e10vk
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, 2007.
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) |
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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, a non-accelerated filer, or a
smaller reporting company. See the definitions of large accelerated filer,
accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
Indicate by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act) Yes o No þ
The aggregate market value of the voting stock held on June 30, 2007
by non-affiliates of the registrant was $1,179,182,383 based on
the closing price of $30.54 per share as reported on the New York Stock Exchange
on June 29, 2007, 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 22,
2008, there were 56,358,318 outstanding shares of Class A common
stock.
Documents incorporated by reference:
Portions of the Proxy Statement for the registrants 2008 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, 2007 to December 31, 2007,
which we refer to as 2007. We refer to the audited calendar year January 1, 2006 to December 31,
2006 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 audited information is provided with respect to the transition period
July 1, 2005 through December 31, 2005, which we refer to as the Transition Period. We refer to
the period beginning July 1, 2004 and ending June 30, 2005 as fiscal 2005.
The Company
We, together with our wholly owned subsidiaries, are a leading independent specialty
pharmaceutical company focusing 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 believe that the U.S. market
for dermatological pharmaceutical sales exceeds $6 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 11.7 million cosmetic surgical and non-surgical
procedures were performed in the United States during 2007, including approximately 9.6 million
non-surgical cosmetic procedures. We also market products in Canada for the treatment of
dermatological and aesthetic conditions.
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 high integrity relationships of trust and confidence with the foremost
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 18 branded products. Our primary brands
are PERLANE® (hyaluronic acid), 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 we consider less critical to our business.
We develop and obtain marketing and distribution rights to pharmaceutical agents in various
stages of development. 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.
Currently, we outsource all of our 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
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nature of these agreements, our expenses for manufacturing are not fixed and could
change from contract to contract.
Our Products
We currently market 18 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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U.S. Market Impact |
PERLANE®
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Injectable gel for implantation into the
deep dermis to superficial subcutis for
the correction of moderate to severe
facial folds and wrinkles, such as
nasolabial folds
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Launched in May 2007 following U.S. Food and
Drug Administration (FDA) approval on
May 2, 2007 |
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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,
launched in January 2004 following FDA approval
on December 12, 2003 |
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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 FDA approval
on May 8, 2006 |
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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, launched during fiscal 1996 |
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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 |
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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 |
Dermal Restorative Products
Our principal branded dermal restorative products are described below (see also Item 1A. Risk
Factors):
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 leading 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® and PERLANE® in the United States on January 6, 2004 and
May 2, 2007, respectively. 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 and medical
device company and its affiliates (collectively Q-Med) through license agreements.
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Prescription Pharmaceuticals
Our principal branded prescription pharmaceutical products are described below (see also Item
1A. Risk Factors):
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 (see also Item 1A. Risk
Factors). Other patent applications covering SOLODYN® are to be filed or are pending (see also Item
1A. Risk Factors). 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 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 three U.S. patents that expire 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 on the
aqueous-based vehicle 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.
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.
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We incurred total research and development costs for all of our sponsored and unreimbursed
co-sponsored pharmaceutical projects for 2007, 2006, the Transition Period, the corresponding
six-month period of 2004 and fiscal 2005 of $39.4 million, $161.8 million, $22.4 million, $45.1
million, and $65.7 million, respectively. Research and development costs for 2007 includes $8.0
million related to our option to acquire Revance Therapeutics, Inc. (Revance) or to license
Revances product currently under development. Research and development costs for 2006 include
$125.2 million paid to Ipsen Ltd., a wholly-owned subsidiary of Ipsen, S.A. (Ipsen) pursuant to
the RELOXIN® development agreements. Research and development costs for the Transition
Period include $11.9 million paid to Dow Pharmaceutical Sciences, Inc. (Dow) pursuant to a
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 Therapeutics, Inc. (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, Inc. (AAIPharma).
On December 11, 2007, we announced a strategic collaboration with Revance whereby we made an
equity investment in Revance and purchased an option to acquire Revance or to license exclusively
in North America Revances novel topical botulinum toxin type A product currently under clinical
development. The consideration to be paid to Revance upon our exercise of the option will be at an
amount that will approximate the then fair value of Revance or the license of the product under
development, as determined by an independent appraisal. The option period will extend through the
end of Phase 2 testing in the United States. In consideration for our $20.0 million payment, we
received preferred stock representing an approximate 13.7 percent ownership in Revance, or
approximately 11.7 percent on a fully diluted basis and the option to acquire Revance or to license the
product under development. The $20.0 million is expected to be used by
Revance primarily for the development of the new product. $12.0 million of the $20.0 million
payment represents the fair value of the investment in Revance at the time of the investment and is included in other long-term assets in our consolidated balance sheets as of December 31,
2007. The remaining $8.0 million, which is non-refundable and is expected to be utilized in the development of
the new product, represents the residual value of the option to acquire Revance or to license the product under development and is included in
research and development expense for the three months ended
December 31, 2007. Additionally, we have committed to make further equity investments in Revance of up
to $5.0 million under certain terms, subject to certain conditions and prior to the exercise of the
option to acquire Revance or to license exclusively Revances topical botulinum toxin type A
product in North America.
Prior to the exercise of the option, Revance will remain primarily responsible for the
worldwide development of Revances topical botulinum toxin type A product in consultation with us
in North America. We will assume primary responsibility for the development of the product should
consummation of either a merger or a license for topically delivered botulinum toxin type A in
North America be completed under the terms of the option. Revance will have sole responsibility
for manufacturing the development product and manufacturing the product during commercialization
worldwide. Our right to exercise the option is triggered upon Revances successful completion of
certain regulatory milestones through the end of Phase 2 testing in the United States. A license
would contain a payment upon exercise of the license option, milestone payments related to
clinical, regulatory and commercial achievements, and royalties based on sales, as defined in the
license. If we elect to exercise the option, the financial terms for the acquisition or license
will be determined through an independent valuation in accordance with specified methodologies.
On October 9, 2007, we entered into a development and license agreement with a company for the
development of a dermatologic product. Under terms of the agreement, we made an initial payment of
$1.5 million upon execution of the agreement. In addition, we are required to pay $18.0 million
upon successful completion of certain clinical milestones and $5.2 million upon the first
commercial sales of the product in the U.S. We will also make royalty payments based on net sales
as defined in the license. The $1.5 million payment was recognized as a charge to research and
development expense during 2007.
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
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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.
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 (including $25.0 million upon the FDAs acceptance of our Biologics License
Application (BLA) for RELOXIN®), $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 December 2036. 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.
On January 30, 2008, we received a letter from the FDA stating that, upon a preliminary review
of our BLA for RELOXIN®, the FDA has determined not to accept the BLA for filing because
it is not sufficiently complete to permit a substantive review. While we are uncertain of the
impact at this time, the FDAs determination not to accept the BLA may result in delays in the
FDAs substantive response to the BLA.
Additionally, on March 17, 2006, 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, as amended, we were obligated to make an additional $35.1 million
payment 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 were recognized as charges
to research and development expense during 2006.
On January 28, 2005, we amended our strategic alliance with 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. In addition to the amendment, we entered into a supply agreement with
AAIPharma for the manufacture of the product by AAIPharma. We have the right to qualify an
alternate manufacturing facility, and AAIPharma agreed to assist us in obtaining these
qualifications. Upon the approval of the alternate facility and approval of the product, we will
pay AAIPharma approximately $1.0 million.
On December 13, 2004, we entered into an exclusive development and license agreement and other
ancillary agreements with Ansata. The development and license agreement granted us the exclusive,
worldwide
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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 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 SubQTM. Q-Med has the exclusive right to manufacture
SubQTM for Medicis. SubQTM 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 SubQTM 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
SubQTM. We also will make additional milestone payments to Q-Med upon the achievement
of certain commercial milestones. SubQTM is comprised of the same NASHATM
substance as RESTYLANE®, PERLANE® and RESTYLANE FINE LINESTM with
a larger gel particle size and has patent protection until at least 2015 in the United States.
On September 26, 2002, we entered into an exclusive license and development agreement with Dow
for the development and commercialization of 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 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 an intangible asset in our consolidated
balance sheets. The agreement also included a one-time milestone payment of $1.0 million payable
to Dow the first time ZIANA® achieved a specific commercialization milestone during a
12-month period ending on the anniversary of ZIANA®s launch date. This milestone was
achieved during the three months ended June 30, 2007, and the $1.0 million milestone payment was
accrued for as of June 30, 2007 and recorded as an addition to intangible assets in our
consolidated balance sheets. In accordance with the agreement, the milestone is payable during the
three months ended March 31, 2008.
Sales and Marketing
Our combined dedicated sales force, consisting of 200 employees as of December 31, 2007,
focuses on high patient volume dermatologists and plastic surgeons. Since a relatively small
number of physicians are responsible for writing a majority of dermatological 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 sales forces consist of 109 employees who regularly call on approximately 12,000
dermatologists. Our dermal aesthetic sales force consists of 91 employees who regularly call on
leading plastic surgeons, facial plastic surgeons, dermatologists and dermatologic surgeons. We
also have eight national account managers who regularly call on major drug wholesalers, managed
care organizations, large retail chains, formularies and related organizations.
Our strategy is to cultivate relationships of trust and confidence with the high prescribing
dermatologists 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 also promote our dermal aesthetic products
through television and radio advertising.
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 2007, 2006, the Transition Period, the comparable six-month period in 2004 and
fiscal 2005, these customers accounted for the following portions of our net revenues:
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Comparable |
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Transition |
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in 2004 |
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Fiscal 2005 |
McKesson |
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52.2 |
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56.8 |
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54.9 |
% |
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|
50.8 |
% |
|
|
51.2 |
% |
Cardinal |
|
|
16.9 |
% |
|
|
19.3 |
% |
|
|
18.9 |
% |
|
|
19.7 |
% |
|
|
21.8 |
% |
McKesson is our sole distributor of our RESTYLANE® and PERLANE® products
in the United States and Canada.
Third-Party Reimbursement
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.
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.
8
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 that would adversely affect our results of
operations.
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 to assist in covering the loss of income for
products where we do not have a secondary manufacturer, 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 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.
Our TRIAZ®, VANOS® 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 RESTYLANE® and PERLANE® 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.
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®. Upon the
approval of the alternate facility and approval of the product, we will pay AAIPharma approximately
$1.0 million.
9
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. 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.
We have obtained and licensed a number of patents covering key aspects of our products,
including a U.S. patent expiring in October of 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, two U.S. patents expiring
in February of 2015 and August of 2020 covering ZIANA® Gel, and three U.S. patents
expiring in December 2021 covering VANOS® Cream. We have patent applications pending
relating to SOLODYN® Tablets, and ZIANA® Gel. 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.
Third parties may challenge and seek to invalidate or circumvent our patents and patent
applications relating to our products, product candidates and technologies. 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, can require a substantial commitment of our managements
time, be costly and can preclude or delay the commercialization of products. For example, on
January 15, 2008, IMPAX Laboratories, Inc. filed a lawsuit against us in the United States District
Court for the Northern District of California seeking a declaratory judgment that our U.S. Patent
No. 5,908,838 related to SOLODYN® is invalid and is not infringed by IMPAXs October
2007 filing of an Abbreviated New Drug
Application for a generic version of SOLODYN®. See Item 3 of Part I of this
report, Legal Proceedings and
10
Note 15, Commitments and Contingencies, in the notes to the
consolidated financial statements listed under Item 15 of Part IV of this report, Exhibits and
Financial Statement Schedules, for information concerning our current intellectual property
litigation.
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, other competitive factors affecting the pharmaceutical industry include
testing, approval and marketing, industry consolidation, product quality and price, product
technology, reputation, customer service and access to technical information.
The largest competitors for our prescription dermatological products include Allergan,
Galderma, Johnson & Johnson, Sanofi-Aventis, Stiefel Laboratories and Warner Chilcott. 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 primarily against Allergan. Among other dermal filler
products, Allergan markets 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®, Sanofi-Aventis Sculptra®, and Anika Therapeutics
ElevessTM have also recently been approved by the FDA. Patients may differentiate these
products from RESTYLANE® and PERLANE® 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, including products from Johnson &
Johnson and Mentor Corporation, which claim to offer equivalent or greater facial aesthetic
benefits to RESTYLANE® and PERLANE® 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 Cosmetic 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.
11
Our RESTYLANE® and PERLANE® dermal filler products are prescription
medical devices intended for human use and are subject to regulation by the FDA in the United
States. Unless an exemption applies, a 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®, PERLANE® 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 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 that 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® and PERLANE® are regulated as a Class III
PMA-required medical device. RESTYLANE® and PERLANE® have 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 typically 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 Abbreviated New Drug Application
(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 patient 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-
12
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 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 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
13
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 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.
Employees
At December 31, 2007, we had 472 full-time employees. No employees are subject to a
collective bargaining agreement. We believe we have a good relationship with our employees.
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 incorporated by reference into this Annual Report on Form 10-K.
14
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 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
Certain of our primary products could lose patent protection in the near future and become subject
to competition from generic forms of such products. If that were to occur, sales of those products
would decline significantly and such decline could have a material adverse effect on our results of
operations.
We depend upon patents to provide us with exclusive marketing rights for certain of our
primary products for some period of time. If product patents for our primary products expire, or
are successfully challenged by our competitors, in the United States and in other countries, we
would face strong competition from lower price generic drugs. Loss of patent protection for any of
our primary products would likely lead to a rapid loss of sales for that product, as lower priced
generic versions of that drug become available. In the case of products that contribute
significantly to our sales, the loss of patent protection could have a material adverse effect on
our results of operations. For example, while current patent coverage for SOLODYN® does
not expire until 2018, SOLODYN® may face generic competition in the near future without
prior notice if a generic competitor decides to enter the market notwithstanding the risk of a suit
for patent infringement. Because SOLODYN® contains an antibiotic drug that was first
approved by the FDA prior to the enactment of the Food and Drug Administration Modernization Act of
1997, or FDAMA, SOLODYN® does not have the benefit of the protections offered under the
Hatch-Waxman Act. Accordingly, we would not receive a Paragraph IV notice regarding
SOLODYN® from any potential generic competitor and would not be entitled to an automatic
30-month stay of generic entry that would be available to a patent owner filing an infringement
suit based on receipt of such a notice. We currently have one issued patent relating to
SOLODYN®. As part of our patent strategy, we are currently pursuing additional patent
protection for SOLODYN®. However, we cannot provide any assurance that any additional
patents will be issued relating to SOLODYN® and the failure to obtain additional patent
protection could adversely affect our ability to deter generic competition, which would adversely
affect SOLODYN® revenue and our results of operations. On January 15, 2008, we announced that
IMPAX Laboratories, Inc. (IMPAX) announced that IMPAX sent us a letter advising that IMPAX has filed an ANDA seeking FDA approval to market a generic version of
SOLODYN® (minocycline HCl) extended-release capsules. IMPAX has not advised us as to the status of
the FDAs review of its filing, or whether IMPAX has complied with recent FDA requirements for
proving bioequivalence. Also on January 15, 2008, IMPAX filed a lawsuit against US in the United
States District Court for the Northern District of California seeking a declaratory judgment that our
U.S. Patent No. 5,908,838 related to SOLODYN® is invalid and is not infringed by IMPAXs ANDA
for a generic version of SOLODYN®. In
addition to SOLODYN®, many of our primary prescription products may be subject to
generic competition in the
15
near future. If any of our primary products are rendered obsolete or
uneconomical by competitive changes, including generic competition, our results of operation would
be materially and adversely affected.
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 or infringement. Any such challenges may result in potentially
significant harm to our business and enable generic entry to markets for our products. The cost of
responding to any such challenges and the cost of prosecuting infringement claims and any related
litigation, could be substantial. In addition, any such litigation also could require a
substantial commitment of our managements time. On January 15, 2008, IMPAX filed a lawsuit
against us in the United States District Court for the Northern District of California seeking a
declaratory judgment that our U.S. Patent No. 5,908,838 related to SOLODYN® is invalid
and is not infringed by IMPAXs filing of an ANDA for a generic version of
SOLODYN®. See Item 3 of Part I of this report, Legal Proceedings and Note 15,
Commitments and Contingencies, in the notes to the consolidated financial statements listed under
Item 15 of Part IV of this report, Exhibits and Financial Statement Schedules, for information
concerning our current intellectual property litigation.
We are pursuing several United States patent applications; although we cannot be sure that any
of these patents will ever be issued. For example, on November 6, 2007, we received notification
of a non-final rejection from the U.S. Patent and Trademark Office relating to certain patent
applications that we filed relating to SOLODYN®. We responded promptly to the non-final
rejections and are continuing our vigorous efforts to obtain additional patent protection for
SOLODYN®. 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
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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.
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. 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, 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.
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. The FDA vigorously monitors the ongoing safety of products,
which can affect the approvability of our products or the continued ability to market our products.
For example, the FDA recently stated it was reviewing the safety of two botulinum toxin products
currently marketed in the U.S. 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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incurring substantial expenses, including fines, penalties, legal fees and costs to
comply with the FDAs requirements; |
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changes in the methods of marketing and selling products; |
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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.
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.
On April 25, 2007, we entered into a Settlement Agreement with the Justice Department, the
Office of Inspector General of the Department of Health and Human Services (OIG) and the TRICARE
Management Activity (collectively, the United States) and private complainants to settle all
outstanding federal and state civil suits against us in connection with claims related to our
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
(the Settlement Agreement). The settlement is neither an admission of liability by us nor a
concession by the United States that its claims are not well founded. Pursuant to the Settlement
Agreement, we agreed to pay approximately $10 million to settle the matter. Pursuant to the
Settlement Agreement, the United States released us from the claims asserted by the United States
and agreed to refrain from instituting action seeking exclusion from Medicare, Medicaid, the
TRICARE Program and other federal health care programs for the alleged conduct. These releases
relate solely to the allegations related to us and do not cover individuals. The Settlement
Agreement also provides that the private complainants release us and our officers, directors and
employees from the asserted claims, and we release the United States and the private complainants
from asserted claims.
As part of the settlement, we have entered into a five-year Corporate Integrity Agreement (the
CIA) with the OIG to resolve any potential administrative claims the OIG may have arising out of
the governments investigation. The CIA acknowledges the existence of our comprehensive existing
compliance program and
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provides for certain other compliance-related activities during the term of
the CIA, including the maintenance of a compliance program that, among other things, is designed to
ensure compliance with the CIA, federal health care programs and FDA requirements. Pursuant to the
CIA, we are required to notify the OIG, in writing, of: (i) any ongoing government investigation or
legal proceeding involving an allegation that we have committed a crime or has engaged in
fraudulent activities; (ii) any other matter that a reasonable person would consider a probable
violation of applicable criminal, civil, or administrative laws; (iii) any written report,
correspondence, or communication to the FDA that materially discusses any unlawful or improper
promotion of our products; and (iv) any change in location, sale, closing, purchase, or
establishment of a new business unit or location related to items or services that may be
reimbursed by Federal health care programs. We are also subject to periodic reporting and
certification requirements attesting that the provisions of the CIA are being implemented and
followed, as well as certain document and record retention mandates. We have hired a Chief
Compliance Officer and created an enterprise-wide compliance function to administer our obligations
under the CIA. Failure to comply under the CIA could result in substantial civil or criminal
penalties and being excluded from government health care programs, which could materially reduce
our sales and adversely affect our financial condition and results of operations.
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 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. As a result of the investigation, prosecutions and
other proceedings, certain past and present sales and marketing
employees and officers are likely to separate from the Company and,
together with the cost of their defense, fines and penalties, could
have a material impact on our reputation, business and financial
condition. See Item 3 of Part I of this report, Legal
Proceedings and Note 15, Commitments and Contingencies, in the notes to the consolidated
financial statements listed under Item 15 of Part IV of this report, Exhibits and Financial
Statement Schedules, for information concerning our current litigation.
Our corporate compliance program cannot guarantee that we are in compliance with all potentially
applicable U.S. federal and state regulations and all potentially applicable foreign regulations.
The development, manufacturing, distribution, pricing, sales, marketing and reimbursement of
our products, together with our general operations, is subject to extensive federal and state
regulation in the United States and in foreign countries. While we have developed and instituted a
corporate compliance program based on what we believe to be current best practices, we cannot
assure you that we or our employees are or will be in compliance with all potentially applicable
U.S. federal and state regulations and/or laws or all potentially applicable foreign regulations
and/or laws. If we fail to comply with any of these regulations and/or laws a range of actions
could result, including, but not limited to, the failure to approve a product candidate,
restrictions on our products or manufacturing processes, including withdrawal of our products from
the market, significant fines, exclusion from government healthcare programs or other sanctions or
litigation.
In addition, we have entered into a five-year CIA with the OIG. The CIA acknowledges the
existence of our comprehensive existing compliance program and provides for certain other
compliance-related activities during the term of the CIA, including the maintenance of a compliance
program that, among other things, is designed to ensure compliance with the CIA, federal health
care programs and FDA requirements. Pursuant to the CIA, we are required to notify the OIG, in
writing, of: (i) any ongoing government investigation or legal proceeding involving an allegation
that we have committed a crime or has engaged in fraudulent activities; (ii) any other matter that
a reasonable person would consider a probable violation of applicable criminal, civil, or
administrative laws; (iii) any written report, correspondence, or communication to the FDA that
materially discusses any unlawful or improper promotion of our products; and (iv) any change in
location, sale, closing, purchase, or establishment of a new business unit or location related to
items or services that may be reimbursed by Federal health care programs. We are also subject to
periodic reporting and certification requirements attesting that the provisions of the CIA are
being implemented and followed, as well as certain document and record retention mandates. We have
hired a Chief
Compliance Officer and created an enterprise-wide compliance function to administer our
obligations under the CIA. Failure to comply under the CIA could result in substantial civil or
criminal penalties and being excluded from government health care programs, which could materially
reduce our sales and adversely affect our financial condition and results of operations.
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 2007, McKesson and
Cardinal accounted for 52.2% and 16.9%, respectively, of our net revenues. 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 either 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®
and
PERLANE®
products in the United States and Canada. We are in the process of
negotiating arrangements with wholesalers for fixed-term purchases.
To date we have been unable to agree to terms with Cardinal Health.
While such arrangements are not necessary for wholesale purchases, if
we are unable to come to terms with any wholesalers, it could have a
material adverse effect on our business, results of operations and
cash flows.
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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 ZIANA®, and sales of our dermal aesthetic products,
RESTYLANE® and PERLANE®, 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®, Sculptra® and ElevessTM have also recently been
approved by the FDA. Patients may differentiate these products from RESTYLANE® and
PERLANE® 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 PERLANE® and, if approved, the companies producing such
products could charge less to doctors for their products.
On January 15, 2008, we announced that IMPAX announced that IMPAX sent us a letter advising that IMPAX has filed an ANDA seeking FDA
approval to market a generic version of SOLODYN® (minocycline HCl) extended-release capsules. IMPAX has not advised us as to the status of
the FDAs review of its filling, or whether IMPAX has complied
with recent FDA requirements for proving bioequivalence. Also on
January 15, 2008, IMPAX filed a lawsuit against us in the United
States District Court for the Northern District of California
seeking a declaratory judgment that our U.S. Patent No. 5,908,838 related to SOLODYN® is invalid and is not infringed by IMPAXs
ANDA for a generic version of SOLODYN®.
Sales related to our primary prescription products, including SOLODYN® and
ZIANA®, and sales of our dermal restorative products, RESTYLANE® and
PERLANE® 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. |
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. For example, on January 30, 2008, we
received a letter from the FDA stating that, upon a preliminary review of our BLA for the botulinum
toxin type A, RELOXIN®, in aesthetics, the FDA has determined
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not to accept the BLA for
filing because it is not sufficiently complete to permit a substantive review. While we are
uncertain of the impact at this time, the FDAs determination not to accept the BLA may result in
delays in the FDAs substantive response to the BLA.
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.
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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costs related to business development transactions; |
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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 |
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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, including the defense of our patents and
other intellectual property; |
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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.
Our investments in other companies and our collaborations with companies could adversely affect our
results of operations and financial condition.
We have made substantial investments in companies and entered into significant collaborations
with companies. We may use these and other methods to develop or commercialize products in the
future. These arrangements typically involve other pharmaceutical companies as partners that may
be competitors of ours in certain markets. In many instances, we will not control these companies
or collaborations, and cannot assure you that these ventures will be profitable or that we will not
lose any or all of our invested capital. If these investments and collaborations provide to
unsuccessful, our results of operations could materially suffer.
