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, 2009.
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 001-14471
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 or other jurisdiction
of incorporation or organization)
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(I.R.S. Employer Identification No.) |
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7720 N. Dobson Road, Scottsdale, Arizona
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85256-2740 |
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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
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Name of each exchange on which registered |
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Class A common stock, $0.014 par value
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New York Stock Exchange |
Preference Share Purchase Rights |
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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
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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 whether the registrant has submitted electronically and posted on its corporate Web site, if any,
every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation
S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes o 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 definition of large accelerated filer,
accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act.
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Large accelerated filer þ
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Accelerated filer o
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Non-accelerated filer o
(do not check if a smaller reporting company)
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act) Yes o No þ
The aggregate market value of the voting stock held on June 30, 2009 by non-affiliates of the
registrant was $932,202,872 based on the closing price of $16.32 per share as reported on the New
York Stock Exchange on June 30, 2009, 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 ten percent or more of the voting power of the
registrants common stock, without conceding that such persons are affiliates of the registrant
for purposes of the federal securities laws). As of February 23, 2010, there were 59,886,025
outstanding shares of Class A common stock, including 1,888,950 shares of unvested restricted stock
awards.
Documents incorporated by reference:
Portions of the Proxy Statement for the registrants
2010 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.
PART I
The Company
Medicis Pharmaceutical Corporation (Medicis, the Company, or as used in the context of
we, us or our), together with our wholly owned subsidiaries, is 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 United States
(U.S.) of products for the treatment of dermatological and aesthetic conditions. We also market
products in Canada for the treatment of dermatological and aesthetic conditions and began
commercial efforts in Europe with our acquisition of LipoSonix, Inc. (LipoSonix) in July 2008.
We believe that the U.S. market for dermatological pharmaceutical sales exceeds $6 billion
annually. According to the American Society for Aesthetic Plastic Surgery (ASAPS), a national
not-for-profit organization for education and research in cosmetic plastic surgery, over 10.2
million cosmetic surgical and non-surgical procedures were performed in the U.S. during 2008,
including approximately 8.5 million non-surgical cosmetic procedures. LipoSonix, now known as
Medicis Technologies Corporation, is a medical device company developing non-invasive body
sculpting technology. In the U.S., the LIPOSONIXTM system is an investigational device
and is currently not cleared or approved for sale. We believe the U.S. non-invasive fat ablation
market could be several hundred million dollars annually.
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 the leading plastic surgeons in the U.S.
We offer a broad range of products addressing various conditions or aesthetic improvements,
including facial wrinkles, acne, fungal infections, rosacea, hyperpigmentation, photoaging,
psoriasis, seborrheic dermatitis and cosmesis (improvement in the texture and appearance of skin).
We currently offer 17 branded products. Our primary brands are DYSPORTTM
(abobotulinumtoxinA) 300 Units for Injection, the LIPOSONIXTM system,
PERLANE® Injectible Gel, RESTYLANE® Injectible Gel, SOLODYN®
(minocycline HCl, USP) Extended Release Tablets, TRIAZ® (benzoyl peroxide) 3%, 6% and 9%
Cleansers, Gels and Pads, and 3% and 6% Foaming Cloths, 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.
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, non-invasive body sculpting
technology and contract revenue. Our non-dermatological field also includes contract revenues
associated with licensing agreements and authorized generic agreements. The following table sets
forth the percentage of net revenues for each of our product categories for 2009, 2008 and 2007:
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Product Category |
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2009 |
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2008 |
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2007 |
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Acne and acne-related dermatological products |
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69.7 |
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62.8 |
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53.2 |
% |
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Non-acne dermatological products |
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23.4 |
% |
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28.6 |
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37.8 |
% |
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Non-dermatological products (including
contract revenues) |
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6.9 |
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8.6 |
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9.0 |
% |
We have historically developed and obtained 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
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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, except for the LIPOSONIXTM technology, 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 nature of these agreements,
our expenses for manufacturing are not fixed and could change from contract to contract.
Our Products
We currently market 17 branded products. Our sales and marketing efforts are currently
focused on our primary brands. The following chart details certain important features of our
primary brands:
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Brand |
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Treatment |
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U.S. Market Impact |
DYSPORTTM
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Temporary improvement in the
appearance of moderate to severe
glabellar lines in adults younger
than 65 years of age
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Launched in June 2009 following U.S. Food and
Drug Administration (FDA) approval on April 29,
2009 |
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LIPOSONIXTM
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Uses high intensity focused ultrasound
to permanently destroy targeted fat just
beneath the skin (subcutaneous adipose
tissue) in the treatment of the anterior
abdomen as a non-invasive, nonsurgical
approach to aesthetic body sculpting
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Acquired with the acquisition of LipoSonix in July
2008; cleared for sale and use in European Union in
2008 and Canada in 2009; not currently approved
or cleared for sale in the U.S; anticipated filing
for FDA approval for sale and use in U.S. in 2010 |
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PERLANE®
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Implantation into the deep dermis to
superficial subcutis for the correction
of moderate to severe facial wrinkles
and folds, such as nasolabial folds
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Launched in May 2007 following FDA approval on
May 2, 2007; PERLANE-LTM was approved
by the FDA on January 29, 2010 |
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RESTYLANE®
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Implantation into the mid to deep
dermis for the correction of moderate
to severe facial wrinkles and folds,
such as nasolabial folds
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The first hyaluronic acid dermal filler approved in the
U.S., and the #1-selling and most-studied
dermal filler in the world; launched in January 2004
following FDA approval on December 12, 2003;
RESTYLANE-LTM was approved by the FDA on
January 29, 2010 |
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SOLODYN®
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Once daily dosage for the treatment of
inflammatory lesions of non-nodular
moderate to severe acne vulgaris in
patients 12 years of age and older
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The #1 dermatology product by dollars in the U.S.;
launched in July 2006 following FDA approval
on May 8, 2006 |
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TRIAZ®
VANOS®
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Topical treatment of acne vulgaris
Super-high potency topical corticosteroid
for the relief of the inflammatory and
pruritic manifestations of corticosteroid
responsive dermatoses (e.g. psoriasis) in
patients 12 years of age or older
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The #1 single-agent branded benzoyl peroxide
product in the market; launched during fiscal 1996
Launched in April 2005 following FDA
approval on February 11, 2005 |
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ZIANA®
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Once daily topical treatment of acne
vulgaris in patients 12 years of age
and older
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First commercial sales to wholesalers in December
2006 and launched in January 2007 following FDA
approval on November 7, 2006 |
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Facial Aesthetic Products
Our principal branded facial aesthetic products are described below:
DYSPORTTM, an
injectable botulinum toxin type A formulation, is an acetylcholine
release inhibitor and a neuromuscular blocking agent. We market DYSPORTTM
in the U.S.
for the aesthetic indication of temporary improvement in the appearance of moderate to severe
glabellar lines in adults younger than 65 years of age. DYSPORTTM
was approved by the
FDA on April 29, 2009 and launched by us in June 2009. We acquired the rights to the aesthetic use
of DYSPORTTM in the U.S., Canada and Japan from Ipsen, S.A. (Ipsen) in March 2006.
According to the ASAPS, injections of botulinum toxin type A have been the number one nonsurgical
cosmetic procedure for the past five years, with over 2.4 million total procedures in 2008 alone.
The U.S. aesthetic market for botulinum toxin type A is estimated to be approximately $300 million
to $400 million annually.
RESTYLANE®,
RESTYLANE-LTM, PERLANE®,
PERLANE-LTM,
RESTYLANE FINE LINESTM and RESTYLANE SUBQTM
are injectable, transparent,
stabilized hyaluronic acid gels, which require no patient sensitivity tests in advance of product
administration. Their unique particle-based gel formulations offer structural support and lift
when implanted into the skin. On a worldwide basis, more than ten million treatments of
RESTYLANE®, RESTYLANE FINE LINESTM and
RESTYLANE SUBQTM have been
successfully performed in more than 70 countries since market introduction in 1996. In the U.S.,
the FDA regulates these products as medical devices. We began offering RESTYLANE® and
PERLANE® in the U.S. on January 6, 2004 and May 21, 2007, respectively, following FDA
approvals on December 12, 2003 and May 2, 2007, respectively. RESTYLANE® is the worlds
#1-selling and most-studied dermal filler, and is the first and only hyaluronic acid dermal filler
whose FDA-approved label includes duration data up to 18 months with one follow-up treatment. On
January 29, 2010, the FDA approved RESTYLANE-LTM
and PERLANE-LTM, which
include the addition of 0.3% lidocaine. We expect to begin shipping RESTYLANE-LTM and
PERLANE-LTM during the first quarter of 2010. We offer RESTYLANE®,
PERLANE®, RESTYLANE FINE LINESTM and RESTYLANE SUBQTM in Canada.
RESTYLANE FINE LINES TM and RESTYLANE SUBQTM
are not approved by the FDA for use in the U.S. We acquired the exclusive U.S. and Canadian rights to these facial aesthetic
products from Q-Med AB, a Swedish biotechnology and medical device company and its affiliates
(collectively Q-Med) through license agreements in March 2003.
Non-Invasive Body Sculpting Technology
The LIPOSONIXTM system uses high intensity focused ultrasound (HIFU) energy to
permanently destroy targeted fat just beneath the skin (subcutaneous adipose tissue) in the
treatment area of the anterior abdomen as a non-invasive, nonsurgical approach to aesthetic body
contouring. The LIPOSONIXTM treatment is not a replacement for liposuction or designed
for weight loss or large scale fat reduction, to treat obesity or to tighten loose skin. The
LIPOSONIXTM system is cleared for sale and use in Canada and the European Union. It is
not approved or cleared for sale in the U.S. We anticipate filing for FDA review of the
LIPOSONIXTM system during the first quarter of 2010.
Prescription Pharmaceuticals
Our principal branded prescription pharmaceutical products are described below:
SOLODYN®,
launched to dermatologists in July 2006 after approval by the FDA on May
8, 2006, is the only branded 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 or
older. SOLODYN®
is the first and only extended release minocycline with five
FDA-approved dosing strengths. SOLODYN®
is available by prescription in 45mg, 65mg,
90mg, 115mg and 135mg extended release tablet dosages. The 65mg and 115mg dosages were approved by
the FDA in July 2009. SOLODYN®
is lipid soluble, and distributes in the skin and sebum.
SOLODYN® is not bioequivalent to any immediate release
minocycline products, and is in
no way interchangeable with any immediate release forms of minocycline. SOLODYN® has
three issued patents (see also Item 1A. Risk Factors). U.S.
patent No. 5,908,838 (the 838
Patent), which expires in 2018, relates to the use of the SOLODYN® unique
dissolution
rate. We believe all forms of SOLODYN®
currently approved for use are covered by one or
more claims of the 838 Patent. The FDA listed this patent in the FDAs Approved Drug Products
with Therapeutic Equivalents (the Orange Book) for SOLODYN® in
December 2008. U.S.
Patent No. 7,541,347, which expires in 2027, relates to the use of the 90mg controlled-release oral
dosage form of minocycline to treat acne. U.S. Patent No. 7,544,373, which expires in 2027,
relates to the composition of the 90mg dosage form. The
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FDA listed these two patents in the Orange Book for SOLODYN® in June 2009. Multiple
patent applications directed to key dosing, labeling and formulation aspects of
SOLODYN®, as well as an ongoing reexamination of the 838 Patent by the U.S. Patent and
Trademark Office (USPTO) are pending (see also Item 1A. Risk Factors).
TRIAZ® is a topical therapy prescribed for the treatment of numerous forms and
varying degrees of acne. 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, and in March 2009 we launched TRIAZ® Foaming Cloths. 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
(e.g. psoriasis) 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. 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 available by prescription in 30 gram, 60 gram and 120 gram tubes. VANOS® Cream is
protected by one U.S. patent that expires in 2021 and two U.S. patents that expire in 2024.
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 available by prescription in 30 gram and 60 gram tubes.
ZIANA® is protected by two U.S. patents for both composition of matter on the
aqueous-based vehicle and method that expire in 2015 and 2020. Each of these patents cover aspects
of the unique vehicle which are used to deliver the active ingredients in ZIANA®.
Sale of Medicis Pediatrics
On June 10, 2009, we, Medicis Pediatrics, Inc. (Medicis Pediatrics, formerly known as Ascent
Pediatrics, Inc.), a wholly-owned subsidiary of Medicis, and BioMarin Pharmaceutical Inc.
(BioMarin) entered into an amendment to the Securities Purchase Agreement (the BioMarin
Securities Purchase Agreement), dated as of May 18, 2004 and amended on January 12, 2005, by and
among Medicis Pediatrics, BioMarin, BioMarin Pediatrics Inc., a wholly-owned subsidiary of BioMarin
that previously merged into BioMarin and us. The amendment was effected to accelerate the closing
of BioMarins option under the BioMarin Securities Purchase Agreement to purchase from us all of
the issued and outstanding capital stock of Medicis Pediatrics (the Option), which was previously
expected to close in August 2009. In accordance with the amendment, the parties consummated the
closing of the Option on June 10, 2009 (the BioMarin Option Closing). The aggregate cash
consideration paid to us in conjunction with the BioMarin Option Closing was approximately $70.3
million and the purchase was completed substantially in accordance with the previously disclosed
terms of the BioMarin Securities Purchase Agreement.
Research and Development
We have historically developed and obtained 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 and license agreements with other
pharmaceutical and biotechnology companies for the development of new products and the enhancement
of existing products.
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We incurred total research and development costs for all of our sponsored and unreimbursed
co-sponsored pharmaceutical projects for 2009, 2008 and 2007, of $71.8 million, $99.9 million and
$39.4 million, respectively. Research and development costs for 2009 include $12.0 million, in
aggregate, of milestone payments made to IMPAX Laboratories, Inc. (IMPAX) related to our joint
development agreement with IMPAX, $10.0 million paid to Revance Therapeutics, Inc. (Revance)
related to a license agreement with Revance, $5.3 million paid to Glenmark Generics Ltd. and
Glenmark Generics Inc., USA (collectively, Glenmark) related to a license and settlement
agreement with Glenmark and $5.0 million paid to Perrigo Israel Pharmaceutical Ltd. and Perrigo
Company (collectively Perrigo) related to a joint development agreement with Perrigo. Research
and development costs for 2008 include a $40.0 million payment to IMPAX related to our joint
development agreement with IMPAX and a $25.0 million payment to Ipsen upon the FDAs May 2008
acceptance of filing of Ipsens Biologics License Application (BLA) for DYSPORTTM.
Research and development costs for 2007 include $8.0 million related to our option to acquire
Revance or to license Revances product currently under development.
On November 14, 2009, we entered into an Asset Purchase and Development Agreement with
Glenmark. In connection with the Asset Purchase and Development Agreement, we purchased from
Glenmark the North American rights of a dermatology product currently under development, including
the underlying technology and regulatory filings. In accordance with terms of the agreement, we
made a $5.0 million payment to Glenmark upon closing of the transaction, and will make additional
payments to Glenmark of up to $7.0 million upon the achievement of certain development and
regulatory milestones. We will make royalty payments to Glenmark on sales of the product. The
initial $5.0 million payment was recognized as research and development expense during the three
months ended December 31, 2009.
On November 26, 2008, we entered into a joint development agreement with IMPAX whereby we and
IMPAX will collaborate on the development of five strategic dermatology product opportunities,
including an advanced-form SOLODYN® product. Under terms of the agreement, we made an
initial payment of $40.0 million upon execution of the agreement. During the three months ended
March 31, 2009, September 30, 2009 and December 31, 2009, we paid IMPAX $5.0 million, $5.0 million
and $2.0 million, respectively, upon the achievement of three separate clinical milestones, in
accordance with terms of the agreement. In addition, we are required to pay up to $11.0 million
upon successful completion of certain other clinical and commercial milestones. We will also make
royalty payments based on sales of the advanced-form SOLODYN® product if and when it is
commercialized by us upon approval by the FDA. We will share equally in the gross profit of the
other four development products if and when they are commercialized by IMPAX upon approval by the
FDA. The $40.0 million payment was recognized as a charge to research and development expense
during the three months ended December 31, 2008, and the three separate $5.0 million, $5.0 million
and $2.0 million clinical milestone achievement payments were recognized as a charge to research
and development expense during the three months ended March 31, 2009, September 30, 2009 and
December 31, 2009, respectively.
On April 8, 2009, we entered into a Joint Development Agreement with Perrigo whereby we will
collaborate with Perrigo to develop a novel proprietary product for which we will have the sole
right to commercialize. If and when a New Drug Application (NDA) for a novel proprietary product
is submitted to the FDA, we and Perrigo shall enter into a commercial supply agreement pursuant to
which, among other terms, for a period of three years following approval of the NDA, Perrigo would
exclusively supply to us all of our novel proprietary product requirements in the U.S. We made an
up-front $3.0 million payment to Perrigo upon execution of the agreement. During the three months
ended September 30, 2009, a development milestone was achieved, and we made a $2.0 million payment
to Perrigo pursuant to the agreement. We will make additional payments to Perrigo of up to $3.0
million upon the achievement of other certain development and regulatory milestones. We will pay
to Perrigo royalty payments on sales of the novel proprietary product. The $3.0 million up-front
payment and the $2.0 million development milestone payment was recognized as research and
development expense during the three months ended June 30, 2009 and September 30, 2009,
respectively.
On March 17, 2006, we entered into a development and distribution agreement with Ipsen,
whereby Ipsen granted us the rights to develop, distribute and commercialize Ipsens botulinum
toxin type A product in the U.S., Canada and Japan for aesthetic use by healthcare professionals.
During the development of the product, the proposed name of the product for aesthetic use was
RELOXIN®. In May 2008, the FDA accepted the filing of Ipsens BLA for
RELOXIN®, and in accordance with the agreement, we paid Ipsen $25.0 million during the
three months ended June 30, 2008. In December 2008, we paid Ipsen $1.5 million upon the
achievement of an additional regulatory milestone.
The $25.0 million payment was recognized as a charge to research and development expense
during the three months ended June 30, 2008, and the $1.5 million payment was recognized as a
charge to research and development expense
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during the three months ended December 31, 2008. On April 29, 2009, the FDA approved the BLA
for Ipsens botulinum toxin type A product, DYSPORTTM. The approval includes two
separate indications, the treatment of cervical dystonia in adults to reduce the severity of
abnormal head position and neck pain, and the temporary improvement in the appearance of moderate
to severe glabellar lines in adults younger than 65 years of age. RELOXIN®, which was
the proposed U.S. name for Ipsens botulinum toxin product for aesthetic use, is now marketed under
the name of DYSPORTTM. Ipsen markets DYSPORTTM in the U.S. for the
therapeutic indication (cervical dystonia), while Medicis began marketing DYSPORTTM in
the U.S. in June 2009 for the aesthetic indication (glabellar lines). In accordance with the
agreement, we paid Ipsen $75.0 million during the three months ended June 30, 2009, as a result of
the approval by the FDA. The $75.0 million payment was capitalized into intangible assets in our
consolidated balance sheet. 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, 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 Canada and Japan. We will be required to pay Ipsen an additional $2.0 million upon regulatory
approval of the product in Japan.
On December 11, 2007, we entered into 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 U.S. 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 was expected to be used by Revance
primarily for the development of the new product. Approximately $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
was 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 was recognized as a charge to research and development
expense during 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 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 July 28, 2009, we entered into a license agreement with Revance granting us worldwide
aesthetic and dermatological rights to Revances novel, investigational, injectable botulinum toxin
type A product, referred to as RT002, currently in pre-clinical studies. The objective of the
RT002 program is the development of a next-generation neurotoxin with favorable duration of effect
and safety profiles. Under the terms of the agreement, we paid Revance $10.0 million upon closing
of the agreement, and will pay additional potential milestone payments totaling approximately $94
million upon successful completion of certain clinical, regulatory and commercial milestones, and a
royalty based on sales and supply price, the total of which is equivalent to a double-digit
percentage of net sales. The initial $10.0 million payment was recognized as research and
development expense during the three months ended September 30, 2009.
Sales and Marketing
Our combined dedicated sales force, consisting of 243 employees as of December 31, 2009,
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 facial aesthetic procedures, we believe that the size of our sales force is appropriate
to reach our target physicians. Our therapeutic dermatology sales forces consist of
8
119 employees who regularly call on approximately 9,000 dermatologists. Our facial aesthetic sales
force consists of 124 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 U.S. We use a variety of marketing
techniques to promote our products including sampling, journal advertising, promotional materials,
specialty publications, coupons, educational conferences and informational websites. We also
promote our facial 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.
Warehousing and Distribution
We utilize an independent national warehousing corporation to store and distribute our
pharmaceutical products in the U.S. from primarily two regional warehouses in Nevada and Georgia,
as well as an additional warehouse in 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 2009, 2008 and 2007, these customers accounted for the following portions of
our net revenues:
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|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
McKesson |
|
|
40.8 |
% |
|
|
45.8 |
% |
|
|
52.2 |
% |
Cardinal |
|
|
37.1 |
% |
|
|
21.2 |
% |
|
|
16.9 |
% |
McKesson is the sole distributor of our RESTYLANE® and PERLANE® products
and DYSPORTTM in the U.S.
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 U.S. 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.
9
Some of our products, such as our facial aesthetics products DYSPORTTM,
RESTYLANE® and PERLANE®, 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.
Seasonality
Our business, taken as a whole, is not materially affected by seasonal factors. 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, except for the LIPOSONIXTM technology, 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 and suppliers
of raw materials 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. In
some cases, the sources of our raw materials are outside of the U.S., and as such we cannot always
guarantee that the political and industry climate in these countries will always be stable and
provide a surety of supply. We also work though U.S. agents for the supply of active
pharmaceutical ingredients brought into the U.S. and in some cases are only able to purchase on a
purchase order basis.
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, the qualification of a new supply source 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 reduce 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 significant
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 at various
in-process stages (e.g., raw material inventory and finished product inventory) that are no greater
than necessary to meet our current projections, which could have the effect of exacerbating supply
problems. Any interruption in the supply of finished products could hinder our ability to timely
distribute finished products and prevent us from increasing raw material and finished product
inventory levels to mitigate supply risks as a temporary solution. 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
10
either party. We are also in the process of evaluating alternative manufacturing facilities
and raw material suppliers for some of these products.
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 2014.
Our DYSPORTTM branded product is manufactured by Ipsen pursuant to a long-term
supply agreement that expires in 2036.
Our SOLODYN® branded product is manufactured by Wellspring Pharmaceutical and
AAIPharma pursuant to long-term supply agreements that expire in 2011 and 2012, respectively,
unless extended by mutual agreement. We are also in the process of evaluating an alternative
manufacturing facility for future SOLODYN® production.
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 U.S. and Canada to various licensees.
Trademarks, Patents and Proprietary Rights
We believe that trademark protection is an important part of establishing product and brand
recognition. We own a number of registered trademarks and trademark applications. U.S. federal
registrations for trademarks remain in force for 10 years and may be renewed every 10 years after
issuance, provided the mark is still being used in commerce.
We have obtained and licensed a number of patents covering key aspects of our products,
including a U.S. patent expiring in October of 2015 covering various formulations of
TRIAZ®, a U.S. patent expiring in December 2017 covering RESTYLANE®, a U.S.
patent expiring in February 2018 covering SOLODYN® Tablets, two U.S. patents expiring in
February 2015 and August 2020 covering ZIANA® Gel, one U.S. patent expiring in December
2021 and two U.S. patents expiring in January 2024 covering VANOS® Cream, a U.S. patent
expiring in December 2024 covering LIPOSONIXTM technology and two U.S. patents expiring
in 2027 covering 90mg SOLODYN® Tablets. We have patent applications pending relating to
SOLODYN® Tablets and LOPROX® Shampoo. We are also pursuing several other
U.S. and foreign patent applications. We hold additional LIPOSONIXTM patents, and have
numerous LIPOSONIXTM patent applications pending in the U.S. and in other countries.
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, and we employ other security measures to protect our trade secrets and other confidential
information. Our success with our products will depend, in part, on our ability to obtain, and
successfully defend if challenged, patent or other proprietary protection. Our patents are
obtained after examination by the USPTO and are presumed valid. 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, patents arising from such patent
applications 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
11
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, limit 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 or result in the
genericization of markets for our products. For example, on December 28, 2009, we filed suit
against Barr Laboratories, Inc. (Barr) and its parent company, Teva Pharmaceuticals USA Inc
(together, Barr/Teva), in the United States District Court for the District of Maryland seeking
an adjudication that Barr/Teva has infringed one or more claims of the 838 Patent by submitting to
the FDA a supplement to its earlier Abbreviated New Drug Application (ANDA) for generic versions
of 65mg and 115mg strength SOLODYN®, and on November 17, 2009 we filed suit against
Lupin Ltd. (Lupin) in the United States District Court for the District of Maryland seeking an
adjudication that Lupin has infringed one or more claims of the 838 Patent by submitting to the
FDA an ANDA for generic versions of 45mg, 90mg and 135mg strength SOLODYN®, and on
December 28, 2009 and February 2, 2010, respectively, we amended our complaint against Lupin
seeking an adjudication that Lupin has infringed one or more claims of the 838 Patent by
submitting to the FDA supplements to its earlier ANDA for generic versions of 65mg and 115mg
strengths of SOLODYN®. See Item 3 of Part I of this report, Legal Proceedings and
Note 12, 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 facial 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
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, GlaxoSmithKline, plc (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. DYSPORTTM
competes directly with Allergans Botox®, an established botulinum toxin product that
was approved by the FDA for aesthetic purposes in 2002. Allergan is a larger company than Medicis,
and has greater financial resources than those available to us. There are also other botulinum
toxin products under development.
12
Among other dermal filler products, Allergan markets Juvéderm® Ultra and
Juvéderm® Ultra Plus. Other dermal filler products on the market include:
Prevelle® Silk by Mentor Corporation (a subsidiary of Johnson & Johnson), BioForm
Medicals Radiesse®, Sanofi-Aventis Sculptra® Aesthetic, Suneva Medicals
Artefill® and Coapt Systems HydrelleTM. 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 its subsididary Mentor Corporation, Allergan and Merz which claim to offer equivalent
or greater facial aesthetic benefits than 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 medical devices, drugs and biological products are subject to
regulation principally by the FDA, but also by other federal agencies, such as the Drug Enforcement
Administration (DEA), 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, as amended (FDCA) 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.
The FDA requires a Boxed Warning (sometimes referred to as a Black Box Warning) for products
that have shown a significant risk of severe or life-threatening adverse events. Because there
have been post-marketing reports of symptoms consistent with botulinum toxin effects (reported
hours to weeks after injection), a Boxed Warning is now required for all botulinum toxin products,
including our product DYSPORTTM, and competitor products Botox®,
Botox® Cosmetic and Myobloc®. This is known as a class label. The FDAs
requirement for a Boxed Warning on all marketed botulinum toxin products is the culmination of a
safety review of Botox®, Botox® Cosmetic, and Myobloc® that the
agency announced in early 2008. In addition to the Boxed Warning, the FDA has required
implementation of a Risk Evaluation and Mitigation Strategy (REMS) for all botulinum toxin
products. The REMS will help ensure that healthcare professionals and patients are adequately
informed about product risks. The FDA notified the manufacturers of Botox®,
Botox® Cosmetic, and Myobloc® that label changes (e.g., the Boxed Warning)
and a REMS are necessary to ensure that the benefits of the products outweigh the risks. The Boxed
Warning and REMS for DYSPORT were approved by the FDA as part of the product approval.
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 U.S. Unless
an exemption applies, a medical device in the U.S. must have a Premarket Approval Application
(PMA) in accordance with the FDCA, 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 system
regulations (QSRs), as verified by detailed FDA inspections 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
premarket 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 Class III PMA-required medical devices. RESTYLANE® and
PERLANE® have been approved by the FDA under a PMA.
13
In general, products falling within the FDAs definition of new drugs, including both drugs
and biological products, require premarket approval by the FDA. Products falling within the FDAs
definition of cosmetics or drugs and that are generally recognized as safe and effective (and
therefore not new drugs) 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.
New drug products are thoroughly tested to demonstrate their safety and effectiveness.
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 Investigational New Drug Application (IND), which must be effective 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 healthy 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 or condition to
determine preliminary efficacy and expanded evidence of safety; the degree of effect, if any, as
compared to the current treatment regimen; and the optimal dose to be used in large scale trials.
In Phase III, typically at least two large-scale, multi-center, comparative trials are conducted
with patients afflicted with a target disease or condition 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.
The steps required before a new drug may be marketed, shipped or sold in the U.S. typically
include (i) preclinical laboratory and animal testing of pharmacology and toxicology; (ii)
submission to the FDA of an IND; (iii) 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 or
biological substance as applicable; (iv) submission to the FDA of an NDA or BLA; (v) FDA approval
of the NDA or BLA; and (vi) manufacture under cGMPs as verified by a pre-approval inspection
(PAI) by the FDA. In addition to obtaining FDA approval for each product, each
drug-manufacturing establishment must be registered with the FDA.
Generic versions of new drugs may also be approved by the agency pursuant to an ANDA if the
product is pharmaceutically equivalent (i.e. it has the same active ingredient, strength, doseage
form and route of administration) and bioequivalent to the reference listed drug (RLD). The
agency will not approve an ANDA, however, if the RLD has statutory marketing exclusivity. If the
RLD has patent protection, the FDA will approve an ANDA only if the applicant filed a paragraph IV
certification and there is no 30-month stay in place. 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 demonstrating equivalence to the innovator drug
product may be required for certain topical drug products submitted under ANDAs. However, even if
no clinical studies are required, the applicant must provide dissolution and/or bioequivalence
studies to show that the active ingredient in an oral generic drug sponsors application is
comparably available to the patient as the RLD upon which the ANDA is based.
FDA approval is required before a new drug product may be marketed in the U.S. 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 OTC active ingredients and associated labeling (OTC drugs). 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 generally recognized as safe and
effective for OTC use; Category II ingredients and labeling, which are deemed not generally
recognized as safe and effective for OTC use; and Category III ingredients and labeling, for which
available data are insufficient to classify as Category I or II, pending further studies. 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,
14
the FDA generally permits continued marketing only of any Category I products and 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.
The active ingredient in the LOPROX® (ciclopirox) products has been approved by the
FDA under multiple NDAs. The active ingredient in the DYNACIN® (minocycline HCl)
branded products has been approved by the FDA under multiple ANDAs. Benzoyl peroxide, 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 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 OTC 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 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 OTC
products or withdraw such products from the market. Under the Orphan Drug Act, the FDA may
designate a product as an orphan drug if it is a drug intended to treat a disease or condition that
affects populations of fewer than 200,000 individuals in the U.S. or a disease whose incidence
rates number more than 200,000 where the sponsor establishes that it does not realistically
anticipate that its product sales will be sufficient to recover its costs. The sponsor that obtains
the first marketing approval for a designated orphan drug for a given rare disease is eligible to
receive marketing exclusivity for use of that drug for the orphan indication for a period of seven
years. AMMONUL®, adjunctive therapy for the treatment of acute hyperammonemia and
associated encephalopathy in patients with deficiencies in enzymes of the urea cycle, has been
granted orphan drug status.
We also will be subject to foreign regulatory authorities governing clinical trials and
pharmaceutical sales for products we seek to market outside the U.S. 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.
15
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 Form
10-K is intended to cover the audited calendar year January 1, 2009 to December 31, 2009, which we
refer to as 2009. We refer to the audited calendar year January 1, 2008 to December 31, 2008 as
2008. We refer to the audited calendar year January 1, 2007 to December 31, 2007 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.
Employees
At December 31, 2009, we had 612 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 (SEC). We
also make available free of charge on or through our website our Business Code of Conduct and
Ethics, Corporate Governance Guidelines, Nominating and Governance Committee Charter, Stock Option
and Compensation Committee Charter, Audit Committee Charter, Employee Development and Retention
Committee Charter and Compliance Committee Charter. The information contained on our website is
not incorporated by reference into this Annual Report on Form 10-K.
Item 1A. Risk Factors
Our statements in this report, other reports that we file with the 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.
16
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.
We currently have one issued patent, the 838 Patent, relating to SOLODYN® that
does not expire until 2018, and two other issued patents, U.S. Patent No. 7,541,347 (the 347
Patent) and U.S. Patent No. 7,544,373 (the 373 Patent), relating to 90mg SOLODYN®
Tablets that do not expire until 2027. As part of our patent strategy, we are currently pursuing
additional patent applications for SOLODYN®. However, we cannot provide any assurance
that any additional patents will be issued relating to SOLODYN®. For example, on
November 17, 2009, we received a non-final office action from the USPTO in SOLODYN®
patent application number 12/253,845 (the 845 Application) in which the sole basis for rejection
could be overcome by the filing of the Terminal Disclaimer. In response, we filed a Terminal
Disclaimer with the USPTO on November 25, 2009. The Terminal Disclaimer has the effect of making
the expiration dates of the 845 Application and the related patent application number 11/166817
(817 Application) the same. On November 25, 2009, we filed a Request for Continued Examination
with the USPTO in the 817 Application so that the USPTO could consider references recently filed
in the Reexamination of the 838 Patent, as discussed in more detail below, and in accordance with
our ongoing obligation to advise the USPTO of any references that could be deemed by the examiner
to be material. 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.
SOLODYN® faced generic competition during 2009 and may face additional generic
competition in the near future.
On January 15, 2008, we 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. 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 the 838 Patent related to SOLODYN® is invalid and is not infringed by IMPAXs ANDA
for a generic version of SOLODYN®. On April 16, 2008, the Court granted Medicis motion
to dismiss the IMPAX complaint for lack of jurisdiction. IMPAX appealed the Courts order
dismissing the case to the United States Court of Appeals for the Federal Circuit. On November 26,
2008, we entered into a License and Settlement Agreement and a Joint Development Agreement with
IMPAX. In connection with the License and Settlement Agreement, Medicis and IMPAX agreed to
terminate all legal disputes between them relating to SOLODYN®. Additionally, under
terms of the License and Settlement Agreement, IMPAX has confirmed that Medicis patents relating
to SOLODYN® are valid and enforceable, and cover IMPAXs activities relating
to its generic product under ANDA #90-024. Under the terms of the License and Settlement
Agreement, IMPAX has a license to market its generic versions of SOLODYN®
45mg, 90mg and 135mg under the SOLODYN® intellectual property
rights belonging to Medicis upon the occurrence of certain events. Upon launch of its generic
formulations of SOLODYN®, IMPAX may be required to pay Medicis a royalty, based on sales
of those generic formulations by IMPAX under terms described in the License and Settlement
Agreement. On December 12, 2008, we announced that we had received a Paragraph IV Patent
Certification from IMPAX, advising it had filed an ANDA with the FDA for generic
SOLODYN® in its current forms of 45mg, 90mg and 135mg strengths. IMPAXs certification
alleged that the 838 Patent will not be infringed by IMPAXs manufacture, use or sale of the
product for which the ANDA was submitted because it has been granted a patent license by us for the
838 Patent. On February 3, 2009, the FDA approved IMPAXs ANDA for generic SOLODYN®.
IMPAX has not yet launched a generic formulation of SOLODYN®.
On June 23, 2009, we and IMPAX entered into a Settlement Agreement (the IMPAX Settlement
Agreement) and Amendment No. 2 to the License and Settlement Agreement. In conjunction with the
IMPAX Settlement Agreement, both we and IMPAX released, acquitted, covenanted not to sue and
forever discharged each
17
other and our affiliates from any and all liabilities relating to the litigation stemming from
the initial License and Settlement Agreement between IMPAX and us. We made a settlement payment to
IMPAX in conjunction with the execution of the IMPAX Settlement Agreement and Amendment No. 2 to
the License and Settlement Agreement, which was included in selling, general and administrative
expenses during the three months ended June 30, 2009.
On August 18, 2008, we announced that the USPTO had granted a Request for Ex Parte
Reexamination of our 838 Patent. In March 2009, the USPTO issued a non-final office action in the
reexamination of the 838 Patent. On May 13, 2009, we filed our response to the non-final office
action with the USPTO, canceling certain claims and adding amended claims. On November 13, 2009,
we received a second non-final office action from the USPTO in the reexamination of the 838
Patent. The latest office action rejects certain claims of the 838 Patent. On January 8, 2010,
we filed our response to the non-final office action with the USPTO. Reexamination can result in
confirmation of the validity of all of a patents claims, the invalidation of all of a patents
claims, or the confirmation of some claims and the invalidation of others. We cannot guarantee the
outcome of the reexamination. It is possible that one or more of our patents covering
SOLODYN® may be found invalid or narrowed in scope as the result of the pending
reexamination or a future reexamination by the USPTO. If the USPTOs action leads the court in a
SOLODYN® patent infringement suit, including the suits described in this Report, to hold
that the patent for SOLODYN® is invalid or not infringed, such a holding would permit
the FDA to lift the 30-month stay on approval of ANDAs for generic versions of SOLODYN®.
Pursuant to Section 125 of the Food and Drug Administration Modernization Act (FDAMA), several
statutory provisions added to the FDCA by the Hatch-Waxman Amendments of 1984, including the patent
listing, certification and notice provisions and the 30-month stay provision, did not apply to
so-called old antibiotics such as minocycline HCl, the active ingredient in SOLODYN®.
On October 8, 2008, the President signed into law the QI Program Supplemental Funding Act of 2008,
Pub. L. No. 110-379, 122 Stat. 4075 (2008) (the Antibiotic Act), which provides that
notwithstanding section 125 of FDAMA or any other provision of law, the provisions of the
Hatch-Waxman Amendments shall apply to old antibiotics. On December 3, 2008, in accordance with
and pursuant to the Antibiotic Act and FDAs recently issued Draft Guidance for Industry entitled
Submission of Patent Information for Certain Old Antibiotics (Nov. 2008) (November 2008
Guidance), Medicis submitted the 838 Patent covering SOLODYN® to the Orange Book.
On December 8, 2008, we announced that we had received a Paragraph IV Patent Certification
from Mylan Inc. (Mylan) advising that Mylans majority owned subsidiary Matrix Laboratories
Limited (Matrix) has filed an ANDA with the FDA for generic SOLODYN® in its
current forms of 45mg, 90mg and 135mg strengths. Mylan has not advised us as to the timing or
status of the FDAs review of Matrixs filing, or whether Matrix has complied with FDA requirements
for proving bioequivalence. Mylans Paragraph IV Certification alleges that our 838 Patent is
invalid, unenforceable and/or will not be infringed by Matrixs manufacture, use, or sale of the
product for which the ANDA was submitted.
On December 12, 2008, we announced that we had received a Paragraph IV Patent Certification
from Sandoz, Inc., a division of Novartis AG (Sandoz), advising that Sandoz had filed an ANDA
with the FDA for generic SOLODYN® in its current forms of 45mg, 90mg and
135mg strengths. Sandozs Paragraph IV Certification alleges that our 838 Patent is invalid,
unenforceable and/or will not be infringed by Sandozs manufacture, use, or sale of the product for
which the ANDA was submitted.
On December 29, 2008 we announced that we had received a Paragraph IV Patent Certification
from Barr Laboratories, Inc. (Barr) advising that Barr has filed an ANDA with the FDA for generic
SOLODYN® in its current forms of 45mg, 90mg and 135mg strengths. Barrs
Paragraph IV Certification alleges that our 838 Patent is invalid, unenforceable and/or will not
be infringed by Barrs manufacture, use, or sale of the product for which the ANDA was submitted.
On January 13, 2009, we filed suit against Mylan, Matrix, Matrix Laboratories Inc., Sandoz and
Barr (collectively Defendants) in the United States District Court for the District of Delaware
seeking an adjudication that Defendants have infringed one or more claims of our 838 Patent by
submitting to the FDA their respective ANDAs for generic versions of SOLODYN®. The
relief we requested includes a request for a permanent injunction preventing Defendants from
infringing the 838 Patent by selling generic versions of SOLODYN®. Mylan has answered
that the 838 Patent is not infringed and/or is invalid. On March 30, 2009, the Delaware court
dismissed the claims between us and Matrix Laboratories Inc. without prejudice, pursuant to a
stipulation between us and Matrix Laboratories Inc.
18
On February 13, 2009, we submitted a Citizen Petition to the FDA arguing that the Agency could
not approve the Mylan, Sandoz and Barr ANDAs for generic versions of SOLODYN® for thirty
(30) months pursuant to Section 505(j)(5)(B)(iii) of the FDCA because we sued the submitters of all
three ANDAs for patent infringement within 45 days of receiving notice from them of the submission
of a Paragraph IV Certification. In light of the recently enacted Antibiotic Act, we argued that
neither FDAMA nor the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA) stood as a barrier to SOLODYN® receiving a 30-month stay. On March 17, 2009, we
received a response from the FDA in which the agency concluded that the Antibiotic Act did not
alter the MMA provision barring ANDA was pending with the FDA at the time the patent was submitted
to the Orange Book. Because the 838 Patent could not be submitted to the Orange Book until the
passage of the Antibiotics Act, the 838 Patent was not submitted to the Orange Book until after
the ANDAs in question were already pending with the FDA. The FDA therefore denied the petition.
On March 17, 2009, Teva Pharmaceutical Industries Ltd. (Teva) was granted final approval by
the FDA for its ANDA #65-485 to market its generic versions of 45mg, 90mg and 135mg
SOLODYN® Extended Release Tablets. Teva commenced shipment of this product immediately
after the FDAs approval of the ANDA. On March 18, 2009, we entered into a settlement agreement
with Teva, whereby all legal disputes between us and Teva relating to SOLODYN® Extended
Release Tablets were terminated and whereby Teva agreed that Medicis patents related to
SOLODYN® are valid and enforceable, and cover Tevas activities relating to its generic
SOLODYN® product under ANDA #65-485. As part of the settlement, Teva agreed to
immediately stop all further shipments of its generic SOLODYN® product. We agreed to
release Teva from liability arising from any prior sales of its generic SOLODYN®
product, which were not authorized by us. Under terms of the agreement, Teva has the option to
market its generic versions of SOLODYN® 45mg, 90mg and 135mg under the
SOLODYN® patent rights belonging to us in November 2011, or earlier under certain
conditions. Tevas shipment of its generic SOLODYN® product upon FDA approval, but
prior to the consummation of the settlement agreement with us on March 18, 2009, caused wholesalers
to reduce ordering levels for SOLODYN®, and caused us to increase our reserves for sales
returns and consumer rebates during the three months ended March 31, 2009. On November 13, 2009,
we entered into an amended and restated settlement agreement with Teva for the purpose of providing
additional detail around certain terms of the original settlement agreement.
On August 13, 2009, Sandoz was granted final approval by the FDA for its ANDA #90-422 to
market its generic versions of 45mg, 90mg and 135mg SOLODYN® Extended Release Tablets.
Sandoz commenced shipment of this product immediately after the FDAs approval of the ANDA. On
August 18, 2009, we entered into a settlement agreement with Sandoz whereby all legal disputes
between us and Sandoz relating to SOLODYN® Extended Release Tablets were terminated and
where Sandoz agreed that our patents relating to SOLODYN® are valid and enforceable, and
cover Sandozs activities relating to its generic SOLODYN® product under ANDA #90-422.
