to concentrations of credit risk consist primarily of investments in debt securities
and trade receivables. The Company generally places its investments with high-credit
quality counterparties. Investments in debt securities with original maturities of greater
than six months consist primarily of AAA rated financial instruments and counterparties.
The Companys investments are primarily in direct obligations of the United States
government or its agencies and municipal auction-rate securities.
At December 31, 2006 and 2005, three customers comprised approximately 76.1% and 83.2%,
respectively, of accounts receivable. The Company does not require collateral from its
customers, but performs periodic credit evaluations of its customers financial condition.
Management does not believe a significant credit risk exists at December 31, 2006.
The Companys inventory is contract manufactured. The Company and the manufacturers of
its products rely on suppliers of raw materials used in the production of its products.
Some of these materials are available from only one source and others may become available
from only one source. Any disruption in the supply of raw materials or an increase in the
cost of raw materials to these manufacturers could have a significant effect on their
ability to supply the Company with its products. The failure of any such suppliers to meet
its commitment on schedule could have a material adverse effect on the Companys business,
operating results and financial condition. If a sole-source supplier were to go out of
business or otherwise become unable to meet its supply commitments, the process of locating
and qualifying alternate sources could require up to several months, during which time the
Companys production could be delayed. Such delays could have a material adverse effect on
the Companys business, operating results and financial condition.
NOTE 21. FAIR VALUE OF FINANCIAL INSTRUMENTS
The carrying amount of cash equivalents approximates fair value because their maturity
is less than three months. The carrying amount of short-term and long-term investments
approximates fair value because the longer-term instruments have interest rate reset
features that regularly adjust to current market rates. The carrying amount of accounts
receivable, accounts payable and accrued liabilities approximates fair value due to the
short-term maturity of the amounts. The fair value of capital lease obligations, long-term
debt and lines of credit approximate their carrying value as they are estimated by
discounting the future cash flows at rates currently offered to the Company for similar debt
instruments.
NOTE 22. DEFINED CONTRIBUTION PLAN
The Company has a defined contribution plan (the Contribution Plan) that is intended
to qualify under Section 401(k) of the Internal Revenue Code. All employees, except those
who have not attained the age of 21, are eligible to participate in the Contribution Plan.
Participants may contribute, through payroll deductions, up to 20.0% of their basic
compensation, not to exceed Internal Revenue Code limitations. Although the Contribution
Plan provides for profit sharing contributions by the Company, the Company had not made any
such contributions since its inception until April 2002. Beginning in April 2002, the
Company began matching employee contributions at 50% of the first 3% of basic compensation
contributed by the participants, and in April 2006 increased the matching contribution to 50%
of the first 6% of basic compensation contributed by the participants. During 2006, the
F-37
Transition Period and fiscal 2005 the Company also made a discretionary contribution to the
plan. During 2006, the Transition Period, the comparable 2004 six months, fiscal 2005 and
fiscal 2004, the Company recognized expense related to matching and discretionary
contributions under the Contribution Plan of $1,436,000, $442,000, $162,000 (unaudited),
$803,000 and $340,000, respectively.