Our profitability is impacted by our continued participation in governmental pharmaceutical pricing
programs.
In order for our products to receive reimbursement by state Medicaid programs, we must
participate in the Medicaid drug rebate program. Participation in the program requires us to
provide a rebate for each unit of our products that is reimbursed by Medicaid. Rebate amounts for
our products are determined by a statutory formula that is based on prices defined by statute:
average manufacturer price (AMP), which we must calculate for all products that are covered
outpatient drugs under the Medicaid program, and best price, which we must calculate only for those
of our covered outpatient drugs that are innovator products. We are required to report AMP and
best price for each of our covered outpatient drugs to the government on a regular basis. In
July 2007, the Centers for Medicare and Medicaid Services (CMS), the federal agency that is
responsible for administering the Medicaid drug rebate program, issued a final rule that, among
other things, clarifies how manufacturers must calculate both
AMP and best price and implements new requirements under the Deficit Reduction Act of 2005 on
the use of AMP to calculate federal upper limits on pharmacy reimbursement amounts under the
Medicaid program. These upper limits are used to determine ceilings placed on the amounts that
state Medicaid programs can pay for certain prescription drugs using federal dollars. We cannot
predict the full impact of these changes, which became
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effective in part on January 1, 2007 and in
part on October 1, 2007, on our business, nor can we predict whether there will be additional
federal legislative or regulatory proposals to modify current Medicaid rebate rules.
To receive reimbursement under state Medicaid programs for our products, we also are required
by federal law to provide discounts under other pharmaceutical pricing programs. For example, we
are required to enter into a Federal Supply Schedule (FSS) contract with the Department of
Veterans Affairs (VA) under which we must make our covered drugs available to the Big Four
federal agencies the VA, the Department of Defense, the Public Health Service, and the Coast
Guard at pricing that is capped pursuant to a statutory Federal ceiling price (FCP) formula set
forth in the Veterans Health Care Act of 1992 (VHCA). The FCP is based on a weighted average
wholesaler price known as the non-federal average manufacturer price, which manufacturers are
required to report on a quarterly and annual basis to the VA. FSS contracts are federal
procurement contracts that include standard government terms and conditions and separate pricing
for each product. In addition to the Big Four agencies, all other federal agencies and some
non-federal entities are authorized to access FSS contracts. FSS contractors are permitted to
charge FSS purchasers other than the Big Four agencies negotiated pricing for covered drugs that
is not capped by the VHCA formula; instead, such pricing is negotiated based on a mandatory
disclosure of the contractors commercial most favored customer pricing. Medicis chooses to
offer one single FCP-based FSS contract price for each product to the Big Four agencies as well as
all to other FSS purchasers. Medicis also offers products that are not VHCA covered drugs on its
FSS contract at negotiated pricing. All items on FSS contracts are subject to a standard FSS
contract clause that requires FSS contract price reductions under certain circumstances where
pricing to an agreed tracking customer is reduced.
To receive reimbursement under state Medicaid programs for our products, we also are required
by federal law to provide discounted purchase prices under the Public Health Service Drug Pricing
Program to certain categories of entities defined by statute. The formula for determining the
discounted purchase price is defined by statute and is based on the AMP and rebate amount for a
particular product as calculated under the Medicaid drug rebate program, discussed above. To the
extent that the statutory and regulatory definitions of AMP and the Medicaid rebate amount change
as a result of the Deficit Reduction Act and final rule discussed above, these changes also could
impact the discounted purchase prices that we are obligated to provide under this program. We
cannot predict the full impact of these changes, which became effective in part on January 1, 2007
and in part on October 1, 2007, on our business, nor can we predict whether there will be
additional federal legislative or regulatory proposals to modify current Medicaid rebate rules
which then could impact this program as well.
Our profitability may be impacted by our ongoing review of our prior reports under certain Federal
pharmaceutical pricing programs.
Under the terms of our Medicaid drug rebate program agreement and our VA Federal Supply
Schedule (FSS) contract and related pricing agreements required under the Veterans Health Care
Act of 1992, we are required to accurately report our pharmaceutical pricing data, which is based,
in part, on accurate classifications of our customers classes of trade. On May 1, 2007, and on
May 15, 2007, we notified the U.S. Department of Health and Human Services and the Department of
Veterans Affairs, respectively, that we may have misclassified certain of our customers classes of
trade, which could affect the prices previously reported under the Medicaid drug rebate program
and/or prices on our VA FSS contract. We have been reviewing this issue and have identified
certain customer class of trade misclassifications. We are therefore undertaking a review and
recalculation of our Non-Federal Average Manufacturer Prices (Non-FAMPs) and related Federal
Ceiling Prices, Average Manufacturer Prices (AMPs), and Best Prices (BPs) for a period going
back at least (3) years to determine the impact, if any, that reclassification of customers to
appropriate classes of trade might have on these reported prices. In doing the recalculation, we
will generally review the methodologies for computing the reported prices, the classification of
products under the various programs, and any other potentially significant issues identified in the
course of the review. We also are conducting a review of our administration of obligations under
the Price Reductions Clause in our FSS contract with the VA. It is unclear whether any issue that
may be identified during this review may result in any changes to our Medicaid rebate liability for
prior quarters or to prices paid under the FSS, or any penalties, or
whether any such changes or penalties would have a material impact on our business, financial
condition, results of operations or cash flows.
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.
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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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non-acceptance by the FDA of our NDAs, ANDAs or BLAs. For example, on January 30,
2008, we received a letter from the FDA stating that, upon a preliminary review of our
BLA for the botulinum toxin type A, RELOXIN®, in aesthetics, the FDA has
determined not to accept the BLA for filing because it is not sufficiently complete to
permit a substantive review. While we are uncertain of the impact at this time, the
FDAs determination not to accept the BLA may result in delays in the FDAs substantive
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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.
Downturns in general economic conditions may adversely affect our financial condition, results of
operations and cash flows.
Our business, including our dermal restorative and branded prescription products, may be
adversely affected by downturns in general economic conditions. Economic conditions such as
employment levels, business conditions, interest rates, energy and fuel costs, consumer confidence
and tax rates could change consumer purchasing habits or reduce personal discretionary spending. A
reduction in consumer spending may have an adverse impact on our financial condition, results of
operations and cash flows.
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The current condition of the credit markets may not allow us to secure financing for potential
future activities on satisfactory terms, or at all.
Our existing cash and short-term investments are available for dividends, strategic
investments, acquisitions of companies or products complimentary to our business, the repayment of
outstanding indebtedness, repurchases of our outstanding securities and other potential large-scale
needs. While we believe existing cash and short-term investments, together with funds generated
from operations, should be sufficient to meet operating requirements for the foreseeable future, we
may also 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. As a result of recent subprime loan losses and write-downs, as
well as other economic trends in the credit market industry, we may not be able to secure
additional financing for future activities on satisfactory terms, or at all, which may adversely
affect our financial condition and results of operations.
Negative conditions in the credit markets may impair the liquidity of a portion of our short-term
and long-term investments.
Our short-term and long-term investments consist of corporate and various government agency
and municipal debt securities and auction rate floating securities. As of December 31, 2007, our
short-term investments included $101.7 million of auction rate floating securities. Our auction
rate floating securities are debt instruments with a long-term maturity and with an interest rate
that is reset in short intervals through auctions. The recent negative conditions in the credit
markets have prevented some investors from liquidating their holdings, including their holdings of
auction rate floating securities. During February 2008 we were informed that there was
insufficient demand at auction for approximately $43.6 million of our auction rate floating
securities. As a result, these affected auction rate floating securities are now not considered
liquid, and we could be required to hold them until they are redeemed by the holder at maturity.
The negative credit markets may affect our other auction rate floating securities as they cycle
through the auction process. We may not be able to make the securities liquid until a future
auction on these investments is successful. At this time, we have not obtained sufficient evidence
to conclude that the fair value of these auction rate floating securities is less than their carrying value or that they will not be
settled in the short-term, although the market for these investments is currently uncertain. All
of our auction rate auction rate floating securities held as of December 31, 2007 successfully
re-set at auction at the first auction interval subsequent to December 31, 2007, and we
subsequently liquidated approximately $56.8 million of our auction rate floating securities at par.
As of February 26, 2008, we had approximately $44.9 million of auction rate floating securities.
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 10 to our consolidated financial
statements, BioMarin will make license payments to us of $1.75 million per quarter for the two
quarters beginning in January 2008 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 2007,
2006, the Transition Period and fiscal 2005, we cannot give any assurances as to BioMarins
continuing ability to make these payments to us. Currently, our revenue recognition of these
payments is on a cash basis. In addition, while we expect BioMarin to make the final payment of $70.6 million
to us in 2009 for the purchase of all of the outstanding shares of Ascent Pediatrics, we cannot give any
assurances as to BioMarins ability to make this payment. Should BioMarin be unable or unwilling to make the required
payments, we may be required to record an impairment of the
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related Ascent goodwill. 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.
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.
We may acquire (whether by acquisition, license or otherwise) technologies, products and companies
in the future and these acquisitions could disrupt our business and harm our financial condition
and results of operations. 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
(whether by acquisition, license or otherwise) of technologies, products and companies that we
believe are complementary to our business. Acquisitions typically entail many risks and could
result in difficulties in integrating the operations, personnel, technologies, products and
companies acquired, and may result in significant charges to earnings. If we are unable to
successfully integrate our acquisitions with our existing business, or we otherwise make an
acquisition that does not result in the benefits that we anticipated, our business, results of
operations, financial condition and cash flows could be materially and adversely affected, which
would adversely affect 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, are also attempting 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.
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.
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Implementation of our new enterprise resource planning system could cause business interruptions
and negatively affect our profitability and cash flows.
During 2007, we began developing and implementing a new enterprise resource planning (ERP)
system to integrate and improve the financial and operational aspects of our business. A
significant portion our new ERP system began to be utilized on January 1, 2008. The design and
implementation of an ERP system, which will continue in 2008, involves risks such as cost overruns,
project delays and business interruption. A significant amount of our resources have been
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.
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 us, cause a reduction in the inventory levels
of distributors and retailers, result in reductions in purchases of our products or 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 all of our 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 to assist in covering the loss of income for
products where we do not have a secondary manufacturer, 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 LINESTM 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, which would materially and adversely affect our results of operations.
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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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timing, scheduling and prioritization of production by our contract manufacturers; |
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labor interruptions; |
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changes in our sources for manufacturing; |
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the timing and delivery of domestic and international shipments; |
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our failure to locate and obtain replacement manufacturers as needed on a timely
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conditions affecting the cost and availability of raw materials; and |
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hurricanes and other natural disasters. |
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
65-75% of our gross revenues are typically derived from two major drug wholesale concerns. While
we attempt to estimate inventory levels of our products at our major wholesale customers by using
written and oral information obtained from certain wholesalers, historical prescription information
and historical purchase patterns, this process is inherently imprecise. We rely wholly upon our
wholesale and drug chain customers to effect the distribution allocation of substantially all 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.
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
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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 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, we expect to expend additional financial resources in
these areas. 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.
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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 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.
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.
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.
RESTYLANE® and PERLANE® are consumer products and as such, are susceptible to
changes in popular trends and applicable laws, which could adversely affect sales or product
margins of RESTYLANE®and PERLANE®.
RESTYLANE® and PERLANE® are consumer products. 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® and PERLANE®. 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® and PERLANE® may be negatively
impacted by these reports and other reasons.
Demand for RESTYLANE® and PERLANE® 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® and PERLANE® 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, 2012 and 2017 or 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 or 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. If a significant portion of the
holders of the New Notes require us to repurchase their New Notes on June 4, 2008, we may not have
sufficient funds on June 4, 2008 or at the time of any such events to make the required
repurchases. If all of the New Notes are put back to us on June 4, 2008, we would be required to
pay $283.9 million
in outstanding principal, plus outstanding accrued interest. We would also be required to pay
an
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accumulated deferred tax liability related to the New Notes. The deferred tax liability related
to the New Notes as of December 31, 2007 was $30.6 million.
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. If sufficient funds are not available to repurchase
the Notes, we may be forced to incur other indebtedness or otherwise reallocate our financial
resources. Furthermore, the use of 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 and the deductibility of executive compensation), changes in our
manufacturing activities and changes in our future levels of research and development spending. In
addition, we are subject to the periodic 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 periodic 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
32
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.
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
33
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 $2.2 million in net revenues during 2007.
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 of
Part I of this report, Legal Proceedings and Note 15, Commitments and Contingencies, in the
notes to the consolidated financial statements listed under Item 15 of Part IV of this report,
Exhibits and Financial Statement Schedules, for information concerning our current litigation.
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.
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.
34
There are several dermal filler products under development and/or in the FDA pipeline for
approval, including products from Johnson & Johnson and Mentor, 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 2007 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. We intend to vacate
this office space during the second quarter of 2008 and move to a new facility (discussed below).
We intend to sublet this office space at lease rates equal to or greater than our existing lease
obligation.
During July 2006, we completed a lease agreement for new headquarter office space to
accommodate our expected long-term growth. The first phase of the lease is for approximately
150,000 square feet with the right to expand. We expect to occupy the new headquarter office
space, which is located approximately one mile from our current headquarter office space in
Scottsdale, Arizona, in the second quarter of 2008. The term of the lease is twelve years.
During October 2006, we executed a lease agreement for additional headquarter office space,
which is also located approximately one mile from our current headquarter office space in
Scottsdale, Arizona to accommodate our current needs and future growth. Under this agreement,
approximately 21,000 square feet of office space is being leased for a period of three years. In
May 2007, we began occupancy of the additional headquarter office space.
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, as
extended, that expires in June 2009.
Rent expense was approximately $2.5 million, $2.2 million, $1.2 million, $1.1 million and $2.3
million for 2007, 2006, the Transition Period, the comparable six-month period in 2004 and fiscal
2005, respectively.
Item 3. Legal Proceedings
On January 15, 2008, IMPAX Laboratories, Inc. filed a lawsuit against us in the United States
District Court for the Northern District of California seeking a declaratory judgment that our U.S.
Patent No. 5,908,838 related to SOLODYN® is invalid and is not infringed by IMPAXs
filing of an Abbreviated New Drug Application for a generic version of
SOLODYN®.
On April 25, 2007, we entered into a Settlement Agreement with the Justice Department, the
Office of Inspector General of the Department of Health and Human Services (OIG) and the TRICARE
Management Activity (collectively, the United States) and private complainants to settle all
outstanding federal and state civil suits against us in connection with claims related to our
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
(the Settlement Agreement). The settlement is neither an admission of liability by us nor a
concession by the United States that its claims are not well founded. Pursuant to the Settlement
Agreement, we agreed to pay approximately $10 million to settle the matter. Pursuant to the
Settlement Agreement, the United States released us from the claims asserted by the United States
and agreed to refrain from instituting action seeking exclusion from Medicare, Medicaid, the
TRICARE Program and other federal health care programs for the alleged conduct. These
releases relate solely to the allegations related to us and do not cover individuals. The
Settlement Agreement also
35
provides that the private complainants release us and our officers,
directors and employees from the asserted claims, and we release the United States and the private
complainants from asserted claims.
As part of the settlement, we have entered into a five-year Corporate Integrity Agreement (the
CIA) with the OIG to resolve any potential administrative claims the OIG may have arising out of
the governments investigation. The CIA acknowledges the existence of our comprehensive existing
compliance program and provides for certain other compliance-related activities during the term of
the CIA, including the maintenance of a compliance program that, among other things, is designed to
ensure compliance with the CIA, federal health care programs and FDA requirements. Pursuant to the
CIA, we are required to notify the OIG, in writing, of: (i) any ongoing government investigation or
legal proceeding involving an allegation that we have committed a crime or has engaged in
fraudulent activities; (ii) any other matter that a reasonable person would consider a probable
violation of applicable criminal, civil, or administrative laws; (iii) any written report,
correspondence, or communication to the FDA that materially discusses any unlawful or improper
promotion of our products; and (iv) any change in location, sale, closing, purchase, or
establishment of a new business unit or location related to items or services that may be
reimbursed by Federal health care programs. We are also subject to periodic reporting and
certification requirements attesting that the provisions of the CIA are being implemented and
followed, as well as certain document and record retention mandates. We have hired a Chief
Compliance Officer and created an enterprise-wide compliance function to administer our obligations
under the CIA. Failure to comply under the CIA could result in substantial civil or criminal
penalties and being excluded from government health care programs, which could materially reduce
our sales and adversely affect our financial condition and results of operations.
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 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. As a result of the investigation, prosecutions and
other proceedings, certain past and present sales and marketing
employees and officers are likely to separate from the Company and,
together with the cost of their defense, fines and penalties, could
have a material impact on our reputation, business and financial
condition.
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 the case until the
conclusion of a patent reexamination request submitted by Medicis.
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.
36
PART II
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
Our 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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DIVIDENDS |
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HIGH |
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LOW |
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DECLARED |
FISCAL YEAR ENDED DECEMBER 31, 2007 |
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First Quarter |
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$ |
39.94 |
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$ |
30.11 |
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$ |
0.03 |
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Second Quarter |
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34.35 |
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29.70 |
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0.03 |
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Third Quarter |
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31.48 |
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26.65 |
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0.03 |
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Fourth Quarter |
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32.18 |
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25.37 |
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0.03 |
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FISCAL YEAR ENDED DECEMBER 31, 2006 |
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First Quarter |
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$ |
34.40 |
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$ |
28.20 |
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$ |
0.03 |
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Second Quarter |
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34.90 |
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23.54 |
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0.03 |
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Third Quarter |
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32.46 |
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22.57 |
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0.03 |
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Fourth Quarter |
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40.31 |
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32.08 |
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0.03 |
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On February 22, 2008, the last reported sale price on the New York Stock Exchange for Medicis
Class A common stock was $19.44 per share. As of such date, there were approximately 192 holders
of record of Class A common stock.
Dividend Policy
We do not have a dividend policy. Since July 2003, we have paid quarterly cash dividends
aggregating approximately $28.5 million on our common stock. In addition, on December 12, 2007, we
declared a cash dividend of $0.03 per issued and outstanding share of common stock payable on
January 31, 2008 to our stockholders of record at the close of business on January 2, 2008. 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
We originally registered an indeterminate amount of plan interests to be offered and sold
under the Medicis Pharmaceutical Corporation 401(k) Plan (the Plan) on a Form S-8 registration
statement, but did not register any shares of our Class A common stock for purchase under the Plan.
On November 29, 2007, we filed a Form S-8 registration statement registering shares of our Class A
common stock that may be acquired under the Plan. During fiscal 2007 and prior to the filing of
such recent registration statement, approximately 89,911 shares were acquired under the Plan by the
Plan administrator through open market purchases at then prevailing market prices. While this may
be deemed to be an unregistered offering of securities, we believe that we have consistently
provided the
37
participants in the Plan with a prospectus and all of the information required by a prospectus as
if the shares had been registered.
Equity Compensation Plan Information
The following table provides information as of December 31, 2007, about compensation plans
under which shares of our common stock may be issued to employees, consultants or non-employee
directors of our board of directors upon exercise of options, warrants or rights under all of our
existing equity compensation plans. Our existing equity compensation plans include our 2006
Incentive Plan, our 2004, 1998, 1996, 1995 and 1992 Stock Option Plans, in which all of our
employees and non-employee directors are eligible to participate, and our 2002 Stock Option Plan,
in which our employees are eligible to participate but our non-employee directors and officers may
not participate. Restricted stock grants may only be made from our 2006 and 2004 Plans. No
further shares are available for issuance under the 2001 Senior Executive Restricted Stock Plan.
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Number of securities |
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remaining available for |
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Number of Securities |
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future issuance under |
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to be issued upon |
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Weighted-average exercise |
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equity compensation |
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exercise of |
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price of outstanding |
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plans (excluding |
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outstanding options, |
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options, warrants and |
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securities reflected in |
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warrants and rights |
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rights |
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column a) |
Plan Category |
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Date |
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(a) |
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(b) |
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(c) |
Plans approved by
stockholders
(1) |
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12/31/2007 |
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7,446,432 |
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$ |
27.30 |
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3,391,796 |
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Plans not approved
by stockholders
(2) |
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12/31/2007 |
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4,220,523 |
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$ |
29.21 |
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0 |
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Total |
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11,666,955 |
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$ |
27.99 |
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3,391,796 |
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(1) |
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Represents options outstanding and shares available for future issuance under the
2006 Incentive Plan. Also includes options outstanding under the 2004, 1998, 1996, 1995 and
1992 Stock Option Plans, which have been terminated as to future grants. |
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(2) |
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Represents the 2002 Stock Option Plan, which was implemented by our board in
November 2002. The 2002 Plan was terminated on May 23, 2006 as part of the stockholders
approval of the 2006 Incentive Plan, and no options can be granted from the 2002 Plan after
May 23, 2006. Options previously granted from this plan remain outstanding and continue to be
governed by the rules of the plan. The 2002 Plan was a non-stockholder approved plan under
which non-qualified incentive options have been granted to our employees and key consultants
who are neither our executive officers nor our directors at the time of grant. The board
authorized 6,000,000 shares of common stock for issuance under the 2002 Plan. The option
price of the options is the fair market value, defined as the closing quoted selling price of
the common stock on the date of the grant. No option granted under the 2002 Plan has a term
in excess of ten years, and each will be subject to earlier termination within a specified
period following the optionees cessation of service with us. As of December 31, 2007, the
weighted average term to expiration of these options is 5.7 years. Each granted option vests
in one or more installments over a period of five years. However, the options will vest on an
accelerated basis in the event we experience a change of control (as defined in the 2002
Plan). |
As of February 22, 2008,
there were 11,576,585 shares subject to issuance upon exercise of
outstanding options or awards under all of our equity compensation plans, at a weighted average
exercise price of $27.98, and with a weighted average remaining life of 4.5 years. In addition,
as of February 22, 2008, there were 542,169 unvested shares of restricted stock outstanding under
all of our equity compensation plans. As of February 22, 2008, there were 3,468,322 shares
available for future issuance under those plans.
38
Repurchases of Common Stock
On August 29, 2007, our Board of Directors approved a stock trading plan to purchase up to
$200.0 million in aggregate value of shares of our Class A common stock upon satisfaction of
certain conditions. The number of shares to be repurchased and the timing of the repurchases (if
any) will depend on factors such as the market price of our Class A common stock, economic and
market conditions, and corporate and regulatory requirements. The plan is scheduled to terminate
on the earlier of the first anniversary of the plan or at the time when the aggregate purchase
limit is reached. As of February 26, 2008, no shares had been repurchased under this plan.
