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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K/T
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the fiscal year
ended . |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the transition period from July 1, 2005 to
December 31, 2005 |
Commission file number 0-18443
MEDICIS PHARMACEUTICAL CORPORATION
(Exact name of registrant as specified in its charter)
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Delaware
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52-1574808 |
(State of other jurisdiction
of incorporation or organization) |
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(I.R.S. Employer
Identification No.) |
8125 North Hayden Road,
Scottsdale, Arizona
(Address of principal executive office) |
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85258-2463
(Zip Code) |
Registrants telephone number, including area code:
(602) 808-8800
Securities registered pursuant to Section 12(b) of the
Act: Class A common stock, $0.014 par value
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New York Stock Exchange
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Preference Share Purchase Rights |
(Name of each exchange on which
registered)
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(Title of each Class) |
Securities registered pursuant to Section 12(g) of the
Act:
NONE
Indicate by check mark if the registrant is a well-known
seasoned issuer, as defined in Rule 405 of the Securities
Act. Yes þ No o
Indicate by check mark if the registrant is not required to file
reports pursuant to Section 13 or Section 15(d) of the
Act. Yes o No þ
Indicate by check mark whether the registrant (1) has filed
all reports required to be filed by Section 13 or 15(d) of
the Securities Exchange Act of 1934 during the preceding
12 months (or for such shorter period that the registrant
was required to file such reports), and (2) has been
subject to such filing requirements for the past
90 days. Yes þ Noo
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/
T o.
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, or a non-accelerated
filer. See definition of accelerated filer and large
accelerated filer in
Rule 12b-2 of the
Exchange Act. (Check one):
Large accelerated
filer þ Accelerated
filer o Non-accelerated
filer o
Indicate by check mark whether the registrant is a shell company
(as defined in
Rule 12b-2 of the
Exchange Act)
Yes o No þ
The aggregate market value of the voting stock held on
December 31, 2005 by non-affiliates of the registrant was
$1,225,975,222 based on the closing price of $32.05 per
share as reported on the New York Stock Exchange on
December 30, 2005, the last business day of the
registrants most recently completed second fiscal quarter
(calculated by excluding all shares held by executive officers,
directors and holders known to the registrant of five percent or
more of the voting power of the registrants common stock,
without conceding that such persons are affiliates
of the registrant for purposes of the federal securities laws).
As of March 10, 2006, there were 54,427,972, outstanding
shares of Class A common stock.
Documents incorporated by reference:
Portions of the Proxy Statement for the registrants 2006
Annual Meeting of Shareholders (the Proxy Statement)
are incorporated herein by reference in Part III of this
Form 10-K/ T to
the extent stated herein.
TABLE OF CONTENTS
PART I
Item 1. Business
Change in Fiscal Year
Effective December 31, 2005, Medicis Pharmaceutical
Corporation (Medicis, the Company, or as
used in the context of we, us or
our) changed its fiscal year end from June 30
to December 31. This change was made to align our fiscal
year end with other companies within our industry. This
Form 10-K/ T is
intended to cover the transition report for the period
July 1, 2005 through December 31, 2005 (the
Transition Period). Subsequent to this, our
Form 10-K will
cover the calendar year January 1 to December 31. We refer
to the period beginning July 1, 2004 and ending
June 30, 2005 as fiscal 2005, the period
beginning July 1, 2003 and ending June 30, 2004 as
fiscal 2004 and the period beginning July 1,
2002 and ending June 30, 2003 as fiscal 2003.
The Company
Medicis Pharmaceutical Corporation, together with its 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 of products for the treatment of
dermatological and aesthetic conditions in the United States and
Canada, and podiatric conditions in the United States. We
believe that annual U.S. pharmaceutical sales in the
dermatological market exceed $5 billion. According to the
American Society for Aesthetic Plastic Surgery, a national
not-for-profit organization for education and research in
cosmetic plastic surgery, nearly 11.5 million surgical and
non-surgical cosmetic procedures were performed in the United
States during 2005, including approximately 9.3 million
non-surgical cosmetic procedures.
We have built our business by executing a four-part growth
strategy: promoting existing core brands, developing new
products and important product line extensions, entering into
strategic collaborations, and acquiring complementary products,
technologies and businesses. Our core philosophy is to cultivate
relationships of trust and confidence with the high prescribing
dermatologists and podiatrists and the leading plastic surgeons
in the United States.
We offer a broad range of products addressing various conditions
including acne, fungal infections, rosacea, hyperpigmentation,
photoaging, psoriasis, eczema, skin and skin-structure
infections, seborrheic dermatitis and cosmesis (improvement in
the texture and appearance of skin). We currently offer 15
branded products. Our core brands are
DYNACIN®
(minocycline HCI),
LOPROX®
(ciclopirox),
OMNICEF®
(cefdinir),
PLEXION®
(sodium sulfacetamide/sulfur),
RESTYLANE®
(hyaluronic acid),
TRIAZ®
(benzoyl peroxide), and
VANOStm
(fluocinonide) Cream 0.1%. All of our core brands enjoy branded
market leadership in the segments in which they compete. Because
of the significance of these brands to our business, we
concentrate our sales and marketing efforts in promoting them to
physicians in our target markets. We also sell a number of other
products that are considered less critical to our business.
We also develop and obtain marketing and distribution rights to
pharmaceutical agents in various stages of development. We have
a variety of products under development, ranging from new
products to existing product line extensions and reformulations
of existing products. Our product development strategy involves
the rapid evaluation and formulation of new therapeutics by
obtaining preclinical safety and efficacy data, when possible,
followed by rapid safety and efficacy testing in humans. In
2003, we expanded into the dermal aesthetic market through our
acquisition of the exclusive United States and Canadian rights
to market, distribute and commercialize the dermal restorative
product lines known as
RESTYLANE®,
PERLANEtm
and RESTYLANE FINE
LINEStm.
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.
1
OMNICEF®
is a trademark of Fujisawa Pharmaceutical Co. Ltd. and is used
under a license from Abbott Laboratories, Inc.
(Abbott). On April 1, 2005, Fujisawa
Pharmaceutical Co. Ltd. merged with Yamanouchi Pharmaceutical
Co. Ltd., creating Astelles Pharma, Inc.
Our Products
We currently market 15 branded products. Our sales and marketing
efforts are currently focused on our core brands, which, during
the Transition Period and fiscal 2005, accounted for
approximately 84% and 76%, respectively, of our total net
revenues. The following chart details certain important features
of our core brands:
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Brand |
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Treatment |
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U.S. Market Impact |
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DYNACIN®
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Oral adjunctive treatment for severe acne |
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The number one branded minocycline product in the U.S.,
DYNACIN®
tablets and capsules are available in a range of strengths |
LOPROX®
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Topical treatment for certain fungal and yeast infections in
adults |
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A leading antifungal agent, including the number one branded
shampoo for seborrheic dermatitis |
OMNICEF®
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A patented oral cephalosporin for skin and skin-structure
infections |
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Superior kill rate compared to most frequently prescribed
antibiotic for this indication |
PLEXION®
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Topical treatments for acne vulgaris, acne rosacea and
seborrheic dermatitis |
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Includes the leading branded prescription cleanser indicated for
the treatment of rosacea, and the first prescription cleansing
cloth for the treatment of acne and rosacea |
RESTYLANE®
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Injectable gel for treatment of severe facial wrinkles and
folds, such as nasolabial folds |
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Launched on January 6, 2004, following approval by the Food
and Drug Administration (FDA) on December 12,
2003, is the leading worldwide injectible dermal filler |
TRIAZ®
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Topical patented gel and cleanser and patent-pending pad
treatments for acne |
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The leading branded prescription benzoyl peroxide product |
VANOS
tm
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Super-high potency topical corticosteroid for the treatment of
plaque-type psoriasis in adult patients affecting up to 10% body
surface area |
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Launched on April 19, 2005 following FDA approval on
February 11, 2005 |
Prescription Pharmaceuticals
Our principal branded pharmaceutical products are described
below:
DYNACIN®
is an oral antibiotic, available in
50-mg.,
75-mg. and
100-mg. tablet and
capsule dosage forms, and is prescribed as an adjunctive therapy
in severe acne. The most commonly prescribed systemic acne
treatments are tetracycline and its derivatives, minocycline and
doxycycline. Minocycline, the active ingredient in
DYNACIN®,
is widely prescribed for the treatment of acne for several
reasons. It has a more convenient dosing schedule, two doses per
day, as compared to other forms of tetracycline, which can
require up to four doses per day. Other forms of tetracycline,
including doxycycline, require ingestion on an empty stomach and
have been reported to often cause gastric irritation and
photosensitivity. In addition, resistance to several commonly
used antibiotics, including erythromycin, clindamycin,
doxycycline and tetracycline, by the primary bacterial organism
responsible for acne has been documented. Our
DYNACIN®
products compete with branded products such as
Doryx®,
Adoxa®,
Monodox®,
and
myractm,
as well as various generic products.
DYNACIN®
capsules were launched in fiscal 1993 with
50-mg. and
100-mg. dosage forms
available. We launched
DYNACIN®
capsules in a 75-mg.
dosage form in fiscal 1999. During fiscal 2003, we launched
2
DYNACIN®
in tablet form in
75-mg. and
100-mg. dosages, and we
launched the 50-mg.
dosage in fiscal 2004.
LOPROX®
gel is a broad-spectrum prescription antifungal agent indicated
for the topical treatment of interdigital tinea pedis, tinea
corporis, and the topical treatment of seborrheic dermatitis of
the scalp. Currently,
LOPROX®
Gel is the only gel approved in the United States for seborrheic
dermatitis. In addition to the gel formulation of
LOPROX®,
we market
LOPROX®
cream and topical suspension for the topical treatment of tinea
pedis, tinea corporis, tinea cruris, tinea versicolor and
cutaneous candidiasis.
LOPROX®
works with a unique mode of action and has been shown to have
fungistatic and fungicidal properties. The most frequently
prescribed topical antifungal products in addition to
LOPROX®
include competitor products
Spectazole®,
Nizoral®,
Oxistat®
and
Lotrisone®
(steroid/antifungal combination). There are also generic
versions of many of our
LOPROX®
products available in the market. During fiscal 2003, we
launched
LOPROX®
Shampoo, which was the first prescription antifungal shampoo
approved in the United States for the treatment of seborrheic
dermatitis of the scalp, a common fungal infection.
OMNICEF®
is indicated for the treatment of uncomplicated skin and
skin-structure infections. Studies show that
OMNICEF®
has superior pathogen eradication rates versus Cephalexin, the
most frequently prescribed antibiotic for uncomplicated skin and
skin-structure infections.
OMNICEF®
has been promoted to dermatologists and podiatrists since May
2001 pursuant to our exclusive co-promotion agreement with
Abbott. In return, we receive commission revenue from Abbott
based on prescriptions generated in these categories. Our
agreement with Abbott expires in 2013.
PLEXION®
treats acne vulgaris, acne rosacea and seborrheic dermatitis
with internally developed cleanser and topical therapies. Acne
rosacea is a chronic skin condition causing inflammation and
redness of the face. The active ingredients in our
PLEXION®
products are sodium sulfacetamide and sulfur.
PLEXION®,
the patented leading branded prescription cleanser indicated for
the treatment of acne rosacea, was launched in fiscal 2000. The
topical acne rosacea market is comprised of competitor products
such as
MetroGel®,
MetroCream®
and
MetroLotion®.
PLEXION
TS®,
a gentle topical suspension, was launched in fiscal 2001. In
addition, during fiscal 2002 we launched PLEXION
SCT®,
a short contact therapy with a silica base that helps remove
impurities from the skin pores. During fiscal 2005, we launched
the first prescription cleansing cloth,
PLEXION®
Cleansing Cloths. Within its first three months on the market,
PLEXION®
Cleansing Cloths became the leading branded sodium sulfacetamide
and sulfur cleansing formulation in new prescriptions.
TRIAZ®,
an internally developed topical therapy prescribed for the
treatment of numerous forms and varying degrees of acne, is
available as a patented gel or cleanser or in a patent-pending
pad in three concentrations.
TRIAZ®
products are manufactured using the active ingredient benzoyl
peroxide in a patented vehicle containing glycolic acid and zinc
lactate. Studies conducted by third parties have shown that
benzoyl peroxide is the most efficacious agent available for
eradicating the bacteria that cause acne with no reported
resistance. We introduced the
TRIAZ®
brand in fiscal 1996. In July 2003, we launched
TRIAZ®
Pads, the first and only benzoyl peroxide pad available in the
U.S. indicated for the topical treatment of acne vulgaris.
VANOStm
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
treatment of plaque-type psoriasis in adult patients.
Plaque-type psoriasis is the most common form of psoriasis, a
chronic, recurrent skin disorder affecting up to 2% of the
United States population and characterized by scaling, often
itching plaques in certain areas of the body that typically
follow a course of exacerbation and remission. The active
ingredient in
VANOStm
is fluocinonide 0.1%, and is the only fluocinonide available in
the Class I category of topical corticosteroids. Physicians
may already be familiar with the fluocinonide 0.05%, the active
ingredient in another of our products, the Class II
corticosteroid
LIDEX®.
Two double blind clinical studies have demonstrated the
efficacy, safety and tolerability of
VANOStm.
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
VANOStm
either once or twice daily. Considering that plaque-type
psoriasis is recognized as a major challenge for physicians, and
that
VANOStm
is a new entry in its category, we believe
VANOStm
will
3
be an important treatment option for patients that suffer from
plaque-type psoriasis. On March 2, 2006, the FDA broadened
the indication of VANOS, and it is now indicated as a primary
therapy for all inflammatory and pruritic skin conditions in
patients 12 years of age of older which are responsive to
cortocosteroids. Such conditions include eczema and poison ivy,
which occur commonly.
Dermal Restorative Products
Our principal branded dermal restorative products are described
below:
RESTYLANE®,
PERLANEtm,
RESTYLANE FINE
LINEStm
and
SubQtm
are injectable, transparent, Non-Animal-Stabilized-Hyaluronic
Acid
(NASHAtm)
gels, which require no patient sensitivity tests in advance of
product administration. These tissue tailored,
transparent, injectable products, which come in pre-packaged,
glass syringes, have varying gel particle sizes which provide
physicians with flexibility in treating fine lines and wrinkles
and correcting deep facial folds. In the United States, the FDA
regulates these products as medical devices. Medicis offers all
four of these products in Canada, and began offering
RESTYLANE®
in the United States on January 6, 2004.
PERLANEtm,
RESTYLANE FINE
LINEStm
and
SubQtm
have not yet been approved by the FDA for use in the United
States.
SubQtm
was approved for use in Canada on June 23, 2005. We
acquired the exclusive U.S. and Canadian rights to these dermal
restorative products from Q-Med AB, a Swedish
biotechnology/medical device company and its affiliates
(collectively Q-Med) through license agreements.
Research and Development
We develop and obtain rights to pharmaceutical agents in various
stages of development. Currently, we have a variety of products
under development, ranging from new products to existing product
line extensions and reformulations of existing products. Our
product development strategy involves the rapid evaluation and
formulation of new therapeutics by obtaining preclinical safety
and efficacy data, when possible, followed by rapid safety and
efficacy testing in humans. As a result of our increasing
financial strength, we have begun adding long-term projects to
our development pipeline. Historically, we have supplemented our
research and development efforts by entering into research and
development agreements with other pharmaceutical and
biotechnology companies.
On September 26, 2002, we entered into an exclusive license
and development agreement with Dow Pharmaceutical Sciences, Inc.
(Dow) for the development and commercialization of a
patented dermatologic product. Under terms of the agreement, as
amended, we made an initial payment of $5.4 million and a
development milestone payment of $8.8 million to Dow during
fiscal 2003, a development milestone payment of
$2.4 million to Dow during fiscal 2004 and development
milestone payments totaling $11.9 million to Dow during the
Transition Period. In accordance with the agreement between the
parties, Medicis is required to make a potential additional
payment of $1.0 million upon the certification that a
certain development milestone has occurred. All payments were
recorded as charges to research and development expense in the
periods in which the milestones were achieved.
On July 15, 2004, we entered into an exclusive license
agreement and other ancillary documents with
Q-Med to market,
distribute, sell and commercialize in the United States and
Canada Q-Meds product currently known as
SubQtm.
Q-Med has the exclusive right to manufacture
SubQtm
for Medicis.
SubQtm
is currently not approved for use in the United States. Under
the terms of the license agreement, Medicis Aesthetics Holdings
Inc., a wholly owned subsidiary of Medicis, licenses
SubQtm
for approximately $80.0 million, due as follows:
approximately $30.0 million paid on July 15, 2004,
which was recorded as research and development expense during
the first quarter of fiscal 2005; approximately
$10.0 million upon successful completion of certain
clinical milestones; approximately $20.0 million upon the
satisfaction of certain defined regulatory milestones; and
approximately $20.0 million upon U.S. launch of
SubQtm.
We also will make additional milestone payments to Q-Med upon
the achievement of certain commercial milestones.
SubQtm
is comprised of the same
NASHAtm
substance as
RESTYLANE®,
PERLANEtm
and RESTYLANE FINE
LINEStm
with a larger gel particle size and has patent protection until
at least 2015 in the United States.
4
On December 13, 2004, we entered into an exclusive
development and license agreement and other ancillary agreements
with Ansata Therapeutics, Inc. (Ansata). The
development and license agreement grants us the exclusive,
worldwide rights to Ansatas early stage, proprietary
antimicrobial peptide technology. In accordance with the
development and license agreement, we paid $5.0 million
upon signing of the contract and will pay approximately
$9.0 million upon the successful completion of certain
developmental milestones. Should we continue with the
development of this technology, we will incur additional
milestone payments beyond the development and license agreement.
The initial $5.0 million payment was recorded as a charge
to research and development expense during the second quarter of
fiscal 2005.
On January 28, 2005, we amended our strategic alliance with
aaiPharma, Inc. (aaiPharma) previously initiated in
June 2002 for the development, commercialization and license of
a dermatologic product. The consummation of the amendment has
not affected the timing of the development project. The
amendment allowed for the immediate transfer of the work product
as defined under the agreement, as well as the products
management and development, to us, and provides that aaiPharma
will continue to assist us with the development of the product
on a fee for services basis. We will have no future financial
obligations to pay aaiPharma on the attainment of clinical
milestones, but we incurred approximately $8.3 million as a
charge to research and development expense during the third
quarter of fiscal 2005, as part of the amendment and the
assumption of all liabilities associated with the project.
We incurred total research and development costs for all of our
sponsored and unreimbursed co-sponsored pharmaceutical projects
for the Transition Period, the corresponding six-month period of
2004, fiscal 2005, fiscal 2004 and fiscal 2003 of
$22.4 million, $45.1 million, $65.7 million,
$16.5 million and $29.6 million, respectively.
Research and development costs for the Transition Period include
$11.9 million paid to Dow pursuant to the development
agreement. Research and development costs for the corresponding
six-month period of 2004 include $30.0 million related to
our license agreement with Q-Med related to the
SubQtm
product, and $5.0 million related to our development and
license agreement with Ansata. Research and development costs
for fiscal 2005 include $30.0 million related to our
license agreement with Q-Med related to the
SubQtm
product, $5.0 million related to our development and
license agreement with Ansata and $8.3 million related to
our research and development collaboration with aaiPharma.
Research and development costs for fiscal 2004 include
$2.4 million paid to Dow pursuant to the development
agreement. Research and development costs for fiscal 2003
include $14.2 million paid to Dow pursuant to the
development agreement, and $6.0 million related to our
research and development collaboration with aaiPharma.
Sales and Marketing
Our combined dedicated sales force, consisting of
163 employees as of December 31, 2005, focuses on high
prescribing dermatologists, plastic surgeons and podiatrists.
Since a relatively small number of physicians are responsible
for writing a majority of dermatological and podiatric
prescriptions and performing dermal aesthetic procedures, we
believe that the size of our sales force is appropriate to reach
our target physicians. Our therapeutic dermatology and podiatric
sales forces consist of 110 employees who regularly call on
approximately 9,300 dermatologists and
3,200 podiatrists. Our dermal aesthetic sales force
consists of 53 employees who regularly call on leading
plastic surgeons, facial plastic surgeons, dermatologists and
dermatologic surgeons. We also have seven national account
managers who regularly call on managed care organizations, large
retail chains, formularies and related organizations.
We cultivate relationships of trust and confidence with the high
prescribing dermatologists and podiatrists and the leading
plastic surgeons in the United States. We use a variety of
marketing techniques to promote our products including sampling,
journal advertising, promotional materials, specialty
publications, coupons, money-back or product replacement
guarantees, educational conferences and informational websites.
We believe we have created an attractive incentive program for
our sales force that is based upon goals in prescription growth
and market share achievement.
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Warehousing and Distribution
We utilize an independent national warehousing corporation to
store and distribute our products from primarily two regional
warehouses in Nevada and Georgia, as well as additional
warehouses in Maryland and North Carolina. Upon the receipt of a
purchase order through electronic data input (EDI),
phone, mail or facsimile, the order is processed through our
inventory management systems and is transmitted electronically
to the appropriate warehouse for picking and packing. Upon
shipment, the warehouse sends back to us via EDI the necessary
information to automatically process the invoice in a timely
manner.
Customers
Our customers include certain of the nations leading
wholesale pharmaceutical distributors, such as AmerisourceBergen
Corporation (AmerisourceBergen), Cardinal Health,
Inc. (Cardinal), McKesson Corporation
(McKesson) and other major drug chains. During the
Transition Period, the comparable six-month period in 2004, and
the last three full fiscal years, these customers accounted for
the following portions of our net revenues:
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Six-Month | |
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Transition | |
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Period in | |
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Fiscal | |
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Fiscal | |
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Fiscal | |
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Period | |
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2004 | |
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2005 | |
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2004 | |
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2003 | |
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McKesson
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54.9 |
% |
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50.8 |
% |
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51.2 |
% |
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36.9 |
% |
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20.2 |
% |
Cardinal
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18.9 |
% |
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19.7 |
% |
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21.8 |
% |
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23.8 |
% |
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25.4 |
% |
Quality King
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17.0 |
% |
AmerisourceBergen
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15.5 |
% |
McKesson is our sole distributor of our
RESTYLANE®
products in the United States and Canada.
RESTYLANE®,
our highest-selling product during the Transition Period and
fiscal 2005, was launched in the United States in January 2004.
Seasonality
Our business, taken as a whole, is not materially affected by
seasonal factors, although a substantial portion of our
prescription product revenues has been recognized in the last
month of each quarter and we schedule our inventory purchases to
meet anticipated customer demand. As a result, relatively small
delays in the receipt of manufactured products by us could
result in revenues being deferred or lost.
Manufacturing
We currently outsource all of our manufacturing needs, and we
are required by the FDA to contract only with manufacturers who
comply with current Good Manufacturing Practices
(cGMP) regulations and other applicable laws and
regulations. Typically our manufacturing contracts are
short-term. We review our manufacturing arrangements on a
regular basis and assess the viability of alternative
manufacturers if our current manufacturers are unable to fulfill
our needs.
Patheon, Inc. (Patheon) manufactures the capsule
form of our
DYNACIN®
branded products under a supply agreement that automatically
renews on an annual basis, unless terminated by either party.
Par Pharmaceutical, Inc. (Par) manufactures the
tablet form of our
DYNACIN®
branded products in accordance with a supply agreement that
expires in June 2012.
Our
PLEXION®
and
TRIAZ®
branded products are manufactured by Contract Pharmaceuticals
Limited pursuant to a manufacturing agreement that automatically
renews on an annual basis, unless terminated by either party.
Our
LOPROX®
gel branded products are manufactured by Aventis S.A.
(Aventis) in accordance with a supply agreement that
renews automatically on an annual basis, unless terminated by
either party. Our
6
LOPROX®
TS and
LOPROX®
shampoo branded products are manufactured by Patheon under a
supply agreement that automatically renews on an annual basis,
unless terminated by either party. Our
LOPROX®
cream branded product is manufactured by both Aventis and
Patheon.
Our
OMNICEF®
branded product, which we promote through a license agreement
with Abbott, is manufactured, warehoused and distributed by
Abbott. The license agreement expires in 2013.
Our
RESTYLANE®
branded product is manufactured by Q-Med pursuant to a long-term
supply agreement that expires no earlier than 2013.
Our
VANOStm
branded product is manufactured by Patheon under a supply
agreement that automatically renews on an annual basis, unless
terminated by either party.
Raw Materials
We and the manufacturers of our products rely on suppliers of
raw materials used in the production of our products. Some of
these materials are available from only one source and others
may become available from only one source. Any disruption in the
supply of raw materials or an increase in the cost of raw
materials to our manufacturers could have a significant effect
on their ability to supply us with our products.
License and Royalty Agreements
Pursuant to license agreements with third parties, we have
acquired rights to manufacture, use or market certain of our
existing products, as well as many of our development products
and technologies. Such agreements typically contain provisions
requiring us to use our best efforts or otherwise exercise
diligence in pursuing market development for such products in
order to maintain the rights granted under the agreements and
may be canceled upon our failure to perform our payment or other
obligations. In addition, we have licensed certain rights to
manufacture, use and sell certain of our technologies outside
the United States and Canada to various licensees.
Trademarks, Patents and Proprietary Rights
We believe that trademark protection is an important part of
establishing product and brand recognition. We own a number of
registered trademarks and trademark applications.
U.S. federal registrations for trademarks remain in force
for 10 years and may be renewed every 10 years after
issuance, provided the mark is still being used in commerce.
We have obtained and licensed a number of patents covering key
aspects of certain of our products, including a U.S. patent
expiring in October 2015 covering various formulations of
TRIAZ®,
a U.S. patent expiring in 2015 covering
RESTYLANE®,
a U.S. patent expiring in 2020 covering
PLEXION®
cleanser formulation, a U.S. patent expiring in 2020
covering
PLEXION®
topical suspension and SCT formulations and a U.S. patent
expiring in December 2021 covering
VANOStm.
We have patent applications pending relating to our
PLEXION®
cleansing cloths formulation and our
LOPROX®
gel and shampoo formulations. We are also pursuing several other
U.S. and foreign patent applications.
We rely and expect to continue to rely upon unpatented
proprietary know-how and technological innovation in the
development and manufacture of many of our principal products.
Our policy is to require all our employees, consultants and
advisors to enter into confidentiality agreements with us.