NOTE 23. QUARTERLY FINANCIAL INFORMATION (UNAUDITED)
The tables below list the quarterly financial information for 2006, the Transition
Period and fiscal 2005. All figures are in thousands, except per share amounts, and certain
amounts do not total the annual amounts due to rounding.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEAR ENDED DECEMBER 31, 2006 |
|
|
(FOR THE QUARTERS ENDED) |
|
|
MARCH 31, 2006 (a) |
|
JUNE 30, 2006 (b) |
|
SEPTEMBER 30, 2006 (c) |
|
DECEMBER 31, 2006 (d) |
Net revenues |
|
$ |
75,158 |
|
|
$ |
85,032 |
|
|
$ |
89,987 |
|
|
$ |
99,067 |
|
Gross profit (1) |
|
|
62,979 |
|
|
|
75,613 |
|
|
|
81,469 |
|
|
|
87,441 |
|
Net (loss) income |
|
|
(88,543 |
) |
|
|
15,519 |
|
|
|
(20,677 |
) |
|
|
17,852 |
|
Basic net (loss) income
per common share |
|
$ |
(1.63 |
) |
|
$ |
0.28 |
|
|
$ |
(0.38 |
) |
|
$ |
0.32 |
|
Diluted net (loss) income
per common share |
|
$ |
(1.63 |
) |
|
$ |
0.25 |
|
|
$ |
(0.38 |
) |
|
$ |
0.27 |
|
|
|
|
|
|
|
|
|
|
|
|
SIX MONTHS ENDED DECEMBER 31, 2005 |
|
|
(FOR THE QUARTERS ENDED) |
|
|
SEPTEMBER 30, 2005 (e) |
|
DECEMBER 31, 2005 (f) |
Net revenues |
|
$ |
83,264 |
|
|
$ |
80,690 |
|
Gross profit (1) |
|
|
71,240 |
|
|
|
68,603 |
|
Net income |
|
|
12,460 |
|
|
|
37,261 |
|
Basic net income
per common share |
|
$ |
0.23 |
|
|
$ |
0.69 |
|
Diluted net income
per common share |
|
$ |
0.20 |
|
|
$ |
0.56 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEAR ENDED JUNE 30, 2005 |
|
|
(FOR THE QUARTERS ENDED) |
|
|
SEPTEMBER 30, 2004 (g) |
|
DECEMBER 31, 2004 (h) |
|
MARCH 31, 2005 (i) |
|
JUNE 30, 2005 (j) |
Net revenues |
|
$ |
88,818 |
|
|
$ |
92,349 |
|
|
$ |
95,188 |
|
|
$ |
100,544 |
|
Gross profit (1) |
|
|
74,985 |
|
|
|
78,911 |
|
|
|
81,274 |
|
|
|
86,282 |
|
Net income |
|
|
1,023 |
|
|
|
20,201 |
|
|
|
19,371 |
|
|
|
24,395 |
|
Basic net income
per common share |
|
$ |
0.02 |
|
|
$ |
0.37 |
|
|
$ |
0.36 |
|
|
$ |
0.45 |
|
Diluted net income
per common share |
|
$ |
0.02 |
|
|
$ |
0.31 |
|
|
$ |
0.30 |
|
|
$ |
0.38 |
|
|
|
|
(1) |
|
Gross profit does not include amortization of the related intangibles. |
Quarterly results were impacted by the following items:
|
|
|
(a) |
|
Operating expenses included approximately $90.9 million related to the Companys
development and distribution agreement with Ipsen for the development of
Reloxin®, $7.2 million of compensation expense related to stock options
and restricted stock, $6.0 million related to a loss contingency for a legal matter
and $1.8 million related to a settlement of a dispute related to the Companys
merger with Ascent. |
|
(b) |
|
Operating expenses included approximately $35.1 million related to the Companys
development and distribution agreement with Ipsen for the development of
Reloxin®, $7.3 million of compensation expense related to stock options
and restricted stock, and $2.0 million related to a loss contingency for a legal
matter. |
|
(c) |
|
Operating expenses included approximately $52.6 million for the write-down of
long-lived assets, $6.6 million of compensation expense related to stock options and
restricted stock and $2.2 million related to a loss contingency for a legal matter. |
F-38
|
|
|
(d) |
|
Operating expenses included approximately $4.9 million of compensation expense
related to stock options and restricted stock. |
|
(e) |
|
Operating expenses included approximately $7.7 million of compensation expense
related to stock options and restricted stock, and approximately $0.7 million of
business integration planning costs related to the proposed merger with Inamed. |
|
(f) |
|
Operating expenses included approximately $11.9 million paid to Dow related to a
research and development collaboration, a charge of approximately $9.2 million for
the write-down of a long-lived asset and approximately $7.3 million of compensation
expense related to stock options and restricted stock. Other income included
approximately $60.0 million related to a termination fee received from
Inamed related to the termination of the proposed merger with Inamed, net of the
expensing of accumulated transaction costs and business integration planning costs
incurred. |
|
(g) |
|
Operating expenses included approximately $30.0 million paid to Q-Med related to
an exclusive license agreement for the development of SubQTM, and
approximately $0.7 million of professional fees related to the agreement. |
|
(h) |
|
Operating expense included approximately $5.0 million paid to Ansata related to