Item 6. Selected Financial Data
The following table sets forth selected consolidated financial data for the year ended
December 31, 2007, 2006 and 2005, the Transition Period, and the corresponding six-month period in
2004. The data for the year ended December 31, 2007 and 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 |
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Year |
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Year |
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Six Months |
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Ended |
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Ended |
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Ended |
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Transition |
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Ended |
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Dec. 31, 2007 |
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Dec. 31, 2006 |
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Dec. 31, 2005 |
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Period |
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Dec. 31, 2004 |
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(unaudited) |
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(unaudited) |
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(in thousands, except per share amounts) |
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Statements of Operations Data: |
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|
|
|
|
|
|
|
Net product revenues |
|
$ |
449,125 |
|
|
$ |
333,625 |
|
|
$ |
313,684 |
|
|
$ |
155,569 |
|
|
$ |
146,999 |
|
Net contract revenues |
|
|
15,526 |
|
|
|
15,617 |
|
|
|
46,002 |
|
|
|
8,385 |
|
|
|
34,168 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
464,651 |
|
|
|
349,242 |
|
|
|
359,686 |
|
|
|
163,954 |
|
|
|
181,167 |
|
Gross profit (a) |
|
|
413,683 |
|
|
|
307,501 |
|
|
|
307,398 |
|
|
|
139,843 |
|
|
|
153,897 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
247,917 |
(b) |
|
|
206,822 |
(d) |
|
|
149,607 |
(f) |
|
|
80,189 |
(i) |
|
|
65,736 |
(k) |
Impairment of intangible assets |
|
|
4,067 |
|
|
|
52,586 |
|
|
|
9,171 |
|
|
|
9,171 |
|
|
|
|
|
Research and development |
|
|
39,428 |
(c) |
|
|
161,837 |
(e) |
|
|
42,903 |
(g) |
|
|
22,367 |
(j) |
|
|
45,140 |
(l) |
Depreciation and amortization |
|
|
24,548 |
|
|
|
23,048 |
|
|
|
24,548 |
|
|
|
12,420 |
|
|
|
10,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
315,960 |
|
|
|
444,293 |
|
|
|
226,229 |
|
|
|
124,147 |
|
|
|
121,098 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
97,723 |
|
|
|
(136,792 |
) |
|
|
81,169 |
|
|
|
15,696 |
|
|
|
32,799 |
|
Other: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
|
|
|
|
|
|
|
|
59,801 |
(h) |
|
|
59,801 |
(h) |
|
|
|
|
Interest and investment income
(expense), net |
|
|
28,372 |
|
|
|
20,147 |
|
|
|
5,804 |
|
|
|
4,726 |
|
|
|
(248 |
) |
Income tax (expense) benefit |
|
|
(51,044 |
) |
|
|
40,796 |
|
|
|
(53,288 |
) |
|
|
(30,502 |
) |
|
|
(11,328 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
75,051 |
|
|
$ |
(75,849 |
) |
|
$ |
93,486 |
|
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share |
|
$ |
1.34 |
|
|
$ |
(1.39 |
) |
|
$ |
1.72 |
|
|
$ |
0.92 |
|
|
$ |
0.38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per share |
|
$ |
1.14 |
|
|
$ |
(1.39 |
) |
|
$ |
1.44 |
(m) |
|
$ |
0.76 |
|
|
$ |
0.34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share |
|
$ |
0.12 |
|
|
$ |
0.12 |
|
|
$ |
0.12 |
|
|
$ |
0.06 |
|
|
$ |
0.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic common shares outstanding |
|
|
55,988 |
|
|
|
54,688 |
|
|
|
54,290 |
|
|
|
54,323 |
|
|
|
55,972 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted common shares outstanding |
|
|
71,246 |
|
|
|
54,688 |
|
|
|
69,558 |
(m) |
|
|
69,772 |
|
|
|
72,160 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Amounts exclude $21.6 million, $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,
2007, 2006 and 2005, the Transition Period, and the six months ended December 31, 2004,
respectively. |
39
|
|
|
(b) |
|
Includes approximately $21.0 million of compensation expense related to stock options and
restricted stock, $2.2 million of professional fees related to a strategic collaboration with
Hyperion Therapeutics, Inc. and $1.3 million of professional fees related to a strategic
collaboration agreement with Revance. |
|
(c) |
|
Includes approximately $8.0 million related to our option to acquire Revance or to license
Revances product currently under development and approximately $0.1 million of compensation
expense related to stock options and restricted stock. |
|
(d) |
|
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. |
|
(e) |
|
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. |
|
(f) |
|
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. |
|
(g) |
|
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. |
|
(h) |
|
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. |
|
(i) |
|
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. |
|
(j) |
|
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. |
|
(k) |
|
Includes approximately $1.3 million of professional fees related to research and development
collaborations with Ansata and Q-Med. |
|
(l) |
|
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. |
|
(m) |
|
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. |
40
The cash flow data for the year ended December 31, 2005 and the six months ended December 31,
2004, is unaudited.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2007 |
|
2006 |
|
2005 |
|
|
(in thousands) |
Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term
investments |
|
$ |
794,680 |
|
|
$ |
554,261 |
(a) |
|
$ |
742,532 |
|
Working capital |
|
|
460,079 |
|
|
|
356,874 |
|
|
|
692,453 |
|
Long-term investments |
|
|
17,072 |
|
|
|
130,290 |
|
|
|
|
|
Total assets |
|
|
1,194,629 |
|
|
|
1,070,232 |
|
|
|
1,145,954 |
|
Current portion of long-term debt |
|
|
283,910 |
|
|
|
169,155 |
|
|
|
|
|
Long-term debt |
|
|
169,145 |
|
|
|
283,910 |
|
|
|
453,065 |
|
Stockholders equity |
|
|
621,955 |
|
|
|
509,559 |
|
|
|
543,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
Year Ended |
|
Transition |
|
Ended |
|
|
Dec. 31, 2007 |
|
Dec. 31, 2006 |
|
Dec. 31, 2005 |
|
Period |
|
Dec. 31, 2004 |
|
|
|
|
|
|
|
|
|
|
(unaudited) |
|
|
|
|
|
(unaudited) |
|
|
(in thousands) |
Cash Flow Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in)
operating activities |
|
$ |
158,944 |
(b) |
|
$ |
(40,963 |
)(c) |
|
$ |
232,506 |
(d) |
|
$ |
147,990 |
(d) |
|
$ |
45,465 |
|
Net cash (used in) provided by
investing activities |
|
|
(269,486 |
)(e) |
|
|
(216,915 |
) |
|
|
187,994 |
|
|
|
123,665 |
|
|
|
76,158 |
|
Net cash provided by (used
in) by financing activities |
|
|
14,470 |
|
|
|
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 provided by operating activities for the year ended December 31, 2007 included
$8.0 million of the $20.0 million payment to Revance, representing the residual value of the
option to acquire Revance or to license Revances product currently under development, and is included in
research and development expense. |
|
(c) |
|
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®. |
|
(d) |
|
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. |
|
(e) |
|
Net cash used in investing activities for the year ended December 31, 2007 includes a
$12.0 million investment in Revance, representing the fair value of the investment in
Revance at the time of the investment. |
41
The following selected consolidated financial data for the three-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 |
|
|
|
(in thousands, except per share amounts) |
|
Statements
of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues |
|
$ |
305,114 |
|
|
$ |
291,607 |
|
|
$ |
241,909 |
|
Net contract revenues |
|
|
71,785 |
|
|
|
12,115 |
|
|
|
5,630 |
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
376,899 |
|
|
|
303,722 |
|
|
|
247,539 |
|
Gross profit (a) |
|
|
321,452 |
|
|
|
257,116 |
|
|
|
209,279 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
135,154 |
(b) |
|
|
118,253 |
|
|
|
91,648 |
|
Research and development |
|
|
65,676 |
(c) |
|
|
16,494 |
(d) |
|
|
29,568 |
(e) |
Depreciation and amortization |
|
|
22,350 |
|
|
|
16,794 |
|
|
|
10,125 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
223,180 |
|
|
|
151,541 |
|
|
|
131,341 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
98,272 |
|
|
|
105,575 |
|
|
|
77,938 |
|
Other: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and investment income (expense), net |
|
|
830 |
|
|
|
(758 |
) |
|
|
(278 |
) |
Loss on early extinguishment of debt |
|
|
|
|
|
|
(58,660 |
) |
|
|
|
|
Income tax expense |
|
|
(34,112 |
) |
|
|
(15,317 |
) |
|
|
(26,404 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
64,990 |
|
|
$ |
30,840 |
|
|
$ |
51,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share |
|
$ |
1.18 |
|
|
$ |
0.55 |
|
|
$ |
0.94 |
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share |
|
$ |
1.01 |
|
|
$ |
0.52 |
|
|
$ |
0.84 |
|
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share |
|
$ |
0.12 |
|
|
$ |
0.10 |
|
|
$ |
0.025 |
|
|
|
|
|
|
|
|
|
|
|
Basic common shares outstanding |
|
|
55,196 |
|
|
|
55,618 |
|
|
|
54,376 |
|
|
|
|
|
|
|
|
|
|
|
Diluted common shares outstanding |
|
|
70,909 |
|
|
|
72,481 |
|
|
|
70,191 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Amounts exclude $19.6 million, $14.9 million and $9.2 million for amortization expense
related to acquired intangible assets in fiscal 2005, 2004 and 2003, 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. |
42
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
2005 |
|
2004 |
|
2003 |
|
|
(in thousands) |
Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, restricted cash
and short-term investments |
|
$ |
603,568 |
|
|
$ |
634,040 |
|
|
$ |
552,663 |
|
Working capital |
|
|
600,070 |
|
|
|
666,743 |
|
|
|
576,781 |
|
Total assets |
|
|
1,043,251 |
|
|
|
1,078,384 |
|
|
|
932,841 |
|
Long-term debt |
|
|
453,065 |
|
|
|
453,067 |
|
|
|
400,000 |
|
Stockholders equity |
|
|
486,346 |
|
|
|
555,303 |
|
|
|
461,121 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended June 30, |
|
|
2005 |
|
2004 |
|
2003 |
|
|
(in thousands) |
Cash Flow Data: |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
$ |
129,981 |
|
|
$ |
127,964 |
|
|
$ |
84,667 |
|
Net cash provided by (used in) investing
activities |
|
|
140,487 |
|
|
|
(166,341 |
) |
|
|
(113,709 |
) |
Net cash (used in) provided by financing
activities |
|
|
(139,793 |
) |
|
|
40,621 |
|
|
|
(23,343 |
) |
43
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 years January 1, 2007 to December 31, 2007, and January
1, 2006 to December 31, 2006, which we refer to as 2007 and 2006, respectively. 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.
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 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).
Our current product lines 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. Our acne and
acne-related dermatological product lines include DYNACIN®, PLEXION®,
SOLODYN®, TRIAZ® and ZIANA®. Our non-acne dermatological product
lines include LOPROX®, OMNICEF®, PERLANE®, RESTYLANE®
and VANOS®. Our non-dermatological product lines include AMMONUL® and
BUPHENYL®. Our non-dermatological field also includes contract revenues associated with
licensing agreements and authorized generic agreements.
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.
Key Aspects of Our Business
We derive a majority of our revenue from our primary products: PERLANE®,
RESTYLANE®, SOLODYN®, TRIAZ®, VANOS® and
ZIANA®. We believe that sales of our primary products will constitute a significant
portion of our sales for the foreseeable future.
44
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 high integrity relationships of trust and confidence with the foremost
dermatologists and podiatrists and the leading plastic surgeons in the United States. We rely on
third parties to manufacture our products.
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 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.
We sell our products primarily to major wholesalers and retail pharmacy chains. Approximately
65%-75% of our gross revenues are typically derived from two major drug wholesale concerns.
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. While we attempt
to estimate inventory levels of our products at our major wholesale customers by using written and
oral information obtained from certain wholesalers, historical prescription information and
historical purchase patterns, this process is inherently imprecise. 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.
45
As described in more detail below, the following significant events and transactions occurred
during 2007, and affected our results of operations, our cash flows and our financial condition:
|
- |
|
FDA approval of PERLANE®; |
|
|
- |
|
Write-down of intangible asset related to OMNICEF® due to impairment; |
|
|
- |
|
Strategic collaboration with Hyperion; and |
|
|
- |
|
Strategic collaboration with Revance. |
FDA approval of PERLANE®
On May 2, 2007, the FDA approved PERLANE® for implantation into the deep dermis to
superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as
nasolabial folds. In accordance with our agreements with Q-Med, we paid $29.1 million to Q-Med
during the three months ended June 30, 2007 as a result of this milestone. The $29.1 million
payment is included in intangible assets in our consolidated balance sheets as of December 31,
2007. The first commercial sales of PERLANE® occurred during May 2007.
Write-down of intangible asset related to OMNICEF® due to impairment
During the quarter ended June 30, 2007, an intangible asset related to OMNICEF® was
determined to be impaired based on our analysis of the intangible assets carrying value and
projected future cash flows. As a result of the impairment analysis, we recorded a write-down of
approximately $4.1 million related to this intangible asset. Factors affecting the future cash
flows of the OMNICEF® intangible asset included an early termination letter received
during May 2007 from Abbott, which, in accordance with our agreement with Abbott, transitions our
co-promotion agreement into a two-year residual period, and competitive pressures in the
marketplace, including generic competition. In addition, as a result of the impairment analysis,
the remaining amortizable life of the intangible asset related to OMNICEF® was reduced
to two years. The intangible asset related to OMNICEF® will become fully amortized by
June 30, 2009. The net impact on amortization expense as a result of the write-down of the
carrying value of the intangible asset and the reduction of its amortizable life is a decrease in
quarterly amortization expense of approximately $126,000.
Strategic Collaboration with Hyperion
On August 28, 2007, we, through our wholly-owned subsidiary Ucyclyd Pharma, Inc. (Ucyclyd),
announced a strategic collaboration with Hyperion Therapeutics, Inc. (Hyperion) whereby Hyperion
will be responsible for the ongoing research and development of a compound referred to as GT4P for
the treatment of Urea Cycle Disorder, Hepatic Encephalopathies and other indications, and
additional indications for AMMONUL®. Under terms of the Collaboration Agreement between
Ucyclyd and Hyperion, dated as of August 23, 2007, Hyperion made an initial non-refundable payment
of $10.0 million to Ucyclyd for the rights and licenses granted to Hyperion in the agreement. In
accordance with EITF No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables,
and SAB 104, Revenue Recognition in Financial Statements, this $10.0 million payment was recorded
as deferred revenue and is being recognized on a straight-line basis over a period of four years.
In addition, if certain specified conditions are satisfied relating to the Ucyclyd development
projects, then Hyperion will have certain purchase rights with respect to the Ucyclyd development
products as well as Ucyclyds existing on-market products, AMMONUL® and
BUPHENYL®, and will pay Ucyclyd royalties and regulatory and sales milestone payments in
connection with certain licenses that would be granted to Hyperion upon exercise of the purchase
rights.
Additionally, Hyperion will be funding all research and development costs for the Ucyclyd
research projects, and will undertake certain sales and marketing efforts for Ucyclyds existing
on-market products. Hyperion will receive a commission from Ucyclyd equal to a certain percentage
of any increase in unit sales. Ucyclyd will continue to record product sales for the existing
on-market Ucyclyd products until such time as Hyperion exercises its purchase rights.
46
Professional fees of approximately $2.2 million were incurred related to the completion of the
agreement with Hyperion. These costs were recognized as general and administrative expenses during
the three months ended September 30, 2007.
Strategic Collaboration with Revance
On December 11, 2007, we announced a strategic collaboration with Revance Therapeutics, Inc.
(Revance), a privately-held, venture-backed development-stage company, whereby we made an equity
investment in Revance and purchased an option to acquire Revance or to license exclusively in North
America Revances novel topical botulinum toxin type A product currently under clinical
development. The consideration to be paid to Revance upon our exercise of the option will be at an
amount that will approximate the then fair value of Revance or the license of the product under
development, as determined by an independent appraisal. The option period will extend through the
end of Phase 2 testing in the United States. In consideration for our $20.0 million payment, we
received preferred stock representing an approximate 13.7 percent ownership in Revance, or
approximately 11.7 percent on a fully diluted basis and the
option to acquire Revance or to license the product under development. The $20.0 million is expected to be used by
Revance primarily for the development of the new product. $12.0 million of the $20.0 million
payment represents the fair value of the investment in Revance at the time of the investment and
is included in other long-term assets in our consolidated balance sheets as of December 31,
2007. The remaining $8.0 million, which is non-refundable and is expected to be utilized in the development of
the new product, represents the residual value of the option to acquire Revance or to license the product under development and is included in
research and development expense for the three months ended
December 31, 2007.
Additionally, we have committed to make further equity investments in Revance of up to $5.0
million under certain terms and prior to the exercise of the option to acquire Revance or to
license exclusively Revances topical botulinum toxin type A product in North America.
Prior to the exercise of the option, Revance will remain primarily responsible for the
worldwide development of Revances topical botulinum toxin type A product in consultation with us
in North America. We will assume primary responsibility for the development of the product should
consummation of either a merger or a license for topically delivered botulinum toxin type A in
North America be completed under the terms of the option. Revance will have sole responsibility
for manufacturing the development product and manufacturing the product during commercialization
worldwide. Our right to exercise the option is triggered upon Revances successful completion of
certain regulatory milestones through the end of Phase 2 testing in the United States. A license
would contain a payment upon exercise of the license option, milestone payments related to
clinical, regulatory and commercial achievements, and royalties based on sales defined in the
license. If we elect to exercise the option, the financial terms for the acquisition or license
will be determined through an independent valuation in accordance with specified methodologies.
Professional fees of approximately $1.3 million were incurred related to the completion of the
agreement with Revance. These costs were recognized as general and administrative expenses during
the three months ended December 31, 2007.
On a going-forward basis,
in the absence of quantitative valuation metrics, such as a recent financing round, we will estimate the impairment and/or
the net realizable value of the investment, based on a hypothetical liquidation at book value approach as of the reporting date.
The amount that will be expensed periodically is uncertain due to the timing of expenditures for research and development,
and the charges will not be immediately, if ever, deductible for income tax purposes and will increase our effective tax
rate. Further equity investments, if any, will also be subject to the same accounting treatment as
our original equity investment.
47
Results of Operations
The following table sets forth certain data as a percentage of net revenues for the periods
indicated.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
Year |
|
|
Year |
|
|
Year |
|
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
|
Dec. 31, |
|
|
Dec. 31, |
|
|
Dec. 31, |
|
|
|
2007(a) |
|
|
2006(b) |
|
|
2005(c) |
|
|
|
|
Net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
Gross profit (d) |
|
|
89.0 |
|
|
|
88.0 |
|
|
|
85.5 |
|
Operating expenses |
|
|
68.0 |
|
|
|
127.2 |
|
|
|
62.9 |
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
21.0 |
|
|
|
(39.2 |
) |
|
|
22.6 |
|
Other income, net |
|
|
|
|
|
|
|
|
|
|
16.6 |
|
Interest and investment income (expense), net |
|
|
6.1 |
|
|
|
5.8 |
|
|
|
1.6 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income tax (expense)
benefit |
|
|
27.1 |
|
|
|
(33.4 |
) |
|
|
40.8 |
|
Income tax (expense) benefit |
|
|
(10.9 |
) |
|
|
11.7 |
|
|
|
(14.8 |
) |
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
|
16.2 |
% |
|
|
(21.7 |
)% |
|
|
26.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Included in operating expense is $21.1 million (4.6% of net revenues) of share-based
compensation expense, $9.3 million (2.0% of net revenues) related to our option to acquire
Revance or to license Revances product currently under development (including $1.3 million of
professional fees incurred related to the agreement), $4.1 million (0.9% of net revenues) for
the write-down of an intangible asset related to OMNICEF® and $2.2 million (0.5% of
net revenues) of professional fees related to a strategic collaboration with Hyperion. |
|
(b) |
|
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 intangible 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. |
|
(c) |
|
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 an
intangible 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. |
|
(d) |
|
Gross profit does not include amortization of the related intangibles as such expense is
included in operating expenses. |
48
Year Ended December 31, 2007 Compared to the Year Ended December 31, 2006
Net Revenues
The following table sets forth the net revenues for the year ended December 31, 2007 and the
year ended December 31, 2006, along with the percentage of net revenues and percentage point change
for each of our product categories (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
$ Change |
|
|
% Change |
|
Net product revenues |
|
$ |
449.2 |
|
|
$ |
333.6 |
|
|
$ |
115.6 |
|
|
|
34.6 |
% |
Net contract revenues |
|
|
15.5 |
|
|
|
15.6 |
|
|
|
(0.1 |
) |
|
|
(0.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
464.7 |
|
|
$ |
349.2 |
|
|
$ |
115.5 |
|
|
|
33.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
|
$ Change |
|
|
% Change |
|
Acne and acne-related
dermatological products |
|
$ |
246.4 |
|
|
$ |
158.2 |
|
|
$ |
88.2 |
|
|
|
55.7 |
% |
Non-acne dermatological
products |
|
|
178.6 |
|
|
|
158.0 |
|
|
|
20.6 |
|
|
|
13.0 |
% |
Non-dermatological products
(including contract revenues) |
|
|
39.7 |
|
|
|
33.0 |
|
|
|
6.7 |
|
|
|
20.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
464.7 |
|
|
$ |
349.2 |
|
|
$ |
115.5 |
|
|
|
33.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Percentage |
|
|
|
|
|
|
|
|
|
|
|
Point |
|
|
|
2007 |
|
|
2006 |
|
|
Change |
|
Acne and acne-related
dermatological products |
|
|
53.0 |
% |
|
|
45.3 |
% |
|
|
7.7 |
|
Non-acne dermatological
products |
|
|
38.5 |
% |
|
|
45.2 |
% |
|
|
(6.7 |
) |
Non-dermatological products
(including contract revenues) |
|
|
8.5 |
% |
|
|
9.5 |
% |
|
|
(1.0 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our total net revenues increased during 2007 primarily as a result of an increase in sales of
SOLODYN®, which was approved by the FDA during the second quarter of 2006,
ZIANA®, which was approved by the FDA during the fourth quarter of 2006, and
PERLANE®, which was approved by the FDA during the second quarter of 2007. Net revenues
associated with our acne and acne-related dermatological products increased by $88.2 million, or
55.7%, and by 7.7 percentage points as a percentage of net revenues during 2007 as compared to 2006
as a result of the increased sales of SOLODYN® and ZIANA®. Net revenues
associated with our non-acne dermatological products decreased as a percentage of net revenues by
6.7 percentage points, but increased in net dollars by $20.6 million, or 13.0% during 2007. Net
revenues associated with our non-dermatological products decreased as a percentage of net revenues,
but increased in net dollars by $6.7 million, or 20.2% during 2007 as compared to 2006.
49
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
intangible assets for 2007 and 2006 was approximately $21.6 million and $20.0 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 sales 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 2007 and 2006, along with the percentage
of net revenues represented by such gross profit (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Gross profit |
|
$ |
413.7 |
|
|
$ |
307.5 |
|
|
$ |
106.2 |
|
|
|
34.5 |
% |
% of net revenues |
|
|
89.0 |
% |
|
|
88.0 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit during 2007, compared to 2006, was due to the increase in our net
revenues and 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 2007 as compared to 2006. The launch of
SOLODYN®, a higher margin product, during the second quarter of 2006, was the primary
change in the mix of products sold during the comparable periods that affected gross profit as a
percentage of net revenues. The impact of the mix of higher margin products being sold during 2007
as compared to 2006 was partially offset by the write-off of $6.1 million of certain inventories
that, during the third quarter of 2007, were determined to be unsalable, and a $2.5 million
increase in our inventory valuation reserve recorded during 2007, as compared to a $0.1 million
increase in our inventory valuation reserve during 2006. The change in the inventory valuation
reserve was due to an increase in inventory during 2007 projected to not be sold by expiry dates.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for 2007 and
2006, along with the percentage of net revenues represented by selling, general and administrative
expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Selling, general and administrative |
|
$ |
247.9 |
|
|
$ |
206.8 |
|
|
$ |
41.1 |
|
|
|
19.9 |
% |
% of net revenues |
|
|
53.4 |
% |
|
|
59.2 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense
included in selling, general and
administrative |
|
$ |
21.0 |
|
|
$ |
24.5 |
|
|
$ |
(3.5 |
) |
|
|
(14.0 |
)% |
The increase in selling, general and administrative expenses during 2007 from 2006 was
attributable to approximately $16.3 million of increased personnel costs, primarily related to an
increase in the number of employees (increasing from 407 as of December 31, 2006 to 472 as of
December 31, 2007) and the effect of the annual salary increase that occurred during February 2007,
$11.5 million of increased promotion expense, primarily related to the promotion of
RESTYLANE® and our new products SOLODYN®, ZIANA® and
PERLANE®, $14.7 million of increased professional and consulting expenses, including
$2.2 million and $1.3 million of professional fees related to our strategic collaboration with
Hyperion and equity investment in Revance, respectively, and costs related to our new enterprise
resource planning (ERP) system, and $11.6 million of other additional selling, general and
administrative expenses incurred during 2007. These increases were partially offset by certain
costs incurred during 2006 that were not incurred during 2007, including $10.2 million related to a
loss contingency for a legal matter related to our marketing of LOPROX® to
pediatricians, $1.8 million related to a settlement of a dispute related to our merger with Ascent
and approximately $1.0 million of professional and other expenses related to our development and
distribution agreement with Ipsen for the development of RELOXIN®. We expect to incur
increased legal and other professional fees during 2008 as a result of patent litigation related to
our SOLODYN® product.
50
Impairment of Intangible Assets
During the second quarter of 2007, an intangible asset related to OMNICEF® was
determined to be impaired based on our analysis of the intangible assets carrying value and
projected future cash flows. As a result of the impairment analysis, we recorded a write-down of
approximately $4.1 million related to this intangible asset.
Factors affecting the future cash flows of the OMNICEF® intangible asset included
an early termination letter received during May 2007 from Abbott, which transitions our
co-promotion agreement with Abbott into a two-year residual period, and competitive pressures in
the marketplace, including generic competition.