Sandoz agreed that any prior sales of its generic SOLODYN® product were not authorized
by us and further agreed to be permanently enjoined from any further distribution of generic
SOLODYN®. The Delaware court subsequently entered a permanent injunction against any
infringement by Sandoz. We agreed in the settlement agreement to release Sandoz from liability
arising from any prior sales of its generic SOLODYN® which were not authorized by us.
Sandoz has the option to market its generic version of SOLODYN® 45mg, 90mg and 135mg
under the SOLODYN® intellectual property rights belonging to us commencing in November
2011, or earlier under certain conditions.
On May 6, 2009, we received a Paragraph IV Patent Certification from Ranbaxy Laboratories
Limited (Ranbaxy) advising that Ranbaxy has filed an ANDA with the FDA for generic
SOLODYN® in its form of 135mg strength. Ranbaxy did not advise us as to the timing or
status of the FDAs review of its filing, or whether it has complied with FDA requirements for
proving bioequivalence. Ranbaxys Paragraph IV Certification alleged that Ranbaxys manufacture,
use, sale or offer for sale of the product for which the ANDA was submitted would not infringe any
valid claim of our 838 Patent. On June 11, 2009, we filed suit against Ranbaxy and Ranbaxy Inc.
(hereinafter collectively Ranbaxy) in the United States District Court for the District of
Delaware seeking an adjudication that Ranbaxy has infringed one or more claims of the 838 Patent
by submitting the above ANDA to the FDA. The relief we requested included a request for a
permanent injunction preventing Ranbaxy from infringing the 838 Patent by selling a generic
version of SOLODYN®. Ranbaxy has answered that the 838 Patent is not infringed, is
invalid and/or is unenforceable. On January 5, 2010, we received a Paragraph IV Patent
Certification from Ranbaxy advising that Ranbaxy has filed a supplement or amendment to its earlier
filed ANDA assigned ANDA #91-118 (Ranbaxy ANDA Supplement/Amendment) with the FDA for generic
SOLODYN® in its forms of 45mg and 90mg strengths. Ranbaxy has not advised us as to the
timing or status of the FDAs review of
19
its filing, or whether Ranbaxy has complied with FDA requirements for proving bioequivalence.
Ranbaxys Paragraph IV Certification alleges that our 838 Patent is invalid, unenforceable and/or
will not be infringed by Ranbaxys manufacture, importation, use, sale and/or offer for sale of the
products for which the Ranbaxy ANDA Supplement/Amendment was submitted. Ranbaxys Paragraph IV
Certification also alleges that neither our 347 Patent nor our 373 Patent is infringed by
Ranbaxys manufacture, importation, use, sale and/or offer for sale of the products for which the
Ranbaxy ANDA Supplement/Amendment was submitted.
Ranbaxys submission as to the 45mg and 90mg
strengths amends an ANDA already subject to a 30-month stay. As such, we believe that the
Ranbaxy ANDA Supplement/Amendment cannot be approved by the FDA until after the expiration of the 30-month
period or in the event of a court decision holding that the patents are invalid or not infringed.
On February 16, 2010, we filed a complaint against Ranbaxy in the
United States District Court for the District of Delaware seeking an
adjudication that Ranbaxy has infringed one or more claims of the
patents by submitting the Ranbaxy ANDA Supplement/Amendment for
generic SOLODYN®
in its forms of 45mg and 90mg strengths.
On October 8, 2009, we received a Paragraph IV Patent Certification from Lupin advising that
Lupin has filed an ANDA with the FDA for generic SOLODYN® in its forms of 45mg, 90mg,
and 135mg strengths. Lupin did not advise us as to the timing or status of the FDAs review of its
filing, or whether it has complied with FDA requirements for proving bioequivalence. Lupins
Paragraph IV Certification alleged that Lupins manufacture, use, sale or offer for sale of the
product for which the ANDA was submitted would not infringe any valid claim of our 838 Patent. On
November 17, 2009, we filed suit against Lupin in the United States District Court for the District
of Maryland seeking an adjudication that Lupin has infringed one or more claims of the 838 Patent
by submitting to the FDA an ANDA for generic SOLODYN® in its forms of 45mg, 90mg and
135mg strengths. The relief we requested includes a request for a permanent injunction preventing
Lupin from infringing the 838 Patent by selling generic versions of SOLODYN®. On
November 24, 2009, we received a Paragraph IV Patent Certification from Lupin, advising that Lupin
has filed a supplement or amendment to its earlier filed ANDA assigned ANDA #91-424 (Lupin ANDA
Supplement/Amendment I) with the FDA for generic SOLODYN® in its form of 65mg strength.
Lupin has not advised us as to the timing or status of the FDAs review of its filing, or whether
Lupin has complied with FDA requirements for proving bioequivalence. Lupins Paragraph IV
Certification alleges that our 838 Patent is invalid and/or will not be infringed by Lupins
manufacture, use, sale and/or importation of the products for which the Lupin ANDA
Supplement/Amendment I was submitted. Lupins submission amends an ANDA already subject to a
30-month stay. As such, we believe that the supplement or amendment cannot be approved by the FDA
until after the expiration of the 30-month period or a court decision that the patent is invalid or
not infringed. On December 23, 2009, we received a Paragraph IV Patent Certification from Lupin,
advising that Lupin has filed a supplement or amendment to its earlier filed ANDA assigned ANDA
#91-424 (Lupin ANDA Supplement/Amendment II) with the FDA for generic SOLODYN ® in its
form of 115mg strength. Lupin has not advised us as to the timing or status of the FDAs review of
its filing, or whether Lupin has complied with FDA requirements for proving bioequivalence. Lupins
Paragraph IV Certification alleges that our 838 Patent is invalid and/or will not be infringed by
Lupins manufacture, use, sale and/or importation of the products for which the Lupin ANDA
Supplement/Amendment II was submitted. Lupins submission amends an ANDA already subject to a
30-month stay. As such, we believe that the supplement or amendment cannot be approved by the FDA
until after the expiration of the 30-month period or a court decision that the patent is invalid or
not infringed. On December 28, 2009, we amended our complaint against Lupin in the United States
District Court for the District of Maryland seeking an adjudication that Lupin has infringed one or
more claims of the 838 Patent by submitting its supplement or amendment to its earlier filed ANDA
assigned ANDA #91-424 for generic SOLODYN® in its form of 65mg strength. On February 2,
2010, we amended our complaint against Lupin in the United States District Court for the District
of Maryland seeking an adjudication that Lupin has infringed one or more claims of the 838 Patent
by submitting its supplement or amendment to its earlier filed ANDA assigned ANDA #91-424 for
generic SOLODYN® in its form of 115mg strength.
On November 20, 2009, we received a Paragraph IV Patent Certification from Barr, advising that
Barr has filed a supplement to its earlier filed ANDA #65-485 (Barr ANDA Supplement) with the FDA
for generic SOLODYN® in its forms of 65mg and 115mg strengths. Barr has not advised us
as to the timing or status of the FDAs review of its filing, or whether Barr has complied with FDA
requirements for proving bioequivalence. Barrs Paragraph IV Certification alleges that our 838
Patent is invalid, unenforceable and/or will not be infringed by Barrs manufacture, use, sale
and/or importation of the products for which the Barr ANDA Supplement was submitted. On December
28, 2009, we filed suit against Barr/Teva, in the United States District Court for the District of
Maryland seeking an adjudication that Barr/Teva has infringed one or more claims of the 838 Patent
by submitting to the FDA the Barr ANDA Supplement seeking marketing approval for generic
SOLODYN® in its forms of 65mg and 115mg strengths. The relief we requested
includes a request for a permanent injunction preventing Barr/Teva from infringing the 838 Patent
by selling generic versions of SOLODYN® in its forms of 65mg and 115mg
strengths. As a result of the filing of the suit, we believe that the supplement to the ANDA
cannot
20
be approved by the FDA until after the expiration of a 30-month stay period or a court
decision that the patent is invalid or not infringed.
On February 1, 2010, we received a Paragraph IV Patent Certification from Sandoz, advising
that Sandoz has filed a supplement to its earlier filed ANDA #91-422 (Sandoz ANDA Supplement)
with the FDA for generic SOLODYN® in its forms of 65mg and 115mg strengths. Sandoz has not advised
us as to the timing or status of the FDAs review of its filing, or whether Sandoz has complied
with FDA requirements for proving bioequivalence. Sandozs Paragraph IV Certification alleges that
the 838 Patent will not be infringed by Sandozs manufacture, importation, use, sale and/or offer
for sale of the products for which the Sandoz ANDA Supplement was submitted because it has been
granted a patent license by us for the 838 Patent.
In addition to SOLODYN®,
our other prescription products, including VANOS
®
and LOPROX®, are or may be subject to generic competition in the near future.
On May 1, 2008, we announced that we received notice from Perrigo Israel Pharmaceuticals Ltd.
(Perrigo Israel), a generic pharmaceutical company, that it had filed an ANDA with the FDA for a
generic version of our VANOS® fluocinonide cream 0.1%. Perrigo Israels notice
indicated that it was challenging only one of the two patents that we listed with the FDA for
VANOS® cream, our U.S. Patent No. 6,765,001 (the 001 Patent) that will expire in
2021. On June 6, 2008, we filed a complaint for patent infringement against Perrigo Israel and,
its domestic corporate parent, Perrigo Company, in the United States District Court for the Western
District of Michigan. In August 2008, we received notice that Perrigo Israel amended its ANDA to
challenge our other patent listed with the FDA for VANOS® cream, our U.S. Patent No.
7,220,424 (the 424 Patent) that will expire in 2023. Our complaint asserts that Perrigo Israel
and Perrigo Company have infringed on both of our patents for VANOS® cream. On April 8,
2009, we entered into a license and settlement agreement with Perrigo. In connection with the
license and settlement agreement, we and Perrigo agreed to terminate all legal disputes between us
relating to our VANOS® cream. In addition, Perrigo confirmed that certain of our patents
relating to VANOS® cream are valid and enforceable, and are infringed by Perrigos
activities relating to its generic product under ANDA #090256. Further, subject to the terms and
conditions contained in the license and settlement agreement, we granted Perrigo, effective
December 15, 2013, or earlier upon the occurrence of certain events, a license to make and sell
generic versions of the existing VANOS® products and, when Perrigo does commercialize
generic versions of VANOS® products, Perrigo will pay us a royalty based on sales of
such generic products.
On May 8, 2009, we received a Paragraph IV Patent Certification from Glenmark advising that
Glenmark has filed an ANDA with the FDA for a generic version of VANOS® cream. Glenmark
has not advised us as to the timing or status of the FDAs review of its filing, or whether it has
complied with FDA requirements for proving bioequivalence. Glenmarks Paragraph IV Certification
alleges that our 001 Patent and 424 Patent will not be infringed by Glenmarks manufacture, use
or sale of the product for which the ANDA was submitted. The expiration date for the 424 Patent
is 2023. On June 19, 2009, we filed a complaint for patent infringement against Glenmark in the
United States District Court for the District of New Jersey. On July 14, 2009, Glenmark and
Glenmark Ltd. answered our complaint, and filed counterclaims seeking a declaration that the
patents we listed with the FDA for VANOS® cream were invalid and unenforceable, and
would not be infringed by Glenmarks generic version of VANOS®. On November 14, 2009,
we entered into a license and settlement agreement with Glenmark Ltd. and Glenmark. In connection
with the license and settlement agreement, we and Glenmark agreed to terminate all legal disputes
between us relating to VANOS®. In addition, Glenmark confirmed that certain of our
patents relating to VANOS® cream are valid and enforceable, and cover Glenmarks
activities relating to its generic versions of VANOS® cream under its ANDA. Further,
subject to the terms and conditions contained in the license and settlement agreement, we granted
Glenmark, effective December 15, 2013, or earlier upon the occurrence of certain events, a license
to make and sell generic versions of the existing VANOS® products. Upon
commercialization by Glenmark of generic versions of VANOS® products, Glenmark will pay
us a royalty based on sales of such generic products.
On September 21, 2009, we received a Paragraph IV Patent Certification from Glenmark advising
that Glenmark has filed an ANDA with the FDA for a generic version of LOPROX® Gel.
Glenmark did not advise us as to the timing or status of the FDAs review of its filing, or whether
it has complied with FDA requirements for proving bioequivalence. Glenmarks Paragraph IV
Certification alleged that our U.S. Patent No. 7,018,656 (the 656 Patent) would not be infringed
by Glenmarks manufacture, use or sale of the product for which the ANDA was submitted. The
expiration date for the 656 Patent is 2018. On November 14, 2009, we entered into a License and
Settlement Agreement with Glenmark and its foreign corporate parent Glenmark Ltd. In connection
with the
21
License and Settlement Agreement, we and Glenmark agreed to terminate all legal disputes
between us relating to LOPROX® Gel. In addition, Glenmark confirmed that certain of our
patents relating to LOPROX® Gel are valid and enforceable, and cover Glenmarks
activities relating to its generic version of LOPROX® Gel under an ANDA. Subject to the
terms and conditions contained in the License and Settlement Agreement, we also granted Glenmark a
license to make and sell generic versions of LOPROX® Gel. Upon commercialization by
Glenmark of generic versions of LOPROX® Gel, Glenmark will pay us a royalty based on
sales of such generic products.
On December 7, 2009, we entered into a Settlement Agreement (the Paddock Settlement
Agreement) with Paddock Laboratories, Inc. (Paddock). In connection with the Paddock Settlement
Agreement, we and Paddock agreed to settle all legal disputes between us relating to our
LOPROX® Shampoo and we agreed to withdraw our complaint against Paddock pending in the
U.S. District Court for the District of Arizona. In addition, Paddock confirmed that Paddocks
activities relating to its generic version of LOPROX® Shampoo are covered by our current
and pending patent applications. Further, subject to the terms and conditions contained in the
Paddock Settlement Agreement, we granted Paddock a non-exclusive, royalty-bearing license to make
and sell limited quantities of its generic version of LOPROX® Shampoo.
On February 16, 2010, the FDA approved an ANDA filed by an affiliate of Perrigo for a generic
version of LOPROX® Shampoo. In addition, other companies may seek approval of an ANDA
covering a generic version of LOPROX® Shampoo.
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.
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.
See the previously listed Risk Factor, 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, Item 3 of Part I of
this report, Legal Proceedings, and Note 12, Commitments and Contingencies in the notes to the
consolidated financial statements 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, but we cannot be sure that any of
these patents will ever be issued. We also have acquired rights under certain patents and patent
applications in connection with our licenses to distribute products and by assignment of rights to
patents and patent applications from certain of our consultants and officers. These patents and
patent applications may be subject to claims of rights by third parties. If there are conflicting
claims to the same patent or patent application, we may not prevail and, even if we do have some
rights in a patent or patent application, those rights may not be sufficient for the marketing and
distribution of products covered by the patent or patent application.
The ownership of a patent or an interest in a patent does not always provide significant
protection. Others may independently develop similar technologies or design around the patented
aspects of our products. 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
22
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 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.
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 and we employ
other strategies to protect our trade secrets and other confidential information. Nevertheless,
these agreements may not provide meaningful protection for our trade secrets and proprietary
know-how if they are used or disclosed. Despite all of the precautions we may take, people who are
not parties to confidentiality agreements may obtain access to our trade secrets or know-how. In
addition, others may independently develop similar or equivalent trade secrets or know-how.
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 research, development and marketing of our products are subject to extensive regulation by
government agencies in the U.S, particularly the FDA, and other countries. The process of
obtaining FDA and other regulatory approvals is time consuming and expensive. Clinical trials are
required, and the manufacturing of pharmaceutical and medical device products is 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. Marketing approval or clearance of a new product or new indication for an approved
product may be delayed, restricted, or denied for many reasons, including:
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determination by the FDA that the product is not safe and effective; |
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a different interpretation of preclinical and clinical data by FDA; |
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failure to obtain approval of the manufacturing process or facilities; |
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results of post-marketing studies; |
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changes in FDA policy or regulations related to product approvals; and |
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failure to comply with applicable regulatory requirements. |
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No amount of time, effort, or resources invested in a new product or new indication for an
approved product can guarantee that regulatory approval will be granted.
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. If adverse events are associated
with products that have already been approved or cleared for marketing, such products could be
subject to increased regulatory scrutiny, changes in regulatory approval or labeling, or withdrawal
from the market. 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, including cGMPs for drug and biologic products and the QSRs
for medical device products; |
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submitting products, facilities and records 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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completion of post-marketing studies; |
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changes to approved product labeling; |
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advertising or marketing restrictions, including direct-to-consumer advertising; |
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REMS; |
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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, re-importation 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 and medical
device 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. From time to time
we may enter into business arrangements (e.g. loans or investments) involving our customers and
those arrangements may be reviewed by federal and state regulators.
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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 and medical device 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 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 have 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 separated from the Company. See Item 3 of Part I of this report, Legal
Proceedings and Note 12,
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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
federal, state or foreign regulations and/or laws or the Corporate Integrity Agreement we entered
into with the Office of Inspector General of the Department of Health and Human Services. If we
fail to comply with the Corporate Integrity Agreement or 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.
We depend on a limited number of customers for a substantial portion of our revenues, 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. We are party to distribution
services agreements with McKesson and Cardinal. During 2009, McKesson and Cardinal accounted for
40.8% and 37.1%, respectively, of our net revenues. During 2008, McKesson and Cardinal accounted
for 45.8% and 21.2%, respectively, of our net revenues. During 2007, McKesson and Cardinal
accounted for 52.2% and 16.9%, 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. McKesson is our sole distributor of our RESTYLANE®
and PERLANE® products and DYSPORTTM in the U.S.
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 derive a majority of our sales revenue 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®, VANOS® and ZIANA®, and sales of our facial aesthetic
products, DYSPORTTM, RESTYLANE® and PERLANE®, will continue to
constitute a significant portion of our sales revenue 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.
DYSPORTTM competes directly with Allergans Botox® Cosmetic, an
established botulinum toxin product that was approved by the FDA for aesthetic purposes in 2002.
We are experiencing intense competition in the dermal filler market. Other dermal filler
products on the market include: Juvéderm®, Prevelle® Silk,
Radiesse®, Sculptra® Aesthetic, Artefill® and
HydrelleTM. Patients may differentiate these products from our RESTYLANE®
and PERLANE® products based on price, efficacy and/or duration, which may appeal to some
patients. In addition, there are several dermal filler products under
26
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.
We are involved in patent litigation with certain competitors, primarily related to our
SOLODYN® and VANOS® branded products. See the previously listed Risk Factor,
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, and Item 3 of Part I of this report, Legal Proceedings, and Note 12, Commitments
and Contingencies in the notes to the consolidated financial statements under Item 15 of Part IV
of this report, Exhibits and Financial Statement Schedules for information concerning our current
intellectual property litigation. There can be no assurance that we will prevail in patent
litigation or that these competitors will not successfully introduce products that would cause a
loss of our market share and reduce our revenues.
Sales related to our primary prescription drug products, including SOLODYN®,
VANOS® and ZIANA®, and sales of our facial aesthetic products,
DYSPORTTM, 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 and/or plastic
surgeons; |
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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 and/or plastic surgeons; |
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restrictions on travel affecting the ability of our sales force to market to
prescribing physicians and plastic surgeons in person; and |
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restrictions on promotional activities. |
Our continued growth depends upon our ability to develop new products.
Our ability to develop new products is the key to our continued growth. Our research and
development activities, as well as the clinical testing and regulatory approval process, which must
be completed before commercial sales can commence, will require significant commitments of
personnel and financial resources. We cannot assure you that we will be able to develop products
or technologies in a timely manner, or at all. Delays in the research, development, testing or
approval processes will cause a corresponding delay in revenue.
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,
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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.
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.
Our products may not gain market acceptance.
There is 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 and launch of new competitive products, including OTC or generic
competitor products; |
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the timing and receipt of FDA approvals or lack of approvals; |
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the timing and receipt of patent claim issuances or lack of issuances or rejections
in prosecution or reexamination proceedings before the USPTO; |
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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 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, and our
ability to recover quickly from such economic and industry conditions; |
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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; |
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failure by us or our contractors to comply with all applicable FDA and other
regulatory requirements; |
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the imposition of a REMS program requirement on any of our products; |
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adverse decisions by FDA advisory committees related to any of our products; and |
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timing of payments and/or 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.
We face significant competition within our industry.
The pharmaceutical and facial 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
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competitors are Allergan, Galderma, Johnson & Johnson, Sanofi-Aventis,
GlaxoSmithKline, plc (Stiefel Laboratories), Warner Chilcott and others.
Many of these companies have greater resources than we do to devote to marketing, sales,
research and development and acquisitions. As a result, they have a greater ability to undertake
more extensive research and development, marketing and pricing policy programs. It is possible
that our competitors may develop new or improved products to treat the same conditions as our
products or make technological advances reducing their cost of production so that they may engage
in price competition through aggressive pricing policies to secure a greater market share to our
detriment. These competitors also may develop products that make our current or future products
obsolete. Any of these events could significantly harm our business, financial condition and
results of operations, including reducing our market share, gross margins, and cash flows.
We sell and distribute prescription brands, medical devices and over-the-counter products.
Each of these products competes with products produced by others to treat the same conditions.
Several of our prescription products compete with generic pharmaceuticals, which claim to offer
equivalent benefit at a lower cost. In some cases, insurers and other health care payment
organizations try to encourage the use of these less expensive generic brands through their
prescription benefits coverage and reimbursement policies. These organizations may make the
generic alternative more attractive to the patient by providing different amounts of reimbursement
so that the net cost of the generic product to the patient is less than the net cost of our
prescription brand product. Aggressive pricing policies by our generic product competitors and the
prescription benefits policies of third-party payors could cause us to lose market share or force
us to reduce our gross margins in response.
There are several dermal filler products under development and/or in the FDA pipeline for
approval which claim to offer equivalent or greater facial aesthetic benefits to
RESTYLANE® and PERLANE® and if approved, the companies producing such
products could charge less to doctors for their products.
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, and entered into significant collaborations with,
other 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 are 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 and the Medicare
Part B program, 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. In December 2007, a federal court issued an
injunction prohibiting the implementation of those provisions in the final rule relating to federal
upper limits, and that injunction is still in place. We cannot predict the full impact of these
changes, which otherwise 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.
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To receive reimbursement under state Medicaid programs and the Medicare Part B program 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 (DoD), 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. 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 and the Medicare Part B program 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 this
program or 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 FSS contract and
related pricing agreements required under the VHCA, 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 VA, 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 reviewed this issue and have
identified certain customer class of trade misclassifications.
Based on this finding, we undertook a review and recalculation of our Non-Federal Average
Manufacturer Prices (Non-FAMPs) and related FCPs, AMPs, and Best Prices (BPs) for a period
going back at least (3) years from the expected completion date of the recalculation 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 generally reviewed 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. In April 2009, we
completed the voluntary review of pricing data submitted to the Medicaid Drug Rebate Program (the
Program) for the period from the first quarter of 2006 through the fourth quarter of 2007. The
review identified certain actions that were needed in relation to the reviewed data. We expect
that the actions, when implemented, would result in an increase to our rebate liability under the
Program in the amount of approximately $3.1 million for the eight-quarter period reviewed. We have
disclosed the results of the review and revised rebate liability to CMS, which administers the
Program, and are awaiting CMSs instruction as to whether and when to re-file the revised pricing
data. Our submission to CMS also included a request that CMS approve a change in drug category for
certain of our products, which CMS approved in December 2009. The fiscal impact of that change is
included in the rebate liability figure noted above. Upon completion of CMSs review of our
submission, we will evaluate the impact that CMSs conclusions will have on our liability under
related drug rebate agreements with various states and the Public Health
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Service Drug Pricing
Program. We accrued $3.1 million for the 2006 and 2007 liability, which was recognized as a
reduction of net revenues during the three months ended March 31, 2009.
In July 2009, we completed the extension of this review to the pricing data submitted to the
Program for the period from the first quarter of 2008 through the fourth quarter of 2008. The
review again identified certain actions that were needed in relation to the reviewed data. We
expect that the actions, when implemented, would result in an
increase to our rebate liability under the Program in the amount of approximately $0.2 million
for the additional four-quarter period reviewed. This change in rebate liability includes the
impact of the drug category change approved by CMS in December 2009. Upon completion of CMSs
review of our submission for this additional four-quarter period, we will evaluate the impact that
CMSs conclusions will have on our liability under related drug rebate agreements with various
states and the Public Health Service Drug Pricing Program. We accrued $0.2 million for the 2008
liability, which was recognized as a reduction of net revenues during the three months ended June
30, 2009.
On March 17, 2009, the Department of Defense (DoD) issued a Final Rule (the Rule)
implementing Section 703 of the National Defense Authorization Act of 2008. The Rule established a
program under which the DoD seeks FCP-based refunds, or rebates, from drug manufacturers on TRICARE
retail pharmacy utilization. Under the Rule, effective May 26, 2009, the DoD is seeking rebates on
TRICARE retail pharmacy program prescriptions filled from January 28, 2008, forward. The Rule sets
forth a program in which the DoD asks manufacturers to enter into agreements with the agency
pursuant to which the manufacturers commit to pay such rebates. Products that are not listed in
such agreements will not be able to be included on the DoD Uniform Formulary. Additionally,
products not listed in TRICARE retail agreements will not be available through TRICARE retail
network pharmacies without prior authorization. Among other things, the Rule further provides that
manufacturers may apply for compromise or waivers of amounts due. As a result of the Rule, our
rebate liability as of March 31, 2009, for 2008 utilization is approximately $1.6 million, the
rebate liability for the first quarter of 2009 is approximately $0.8 million, and the rebate
liability for the second quarter of 2009 prior to the date of execution of our TRICARE retail
agreement on June 29, 2009 is $0.6 million. It is possible that, pursuant to the compromise or
waiver process set forth in the Rule, the DoD will agree to accept a lesser sum for the 2008 period
and for the first and second quarters of 2009. We applied timely for a waiver of liability from
January 28, 2008 through the date of our TRICARE rebate agreement, which was executed on June 29,
2009. We accrued $2.4 million in the aggregate for the liability for 2008 and the first quarter of
2009, which was recognized as a reduction of net revenues during the three months ended March 31,
2009. We also accrued $0.6 million in our financial statements as of June 30, 2009 for TRICARE
rebate liability for the second quarter of 2009 through June 28, 2009, the day prior to execution
of our TRICARE rebate agreement. This sum was recognized as a reduction of net revenues during
that period.
In addition, we conducted a review and recalculation of our Non-FAMPs and FCPs for a period
spanning the duration of our current FSS contract to determine what, if any, impact
reclassification of customers to appropriate classes of trade and any other issues identified in
the course of the review might have on these reported prices. In doing the recalculation, we
assigned all customers to an appropriate class of trade, implemented a revised calculation
methodology, and addressed all other issues identified in the course of the review. Our review
also involved assessment of compliance with the FSS Price Reductions Clause for the products on our
current FSS contract.
On September 15, 2008, we submitted a report to the VA detailing the recalculations and the
impact figures associated with overcharges under the current FSS contract. The submission showed
liability in the amount of $121,646, resulting from overcharges under our FSS contract through July
31, 2008. On December 18, 2008, we submitted a supplement to the September 15 submission, which,
based on certain issues uncovered subsequent to the September 15, 2008 submission, showed an
additional $61,459 in overcharges. The VA informed us that our submission is under review. Upon
VA approval of our submissions, we will calculate the impact, if any, associated with August
December 2008.
We will be unable to meet our anticipated development and commercialization timelines if clinical
trials for our products are unsuccessful, delayed, or additional information is required by the
FDA.
The production and marketing of our products and our ongoing research and development,
pre-clinical testing and clinical trials activities are subject to extensive regulation and review
by numerous governmental authorities. Before obtaining regulatory approvals for the commercial
sale of any products, we and/or our partners
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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 that may be subject to unexpected delays.
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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severe or harmful side effects; |
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failure to obtain necessary proprietary rights; |
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shortage or lack of supply sufficient to complete studies; |
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the decision to modify the product; |
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lack of economical pathway to manufacture and commercialize product; |
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cost-effectiveness of continued product development; |
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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; |
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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, and in particular our facial aesthetic and branded prescription products, have
been and are expected to continue to 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. In addition, our ability
to meet our expected financial performance is dependent upon our ability to rapidly recover from
downturns in general economic conditions.
Recent global market and economic conditions have been unprecedented and challenging with
tighter credit conditions and recession in most major economies continuing into 2010. Continued
concerns about the systemic impact of potential long-term and wide-spread recession, energy costs,
geopolitical issues, the availability and cost of credit, and the global housing and mortgage
markets have contributed to increased market volatility and diminished expectations for western and
emerging economies. These conditions, combined with volatile oil prices, declining business and
consumer confidence and increased unemployment, have contributed to volatility of unprecedented
levels.
As a result of these market conditions, the cost and availability of credit has been and may
continue to be adversely affected by illiquid credit markets and wider credit spreads. Concern
about the stability of the markets generally and the strength of counterparties specifically has
led many lenders and institutional investors to reduce,
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and in some cases, cease to provide credit
to businesses and consumers. These factors have led to a decrease in spending by businesses and
consumers alike, and a corresponding decrease in global infrastructure spending. Continued
turbulence in the U.S. and international markets and economies and prolonged declines in business
consumer spending may adversely affect our liquidity and financial condition, and the liquidity and
financial
condition of our customers, including our ability to refinance maturing liabilities and access
the capital markets to meet liquidity needs.
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. 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. 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, 2009, our
investments included $26.8 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. Since early 2008, there has been insufficient demand at auction for auction
rate floating securities. As a result, these affected auction rate floating securities are now
considered illiquid, and we could be required to hold them until they are redeemed by the holder at
maturity. We may not be able to liquidate the securities until a future auction on these
investments is successful. We could be required to record impairment losses in the future,
depending on market conditions.
If Q-Med is unable to protect its intellectual property and proprietary rights with respect to our
dermal filler products, our business could suffer.
The exclusivity period of the license granted to us by Q-Med for RESTYLANE®,
RESTYLANE-LTM, PERLANE®, PERLANE-LTM, RESTYLANE FINE
LINESTM and RESTYLANE SUBQTM will terminate on the later of (i) the
expiration of the last patent covering the products (estimated to be 2017) or (ii) upon the
licensed know-how becoming publicly known. If the validity or enforceability of our 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 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, including Mr. Shacknai, 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 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.
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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 realize all of the anticipated benefits of our acquisition of LipoSonix.
Our ability to realize the anticipated benefits of our acquisition of LipoSonix could be
affected by a number of factors, including:
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our ability to attain regulatory approvals, both in the United States and worldwide,
and the timing of such approvals; |
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our compliance with existing and future legal and regulatory requirements, both in
the United States and worldwide; |
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the efficacy of the LIPOSONIXTM system; |
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market acceptance of the LIPOSONIXTM system; |
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increases or decreases in the expected costs to be incurred in connection with the
research and development, clinical trials, regulatory approvals, commercialization and
marketing of the LIPOSONIXTM system; |
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the costs associated with investment in new infrastructure to support worldwide
operations; |
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the strength of our intellectual property portfolio related to the
LIPOSONIXTM system; |
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the ability of other companies to design around the proprietary technology in the
LIPOSONIXTM system; |
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the anticipated pricing, margins, size of the markets and demand related to the
LIPOSONIXTM system; |
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the challenges associated with using distributors or finding new distributors for
marketing and sales of the LIPOSONIXTM system; |
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the challenges associated with advertisement and promotion related to the
LIPOSONIXTM system, which is dynamic and varies according to jurisdiction
and distribution channel mode; |
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the possibility of adverse patient events pertaining to the LIPOSONIXTM
system; |
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risks inherent to operations outside of the United States, including foreign
currency exchange rate fluctuations; |
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our ability to integrate the operations of LipoSonix with our operations; |
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our ability to retain key personnel of LipoSonix; and |
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our ability to effectively compete in the fat removal marketplace. |
We rely on third parties to conduct business operations outside of the U.S., and we may be
adversely affected if they act in violation of the U.S. Foreign Corrupt Practices Act or other
anti-bribery laws.
The U.S. Foreign Corrupt Practices Act and similar anti-bribery laws in other jurisdictions
prohibit companies and their agents from making improper payments to government officials for the
purpose of obtaining or retaining business. These laws are complex and often difficult to
interpret and apply, and in certain cases, local business practices may conflict with strict
adherence to anti-bribery laws. Our policies and contractual arrangements are designed to maintain
compliance with these anti-bribery laws. We perform, on a periodic basis, an extensive background
check to verify several aspects of compliance, including but not limited to, national and
international black lists. We also provide training to relevant employees and agents regarding
compliance with anti-bribery laws. We cannot guarantee that our policies and procedures,
contractual obligations, background checks and training programs will prevent reckless or criminal
acts committed by our employees or agents. Violations may result in criminal and civil penalties,
including fines, imprisonment, loss of our export licenses,
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suspension of our ability to do business with the federal government, denial of government
reimbursement for our products, and exclusion from participation in government healthcare programs.
Allegations or evidence that we or our agents have violated these laws could disrupt our business
and subject us to criminal or civil enforcement actions. Such action could have a material adverse
effect on our business.
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.
We rely on others to manufacture our products.
Currently, we rely on third-party manufacturers for much of our product manufacturing needs.
All third-party manufacturers are required by law to comply with the FDAs regulations, including
the cGMP regulations (for drugs and biologics) and the QSR (for medical devices), as applicable.
These regulations set forth standards for both quality assurance and quality control. Third-party
manufacturers also must maintain records and other documentation as required by applicable laws and
regulations. In addition to a legal obligation to comply, our third-party manufacturers are
contractually obligated to comply with all applicable laws and regulations. However, we cannot
guarantee that third-party manufacturers will ensure compliance with all applicable laws and
regulations. Failure of a third-party manufacturer to maintain compliance with applicable laws and
regulations could result in decreased sales of our products and decreased revenues. Failure of a
third-party manufacturer to maintain compliance with applicable laws and regulations also could
result in reputational harm to Medicis and potentially subject us to sanctions, including:
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delays, warning letters, and fines; |
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product recalls or seizures; |
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injunctions on sales; |
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refusal of FDA to review pending applications; |
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total or partial suspension of production; |
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withdrawal of prior marketing approvals or clearances; and |
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civil penalties and criminal prosecutions. |
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 and in accordance with good manufacturing standards and
applicable product specifications. As a result, we are subject to and have little or no control
over delays and quality control lapses that our third-party manufacturers and suppliers may suffer.
For example, in early May 2008, we became aware that our third-party manufacturer and supplier of
SOLODYN® mistakenly filled at least one bottle labeled as SOLODYN® with a
different pharmaceutical product. As a result of this occurrence, we initiated a voluntary recall
of the two affected lots. We were able, however, to recoup some of our losses from this voluntary
recall during 2009 as a result of an indemnification claim against the manufacturer.
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
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primary supplier of any of our primary products is
unable to fulfill our requirements for any 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.
Manufacturing facilities must be approved by the FDA before they are used to manufacture our
products. The validation of a new facility and the approval of that manufacturer for a new 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. The new facility also may be subject to follow-up inspections. 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 effect 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®,
RESTYLANE-LTM, PERLANE®, PERLANE-LTM, RESTYLANE FINE
LINESTM and RESTYLANE SUBQTM.
The manufacturing process to create bulk non-animal stabilized hyaluronic acid necessary to
produce RESTYLANE®, RESTYLANE-LTM, PERLANE®,
PERLANE-LTM, RESTYLANE FINE LINESTM and RESTYLANE 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®, RESTYLANE-LTM, PERLANE®, PERLANE-LTM,
RESTYLANE FINE LINESTM and RESTYLANE SUBQTM products and a resulting decrease
in sales of the products.
We depend exclusively on Q-Med for our supply of RESTYLANE®,
RESTYLANE-LTM, PERLANE®, PERLANE-LTM, RESTYLANE FINE
LINESTM and RESTYLANE 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®, RESTYLANE-LTM, PERLANE®,
PERLANE-LTM, RESTYLANE FINE LINESTM and RESTYLANE 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.
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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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 basis; |
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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. We have
recently entered into distribution services agreements with our two largest wholesale customers.
We review the supply levels of our significant products sold to major wholesalers by reviewing
periodic inventory reports supplied by our major wholesalers. 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.
From time to time, we may enter into business arrangements (e.g., loans or investments) involving
our customers and those arrangements may be reviewed by federal and state regulators.
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 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
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you that we will be able to
obtain adequate supplies of such services or products in a timely fashion, on acceptable terms, or
at all.
Importation of products from Canada and other countries into the United States may lower the prices
we receive for our products.
Our products are subject to competition from lower priced versions of our products and
competing products from Canada and other countries where government price controls or other market
dynamics result in lower prices. The ability of patients and other customers to obtain these lower
priced imports has grown significantly as a result of the Internet, an expansion of pharmacies in
Canada and elsewhere targeted to American purchasers, the increase in United States-based
businesses affiliated with Canadian pharmacies marketing to American purchasers, and other factors.
Most of these foreign imports are illegal under current United States law. However, the volume of
imports continues to rise due to the limited enforcement resources of the FDA and the United States
Customs Service, and there is increased political pressure to permit the imports as a mechanism for
expanding access to lower priced medicines.
In December 2003, Congress enacted the Medicare Prescription Drug, Improvement and
Modernization Act of 2003. This law contains provisions that may change United States import laws
and expand consumers ability to import lower priced versions of our and competing products from
Canada, where there are government price controls. These changes to United States import laws will
not take effect unless and until the Secretary of Health and Human Services certifies that the
changes will lead to substantial savings for consumers and will not create a public health safety
issue. The former Secretary of Health and Human Services did not make such a certification.
However, it is possible that the current Secretary or a subsequent Secretary could make the
certification in the future. As directed by Congress, a task force on drug importation recently
conducted a comprehensive study regarding the circumstances under which drug importation could be
safely conducted and the consequences of importation on the health, medical costs and development
of new medicines for United States consumers. The task force issued its report in December 2004,
finding that there are significant safety and economic issues that must be addressed before
importation of prescription drugs is permitted, and the current Secretary has not yet announced any
plans to make the required certification. In addition, federal legislative proposals have been made
to implement the changes to the United States import laws without any certification, and to broaden
permissible imports in other ways. Even if the changes to the United States import laws do not
take effect, and other changes are not enacted, imports from Canada and elsewhere may continue to
increase due to market and political forces, and the limited enforcement resources of the FDA, the
United States Customs Service and other government agencies.
The importation of foreign products adversely affects our profitability in the United States.
This impact could become more significant in the future, and the impact could be even greater if
there is a further change in the law or if state or local governments take further steps to
facilitate the importation of products from abroad.
If we become subject to product liability claims, our earnings and financial condition could
suffer.
We are exposed to risks of product liability claims from allegations that our products
resulted in adverse effects to the patient or others. These risks exist even with respect to those
products that are approved for commercial sale by the FDA and manufactured in facilities licensed
and regulated by the FDA.
In addition to our desire to reduce the scope of our potential exposure to these types of
claims, many of our customers require us to maintain product liability insurance as a condition of
conducting business with us. We currently carry product liability insurance 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
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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, has been relatively stable in recent years but 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.
DYSPORTTM,
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 DYSPORTTM, RESTYLANE® and
PERLANE®.
DYSPORTTM, 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 glabellar lines, fine lines,
wrinkles and deep facial folds, we may experience a decline in demand for DYSPORTTM,
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 DYSPORTTM,
RESTYLANE® and PERLANE® may be negatively impacted by these reports and other
reasons.
Demand for DYSPORTTM, 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 DYSPORTTM, RESTYLANE® and
PERLANE® could be adversely affected.
The restatement of our consolidated financial statements has subjected us to a number of additional
risks and uncertainties, including increased costs for accounting and legal fees and the increased
possibility of legal proceedings.
As discussed in our Form 10-K/A for the year ended December 31, 2007 filed with the SEC on
November 10, 2008, and in Note 2 to our consolidated financial statements therein, we determined
that our consolidated financial statements for the annual, transition and quarterly periods in
fiscal years 2003 through 2007 and the first and second quarters of 2008 should be restated due to
an error in our interpretation and application of Statement of Financial Accounting Standards No.
48, Revenue Recognition When Right of Return Exists (SFAS 48), as it applies to a component of
our sales return reserve calculations. SFAS 48 is now part of ASC 605, Revenue Recognition (ASC
605). As a result of the restatement, we have become subject to a number of additional risks and
uncertainties, including:
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We incurred substantial unanticipated costs for accounting and legal fees in
connection with the restatement. Although the restatement is complete, we expect to
continue to incur accounting and legal costs as noted below. |
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As a result of the restatement, we have been named in a putative shareholder class
action complaint, as discussed in Item 3 of Part I of this report, Legal Proceedings
and Note 12, Commitments and Contingencies. The plaintiffs in this consolidated
lawsuit may make additional claims, expand existing claims and/or expand the time
periods covered by the complaints. Other plaintiffs may bring additional actions with
other claims, based on the restatement. If such events occur, we may incur substantial
defense costs regardless of the outcome of these actions and insurance and
indemnification may not be sufficient to cover the losses we may incur. Likewise, such
events might cause a diversion of our managements time and attention. If we do not
prevail in this action or other potential actions, we could be required to pay
substantial damages or settlement costs, which could adversely affect our business,
financial condition, results of operations and liquidity. |
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On January 21, 2009, we received a letter from a stockholder demanding that our
Board of Directors take certain actions, including potentially legal action, in
connection with the restatement of our consolidated financial statements in 2008, and
threatening to pursue a derivative claim if our Board of Directors does not comply with
the stockholders demands. We may receive similar letters from other stockholders.
Our Board of Directors reviewed the letter during the course of 2009 and established a special committee
of the Board, comprised of directors who are independent and disinterested with respect
to the letter, (i) to assess whether there is any merit to the allegations contained in
the letter, (ii) if the special committee were to conclude that there may be merit to any
of the allegations contained in the letter, to further assess whether it is in our best
interest to pursue litigation or other action against any or all of the persons named
in the letter or any other persons not named in the letter, and (iii) to recommend to
the Board any other appropriate action to be taken. The special committee engaged
outside counsel to conduct an inquiry. The ultimate outcome of
these potential actions could have a material adverse effect on our business, financial
condition, results of operations, cash flows and the trading price for our securities. |
In 2008, management identified a material weakness in our internal control over financial reporting
with respect to our accounting for sales return reserves. Although as of December 31, 2008
management determined that the material weakness identified in 2008 had been remediated, management
may identify material weaknesses in the future that could adversely affect investor confidence,
impair the value of our common stock and increase our cost of raising capital.
In connection with the restatement of our consolidated financial statements in 2008,
management identified a material weakness in our internal control over financial reporting with
respect to our interpretation and application of SFAS 48 (now part of ASC 605) as it applies to the
calculation of sales return reserves. Management took steps to remediate the material weakness in
our internal control over financial reporting and, as of December 31, 2008, management determined
that the material weakness identified in 2008 had been remediated. There can be no assurance,
however, that additional material weaknesses will not be identified in the future.
Any failure to remedy additional deficiencies in our internal control over financial reporting
that may be discovered in the future could harm our operating results, cause us to fail to meet our
reporting obligations or result in material misstatements in our financial statements. Any such
failure could, in turn, affect the future ability of our management to certify that our internal
control over our financial reporting is effective and, moreover, affect the results of our
independent registered public accounting firms attestation report regarding our managements
assessment. Inferior internal control over financial reporting could also subject us to the
scrutiny of the SEC and other regulatory bodies and could cause investors to lose confidence in our
reported financial information, which could have an adverse effect on the trading price of our
common stock.