Our success with our products will depend, in part, on our
ability to obtain, and successfully defend if challenged, patent
or other proprietary protection. However, the issuance of a
patent is not conclusive as to its validity or as to the
enforceable scope of the claims of the patent. Accordingly, our
patents may not prevent other companies from developing similar
or functionally equivalent products or from successfully
challenging the validity of our patents. As a result, if our
patent applications are not approved or, even if approved, such
patents are circumvented or not upheld in a legal proceeding,
our ability to competitively exploit our patented products and
technologies may be significantly reduced. Also, such patents
may or may not provide
7
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.
From time to time, we may need to obtain licenses to patents and
other proprietary rights held by third parties to develop,
manufacture and market our products. If we are unable to timely
obtain these licenses on commercially reasonable terms, our
ability to commercially exploit such products may be inhibited
or prevented.
Competition
The pharmaceutical and dermal aesthetics industries are
characterized by intense competition, rapid product development
and technological change. As a result, competition is intense
among manufacturers of prescription pharmaceuticals and dermal
injection products, such as for our core brands.
Many of our competitors are large, well-established
pharmaceutical, chemical, cosmetic or health care companies with
considerably greater financial, marketing, sales and technical
resources than those available to us. Additionally, many of our
present and potential competitors have research and development
capabilities that may allow them to develop new or improved
products that may compete with our product lines. Our products
could be rendered obsolete or made uneconomical by the
development of new products to treat the conditions addressed by
our products, technological advances affecting the cost of
production, or marketing or pricing actions by one or more of
our competitors. Each of our products competes for a share of
the existing market with numerous products that have become
standard treatments recommended or prescribed by dermatologists
and podiatrists and administered by plastic surgeons and
aesthetic dermatologists.
The largest competitors for our prescription dermatological
products include Bristol-Myers Squibb, Galderma,
GlaxoSmithKline, Johnson & Johnson, Pfizer,
sanofi-aventis, Schering-Plough, Valeant Pharmaceuticals, Wyeth
and others. Several of our core 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 and other
third-party payors seek to encourage the use of generic
products, making branded products less attractive, from a cost
perspective, to buyers. On July 18, 2004, Glades
Pharmaceuticals, LLC (Glades), a wholly owned
subsidiary of Stiefel Laboratories, Inc., announced the launch
of
myractm
(minocycline hydrochloride tablets, USP), as a branded
pharmaceutical product.
Myractm
tablets is a prescription product that competes directly with
our
DYNACIN®
tablet products. During the third quarter of our fiscal 2005,
myractm
began being marketed as a generic product. On August 6,
2004, the FDA approved an Abbreviated New Drug Application
(ANDA) submitted by Altana, Inc.
(Altana) for its ciclopirox topical suspension, a
generic version of our
LOPROX®
TS product. On December 29, 2004, the FDA approved an ANDA
submitted by Altana for its ciclopirox cream, a generic version
of our
LOPROX®
Cream product. On August 10, 2005, the FDA approved an ANDA
submitted by Taro Pharmaceuticals U.S.A. Inc. (Taro)
for its ciclopirox topical suspension, a generic version of our
LOPROX®
topical suspension. On March 7, 2006, the Perrigo Company
announced that it received approval from the FDA to manufacture
and market its ciclopirox olamine cream USP, 0.77%, a generic
version of our
LOPROX®
Cream product.
Our facial aesthetics products compete against Inamed
Corporation (Inamed) and Allergan Inc. On
December 6, 2005, Inamed announced that it had submitted
the fourth and final module of its Premarket Approval
Application for three formulations of
Juvedermtm,
a dermal filler product. Allergan Inc., the marketer of
Botox®,
is a larger company than Medicis, and has greater financial,
marketing, sales and technical resources than those available to
us. Allergan Inc. and Inamed are parties to a definitive merger
agreement pursuant to which Allergan will acquire Inamed. In
addition, there are several dermal filler products under
development and/or in the FDA pipeline for approval which claim
to offer equivalent or greater facial aesthetic benefits to
RESTYLANE®
and, if approved, the companies producing such products could
charge less to doctors for their products.
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Government Regulation
The manufacture and sale of biological products, drugs and
medical devices are subject to regulation principally by the
FDA, but also by other federal agencies and state and local
authorities in the United States, and by comparable agencies in
certain foreign countries. The Federal Trade Commission
(FTC), the FDA and state and local authorities
regulate the advertising of
over-the-counter drugs
and cosmetics. The Federal Food, Drugs and Cosmetics Act and the
regulations promulgated thereunder, and other federal and state
statutes and regulations, govern, among other things, the
testing, manufacture, safety, effectiveness, labeling, storage,
record keeping, approval, sale, distribution, advertising and
promotion of our products.
Our
RESTYLANE®
dermal filler product is a medical device intended for human use
and is subject to regulation by the FDA in the United States.
Unless an exemption applies, each medical device we market in
the U.S. must have a Premarket Approval Application
(PMA) in accordance with the Federal Food, Drug, and
Cosmetic Act, as amended, or a 510(k) clearance (a demonstration
that the new device is substantially equivalent to a
device already on the market). FDA device regulations 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 require compliance with
quality systems regulations (QSRs), as
verified by detailed FDA investigations of manufacturing
facilities. These regulations also require post-approval
reporting of alleged product defects, recalls and certain
adverse experiences to the FDA. 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. Class II devices are subject to
special controls in addition to general controls and generally
require the submission of a premarket notification before
marketing is permitted. Class III devices are subject to
the most comprehensive regulation and in most cases require
submission to the FDA of a PMA application that includes
biocompatibility, manufacturing and clinical data supporting the
safety and effectiveness of the device as well as compliance
with the same provisions applicable to all medical devices such
as QSRs. Annual reports must be submitted to the FDA, as well as
descriptions of certain adverse events that are reported to the
sponsor within specified timeframes of receipt of such reports.
RESTYLANE®
is regulated as a Class III medical device.
RESTYLANE®
has been approved by the FDA under a PMA.
In general, products falling within the FDAs definition of
new drugs require premarket approval by the FDA.
Products falling within the FDAs definition of
cosmetics or of drugs (if they are not
also new drugs) and that are generally recognized as
safe and effective do not require premarketing
clearance although all drugs must comply with a host of
post-market regulations, including manufacture under cGMP. The
steps required before a new drug may be marketed in
the United States include (i) preclinical laboratory and
animal testing; (ii) manufacture under cGMP;
(iii) submission to the FDA of an Investigational New Drug
(or IND) application, which must become effective
before clinical trials may commence; (iv) usually 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) (v) submission to
the FDA of a New Drug Application (or NDA); and
(vi) FDA approval of the NDA before any commercial sale or
shipment of the drug. In addition to obtaining FDA approval for
each product, each drug-manufacturing establishment must be
registered with, and approved by, the FDA.
New drugs may also be approved by the agency pursuant to an ANDA
for generic drugs if the same active ingredient has previously
been approved by the agency and the original sponsor of the NDA
no longer has patent protection or statutory marketing
exclusivity. Approval of an ANDA does not require the submission
of clinical data on the safety and effectiveness of the drug
product. However, the applicant must provide dissolution and/or
metabolic studies to show that the active ingredient in the
generic drug sponsors application is comparably available
to the patent as the original product in the NDA upon which the
ANDA is based.
Preclinical or biocompatibility testing is generally conducted
on laboratory animals to evaluate the potential safety and
toxicity of a drug. The results of these studies are submitted
to the FDA as a part of an IND or IDE application, which must be
approved before clinical trials in humans can begin. Typically,
clinical
9
evaluation of new drugs involves a time consuming and costly
three-phase process. In Phase I, clinical trials are
conducted with a small number of subjects to determine the early
safety profile, the relationship of safety to dose, and the
pattern of drug distribution and metabolism. In Phase II,
one or more clinical trials are conducted with groups of
patients afflicted with a specific disease to determine
preliminary efficacy and expanded evidence of safety. In
Phase III, at least two large-scale, multi-center,
comparative trials are conducted with patients afflicted with a
target disease to provide sufficient confirmatory data to
support the efficacy and safety required by the FDA. The FDA
closely monitors the progress of each of the three phases of
clinical trials and may, at its discretion, re-evaluate, alter,
suspend or terminate the testing based upon the data that have
been accumulated to that point and its assessment of the
risk/benefit ratio to the patient.
FDA approval is required before a new drug product
may be marketed in the United States. However, many historically
over-the-counter
(OTC) drugs are exempt from the FDAs premarket
approval requirements. In 1972, the FDA instituted the ongoing
OTC Drug Review to evaluate the safety and effectiveness of OTC
drugs then in the market before enactment of the Drug Amendments
of 1962. Through this process, the FDA issues monographs that
set forth the specific active ingredients, dosages, indications
and labeling statements for OTC drugs that the FDA will consider
generally recognized as safe and effective and therefore not
subject to premarket approval. Before issuance of a final OTC
drug monograph as a federal regulation, OTC drugs are classified
by the FDA in one of three categories: Category I ingredients
which are deemed safe and effective for
over-the-counter
use; Category II ingredients which are deemed
not generally recognized as safe and effective for
over-the-counter
use; and Category III ingredients which are deemed
possibly safe and effective with studies ongoing.
Based upon the results of these ongoing studies, the FDA must
reclassify all Category III ingredients as either Category
I or Category II before issuance of a final monograph. For
certain categories of OTC drugs not yet subject to a final
monograph, the FDA usually permits such drugs to continue to be
marketed until a final monograph becomes effective, unless the
drug will pose a potential health hazard to consumers. Stated
differently, the FDA generally permits continued marketing only
of Category I and III 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 subject to
various FDA regulations concerning, for example, cGMP, general
and specific OTC labeling requirements and prohibitions against
promotion for conditions other than those stated in the
labeling. OTC drug manufacturing facilities are subject to FDA
inspection, and failure to comply with applicable regulatory
requirements may lead to administrative or judicially imposed
penalties.
Each of the active ingredients in
LOPROX®
products and
OMNICEF®
products have been approved by the FDA under an NDA. The active
ingredient in
DYNACIN®
branded products has been approved by the FDA under an ANDA. The
active ingredient in the
TRIAZ®
products has been classified as a Category III ingredient
under a tentative final FDA monograph for OTC use in treatment
of labeled conditions. The FDA has requested, and a task force
of the Non-Prescription Drug Manufacturers Association (or
NDMA), a trade association of OTC drug
manufacturers, has undertaken further studies to confirm that
benzoyl peroxide, an active ingredient in the
TRIAZ®
products, is not a tumor promoter when tested in conjunction
with UV light exposure. The
TRIAZ®
products, which we sell on a prescription basis, have the same
ingredients at the same dosage levels as the OTC products. When
the FDA issues the final monograph, one of several possible
outcomes that may occur is that we may be required by the FDA to
discontinue sales of
TRIAZ®
products until and unless we file an NDA covering such product.
There can be no assurance as to the results of these studies or
any FDA action to reclassify benzoyl peroxide. In addition,
there can be no assurance that adverse test results would not
result in withdrawal of
TRIAZ®
products from marketing. An adverse decision by the FDA with
respect to the safety of benzoyl peroxide could result in the
assertion of product liability claims against us and could have
a material adverse effect on our business, financial condition
and results of operations.
Our
TRIAZ®
branded products must meet the composition and labeling
requirements established by the FDA for products containing
their respective basic ingredients. We believe that compliance
with those established standards avoids the requirement for
premarket clearance of these products. There can be no assurance
that the FDA will not take a contrary position in the future.
Our
PLEXION®
branded products,
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which contain the active ingredients sodium sulfacetamide and
sulfur, are marketed under the FDA compliance policy entitled
Marketed New Drugs without Approved NDAs or ANDAs.
We believe that certain of our products, as they are promoted
and intended by us for use, are exempt from being considered
new drugs based upon the introduction date of their
active ingredients and therefore do not require premarket
clearance. There can be no assurance that the FDA will not take
a contrary position in the future. If the FDA were to do so, we
may be required to seek FDA approval for these products, market
these products as
over-the-counter
products or withdraw such products from the market. We believe
that these products are compliant with applicable regulations
governing product safety, use of ingredients, labeling,
promotion and manufacturing methods.
We also will be subject to foreign regulatory authorities
governing clinical trials and pharmaceutical sales for products
we seek to market outside the United States. Whether or not FDA
approval has been obtained, approval of a product by the
comparable regulatory authorities of foreign countries must be
obtained before marketing the product in those countries. The
approval process varies from country to country, the approval
process time required may be longer or shorter than that
required for FDA approval, and any foreign regulatory agency may
refuse to approve any product we submit for review.
Our History
We filed our certificate of incorporation with the Secretary of
State of Delaware on July 28, 1988. We completed our
initial public offering during our fiscal year ended
June 30, 1990, and launched our initial pharmaceutical
products during our fiscal year ended June 30, 1991. During
our fiscal year ended June 30, 2003, we acquired the
exclusive U.S. and Canada license to the
RESTYLANE®
family of products.
Financial Information About Segments
We operate in one significant business segment: Pharmaceuticals.
Our current pharmaceutical franchises are divided between the
dermatological and non-dermatological fields. Information on
revenues, operating income, identifiable assets and supplemental
revenue of our business franchises appears in the consolidated
financial statements included in Item 8 hereof.
Employees
At December 31, 2005, we had 356 full-time employees.
No employees are subject to a collective bargaining agreement.
We believe our relationship with our employees is good.
Available Information
We make available free of charge on or through our Internet
website, www.medicis.com, our annual reports on
Form 10-K,
quarterly reports on
Form 10-Q, current
reports on
Form 8-K, and all
amendments to those reports, if any, filed or furnished pursuant
to Section 13(a) of 15(d) of the Securities Exchange Act of
1934 as soon as reasonably practicable after they are
electronically filed with, or furnished to, the Securities and
Exchange Commission. We also make available free of charge on or
through our website our Business Code of Conduct and Ethics,
Corporate Governance Guidelines, Nominating and Corporate
Governance Committee Charter, Compensation Committee Charter and
Audit Committee Charter. The information contained on our
website is not intended to be incorporated into this annual
report on Form 10-K/T.
Our statements in this report, other reports that we file with
the Securities and Exchange Commission, 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, Section 21
of the Securities Exchange Act of 1934 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,
11
could, target and other words of similar
meaning in connection with discussion of future operating or
financial performance. These include statements relating to
future actions, prospective products or product approvals,
future performance or results of current and anticipated
products, sales efforts, expenses, the outcome of contingencies
such as legal proceedings and financial results. These
statements are based on certain assumptions made by us based on
our experience and perception of historical trends, current
conditions, expected future developments and other factors we
believe are appropriate in the circumstances. Such statements
are subject to a number of assumptions, risks and uncertainties,
many of which are beyond our control. These forward-looking
statements reflect the current views of senior management with
respect to future events and financial performance. No
assurances can be given, however, that these activities, events
or developments will occur or that such results will be
achieved, and actual results may vary materially from those
anticipated in any forward-looking statement. Any such
forward-looking statements, whether made in this report or
elsewhere, should be considered in context of the various
disclosures made by us about our businesses including, without
limitation, the risk factors discussed below. We do not plan to
update any such forward-looking statements and expressly
disclaim any duty to update the information contained in this
filing except as required by law.
We operate in a rapidly changing environment that involves a
number of risks. The following discussion highlights some of
these risks and others are discussed elsewhere in this report.
These and other risks could materially and adversely affect our
business, financial condition, prospects, operating results or
cash flows.
Risks Related To Our Business
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We derive a majority of our sales from our core 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 core prescription
products and sales of our dermal aesthetic product,
RESTYLANE®,
which we began selling in the United States on January 6,
2004, will continue to constitute a significant portion of our
sales for the foreseeable future. Accordingly, any factor
adversely affecting our sales related to these products,
individually or collectively, could harm our business, financial
condition and results of operations. On December 6, 2005,
Inamed announced that it had submitted the fourth and final
module of its Premarket Approval Application for three
formulations of
Juvedermtm,
a dermal filler product that would compete with
RESTYLANE®
if approved by the FDA. Many of our core prescription products,
including
DYNACIN®
and
LOPROX®,
are subject to generic competition or may be in the near future.
On July 18, 2004, Glades announced the launch of
myractm
(minocycline hydrochloride tablets, USP), as a branded
pharmaceutical product.
Myractm
tablets is a prescription product that competes directly with
our
DYNACIN®
tablet products. During the third quarter of our fiscal 2005,
myractm
began being marketed as a generic product. On August 6,
2004, the FDA approved an ANDA submitted by Altana for its
ciclopirox topical suspension, a generic version of our
LOPROX®
TS product. On December 29, 2004, the FDA approved an ANDA
submitted by Altana for its ciclopirox cream, a generic version
of our
LOPROX®
cream product. On August 10, 2005, the FDA approved an ANDA
submitted by Taro Pharmaceuticals U.S.A. Inc. (Taro)
for its ciclopirox topical suspension, a generic version of our
LOPROX®
topical suspension. On March 7, 2006, the Perrigo Company
announced that it received approval from the FDA to manufacture
and market its ciclopirox olamine cream USP, 0.77%, a generic
version of our
LOPROX®
Cream product. Each of our core products could be rendered
obsolete or uneconomical by competitive changes, including
generic competition.
Sales related to our core prescription products and
RESTYLANE®
could also be adversely affected by other factors, including:
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manufacturing or supply interruptions; |
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the development of new competitive pharmaceuticals and
technological advances to treat the conditions addressed by our
core products, including the introduction of new products into
the marketplace; |
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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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changes in the prescribing or procedural practices of
dermatologists, plastic surgeons and/or podiatrists; |
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changes in the reimbursement or substitution policies of
third-party payors or retail pharmacies; |
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product liability claims; |
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the outcome of disputes relating to trademarks, patents, license
agreements and other rights; |
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changes in state and federal law that adversely affect our
ability to market our products to dermatologists, plastic
surgeons and/or podiatrists; and |
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restrictions on travel affecting the ability of our sales force
to market to prescribing physicians and plastic surgeons in
person. |
If we do not comply with applicable regulatory requirements,
such violations could result in warning letters, non-approval,
suspensions of regulatory approvals, civil penalties and
criminal fines, product seizures and recalls, operating
restrictions, injunctions and criminal prosecution. The
government has notified us that we have been named as a
defendant in a qui tam (whistleblower) lawsuit filed under
the False Claims Act. We are cooperating with the government in
its investigation, which relates to our marketing and promotion
of
LOPROX®
products to pediatricians prior to our May 2004 disposition of
our pediatric sales division.
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Our operating results and financial condition may
fluctuate |
Our operating results and financial condition may fluctuate from
quarter to quarter and year to year for a number of reasons. The
following events or occurrences, among others, could cause
fluctuations in our financial performance from period to period:
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development of new competitive products by others; |
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the timing and receipt of FDA approvals; |
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changes in the amount we spend to develop, acquire or license
new products, technologies or businesses; |
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untimely contingent research and development payments under our
third-party product development agreements; |
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changes in the amount we spend to promote our products; |
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delays between our expenditures to acquire new products,
technologies or businesses and the generation of revenues from
those acquired products, technologies or businesses; |
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changes in treatment practices of physicians that currently
prescribe our products; |
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changes in reimbursement policies of health plans and other
similar health insurers, including changes that affect newly
developed or newly acquired products; |
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increases in the cost of raw materials used to manufacture our
products; |
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manufacturing and supply interruptions, including failure to
comply with manufacturing specifications; |
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changes in prescription levels and the effect of economic
changes in hurricane and other natural disaster-affected areas; |
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the impact on our employees, customers, patients, manufacturers,
suppliers, vendors, and other companies we do business with and
the resulting impact on the results of operations associated
with the possible mutation of the avian form of influenza from
birds or other animal species to humans, current human
morbidity, and mortality levels persist following such potential
mutation; |
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the mix of products that we sell during any time period; |
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lower than expected demand for our products; |
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our responses to price competition; |
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expenditures as a result of legal actions; |
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market acceptance of our products; |
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the impairment and write-down of goodwill or other intangible
assets; |
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implementation of new or revised accounting or tax rules or
policies; |
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disposition of core products, technologies and other rights; |
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termination or expiration of, or the outcome of disputes
relating to, trademarks, patents, license agreements and other
rights; |
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increases in insurance rates for existing products and the cost
of insurance for new products; |
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general economic and industry conditions, including changes in
interest rates affecting returns on cash balances and
investments that affect customer demand; |
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seasonality of demand for our products; |
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our level of research and development activities; |
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new accounting standards and/or changes to existing accounting
standards that would have a material effect on our consolidated
financial position, results of operations or cash flows; |
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costs and outcomes of any tax audits or any litigation involving
intellectual property, customers or other issues; and |
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timing of revenue recognition related to licensing agreements
and/or strategic collaborations. |
As a result, we believe that
period-to-period
comparisons of our results of operations are not necessarily
meaningful, and these comparisons should not be relied upon as
an indication of future performance. The above factors may cause
our operating results to fluctuate and adversely affect our
financial condition and results of operations.
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We will be unable to meet our anticipated development and
commercialization timelines if clinical trials for our products
are unsuccessful or delayed |
The production and marketing of our products and our ongoing
research and development, pre-clinical testing and clinical
trials activities are subject to extensive regulation and review
by numerous governmental authorities. Before obtaining
regulatory approvals for the commercial sale of any products, we
and/or our partners must demonstrate through pre-clinical
testing and clinical trials that our products are safe and
effective for use in humans. Conducting clinical trials is a
lengthy, time-consuming and expensive process. In addition to
testing and approval procedures, extensive regulations also
govern marketing, manufacturing, distribution, labeling and
record-keeping procedures.
Completion of clinical trials may take several years or more.
Our commencement and rate of completion of clinical trials may
be delayed by many factors, including:
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lack of efficacy during the clinical trials; |
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unforeseen safety issues; |
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slower than expected patient recruitment; |
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government or regulatory delays; and |
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unanticipated requests from the FDA for new or additional
information. |
14
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.
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If we are unable to secure and protect our intellectual
property and proprietary rights, or if our intellectual property
rights are found to infringe upon the intellectual property
rights of other parties, our business could suffer |
Our success depends in part on our ability to obtain patents or
rights to patents, protect trade secrets, operate without
infringing upon the proprietary rights of others, and prevent
others from infringing on our patents, trademarks, service marks
and other intellectual property rights.
We believe that the protection of our trademarks and service
marks is an important factor in product recognition and in our
ability to maintain or increase market share. If we do not
adequately protect our rights in our various trademarks and
service marks from infringement, their value to us could be lost
or diminished. If the marks we use are found to infringe upon
the trademark or service mark of another company, we could be
forced to stop using those marks and, as a result, we could lose
the value of those marks and could be liable for damages caused
by an infringement.
The patents and patent applications in which we have an interest
may be challenged as to their validity or enforceability.
Challenges may result in potentially significant harm to our
business. The cost of responding to these challenges and the
inherent costs to defend the validity of our patents, including
the prosecution of infringements and the related litigation,
could be substantial. Such litigation also could require a
substantial commitment of our managements time.
We are pursuing several United States patent applications;
although we cannot be sure that any of these patents will ever
be issued. We also have acquired rights under certain patents
and patent applications in connection with our licenses to
distribute products and by assignment of rights to patents and
patent applications from certain of our consultants and
officers. These patents and patent applications may be subject
to claims of rights by third parties. If there are conflicting
claims to the same patent or patent application, we may not
prevail and, even if we do have some rights in a patent or
patent application, those rights may not be sufficient for the
marketing and distribution of products covered by the patent or
patent application.
The ownership of a patent or an interest in a patent does not
always provide significant protection. Others may independently
develop similar technologies or design around the patented
aspects of our technology. We only conduct patent searches to
determine whether our products infringe upon any existing
patents when we think such searches are appropriate. As a
result, the products and technologies we currently market, and
those we may market in the future, may infringe on patents and
other rights owned by others. If we are unsuccessful in any
challenge to the marketing and sale of our products or
technologies, we may be required to license the disputed rights,
if the holder of those rights is willing to license such rights,
otherwise we may be required to cease marketing the challenged
products, or to modify our products to avoid infringing upon
those rights. A claim or finding of infringement regarding one
of our products could harm our business, financial condition and
results of operations. The costs of responding to infringement
claims could be substantial and could require a substantial
commitment of our managements time. The expiration of
patents may expose our products to additional competition.
We also rely upon trade secrets, unpatented proprietary know-how
and continuing technological innovation in developing and
manufacturing many of our core products. It is our policy to
require all of our employees, consultants and advisors to enter
into confidentiality agreements prohibiting them from taking or
disclosing our proprietary information and technology.
Nevertheless, these agreements may not provide
15
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.
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If Q-Med is unable to protect its intellectual property
and proprietary rights with respect to our dermal aesthetic
enhancement products, our business could suffer |
RESTYLANE®,
PERLANEtm
and RESTYLANE FINE
LINEStm
currently have patent protection in the United States until
2015, and the exclusivity period of the license granted to us by
Q-Med will terminate on the later of (i) the expiration of
the last patent covering the products or (ii) upon the
licensed know-how becoming publicly known. If the validity or
enforceability of these patents is successfully challenged, the
cost to us could be significant and our business may be harmed.
For example, if any such challenges are successful, Q-Med may be
unable to supply products to us. As a result, we may be unable
to market, distribute and commercialize the products or it may
no longer be profitable for us to do so.
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We may not be able to collect all scheduled license
payments from BioMarin |
As part of our asset purchase agreement, license agreement and
securities purchase agreement with BioMarin Pharmaceutical Inc.
(BioMarin) discussed in Note 7 to our
consolidated financial statements, BioMarin will make license
payments to us of $2.1 million per quarter for four
quarters beginning in July 2005; $1.75 million per quarter
for the subsequent eight quarters beginning in July 2006; and
$1.5 million per quarter for the subsequent four quarters
beginning in July 2008. While we did receive all scheduled
quarterly license payments during the Transition Period and
during the fiscal year ending June 30, 2005, we cannot give
any assurances as to BioMarins continuing ability to make
payments to us. Currently, our revenue recognition of these
payments is on a cash basis. In addition, we cannot give any
assurances as to BioMarins ability to make the
$70.6 million payment to us in 2009 for the purchase of all
of the outstanding shares of Ascent Pediatrics.
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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. We
have not entered into employment agreements with any of our key
managers, with the exception of our Chairman and Chief Executive
Officer. The loss of the services of any member of our senior
management 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.
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Our continued growth depends upon our ability to develop
new products |
We have internally developed potential pharmaceutical compounds
and agents. We also have acquired the rights to certain
potential compounds and agents in various stages of development.