an exclusive development and license agreement, and approximately $0.5 million of
professional fees related to the agreement. |
|
(i) |
|
Operating expenses included approximately $8.3 million paid to AAIPharma related
to a research and development collaboration. Effective January 1, 2005, the Company
changed the estimated useful life for certain intangible assets related to its
merger with Ascent. This change increased amortization expense by approximately
$0.8 million during the quarter ended March 31, 2005. |
|
(j) |
|
Operating expenses included approximately $5.3 million of business integration
planning costs related to the proposed merger with Inamed. Effective January 1,
2005, the Company accelerated the estimated useful life for certain intangible
assets related to its merger with Ascent. This change increased amortization
expense by approximately $0.8 million during the quarter ended June 30, 2005. |
F-39
SCHEDULE II VALUATION AND QUALIFYING ACCOUNTS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
Charged to |
|
|
|
|
|
|
|
|
|
|
beginning of |
|
costs and |
|
Charged to other |
|
|
|
|
|
Balance at end of |
Description |
|
year |
|
expenses |
|
accounts |
|
Deductions |
|
year |
Year Ended December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted from Asset Accounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances |
|
$ |
18,160 |
|
|
$ |
128,602 |
|
|
|
|
|
|
$ |
(109,319 |
) |
|
$ |
37,443 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended
December 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted from Asset Accounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances |
|
$ |
19,073 |
|
|
$ |
42,755 |
|
|
|
|
|
|
$ |
(43,668 |
) |
|
$ |
18,160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted from Asset Accounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances |
|
$ |
15,955 |
|
|
$ |
95,979 |
|
|
|
|
|
|
$ |
(92,861 |
) |
|
$ |
19,073 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended June 30, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted from Asset Accounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances |
|
$ |
15,079 |
|
|
$ |
96,263 |
|
|
|
|
|
|
$ |
(95,387 |
) |
|
$ |
15,955 |
|
S-1
Exhibit Index
|
|
|
|
|
Exhibit No. |
|
|
|
Description |
2.1
|
|
|
|
Agreement of Merger by and between the Company, Medicis Acquisition Corporation and GenDerm
Corporation, dated November 28, 1997 (11) |
|
|
|
|
|
2.2
|
|
|
|
Agreement of Plan of Merger, dated as of October 1, 2001, by and among the Company, MPC
Merger Corp. and Ascent Pediatrics, Inc. (17) |
|
|
|
|
|
3.1
|
|
|
|
Certificate of Incorporation of the Company, as amended (23) |
|
|
|
|
|
3.2
|
|
|
|
Amended and Restated By-Laws of the Company (13) |
|
|
|
|
|
4.1
|
|
|
|
Amended and Restated Rights Agreement, dated as of August 17, 2005, between the Company and
Wells Fargo Bank, N.A., as Rights Agent(26) |
|
|
|
|
|
4.2
|
|
|
|
Indenture, dated as of August 19, 2003, by and between the Company, as issuer, and Deutsche
Bank Trust Company Americas, as trustee (23) |
|
|
|
|
|
4.3
|
|
|
|
Indenture, dated as of June 4, 2002, by and between the Company, as issuer, and Deutsche Bank
Trust Company Americas, as trustee. (19) |
|
|
|
|
|
4.4
|
|
|
|
Supplemental Indenture dated as of February 1, 2005 to Indenture dated as of August 19, 2003
between the Company and Deutsche Bank Trust Company Americas as Trustee (25) |
|
|
|
|
|
4.5
|
|
|
|
Registration Rights Agreement, dated as of June 4, 2002, by and between the Company and
Deutsche Bank Securities Inc. (19) |
|
|
|
|
|
4.6
|
|
|
|
Form of specimen certificate representing Class A common stock (1) |
|
|
|
|
|
10.1
|
|
|
|
Asset Purchase Agreement among the Company, Ascent Pediatrics, Inc., BioMarin Pharmaceutical
Inc., and BioMarin Pediatrics Inc., dated April 20, 2004 (23) |
|
|
|
|
|
10.2
|
|
|
|
Merger Termination Agreement, dated as of December 13, 2005, by and among the Company,
Masterpiece Acquisition Corp., and Inamed Corporation(31) |
|
|
|
|
|
10.3
|
|
|
|
Securities Purchase Agreement among the Company, Ascent Pediatrics, Inc., BioMarin
Pharmaceutical Inc. and BioMarin Pediatrics Inc., dated May 18, 2004 (23) |
|
|
|
|
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10.4
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|
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|
Termination Agreement dated October 19, 2005 between the Company and Michael A.