In addition, if we or our independent registered public accounting firm identify additional
deficiencies in our internal control over financial reporting, the disclosure of that fact, even if
quickly remedied, could reduce the markets confidence in our financial statements and harm our
share price. Furthermore, additional deficiencies could result in future non-compliance with
Section 404 of the Sarbanes-Oxley Act of 2002. Such non-compliance could subject us to a variety
of administrative sanctions, including the suspension or delisting of our ordinary shares from the
NYSE and review by the NYSE, the SEC, or other regulatory authorities.
We may not be able to repurchase the Old Notes when required.
We have $169.2 million principal amount of outstanding 2.5% Contingent Convertible Senior
Notes due 2032 (the Old Notes). 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.
The source of funds for any repurchase required as a result of any such event 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 event to make any
required repurchases of the Notes tendered. If sufficient funds are not available to repurchase
the Old 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 may
impair our ability to obtain additional financing in the future.
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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 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,
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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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changes to advertising; |
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suspensions of regulatory approvals of products; |
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product withdrawals and recalls; |
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delays in product distribution, marketing and sale; and |
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civil or criminal sanctions. |
For example, in early May 2008, we became aware that our third-party manufacturer and supplier
of SOLODYN® mistakenly filled at least one bottle labeled as SOLODYN® with a
different pharmaceutical product. As a result of this occurrence, we initiated a voluntary recall
of the two affected lots, each of which was shipped subsequent to March 31, 2008, and we may be
subject to claims, fines or other penalties.
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.
Sales representative activities may also be subject to the Voluntary Compliance Guidance
issued for pharmaceutical manufacturers by the 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.
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 2009 and that remain unresolved.
Item 2. Properties
During July 2006, we executed a lease agreement for new headquarter office space to
accommodate our expected long-term growth. The first phase is for approximately 150,000 square
feet with the right to expand. We occupied the new headquarter office space, which is located
approximately one mile from our previous headquarter office space in Scottsdale, Arizona, during
the second quarter of 2008. We obtained possession of the leased premises and therefore began
accruing rent expense during the first quarter of 2008. The term of the lease is twelve years.
The average annual expense under the amended lease agreement is approximately $3.9 million. During
the first quarter of 2008, we received approximately $6.7 million in tenant improvement incentives
from the landlord. This amount has been capitalized into leasehold improvements and is being
depreciated on a straight-line basis over the lesser of the useful life or the term of the lease.
The tenant improvement incentives are also included in other long-term liabilities as deferred
rent, and will be recognized as a reduction of rent expense on a straight-line basis over the term
of the lease. In 2008, upon vacating our previous headquarters facility, we recorded a charge for
the estimated remaining net cost for the lease, net of potential sublease income, of $4.8 million.
See Item 7 of Part II of
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this report, Managements Discussion and Analysis of Financial Condition
and Results of Operations Contingent Convertible Senior Notes and Other Long-Term Commitments.
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. The lease expires in May
2010. We intend to extend the lease beyond May 2010.
LipoSonix, now known as Medicis Technologies Corporation, presently leases approximately
24,700 square feet of office, laboratory and manufacturing space in Bothell, Washington, under a
lease agreement that expires in October 2012.
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 2010.
Rent expense was approximately $3.6 million, $9.4 million and $2.5 million for 2009, 2008 and
2007, respectively. Rent expense for 2008 includes a $4.8 million charge for the estimated
remaining net cost for our previous headquarters facility lease, net of potential sublease income.
Item 3. Legal Proceedings
On November 20, 2009, we received a Paragraph IV Patent Certification from Barr, advising
that Barr has filed a supplement to its earlier filed ANDA # 65-485 (Barr ANDA Supplement) with
the FDA for generic SOLODYN® in its forms of 65mg and 115mg strengths. Barr has not
advised us as to the timing or status of the FDAs review of its filing, or whether Barr has
complied with FDA requirements for proving bioequivalence. Barrs Paragraph IV Certification
alleges that our 838 Patent is invalid, unenforceable and/or will not be infringed by Barrs
manufacture, use, sale and/or importation of the products for which the Barr ANDA Supplement was
submitted. On December 28, 2009, we filed suit against Barr/Teva, in the United States District
Court for the District of Maryland seeking an adjudication that Barr/Teva has infringed one or more
claims of the 838 Patent by submitting to the FDA the Barr ANDA Supplement seeking marketing
approval for generic SOLODYN® in its forms of 65mg and 115mg strengths. The
relief we requested includes a request for a permanent injunction preventing Barr/Teva from
infringing the 838 Patent by selling generic versions of SOLODYN® in its
forms of 65mg and 115mg strengths. As a result of the filing of the suit, we believe that the
supplement to the ANDA cannot be approved by the FDA until after the expiration of a 30-month stay
period or a court decision that the patent is invalid or not infringed.
On October 8, 2009, we received a Paragraph IV Patent Certification from Lupin advising that
Lupin had filed an ANDA with the FDA for generic SOLODYN® in its forms of 45mg, 90mg,
and 135mg strengths. Lupin did not advise us as to the timing or status of the FDAs review of its
filing, or whether it has complied with FDA requirements for proving bioequivalence. Lupins
Paragraph IV Certification alleged that Lupins manufacture, use, sale or offer for sale of the
product for which the ANDA was submitted would not infringe any valid claim of our 838 Patent. On
November 17, 2009, we filed suit against Lupin in the United States District Court for the District
of Maryland seeking an adjudication that Lupin has infringed one or more claims of the 838 Patent
by submitting to the FDA an ANDA for generic SOLODYN® in its forms of 45mg, 90mg and
135mg strengths. The relief we requested includes a request for a permanent injunction preventing
Lupin from infringing the 838 Patent by selling generic versions of SOLODYN®. On
November 24, 2009, we received a Paragraph IV Patent Certification from Lupin, advising that Lupin
has filed a supplement or amendment to its earlier filed ANDA assigned ANDA #91-424 (Lupin ANDA
Supplement/Amendment I) with the FDA for generic SOLODYN ® in its form of 65mg
strength. Lupin has not advised us as to the timing or status of the FDAs review of its filing,
or whether Lupin has complied with FDA requirements for proving bioequivalence. Lupins
Paragraph IV Certification alleges that our 838 Patent is invalid and/or will not be infringed by
Lupins manufacture, use, sale and/or importation of the products for which the Lupin ANDA
Supplement/Amendment I was submitted. Lupins submission amends an ANDA already subject to a
30-month stay. As such, we believe that the amendment cannot be approved by the FDA until after
the expiration of the 30-month period or a court decision that the patent is invalid or not
infringed. On December 23, 2009, we received a Paragraph IV Patent Certification from Lupin,
advising that Lupin has filed a supplement or amendment to its earlier filed ANDA assigned ANDA
#91-424 (Lupin ANDA Supplement/Amendment II) with the FDA for generic SOLODYN ® in its
form of 115mg strength. Lupin has not advised us as to the timing or status
44
of the FDAs review of
its filing, or whether Lupin has complied with FDA requirements for proving bioequivalence. Lupins
Paragraph IV Certification alleges that our 838 Patent is invalid and/or will not be infringed by
Lupins manufacture, use, sale and/or importation of the products for which the Lupin ANDA
Supplement/Amendment II was submitted. Lupins submission amends an ANDA already subject to a
30-month stay. As such, we believe that the amendment cannot be approved by the FDA until after
the expiration of the 30-month period or a court decision that the patent is invalid or not
infringed. On December 28, 2009, we amended our complaint against Lupin in the United States
District Court for the District of Maryland seeking an adjudication that Lupin has infringed one or
more claims of the 838 Patent by submitting its supplement or amendment to its earlier filed ANDA
assigned ANDA #91-424 for generic SOLODYN® in its form of 65mg strength. On February 2,
2010, we amended our complaint against Lupin in the United States District Court for the District
of Maryland seeking an adjudication that Lupin has infringed one or more claims of the 838 Patent
by submitting its supplement or amendment to its earlier filed ANDA assigned ANDA #91-424 for
generic SOLODYN® in its form of 115mg strength.
On September 21, 2009, we received a Paragraph IV Patent Certification from Glenmark advising
that Glenmark has filed an ANDA with the FDA for a generic version of LOPROX® Gel.
Glenmark did not advise us as to the timing or status of the FDAs review of its filing, or whether
it has complied with FDA requirements for proving bioequivalence. Glenmarks Paragraph IV
Certification alleged that our U.S. Patent No. 7,018,656 (the 656 Patent) would not be infringed
by Glenmarks manufacture, use or sale of the product for which the ANDA was submitted. The
expiration date for the 656 Patent is 2018. On November 14, 2009, we entered into a License and
Settlement Agreement with Glenmark and its foreign corporate parent Glenmark Ltd. In connection
with the License and Settlement Agreement, we and Glenmark agreed to terminate all legal disputes
between us relating to LOPROX® Gel. In addition, Glenmark confirmed that certain of our
patents relating to LOPROX® Gel are valid and enforceable, and cover Glenmarks
activities relating to its generic version of LOPROX® Gel under an ANDA. Subject to the
terms and conditions contained in the License and Settlement Agreement, we also granted Glenmark a
license to make and sell generic versions of LOPROX® Gel. Upon commercialization by
Glenmark of generic versions of LOPROX® Gel, Glenmark will pay us a royalty based on
sales of such generic products.
On December 7, 2009, we entered into a Settlement Agreement (the Paddock Settlement
Agreement) with Paddock Laboratories, Inc. (Paddock). In connection with the Paddock Settlement
Agreement, we and Paddock agreed to settle all legal disputes between us relating to our
LOPROX® Shampoo and we agreed to withdraw our complaint against Paddock pending in the
U.S. District Court for the District of Arizona. In addition, Paddock confirmed that Paddocks
activities relating to its generic version of LOPROX® Shampoo are covered by our current
and pending patent applications. Further, subject to the terms and conditions contained in the
Paddock Settlement Agreement, we granted Paddock a non-exclusive, royalty-bearing license to make
and sell limited quantities of its generic version of LOPROX® Shampoo.
On May 8, 2009, we received a Paragraph IV Patent Certification from Glenmark advising that
Glenmark has filed an ANDA with the FDA for a generic version of VANOS® cream. Glenmark
has not advised us as to the timing or status of the FDAs review of its filing, or whether it has
complied with FDA requirements for proving bioequivalence. Glenmarks Paragraph IV Certification
alleges that our 001 Patent and 424 Patent will not be infringed by Glenmarks manufacture, use or
sale of the product for which the ANDA was submitted. The expiration date for the 424 Patent is
2023. On June 19, 2009, we filed a complaint for patent infringement against Glenmark in the
United States District Court for the District of New Jersey. On July 14, 2009, Glenmark and
Glenmark Ltd. answered our complaint, and filed counterclaims seeking a declaration that the
patents we listed with the FDA for VANOS® cream were invalid and unenforceable, and
would not be infringed by Glenmarks generic version of VANOS®. On November 14, 2009,
we entered into a license and settlement agreement with Glenmark Ltd. and Glenmark. In connection
with the license and settlement agreement, we and Glenmark agreed to terminate all legal disputes
between us relating to VANOS®. In addition, Glenmark confirmed that certain of our
patents relating to VANOS® cream are valid and enforceable, and cover Glenmarks
activities relating to its generic versions of VANOS® cream under its ANDA. Further,
subject to the terms and conditions contained in the license and settlement agreement, we granted
Glenmark, effective December 15, 2013, or earlier upon the occurrence of certain events, a license
to make and sell generic versions of the existing VANOS® products. Upon
commercialization by Glenmark of generic versions of VANOS® products, Glenmark will pay
us a royalty based on sales of such generic products.
On May 6, 2009, we received a Paragraph IV Patent Certification from Ranbaxy advising that
Ranbaxy had filed an ANDA with the FDA for generic SOLODYN® in its form of 135mg
strength. Ranbaxy did not advise us as
45
to the timing or status of the FDAs review of its filing,
or whether it has complied with FDA requirements for proving bioequivalence. Ranbaxys
Paragraph IV Certification alleged that Ranbaxys manufacture, use, sale or offer for sale of the
product for which the ANDA was submitted would not infringe any valid claim of our 838 Patent. On
June 11, 2009, we filed suit against Ranbaxy in the United States District Court for the District
of Delaware seeking an adjudication that Ranbaxy has infringed one or more claims of the 838
Patent by submitting the above ANDA to the FDA. The relief we requested included a request for a
permanent injunction preventing Ranbaxy from infringing the 838 Patent by selling a generic
version of SOLODYN®. Ranbaxy has answered that the 838 Patent is not infringed, is
invalid, and/or is unenforceable. On January 5, 2010, we received a Paragraph IV Patent
Certification from Ranbaxy advising that Ranbaxy has filed a supplement or amendment to its earlier
filed ANDA assigned ANDA #91-118 (Ranbaxy ANDA Supplement/Amendment) with the FDA for generic
SOLODYN® in its forms of 45mg and 90mg strengths. Ranbaxy has not advised us as to the
timing or status of the FDAs review of its filing, or whether Ranbaxy has complied with FDA
requirements for proving bioequivalence. Ranbaxys Paragraph IV Certification alleges that our
838 Patent is invalid, unenforceable, and/or will not be infringed by Ranbaxys manufacture,
importation, use, sale and/or offer for sale of the products for which the Ranbaxy ANDA
Supplement/Amendment was submitted. Ranbaxys Paragraph IV Certification also alleges that our
347 Patent or 373 Patent is not infringed by Ranbaxys manufacture, importation, use, sale and/or
offer for sale of the products for which the Ranbaxy ANDA Supplement/Amendment was submitted.
Ranbaxys submission as to the 45mg and 90mg strengths amends an ANDA already subject to a 30-month
stay. As such, we believe that the Ranbaxy ANDA Supplement/Amendment cannot be approved by the FDA until
after the expiration of the 30-month period or in the event of a court decision holding that the
patents are invalid or not infringed. On February 16, 2010, we filed a complaint against Ranbaxy in the United
States District Court for the District of Delaware seeking an adjudication that Ranbaxy has infringed one or more
claims of the patents by submitting the Ranbaxy ANDA Supplement/Amendment for generic
SOLODYN® in its forms of 45mg and 90mg strengths.
On June 23, 2009, the Company and IMPAX entered into a Settlement Agreement (the IMPAX
Settlement Agreement) and Amendment No. 2 to the License and Settlement Agreement initially
entered into between IMPAX and the Company. In conjunction with the IMPAX Settlement Agreement,
both IMPAX and the Company released, acquitted, covenanted not to sue and forever discharged one
another and their affiliates from any and all liabilities relating to the litigation stemming from
the initial License and Settlement Agreement between IMPAX and the Company.
A third party has requested that the USPTO conduct an Ex Parte Reexamination of the 838
Patent. The USPTO granted this request. In March 2009, the USPTO issued a non-final office action
in the reexamination of the 838 Patent. On May 13, 2009, Medicis filed its response to the
non-final office action with the USPTO, canceling certain claims and adding amended claims. On
November 13, 2009, we received a second non-final office action from the USPTO in the reexamination
of the 838 Patent. The latest office action rejects certain claims of the 838 Patent. On
January 8, 2010, the Company filed its response to the non-final office action with the USPTO.
Reexamination can result in confirmation of the validity of all of a patents claims, the
invalidation of all of a patents claims, or the confirmation of some claims and the invalidation
of others. We cannot guarantee the outcome of the reexamination. It is possible that one or more
of our patents covering SOLODYN® may be found invalid or narrowed in scope as the result
of the pending reexamination or a future reexamination by the USPTO. If the USPTOs action leads
the court in a SOLODYN® patent infringement suit, including the suits described in this
Report, to hold that the patent for SOLODYN® is invalid or not infringed, such a holding
would permit the FDA to lift the 30-month stay on approval of ANDAs for generic versions of
SOLODYN®.
On January 13, 2009, we filed suit against Mylan, Matrix, Matrix Laboratories Inc., Sandoz,
and Barr (collectively Defendants) in the United States District Court for the District of
Delaware seeking an adjudication that Defendants have infringed one or more claims of our 838
Patent by submitting to the FDA their respective ANDAs for generic versions of SOLODYN®.
The relief we requested includes a request for a permanent injunction preventing Defendants from
infringing the 838 Patent by selling generic versions of SOLODYN®. Mylan has answered
that the 838 Patent is not infringed and/or invalid. On March 18, 2009, we entered into a
settlement agreement with Barr, a subsidiary of Teva, whereby all legal disputes between us and
Teva relating to SOLODYN® were terminated and whereby Teva agreed that our patent
related to SOLODYN® valid, and enforceable and cover Tevas activities relating to its
generic SOLODYN®. As part of the settlement, Teva agreed to immediately stop all
further shipments of its generic SOLODYN® product. On March 30, 2009, the Delaware
Court dismissed the claims between us and Matrix Laboratories Inc. without prejudice, pursuant to a
stipulation between us and Matrix Laboratories Inc. On August 18, 2009, we entered into a
Settlement Agreement with Sandoz whereby all legal disputes between us and Sandoz relating to
SOLODYN® were terminated and where Sandoz agreed that our patents related to
SOLODYN® are valid and enforceable, and cover Sandozs activities relating to its
generic SOLODYN®
46
product under ANDA #90-422. Sandoz agreed to be permanently enjoined
from any further distribution of generic SOLODYN®.
On February 1, 2010, we received a Paragraph IV Patent Certification from Sandoz, advising
that Sandoz has filed a supplement to its earlier filed ANDA #91-422 (Sandoz ANDA Supplement)
with the FDA for generic SOLODYN® in its forms of 65mg and 115mg strengths. Sandoz has not advised
us as to the timing or status of the FDAs review of its filing, or whether Sandoz has complied
with FDA requirements for proving bioequivalence. Sandozs Paragraph IV Certification alleges that
the 838 Patent will not be infringed by Sandozs manufacture, importation, use, sale and/or offer
for sale of the products for which the ANDA Supplement was submitted because it has been granted a
patent license by us for the 838 Patent.
On January 21, 2009, we received a letter from an alleged stockholder demanding that our Board
of Directors take certain actions, including potentially legal action, in connection with the
restatement of our consolidated financial statements in 2008. The letter states that, if the Board
of Directors does not take the demanded action, the alleged stockholder will commence a derivative
action on behalf of us. Our Board of Directors reviewed the letter during the course of 2009
and established a special committee of the Board, comprised of directors who are independent and disinterested with
respect to the allegations in the letter, (i) to assess whether there is any merit to the
allegations contained in the letter, (ii) if the special committee were to conclude that there may be
merit to any of the allegations contained in the letter, to further assess whether it is in the
best interest of us and our shareholders to pursue litigation or other action against any or all of
the persons named in the letter or any other persons not named in the letter, and (iii) to
recommend to the Board of Directors any other appropriate action to be taken. The special
committee engaged outside counsel to assist with the investigation.
On October 3, 10 and 27, 2008, purported stockholder class action lawsuits styled Andrew Hall
v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01821-MHB); Steamfitters Local 449
Pension Fund v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01870-DKD); and Darlene
Oliver v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01964-JAT) were filed in the
United States District Court for the District of Arizona on behalf of stockholders who purchased
our securities during the period between October 30, 2003, and approximately September 24, 2008.
The Court has consolidated these actions into a single proceeding and appointed a lead plaintiff
and lead plaintiffs counsel. On May 18, 2009, the lead plaintiff filed an amended complaint. The
amended complaint names as defendants Medicis Pharmaceutical Corp. and our Chief Executive Officer
and Chairman of the Board, Jonah Shacknai, our Chief Financial Officer, Executive Vice President
and Treasurer, Richard D. Peterson, our Chief Operating Officer and Executive Vice President, Mark
A. Prygocki, and our independent auditors, Ernst & Young LLP. The claims alleged in the amended
complaint arose in connection with the restatement of our annual, transition, and quarterly periods
in fiscal years 2003 through 2007 and the first and second quarters of 2008. The amended complaint
alleges violations of federal securities laws, (Sections 10(b) and 20(a) of the Securities Exchange
Act of 1934 and Rule 10b-5), based on alleged material misrepresentations to the market that
allegedly had the effect of artificially inflating the market price of our stock. The amended
complaint sought to recover unspecified damages and costs, including counsel and expert fees. On
July 17, 2009, we and the other defendants filed motions to dismiss the amended complaint in its
entirety on various grounds. The lead plaintiff filed an opposition to the motions to dismiss on
August 31, 2009, and we and the other defendants filed reply memoranda in support of the motions to
dismiss on October 15, 2009. On December 2, 2009, the court dismissed the consolidated amended
complaint without prejudice, permitting the lead plaintiff the opportunity to replead. On January
18, 2010, the lead plaintiff filed a second amended complaint. On February 19, 2010, we and the
other defendants filed motions to dismiss the second amended complaint in its entirety on various
grounds. We will continue to vigorously defend the claims in these consolidated matters. There
can be no assurance, however, that we will be successful, and an adverse resolution of the lawsuits
could have a material adverse effect on our financial position and results of operations in the
period in which the lawsuits are resolved. We are not presently able to reasonably estimate
potential losses, if any, related to the lawsuits.
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 ASC 450, Contingencies) 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
47
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.
The information set forth under Legal Matters in Note 12 in the notes to the consolidated
financial statements under Item 15 of Part IV of this report, Exhibits and Financial Statement
Schedules, is incorporated herein by reference. For an additional discussion of certain risks
associated with legal proceedings, see Risk Factors in Item 1A of this Report.
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
HIGH |
|
LOW |
|
DIVIDENDS DECLARED |
|
YEAR ENDED DECEMBER 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
15.59 |
|
|
$ |
7.85 |
|
|
$ |
0.04 |
|
Second Quarter |
|
|
16.74 |
|
|
|
11.61 |
|
|
|
0.04 |
|
Third Quarter |
|
|
22.40 |
|
|
|
14.70 |
|
|
|
0.04 |
|
Fourth Quarter |
|
|
27.82 |
|
|
|
20.48 |
|
|
|
0.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEAR ENDED DECEMBER 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
27.02 |
|
|
$ |
18.51 |
|
|
$ |
0.04 |
|
Second Quarter |
|
|
24.49 |
|
|
|
18.84 |
|
|
|
0.04 |
|
Third Quarter |
|
|
22.10 |
|
|
|
13.60 |
|
|
|
0.04 |
|
Fourth Quarter |
|
|
15.19 |
|
|
|
9.66 |
|
|
|
0.04 |
|
On February 23, 2010, the last reported sale price on the New York Stock Exchange for Medicis
Class A common stock was $22.78 per share. As of such date, there were approximately 180 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 $46.6 million on our common stock. In addition, on December 16, 2009, we
declared a cash dividend of $0.04 per issued and outstanding share of common stock payable on
January 29, 2010 to our stockholders of record at the close of business on January 4, 2010. 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.
48
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. As of December 31,
2009, $181,000 of our 1.5% Contingent Convertible Senior Notes was outstanding.
Recent Sales of Unregistered Securities
None.
Equity Compensation Plan Information
The following table provides information as of December 31, 2009, 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
remaining available for |
|
|
|
|
|
|
Number of securities |
|
Weighted-average |
|
future issuance under |
|
|
|
|
|
|
to be issued upon |
|
exercise price |
|
equity compensation |
|
|
|
|
|
|
exercise of |
|
of outstanding |
|
plans (excluding |
|
|
|
|
|
|
outstanding options, |
|
options, warrants |
|
securities reflected in |
|
|
|
|
|
|
warrants and rights |
|
and rights |
|
column a) |
Plan Category |
|
Date |
|
(a) |
|
(b) |
|
(c) |
|
Plans approved by
stockholders (1) |
|
|
12/31/2009 |
|
|
|
6,332,755 |
|
|
$ |
28.70 |
|
|
|
2,818,071 |
|
Plans not approved
by stockholders (2) |
|
|
12/31/2009 |
|
|
|
2,921,092 |
|
|
$ |
30.40 |
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
9,253,847 |
|
|
$ |
29.24 |
|
|
|
2,818,071 |
|
|
|
|
(1) |
|
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. |
|
(2) |
|
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, 2009, the
weighted average term to expiration of these options is 3.8 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 23, 2010, there were 9,223,782 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 $29.23, and with a weighted average remaining life of 2.8 years. In addition, as
of February 23, 2010, there were 1,888,950
49
unvested shares of restricted stock outstanding under all of our equity compensation plans.
As of February 23, 2010, there were 2,852,360 shares available for future issuance under those
plans.
|
|
|
Item 6. |
|
Selected Financial Data |
The following table sets forth selected consolidated financial data for the year ended
December 31, 2009, 2008, 2007 and 2006. The data for the year ended December 31, 2009, 2008, 2007
and 2006 is derived from our audited consolidated financial statements and accompanying notes. 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year |
|
|
Year |
|
|
Year |
|
|
Year |
|
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
|
Dec. 31, 2009 |
|
|
Dec. 31, 2008 |
|
|
Dec. 31, 2007 |
|
|
Dec. 31, 2006 |
|
|
|
|
|
|
|
(in thousands, except per share amounts) |
|
|
|
|
|
Statements of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues |
|
$ |
561,761 |
|
|
$ |
500,977 |
|
|
$ |
441,868 |
|
|
$ |
377,548 |
|
Net contract revenues |
|
|
10,154 |
|
|
|
16,773 |
|
|
|
15,526 |
|
|
|
15,617 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
571,915 |
|
|
|
517,750 |
|
|
|
457,394 |
|
|
|
393,165 |
|
Gross profit (a) |
|
|
515,082 |
|
|
|
479,036 |
|
|
|
401,284 |
|
|
|
347,059 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
282,950 |
(b) |
|
|
279,768 |
(e) |
|
|
242,633 |
(i) |
|
|
202,457 |
(k) |
Research and development |
|
|
71,765 |
(c) |
|
|
99,916 |
(f) |
|
|
39,428 |
(j) |
|
|
161,837 |
(l) |
Depreciation and amortization |
|
|
29,047 |
|
|
|
27,698 |
|
|
|
24,548 |
|
|
|
23,048 |
|
In-process research and development |
|
|
|
|
|
|
30,500 |
(g) |
|
|
|
|
|
|
|
|
Impairment of intangible assets |
|
|
|
|
|
|
|
|
|
|
4,067 |
|
|
|
52,586 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
383,762 |
|
|
|
437,882 |
|
|
|
310,676 |
|
|
|
439,928 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
131,320 |
|
|
|
41,154 |
|
|
|
90,608 |
|
|
|
(92,869 |
) |
Other: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and investment (income)
expense, net |
|
|
(3,403 |
) |
|
|
(16,722 |
) |
|
|
(28,372 |
) |
|
|
(20,147 |
) |
Other income, net |
|
|
(867 |
)(d) |
|
|
15,470 |
(h) |
|
|
|
|
|
|
|
|
Income tax expense |
|
|
59,639 |
|
|
|
32,130 |
|
|
|
48,544 |
|
|
|
(24,570 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
75,951 |
|
|
$ |
10,276 |
|
|
$ |
70,436 |
|
|
$ |
(48,152 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share |
|
$ |
1.29 |
|
|
$ |
0.18 |
|
|
$ |
1.25 |
|
|
$ |
(0.88 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share |
|
$ |
1.21 |
|
|
$ |
0.18 |
|
|
$ |
1.07 |
|
|
$ |
(0.88 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share |
|
$ |
0.16 |
|
|
$ |
0.16 |
|
|
$ |
0.12 |
|
|
$ |
0.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic common shares outstanding |
|
|
57,252 |
|
|
|
56,567 |
|
|
|
55,988 |
|
|
|
54,688 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted common shares outstanding |
|
|
63,172 |
|
|
|
56,567 |
|
|
|
71,179 |
|
|
|
54,688 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Amounts exclude $22.4 million, $21.5 million, $21.6 million, and $20.0 million of
amortization expense related to acquired intangible assets for the year ended December 31,
2009, 2008, 2007 and 2006, respectively. |
|
(b) |
|
Includes approximately $18.1 million of compensation expense related to stock options,
restricted stock and stock appreciation rights. |
|
(c) |
|
Includes $12.0 million paid to IMPAX related to a development agreement, $10.0 million paid
to Revance related to a license agreement, $5.0 million paid to Glenmark related to a
development agreement, $5.0 |
50
|
|
|
|
|
million paid to Perrigo related to a development agreement and approximately $1.1 million of
compensation expense related to stock options, restricted stock and stock appreciation
rights. |
|
(d) |
|
Includes a $2.9 million reduction in the carrying value of our investment in Revance as a
result of a reduction in the net realizable value of the investment using the hypothetical
liquidation at book value approach and a $2.2 million gain on the sale of Medicis Pediatrics
to BioMarin. See Item 7 of Part II of this report, Managements Discussion and Analysis of
Financial Condition and Results of Operations Recent Developments. |
|
(e) |
|
Includes approximately $16.3 million of compensation expense related to stock options and
restricted stock and $4.8 million of lease exit costs related to our previous headquarters
facility. |
|
(f) |
|
Includes $40.0 million paid to IMPAX related to a development agreement and $25.0 million
paid to Ipsen upon the FDAs acceptance of Ipsens BLA for DYSPORTTM and
approximately $0.3 million of compensation expense related to stock options and restricted
stock. |
|
(g) |
|
In-process research and development expense of $30.5 million is related to our acquisition of
LipoSonix. |
|
(h) |
|
Represents a $9.1 million reduction in the carrying value of our investment in Revance as a
result of a reduction in the net realizable value of the investment using the hypothetical
liquidation at book value approach as of December 31, 2008, and a $6.4 million
other-than-temporary impairment loss recognized related to our auction-rate securities
investments. |
|
(i) |
|
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. |
|
(j) |
|
Includes approximately $8.0 million related to our option to acquire Revance or to license
Revances topical product currently under development and approximately $0.1 million of
compensation expense related to stock options and restricted stock. |
|
(k) |
|
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. |
|
(l) |
|
Includes approximately $125.2 million paid to Ipsen related to the DYSPORTTM
development and distribution agreement and approximately $1.6 million of compensation expense
related to stock options and restricted stock. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2009 |
|
2008 |
|
|
2007 |
|
2006 |
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|
|
Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term
investments |
|
$ |
528,280 |
|
|
$ |
343,885 |
|
(a) |
|
$ |
794,680 |
|
|
$ |
554,261 |
|
(b) |
Working capital |
|
|
434,639 |
|
|
|
307,635 |
|
|
|
|
422,971 |
|
|
|
323,070 |
|
|
Long-term investments |
|
|
25,524 |
|
|
|
55,333 |
|
|
|
|
17,072 |
|
|
|
130,290 |
|
|
Total assets |
|
|
1,172,198 |
|
|
|
973,434 |
|
|
|
|
1,213,411 |
|
|
|
1,122,720 |
|
|
Current portion of long-term debt |
|
|
|
|
|
|
|
|
|
|
|
283,910 |
|
|
|
169,155 |
|
|
Long-term debt |
|
|
169,326 |
|
|
|
169,326 |
|
|
|
|
169,145 |
|
|
|
283,910 |
|
|
Stockholders equity |
|
|
695,259 |
|
|
|
603,694 |
|
|
|
|
583,301 |
|
|
|
475,520 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
|
Dec. 31, 2009 |
|
|
Dec. 31, 2008 |
|
Dec. 31, 2007 |
|
|
Dec. 31, 2006 |
|
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|
|
Cash Flow Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in)
operating activities |
|
$ |
177,885 |
|
(c) |
|
$ |
45,770 |
|
(d) |
$ |
158,944 |
|
(e) |
|
$ |
(40,963 |
) |
(f) |
Net cash (used in) provided by
investing activities |
|
|
(62,226 |
) |
|
|
|
220,091 |
|
(g) |
|
(269,486 |
)
|
(h) |
|
|
(216,915 |
) |
|
Net cash provided by (used in)
financing activites |
|
|
6,953 |
|
|
|
|
(287,314 |
) |
(i) |
|
14,470 |
|
|
|
|
14,278 |
|
|
51
|
|
|
(a) |
|
Decrease in cash, cash equivalents and short-term investments from December 31, 2007 to
December 31, 2008 primarily due to the repurchase of $283.7 million of our 1.5% Contingent
Convertible Senior Notes,our $150.0 million acquisition of LipoSonix, $40.0 million paid to IMPAX related to a
development agreement, $25.0 million paid to Ipsen upon the FDAs acceptance of Ipsens BLA
for DYSPORTTM, and payments totaling $87.8 million for income taxes during 2008. |
|
(b) |
|
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 DYSPORTTM,
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. |
|
(c) |
|
Net cash provided by operating activities for the year ended December 31, 2009 is net
of $12.0 million paid to IMPAX related to a development agreement, $10.0 million paid to
Revance related to a license agreement, $5.0 million paid to Glenmark related to a
development agreement and $5.0 million paid to Perrigo related to a development agreement. |
|
(d) |
|
Net cash provided by operating activities for the year ended December 31, 2008 is net
of $40.0 million paid to IMPAX related to a development agreement and $25.0 million paid to
Ipsen upon the FDAs acceptance of Ipsens BLA for DYSPORTTM. |
|
(e) |
|
Net cash provided by operating activities for the year ended December 31, 2007 is net
of $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 topical product currently under
development, included in research and development expense. |
|
(f) |
|
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 DYSPORTTM. |
|
(g) |
|
Net cash provided by investing activities for the year ended December 31, 2008 included
$150.0 million of cash used for our acquisition of LipoSonix. |
|
(h) |
|
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. |
|
(i) |
|
Net cash used in financing activities for the year ended December 31, 2008 includes the
repurchase of $283.7 million of our 1.5% Contingent Convertible Senior Notes. |
52
The following table sets forth selected consolidated financial data for the year ended
December 31, 2005, the Transition Period, the corresponding six-month period in 2004, and the year
ended June 30, 2005. The data for the Transition Period and the year ended June 30, 2005 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.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal |
|
|
|
|
|
|
|
|
|
Transition |
|
|
|
Six Months |
|
|
Year Ended |
|
|
|
|
Year Ended |
|
|
|
Period Ended |
|
|
|
Ended |
|
|
June 30, |
|
|
|
|
Dec. 31, 2005 |
|
|
|
Dec. 31, 2005 |
|
|
|
Dec. 31, 2004 |
|
|
2005 |
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(in thousands, except per share amounts) |
|
|
|
|
|
|
|
Statements of Income Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues |
|
$ |
306,735 |
|
|
|
$ |
156,963 |
|
|
|
$ |
144,116 |
|
|
$ |
293,888 |
|
|
Net contract revenues |
|
|
46,002 |
|
|
|
|
8,385 |
|
|
|
|
34,168 |
|
|
|
71,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues |
|
|
352,737 |
|
|
|
|
165,348 |
|
|
|
|
178,284 |
|
|
|
365,673 |
|
|
Gross profit (a) |
|
|
297,000 |
|
|
|
|
139,583 |
|
|
|
|
148,859 |
|
|
|
307,548 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
|
146,158 |
|
(b) |
|
|
78,535 |
|
(f) |
|
|
63,305 |
|
(h) |
|
130,927 |
|
(j) |
Research and development |
|
|
42,903 |
|
(c) |
|
|
22,367 |
|
(g) |
|
|
45,140 |
|
(i) |
|
65,676 |
|
(k) |
Depreciation and amortization |
|
|
24,548 |
|
|
|
|
12,420 |
|
|
|
|
10,222 |
|
|
|
22,350 |
|
|
Impairment of intangible assets |
|
|
9,171 |
|
|
|
|
9,171 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
222,780 |
|
|
|
|
122,493 |
|
|
|
|
118,667 |
|
|
|
218,953 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
74,220 |
|
|
|
|
17,090 |
|
|
|
|
30,192 |
|
|
|
88,595 |
|
|
Other: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and investment (income) expense, net |
|
|
(5,804 |
) |
|
|
|
(4,726 |
) |
|
|
|
248 |
|
|
|
(830 |
) |
|
Other income, net |
|
|
(59,801 |
) |
(d) |
|
|
(59,801 |
) |
(d) |
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
49,551 |
|
|
|
|
29,811 |
|
|
|
|
10,377 |
|
|
|
30,996 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
90,274 |
|
|
|
$ |
51,806 |
|
|
|
$ |
19,567 |
|
|
$ |
58,429 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share |
|
$ |
1.66 |
|
|
|
$ |
0.95 |
|
|
|
$ |
0.35 |
|
|
$ |
1.06 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share |
|
$ |
1.39 |
|
(e) |
|
$ |
0.79 |
|
|
|
$ |
0.32 |
|
|
$ |
0.92 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share |
|
$ |
0.12 |
|
|
|
$ |
0.06 |
|
|
|
$ |
0.06 |
|
|
$ |
0.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic common shares outstanding |
|
|
54,290 |
|
|
|
|
54,323 |
|
|
|
|
55,972 |
|
|
|
55,196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted common shares outstanding |
|
|
69,558 |
|
(e) |
|
|
69,772 |
|
|
|
|
72,160 |
|
|
|
70,909 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Amounts exclude $21.6 million, $10.9 million, $8.9 million and $19.6 million for
amortization expense related to acquired intangible assets in the year ended December 31,
2005, the Transition Period, the six months ended December 31, 2004 and fiscal 2005,
respectively. |
|
(b) |
|
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. |
|
(c) |
|
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. |
|
(d) |
|
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 |
53
|
|
|
|
|
accumulated transactions costs of $27.0 million, and integration costs incurred
during the three months ended December 31, 2005 of $3.7 million. |
|
(e) |
|
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. |
|
(f) |
|
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. |
|
(g) |
|
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. |
|
(h) |
|
Includes approximately $1.3 million of professional fees related to research and development
collaborations with Ansata and Q-Med. |
|
(i) |
|
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 RESTYLANE SUBQTM. |
|
(j) |
|
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. |
|
(k) |
|
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 RESTYLANE SUBQTM. |
The cash flow data for the year ended December 31, 2005 and the six months ended December 31,
2004, is unaudited.
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
June 30, |
|
|
2005 |
|
2005 |
|
|
(in thousands) |
Balance Sheet Data: |
|
|
|
|
|
|
|
|
Cash, cash equivalents, and short-term
investments |
|
$ |
742,532 |
|
|
$ |
603,568 |
|
Working capital |
|
|
630,951 |
|
|
|
530,850 |
|
Total assets |
|
|
1,196,354 |
|
|
|
1,095,087 |
|
Long-term debt |
|
|
453,065 |
|
|
|
453,065 |
|
Stockholders equity |
|
|
481,751 |
|
|
|
416,891 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal |
|
|
Year |
|
|
|
|
|
Six Months |
|
Year Ended |
|
|
Ended |
|
Transition |
|
Ended |
|
June 30, |
|
|
Dec. 31, 2005 |
|
Period |
|
Dec. 31, 2004 |
|
2005 |
|
|
(unaudited) |
|
|
|
|
|
(unaudited) |
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|
|
|
|
Cash Flow Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
$ |
232,506 |
(a) |
|
$ |
147,990 |
(a) |
|
$ |
45,465 |
|
|
$ |
129,981 |
|
Net cash provided by investing activities |
|
|
187,994 |
|
|
|
123,665 |
|
|
|
76,158 |
|
|
|
140,487 |
|
Net cash used in financing activities |
|
|
(5,137 |
) |
|
|
(2,792 |
) |
|
|
(137,447 |
) |
|
|
(139,793 |
) |
|
|
|
(a) |
|
Net cash provided by operating activities for the year ended December 31, 2005 and the
Transition Period included a $90.5 million termination fee received from Inamed related to the
termination of a proposed merger. |
54
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
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.
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 and aesthetic conditions. We
also market products in Canada for the treatment of dermatological and aesthetic conditions and
began commercial efforts in Europe with our acquisition of LipoSonix in July 2008. We offer a
broad range of products addressing various conditions or aesthetics improvements, including facial
wrinkles, acne, fungal infections, rosacea, hyperpigmentation, photoaging, psoriasis, 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, non-invasive body sculpting
technology 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 DYSPORTTM,
LOPROX®, PERLANE®, RESTYLANE® and VANOS®. Our
non-dermatological product lines include AMMONUL®, BUPHENYL® and the
LIPOSONIXTM system. Our non-dermatological field also includes contract revenues
associated with licensing agreements and authorized generic agreements.
Financial Information About Segments
We operate in one 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: DYSPORTTM,
PERLANE®, RESTYLANE®, SOLODYN®, TRIAZ®,
VANOS® and ZIANA®. We believe that sales of our primary products will
constitute a significant portion of our revenue for 2010.
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 the leading plastic surgeons in the U.S. We rely on third parties to
manufacture our products (except for the LIPOSONIXTM system).
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
55
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 and sudden changes in market conditions 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. As a result of certain modifications
made to our distribution services agreement with McKesson, our exclusive U.S. distributor of our
aesthetics products DYSPORTTM, PERLANE® and RESTYLANE®, we began
recognizing revenue on these products upon the shipment from McKesson to physicians beginning in
the second quarter of 2009. 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 have distribution services agreements
with our two largest wholesale customers. We review the supply levels of our significant products
sold to major wholesalers by reviewing periodic inventory reports that are supplied to us by our
major wholesalers in accordance with the distribution services agreements. We rely wholly upon our
wholesale and drug chain customers to effect the distribution allocation of substantially all of
our prescription products. We believe our estimates of trade inventory levels of our products,
based on our review of the periodic inventory reports supplied by our major wholesalers and the
estimated demand for our products based on prescription and other data, 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. From time to time we may enter into business arrangements (e.g. loans or investments)
involving our customers and those arrangements may be reviewed by federal and state regulators.
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.
Recent Developments
As described in more detail below, the following significant events and transactions occurred
during 2009, and affected our results of operations, our cash flows and our financial condition:
- |
|
Asset Purchase and Development Agreement and License and Settlement Agreements with Glenmark; |
|
- |
|
FDA approval of additional strengths of SOLODYN®; |
|
- |
|
License Agreement with Revance; |
|
- |
|
License and Settlement Agreement and Joint Development Agreement with Perrigo; |
|
- |
|
FDA approval of DYSPORTTM; |
|
- |
|
Sale of Medicis Pediatrics; |
|
- |
|
Tevas launch of a generic to SOLODYN®, our settlement agreement with Teva and the impact of the launch on our
sales reserves; |
56
- |
|
Clinical milestone payments related to our collaboration with IMPAX; |
|
- |
|
Reduction in the carrying value of our investment in Revance; and |
|
- |
|
Obtainment of a CE Mark verification for the LIPOSONIXTM system in Europe and Health Canadas approval of
LIPOSONIXTM system sales in Canada. |
Asset Purchase and Development Agreement and License and Settlement Agreements with Glenmark
On November 14, 2009, we entered into an Asset Purchase and Development Agreement with
Glenmark Generics Ltd. and Glenmark Generics Inc., USA (collectively, Glenmark) (the Glenmark
Asset Purchase and Development Agreement) and two License and Settlement Agreements with Glenmark
(one, the Vanos License and Settlement Agreement, the other, the Loprox License and Settlement
Agreement and, collectively, the Glenmark License and Settlement Agreements) with Glenmark.