We currently have a variety of new products in various stages of
research and development and are working on possible
improvements, extensions and reformulations of some existing
products. These research and development activities, as well as
the clinical testing and regulatory approval process, which must
be completed before commercial quantities of these developments
can be sold, will require significant commitments of personnel
and financial resources. We cannot assure you that we will be
able to develop a product or technology in a timely manner, or
at all. Delays in the research, development, testing or approval
processes will cause a corresponding delay in revenue generation
from those products. Regardless of whether they are ever
released to the market, the expense of such processes will have
already been incurred.
We reevaluate our research and development efforts regularly to
assess whether our efforts to develop a particular product or
technology are progressing at a rate that justifies our
continued expenditures. On the basis of these reevaluations, we
have abandoned in the past, and may abandon in the future, our
efforts on a particular product or technology. Products that we
research or develop may not be successfully commercial-
16
ized. If we fail to take a product or technology from the
development stage to market on a timely basis, we may incur
significant expenses without a near-term financial return.
We have in the past, and may in the future, supplement our
internal research and development by entering into research and
development agreements with other pharmaceutical companies. We
may, upon entering into such agreements, be required to make
significant up-front payments to fund the projects. We cannot be
sure, however, that we will be able to locate adequate research
partners or that supplemental research will be available on
terms acceptable to us in the future. If we are unable to enter
into additional research partnership arrangements, we may incur
additional costs to continue research and development internally
or abandon certain projects. Even if we are able to enter into
collaborations, we cannot assure you that these arrangements
will result in successful product development or
commercialization.
There is also a risk that our products may not gain market
acceptance among physicians, patients and the medical community
generally. The degree of market acceptance of any medical device
or other product that we develop will depend on a number of
factors, including demonstrated clinical efficacy and safety,
cost-effectiveness, potential advantages over alternative
products, and our marketing and distribution capabilities.
Physicians will not recommend our products until clinical data
or other factors demonstrate their safety and efficacy compared
to other competing products. Even if the clinical safety and
efficacy of using our products is established, physicians may
elect to not recommend using them for any number of other
reasons, including whether our products best meet the particular
needs of the individual patient.
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We may acquire companies in the future and these
acquisitions could disrupt our business |
As part of our business strategy, we regularly consider and, as
appropriate, make acquisitions of technologies, products and
businesses that we believe are complementary to our business.
Acquisitions typically entail many risks and could result in
difficulties in integrating the operations, personnel,
technologies and products of the companies acquired, some of
which may result in significant charges to earnings. If we are
unable to successfully integrate our acquisitions with our
existing business, we may not obtain the advantages that the
acquisitions were intended to create, which may materially
adversely affect our business, results of operations, financial
condition and cash flows, our ability to develop and introduce
new products and the market price of our stock. In addition, in
connection with acquisitions, we could experience disruption in
our business or employee base, or key employees of companies
that we acquire may seek employment elsewhere, including with
our competitors.
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We may not be able to identify and acquire products,
technologies and businesses on acceptable terms, if at all,
which may constrain our growth |
Our strategy for continued growth includes the acquisition of
products, technologies and businesses. These acquisitions could
involve acquiring other pharmaceutical companies assets,
products or technologies. In addition, we may seek to obtain
licenses or other rights to develop, manufacture and distribute
products. We cannot be certain that we will be able to identify
suitable acquisition or licensing candidates, if they will be
accretive in the near future, or if any will be available on
acceptable terms. Other pharmaceutical companies, with greater
financial, marketing and sales resources than we have, have also
tried to grow through similar acquisition and licensing
strategies. Because of their greater resources, our competitors
may be able to offer better terms for an acquisition or license
than we can offer, or they may be able to demonstrate a greater
ability to market licensed products. In addition, even if we
identify potential acquisitions and enter into definitive
agreements relating to such acquisitions, we may not be able to
consummate planned acquisitions on the terms originally agreed
upon or at all. For example, on March 20, 2005, we entered
into an agreement and plan of merger with Inamed, pursuant to
which we agreed to acquire Inamed pursuant to the terms of such
agreement. 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.
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Our success depends on our ability to manage our
growth |
We recently experienced a period of rapid growth from both
acquisitions and internal expansion of our operations. This
growth has placed significant demands on our human and financial
resources. We must continue to improve our operational,
financial and management information controls and systems and
effectively motivate, train and manage our employees to properly
manage this growth. Even if these steps are taken, we cannot be
sure that our recent acquisitions will be integrated
successfully into our business operations. If we are not able to
successfully integrate our acquisitions, we may not obtain the
advantages that the acquisitions were intended to create. In
addition, if we do not manage this growth effectively, maintain
the quality of our products despite the demands on our resources
and retain key personnel, our business could be harmed.
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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 core 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, and lack
of market development despite our diligence and lack of product
acceptance. Our failure to fulfill our obligations could result
in the loss of our rights under a license agreement.
Our inability to continue the distribution of any particular
licensed product could harm our business, market share and
profitability. Also, certain products we license are used in
connection with other products we own or license. A loss of a
license in such circumstances could materially harm our ability
to market and distribute these other products.
Our growth and acquisition strategy depends upon the successful
integration of licensed products with our existing products.
Therefore, any loss, limitation or flaw in a licensed product
could impair our ability to market and sell our products, delay
new product development and introduction, and harm our
reputation. These problems, individually or together, could harm
our business and results of operations.
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We depend on a limited number of customers, and if we lose
any of them, our business could be harmed |
Our customers include some of the United States leading
wholesale pharmaceutical distributors, such as
AmerisourceBergen, Cardinal, McKesson, and major drug chains.
During the Transition Period, McKesson and Cardinal accounted
for 54.9% and 18.9%, respectively, of our net revenues. During
fiscal 2005, McKesson and Cardinal accounted for 51.2%, and
21.8%, respectively, of our net revenues. The loss of any of
these customers accounts or a material reduction in their
purchases could harm our business, financial condition or
results of operations. In addition, we may face pricing pressure
from our customers.
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The consolidation of drug wholesalers could increase
competition and pricing pressures throughout the pharmaceutical
industry |
We sell our pharmaceutical products primarily through major
wholesalers. These customers comprise a significant part of the
distribution network for pharmaceutical products in the United
States. This distribution network is continuing to undergo
significant consolidation marked by mergers and acquisitions. As
a result, a smaller number of large wholesale distributors
control a significant share of the market. In addition, the
number of independent drug stores and small chains has decreased
as retail consolidation has occurred. Further consolidation
among, or any financial difficulties of, distributors or
retailers could result in the combination or elimination of
warehouses which may result in product returns to our company,
cause a reduction in the inventory levels of distributors and
retailers, result in reductions in purchases of our products,
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increase competitive and pricing pressures on pharmaceutical
manufacturers, any of which could harm our business, financial
condition and results of operations.
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We rely on others to manufacture our products |
Currently, we outsource our entire product manufacturing needs.
Typically, our manufacturing contracts are short-term. We are
dependent upon renewing agreements with our existing
manufacturers or finding replacement manufacturers to satisfy
our requirements. As a result, we cannot be certain that
manufacturing sources will continue to be available or that we
can continue to outsource the manufacturing of our products on
reasonable or acceptable terms.
The underlying cost to us for manufacturing our products is
established in our agreements with these outside manufacturers.
Because of the short-term nature of these agreements, our
expenses for manufacturing are not fixed and could change from
contract to contract. If the cost of production increases, our
gross margins could be negatively affected.
In addition, we rely on outside manufacturers to provide us with
an adequate and reliable supply of our products on a timely
basis. Loss of a supplier or any difficulties that arise in the
supply chain could significantly affect our inventories and
supply of products available for sale. We do not have
alternative sources of supply for all of our products. If a
primary supplier of any of our core 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. The FDA requires
that all manufacturers used by pharmaceutical companies comply
with the FDAs regulations, including the cGMP regulations
applicable to manufacturing processes. The cGMP validation of a
new facility and the approval of that manufacturer for a new
drug product may take a year or more before manufacture can
begin at the facility. Delays in obtaining FDA validation of a
replacement manufacturing facility could cause an interruption
in the supply of our products. Although we have business
interruption insurance covering the loss of income for up to
12 months, which may mitigate the harm to us from the
interruption of the manufacturing of our largest selling
products caused by certain events, the loss of a manufacturer
could still cause a reduction in our sales, margins and market
share, as well as harm our overall business and financial
results.
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Our reliance on third-party manufacturers and suppliers
can 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. 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.
We try to maintain inventory levels that are no greater than
necessary to meet our current projections. 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.
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We could experience difficulties in obtaining supplies of
RESTYLANE®,
PERLANETM,
RESTYLANE FINE
LINESTM
and
SubQTM |
The manufacturing process to create bulk non-animal stabilized
hyaluronic acid necessary to produce
RESTYLANE®,
PERLANEtm,
RESTYLANE FINE
LINEStm
and
SubQtm
products is technically complex and requires significant
lead-time. Any failure by us to accurately forecast demand for
finished product
19
could result in an interruption in the supply of
RESTYLANE®,
PERLANEtm,
RESTYLANE FINE
LINEStm
and
SubQtm
products and a resulting decrease in sales of the products.
We depend exclusively on Q-Med for our supply of
RESTYLANE®,
PERLANEtm,
RESTYLANE FINE
LINEStm
and
SubQtm
products. There are currently no alternative suppliers of these
products. Q-Med has committed to supply
RESTYLANE®
to us under a long-term license that is subject to customary
conditions and our delivery of specified milestone payments.
Q-Med manufactures
RESTYLANE®,
PERLANEtm,
RESTYLANE FINE
LINEStm
and
SubQtm
at its facility in Uppsala, Sweden. We cannot be certain that
Q-Med will be able to meet our current or future supply
requirements. Any impairment of
Q-Meds
manufacturing capacities could significantly affect our
inventories and our supply of products available for sale.
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Supply interruptions may disrupt our inventory levels and
the availability of our products |
Numerous factors could cause interruptions in the supply of our
finished products, including:
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timing, scheduling and prioritization of production by our
contract manufacturers; |
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labor interruptions; |
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changes in our sources for manufacturing; |
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the timing and delivery of domestic and international shipments; |
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our failure to locate and obtain replacement manufacturers as
needed on a timely 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. These data are extrapolations
from information provided only by certain pharmacies, and are
estimates of historical demand levels. 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. There is no such timely data for
the aesthetics market, in particular
RESTYLANE®,
our highest-selling product during the Transition Period and
fiscal 2005. Our forecasts may fail to accurately anticipate
ultimate customer demand for products. Overestimates of demand
may result in excessive inventory production; 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. Consistent with pharmaceutical industry
patterns, approximately 80% of our revenues are derived from
three major drug wholesale concerns. While we attempt to
estimate inventory levels of our products at our major wholesale
customers, using historical prescription information and
historical purchase patterns, this process is inherently
imprecise. Rarely do wholesale customers provide us complete
inventory levels at regional distribution centers, or within
their national distribution systems. We rely wholly upon our
wholesale and drug chain customers to effect the distribution
allocation of our products.
We periodically offer promotions to wholesale and chain
drugstore customers to encourage dispensing of our products,
consistent with prescriptions written by licensed health care
providers. Because many of our 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
20
customers as may be necessary to ensure the fullest possible
distribution of our branded products within the pharmaceutical
chain of commerce.
We cannot control or influence greatly the purchasing patterns
of our wholesale and retail drug chain customers. These are
highly sophisticated customers that purchase our products in a
manner consistent with their industry practices and, presumably,
based upon their projected demand levels. Purchases by any given
customer, during any given period, may be above or below actual
prescription volumes of any of our products during the same
period, resulting in fluctuations in product inventory in the
distribution channel.
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Fluctuations in demand for our products create inventory
maintenance uncertainties |
As a result of customer buying patterns, a substantial portion
of our prescription revenues has traditionally been recognized
in the last month of each quarter, and we schedule our inventory
purchases to meet anticipated customer demand. As a result,
relatively small delays in the receipt of manufactured products
by us could result in revenues being deferred or lost. Our
operating expenses are based upon anticipated sales levels, and
a high percentage of our operating expenses are relatively fixed
in the short term. 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.
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We selectively outsource certain non-sales and
non-marketing services, and cannot assure you that we will be
able to obtain adequate supplies of such services on acceptable
terms |
To enable us to focus on our core marketing and sales
activities, we selectively outsource certain non-sales and
non-marketing functions, such as laboratory research,
manufacturing and warehousing. As we expand our activities in
these areas, additional financial resources are expected to be
utilized. We typically do not enter into long-term manufacturing
contracts with third party manufacturers. Whether or not such
contracts exist, we cannot assure you that we will be able to
obtain adequate supplies of such services or products in a
timely fashion, on acceptable terms, or at all.
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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
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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.
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If we become subject to product liability claims, our
earnings and financial condition could suffer |
We are exposed to risks of product liability claims from
allegations that our products resulted in adverse effects to the
patient or others. These risks exist even with respect to those
products that are approved for commercial sale by the FDA and
manufactured in facilities licensed and regulated by the FDA.
In addition to our desire to reduce the scope of our potential
exposure to these types of claims, many of our customers require
us to maintain product liability insurance as a condition of
conducting business with us. We currently carry product
liability insurance in the amount of $50.0 million per
claim and $50.0 million in the aggregate on a claims-made
basis. Nevertheless, this insurance may not be sufficient to
cover all claims made against us. Insurance coverage is
expensive and may be difficult to obtain. As a result, we cannot
be certain that our current coverage will continue to be
available in the future on reasonable terms, if at all. If we
are liable for any product liability claims in excess of our
coverage or outside of our coverage, the cost and expense of
such liability could cause our earnings and financial condition
to suffer.
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Rising insurance costs could negatively impact
profitability |
The cost of insurance, including workers compensation, product
liability and general liability insurance, have risen
significantly in recent years and may increase in the future. In
response, we may increase deductibles and/or decrease certain
coverages to mitigate these costs. These increases, and our
increased risk due to increased deductibles and reduced
coverages, could have a negative impact on our results of
operations, financial condition and cash flows.
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If we suffer negative publicity concerning the safety of
our products, our sales may be harmed and we may be forced to
withdraw products |
Physicians and potential patients may have a number of concerns
about the safety of our products, whether or not such concerns
have a basis in generally accepted science or peer-reviewed
scientific research. Negative publicity, whether accurate or
inaccurate, concerning our products could reduce market or
governmental acceptance of our products and could result in
decreased product demand or product withdrawal. In addition,
significant negative publicity could result in an increased
number of product liability claims, whether or not these claims
are supported by applicable law.
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RESTYLANE®
is a consumer product and as such, it is susceptible to changes
in popular trends and applicable laws, which could adversely
affect sales or product margins of
RESTYLANE® |
RESTYLANE®
is a consumer product. If we fail to anticipate, identify or
react to competitive products or if consumer preferences in the
cosmetic marketplace shift to other treatments for the treatment
of fine lines, wrinkles and deep facial folds, we may experience
a decline in demand for
RESTYLANE®.
In addition, the popular media has at times in the past
produced, and may continue in the future to produce, negative
reports regarding the efficacy, safety or side effects of facial
aesthetic products. Consumer perceptions of
RESTYLANE®
may be negatively impacted by these reports and other reasons.
Demand for
RESTYLANE®
may be materially adversely affected by changing economic
conditions. Generally, the costs of cosmetic procedures are
borne by individuals without reimbursement from their
22
medical insurance providers or government programs. Individuals
may be less willing to incur the costs of these procedures in
weak or uncertain economic environments, and demand for
RESTYLANE®
could be adversely affected.
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We may not be able to repurchase the Old Notes and New
Notes when required |
In June 2002, we sold Contingent Convertible Senior Notes, due
in 2032 (the Old Notes), in the amount of
$400.0 million. In August 2003, we exchanged approximately
$230.8 million in principal of these Old Notes for
approximately $283.9 million of our Contingent Convertible
Senior Notes due in 2033 (the New Notes).
On June 4, 2007, 2012 and 2017 and upon the occurrence of a
change in control, holders of the remaining Old Notes may
require us to offer to repurchase their Old Notes for cash. On
June 4, 2008, 2013 and 2018 and upon the occurrence of a
change in control, holders of the New Notes may require us to
offer to repurchase their New Notes for cash. We may not have
sufficient funds at the time of any such events to make the
required repurchases.
The source of funds for any repurchase required as a result of
any such events will be our available cash or cash generated
from operating activities or other sources, including
borrowings, sales of assets, sales of equity or funds provided
by a new controlling entity. We cannot assure you, however, that
sufficient funds will be available at the time of any such
events to make any required repurchases of the Notes tendered.
Furthermore, the use of available cash to fund the repurchase of
the Old Notes or New Notes may impair our ability to obtain
additional financing in the future.
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Our publicly-filed reports are reviewed by the Securities
and Exchange Commission (the SEC) from time to time
and any significant changes required as a result of any such
review may result in material liability to us, and have a
material adverse impact on the trading price of our common
stock |
The reports of publicly-traded companies are subject to review
by the SEC from time to time for the purpose of assisting
companies in complying with applicable disclosure requirements
and to enhance the overall effectiveness of companies
public filings, and comprehensive reviews of such reports are
now required at least every three years under the Sarbanes-Oxley
Act of 2002. SEC reviews may be initiated at any time. While we
believe that our previously filed SEC reports comply, and we
intend that all future reports will comply in all material
respects with the published rules and regulations of the SEC, we
could be required to modify or reformulate information contained
in prior filings as a result of an SEC review. Any modification
or reformulation of information contained in such reports could
be significant and result in material liability to us and have a
material adverse impact on the trading price of our common stock.
Risks Related to Our Industry
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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
23
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.
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We are subject to extensive governmental regulation |
Pharmaceutical companies are subject to significant regulation
by a number of national, state and local governments and
agencies. The FDA administers requirements covering testing,
manufacturing, safety, effectiveness, labeling, storage, record
keeping, approval, sampling, advertising and promotion of our
products. Several states have also instituted laws and
regulations covering some of these same areas. In addition, the
FTC and state and local authorities regulate the advertising of
over-the-counter drugs
and cosmetics. Failure to comply with applicable regulatory
requirements could, among other things, result in:
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fines; |
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changes to advertising; |
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suspensions of regulatory approvals of products; |
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product recalls; |
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delays in product distribution, marketing and sale; and |
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civil or criminal sanctions. |
Our prescription and
over-the-counter
products receive FDA review regarding their safety and
effectiveness. However, the FDA is permitted to revisit and
change its prior determinations. We cannot be sure that the FDA
will not change its position with regard to the safety or
effectiveness of our products. If the FDAs position
changes, we may be required to change our labeling or
formulations or cease to manufacture and market the challenged
products. Even prior to any formal regulatory action, we could
voluntarily decide to cease distribution and sale or recall any
of our products if concerns about their safety or effectiveness
develop.
Before marketing any drug that is considered a new
drug by the FDA, the FDA must provide its approval of the
product. All products which are considered drugs which are not
new drugs and that generally are recognized by the
FDA as safe and effective for use do not require the FDAs
approval. We believe that some of our products, as they are
promoted and intended for use, are exempt from treatment as
new drugs and are not subject to approval by the
FDA. The FDA, however, could take a contrary position, and we
could
24
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 Office of Inspector General
(OIG) of the Department of Health and Human
Services, as well as state laws and regulations. We have
established compliance program policies and training programs
for our sales force, which we believe are appropriate. The OIG
and/or state law enforcement entities, however, could take a
contrary position, and we could be required to modify our sales
representative activities.
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If we market products in a manner that violates health
care fraud and abuse laws, we may be subject to civil or
criminal penalties |
Federal health care program anti-kickback statutes prohibit,
among other things, knowingly and willfully offering, paying,
soliciting or receiving remuneration to induce, or in return for
purchasing, leasing, ordering or arranging for the purchase,
lease or order of any health care item or service reimbursable
under Medicare, Medicaid, or other federally financed health
care programs. This statute has been interpreted to apply to
arrangements between pharmaceutical manufacturers on one hand
and prescribers, purchasers and formulary managers on the other.
Although there are a number of statutory exemptions and
regulatory safe harbors protecting certain common activities
from prosecution, the exemptions and safe harbors are drawn
narrowly, and practices that involve remuneration intended to
induce prescribing, purchasing, or recommending may be subject
to scrutiny if they do not qualify for an exemption or safe
harbor. Although we believe that we are in compliance, our
practices may be determined to fail to meet all of the criteria
for safe harbor protection from anti-kickback liability. For
example, we have been notified by the government that we have
been named as a defendant in a qui tam
(whistleblower) lawsuit filed under the federal False
Claims Act, related to our marketing and promotion of
LOPROX®
products to pediatricians. See Item 3. Legal Proceedings of
this Form 10-K/ T.
Federal false claims laws prohibit any person from knowingly
presenting, or causing to be presented, a false claim for
payment to the federal government, or knowingly making, or
causing to be made, a false statement to get a false claim paid.
Pharmaceutical companies have been prosecuted under these laws
for a variety of alleged promotional and marketing activities,
such as allegedly providing free product to customers with the
expectation that the customers would bill federal programs for
the product; reporting to pricing services inflated average
wholesale prices that were then used by federal programs to set
reimbursement rates; engaging in off-label promotion that caused
claims to be submitted to Medicaid for non-covered off-label
uses; and submitting inflated best price information to the
Medicaid Rebate Program. The majority of states also have
statutes or regulations similar to the federal anti-kickback law
and false claims laws, which apply to items and services
reimbursed under Medicaid and other state programs, or, in
several states, apply regardless of the payor. Sanctions under
these federal and state laws may include civil monetary
penalties, exclusion of a manufacturers products from
reimbursement under government programs, criminal fines, and
imprisonment. Because of the breadth of these laws and the
narrowness of the safe harbors, it is possible that some of our
business activities could be subject to challenge under one or
more of such laws.
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Obtaining FDA and other regulatory approvals is time
consuming, expensive and uncertain |
The process of obtaining FDA and other regulatory approvals is
time consuming and expensive. Clinical trials are required and
the marketing and manufacturing of pharmaceutical products are
subject to rigorous testing procedures. We may not be able to
obtain FDA approval to conduct clinical trials or to manufacture
or market any of the products we develop, acquire or license on
a timely basis or at all. Moreover, the costs to obtain
approvals could be considerable, and the failure to obtain or
delays in obtaining an approval could significantly harm our
business performance and financial results. Even if
pre-marketing approval from the FDA is received, the FDA is
authorized to impose post-marketing requirements such as:
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testing and surveillance to monitor the product and its
continued compliance with regulatory requirements; |
25
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submitting products for inspection and, if any inspection
reveals that the product is not in compliance, prohibiting the
sale of all products from the same lot; |
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suspending manufacturing; |
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switching status from prescription to
over-the-counter drug; |
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recalling products; and |
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withdrawing marketing clearance. |
In their regulation of advertising, the FDA and FTC from time to
time issue correspondence to pharmaceutical companies alleging
that some advertising or promotional practices are false,
misleading or deceptive. The FDA has the power to impose a wide
array of sanctions on companies for such advertising practices,
and the receipt of correspondence from the FDA alleging these
practices could result in the following:
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incurring substantial expenses, including fines, penalties,
legal fees and costs to comply with the FDAs requirements; |
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changes in the methods of marketing and selling products; |
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taking FDA-mandated corrective action, which may include placing
advertisements or sending letters to physicians rescinding
previous advertisements or promotion; and |
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disruption in the distribution of products and loss of sales
until compliance with the FDAs position is obtained. |
In recent years, various legislative proposals have been offered
in Congress and in some state legislatures that include major
changes in the health care system. These proposals have included
price or patient reimbursement constraints on medicines,
restrictions on access to certain products, reimportation of
products from Canada or other sources and mandatory substitution
of generic for branded products. We cannot predict the outcome
of such initiatives, and it is difficult to predict the future
impact of the broad and expanding legislative and regulatory
requirements affecting us.
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We face significant competition within our industry |
The pharmaceutical and dermal aesthetics industries are highly
competitive. Competition in our industry occurs on a variety of
fronts, including:
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developing and bringing new products to market before others; |
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developing new technologies to improve existing products; |
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developing new products to provide the same benefits as existing
products at less cost; and |
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developing new products to provide benefits superior to those of
existing products. |
The intensely competitive environment requires an ongoing,
extensive search for technological innovations and the ability
to market products effectively. Consequently, we must continue
to develop and introduce products in a timely and cost-efficient
manner to effectively compete in the marketplace and maintain
our revenue and gross margins.
Our competitors vary depending upon product categories. Many of
our competitors are large, well-established companies in the
fields of pharmaceuticals, chemicals, cosmetics and health care.
Among our largest competitors are Allergan, Bristol-Myers
Squibb, Galderma, GlaxoSmithKline, Inamed, Johnson &
Johnson, Pfizer, sanofi-aventis, Schering-Plough, Valeant
Pharmaceuticals, Wyeth 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
26
their cost of production so that they may engage in price
competition through aggressive pricing policies to secure a
greater market share to our detriment. These competitors also
may develop products that make our current or future products
obsolete. Any of these events could significantly harm our
business, financial condition and results of operations,
including reducing our market share, gross margins, and cash
flows.
We sell and distribute prescription brands, medical devices and
over-the-counter
products. Each of these products competes with products produced
by others to treat the same conditions. Several of our
prescription products compete with generic pharmaceuticals,
which claim to offer equivalent benefit at a lower cost. In some
cases, insurers and other health care payment organizations try
to encourage the use of these less expensive generic brands
through their prescription benefits coverage and reimbursement
policies. These organizations may make the generic alternative
more attractive to the patient by providing different amounts of
reimbursement so that the net cost of the generic product to the
patient is less than the net cost of our prescription brand
product. Aggressive pricing policies by our generic product
competitors and the prescription benefits policies of third
party payors could cause us to lose market share or force us to
reduce our gross margins in response.
There are several dermal filler products under development
and/or in the FDA pipeline for approval which claim to offer
equivalent or greater facial aesthetic benefits to
RESTYLANE®
and, if approved, the companies producing such products could
charge less to doctors for their products.
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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 the Transition Period
and that remain unresolved.
Our office space in Scottsdale, Arizona has approximately
75,000 square feet under an amended lease agreement that
expires in December 2010. The average annual expense under the
amended lease agreement is approximately $2.1 million. The
lease contains certain rent escalation clauses and, upon
expiration, can be renewed for two additional periods of five
years each.
Medicis Aesthetics Canada Ltd., a wholly owned subsidiary,
presently leases approximately 3,600 square feet of office
space in Toronto, Ontario, Canada, under a lease agreement that
expires in February 2008.