Pietrangelo(28) |
|
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10.5
|
|
|
|
License Agreement among the Company, Ascent Pediatrics, Inc. and BioMarin Pediatrics Inc.,
dated May 18, 2004 (23) |
|
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Exhibit No. |
|
|
|
Description |
10.6
|
|
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|
Medicis Pharmaceutical Corporation 1995 Stock Option Plan (incorporated by
reference to Exhibit C to the definitive Proxy Statement for the 1995 Annual
Meeting of Shareholders previously filed with the SEC, File No. 0-18443) |
|
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10.7(a)
|
|
|
|
Employment Agreement between the Company and Jonah Shacknai, dated
July 24, 1996 (8) |
|
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|
10.7(b)
|
|
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|
Amendment to Employment Agreement by and between the Company and
Jonah Shacknai, dated April 1, 1999 (15) |
|
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10.7(c)
|
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|
Amendment to Employment Agreement by and between the Company and
Jonah Shacknai, dated February 21, 2001 (15) |
|
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10.7(d)
|
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|
Third Amendment, dated December 30, 2005, to Employment Agreement between the Company and
Jonah Shacknai(32) |
|
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10.8
|
|
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|
Medicis Pharmaceutical Corporation 2001 Senior Executive Restricted Stock Plan(30) |
|
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10.9(a)
|
|
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|
Medicis Pharmaceutical Corporation 2002 Stock Option Plan (20) |
|
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10.9(b)
|
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|
|
Amendment No. 1 to the Medicis Pharmaceutical Corporation 2002 Stock Option Plan, dated
August 1, 2005(29) |
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10.10(a)
|
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Medicis Pharmaceutical Corporation 2004 Stock Incentive Plan(27) |
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10.10(b)
|
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|
|
Amendment No. 1 to the Medicis Pharmaceutical Corporation 2004 Stock Option Plan, dated
August 1, 2005(29) |
|
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10.11(a)
|
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|
Medicis Pharmaceutical Corporation 1998 Stock Option Plan(33) |
|
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10.11(b)
|
|
|
|
Amendment No. 1 to the Medicis Pharmaceutical Corporation 1998 Stock Option Plan, dated
August 1, 2005(29) |
|
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10.11(c)
|
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Amendment No. 2 to the Medicis Pharmaceutical Corporation 1998 Stock Option Plan, dated
September 30, 2005(29) |
|
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10.12(a)
|
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|
Medicis Pharmaceutical Corporation 1996 Stock Option Plan(34) |
|
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10.12(b)
|
|
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|
Amendment No. 1 to the Medicis Pharmaceutical Corporation 1996 Stock Option Plan, dated
August 1, 2005(29) |
|
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|
10.13
|
|
|
|
Waiver Letter dated March 18, 2005 between the Company and Q-Med AB(27) |
|
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10.14
|
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|
Supply Agreement, dated October 21, 1992, between Schein Pharmaceutical and the Company