In connection with the Glenmark Asset Purchase and Development Agreement, we purchased from
Glenmark the North American rights of a dermatology product currently under development, including the
underlying technology and regulatory filings. In accordance with terms of the agreement, we made a
$5.0 million payment to Glenmark upon closing of the transaction, and will make additional payments
to Glenmark of up to $7.0 million upon the achievement of certain development and regulatory
milestones. We will make royalty payments to Glenmark on sales of the product. The initial $5.0
million payment was recognized as research and development expense during the three months ended
December 31, 2009.
In connection with the Glenmark License and Settlement Agreements, we and Glenmark agreed to
terminate all legal disputes between us relating to our VANOS® (fluocinonide) Cream 0.1%
and LOPROX® Gel. In addition, Glenmark confirmed that certain of our patents relating
to VANOS® and LOPROX® are valid and enforceable, and cover Glenmarks
activities relating to its generic versions of VANOS® and LOPROX® Gel under
ANDAs. Further, subject to the terms and conditions contained in the Vanos License and Settlement
Agreement, we granted Glenmark, effective December 15, 2013, or earlier upon the occurrence of
certain events, a license to make and sell generic versions of the existing VANOS®
products. Upon commercialization by Glenmark of generic versions of VANOS® products,
Glenmark will pay us a royalty based on sales of such generic products. Subject to the terms and
conditions contained in the Loprox License and Settlement Agreement, we also granted Glenmark a
license to make and sell generic versions of LOPROX® Gel. Upon commercialization by
Glenmark of generic versions of LOPROX® Gel, Glenmark will pay us a royalty based on
sales of such generic products. In accordance with the terms of the Glenmark License and
Settlement Agreements, we paid Glenmark $0.3 million for attorneys fees incurred by Glenmark
related to the legal disputes. The $0.3 million payment was recognized as selling, general and
administrative expense during the three months ended December 31, 2009.
FDA approval of additional strengths of SOLODYN®
On July 27, 2009, we announced that the FDA had approved additional strengths of
SOLODYN® in 65mg and 115mg dosages for the treatment of inflammatory lesions of
non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. With the
addition of these newly-approved strengths, SOLODYN® is now available in five dosages:
45mg, 65mg, 90mg, 115mg, and 135mg. Shipment of the newly-approved 65mg and 115mg products to
wholesalers began during the third quarter of 2009.
License Agreement with Revance
On July 28, 2009, we and Revance, a privately-held, venture-backed development-stage company,
entered into a license agreement granting us worldwide aesthetic and dermatological rights to
Revances novel, investigational, injectable botulinum toxin type A product, referred to as
RT002, currently in pre-clinical studies. The objective of the RT002 program is the development
of a next-generation neurotoxin with favorable duration of effect and safety profiles.
Under the terms of the agreement, we paid Revance $10.0 million upon execution of the
agreement, and will pay additional potential milestone payments totaling approximately $94 million
upon successful completion of certain clinical, regulatory and commercial milestones, and a royalty
based on sales and supply price, the total of which is equivalent to a double-digit percentage of
net sales. The initial $10.0 million payment was recognized as research and development expense
during the three months ended September 30, 2009.
57
License and Settlement Agreement and Joint Development Agreement with Perrigo
On April 8, 2009, we entered into a License and Settlement Agreement (the Perrigo License and
Settlement Agreement) and a Joint Development Agreement (the Perrigo Joint Development
Agreement) with Perrigo Israel Pharmaceuticals Ltd. Perrigo Company was also a party to the
Perrigo License and Settlement Agreement. Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company
are collectively referred to as Perrigo.
In connection with the Perrigo License and Settlement Agreement, we and Perrigo agreed to
terminate all legal disputes between us relating to our VANOS® (fluocinonide) Cream
0.1%. On April 17, 2009, the Court entered a consent judgment dismissing all claims and
counterclaims between us and Perrigo, and enjoining Perrigo from marketing a generic version of
VANOS® other than under the terms of the settlement agreement. In addition, Perrigo
confirmed that certain of our patents relating to VANOS® are valid and enforceable, and
cover Perrigos activities relating to its generic product under ANDA #090256. Further, subject to
the terms and conditions contained in the Perrigo License and Settlement Agreement:
|
|
|
we granted Perrigo, effective December 15, 2013, or earlier upon the occurrence of
certain events, a license to make and sell generic versions of the existing
VANOS® products; and |
|
|
|
|
when Perrigo does commercialize generic versions of VANOS® products, Perrigo
will pay us a royalty based on sales of such generic products. |
|
|
|
|
Pursuant to the Perrigo Joint Development Agreement, subject to the terms and conditions
contained therein: |
|
|
|
|
we and Perrigo will collaborate to develop a novel proprietary product; |
|
|
|
|
we have the sole right to commercialize the novel proprietary product; |
|
|
|
|
if and when a New Drug Application (NDA) for a novel proprietary product is submitted
to the FDA, we and Perrigo shall enter into a commercial supply agreement pursuant to
which, among other terms, for a period of three years following approval of the NDA,
Perrigo would exclusively supply to us all of our novel proprietary product requirements in
the U.S.; |
|
|
|
|
we made an up-front $3.0 million payment to Perrigo, and will make additional payments
to Perrigo of up to $5.0 million upon the achievement of certain development, regulatory
and commercialization milestones; and |
|
|
|
|
we will pay to Perrigo royalty payments on sales of the novel proprietary product. |
During the three months ended September 30, 2009, a development milestone was achieved, and we
made a $2.0 million payment to Perrigo pursuant to the Perrigo Joint Development Agreement. The
$3.0 million up-front payment and the $2.0 million development milestone payment was recognized as
research and development expense during the three months ended June 30, 2009 and September 30,
2009, respectively.
FDA approval of DYSPORTTM
On April 29, 2009, the FDA approved the Biologics License Application (BLA) for
DYSPORTTM, an acetylcholine release inhibitor and a neuromuscular blocking agent. The
approval includes two separate indications, the treatment of cervical dystonia in adults to reduce
the severity of abnormal head position and neck pain, and the temporary improvement in the
appearance of moderate to severe glabellar lines in adults younger than 65 years of age.
RELOXIN®, which was the proposed U.S. name for Ipsens botulinum toxin product for
aesthetic use, is now marketed under the name of DYSPORTTM. Ipsen markets
DYSPORTTM in the U.S. for the therapeutic indication (cervical dystonia), while Medicis
began marketing DYSPORTTM in the U.S. during June 2009 for the aesthetic indication
(glabellar lines).
In March 2006, Ipsen granted us the rights to develop, distribute and commercialize Ipsens
botulinum toxin product for aesthetic use in the U.S., Canada and Japan. In accordance with the
agreement, we paid Ipsen $75.0 million during the second quarter of 2009 as a result of the
approval by the FDA. The $75.0 million payment was capitalized into
58
intangible assets in our
consolidated balance sheet. We will pay Ipsen a royalty based on sales and a supply price, as
defined under the agreement.
Sale of Medicis Pediatrics
On June 10, 2009, we, Medicis Pediatrics, Inc. (Medicis Pediatrics, formerly known as Ascent
Pediatrics, Inc.), a wholly-owned subsidiary of Medicis, and BioMarin Pharmaceutical Inc.
(BioMarin) entered into an amendment to the Securities Purchase Agreement (the BioMarin
Securities Purchase Agreement), dated as of May 18, 2004 and amended on January 12, 2005, by and
among, Medicis Pediatrics, BioMarin and BioMarin Pediatrics Inc., a wholly-owned subsidiary of
BioMarin that previously merged into BioMarin, and us. The amendment was effected to accelerate
the closing of BioMarins option under the BioMarin Securities Purchase Agreement to purchase from
us all of the issued and outstanding capital stock of Medicis Pediatrics (the Option), which was
previously expected to close in August 2009. In accordance with the amendment, the parties
consummated the closing of the Option on June 10, 2009 (the BioMarin Option Closing). The
aggregate cash consideration paid to us in conjunction with the BioMarin Option Closing was
approximately $70.3 million and the purchase was completed substantially in accordance with the
previously disclosed terms of the BioMarin Securities Purchase Agreement.
As a result of the BioMarin Option Closing, we recognized a pretax gain of $2.2 million during
the three months ended June 30, 2009, which is included in other (income) expense, net, in the
accompanying consolidated statements of income for the year ended December 31, 2009. Because of
the difference between our book and tax basis of goodwill in Medicis Pediatrics, the transaction
resulted in a $24.8 million gain for income tax purposes, and, accordingly, we recorded a $9.0
million income tax provision during the three months ended June 30, 2009, which is included in
income tax expense in the accompanying consolidated statements of operations for the year ended
December 31, 2009.
Tevas launch of a generic to SOLODYN®, our settlement agreement with Teva, and the
impact of the launch on our sales reserves
On March 17, 2009, Teva Pharmaceutical Industries Ltd. (Teva) was granted final approval by
the FDA for its ANDA #065485 to market its generic version of 45mg, 90mg and 135mg
SOLODYN® Extended Release Tablets. Teva commenced shipment of this product immediately
after the FDAs approval of the ANDA.
On March 18, 2009, we entered into a Settlement Agreement with Teva whereby all legal disputes
between us and Teva relating to SOLODYN® were terminated. Pursuant to the agreement,
Teva confirmed that our patents relating to SOLODYN® are valid and enforceable, and
cover Tevas activities relating to its generic SOLODYN® product. As part of the
settlement, Teva agreed to immediately stop all further shipments of its generic
SOLODYN® product. We agreed to release Teva from liability arising from any prior sales
of its generic SOLODYN® product, which were not authorized by Medicis. Under terms of
the agreement, Teva has the option to market its generic versions of 45mg, 90mg and 135mg
SOLODYN® Extended Release Tablets under the SOLODYN® patent rights belonging
to us in November 2011, or earlier under certain conditions.
Tevas shipment of its generic SOLODYN® product upon FDA approval, but prior to the
consummation of the Settlement Agreement with us on March 18, 2009, caused wholesalers to reduce
ordering levels for SOLODYN®, and caused us to increase our reserves for sales returns
and consumer rebates. As a result, net revenues of SOLODYN® during the three months
ended March 31, 2009, decreased as compared to the three months ended March 31, 2008, and as
compared to the three months ended December 31, 2008.
Clinical milestone payments related to our collaboration with IMPAX
On November 26, 2008, we entered into a License and Settlement Agreement and a Joint
Development Agreement with IMPAX. In connection with the License and Settlement Agreement, we and
IMPAX agreed to terminate all legal disputes between us relating to SOLODYN®.
Additionally, under terms of the License and Settlement Agreement, IMPAX confirmed that our patents
relating to SOLODYN® are valid and enforceable, and cover IMPAXs activities relating to
its generic product under ANDA #090024. Under the terms of the License and Settlement Agreement,
IMPAX has a license to market its generic versions of SOLODYN® 45mg, 90mg and 135mg
under the SOLODYN® patent rights belonging to us upon the occurrence of certain events.
Upon launch of its generic formulations of SOLODYN®, IMPAX may be required to pay us a
royalty, based on sales of those generic
59
formulations by IMPAX under terms described in the License
and Settlement Agreement. Under the Joint Development Agreement, we and IMPAX will collaborate on
the development of five strategic dermatology product opportunities, including an advanced-form
SOLODYN® product. Under terms of the agreement, we made an initial payment of $40.0
million upon execution of the agreement. During the three months ended March 31, 2009, September
30, 2009, and December 31, 2009, we paid IMPAX $5.0 million, $5.0 million and $2.0 million,
respectively, upon the achievement of three separate clinical milestones, in accordance with terms
of the agreement. In addition, we are required to pay up to $11.0 million upon successful
completion of certain other clinical and commercial milestones. We will also make royalty payments
based on sales of the advanced-form SOLODYN® product if and when it is commercialized by
us upon approval by the FDA. We will share equally in the gross profit of the other four
development products if and when they are commercialized by IMPAX upon approval by the FDA. The
$40.0 million initial payment was recognized as a charge to research and development expense during
the three months ended December 31, 2008, and the three separate $5.0 million, $5.0 million and
$2.0 million clinical milestone achievement payments were recognized as a charge to research and
development expense during the three months ended March 31, 2009, September 30, 2009 and December
31, 2009, respectively.
Reduction in the carrying value of our investment in Revance
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 U.S. 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 was expected to be used by Revance primarily for the
development of the product. Approximately $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 was 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 was recognized as research and development expense during the three months
ended December 31, 2007.
We estimate the net realizable value of the Revance investment based on a hypothetical
liquidation at book value approach as of the reporting date, unless a quantitative valuation metric
is available for these purposes (such as the completion of an equity financing by Revance).
During 2008, we reduced the carrying value of our investment in Revance and recorded a related
charge to earnings of approximately $9.1 million as a result of a reduction in the estimated net
realizable value of the investment using the hypothetical liquidation at book value approach as of
December 31, 2008. Additionally, during the three months ended March 31, 2009, we reduced the
carrying value of our investment in Revance by approximately $2.9 million as a result of a
reduction in the estimated net realizable value of the investment using the hypothetical
liquidation at book value approach as of March 31, 2009. We recognized the $2.9 million as other
expense in our consolidated statement of operations during the three months ended March 31, 2009,
and as a result, our investment in Revance as of March 31, 2009, was $0.
Obtainment of a CE Mark verification for the LIPOSONIXTM system in Europe and Health
Canadas approval of LIPOSONIXTM system sales in Canada.
During 2009, we filed for a CE Marking certification for the LIPOSONIXTM system in
Europe in accordance with the European Unions (EU) Medical Device Directive (MDD). A CE
marking certifies that a product has met EU consumer safety, health or environmental requirements.
We also filed in 2009 for approval from Health Canada for the use and sale of the
LIPOSONIXTM system in Canada. The filing process in Europe and Canada required us to
provide efficacy, safety and scientific information about the LIPOSONIXTM system. In
September 2009, LipoSonix was granted the CE marking in accordance with the MDD. In June 2009,
Health Canada provided its market clearance approval. The LIPOSONIXTM system is not
approved for sales in the U.S. We anticipate filing for FDA approval for the sale and use of the
LIPOSONIXTM system in the U.S. in 2010.
60
Subsequent Event
On January 29, 2010, the FDA approved our dermal fillers RESTYLANE-LTM and
PERLANE-LTM, which include the addition of 0.3% lidocaine. RESTYLANE-LTM is
approved for implantation into the mid to deep dermis, and PERLANE-LTM is approved for
implantation into the deep dermis to superficial subcutis, both for the correction of moderate to
severe facial wrinkles and folds, such as nasolabial folds. We began shipping
RESTYLANE-LTM and PERLANE-LTM during February 2010.
Results of Operations
The following table sets forth certain data as a percentage of net revenues for the periods
indicated.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED DECEMBER 31, |
|
|
|
2009 |
|
|
|
2008 |
|
|
|
2007 |
|
|
|
|
Net revenues |
|
|
100.0 |
% |
|
|
|
100.0 |
% |
|
|
|
100.0 |
% |
|
Gross profit (d) |
|
|
90.1 |
|
|
|
|
92.5 |
|
|
|
|
87.7 |
|
|
Operating expenses |
|
|
67.1 |
|
(a) |
|
|
84.6 |
|
(b) |
|
|
67.9 |
|
(c) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
23.0 |
|
|
|
|
7.9 |
|
|
|
|
19.8 |
|
|
Other income (expense), net |
|
|
0.2 |
|
|
|
|
(3.0 |
) |
|
|
|
|
|
|
Interest and investment income, net |
|
|
0.6 |
|
|
|
|
3.3 |
|
|
|
|
6.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income tax expense |
|
|
23.8 |
|
|
|
|
8.2 |
|
|
|
|
26.0 |
|
|
Income tax expense |
|
|
(10.4 |
) |
|
|
|
(6.2 |
) |
|
|
|
(10.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
13.4 |
% |
|
|
|
2.0 |
% |
|
|
|
15.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Included in operating expenses is $12.0 million (2.1% of net revenues) paid to Impax
related to a product development agreement, $10.0 million (1.7% of net revenues) paid to
Revance related to a product development agreement, $5.3 million (0.9% of net revenues) paid
to Glenmark related to a product development agreement and two license and settlement
agreements, $5.0 million (0.9% of net revenues) paid to Perrigo related to a product
development agreement and $19.2 million (3.4% of net revenues) of compensation expense related
to stock options, restricted stock and stock appreciation rights. |
|
(b) |
|
Included in operating expenses is $40.0 million (7.8% of net revenues) paid to IMPAX related
to a development agreement, $30.5 million (5.9% of net revenues) of acquired
in-process research and development expense related to our acquisition of LipoSonix, $25.0
million (4.9% of net revenues) paid to Ipsen upon the FDAs acceptance of Ipsens BLA for
DYSPORTTM, $16.6 million (3.2% of net revenues) of compensation expense related to
stock options and restricted stock and $4.8 million (0.9% of net revenues) of lease exit costs
related to our previous headquarters facility. |
|
(c) |
|
Included in operating expenses is $21.1 million (4.6% of net revenues) of share-based
compensation expense related to stock options and restricted stock, $9.3 million (2.0% of net
revenues) related to our option to acquire Revance or to license Revances topical 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. |
|
(d) |
|
Gross profit does not include amortization of the related intangibles as such expense is
included in operating expenses. |
61
Year Ended December 31, 2009 Compared to the Year Ended December 31, 2008
Net Revenues
The following table sets forth our net revenues for the year ended December 31, 2009 and the
year ended December 31, 2008, along with the percentage of net revenues and percentage point change
for each of our product categories (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
|
Net product revenues |
|
$ |
561.7 |
|
|
$ |
501.0 |
|
|
$ |
60.7 |
|
|
|
12.1 |
% |
Net contract revenues |
|
|
10.2 |
|
|
|
16.8 |
|
|
|
(6.6 |
) |
|
|
(39.3) |
% |
|
|
|
Total net revenues |
|
$ |
571.9 |
|
|
$ |
517.8 |
|
|
$ |
54.1 |
|
|
|
10.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
|
Acne and acne-related dermatological products |
|
$ |
398.8 |
|
|
$ |
325.0 |
|
|
$ |
73.8 |
|
|
|
22.7 |
% |
Non-acne dermatological products |
|
|
133.6 |
|
|
|
148.0 |
|
|
|
(14.4 |
) |
|
|
(9.7) |
% |
Non-dermatological products (including contract revenues) |
|
|
39.5 |
|
|
|
44.8 |
|
|
|
(5.3 |
) |
|
|
(11.8) |
% |
|
|
|
Total net revenues |
|
$ |
571.9 |
|
|
$ |
517.8 |
|
|
$ |
54.1 |
|
|
|
10.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
2008 |
|
Change |
|
Acne and acne-related dermatological products |
|
|
69.7 |
% |
|
|
62.8 |
% |
|
|
6.9 |
% |
Non-acne dermatological products |
|
|
23.4 |
% |
|
|
28.6 |
% |
|
|
(5.2) |
% |
Non-dermatological products (including contract revenues) |
|
|
6.9 |
% |
|
|
8.6 |
% |
|
|
(1.7) |
% |
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
Net revenues associated with our acne and acne-related dermatological products increased by
$73.8 million, or 22.7%, during 2009 as compared to 2008 primarily as a result of increased sales
of SOLODYN®. The increased sales of SOLODYN® were primarily generated by
strong prescription growth, partially offset by the negative impact of units of Tevas and Sandoz
respective unauthorized generic SOLODYN® products that were sold into the distribution
channel prior to the consummation of settlement agreements with us on March 18, 2009, and August
18, 2009, respectively. In addition, during the third quarter of 2009 we launched new 65mg and
115mg strengths of SOLODYN® after they were approved by the FDA. We expect net revenues
of SOLODYN® will continue to be negatively affected during 2010 as units of Tevas and
Sandoz respective unauthorized generic SOLODYN® products are sold and prescribed
through the distribution channel.
Net revenues associated with our non-acne dermatological products decreased as a percentage of
net revenues, and decreased in net dollars by $14.4 million, or 9.7%, during 2009 as compared to
2008, primarily due to decreased sales of RESTYLANE® and PERLANE®, partially
offset by the initial sales of DYSPORTTM, which was launched in June 2009. As a result
of certain modifications made to our distribution services agreement with McKesson, our exclusive
U.S. distributor of our aesthetics products DYSPORTTM, PERLANE® and
RESTYLANE®, we began recognizing revenue on these products upon the shipment from
McKesson to physicians beginning in the second quarter of 2009.
62
Net revenues associated with our non-dermatological products decreased by $5.3 million, or
11.8%, during 2009 as compared to 2008, primarily due to a decrease in contract revenues.
Gross Profit
Gross profit represents our net revenues less our cost of product revenue. Our cost of
product revenue primarily 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 2009 and 2008 was approximately $22.4 million and $21.5 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 2009 and 2008, along with the percentage
of net revenues represented by such gross profit (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
|
Gross profit |
|
$ |
515.1 |
|
|
$ |
479.0 |
|
|
$ |
36.1 |
|
|
|
7.5 |
% |
% of net revenues |
|
|
90.1 |
% |
|
|
92.5 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit during 2009, compared to 2008, was due to the increase in our net
revenues, while the decrease in gross profit as a percentage of net revenues was primarily due to
the different mix of products sold during 2009 as compared to 2008, including the impact of the
launch of DYSPORTTM during the second quarter of 2009, which has a lower gross profit
margin than most of our other products, and the decrease in contract revenues. In addition, gross
margin for 2009 included a charge of $4.8 million associated with an increase in our inventory
reserve during 2009, due to an increase in the amount of inventory projected not to be sold by
expiry dates.
Selling, General and Administrative Expenses
The following table sets forth our selling, general and administrative expenses for 2009 and
2008, along with the percentage of net revenues represented by selling, general and administrative
expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
|
Selling, general and administrative |
|
$ |
283.0 |
|
|
$ |
279.8 |
|
|
$ |
3.2 |
|
|
|
1.1 |
% |
% of net revenues |
|
|
49.5 |
% |
|
|
54.0 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense
included in selling, general and
administrative |
|
$ |
18.1 |
|
|
$ |
16.3 |
|
|
$ |
1.8 |
|
|
|
11.0 |
% |
The $3.2 million increase in selling, general and administrative expenses during 2009 as
compared to 2008 was attributable to approximately $10.6 million of increased personnel costs,
primarily related to an increase in the number of employees from 587 as of December 31, 2008, to
620 as of December 31, 2009, and the effect of the annual salary increase that occurred during
February 2009, and $8.5 million of increased promotion expenses, primarily due to the launch of
DYSPORTTM during the second quarter of 2009, partially offset by $9.4 million of
decreased professional and consulting expenses, $4.8 million related to a lease retirement
obligation recorded during 2008 and a net reduction of $1.7 million of other selling, general and
administrative costs incurred during 2009. Professional and consulting expenses incurred during
2008 included costs related to the restatement of our 2007 Form 10-K and our Form 10-Qs for the
first and second quarters of 2008 and the implementation of our new enterprise resource planning
(ERP) system. The decrease of selling, general and administrative expenses as a percentage of net
revenues during 2009 as compared to 2008 was primarily due to the $54.1 million increase in net
revenues.
63
Research and Development Expenses
The following table sets forth our research and development expenses for 2009 and 2008 (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
|
Research and development |
|
$ |
71.8 |
|
|
$ |
99.9 |
|
|
$ |
(28.1 |
) |
|
|
(28.1) |
% |
Up-front and milestone
payments included in
research
and development |
|
$ |
32.5 |
|
|
$ |
65.0 |
|
|
$ |
(32.5 |
) |
|
|
(50.0) |
% |
Share-based compensation
expense included in
research and development |
|
$ |
1.1 |
|
|
$ |
0.3 |
|
|
$ |
0.8 |
|
|
|
266.7 |
% |
Included in research and development expenses for 2009 was a $10.0 million up-front payment to
Revance related to a product development agreement, $12.0 million (in aggregate) of milestone
payments to Impax related to a product development agreement, a $5.0 million up-front payment to
Glenmark related to a product development agreement, $5.0 million (in aggregate) of up-front and
milestone payments to Perrigo related to a product development agreement and a $0.5 million
milestone payment made to a U.S. company related to a product development agreement. Included in
research and development expenses for 2008 was a $40.0 million up-front payment to Impax related to
a development agreement and a $25.0 million milestone payment to Ipsen, upon the FDAs acceptance
of Ipsens BLA for DYSPORTTM, which was formerly known as RELOXIN® during
clinical development. 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.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during 2009 increased $1.3 million, or 4.9%, to $29.0
million from $27.7 million during 2008. This increase was primarily due to initial amortization of
the $75.0 million milestone payment made to Ipsen during the second quarter of 2009 upon the FDAs
approval of DYSPORTTM, which was capitalized as an intangible asset, and depreciation
incurred related to our new headquarters facility.
In-Process Research and Development Expense
On July 1, 2008, we acquired LipoSonix, a medical device company developing non-invasive body
sculpting technology. As part of the acquisition, we recorded a $30.5 million charge for acquired
in-process research and development during the third quarter of 2008. No income tax benefit was
recognized related to this charge.
Interest and Investment Income
Interest and investment income during 2009 decreased $15.8 million, or 67.4%, to $7.6 million
from $23.4 million during 2008, due to an decrease in the funds available for investment due to the
repurchase of $283.7 million of our New Notes in June 2008 and our $150.0 million acquisition of
LipoSonix in July 2008, and a decrease in the interest rates achieved by our invested funds during
2009.
Interest Expense
Interest expense during 2009 decreased $2.4 million, to $4.2 million during 2009 from $6.7
million during 2008. Our interest expense during 2009 and 2008 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
New Notes. The decrease in interest expense during 2009 as compared to 2008 was primarily due to
the repurchase of $283.7 million of our New Notes in June 2008, and the fees and origination costs
related to the issuance of the New Notes becoming fully amortized during the second quarter of
2008. See Note 11, Contingent Convertible Senior Notes in the notes to the consolidated
financial statements under Item 15 of Part IV of this report, Exhibits and Financial Statement
Schedules for further discussion on the Old Notes and New Notes.
64
Other (Income) Expense, net
Other income, net, of $0.9 million recognized during 2009 primarily represented a $2.2 million
gain on the sale of Medicis Pediatrics to BioMarin, which closed during June 2009 and a $1.5
million gain on the sale of certain auction rate floating securities, partially offset by a $2.9
million reduction in the carrying value of our investment in Revance as a result of a reduction in
the estimated net realizable value of the investment using the hypothetical liquidation at book
value approach as of March 31, 2009. The $1.5 million gain on the sale of certain auction rate
floating securities was the result of a transaction whereby the broker through which we purchased
auction rate floating securities agreed to repurchase from us three auction rate floating
securities with an aggregate par value of $7.0 million, at par. The adjusted basis of these
securities was $5.5 million, in aggregate, as a result of an other-than-temporary impairment loss
of $1.5 million recorded during the year ended December 31, 2008. The realized gain of $1.5
million was recognized as other income during 2009.
Other expense of $15.5 million recognized during 2008 represented a $9.1 million reduction in
the carrying value of our investment in Revance as a result of a reduction in the estimated net
realizable value of the investment using the hypothetical liquidation at book value approach as of
December 31, 2008, and a $6.4 million other-than-temporary impairment loss recognized related to
our auction-rate securities investments. $1.5 million of this impairment loss was recognized as a
gain during 2009 upon the sale, at par, of certain auction rate floating securities, as discussed
above.
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 2009 and 2008 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
2008 |
|
$ Change |
|
% Change |
|
Income tax expense |
|
$ |
59.6 |
|
|
$ |
32.1 |
|
|
$ |
27.5 |
|
|
|
85.7 |
% |
Effective tax rate |
|
|
44.0 |
% |
|
|
75.8 |
% |
|
|
|
|
|
|
|
|
The effective tax rate for 2009 reflects a $9.0 million discrete tax expense due to the
taxable gain on the sale of Medicis Pediatrics. Our effective tax rate for 2008 included the
impact of no tax benefit being recorded on the charge associated with the reduction in carrying
value of our investment in Revance or on the in-process research and development charge related to
our investment in LipoSonix. As of December 31, 2009, the cumulative $21.0 million reduction in
the carrying value of the Revance investment is currently an unrealized loss for income tax
purposes. We will not be able to determine the character of the loss until we exercise or fail to
exercise our option. A realized loss is characterized as a capital loss can only be utilized to
offset capital gains. We recorded a valuation allowance against the deferred tax asset associated
with this unrealized tax loss to reduce the carrying value to $0, which is the amount that we
believe is more likely than not to be realized.
65
Year Ended December 31, 2008 Compared to the Year Ended December 31, 2007
Net Revenues
The following table sets forth our net revenues for the year ended December 31, 2008 and the
year ended December 31, 2007, along with the percentage of net revenues and percentage point change
for each of our product categories (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
$ Change |
|
|
% Change |
|
| | | | |
Net product revenues |
|
$ |
501.0 |
|
|
$ |
441.9 |
|
|
$ |
59.1 |
|
|
|
13.4 |
% |
Net contract revenues |
|
|
16.8 |
|
|
|
15.5 |
|
|
|
1.3 |
|
|
|
8.4 |
% |
|
|
|
Total net revenues |
|
$ |
517.8 |
|
|
$ |
457.4 |
|
|
$ |
60.4 |
|
|
|
13.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
$ Change |
|
|
% Change |
|
| | | | |
Acne and acne-related
dermatological products |
|
$ |
325.0 |
|
|
$ |
243.4 |
|
|
$ |
81.6 |
|
|
|
33.5 |
% |
Non-acne dermatological
products |
|
|
148.0 |
|
|
|
172.9 |
|
|
|
(24.9 |
) |
|
|
(14.4 |
)% |
Non-dermatological products
(including contract revenues) |
|
|
44.8 |
|
|
|
41.1 |
|
|
|
3.7 |
|
|
|
9.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
$ |
517.8 |
|
|
$ |
457.4 |
|
|
$ |
60.4 |
|
|
|
13.2 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2007 |
|
|
Change |
|
|
Acne and acne-related
dermatological products |
|
|
62.8 |
% |
|
|
53.2 |
% |
|
|
9.6 |
% |
Non-acne dermatological
products |
|
|
28.6 |
% |
|
|
37.8 |
% |
|
|
(9.2 |
)% |
Non-dermatological products
(including contract revenues) |
|
|
8.6 |
% |
|
|
9.0 |
% |
|
|
(0.4 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
% |
|
|
|
Our total net revenues increased during 2008 primarily as a result of an increase in sales of
SOLODYN®.
Net revenues associated with our acne and acne-related dermatological products increased by
$81.6 million, or 33.5%, and by 9.6 percentage points as a percentage of net revenues during 2008
as compared to 2007 primarily as a result of the increased sales of SOLODYN®.
Net revenues associated with our non-acne dermatological products decreased as a percentage of
net revenues, and decreased in net dollars by 14.4% during 2008 as compared to 2007. This decrease
is a result of the non-acne dermatological product category being more sensitive to weakness in the
U.S. economy than the acne and acne-related dermatological product category.
Net revenues associated with our non-dermatological products increased by $3.7 million, or
9.0%, during 2008 as compared to 2007, primarily due to an increase in sales of
BUPHENYL® and AMMONUL® and an increase in contract revenue.
66
Gross Profit
Gross profit represents our net revenues less our cost of product revenue. Our cost of
product revenue primarily 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 2008 and 2007 was approximately $21.5 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 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 2008 and 2007, along with the percentage
of net revenues represented by such gross profit (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
2007 |
|
$ Change |
|
% Change |
|
Gross profit |
|
$ |
479.0 |
|
|
$ |
401.3 |
|
|
$ |
77.7 |
|
|
|
19.4 |
% |
% of net revenues |
|
|
92.5 |
% |
|
|
87.7 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit during 2008, compared to 2007, 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 2008 as compared to 2007. Increased sales
of SOLODYN®, a higher margin product, during 2008, was the primary change in the mix of
products sold during the comparable periods that affected gross profit as a percentage of net
revenues. In addition, gross margin for 2007 included a charge for the write-off of $6.1 million
of certain inventories that, during the third quarter of 2007, were determined to be unsaleable,
and a $2.5 million increase in our inventory valuation reserve recorded during 2007, as compared to
a $2.4 million decrease in our inventory valuation reserve during 2008. The change in the
inventory valuation reserve during 2008 was due to a decrease in the amount of inventory 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 2008 and
2007, along with the percentage of net revenues represented by selling, general and administrative
expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
2007 |
|
$ Change |
|
% Change |
|
Selling, general and administrative |
|
$ |
279.8 |
|
|
$ |
242.6 |
|
|
$ |
37.2 |
|
|
|
15.3 |
% |
% of net revenues |
|
|
54.0 |
% |
|
|
53.0 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense
included in selling, general and
administrative expense |
|
$ |
16.3 |
|
|
$ |
21.0 |
|
|
$ |
(4.7 |
) |
|
|
(22.4 |
)% |
The increase in selling, general and administrative expenses during 2008 from 2007 was
attributable to approximately $19.0 million of increased personnel costs, primarily related to an
increase in the number of employees from 472 as of December 31, 2007 to 587 as of December 31, 2008
and the effect of the annual salary increase that occurred during February 2008, $19.7 million of
increased professional and consulting expenses, including costs related to patent litigation
associated with our SOLODYN® product, business development costs, costs related to the
restatement of our 2007 Form 10-K and our Form 10-Qs for the first and second quarters of 2008 and
the implementation of our new enterprise resource planning (ERP) system, and $4.8 million related
to a lease retirement obligation recorded during the third quarter of 2008 related to our prior
headquarters location, partially offset by a $4.5 million decrease in promotion costs and a $1.8
million decrease in other selling, general and administrative costs during 2008.
67
Research and Development Expenses
The following table sets forth our research and development expenses for 2008 and 2007 (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
2007 |
|
$ Change |
|
% Change |
|
Research and development |
|
$ |
99.9 |
|
|
$ |
39.4 |
|
|
$ |
60.5 |
|
|
|
153.6 |
% |
Up-front and milestone
payments included in
research
and development |
|
$ |
65.0 |
|
|
$ |
8.0 |
|
|
$ |
57.0 |
|
|
|
712.5 |
% |
Share-based compensation
expense included in
research and development |
|
$ |
0.3 |
|
|
$ |
0.1 |
|
|
$ |
0.2 |
|
|
|
200.0 |
% |
Included in research and development expenses for 2008 was a $40.0 million payment to IMPAX
related to a development agreement and a $25.0 million milestone payment made to Ipsen after the
FDAs May 19, 2008 acceptance of the filing of Ipsens BLA for DYSPORTTM. Included in
research and development expense for 2007 was $8.0 million related to our option to acquire Revance
or to license Revances topical product currently under development. The primary product under
development during 2008 and 2007 was DYSPORTTM. 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.
Depreciation and Amortization Expenses
Depreciation and amortization expenses during 2008 increased $3.2 million, or 12.8%, to $27.7
million from $24.5 million during 2007. This increase was primarily due to amortization related to
a $29.1 million milestone payment made to Q-Med related to the FDA approval of PERLANE®,
which was capitalized during the second quarter of 2007, and depreciation incurred in 2008 related
to our new ERP system and our new headquarters facility.
In-Process Research and Development Expense
On July 1, 2008, we acquired LipoSonix, a medical device company developing non-invasive body
sculpting technology. As part of the acquisition, we recorded a $30.5 million charge for acquired
in-process research and development during the third quarter of 2008. No income tax benefit was
recognized related to this charge.
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 Laboratories, Inc. (Abbott),
which transitioned our co-promotion agreement with Abbott for OMNICEF® into a two-year
residual period, and competitive pressures in the marketplace, including generic competition.
Interest and Investment Income
Interest and investment income during 2008 decreased $15.0 million, or 39.1%, to $23.4 million
from $38.4 million during 2007, due to a decrease in the funds available for investment as a result
of the repurchase of $283.7 million of our New Notes in June 2008 and our $150.0 million
acquisition of LipoSonix in July 2008, and a decrease in the interest rates achieved by our
invested funds during 2008. We expect interest and investment income to be lower in the first half
of 2009 as compared to the first half of 2008 due to the decrease in funds available for investment
resulting from the repurchase of $283.7 million of our New Notes in June 2008 and our $150.0
million acquisition of LipoSonix in July 2008. See Note 11, Contingent Convertible Senior Notes
in the notes to the consolidated financial statements under Item 15 of Part IV of this report,
Exhibits and Financial Statement Schedules for further discussion on the New Notes.
68
Interest Expense
Interest expense during 2008 decreased $3.3 million, or 33.4%, to $6.7 million from $10.0
million during 2007. Our interest expense during 2008 and 2007 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 2008 as compared to 2007 was
primarily due to the repurchase of $283.7 million of our New Notes in June 2008, the fees and
origination costs related to the issuance of the Old Notes becoming fully amortized during the
second quarter of 2007, and the fees and origination costs related to the issuance of the New Notes
becoming fully amortized during the second quarter of 2008. See Note 13 in our accompanying
consolidated financial statements for further discussion on the Old Notes and New Notes.
Other Expense
Other expense of $15.5 million recognized during 2008 represented a $9.1 million reduction in
the carrying value of our investment in Revance as a result of a reduction in the estimated net
realizable value of the investment using the hypothetical liquidation at book value approach as of
December 31, 2008, and a $6.4 million other-than-temporary impairment loss recognized related to
our auction-rate securities investments.
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 2008 and 2007 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
2007 |
|
$ Change |
|
% Change |
|
Income tax expense |
|
$ |
32.1 |
|
|
$ |
48.5 |
|
|
$ |
(16.4 |
) |
|
|
(33.8 |
)% |
Effective tax rate |
|
|
75.8 |
% |
|
|
40.8 |
% |
|
|
|
|
|
|
|
|
Our effective rate was higher during 2008 as compared to 2007 as no tax benefits were
recorded related to the charge associated with the reduction in carrying value of our investment in
Revance and on the in-process research and development charge related to our acquisition of
LipoSonix. The effective tax rate for 2007 of 40.8% 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
topical product that is under development. As of December 31, 2008, the cumulative $18.1 million
reduction in the carrying value of the Revance investment is currently an unrealized loss for
income tax purposes. We will not be able to determine the character of the loss until we exercise
or fail to exercise our option. A realized loss characterized as a capital loss can only be
utilized to offset capital gains. We recorded a valuation allowance against the deferred tax asset
associated with this unrealized tax loss to reduce the carrying value to $0, which is the amount
that we believe is more likely than not to be realized.
69
Liquidity and Capital Resources
Overview
The following table highlights selected cash flow components for the year ended December 31,
2009 and 2008, and selected balance sheet components as of December 31, 2009 and 2008 (dollar
amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
$ Change |
|
|
% Change |
|
|
Cash provided by (used in): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities |
|
$ |
177.9 |
|
|
$ |
45.8 |
|
|
$ |
132.1 |
|
|
|
288.4 |
% |
Investing activities |
|
|
(62.2 |
) |
|
|
220.1 |
|
|
|
(282.3 |
) |
|
|
(128.3) |
% |
Financing activities |
|
|
7.0 |
|
|
|
(287.3 |
) |
|
|
294.3 |
|
|
|
(102.4) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dec. 31, 2009 |
|
Dec. 31, 2008 |
|
$ Change |
|
% Change |
|
Cash, cash equivalents,
and short-term investments |
|
$ |
528.3 |
|
|
$ |
343.9 |
|
|
$ |
184.4 |
|
|
|
53.6 |
% |
Working capital |
|
|
434.6 |
|
|
|
307.6 |
|
|
|
127.0 |
|
|
|
41.3 |
% |
Long-term investments |
|
|
25.5 |
|
|
|
55.3 |
|
|
|
(29.8 |
) |
|
|
(53.9) |
% |
2.5% contingent convertible
senior notes due 2032 |
|
|
169.2 |
|
|
|
169.2 |
|
|
|
|
|
|
|
|
% |
1.5% contingent convertible
senior notes due 2033 |
|
|
0.2 |
|
|
|
0.2 |
|
|
|
|
|
|
|
|
% |
Working Capital
Working capital as of December 31, 2009 and 2008, consisted of the following (dollar amounts
in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dec. 31, 2009 |
|
Dec. 31, 2008 |
|
$ Change |
|
% Change |
|
Cash, cash equivalents,
and short-term investments |
|
$ |
528.3 |
|
|
$ |
343.9 |
|
|
$ |
184.4 |
|
|
|
53.6 |
% |
Accounts receivable, net |
|
|
95.2 |
|
|
|
52.6 |
|
|
|
42.6 |
|
|
|
81.0 |
% |
Inventories, net |
|
|
26.0 |
|
|
|
24.2 |
|
|
|
1.8 |
|
|
|
7.4 |
% |
Deferred tax assets, net |
|
|
66.3 |
|
|
|
53.2 |
|
|
|
13.1 |
|
|
|
24.6 |
% |
Other current assets |
|
|
16.5 |
|
|
|
19.6 |
|
|
|
(3.1 |
) |
|
|
(15.8 |
) % |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
732.3 |
|
|
|
493.5 |
|
|
|
238.8 |
|
|
|
48.4 |
% |
Accounts payable |
|
|
44.2 |
|
|
|
39.0 |
|
|
|
5.2 |
|
|
|
13.3 |
% |
Reserve for sales returns |
|
|
48.0 |
|
|
|
59.6 |
|
|
|
(11.6 |
) |
|
|
(19.5) |
% |
Accrued consumer rebate and
loyalty programs |
|
|
73.3 |
|
|
|
28.4 |
|
|
|
44.9 |
|
|
|
158.1 |
% |
Managed care and Medicaid
reserves |
|
|
47.1 |
|
|
|
17.0 |
|
|
|
30.1 |
|
|
|
177.1 |
% |
Income taxes payable |
|
|
16.7 |
|
|
|
|
|
|
|
16.7 |
|
|
|
100.0 |
% |
Other current liabilities |
|
|
68.4 |
|
|
|
41.9 |
|
|
|
26.5 |
|
|
|
63.2 |
% |
|
|
|
Total current liabilities |
|
|
297.7 |
|
|
|
185.9 |
|
|
|
111.8 |
|
|
|
60.1 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital |
|
$ |
434.6 |
|
|
$ |
307.6 |
|
|
$ |
127.0 |
|
|
|
41.3 |
% |
|
|
|
|
|
|
|
70
We had cash, cash equivalents and short-term investments of $528.3 million and working capital
of $434.6 million at December 31, 2009, as compared to $343.9 million and $307.6 million,
respectively, at December 31, 2008. The increases were primarily due to the generation of $177.9
million of operating cash flow during 2009.
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, milestone payments related to our
product development collaborations, strategic investments, acquisitions of companies or products
complementary to our business, the repayment of outstanding indebtedness, repurchases of our
outstanding securities and other potential large-scale needs. In addition, we may consider
incurring additional indebtedness and issuing additional debt or equity securities in the future to
fund potential acquisitions or investments, to refinance existing debt or for general corporate
purposes. If a material acquisition or investment is completed, our operating results and
financial condition could change materially in future periods. However, no assurance can be given
that additional funds will be available on satisfactory terms, or at all, to fund such activities.
On July 1, 2008, we acquired LipoSonix, an independent, privately-held company with a staff of
approximately 40 scientists, engineers and clinicians located near Seattle, Washington.