During the third quarter of 2006, intangible assets related to certain of our products were
determined to be impaired based on our analysis of the intangible 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 intangible assets. This write-down included the
following (in thousands):
|
|
|
|
|
Intangible asset related to LOPROX® products |
|
$ |
49,163 |
|
Intangible asset related to ESOTERICA® products |
|
|
3,267 |
|
Other intangible asset |
|
|
156 |
|
|
|
|
|
|
|
$ |
52,586 |
|
|
|
|
|
Factors affecting the future cash flows of the LOPROX® intangible 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® intangible 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.
Research and Development Expenses
The following table sets forth our research and development expenses for 2007 and 2006 (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Research and development |
|
$ |
39.4 |
|
|
$ |
161.8 |
|
|
$ |
(122.4 |
) |
|
|
(75.6 |
)% |
Charges included in research
and development |
|
$ |
8.0 |
|
|
$ |
125.2 |
|
|
$ |
(117.2 |
) |
|
|
(93.6 |
)% |
Share-based compensation
expense included in
research and development |
|
$ |
0.1 |
|
|
$ |
1.6 |
|
|
$ |
(1.5 |
) |
|
|
(93.1 |
)% |
Included in research and development expense for 2007 was $8.0 million related to our option
to acquire Revance or to license Revances product currently under development and $0.1 million of
share-based compensation, which included a reversal of previously recognized share-based
compensation expense of approximately $0.3 million due to the cancellation of share-based awards
during the third quarter of 2007. Included in research and development expense 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. The
primary product under development during 2007 and 2006 was RELOXIN®. 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.
51
Depreciation and Amortization Expenses
Depreciation and amortization expenses during 2007 increased $1.5 million, or 6.5%, to $24.5
million from $23.0 million during 2006. This increase included amortization related to a $29.1
million milestone payment made to Q-Med related to the FDA approval of PERLANE®
capitalized during the second quarter of 2007. This increase in amortization was partially offset
by a decrease in amortization due to the write-down of intangible assets due to impairment during
the third quarter of 2006. The remaining amortizable lives of these intangible assets were also
shortened. These intangible assets had an aggregate cost basis of approximately $76.6 million and
were being amortized at a rate of approximately $0.4 million per quarter. These intangible assets
were written-down to an aggregate new cost basis of approximately $3.6 million, and are being
amortized at an aggregate rate of approximately $0.1 million per quarter.
Interest and Investment Income
Interest and investment income during 2007 increased $7.6 million, or 24.7%, to $38.4 million
from $30.8 million during 2006, due to an increase in the funds available for investment and an
increase in the interest rates achieved by our invested funds during 2007.
Interest Expense
Interest expense during 2007 decreased $0.6 million, to $10.0 million in 2007 from $10.6
million in 2006. Our interest expense in 2007 and 2006 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. The decrease in interest expense during 2007 as compared to 2006 was due to
the fees and origination costs related to the issuance of the Old Notes becoming fully amortized
during the second quarter of 2007. See Liquidity and Capital Resources 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 2007 and 2006 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
2006 |
|
$ Change |
|
% Change |
Income tax (benefit) expense |
|
$ |
51.0 |
|
|
$ |
(40.8 |
) |
|
$ |
91.8 |
|
|
|
225.1 |
% |
Effective tax rate |
|
|
40.5 |
% |
|
|
(35.0 |
)% |
|
|
|
|
|
|
|
|
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 tax expense during 2007 was $51.0 million compared to an income tax benefit during 2006
of $40.8 million. The income tax benefit recorded in 2006 is primarily due to our pre-tax loss
recognized during 2006. The effective tax rate for 2007 of 40.5%
includes a $3.3 million tax charge
recorded during the fourth quarter of 2007 relating to a valuation allowance recorded against the
deferred tax asset associated with the expensing of the option to acquire Revance or license
Revances product that is under development. The expense is currently an
52
unrealized loss for tax
purposes. The Company will not be able to determine the character of the loss until the
Company exercises or fails to exercise its option. A realized loss characterized as a capital
loss can only be utilized to offset capital gains. The Company recorded a valuation allowance to
the deferred tax asset associated with this unrealized tax loss to reduce the carrying values to
$0, or the amount that management believes is more likely than not to be realized. The effective
tax rate for 2007 absent this $3.2 million charge is 38%.
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 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2006 |
|
|
2005 |
|
|
$ Change |
|
|
% Change |
|
Acne and acne-related
dermatological products |
|
$ |
158.2 |
|
|
$ |
97.8 |
|
|
$ |
60.4 |
|
|
|
61.8 |
% |
Non-acne dermatological
products |
|
|
158.0 |
|
|
|
193.6 |
|
|
|
(35.6 |
) |
|
|
(18.4 |
)% |
Non-dermatological products
(including contract revenues) |
|
|
33.0 |
|
|
|
68.3 |
|
|
|
(35.3 |
) |
|
|
(51.6 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total 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.
53
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.
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 Item 3, Legal Proceedings of this Form 10-K),
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 Intangible Assets
During the third quarter of 2006, intangible assets related to certain of our products were
determined to be impaired based on our analysis of the intangible 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 intangible 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 |
|
|
|
|
|
54
Factors affecting the future cash flows of the LOPROX® intangible 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® intangible 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.
During the fourth quarter of 2005, an intangible asset related to our DYNACIN®
capsule products was determined to be impaired based on our analysis of the intangible assets
carrying value and projected future cash flows. Factors affecting the intangible 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 intangible 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
ZIANA®, $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.
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 Liquidity
and Capital Resources for further discussion on the Old Notes and New Notes.
55
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)%.
56
Liquidity and Capital Resources
Overview
The following table highlights selected cash flow components for the year ended December 31,
2007 and 2006, and selected balance sheet components as of December 31, 2007 and 2006 (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
2006 |
|
$ Change |
|
%
Change |
Cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
158.9 |
|
|
$ |
(41.0 |
) |
|
$ |
199.9 |
|
|
|
488.0 |
% |
Investing activities |
|
|
(269.5 |
) |
|
|
(216.9 |
) |
|
|
(52.6 |
) |
|
|
(24.2 |
)% |
Financing activities |
|
|
14.5 |
|
|
|
14.3 |
|
|
|
0.2 |
|
|
|
1.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dec. 31, 2007 |
|
Dec. 31, 2006 |
|
$ Change |
|
% Change |
Cash, cash equivalents and
short-term investments |
|
$ |
794.7 |
|
|
$ |
554.3 |
|
|
$ |
240.4 |
|
|
|
43.4 |
% |
Working capital |
|
|
460.1 |
|
|
|
356.9 |
|
|
|
103.2 |
|
|
|
28.9 |
% |
Long-term investments |
|
|
17.1 |
|
|
|
130.3 |
|
|
|
(113.2 |
) |
|
|
(86.9 |
)% |
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, 2007 and 2006 consisted of the following (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dec. 31, 2007 |
|
|
Dec. 31, 2006 |
|
|
$ Change |
|
|
% Change |
|
Cash, cash equivalents and
short-term investments |
|
$ |
794.7 |
|
|
$ |
554.3 |
|
|
$ |
240.4 |
|
|
|
43.4. |
% |
Accounts receivable, net |
|
|
12.4 |
|
|
|
36.4 |
|
|
|
(24.0 |
) |
|
|
(66.0 |
)% |
Inventories, net |
|
|
30.0 |
|
|
|
27.0 |
|
|
|
3.0 |
|
|
|
10.1 |
% |
Other current assets |
|
|
18.0 |
|
|
|
15.9 |
|
|
|
2.1 |
|
|
|
12.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
855.1 |
|
|
|
633.6 |
|
|
|
221.5 |
|
|
|
35.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable |
|
|
34.9 |
|
|
|
47.5 |
|
|
|
(12.6 |
) |
|
|
(26.6 |
)% |
Current portion of long-term debt |
|
|
283.9 |
|
|
|
169.2 |
|
|
|
114.7 |
|
|
|
67.8 |
% |
Income taxes payable |
|
|
7.7 |
|
|
|
11.3 |
|
|
|
(3.6 |
) |
|
|
(31.8 |
)% |
Deferred tax liabilities, net |
|
|
11.7 |
|
|
|
0.9 |
|
|
|
10.8 |
|
|
|
1,134.2 |
% |
Other current liabilities |
|
|
56.8 |
|
|
|
47.8 |
|
|
|
9.0 |
|
|
|
18.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
395.0 |
|
|
|
276.7 |
|
|
|
118.3 |
|
|
|
42.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital |
|
$ |
460.1 |
|
|
$ |
356.9 |
|
|
$ |
103.2 |
|
|
|
28.9 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We had cash, cash equivalents and short-term investments of $794.7 million and working capital
of $460.1 million at December 31, 2007, as compared to $554.3 million and $356.9 million,
respectively, at December 31, 2006. The increases were primarily due to the generation of $158.9
million of operating cash flow, $19.7 million of cash received from employees exercise of stock
options and a net transfer of $113.2 million of our long-term investments into short-term
investments, partially offset by the payment of $29.1 million to Q-Med upon the FDAs approval of
PERLANE®, the payment of $20.0 million to Revance and $9.5 million of costs incurred
related to our new ERP system during 2007.
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 investments are available for dividends, strategic investments,
acquisitions of companies or products complimentary to our business, the repayment of outstanding
indebtedness, repurchases of our outstanding securities and other
57
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.
As of December 31, 2007, our short-term investments included $101.7 million of auction rate
floating securities. Our auction rate floating securities are debt instruments with a long-term
maturity and with an interest rate that is reset in short intervals through auctions. The recent
negative conditions in the credit markets have prevented some investors from liquidating their
holdings, including their holdings of auction rate floating securities. During February 2008 we
were informed that there was insufficient demand at auction for approximately $43.6 million of our
auction rate floating securities. As a result, these affected auction rate floating securities are
now not considered liquid, and we could be required to hold them until they are redeemed by the
holder at maturity. The negative credit markets may affect our other auction rate floating
securities as they cycle through the auction process. We may not be able to make the securities
liquid until a future auction on these investments is successful. At this time, we have not
obtained sufficient evidence to conclude that the fair value of these auction rate floating securities is less than their carrying value or that they will not be settled in the short-term, although the market for these investments is
currently uncertain. All of our auction rate floating securities held as of December 31, 2007
successfully re-set at the first auction interval subsequent to December 31, 2007, and we
subsequently liquidated approximately $56.8 million of our auction rate floating securities at par.
As of February 26, 2008, we had approximately $44.9 million of auction rate floating securities.
During July 2006, we executed a lease agreement for new headquarter office space to
accommodate our expected long-term growth. The first phase of this lease is for approximately
150,000 square feet with the right to expand. We expect to occupy the new headquarter office
space, which is located approximately one mile from our current headquarter office space in
Scottsdale, Arizona, in the second quarter of 2008. There is no financial obligation for lease
payments until 2009.
During October 2006, we executed a lease agreement for additional headquarter office space,
which is also located approximately one mile from our current headquarter office space in
Scottsdale, Arizona, to accommodate our current needs and future growth. Under this agreement,
approximately 21,000 square feet of office space is being leased for a period of three years. In
May 2007, we began occupancy of the additional headquarter office space.
During 2007, we began designing and implementing a new ERP system to integrate and improve the
financial and operational aspects of our business. 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. During 2007, we invested approximately $9.5 million on this project.
58
Operating Activities
Net cash provided by operating activities during the year ended December 31, 2007 was
approximately $158.9 million, compared to cash used in operating activities of approximately $41.0
million during the year ended December 31, 2006. The following is a summary of the primary
components of cash provided by (used in) operating activities during the year ended December 31,
2007 and 2006 (in millions):
|
|
|
|
|
|
|
|
|
|
|
2007 |
|
|
2006 |
|
Payment made to Revance related to our option to acquire
Revance or to license Revances product currently
under development |
|
$ |
(8.0 |
) |
|
$ |
|
|
Expenses related to our new ERP system |
|
|
(3.1 |
) |
|
|
|
|
Payments made to Ipsen related to development of RELOXIN® |
|
|
(29.1 |
) |
|
|
(125.2 |
) |
Payment of professional fees related to termination of proposed
merger with Inamed |
|
|
|
|
|
|
(16.7 |
) |
Income taxes paid |
|
|
(35.4 |
) |
|
|
(35.7 |
) |
Payment received from Hyperion related to strategic collaboration |
|
|
10.0 |
|
|
|
|
|
Other cash provided by operating activities |
|
|
224.5 |
|
|
|
136.6 |
|
|
|
|
|
|
|
|
Cash (used in) provided by operating activities |
|
$ |
158.9 |
|
|
$ |
(41.0 |
) |
|
|
|
|
|
|
|
Investing Activities
Net cash used in investing activities during the year ended December 31, 2007 was
approximately $269.5 million, compared to net cash used in investing activities during the year
ended December 31, 2006 of $216.9 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 $29.1 million was paid to Q-Med during the second quarter of 2007 upon the FDAs
approval of PERLANE®, $20.0 million was paid to Revance during the fourth quarter of
2007 related to our investment in Revance ($12.0 million classified as a long-term asset, $8.0
million recognized as research and development expense), $6.4 million of costs related to our new
ERP system was capitalized and $27.4 million was paid during the first quarter of 2006 for
contingent payments related to our merger with Ascent.
Financing Activities
Net cash provided by financing activities during the year ended December 31, 2007 was $14.5
million, compared to net cash provided by financing activities of $14.3 million during the year
ended December 31, 2006. Proceeds from the exercise of stock options were $19.7 million during
2007 compared to $18.7 million during 2006. Dividends paid during 2007 was $6.8 million compared
to $6.6 million during 2006.
Contingent Convertible Senior Notes and Other Long-Term Commitments
We have two outstanding series of Contingent Convertible Senior Notes, consisting of $169.2
million principal amount of 2.5% Contingent Convertible Senior Notes due 2032 (the Old Notes) and
$283.9 million principal amount of 1.5% Contingent Convertible Senior Notes due 2033 (the New
Notes). 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.
Holders of the Old Notes had the option to require us to repurchase all or a portion of their Old
Notes on June 4, 2007 (extended to July 11, 2007). Holders of $5,000 of outstanding principal
amounts of the Old Notes exercised their right to require us to purchase their Old Notes for cash.
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. On June 4, 2012 and 2017 or upon the occurrence of a change in
control, holders of the Old Notes may require us to offer to repurchase their Old Notes for cash.
On June 4, 2008, 2013 and 2018 or 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. If significant
59
portion of
the holders of the New Notes require us to repurchase their New Notes on June 4, 2008, we may not
have sufficient funds on June 4, 2008 or at the time of any such events to make the required
repurchases. If all of the New Notes are put back to us on June 4, 2008, we would be required to
pay $283.9 million in outstanding principal, plus outstanding accrued interest. We would also be
required to pay an accumulated deferred tax liability related to the New Notes. The deferred tax
liability related to the New Notes as of December 31, 2007 was $30.6 million.
Except for the Old Notes, we had only $8.5 million of long-term liabilities at December 31,
2007. Except for the New Notes and deferred tax liabilities, we had only $99.4 million of current
liabilities at December 31, 2007. 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 continuing our implementation of a new ERP system during 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, but may be repaid by BioMarin at any time prior to the option purchase date. As of
February 29, 2008, BioMarin has not requested any monies to be advanced under the Convertible Note,
and no amounts are outstanding.
Repurchases of Common Stock
On August 29, 2007, our Board of Directors approved a stock trading plan to purchase up to
$200.0 million in aggregate value of shares of our Class A common stock upon satisfaction of
certain conditions. The number of shares to be repurchased and the timing of the repurchases (if
any) will depend on factors such as the market price of our Class A common stock, economic and
market conditions, and corporate and regulatory requirements. The plan is scheduled to terminate
on the earlier of the first anniversary of the plan or at the time when the aggregate purchase
limit is reached. As of February 29, 2008, no shares had been repurchased under this plan.
Dividends
We do not have a dividend policy. Since July 2003, we have paid quarterly cash dividends
aggregating approximately $28.5 million on our common stock. In addition, on December 12, 2007, we
declared a cash dividend of $0.03 per issued and outstanding share of common stock payable on
January 31, 2008 to our stockholders of record at the close of business on January 2, 2008. 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, 2007, we are not involved in any off-balance sheet arrangements, as defined
in Item 3(a)(4)(ii) of SEC Regulation S-K.
60
Contractual Obligations
The following table summarizes our significant contractual obligations at December 31, 2007,
and the effect such obligations are expected to have on our liquidity and cash flows in future
periods. This table excludes 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 |
|
$ |
453,055 |
|
|
$ |
283,910 |
|
|
$ |
|
|
|
$ |
169,145 |
|
|
$ |
|
|
Interest on long-term debt |
|
|
212,197 |
|
|
|
8,487 |
|
|
|
16,975 |
|
|
|
16,975 |
|
|
|
169,760 |
|
Operating leases |
|
|
58,075 |
|
|
|
2,624 |
|
|
|
11,387 |
|
|
|
8,676 |
|
|
|
35,388 |
|
Other purchase obligations
and commitments |
|
|
867 |
|
|
|
173 |
|
|
|
347 |
|
|
|
347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
724,194 |
|
|
$ |
295,194 |
|
|
$ |
28,709 |
|
|
$ |
195,143 |
|
|
$ |
205,148 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The long-term debt
consists of our Old Notes and New Notes. We 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 us to repurchase all or a
portion of their Old Notes on June 4, 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. As of December 31, 2007, $283.9 million of the New Notes were classified
as current liabilities as the holders of the New Notes may require us to repurchase all or a portion of their New
Notes on June 4, 2008, which is less than twelve months from the
December 31, 2007 balance sheet date. As of December 31, 2007, $169.1
million of the Old Notes were classified in the More than 3
years and less than 5 years category as the holders of the Old
Notes may require us to repurchase all or a portion of their Old
Notes on June 4, 2012, which is more than 3 years but less than 5
years from the December 31, 2007 balance sheet date.
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 $208.7 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
minimum quantities or set prices that exceed our short-term expected requirements. We also
enter into contracts for
61
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 consumer rebate and loyalty programs 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,
including but not limited to, prescription data, industry trends, competitive developments and
estimated inventory in the distribution channel. 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
62
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. 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.
Currently, we are unable to specify if actual returns or credits relate to a sale that
occurred in the current period or prior period, and therefore, we cannot currently specify how much
of the provision recorded relates to sales made in prior periods. However, we believe the data
discussed above is appropriate to allow us to reasonably estimate the level of product returns
expected from current sales activities, as well as estimate the level of expected credits
associated with rebates or chargebacks.
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 consumer rebate and loyalty programs 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.
The following table shows the activity of each reserve, associated with the various sales
provisions that serve to reduce our accounts receivable balance or increase our accrued expenses,
for the years ended December 31, 2006 and 2007 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Managed |
|
Consumer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Care & |
|
Rebate |
|
|
|
|
Product |
|
Sales |
|
|
|
|
|
Medicaid |
|
and |
|
|
|
|
Returns |
|
Discounts |
|
Chargebacks |
|
Rebates |
|
Loyalty |
|
|
|
|
Reserve |
|
Reserve |
|
Reserve |
|
Reserve |
|
Programs |
|
Total |
|
|
|
Balance at December 31, 2005 |
|
$ |
16,167 |
|
|
$ |
1,344 |
|
|
$ |
649 |
|
|
$ |
6,081 |
|
|
$ |
2,420 |
|
|
$ |
26,661 |
|
Actual |
|
|
(95,731 |
) |
|
|
(9,363 |
) |
|
|
(4,225 |
) |
|
|
(12,070 |
) |
|
|
(8,224 |
) |
|
|
(129,613 |
) |
Provision |
|
|
114,859 |
|
|
|
9,720 |
|
|
|
4,023 |
|
|
|
13,100 |
|
|
|
11,449 |
|
|
|
153,151 |
|
|
|
|
Balance at December 31, 2006 |
|
$ |
35,295 |
|
|
$ |
1,701 |
|
|
$ |
447 |
|
|
$ |
7,111 |
|
|
$ |
5,645 |
|
|
$ |
50,199 |
|
|
|
|
Actual |
|
|
(57,216 |
) |
|
|
(11,270 |
) |
|
|
(1,432 |
) |
|
|
(9,814 |
) |
|
|
(15,942 |
) |
|
|
(95,674 |
) |
Provision |
|
|
31,749 |
|
|
|
10,080 |
|
|
|
1,305 |
|
|
|
9,052 |
|
|
|
26,313 |
|
|
|
78,499 |
|
|
|
|
Balance at December 31, 2007 |
|
$ |
9,828 |
|
|
$ |
511 |
|
|
$ |
320 |
|
|
$ |
6,349 |
|
|
$ |
16,016 |
|
|
$ |
33,024 |
|
|
|
|
63
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 for our established products 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 similar 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 estimate inventory in the distribution channel by
monitoring inventories held by our distributors, as well as prescription trends to help us assess
the rate of return. We determine our estimates of the sales return accrual for new products
primarily based on our historical acceptance of our new product introductions by our customers and
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. Changes due to our competitors price movements have not
adversely affected us. We do not provide material pricing incentives to our distributors that are
intended to have them assume additional inventory levels beyond what is customary in their ordinary
course of business.
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 when it appears product returns may differ from our original estimates.
The provision for product returns was $31.7 million, or 5.9% of gross product sales, and
$114.9 million, or 23.3% of gross product sales, for the years ended December 31, 2007 and 2006,
respectively. The reserve for product returns was $9.8 million and $35.3 million as of December
31, 2007 and 2006, respectively. The decrease in the provision and the reserve was primarily
related to a reduction in product returns experienced during 2007 and lower levels of inventory in
the distribution channel at December 31, 2007.
If the forecasted prescription data used to estimate the appropriate amount of inventory in
the distribution channel increased by 10.0 percent, our sales returns reserve at December 31, 2007
would decrease by approximately $1.1 million and corresponding revenue would increase by the same
amount. Conversely, if the forecasted prescription data used to estimate the appropriate amount of
inventory in the distribution channel decreased by 10.0 percent, our sales returns reserve at
December 31, 2007 would increase by approximately $1.8 million and corresponding revenue would
decrease by the same amount.
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.
The provision for cash discounts was $10.1 million, or 1.9% of gross product sales, and $9.7
million, or 2.0% of gross product sales, for the years ended December 31, 2007 and 2006,
respectively. The reserve for cash discounts was $0.5 million and $1.7 million as of December 31,
2007 and 2006, respectively. The increase in the provision was due to an increase in gross product
sales. The balance in the reserve for sales discounts at the end of the fiscal year is related to
the amount of accounts receivable that is outstanding at that date that is still eligible for the
cash discounts to be taken by the customers. The fluctuations in the reserve for sales discounts
between periods is normally reflective of increases or decreases in the related eligible
outstanding accounts receivable amounts at the comparable dates.
As our customer base is made up primarily of major wholesalers and retail chains, cash
discounts have historically become earned by our customers. Therefore, we record a provision and
maintain a reserve for the maximum amount of potential cash discounts. If there was a 10.0 percent
decrease in the number of customers that
64
earned a cash discount during 2007, the provision for 2007 would have been reduced by
approximately $0.1 million and the reserve at December 31, 2007 would have been reduced by
approximately $0.1 million.
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 continually monitor our historical experience and current pricing trends
to ensure the liability for future chargebacks is fairly stated.
The provision for contract chargebacks was $1.3 million, or 0.2% of gross product sales, and
$4.0 million, or 0.8% of gross product sales, for the years ended December 31, 2007 and 2006,
respectively. The reserve for contract chargebacks was $0.3 million and $0.4 million as of
December 31, 2007 and 2006, respectively. The decrease in the provision and the reserve was due to
a decrease in the number of pricing contracts in place during the comparable periods.
If our estimate for contract chargeback claim activity changed by 10.0 percent our reserve for
contract chargebacks would be impacted by approximately $0.1 million and corresponding revenue
would be impacted by the same amount.
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.
We continually monitor historical payment rates and actual claim data to ensure the liability is
fairly stated.
The provision for managed care and Medicaid rebates was $9.1 million, or 1.7% of gross product
sales, and $13.1 million, or 2.7% of gross product sales, for the years ended December 31, 2007 and
2006, respectively. The reserve for managed care and Medicaid rebates was $6.3 million and $7.1
million as of December 31, 2007 and 2006, respectively. The decrease in the provision was
primarily due to a decrease in the amount of Medicaid rebates related to LOPROX®, due to
decreasing demand and fewer rebate transactions. The decrease in the reserve is due to a decrease
in the amount of rebates outstanding at the comparable dates.