Rent expense was approximately $1.2 million,
$1.1 million, $2.3 million, $2.1 million and
$1.5 million for the Transition Period, the comparable
six-month period in 2004 and fiscal 2005, fiscal 2004 and fiscal
2003, respectively. We believe these properties are adequate for
our current purposes, and we are currently pursuing additional
headquarter office space to accommodate our expected long-term
growth.
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Item 3. |
Legal Proceedings |
On November 9, 2001, prior to its merger with our company,
Ascent received notice that Triumph-Connecticut Limited
Partnership and related parties (Triumph) had
brought a civil action against it in the Business Session of the
Superior Court of the Commonwealth of Massachusetts. In the
action, the Triumph group claimed that the execution by Ascent
of the merger agreement and the consummation of the merger
without the consent of the Triumph group or the payment to the
Triumph group of a specified amount breached the terms of a
January 1997 securities purchase agreement, the terms of
warrants issued to the Triumph group, an implied covenant of
good faith and fair dealing, and certain deceptive trade laws.
The Triumph group sought damages in an amount not less than
$22.1 million, plus treble damages. A hearing on
cross-motions for summary judgment was held on October 16,
2003. On April 9, 2004, the court ruled on the
cross-motions in Ascents favor. Triumphs
cross-motion for summary judgment was denied and Ascents
cross-motion for summary judgment was granted on all claims. The
court entered its order dismissing the lawsuit on April 13,
2004. Triumph filed a notice of appeal on May 6, 2004. Both
Triumph and Ascent filed appellate briefs. The Massachusetts
Appeals Court held a hearing regarding Triumphs appeal on
April 15,
27
2005. On November 14, 2005, the Massachusetts Appeals Court
issued a decision and order affirming the grant of summary
judgment in favor of Ascent on all claims. Triumph did not file
a timely request for further appellate review from the
Massachusetts Supreme Judicial Court. Accordingly, the Appeals
Court issued its rescript to the Massachusetts
Superior Court and on December 28, 2005, the Superior Court
entered judgment for defendant Ascent. This matter is closed. We
are in the process of distributing the accumulated contingent
purchase price payments of $27.4 million to the former
shareholders of Ascent, as they were withheld pending final
resolution of this matter.
On June 21, 2004, the United States International Trade
Commission (ITC) instituted an investigation
pursuant to Section 337 of the Tariff Act of 1930, as
amended, at the request of Inamed. The investigation identified
Medicis Aesthetics, Inc., a wholly owned subsidiary of our
company, and Q-Med as respondents in the investigation regarding
Inameds allegation of infringement of its U.S. Patent
No. 4,803,075, dated February 7, 1989, by the dermal
filler,
RESTYLANE®.
On September 16, 2004, Inamed moved to add our distributor,
McKesson Corporation (McKesson), as a respondent.
The motion was granted by the Administrative Law Judge
(ALJ) and affirmed by the ITC during November 2004.
Inamed also filed a parallel infringement action against us and
Q-Med in the U.S. District Court of the Southern District
of California regarding the same patent. Inamed amended its
complaint to add McKesson as a party to this action as well.
This action was stayed pending the outcome of the ITC
investigation. Pursuant to the Agreement and Plan of Merger (the
Merger Agreement) and related transactions entered
into by Medicis, Inamed and a wholly-owned subsidiary of Medicis
on March 20, 2005, Inamed filed a motion to dismiss with
prejudice Inameds patent infringement action. In addition,
Inamed consented to the dismissal of the ITC matter, which has
been granted and has been made final. The matters are closed.
The government notified us on December 14, 2004, that it is
investigating claims that we violated the federal False Claims
Act. We are fully cooperating with the government in its
investigation, which relates to our marketing and promotion of
LOPROX®
products to pediatricians prior to our May 2004, disposition of
the Companys pediatric sales division.
On October 27, 2005, we filed suit against Upsher-Smith
Laboratories, Inc. of Plymouth, Minnesota and against Prasco
Laboratories of Cincinnati, Ohio for infringement of Patent
No. 6,905,675 entitled Sulfur Containing
Dermatological Compositions and Methods for Reducing Malodors in
Dermatological Compositions covering our sodium
sulfacetamide/sulfur technology. This intellectual property is
related to our
PLEXION®
Cleanser product. The suit was filed in the U.S. District
Court for the District of Arizona, and seeks an award of
damages, as well as a preliminary and a permanent injunction. We
are in the midst of accelerated discovery. A hearing on our
preliminary injunction motion was heard on
March 8th and 9th, 2006.
We record contingent liabilities resulting from claims against
us when it is probable (as that word is defined in Statement of
Financial Accounting Standards No. 5) that a liability has
been incurred and the amount of the loss is reasonably
estimable. We disclose material contingent liabilities when
there is a reasonable possibility that the ultimate loss will
exceed the recorded liability. Estimating probable losses
requires analysis of multiple factors, in some cases including
judgments about the potential actions of third-party claimants
and courts. Therefore, actual losses in any future period are
inherently uncertain. In all of the cases noted where we are the
defendant, we believe we have meritorious defenses to the claims
in these actions and resolution of these matters will not have a
material adverse effect on our business, financial condition, or
results of operation; however, the results of the proceedings
are uncertain, and there can be no assurance to that effect.
28
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Item 4. |
Submission of Matters to a Vote of Security Holders |
On December 19, 2005, the Company held its 2005 Annual
Meeting of Shareholders (the Annual Meeting). The
holders of 50,551,674 shares of Class A Common Stock
were present in person or represented by proxy at the meeting.
The following is a summary of the results of the voting by the
Companys shareholders at the Annual Meeting:
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1) Election of Directors |
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The stockholders elected the following persons to serve as
directors of the Company for a term of three years, or until
their successors are duly elected and qualified or until their
earlier resignation or removal. Votes were cast as follows: |
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Number of Votes | |
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For | |
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Withheld | |
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Spencer Davidson
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30,806,330 |
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19,745,344 |
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Stuart Diamond
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29,640,722 |
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20,910,952 |
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Peter S. Knight, Esq.
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30,874,639 |
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19,677,035 |
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The directors of the Company whose terms of office continued
were Mr. Jonah Shacknai, Mr. Arthur G.
Altschul, Jr., Mr. Michael A. Pietrangelo,
Mr. Philip S. Schein, M.D. and Ms. Lottie H.
Shackelford. |
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2) The stockholders approved the appointment of
Ernst & Young LLP as independent auditors for the
Transition Period ending December 31, 2005. Votes were cast
as follows: |
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For |
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Against |
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Abstain |
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50,405,690
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134,354 |
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11,630 |
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3) Three proposals contained in our proxy statement were
not acted upon at the Annual Meeting as a result of the
termination of our Agreement and Plan of Merger with Inamed
Corporation, dated March 20, 2005. These proposals were:
(i) the issuance of shares of Medicis Class A common
stock pursuant to the agreement and plan of merger, (ii) an
amendment to our certificate of incorporation to increase the
number of authorized shares of Medicis Class A common stock
from 150,000,000 to 300,000,000 and change our name from
Medicis Pharmaceutical Corporation to
Medicis and (iii) authorization to postpone or
adjourn the Annual Meeting to permit further solicitation of
proxies if there were not sufficient votes at the time of the
Annual Meeting in favor of the other matters being voted upon. |
29
PART II
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Item 5. |
Market for Registrants Common Equity, Related
Stockholder Matters and Issuer Purchases of Equity
Securities |
Description of Registrants Securities, Price Range of
Common Stock and Dividends Declared
Medicis Class A common stock trades on the New York
Stock Exchange under the symbol MRX. The following
table sets forth the high and low sale prices for our
Class A common stock on the New York Stock Exchange for the
fiscal periods indicated. Prices have been restated to reflect
the 2 for 1 stock split effected in the form of a stock dividend
that occurred on January 23, 2004:
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Dividends | |
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High | |
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Low | |
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Declared | |
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TRANSITION PERIOD
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Three Months Ended September 30, 2005
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$ |
35.45 |
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$ |
31.08 |
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$ |
0.03 |
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Three Months Ended December 31, 2005
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35.16 |
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26.30 |
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0.03 |
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FISCAL YEAR ENDED JUNE 30, 2005
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First Quarter
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$ |
40.65 |
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$ |
32.85 |
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$ |
0.03 |
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Second Quarter
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41.00 |
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34.64 |
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0.03 |
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Third Quarter
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37.67 |
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28.69 |
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0.03 |
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Fourth Quarter
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31.97 |
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26.80 |
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0.03 |
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FISCAL YEAR ENDED JUNE 30, 2004
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First Quarter
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$ |
32.00 |
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$ |
27.27 |
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$ |
0.025 |
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Second Quarter
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36.01 |
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27.81 |
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0.025 |
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Third Quarter
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41.50 |
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33.86 |
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|
|
0.025 |
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Fourth Quarter
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45.26 |
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38.45 |
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|
0.025 |
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On March 10, 2006, the last reported sale price on the New
York Stock Exchange for Medicis Class A common stock
was $28.93 per share. As of such date, there were
approximately 223 holders of record of Class A common stock.
Dividend Policy
Since the beginning of fiscal 2004, we have paid quarterly cash
dividends aggregating approximately $15.2 million on our
common stock. In addition, on December 14, 2005, we
declared a cash dividend of $0.03 per issued and
outstanding share of common stock payable on January 31,
2006 to our stockholders of record at the close of business on
January 3, 2006. Prior to these dividends, we had not paid
a cash dividend on our common stock, and we have not adopted a
dividend policy. Any future determinations to pay cash dividends
will be at the discretion of our Board of Directors and will be
dependent upon our financial condition, operating results,
capital requirements and other factors that our Board of
Directors deems relevant.
Our 1.5% Contingent Convertible Senior Notes due 2033 require an
adjustment to the conversion price if the cumulative aggregate
of all current and prior dividend increases above
$0.025 per share would result in at least a one percent
(1%) increase in the conversion price. This threshold has not
been reached and no adjustment to the conversion price has been
made.
Recent Sales of Unregistered Securities
None.
Equity Compensation Plan Information
Information required to be included about our equity
compensation plan is incorporated by reference to the material
under the caption Equity Compensation Plan
Information in the proxy statement for our 2006 annual
meeting of stockholders.
30
|
|
Item 6. |
Selected Financial Data |
The following table sets forth selected consolidated financial
data for the Transition Period, the corresponding six-month
period in 2004 and the year ended December 31, 2005. The
data for the Transition Period is derived from our audited
consolidated financial statements and accompanying notes, while
the data for the corresponding six-month period in 2004 and the
year ended December 31, 2005 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 the related intangibles.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months | |
|
|
|
|
|
|
Ended | |
|
Year Ended | |
|
|
Transition | |
|
December 31, | |
|
December 31, | |
|
|
Period | |
|
2004 | |
|
2005 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands, except per share amounts) | |
Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues
|
|
$ |
155,569 |
|
|
$ |
146,999 |
|
|
$ |
313,684 |
|
Net contract revenues
|
|
|
8,385 |
|
|
|
34,168 |
|
|
|
46,002 |
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
|
163,954 |
|
|
|
181,167 |
|
|
|
359,686 |
|
Gross profit(a)
|
|
|
139,843 |
|
|
|
153,897 |
|
|
|
307,398 |
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
89,360 |
(b) |
|
|
65,736 |
(e) |
|
|
158,778 |
(g) |
|
Research and development
|
|
|
22,367 |
(c) |
|
|
45,140 |
(f) |
|
|
42,903 |
(h) |
|
Depreciation and amortization
|
|
|
12,420 |
|
|
|
10,222 |
|
|
|
24,548 |
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
124,147 |
|
|
|
121,098 |
|
|
|
226,229 |
|
|
|
|
|
|
|
|
|
|
|
Operating income
|
|
|
15,696 |
|
|
|
32,799 |
|
|
|
81,169 |
|
Other:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net
|
|
|
59,801 |
(d) |
|
|
|
|
|
|
59,801 |
(d) |
|
Net interest income (expense)
|
|
|
4,726 |
|
|
|
(248 |
) |
|
|
5,804 |
|
|
Income tax expense
|
|
|
(30,502 |
) |
|
|
(11,328 |
) |
|
|
(53,288 |
) |
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
93,486 |
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share
|
|
$ |
0.92 |
|
|
$ |
0.38 |
|
|
$ |
1.72 |
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share
|
|
$ |
0.76 |
|
|
$ |
0.34 |
|
|
$ |
1.44 |
(i) |
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share
|
|
$ |
0.06 |
|
|
$ |
0.06 |
|
|
$ |
0.12 |
|
|
|
|
|
|
|
|
|
|
|
Basic common shares outstanding
|
|
|
54,323 |
|
|
|
55,972 |
|
|
|
54,290 |
|
|
|
|
|
|
|
|
|
|
|
Diluted common shares outstanding
|
|
|
69,772 |
|
|
|
72,160 |
|
|
|
69,558 |
(i) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Amounts exclude $10.9 million, $8.9 million and
$21.6 million of amortization expense related to acquired
intangible assets for the Transition Period, the six months
ended December 31, 2004, and the year ended
December 31, 2005. |
|
(b) |
|
Includes approximately $13.9 million of compensation
expense related to stock options and restricted stock recognized
during the Transition Period, a charge of approximately
$9.2 million for the write-down of a long-lived asset and
approximately $0.7 million of integration planning costs
incurred related to the proposed Inamed transaction during the
three months ended September 30, 2005. |
|
(c) |
|
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. |
31
|
|
|
(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 accumulated transactions costs of
$27.0 million, and integration costs incurred during the
three months ended December 31, 2005 of $3.7 million. |
|
(e) |
|
Includes approximately $1.3 million of professional fees
related to research and development collaborations with Ansata
and Q-Med. |
|
(f) |
|
Includes $5.0 million paid to Ansata related to an
exclusive development and license agreement and
$30.0 million paid to Q-Med related to an exclusive license
agreement for the development of
SubQtm. |
|
(g) |
|
Includes approximately $13.9 million of compensation
expense related to stock options and restricted stock recognized
during the Transition Period, a charge of approximately
$9.2 million for the write-down of a long-lived asset 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. |
|
(h) |
|
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. |
|
(i) |
|
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. |
The balance sheet data as of December 31, 2004, and the
cash flow data for the six months ended December 31, 2004,
is unaudited.
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
(In thousands) | |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments
|
|
$ |
742,532 |
(a) |
|
$ |
532,518 |
|
Working capital
|
|
|
692,453 |
|
|
|
552,391 |
|
Total assets
|
|
|
1,145,954 |
|
|
|
979,871 |
|
Long-term debt
|
|
|
453,065 |
|
|
|
453,065 |
|
Stockholders equity
|
|
|
543,487 |
|
|
|
444,826 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months | |
|
|
Transition | |
|
Ended | |
|
|
Period | |
|
Dec. 31, 2004 | |
|
|
| |
|
| |
|
|
(In thousands) | |
Cash Flow Data:
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities
|
|
$ |
147,990 |
|
|
$ |
45,465 |
|
Net cash provided by investing activities
|
|
|
123,665 |
|
|
|
76,158 |
|
Net cash used in by financing activities
|
|
|
(2,792 |
) |
|
|
(137,447 |
) |
|
|
|
(a) |
|
Increase in cash, cash equivalents and short-term investments
from December 31, 2004 to December 31, 2005 includes
the receipt of a termination fee of $90.5 million received
from Inamed upon the termination of the proposed merger with
Inamed, net of expenses related to the proposed transaction. |
32
The following selected consolidated financial data for the
five-year period ended June 30, 2005 is derived from our
audited consolidated financial statements and accompanying
notes. The comparability of the years presented is impacted by
certain product rights and business acquisitions and
dispositions. All business acquisitions were accounted for under
the purchase method and accordingly, the results of operations
reflect the financial results of each business acquisition from
the date of the acquisition. Certain business acquisitions
resulted in the write-off of in-process research and development
resulting from an independent valuation. Gross profit does not
include amortization of the related intangibles. All share and
per share data have been restated to reflect the 2 for 1 stock
split effected in the form of a stock dividend that occurred on
January 23, 2004.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended June 30, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except per share amounts) | |
Statements of Operations Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net product revenues
|
|
$ |
305,114 |
|
|
$ |
291,607 |
|
|
$ |
241,909 |
|
|
$ |
211,248 |
|
|
$ |
159,677 |
|
Net contract revenues
|
|
|
71,785 |
|
|
|
12,115 |
|
|
|
5,630 |
|
|
|
1,559 |
|
|
|
8,125 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
|
376,899 |
|
|
|
303,722 |
|
|
|
247,539 |
|
|
|
212,807 |
|
|
|
167,802 |
|
Gross profit(a)
|
|
|
321,452 |
|
|
|
257,116 |
|
|
|
209,279 |
|
|
|
177,042 |
|
|
|
137,105 |
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative
|
|
|
135,154 |
(b) |
|
|
118,253 |
|
|
|
91,648 |
|
|
|
77,314 |
|
|
|
59,508 |
|
|
Research and development
|
|
|
65,676 |
(c) |
|
|
16,494 |
(d) |
|
|
29,568 |
(e) |
|
|
15,132 |
(f) |
|
|
25,515 |
(g) |
|
In-process research and development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,217 |
|
|
|
|
|
|
Depreciation and amortization
|
|
|
22,350 |
|
|
|
16,794 |
|
|
|
10,125 |
|
|
|
7,928 |
|
|
|
8,261 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
223,180 |
|
|
|
151,541 |
|
|
|
131,341 |
|
|
|
106,591 |
|
|
|
93,284 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
|
|
|
98,272 |
|
|
|
105,575 |
|
|
|
77,938 |
|
|
|
70,451 |
|
|
|
43,821 |
|
Other:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net interest income (expense)
|
|
|
830 |
|
|
|
(758 |
) |
|
|
(278 |
) |
|
|
8,533 |
|
|
|
15,504 |
|
|
Loss on early extinguishment of debt
|
|
|
|
|
|
|
(58,660 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
|
|
|
(34,112 |
) |
|
|
(15,317 |
) |
|
|
(26,404 |
) |
|
|
(28,960 |
) |
|
|
(18,905 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$ |
64,990 |
|
|
$ |
30,840 |
|
|
$ |
51,256 |
|
|
$ |
50,024 |
|
|
$ |
40,420 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per share
|
|
$ |
1.18 |
|
|
$ |
0.55 |
|
|
$ |
0.94 |
|
|
$ |
0.83 |
|
|
$ |
0.67 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per share
|
|
$ |
1.01 |
|
|
$ |
0.52 |
|
|
$ |
0.84 |
|
|
$ |
0.79 |
|
|
$ |
0.64 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share
|
|
$ |
0.12 |
|
|
$ |
0.10 |
|
|
$ |
0.025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic common shares outstanding
|
|
|
55,196 |
|
|
|
55,618 |
|
|
|
54,376 |
|
|
|
60,536 |
|
|
|
60,268 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted common shares outstanding
|
|
|
70,909 |
|
|
|
72,481 |
|
|
|
70,191 |
|
|
|
63,828 |
|
|
|
63,388 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Amounts exclude $19.6 million, $14.9 million,
$9.2 million, $7.1 million and $7.6 million for
amortization expense related to acquired intangible assets in
fiscal 2005, 2004, 2003, 2002 and 2001, respectively. |
|
(b) |
|
Includes approximately $5.3 million of business integration
planning costs related to the proposed merger with Inamed, and
approximately $1.3 million of professional fees related to
research and development collaborations with aaiPharma, Ansata
and Q-Med. |
33
|
|
|
(c) |
|
Includes approximately $8.3 million paid to aaiPharma
related to a research and development collaboration,
$5.0 million paid to Ansata related to an exclusive
development and license agreement and $30.0 million paid to
Q-Med related to an exclusive license agreement for the
development of
SubQtm. |
|
(d) |
|
Includes approximately $2.4 million paid to Dow for a
research and development collaboration. |
|
(e) |
|
Includes $14.2 million paid to Dow for a research and
development collaboration and approximately $6.0 million
paid to aaiPharma for a research and development collaboration. |
|
(f) |
|
Includes $7.7 million paid to aaiPharma for a research and
development collaboration. |
|
(g) |
|
Includes $17.0 million paid to Corixa Corporation for a
development, commercialization and licensing agreement. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, restricted cash and short-term
investments
|
|
$ |
603,568 |
|
|
$ |
634,040 |
|
|
$ |
552,663 |
|
|
$ |
577,576 |
|
|
$ |
334,157 |
|
Working capital
|
|
|
600,070 |
|
|
|
666,743 |
|
|
|
576,781 |
|
|
|
611,259 |
|
|
|
358,468 |
|
Total assets
|
|
|
1,043,251 |
|
|
|
1,078,384 |
|
|
|
932,841 |
|
|
|
876,273 |
|
|
|
550,007 |
|
Long-term debt
|
|
|
453,065 |
|
|
|
453,067 |
|
|
|
400,000 |
|
|
|
400,000 |
|
|
|
|
|
Stockholders equity
|
|
|
486,346 |
|
|
|
555,303 |
|
|
|
461,121 |
|
|
|
429,059 |
|
|
|
503,453 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal Year Ended June 30, | |
|
|
| |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Cash Flow Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities
|
|
$ |
129,981 |
|
|
$ |
127,964 |
|
|
$ |
84,667 |
|
|
$ |
73,542 |
|
|
$ |
71,120 |
|
Net cash provided by (used in) investing activities
|
|
|
140,487 |
|
|
|
(166,341 |
) |
|
|
(113,709 |
) |
|
|
(341,660 |
) |
|
|
(97,981 |
) |
Net cash (used in) provided by financing activities
|
|
|
(139,793 |
) |
|
|
40,621 |
|
|
|
(23,343 |
) |
|
|
254,938 |
|
|
|
12,548 |
|
34
|
|
Item 7. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations |
The following Managements Discussion and Analysis of
Financial Condition and Results of Operations
(MD&A) summarizes the significant factors
affecting our results of operations, liquidity, capital
resources and contractual obligations, as well as discusses our
critical accounting policies and estimates. You should read the
following discussion and analysis together with our consolidated
financial statements, including the related notes, which are
included in this report on
Form 10-K/T.
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/T for a
discussion of important factors that could cause actual results
to differ materially from the results described in or implied by
the forward-looking statements in this report. Our MD&A is
composed of four major sections; Executive Summary, Results of
Operations, Liquidity and Capital Resources and Critical
Accounting Policies and Estimates.
Change in Fiscal Year
On December 12, 2005, our Board of Directors resolved to
change our fiscal year end from June 30 to
December 31, effective December 31, 2005. This change
was made to align our fiscal year end with other companies
within our industry. Our six-month results discussed below
relate to the transitional six-month fiscal period ended
December 31, 2005 (the Transition Period). We
refer to the period beginning July 1, 2004 and ending
June 30, 2005 as fiscal 2005, the period
beginning July 1, 2003 and ending June 30, 2004 as
fiscal 2004 and the period beginning July 1,
2002 and ending June 30, 2003 as fiscal 2003.
Executive Summary
We are a leading independent specialty pharmaceutical company
focusing primarily on helping patients attain a healthy and
youthful appearance and self-image through the development and
marketing of products in the U.S. for the treatment of
dermatological, aesthetic and podiatric conditions. We also
market products in Canada for the treatment of dermatological
and aesthetic conditions. We offer a broad range of products
addressing various conditions or aesthetics improvements,
including dermal fillers, acne, fungal infections, rosacea,
hyperpigmentation, photoaging, psoriasis, eczema, skin and
skin-structure infections, seborrheic dermatitis and cosmesis
(improvement in the texture and appearance of skin).
Our current product lines are divided between the dermatological
and non-dermatological fields. Our dermatological field
represents products for the treatment of acne and acne-related
dermatological conditions and non-acne dermatological
conditions. Our non-dermatological field represents products for
the treatment of asthma (until May 2004), urea cycle disorder
and contract revenue. Our acne and acne-related dermatological
product lines include core brands
DYNACIN®,
PLEXION®
and
TRIAZ®.
Our non-acne dermatological product lines include core brands
LOPROX®,
OMNICEF®,
RESTYLANE®
and
VANOStm.
Our non-dermatological product lines include
AMMONUL®,
BUPHENYL®
and
ORAPRED®.
ORAPRED®
was one of the Companys core brands until it was licensed
to BioMarin in May 2004. Our non-dermatological field also
includes contract revenues associated with licensing and
authorized generic agreements.
|
|
|
Key Aspects of Our Business |
We derive a majority of our prescription volume from our core
prescription products:
DYNACIN®,
LOPROX®,
OMNICEF®,
PLEXION®,
TRIAZ®
and
VANOStm.
We believe that sales of our core prescription products and
sales of our dermal aesthetic product,
RESTYLANE®,
which we began selling in the U.S. on January 6, 2004,
will continue to constitute a significant portion of our sales
for the foreseeable future.
We have built our business by executing a four-part growth
strategy: promoting existing core 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
relation-
35
ships of trust and confidence with the high prescribing
dermatologists and podiatrists and the leading plastic surgeons
in the United States.
As a result of customer buying patterns, a substantial portion
of our product revenues has been recognized in the last month of
each quarter, and we schedule our inventory purchases to meet
anticipated customer demand. As a result, relatively small
delays in the receipt of manufactured products by us 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. Consequently, variations in the timing of revenue
recognition could cause significant fluctuations in operating
results from period to period and may result in unanticipated
periodic earnings shortfalls or losses.
We estimate customer demand for our prescription products
primarily through use of third party syndicated data sources
which track prescriptions written by health care providers and
dispensed by licensed pharmacies. The data represents
extrapolations from information provided only by certain
pharmacies and are estimates of historical demand levels. We
estimate customer demand for our non-prescription products
primarily through internal data that we compile. We observe
trends from these data, and, coupled with certain proprietary
information, prepare demand forecasts that are the basis for
purchase orders for finished and component inventory from our
third party manufacturers and suppliers. Our forecasts may fail
to accurately anticipate ultimate customer demand for our
products. Overestimates of demand may result in excessive
inventory production and underestimates may result in inadequate
supply of our products in channels of distribution.
We sell our products primarily to major wholesalers and retail
pharmacy chains. Consistent with pharmaceutical industry
patterns, approximately 80% of our revenues are derived from
three major drug wholesale concerns. While we attempt to
estimate inventory levels of our products at our major wholesale
customers by using historical prescription information and
historical purchase patterns, this process is inherently
imprecise. Rarely do wholesale customers provide us complete
inventory levels at regional distribution centers, or within
their national distribution systems. We rely wholly upon our
wholesale and drug chain customers to effect the distribution
allocation of our products. Based upon historically consistent
purchasing patterns of our major wholesale customers, we believe
our estimates of trade inventory levels of our products are
reasonable. We further believe that inventories of our products
among wholesale customers, taken as a whole, are similar to
those of other specialty pharmaceutical companies, and that our
trade practices, which periodically involve volume discounts and
early payment discounts, are typical of the industry.