LipoSonix, now known as Medicis Technologies Corporation, is a medical device company developing
non-invasive body sculpting technology. Its first product, the LIPOSONIXTM system, is
currently marketed and sold through distributors in Europe and Canada. On June 15, 2009, Medicis
Aesthetics Canada, Ltd. announced that Health Canada had issued a Medical Device License
authorizing the sale of the LIPOSONIXTM system in Canada. In the U.S., the
LIPOSONIXTM system is an investigational device and is not currently cleared or approved
for sale. Under terms of the transaction, we paid $150 million in cash for all of the outstanding
shares of LipoSonix. In addition, we will pay LipoSonix stockholders certain milestone payments up
to an additional $150 million upon FDA approval of the LIPOSONIXTM system and if various
commercial milestones are achieved on a worldwide basis.
As of December 31, 2009, and December 31, 2008, our short-term investments included $26.8
million and $38.2 million, respectively, 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. During the three months ended March 31, 2008, we
were informed that there was insufficient demand at auction for the auction rate floating
securities, and since that time we have been unable to liquidate our holdings in such securities.
As a result, these affected auction rate floating securities are now considered illiquid, and we
could be required to hold them until they are redeemed by the holder at maturity or until a future
auction on these investments is successful. As a result of the continued lack of liquidity of
these investments, we recorded an other-than-temporary impairment loss of $6.4 million during the
fourth quarter of 2008 on our auction rate floating securities, based on our estimate of the fair
value of these investments. On April 9, 2009, the Financial Accounting Standards Board (FASB)
released FSP FAS 115-2 and FAS 124-2, Recognition and Presentation of Other-Than-Temporary
Impairments (FSP FAS 115-2), effective for interim and annual reporting periods ending after June
15, 2009. Upon adoption, FSP FAS 115-2, which is now part of ASC 320, Investments Debt and
Equity Securities, requires that entities should report a cumulative effect adjustment as of the
beginning of the period of adoption to reclassify the non-credit component of previously recognized
other-than-temporary impairments on debt securities held at that date from retained earnings to
other comprehensive income if the entity does not intend to sell the security and it is not more
likely than not that the entity will be required to sell the security before recovery of its
amortized cost basis. We adopted FSP FAS 115-2 during the three months ended June 30, 2009, and
accordingly, we reclassified $3.1 million of previously recognized other-than-temporary impairment
losses, net of income taxes, related to our auction rate floating securities from retained earnings
to other comprehensive income in our consolidated balance sheets during the three months ended June
30, 2009. During 2009, we liquidated $9.6 million of our auction rate floating securities.
71
Operating Activities
Net cash provided by operating activities during the year ended December 31, 2009 was
approximately $177.9 million, compared to cash provided by operating activities of approximately
$45.8 million during the year ended December 31, 2008. The following is a summary of the primary
components of cash provided by operating activities during the year ended December 31, 2009 and
2008 (in millions):
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
Payment made to Revance related to a development agreement |
|
$ |
(10.0 |
) |
|
$ |
|
|
Payments made to IMPAX related to a development agreement |
|
|
(12.0 |
) |
|
|
(40.0 |
) |
Payments made to Perrigo related to a development agreement |
|
|
(5.0 |
) |
|
|
|
|
Payment made to Glenmark related to a development agreement
and license and settlement agreements |
|
|
(5.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment made to Ipsen related to development of DYSPORTTM |
|
|
|
|
|
|
(25.0 |
) |
Income taxes paid |
|
|
(44.6 |
) |
|
|
(87.8 |
) |
Other cash provided by operating activities |
|
|
254.8 |
|
|
|
198.6 |
|
|
|
|
Cash provided by operating activities |
|
$ |
177.9 |
|
|
$ |
45.8 |
|
|
|
|
Other cash flows provided by operating activities increased from $198.6 million during the
year ended December 31, 2008, to $254.8 million during the year ended December 31, 2009, primarily
due to an increase in other current liabilities, primarily related to increases in consumer rebate
and Medicaid and managed care rebate liabilities. The change in other current liabilities during
the year ended December 31, 2008, was operating cash provided of $28.4 million, as compared to
operating cash provided of $94.0 million during the year ended December 31, 2009.
Investing Activities
Net cash used in investing activities during the year ended December 31, 2009, was
approximately $62.2 million, compared to net cash provided by investing activities during the year
ended December 31, 2008, of $220.1 million. The change was primarily due to the net purchases and
sales of our short-term and long-term investments during the respective periods. During 2009, we
paid $75.0 million to Ipsen upon the FDAs approval of DYSPORTTM, and we received $70.3
million upon the sale of Medicis Pediatrics to BioMarin, which closed in June 2009. During 2008,
we paid $149.8 million for the acquisition of LipoSonix, net of cash acquired.
Financing Activities
Net cash provided by financing activities during the year ended December 31, 2009, was $7.0
million, compared to net cash used in financing activities of $287.3 million during the year ended
December 31, 2008. Cash used during 2008 included the repurchase of $283.7 million of New Notes
during June 2008. Proceeds from the exercise of stock options were $16.1 million during the year
ended December 31, 2009, compared to $4.8 million during the year ended December 31, 2008.
Dividends paid during the year ended December 31, 2009, were $9.4 million, compared to dividends
paid during the year ended December 31, 2008, of $8.6 million.
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
$0.2 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.
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, 2013 and 2018, or upon
72
the occurrence of a change in control, holders of the New Notes may require us to offer to
repurchase their New Notes for cash.
Except for the New Notes and Old Notes, we had only $9.9 million of long-term liabilities at
December 31, 2009, and we had $297.7 million of current liabilities at December 31, 2009. 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 connection with occupancy of the new headquarter office during 2008, we ceased use of the
prior headquarter office, which consists of approximately 75,000 square feet of office space, at an
average annual expense of approximately $2.1 million, under an amended lease agreement that expires
in December 2010. Under ASC 420, Exit or Disposal Cost Obligations (formerly SFAS 146, Accounting
for Costs Associated with Exit or Disposal Activities), a liability for the costs associated with
an exit or disposal activity is recognized when the liability is incurred. We recorded lease exit
costs of approximately $4.8 million during the three months ended September 30, 2008, consisting of
the initial liability of $4.7 million and accretion expense of $0.1 million. These amounts were
recorded as selling, general and administrative expenses in our consolidated statements of income.
We have not recorded any other costs related to the lease for the prior headquarters, other than
accretion expense.
As of December 31, 2009, approximately $2.1 million of lease exit costs remain accrued and are
expected to be paid by December 2010, all of which is classified in other current liabilities.
Although we no longer use the facilities, the lease exit cost accrual has not been offset by an
adjustment for estimated sublease rentals. After considering sublease market information as well
as factors specific to the lease, we concluded it was probable we would be unable to reasonably
obtain sublease rentals for the prior headquarters and therefore we would not be subleased for the
remaining lease term. We will continue to monitor the sublease market conditions and reassess the
impact on the lease exit cost accrual.
The following is a summary of the activity in the liability for lease exit costs for the year
ended December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability as of |
|
Amounts Charged |
|
Cash Payments |
|
Cash Received |
|
Liability as of |
|
|
December 31, 2008 |
|
to Expense |
|
Made |
|
from Sublease |
|
Dec. 31, 2009 |
Lease exit costs
liability |
|
$ |
3,996,102 |
|
|
$ |
211,545 |
|
|
$ |
(2,143,970 |
) |
|
$ |
|
|
|
$ |
2,063,677 |
|
Dividends
We do not have a dividend policy. Since July 2003, we have paid quarterly cash dividends
aggregating approximately $46.6 million on our common stock. In addition, on December 16, 2009, we
declared a cash dividend of $0.04 per issued and outstanding share of common stock payable on
January 29, 2010, to our stockholders of record at the close of business on January 4, 2010. 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.
Fair Value Measurements
We utilize unobservable (Level 3) inputs in determining the fair value of our auction rate
floating security investments, which totaled $26.8 million at December 31, 2009. These securities
were included in long-term investments at December 31, 2009. We also utilize unobservable (Level
3) inputs to value our investments in Revance and Hyperion.
Our auction rate floating securities are classified as available for sale securities and are
reflected at fair value. In prior periods, due to the auction process which took place every 30-35
days for most securities, quoted market prices were readily available, which would qualify as Level
1 under ASC 820, Fair Value Measurements and Disclosure (formerly SFAS No 157). However, due to
events in credit markets that began during the first quarter of 2008, the auction events for most
of these instruments failed, and, therefore, we determined the estimated fair values of these
securities, beginning in the first quarter of 2008, utilizing a discounted cash flow
analysis. These analyses
73
consider, among other items, the collateralization underlying the security investments, the
expected future cash flows, including the final maturity, associated with the securities, and the
expectation of the next time the security is expected to have a successful auction. These
securities were also compared, when possible, to other observable market data with similar
characteristics to the securities held by us. Due to these events, we reclassified these
instruments as Level 3 during the first quarter of 2008, and we recorded an other-than-temporary
impairment loss of $6.4 million during the fourth quarter of 2008 on our auction rate floating
securities, based on our estimate of the fair value of these investments. Our estimate of fair
value of our auction-rate floating securities was based on market information and estimates
determined by our management, which could change in the future based on market conditions. In
accordance with a new accounting standard which is now part of ASC 320, Investments Debt and
Equity Securities, during the three months ended June 30, 2009, we reclassified $3.1 million of
previously recognized other-than-temporary impairment losses, net of income taxes, related to our
auction rate floating securities from retained earnings to other comprehensive income in our
consolidated balance sheets during the three months ended June 30, 2009.
In November 2008, we entered into a settlement agreement with the broker through which we
purchased auction rate floating securities. The settlement agreement provides us with the right to
put an auction rate floating security currently held by us back to the broker beginning on June 30,
2010. At December 31, 2009, and December 31, 2008, we held one auction rate floating security with
a par value of $1.3 million that was subject to the settlement agreement. We elected the
irrevocable Fair Value Option treatment under ASC 825, Financial Instruments (formerly SFAS No.
159, The Fair Value Option for Financial Assets and Financial Liabilities), and adjusted the put
option to fair value. We reclassified this auction rate floating security from available-for-sale
to trading securities as of December 31, 2008, and future changes in fair value related to this
investment and the related put right will be recorded in earnings.
On July 14, 2009, the broker through which we purchased auction rate floating securities
agreed to repurchase from us three auction rate floating securities with an aggregate par value of
$7.0 million, at par. The adjusted basis of these securities was $5.5 million, in aggregate, as a
result of an other-than-temporary impairment loss of $1.5 million recorded during the year ended
December 31, 2008. The realized gain of $1.5 million was recognized in other (income) expense
during the three months ended September 30, 2009.
Off-Balance Sheet Arrangements
As of December 31, 2009, we are not involved in any off-balance sheet arrangements, as defined
in Item 3(a)(4)(ii) of SEC Regulation S-K.
Contractual Obligations
The following table summarizes our significant contractual obligations at December 31, 2009,
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 |
|
$ |
169,326 |
|
|
$ |
|
|
|
$ |
169,145 |
|
|
$ |
181 |
|
|
$ |
|
|
Interest on long-term debt |
|
|
95,208 |
|
|
|
4,231 |
|
|
|
8,463 |
|
|
|
8,463 |
|
|
|
74,051 |
|
Operating leases |
|
|
49,702 |
|
|
|
6,635 |
|
|
|
9,013 |
|
|
|
8,972 |
|
|
|
25,082 |
|
Other purchase obligations
and commitments |
|
|
867 |
|
|
|
173 |
|
|
|
347 |
|
|
|
347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
315,103 |
|
|
$ |
11,039 |
|
|
$ |
186,968 |
|
|
$ |
17,963 |
|
|
$ |
99,133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
74
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, 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, 2009, $169.1 million of the Old Notes were classified in the More than 1 year and
less than 3 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 1 year but less than 3 years from
the December 31, 2009 balance sheet date. As of December 31, 2009, $0.2 million of New Notes were
classified in the More than 3 years and less than 5 years category as the holders of the New
Notes may require us to repurchase all or a portion of their New Notes on June 4, 2013, which is
more than 3 years but less than 5 years from the December 31, 2009 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 $353.7 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, based on expected
demand, and are fulfilled by our vendors, in most cases, 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 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, Summary of Significant Accounting Policies in the notes to the
consolidated financial statements under Item 15 of Part IV of this report, Exhibits and Financial
Statement Schedules. We believe the following critical
75
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, which is now part of ASC 605, Revenue
Recognition. 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 and product, 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 result of certain modifications made to our distribution services
agreement with McKesson, our exclusive U.S. distributor of our aesthetics products
DYSPORTTM, PERLANE® and RESTYLANE®, we began recognizing revenue
on these products upon the shipment from McKesson to physicians beginning in the second quarter of
2009. As a general practice, we do not ship prescription product that has less than 12 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 prescription
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 estimated product returns, sales discounts and chargebacks are established as a
reduction of product sales revenues at the time such revenues are recognized. Provisions for
managed care and Medicaid rebates and consumer rebate and loyalty programs are established as a
reduction of product sales revenues at the later of the date at which revenue is recognized or the
date at which the sales incentive is offered. In addition, we defer revenue for certain sales of
inventory into the distribution channel that are in excess of eight (8) weeks of projected demand.
These deductions from gross revenue are established by us as our best estimate 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 inventory information reported to us by our major wholesale customers for which we have
inventory management agreements, 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 regularly monitor internal as well as
external data from our wholesalers, in order to assess the reasonableness of the information
obtained from external sources. We also utilize projected prescription demand for our products, as
well as, our internal information regarding our products. These deductions from gross revenue are
generally reflected either as a direct reduction to accounts receivable through an allowance, as a
reserve within current liabilities, or as an addition to accrued expenses.
We identify product returns by their manufacturing lot number. Because we manufacture in
bulk, lot sizes can be large and, as a result, sales of any individual lot may occur over several
periods. As a result, we are unable to specify if actual returns or credits relate to a sale that
occurred in the current period or a prior period, and therefore, we cannot specify how much of the
provision recorded relates to sales made in prior periods. However, we believe the process
discussed above, including the tracking of returns by lot, and the availability of other internal
and external data allows us to reasonably estimate the level of product returns, as well as
estimate the level of expected credits associated with rebates or chargebacks.
76
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, inventory in the distribution channel, 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 or
deferred revenue, for the years ended December 31, 2008 and 2009 (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Managed |
|
|
Consumer |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Care & |
|
|
Rebate |
|
|
|
|
|
|
Reserve |
|
|
|
|
|
|
Sales |
|
|
|
|
|
|
Medicaid |
|
|
and |
|
|
|
|
|
|
for Sales |
|
|
Deferred |
|
|
Discounts |
|
|
Chargebacks |
|
|
Rebates |
|
|
Loyalty |
|
|
|
|
|
|
Returns |
|
|
Revenue |
|
|
Reserve |
|
|
Reserve |
|
|
Reserve |
|
|
Programs |
|
|
Total |
|
|
Balance at December 31, 2007 |
|
$ |
68,787 |
|
|
$ |
1,907 |
|
|
$ |
511 |
|
|
$ |
320 |
|
|
$ |
4,881 |
|
|
$ |
14,745 |
|
|
$ |
91,151 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual |
|
|
(50,042 |
) |
|
|
|
|
|
|
(12,268 |
) |
|
|
(2,001 |
) |
|
|
(17,230 |
) |
|
|
(49,462 |
) |
|
|
(131,003 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision |
|
|
40,866 |
|
|
|
(1,193 |
) |
|
|
13,005 |
|
|
|
2,152 |
|
|
|
29,305 |
|
|
|
63,165 |
|
|
|
147,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
$ |
59,611 |
|
|
$ |
714 |
|
|
$ |
1,248 |
|
|
$ |
471 |
|
|
$ |
16,956 |
|
|
$ |
28,448 |
|
|
$ |
107,448 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Actual |
|
|
(29,498 |
) |
|
|
|
|
|
|
(18,042 |
) |
|
|
(2,812 |
) |
|
|
(68,578 |
) |
|
|
(168,196 |
) |
|
|
(287,126 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision |
|
|
17,949 |
|
|
|
549 |
|
|
|
18,954 |
|
|
|
3,029 |
|
|
|
98,700 |
|
|
|
213,059 |
|
|
|
352,240 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
$ |
48,062 |
|
|
$ |
1,263 |
|
|
$ |
2,160 |
|
|
$ |
688 |
|
|
$ |
47,078 |
|
|
$ |
73,311 |
|
|
$ |
172,562 |
|
|
|
|
Reserve for Sales 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
whether historical rates of return continue to be appropriate given current conditions. We
estimate returns of 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 $17.9 million, or 1.9% of gross product sales, and $40.9
million, or 6.2% of gross product sales, for the years ended December 31, 2009 and 2008,
respectively. The reserve for
77
product returns was $48.1 million and $59.6 million as of December 31, 2009 and 2008,
respectively. The decrease
in the provision and the reserve was primarily related to a reduction in product returns
experienced during 2009 and lower levels of inventory in the distribution channel at December 31,
2009.
If the amount of our estimated quarterly returns increased by 10.0 percent, our sales returns
reserve at December 31, 2009, would increase by approximately $4.2 million and corresponding
revenue would decrease by the same amount. Conversely, if the amount of our estimated quarterly
returns decreased by 10.0 percent, our sales returns reserve at December 31, 2009, would decrease
by approximately $4.2 million and corresponding revenue would increase by the same amount. We
consider the sensitivity analysis of a 10.0 percent variance between estimated and actual sales
returns to be representative of the range of other outcomes that we are reasonably likely to
experience in estimating our sales returns reserves.
For newly-launched products, if the returns reserve percentage increased by one percentage
point, our sales return reserve at December 31, 2009, would increase by approximately $1.3 million
and corresponding revenue would decrease by the same amount. Conversely, if the returns reserve
percentage decreased by one percentage point, our sales returns reserve at December 31, 2009, would
have decreased by approximately $1.3 million and corresponding revenue would increase by the same
amount. We consider the sensitivity analysis of a one percentage point variance between estimated
and actual returns reserve percentage to be representative of the range of other outcomes that we
are reasonably likely to experience in estimating our sales returns reserves for newly-launched
products.
We also defer the recognition of revenue and related cost of revenue for certain sales of
inventory into the distribution channel that are in excess of eight (8) weeks of projected demand.
The distribution channels market demand requirement is estimated based on inventory information
reported to us by our major wholesale customers for which we have inventory management agreements,
who make up a significant majority of our total sales of inventory into the distribution channel.
No adjustment is made for those customers who do not provide inventory information to us. Deferred
product revenue associated with estimated excess inventory at wholesalers was approximately $1.2
million and $0.7 million as of December 31, 2009 and 2008, respectively.
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 $19.0 million, or 2.0% of gross product sales, and $13.0
million, or 2.0% of gross product sales, for the years ended December 31, 2009 and 2008,
respectively. The reserve for cash discounts was $2.2 million and $1.2 million as of December 31,
2009 and 2008, 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 are normally reflective of increases or decreases in the related eligible
outstanding accounts receivable amounts at the comparable dates.
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.
78
The provision for contract chargebacks was $3.0 million, or 0.3% of gross product sales, and
$2.2 million, or 0.3% of gross product sales, for the years ended December 31, 2009 and 2008,
respectively. The reserve for contract chargebacks was $0.7 million and $0.5 million as of
December 31, 2009 and 2008, respectively.
Managed Care and Medicaid Rebates
Managed care and Medicaid 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 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 $98.7 million, or 10.5% of gross
product sales, and $29.3 million, or 4.4% of gross product sales, for the years ended December 31,
2009 and 2008, respectively. The reserve for managed care and Medicaid rebates was $47.1 million
and $17.0 million as of December 31, 2009 and 2008, respectively. The increase in the provision
was primarily due to an increase in the number of pricing contracts in place during the comparable
periods related to SOLODYN®. The increase in the reserve is due to an increase in the
amount of rebates outstanding at the comparable dates, due to the increase in the number of
SOLODYN® pricing contracts in place.
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.
The provision for consumer rebates and loyalty programs was $213.1 million, or 22.6% of gross
product sales, and $63.2 million, or 9.6% of gross product sales, for the years ended December 31,
2009 and 2008, respectively. The reserve for consumer rebates and loyalty programs was $73.3
million and $28.4 million as of December 31, 2009 and 2008, respectively. The increase in the
provision and the reserve was primarily due to new consumer rebate programs initiated during 2009
related to our SOLODYN®, ZIANA®, DYSPORTTM, RESTYLANE®
and PERLANE® products.
If our 2009 estimates of rebate redemption rates or average rebate amounts for our consumer
rebate programs changed by 10.0 percent, or 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 $4.1 million and corresponding revenue would be impacted by the same
amount. We consider the sensitivity analysis of a 10.0 percent variance in our estimated rebate
redemption rates and average rebate amounts to be representative of the range of other outcomes
that we are reasonably likely to experience in estimating our reserve for consumer rebates and
loyalty programs.
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
regularly monitor internal data as well as external data from our wholesalers, in order to assess
the reasonableness of the information obtained from external sources. 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.
79
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.
Share-Based Compensation
In accordance with ASC 718, Compensation Stock Compensation, we are 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 0.45 0.46 percent to 0.475 0.485
percent) would have increased the fair value of stock options granted in 2009 to $7.56 per share.
Conversely, decreasing the weighted average volatility by 2.5 percent (from 0.45 0.46 percent to
0.425 0.435 percent) would have decreased the fair value of stock options granted in 2009 to
$6.96 per share. The expected life of the awards is based on historical experience of awards with
similar characteristics. Stock option awards granted during 2009 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 2009 to $7.06 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.
The fair value of stock appreciation rights (SARs) is adjusted at the end of each reporting
period based on updated valuation variables at the end of each reporting period. The fair value of
SARs is most affected by changes in the fair market value of our common stock at the end of each
reporting period.
We are required 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 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 2010 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.
80
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 December 31, 2009, there were $0.3 million of costs capitalized into inventory for
products that have not yet received regulatory approval. We believe that it is probable that these
products will receive regulatory approval and future revenues that exceed costs will be generated
from the sale of the inventory.
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 2009 and 2008, we did not recognize an impairment charge as a result of our review of
long-lived assets. During 2007, an impairment charge of $4.1 million was recognized related to our
review of long-lived assets, and the remaining useful life of the intangible asset that was deemed
to be impaired was 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 that are not designed to normally result in tax deductions, various
expenses that are not deductible for tax purposes, changes in valuation allowances against deferred
tax assets 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
tax benefits only if the tax position is more likely than not to be sustained. 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.
81
Based on our historical pre-tax earnings, we believe it is more likely than not that we will
realize the benefit of substantially all of the existing net deferred tax assets at December 31,
2009. 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.
The Company has an option to acquire Revance or license Revances topical product that is
under development. Through December 31, 2009, we have recorded $21.0 million of charges related to
the reduction in the carrying value of the Revance investment. The reduction in the carrying value
of the Revance investment is currently an unrealized loss for tax purposes. We will not be able to
determine the character of the loss until we exercise or fail to exercise our option. A realized
loss characterized as a capital loss can only be utilized to offset capital gains. We have
recorded a $7.6 million valuation allowance against the deferred tax asset associated with this
unrealized tax loss in order to reduce the carrying value of the deferred tax asset to $0, which is
the amount that we believe is more likely than not to be realized.
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.
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. 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 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 April 2009, the FASB issued new guidance that provides additional guidance for estimating
fair value when the volume and level of activity for the asset or liability have significantly
decreased. This new guidance, which is now part of ASC 820, Fair Value Measurements and
Disclosures, also includes guidance on identifying circumstances that indicate a transaction is not
orderly and applies to all assets and liabilities within the scope of accounting pronouncements
that require or permit fair value measurements. The new guidance is effective for interim and
annual reporting periods ending after June 15, 2009. We adopted the new guidance on April 1, 2009,
and it did not have a material impact on our consolidated results of operations and financial
condition.
82
In April 2009, the FASB issued new guidance related to the disclosure about the fair value of
a reporting entitys financial instruments whenever it issues summarized financial information for
interim reporting periods. The new guidance, which is now part of ASC 825, Financial Instruments,
is effective for financial statements issued for interim reporting periods ending after June 15,
2009. We adopted the new guidance on April 1, 2009, and it did not have a material impact on our
consolidated results of operations and financial condition.
In June 2009, the FASB issued revised guidance on the accounting for variable interest
entities. The revised guidance, which was issued as SFAS No. 167, New Consolidation Guidance for
Variable Interest Entities (VIE), which amends FIN 46 (R), Consolidation of Variable Interest
Entities, has not yet been adopted into the FASB Standards Accounting Codification
(Codification). The revised guidance addresses the elimination of the concept of a qualifying
special purpose entity and replaces the quantitative-based risks and rewards calculation for
determining which enterprise has a controlling financial interest in a variable interest entity
with an approach focused on identifying which enterprise has the power to direct the activities of
the variable interest entity, and the obligation to absorb losses of the entity or the right to
receive benefits from the entity. Additionally, the revised guidance requires any enterprise that
holds a variable interest in a variable interest entity to provide enhanced disclosures that will
provide users of financial statements with more transparent information about an enterprises
involvement in a variable interest entity. The revised guidance is effective for annual reporting
periods beginning after November 30, 2009. We are currently assessing what impact, if any, the
revised guidance will have on our results of operations and financial condition.
In October 2009, the FASB approved for issuance Accounting Standard Update (ASU) No.
2009-13, Revenue Recognition (ASC 605) Multiple Deliverable Revenue Arrangements, a consensus
of EITF 08-01, Revenue Arrangements with Multiple Deliverables. This guidance modifies the fair
value requirements of ASC subtopic 605-25 Revenue Recognition Multiple Element Arrangements by
providing principles for allocation of consideration among its multiple-elements, allowing more
flexibility in identifying and accounting for separate deliverables under an arrangement. An
estimated selling price method is introduced for valuing the elements of a bundled arrangement if
vendor-specific objective evidence or third-party evidence of selling price is not available, and
significantly expands related disclosure requirements. This updated guidance is effective on a
prospective basis for revenue arrangements entered into or materially modified in fiscal years
beginning on or after June 15, 2010. Alternatively, adoption may be on a retrospective basis, and
early application is permitted. We are currently assessing what impact, if any, the updated
guidance will have on our results of operations and financial condition.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
At December 31, 2009, $197.5 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 policy for our short-term and long-term investments is to establish a high-quality
portfolio that preserves principal, meets liquidity needs, avoids inappropriate concentrations and
delivers an appropriate yield in relationship to our investment guidelines and market conditions.
Our investment portfolio, consisting of fixed income securities that we hold on an
available-for-sale basis, was approximately $344.8 million as of December 31, 2009, and $312.8
million as of December 31, 2008. 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, 2009, and December 31, 2008, our short-term investments included auction
rate floating securities with a fair value of $26.8 million and $38.2 million, respectively. 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 negative conditions in the
credit markets during 2008 and 2009 have prevented some investors from liquidating their holdings,
including their holdings of auction rate floating securities. As a result, these affected auction
rate floating securities are now considered illiquid, and we could be required to hold them until
they are redeemed by the holder at maturity. We may not be able to liquidate the securities until
a future auction on these investments is successful. As a result of the lack of liquidity of these
investments, we recorded an
83
other-than-temporary impairment loss of $6.4 million during 2008 on our auction rate floating
securities. During the three months ended June 30, 2009, we adopted FSP FAS 115-2 (now part of ASC
320), and accordingly, we reclassified $3.1 million of this other-than-temporary impairment loss,
net of income taxes, from retained earnings to other comprehensive income in our consolidated
balance sheets during the three months ended June 30, 2009.
The following table provides information about our available-for-sale and trading 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, 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial instruments mature during year ended December 31, |
|
|
|
2010 |
|
|
2011 |
|
|
2012 |
|
|
2013 |
|
|
2014 |
|
|
Thereafter |
|
Financial instruments mature during year ended December 31, |
|
Available-for-sale and
trading securities |
|
$ |
143,417 |
|
|
$ |
167,522 |
|
|
$ |
8,290 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
25,524 |
|
Weighted-average yield rate |
|
|
1.2 |
% |
|
|
1.2 |
% |
|
|
1.4 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
1.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent convertible
senior notes due 2032 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
169,145 |
|
Interest rate |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.5 |
% |
Contingent convertible
senior notes due 2033 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
181 |
|
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 U.S. and, accordingly, we have
not been susceptible to significant risk from changes in foreign currencies.
During the normal course of business we could be subjected to a variety of market risks,
examples of which include, but are not limited to, interest rate movements and foreign currency
fluctuations, as we discussed above, and collectibility of accounts receivable. We continuously
assess these risks and have established policies and procedures to protect against the adverse
effects of these and other potential exposures. Although we do not anticipate any material losses
in these risk areas, no assurance can be made that material losses will not be incurred in these
areas in the future.
Item 8. Financial Statements and Supplementary Data
Our financial statements and related financial statement schedule and the Independent
Registered Public Accounting Firms Reports are incorporated herein by reference to the financial
statements set forth in Item 15 of Part IV of this report.
Item 9. Changes in and Disagreements with Accountants on Accounting 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
84
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 management of the 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 the 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, 2009, 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.
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 our internal control
over financial reporting as of December 31, 2009. 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 our
internal control over financial reporting was effective as of December 31, 2009.
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 is included below.
85
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders of Medicis Pharmaceutical Corporation
We have audited Medicis Pharmaceutical Corporations (the Company) internal control over
financial reporting as of December 31, 2009, 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 above under the heading
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, 2009, 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, 2009 consolidated financial statements of Medicis
Pharmaceutical Corporation and subsidiaries and our report dated March 1, 2010 expressed an
unqualified opinion thereon.
/s/ Ernst & Young LLP
Phoenix, Arizona
March 1, 2010
86
Item 9B. Other Information
None.
PART III
Item 10. Directors and Executive Officers and Corporate Governance
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, 2009, the certifications of its Chief Executive Officer and Chief Financial Officer
required pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
On May 26, 2009, 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 and Related Stockholder
Matters
The information to be included in the section entitled Security Ownership of Directors and
Executive Officers and Certain Beneficial Owners in the Proxy Statement and in the section
entitled Equity Compensation Plan Information in Item 5 of this Annual Report on Form 10-K is
incorporated herein by reference.
Item 13. Certain Relationships and Related Transactions, and Director Independence
The information to be included in the section entitled Certain Relationships and Related
Transactions in the Proxy Statement is incorporated herein by reference.
Item 14. Principal Accounting Fees and Services
The information to be included in the section entitled Independent Public Accountants in the
Proxy Statement is incorporated herein by reference.
87
PART IV
Item 15. Exhibits, Financial Statement Schedules
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Page |
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(a) Documents filed as a part of this Report |
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(1) Financial Statements: |
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F-1 |
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F-2 |
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F-3 |
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F-5 |
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F-6 |
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F-8 |
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F-9 |
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(2) Financial Statement Schedule: |
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S-1 |
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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. |
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(3) Exhibits filed as part of this Report: |
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Exhibit No. |
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Description |
2.1
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Agreement of Merger by and between the Company, Medicis Acquisition Corporation and GenDerm
Corporation, dated November 28, 1997 (11) |
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2.2
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Agreement of Plan of Merger, dated as of October 1, 2001, by and among the Company, MPC
Merger Corp. and Ascent Pediatrics, Inc. (17) |
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2.3
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Agreement and Plan of Merger by and among the Company, Donatello, Inc., and LipoSonix, Inc.
dated June 16, 2008(49) |
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3.1
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Certificate of Incorporation of the Company, as amended (23) |
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3.2
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Amended and Restated By-Laws of the Company (43) |
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4.1
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Amended and Restated Rights Agreement, dated as of August 17, 2005, between the Company and
Wells Fargo Bank, N.A., as Rights Agent(26) |
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4.2
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Indenture, dated as of August 19, 2003, by and between the Company, as issuer, and Deutsche
Bank Trust Company Americas, as trustee (23) |
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4.3
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Indenture, dated as of June 4, 2002, by and between the Company, as issuer, and Deutsche Bank
Trust Company Americas, as trustee. (19) |
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4.4
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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) |
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4.5
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Registration Rights Agreement, dated as of June 4, 2002, by and between the Company and
Deutsche Bank Securities Inc. (19) |
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4.6
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Form of specimen certificate representing Class A common stock (1) |
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10.1
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Asset Purchase Agreement among the Company, Ascent Pediatrics, Inc., BioMarin Pharmaceutical
Inc., and BioMarin Pediatrics Inc., dated April 20, 2004 (23) |
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10.2
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Merger Termination Agreement, dated as of December 13, 2005, by and among the Company,
Masterpiece Acquisition Corp., and Inamed Corporation(31) |
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10.3
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Securities Purchase Agreement among the Company, Ascent Pediatrics, Inc., BioMarin
Pharmaceutical Inc. and BioMarin Pediatrics Inc., dated May 18, 2004 (23) |
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10.4
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Termination Agreement dated October 19, 2005 between the Company and Michael A.
Pietrangelo(28) |
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10.5
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License Agreement among the Company, Ascent Pediatrics, Inc. and BioMarin Pediatrics Inc.,
dated May 18, 2004 (23) |
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10.6
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Medicis Pharmaceutical Corporation 1995 Stock Option Plan (incorporated by
reference to Exhibit C to the definitive Proxy Statement for the 1995 Annual |
88
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Exhibit No. |
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Description |
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Meeting of Shareholders previously filed with the SEC, File No. 0-18443) |
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10.7(a)
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Employment Agreement between the Company and Jonah Shacknai, dated
July 24, 1996 (8) |
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10.7(b)
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Amendment to Employment Agreement by and between the Company and
Jonah Shacknai, dated April 1, 1999 (15) |
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10.7(c)
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Amendment to Employment Agreement by and between the Company and
Jonah Shacknai, dated February 21, 2001 (15) |
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10.7(d)
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Third Amendment, dated December 30, 2005, to Employment Agreement between the Company and
Jonah Shacknai(32) |
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10.8
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Medicis Pharmaceutical Corporation 2001 Senior Executive Restricted Stock Plan(30) |
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10.9(a)
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Medicis Pharmaceutical Corporation 2002 Stock Option Plan (20) |
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10.9(b)
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Amendment No. 1 to the Medicis Pharmaceutical Corporation 2002 Stock Option Plan, dated
August 1, 2005(29) |
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10.10(a)
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Medicis Pharmaceutical Corporation 2004 Stock Incentive Plan(27) |
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10.10(b)
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Amendment No. 1 to the Medicis Pharmaceutical Corporation 2004 Stock Option Plan, dated
August 1, 2005(29) |
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10.11(a)
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Medicis Pharmaceutical Corporation 1998 Stock Option Plan(33) |
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10.11(b)
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Amendment No. 1 to the Medicis Pharmaceutical Corporation 1998 Stock Option Plan, dated
August 1, 2005(29) |
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10.11(c)
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Amendment No. 2 to the Medicis Pharmaceutical Corporation 1998 Stock Option Plan, dated
September 30, 2005(29) |
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10.12(a)
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Medicis Pharmaceutical Corporation 1996 Stock Option Plan(34) |
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10.12(b)
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Amendment No. 1 to the Medicis Pharmaceutical Corporation 1996 Stock Option Plan, dated
August 1, 2005(29) |
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10.13
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Waiver Letter dated March 18, 2005 between the Company and Q-Med AB(27) |
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10.14
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Supply Agreement, dated October 21, 1992, between Schein Pharmaceutical and the Company
(2) |
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10.15
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Amendment to Manufacturing and Supply Agreement, dated March 2, 1993, between
Schein Pharmaceutical and the Company (3) |
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10.16(a)
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Credit and Security Agreement, dated August 3, 1995, between the Company and
Norwest Business Credit, Inc. (5) |
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10.16(b)
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First Amendment to Credit and Security Agreement, dated May 29, 1996,
between the Company and Norwest Bank Arizona, N.A. (8) |
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10.16(c)
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Second Amendment to Credit and Security Agreement, dated November 22, 1996,
by and between the Company and Norwest Bank Arizona, N.A. as successor-in-interest
to Norwest Business Credit, Inc. (10) |
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10.16(d)
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Third Amendment to Credit and Security Agreement, dated November 22, 1998, by
and between the Company and Norwest Bank Arizona, N.A., as successor-in-interest
to Norwest Business Credit, Inc. (12) |
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10.16(e)
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Fourth Amendment to Credit and Security Agreement, dated November 22, 2000,
by and between the Company and Wells Fargo Bank Arizona, N.A., formerly
known as Norwest Bank Arizona, N.A., as successor-in-interest to Norwest Business
Credit, Inc. (16) |
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10.16(f)
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Fifth Amendment to Credit and Security Agreement, dated November 22, 2002, by and between the
Company and Wells Fargo Bank Arizona, N.A., formerly known as Norwest Bank Arizona, N.A., as
successor-in-interest to Norwest Business Credit, Inc. (23) |
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10.17(a)
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Patent Collateral Assignment and Security Agreement, dated August 3, 1995, by
the Company to Norwest Business Credit, Inc. (6) |
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10.17(b)
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First Amendment to Patent Collateral Assignment and Security Agreement, dated
May 29, 1996, by the Company to Norwest Bank Arizona, N.A. (8) |
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10.17(c)
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Amended and Restated Patent Collateral Assignment and Security Agreement, dated
November 22, 1998, by the Company to Norwest Bank Arizona, N.A. (12) |
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10.18(a)
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Trademark Collateral Assignment and Security Agreement, dated August 3, 1995,
by the Company to Norwest Business Credit, Inc. (7) |
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10.18(b)
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First Amendment to Trademark Collateral Assignment and Security Agreement, dated
May 29, 1996, by the Company to Norwest Bank Arizona, N.A. (8) |
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10.18(c)
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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) |
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10.19
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Assignment and Assumption of Loan Documents, dated May 29, 1996, from
Norwest Business Credit, Inc., to and by Norwest Bank Arizona, N.A. (8) |
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10.20
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Multiple Advance Note, dated May 29, 1996, from the Company to Norwest Bank |
89
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Exhibit No. |
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Description |
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Arizona, N.A. (8) |
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10.21
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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) |
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10.22
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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) |
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10.23
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Loprox Lotion Supply Agreement dated November 15, 1998, by and between the
Company and Hoechst Marion Roussel, Inc. (12) |
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10.24
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Supply Agreement dated November 15, 1998, by and between the Company and
Hoechst Marion Roussel Deutschland GMBH (12) |
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10.25
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Asset Purchase Agreement effective January 31, 1999, between the Company and
Bioglan Pharma Plc (14) |
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10.26
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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) |
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10.27
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Asset Purchase Agreement by and between the Company and Bioglan Pharma Plc,
dated June 29, 1999 (14) |
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10.28
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Asset Purchase Agreement by and among The Exorex Company, LLC, Bioglan
Pharma Plc, the Company and IMX Pharmaceuticals, Inc., dated June 29, 1999 (16) |
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10.29
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Medicis Pharmaceutical Corporation Executive Retention Plan (14) |
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10.30
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Asset Purchase Agreement between Warner Chilcott, plc and the Company, dated
September 14, 1999(14) |
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10.31(a)
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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) |
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10.31(b)
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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) |
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10.32
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Supply Agreement between Q-Med AB and the Company,
dated March 7, 2003(21) |
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10.33
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Amended and Restated Intellectual Property Agreement between Q-Med AB and HA
North American Sales AB, dated March 7, 2003(21) |
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10.34
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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. |
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10.35
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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. |
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10.36
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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) |
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10.37
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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) |
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10.38
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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) |
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10.39
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Medicis Pharmaceutical Corporation 1992 Stock Option Plan(35) |
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10.40
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Form of Stock Option Agreement for Medicis Pharmaceutical Corporation 2004 Stock Incentive
Plan(36) |
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10.41
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Form of Restricted Stock Agreement for Medicis Pharmaceutical Corporation 2004 Stock
Incentive Plan(36) |
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10.42
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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) |
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10.43
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*
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Development and Distribution Agreement by and between Aesthetica, Ltd. and Ipsen, |
90
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Exhibit No. |
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Description |
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Ltd.(38) |
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10.44
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*
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Trademark License Agreement by and between Aesthetica, Ltd. and Ipsen, Ltd. (38) |
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10.45
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*
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Trademark Assignment Agreement by and between Aesthetica, Ltd. and Ipsen, Ltd. (38) |
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10.46(a)
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Medicis 2006 Incentive Award Plan(39) |
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10.46(b)
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Amendment to the Medicis 2006 Incentive Award Plan, dated July 10, 2006(41) |
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10.46(c)
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Amendment No. 2 to the Medicis 2006 Incentive Award Plan, dated April 11, 2007(46) |
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10.46(d)
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Amendment No. 3 to the Medicis 2006 Incentive Award Plan, dated April 16, 2007(45) |
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10.46(e)
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Form of Stock Option Agreement for Medicis Pharmaceutical Corporation 2006 Incentive Award
Plan(48) |
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10.46(f)
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Form of Restricted Stock Agreement for Medicis Pharmaceutical Corporation 2006 Incentive
Award Plan(48) |
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10.47
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Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical Corporation and
Mark A. Prygocki, Sr. (40) |
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10.48
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Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical Corporation and
Mitchell S. Wortzman, Ph.D. (40) |
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10.49
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Employment Agreement, dated July 25, 2006, between Medicis Pharmaceutical Corporation and
Richard J. Havens (40) |
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10.50
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Employment Agreement, dated July 27, 2006, between Medicis Pharmaceutical Corporation and
Jason D. Hanson (40) |
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10.51
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*
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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) |
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10.52
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Corporate Integrity Agreement between the Office of Inspector General of the department of
Health and Human Services and Medicis Pharmaceutical Corporation(44) |
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10.53
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*
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Collaboration Agreement, dated as of August 23, 2007, by and between Ucyclyd Pharma, Inc. and
Hyperion Therapuetics, Inc. (47) |
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10.54
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Employment Agreement, dated December 23, 2008, by and between the Company and Joseph P.
Cooper (50) |
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10.55
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Amended and Restated Employment Agreement, dated December 23, 2008, by and between the
Company and Jason D. Hanson (50) |
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10.56
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Employment Agreement, dated December 23, 2008, by and between the Company and Vincent P.
Ippolito (50) |
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10.57
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Employment Agreement, dated December 23, 2008, by and between the Company and Richard D.