If the forecasted prescription data used to estimate the appropriate amount of inventory in
the distribution channel changed by 10.0 percent or our historical percentage of sales that
generated a rebate were to change by 10.0 percent our reserve for managed care and Medicaid rebates
would be impacted by approximately $0.5 million and corresponding revenue would be impacted by the
same amount.
Consumer Rebates and Loyalty Programs
We offer consumer rebates on many of our products and we have consumer loyalty programs. We
generally account for these programs by establishing an accrual based on our estimate of the rebate
and loyalty incentives attributable to a sale. We generally base our estimates for the accrual of
these items 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, to ensure the balance is fairly stated.
65
The provision for consumer rebates and loyalty programs was $26.3 million, or 4.9% of gross
product sales, and $11.4 million, or 2.3% of gross product sales, for the years ended December 31,
2007 and 2006, respectively. The reserve for consumer rebates and loyalty programs was $16.0
million and $5.6 million as of December 31, 2007 and 2006, respectively. The increase in the
provision and the reserve was primarily due to new consumer rebate programs initiated during 2007
related to our SOLODYN® and ZIANA® products and increased sales of
RESTYLANE® and participation in the RESTYLANE® customer loyalty program.
If our 2007 estimates of rebate redemption rates and average rebate amounts for our consumer
rebate programs changed by 10.0 percent, and our estimates of eligible procedures completed related
to our customer loyalty programs were to change by 10.0 percent, our reserve for these items would
be impacted by approximately $4.5 million and corresponding revenue would be impacted by the same
amount.
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.
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®. 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.
66
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 0.35 percent to 0.375 percent) would have
increased the fair value of stock options granted in 2007 to $15.67 per share. Conversely,
decreasing the weighted average volatility by 2.5 percent (from 0.35 percent to 0.325 percent)
would have decreased the fair value of stock options granted in 2007 to $14.39 per share. The
expected life of the awards is based on historical experience of awards with similar
characteristics. Stock option awards granted during 2007 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 2007 to $14.49 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 2008 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
if previously expensed pre-approval inventory becomes available and is used for commercial sale.
As of
67
December 31, 2007, 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 2007, 2006 and 2005, impairment charges of $4.1 million, $52.6 million and $9.2
million, respectively, were recognized related to our review of long-lived assets. During 2007,
the remaining useful life of the intangible asset that was deemed to be impaired was reduced.
During 2006, the remaining useful lives of two of the intangible assets that were deemed to be
impaired were reduced. 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, primarily because of state and local income taxes, enhanced
charitable contribution deductions for inventory, 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 not 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.
Based on our historical pre-tax earnings, we believe it is more likely than not that we will
realize the benefit of the existing net deferred tax assets at December 31, 2007. We believe the
existing net deductible temporary differences will reverse during periods in which we generate net
taxable income; however, there can be no assurance that we 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 new technologies and 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.
68
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, 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. As of December 31, 2006, we accrued a loss contingency of $10.2 million related our
settlement of all outstanding federal and state civil suits against the Company in connection with
claims related to our 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. 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 operations. This loss contingency of $10.2 million was paid during
2007. 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 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. SFAS No. 159 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.
In June 2007, the EITF reached a consensus on EITF 07-03, Accounting for Nonrefundable Advance
Payments for Goods or Services to Be Used in Future Research and Development Activities. EITF
07-03 concludes that non-refundable advance payments for future research and development activities
should be deferred and capitalized until the goods have been delivered or the related services have
been performed. If an entity does not expect the goods to be delivered or services to be rendered,
the capitalized advance payment should be charged to
expense. This consensus is effective for financial statements issued for fiscal years
beginning after December 15,
69
2007, and interim periods within those fiscal years. Earlier adoption
is not permitted. The effect of applying the consensus will be prospective for new contracts
entered into on or after that date. We do not expect EITF 07-03 to have a material impact on our
consolidated results of operations and financial condition upon adoption.
In December 2007, the FASB issued SFAS No. 141R, Business Combinations, which replaces SFAS
No. 141 and establishes principles and requirements for how an acquirer in a business combination
recognizes and measures in its financial statements the identifiable assets acquired, the
liabilities assumed and any controlling interest. It also established principles and requirements
for how an acquirer in a business combination recognizes and measures the goodwill acquired in the
business combination or a gain from a bargain purchase, and determines what information to disclose
to enable users of the financial statements to evaluate the nature and financial effects of the
business combination. We are currently evaluating SFAS No. 141R and its impact, if any, on our
consolidated results of operations and financial condition.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements an amendment of Accounting Research Bulletin No. 51. SFAS No. 160
establishes new accounting and reporting standards for the noncontrolling interest in a subsidiary
and for the deconsolidation of a subsidiary. Specifically, this statement requires the recognition
of a noncontrolling interest, or minority interest, as equity in the consolidated financial
statements and separate from the parents equity. The amount of net income attributable to the
noncontrolling interest will be included in consolidated net income on the face of the statement of
operations. SFAS No. 160 clarifies that changes in a parents ownership interest in a subsidiary
that do not result in deconsolidation are equity transactions if the parent retains it controlling
financial interest. In addition, this statement requires that a parent recognize a gain or loss in
net income when a subsidiary is deconsolidated. Such gain or loss will be measured using the fair
value of the noncontrolling equity investment on the deconsolidation date. SFAS No. 160 also
includes expanded disclosure requirements regarding the interests of the parent and its
noncontrolling interest. SFAS No. 160 is effective for fiscal years beginning on or after
December 15, 2008. We are currently evaluating SFAS No. 160 and its impact, if any, on our
consolidated results of operations and financial condition.
In December 2007, the EITF reached a consensus on EITF 07-01, Accounting for Collaborative
Agreements. EITF 07-01 prohibits companies from applying the equity method of accounting to
activities performed outside a separate legal entity by a virtual joint venture. Instead, revenues
and costs incurred with third parties in connection with the collaborative arrangement should be
presented gross or net by the collaborators based on the criteria in EITF Issue No. 99-19,
Reporting Revenue Gross as a Principal versus Net as an Agent, and other applicable accounting
literature. The consensus should be applied to collaborative arrangements in existence at the date
of adoption using a modified retrospective method that requires reclassification in all periods
presented for those arrangements still in effect at the transition date, unless that application is
impracticable. The consensus is effective for fiscal years beginning after December 15, 2008. We
are currently evaluating EITF 07-01 and its impact, if any, on our consolidated results of
operations and financial condition.
70
Item 7A. Quantitative and Qualitative Disclosure About Market Risk
At December 31, 2007, $116.5 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 $703.7 million as of December 31, 2007, $481.2 million
as of December 31, 2006 and $295.5 million as of December 31, 2005. 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.
As of December 31, 2007, our short-term investments included $101.7 million of auction rate
floating securities. Our auction rate floating securities are debt instruments with a long-term
maturity and with an interest rate that is reset in short intervals through auctions. The recent
negative conditions in the credit markets have prevented some investors from liquidating their
holdings, including their holdings of auction rate floating securities. During February 2008 we
were informed that there was insufficient demand at auction for approximately $43.6 million of our
auction rate floating securities. As a result, these affected auction rate floating securities are
now not considered liquid, and we could be required to hold them until they are redeemed by the
holder at maturity. The negative credit markets may affect our other auction rate floating
securities as they cycle through the auction process. We may not be able to make the securities
liquid until a future auction on these investments is successful. At this time, we have not
obtained sufficient evidence to conclude that the fair value of these auction rate floating securities is less than their carrying value
or that they will not be settled in the short-term, although the market for these investments is
currently uncertain. All of our auction rate floating securities held as of December 31, 2007
successfully re-set at auction at the first auction interval subsequent to December 31, 2007, and
we subsequently liquidated approximately $56.8 million of our auction rate floating securities at
par. As of February 26, 2008, we had approximately $44.9 million of auction rate floating
securities.
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, 2007
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|
Thereafter |
Available-for-sale securities |
|
$ |
409,544 |
|
|
$ |
192,513 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
101,649 |
|
Weighted-average yield rate |
|
|
5.15 |
% |
|
|
4.82 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6.44 |
% |
Contingent convertible
senior notes due 2032 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
169,145 |
|
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.
71
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.
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 have concluded that our disclosure controls and procedures were
effective and designed 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 in 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.
During the three months ended December 31, 2007, there was no change in our internal control
over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
72
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, 2007. 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 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, 2007.
Our independent registered public accounting firm, Ernst & Young LLP, who also audited our
consolidated financial statements, audited the effectiveness of our internal control over financial
reporting. Ernst & Young LLP has issued their attestation report, which follows:
73
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Medicis Pharmaceutical Corporation
We have audited Medicis Pharmaceutical Corporations internal control over financial reporting
as of December 31, 2007, 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 included in the accompanying Managements Report on Internal Control over
Financial Reporting. Our responsibility is to express an opinion on 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, assessing the risk that a material weakness exists, testing and
evaluating the design and operating effectiveness of internal control based on the assessed risk,
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, Medicis Pharmaceutical Corporation maintained, in all material respects,
effective internal control over financial reporting as of December 31, 2007, 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, 2007 consolidated financial statements of Medicis
Pharmaceutical Corporation and subsidiaries and our report dated February 26, 2008 expressed an
unqualified opinion thereon.
/s/ Ernst & Young LLP
Phoenix, Arizona
February 26, 2008
74
Item 9B. Other Information
None.
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, 2007, 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, 2007, 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, Director Biographical Information, Board Nominees, Executive Officers and
Governance of Medicis 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 Directors 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 Stock Option 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 Public Accountants in the
Proxy Statement is incorporated herein by reference.
75
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 |
|
Report of Independent Registered Public Accounting Firm |
|
|
F-2 |
|
Consolidated balance sheets as of December 31, 2007 and 2006 |
|
|
F-3 |
|
Consolidated statements of operations for the years ended December
31, 2007 and 2006, the six months ended December 31, 2005 and
2004 (unaudited) and the fiscal year ended June 30, 2005 |
|
|
F-5 |
|
Consolidated statements of stockholders equity for the years ended
December 31, 2007 and 2006, the six months ended December 31,
2005 and the fiscal year ended June 30, 2005 |
|
|
F-6 |
|
Consolidated statements of cash flows for the years ended
December 31, 2007 and 2006, the six months ended December 31,
2005 and 2004 (unaudited) and the fiscal year ended June 30,
2005 |
|
|
F-10 |
|
Notes to consolidated financial statements |
|
|
F-11 |
|
(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 (43) |
|
|
|
|
|
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) |
76
|
|
|
|
|
Exhibit No. |
|
|
|
Description |
10.5
|
|
|
|
License Agreement among the Company, Ascent Pediatrics, Inc. and BioMarin Pediatrics Inc.,
dated May 18, 2004 (23) |
|
|
|
|
|
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) |
77
|
|
|
|
|
Exhibit No. |
|
|
|
Description |
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) |
|
|
|
|
|
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) |
78
|
|
|
|
|
Exhibit No. |
|
|
|
Description |
10.39
|
|
|
|
Medicis Pharmaceutical Corporation 1992 Stock Option Plan(35) |
|
|
|
|
|
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) |
|
|
|
|
|
10.46(c)
|
|
|
|
Amendment No. 2 to the Medicis 2006 Incentive Award Plan, dated April 11, 2007(46) |
|
|
|
|
|
10.46(d)
|
|
|
|
Amendment No. 3 to the Medicis 2006 Incentive Award Plan, dated April 16, 2007(45) |
|
|
|
|
|
10.46(e)
|
|
+
|
|
Form of Stock Option Agreement for Medicis Pharmaceutical Corporation 2006 Incentive Award
Plan |
|
|
|
|
|
10.46(f)
|
|
+
|
|
Form of Restricted Stock Agreement for Medicis Pharmaceutical Corporation 2006 Incentive
Award Plan |
|
|
|
|
|
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) |
|
|
|
|
|
10.52
|
|
|
|
Corporate Integrity Agreement between the Office of Inspector General of the department of
Health and Human Services and Medicis Pharmaceutical Corporation(44) |
|
|
|
|
|
10.53
|
|
|
|
Collaboration Agreement, dated as of August 23, 2007, by and between Ucyclyd Pharma, Inc. and
Hyperion Therapuetics, Inc. (47) |
|
|
|
|
|
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 Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended |
|
|
|
|
|
31.2
|
|
+ |
|
Certification of Chief Financial
Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the Securities Exchange Act, as amended |
|
|
|
|
|
32.1
|
|
+
|
|
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
|
|
32.2
|
|
+
|
|
Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted
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 |
79
|
|
|
(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 |
80
|
|
|
(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 |
|
(43) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on April 16, 2007 |
|
(44) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on April 30, 2007 |
|
(45) |
|
Incorporated by reference to Appendix A to the Companys Definitive Proxy Statement on
Schedule 14A filed with the SEC on April 16, 2007 |
|
(46) |
|
Incorporated by reference to the Companys Registration Statement on Form S-8 dated
September 3, 2007 |
|
(47) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended
September 30, 2007, 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. |
81
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: February 29, 2008
|
|
|
|
|
|
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
Jonah
Shacknai
|
|
Chairman of the Board of Directors
and Chief Executive Officer
(Principal Executive Officer)
|
|
February 29, 2008 |
|
|
|
|
|
/s/ MARK A. PRYGOCKI, SR.
Mark
A. Prygocki, Sr.
|
|
Executive Vice President, Chief Financial
Officer,
and Treasurer
(Principal Financial and Accounting Officer)
|
|
February 29, 2008 |
|
|
|
|
|
/s/ ARTHUR G. ALTSCHUL, JR.
Arthur G. Altschul, Jr.
|
|
Director
|
|
February 29, 2008 |
|
|
|
|
|
/s/ SPENCER DAVIDSON
Spencer Davidson
|
|
Director
|
|
February 29, 2008 |
|
|
|
|
|
/s/ STUART DIAMOND
Stuart Diamond
|
|
Director
|
|
February 29, 2008 |
|
|
|
|
|
/s/ PETER S. KNIGHT, ESQ.
Peter S. Knight, Esq.
|
|
Director
|
|
February 29, 2008 |
|
|
|
|
|
/s/ MICHAEL A. PIETRANGELO
Michael A. Pietrangelo
|
|
Director
|
|
February 29, 2008 |
|
|
|
|
|
/s/ PHILIP S. SCHEIN, M.D.
Philip S. Schein, M.D.
|
|
Director
|
|
February 29, 2008 |
|
|
|
|
|
/s/ LOTTIE SHACKELFORD
Lottie Shackelford
|
|
Director
|
|
February 29, 2008 |
82
MEDICIS PHARMACEUTICAL CORPORATION
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
PAGE |
Report of Independent Registered Public Accounting Firm
|
|
F-2 |
|
|
|
Consolidated Balance Sheets as of December 31, 2007 and 2006
|
|
F-3 |
|
|
|
Consolidated Statements of Operations for the years ended
December 31, 2007 and 2006, the six months ended December
31, 2005 and December 31, 2004 (unaudited), and the fiscal
year ended June 30, 2005
|
|
F-5 |
|
|
|
Consolidated Statements of Stockholders Equity for the
years ended December 31, 2007 and 2006, the six months ended
December 31, 2005, and the fiscal year ended June 30, 2005
|
|
F-6 |
|
|
|
Consolidated Statements of Cash Flows for the years ended
December 31, 2007 and 2006, the six months ended December
31, 2005 and December 31, 2004 (unaudited), and the fiscal
year ended June 30, 2005
|
|
F-10 |
|
|
|
Notes to Consolidated Financial Statements
|
|
F-11 |
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, 2007 and 2006, and the related
consolidated statements of operations, stockholders equity, and cash flows for each of the
two years in the period ended December 31, 2007, the six months ended December 31, 2005 and
the year 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, 2007 and 2006 and the consolidated results of their
operations and their cash flows for each of the two years in the period ended December 31,
2007, the six months ended December 31, 2005 and the year 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.
As discussed in Notes 2 and 16, in 2007 the Company adopted Financial Accounting
Standards Board Interpretation No. 48, Accounting for Uncertainty in Income Taxes. Also,
as discussed in Notes 2 and 19, in 2005 the Company adopted Statement of Financial
Accounting Standards No. 123 (revised), Share-Based Payment.
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, 2007, 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, 2008 expressed an
unqualified opinion thereon.
/s/ Ernst & Young LLP
Phoenix, Arizona
February 26, 2008
F-2
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED BALANCE SHEETS
(in thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2007 |
|
|
2006 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
108,046 |
|
|
$ |
203,319 |
|
Short-term investments |
|
|
686,634 |
|
|
|
350,942 |
|
Accounts receivable, less allowances: |
|
|
|
|
|
|
|
|
December 31, 2007 and 2006: $10,658
and $37,443, respectively |
|
|
12,377 |
|
|
|
36,370 |
|
Inventories, net |
|
|
29,973 |
|
|
|
27,016 |
|
Other current assets |
|
|
18,049 |
|
|
|
15,990 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
855,079 |
|
|
|
633,637 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
13,850 |
|
|
|
6,576 |
|
Intangible assets: |
|
|
|
|
|
|
|
|
Intangible assets related to product line
acquisitions and business combinations |
|
|
258,873 |
|
|
|
239,396 |
|
Other intangible assets |
|
|
7,063 |
|
|
|
6,052 |
|
|
|
|
|
|
|
|
|
|
|
265,936 |
|
|
|
245,448 |
|
Less: accumulated amortization |
|
|
92,482 |
|
|
|
76,241 |
|
|
|
|
|
|
|
|
Net intangible assets |
|
|
173,454 |
|
|
|
169,207 |
|
Goodwill |
|
|
63,107 |
|
|
|
63,107 |
|
Deferred tax assets, net |
|
|
59,445 |
|
|
|
65,234 |
|
Long-term investments |
|
|
17,072 |
|
|
|
130,290 |
|
Other assets |
|
|
12,622 |
|
|
|
2,181 |
|
|
|
|
|
|
|
|
|
|
$ |
1,194,629 |
|
|
$ |
1,070,232 |
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-3
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED BALANCE SHEETS, Continued
(in thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2007 |
|
|
2006 |
|
Liabilities |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
34,891 |
|
|
$ |
47,513 |
|
Current portion of contingent convertible senior notes |
|
|
283,910 |
|
|
|
169,155 |
|
Income taxes payable |
|
|
7,734 |
|
|
|
11,346 |
|
Deferred tax liabilities, net |
|
|
11,684 |
|
|
|
946 |
|
|
|
|
|
|
|
|
Other current liabilities |
|
|
56,781 |
|
|
|
47,803 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
395,000 |
|
|
|
276,763 |
|
|
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Contingent convertible senior notes |
|
|
169,145 |
|
|
|
283,910 |
|
Deferred revenue |
|
|
6,667 |
|
|
|
|
|
Other liabilities |
|
|
1,862 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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: 69,005,019, and 68,044,363 at
December 31, 2007 and 2006, respectively |
|
|
965 |
|
|
|
952 |
|
|
|
|
|
|
|
|
|
|
Class B
common stock, $0.014 par value; shares authorized: 1,000,000; issued and outstanding: none |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
641,907 |
|
|
|
598,435 |
|
Accumulated other comprehensive income |
|
|
2,221 |
|
|
|
537 |
|
Accumulated earnings |
|
|
319,872 |
|
|
|
252,431 |
|
Less: Treasury stock, 12,656,503 and 12,650,233 shares at cost at
December 31, 2007 and 2006, respectively |
|
|
(343,010 |
) |
|
|
(342,796 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity |
|
|
621,955 |
|
|
|
509,559 |
|
|
|
|
|
|
|
|
|
|
$ |
1,194,629 |
|
|
$ |
1,070,232 |
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-4
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SIX MONTHS ENDED |
|
|
YEAR ENDED |
|
|
|
YEARS ENDED DECEMBER 31, |
|
|
DECEMBER 31, |
|
|
JUNE 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(UNAUDITED) |
|
|
|
|
|
Net product revenues |
|
$ |
449,125 |
|
|
$ |
333,625 |
|
|
$ |
155,569 |
|
|
$ |
146,999 |
|
|
$ |
305,114 |
|
Net contract revenues |
|
|
15,526 |
|
|
|
15,617 |
|
|
|
8,385 |
|
|
|
34,168 |
|
|
|
71,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
464,651 |
|
|
|
349,242 |
|
|
|
163,954 |
|
|
|
181,167 |
|
|
|
376,899 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues (1) |
|
|
50,968 |
|
|
|
41,741 |
|
|
|
24,111 |
|
|
|
27,270 |
|
|
|
55,447 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
413,683 |
|
|
|
307,501 |
|
|
|
139,843 |
|
|
|
153,897 |
|
|
|
321,452 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (2) |
|
|
247,917 |
|
|
|
206,822 |
|
|
|
80,189 |
|
|
|
65,736 |
|
|
|
135,154 |
|
Impairment of intangible assets |
|
|
4,067 |
|
|
|
52,586 |
|
|
|
9,171 |
|
|
|
|
|
|
|
|
|
Research and development (3) |
|
|
39,428 |
|
|
|
161,837 |
|
|
|
22,367 |
|
|
|
45,140 |
|
|
|
65,676 |
|
Depreciation and amortization |
|
|
24,548 |
|
|
|
23,048 |
|
|
|
12,420 |
|
|
|
10,222 |
|
|
|
22,350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
97,723 |
|
|
|
(136,792 |
) |
|
|
15,696 |
|
|
|
32,799 |
|
|
|
98,272 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
|
|
|
|
|
|
|
|
59,801 |
|
|
|
|
|
|
|
|
|
Interest and investment income |
|
|
38,390 |
|
|
|
30,787 |
|
|
|
10,059 |
|
|
|
5,076 |
|
|
|
11,470 |
|
Interest expense |
|
|
(10,018 |
) |
|
|
(10,640 |
) |
|
|
(5,333 |
) |
|
|
(5,324 |
) |
|
|
(10,640 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income tax |
|
|
126,095 |
|
|
|
(116,645 |
) |
|
|
80,223 |
|
|
|
32,551 |
|
|
|
99,102 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense (benefit) |
|
|
51,044 |
|
|
|
(40,796 |
) |
|
|
30,502 |
|
|
|
11,328 |
|
|
|
34,112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
75,051 |
|
|
$ |
(75,849 |
) |
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per share |
|
$ |
1.34 |
|
|
$ |
(1.39 |
) |
|
$ |
0.92 |
|
|
$ |
0.38 |
|
|
$ |
1.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per share |
|
$ |
1.14 |
|
|
$ |
(1.39 |
) |
|
$ |
0.76 |
|
|
$ |
0.34 |
|
|
$ |
1.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share |
|
$ |
0.12 |
|
|
$ |
0.12 |
|
|
$ |
0.06 |
|
|
$ |
0.06 |
|
|
$ |
0.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic common shares outstanding |
|
|
55,988 |
|
|
|
54,688 |
|
|
|
54,323 |
|
|
|
55,972 |
|
|
|
55,196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted common shares outstanding |
|
|
71,246 |
|
|
|
54,688 |
|
|
|
69,772 |
|
|
|
72,160 |
|
|
|
70,909 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) amounts exclude amortization of
intangible assets related to acquired
products |
|
$ |
21,606 |
|
|
$ |
20,017 |
|
|
$ |
10,899 |
|
|
$ |
8,933 |
|
|
$ |
19,620 |
|
(2) amounts include share-based
compensation expense |
|
$ |
21,031 |
|
|
$ |
24,453 |
|
|
$ |
13,947 |
|
|
$ |
258 |
|
|
$ |
515 |
|
(3) amounts include share-based
compensation expense |
|
$ |
112 |
|
|
$ |
1,626 |
|
|
$ |
1,000 |
|
|
$ |
|
|
|
$ |
|
|
See accompanying notes to consolidated financial statements.