We periodically offer promotions to wholesale and chain
drugstore customers to encourage dispensing of our products,
consistent with prescriptions written by licensed health care
providers. Because many of our products compete in multi-source
markets, it is important for us to ensure the licensed health
care providers dispensing instructions are fulfilled with
our branded products and are not substituted with a generic
product or another therapeutic alternative product which may be
contrary to the licensed health care providers recommended
and prescribed Medicis brand. We believe that a critical
component of our brand protection program is maintenance of full
product availability at drugstore and wholesale customers. We
believe such availability reduces the probability of local and
regional product substitutions, shortages and backorders, which
could result in lost sales. We expect to continue providing
favorable terms to wholesale and retail drug chain customers as
may be necessary to ensure the fullest possible distribution of
our branded products within the pharmaceutical chain of commerce.
We cannot control or significantly influence the purchasing
patterns of our wholesale and retail drug chain customers. They
are highly sophisticated customers that purchase products in a
manner consistent with their industry practices and, presumably,
based upon their projected demand levels. Purchases by any given
customer, during any given period, may be above or below actual
prescription volumes of any of our products during the same
period, resulting in fluctuations of product inventory in the
distribution channel.
36
As described in more detail below, the following significant
events and transactions occurred during the Transition Period,
and affected our results of operations, our cash flows and our
financial condition:
|
|
|
|
|
Termination of the proposed definitive merger agreement with
Inamed Corporation; |
|
|
|
Adoption of SFAS No. 123R; and |
|
|
|
Write-down of a long-lived asset due to impairment. |
|
|
|
Termination of the Proposed Definitive Merger Agreement
with Inamed Corporation |
On March 20, 2005, Medicis and Inamed Corporation
(Inamed) entered into an Agreement and Plan of
Merger (the Agreement). Inamed is a global
healthcare company that develops, manufactures, and markets
breast implants for aesthetic augmentation and reconstructive
surgery following a mastectomy, a range of dermal products to
correct facial wrinkles, the
BioEnterics®
LAP-BAND®
System designed to treat severe and morbid obesity, and the
BioEnterics®
Intragastric Balloon
(BIB®)
system for the treatment of obesity. Under the terms of the
Agreement, Inamed was to merge with and into a subsidiary of
Medicis and each share of Inamed common stock would have been
converted into the right to receive 1.4205 shares of
Medicis common stock and $30.00 in cash. The completion of the
transaction was subject to several customary conditions,
including the receipt of applicable approvals from Medicis
and Inameds stockholders, the absence of any material
adverse effect on either partys business and the receipt
of regulatory approvals.
On December 13, 2005, 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, pursuant to which Medicis and Inamed
agreed to terminate the Agreement. In accordance with the terms
of the Agreement and the merger termination agreement, Inamed
paid Medicis a termination fee of $90.0 million, plus
$0.5 million in expense reimbursement fees on
December 13, 2005.
From the inception of the proposed transaction with Inamed
through the termination of the Agreement, we had incurred
approximately $14.0 million of professional and other costs
related to the transaction. These costs, which were maintained
in other long-term assets in our consolidated balance sheet
during the transaction approval process, were expensed upon
termination of the Agreement. As a result of the termination, we
were required to pay Deutsche Bank Trust Company Americas a fee
pursuant to a provision in the merger engagement letter with
them whereby they were entitled to a portion of the termination
fee. We also incurred business integration costs related to the
transaction, including the planning for and implementation of
integration activities. These costs were expensed as incurred.
During the Transition Period, we incurred approximately
$4.4 million of business integration planning costs. These
costs were primarily consulting and other professional fees.
During the Transition Period, we recognized a net benefit
related to the above items of approximately $59.1 million.
This is summarized as follows (in millions):
|
|
|
|
|
Termination fee received from Inamed, including expense
reimbursement fees
|
|
$ |
90.5 |
|
Less:
|
|
|
|
|
Transaction costs expensed, including legal and advisory fees
|
|
|
27.0 |
|
Integration planning costs
|
|
|
4.4 |
|
|
|
|
|
|
|
$ |
59.1 |
|
|
|
|
|
Approximately $0.7 million of the integration planning
costs, incurred during the three months ended September 30,
2005, are included in selling, general and administrative
expenses in the accompanying consolidated statements of income.
Approximately $59.8 million of the net benefit related to
the above items, including $3.7 million of integration
planning costs incurred during the three months ended
December 31, 2005, is included in other income, net, in the
accompanying consolidated statements of income.
The total net benefit we recognized from the inception of the
proposed transaction through the termination of the Agreement
was approximately $53.8 million. This includes the
$59.1 million benefit
37
recognized during the Transition Period, partially offset by
approximately $5.3 million of integration planning costs
incurred during the three months ended June 30, 2005.
|
|
|
Adoption of SFAS No. 123R |
In December 2004, the FASB issued Statement of Financial
Accounting Standards No. 123, Accounting for
Stock-Based Compensation
(SFAS No. 123R), which requires companies
to measure and recognize compensation expense for all
share-based payments at fair value. Share-based payments include
stock option and nonvested share grants. We grant options to
purchase common stock to some of our employees and directors
under various plans at prices equal to the market value of the
stock on the dates the options were granted. We historically
have accounted for stock options using the method prescribed in
Accounting Principles Board Opinion No. 25,
Accounting for Stock Issued to Employees, (APB
Opinion No. 25) whereby stock options are granted at
market price and no compensation cost is recognized, and
disclosed the pro forma effect on net earnings assuming
compensation cost had been recognized in accordance with
SFAS No. 123. SFAS No. 123R, which was
effective for us beginning in the first quarter of the
Transition Period, eliminates the ability to account for
share-based compensation transactions using APB Opinion
No. 25, and generally requires that such transactions be
accounted for using prescribed fair-value-based methods.
SFAS No. 123R permits public companies to adopt its
requirements using one of two methods: (a) a modified
prospective method in which compensation costs are
recognized beginning with the effective date based on the
requirements of SFAS No. 123R for all share-based
payments granted or modified after the effective date, and based
on the requirements of SFAS No. 123 for all awards
granted to employees prior to the effective date of
SFAS No. 123R that remain unvested on the effective
date or (b) a modified retrospective method
which includes the requirements of the modified prospective
method described above, but also permits companies to restate
based on the amounts previously recognized under
SFAS No. 123 for purposes of pro forma disclosures
either for all periods presented or prior interim periods of the
year of adoption. We decided to adopt SFAS No. 123R
using the modified prospective method. SFAS No. 123R
also requires the benefits of tax deductions in excess of
recognized compensation cost to be reported as a financing cash
flow, rather than as an operating cash flow as required under
historical literature.
During the six months ended December 31, 2005, we
recognized approximately $14.9 million (before income tax
expense) of compensation expense related to the expensing of
stock options and restricted stock in accordance with
SFAS No. 123R. Approximately $13.9 million and
$1.0 million is included in selling, general and
administrative expenses and research and development expenses,
respectively, in the accompanying consolidated statements of
income. Basic and diluted net income per common share for the
Transition Period would have been $1.12 and $0.92, respectively,
if the Company had not adopted SFAS No. 123R, compared
to reported basic and diluted net income per common share of
$0.92 and $0.76, respectively.
|
|
|
Write-down of a Long-lived Asset Due to Impairment |
We assess the potential impairment of long-lived assets on a
periodic basis and when events or changes in circumstances
indicate that the carrying value of the assets may not be
recoverable. Factors that we consider in deciding when to
perform an impairment review include significant
under-performance of a product line in relation to expectations,
significant negative industry or economic trends, and
significant changes or planned changes in our use of the assets.
Recoverability of assets that will continue to be used in our
operations is measured by comparing the carrying amount of the
asset grouping to our estimate of the related total future net
cash flows. If an asset carrying value is not recoverable
through the related cash flows, the asset is considered to be
impaired. The impairment is measured by the difference between
the asset groupings carrying amount and its fair value,
based on the best information available, including market prices
or discounted cash flow analysis.
During the quarter ended December 31, 2005, a long-lived
asset related to our
DYNACIN®
capsule products was determined to be impaired based on our
analysis of the long-lived assets carrying value and
projected future cash flows. Factors affecting the long-lived
assets future cash flows included our promotional focus on
our
DYNACIN®
tablet products, and competitive pressures in the marketplace.
As a result of the impairment analysis, we recorded a write-down
of approximately $9.2 million related to this long-lived
asset,
38
which is included in selling, general and administrative
expenses in the accompanying consolidated statements of income.
Results of Operations
The following table sets forth certain data as a percentage of
net revenues for the periods indicated.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months | |
|
|
|
|
|
|
Ended | |
|
Fiscal Year Ended | |
|
|
Transition | |
|
December 31, | |
|
| |
|
|
Period(a) | |
|
2004(b) | |
|
2005(c) | |
|
2004(d) | |
|
2003(e) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(Unaudited) | |
|
|
|
|
|
|
Net revenues
|
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
100.0 |
% |
Gross profit(f)
|
|
|
85.3 |
|
|
|
84.9 |
|
|
|
85.3 |
|
|
|
84.7 |
|
|
|
84.5 |
|
Operating expenses
|
|
|
75.7 |
|
|
|
66.8 |
|
|
|
59.2 |
|
|
|
49.9 |
|
|
|
53.1 |
|
Operating income
|
|
|
9.6 |
|
|
|
18.1 |
|
|
|
26.1 |
|
|
|
34.8 |
|
|
|
31.5 |
|
Other income, net
|
|
|
36.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense), net
|
|
|
2.9 |
|
|
|
(0.1 |
) |
|
|
0.2 |
|
|
|
(0.2 |
) |
|
|
(0.1 |
) |
Loss on early extinguishment of debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(19.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax expense
|
|
|
(18.7 |
) |
|
|
(6.3 |
) |
|
|
(9.1 |
) |
|
|
(5.0 |
) |
|
|
(10.7 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
30.3 |
% |
|
|
11.7 |
% |
|
|
17.2 |
% |
|
|
10.2 |
% |
|
|
20.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(a) |
|
Included in operating expenses is $14.9 million (9.1%) of
net revenues) of compensation expense related to stock options
and restricted stock, a charge of approximately
$9.2 million (5.6% of net revenues) for the write-down of a
long-lived asset, and $0.7 million (0.4% of net revenues)
related to integration planning costs incurred during the three
months ended September 30, 2005 related to the proposed
merger with Inamed. Included in other income, net, is
$59.8 million (36.5% of net revenue) related to a
termination fee of $90.5 million received from Inamed upon
the termination of the proposed merger with Inamed, net of a fee
paid to an investment banker and the expensing of accumulated
transaction costs of $27.0 million, and integration
planning costs incurred during the three months ended
December 31, 2005 of $3.7 million. |
|
(b) |
|
Included in operating expenses is $5.5 million (3.1% of net
revenues) related to our exclusive development and license
agreement with Ansata for proprietary technology and
$30.7 million (17.0% of net revenues) related to our
exclusive license agreement with Q-Med for the development of
SubQtm. |
|
(c) |
|
Included in operating expenses is $5.3 million (1.4% of net
revenues) of business integration planning costs related to the
proposed merger with Inamed, $8.3 million (2.2% of net
revenues) related to a research and development collaboration
with aaiPharma, $5.5 million (1.5% of net revenues) related
to our exclusive development and license agreement with Ansata
for proprietary technology and $30.7 million (8.2% of net
revenues) related to our exclusive license agreement with Q-Med
for the development of
SubQtm. |
|
(d) |
|
Included in operating expenses is a $2.4 million payment
(0.8% of net revenues) to Dow for a research and development
collaboration. |
|
(e) |
|
Included in operating expenses is $14.2 million in payments
(5.7% of net revenues) to Dow for a research and development
collaboration and a $6.0 million payment (2.4% of net
revenues) to aaiPharma for a research and development
collaboration. |
|
(f) |
|
Gross profit does not include amortization of the related
intangibles as such expense is included in operating expenses. |
39
|
|
|
Six Months Ended December 31, 2005 Compared To Six
Months Ended December 31, 2004 |
The following table sets forth the net revenues for the
Transition Period and December 31, 2004 (the
comparable 2004 six months), along with the
percentage of net revenues for each of our product categories
(amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable | |
|
|
|
|
|
|
Transition | |
|
2004 | |
|
$ | |
|
% | |
|
|
Period | |
|
Six Months | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Net product revenues
|
|
$ |
155.6 |
|
|
$ |
147.0 |
|
|
$ |
8.6 |
|
|
|
5.8 |
% |
Net contract revenues
|
|
|
8.4 |
|
|
|
34.2 |
|
|
|
(25.8 |
) |
|
|
(75.5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
$ |
164.0 |
|
|
$ |
181.2 |
|
|
$ |
(17.2 |
) |
|
|
(9.5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable | |
|
|
|
|
Transition | |
|
2004 | |
|
|
|
|
Period | |
|
Six Months | |
|
Change | |
|
|
| |
|
| |
|
| |
Acne and acne-related dermatological products
|
|
|
28.1 |
% |
|
|
32.8 |
% |
|
|
(4.7 |
)% |
Non-acne dermatological products
|
|
|
58.9 |
% |
|
|
44.4 |
% |
|
|
14.5 |
% |
Non-dermatological products
|
|
|
13.0 |
% |
|
|
22.8 |
% |
|
|
(9.8 |
)% |
|
|
|
|
|
|
|
|
|
|
|
Total net revenues
|
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our total net revenues decreased during the Transition Period
primarily as a result of a decrease in net contract revenues
associated with licensing agreements and authorized generic
agreements. Net contract revenues decreased primarily due to a
decrease in contract revenues during the Transition Period
related to our outlicensing of the
ORAPRED®
brand pursuant to the terms of our license agreement with
BioMarin. Core brand revenues, which are included in net product
revenues and includes revenues associated with
RESTYLANE®,
DYNACIN®,
LOPROX®,
OMNICEF®,
PLEXION®,
TRIAZ®
and
VANOStm,
represented approximately $138.3 million, or approximately
84.4% of net revenues, during the Transition Period, a slight
decrease of approximately 0.3%, compared to core brand revenues
of approximately $138.7 million, or approximately 76.6% of
net revenues, for the comparable 2004 six months. Net revenues
associated with our acne and acne-related dermatological
products decreased as a percentage of net revenues and decreased
in net dollars by 22.6% during the Transition Period as compared
to the comparable 2004 six months, primarily due to generic
competition with our
DYNACIN®
brand of products. Net revenues associated with our non-acne
dermatological products increased as a percentage of net
revenues, and increased in net dollars by 20.0% during the
Transition Period, primarily due to the launch of VANOS in April
2005, and an increase in sales of
RESTYLANE®.
Net revenues associated with our non-dermatological products
decreased as a percentage of net revenues and decreased in net
dollars by 48.1% during the Transition Period, primarily due to
the decrease in
ORAPRED®
contract revenues discussed above.
Gross profit represents our net revenues less our cost of
product revenue. Our cost of product revenue includes our
acquisition cost for the products we purchase from our third
party manufacturers and royalty payments made to third parties.
Amortization of intangible assets related to products sold is
not included in gross profit. Product mix plays a significant
role in our quarterly and annual gross profit as a percentage of
net revenues. Different products generate different gross profit
margins, and the relative mix of higher gross profit products
and lower gross profit products can affect our total gross
profit.
40
The following table sets forth our gross profit for the
Transition Period and comparable 2004 six months, along with the
percentage of net revenues represented by such gross profit
(amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable | |
|
|
|
|
|
|
Transition | |
|
2004 | |
|
$ | |
|
% | |
|
|
Period | |
|
Six Months | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Gross profit
|
|
$ |
139.8 |
|
|
$ |
153.9 |
|
|
$ |
(14.1 |
) |
|
|
(9.1 |
)% |
% of net revenues
|
|
|
85.3 |
% |
|
|
84.9 |
% |
|
|
|
|
|
|
|
|
The decrease in gross profit during the Transition Period as
compared to the comparable 2004 six months was due to the
decrease in our net revenues, while the increase in gross profit
as a percentage of net revenues was primarily due to the
different mix of products sold during the Transition Period as
compared to the comparable 2004 six months.
|
|
|
Selling, General and Administrative Expenses |
The following table sets forth our selling, general and
administrative expenses for the Transition Period and comparable
2004 six months, along with the percentage of net revenues
represented by selling, general and administrative expenses
(amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable | |
|
|
|
|
|
|
Transition | |
|
2004 | |
|
$ | |
|
% | |
|
|
Period | |
|
Six Months | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Selling, general and administrative
|
|
$ |
89.4 |
|
|
$ |
65.7 |
|
|
$ |
23.7 |
|
|
|
35.9 |
% |
% of net revenues
|
|
|
54.5 |
% |
|
|
36.3 |
% |
|
|
|
|
|
|
|
|
Share-based compensation expense included in selling, general
and administrative
|
|
$ |
13.9 |
|
|
$ |
0.3 |
|
|
$ |
13.6 |
|
|
|
5,416.1 |
% |
The increase in selling, general and administrative expenses
during the Transition Period from the comparable 2004 six months
was attributable to $13.6 million of additional share-based
compensation expense recognized upon our adoption of
SFAS No. 123R, a charge of approximately
$9.2 million for the write-down of a long-lived asset,
$0.7 million of integration costs related to the proposed
merger with Inamed incurred during the three months ended
September 30, 2005, and $1.5 million of additional
selling, general and administrative expenses incurred during the
Transition Period, partially offset by approximately
$1.3 million of professional fees related to a research and
development agreements with
Q-Med (for the
development of
SubQtm)
and Ansata incurred during the comparable 2004 six months.
|
|
|
Research and Development Expenses |
The following table sets forth our research and development
expenses for the Transition Period and comparable 2004 six
months (amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable | |
|
|
|
|
|
|
Transition | |
|
2004 | |
|
$ | |
|
% | |
|
|
Period | |
|
Six Months | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Research and development
|
|
$ |
22.4 |
|
|
$ |
45.1 |
|
|
$ |
(22.7 |
) |
|
|
(50.4 |
)% |
Charges included in research and development
|
|
|
11.9 |
|
|
|
35.0 |
|
|
|
(23.1 |
) |
|
|
(65.9 |
)% |
Share-based compensation expense included in research and
development
|
|
|
1.0 |
|
|
|
|
|
|
|
1.0 |
|
|
|
100.0 |
% |
Included in research and development expenses for the Transition
Period was approximately $11.9 million of milestone
payments related to the license and development agreement with
Dow for a patented dermatological product and approximately
$1.0 million of compensation expense for stock options and
restricted stock recognized upon our adoption of
SFAS No. 123R. Included in research and development
expenses for the comparable 2004 six months was approximately
$30.0 million related to the
SubQtm
license agreement and $5.0 million related to the Ansata
development and license agreement. Absent these charges,
research and development expenses decreased $0.7 million,
or 7.1%, to $9.4 million during the Transition Period from
$10.1 million during the comparable 2004 six months. This
decrease was due to the timing of
41
various research and development projects. 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 the Transition
Period increased $2.2 million, or 21.5%, to
$12.4 million from $10.2 million during the comparable
2004 six months. This increase was primarily due to increased
amortization that began during the third quarter of fiscal 2005
related to certain intangible assets whose useful lives were
determined to be shorter than originally estimated.
Other income, net, during the Transition Period represented a
termination fee received from Inamed as a result of the
termination of the proposed merger, net of the expensing of
accumulated transaction costs related to the transaction and
integration planning costs incurred during the three months
ended December 31, 2005. The net amount of these items is
summarized as follows (in millions):
|
|
|
|
|
Termination fee received from Inamed, including expense
reimbursement fees
|
|
$ |
90.5 |
|
Less:
|
|
|
|
|
Transaction costs expensed, including legal and advisory fees
|
|
|
27.0 |
|
Integration planning costs incurred during the three months
ended December 31, 2005
|
|
|
3.7 |
|
|
|
|
|
|
|
$ |
59.8 |
|
|
|
|
|
Interest income during the Transition Period increased
$5.0 million, or 98.2%, to $10.1 million from
$5.1 million during the comparable 2004 six months,
primarily due to an increase in funds available for investment
and an increase in the interest rates achieved by our invested
funds during the Transition Period. The increase in interest
rates achieved was partially due to a shift from non-taxable to
taxable investments, which yield higher rates.
Interest expense during the Transition Period remained
consistent with the comparable 2004 six months, at
$5.3 million. Our interest expense during the Transition
Period and the comparable 2004 six months consisted of interest
expense on our Old Notes, which accrue interest at 2.5% per
annum, our New Notes, which accrue interest at 1.5% per
annum, and amortization of fees and other origination costs
related to the issuance of the Old Notes and New Notes. See
Note 13 in our accompanying consolidated financial
statements for further discussion on the Old Notes and New Notes.
The following table sets forth our income tax expense and the
resulting effective tax rate stated as a percentage of pre-tax
income for the Transition Period and comparable 2004 six months
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable | |
|
|
|
|
|
|
Transition | |
|
2004 | |
|
$ | |
|
% | |
|
|
Period | |
|
Six Months | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Income tax expense
|
|
$ |
30.5 |
|
|
$ |
11.3 |
|
|
$ |
19.2 |
|
|
|
169.3% |
|
Effective tax rate
|
|
|
38.0 |
% |
|
|
34.8 |
% |
|
|
|
|
|
|
|
|
Income taxes are determined using an annual effective tax rate,
which generally differs from the U.S. Federal statutory
rate, primarily because of state and local income taxes,
tax-exempt interest, charitable
42
contribution deductions and research and development tax credits
available in the U.S. Our effective tax rate may be subject
to fluctuations during the fiscal year as new information is
obtained which may affect the assumptions we use to estimate our
annual effective tax rate, including factors such as our mix of
pre-tax earnings in the various tax jurisdictions in which we
operate, changes in valuation allowances against deferred tax
assets, reserves for tax audit issues and settlements,
utilization of research and development tax credits and changes
in tax laws in jurisdictions where we conduct operations. We
recognize deferred tax assets and liabilities for temporary
differences between the financial reporting basis and the tax
basis of our assets and liabilities. We record valuation
allowances against our deferred tax assets to reduce the net
carrying values to amounts that management believes is more
likely than not to be realized.
Income tax expense during the Transition Period increased
169.3%, or $19.2 million, to $30.5 million, from
$11.3 million in the comparable 2004 six months. The
increase in income tax expense was primarily due to the increase
in our pre-tax income for the same period. The increase in our
Transition Period effective tax rate from the comparable 2004
six months effective tax rate was primarily due to: (i) an
increase in the relative weighting of interest income in our mix
of taxable and tax-exempt investments and (ii) the adoption
of SFAS No. 123R which precludes the recognition of
tax benefits relating to the expensing of share-based awards
that are not ordinarily designed to result in a tax deduction.
|
|
|
Fiscal Year Ended June 30, 2005 Compared To Fiscal
Year Ended June 30, 2004 |
The following table sets forth the net revenues for the fiscal
years ended June 30, 2005 (fiscal 2005) and
June 30, 2004 (fiscal 2004), along with the
percentage of net revenues for each of our product categories
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
$ | |
|
% | |
|
|
2005 | |
|
2004 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Net revenues
|
|
$ |
376.9 |
|
|
$ |
303.7 |
|
|
$ |
73.2 |
|
|
|
24.1% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
|
|
|
2005 | |
|
2004 | |
|
Change | |
|
|
| |
|
| |
|
| |
Acne and acne-related dermatological products
|
|
|
29.5 |
% |
|
|
30.5 |
% |
|
|
(1.0 |
)% |
Non-acne dermatological products
|
|
|
47.1 |
% |
|
|
50.9 |
% |
|
|
(3.8 |
)% |
Non-dermatological products
|
|
|
23.4 |
% |
|
|
18.6 |
% |
|
|
4.8 |
% |
|
|
|
|
|
|
|
|
|
|
|
Total net revenues
|
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our total net revenues increased during fiscal 2005 primarily as
a result of growth in sales of the
PLEXION®,
RESTYLANE®
and
VANOStm
products and an increase in contract revenue. Core brand
revenues, which includes revenues associated with
RESTYLANE®,
DYNACIN®,
LOPROX®,
OMNICEF®,
PLEXION®,
TRIAZ®
and
VANOStm
represented approximately $284.6 million, or approximately
75.5% of net revenues, during fiscal 2005, an increase of
approximately 8.3%, compared to core brand revenues of
approximately $262.7 million, or approximately 86.5% of net
revenues, for fiscal 2004. Core brand revenues for fiscal 2004
included net revenues of
ORAPRED®,
which was licensed to BioMarin in May 2004. Net revenues
associated with our Acne and acne-related dermatological
products decreased as a percentage of net revenues, but
increased in net dollars by 20.0% primarily due to an increase
in
PLEXION®
net revenues due to the launch of
PLEXION®
Cleansing Cloths during the first quarter of fiscal 2005. Net
revenues associated with our Non-acne dermatological products
decreased as a percentage of net revenues, but increased in net
dollars by 14.8% during fiscal 2005, primarily due to the launch
of
RESTYLANE®
in the United States in January 2004 and the launch of
VANOStm
in April 2005, partially offset by a decrease in
LOPROX®
net revenues due to increased competition from generic products
launched during fiscal 2005. Net revenues associated with our
Non-dermatological products increased as a percentage of net
revenues primarily due to the increase in contract revenues
associated with the outlicensing of the
ORAPRED®
and
LUSTRA®
brands, which was greater than the revenues generated by those
products for the comparable period during
43
fiscal 2004. Contract revenue during fiscal 2005 included fees
derived from authorized generics launched on our behalf.
Gross profit represents our net revenues less our cost of
product revenue. Our cost of product revenue includes our
acquisition cost for the products we purchase from our third
party manufacturers and royalty payments made to third parties.
Amortization of intangible assets related to acquired products
is not included in gross profit. Amortization expense related to
these intangibles for fiscal 2005 and fiscal 2004 was
approximately $19.6 million and $14.9 million,
respectively. Product mix plays a significant role in our
quarterly and annual gross profit as a percentage of net
revenues. Different products generate different gross profit
margins, and the relative mix of higher gross profit products
and lower gross profit products can affect our total gross
profit.