Peterson (50) |
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10.58
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Amended and Restated Employment Agreement, dated December 23, 2008, by and between the
Company and Mark A. Prygocki (50) |
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10.59
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Amended and Restated Employment Agreement, dated December 23, 2008, by and between the
Company and Mitchell S. Wortzman, Ph.D. (50) |
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10.60
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Fourth Amendment to Employment Agreement, dated December 23, 2008, by and between the Company
and Jonah Shacknai (50) |
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10.61
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*
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Joint Development Agreement, dated as of November 26, 2008, between the Company and Impax
Laboratories, Inc. |
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10.62
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*
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License and Settlement Agreement, dated as of November 26, 2008, between the Company and
Impax Laboratories, Inc. |
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10.63
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Amendment No. 4 to the Medicis 2006 Incentive Award Plan, dated March 26, 2009.(52) |
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10.64
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*
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Settlement Agreement, dated March 18, 2009, between the Company and Barr Laboratories, Inc.,
a wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.(52) |
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10.65
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*
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License and Settlement Agreement, dated April 8, 2009, between the Company and Perrigo Israel
Pharmaceuticals Ltd. and Perrigo Company.(52) |
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10.66
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*
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Joint Development Agreement, dated April 8, 2009, between the Company and Perrigo Israel
Pharmaceuticals Ltd.(52) |
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10.67
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Form of Indemnification Agreement for Directors and Officers of the Company.(52) |
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10.68
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*
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Second Amendment to the Collaboration Agreement between Ucyclyd Pharma, Inc. and Hyperion
Therapeutics, Inc.(53) |
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10.69
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Settlement Agreement and Mutual Releases, dated August 18, 2009 between the Company and
Sandoz, Inc.(54) |
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10.70
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+*
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Transition Agreement, dated as of January 25, 2005, between the Company and aaiPharma Inc. |
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10.71
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+*
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First Amendment to the Transition Agreement, dated as of August 11, 2006, between the Company
and aaiPharma Inc. |
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10.72
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+*
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Second Amendment to the Transition Agreement, dated as of September 8, 2006, between the
Company and aaiPharma Inc. |
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10.73
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+*
|
Master Manufacturing Agreement, dated as of March 20, 2008, between Medicis Global |
91
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Exhibit No. |
|
|
Description |
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|
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Services Corporation and WellSpring Pharmaceutical Canada Corp. |
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10.74
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+*
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License and Settlement Agreement, dated as of November 14, 2009, among the Company, Glenmark
Generics Ltd. and Glenmark Generics Inc., USA |
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10.75
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+*
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Amended and Restated Settlement Agreement, dated as of November 13, 2009, between the Company
and Teva Pharmaceutical Industries Ltd. |
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12
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+
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Computation of Ratios of Earnings to Fixed Charges |
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21.1
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+
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Subsidiaries |
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23.1
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+
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Consent of Independent Registered Public Accounting Firm |
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24.1
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Power of Attorney See signature page |
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31.1
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+
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Certification of Chief Executive Officer pursuant to Rule 13a-14(a) and Rule 15d-14(a) of the
Securities Exchange Act, as amended |
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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
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+
|
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
|
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+
|
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 |
|
|
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+ |
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Filed herewith |
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* |
|
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. |
|
(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 |
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(2) |
|
Incorporated by reference to the Registration Statement on Form S-1 of the Company, File
No. 33-54276, filed with the SEC on June 11, 1993 |
|
(3) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 1993, File No. 0-18443, filed with the SEC on October 13, 1993 |
|
(4) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 1995, File No. 0-18443, previously filed with the SEC (the 1994 Form 10-K) |
|
(5) |
|
Incorporated by reference to the Companys 1995 Form 10-K |
|
(6) |
|
Incorporated by reference to the Companys 1995 Form 10-K |
|
(7) |
|
Incorporated by reference to the Companys 1995 Form 10-K |
|
(8) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K for the fiscal year
ended June 30, 1996, File No. 0-18443, previously filed with the SEC |
|
(9) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended March 31, 1997, File No. 0-18443, previously filed with the SEC |
|
(10) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended December 31, 1996, File No. 0-18443, previously filed with the SEC |
|
(11) |
|
Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC
on December 15, 1997 |
|
(12) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended December 31, 1998, File No. 001-14471, 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. 001-14471, 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. 001-14471, 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. 001-14471, 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 |
92
|
|
|
|
|
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. 001-14471, 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. 001-14471, 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. 001-14471, 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. 001-14471, 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. 001-14471, 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. 001-14471, previously filed
with the SEC |
|
(31) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on December 13, 2005 |
|
(32) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on January 3, 2006 |
|
(33) |
|
Incorporated by reference to Appendix 1 to the Companys definitive Proxy Statement for
the 1998 Annual
Meeting of Stockholders filed with the SEC on December 2, 1998 |
|
(34) |
|
Incorporated by reference to Appendix 2 to the Companys definitive Proxy Statement for
the 1996 Annual
Meeting of Stockholders filed with the SEC on October 23, 1996 |
|
(35) |
|
Incorporated by reference to Exhibit B to the Companys definitive Proxy Statement for
the 1992 Annual
Meeting of Stockholders previously filed with the SEC |
|
(36) |
|
Incorporated by reference to the Companys Annual Report on Form 10-K/T for the six month
transition
period ended December 31, 2005, File No. 001-14471, 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. 001-14471, 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. 001-14471, 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. 001-14471, previously filed
with the SEC |
|
(43) |
|
Incorporated by reference to the Companys Current Report on
Form 8-K filed with the SEC on February 18, 2009 |
|
(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. 001-14471, previously filed with the SEC |
|
(48) |
|
Incorporated by reference to the Companys Annual Report on
Form 10-K for the year ended December 31, 2007, File No. 001-14471, previously filed with
the SEC |
|
(49) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended June 30, 2008, File No. 001-14471, previously filed with the SEC. |
93
|
|
|
(50) |
|
Incorporated by reference to the Companys Current Report on Form 8-K filed with the SEC
on December 30, 2008 |
|
(51) |
|
Incorporated by reference to the Companys Annual Report on 10-K for the year ended
December 31, 2008, File No. 0-14471, previously filed with the SEC |
|
(52) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended March 31, 2009, File No. 001-14471, previously filed with the SEC. |
|
(53) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended June 30, 2009, File No. 001-14471, previously filed with the SEC. |
|
(54) |
|
Incorporated by reference to the Companys Quarterly Report on Form 10-Q for the quarter
ended September 30, 2009, File No. 001-14471, 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. |
94
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
Date: March 1, 2010
|
|
|
|
|
|
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 Richard D. Peterson, 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. This power of attorney shall be governed by and construed with the laws of
the States of Delaware and applicable federal securities laws.
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)
|
|
March 1, 2010 |
|
|
|
|
|
/s/ RICHARD D. PETERSON
Richard D. Peterson
|
|
Executive Vice President, Chief Financial
Officer, and
Treasurer
(Principal Financial and Accounting Officer)
|
|
March 1, 2010 |
|
|
|
|
|
/s/ ARTHUR G. ALTSCHUL, JR.
Arthur G. Altschul, Jr.
|
|
Director
|
|
March 1, 2010 |
|
|
|
|
|
/s/ SPENCER DAVIDSON
Spencer Davidson
|
|
Director
|
|
March 1, 2010 |
|
|
|
|
|
/s/ STUART DIAMOND
Stuart Diamond
|
|
Director
|
|
March 1, 2010 |
|
|
|
|
|
/s/ PETER S. KNIGHT, ESQ.
Peter S. Knight, Esq.
|
|
Director
|
|
March 1, 2010 |
|
|
|
|
|
/s/ MICHAEL A. PIETRANGELO
Michael A. Pietrangelo
|
|
Director
|
|
March 1, 2010 |
|
|
|
|
|
/s/ PHILIP S. SCHEIN, M.D.
Philip S. Schein, M.D.
|
|
Director
|
|
March 1, 2010 |
|
|
|
|
|
/s/ LOTTIE SHACKELFORD
Lottie Shackelford
|
|
Director
|
|
March 1, 2010 |
95
MEDICIS PHARMACEUTICAL CORPORATION
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
|
|
PAGE |
|
|
|
|
F-2 |
|
|
|
|
|
F-3 |
|
|
|
|
|
F-5 |
|
|
|
|
|
F-6 |
|
|
|
|
|
F-8 |
|
|
|
|
|
F-9 |
|
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, 2009 and 2008, and the related
consolidated statements of income, stockholders equity, and cash flows for each of the three years
in the period ended December 31, 2009. 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, 2009 and 2008 and the consolidated results of their operations and
their cash flows for each of the three years in the period ended December 31, 2009, in conformity
with U.S. generally accepted accounting principles. Also, in our opinion, the related financial
statement schedule, when considered in relation to the basic financial statements taken as a whole,
presents fairly in all material respects the information set forth therein.
We also have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), Medicis Pharmaceutical Corporations internal control over
financial reporting as of December 31, 2009, based on criteria established in Internal
ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission and our report dated March 1, 2010 expressed an unqualified opinion thereon.
Phoenix, Arizona
March 1, 2010
F-2
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED BALANCE SHEETS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
209,051 |
|
|
$ |
86,450 |
|
Short-term investments |
|
|
319,229 |
|
|
|
257,435 |
|
Accounts receivable, less allowances: |
|
|
|
|
|
|
|
|
December 31, 2009 and 2008: $2,848
and $1,719, respectively |
|
|
95,222 |
|
|
|
52,588 |
|
Inventories, net |
|
|
25,985 |
|
|
|
24,226 |
|
Deferred tax assets, net |
|
|
66,321 |
|
|
|
53,161 |
|
Other current assets |
|
|
16,525 |
|
|
|
19,676 |
|
|
|
|
Total current assets |
|
|
732,333 |
|
|
|
493,536 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
25,247 |
|
|
|
26,300 |
|
Net intangible assets |
|
|
227,840 |
|
|
|
161,429 |
|
Goodwill |
|
|
93,282 |
|
|
|
156,762 |
|
Deferred tax assets, net |
|
|
64,947 |
|
|
|
77,149 |
|
Long-term investments |
|
|
25,524 |
|
|
|
55,333 |
|
Other assets |
|
|
3,025 |
|
|
|
2,925 |
|
|
|
|
|
|
$ |
1,172,198 |
|
|
$ |
973,434 |
|
|
|
|
See accompanying notes to consolidated financial statements.
F-3
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED BALANCE SHEETS, Continued
(in thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
|
Liabilities |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
44,183 |
|
|
$ |
39,032 |
|
Reserve for sales returns |
|
|
48,062 |
|
|
|
59,611 |
|
Accrued consumer rebate and loyalty programs |
|
|
73,311 |
|
|
|
28,449 |
|
Managed care and Medicaid reserves |
|
|
47,078 |
|
|
|
16,956 |
|
Income taxes payable |
|
|
16,679 |
|
|
|
|
|
Other current liabilities |
|
|
68,381 |
|
|
|
41,853 |
|
|
|
|
Total current liabilities |
|
|
297,694 |
|
|
|
185,901 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term liabilities: |
|
|
|
|
|
|
|
|
Contingent convertible senior notes |
|
|
169,326 |
|
|
|
169,326 |
|
Other liabilities |
|
|
9,919 |
|
|
|
14,513 |
|
|
|
|
|
|
|
|
|
|
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: 70,732,409 and 69,396,394 at
December 31, 2009 and December 31, 2008,
respectively |
|
|
985 |
|
|
|
969 |
|
Class B common stock, $0.014 par value; shares
authorized: 1,000,000; issued and outstanding: none |
|
|
|
|
|
|
|
|
Additional paid-in capital |
|
|
690,497 |
|
|
|
661,703 |
|
Accumulated other comprehensive (loss) income |
|
|
(3,814 |
) |
|
|
2,106 |
|
Accumulated earnings |
|
|
351,842 |
|
|
|
282,284 |
|
Less: Treasury stock, 12,749,261 and 12,678,559 shares
at cost at December 31, 2009 and December 31,
2008, respectively |
|
|
(344,251 |
) |
|
|
(343,368 |
) |
|
|
|
Total stockholders equity |
|
|
695,259 |
|
|
|
603,694 |
|
|
|
|
|
|
$ |
1,172,198 |
|
|
$ |
973,434 |
|
|
|
|
See accompanying notes to consolidated financial statements.
F-4
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF INCOME
(in thousands, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
Net product revenues |
|
$ |
561,761 |
|
|
$ |
500,977 |
|
|
$ |
441,868 |
|
Net contract revenues |
|
|
10,154 |
|
|
|
16,773 |
|
|
|
15,526 |
|
|
|
|
Net revenues |
|
|
571,915 |
|
|
|
517,750 |
|
|
|
457,394 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenues (1) |
|
|
56,833 |
|
|
|
38,714 |
|
|
|
56,110 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
515,082 |
|
|
|
479,036 |
|
|
|
401,284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative (2) |
|
|
282,950 |
|
|
|
279,768 |
|
|
|
242,633 |
|
Research and development (3) |
|
|
71,765 |
|
|
|
99,916 |
|
|
|
39,428 |
|
Depreciation and amortization |
|
|
29,047 |
|
|
|
27,698 |
|
|
|
24,548 |
|
In-process research and development |
|
|
|
|
|
|
30,500 |
|
|
|
|
|
Impairment of intangible assets |
|
|
|
|
|
|
|
|
|
|
4,067 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income |
|
|
131,320 |
|
|
|
41,154 |
|
|
|
90,608 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and investment income |
|
|
(7,631 |
) |
|
|
(23,396 |
) |
|
|
(38,390 |
) |
Interest expense |
|
|
4,228 |
|
|
|
6,674 |
|
|
|
10,018 |
|
Other (income) expense, net |
|
|
(867 |
) |
|
|
15,470 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income tax expense |
|
|
135,590 |
|
|
|
42,406 |
|
|
|
118,980 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense |
|
|
59,639 |
|
|
|
32,130 |
|
|
|
48,544 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
75,951 |
|
|
$ |
10,276 |
|
|
$ |
70,436 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share |
|
$ |
1.29 |
|
|
$ |
0.18 |
|
|
$ |
1.25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share |
|
$ |
1.21 |
|
|
$ |
0.18 |
|
|
$ |
1.07 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share |
|
$ |
0.16 |
|
|
$ |
0.16 |
|
|
$ |
0.12 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common shares used in calculating: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share |
|
|
57,252 |
|
|
|
56,567 |
|
|
|
55,988 |
|
|
|
|
Diluted net income per share |
|
|
63,172 |
|
|
|
56,567 |
|
|
|
71,179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) amounts exclude amortization
of intangible assets related to
acquired products |
|
$ |
22,378 |
|
|
$ |
21,479 |
|
|
$ |
21,606 |
|
(2) amounts include share-based
compensation expense |
|
$ |
18,122 |
|
|
$ |
16,265 |
|
|
$ |
21,031 |
|
(3) amounts include share-based
compensation expense |
|
$ |
1,053 |
|
|
$ |
332 |
|
|
$ |
112 |
|
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 December 31, 2006 |
|
|
68,044 |
|
|
$ |
952 |
|
|
|
|
|
|
$ |
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains on available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustment for adoption of FIN 48 (a) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gains on available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted shares issued for deferred compensation |
|
|
110 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted shares held in lieu of employee taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
281 |
|
|
|
4 |
|
|
|
|
|
|
|
|
|
Tax effect of stock options exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
69,396 |
|
|
|
969 |
|
|
|
|
|
|
|
|
|
Comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized losses on available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustment for adoption of FSP FAS 115-2 (b) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted shares issued for deferred compensation |
|
|
202 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted shares held in lieu of employee taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercise of stock options |
|
|
1,134 |
|
|
|
16 |
|
|
|
|
|
|
|
|
|
Tax effect of stock options exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
70,732 |
|
|
$ |
985 |
|
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
FIN 48 is now part of ASC 740, Income Taxes. |
|
(b) |
|
FSP FAS 115-2 is now part of ASC 320, Investments Debt and Equity Securities. |
See accompanying notes to consolidated financial statements.
F-6
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
Other |
|
|
|
|
|
|
Treasury |
|
|
|
|
Paid-in |
|
Comprehensive |
|
|
Accumulated |
|
|
Stock |
|
|
|
|
Capital |
|
Income (Loss) |
|
|
Earnings |
|
|
Shares |
|
|
Amount |
|
|
Total |
|
|
$598,435 |
|
$ |
537 |
|
|
$ |
218,392 |
|
|
|
(12,650 |
) |
|
$ |
(342,796 |
) |
|
$ |
475,520 |
|
|
|
|
|
|
|
|
70,436 |
|
|
|
|
|
|
|
|
|
|
|
70,436 |
|
|
|
|
885 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
885 |
|
|
|
|
799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
72,120 |
|
|
|
|
|
|
|
|
(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 |
|
|
|
281,218 |
|
|
|
(12,656 |
) |
|
|
(343,010 |
) |
|
|
583,301 |
|
|
|
|
|
|
|
|
10,276 |
|
|
|
|
|
|
|
|
|
|
|
10,276 |
|
|
|
|
28 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
28 |
|
|
|
|
(143 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(143 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,161 |
|
16,597 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,597 |
|
|
|
|
|
|
|
|
(9,210 |
) |
|
|
|
|
|
|
|
|
|
|
(9,210 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(23 |
) |
|
|
(358 |
) |
|
|
(358 |
) |
4,842 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,846 |
|
(1,643) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,643 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
661,703 |
|
|
2,106 |
|
|
|
282,284 |
|
|
|
(12,679 |
) |
|
|
(343,368 |
) |
|
|
603,694 |
|
|
|
|
|
|
|
|
75,951 |
|
|
|
|
|
|
|
|
|
|
|
75,951 |
|
|
|
|
(2,814 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,814 |
) |
|
|
|
(11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
73,126 |
|
|
|
|
(3,095 |
) |
|
|
3,095 |
|
|
|
|
|
|
|
|
|
|
|
|
|
13,556 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,556 |
|
|
|
|
|
|
|
|
(9,488 |
) |
|
|
|
|
|
|
|
|
|
|
(9,488 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(70 |
) |
|
|
(883 |
) |
|
|
(883 |
) |
16,107 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,123 |
|
(869) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(869 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$690,497 |
|
$ |
(3,814 |
) |
|
$ |
351,842 |
|
|
|
(12,749 |
) |
|
$ |
(344,251 |
) |
|
$ |
695,259 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-7
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED DECEMBER 31, |
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
Operating Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
75,951 |
|
|
$ |
10,276 |
|
|
$ |
70,436 |
|
Adjustments to reconcile net income to
net cash provided by operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
In-process research and development |
|
|
|
|
|
|
30,500 |
|
|
|
|
|
Depreciation and amortization |
|
|
29,046 |
|
|
|
27,698 |
|
|
|
24,548 |
|
Amortization of deferred financing fees |
|
|
|
|
|
|
666 |
|
|
|
1,519 |
|
Impairment of intangible assets |
|
|
|
|
|
|
|
|
|
|
4,067 |
|
Loss on disposal of property and equipment |
|
|
|
|
|
|
20 |
|
|
|
19 |
|
(Gain) loss on sale of product rights |
|
|
(350 |
) |
|
|
398 |
|
|
|
259 |
|
Gain on sale of Medicis Pediatrics |
|
|
(2,915 |
) |
|
|
|
|
|
|
|
|
Impairment of available-for-sale investments |
|
|
|
|
|
|
6,400 |
|
|
|
|
|
Charge reducing value of investment in Revance |
|
|
2,886 |
|
|
|
9,071 |
|
|
|
|
|
Gain on sale of available-for-sale investments, net |
|
|
(1,609 |
) |
|
|
(1,020 |
) |
|
|
(105 |
) |
Share-based compensation expense |
|
|
19,175 |
|
|
|
16,597 |
|
|
|
21,143 |
|
Deferred income tax (benefit) expense |
|
|
(3,408 |
) |
|
|
(42,690 |
) |
|
|
14,027 |
|
Tax (expense) benefit from exercise of stock options and
vesting of restricted stock awards |
|
|
(925 |
) |
|
|
(1,643 |
) |
|
|
2,590 |
|
Excess tax benefits from share-based payment arrangements |
|
|
(241 |
) |
|
|
(169 |
) |
|
|
(1,494 |
) |
Increase (decrease) in provision for sales discounts
and chargebacks |
|
|
1,129 |
|
|
|
888 |
|
|
|
(1,318 |
) |
Accretion (amortization) of premium/(discount) on investments |
|
|
3,273 |
|
|
|
(60 |
) |
|
|
(3,369 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable |
|
|
(43,763 |
) |
|
|
(30,259 |
) |
|
|
50,777 |
|
Inventories |
|
|
(1,759 |
) |
|
|
6,693 |
|
|
|
(2,957 |
) |
Other current assets |
|
|
3,152 |
|
|
|
(1,176 |
) |
|
|
(2,060 |
) |
Accounts payable |
|
|
5,151 |
|
|
|
3,707 |
|
|
|
(12,622 |
) |
Reserve for sales returns |
|
|
(11,549 |
) |
|
|
(9,176 |
) |
|
|
(18,625 |
) |
Income taxes payable |
|
|
16,679 |
|
|
|
(7,731 |
) |
|
|
(4,420 |
) |
Other current liabilities |
|
|
93,981 |
|
|
|
28,417 |
|
|
|
8,000 |
|
Other liabilities |
|
|
(6,019 |
) |
|
|
(1,637 |
) |
|
|
8,529 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
177,885 |
|
|
|
45,770 |
|
|
|
158,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(5,339 |
) |
|
|
(11,071 |
) |
|
|
(10,020 |
) |
Equity investment in an unconsolidated entity |
|
|
(616 |
) |
|
|
|
|
|
|
(11,957 |
) |
LipoSonix acquisition, net of cash acquired |
|
|
|
|
|
|
(149,805 |
) |
|
|
|
|
Payment of direct merger costs |
|
|
|
|
|
|
(3,637 |
) |
|
|
|
|
Payments for purchase of product rights |
|
|
(88,860 |
) |
|
|
(1,024 |
) |
|
|
(30,394 |
) |
Proceeds from sale of product rights |
|
|
350 |
|
|
|
|
|
|
|
1,000 |
|
Proceeds from sale of Medicis Pediatrics |
|
|
70,294 |
|
|
|
|
|
|
|
|
|
Purchase of available-for-sale investments |
|
|
(414,527 |
) |
|
|
(393,862 |
) |
|
|
(741,075 |
) |
Sale of available-for-sale investments |
|
|
131,914 |
|
|
|
417,536 |
|
|
|
291,804 |
|
Maturity of available-for-sale investments |
|
|
244,553 |
|
|
|
361,988 |
|
|
|
231,156 |
|
Decrease (increase) in other assets |
|
|
5 |
|
|
|
(34 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities |
|
|
(62,226 |
) |
|
|
220,091 |
|
|
|
(269,486 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Financing Activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Payment of dividends |
|
|
(9,411 |
) |
|
|
(8,600 |
) |
|
|
(6,771 |
) |
Payment of contingent convertible senior notes |
|
|
|
|
|
|
(283,729 |
) |
|
|
(5 |
) |
Proceeds from the exercise of stock options |
|
|
16,123 |
|
|
|
4,846 |
|
|
|
19,752 |
|
Excess tax benefits from share-based payment arrangements |
|
|
241 |
|
|
|
169 |
|
|
|
1,494 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
6,953 |
|
|
|
(287,314 |
) |
|
|
14,470 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate on cash and cash equivalents |
|
|
(11 |
) |
|
|
(143 |
) |
|
|
799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
122,601 |
|
|
|
(21,596 |
) |
|
|
(95,273 |
) |
Cash and cash equivalents at beginning of period |
|
|
86,450 |
|
|
|
108,046 |
|
|
|
203,319 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
209,051 |
|
|
$ |
86,450 |
|
|
$ |
108,046 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-8
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. THE COMPANY AND BASIS OF PRESENTATION
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 and aesthetic conditions. Medicis also
markets products in Canada for the treatment of dermatological and aesthetic conditions and began
commercial efforts in Europe with the Companys acquisition of LipoSonix, Inc. (LipoSonix) in
July 2008.
The Company offers a broad range of products addressing various conditions or aesthetic
improvements including facial wrinkles, glabellar lines, acne, fungal infections, rosacea,
hyperpigmentation, photoaging, psoriasis, seborrheic dermatitis and cosmesis (improvement in the
texture and appearance of skin). Medicis currently offers 17 branded products. Its primary brands
are DYSPORT, PERLANE®, RESTYLANE®, SOLODYN®, TRIAZ®,
VANOS® and ZIANA®. Medicis entered the non-invasive body contouring market
with its acquisition of LipoSonix in July 2008.
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.
In June 2009, the Financial Accounting Standards Board (FASB) issued SFAS No. 168, The FASB
Accounting Standards Codification and the Hierarchy of Generally Accepted Accounting Principlesa
replacement of FASB Statement No. 162. SFAS No. 168 establishes the FASB Standards Accounting
Codification (Codification) as the source of authoritative U.S. generally accepted accounting
principles (GAAP) recognized by the FASB to be applied to nongovernmental entities, and rules and
interpretive releases of the SEC as authoritative GAAP for SEC registrants. The Codification
supersedes all of the existing non-SEC accounting and reporting standards, but is not intended to
change or alter existing U.S. GAAP. The Codification changes the references of financial standards
within the Companys financial statements. All references made to U.S. GAAP use the new Accounting
Standards Codification (ASC) and the new Codification numbering system prescribed by the FASB.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Cash and Cash Equivalents
At December 31, 2009, cash and cash equivalents included highly liquid investments 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.
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 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.
F-9
Inventories
The Company primarily 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
third-party 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, 2009 and 2008, there was $0.3 million and $1.1 million of costs
capitalized into inventory for products that have not yet received regulatory approval.
Inventories are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
|
Raw materials |
|
$ |
7,472 |
|
|
$ |
4,462 |
|
Work-in-process |
|
|
3,660 |
|
|
|
2,508 |
|
Finished goods |
|
|
21,087 |
|
|
|
18,671 |
|
Valuation reserve |
|
|
(6,234 |
) |
|
|
(1,415 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total inventories |
|
$ |
25,985 |
|
|
$ |
24,226 |
|
|
|
|
|
|
|
|
The increase in the valuation reserve during 2009, which primarily occurred during the fourth
quarter of 2009, was due to an increase in the amount of inventory that was projected to not be
sold by expiry dates, as of December 31, 2009 as compared to December 31, 2008.
Selling, general and administrative costs capitalized into inventory during 2009, 2008 and
2007 was $1.4 million, $0.5 million and $0, respectively. Selling, general and administrative
expenses included in inventory as of December 31, 2009 and 2008 was $1.2 million and $0.4 million,
respectively.
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, |
|
|
|
2009 |
|
|
2008 |
|
|
Furniture, fixtures and equipment |
|
$ |
31,765 |
|
|
$ |
26,661 |
|
Leasehold improvements |
|
|
14,655 |
|
|
|
14,489 |
|
|
|
|
|
|
|
|
|
|
|
46,420 |
|
|
|
41,150 |
|
Less: accumulated depreciation |
|
|
(21,173 |
) |
|
|
(14,850 |
) |
|
|
|
|
|
|
|
|
|
$ |
25,247 |
|
|
$ |
26,300 |
|
|
|
|
|
|
|
|
F-10
Total depreciation expense for property and equipment was approximately $6.4 million, $6.0
million and $2.7 million for 2009, 2008 and 2007, respectively.
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 impairment assessment at least annually, and more frequently under certain
circumstances. The goodwill is subject to this annual impairment test 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 operations.
For the years ended December 31, 2009, 2008 and 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.
The following is a summary of changes in the Companys recorded goodwill during 2008 and 2009
(amounts in thousands):
|
|
|
|
|
Balance at December 31, 2007 |
|
$ |
63,107 |
|
|
|
|
|
|
Acquisition of Liposonix (see Note 8) |
|
|
93,655 |
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
156,762 |
|
|
|
|
|
|
Sale of Medicis Pediatrics (see Note 6) |
|
|
(63,107 |
) |
|
|
|
|
|
Adjustment of LipoSonix tax
attributes acquired |
|
|
(373 |
) |
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
$ |
93,282 |
|
|
|
|
|
Prior to December 31, 2007, there were no impairments or other adjustments made to the
Companys recorded goodwill.
Intangible Assets
The Company has acquired license agreements, product rights, and other identifiable intangible
assets. The Company amortizes intangible assets on a straight-line basis over their expected
useful lives, which range between five and 25 years. Details of total intangible assets were as
follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
December 31, 2009 |
|
|
December 31, 2008 |
|
|
|
Average |
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
Life |
|
|
Gross |
|
|
Amortization |
|
|
Net |
|
|
Gross |
|
|
Amortization |
|
|
Net |
|
|
Related to product line acquisitions |
|
|
15.6 |
|
|
$ |
320,796 |
|
|
$ |
(107,278 |
) |
|
$ |
213,518 |
|
|
$ |
253,142 |
|
|
$ |
(107,377 |
) |
|
$ |
145,765 |
|
Related to business combinations |
|
|
10.0 |
|
|
|
9,400 |
|
|
|
(1,005 |
) |
|
|
8,395 |
|
|
|
14,482 |
|
|
|
(5,176 |
) |
|
|
9,306 |
|
Patents and trademarks |
|
|
19.3 |
|
|
|
7,598 |
|
|
|
(1,671 |
) |
|
|
5,927 |
|
|
|
7,752 |
|
|
|
(1,394 |
) |
|
|
6,358 |
|
|
|
|
|
|
|
|
|
|
Total intangible assets |
|
|
|
|
|
$ |
337,794 |
|
|
$ |
(109,954 |
) |
|
$ |
227,840 |
|
|
$ |
275,376 |
|
|
$ |
(113,947 |
) |
|
$ |
161,429 |
|
|
|
|
|
|
|
|
|
|
Total amortization expense was approximately $22.7 million, $21.7 million and $21.8
million for 2009, 2008 and 2007, respectively. Based on the intangible assets recorded at December
31, 2009, and assuming no subsequent impairment of the underlying assets, annual amortization
expense for the next five years is expected to be as follows: $21.7 million for the years ended
December 31, 2010, 2011, 2012 and 2013, and $20.4 million for the year ended December 31, 2014.
F-11
Impairment of Long-Lived Assets
The Company assesses the potential 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
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.
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.
During the year ended December 31, 2007, an intangible asset related to OMNICEF®
was determined to be impaired based on the Companys analysis of its 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.
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, and accordingly was fully
amortized by June 30, 2009.
Managed Care and Medicaid Reserves
Rebates are contractual discounts offered to government agencies 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 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 Rebate 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 Company
estimates its accruals for consumer rebates based on estimated redemption rates and average rebate
amounts based on historical and other relevant data. The Company estimates its accruals for loyalty
programs, which are related to the Companys aesthetic products, 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, |
|
|
|
2009 |
|
|
2008 |
|
Accrued incentives |
|
$ |
26,671 |
|
|
$ |
18,910 |
|
Deferred revenue |
|
|
18,508 |
|
|
|
3,341 |
|
Other accrued expenses |
|
|
23,202 |
|
|
|
19,602 |
|
|
|
|
|
|
|
|
|
|
$ |
68,381 |
|
|
$ |
41,853 |
|
|
|
|
|
|
|
|
F-12
Included in deferred revenue as of December 31, 2009 and 2008 was $1.2 million and $0.7
million, respectively, associated with the deferral of revenue and related cost of revenue for
certain sales of inventory into the distribution channel that are in excess of eight (8) weeks of
projected demand.
Revenue Recognition
Revenue from product sales is recognized pursuant to Staff Accounting Bulletin No. 104 (SAB
104), Revenue Recognition in Financial Statements, which is now part of ASC 605, Revenue
Recognition. 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 estimated product returns, sales discounts and
chargebacks are established as a reduction of product sales revenues at the time such revenues are
recognized. Provisions for managed care and Medicaid rebates and consumer rebate and loyalty
programs are established as a reduction of product sales revenues at the later of the date at which
revenue is recognized or the date at which the sales incentive is offered. These deductions from
gross revenue are established by the Companys management as its best estimate 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 inventory information reported to the Company by its major wholesale customers
for which the Company has inventory management agreements, 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
continually monitors internal and external data, in order to ensure that information obtained from
external sources is reasonable. The Company also utilizes projected prescription demand for its
products, as well as, the Companys internal information regarding its products. These deductions
from gross revenue are generally reflected either as a direct reduction to accounts receivable
through an allowance, as a reserve within current liabilities, or as an addition to accrued
expenses.
The Company enters into licensing arrangements with other parties whereby the Company receives
contract revenue based on the terms of the agreement. The timing of revenue recognition is
dependent on the level of the Companys continuing involvement in the manufacture and delivery of
licensed products. If the Company has continuing involvement, the revenue is deferred and
recognized on a straight-line basis over the period of continuing involvement. In addition, if the
licensing arrangements require no continuing involvement and payments are merely based on the
passage of time, the Company assesses such payments for revenue recognition under the
collectibility criteria of SAB 104. Direct costs related to contract acquisition and origination
of licensing agreements are expensed as incurred.
The Company does not provide any material forms of price protection to its wholesale customers
and permits product returns if the product is damaged, or, depending on the customer and product,
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 result of certain modifications made to the Companys distribution
services agreement with McKesson, the Companys exclusive U.S. distributor of its aesthetics
products DYSPORTTM, PERLANE® and RESTYLANE®, the Company began
recognizing revenue on these products upon the shipment from McKesson to physicians beginning in
the second quarter of 2009. As a general practice, the Company does not ship prescription product
that has less than 12 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 costs as incurred. Advertising expenses for 2009, 2008 and
2007 were $51.9 million, $47.0 million and $47.9 million, respectively. Advertising expenses
include samples of the Companys products given to physicians for marketing to their patients.
F-13
Share-Based Compensation
At December 31, 2009, the Company had seven active share-based employee compensation plans.
Of these seven share-based compensation plans, only the 2006 Incentive Award Plan is eligible for
the granting of future awards. Stock option awards granted from these plans are granted at the
fair market value on the date of grant. The 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.
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, 2009, total unrecognized compensation cost
related to stock option awards, to be recognized as expense subsequent to December 31, 2009, was
approximately $1.6 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 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
of Shares |
|
|
Price |
|
|
Term |
|
|
Value |
|
| | | | |
Balance at December 31, 2008 |
|
|
10,707,357 |
|
|
$ |
27.98 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
182,017 |
|
|
$ |
13.94 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(1,134,415 |
) |
|
$ |
14.21 |
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
(501,112 |
) |
|
$ |
30.70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
9,253,847 |
|
|
$ |
29.24 |
|
|
|
3.0 |
|
|
$ |
11,860,331 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The intrinsic value of options exercised during 2009 was $5,405,151. Options exercisable
under the Companys share-based compensation plans at December 31, 2009, were 8,917,859 with a
weighted average exercise price of $29.52, a weighted average remaining contractual term of 2.9
years, and an aggregate intrinsic value of $9,369,695.
A summary of outstanding stock options that are fully vested and are expected to vest, based
on historical forfeiture rates, and those stock options that are exercisable, as of December 31,
2009, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
of Shares |
|
|
Price |
|
|
Term |
|
|
Value |
|
|
Outstanding, net of expected forfeitures |
|
|
8,480,159 |
|
|
$ |
29.34 |
|
|
|
3.1 |
|
|
$ |
10,739,330 |
|
Exercisable |
|
|
8,179,147 |
|
|
$ |
29.62 |
|
|
|
2.9 |
|
|
$ |
8,485,569 |
|
F-14
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 |
|
|
DECEMBER 31, 2009 |
|
DECEMBER 31, 2008 |
|
DECEMBER 31, 2007 |
|
Expected dividend yield
|
|
0.3% to 1.0%
|
|
0.6% to 0.7%
|
|
|
0.4 |
% |
Expected stock price volatility
|
|
0.45 to 0.46
|
|
0.35 to 0.38
|
|
|
0.35 |
|
Risk-free interest rate
|
|
2.2% to 2.8%
|
|
3.0% to 3.4%
|
|
4.5% to 4.8%
|
Expected life of options
|
|
7.0 Years
|
|
7.0 Years
|
|
7.0 Years
|
The expected dividend yield is based on expected annual dividends 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 2009, 2008 and 2007 was $6.44,
$8.90 and $14.98, respectively.
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 2009, 975,173 shares of restricted stock were granted to certain
employees. Share-based compensation expense related to all restricted stock awards outstanding
during 2009, 2008 and 2007 was approximately $8.7 million, $5.9 million and $3.7 million,
respectively. As of December 31, 2009, the total amount of unrecognized compensation cost related
to nonvested restricted stock awards, to be recognized as expense subsequent to December 31, 2009,
was approximately $24.1 million, and the related weighted-average period over which it is expected
to be recognized is approximately 3.0 years.
A summary of restricted stock activity within the Companys share-based compensation plans and
changes for 2009 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant-Date |
|
Nonvested Shares |
|
Shares |
|
|
Fair Value |
|
|
Nonvested at December 31, 2008 |
|
|
1,204,851 |
|
|
$ |
23.38 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
975,173 |
|
|
$ |
11.28 |
|
Vested |
|
|
(201,600 |
) |
|
$ |
25.35 |
|
Forfeited |
|
|
(62,955 |
) |
|
$ |
20.08 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2009 |
|
|
1,915,469 |
|
|
$ |
17.12 |
|
|
|
|
|
|
|
|
|
The total fair value of restricted shares vested during 2009, 2008 and 2007 was approximately
$5.1 million, $3.9 million and $1.3 million, respectively.
Stock Appreciation Rights
During 2009, the Company granted, in aggregate, 2,039,558 cash-settled stock appreciation
rights (SARs) to over 200 of its employees. SARs generally vest over a graduated five-year
period and expire seven years from the date of grant, unless such expiration occurs sooner due to
the employees termination of employment, as provided in the
F-15
applicable SAR award agreement. SARs allow the holder to receive cash (less applicable tax
withholding) upon the holders exercise, equal to the excess, if any, of the market price of the
Companys Class A common stock on the exercise date over the exercise price, multiplied by the
number of shares relating to the SAR with respect to which the SAR is exercised. The exercise
price of the SAR is the fair market value of a share of the Companys Class A common stock relating
to the SAR on the date of grant. The total value of the SARs is expensed over the service period
of the employees receiving the grants, and a liability is recognized in the Companys consolidated
balance sheets until settled. The fair value of SARs is required to be remeasured at the end of
each reporting period until the award is settled, and changes in fair value must be recognized as
compensation expense to the extent of vesting each reporting period based on the new fair value.
Share-based compensation expense related to SARs during 2009 was approximately $5.6 million. As of
December 31, 2009, the total measured amount of unrecognized compensation cost related to
outstanding SARs, based on the valuation performed on December 31, 2009, to be recognized as
expense subsequent to December 31, 2009, was approximately $27.9 million, and the related weighted
average remaining vesting period for the awards is approximately 4.2 years.
The fair value of each SAR was estimated on the date of the grant, and was remeasured at
year-end, using the Black-Scholes option pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
SARS Granted During |
|
|
Remeasurement |
|
|
|
the Year Ended |
|
|
as of |
|
|
|
December 31, 2009 |
|
|
December 31, 2009 |
|
|
Expected dividend yield |
|
0.3% to 1.0% |
|
|
0.6% |
|
Expected stock price volatility |
|
|
0.38 to 0.46 |
|
|
|
0.34 |
|
Risk-free interest rate |
|
2.2% to 3.0% |
|
|
3.4 |
|
Expected life of SARs |
|
7.0 years |
|
|
6.2 to 6.8 years |
|
The weighted average fair value of SARs granted during 2009, as of the respective grant
dates, was $5.36. The weighted average fair value of all SARs outstanding as of the remeasurement
date of December 31, 2009, was $17.50
A summary of SARs activity for the year ended December 31, 2009, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
Remaining |
|
|
Aggregate |
|
|
|
Number |
|
|
Exercise |
|
|
Contractual |
|
|
Intrinsic |
|
|
|
of SARs |
|
|
Price |
|
|
Term |
|
|
Value |
|
| | | | |
Balance at December 31, 2008 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
2,039,558 |
|
|
$ |
11.39 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
Terminated/expired |
|
|
(123,402 |
) |
|
$ |
11.28 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
1,916,156 |
|
|
$ |
11.40 |
|
|
|
6.2 |
|
|
$ |
29,991,583 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
No SARs were exercisable as of December 31, 2009.
See Note 15 for further discussion of the Companys share-based employee compensation plans.
Shipping and Handling Costs
Substantially all costs of shipping and handling of products to customers are included in
selling, general and administrative expense. Shipping and handling costs for 2009, 2008 and 2007
were approximately $2.5 million, $2.8 million and $2.8 million, respectively.
F-16
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 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 Company recognizes tax benefits only if the tax position is more likely than
not of being sustained. 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 will have a material
adverse effect on its results of operations or financial condition. See Note 12 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. All balance sheet
accounts have been translated using the exchange rates in effect at the balance sheet date. Income
statement amounts have been translated using the average exchange rate for the year. The gains and
losses resulting from the changes in exchange rates from year to year have been reported in other
comprehensive income. Total accumulated gains from foreign currency translation, included in
accumulated other comprehensive (loss) income at December 31, 2009, and December 31, 2008, was
approximately $1.3 million and $1.3 million, respectively. The effect on the consolidated
statements of income 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 ASC 260, Earnings Per Share. Because the Company has Contingently Convertible Debt (see Note
11), diluted net income per common share must be calculated using the if-converted method.
Diluted net income per common
F-17
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.
In June 2008, the FASB issued new guidance on determining whether instruments granted in
share-based payment transactions are participating securities. In the new guidance, which is now
part of ASC 260, unvested share-based payment awards that contain rights to receive nonforfeitable
dividends or dividend equivalents (whether paid or unpaid) are participating securities, and thus,
should be included in the two-class method of computing earnings per share. The two-class method
is an earnings allocation formula that treats a participating security as having rights to earnings
that would otherwise have been available to common stockholders. Restricted stock granted to
certain employees by the Company participate in dividends on the same basis as common shares, and
these dividends are not forfeitable by the holders of the restricted stock. As a result, the
restricted stock grants meet the definition of a participating security. The Company
adopted the new guidance on January 1, 2009.
A detailed presentation of earnings per share is included in Note 16.
Use of Estimates and Risks and Uncertainties
The preparation of the consolidated financial statements in conformity with U.S. GAAP 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 valuation of auction rate floating securities; 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 and rebate
reserves. 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 and a discounted cash
flow analysis for auction rate floating securities. The fair value of the Companys contingent
convertible senior notes, based on market quotations, is approximately $171.7 million at December
31, 2009.
Supplemental Disclosure of Cash Flow Information
During 2009, 2008 and 2007, the Company made interest payments of $4.2 million, $6.4 million
and $8.5 million, respectively.
Accumulated Other Comprehensive (Loss) Income
Accumulated other comprehensive loss of $3.8 million as of December 31, 2009 included $5.1
million of accumulated unrealized losses related the Companys short-term and long-term
available-for-sale securities investments, partially offset by $1.3 million of accumulated foreign
currency translation adjustments.
Recent Accounting Pronouncements
In April 2009, the FASB issued new guidance that provides additional guidance for estimating
fair value when the volume and level of activity for the asset or liability have significantly
decreased. This new guidance, which is now part of ASC 820, Fair Value Measurements and
Disclosures, also includes guidance on identifying circumstances that indicate a transaction is not
orderly and applies to all assets and liabilities within the scope of accounting pronouncements
that require or permit fair value measurements. The new guidance is effective for interim and
annual reporting periods ending after June 15, 2009. The Company adopted the new guidance on April
1, 2009, and it did not have a material impact on its consolidated results of operations and
financial condition.
F-18
In April 2009, the FASB issued new guidance related to the disclosure of the fair value of a
reporting entitys financial instruments whenever it issues summarized financial information for
interim reporting periods. The new guidance, which is now part of ASC 825, Financial Instruments,
is effective for financial statements issued for interim reporting periods ending after June 15,
2009. The Company adopted the new guidance on April 1, 2009, and it did not have a material impact
on its results of operations and financial condition.