(2) |
|
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10.15
|
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|
Amendment to Manufacturing and Supply Agreement, dated March 2, 1993, between
Schein Pharmaceutical and the Company (3) |
|
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10.16(a)
|
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|
Credit and Security Agreement, dated August 3, 1995, between the Company and
Norwest Business Credit, Inc. (5) |
|
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10.16(b)
|
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|
First Amendment to Credit and Security Agreement, dated May 29, 1996,
between the Company and Norwest Bank Arizona, N.A. (8) |
|
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10.16(c)
|
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|
Second Amendment to Credit and Security Agreement, dated November 22, 1996,
by and between the Company and Norwest Bank Arizona, N.A. as successor-in-interest
to Norwest Business Credit, Inc. (10) |
|
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10.16(d)
|
|
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|
Third Amendment to Credit and Security Agreement, dated November 22, 1998, by
and between the Company and Norwest Bank Arizona, N.A., as successor-in-interest
to Norwest Business Credit, Inc. (12) |
|
|
|
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10.16(e)
|
|
|
|
Fourth Amendment to Credit and Security Agreement, dated November 22, 2000,
by and between the Company and Wells Fargo Bank Arizona, N.A., formerly
known as Norwest Bank Arizona, N.A., as successor-in-interest to Norwest Business
Credit, Inc. (16) |
|
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10.16(f)
|
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|
|
Fifth Amendment to Credit and Security Agreement, dated November 22, 2002, by and between the
Company and Wells Fargo Bank Arizona, N.A., formerly known as Norwest Bank Arizona, N.A., as
successor-in-interest to Norwest Business Credit, Inc. (23) |
|
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10.17(a)
|
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|
Patent Collateral Assignment and Security Agreement, dated August 3, 1995, by
the Company to Norwest Business Credit, Inc. (6) |
|
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10.17(b)
|
|
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|
First Amendment to Patent Collateral Assignment and Security Agreement, dated
May 29, 1996, by the Company to Norwest Bank Arizona, N.A. (8) |
|
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10.17(c)
|
|
|
|
Amended and Restated Patent Collateral Assignment and Security Agreement, dated
November 22, 1998, by the Company to Norwest Bank Arizona, N.A. (12) |
|
|
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10.18(a)
|
|
|
|
Trademark Collateral Assignment and Security Agreement, dated August 3, 1995,
by the Company to Norwest Business Credit, Inc. (7) |
|
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10.18(b)
|
|
|
|
First Amendment to Trademark Collateral Assignment and Security Agreement, dated
May 29, 1996, by the Company to Norwest Bank Arizona, N.A. (8) |
|
|
|
|
|
10.18(c)
|
|
|
|
Amended and Restated Trademark,
Tradename, and Service Mark Collateral Assignment and Security Agreement, dated November 22, 1998, by the Company
to Norwest Bank Arizona, N.A. (12) |
|
|
|
|
|
Exhibit No. |
|
|
|
Description |
10.19
|
|
|
|
Assignment and Assumption of Loan Documents, dated May 29, 1996, from
Norwest Business Credit, Inc., to and by Norwest Bank Arizona, N.A. (8) |
|
|
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|
|
10.20
|
|
|
|
Multiple Advance Note, dated May 29, 1996, from the Company to Norwest Bank
Arizona, N.A. (8) |