F-5
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, 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 |
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Other |
|
|
|
|
|
|
|
|
|
|
Treasury |
|
|
|
|
|
|
Paid-In |
|
|
Comprehensive |
|
|
Deferred |
|
|
Accumulated |
|
|
Stock |
|
|
|
|
|
|
Capital |
|
|
Income (Loss) |
|
|
Compensation |
|
|
Earnings |
|
|
Shares |
|
|
Amount |
|
|
Total |
|
|
|
$ |
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
F-7
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Class A |
|
|
Class B |
|
|
|
Common Stock |
|
|
Common Stock |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
Balance at December 31, 2005 |
|
|
67,052 |
|
|
$ |
938 |
|
|
|
|
|
|
$ |
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 FIN 48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted shares issued for deferred
compensation |
|
|
37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted shares held in lieu of employee taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
924 |
|
|
|
13 |
|
|
|
|
|
|
|
|
|
Tax effect of stock options exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
69,005 |
|
|
$ |
965 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-8
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Other |
|
|
|
|
|
|
|
|
|
|
Treasury |
|
|
|
|
|
|
Paid-In |
|
|
Comprehensive |
|
|
Deferred |
|
|
Accumulated |
|
|
Stock |
|
|
|
|
|
|
Capital |
|
|
Income (Loss) |
|
|
Compensation |
|
|
Earnings |
|
|
Shares |
|
|
Amount |
|
|
Total |
|
|
|
$ |
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
75,051 |
|
|
|
|
|
|
|
|
|
|
|
75,051 |
|
|
|
|
|
|
|
|
885 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
885 |
|
|
|
|
|
|
|
|
799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
76,735 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(808 |
) |
|
|
|
|
|
|
|
|
|
|
(808 |
) |
|
|
|
21,143 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,143 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,802 |
) |
|
|
|
|
|
|
|
|
|
|
(6,802 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6 |
) |
|
|
(214 |
) |
|
|
(214 |
) |
|
|
|
19,739 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,752 |
|
|
|
|
2,590 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,590 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
641,907 |
|
|
$ |
2,221 |
|
|
$ |
|
|
|
$ |
319,872 |
|
|
|
(12,656 |
) |
|
$ |
(343,010 |
) |
|
$ |
621,955 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-9
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
SIX MONTHS ENDED |
|
|
YEAR ENDED |
|
|
|
YEARS ENDED DECEMBER 31, |
|
|
DECEMBER 31, |
|
|
JUNE 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(UNAUDITED) |
|
|
|
|
|
Operating Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
75,051 |
|
|
$ |
(75,849 |
) |
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
Adjustments to reconcile net income (loss) to net
cash provided by (used in) operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
24,548 |
|
|
|
23,048 |
|
|
|
12,420 |
|
|
|
10,222 |
|
|
|
22,350 |
|
Amortization of deferred financing fees |
|
|
1,519 |
|
|
|
2,144 |
|
|
|
1,072 |
|
|
|
1,072 |
|
|
|
2,143 |
|
Impairment of intangible assets |
|
|
4,067 |
|
|
|
52,586 |
|
|
|
9,171 |
|
|
|
|
|
|
|
|
|
Loss on disposal of property and equipment |
|
|
19 |
|
|
|
449 |
|
|
|
34 |
|
|
|
39 |
|
|
|
52 |
|
Loss on sale of product rights |
|
|
259 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Gain) loss on sale of
available-for-sale investments |
|
|
(105 |
) |
|
|
(421 |
) |
|
|
599 |
|
|
|
103 |
|
|
|
882 |
|
Write-off of Inamed transaction costs |
|
|
|
|
|
|
|
|
|
|
14,042 |
|
|
|
|
|
|
|
|
|
Share-based compensation expense |
|
|
21,143 |
|
|
|
26,079 |
|
|
|
14,947 |
|
|
|
258 |
|
|
|
515 |
|
Deferred income tax expense (benefit) |
|
|
16,527 |
|
|
|
(60,122 |
) |
|
|
1,849 |
|
|
|
(3,060 |
) |
|
|
5,369 |
|
Tax benefit from exercise of stock options and
vesting of restricted stock awards |
|
|
2,590 |
|
|
|
3,921 |
|
|
|
|
|
|
|
5,058 |
|
|
|
5,104 |
|
Excess tax benefits from share-based
payment arrangements |
|
|
(1,494 |
) |
|
|
(2,166 |
) |
|
|
(73 |
) |
|
|
|
|
|
|
|
|
(Decrease) increase in provision for doubtful
accounts and returns |
|
|
(26,785 |
) |
|
|
19,282 |
|
|
|
(913 |
) |
|
|
3,100 |
|
|
|
3,118 |
|
(Amortization) accretion of (discount)/premium
on
investments |
|
|
(3,369 |
) |
|
|
(2,159 |
) |
|
|
(418 |
) |
|
|
5,010 |
|
|
|
6,528 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
50,777 |
|
|
|
(8,955 |
) |
|
|
1,436 |
|
|
|
(957 |
) |
|
|
(2,480 |
) |
Inventories |
|
|
(2,957 |
) |
|
|
(7,940 |
) |
|
|
1,625 |
|
|
|
2,621 |
|
|
|
(1,160 |
) |
Other current assets |
|
|
(2,060 |
) |
|
|
(3,749 |
) |
|
|
4,194 |
|
|
|
(1,942 |
) |
|
|
1,886 |
|
Accounts payable |
|
|
(12,622 |
) |
|
|
(10,195 |
) |
|
|
27,220 |
|
|
|
4,557 |
|
|
|
15,580 |
|
Income taxes payable |
|
|
(4,420 |
) |
|
|
(20,175 |
) |
|
|
17,255 |
|
|
|
5,974 |
|
|
|
9,524 |
|
Other current liabilities |
|
|
7,727 |
|
|
|
23,259 |
|
|
|
(6,191 |
) |
|
|
(7,813 |
) |
|
|
(4,420 |
) |
Other liabilities |
|
|
8,529 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in)
operating activities |
|
|
158,944 |
|
|
|
(40,963 |
) |
|
|
147,990 |
|
|
|
45,465 |
|
|
|
129,981 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(10,020 |
) |
|
|
(4,450 |
) |
|
|
(748 |
) |
|
|
(1,829 |
) |
|
|
(2,913 |
) |
Equity investment in an unconsolidated entity |
|
|
(11,957 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment of direct merger costs |
|
|
|
|
|
|
(27,420 |
) |
|
|
(5,811 |
) |
|
|
(129 |
) |
|
|
(7,454 |
) |
Payments for purchase of product rights |
|
|
(30,394 |
) |
|
|
(2,164 |
) |
|
|
(481 |
) |
|
|
(3,085 |
) |
|
|
(3,296 |
) |
Proceeds from sale of product rights |
|
|
1,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of available-for-sale investments |
|
|
(741,075 |
) |
|
|
(822,512 |
) |
|
|
(203,247 |
) |
|
|
(440,602 |
) |
|
|
(762,561 |
) |
Sale of available-for-sale investments |
|
|
291,804 |
|
|
|
349,034 |
|
|
|
159,597 |
|
|
|
489,352 |
|
|
|
846,143 |
|
Maturity of available-for-sale investments |
|
|
231,156 |
|
|
|
290,597 |
|
|
|
174,355 |
|
|
|
32,451 |
|
|
|
70,568 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by
investing activities Activities |
|
|
(269,486 |
) |
|
|
(216,915 |
) |
|
|
123,665 |
|
|
|
76,158 |
|
|
|
140,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment of financing costs |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6 |
) |
|
|
(6 |
) |
Payment of dividends |
|
|
(6,771 |
) |
|
|
(6,581 |
) |
|
|
(3,295 |
) |
|
|
(3,115 |
) |
|
|
(6,370 |
) |
Payment of contingent convertible senior notes |
|
|
(5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of treasury stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(150,000 |
) |
|
|
(150,000 |
) |
Excess tax benefits from share-based
payment arrangements |
|
|
1,494 |
|
|
|
2,166 |
|
|
|
73 |
|
|
|
|
|
|
|
|
|
Proceeds from the exercise of stock options |
|
|
19,752 |
|
|
|
18,693 |
|
|
|
430 |
|
|
|
15,674 |
|
|
|
16,583 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in)
financing activities |
|
|
14,470 |
|
|
|
14,278 |
|
|
|
(2,792 |
) |
|
|
(137,447 |
) |
|
|
(139,793 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate on cash and
cash equivalents |
|
|
799 |
|
|
|
(78 |
) |
|
|
349 |
|
|
|
724 |
|
|
|
489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (decrease) increase in cash and cash
equivalents |
|
|
(95,273 |
) |
|
|
(243,678 |
) |
|
|
269,212 |
|
|
|
(15,100 |
) |
|
|
131,164 |
|
Cash and cash equivalents at beginning
of period |
|
|
203,319 |
|
|
|
446,997 |
|
|
|
177,785 |
|
|
|
46,621 |
|
|
|
46,621 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
108,046 |
|
|
$ |
203,319 |
|
|
$ |
446,997 |
|
|
$ |
31,521 |
|
|
$ |
177,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-10
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 18
branded products. Its primary brands are PERLANE®, RESTYLANE®,
SOLODYN®, TRIAZ®, VANOS®, and ZIANA®.
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 years January 1, 2007 to December
31, 2007 and January 1, 2006 to December 31, 2006, are referred to as 2007 and 2006,
respectively. 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.
NOTE 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Cash and Cash Equivalents
At December 31, 2007, 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-11
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, 2007 and 2006, 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, |
|
|
|
2007 |
|
|
2006 |
|
Raw materials |
|
$ |
9,002 |
|
|
$ |
8,637 |
|
Finished goods |
|
|
24,789 |
|
|
|
19,709 |
|
Valuation reserve |
|
|
(3,818 |
) |
|
|
(1,330 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total inventories |
|
$ |
29,973 |
|
|
$ |
27,016 |
|
|
|
|
|
|
|
|
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, |
|
|
|
2007 |
|
|
2006 |
|
Furniture, fixtures and equipment |
|
$ |
19,102 |
|
|
$ |
12,330 |
|
Leasehold improvements |
|
|
4,082 |
|
|
|
2,203 |
|
|
|
|
|
|
|
|
|
|
|
23,184 |
|
|
|
14,533 |
|
Less: accumulated depreciation |
|
|
(9,334 |
) |
|
|
(7,957 |
) |
|
|
|
|
|
|
|
|
|
$ |
13,850 |
|
|
$ |
6,576 |
|
|
|
|
|
|
|
|
Total depreciation expense for property and equipment was approximately $2.7 million,
$2.8 million, $1.4 million, $1.2 million (unaudited) and $2.6 million for 2007, 2006, the
Transition Period, the comparable 2004 six months and fiscal 2005, respectively.
F-12
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. 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, 2007, 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 $173.5 million and $169.2 million as of December 31, 2007 and 2006,
respectively. The Company amortizes intangible assets on a straight-line basis over their
expected useful lives, which range between five and 25 years. Total intangible assets as
of December 31, 2007 and 2006 were as follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
|
December 31, 2006 |
|
|
|
Weighted |
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Average Life |
|
|
Gross |
|
|
Amortization |
|
|
Net |
|
|
Gross |
|
|
Amortization |
|
|
Net |
|
Related to product line
acquisitions |
|
|
15.7 |
|
|
$ |
253,791 |
|
|
$ |
(87,406 |
) |
|
$ |
166,385 |
|
|
$ |
234,314 |
|
|
$ |
(72,299 |
) |
|
$ |
162,015 |
|
Related to business
combinations |
|
|
7.5 |
|
|
|
5,082 |
|
|
|
(3,919 |
) |
|
|
1,163 |
|
|
|
5,082 |
|
|
|
(2,996 |
) |
|
|
2,086 |
|
Patents and trademarks |
|
|
18.0 |
|
|
|
7,063 |
|
|
|
(1,157 |
) |
|
|
5,906 |
|
|
|
6,052 |
|
|
|
(946 |
) |
|
|
5,106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets |
|
|
|
|
|
$ |
265,936 |
|
|
$ |
(92,482 |
) |
|
$ |
173,454 |
|
|
$ |
245,448 |
|
|
$ |
(76,241 |
) |
|
$ |
169,207 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total amortization expense was approximately $21.8 million, $20.2 million, $11.0
million, $9.0 million (unaudited) and $19.8 million for 2007, 2006, the Transition Period,
the comparable 2004 six months and fiscal 2005, respectively. Based on the intangible
assets recorded at December 31, 2007, and assuming no subsequent impairment of the
underlying assets, the annual amortization expense for each period, is expected to be as
follows: approximately $21.3 million for the year ended December 31, 2008, approximately
$18.6 million for the year ended December 31, 2009, and approximately $15.9 million for the
years ended December 31, 2010, 2011 and 2012.
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-13
During the quarter ended June 30, 2007, an intangible asset related to
OMNICEF® was determined to be impaired based on the Companys analysis of the
intangible assets carrying value and projected future cash flows. As a result of the
impairment analysis, the Company recorded a write-down of approximately $4.1 million related
to this intangible asset.
Factors affecting the future cash flows of the OMNICEF® intangible asset
included an early termination letter received during May 2007 from Abbott Laboratories, Inc.
(Abbott), which, in accordance with the Companys agreement with Abbott, transitions the
Companys co-promotion agreement into a two-year residual period, and competitive pressures
in the marketplace, including generic competition.
In addition, as a result of the impairment analysis, the remaining amortizable life of
the intangible asset related to OMNICEF® was reduced to two years. The
intangible asset related to OMNICEF® will be fully amortized by June 30, 2009.
The net impact on amortization expense as a result of the write-down of the carrying value
of the intangible asset and the reduction of its amortizable life is a decrease in quarterly
amortization expense of approximately $126,000.
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 $10.0 million, with approximately $0.7
million remaining to be amortized as of December 31, 2007.
F-14
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.
Consumer Rebates and Loyalty Programs
Consumer rebate and loyalty programs are contractual discounts and incentives offered
to consumers at the time prescriptions are dispensed, subject to various conditions. The
accruals for consumer rebates are estimated for inventory in the distribution channel and
prescriptions filled using estimated redemption rates and average rebate amounts based on
historical and other relevant data. The Company estimates its accruals for loyalty programs
based on an estimate of eligible procedures based on historical and other relevant data.
Other Current Liabilities
Other current liabilities are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2007 |
|
|
2006 |
|
Accrued incentives |
|
$ |
15,324 |
|
|
$ |
13,479 |
|
Managed care and Medicaid
reserves |
|
|
6,349 |
|
|
|
7,111 |
|
Legal reserves |
|
|
350 |
|
|
|
10,500 |
|
Accrued consumer rebate and loyalty
programs |
|
|
16,016 |
|
|
|
5,645 |
|
Deferred revenue |
|
|
2,993 |
|
|
|
258 |
|
Other accrued expenses |
|
|
15,749 |
|
|
|
10,810 |
|
|
|
|
|
|
|
|
|
|
$ |
56,781 |
|
|
$ |
47,803 |
|
|
|
|
|
|
|
|
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 estimates for product returns and exchanges, sales
discounts, chargebacks, managed care and Medicaid rebates and consumer rebates and loyalty
programs 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, including but not limited
to, prescription data, industry trends, competitive developments and estimated inventory in
the distribution channel. The Companys estimates of inventory in the distribution channel
are based on historical shipment and return information from its accounting records and data
on prescriptions filled, which the Company purchases from one of the leading providers of
prescription-based information. The Company also utilizes projected prescription demand for
its products, as well as, written and oral information obtained from certain wholesalers
with respect to their inventory levels and the Companys internal information. 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
F-15
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.
Advertising
The Company expenses advertising as incurred. Advertising expenses for 2007, 2006, the
Transition Period, the comparable 2004 six months and fiscal 2005 were approximately $47.9
million, $34.6 million, $12.9 million, $13.3 million (unaudited) and $24.2 million,
respectively. Advertising expenses include samples of the Companys products given to
physicians for marketing to their patients.
Share-Based Compensation
At December 31, 2007, 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. At the Companys 2007 Annual Meeting of
Shareholders held on May 22, 2007, the stockholders of the Company approved an amendment to
the 2006 Incentive Award Plan, increasing the number of shares of common stock reserved for
issuance under the plan by 2,500,000 shares. Stock option awards granted from these plans
are granted at the fair market value on the date of grant. The 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 total value of the stock options awards is expensed ratably over the service period
of the employees receiving the awards. As of December 31, 2007, total unrecognized
compensation cost related to stock option awards, to be recognized as expense subsequent to
December 31, 2007, was approximately $17.1 million and the related weighted-average period
over which it is expected to be recognized is approximately 1.6 years.
A summary of stock option activity within the Companys stock-based compensation plans
and changes for 2007 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
of Shares |
|
Price |
|
Term |
|
Value |
Balance at December 31, 2006 |
|
|
12,989,011 |
|
|
$ |
27.63 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
119,553 |
|
|
$ |
33.75 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(891,739 |
) |
|
$ |
20.65 |
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
(549,870 |
) |
|
$ |
32.70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
11,666,955 |
|
|
$ |
27.99 |
|
|
|
4.69 |
|
|
$ |
24,241,643 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The intrinsic value of options exercised during 2007 was $10,800,923. Options
exercisable under the Companys share-based compensation plans at December 31, 2007 were
9,325,143, with an average exercise price of $26.40, an average remaining contractual term
of 4.3 years, and an aggregate intrinsic value of $24,126,379.
F-16
A summary of fully vested stock options and stock options expected to vest, based on
historical forfeiture rates, as of December 31, 2007, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
Weighted |
|
Average |
|
|
|
|
|
|
|
|
Average |
|
Remaining |
|
Aggregate |
|
|
Number |
|
Exercise |
|
Contractual |
|
Intrinsic |
|
|
of Shares |
|
Price |
|
Term |
|
Value |
Outstanding |
|
|
10,784,370 |
|
|
$ |
28.23 |
|
|
|
4.8 |
|
|
$ |
21,333,338 |
|
Exercisable |
|
|
8,530,424 |
|
|
$ |
26.62 |
|
|
|
4.4 |
|
|
$ |
21,218,606 |
|
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
Year Ended |
|
Six Months Ended |
|
|
December 31, 2007 |
|
December 31, 2006 |
|
December 31, 2005 |
Expected dividend yield |
|
0.4% |
|
0.4% |
|
0.4% |
Expected stock price volatility |
|
0.35 |
|
0.36 |
|
0.36 |
Risk-free interest rate |
|
4.5% to 4.8% |
|
4.5% to 4.6% |
|
4.1% to 4.2% |
Expected life of options |
|
7 Years |
|
7 Years |
|
6 to 8 Years |
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended |
|
Year Ended |
|
|
December 31, 2004 |
|
June 30, 2005 |
|
|
(UNAUDITED) |
|
|
|
|
Expected dividend yield |
|
|
0.3 |
% |
|
|
0.3 |
% |
Expected stock price volatility |
|
|
0.44 |
|
|
|
0.44 |
|
Risk-free interest rate |
|
|
3.6 |
% |
|
|
3.6 |
% |
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 2007, 2006, the
Transition Period, the comparable 2004 six months and fiscal 2005 was $14.98, $14.00,
$14.15, $16.08 (unaudited) and $11.66, respectively.
F-17
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 |
|
|
|
Ended |
|
|
Ended |
|
|
|
December 31, 2004 |
|
|
June 30, 2005 |
|
|
|
(UNAUDITED) |
|
|
|
|
|
Net income, as reported |
|
$ |
21,223 |
|
|
$ |
64,990 |
|
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 |
|
|
|
|
|
|
|
|
Pro-forma net income |
|
$ |
11,028 |
|
|
$ |
43,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share: |
|
|
|
|
|
|
|
|
Basic, as reported |
|
$ |
0.38 |
|
|
$ |
1.18 |
|
Basic, pro forma |
|
$ |
0.20 |
|
|
$ |
0.78 |
|
Diluted, as reported |
|
$ |
0.34 |
|
|
$ |
1.01 |
|
Diluted, pro forma |
|
$ |
0.20 |
|
|
$ |
0.70 |
|
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 2007, 334,179 shares of restricted stock were
granted to certain employees. Share-based compensation expense related to all restricted
stock awards outstanding during 2007, 2006, the Transition Period, the comparable 2004 six
months and fiscal 2005 was approximately $3.7 million, $2.0 million, $0.7 million, $0.3
million (unaudited) and $0.5 million, respectively. As of December 31, 2007, the total
amount of unrecognized compensation cost related to nonvested restricted stock awards, to be
recognized as expense subsequent to December 31, 2007, was approximately $12.9 million, and
the related weighted-average period over which it is expected to be recognized is
approximately 3.8 years.
A summary of restricted stock activity within the Companys share-based compensation
plans and changes for 2007 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant-Date |
|
Nonvested Shares |
|
Shares |
|
|
Fair Value |
|
Nonvested at December 31, 2006 |
|
|
295,579 |
|
|
$ |
29.98 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
334,179 |
|
|
$ |
33.39 |
|
Vested |
|
|
(42,657 |
) |
|
$ |
30.37 |
|
Forfeited |
|
|
(34,332 |
) |
|
$ |
32.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2007 |
|
|
552,769 |
|
|
$ |
31.87 |
|
|
|
|
|
|
|
|
|
The total fair value of restricted shares vested during 2007, 2006, the Transition
Period, the comparable 2004 six months and fiscal 2005 was $1.3 million, $1.8 million, $0.6
million, $0.4 million (unaudited) and $0.4 million, respectively. No restricted shares
vested during fiscal 2004.
See Note 19 for further discussion of the Companys share-based employee compensation plans.
F-18
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 2007, 2006,
the Transition Period, the comparable 2004 six months and fiscal 2005 were approximately
$2.8 million, $2.4 million, $1.4 million, $1.6 million (unaudited) 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. 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, 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, primarily because of state and local income taxes,
enhanced charitable contribution deductions for inventory, 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 not deductible for tax
purposes, and differences in tax rates in certain non-U.S. jurisdictions The Companys
effective tax rate may be subject to fluctuations during the year as new information is
obtained which may affect the assumptions 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, 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 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, along with net operating losses and credit
carryforwards. The Company records valuation allowances against its deferred tax assets to
reduce the net carrying value to amounts 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 estimable.
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 15 for further discussion.
Foreign Currency Translations
The U.S. Dollar is the functional currency of all our foreign subsidiaries. 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
F-19
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. Total accumulated gains from
foreign currency translation, included in accumulated other comprehensive income at December
31, 2007 was approximately $1.5 million. 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 14), 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 and goodwill; 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
various items, including 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 immediate or short-term maturity of these
financial instruments. Long-term investments are carried at fair value based on market
quotations. The fair market value of the Companys long-term debt is estimated based on
market quotations at year-end. The fair market value of the Companys long-term debt approximates $453.2 million at
December 31, 2007.
Supplemental Disclosure of Cash Flow Information
During 2007, 2006, the Transition Period, the comparable 2004 six months and fiscal
2005, the Company made interest payments of $8.5 million, $8.5 million, $4.2 million, $4.2
million (unaudited) and $8.5 million, respectively.
Reclassifications
Certain prior year amounts have been reclassified to conform with the current year
presentation.
Recent Accounting Pronouncements
Effective January 1, 2007, the Company adopted FIN No. 48, Accounting for Uncertainty
in Income Taxes an interpretation of FASB Statement No. 109. FIN No. 48 provides guidance
for the recognition threshold and measurement attributes for financial statement recognition
and measurement of a tax position taken, or expected to be taken, in a tax return. In
accordance with FIN No. 48, the Company recognized a cumulative-effect adjustment of
approximately $808,000, increasing its liability for unrecognized tax benefits, interest,
and penalties and reducing the January 1, 2007 balance of retained earnings. See Note 16
for more information on income taxes.
F-20
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.
In June 2007, the EITF reached a consensus on EITF 07-03, Accounting for Nonrefundable
Advance Payments for Goods or Services to Be Used in Future Research and Development
Activities. EITF 07-03 concludes that non-refundable advance payments for future research
and development activities should be deferred and capitalized until the goods have been
delivered or the related services have been performed. If an entity does not expect the
goods to be delivered or services to be rendered, the capitalized advance payment should be
charged to expense. This consensus is effective for financial statements issued for fiscal
years beginning after December 15, 2007, and interim periods within those fiscal years.
Earlier adoption is not permitted. The effect of applying the consensus will be prospective
for new contracts entered into on or after that date. The Company does not expect EITF
07-03 to have a material impact on the Companys consolidated results of operations and
financial condition upon adoption.