In May 2009, the FASB issued new guidance for accounting for subsequent events. The new
guidance, which is now part of ASC 855, Subsequent Events, is effective for financial statements
ending after June 15, 2009, and the Company adopted the new guidance during the three months ended
June 30, 2009. The new guidance establishes general standards of accounting for and disclosure of
subsequent events that occur after the balance sheet date. The Company has evaluated subsequent
events through the date of issuance of its financial statements.
In June 2009, the FASB issued revised guidance on the accounting for variable interest
entities. The revised guidance, which was issued as SFAS No. 167, New Consolidation Guidance for
Variable Interest Entities (VIE), which amends FIN 46 (R), Consolidation of Variable Interest
Entities, has not yet been adopted into the Codification. The revised guidance addresses the
elimination of the concept of a qualifying special purpose entity and replaces the
quantitative-based risks and rewards calculation for determining which enterprise has a controlling
financial interest in a variable interest entity with an approach focused on identifying which
enterprise has the power to direct the activities of the variable interest entity, and the
obligation to absorb losses of the entity or the right to receive benefits from the entity.
Additionally, the revised guidance requires any enterprise that holds a variable interest in a
variable interest entity to provide enhanced disclosures that will provide users of financial
statements with more transparent information about an enterprises involvement in a variable
interest entity. The revised guidance is effective for annual reporting periods beginning after
November 30, 2009. The Company is currently assessing what impact, if any, the revised guidance
will have on its results of operations and financial condition.
In October 2009, the FASB approved for issuance Accounting Standard Update (ASU) No.
2009-13, Revenue Recognition (ASC 605) Multiple Deliverable Revenue Arrangements, a consensus
of EITF 08-01, Revenue Arrangements with Multiple Deliverables. This guidance modifies the fair
value requirements of ASC subtopic 605-25 Revenue Recognition Multiple Element Arrangements by
providing principles for allocation of consideration among its multiple-elements, allowing more
flexibility in identifying and accounting for separate deliverables under an arrangement. An
estimated selling price method is introduced for valuing the elements of a bundled arrangement if
vendor-specific objective evidence or third-party evidence of selling price is not available, and
significantly expands related disclosure requirements. This updated guidance is effective on a
prospective basis for revenue arrangements entered into or materially modified in fiscal years
beginning on or after June 15, 2010. Alternatively, adoption may be on a retrospective basis, and
early application is permitted. The Company is currently assessing what impact, if any, the
updated guidance will have on its results of operations and financial condition.
3. SEGMENT AND PRODUCT INFORMATION
The Company operates in one 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, non-invasive body sculpting
technology 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 DYSPORTTM,
LOPROX®, PERLANE®, RESTYLANE® and VANOS®. The
non-dermatological product lines include AMMONUL®, BUPHENYL® and the
LIPOSONIXTM system. The non-dermatological field also includes contract revenues
associated with licensing agreements and authorized generics.
F-19
The Companys pharmaceutical products, with the exception of AMMONUL® and
BUPHENYL®, are promoted to dermatologists 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, the Companys products are sold primarily to wholesalers and retail chain drug
stores. During 2009, 2008 and 2007, two wholesalers accounted for the following portions of the
Companys net revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
McKesson |
|
|
40.8 |
% |
|
|
45.8 |
% |
|
|
52.2 |
% |
Cardinal |
|
|
37.1 |
% |
|
|
21.2 |
% |
|
|
16.9 |
% |
McKesson is the sole distributor for the Companys RESTYLANE® and
PERLANE® products and DYSPORTTM in the U.S.
Net revenues and the percentage of net revenues for each of the product categories are as
follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
Acne and acne-related
dermatological products |
|
$ |
398,861 |
|
|
$ |
325,020 |
|
|
$ |
243,414 |
|
Non-acne dermatological products |
|
|
133,595 |
|
|
|
147,954 |
|
|
|
172,902 |
|
Non-dermatological products |
|
|
39,459 |
|
|
|
44,776 |
|
|
|
41,078 |
|
|
|
|
Total net revenues |
|
$ |
571,915 |
|
|
$ |
517,750 |
|
|
$ |
457,394 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
Acne and acne-related
dermatological products |
|
|
70 |
% |
|
|
63 |
% |
|
|
53 |
% |
Non-acne dermatological products |
|
|
23 |
|
|
|
29 |
|
|
|
38 |
|
Non-dermatological products |
|
|
7 |
|
|
|
8 |
|
|
|
9 |
|
|
|
|
Total net revenues |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
During 2009, 2008 and 2007, the Companys top three products constituted 71.4%, 69.4% and
70.8%, respectively, of its total net revenues. Less than 5% of the Companys net revenues are
generated outside the U.S.
4. STRATEGIC COLLABORATIONS
Glenmark
On November 14, 2009, the Company entered into an Asset Purchase and Development Agreement
with Glenmark Generics Ltd. and Glenmark Generics Inc., USA (collectively, Glenmark) (the
Glenmark Asset Purchase Agreement) and two License and Settlement Agreements with Glenmark (one,
the Vanos License and Settlement Agreement, the other, the Loprox License and Settlement
Agreement and, collectively, the License and Settlement Agreements)
In connection with the Glenmark Asset Purchase and Development Agreement, the Company
purchased from Glenmark the North American rights of a dermatology product currently under development,
including the underlying technology and regulatory filings. In accordance with terms of the
agreement, the Company made a $5.0 million
F-20
payment to Glenmark upon closing of the transaction, and will make additional payments to
Glenmark of up to $7.0 million upon the achievement of certain development and regulatory
milestones. The Company will make royalty payments to Glenmark on sales of the product. The
initial $5.0 million payment was recognized as a charge to research and development expense during
the three months ended December 31, 2009.
In connection with the Glenmark License and Settlement Agreements, the Company and Glenmark
agreed to terminate all legal disputes between them relating to the Companys VANOS®
(fluocinonide) Cream 0.1% and LOPROX® Gel. In addition, Glenmark confirmed that certain
of the Companys patents relating to VANOS® and LOPROX® are valid and
enforceable, and cover Glenmarks activities relating to its generic versions of VANOS®
and LOPROX® Gel under ANDAs. Further, subject to the terms and conditions contained in
the Vanos License and Settlement Agreement, the Company granted Glenmark, effective December 15,
2013, or earlier upon the occurrence of certain events, a license to make and sell generic versions
of the existing VANOS® products. Upon commercialization by Glenmark of generic versions
of VANOS® products, Glenmark will pay the Company a royalty based on sales of such
generic products. Subject to the terms and conditions contained in the Loprox License and
Settlement Agreement, the Company also granted Glenmark a license to make and sell generic versions
of LOPROX® Gel. Upon commercialization by Glenmark of generic versions of
LOPROX® Gel, Glenmark will pay the Company a royalty based on sales of such generic
products. In accordance with the terms of the License and Settlement Agreements, the Company paid
Glenmark $0.3 million for attorneys fees incurred by Glenmark related to the legal disputes. The
$0.3 million payment was recognized as selling, general and administrative expense during the three
months ended December 31, 2009.
Revance
On July 28, 2009, the Company and Revance Therapeutics, Inc. (Revance) entered into a
license agreement granting Medicis worldwide aesthetic and dermatological rights to Revances
novel, investigational, injectable botulinum toxin type A product, referred to as RT002,
currently in pre-clinical studies. The objective of the RT002 program is the development of a
next-generation neurotoxin with favorable duration of effect and safety profiles.
Under the terms of the agreement, Medicis paid Revance $10.0 million upon execution of the
agreement, and will pay additional potential milestone payments totaling approximately $94 million
upon successful completion of certain clinical, regulatory and commercial milestones, and a royalty
based on sales and supply price, the total of which is equivalent to a double-digit percentage of
net sales. The initial $10.0 million payment was recognized as research and development expense
during the year ended December 31, 2009.
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 Ucyclyd for the rights and licenses granted to Hyperion
in the agreement. This $10.0 million payment was recorded as deferred revenue and is being
recognized on a ratable 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. Hyperion will be funding all
research and development costs for the Ucyclyd research projects.
Until June 6, 2008, Hyperion undertook certain sales and marketing efforts for Ucyclyds
existing on-market products. Hyperion received a commission from Ucyclyd equal to a certain
percentage of any increase in unit sales during the period Hyperion was performing these sales and
marketing efforts. Ucyclyd will continue to record product sales for the existing on-market
Ucyclyd products until such time as Hyperion exercises its purchase rights.
Ucyclyd entered into an amendment (the Amendment), effective as of November 24, 2008, to the
Collaboration Agreement with Hyperion. Among other actions, the Amendment terminates all rights,
including research and development rights, granted to Hyperion under the Collaboration Agreement
related to Ammonul for the
F-21
treatment of hepatic encephalopathy (Ammonul HE). Hyperion retains buyout rights to Ammonul
HE in the event Hyperion exercises its buyout rights to Ucyclyds on-market and other development
products. Hyperion and Ucyclyd also agreed that Hyperions rights to promote AMMONUL®
and BUPHENYL® for the treatment of urea cycle disorder were terminated, effective June
6, 2008.
On June 29, 2009, Ucyclyd and Hyperion entered into a second amendment (the Second
Amendment) to their existing Collaboration Agreement. In connection with Hyperion obtaining
additional venture financing, Ucyclyd agreed in the Second Amendment to restructure the royalty and
milestone payments in exchange for Hyperion having agreed to issue five percent of its
fully-diluted common stock to Ucyclyd. In addition, pursuant to the Second Amendment, Ucyclyd
agreed to provide seller financing in the event that Hyperion exercises its buyout rights with
respect to GT4P.
The common stock of Hyperion that was received by Ucyclyd in consideration for the
restructuring of the royalty and milestone payments was valued at $2.4 million, which was derived
utilizing the per share price of preferred shares issued by Hyperion at the same time as the common
shares that were issued to Ucyclyd. The $2.4 million value of the Hyperion common shares is
included in other assets in the Companys consolidated balance sheets at December 31, 2009, along
with corresponding deferred revenue, which is being recognized as contract revenue ratably over a
30-month period ending December 31, 2011, which corresponds to the period over which the Company is
recording contract revenue on the original license for GT4P.
On October 12, 2009, Ucyclyd and Hyperion entered into a third amendment to the existing
Collaboration Agreement (Third Amendment). Under the terms of the Third Amendment, Ucyclyd
agreed to disclose to Hyperion certain know-how for the manufacture of GT4P.
The Company recognized approximately $2.8 million, $2.5 million and $0.8 million of contract
revenue during 2009, 2008 and 2007, respectively, related to this transaction, as amended.
Professional fees of approximately $2.2 million were incurred related to the completion of the
original August 2007 agreement with Hyperion. These costs were recognized as general and
administrative expenses during 2007.
Perrigo
On April 8, 2009, the Company entered into a License and Settlement Agreement (the Perrigo
License and Settlement Agreement) and a Joint Development Agreement (the Perrigo Joint
Development Agreement) with Perrigo Israel Pharmaceuticals Ltd. Perrigo Company was also a party
to the License and Settlement Agreement. Perrigo Israel Pharmaceuticals Ltd. and Perrigo Company
are collectively referred to as Perrigo.
In connection with the Perrigo License and Settlement Agreement, the Company and Perrigo
agreed to terminate all legal disputes between them relating to the Companys VANOS®
(fluocinonide) Cream 0.1%. On April 17, 2009, the Court entered a consent judgment dismissing all
claims and counterclaims between Medicis and Perrigo, and enjoining Perrigo from marketing a
generic version of VANOS® other than under the terms of the Perrigo License and
Settlement Agreement. In addition, Perrigo confirmed that certain of the Companys patents
relating to VANOS® are valid and enforceable, and cover Perrigos activities relating to
its generic product under ANDA #090256. Further, subject to the terms and conditions contained in
the Perrigo License and Settlement Agreement:
|
|
|
the Company granted Perrigo, effective December 15, 2013, or earlier upon the occurrence
of certain events, a license to make and sell generic versions of the existing
VANOS® products; and |
|
|
|
|
when Perrigo does commercialize generic versions of VANOS® products, Perrigo
will pay the Company a royalty based on sales of such generic products. |
|
|
|
|
Pursuant to the Perrigo Joint Development Agreement, subject to the terms and conditions
contained therein: |
|
|
|
|
the Company and Perrigo will collaborate to develop a novel proprietary product; |
F-22
|
|
|
the Company has the sole right to commercialize the novel proprietary product; |
|
|
|
|
if and when an NDA for a novel proprietary product is submitted to the U.S. Food and
Drug Administration (FDA), the Company and Perrigo shall enter into a commercial supply
agreement pursuant to which, among other terms, for a period of three years following
approval of the NDA, Perrigo would exclusively supply to the Company all of the Companys
novel proprietary product requirements in the U.S.; |
|
|
|
|
the Company made an up-front $3.0 million payment to Perrigo and will make additional
payments to Perrigo of up to $5.0 million upon the achievement of certain development,
regulatory and commercialization milestones; and |
|
|
|
|
the Company will pay to Perrigo royalty payments on sales of the novel proprietary
product. |
During the year ended December 31, 2009, a development milestone was achieved, and the Company
made a $2.0 million payment to Perrigo pursuant to the Perrigo Joint Development Agreement. The
$3.0 million up-front payment and the $2.0 million development milestone payment were recognized as
research and development expense during the year ended December 31, 2009.
IMPAX
On November 26, 2008, the Company entered into a License and Settlement Agreement and a Joint
Development Agreement with IMPAX Laboratories, Inc. (IMPAX). In connection with the License and
Settlement Agreement, the Company and IMPAX agreed to terminate all legal disputes between them
relating to SOLODYN®. Additionally, under terms of the License and Settlement
Agreement, IMPAX confirmed that the Companys patents relating to SOLODYN® are valid and
enforceable, and cover IMPAXs activities relating to its generic product under ANDA #09-024.
Under the terms of the License and Settlement Agreement, IMPAX has a license to market its
generic versions of SOLODYN® 45mg, 90mg and 135mg under the SOLODYN® patent
rights belonging to the Company upon the occurrence of specific events. Upon launch of its generic
formulations of SOLODYN®, IMPAX may be required to pay the Company a royalty, based on
sales of those generic formulations by IMPAX under terms described in the License and Settlement
Agreement.
Under the Joint Development Agreement, the Company and IMPAX will collaborate on the
development of five strategic dermatology product opportunities, including an advanced-form
SOLODYN® product. Under terms of the agreement, the Company made an initial payment of
$40.0 million upon execution of the agreement. During the year ended December 31, 2009, the
Company paid IMPAX $12.0 million upon the achievement of clinical milestones, in accordance with
terms of the agreement. In addition, the Company will be required to pay up to $11.0 million upon
successful completion of certain other clinical and commercial milestones. The Company will also
make royalty payments based on sales of the advanced-form SOLODYN® product if and when
it is commercialized by Medicis upon approval by the FDA. The Company will share equally in the
gross profit of the other four development products if and when they are commercialized by IMPAX
upon approval by the FDA.
The $40.0 million initial payment was recognized as a charge to research and development
expense during 2008, and the $12.0 million of clinical milestone payments were recognized as a
charge to research and development expense during the year ended December 31, 2009.
5. |
|
DEVELOPMENT AND DISTRIBUTION AGREEMENT WITH IPSEN FOR RIGHTS TO IPSENS BOTULINUM TOXIN TYPE
A PRODUCT KNOWN AS DYSPORTTM |
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., rights to develop, distribute and commercialize Ipsens botulinum toxin type A product in the
United States, Canada and Japan for aesthetic use by healthcare professionals. During the
development of the product, the proposed name of the product for aesthetic use in the U.S. was
RELOXIN®.
In May 2008, the FDA accepted the filing of Ipsens Biologics License Application (BLA) for
RELOXIN® and, in accordance with the agreement, Medicis paid Ipsen $25.0 million upon
achievement of this
F-23
milestone. The $25.0 million was recognized as a charge to research and
development expense during the year ended December 31, 2008.
On April 29, 2009, the FDA approved the BLA for Ipsens botulinum toxin type A product,
DYSPORTTM. The approval includes two separate indications, the treatment of cervical
dystonia in adults to reduce the severity of abnormal head position and neck pain, and the
temporary improvement in the appearance of moderate to severe glabellar lines in adults younger
than 65 years of age. RELOXIN®, which was the proposed U.S. name for Ipsens botulinum
toxin product for aesthetic use, is now marketed under the name of DYSPORTTM. Ipsen
will market DYSPORTTM in the U.S. for the therapeutic indication (cervical dystonia),
while Medicis markets DYSPORTTM in the U.S. for the aesthetic indication (glabellar
lines).
In accordance with the agreement, the Company paid Ipsen $75.0 million as a result of the
approval by the FDA. The $75.0 million payment was capitalized into intangible assets in the
Companys consolidated balance sheet, and is being amortized on a straight-line basis over a period
of 15 years. Ipsen will manufacture and provide the product to Medicis for the term of the
agreement, which extends to December 2036. Medicis will pay Ipsen a royalty based on sales and a
supply price, as defined under the agreement.
The product is not currently approved for aesthetic use in Canada or Japan. Under the terms
of the agreement, Medicis is responsible for all remaining research and development costs
associated with obtaining the products approval in Canada and Japan. Medicis will pay an
additional $2.0 million to Ipsen upon regulatory approval of the product in Japan.
6. |
|
SALE OF MEDICIS PEDIATRICS |
On June 10, 2009, Medicis, Medicis Pediatrics, Inc. (Medicis Pediatrics, formerly known as
Ascent Pediatrics, Inc.), a wholly-owned subsidiary of Medicis, and BioMarin Pharmaceutical Inc.
(BioMarin) entered into an amendment to the Securities Purchase Agreement (the BioMarin
Securities Purchase Agreement), dated as of May 18, 2004, and amended on January 12, 2005, by and
among Medicis, Medicis Pediatrics, BioMarin and BioMarin Pediatrics Inc., a wholly-owned subsidiary
of BioMarin that previously merged into BioMarin. The Amendment was effected to accelerate the
closing of BioMarins option under the BioMarin Securities Purchase Agreement to purchase from
Medicis all of the issued and outstanding capital stock of Medicis Pediatrics (the Option), which
was previously expected to close in August 2009. In accordance with the Amendment, the parties
consummated the closing of the Option on June 10, 2009 (the BioMarin Option Closing). The
aggregate cash consideration paid to Medicis in conjunction with the BioMarin Option Closing was
approximately $70.3 million and the purchase was completed substantially in accordance with the
previously disclosed terms of the BioMarin Securities Purchase Agreement.
As a result of the BioMarin Option Closing, the Company recognized a pretax gain of $2.2
million, which is included in other (income) expense, net, in the consolidated statements of income
for the year ended December 31, 2009. The $2.2 million pretax gain is net of approximately $0.7
million of professional fees related to the transaction. Because of the difference between the
Companys book and tax basis of goodwill in Medicis Pediatrics, the transaction resulted in a $24.8
million gain for income tax purposes, and, accordingly, the Company recorded a $9.0 million income
tax provision, which is included in income tax expense in the consolidated statements of income for
the year ended December 31, 2009.
On December 11, 2007, the Company announced a strategic collaboration with 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 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 was used
by Revance primarily for the development of the product. Approximately $12.0 million of the $20.0
million payment represented the fair value of the investment in Revance
F-24
at the time of the
investment and was 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 was expected to
be utilized in the development of the new product, represented the residual value of the option to
acquire Revance or to license the product under development and was recognized as research and
development expense during the year 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 U.S. 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.
The Company estimates 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, unless a
quantitative valuation metric is available for these purposes (such as the completion of an equity
financing by Revance). During 2009 and 2008, the Company reduced the carrying value of its
investment in Revance by approximately $2.9 million and $9.1 million, respectively, as a result of
a reduction in the estimated net realizable value of the investment using the hypothetical
liquidation at book value approach. Such amounts were recognized in other (income) expense. As of
December 31, 2009, the Companys investment in Revance related to this transaction was $0.
A business entity is subject to consolidation rules 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 certain
criteria. Disclosures are required 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.
8. |
|
ACQUISITION OF LIPOSONIX |
On July 1, 2008, the Company, through its wholly-owned subsidiary Donatello, Inc., acquired
LipoSonix, an independent, privately-held company with a staff of approximately 40 scientists,
engineers and clinicians located near Seattle, Washington. LipoSonix, now known as Medicis
Technologies Corporation, is a medical device company developing non-invasive body sculpting
technology. It launched its first product, the LIPOSONIXTM system, in Europe in 2008
and recently launched in Canada. The LIPOSONIXTM system is being marketed and sold
through distributors in Europe. In the U.S., the LIPOSONIXTM system is an
investigational device and is currently not cleared or approved for sale.
Under terms of the transaction, Medicis paid $150 million in cash for all of the outstanding
shares of LipoSonix. In addition, Medicis will pay LipoSonix stockholders certain milestone
payments up to an additional $150 million upon FDA approval of the LIPOSONIXTM
technology and if various commercial milestones are achieved on a worldwide basis.
The following is a summary of the components of the LipoSonix purchase price (in millions):
|
|
|
|
|
Cash consideration |
|
$ |
150.0 |
|
Transaction costs |
|
|
3.6 |
|
|
|
|
|
|
|
$ |
153.6 |
|
|
|
|
|
F-25
The following is a summary of the estimated fair values of the net assets acquired (in millions):
|
|
|
|
|
Current assets |
|
$ |
2.1 |
|
Deferred tax assets, short-term |
|
|
3.8 |
|
Deferred tax assets, long-term |
|
|
14.9 |
|
Property and equipment |
|
|
0.7 |
|
Identifiable intangible assets |
|
|
9.4 |
|
In-process research and development |
|
|
30.5 |
|
Goodwill |
|
|
93.7 |
|
Accounts payable and other current liabilities |
|
|
(1.5 |
) |
|
|
|
|
|
|
$ |
153.6 |
|
|
|
|
|
The Company believes the fair values assigned to the assets acquired and liabilities assumed
are based on reasonable assumptions.
During the three months ended September 30, 2009, the Company recorded $0.4 million of net
deferred tax assets and decreased goodwill by $0.4 million as a result of an adjustment to the tax
attributes acquired.
Identifiable intangible assets of $9.4 million include existing technology of $6.7 million,
with an estimated amortizable life of ten years, and trademarks and trade names of $2.7 million,
with an estimated indefinite amortizable life.
The $30.5 million of acquired in-process research and development was recognized as in-process
research and development expense in the Companys statement of operations during the three months
ended September 30, 2008. No tax benefit was recognized related to this charge.
The results of operations of LipoSonix are included in the Companys consolidated financial
statements beginning on July 1, 2008.
The following unaudited proforma financial information for the years ended December 31, 2008
and 2007 gives effect to the acquisition of LipoSonix as if it had occurred on January 1, 2007.
Such unaudited proforma information is based on historical financial information with respect to
the acquisition and does not reflect operational and administrative cost savings, or synergies,
that management of the combined company estimates may be achieved as a result of the acquisition.
The $30.5 million in-process research and development charge has not been included in the unaudited
proforma financial information since this adjustment is non-recurring in nature.
|
|
|
|
|
|
|
|
|
|
|
YEAR ENDED DECEMBER 31, |
|
|
2008 |
|
2007 |
|
|
(in millions, except per share data) |
Net revenues |
|
$ |
518.5 |
|
|
$ |
457.4 |
|
Net income |
|
|
4.6 |
|
|
|
59.2 |
|
Diluted net income per share |
|
$ |
0.08 |
|
|
$ |
0.92 |
|
9. |
|
SHORT-TERM AND LONG-TERM INVESTMENTS |
The Companys policy for its short-term and long-term investments is 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 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
other expense in the consolidated statement of 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
impairment of 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
F-26
interest income are recognized when earned. The cost of securities sold is calculated using
the specific identification method. At December 31, 2009, the Company has recorded the estimated
fair value in available-for-sale and trading securities for short-term and long-term investments of
approximately $319.2 million and $25.5 million, respectively.
Available-for-sale and trading securities consist of the following at December 31, 2009
and 2008 (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other-Than |
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Temporary |
|
|
|
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Impairment |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Losses |
|
|
Value |
|
|
Corporate notes and bonds |
|
$ |
98,993 |
|
|
$ |
506 |
|
|
$ |
(83 |
) |
|
$ |
|
|
|
$ |
99,416 |
|
Federal agency notes and bonds |
|
|
215,759 |
|
|
|
221 |
|
|
|
(203 |
) |
|
|
|
|
|
|
215,777 |
|
Auction rate floating securities |
|
|
35,000 |
|
|
|
|
|
|
|
(8,179 |
) |
|
|
|
|
|
|
26,821 |
|
Asset-backed securities |
|
|
3,070 |
|
|
|
25 |
|
|
|
(356 |
) |
|
|
|
|
|
|
2,739 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
352,822 |
|
|
$ |
752 |
|
|
$ |
(8,821 |
) |
|
$ |
|
|
|
$ |
344,753 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other-Than |
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Temporary |
|
|
|
|
|
|
|
|
|
|
Unrealized |
|
|
Unrealized |
|
|
Impairment |
|
|
Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Losses |
|
|
Value |
|
|
Corporate notes and bonds |
|
$ |
124,622 |
|
|
$ |
418 |
|
|
$ |
(429 |
) |
|
$ |
|
|
|
$ |
124,611 |
|
Federal agency notes and bonds |
|
|
117,040 |
|
|
|
1,841 |
|
|
|
|
|
|
|
|
|
|
|
118,881 |
|
Auction rate floating securities |
|
|
44,625 |
|
|
|
|
|
|
|
|
|
|
|
(6,400 |
) |
|
|
38,225 |
|
Asset-backed securities |
|
|
31,681 |
|
|
|
|
|
|
|
(630 |
) |
|
|
|
|
|
|
31,051 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
317,968 |
|
|
$ |
2,259 |
|
|
$ |
(1,059 |
) |
|
$ |
(6,400 |
) |
|
$ |
312,768 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
During 2009, 2008 and 2007, the gross realized gains on sales of available-for-sale
securities totaled $1.6 million, $1.1 million and $0.1 million, respectively, and gross losses
totaled $0, $6.5 million (including $6.4 million of other-than-temporary impairment losses) and $0,
respectively. Such amounts were determined based on the specific identification method. The net
adjustment to unrealized gains during 2009, 2008 and 2007, on available-for-sale securities
included in stockholders equity totaled $5.9 million, $0 and $0.9 million, respectively. Of the
2009 amount, $3.1 million was reclassified from retained earnings to other comprehensive income in
accordance with a new accounting standard (see below) during the three months ended June 30, 2009.
The amortized cost and estimated fair value of the available-for-sale securities at December 31,
2009, by maturity, are shown below (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
DECEMBER 31, 2009 |
|
|
|
|
|
|
|
Estimated |
|
|
|
Cost |
|
|
Fair Value |
|
|
Available-for-sale |
|
|
|
|
|
|
|
|
Due in one year or less |
|
$ |
142,256 |
|
|
$ |
142,120 |
|
Due after one year
through five years |
|
|
175,566 |
|
|
|
175,812 |
|
Due after 10 years |
|
|
33,700 |
|
|
|
25,524 |
|
|
|
|
|
|
|
|
|
|
$ |
351,522 |
|
|
$ |
343,456 |
|
|
|
|
|
|
|
|
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, 2009,
approximately $25.5 million in estimated fair value
F-27
expected to mature greater than one year has
been classified as long-term investments because these investments are in an unrealized loss
position, and management has both the ability and intent to hold these investments until recovery
of fair value, which may be maturity.
As of December 31, 2009, the Companys investments included auction rate floating securities
with a fair value of $26.8 million. 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 negative conditions in the credit markets during 2008 and 2009 have
prevented some investors from liquidating their holdings, including their holdings of auction rate
floating securities. During the three months ended March 31, 2008, the Company was informed that
there was insufficient demand at auction for the auction rate floating securities. As a result,
these affected auction rate floating securities are now considered illiquid, and the Company could
be required to hold them until they are redeemed by the holder at maturity. The Company may not be
able to liquidate the securities until a future auction on these investments is successful. As a
result of the continued lack of liquidity of these investments, the Company recorded an
other-than-temporary impairment loss of $6.4 million during the year ended December 31, 2008, based
on the Companys estimate of the fair value of these investments. The Companys estimate of the
fair value of its auction rate floating securities was based on market information and assumptions
determined by the Companys management, which could change significantly based on market
conditions. On April 9, 2009, the FASB released FASB Staff Position (FSP) FAS 115-2 and FAS
124-2, Recognition and Presentation of Other-Than-Temporary Impairments (FSP FAS 115-2),
effective for interim and annual reporting periods ending after June 15, 2009. Upon adoption, FSP
FAS 115-2, which is now part of ASC 320, Investments Debt and Equity Securities, requires that
entities should report a cumulative effect adjustment as of the beginning of the period of adoption
to reclassify the non-credit component of previously recognized other-than-temporary impairments on
debt securities held at that date from retained earnings to other comprehensive income if the
entity does not intend to sell the security and it is not more likely than not that the entity will
be required to sell the security before recovery of its amortized cost basis. The Company adopted
FSP FAS 115-2 during the three months ended June 30, 2009, and accordingly, reclassified
approximately $3.1 million of previously recognized other-than-temporary impairment losses, net of
income taxes, related to its auction rate floating securities from retained earnings to other
comprehensive income in the Companys consolidated balance sheets.
In November 2008, the Company entered into a settlement agreement with the broker through
which the Company purchased auction rate floating securities. The settlement agreement provides
the Company with the right to put an auction rate floating security currently held by the Company
back to the broker beginning on June 30, 2010. At December 31, 2009, and December 31, 2008, the
Company held one auction rate floating security with a par value of $1.3 million that was subject
to the settlement agreement. At inception, the Company elected the irrevocable Fair Value Option
treatment under ASC 825, Financial Instruments (formerly SFAS No. 159, The Fair Value Option for
Financial Assets and Financial Liabilities), and accordingly adjusts the put option to fair value
at each reporting date. Concurrent with the execution of the settlement agreement, the Company
reclassified this auction rate floating security from available-for-sale to trading securities and
accordingly, future changes in fair value related to this investment and the related put option
will be recorded in earnings.
On July 14, 2009, the broker through which the Company purchased auction rate floating
securities agreed to repurchase from the Company three auction rate floating securities with an
aggregate par value of $7.0 million, at par. The adjusted basis of these securities was $5.5
million, in aggregate, as a result of an other-than-temporary impairment loss of $1.5 million
recorded during the year ended December 31, 2008. The realized gain of $1.5 million was recognized
in other (income) expense during the three months ended September 30, 2009.
F-28
The following table shows the gross unrealized losses and the 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, 2009 (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 |
|
$ |
18,968 |
|
|
$ |
83 |
|
|
$ |
|
|
|
$ |
|
|
Federal agency notes and bonds |
|
|
103,635 |
|
|
|
203 |
|
|
|
|
|
|
|
|
|
Auction rate floating securities |
|
|
|
|
|
|
|
|
|
|
26,821 |
|
|
|
8,179 |
|
Asset-backed securities |
|
|
|
|
|
|
|
|
|
|
1,193 |
|
|
|
356 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities |
|
$ |
122,603 |
|
|
$ |
286 |
|
|
$ |
28,014 |
|
|
$ |
8,535 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2009, the Company has concluded that the unrealized losses on its
investment securities are temporary in nature and are caused by changes in credit spreads and
liquidity issues in the marketplace. Available-for-sale securities are reviewed quarterly for
possible other-than-temporary impairment. This review includes an analysis of the facts and
circumstances of each individual investment such as the severity of loss, the length of time the
fair value has been below cost, the expectation for that securitys performance and the
creditworthiness of the issuer. Additionally, the Company has the intent and ability to hold these
investments for the time necessary to recover its cost, which for debt securities may be at
maturity.
10. FAIR VALUE MEASUREMENTS
As of December 31, 2009, the Company held certain assets that are required to be measured at
fair value on a recurring basis. These included certain of the Companys short-term and long-term
investments, including investments in auction rate floating securities, and the Companys
investments in Revance and Hyperion.
The Company has invested in auction rate floating securities, which are classified as
available-for-sale or trading securities and reflected at fair value. Due to events in credit
markets, the auction events for some of these instruments held by the Company failed during the
three months ended March 31, 2008 (see Note 9). Therefore, the fair values of these auction rate
floating securities, which are primarily rated AAA, are estimated utilizing a discounted cash flow
analysis as of December 31, 2009. These analyses consider, among other items, the
collateralization underlying the security investments, the creditworthiness of the counterparty,
the timing of expected future cash flows, and the expectation of the next time the security is
expected to have a successful auction. These investments were also compared, when possible, to
other observable market data with similar characteristics to the securities held by the Company.
Changes to these assumptions in future periods could result in additional declines in fair value of
the auction rate floating securities.
The Company estimates changes in the net realizable value of its investment in Revance based
on a hypothetical liquidation at book value approach (see Note 7). During the year ended December
31, 2009, the Company reduced the carrying value of its investment in Revance by approximately $2.9
million as a result of a reduction in the estimated net realizable value of the investment using
the hypothetical liquidation at book value approach, which reduced the Companys investment in
Revance to $0 as of December 31, 2009.
F-29
The Companys assets measured at fair value on a recurring basis subject to the disclosure
requirements of ASC 820, Fair Value Measurements and Disclosures (formerly SFAS No. 157, Fair Value
Measurements), at December 31, 2009, were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement at Reporting Date Using |
|
|
|
|
|
|
|
Quoted |
|
|
Significant |
|
|
|
|
|
|
|
|
|
|
Prices in |
|
|
Other |
|
|
Significant |
|
|
|
|
|
|
|
Active |
|
|
Observable |
|
|
Unobservable |
|
|
|
|
|
|
|
Markets |
|
|
Inputs |
|
|
Inputs |
|
|
|
Dec. 31, 2009 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
|
Auction rate floating securities |
|
$ |
26,821 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
26,821 |
|
Other available-for-sale securities |
|
|
317,932 |
|
|
|
317,932 |
|
|
|
|
|
|
|
|
|
Investment in Hyperion |
|
|
2,375 |
|
|
|
|
|
|
|
|
|
|
|
2,375 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets measured at fair value |
|
$ |
347,128 |
|
|
$ |
317,932 |
|
|
$ |
|
|
|
$ |
29,196 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents the Companys assets measured at fair value on a recurring
basis using significant unobservable inputs (Level 3) for the year ended December 31, 2009 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using Significant |
|
|
|
Unobservable Inputs (Level 3) |
|
|
|
Auction Rate |
|
|
Investment |
|
|
Investment |
|
|
|
Floating |
|
|
in |
|
|
in |
|
|
|
Securities |
|
|
Revance |
|
|
Hyperion |
|
|
Balance at December 31, 2008 |
|
$ |
38,225 |
|
|
$ |
2,887 |
|
|
$ |
|
|
Total gains (losses) included in other
(income) expense, net |
|
|
1,525 |
|
|
|
(2,887 |
) |
|
|
|
|
Total losses included in other
comprehensive income |
|
|
(3,304 |
) |
|
|
|
|
|
|
|
|
Common stock of Hyperion related
to amendment of collaboration
agreement (see Note 4) |
|
|
|
|
|
|
|
|
|
|
2,375 |
|
Purchases and settlements (net) |
|
|
(9,625 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
$ |
26,821 |
|
|
$ |
|
|
|
$ |
2,375 |
|
|
|
|
|
|
|
|
|
|
|
11. CONTINGENT CONVERTIBLE SENIOR NOTES
In June 2002, the Company sold $400.0 million aggregate principal amount of its 2.5%
Contingent Convertible Senior 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, 2009. 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, 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. Under GAAP, 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
F-30
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, 2012 and June 4, 2017.
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, 2009. The New Notes
mature on June 4, 2033.
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. The Company incurred approximately
$5.1 million of fees and other origination costs related to the issuance of the New Notes. The
Company amortized these costs over the first five-year Put period, which ran through June 4, 2008.
Holders of the New Notes were able to require the Company to repurchase all or a portion of
their New Notes on June 4, 2008, at 100% of the principal amount of the New Notes, plus accrued and
unpaid interest, including contingent interest, if any, to the date of the repurchase, payable in
cash. Holders of approximately $283.7 million of New Notes elected to require the Company to
repurchase their New Notes on June 4, 2008. The Company paid $283.7 million, plus accrued and
unpaid interest of approximately $2.2 million, to the holders of New Notes that elected to require
the Company to repurchase their New Notes. The Company was also required to pay an accumulated
deferred tax liability of approximately $34.9 million related to the repurchased New Notes. This
$34.9 million deferred tax liability was paid during the second half of 2008. Following the
repurchase of these New Notes, $181,000 of principal amount of New Notes remained, and are still
outstanding as of December 31, 2009.
F-31
The remaining New Notes are convertible, at the holders option, prior to the maturity date
into shares of the Companys Class A common stock in the following circumstances:
|
|
|
during any quarter commencing after September 30, 2003, if the closing price of the
Companys Class A common stock over a specified number of trading days during the previous
quarter, including the last trading day of such quarter, is more than 120% of the
conversion price of the New Notes, or $46.51. The Notes are initially convertible at a
conversion price of $38.76 per share, which is equal to a conversion rate of approximately
25.7998 shares per $1,000 principal amount of New Notes, subject to adjustment; |
|
|
|
|
if the Company has called the New Notes for redemption; |
|
|
|
|
during the five trading day period immediately following any nine consecutive day
trading period in which the trading price of the New Notes per $1,000 principal amount for
each day of such period was less than 95% of the product of the closing sale price of the
Companys Class A common stock on that day multiplied by the number of shares of the
Companys Class A common stock issuable upon conversion of $1,000 principal amount of the
New Notes; or |
|
|
|
|
upon the occurrence of specified corporate transactions. |
The remaining 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.
During all of the fiscal quarters during 2009, 2008 and 2007, the Old Notes and New Notes did
not meet the criteria for the right of conversion. At the end of each future quarter, the
conversion rights will be reassessed in accordance with the bond indenture agreement to determine
if the conversion trigger rights have been achieved.
12. COMMITMENTS AND CONTINGENCIES
Occupancy Arrangements
During July 2006, the Company executed a lease agreement for new headquarter office space to
accommodate its expected long-term growth. The first phase is for approximately 150,000 square
feet with the right to expand. The Company occupied the new headquarter office space, which is
located approximately one mile from its previous headquarter office space in Scottsdale, Arizona,
during the second quarter of 2008. The Company obtained possession of the leased premises and,
therefore, began accruing rent expense during the first quarter of 2008. The term of the lease is
twelve years. The average annual expense under the amended lease agreement is approximately $3.9
million. During the first quarter of 2008, the Company received approximately $6.7 million in
tenant improvement incentives from the landlord. This amount has been capitalized into leasehold
improvements and is being depreciated on a straight-line basis over the lesser of the useful life
or the term of the lease. The tenant improvement incentives are also included in other long-term
liabilities as deferred rent, and will be recognized as a reduction of rent expense on a
straight-line basis over the term of the lease.
During October 2006, the Company executed a lease agreement for additional headquarter office
space, which is also located approximately one mile from the Companys current headquarter office
space in Scottsdale, Arizona to accommodate its 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, the Company began occupancy of the additional headquarter office space. The
lease expires in May 2010. The Company intends to extend the lease beyond May 2010.
LipoSonix, now known as Medicis Technologies Corporation, presently leases approximately
24,700 square feet of office, laboratory and manufacturing space in Bothell, Washington under a
lease agreement that expires in October 2012.
F-32
Medicis Aesthetics Canada Ltd., a wholly owned subsidiary of the Company, presently leases
approximately 3,600 square feet of office space in Toronto, Ontario, Canada, under a lease
agreement, as extended, that expires in June 2010.
Rent expense was approximately $3.6 million, $9.4 million and $2.5 million for 2009, 2008 and
2007, respectively. Rent expense for 2008 includes a $4.8 million charge for the estimated
remaining net cost for the Companys previous headquarters facility lease, net of potential
sublease income.
At December 31, 2009, approximate future lease payments under the Companys operating leases
are as follows (amounts in thousands):
|
|
|
|
|
YEAR ENDING DECEMBER 31, |
|
|
|
2010 |
|
$ |
6,635 |
|
2011 |
|
|
4,532 |
|
2012 |
|
|
4,481 |
|
2013 |
|
|
4,413 |
|
2014 |
|
|
4,559 |
|
Thereafter |
|
|
25,082 |
|
|
|
|
|
|
|
$ |
49,702 |
|
|
|
|
|
Lease Exit Costs
In connection with occupancy of the new headquarter office, the Company ceased use of the
prior headquarter office in July 2008, which consists of approximately 75,000 square feet of office
space, at an average annual expense of approximately $2.1 million, under an amended lease agreement
that expires in December 2010. Under ASC 420, Exit or Disposal Cost Obligations (formerly SFAS
146, Accounting for Costs Associated with Exit or Disposal Activities), a liability for the costs
associated with an exit or disposal activity is recognized when the liability is incurred. The
Company recorded lease exit costs of approximately $4.8 million during the three months ended
September 30, 2008, consisting of the initial liability of $4.7 million and accretion expense of
$0.1 million. These amounts were recorded as selling, general and administrative expenses. The
Company has not recorded any other costs related to the lease for the prior headquarters, other
than accretion expense.
As of December 31, 2009, approximately $2.1 million of lease exit costs remain accrued and are
expected to be paid by December 2010, all of which is classified in other current liabilities.
Although the facilities are no longer in use by the Company, the lease exit cost accrual has not
been offset by an adjustment for estimated sublease rentals. After considering sublease market
information as well as factors specific to the lease, the Company concluded it was probable it
would be unable to obtain sublease rentals for the prior headquarters, and, therefore, it would not
be subleased for the remaining lease term. The Company will continue to monitor the sublease
market conditions and reassess the impact on the lease exit cost accrual.
The following is a summary of the activity in the liability for lease exit costs for the year
ended December 31, 2009:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liability as of |
|
Amounts Charged |
|
Cash Payments |
|
Cash Received |
|
Liability as of |
|
|
December 31, 2008 |
|
to Expense |
|
Made |
|
from Sublease |
|
Dec. 31, 2009 |
Lease exit costs
liability |
|
$ |
3,996,102 |
|
|
$ |
211,545 |
|
|
$ |
(2,143,970 |
) |
|
$ |
|
|
|
$ |
2,063,677 |
|
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, 2009, 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.
F-33
Medicaid Drug Rebates
During 2009, the Company completed a voluntary review of pricing data submitted to the
Medicaid Drug Rebate Program (the Program) for 2006, 2007 and 2008. The review identified
certain actions that were needed in relation to the reviewed data. The Company expects that the
actions, when implemented, will result in an increase to the Companys rebate liability under the
Program in the amount of approximately $3.3 million for the period reviewed. The Company has
disclosed the results of the review and revised rebate liability to the Centers for Medicare and
Medicaid Services (CMS), which administers the Program, and is awaiting CMS instruction as to
whether and when to re-file the revised pricing data. The Companys submission to CMS also
included a request that CMS approve a change in drug category for certain Company products, which
CMS approved in December 2009. The fiscal impact of that change is included in the rebate
liability figure noted above. Upon completion of CMSs review of the Companys submission, the
Company will evaluate the impact that CMSs conclusions will have on the Companys liability under
related drug rebate agreements with various states and the Public Health Service Drug Pricing
Program. The Company has accrued $3.3 million for this liability, and recognized a corresponding
reduction of net revenues during the year ended December 31, 2009.