|
|
|
|
|
10.21
|
|
|
|
Asset Purchase Agreement dated November 15, 1998, by and among the Company and
Hoechst Marion Roussel, Inc., Hoechst Marion Roussel Deutschland GMHB and
Hoechst Marion Roussel, S.A. (12) |
|
|
|
|
|
10.22
|
|
|
|
License and Option Agreement dated November 15, 1998, by and among the Company
and Hoechst Marion Roussel, Inc., Hoechst Marion Roussel Deutschland GMBH and
Hoechst Marion Roussel, S.A. (12) |
|
|
|
|
|
10.23
|
|
|
|
Loprox Lotion Supply Agreement dated November 15, 1998, by and between the
Company and Hoechst Marion Roussel, Inc. (12) |
|
|
|
|
|
10.24
|
|
|
|
Supply Agreement dated November 15, 1998, by and between the Company and
Hoechst Marion Roussel Deutschland GMBH (12) |
|
|
|
|
|
10.25
|
|
|
|
Asset Purchase Agreement effective January 31, 1999, between the Company and
Bioglan Pharma Plc (14) |
|
|
|
|
|
10.26
|
|
|
|
Stock Purchase Agreement by and among the Company, Ucyclyd Pharma, Inc. and
Syed E. Abidi, William Brusilow, Susan E. Brusilow and Norbert L. Wiech, dated
April 19, 1999 (14) |
|
|
|
|
|
10.27
|
|
|
|
Asset Purchase Agreement by and between the Company and Bioglan Pharma Plc,
dated June 29, 1999 (14) |
|
|
|
|
|
10.28
|
|
|
|
Asset Purchase Agreement by and among The Exorex Company, LLC, Bioglan
Pharma Plc, the Company and IMX Pharmaceuticals, Inc., dated June 29, 1999 (16) |
|
|
|
|
|
10.29
|
|
|
|
Medicis Pharmaceutical Corporation Executive Retention Plan (14) |
|
|
|
|
|
10.30
|
|
|
|
Asset Purchase Agreement between Warner Chilcott, plc and the Company, dated
September 14, 1999(14) |
|
|
|
|
|
10.31(a)
|
|
|
|
Share Purchase Agreement between Q-Med International B.V. and Startskottet 21914
AB (under proposed change of name to Medicis Sweden Holdings AB), dated
February 10, 2003(21) |
|
|
|
|
|
10.31(b)
|
|
|
|
Amendment No. 1 to Share Purchase Agreement between Q-Med International
B.V. and Startskottet 21914 AB (under proposed change of name to Medicis Sweden
Holdings AB), dated March 7, 2003(21) |
|
|
|
|
|
10.32
|
|
|
|
Supply Agreement between Q-Med AB and the Company,
dated March 7, 2003(21) |
|
|
|
|
|
10.33
|
|
|
|
Amended and Restated Intellectual Property Agreement between Q-Med AB and HA
North American Sales AB, dated March 7, 2003(21) |
|
|
|
|
|
10.34
|
|
|
|
Supply Agreement between Medicis Aesthetics Holdings Inc., a wholly owned subsidiary of the
Company, and Q-Med AB, dated July 15, 2004 (23) Portions of this exhibit
(indicated by asterisks) have been omitted pursuant to a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of 1934. |
|
|
|
|
|
10.35
|
|
|
|
Intellectual Property License Agreement between Q-Med AB and Medicis Aesthetics Holdings
Inc., dated July 15, 2004 (23) Portions of this exhibit (indicated by asterisks)
have been omitted pursuant to a request for confidential treatment pursuant to Rule 24b-2
under the Securities Exchange Act of 1934. |
|
|
|
|
|
10.36
|
|
|
|
Note Agreement, dated as of October 1, 2001, by and among Ascent Pediatrics, Inc., the
Company, Furman Selz Investors II L.P., FS Employee Investors LLC, FS Ascent Investments LLC,
FS Parallel Fund L.P., BancBoston Ventures Inc. and Flynn Partners (17) |
|
|
|
|
|
10.37
|
|
|
|
Voting Agreement, dated as of October 1, 2001, by and among the Company, MPC Merger Corp., FS
Private Investments LLC, Furman Selz Investors II L.P., FS Employee Investors LLC, FS Ascent
Investments LLC and FS Parallel Fund L.P. (17) |
|
|
|
|
|
10.38
|
|
|
|
Exclusive Remedy Agreement, dated as of October 1, 2001, by and among the Company, Ascent
Pediatrics, Inc., FS Private Investments LLC, Furman Selz Investors II L.P., FS Employee
Investors LLC, FS Ascent Investments LLC and FS Parallel Fund L.P., BancBoston Ventures Inc.,
Flynn Partners, Raymond F. Baddour, Sc.D., Robert E. Baldini, Medical Science Partners L.P.