The following table sets forth our gross profit for fiscal 2005
and fiscal 2004, along with the percentage of net revenues
represented by such gross profit (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
$ | |
|
% | |
|
|
2005 | |
|
2004 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Gross profit
|
|
$ |
321.5 |
|
|
$ |
257.1 |
|
|
$ |
64.4 |
|
|
|
25.0% |
|
% of net revenues
|
|
|
85.3 |
% |
|
|
84.7 |
% |
|
|
|
|
|
|
|
|
The increase in gross profit during fiscal 2005 as compared to
fiscal 2004 was due to the increase in our net revenues, while
the increase in gross profit as a percentage of net revenues was
primarily due to the different mix of products sold during
fiscal 2005 as compared to during fiscal 2004, and an increase
in contract revenue during fiscal 2005 as compared to during
fiscal 2004.
|
|
|
Selling, General and Administrative Expenses |
The following table sets forth our selling, general and
administrative expenses for fiscal 2005 and fiscal 2004, along
with the percentage of net revenues represented by selling,
general and administrative expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
$ | |
|
% | |
|
|
2005 | |
|
2004 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Selling, general and administrative
|
|
$ |
135.2 |
|
|
$ |
118.3 |
|
|
$ |
16.9 |
|
|
|
14.3% |
|
% of net revenues
|
|
|
35.9 |
% |
|
|
38.9 |
% |
|
|
|
|
|
|
|
|
The increase in selling, general and administrative expenses
from fiscal 2004 to fiscal 2005 was primarily attributable to
incremental costs associated with
RESTYLANE®,
$5.3 million of business integration planning costs related
to the proposed merger with Inamed and approximately
$1.3 million of professional fees related to research and
development collaborations. The decrease in selling, general and
administrative expenses as a percentage of net revenues from
fiscal 2004 to fiscal 2005 was due to net revenues during fiscal
2005 outpacing the increase in selling, general and
administrative spending. A pre-market approval application for
RESTYLANE®
was approved by the FDA on December 12, 2003, followed by
the product launch and first U.S. commercial sales of
RESTYLANE®
on January 6, 2004. During fiscal 2004, we incurred
incremental costs associated with the establishment of a sales
and marketing strategy for
RESTYLANE®,
prior to the commercial launch of the product.
44
|
|
|
Research and Development Expenses |
The following table sets forth our research and development
expenses for fiscal 2005 and fiscal 2004 (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
$ | |
|
|
|
|
2005 | |
|
2004 | |
|
Change | |
|
% Change | |
|
|
| |
|
| |
|
| |
|
| |
Research and development
|
|
$ |
65.7 |
|
|
$ |
16.5 |
|
|
$ |
49.2 |
|
|
|
298.2% |
|
Charges included in research and development associated with
research and development transactions
|
|
|
43.3 |
|
|
|
2.4 |
|
|
|
40.9 |
|
|
|
1,686.2% |
|
Included in research and development expenses for fiscal 2005
was approximately $8.3 million related to the aaiPharma
research and development collaboration, $30.0 million
related to the
SubQtm
license agreement and $5.0 million related to the Ansata
development and license agreement. Included in research and
development expenses for fiscal 2004 was a $2.4 million
milestone payment under a license and development agreement with
Dow for a patented dermatological product. Absent these charges,
research and development expenses increased $8.3 million,
or 59.2%, to $22.4 million during fiscal 2005 from
$14.1 million during fiscal 2004. This increase was due to
the timing of various research and development projects. We
expect research and development expenses 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 fiscal 2005
increased $5.5 million, or 33.1%, to $22.3 million
from $16.8 million during fiscal 2004. This increase was
primarily due to the amortization of expenses related to the
$53.3 million and $19.4 million milestone payments
made to Q-Med in December 2003 and May 2004, respectively, which
are being amortized over the period from the date of payment
through January 2018 and increased amortization related to
certain intangible assets whose useful lives were determined to
be shorter than originally estimated.
Interest income during fiscal 2005 increased $1.5 million,
or 14.1%, to $11.5 million from $10.0 million during
fiscal 2004, primarily due to an increase in the rates achieved
by our invested funds during fiscal 2005.
Interest expense during fiscal 2005 decreased $0.2 million,
or 1.6%, to $10.6 million from $10.8 million during
fiscal 2004. This decrease was due to the August 2003 exchange
of a portion of our Old Notes, which accrue interest at
2.5% per annum, for our New Notes, which accrue interest at
1.5% per annum.
The following table sets forth our income tax expense and the
resulting effective tax rate stated as a percentage of pre-tax
income for fiscal 2005 and fiscal 2004 (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
$ | |
|
% | |
|
|
2005 | |
|
2004 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Income tax expense
|
|
$ |
34.1 |
|
|
$ |
15.3 |
|
|
$ |
18.8 |
|
|
|
122.7% |
|
Effective tax rate
|
|
|
34.4 |
% |
|
|
33.2 |
% |
|
|
|
|
|
|
|
|
The increase in income tax expense from fiscal 2004 to fiscal
2005 was primarily due to the increase in pretax earnings over
the same period. Excluding the loss on early extinguishment of
debt in fiscal 2004, our adjusted effective tax rate for fiscal
2004 was 35%. The effective rate is lower than the expected
combined federal and state income tax rates due primarily to
tax-exempt interest income and contributions to charitable
programs that receive favorable tax treatment. Our full year
effective tax rate may increase in fiscal 2006
45
compared to our effective tax rate in fiscal 2005 due to
expected changes in the mix of earnings, the adoption of
Financial Accounting Standards Board (FASB)
Statement No. 123R, Share-Based Payment
(SFAS No. 123R), and the expiration of the
U.S. research and development tax credit, the latter of
which is currently expected to sunset on December 31, 2005.
|
|
|
Fiscal Year Ended June 30, 2004 Compared To Fiscal
Year Ended June 30, 2003 |
The following table sets forth the net revenues for the fiscal
years ended June 30, 2004 (fiscal 2004) and
June 30, 2003 (fiscal 2003), along with the
percentage of net revenues for each of our product categories
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
$ | |
|
% | |
|
|
2004 | |
|
2003 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Net revenues
|
|
$ |
303.7 |
|
|
$ |
247.5 |
|
|
$ |
56.2 |
|
|
|
22.7 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
|
|
|
2004 | |
|
2003 | |
|
Change | |
|
|
| |
|
| |
|
| |
Acne and acne-related dermatological products
|
|
|
30.5 |
% |
|
|
33.6 |
% |
|
|
(3.1 |
)% |
Non-acne dermatological Products
|
|
|
50.9 |
% |
|
|
36.7 |
% |
|
|
14.2 |
% |
Non-dermatological products
|
|
|
18.6 |
% |
|
|
29.7 |
% |
|
|
(11.1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
Total net revenues
|
|
|
100.0 |
% |
|
|
100.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our total net revenues increased during fiscal 2004 primarily as
a result of growth in sales of the
DYNACIN®,
LOPROX®,
RESTYLANE®
and
TRIAZ®
products. The Acne and acne-related dermatological product net
revenues decreased as a percentage of net revenues, but
increased in net dollars by 11.5% primarily due to the
introduction of
DYNACIN®
in tablet form in May 2003 and the introduction of
TRIAZ®
in pad form in July 2003. The Non-acne dermatological product
net revenues increased as a percentage of net revenues during
fiscal 2004 primarily due to the launch of
RESTYLANE®
in the United States in January 2004 and the introduction of
LOPROX®
Shampoo in March 2003. The Non-dermatological product net
revenues decreased as a percentage of net revenues primarily due
to the increase in net revenues in the other products, and
decreased net revenues of
ORAPRED®.
The Non-dermatological product net revenues decreased 23.4% from
fiscal 2003 to fiscal 2004.
ORAPRED®
was licensed to BioMarin as of May 18, 2004, and the
licensing revenue recognized during fiscal 2004 subsequent to
that date was less than the
ORAPRED®
product revenue for the comparable period during fiscal 2003.
Gross profit represents our net revenues less our cost of
product revenue. Our cost of product revenue includes our
acquisition cost for the products we purchase from our third
party manufacturers and royalty payments made to third parties.
Amortization of intangible assets related to products sold is
not included in gross profit. Product mix plays a significant
role in our quarterly and annual gross profit as a percentage of
net revenues. Different products generate different gross profit
margins, and the relative mix of higher gross product profit
products and lower gross profit products can affect our total
gross profit.
The following table sets forth our gross profit for fiscal years
2004 and 2003, along with the percentage of net revenues
represented by such gross profit (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
$ | |
|
% | |
|
|
2004 | |
|
2003 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Gross profit
|
|
$ |
257.1 |
|
|
$ |
209.3 |
|
|
$ |
47.8 |
|
|
|
22.9% |
|
% of net revenues
|
|
|
84.7 |
% |
|
|
84.5 |
% |
|
|
|
|
|
|
|
|
46
The increase in gross profit during fiscal 2004 as compared to
fiscal 2003 was due to the increase in our net revenues, while
the increase in gross profit as a percentage of net revenues was
primarily due to the different mix of products sold during
fiscal 2004 as compared to during fiscal 2003.
|
|
|
Selling, General and Administrative Expenses |
The following table sets forth our selling, general and
administrative expenses for fiscal years 2004 and 2003, along
with the percentage of net revenues represented by such selling,
general and administrative expenses (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
$ | |
|
% | |
|
|
2004 | |
|
2003 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Selling, general and administrative
|
|
$ |
118.3 |
|
|
$ |
91.6 |
|
|
$ |
26.7 |
|
|
|
29.0% |
|
% of net revenues
|
|
|
38.9 |
% |
|
|
37.0 |
% |
|
|
|
|
|
|
|
|
The increase in selling, general and administrative expenses
from fiscal 2003 to fiscal 2004 was primarily attributable to
incremental costs associated with the establishment of a sales
and marketing program for
RESTYLANE®.
We have incurred incremental costs associated with the hiring of
a dedicated aesthetics sales force, additional headquarters
personnel to support sales force efforts, including product
management, customer service and training personnel, expenses
associated with public relations, physician training and
continuing medical education, and other administrative expenses.
A pre-market approval application for
RESTYLANE®
was approved by the FDA on December 12, 2003, followed by
the product launch and first U.S. commercial sales of
RESTYLANE®
on January 6, 2004.
|
|
|
Research and Development Expenses |
The following table sets forth our research and development
expenses for fiscal years 2004 and 2003 (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
$ | |
|
% | |
|
|
2004 | |
|
2003 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Research and development
|
|
$ |
16.5 |
|
|
$ |
29.6 |
|
|
$ |
(13.1 |
) |
|
|
(44.2 |
)% |
Charges included in research and development associated with
research and development transactions
|
|
|
2.4 |
|
|
|
20.2 |
|
|
|
(17.8 |
) |
|
|
(88.0 |
)% |
Included in research and development expenses for fiscal 2004
was a milestone payment of $2.4 million under a license and
development agreement with Dow for a patented dermatological
product. Included in fiscal 2003 research and development
expense was $14.2 million in milestone payments under a
license and development agreement with Dow for a patented
dermatologic product, and a $6.0 million milestone payment
to aaiPharma under an agreement for the development,
commercialization and license of a key dermatologic product.
Absent these charges, research and development expenses
increased 50.1%, or $4.7 million, to $14.1 million
during fiscal 2004 from $9.4 million during fiscal 2003.
This increase is due to the timing of various research and
development projects. We expect research and development
expenses 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 fiscal 2004
increased 65.9%, or $6.7 million, to $16.8 million
from $10.1 million during fiscal 2003. This increase was
primarily due to the amortization of expenses associated with
the acquisition of the
RESTYLANE®
family of products, which began in March 2003, and the
amortization related to the $53.3 million and
$19.4 million milestone payments made to Q-Med in December
2003 and May 2004, respectively, which are being amortized over
15 years.
47
Interest income during fiscal 2004 decreased 18.3%, or
$2.2 million, to $10.1 million from $12.3 million
during fiscal 2003, primarily due to a decrease in interest rate
yields.
Interest expense during fiscal 2004 decreased 14.1%, or
$1.8 million, to $10.8 million from $12.6 million
during fiscal 2003. This decrease was due to the August 2003
exchange of a portion of our Old Notes, which accrue interest at
2.5% per annum, for our New Notes, which accrue interest at
1.5% per annum.
|
|
|
Loss on Early Extinguishment of Debt |
On August 14, 2003, we exchanged $230.8 million in
principal amount of our Old Notes for $283.9 million in
principal amount of our New Notes. As a result of the exchange,
we recognized a loss on early extinguishment of debt totaling
$58.7 million, consisting of a $53.1 million premium
and a $5.6 million write-off of corresponding Old Notes
fees.
The following table sets forth our income tax expense and the
resulting effective tax rate stated as a percentage of pre-tax
income for fiscal years 2004 and 2003 (dollar amounts in
millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
$ | |
|
% | |
|
|
2004 | |
|
2003 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Income tax expense
|
|
$ |
15.3 |
|
|
$ |
26.4 |
|
|
$ |
(11.1 |
) |
|
|
(42.0 |
)% |
Effective tax rate
|
|
|
33.2 |
% |
|
|
34.0 |
% |
|
|
|
|
|
|
|
|
The decrease in income tax expense and the effective tax rate
from fiscal 2003 to fiscal 2004 was primarily due to the
decrease in pretax earnings as a result of the loss on the early
extinguishment of debt. Excluding the loss on early
extinguishment of debt, our adjusted effective tax rate for
fiscal 2004 was 35%. The increase in the adjusted effective tax
rate to 35% in fiscal 2004 compared to the effective tax rate of
34% in fiscal 2003 is primarily attributable to a decrease in
research and development credits associated with the decrease in
research and development expenditures. The effective rate is
lower than the expected combined federal and state income tax
rates due to approximately $5.3 million and
$5.9 million of tax-exempt interest income in fiscal 2004
and fiscal 2003, respectively, and contributions to charitable
programs that receive favorable tax treatment. Our full year
effective tax rate may increase in fiscal 2005 compared to our
adjusted effective tax rate in fiscal 2004 due to expected
changes in the mix of earnings and the expiration of the
U.S. research and development tax credit.
Liquidity and Capital Resources
The following table highlights selected cash flow components for
the Transition Period and the comparable 2004 six months, and
selected balance sheet components as of December 31, 2005
and June 30, 2005 (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comparable | |
|
|
|
|
|
|
Transition | |
|
2004 | |
|
$ | |
|
% | |
|
|
Period | |
|
Six Months | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Cash provided by (used in):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities
|
|
$ |
148.0 |
|
|
$ |
45.5 |
|
|
$ |
102.5 |
|
|
|
225.5 |
% |
|
Investing activities
|
|
|
123.7 |
|
|
|
76.2 |
|
|
|
47.5 |
|
|
|
62.4 |
% |
|
Financing activities
|
|
|
(2.8 |
) |
|
|
(137.4 |
) |
|
|
134.6 |
|
|
|
(98.0 |
)% |
48
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
June 30, | |
|
$ | |
|
% | |
|
|
2005 | |
|
2005 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Cash, cash equivalents, restricted cash and short-term
investments
|
|
$ |
742.5 |
|
|
$ |
603.6 |
|
|
$ |
138.9 |
|
|
|
23.0 |
% |
Working capital
|
|
|
692.5 |
|
|
|
600.1 |
|
|
|
92.4 |
|
|
|
15.4 |
% |
2.5% contingent convertible senior notes due 2032
|
|
|
169.2 |
|
|
|
169.2 |
|
|
|
|
|
|
|
|
|
1.5% contingent convertible senior notes due 2033
|
|
|
283.9 |
|
|
|
283.9 |
|
|
|
|
|
|
|
|
|
The following table highlights selected cash flow components for
fiscal 2005 and fiscal 2004, and selected balance sheet
components as of June 30, 2005 and June 30, 2004
(dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fiscal | |
|
Fiscal | |
|
|
|
% | |
|
|
2004 | |
|
2003 | |
|
$ Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Cash provided by (used in):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating activities
|
|
$ |
130.0 |
|
|
$ |
128.0 |
|
|
$ |
2.0 |
|
|
|
1.6 |
% |
|
Investing activities
|
|
|
140.5 |
|
|
|
(166.3 |
) |
|
|
306.8 |
|
|
|
184.5 |
% |
|
Financing activities
|
|
|
(139.8 |
) |
|
|
40.6 |
|
|
|
(180.4 |
) |
|
|
(444.1 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
June 30, | |
|
$ | |
|
% | |
|
|
2005 | |
|
2004 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Cash, cash equivalents, restricted cash and short-term
investments
|
|
$ |
603.6 |
|
|
$ |
634.0 |
|
|
$ |
(30.4 |
) |
|
|
(4.8 |
)% |
Working capital
|
|
|
600.1 |
|
|
|
666.7 |
|
|
|
(66.6 |
) |
|
|
(10.0 |
)% |
2.5% contingent convertible senior notes due 2032
|
|
|
169.2 |
|
|
|
169.2 |
|
|
|
|
|
|
|
|
|
1.5% contingent convertible senior notes due 2033
|
|
|
283.9 |
|
|
|
283.9 |
|
|
|
|
|
|
|
|
|
Working capital as of December 31, 2005 and June 30,
2005 consisted of the following (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
June 30, | |
|
$ | |
|
% | |
|
|
2005 | |
|
2005 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Cash, cash equivalents and short-term investments
|
|
$ |
742.5 |
|
|
$ |
603.6 |
|
|
$ |
138.9 |
|
|
|
23.0 |
% |
Accounts receivable, net
|
|
|
46.7 |
|
|
|
47.2 |
|
|
|
(0.5 |
) |
|
|
(1.1 |
)% |
Inventories, net
|
|
|
19.1 |
|
|
|
20.7 |
|
|
|
(1.6 |
) |
|
|
(7.9 |
)% |
Deferred tax assets, net
|
|
|
12.7 |
|
|
|
11.0 |
|
|
|
1.7 |
|
|
|
15.8 |
% |
Other current assets
|
|
|
12.3 |
|
|
|
16.4 |
|
|
|
(4.1 |
) |
|
|
(25.5 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
833.3 |
|
|
|
698.9 |
|
|
|
134.4 |
|
|
|
19.2 |
% |
Accounts payable
|
|
|
57.7 |
|
|
|
30.8 |
|
|
|
26.9 |
|
|
|
87.2 |
% |
Short-term contract obligation
|
|
|
27.4 |
|
|
|
27.4 |
|
|
|
|
|
|
|
|
% |
Income taxes payable
|
|
|
31.5 |
|
|
|
10.2 |
|
|
|
21.3 |
|
|
|
207.9 |
% |
Other current liabilities
|
|
|
24.2 |
|
|
|
30.4 |
|
|
|
(6.2 |
) |
|
|
(20.4 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
140.8 |
|
|
|
98.8 |
|
|
|
42.0 |
|
|
|
42.5 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital
|
|
$ |
692.5 |
|
|
$ |
600.1 |
|
|
$ |
92.4 |
|
|
|
15.4 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We had cash, cash equivalents and short-term investments of
$742.5 million and working capital of $692.5 million
at December 31, 2005, as compared to $603.6 million
and $600.1 million, respectively, at June 30, 2005.
The increases were primarily due to the $90.5 million
termination fee received from Inamed due to the termination of
the proposed merger (before expenses), and other operating cash
flows generated during the Transition Period.
49
Working capital as of June 30, 2005 and June 30, 2004
consisted of the following (dollar amounts in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
June 30, | |
|
$ | |
|
% | |
|
|
2005 | |
|
2004 | |
|
Change | |
|
Change | |
|
|
| |
|
| |
|
| |
|
| |
Cash, cash equivalents and short-term investments
|
|
$ |
603.6 |
|
|
$ |
634.0 |
|
|
$ |
(30.4 |
) |
|
|
(4.8 |
)% |
Accounts receivable, net
|
|
|
47.2 |
|
|
|
47.9 |
|
|
|
(0.7 |
) |
|
|
(1.3 |
)% |
Inventories, net
|
|
|
20.7 |
|
|
|
19.5 |
|
|
|
1.2 |
|
|
|
5.9 |
% |
Deferred tax assets, net
|
|
|
11.0 |
|
|
|
14.1 |
|
|
|
(3.1 |
) |
|
|
(22.0 |
)% |
Other current assets
|
|
|
16.4 |
|
|
|
18.3 |
|
|
|
(1.9 |
) |
|
|
(10.3 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
698.9 |
|
|
|
733.8 |
|
|
|
(34.9 |
) |
|
|
(4.8 |
)% |
Accounts payable
|
|
|
30.8 |
|
|
|
13.9 |
|
|
|
16.9 |
|
|
|
121.6 |
% |
Short-term contract obligation
|
|
|
27.4 |
|
|
|
17.9 |
|
|
|
9.5 |
|
|
|
53.2 |
% |
Income taxes payable
|
|
|
10.2 |
|
|
|
0.7 |
|
|
|
9.5 |
|
|
|
1,337.3 |
% |
Other current liabilities
|
|
|
30.4 |
|
|
|
34.6 |
|
|
|
(4.2 |
) |
|
|
(12.2 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
98.8 |
|
|
|
67.1 |
|
|
|
31.7 |
|
|
|
47.3 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Working capital
|
|
$ |
600.1 |
|
|
$ |
666.7 |
|
|
$ |
(66.6 |
) |
|
|
(10.0 |
)% |
|
|
|
|
|
|
|
|
|
|
|
|
|
We had cash, cash equivalents and short-term investments of
$603.6 million and working capital of $600.1 million
at June 30, 2005, as compared to $634.0 million and
$666.7 million, respectively, at June 30, 2004. The
decreases were primarily due to $150.0 million of
repurchases of our Class A common stock, $30.7 million
paid in respect of the
SubQtm
license agreement during the first quarter of fiscal 2005
(including $0.7 million of related professional fees),
$5.5 million paid in respect of the Ansata development and
license agreement during the second quarter of fiscal 2005
(including $0.5 million of related professional fees) and
$8.3 million paid in respect of the research and
development collaboration with aaiPharma during the third
quarter of fiscal 2005, partially offset by operating cash flow
generated during fiscal 2005 and proceeds from the exercise of
stock options received during fiscal 2005.
Management believes existing cash and short-term investments,
together with funds generated from operations, should be
sufficient to meet operating requirements for the foreseeable
future. Our cash and short-term investments are available for
strategic investments, mergers and acquisitions, and other
potential large-scale needs. In addition, we may consider
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.
Net cash provided by operating activities during the Transition
Period increased 225.5%, or $102.5 million, to
$148.0 million from $45.5 million during the
comparable 2004 six months. Our operating cash flow for the
Transition Period was generated principally by our net earnings,
(including the $90.5 million termination fee received from
Inamed related to the termination of the proposed merger, before
expenses), adjusted for non-cash charges including depreciation
and amortization.
Net cash provided by operating activities during fiscal 2005
increased 1.6%, or $2.0 million, to $130.0 million
from $128.0 million during fiscal 2004. Our operating cash
flow for fiscal 2005 was generated principally by our net
earnings, adjusted for non-cash charges including depreciation
and amortization.
Net cash provided by investing activities during the Transition
Period was $123.7 million, as compared to
$76.2 million during the comparable 2004 six months. Net
cash provided by investing activities during the
50
Transition Period included net dispositions and maturities of
available-for-sale investments of approximately
$130.7 million, as compared to approximately
$81.2 million during the comparable 2004 six months.
Net cash provided by investing activities during fiscal 2005 was
$140.5 million, as compared to net cash used in investing
activities during fiscal 2004 of $166.3 million. Net cash
provided by investing activities during fiscal 2005 included net
sales of available-for-sale investments of approximately
$154.1 million, as compared to net purchases of
available-for-sale investments of approximately
$143.1 million during fiscal 2004. Net cash used in
investing activities during fiscal 2004 included
$84.1 million in payments for the purchase of product
rights, including $72.7 million in milestone payments to
Q-Med, as compared to $3.3 million in payments for the
purchase of product rights during fiscal 2005.
On December 12, 2003, the FDA approved
RESTYLANE®
for use in the United States, and a payment of
$53.3 million was made to Q-Med upon the occurrence of this
milestone. In May 2004, we paid $19.4 million to Q-Med as a
result of certain cumulative commercial milestones being
achieved. We will pay Q-Med approximately $29.1 million
upon FDA approval of
PERLANE®.
Net cash used in financing activities during the Transition
Period was $2.8 million compared to $137.4 million
during the comparable 2004 six months. The change is primarily
attributable to the purchase of $150.0 million of our
common stock during the comparable 2004 six months while no cash
was used to purchase our common stock during the Transition
Period, as well as $15.7 million of proceeds from the
exercise of stock options received during the comparable 2004
six months, as compared to $0.4 million received during the
Transition Period.
Net cash used in financing activities during fiscal 2005 was
$139.8 million compared to net cash provided by financing
activities of $40.6 million during fiscal 2004. The change
is primarily attributable to the purchase of $150.0 million
of our common stock during fiscal 2005 while no cash was used to
purchase our common stock during fiscal 2004, as well as
$16.6 million of proceeds from the exercise of stock
options received during fiscal 2005, as compared to
$51.4 million received during fiscal 2004.
|
|
|
Contingent Convertible Senior Notes and Other Long-Term
Commitments |
On August 14, 2003, we exchanged $230.8 million in
principal amount of our Old Notes for $283.9 million in
principal amount of our New Notes. Holders of Old Notes that
accepted the Companys exchange offer received $1,230 in
principal amount of New Notes for each $1,000 in principal
amount of Old Notes. The terms of the New Notes are similar to
the terms of the Old Notes, but have a different interest rate,
conversion rate and maturity date. Holders of Old Notes that
chose to not exchange will continue to be subject to the terms
of the Old Notes. See Note 13 of Notes to Consolidated
Financial Statements for further discussion.
The New Notes and the Old Notes are unsecured and do not contain
any restrictions on the incurrence of additional indebtedness or
the repurchase of our securities, and do not contain any
financial covenants. The Old Notes do not contain any
restrictions on the payment of dividends. The New Notes require
an adjustment to the conversion price if the cumulative
aggregate of all current and prior dividend increases above
$0.025 per share would result in at least a one percent
(1%) increase in the conversion price. This threshold has not
been reached and no adjustment to the conversion price has been
made.
Except for the Old Notes, the New Notes and deferred tax
liabilities, we have no long-term liabilities and had only
$140.8 million of current liabilities at December 31,
2005. 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.
On March 20, 2005, Medicis entered into a Senior Secured
Financing Commitment Letter with Deutsche Bank Trust Company
Americas and Deutsche Securities Inc. (the Letter).
Subject to the terms and conditions of the Letter, Deutsche Bank
Trust Company Americas and Deutsche Securities Inc.