Department of Defense/TRICARE
On March 17, 2009, the Department of Defense (DoD) issued a Final Rule (the Rule)
implementing Section 703 of the National Defense Authorization Act of 2008. The Rule established a
program under which the DoD seeks FCP-based refunds, or rebates, from drug manufacturers on TRICARE
retail pharmacy utilization. Under the Rule, effective May 26, 2009, the DoD is seeking rebates on
TRICARE retail pharmacy program prescriptions filled from January 28, 2008, forward. The Rule sets
forth a program in which the DoD asks manufacturers to enter into agreements with the agency
pursuant to which the manufacturers commit to pay such rebates. Products that are not listed in
such agreements will not be able to be included on the DoD Uniform Formulary. Additionally,
products not listed in TRICARE retail agreements will not be available through TRICARE retail
network pharmacies without prior authorization. Among other things, the Rule further provides that
manufacturers may apply for compromise or waivers of amounts due. As a result of the Rule, the
Companys rebate liability as of March 31, 2009 for 2008 utilization is approximately $1.6 million,
the rebate liability for the first quarter of 2009 is approximately $0.8 million and the rebate
liability for the second quarter of 2009 prior to the date of execution of the Companys TRICARE
retail agreement on June 29, 2009 is $0.6 million. It is possible that, pursuant to the compromise
or waiver process set forth in the Rule, the DoD will agree to accept a lesser sum for the 2008
period and for the first and second quarters of 2009. The Company applied timely for a waiver of
liability from January 28, 2008 through the date of its TRICARE rebate agreement, which was
executed on June 29, 2009. The Company accrued $2.4 million in aggregate for the liability for
2008 and the first quarter of 2009, which was recognized as a reduction of net revenues during the
three months ended March 31, 2009. The Company also accrued $0.6 million in its financial
statements as of June 30, 2009 for TRICARE rebate liability for the second quarter of 2009 through
June 28, 2009, the day prior to execution of the Companys TRICARE rebate agreement. This sum was
recognized as a reduction of net revenues during that period.
Legal Matters
On October 8, 2009, the Company received a Paragraph IV Patent Certification from Lupin
advising that Lupin had filed an ANDA with the FDA for generic SOLODYN® in its forms of
45mg, 90mg, and 135mg strengths. Lupin did not advise the Company as to the timing or status of
the FDAs review of its filing, or whether it has complied with FDA requirements for proving
bioequivalence. Lupins Paragraph IV Certification alleged that Lupins manufacture, use, sale or
offer for sale of the product for which the ANDA was submitted would not infringe any valid claim
of the Companys 838 Patent. The expiration date for the 838 Patent is 2018. On November 17,
2009, the Company filed suit against Lupin in the United States District Court for the District of
Maryland seeking an adjudication that Lupin has infringed one or more claims of the 838 Patent by
submitting to the FDA an ANDA for generic SOLODYN® in its forms of 45mg, 90mg and 135mg
strengths. The relief the Company requested includes a request for a permanent injunction
preventing Lupin from infringing the 838 Patent by selling generic versions of
SOLODYN®. On November 24, 2009, the Company received a Paragraph IV Patent
Certification from Lupin, advising that Lupin has filed a supplement or amendment to its earlier
filed ANDA assigned ANDA #91-424 (Lupin ANDA Supplement/Amendment I) with the FDA for generic
SOLODYN ® in its form of 65mg strength. Lupin has not advised the Company as to the
timing or status of the FDAs review of its filing, or whether Lupin has complied with FDA
requirements for proving bioequivalence. Lupins Paragraph IV Certification alleges that the
Companys 838 Patent is invalid and/or will not be infringed by Lupins manufacture,
F-34
use, sale and/or importation of the products for which the Lupin ANDA Supplement/Amendment I
was submitted. Lupins submission amends an ANDA already subject to a 30-month stay. As such,
the Company believes that the amendment cannot be approved by the FDA until after the expiration of
the 30-month period or a court decision that the patent is invalid or not infringed. On
December 23, 2009, the Company received a Paragraph IV Patent Certification from Lupin, advising
that Lupin has filed a supplement or amendment to its earlier filed
ANDA assigned ANDA # 91-424
(Lupin ANDA Supplement/Amendment II) with the FDA for generic SOLODYN ® in its form of
115mg strength. Lupin has not advised the Company as to the timing or status of the FDAs review
of its filing, or whether Lupin has complied with FDA requirements for proving bioequivalence.
Lupins Paragraph IV Certification alleges that the Companys 838 Patent is invalid and/or will
not be infringed by Lupins manufacture, use, sale and/or importation of the products for which the
Lupin ANDA Supplement/Amendment II was submitted. Lupins submission amends an ANDA already
subject to a 30-month stay. As such, the Company believes that the amendment cannot be approved by
the FDA until after the expiration of the 30-month period or a court decision that the patent is
invalid or not infringed. On December 28, 2009, the Company amended its complaint against Lupin
in the United States District Court for the District of Maryland seeking an adjudication that Lupin
has infringed one or more claims of the 838 Patent by submitting its supplement or amendment to
its earlier filed ANDA assigned ANDA #91-424 for generic SOLODYN® in its form of 65mg
strength. On February 2, 2010, the Company amended its complaint against Lupin in the United
States District Court for the District of Maryland seeking an adjudication that Lupin has infringed
one or more claims of the 838 Patent by submitting its supplement or amendment to its earlier
filed ANDA assigned ANDA #91-424 for generic SOLODYN® in its form of 115mg strength.
On September 21, 2009, the Company received a Paragraph IV Patent Certification from Glenmark
advising that Glenmark has filed an ANDA with the FDA for a generic version of LOPROX®
Gel. Glenmark did not advise the Company as to the timing or status of the FDAs review of its
filing, or whether it has complied with FDA requirements for proving bioequivalence. Glenmarks
Paragraph IV Certification alleged that the Companys U.S. Patent No. 7,018,656 (the 656 Patent)
would not be infringed by Glenmarks manufacture, use or sale of the product for which the ANDA was
submitted. The expiration date for the 656 Patent is 2018. On November 14, 2009, the Company
entered into a License and Settlement Agreement with Glenmark and its foreign corporate parent
Glenmark Ltd. In connection with the License and Settlement Agreement, the Company and Glenmark
agreed to terminate all legal disputes between them relating to LOPROX® Gel. In
addition, Glenmark confirmed that certain of the Companys patents relating to LOPROX®
Gel are valid and enforceable, and cover Glenmarks activities relating to its generic version of
LOPROX® Gel under an ANDA. Subject to the terms and conditions contained in the License
and Settlement Agreement, the Company also granted Glenmark a license to make and sell generic
versions of LOPROX® Gel. Upon commercialization by Glenmark of generic versions of
LOPROX® Gel, Glenmark will pay the Company a royalty based on sales of such generic
products.
On December 7, 2009, the Company entered into a Settlement Agreement (the Paddock Settlement
Agreement) with Paddock Laboratories, Inc. (Paddock). In connection with the Paddock Settlement
Agreement, the Company and Paddock agreed to settle all legal disputes between them relating to the
Companys LOPROX® Shampoo and the Company agreed to withdraw its complaint against
Paddock pending in the U.S. District Court for the District of Arizona. In addition, Paddock
confirmed that Paddocks activities relating to its generic version of LOPROX® Shampoo
are covered by the Companys current and pending patent applications. Further, subject to the
terms and conditions contained in the Paddock Settlement Agreement, the Company granted Paddock a
non-exclusive, royalty-bearing license to make and sell limited quantities of its generic version
of LOPROX® Shampoo.
On June 23, 2009, the Company and IMPAX entered into a Settlement Agreement (the IMPAX
Settlement Agreement) and Amendment No. 2 to the License and Settlement Agreement . initially
entered into between IMPAX and the Company In conjunction with the IMPAX Settlement Agreement, both
IMPAX and the Company released, acquitted, covenanted not to sue and forever discharged one another
and their affiliates from any and all liabilities relating to the litigation stemming from the
initial License and Settlement Agreement between IMPAX and the Company. The Company made a
settlement payment to IMPAX in conjunction with the execution of the IMPAX Settlement Agreement and
Amendment No. 2 to the License and Settlement Agreement, which was included in selling, general and
administrative expenses during the three months ended June 30, 2009.
On May 8, 2009, the Company received a Paragraph IV Patent Certification from Glenmark
advising that Glenmark had filed an ANDA with the FDA for a generic version of VANOS®.
Glenmark did not advise the Company as to the timing or status of the FDAs review of its filing,
or whether it has complied with FDA requirements for proving bioequivalence. Glenmarks
Paragraph IV Certification alleged that the Companys U.S.
F-35
Patent No. 6,765,001 (the 001 Patent) and U.S. Patent No. 7,220,424 (the 424 Patent)
would not be infringed by Glenmarks manufacture, use or sale of the product for which the ANDA was
submitted. The expiration date for the 001 Patent is 2021, and the expiration date for the 424
Patent is 2023. On June 19, 2009, the Company filed a complaint for patent infringement against
Glenmark and its foreign corporate parent Glenmark Ltd. in the United States District Court for the
District of New Jersey. On July 14, 2009, Glenmark and Glenmark Ltd. answered the Companys
complaint, and filed counterclaims seeking a declaration that the patents the Company listed with
the FDA for VANOS® cream were invalid and unenforceable, and would not be infringed by
Glenmarks generic version of VANOS® cream. On November 14, 2009, the parties entered
into a settlement agreement whereby Glenmark obtained certain patent rights and rights to market
its ANDA product on a certain timeline. On November 14, 2009, the court entered a consent judgment
dismissing all claims of patent inifringement and enjoining Glenmark from marketing a generic
version of VANOS® cream other than under the terms of the settlement agreement.
On May 6, 2009, the Company received a Paragraph IV Patent Certification from Ranbaxy advising
that Ranbaxy had filed an ANDA with the FDA for generic SOLODYN® in its form of 135mg
strength. Ranbaxy did not advise us as to the timing or status of the FDAs review of its filing,
or whether it has complied with FDA requirements for proving bioequivalence. Ranbaxys
Paragraph IV Certification alleged that Ranbaxys manufacture, use, sale or offer for sale of the
product for which the ANDA was submitted would not infringe any valid claim of our 838 Patent.
The expiration date for the 838 Patent is 2018. On June 11, 2009, we filed suit against Ranbaxy
in the United States District Court for the District of Delaware seeking an adjudication that
Ranbaxy has infringed one or more claims of the 838 Patent by submitting the above ANDA to the
FDA. The relief we requested included a request for a permanent injunction preventing Ranbaxy from
infringing the 838 Patent by selling a generic version of SOLODYN®. Ranbaxy has
answered that the 838 Patent is not infringed, invalid, and/or unenforceable. On January 5, 2010,
the Company received a Paragraph IV Patent Certification from Ranbaxy advising that Ranbaxy has
filed a supplement or amendment to its earlier filed ANDA assigned ANDA #91-118 (Ranbaxy ANDA
Supplement/Amendment) with the FDA for generic SOLODYN® in its forms of 45mg and 90mg
strengths. Ranbaxy has not advised the Company as to the timing or status of the FDAs review of
its filing, or whether Ranbaxy has complied with FDA requirements for proving bioequivalence.
Ranbaxys Paragraph IV Certification alleges that the Companys 838 Patent is invalid,
unenforceable, and/or will not be infringed by Ranbaxys manufacture, importation, use, sale and/or
offer for sale of the products for which the Ranbaxy ANDA Supplement/Amendment was submitted.
Ranbaxys Paragraph IV Certification also alleges that the Companys 347 Patent or 373 Patent is
not infringed by Ranbaxys manufacture, importation, use, sale and/or offer for sale of the
products for which the Ranbaxy ANDA Supplement/Amendment was submitted.
Ranbaxys submission as
to the 45mg and 90mg strengths amends an ANDA already subject to a 30-month stay. As such, the
Company believes that the Ranbaxy ANDA Supplement/Amendment cannot be approved by the FDA until after the
expiration of the 30-month period or in the event of a court decision holding that the patents are
invalid or not infringed. On February 16, 2010, the Company filed a complaint against Ranbaxy in the
United States District Court for the District of Delaware seeking an adjudication that Ranbaxy has infringed one
or more claims of the patents by submitting the Ranbaxy ANDA Supplement/Amendment for generic
SOLODYN® in its forms of 45mg and 90mg strengths.
On May 1, 2008, the Company announced that it received notice from Perrigo Israel
Pharmaceuticals Ltd. (Perrigo Israel), a generic pharmaceutical company, that it had filed an
ANDA with the FDA for a generic version of the Companys VANOS® fluocinonide cream 0.1%.
Perrigo Israels notice indicated that it was challenging only one of the two patents that the
Company listed with the FDA for VANOS® cream, the Companys U.S. Patent No. 6,765,001
(the 001 Patent) that will expire in 2021. On June 6, 2008, the Company filed a complaint for
patent infringement against Perrigo Israel and, its domestic corporate parent, Perrigo Company, in
the United States District Court for the Western District of Michigan. In August 2008, the Company
received notice that Perrigo Israel amended its ANDA to challenge the Companys other patent listed
with the FDA for VANOS® cream, its U.S. Patent No. 7,220,424 (the 424 Patent) that
will expire in 2023. The Companys complaint asserts that Perrigo Israel and Perrigo Company have
infringed on both of the Companys patents for VANOS® cream. On April 8, 2009, the
Company entered into a license and settlement agreement with Perrigo. In connection with the
license and settlement agreement, the Company and Perrigo agreed to terminate all legal disputes
between them relating to our VANOS® cream. In addition, Perrigo confirmed that certain
of the Companys patents relating to VANOS® cream are valid and enforceable, and are
infringed by Perrigos activities relating to its generic product under ANDA #090256. Further,
subject to the terms and conditions contained in the license and settlement agreement, the Company
granted Perrigo, effective December 15, 2013, or earlier upon the occurrence of certain events, a
license to make and sell generic versions of the existing VANOS® products and, when
Perrigo does commercialize generic versions of VANOS® products, Perrigo will pay the
Company a royalty based on sales of such generic products.
F-36
On November 20, 2009, the Company received a Paragraph IV Patent Certification from Barr,
advising that Barr has filed a supplement to its earlier filed ANDA #65-485 (Barr ANDA
Supplement) with the FDA for generic SOLODYN® in its forms of 65mg and 115mg strengths.
Barr has not advised the Company as to the timing or status of the FDAs review of its filing, or
whether Barr has complied with FDA requirements for proving bioequivalence. Barrs Paragraph IV
Certification alleges that the Companys 838 Patent is invalid, unenforceable and/or will not be
infringed by Barrs manufacture, use, sale and/or importation of the products for which the Barr
ANDA Supplement was submitted. On December 28, 2009, the Company filed suit against Barr/Teva, in
the United States District Court for the District of Maryland seeking an adjudication that
Barr/Teva has infringed one or more claims of the 838 Patent by submitting to the FDA the Barr
ANDA Supplement seeking marketing approval for generic SOLODYN® in its forms
of 65mg and 115mg strengths. The relief the Company requested includes a request for a permanent
injunction preventing Barr/Teva from infringing the 838 Patent by selling generic versions of
SOLODYN® in its forms of 65mg and 115mg strengths. As a result of the filing
of the suit, the Company believes that the supplement to the ANDA cannot be approved by the FDA
until after the expiration of a 30-month stay period or a court decision that the patent is invalid
or not infringed.
A third party has requested that the U.S. Patent and Trademark Office (USPTO) conduct an Ex
Parte Reexamination of the 838 patent. The USPTO granted this request. In March 2009, the USPTO
issued a non-final office action in the reexamination of the 838 patent. On May 13, 2009,
Medicis filed its response to the non-final office action with the USPTO, canceling certain claims
and adding amended claims. On November 10, 2009, the USPTO issued a second non-final office action
in the reexamination of the 838 patent. On January 8, 2010, the Company filed its response to the
non-final office action with the USPTO. Reexamination can result in confirmation of the validity
of all of a patents claims, the invalidation of all of a patents claims, or the confirmation of
some claims and the invalidation of others. The Company cannot guarantee the outcome of the
reexamination. It is possible that one or more of the Companys patents covering
SOLODYN® may be found invalid or narrowed in scope as the result of the pending
reexamination or a future reexamination by the USPTO. If the USPTOs action leads the court in a
SOLODYN® patent infringement suit, including the suits described in this Report, to hold
that the patent for SOLODYN® is invalid or not infringed, such a holding would permit
the FDA to lift the 30-month stay on approval of ANDAs for generic versions of SOLODYN®.
On January 13, 2009, the Company filed suit against Mylan, Inc., Matrix Laboratories Ltd.,
Matrix Laboratories Inc., Sandoz, Inc., (Sandoz) and Barr Laboratories, Inc. (Barr)
(collectively Defendants) in the United States District Court for the District of Delaware
seeking an adjudication that Defendants have infringed one or more claims of the Companys 838
patent by submitting to the FDA their respective ANDAs for generic versions of SOLODYN®.
The relief requested by the Company includes a request for a permanent injunction preventing
Defendants from infringing the 838 patent by selling generic versions of SOLODYN®.
Mylan has answered that the 838 Patent is not infringed and/or invalid. On March 18, 2009, the
Company entered into a settlement agreement with Barr, a subsidiary of Teva Pharmaceutical
Industries Ltd. (Teva), whereby all legal disputes between the Company and Teva relating to
SOLODYN® were terminated and whereby Barr/Teva agreed that Medicis patent-in-suit is
valid, enforceable and not infringed and that it should be permanently enjoined from infringement.
The Delaware court subsequently entered a permanent injunction against any infringement by
Barr/Teva. On March 30, 2009, the Delaware Court dismissed the claims between the Company and
Matrix Laboratories Inc. without prejudice, pursuant to a stipulation between Medicis and Matrix
Laboratories Inc. On August 18, 2009, the Company entered into a Settlement Agreement with Sandoz
whereby all legal disputes between the Company and Sandoz relating to SOLODYN® were
terminated and where Sandoz agreed that Medicis patent-in-suit is valid, enforceable and not
infringed and that it should be permanently enjoined from infringement. The Delaware court
subsequently entered a permanent injunction against any infringement by Sandoz.
On January 21, 2009, the Company received a letter from an alleged stockholder demanding that
its Board of Directors take certain actions, including potentially legal action, in connection with
the restatement of its consolidated financial statements in 2008. The letter states that, if the
Board of Directors does not take the demanded action, the alleged stockholder will commence a
derivative action on behalf of the Company. The Companys Board of Directors reviewed the
letter during the course of 2009 and established a special committee of the Board, comprised of directors who are
independent and disinterested with respect to the allegations in the letter, (i) to assess whether
there is any merit to the allegations contained in the letter, (ii) if the special committee were to
conclude that there may be merit to any of the allegations contained in the letter, to further
assess whether it is in the best interest of the Company and its shareholders to pursue litigation
or other action against any or all of the persons named in the letter or any other persons not
named in the letter, and (iii) to recommend to the Board of Directors any other appropriate action
to be taken. The special committee engaged outside counsel to assist with the investigation.
F-37
On October 3, 10, and 27, 2008, purported stockholder class action lawsuits styled Andrew Hall
v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01821-MHB); Steamfitters Local 449
Pension Fund v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01870-DKD); and Darlene
Oliver v. Medicis Pharmaceutical Corp., et al. (Case No. 2:08-cv-01964-JAT) were filed in the
United States District Court for the District of Arizona on behalf of stockholders who purchased
securities of the Company during the period between October 30, 2003, and approximately September
24, 2008. The Court has consolidated these actions into a single proceeding and appointed a lead
plaintiff and lead plaintiffs counsel. On May 18, 2009, the lead plaintiff filed an amended
complaint. The amended complaint names as defendants Medicis Pharmaceutical Corp. and the
Companys Chief Executive Officer and Chairman of the Board, Jonah Shacknai, the Companys Chief
Financial Officer, Executive Vice President and Treasurer, Richard D. Peterson, the Companys Chief
Operating Officer and Executive Vice President, Mark A. Prygocki, and the Companys independent
auditors, Ernst & Young LLP. The claims alleged in the amended complaint arise in connection with
the restatement of the Companys annual, transition, and quarterly periods in fiscal years 2003
through 2007 and the first and second quarters of 2008. The amended complaint alleges violations
of federal securities laws, (Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and
Rule 10b-5), based on alleged material misrepresentations to the market that allegedly had the
effect of artificially inflating the market price of the Companys stock. The amended complaint
seeks to recover unspecified damages and costs, including counsel and expert fees. On July 17,
2009, the Company and the other defendants filed motions to dismiss the amended complaint in its
entirety on various grounds. The lead plaintiff filed an opposition to the motions to dismiss on
August 31, 2009, and the Company and the other defendants filed reply memoranda in support of the
motions to dismiss on October 15, 2009. On December 2, 2009, the court dismissed the consolidated
amended complaint without prejudice, permitting the lead plaintiff the opportunity to replead. On
January 18, 2010, the lead plaintiff filed a second amended complaint. On February 19, 2010, the
Company and the other defendants filed motions to dismiss the second amended complaint in its
entirety on various grounds. The Company will continue to vigorously defend the claims in these
consolidated matters. There can be no assurance, however, that the Company will be successful, and
an adverse resolution of the lawsuits could have a material adverse effect on the Companys
financial position and results of operations in the period in which the lawsuits are resolved. The
Company is not presently able to reasonably estimate potential losses, if any, related to the
lawsuits.
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, financial condition or cash flows
of the Company.
13. INCOME TAXES
The provision (benefit) for income taxes consists of the following (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
Current |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
55,978 |
|
|
$ |
68,767 |
|
|
$ |
31,639 |
|
State |
|
|
4,364 |
|
|
|
3,631 |
|
|
|
186 |
|
Foreign |
|
|
2,704 |
|
|
|
2,422 |
|
|
|
3,194 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
63,046 |
|
|
|
74,820 |
|
|
|
35,019 |
|
|
|
|
|
|
|
|
|
|
|
Deferred |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
(2,873 |
) |
|
|
(40,435 |
) |
|
|
13,091 |
|
State |
|
|
(534 |
) |
|
|
(2,255 |
) |
|
|
434 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,407 |
) |
|
|
(42,690 |
) |
|
|
13,525 |
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
59,639 |
|
|
$ |
32,130 |
|
|
$ |
48,544 |
|
|
|
|
|
|
|
|
|
|
|
F-38
During 2009, 2008 and 2007, Additional paid-in-capital was (decreased)/increased by
$(0.9) million, $(1.6) million and $2.6 million, respectively, as a result of tax
(shortfalls)/windfalls related to the vesting of restricted stock and exercise of employee stock
options.
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:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
Statutory federal income tax rate |
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
State tax rate, net of federal benefit |
|
|
0.9 |
|
|
|
2.2 |
|
|
|
0.9 |
|
Share-based payments |
|
|
0.7 |
|
|
|
2.4 |
|
|
|
0.4 |
|
Foreign taxes |
|
|
1.2 |
|
|
|
3.3 |
|
|
|
1.7 |
|
Tax contingencies reserve |
|
|
|
|
|
|
0.3 |
|
|
|
(0.4 |
) |
Non-deductible research and
development
expense |
|
|
|
|
|
|
25.2 |
|
|
|
|
|
Taxable gain in excess of book gain on
sale of subsidiary |
|
|
5.9 |
|
|
|
|
|
|
|
|
|
Other non-deductible items |
|
|
0.7 |
|
|
|
4.2 |
|
|
|
1.3 |
|
Credits and other |
|
|
(1.1 |
) |
|
|
(4.5 |
) |
|
|
(0.8 |
) |
Valuation allowance |
|
|
0.7 |
|
|
|
7.7 |
|
|
|
2.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
44.0 |
% |
|
|
75.8 |
% |
|
|
40.8 |
% |
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
2009 |
|
|
2008 |
|
|
|
Current |
|
|
Long-term |
|
|
Current |
|
|
Long-term |
|
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards |
|
$ |
7,177 |
|
|
$ |
2,706 |
|
|
$ |
7,558 |
|
|
$ |
13,547 |
|
Reserves and liabilities |
|
|
59,104 |
|
|
|
11,826 |
|
|
|
46,037 |
|
|
|
6,176 |
|
Unrealized losses on securities |
|
|
40 |
|
|
|
2,885 |
|
|
|
|
|
|
|
2,319 |
|
Excess of tax basis over net
book value of intangible assets |
|
|
|
|
|
|
83,204 |
|
|
|
|
|
|
|
80,182 |
|
Share-based payment awards |
|
|
|
|
|
|
18,511 |
|
|
|
|
|
|
|
17,665 |
|
Depreciation on property and equipment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
141 |
|
Credits and other |
|
|
|
|
|
|
1,775 |
|
|
|
|
|
|
|
1,387 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
66,321 |
|
|
|
120,907 |
|
|
|
53,595 |
|
|
|
121,417 |
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gains on securities |
|
|
|
|
|
|
|
|
|
|
(434 |
) |
|
|
|
|
Bond interest |
|
|
|
|
|
|
(45,334 |
) |
|
|
|
|
|
|
(37,605 |
) |
Depreciation on property and equipment |
|
|
|
|
|
|
(3,009 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(48,343 |
) |
|
|
(434 |
) |
|
|
(37,605 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Valuation allowance |
|
|
|
|
|
|
(7,617 |
) |
|
|
|
|
|
|
(6,663 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
66,321 |
|
|
$ |
64,947 |
|
|
$ |
53,161 |
|
|
$ |
77,149 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-39
On June 10, 2009, the Company sold all of the outstanding capital stock of Medicis Pediatrics
(see Note 6). The transaction generated a $24.8 million net gain for income tax purposes and,
accordingly, a $9.0 million income tax provision was established as part of the transaction.
In connection with its acquisition of LipoSonix in July 2008, the Company recorded $18.7
million of net deferred tax assets and decreased goodwill by $18.7 million as a result of tax
attributes acquired and basis differences in the net assets acquired. During the three months
ended September 30, 2009, the Company recorded $0.4 million of net deferred tax assets and
decreased goodwill by $0.4 million as a result of an adjustment to the tax attributes acquired.
At December 31, 2009, the Company has a federal net operating loss carryforward of
approximately $28.2 million, of which a portion will expire beginning in 2021 if not previously
utilized. The entire net operating loss carryforward was acquired in connection with the Companys
acquisition of LipoSonix. As a result of the related ownership change for LipoSonix, the annual
utilization of the net operating loss carryforward is limited under Internal Revenue Code Section
382. The federal net operating loss of $28.2 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, 2009 and 2008, the Company has an unrealized tax loss of $21.0 million and
$18.1 million, respectively, related to the Companys option to acquire Revance or license
Revances topical product that is under development. 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. At December 31, 2009
and 2008, the Company has recorded a valuation allowance of $7.6 million and $6.7 million,
respectively, against the deferred tax asset associated with this unrealized tax loss in order to
reduce the carrying value of the deferred tax asset to $0, which is the amount that management
believes is more likely than not to be realized.
The Company recorded a deferred tax asset (liability) of approximately $2.9 million, $(0.4)
million and $(0.4) million related to unrealized gains on available-for-sale securities in 2009,
2008 and 2007, respectively. All amounts have been presented as a component of other comprehensive
income in stockholders equity.
During 2009, 2008 and 2007, the Company made net tax payments of $44.6 million, $87.8 million
and $35.4 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 recently completed a
limited scope examination of the Companys tax return for the period ending December 31, 2007. The
exam resulted in no changes to the tax return as filed. In addition, the state of California is
currently conducting an examination on the Companys tax return for the periods ended June 30,
2005, December 31, 2005, December 31, 2006 and December 31, 2007.
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 limitations
may be open for up to five years from the date the tax return was filed. Thus, all returns filed
from fiscal 2005 forward are open under the statute of limitations.
F-40
Effective January 1, 2007, the Company adopted FIN No. 48, Accounting for Uncertainty in
Income Taxes. In accordance with FIN No. 48 (now part of ASC 740, Income Taxes), 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 2009, 2008 and 2007 beginning and ending amount of
unrecognized tax benefits is as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
Balance at beginning of period |
|
$ |
2,512 |
|
|
$ |
3,410 |
|
|
$ |
4,310 |
|
Additions based on tax positions related to the
current year |
|
|
118 |
|
|
|
|
|
|
|
|
|
Additions for tax positions of prior years |
|
|
1,010 |
|
|
|
|
|
|
|
200 |
|
Reductions for tax positions of prior years |
|
|
|
|
|
|
|
|
|
|
(1,100 |
) |
Settlements |
|
|
|
|
|
|
(898 |
) |
|
|
|
|
Reductions due to lapse in statute of limitations |
|
|
(1,383 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at end of period |
|
$ |
2,257 |
|
|
$ |
2,512 |
|
|
$ |
3,410 |
|
|
|
|
|
|
|
|
|
|
|
The amount of unrecognized tax benefits which, if ultimately recognized, could favorably
affect the effective tax rate in a future period is $1.7 million, $2.1 million and $2.5 million as
of December 31, 2009, 2008 and 2007, respectively. The Company estimates that it is reasonably
possible that the amount of unrecognized tax benefits will decrease by $0.8 million in the next
twelve months due to normal statute closures.
The Company recognizes accrued interest and penalties, if applicable, related to unrecognized
tax benefits in income tax expense. During the years ended December 31, 2009, 2008 and 2007, the
Company did not recognize a material amount in interest and penalties. The Company had
approximately $0.5 million and $0.3 million for the payment of interest and penalties accrued (net
of tax benefit) at December 31, 2009 and 2008, respectively.
14. DIVIDENDS DECLARED ON COMMON STOCK
During 2009, 2008 and 2007, the Company paid quarterly cash dividends aggregating $9.4
million, $8.6 million and $6.8 million, respectively, on its common stock. In addition, on
December 16, 2009, the Company declared a cash dividend of $0.04 per issued and outstanding share
of its Class A common stock payable on January 29, 2010, to stockholders of record at the close of
business on January 4, 2010. The $2.4 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, 2009. The Company has not adopted a dividend policy.
F-41
15. STOCK OPTION PLANS
As of December 31, 2009, 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,
2009, 9,253,847 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, 2009 vary in price from $11.28
to $39.04, with a weighted average exercise price of $29.24 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 |
|
|
Exerciseable |
|
|
Price |
|
|
$11.28 - $18.33 |
|
|
1,022,899 |
|
|
|
3.4 |
|
|
$ |
17.56 |
|
|
|
842,834 |
|
|
$ |
18.33 |
|
$19.60 - $26.89 |
|
|
536,849 |
|
|
|
3.2 |
|
|
$ |
23.28 |
|
|
|
518,720 |
|
|
$ |
23.41 |
|
$26.95 - $26.95 |
|
|
1,306,464 |
|
|
|
1.5 |
|
|
$ |
26.95 |
|
|
|
1,306,464 |
|
|
$ |
26.95 |
|
$27.30 - $27.63 |
|
|
1,512,068 |
|
|
|
0.6 |
|
|
$ |
27.63 |
|
|
|
1,512,068 |
|
|
$ |
27.63 |
|
$27.70 - $28.87 |
|
|
62,510 |
|
|
|
2.9 |
|
|
$ |
28.20 |
|
|
|
62,510 |
|
|
$ |
28.20 |
|
$29.20 - $29.20 |
|
|
1,666,710 |
|
|
|
3.6 |
|
|
$ |
29.20 |
|
|
|
1,666,710 |
|
|
$ |
29.20 |
|
$29.30 - $32.56 |
|
|
1,095,330 |
|
|
|
3.7 |
|
|
$ |
31.54 |
|
|
|
968,264 |
|
|
$ |
31.44 |
|
$32.81 - $36.06 |
|
|
171,607 |
|
|
|
4.3 |
|
|
$ |
33.78 |
|
|
|
160,879 |
|
|
$ |
33.81 |
|
$38.45 - $39.04 |
|
|
1,879,410 |
|
|
|
4.6 |
|
|
$ |
38.50 |
|
|
|
1,879,410 |
|
|
$ |
38.50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
9,253,847 |
|
|
|
3.0 |
|
|
$ |
29.24 |
|
|
|
8,917,859 |
|
|
$ |
29.52 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-42
A summary of stock options granted within the Plans and related information for 2009,
2008 and 2007 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
Qualified |
|
|
Non-Qualified |
|
|
Total |
|
|
Price |
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
127,702 |
|
|
|
127,702 |
|
|
$ |
22.22 |
|
Exercised |
|
|
(62,422 |
) |
|
|
(216,070 |
) |
|
|
(278,492 |
) |
|
$ |
15.59 |
|
Terminated/expired |
|
|
(58,936 |
) |
|
|
(749,872 |
) |
|
|
(808,808 |
) |
|
$ |
31.55 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
504,289 |
|
|
|
10,203,068 |
|
|
|
10,707,357 |
|
|
$ |
27.98 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
|
|
|
|
182,017 |
|
|
|
182,017 |
|
|
$ |
13.94 |
|
Exercised |
|
|
(157,515 |
) |
|
|
(976,900 |
) |
|
|
(1,134,415 |
) |
|
$ |
14.21 |
|
Terminated/expired |
|
|
(51,884 |
) |
|
|
(449,228 |
) |
|
|
(501,112 |
) |
|
$ |
30.70 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
294,890 |
|
|
|
8,958,957 |
|
|
|
9,253,847 |
|
|
$ |
29.24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16. NET INCOME PER COMMON SHARE
In June 2008, the FASB issued new guidance on determining whether instruments granted in
share-based payment transactions are participating securities. In the new guidance, which is now
part of ASC 260, Earnings per Share, unvested share-based payment awards that contain rights to
receive nonforfeitable dividends or dividend equivalents (whether paid or unpaid) are participating
securities, and thus, should be included in the two-class method of computing earnings per share.
The two-class method is an earnings allocation formula that treats a participating security as
having rights to earnings that would otherwise have been available to common stockholders.
Restricted stock granted to certain employees by the Company (see Note 2) participate in dividends
on the same basis as common shares, and these dividends are not forfeitable by the holders of the
restricted stock. As a result, the restricted stock grants meet the definition of a participating
security. The Company adopted the new guidance on January 1, 2009. Prior periods have
been restated as the provisions of the new guidance are to be applied retrospectively. The
adoption of the new guidance reduced basic earnings per share for years ended December 31, 2009 and
2007, by $0.04 and $0.01, respectively. The adoption of the new guidance reduced diluted earnings
per share for the years ended December 31, 2009 and 2007 by $0.03 and $0.01, respectively. There
was no impact to basic or diluted earnings per share for the year ended December 31, 2008.
F-43
The following table sets forth the computation of basic and diluted net income per common
share (in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEARS ENDED DECEMBER 31, |
|
|
|
2009 |
|
|
2008 |
|
|
2007 |
|
|
BASIC |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
75,951 |
|
|
$ |
10,276 |
|
|
$ |
70,436 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: income allocated to participating securities |
|
|
2,363 |
|
|
|
158 |
|
|
|
657 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income available to common stockholders |
|
$ |
73,588 |
|
|
$ |
10,118 |
|
|
$ |
69,779 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
57,252 |
|
|
|
56,567 |
|
|
|
55,988 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per common share |
|
$ |
1.29 |
|
|
$ |
0.18 |
|
|
$ |
1.25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
DILUTED |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
$ |
75,951 |
|
|
$ |
10,276 |
|
|
$ |
70,436 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: income allocated to participating securities |
|
|
2,363 |
|
|
|
158 |
|
|
|
657 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income available to common stockholders |
|
|
73,588 |
|
|
|
10,118 |
|
|
|
69,779 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less: |
|
|
|
|
|
|
|
|
|
|
|
|
Undistributed earnings allocated to unvested stockholders |
|
|
(2,099 |
) |
|
|
|
|
|
|
(597 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: |
|
|
|
|
|
|
|
|
|
|
|
|
Undistributed earnings re-allocated to unvested stockholders |
|
|
2,096 |
|
|
|
|
|
|
|
576 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Add: |
|
|
|
|
|
|
|
|
|
|
|
|
Tax-effected interest expense and issue costs related to Old Notes |
|
|
2,664 |
|
|
|
|
|
|
|
2,950 |
|
Tax-effected interest expense and issue costs related to New Notes |
|
|
2 |
|
|
|
|
|
|
|
3,357 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income assuming dilution |
|
$ |
76,251 |
|
|
$ |
10,118 |
|
|
$ |
76,065 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares outstanding |
|
|
57,252 |
|
|
|
56,567 |
|
|
|
55,988 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
Old Notes |
|
|
5,823 |
|
|
|
|
|
|
|
5,823 |
|
New Notes |
|
|
4 |
|
|
|
|
|
|
|
7,325 |
|
Stock options |
|
|
93 |
|
|
|
|
|
|
|
2,043 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares assuming dilution |
|
|
63,172 |
|
|
|
56,567 |
|
|
|
71,179 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per common share |
|
$ |
1.21 |
|
|
$ |
0.18 |
|
|
$ |
1.07 |
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per common share must be calculated using the if-converted method.
Diluted net income per share using the if-converted method 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 2009 excludes 10,329,522 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.
F-44
The diluted net income per common share computation for 2008 excludes 9,919,690 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 2008 also excludes restricted stock and stock options convertible
into 755,408 shares in the aggregate, and 5,822,551 and 3,124,742 shares of common stock, issuable
upon conversion of the Old Notes and New Notes, respectively, as they were anti-dilutive.
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.
17. 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 corporate notes and bonds.
At December 31, 2009 and 2008, two customers comprised approximately 84.2% and 64.7%,
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, 2009.
Substantially all of 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.
18. 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 2009, 2008 and 2007, the Company also made a discretionary contribution to
the plan. During 2009, 2008 and 2007, the Company recognized expense related to matching and
discretionary contributions under the Contribution Plan of $3.7 million, $2.7 million and $2.3
million, respectively.
F-45
19. QUARTERLY FINANCIAL INFORMATION (UNAUDITED)
The tables below list the quarterly financial information for 2009 and 2008. 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, 2009 |
|
|
|
(FOR THE QUARTERS ENDED) |
|
|
|
MARCH 31, 2009 (a) |
|
|
JUNE 30, 2009 (b) |
|
|
SEPTEMBER 30, 2009 (c) |
|
|
DECEMBER 31, 2009 (d) |
|
|
Net revenues |
|
$ |
99,819 |
|
|
$ |
141,246 |
|
|
$ |
151,811 |
|
|
$ |
179,040 |
|
Gross profit (1) |
|
|
90,373 |
|
|
|
128,179 |
|
|
|
138,271 |
|
|
|
158,259 |
|
Net income |
|
|
329 |
|
|
|
15,593 |
|
|
|
21,148 |
|
|
|
38,882 |
|
Basic net income per common share |
|
$ |
0.01 |
|
|
$ |
0.26 |
|
|
$ |
0.36 |
|
|
$ |
0.65 |
|
Diluted net income per common share |
|
$ |
0.01 |
|
|
$ |
0.25 |
|
|
$ |
0.33 |
|
|
$ |
0.60 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
YEAR ENDED DECEMBER 31, 2008 |
|
|
(FOR THE QUARTERS ENDED) |
|
|
MARCH 31, 2008 (e) |
|
JUNE 30, 2008 (f) |
|
SEPTEMBER 30, 2008 (g) |
|
DECEMBER 31, 2008 (h) |
|
Net revenues
|
|
$ |
128,903 |
|
|
$ |
137,450 |
|
|
$ |
115,425 |
|
|
$ |
135,971 |
|
Gross profit (1)
|
|
|
117,771 |
|
|
|
128,246 |
|
|
|
104,577 |
|
|
|
128,442 |
|
Net income (loss)
|
|
|
20,525 |
|
|
|
13,009 |
|
|
|
(14,657 |
) |
|
|
(8,601 |
) |
Basic net income (loss) per common share
|
|
$ |
0.36 |
|
|
$ |
0.23 |
|
|
$ |
(0.26 |
) |
|
$ |
(0.15 |
) |
Diluted net income (loss) per common share
|
|
$ |
0.31 |
|
|
$ |
0.21 |
|
|
$ |
(0.26 |
) |
|
$ |
(0.15 |
) |
|
|
|
(1) |
|
Gross profit does not include amortization of the related intangibles. |
Quarterly results were impacted by the following items:
|
(a) |
|
Operating expenses included $5.0 million paid to IMPAX related to a product development
agreement and approximately $3.9 million of compensation expense related to stock options,
restricted stock and stock appreciation rights. |
|
|
(b) |
|
Operating expenses included approximately $5.0 million of compensation expense related
to stock options, restricted stock and stock appreciation rights and $3.0 million paid to
Perrigo related to a product development agreement. |
|
|
(c) |
|
Operating expenses included $10.0 million paid to Revance related to a product
development agreement, $5.0 million paid to IMPAX related to a product development
agreement, $2.0 million paid to Perrigo related to a product development agreement and
approximately $4.7 million of compensation expense related to stock options, restricted
stock and stock appreciation rights. |
|
|
(d) |
|
Operating expenses included $5.3 million paid to Glenmark related to license and
settlement agreements, $2.0 million paid to IMPAX related to a product development
agreement and approximately $5.6 million of compensation expense related to stock options,
restricted stock and stock appreciation rights. |
|
|
(e) |
|
Operating expenses included approximately $4.4 million of compensation expense related
to stock options and restricted stock. |
|
|
(f) |
|
Operating expenses included a $25.0 million payment to Ipsen upon the FDAs acceptance
of Ipsens BLA for DYSPORTTM and approximately $4.7 million of compensation
expense related to stock options and restricted stock. |
|
|
(g) |
|
Operating expenses included $30.5 million of acquired in-process research and
development expense related to the Companys acquisition of LipoSonix, approximately $4.8
million of lease exit costs related to |
F-46
|
|
|
the Companys previous headquarters facility and approximately $4.1 million of compensation
expense related to stock options and restricted stock. |
|
|
(h) |
|
Operating expenses included $40.0 million paid to IMPAX related to a product
development agreement and approximately $3.4 million of compensation expense related to
stock options and restricted stock. |
F-47
SCHEDULE II VALUATION AND QUALIFYING ACCOUNTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Charged to |
|
|
|
|
|
|
|
|
|
|
|
|
|
beginning of |
|
|
costs and |
|
|
Charged to |
|
|
|
|
|
|
Balance at end |
|
Description |
|
period |
|
|
expense |
|
|
other accounts |
|
|
Deductions |
|
|
of period |
|
|
|
(in thousands) |
Year Ended December 31, 2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted from Asset Accounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances |
|
$ |
1,719 |
|
|
$ |
21,983 |
|
|
$ |
|
|
|
$ |
(20,854 |
) |
|
$ |
2,848 |
|
Year Ended December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted from Asset Accounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances |
|
$ |
830 |
|
|
$ |
15,157 |
|
|
$ |
|
|
|
$ |
(14,268 |
) |
|
$ |
1,719 |
|
Year Ended December 31, 2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted from Asset Accounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances |
|
$ |
2,148 |
|
|
$ |
11,385 |
|
|
$ |
|
|
|
$ |
(12,703 |
) |
|
$ |
830 |
|
S-1