In December 2007, the FASB issued SFAS No. 141R, Business Combinations, which replaces
SFAS No. 141 and establishes principles and requirements for how an acquirer in a business
combination recognizes and measures in its financial statements the identifiable assets
acquired, the liabilities assumed and any controlling interest. It also established
principles and requirements for how an acquirer in a business combination recognizes and
measures the goodwill acquired in the business combination or a gain from a bargain
purchase, and determines what information to disclose to enable users of the financial
statements to evaluate the nature and financial effects of the business combination. The
Company is currently evaluating SFAS No. 141R and its impact, if any, on the Companys
consolidated results of operations and financial condition.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in
Consolidated Financial Statements an amendment of Accounting Research Bulletin No. 51.
SFAS No. 160 establishes new accounting and reporting standards for the noncontrolling
interest in a subsidiary and for the deconsolidation of a subsidiary. Specifically, this
statement requires the recognition of a noncontrolling interest, or minority interest, as
equity in the consolidated financial statements and separate from the parents equity. The
amount of net income attributable to the noncontrolling interest will be included in
consolidated net income on the face of the statement of operations. SFAS No. 160 clarifies
that changes in a parents ownership interest in a subsidiary that do not result in
deconsolidation are equity transactions if the parent retains it controlling financial
interest. In addition, this statement requires that a parent recognize a gain or loss in
net income when a subsidiary is deconsolidated. Such gain or loss will be measured using
the fair value of the noncontrolling equity investment on the deconsolidation date.
SFAS No. 160 also includes expanded disclosure requirements regarding the interests of the
parent and its noncontrolling interest. SFAS No. 160 is effective for fiscal years
beginning on or after December 15, 2008. The Company is currently evaluating SFAS No. 160
and its impact, if any, on our consolidated results of operations and financial condition.
In December 2007, the EITF reached a consensus on EITF 07-01, Accounting for
Collaborative Agreements. EITF 07-01 prohibits companies from applying the equity method of
accounting to activities performed outside a separate legal entity by a virtual joint
venture. Instead, revenues and costs incurred with third parties in connection with the
collaborative arrangement should be presented gross or net by the collaborators based on the
criteria in EITF Issue No. 99-19, Reporting Revenue Gross as a Principal versus Net as an
Agent, and other applicable accounting literature. The consensus should be applied to
collaborative arrangements in existence at the date of adoption using a modified
retrospective method that requires reclassification in all periods presented for those
arrangements still in effect at the transition date, unless that application is
impracticable. The consensus is
F-21
effective for fiscal years beginning after December 15, 2008. The Company is currently
evaluating EITF 07-01 and its impact, if any, on our 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 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.
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®, PERLANE®, 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.
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. During 2007, 2006, the Transition
Period, the comparable 2004 six months and fiscal 2005, two wholesalers accounted for the
following portions of the Companys net revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED |
|
SIX MONTHS ENDED |
|
YEAR ENDED |
|
|
DECEMBER 31, |
|
DECEMBER 31, |
|
JUNE 30, |
|
|
2007 |
|
2006 |
|
2005 |
|
2004 |
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
McKesson |
|
|
52.2 |
% |
|
|
56.8 |
% |
|
|
54.9 |
% |
|
|
50.8 |
% |
|
|
51.2 |
% |
Cardinal |
|
|
16.9 |
% |
|
|
19.3 |
% |
|
|
18.9 |
% |
|
|
19.7 |
% |
|
|
21.8 |
% |
McKesson is the sole distributor for the Companys PERLANE® and
RESTYLANE® products in the U.S. and Canada.
F-22
Net revenues and the percentage of net revenues for each of the product categories are
as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED |
|
|
SIX MONTHS ENDED |
|
|
YEAR ENDED |
|
|
|
DECEMBER 31, |
|
|
DECEMBER 31, |
|
|
JUNE 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
Acne and acne-related
dermatological products |
|
$ |
246,396 |
|
|
$ |
158,250 |
|
|
$ |
46,053 |
|
|
$ |
59,501 |
|
|
$ |
111,242 |
|
Non-acne dermatological
products |
|
|
178,560 |
|
|
|
157,958 |
|
|
|
96,524 |
|
|
|
80,459 |
|
|
|
177,570 |
|
Non-dermatological products |
|
|
39,695 |
|
|
|
33,035 |
|
|
|
21,377 |
|
|
|
41,207 |
|
|
|
88,087 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
464,651 |
|
|
$ |
349,243 |
|
|
$ |
163,954 |
|
|
$ |
181,167 |
|
|
$ |
376,899 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED |
|
|
SIX MONTHS ENDED |
|
|
YEAR ENDED |
|
|
|
DECEMBER 31, |
|
|
DECEMBER 31, |
|
|
JUNE 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
Acne and acne-related
dermatological products |
|
|
53 |
% |
|
|
45 |
% |
|
|
28 |
% |
|
|
33 |
% |
|
|
30 |
% |
Non-acne dermatological
products |
|
|
38 |
|
|
|
45 |
|
|
|
59 |
|
|
|
44 |
|
|
|
47 |
|
Non-dermatological products |
|
|
9 |
|
|
|
10 |
|
|
|
13 |
|
|
|
23 |
|
|
|
23 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 5. STRATEGIC COLLABORATIONS
On October 9, 2007, the Company entered into a development and license agreement with
an Israeli company for the development of a dermatologic product. Under terms of the
agreement, the Company made an initial payment of $1.5 million upon execution of the
agreement. In addition, the Company will be required to pay $18.0 million upon successful
completion of certain clinical milestones and $5.2 million upon the first commercial sales
of the product in the U.S. The Company will also make royalty payments based on net sales
as defined in the license. The $1.5 million payment was recognized as a charge to research
and development expense during 2007.
On June 19, 2006, the Company entered into an exclusive start-up development agreement
with a German company for the development of a dermatologic product. Under terms of the
agreement, the Company made an initial payment of $1.0 million upon signing of the contract.
The Company 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.
On September 26, 2002, the Company 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, the Company 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, the Company 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.
The license and development agreement included a one-time milestone payment of $1.0 million
payable to Dow the first time the product achieved a specific commercialization milestone
during a 12-month period ending on the anniversary of the products launch date. This
milestone was achieved during the three months ended June 30, 2007, and the $1.0 million
milestone payment was
F-23
accrued for as of June 30, 2007 and recorded as an addition to intangible assets in the
Companys consolidated balance sheets. In accordance with the agreement, the milestone is
payable during the three months ended March 31, 2008.
On June 26, 2002, the Company entered into an exclusive strategic alliance with
AAIPharma, Inc. (AAIPharma) for the development, commercialization and license of a key
dermatologic product. The Company 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 the Company, and provided that AAIPharma would continue to assist the
Company with the development of the product on a fee for services basis. The Company 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, the Company entered into a supply agreement with
AAIPharma for the manufacture of the product by AAIPharma. The Company has the right to
qualify an alternate manufacturing facility, and AAIPharma agreed to assist the Company in
obtaining these qualifications. Upon the approval of the alternate facility and approval of
the product, the Company will pay AAIPharma approximately $1.0 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 the Company the exclusive, worldwide rights to
Ansatas early stage, proprietary antimicrobial peptide technology. In accordance with the
development and license agreement, the Company 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. The Company
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 the Company. 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 the Company, 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. No
milestones have been achieved or paid, beyond the original $30 million payment made on July
15, 2004, since the inception of the agreement.
NOTE 6. INVESTMENT IN REVANCE
On December 11, 2007, the Company announced a strategic collaboration with Revance
Therapeutics, Inc. (Revance), a privately-held, venture-backed development-stage entity,
whereby the Company made an equity investment in Revance and purchased an option to acquire
Revance or to license exclusively in North America Revances novel topical botulinum toxin
type A product currently under clinical development. The consideration to be paid to
Revance upon the Companys exercise of the option will be at an amount that will approximate
the then fair value of Revance or the license of the product under development, as
determined by an independent appraisal. The option period will extend through the end of
Phase 2 testing in the United States. In consideration for the
F-24
Companys $20.0 million payment, the Company received preferred stock representing an
approximate 13.7 percent ownership in Revance, or approximately 11.7 percent on a fully
diluted basis and the option to acquire Revance or to license the product under development. The $20.0 million is expected to be used by Revance primarily for the
development of the new product. $12.0 million of the $20.0 million payment represents the fair value of the investment in Revance at the time of the investment and is included in
other long-term assets in the Companys consolidated balance sheets as of December 31, 2007.
The remaining $8.0 million, which is non-refundable and is expected to be utilized in the
development of the new product, represents the residual value of the option to acquire Revance or to license the product under development and is included in
research and development expense for the three months ended December 31, 2007.
Prior to the exercise of the option, Revance will remain primarily responsible for the
worldwide development of Revances topical botulinum toxin type A product in consultation
with the Company in North America. The Company will assume primary responsibility for the
development of the product should consummation of either a merger or a license for topically
delivered botulinum toxin type A in North America be completed under the terms of the
option. Revance will have sole responsibility for manufacturing the development product and
manufacturing the product during commercialization worldwide. The Companys right to
exercise the option is triggered upon Revances successful completion of certain regulatory
milestones through the end of Phase 2 testing in the United States. A license would contain
a payment upon exercise of the license option, milestone payments related to clinical,
regulatory and commercial achievements, and royalties based on sales defined in the license.
If the Company elects to exercise the option, the financial terms for the acquisition or
license will be determined through an independent valuation in accordance with specified
methodologies.
On a going-forward basis,
in the absence of quantitative valuation metrics, such as a recent financing round, the Company will estimate the
impairment and/or the net realizable value of the investment based on a hypothetical liquidation at book value
approach as of the reporting date. The amount that will be expensed periodically is uncertain due to the timing of expenditures for research and
development, and the charges will not be immediately, if ever, deductible for income tax
purposes and will increase the Companys effective tax rate. Further equity investments, if
any, will also be subject to the same accounting treatment as the Companys original equity
investment.
A business entity is subject to the consolidation rules of FASB Interpretation No. 46,
Consolidation of Variable Interest Entities an Interpretation of Accounting Research
Bulletin No. 51 (FIN 46) and is referred to as a variable interest entity if it lacks
sufficient equity to finance its activities without additional financial support from other
parties or its equity holders lack adequate decision making ability based on criteria set
forth in FIN 46. FIN 46 also requires disclosures about variable interest entities that a
company is not required to consolidate, but in which a company has a significant variable
interest. The Company has determined that Revance is a variable interest entity and that
the Company is not the primary beneficiary, and therefore the Companys equity investment in
Revance currently does not require the Company to consolidate Revance into its financial
statements. The consolidation status could change in the future, however, depending on
changes in the Companys relationship with Revance.
NOTE 7. STRATEGIC COLLABORATION WITH HYPERION
On August 28, 2007, the Company, through its wholly-owned subsidiary Ucyclyd Pharma,
Inc. (Ucyclyd), announced a strategic collaboration with Hyperion Therapeutics, Inc.
(Hyperion) whereby Hyperion will be responsible for the ongoing research and development
of a compound referred to as GT4P for the treatment of Urea Cycle Disorder, Hepatic
Encephalopathies and other indications, and additional indications for AMMONUL®.
Under terms of the Collaboration Agreement between Ucyclyd and Hyperion, dated as of August
23, 2007, Hyperion made an initial non-refundable payment of $10.0 million to the Company
for the rights and licenses granted to Hyperion in the agreement. In accordance with EITF
No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables, and SAB 104,
Revenue Recognition in Financial Statements, this $10.0 million payment was recorded as
deferred revenue and is being recognized on a ratable basis over a period of four years.
The Company recognized approximately $0.8 million of contract revenue during 2007 related to
this transaction. In addition, if certain specified conditions are satisfied relating to
the Ucyclyd development projects, then Hyperion will have certain purchase rights with
respect to the Ucyclyd development products, as well as Ucyclyds existing on-market
products, AMMONUL® and BUPHENYL®, and will pay Ucyclyd royalties and
regulatory and sales milestone payments in connection with certain licenses that would be
granted to Hyperion upon exercise of the purchase rights.
Additionally, Hyperion will be funding all research and development costs for the
Ucyclyd research projects, and will undertake certain sales and marketing efforts for
Ucyclyds existing on-market products.
F-25
Hyperion will receive a commission from Ucyclyd equal to a certain percentage of any
increase in unit sales. Ucyclyd will continue to record product sales for the existing
on-market Ucyclyd products until such time as Hyperion exercises its purchase rights.
Professional fees of approximately $2.2 million were incurred related to the completion
of the agreement with Hyperion. These costs were recognized as general and administrative
expenses during the three months ended September 30, 2007.
NOTE 8. 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 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. 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, as amended, Medicis was obligated to make an
additional $35.1 million payment 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 (including $25.0 million upon the FDAs acceptance of the
Companys Biologics License Application (BLA) for RELOXIN®), $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 December 2036. 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.
On January 30, 2008, the Company received a letter from the FDA stating that, upon a
preliminary review of the Companys BLA for RELOXIN®, the FDA has determined not
to accept the BLA for filing because it is not sufficiently complete to permit a substantive
review. While the Company is uncertain of the impact at this time, the FDAs determination
not to accept the BLA may result in delays in the FDAs substantive response to the BLA.
NOTE 9. 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
F-26
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 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 10. 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
F-27
million per quarter for six quarters beginning in July 2004 for reimbursement of
certain contingent payments as discussed in Note 12. 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 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 operations.
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. Should BioMarin be unable or unwilling to make the required payments, the
Company may be required to record an impairment of the related Ascent goodwill. 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, 2007, BioMarin had paid $88.9 million to Medicis
under the license agreement, which represents all scheduled payments due through that date
under the license agreement.
NOTE 11. 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® and PERLANE® have 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
F-28
approval of RESTYLANE®, $19.4 million in May 2004 upon certain cumulative
commercial milestones being achieved and $29.1 million in May 2007 upon FDA approval of
PERLANE®. Payments and costs related to this acquisition are capitalized as an
intangible asset and are being amortized on a straight-line basis over their useful lives.
The intangible asset will be fully amortized in the first quarter of 2018.
NOTE 12. MERGER OF ASCENT PEDIATRICS, INC.
As part of its merger with Ascent Pediatrics, Inc. (Ascent), which was completed in
November 2001, the Company was 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 15, 2006, subject to certain deductions and set-offs. Payment of
the contingent portion of the purchase price was withheld pending the final outcome of a
litigation matter. The Company distributed the accumulated $27.4 million in Contingent
Payments, representing the first four years 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. The
resulting $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 13. 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. The Companys investments in
auction rate floating securities consist primarily of investments in student loans.
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, 2007, the Company has recorded the estimated fair value in available-for-sale securities
for short-term and long-term investments of approximately $686.6 million and $17.1 million,
respectively.
F-29
Available-for-sale securities consist of the following at December 31, 2007 and 2006
(amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, 2007 |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
Corporate notes and bonds |
|
$ |
283,248 |
|
|
$ |
498 |
|
|
$ |
(624 |
) |
|
$ |
283,122 |
|
Federal agency notes and bonds |
|
|
206,308 |
|
|
|
968 |
|
|
|
|
|
|
|
207,276 |
|
Auction rate floating securities |
|
|
101,649 |
|
|
|
1 |
|
|
|
|
|
|
|
101,650 |
|
Asset-backed securities |
|
|
76,936 |
|
|
|
399 |
|
|
|
(83 |
) |
|
|
77,252 |
|
Commercial paper |
|
|
34,409 |
|
|
|
3 |
|
|
|
(6 |
) |
|
|
34,406 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
702,550 |
|
|
$ |
1,869 |
|
|
$ |
(713 |
) |
|
$ |
703,706 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, 2006 |
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
Corporate notes and bonds |
|
$ |
165,993 |
|
|
$ |
32 |
|
|
$ |
(168 |
) |
|
$ |
165,857 |
|
Federal agency notes and bonds |
|
|
219,067 |
|
|
|
49 |
|
|
|
(134 |
) |
|
|
218,982 |
|
Auction rate floating securities |
|
|
37,850 |
|
|
|
|
|
|
|
|
|
|
|
37,850 |
|
Asset-backed securities |
|
|
48,726 |
|
|
|
27 |
|
|
|
(37 |
) |
|
|
48,716 |
|
Commercial paper |
|
|
9,828 |
|
|
|
|
|
|
|
(1 |
) |
|
|
9,827 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
481,464 |
|
|
$ |
108 |
|
|
$ |
(340 |
) |
|
$ |
481,232 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During 2007, 2006, the Transition Period, the comparable six month period in 2004 and
fiscal 2005, the gross realized gains on sales of available-for-sale securities totaled
$104,777, $430,122, $658, $217,361 (unaudited) and $231,766, respectively, and the gross
realized losses totaled $0, $8,547, $599,200, $320,382 (unaudited) and $1,117,366,
respectively. Such amounts of gains and losses are determined based on the specific
identification method. The net adjustment to unrealized gains during 2007, 2006, the
Transition Period, the comparable six month period in 2004 and fiscal 2005 on
available-for-sale securities included in stockholders equity totaled $884,854, $235,718,
$636,777, $(107,204) (unaudited) and $(75,721), respectively. The amortized cost and
estimated fair value of the available-for-sale securities at December 31, 2007, by maturity,
are shown below (amounts in thousands).
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, 2007 |
|
|
|
|
|
|
|
Estimated |
|
|
|
Cost |
|
|
Fair Value |
|
Available-for-sale |
|
|
|
|
|
|
|
|
Due in one year or less |
|
$ |
409,569 |
|
|
$ |
409,543 |
|
Due after one year through five years |
|
|
191,332 |
|
|
|
192,513 |
|
Due after five years through 10 years |
|
|
|
|
|
|
|
|
Due after 10 years |
|
|
101,649 |
|
|
|
101,650 |
|
|
|
|
|
|
|
|
|
|
$ |
702,550 |
|
|
$ |
703,706 |
|
|
|
|
|
|
|
|
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. At
December 31, 2007, approximately $17.1 million in estimated fair value expected to mature
greater than one year has been classified as long-term investments since these investments
are in an unrealized loss position, and it is managements intent to hold these investments
until recovery of fair value, which may be maturity.
As of December 31, 2007, the Companys short-term investments included $101.7 million
of auction rate floating securities. The Companys auction rate floating securities are
debt instruments with a long-term maturity and with an interest rate that is reset in short
intervals through auctions. The recent negative conditions in the credit
markets have prevented some investors from liquidating their holdings, including their
holdings of auction rate
F-30
floating securities. During February 2008 the Company was informed
that there was insufficient demand at auction for approximately $43.6 million of the
Companys auction rate floating securities. As a result, these affected auction rate
floating securities are now not considered liquid, and the Company could be required to hold
them until they are redeemed by the holder at maturity. The negative credit markets may
affect the Companys other auction rate floating securities as they cycle through the
auction process. The Company may not be able to make the securities liquid until a future
auction on these investments is successful.
At this time, the Company has not obtained sufficient evidence to conclude that the fair
value of these auction rate floating securities is less than their carrying value or that
they will not be settled in the short-term, although the market for these investments is currently uncertain. All of the Companys auction rate floating
securities held as of December 31, 2007 successfully re-set at auction at the first auction
interval subsequent to December 31, 2007, and the Company subsequently liquidated
approximately $56.8 million of its auction rate floating securities at par. As of February
26, 2008, the Company had approximately $44.9 million of auction rate floating securities.
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, 2007 (amounts in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than 12 Months |
|
|
Greater Than 12 Months |
|
|
|
|
|
|
|
Gross |
|
|
|
|
|
|
Gross |
|
|
|
Fair |
|
|
Unrealized |
|
|
Fair |
|
|
Unrealized |
|
|
|
Value |
|
|
Loss |
|
|
Value |
|
|
Loss |
|
Corporate notes and bonds |
|
$ |
114,905 |
|
|
$ |
615 |
|
|
$ |
17,471 |
|
|
$ |
8 |
|
Federal agency notes and bonds |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Auction rate floating securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asset-backed securities |
|
|
6,294 |
|
|
|
83 |
|
|
|
309 |
|
|
|
1 |
|
Commercial paper |
|
|
25,252 |
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
146,451 |
|
|
$ |
704 |
|
|
$ |
17,780 |
|
|
$ |
9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, 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, 2007.
NOTE 14. 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. No contingent
interest related to the Old Notes was payable at December 31, 2007. 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, June 4, 2012 and June 4, 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. Pursuant to
SFAS No. 48, Classification of Obligations That Are Callable by the Creditor, if an
obligation is due on demand or will be due on demand within one year from the balance sheet
date, even though liquidation may not be expected within that period, it should be
classified as a current liability. Accordingly, the outstanding balance of Old Notes along
with the deferred tax liability associated with accelerated interest deductions on the Old
Notes will be classified as a current liability during the respective twelve month periods
prior to June 4, 2007, June 4, 2012 and June 4, 2017. As of December 31, 2006, $169.2
million of the Old Notes and $24.0 million of deferred tax liabilities were classified as
current liabilities in the Companys consolidated balance sheets. All Old Notes for which
the holders did not request to have their Old Notes repurchased by the Company were
reflected in long-term liabilities at December 31, 2007.
F-31
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 amortized these costs over the first five-year Put
period, which ran through June 4, 2007.
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 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. No contingent interest related to the New Notes was payable at December
31, 2007. 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, June 4, 2013 and June 4, 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. Pursuant to
SFAS No. 48, Classification of Obligations That Are Callable by the Creditor, if an
obligation is due on demand or will be due on demand within one year from the balance sheet
date, even though liquidation may not be expected within that period it should be classified
as a current liability. Accordingly, the outstanding balance of New Notes along with the
deferred tax liability associated with the accelerated interest deductions on the New Notes
will be classified as a current liability during the respective twelve months periods prior
to June 4, 2008, June 4, 2013 and June 4, 2018. As of December 31, 2007, $283.9 million of
the New Notes and $30.6 million of deferred tax liabilities were classified as current
liabilities in the Companys consolidated balance sheets. If all of the New Notes are put
back to the Company on June 4, 2008, the Company would be required to pay $283.9 million in
outstanding principal, plus accrued interest. The Company would also be required to pay the
accumulated deferred tax liability related to the New Notes.
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 |
F-32
|
|
|
$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.
Contingent interest was not payable during the initial six-month period commencing June
4, 2007, and is not payable for the six-month period commencing December 4, 2007, as the
average trading price of the Old Notes did not reach certain thresholds.
As of July 11, 2007, the closing date of the first period whereby holders had the
option to require the Company to purchase their Old Notes for cash, holders of $5,000 of
outstanding principal amounts of the Old Notes exercised their right to require the Company
to purchase their Old Notes for cash.
F-33
The following is a quarterly summary of whether or not the criteria for the right of
conversion into shares of the Companys Class A common stock for holders of the Old Notes
and New Notes were met during 2007, 2006, the Transition Period and fiscal 2005. The right
of conversion is triggered by the stock closing above $31.96 and $46.51 for the Old Notes
and New Notes, respectively, on 20 of the last 30 trading days and the last trading day of a
quarter. If the criteria is met, the holders of the Old Notes and New Notes have the right
to convert their Old Notes and New Notes, respectively, into shares during the subsequent
quarterly period.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding |
|
|
|
|
|
Outstanding |
|
|
Conversion |
|
Principal Amounts |
|
Conversion |
|
Principal Amounts |
|
|
Eligibility |
|
of Old Notes |
|
Eligibility |
|
of New Notes |
|
|
Criteria Met |
|
Converted During |
|
Criteria Met |
|
Converted During |
Quarter Ended |
|
For Old Notes? |
|
Subsequent Quarter |
|
For New Notes? |
|
Subsequent Quarter |
December 31, 2007 |
|
No |
|
|
N/A |
|
|
No |
|
|
N/A |
|
September 30, 2007 |
|
No |
|
|
N/A |
|
|
No |
|
|
N/A |
|
June 30, 2007 |
|
No |
|
|
N/A |
|
|
No |
|
|
N/A |
|
March 31, 2007 |
|
No |
|
|
N/A |
|
|
No |
|
|
N/A |
|
December 31, 2006 |
|
Yes |
|
$ |
5,000 |
|
|
No |
|
|
N/A |
|
September 30, 2006 |
|
No |
|
|
N/A |
|
|
No |
|
|
N/A |
|
June 30, 2006 |
|
No |
|
|
N/A |
|
|
No |
|
|
N/A |
|
March 31, 2006 |
|
No |
|
|
N/A |
|
|
No |
|
|
N/A |
|
December 31, 2005 |
|
Yes |
|
$ |
|
|
|
No |
|
|
N/A |
|
September 30, 2005 |
|
Yes |
|
$ |
|
|
|
No |
|
|
N/A |
|
June 30, 2005 |
|
No |
|
|
N/A |
|
|
No |
|
|
N/A |
|
March 31, 2005 |
|
No |
|
|
N/A |
|
|
No |
|
|
N/A |
|
December 31, 2004 |
|
Yes |
|
$ |
|
|
|
No |
|
|
N/A |
|
September 30, 2004 |
|
Yes |
|
$ |
|
|
|
No |
|
|
N/A |
|
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.