and Emmett Clemente, Ph.D. (17) |
|
|
|
|
|
10.39
|
|
|
|
Medicis Pharmaceutical Corporation 1992 Stock Option Plan(35) |
|
|
|
|
|
Exhibit No. |
|
|
|
Description |
10.40
|
|
|
|
Form of Stock Option Agreement for Medicis Pharmaceutical Corporation 2004 Stock Incentive
Plan(36) |
|
|
|
|
|
10.41
|
|
|
|
Form of Restricted Stock Agreement for Medicis Pharmaceutical Corporation 2004 Stock
Incentive Plan(36) |
|
|
|
|
|
10.42
|
|
|
|
Letter Agreement dated as of March 13, 2006 among Medicis Pharmaceutical Corporation,
Aesthetica Ltd., Medicis Aesthetics Holdings Inc., Ipsen S.A. and Ipsen Ltd. (37) |
|
|
|
|
|
10.43
|
|
|
|
Development and Distribution Agreement by and between Aesthetica, Ltd. and Ipsen, Ltd.
(38) |
|
|
|
|
|
10.44
|
|
|
|
Trademark License Agreement by and between Aesthetica, Ltd. and Ipsen, Ltd. (38) |
|
|
|
|
|
10.45
|
|
|
|
Trademark Assignment Agreement by and between Aesthetica, Ltd. and Ipsen, Ltd. (38) |
|
|
|
|
|
10.46(a)
|
|
|
|
Medicis 2006 Incentive Award Plan(39) |
|
|
|
|
|
10.46(b)
|
|
|
|
Amendment to the Medicis 2006 Incentive Award Plan, dated July 10, 2006(41) |
|
|
|
|
|
10.47
|
|
|
|
Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical Corporation and
Mark A. Prygocki, Sr. (40) |
|
|
|
|
|
10.48
|
|
|
|
Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical Corporation and
Mitchell S. Wortzman, Ph.D. (40) |
|
|
|
|
|
10.49
|
|
|
|
Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical Corporation and
Richard J. Havens (40) |
|
|
|
|
|
10.50
|
|
|
|
Employment Agreement, dated July 27, 2006, between Medicis Pharmaceutical Corporation and
Jason D. Hanson (40) |
|
|
|
|
|
10.51
|
|
|
|
Office Sublease by and between Apex 7720 North Dobson, L.L.C., an Arizona limited liability
company, and Medicis Pharmaceutical Corporation, dated as of July 26, 2006(42) |
|
|
|
|
|
12
|
|
+
|
|
Computation of Ratios of Earnings to Fixed Charges |
|
|
|
|
|
21.1
|
|
+
|
|
Subsidiaries |
|
|
|
|
|
23.1
|
|
+
|
|
Consent of Independent Registered Public Accounting Firm |
|
|
|
|
|
24.1
|
|
|
|
Power of Attorney See signature page
Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the
Securities Exchange Act, as amended
Certification of Chief Financial Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the
Securities Exchange Act, as amended |
|
|
|
|
|
31.1
|
|
+
|
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted |
|
|
|
|
|
31.2
|
|
+
|
|
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
|
|
32.1
|
|
+
|
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted |
|
|
|
|
|
32.2
|
|
+
|
|
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
+ |
|
Filed herewith |
|
(1) |
|
Incorporated by reference to the Registration Statement on Form S-1 of the Registrant,
File No. 33-32918, filed with the SEC on January 16, 1990 |
|
(2) |
|
Incorporated by reference to the Registration Statement on Form S-1 of the Company, File
No. 33-54276, filed with the SEC on June 11, 1993 |
|
(3) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 1993, File No. 0-18443, filed with the SEC on October 13, 1993 |
|
(4) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 1995, File No. 0-18443, previously filed with the SEC (the 1994 Form 10-K) |
|
(5) |
|
Incorporated by reference to the Companys 1995 Form 10-K |
|
(6) |
|
Incorporated by reference to the Companys 1995 Form 10-K |
|
(7) |
|
Incorporated by reference to the Companys 1995 Form 10-K |
|
(8) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 1996, File No. 0-18443, previously filed with the SEC |
|
(9) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended March 31, 1997, File No. 0-18443, previously filed with the SEC |
|
(10) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended December 31, 1996, File No. 0-18443, previously filed with the SEC |
|
(11) |
|
Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC
on December 15, 1997 |
|
(12) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended December 31, 1998, File No. 0-18443, previously filed with the SEC |
|
|
|
(13) |
|
Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC
on July 13, 2006 |
|
(14) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 1999, File No. 0-18443, previously filed with the SEC |
|
(15) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended March 31, 2001, File No. 0-18443, previously filed with the SEC |
|
(16) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 2001, File No. 0-18443, previously filed with the SEC |
|
(17) |
|
Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC
on October 2, 2001 |
|
(18) |
|
Incorporated by reference to the Companys registration statement on Form 8-A12B/A filed
with the SEC
on June 4, 2002 |
|
(19) |
|
Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC
on
June 6, 2002 |
|
(20) |
|
Incorporated by reference to the Companys Annual Report on Form
10-K for the fiscal year ended June 30, 2002, File No. 0-18443, previously filed with the
SEC |
|
(21) |
|
Incorporated by reference to the Companys Current Report on Form
8-K filed with the SEC on March 10, 2003 |
|
(22) |
|
Incorporated by reference to the Companys Quarterly Report on
Form 10-Q for the quarter ended December 31, 2003, File No. 0-18443, previously filed with
the SEC |
|
(23) |
|
Incorporated by reference to the Companys Annual Report on Form
10-K for the fiscal year ended June 30, 2004, File No. 0-18443, previously filed with the
SEC |
|
(24) |
|
Incorporated by reference to the Companys Current Report on Form
8-K filed with the SEC on March 21, 2005 |
|
(25) |
|
Incorporated by reference to the Companys Quarterly Report on
Form 10-Q for the quarter ended March 31, 2005, File No. 0-18443, previously filed with the
SEC |
|
(26) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on August 18, 2005 |
|
(27) |
|
Incorporated by reference to the Companys Annual Report on
Form 10-K for the fiscal year ended June 30, 2005, File No. 0-18443, previously filed with
the SEC |
|
(28) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on October 20, 2005 |
|
(29) |
|
Incorporated by reference to the Companys Annual Report on
Form 10-K/A for the fiscal year ended June 30, 2005, File No. 0-18443, previously filed with
the SEC on October 28, 2005 |
|
(30) |
|
Incorporated by reference to the Companys Quarterly Report on
Form 10-Q for the quarter ended September 30, 2005, File No. 0-18443, previously filed with
the SEC |
|
(31) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on December 13, 2005 |
|
(32) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on January 3, 2006 |
|
(33) |
|
Incorporated by reference to Appendix 1 to the Companys definitive Proxy Statement for
the 1998 Annual
Meeting of Stockholders filed with the SEC on December 2, 1998 |
|
(34) |
|
Incorporated by reference to Appendix 2 to the Companys definitive Proxy Statement for
the 1996 Annual
Meeting of Stockholders filed with the SEC on October 23, 1996 |
|
(35) |
|
Incorporated by reference to Exhibit B to the Companys definitive Proxy Statement for
the 1992 Annual
Meeting of Stockholders previously filed with the SEC |
|
(36) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K/T for the six month
transition
period ended December 31, 2005, File No. 0-18443, previously filed with the SEC on March 16,
2006 |
|
(37) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on March 16, 2006 |
|
(38) |
|
Incorporated by reference to the Companys Quarterly Report on
Form 10-Q for the quarter ended March 31, 2006, File No. 0-18443, previously filed with the
SEC |
|
(39) |
|
Incorporated by reference to Appendix A to the Companys Definitive Proxy Statement for
the 2006
Annual Meeting of Stockholders filed with the SEC on April 13, 2006 |
|
|
|
(40) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on July 31, 2006 |
|
(41) |
|
Incorporated by reference to the Companys Quarterly Report on
Form 10-Q for the quarter ended June 30, 2006, File No. 0-18443, previously filed with
the SEC |
|
(42) |
|
Incorporated by reference to the Companys Quarterly Report on
Form 10-Q for the quarter ended September 30, 2006, File No. 0-18443, previously filed
with the SEC |
|