(Deutsche Bank) committed to provide
$650.0 million of senior secured financing to Medicis. The
Letter
51
provided that the committed financing would mature in seven
years and bear interest at an adjustable rate plus LIBOR. The
indebtedness would have been guaranteed by the Medicis
domestic subsidiaries and secured by all assets and stock owned
by Medicis and its domestic subsidiaries. The Letter included
customary conditions to funding, including, without limitation,
no material adverse change to the market for credit facilities
similar in nature to the facility contemplated by the Letter
that has had a material adverse effect on syndication, the
absence of a material adverse effect on Inamed, certain ratings
requirements, the accuracy of representations and warranties of
the parties, and the absence of a material adverse effect on
Inamed relating to the Securities and Exchange Commissions
investigation of Inamed as disclosed in Inameds Annual
Report on
Form 10-K for the
year ended December 31, 2004. The Letter was entered into
in connection with the execution of the Agreement and Plan of
Merger with Inamed. As a result of the termination of our merger
with Inamed on December 13, 2005, the Letter was cancelled.
We have made available to BioMarin the ability to draw down on a
Convertible Note up to $25.0 million beginning July 1,
2005 (the Convertible Note). The Convertible Note is
convertible based on certain terms and conditions including a
change of control provision. Money advanced under the
Convertible Note is convertible into BioMarin shares at a strike
price equal to the BioMarin average closing price for the
20 trading days prior to such advance. The Convertible Note
matures on the option purchase date in 2009 as defined in the
Securities Purchase Agreement entered into on May 18, 2004
(the Securities Purchase Agreement) but may be
repaid by BioMarin at any time prior to the option purchase
date. As of March 10, 2006, BioMarin has not requested any
monies to be advanced under the Convertible Note, and no amounts
are outstanding.
|
|
|
Repurchases of Common Stock |
In May 2003, our Board of Directors approved a new repurchase
program that authorized the repurchase of up to
$75.0 million of our common stock. This program provided
for the repurchase of Class A common stock at such times as
management determined. As of June 30, 2004, we had not
repurchased any shares of our Class A common stock under
this program. In August 2004, our Board of Directors approved a
new program that replaced the May 2003 program, which authorized
the repurchase of up to $150.0 million of our Class A
common stock. During the first two quarters of fiscal 2005, we
purchased a total of 3,921,086 shares of our Class A
common stock in the open market at an average price of
$38.25 per share, for an aggregate purchase price of
approximately $150.0 million. As the purchase limit had
been reached, the plan was terminated during the second quarter
of fiscal 2005.
Since the beginning of fiscal 2004, we have paid quarterly cash
dividends aggregating approximately $15.2 million on our
common stock. In addition, on December 14, 2005, we
declared a cash dividend of $0.03 per issued and
outstanding share of common stock payable on January 31,
2006 to our stockholders of record at the close of business on
January 3, 2006. Prior to these dividends, we had not paid
a cash dividend on our common stock, and we have not adopted a
dividend policy. 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.
We have a revolving line of credit facility of up to
$25.0 million from Wells Fargo Bank, N.A. The facility may
be drawn upon by us, at our discretion, and is collateralized by
certain short-term investments. Any outstanding balance of the
credit facility bears interest at a floating rate of
150 basis points in excess of the
30-day London Interbank
Offered Rate and expires in November 2006. The agreement
requires us to comply with certain covenants, including
covenants relating to our financial condition and results of
operations; we are in compliance with such covenants. We have
never drawn on this credit facility.
52
|
|
|
Off-Balance Sheet Arrangements |
As of December 31, 2005, we are not involved in any
off-balance sheet arrangements, as defined in
Item 3(a)(4)(ii) of SEC
Regulation S-K.
The following table summarizes our significant contractual
obligations at December 31, 2005, and the effect such
obligations are expected to have on our liquidity and cash flows
in future periods. This table excludes amounts already recorded
on our balance sheet as current liabilities at December 31,
2005 or certain other purchase obligations as discussed below
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due By Period | |
|
|
| |
|
|
|
|
More Than | |
|
More Than | |
|
|
|
|
|
|
1 Year and | |
|
3 Years and | |
|
|
|
|
|
|
Less Than | |
|
Less Than | |
|
Less Than | |
|
More Than | |
|
|
Total | |
|
1 Year | |
|
3 Years | |
|
5 Years | |
|
5 Years | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Long-term debt
|
|
$ |
453,065 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
453,065 |
|
Interest on long-term debt
|
|
|
229,178 |
|
|
|
8,488 |
|
|
|
16,975 |
|
|
|
16,975 |
|
|
|
186,740 |
|
Operating leases
|
|
|
10,605 |
|
|
|
2,112 |
|
|
|
4,217 |
|
|
|
4,276 |
|
|
|
|
|
Other purchase obligations and commitments
|
|
|
867 |
|
|
|
173 |
|
|
|
347 |
|
|
|
347 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations
|
|
$ |
693,715 |
|
|
$ |
10,773 |
|
|
$ |
21,539 |
|
|
$ |
21,598 |
|
|
$ |
639,805 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The long-term debt consists of the Companys Old Notes and
New Notes. The table above reflects the maturity date of debt.
However, the Company may redeem some or all of the Old Notes and
New Notes at any time on or after June 11, 2007 and
June 11, 2008, respectively, at a redemption price, payable
in cash, of 100% of the principal amount, plus accrued and
unpaid interest, including contingent interest, if any. Holders
of the Old Notes and New Notes may require the Company to
repurchase all or a portion of their Old Notes on June 4,
2007, 2012 and 2017 and New Notes on June 4, 2008, 2013 and
2018, or upon a change in control, as defined in the indenture
agreements governing the Old Notes and New Notes, at 100% of the
principal amount of the Old Notes and New Notes, plus accrued
and unpaid interest to the date of the repurchase, payable in
cash.
Interest on long-term debt includes interest payable on our Old
Notes and New Notes, assuming the Old Notes and New Notes will
not have any redemptions or conversions into shares of our
Class A common stock until their respective maturities in
2032 and 2033, but does not include any contingent interest. The
amount of interest ultimately paid in future years could change
if any of the Old Notes or New Notes are converted or redeemed
and/or if contingent interest becomes payable if certain future
criteria are met.
Other purchase obligations and commitments include payments due
under research and development and consulting contracts.
We have committed to make potential future milestone
payments to third-parties as part of certain product development
and license agreements. Payments under these agreements
generally become due and payable only upon achievement of
certain developmental, regulatory and/or commercial milestones.
Because the achievement and timing of these milestones are not
fixed or reasonably determinable, such contingencies have not
been recorded on our consolidated balance sheets and are not
included in the above table. The total amount of potential
future milestone payments related to development and license
agreements is approximately $101.8 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:
53
fixed or minimum quantities to be purchased; fixed, minimum or
variable price provisions; and the approximate timing of the
transaction. Our purchase orders are based on our current
manufacturing needs and are fulfilled by our vendors with
relatively short timetables. We do not have significant
agreements for the purchase of raw materials or finished goods
specifying minimum quantities or set prices that exceed our
short-term expected requirements. We also enter into contracts
for outsourced services; however, the obligations under these
contracts were not significant and the contracts generally
contain clauses allowing for cancellation without significant
penalty.
The expected timing of payment of the obligations discussed
above is estimated based on current information. Timing of
payments and actual amounts paid may be different depending on
the time of receipt of goods or services or changes to
agreed-upon amounts for some obligations.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and
results of operations are based upon our consolidated financial
statements, which have been prepared in conformity with
U.S. generally accepted accounting principles. The
preparation of the consolidated financial statements requires us
to make estimates and assumptions that affect the amounts
reported in the consolidated financial statements and
accompanying notes. On an ongoing basis, we evaluate our
estimates related to sales allowances, chargebacks, rebates,
returns and other pricing adjustments, depreciation and
amortization and other contingencies and litigation. We base our
estimates on historical experience and various other factors
related to each circumstance. Actual results could differ from
those estimates based upon future events, which could include,
among other risks, changes in the regulations governing the
manner in which we sell our products, changes in the health care
environment and managed care consumption patterns. Our
significant accounting policies are described in Note 2 to
the consolidated financial statements included in this report.
We believe the following critical accounting policies affect our
most significant estimates and assumptions used in the
preparation of our consolidated financial statements and are
important in understanding our financial condition and results
of operations.
Revenue from our product sales is recognized pursuant to Staff
Accounting Bulletin No. 104 (SAB 104),
Revenue Recognition in Financial Statements.
Accordingly, revenue is recognized when all four of the
following criteria are met: (i) persuasive evidence that an
arrangement exists; (ii) delivery of the products has
occurred; (iii) the selling price is both fixed and
determinable; and (iv) collectibility is reasonably
assured. Our customers consist primarily of large pharmaceutical
wholesalers who sell directly into the retail channel.
We do not provide any forms of price protection to our wholesale
customers and permit product returns if the product is damaged,
or 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.
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 will assess
such payments for revenue recognition under the collectibility
criteria of SAB 104.
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Items Deducted From Gross Revenue |
Provisions for estimates for product returns and exchanges,
sales discounts, chargebacks, managed care and Medicaid rebates
and other adjustments are established as a reduction of product
sales revenues at the time such revenues are recognized. These
deductions from gross revenue are established by us as our best
54
estimate at the time of sale based on historical experience
adjusted to reflect known changes in the factors that impact
such reserves. These deductions from gross revenue are generally
reflected either as a direct reduction to accounts receivable
through an allowance, or as an addition to accrued expenses if
the payment is due to a party other than the wholesale or retail
customer.
Our accounting policies for revenue recognition have a
significant impact on our reported results and rely on certain
estimates that require complex and subjective judgment on the
part of our management. If the levels of product returns and
exchanges, cash discounts, chargebacks, managed care and
Medicaid rebates and other adjustments fluctuate significantly
and/or if our estimates do not adequately reserve for these
reductions of gross product revenues, our reported net product
revenues could be negatively affected.
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|
Product Returns and Exchanges |
We account for returns and exchanges of product in accordance
with SFAS 48, Revenue Recognition When Right of
Return Exists, whereby an allowance is established based
on our estimate of revenues recorded for which the related
products are expected to be returned in the future. We determine
our estimate of product returns and exchanges based on
historical experience and other qualitative factors that could
impact the level of future product returns and exchanges. These
factors include estimated shelf life, competitive developments
including introductions of generic products, product
discontinuations and our introduction of new formulations of our
products. Typically, these other factors that influence our
allowance for product returns and exchanges do not change
significantly from quarter to quarter. 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 and exchanges. Estimates for returns and
exchanges of new products are based on historical experience of
new products at various stages of their life cycle.
Our actual experience and the qualitative factors that we use to
determine the necessary allowance for future product returns and
exchanges are susceptible to change based on unforeseen events
and uncertainties. We review our allowance for product returns
and exchanges quarterly to assess the trends being considered to
estimate the allowance, and make changes to the allowance as
necessary.
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 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.
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Managed Care and Medicaid Rebates |
We establish and maintain reserves for amounts payable by us to
managed care organizations and state Medicaid programs for the
reimbursement of portions of the retail price of prescriptions
filled that are covered by these programs. The amounts estimated
to be paid relating to products sold are recognized as
deductions from gross revenue and as additions to accrued
expenses at the time of sale based on our best estimate of the
expected prescription fill rate to these managed care and state
Medicaid patients, using historical experience adjusted to
reflect known changes in the factors that impact such reserves,
including changes in formulary status and contractual pricing.
55
In addition to the significant items deducted from gross revenue
described above, we deduct other items from gross revenue. For
example, we offer consumer rebates on many of our products and a
consumer loyalty program for our
RESTYLANE®
dermal filler product. We generally account for these other
items deducted from gross revenue by establishing an accrual
based on our estimate of the adjustments attributable to a sale.
We generally base our estimates for the accrual of these items
deducted from gross sales on historical experience and other
relevant factors. We adjust our accruals periodically throughout
each quarter based on actual experience and changes in other
factors, if any.
We believe that our allowances and accruals for items that are
deducted from gross revenue are reasonable and appropriate based
on current facts and circumstances. However, it is possible 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 revenue.
Additionally, changes in actual experience or changes in other
qualitative factors could cause our allowances and accruals to
fluctuate. A five percent change in the amounts related to the
allowances and accruals described above would lead to an
approximate $5.9 million annual effect on our income before
income tax expense, based on the amount of sales allowances we
recognized during fiscal 2005 related to the allowances and
accruals described above.
As part of our adoption of SFAS No. 123R as of
July 1, 2005, we were required to recognize the fair value
of share-based compensation awards as an expense. We apply the
Black-Scholes option-pricing model in order to determine the
fair value of stock options on the date of grant, and we apply
judgment in estimating key assumptions that are important
elements in the model, such as the expected stock-price
volatility, expected stock option life and expected forfeiture
rates. 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.
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 the Transition Period, an impairment charge of
approximately $9.2 million was recognized related to our
review of long-lived assets. No acceleration of amortization was
recorded during the Transition Period. This process requires the
use of estimates and assumptions, which are subject to a high
degree of judgment. If these assumptions change in the future,
we may be required to record additional impairment charges for,
and/or accelerate amortization of, long-lived assets.
56
Income taxes are determined using an annual effective tax rate,
which generally differs from the U.S. Federal statutory
rate because of state and local income taxes, tax-exempt
interest, charitable contribution deductions, nondeductible
expenses and research and experimentation tax credits available
in the U.S.. Our effective tax rate may be subject to
fluctuations during the fiscal year as new information is
obtained which may affect the assumptions we use to estimate our
annual effective tax rate, including factors such as our mix of
pre-tax earnings in the various tax jurisdictions in which we
operate, valuation allowances against deferred tax assets,
reserves for tax audit issues and settlements, utilization of
research and experimentation tax credits and changes in tax laws
in jurisdictions where we conduct operations. We recognize
deferred tax assets and liabilities for temporary differences
between the financial reporting basis and the tax basis of our
assets and liabilities. We record valuation allowances against
our deferred tax assets to reduce the net carrying value to an
amount that management believes is more likely than not to be
realized.
Based on the Companys historical pre-tax earnings,
management believes it is more likely than not that the Company
will realize the benefit of the existing net deferred tax assets
at December 31, 2005. Management believes the existing net
deductible temporary differences will reverse during periods in
which the Company generates net taxable income; however, there
can be no assurance that the Company will generate any earnings
or any specific level of continuing earnings in future years.
Certain tax planning or other strategies could be implemented,
if necessary, to supplement income from operations to fully
realize recorded tax benefits.
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|
Research and Development Costs and Accounting for
Strategic Collaborations |
All research and development costs, including payments related
to products under development and research consulting
agreements, are expensed as incurred. We may continue to make
non-refundable payments to third parties for new technologies
and for research and development work that has been completed.
These payments may be expensed at the time of payment depending
on the nature of the payment made.
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 available, 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 that are in the development phase and as
to which we have no assurance that the third party is required
to perform additional research efforts, we expense such payments.
We record contingent liabilities resulting from asserted and
unasserted claims against us, when it is probable that a
liability has been incurred and the amount of the loss is
reasonably estimable. We disclose material contingent
liabilities, when there is a reasonable possibility, that the
ultimate loss will exceed the recorded liability. Estimating
probable losses requires analysis of multiple factors, in some
cases including judgments about the potential actions of
third-party claimants and courts. Therefore, actual losses in
any future period are inherently uncertain. We currently are
involved in certain legal proceedings. We do not believe these
proceedings will have a material adverse effect on our
consolidated financial position. 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.
57
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|
Recent Accounting Pronouncements |
In October 2005, the FASB issued FASB Staff Position
(FSP) No. 123R-2, Practical Accommodation to
the Application of Grant Date as Defined in FASB Statement
No. 123R, to provide guidance on determining the grant
date for an award as defined in SFAS No. 123R. This
FSP stipulates that assuming all other criteria in the grant
date definition are met, a mutual understanding of the key terms
and conditions of an award to an individual employee is presumed
to exist upon the awards approval in accordance with the
relevant corporate governance requirements, provided that the
key terms and conditions of an award (a) cannot be
negotiated by the recipient with the employer because the award
is a unilateral grant, and (b) are expected to be
communicated to an individual recipient within a relatively
short time period from the date of approval. We have applied the
principles set forth in this FSP upon its adoption of
SFAS No. 123R.
In November 2005, the FASB issued FSP No. 123R-3,
Transition Election to Accounting for the Tax Effects of
Share-Based Payment Awards. This FSP requires an entity to
follow either the transition guidance for the
additional-paid-in-capital
pool as prescribed in SFAS No. 123R, or the
alternative transition method as described in the FSP. An entity
that adopts SFAS No. 123R using the modified
prospective application may make a one-time election to adopt
the transition method described in this FSP. This FSP became
effective in November 2005. We will continue to evaluate the
impact that the adoption of this FSP could have on our financial
statements as we have until one year from the later of our
initial adoption of SFAS No. 123R or the effective
date of this FSP to evaluate our available transition
alternatives and make our one-time election.
In December 2004, the FASB issued SFAS No. 153,
Exchanges of Nonmonetary Assets
(SFAS No. 153), an amendment of APB
Opinion No. 29 Accounting for Nonmonetary Transactions
(APB No. 29). SFAS No. 153
eliminates the exception from fair value measurement for
nonmonetary exchanges of similar productive assets in
paragraph 21 (b) of APB No. 29, and replaces it
with an exception for exchanges that do not have commercial
substance. SFAS No. 153 specifies that a nonmonetary
exchange has commercial substance if the future cash flows of
the entity are expected to change significantly as a result of
the exchange. SFAS No. 153 is effective for the fiscal
periods beginning after June 15, 2005 and we will adopt
this Statement in the first quarter of fiscal 2006. We currently
does not anticipate that the effects of the statement will
materially affect its consolidated financial position or
consolidated results of operations upon adoption.
In May 2005, the FASB issued SFAS No. 154,
Accounting Changes and Error Corrections A
Replacement of APB Opinion No. 20 and FASB Statement
No. 3 (SFAS No. 154).
SFAS No. 154 requires the retrospective application to
prior periods financial statements of changes in
accounting principle, unless it is impractical to determine
either the period-specific effects or cumulative effect of the
accounting change. SFAS No. 154 also requires that a
change in depreciation, amortization, or depletion method for
long-lived non-financial assets be accounted for as a change in
accounting estimate affected by a change in accounting
principle. SFAS No. 154 is affective for accounting changes
and corrections of errors made in fiscal years beginning after
December 15, 2005 and we will adopt this provision, as
applicable, during fiscal year 2006.
In November 2005, the FASB issued FSP FAS 115-1 and
FAS 124-1, The Meaning of Other-Than-Temporary
Impairment and Its Application to Certain Investments
(FSP 115-1), which provides guidance on determining
when investments in certain debt and equity securities are
considered impaired, whether that impairment is
other-than-temporary, and on measuring such impairment loss. FSP
115-1 also includes accounting considerations subsequent to the
recognition of other-than temporary impairment and requires
certain disclosures about unrealized losses that have not been
recognized as other-than-temporary impairments. FSP 115-1 is
required to be applied to reporting periods beginning after
December 15, 2005 and is required to be adopted by us in
the first quarter of fiscal 2006. We are currently evaluating
the effect that the adoption of FSP 115-1 will have on our
consolidated results of operations and financial condition but
do not expect it to have a material impact.
|
|
Item 7A. |
Quantitative and Qualitative Disclosure About Market
Risk |
At December 31, 2005, $446.2 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
58
securities are commercial paper, Federal agency discount notes
and money market funds. Our interest rate risk with respect to
these investments is limited due to the short-term duration of
these arrangements and the yields earned, which approximate
current interest rates.
Our investment portfolio, consisting of fixed income securities
that we hold on an available-for-sale basis, was approximately
$295.5 million as of December 31, 2005,
$425.8 million as of June 30, 2005, and
$587.4 million as of June 30, 2004. These securities,
like all fixed income instruments, are subject to interest rate
risk and will decline in value if market interest rates
increase. We have the ability to hold our fixed income
investments until maturity and, therefore, we would not expect
to recognize any material adverse impact in income or cash flows
if market interest rates increase. The following table provides
information about our available-for-sale securities that are
sensitive to changes in interest rates. We have aggregated our
available-for-sale securities for presentation purposes since
they are all very similar in nature (dollar amounts in
thousands):
Interest Rate Sensitivity
Principal Amount by Expected Maturity as of December 31,
2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Financial Instruments Mature During Year Ended December 31, | |
|
|
| |
|
|
2006 | |
|
2007 | |
|
2008 | |
|
2009 | |
|
2010 | |
|
Thereafter | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Available-for-sale securities
|
|
$ |
97,560 |
|
|
$ |
20,883 |
|
|
$ |
4,897 |
|
|
$ |
2,464 |
|
|
$ |
749 |
|
|
$ |
167,350 |
|
Weighted-average yield rate
|
|
|
2.91 |
% |
|
|
3.89 |
% |
|
|
2.64 |
% |
|
|
3.62 |
% |
|
|
3.09 |
% |
|
|
4.33 |
% |
Contingent convertible senior notes due 2032
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
169,155 |
|
Interest rate
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2.5 |
% |
Contingent convertible senior notes due 2033
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
283,910 |
|
Interest rate
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.5 |
% |
Changes in interest rates do not affect interest expense
incurred on our Contingent Convertible Senior Notes as the
interest rates are fixed. We have not entered into derivative
financial instruments. We have minimal operations outside of the
United States and, accordingly, we have not been susceptible to
significant risk from changes in foreign currencies.
During the normal course of business we could be subjected to a
variety of market risks, examples of which include, but are not
limited to, interest rate movements and foreign currency
fluctuations, as we discussed above, and collectibility of
accounts receivable. We continuously assess these risks and have
established policies and procedures to protect against the
adverse effects of these and other potential exposures. Although
we do not anticipate any material losses in these risk areas, no
assurance can be made that material losses will not be incurred
in these areas in the future.
|
|
Item 8. |
Financial Statements and Supplementary Data |
Our financial statements and related financial statement
schedule at December 31, 2005, June 30, 2005 and
June 30, 2004, and for the Transition Period, the
comparable 2004 six months, and each of the three years in the
period ended June 30, 2005 and the Independent Registered
Public Accounting Firms Report are incorporated herein by
reference to the financial statements set forth in Item 15
of Part IV of this report.
|
|
Item 9. |
Changes in and Disagreements with Accountants and
Financial Disclosure |
None.
|
|
Item 9A. |
Controls and Procedures |
Medicis maintains disclosure controls and procedures that are
designed to ensure that information required to be disclosed in
reports filed by Medicis under the Securities Exchange Act of
1934, as amended, is
59
recorded, processed, summarized and reported within the time
periods specified in the Securities and Exchange
Commissions rules and forms and that such information is
accumulated and communicated to Medicis management,
including its 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 evaluated, with the participation of other
members of management, the effectiveness of Medicis
disclosure controls and procedures (as defined in Exchange Act
Rule 15d-15(e)),
as of the end of the period covered by this Transition Report on
Form 10-K/ T.
Based on this evaluation, our Chief Executive Officer and Chief
Financial Officer concluded that the Companys disclosure
controls and procedures were effective at the reasonable
assurance level.
Although the management of our Company, including the Chief
Executive Officer and the Chief Financial Officer, believes that
our disclosure controls and internal controls currently provide
reasonable assurance that our desired control objectives have
been met, management does not expect that our disclosure
controls or internal controls will prevent all error and all
fraud. A control system, no matter how well conceived and
operated, can provide only reasonable, not absolute, assurance
that the objectives of the control system are met. Further, the
design of a control system must reflect the fact that there are
resource constraints, and the benefits of controls must be
considered relative to their costs. Because of the inherent
limitations in all control systems, no evaluation of controls
can provide absolute assurance that all control issues and
instances of fraud, if any, within our Company have been
detected. These inherent limitations include the realities that
judgments in decision-making can be faulty, and that breakdowns
can occur because of simple error or mistake. Additionally,
controls can be circumvented by the individual acts of some
persons, by collusion of two or more people, or by management
override of the controls. The design of any system of controls
is also based in part upon certain assumptions about the
likelihood of future events, and there can be no assurance that
any design will succeed in achieving its stated goals under all
potential future conditions.
There were no significant changes in our internal controls over
financial reporting identified in connection with this
evaluation that occurred during our last fiscal quarter that
have materially affected, or are reasonably likely to materially
affect, Medicis internal controls over financial reporting.
Managements Report on Internal Control over Financial
Reporting
The management of Medicis Pharmaceutical Corporation is
responsible for establishing and maintaining adequate internal
control over financial reporting as such term is defined in
Exchange Act
Rules 13a-15(f)
and 15d-15(f). Our
internal control over financial reporting is designed to provide
reasonable assurance regarding the reliability of financial
reporting and the preparation of financial statements for
external purposes in accordance with accounting principles
generally accepted in the United States of America.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
Under the supervision and with the participation of the Chief
Executive Officer and Chief Financial Officer, management
conducted an evaluation of the effectiveness of its internal
control over financial reporting as of December 31, 2005.
The framework on which such evaluation was based is contained in
the report entitled Internal Control
Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (the COSO
Report). Based on that evaluation and the criteria set
forth in the COSO Report, management concluded that its internal
control over financial reporting was effective as of
December 31, 2005.
Our independent registered public accounting firm,
Ernst & Young LLP, who also audited our consolidated
financial statements, audited managements assessment and
independently assessed the effectiveness of our internal control
over financial reporting. Ernst & Young LLP has issued
their attestation report, which is included in Item 15 of
this Form 10-K/ T.
60
|
|
Item 9B. |
Other Information |
None.
PART III
|
|
Item 10. |
Directors and Executive Officers of the Registrant |
The Company has adopted a written code of ethics, Medicis
Pharmaceutical Corporation Code of Business Conduct and
Ethics, which is applicable to all directors, officers and
employees of the Company, including the Companys principal
executive officer, principal financial officer, principal
accounting officer or controller and other executive officers
identified pursuant to this Item 10 who perform similar
functions (collectively, the Selected Officers). In
accordance with the rules and regulations of the SEC, a copy of
the code is available on the Companys website. The Company
will disclose any changes in or waivers from its code of ethics
applicable to any Selected Officer on its website at
http://www.medicis.com or by filing a
Form 8-K.
The Company has filed, as exhibits to this Annual Report on
Form 10-K/ T for
the year ended December 31, 2005, the certifications of its
Chief Executive Officer and Chief Financial Officer required
pursuant to Section 302 of the Sarbanes-Oxley Act of 2004.
On December 30, 2005, the Company submitted to the New York
Stock Exchange the Annual CEO Certification required pursuant to
Section 303A.12(a) of the New York Stock Exchange Listed
Company Manual.