NOTE 15. 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 $2.5 million, $2.2 million, $1.2 million, $1.1
million (unaudited) and $2.3 million for 2007, 2006, the Transition Period, the comparable
2004 six months and fiscal 2005, 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, as extended, that expires in June 2009.
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 the second quarter of 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, occurred in May 2007.
F-34
At December 31, 2007, approximate future lease payments under the Companys operating
leases are as follows (amounts in thousands):
|
|
|
|
|
YEAR ENDING DECEMBER 31, |
|
|
|
|
2008 |
|
$ |
2,624 |
|
2009 |
|
|
5,010 |
|
2010 |
|
|
6,376 |
|
2011 |
|
|
4,324 |
|
2012 |
|
|
4,353 |
|
Thereafter |
|
|
35,388 |
|
|
|
|
|
|
|
$ |
58,075 |
|
|
|
|
|
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, 2007, 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
On January 15, 2008, IMPAX Laboratories, Inc. filed a lawsuit against the Company in
the United States District Court for the Northern District of California seeking a
declaratory judgment that our U.S. Patent No. 5,908,838 related to SOLODYN® is
invalid and is not infringed by IMPAXs filing of an Abbreviated New Drug
Application for a generic version of SOLODYN®.
On April 25, 2007, the Company entered into a Settlement Agreement with the Justice
Department, the Office of Inspector General of the Department of Health and Human Services
(OIG) and the TRICARE Management Activity (collectively, the United States) and private
complainants to settle all outstanding federal and state civil suits against the Company in
connection with claims related to the Companys alleged off-label marketing and promotion of
LOPROX® and LOPROX® TS products to pediatricians during periods prior
to the Companys May 2004 disposition of its pediatric sales division (the Settlement
Agreement). The settlement is neither an admission of liability by the Company nor a
concession by the United States that its claims are not well founded. Pursuant to the
Settlement Agreement, the Company agreed to pay approximately $10 million to settle the
matter. Pursuant to the Settlement Agreement, the United States released the Company from
the claims asserted by the United States and agreed to refrain from instituting action
seeking exclusion from Medicare, Medicaid, the TRICARE Program and other federal health care
programs for the alleged conduct. These releases relate solely to the allegations related
to the Company and do not cover individuals. The Settlement Agreement also provides that
the private complainants release the Company and its officers, directors and employees from
the asserted claims, and the Company releases the United States and the private complainants
from asserted claims. During 2006, the Company 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. During the
three months ended June 30, 2007, $5.8 million of the settlement amount was paid pursuant to
the terms of the Settlement Agreement, and the remaining $4.4 million of the settlement
amount was paid during the three months ended September 30, 2007. The $10.2 million is
included in selling, general and administrative expenses in the accompanying consolidated
statements of operations for 2006.
As part of the Settlement Agreement, the Company has entered into a five-year Corporate
Integrity Agreement (the CIA) with the OIG to resolve any potential administrative claims
the OIG may have arising out of the governments investigation. The CIA acknowledges the
existence of the Companys comprehensive existing compliance program and provides for
certain other compliance-related activities during the term of the CIA, including the
maintenance of a compliance program that, among other things, is designed to ensure
compliance with the CIA, federal health care programs and FDA requirements. Pursuant to the
CIA, the Company is required to notify the OIG, in writing, of: (i) any ongoing government
investigation or legal proceeding involving an allegation that the Company has committed a
crime or has engaged in fraudulent activities; (ii) any other matter that a reasonable
person would consider a probable violation of applicable criminal, civil, or administrative
laws; (iii) any
F-35
written report, correspondence, or communication to the FDA that materially discusses
any unlawful or improper promotion of the Companys products; and (iv) any change in
location, sale, closing, purchase, or establishment of a new business unit or location
related to items or services that may be reimbursed by Federal health care programs. The
Company is also subject to periodic reporting and certification requirements attesting that
the provisions of the CIA are being implemented and followed, as well as certain document
and record retention mandates. Failure to comply under the CIA could result in substantial
civil or criminal penalties and being excluded from government health care programs, which
would materially reduce our sales and adversely affect our financial condition and results
of operations.
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. As a result of the investigation, prosecutions and
other proceedings, certain past and present sales and marketing
employees and officers are likely to separate from the Company and,
together with the cost of their defense, fines and penalties, could
have a material impact on our reputation, business and financial
condition.
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 16. INCOME TAXES
The provision for income taxes consists of the following (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED |
|
|
SIX MONTHS ENDED |
|
|
YEAR ENDED |
|
|
|
DECEMBER 31, |
|
|
DECEMBER 31, |
|
|
JUNE 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
Current |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
31,639 |
|
|
$ |
14,172 |
|
|
$ |
26,780 |
|
|
$ |
13,392 |
|
|
$ |
27,516 |
|
State |
|
|
186 |
|
|
|
1,415 |
|
|
|
1,543 |
|
|
|
822 |
|
|
|
1,215 |
|
Foreign |
|
|
3,194 |
|
|
|
3,870 |
|
|
|
750 |
|
|
|
110 |
|
|
|
156 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
35,019 |
|
|
|
19,457 |
|
|
|
29,073 |
|
|
|
14,324 |
|
|
|
28,887 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
15,552 |
|
|
|
(58,068 |
) |
|
|
1,366 |
|
|
|
(2,854 |
) |
|
|
4,456 |
|
State |
|
|
473 |
|
|
|
(2,185 |
) |
|
|
45 |
|
|
|
(142 |
) |
|
|
787 |
|
Foreign |
|
|
|
|
|
|
|
|
|
|
18 |
|
|
|
|
|
|
|
(18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,025 |
|
|
|
(60,253 |
) |
|
|
1,429 |
|
|
|
(2,996 |
) |
|
|
5,225 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
51,044 |
|
|
$ |
(40,796 |
) |
|
$ |
30,502 |
|
|
$ |
11,328 |
|
|
$ |
34,112 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current income tax expense does not reflect the benefit of $2.6 million, $3.9 million,
$0.1 million, $5.1 million (unaudited) and $5.1 million for 2007, 2006, the Transition
Period, the comparable 2004 six months and fiscal 2005, 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-36
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 |
|
|
|
YEARS ENDED |
|
|
SIX MONTHS ENDED |
|
|
ENDED |
|
|
|
DECEMBER 31, |
|
|
DECEMBER 31, |
|
|
JUNE 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
Statutory federal income tax rate |
|
|
35.0 |
% |
|
|
(35.0 |
)% |
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
State tax rate, net of federal benefit |
|
|
0.8 |
|
|
|
(1.1 |
) |
|
|
1.3 |
|
|
|
1.4 |
|
|
|
1.4 |
|
Share-based payments |
|
|
0.4 |
|
|
|
1.9 |
|
|
|
1.6 |
|
|
|
|
|
|
|
|
|
Foreign taxes |
|
|
1.6 |
|
|
|
2.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax exposures reserve |
|
|
(0.4 |
) |
|
|
(4.2 |
) |
|
|
1.4 |
|
|
|
|
|
|
|
0.1 |
|
Non-deductible items |
|
|
1.2 |
|
|
|
3.2 |
|
|
|
0.6 |
|
|
|
|
|
|
|
1.2 |
|
Tax-exempt interest |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2.4 |
) |
|
|
(1.0 |
) |
Credits and other |
|
|
(0.7 |
) |
|
|
(2.2 |
) |
|
|
(1.9 |
) |
|
|
0.8 |
|
|
|
(2.3 |
) |
Valuation allowance |
|
|
2.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
40.5 |
% |
|
|
(35.0 |
)% |
|
|
38.0 |
% |
|
|
34.8 |
% |
|
|
34.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
2007 |
|
|
2006 |
|
|
|
Current |
|
|
Long-term |
|
|
Current |
|
|
Long-term |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards |
|
$ |
|
|
|
$ |
4,959 |
|
|
$ |
|
|
|
$ |
5,340 |
|
Reserves and liabilities |
|
|
19,373 |
|
|
|
774 |
|
|
|
22,963 |
|
|
|
|
|
Unrealized losses on securities |
|
|
|
|
|
|
|
|
|
|
84 |
|
|
|
|
|
Excess of net book value over tax
basis of intangible assets |
|
|
|
|
|
|
64,928 |
|
|
|
|
|
|
|
68,105 |
|
Share-based payment awards |
|
|
|
|
|
|
15,946 |
|
|
|
|
|
|
|
10,199 |
|
Depreciation on property and equipment |
|
|
|
|
|
|
249 |
|
|
|
|
|
|
|
38 |
|
Capital loss carryover |
|
|
|
|
|
|
3,765 |
|
|
|
|
|
|
|
426 |
|
Charitable contributions, other |
|
|
|
|
|
|
2,623 |
|
|
|
|
|
|
|
1,783 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19,373 |
|
|
|
93,244 |
|
|
|
23,047 |
|
|
|
85,891 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains on securities |
|
|
(418 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Bond interest |
|
|
(30,639 |
) |
|
|
(30,537 |
) |
|
|
(23,993 |
) |
|
|
(20,657 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(31,057 |
) |
|
|
(30,537 |
) |
|
|
(23,993 |
) |
|
|
(20,657 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Valuation allowance |
|
|
|
|
|
|
(3,262 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax (liabilities) assets |
|
$ |
(11,684 |
) |
|
$ |
59,445 |
|
|
$ |
(946 |
) |
|
$ |
65,234 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2007, the Company has a federal net operating loss carryforward of
approximately $14.2 million, of which approximately $1.1 million will expire each year from
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 $14.2 million is net of the Section 382 limitation, thus
representing the Companys estimate of the net operating loss carryforward that will be
realized.
At December 31, 2007, the Company had a charitable contribution carryover of
approximately $6.3 million. Approximately $2.1 million, $3.0 million and $1.2 million of the
charitable contribution carryover will expire in 2008, 2011 and 2012, respectively, if not
utilized. Additionally, at December 31, 2007 the Company has an unrealized tax loss of $9.3
million related to the Companys option to acquire Revance or license Revances product that
is under development. The Company has currently assessed that the unrealized loss would
result in a capital loss carryover if realized. Due to tax limitations on the utilization
of capital loss carryovers, the Company has recorded a valuation allowance of $3.3 million
against the capital loss carryover at December 31, 2007.
F-37
The Company recorded a deferred tax liability of $418,000 relating to unrealized gains
on available-for-sale-securities for 2007 and recorded a deferred tax asset of approximately
$84,000, $215,000, $617,000 (unaudited) and $586,000 for 2006, the Transition Period, the
comparable 2004 six months and fiscal 2005,
respectively, relating to unrealized losses on available-for-sale securities presented
in other comprehensive income in stockholders equity.
During 2007, 2006, the Transition Period, the comparable 2004 six months and fiscal
2005, the Company made net tax payments of $35.4 million, $35.7 million, $11.8 million, $3.1
million (unaudited) and $13.9 million, respectively.
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 Internal
Revenue Service has recently informed the Company that the tax return for the Transition
Period ending December 31, 2005 has been selected for a limited scope examination.
The Company owns two subsidiaries that file corporate tax returns in Sweden. The
Swedish tax authorities examined the tax return of one of the subsidiaries for fiscal 2004.
The examiners issued a no change letter, and the examination is complete. The Companys
other subsidiary in Sweden has not been examined by the Swedish tax authorities. The
Swedish statute of limitation may be open for up to five years from the date the tax return
was filed. Thus, all returns filed since this entitys formation in fiscal 2003 are open
under the statute of limitation.
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 and the Arizona Department of Revenue have agreed to
the resolution of certain proposed adjustments. The Company expects to pay $315,000 within
the next twelve months as part of the settlement negotiation, and is included in income
taxes payable in the Companys consolidated balance sheets as of December 31, 2007.
Effective January 1, 2007, the Company adopted FIN No. 48, Accounting for Uncertainty
in Income Taxes. In accordance with FIN No. 48, the Company recognized a cumulative-effect
adjustment of approximately $808,000, increasing its liability for unrecognized tax
benefits, interest, and penalties and reducing the January 1, 2007 balance of retained
earnings. A reconciliation of the beginning and ending amount of unrecognized tax benefits
is as follows (amounts in thousands):
|
|
|
|
|
Balance at January 1, 2007 |
|
$ |
3,000 |
|
Additions based on tax positions related to the current year |
|
|
|
|
Additions for tax positions of prior years |
|
|
200 |
|
Reductions for tax positions of prior years |
|
|
(1,100 |
) |
Settlements |
|
|
|
|
Reductions due to lapse in statute of limitations |
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
$ |
2,100 |
|
|
|
|
|
The amount of unrecognized tax benefits which, if ultimately recognized, could
favorably affect the effective tax rate in a future period is $1.8 million as of January 1, 2007 and $1.4 million as of December 31, 2007.
The Company recognizes accrued interest and penalties, if applicable, related to
unrecognized tax benefits in income tax expense. During the Transition Period ended
December 31, 2005 and the years ended December 31, 2006 and 2007, the Company did not
recognize a material amount in interest and penalties. The Company had approximately
$200,000 and $250,000 for the payment of interest and penalties accrued at December 31,
2007, and 2006, respectively.
NOTE 17. SHARE REPURCHASE PROGRAM
On August 29, 2007, the Companys Board of Directors approved a stock trading plan to
purchase up to $200.0 million in aggregate value of shares of Medicis Class A common stock
upon satisfaction of certain conditions. The number of shares to be repurchased and the
timing of the repurchases (if any) will depend on factors such as the market price of
Medicis Class A common stock, economic and market conditions, and corporate and regulatory
requirements.
F-38
The plan is scheduled to terminate on the earlier of the first anniversary of
the plan or at the time when the aggregate purchase limit is reached. As of December 31,
2007, no shares had been repurchased under this plan.
NOTE 18. DIVIDENDS DECLARED ON COMMON STOCK
During 2007, 2006, the Transition Period, the comparable 2004 six months and fiscal
2005, the Company paid quarterly cash dividends aggregating $6.8 million, $6.6 million, $3.3
million, $3.1 million (unaudited) and $6.4 million, respectively, on its common stock. In
addition, on December 12, 2007, the Company declared a cash dividend of $0.03 per issued and
outstanding share of common stock payable on January 31, 2008 to stockholders of record at
the close of business on January 2, 2008. 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, 2007. The Company has not
adopted a dividend policy.
NOTE 19. STOCK OPTION PLANS
As of December 31, 2007, 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, 2007, 11,666,955 options were outstanding under these Plans. 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, 2007 vary in price from $10.13 to $39.04, with a weighted average exercise
price of $27.99 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 |
|
$10.13 - $11.00 |
|
|
657,577 |
|
|
|
1.57 |
|
|
$ |
10.97 |
|
|
|
657,577 |
|
|
$ |
10.97 |
|
$11.53 - $18.33 |
|
|
1,620,504 |
|
|
|
4.19 |
|
|
$ |
17.86 |
|
|
|
1,620,504 |
|
|
$ |
17.86 |
|
$18.57 - $26.90 |
|
|
483,333 |
|
|
|
4.27 |
|
|
$ |
23.48 |
|
|
|
428,643 |
|
|
$ |
23.42 |
|
$26.95 - $26.95 |
|
|
1,464,244 |
|
|
|
3.54 |
|
|
$ |
26.95 |
|
|
|
1,464,244 |
|
|
$ |
26.95 |
|
$26.98 - $27.63 |
|
|
1,621,594 |
|
|
|
2.61 |
|
|
$ |
27.62 |
|
|
|
1,615,294 |
|
|
$ |
27.63 |
|
$27.70 - $29.13 |
|
|
105,310 |
|
|
|
4.99 |
|
|
$ |
28.34 |
|
|
|
87,130 |
|
|
$ |
28.31 |
|
$29.20 - $29.20 |
|
|
1,998,590 |
|
|
|
5.58 |
|
|
$ |
29.20 |
|
|
|
1,479,452 |
|
|
$ |
29.20 |
|
$29.25 - $32.56 |
|
|
1,249,480 |
|
|
|
5.83 |
|
|
$ |
31.57 |
|
|
|
745,281 |
|
|
$ |
31.15 |
|
$32.81 - $36.06 |
|
|
193,553 |
|
|
|
7.80 |
|
|
$ |
33.77 |
|
|
|
52,280 |
|
|
$ |
33.77 |
|
$38.45 - $39.04 |
|
|
2,272,770 |
|
|
|
6.55 |
|
|
$ |
38.49 |
|
|
|
1,174,738 |
|
|
$ |
38.52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11,666,955 |
|
|
|
4.69 |
|
|
$ |
27.99 |
|
|
|
9,325,143 |
|
|
$ |
26.40 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-39
A summary of stock options granted within the Plans and related information for 2007,
2006, the Transition Period and fiscal 2005 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Qualified |
|
Non-Qualified |
|
Total |
|
Price |
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
119,553 |
|
|
|
119,553 |
|
|
$ |
33.75 |
|
Exercised |
|
|
(270,194 |
) |
|
|
(621,545 |
) |
|
|
(891,739 |
) |
|
$ |
20.65 |
|
Terminated/expired |
|
|
(29,948 |
) |
|
|
(519,922 |
) |
|
|
(549,870 |
) |
|
$ |
32.70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2007 |
|
|
625,647 |
|
|
|
11,041,308 |
|
|
|
11,666,955 |
|
|
$ |
27.99 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-40
NOTE 20. NET INCOME (LOSS) PER COMMON SHARE
The following table sets forth the computation of basic and diluted net income (loss) per
common share (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEAR |
|
|
|
YEARS ENDED |
|
|
SIX MONTHS ENDED |
|
|
ENDED |
|
|
|
DECEMBER 31, |
|
|
DECEMBER 31, |
|
|
JUNE 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
|
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Unaudited) |
|
|
|
|
|
BASIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
75,051 |
|
|
$ |
(75,849 |
) |
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares outstanding |
|
|
55,988 |
|
|
|
54,688 |
|
|
|
54,323 |
|
|
|
55,972 |
|
|
|
55,196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per common
share |
|
$ |
1.34 |
|
|
$ |
(1.39 |
) |
|
$ |
0.92 |
|
|
$ |
0.38 |
|
|
$ |
1.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
75,051 |
|
|
$ |
(75,849 |
) |
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax-effected interest expense and
issue costs related to Old Notes |
|
|
2,950 |
|
|
|
|
|
|
|
1,677 |
|
|
|
1,675 |
|
|
|
3,347 |
|
Tax-effected interest expense and
issue costs related to New Notes |
|
|
3,357 |
|
|
|
|
|
|
|
1,677 |
|
|
|
1,677 |
|
|
|
3,353 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) assuming dilution |
|
$ |
81,358 |
|
|
$ |
(75,849 |
) |
|
$ |
53,075 |
|
|
$ |
24,575 |
|
|
$ |
71,690 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares outstanding |
|
|
55,988 |
|
|
|
54,688 |
|
|
|
54,323 |
|
|
|
55,972 |
|
|
|
55,196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Old Notes |
|
|
5,823 |
|
|
|
|
|
|
|
5,823 |
|
|
|
5,823 |
|
|
|
5,823 |
|
New Notes |
|
|
7,325 |
|
|
|
|
|
|
|
7,325 |
|
|
|
7,325 |
|
|
|
7,325 |
|
Stock options and restricted stock |
|
|
2,110 |
|
|
|
|
|
|
|
2,301 |
|
|
|
3,040 |
|
|
|
2,565 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares assuming dilution |
|
|
71,246 |
|
|
|
54,688 |
|
|
|
69,772 |
|
|
|
72,160 |
|
|
|
70,909 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income (loss) per
common share |
|
$ |
1.14 |
|
|
$ |
(1.39 |
) |
|
$ |
0.76 |
|
|
$ |
0.34 |
|
|
$ |
1.01 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 share is calculated by adjusting net 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.
The diluted net income per common share computation for 2007 excludes 3,585,908 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.
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
F-41
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 whose exercise price
were greater than the average market price of the common shares during the period and were
anti-dilutive.
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 excludes 2,734,600
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 period and
were anti-dilutive.
NOTE 21. 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 Companys investment policy requires it to place its investments
with high-credit quality counterparties, and requires investments in debt securities with
original maturities of greater than six months to 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, 2007 and 2006, two customers comprised approximately 93.9% and 68.5%,
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, 2007.
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 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 2007,
2006, the Transition Period and fiscal 2005 the Company also made a discretionary
contribution to the plan. During 2007, 2006, the Transition Period, the comparable 2004 six
months and fiscal 2005, the Company recognized expense
related to matching and discretionary contributions under the Contribution Plan of
$2,280,000, $1,436,000, $442,000, $162,000 (unaudited) and $803,000, respectively.
F-42
NOTE 23. QUARTERLY FINANCIAL INFORMATION (UNAUDITED)
The tables below list the quarterly financial information for 2007 and 2006. 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, 2007 |
|
|
(FOR THE QUARTERS ENDED) |
|
|
MARCH 31, 2007 (a) |
|
JUNE 30, 2007 (b) |
|
SEPTEMBER 30, 2007 (c) |
|
DECEMBER 31, 2007 (d) |
Net revenues |
|
$ |
95,114 |
|
|
$ |
108,864 |
|
|
$ |
120,422 |
|
|
$ |
140,251 |
|
Gross profit (1) |
|
|
84,617 |
|
|
|
94,853 |
|
|
|
102,961 |
|
|
|
131,253 |
|
Net income |
|
|
9,288 |
|
|
|
15,523 |
|
|
|
22,761 |
|
|
|
27,479 |
|
Basic net income
per common share |
|
$ |
0.17 |
|
|
$ |
0.28 |
|
|
$ |
0.41 |
|
|
$ |
0.49 |
|
Diluted net income
per common share |
|
$ |
0.15 |
|
|
$ |
0.24 |
|
|
$ |
0.34 |
|
|
$ |
0.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEAR ENDED DECEMBER 31,
2006 |
|
|
(FOR THE QUARTERS ENDED) |
|
|
MARCH 31, 2006 (e) |
|
JUNE 30, 2006 (f) |
|
SEPTEMBER 30, 2006 (g) |
|
DECEMBER 31, 2006 (h) |
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 |
|
|
|
|
(1) |
|
Gross profit does not include amortization of the related intangibles. |
Quarterly results were impacted by the following items:
|
|
|
(a) |
|
Operating expenses included approximately $5.5 million of compensation expense
related to stock options and restricted stock. |
|
(b) |
|
Operating expenses included approximately $5.6 million of compensation expense
related to stock options and restricted stock and approximately $4.1 million for the
write-down of an intangible asset. |
|
(c) |
|
Operating expenses included approximately $4.5 million of compensation expense
related to stock options and restricted stock and approximately $2.2 million of
professional fees related to the Companys strategic collaboration with Hyperion. |
|
(d) |
|
Operating expenses included approximately $9.3 million related to the Companys
option to acquire Revance or to license Revances product currently under
development, including approximately $1.3 million of professional fees incurred
related to the transaction, and approximately $5.5 million of compensation expense
related to stock options and restricted stock. |
|
(e) |
|
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. |
|
(f) |
|
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. |
|
(g) |
|
Operating expenses included approximately $52.6 million for the write-down of
intangible 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. |
|
(h) |
|
Operating expenses included approximately $4.9 million of compensation expense
related to stock options and restricted stock. |
F-43
SCHEDULE II VALUATION AND QUALIFYING ACCOUNTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
Charged to |
|
|
|
|
|
|
|
|
|
|
beginning of |
|
costs and |
|
Charged to |
|
|
|
|
|
Balance at |
Description |
|
period |
|
expenses |
|
other accounts |
|
Deductions |
|
end of period |
|
|
|
|
(in thousands) |
|
|
|
|
|
|
Year Ended December 31, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted from Asset Accounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances |
|
$ |
37,443 |
|
|
$ |
43,134 |
|
|
|
|
|
|
$ |
(69,919 |
) |
|
$ |
10,658 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
S-1