The information in the section entitled Section 16(a)
Beneficial Ownership Reporting Compliance,
Directors, Director Nominees and Executive Officers
and Committee Meetings in the Proxy Statement is
incorporated herein by reference.
|
|
Item 11. |
Executive Compensation |
The information to be included in the sections entitled
Executive Compensation and Director
Compensation in the Proxy Statement is incorporated herein
by reference.
|
|
Item 12. |
Security Ownership of Certain Beneficial Owners and
Management |
The information to be included in the section entitled
Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters in the Proxy
Statement is incorporated herein by reference.
|
|
Item 13. |
Certain Relationships and Related Transactions |
The information to be included in the sections entitled
Certain Relationships and Related Transactions and
Compensation Committee Interlocks and Insider
Participation in the Proxy Statement is incorporated
herein by reference.
|
|
Item 14. |
Principal Accountant Fees and Services |
The information to be included in the section entitled
Independent Registered Public Accounting Firm Fees
in the Proxy Statement is incorporated herein by reference.
61
PART IV
|
|
Item 15. |
Exhibits, Financial Statement Schedules |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Page |
|
|
|
|
|
|
|
(a)
|
|
Documents filed as a part of this Report |
|
|
|
|
(1) |
|
Financial Statements: |
|
|
|
|
|
|
Index to consolidated financial statements |
|
F-1 |
|
|
|
|
Reports of Independent Registered Public Accounting Firm |
|
F-2 |
|
|
|
|
Consolidated balance sheets as of December 31, 2005,
June 30, 2005 and June 30, 2004 |
|
F-4 |
|
|
|
|
Consolidated statements of income for the six months ended
December 31, 2005 and 2004 (unaudited) and the fiscal
years ended June 30, 2005, 2004 and 2003 |
|
F-6 |
|
|
|
|
Consolidated statements of stockholders equity for the six
months ended December 31, 2005 and the fiscal years ended
June 30, 2005, 2004 and 2003 |
|
F-7 |
|
|
|
|
Consolidated statements of cash flows for the six months ended
December 31, 2005 and 2004 (unaudited) and the fiscal
years ended June 30, 2005, 2004 and 2003 |
|
F-9 |
|
|
|
|
Notes to consolidated financial statements |
|
F-10 |
|
|
(2) |
|
Financial Statement Schedule: |
|
|
|
|
|
|
Schedule II Valuation and Qualifying Accounts |
|
S-1 |
|
|
|
|
|
This financial statement schedule should be read in conjunction
with the consolidated financial statements. Financial statement
schedules not included in this Annual Report on Form 10-K/T
have been omitted because they are not applicable or the
required information is shown in the financial statements or
notes thereto. |
|
|
|
|
(3) |
|
Exhibits filed as part of this Report: |
|
|
|
|
|
|
|
Exhibit No. |
|
Description |
|
|
|
|
2 |
.1 |
|
Agreement of Merger by and between the Company, Medicis
Acquisition Corporation and GenDerm Corporation, dated
November 28, 1997(11) |
|
2 |
.2 |
|
Agreement of Plan of Merger, dated as of October 1, 2001,
by and among the Company, MPC Merger Corp. and Ascent
Pediatrics, Inc.(17) |
|
3 |
.1 |
|
Certificate of Incorporation of the Company, as amended(23) |
|
3 |
.2 |
|
Amended and Restated By-Laws of the Company(13) |
|
4 |
.1 |
|
Amended and Restated Rights Agreement, dated as of
August 17, 2005, between the Company and Wells Fargo Bank,
N.A., as Rights Agent(26) |
|
4 |
.2 |
|
Indenture, dated as of August 19, 2003, by and between the
Company, as issuer, and Deutsche Bank Trust Company Americas, as
trustee(23) |
|
4 |
.3 |
|
Indenture, dated as of June 4, 2002, by and between the
Company, as issuer, and Deutsche Bank Trust Company Americas, as
trustee(19) |
|
4 |
.4 |
|
Supplemental Indenture dated as of February 1, 2005 to
Indenture dated as of August 19, 2003 between the Company
and Deutsche Bank Trust Company Americas as Trustee(25) |
|
4 |
.5 |
|
Registration Rights Agreement, dated as of June 4, 2002, by
and between the Company and Deutsche Bank Securities Inc.(19) |
|
4 |
.6 |
|
Form of specimen certificate representing Class A common
stock(1) |
|
10 |
.1 |
|
Asset Purchase Agreement among the Company, Ascent Pediatrics,
Inc., BioMarin Pharmaceutical Inc., and BioMarin Pediatrics
Inc., dated April 20, 2004(23) |
|
10 |
.2 |
|
Merger Termination Agreement, dated as of December 13,
2005, by and among the Company, Masterpiece Acquisition Corp.,
and Inamed Corporation(31) |
62
|
|
|
|
|
Exhibit No. |
|
Description |
|
|
|
|
10 |
.3 |
|
Securities Purchase Agreement among the Company, Ascent
Pediatrics, Inc., BioMarin Pharmaceutical Inc. and BioMarin
Pediatrics Inc., dated May 18, 2004(23) |
|
10 |
.4 |
|
Termination Agreement dated October 19, 2005 between the
Company and Michael A. Pietrangelo(28) |
|
10 |
.5 |
|
License Agreement among the Company, Ascent Pediatrics, Inc. and
BioMarin Pediatrics Inc., dated May 18, 2004(23) |
|
10 |
.6 |
|
Medicis Pharmaceutical Corporation 1995 Stock Option Plan
(incorporated by reference to Exhibit C to the definitive
Proxy Statement for the 1995 Annual Meeting of Shareholders
previously filed with the SEC, File No. 0-18443) |
|
10 |
.7(a) |
|
Employment Agreement between the Company and Jonah Shacknai,
dated July 24, 1996(8) |
|
10 |
.7(b) |
|
Amendment to Employment Agreement by and between the Company and
Jonah Shacknai, dated April 1, 1999(15) |
|
10 |
.7(c) |
|
Amendment to Employment Agreement by and between the Company and
Jonah Shacknai, dated February 21, 2001(15) |
|
10 |
.7(d) |
|
Third Amendment, dated December 30, 2005, to Employment
Agreement between the Company and Jonah Shacknai(32) |
|
10 |
.8 |
|
Medicis Pharmaceutical Corporation 2001 Senior Executive
Restricted Stock Plan(30) |
|
10 |
.9(a) |
|
Medicis Pharmaceutical Corporation 2002 Stock Option Plan(20) |
|
10 |
.9(b) |
|
Amendment No. 1 to the Medicis Pharmaceutical Corporation
2002 Stock Option Plan, dated August 1, 2005(29) |
|
10 |
.10(a) |
|
Medicis Pharmaceutical Corporation 2004 Stock Incentive Plan(27) |
|
10 |
.10(b) |
|
Amendment No. 1 to the Medicis Pharmaceutical Corporation
2004 Stock Option Plan, dated August 1, 2005(29) |
|
10 |
.11(a) |
|
Medicis Pharmaceutical Corporation 1998 Stock Option Plan(33) |
|
10 |
.11(b) |
|
Amendment No. 1 to the Medicis Pharmaceutical Corporation
1998 Stock Option Plan, dated August 1, 2005(29) |
|
10 |
.11(c) |
|
Amendment No. 2 to the Medicis Pharmaceutical Corporation
1998 Stock Option Plan, dated September 30, 2005(29) |
|
10 |
.12(a) |
|
Medicis Pharmaceutical Corporation 1996 Stock Option Plan(34) |
|
10 |
.12(b) |
|
Amendment No. 1 to the Medicis Pharmaceutical Corporation
1996 Stock Option Plan, dated August 1, 2005(29) |
|
10 |
.13 |
|
Waiver Letter dated March 18, 2005 between the Company and
Q-Med AB(27) |
|
10 |
.14 |
|
Supply Agreement, dated October 21, 1992, between Schein
Pharmaceutical and the Company(2) |
|
10 |
.15 |
|
Amendment to Manufacturing and Supply Agreement, dated
March 2, 1993, between Schein Pharmaceutical and the
Company(3) |
|
10 |
.16(a) |
|
Credit and Security Agreement, dated August 3, 1995,
between the Company and Norwest Business Credit, Inc.(5) |
|
10 |
.16(b) |
|
First Amendment to Credit and Security Agreement, dated
May 29, 1996, between the Company and Norwest Bank Arizona,
N.A.(8) |
|
10 |
.16(c) |
|
Second Amendment to Credit and Security Agreement, dated
November 22, 1996, by and between the Company and Norwest
Bank Arizona, N.A. as successor-in-interest to Norwest Business
Credit, Inc.(10) |
|
10 |
.16(d) |
|
Third Amendment to Credit and Security Agreement, dated
November 22, 1998, by and between the Company and Norwest
Bank Arizona, N.A., as successor-in-interest to Norwest Business
Credit, Inc.(12) |
63
|
|
|
|
|
Exhibit No. |
|
Description |
|
|
|
|
10 |
.16(e) |
|
Fourth Amendment to Credit and Security Agreement, dated
November 22, 2000, by and between the Company and Wells
Fargo Bank Arizona, N.A., formerly known as Norwest Bank
Arizona, N.A., as successor-in-interest to Norwest Business
Credit, Inc.(16) |
|
10 |
.16(f) |
|
Fifth Amendment to Credit and Security Agreement, dated
November 22, 2002, by and between the Company and Wells
Fargo Bank Arizona, N.A., formerly known as Norwest Bank
Arizona, N.A., as successor-in-interest to Norwest Business
Credit, Inc.(23) |
|
10 |
.17(a) |
|
Patent Collateral Assignment and Security Agreement, dated
August 3, 1995, by the Company to Norwest Business Credit,
Inc.(6) |
|
10 |
.17(b) |
|
First Amendment to Patent Collateral Assignment and Security
Agreement, dated May 29, 1996, by the Company to Norwest
Bank Arizona, N.A.(8) |
|
10 |
.17(c) |
|
Amended and Restated Patent Collateral Assignment and Security
Agreement, dated November 22, 1998, by the Company to
Norwest Bank Arizona, N.A.(12) |
|
10 |
.18(a) |
|
Trademark Collateral Assignment and Security Agreement, dated
August 3, 1995, by the Company to Norwest Business Credit,
Inc.(7) |
|
10 |
.18(b) |
|
First Amendment to Trademark Collateral Assignment and Security
Agreement, dated May 29, 1996, by the Company to Norwest
Bank Arizona, N.A.(8) |
|
10 |
.18(c) |
|
Amended and Restated Trademark, Tradename, and Service Mark
Collateral Assignment and Security Agreement, dated
November 22, 1998, by the Company to Norwest Bank Arizona,
N.A.(12) |
|
10 |
.19 |
|
Assignment and Assumption of Loan Documents, dated May 29,
1996, from Norwest Business Credit, Inc., to and by Norwest Bank
Arizona, N.A.(8) |
|
10 |
.20 |
|
Multiple Advance Note, dated May 29, 1996, from the Company
to Norwest Bank Arizona, N.A.(8) |
|
10 |
.21 |
|
Asset Purchase Agreement dated November 15, 1998, by and
among the Company and Hoechst Marion Roussel, Inc., Hoechst
Marion Roussel Deutschland GMHB and Hoechst Marion Roussel,
S.A.(12) |
|
10 |
.22 |
|
License and Option Agreement dated November 15, 1998, by
and among the Company and Hoechst Marion Roussel, Inc., Hoechst
Marion Roussel Deutschland GMBH and Hoechst Marion Roussel,
S.A.(12) |
|
10 |
.23 |
|
Loprox Lotion Supply Agreement dated November 15, 1998, by
and between the Company and Hoechst Marion Roussel, Inc.(12) |
|
10 |
.24 |
|
Supply Agreement dated November 15, 1998, by and between
the Company and Hoechst Marion Roussel Deutschland GMBH(12) |
|
10 |
.25 |
|
Asset Purchase Agreement effective January 31, 1999,
between the Company and Bioglan Pharma Plc(14) |
|
10 |
.26 |
|
Stock Purchase Agreement by and among the Company, Ucyclyd
Pharma, Inc. and Syed E. Abidi, William Brusilow, Susan E.
Brusilow and Norbert L. Wiech, dated April 19, 1999(14) |
|
10 |
.27 |
|
Asset Purchase Agreement by and between the Company and Bioglan
Pharma Plc, dated June 29, 1999(14) |
|
10 |
.28 |
|
Asset Purchase Agreement by and among The Exorex Company, LLC,
Bioglan Pharma Plc, the Company and IMX Pharmaceuticals, Inc.,
dated June 29, 1999(16) |
|
10 |
.29 |
|
Medicis Pharmaceutical Corporation Executive Retention Plan(14) |
|
10 |
.30 |
|
Asset Purchase Agreement between Warner Chilcott, plc and the
Company, dated September 14, 1999(14) |
|
10 |
.31(a) |
|
Share Purchase Agreement between Q-Med International B.V. and
Startskottet 21914 AB (under proposed change of name to Medicis
Sweden Holdings AB), dated February 10, 2003(21) |
64
|
|
|
|
|
Exhibit No. |
|
Description |
|
|
|
|
10 |
.31(b) |
|
Amendment No. 1 to Share Purchase Agreement between Q-Med
International B.V. and Startskottet 21914 AB (under proposed
change of name to Medicis Sweden Holdings AB), dated
March 7, 2003(21) |
|
10 |
.32 |
|
Supply Agreement between Q-Med AB and the Company, dated
March 7, 2003(21) |
|
10 |
.33 |
|
Amended and Restated Intellectual Property Agreement between
Q-Med AB and HA North American Sales AB, dated March 7,
2003(21) |
|
10 |
.34 |
|
Supply Agreement between Medicis Aesthetics Holdings Inc., a
wholly owned subsidiary of the Company, and Q-Med AB, dated
July 15, 2004(23) Portions of this exhibit (indicated by
asterisks) have been omitted pursuant to a request for
confidential treatment pursuant to Rule 24b-2 under the
Securities Exchange Act of 1934 |
|
10 |
.35 |
|
Intellectual Property License Agreement between Q-Med AB and
Medicis Aesthetics Holdings Inc., dated July 15, 2004(23)
Portions of this exhibit (indicated by asterisks) have been
omitted pursuant to a request for confidential treatment
pursuant to Rule 24b-2 under the Securities Exchange Act of
1934 |
|
10 |
.36 |
|
Note Agreement, dated as of October 1, 2001, by and
among Ascent Pediatrics, Inc., the Company, Furman Selz
Investors II L.P., FS Employee Investors LLC, FS Ascent
Investments LLC, FS Parallel Fund L.P., BancBoston Ventures Inc.
and Flynn Partners(17) |
|
10 |
.37 |
|
Voting Agreement, dated as of October 1, 2001, by and among
the Company, MPC Merger Corp., FS Private Investments LLC,
Furman Selz Investors II L.P., FS Employee Investors LLC,
FS Ascent Investments LLC and FS Parallel Fund L.P.(17) |
|
10 |
.38 |
|
Exclusive Remedy Agreement, dated as of October 1, 2001, by
and among the Company, Ascent Pediatrics, Inc., FS Private
Investments LLC, Furman Selz Investors II L.P., FS Employee
Investors LLC, FS Ascent Investments LLC and FS Parallel Fund
L.P., BancBoston Ventures Inc., Flynn Partners, Raymond F.
Baddour, Sc.D., Robert E. Baldini, Medical Science Partners L.P.
and Emmett Clemente, Ph.D.(17) |
|
10 |
.39 |
|
Medicis Pharmaceutical Corporation 1992 Stock Option Plan(35) |
|
10 |
.40+ |
|
Form of Stock Option Agreement for Medicis Pharmaceutical
Corporation 2004 Stock Incentive Plan |
|
10 |
.41+ |
|
Form of Restricted Stock Agreement for Medicis Pharmaceutical
Corporation 2004 Stock Incentive Plan |
|
12+ |
|
|
Computation of Ratios of Earnings to Fixed Charges |
|
21 |
.1+ |
|
Subsidiaries |
|
23 |
.1+ |
|
Consent of Ernst & Young LLP, Independent Registered
Public Accounting Firm |
|
24 |
.1 |
|
Power of Attorney See signature page |
|
31 |
.1+ |
|
Certification of Chief Executive Officer pursuant to
Rule 13a-14(a) and Rule 15d-14(a) of the Securities
Exchange Act, as amended |
|
31 |
.2+ |
|
Certification of Chief Financial Officer pursuant to
Rule 13a-14(a) and Rule 15d-14(a) of the Securities
Exchange Act, as amended |
|
32 |
.1+ |
|
Certification of Chief Executive Officer pursuant to
18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 |
|
32 |
.2+ |
|
Certification of Chief Financial Officer pursuant to
18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 |
+ Filed herewith
|
|
|
|
(1) |
Incorporated by reference to the Registration Statement on
Form S-1 of the
Registrant, File
No. 33-32918,
filed with the SEC on January 16, 1990 |
|
|
(2) |
Incorporated by reference to the Registration Statement on
Form S-1 of the
Company, File
No. 33-54276,
filed with the SEC on June 11, 1993 |
65
|
|
|
|
(3) |
Incorporated by reference to the Companys Annual Report on
Form 10-K for the
fiscal year ended June 30, 1993, File No. 0-18443,
filed with the SEC on October 13, 1993 |
|
|
(4) |
Incorporated by reference to the Companys Annual Report on
Form 10-K for the
fiscal year ended June 30, 1995, File No. 0-18443,
previously filed with the SEC (the 1994
Form 10-K)
|
|
|
(5) |
Incorporated by reference to the Companys 1995
Form 10-K
|
|
|
(6) |
Incorporated by reference to the Companys 1995
Form 10-K
|
|
|
(7) |
Incorporated by reference to the Companys 1995
Form 10-K
|
|
|
(8) |
Incorporated by reference to the Companys Annual Report on
Form 10-K for the
fiscal year ended June 30, 1996, File No. 0-18443,
previously filed with the SEC |
|
|
(9) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q for
the quarter ended March 31, 1997, File No. 0-18443,
previously filed with the SEC |
|
|
(10) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q for
the quarter ended December 31, 1996, File No. 0-18443,
previously filed with the SEC |
|
(11) |
Incorporated by reference to the Companys Current Report
on Form 8-K filed
with the SEC on December 15, 1997 |
|
(12) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q for
the quarter ended December 31, 1998, File No. 0-18443,
previously filed with the SEC |
|
(13) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q for
the quarter ended March 31, 1999, File No. 0-18443,
previously filed with the SEC |
|
(14) |
Incorporated by reference to the Companys Annual Report on
Form 10-K for the
fiscal year ended June 30, 1999, File No. 0-18443,
previously filed with the SEC |
|
(15) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q for
the quarter ended March 31, 2001, File No. 0-18443,
previously filed with the SEC |
|
(16) |
Incorporated by reference to the Companys Annual Report on
Form 10-K for the
fiscal year ended June 30, 2001, File No. 0-18443,
previously filed with the SEC |
|
(17) |
Incorporated by reference to the Companys Current Report
on Form 8-K filed
with the SEC on October 2, 2001 |
|
(18) |
Incorporated by reference to the Companys registration
statement on
Form 8-A12B/ A
filed with the SEC on June 4, 2002 |
|
(19) |
Incorporated by reference to the Companys Current Report
on Form 8-K filed
with the SEC on June 6, 2002 |
|
(20) |
Incorporated by reference to the Companys Annual Report on
Form 10-K for the
fiscal year ended June 30, 2002, File No. 0-18443,
previously filed with the SEC |
|
(21) |
Incorporated by reference to the Companys Current Report
on Form 8-K filed
with the SEC on March 10, 2003 |
|
(22) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q for
the quarter ended December 31, 2003, File No. 0-18443,
previously filed with the SEC |
|
(23) |
Incorporated by reference to the Companys Annual Report on
Form 10-K for the
fiscal year ended June 30, 2004, File No. 0-18443,
previously filed with the SEC |
|
(24) |
Incorporated by reference to the Companys Current Report
on Form 8-K filed
with the SEC on March 21, 2005 |
|
(25) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q for
the quarter ended March 31, 2005, File No. 0-18443,
previously filed with the SEC |
|
(26) |
Incorporated by reference to the Companys Current Report
on Form 8-K filed
with the SEC on August 18, 2005 |
|
(27) |
Incorporated by reference to the Companys Annual Report on
Form 10-K for the
fiscal year ended June 30, 2005, File No. 0-18443,
previously filed with the SEC |
66
|
|
(28) |
Incorporated by reference to the Companys Current Report
on Form 8-K filed
with the SEC on October 20, 2005 |
|
(29) |
Incorporated by reference to the Companys Annual Report on
Form 10-K/A for
the fiscal year ended June 30, 2005, File No. 0-18443,
previously filed with the SEC on October 28, 2005 |
|
(30) |
Incorporated by reference to the Companys Quarterly Report
on Form 10-Q for
the quarter ended September 30, 2005, File
No. 0-18443, previously filed with the SEC |
|
(31) |
Incorporated by reference to the Companys Current Report
on Form 8-K filed
with the SEC on December 13, 2005 |
|
(32) |
Incorporated by reference to the Companys Current Report
on Form 8-K filed
with the SEC on January 3, 2006 |
|
(33) |
Incorporated by reference to Appendix 1 to the
Companys definitive Proxy Statement for the 1998 Annual
Meeting of Stockholders filed with the SEC on December 2,
1998 |
|
(34) |
Incorporated by reference to Appendix 2 to the
Companys definitive Proxy Statement for the 1996 Annual
Meeting of Stockholders filed with the SEC on October 23,
1996 |
|
(35) |
Incorporated by reference to Exhibit B to the
Companys definitive Proxy Statement for the 1992 Annual
Meeting of Stockholders previously filed with the SEC |
|
|
(b) |
The exhibits to this
Form 10-K/T follow
the Companys Financial Statement Schedule included in this
Form 10-K/T.
|
|
(c) |
The Financial Statement Schedule to this
Form 10-K/T
appears on page S-1 of this
Form 10-K/T.
|
67
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.
|
|
|
MEDICIS PHARMACEUTICAL
CORPORATION
|
|
|
|
|
|
Jonah Shacknai |
|
Chairman of the Board and
Chief Executive Officer |
Date: March 16, 2006
POWER OF ATTORNEY
KNOW ALL MEN BY THESE PRESENTS, that each person whose signature
appears below constitutes and appoints Jonah Shacknai and Mark
A. Prygocki, Sr., or either of them, as his true and lawful
attorneys-in-fact and
agents, with full power of substitution and resubstitution, for
him and in his name, place and stead, in any and all capacities,
to sign any and all amendments to this Transition Report on
Form 10-K/ T and
any documents related to this report and filed pursuant to the
Securities Exchange Act of 1934, and to file the same, with all
exhibits thereto, and other documents in connection therewith,
with the Securities and Exchange Commission, granting unto said
attorneys-in-fact and
agents, full power and authority to do and perform each and
every act and thing requisite and necessary to be done in
connection therewith as fully to all intents and purposes as he
might or could do in person, hereby ratifying and confirming all
that said
attorneys-in-fact and
agents, or their substitute or substitutes may lawfully do or
cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of
1934, this report has been signed below by the following persons
on behalf of the Registrant in the capacities and on the dates
indicated.
|
|
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ JONAH SHACKNAI
Jonah Shacknai |
|
Chairman of the Board of Directors and Chief Executive Officer
(Principal Executive Officer) |
|
March 16, 2006 |
|
/s/ MARK A.
PRYGOCKI, SR.
Mark A. Prygocki, Sr. |
|
Executive Vice President, Chief Financial Officer, Corporate
Secretary and Treasurer (Principal Financial and Accounting
Officer) |
|
March 16, 2006 |
|
/s/ ARTHUR G.
ALTSCHUL, JR.
Arthur G. Altschul, Jr. |
|
Director |
|
March 16, 2006 |
|
/s/ SPENCER DAVIDSON
Spencer Davidson |
|
Director |
|
March 16, 2006 |
68
|
|
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ STUART DIAMOND
Stuart Diamond |
|
Director |
|
March 16, 2006 |
|
/s/ PETER S.
KNIGHT, ESQ.
Peter S. Knight, Esq. |
|
Director |
|
March 16, 2006 |
|
/s/ MICHAEL A.
PIETRANGELO
Michael A. Pietrangelo |
|
Director |
|
March 16, 2006 |
|
/s/ PHILIP S.
SCHEIN, M.D.
Philip S. Schein, M.D. |
|
Director |
|
March 16, 2006 |
|
/s/ LOTTIE SHACKELFORD
Lottie Shackelford |
|
Director |
|
March 16, 2006 |
69
MEDICIS PHARMACEUTICAL CORPORATION
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
|
|
|
|
Page | |
|
|
| |
Reports of Independent Registered Public Accounting Firm
|
|
|
F-2 |
|
Consolidated Balance Sheets as of December 31, 2005,
June 30, 2005 and June 30, 2004
|
|
|
F-4 |
|
Consolidated Statements of Income for the six months ended
December 31, 2005 and 2004 (unaudited), and the fiscal
years ended June 30, 2005, 2004 and 2003
|
|
|
F-6 |
|
Consolidated Statements of Stockholders Equity for the six
months ended December 31, 2005 and the fiscal years ended
June 30, 2005, 2004 and 2003
|
|
|
F-7 |
|
Consolidated Statements of Cash Flows for the six months ended
December 31, 2005 and 2004 (unaudited) and the fiscal
years ended June 30, 2005, 2004 and 2003
|
|
|
F-9 |
|
Notes to Consolidated Financial Statements
|
|
|
F-10 |
|
Schedule II Valuation and Qualifying Accounts
|
|
|
S-1 |
|
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, 2005, June 30, 2005 and
June 30, 2004, and the related consolidated statements of
income, stockholders equity, and cash flows for the six
months ended December 31, 2005 and each of the three years
in the period ended June 30, 2005. Our audits also included
the financial statement schedule listed in Item 15(a)(2).
These financial statements and schedule are the responsibility
of the Companys management. Our responsibility is to
express an opinion on these financial statements and schedule
based upon our audits.
We conducted our audits in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are
free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in
the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by
management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the financial statements referred to above
present fairly, in all material respects, the consolidated
financial position of Medicis Pharmaceutical Corporation and
subsidiaries at December 31, 2005, June 30, 2005 and
June 30, 2004, and the consolidated results of their
operations and their cash flows for the six months ended
December 31, 2005 and each of the three years in the period
ended June 30, 2005, in conformity with U.S. generally
accepted accounting principles. Also, in our opinion, the
related financial statement schedule, when considered in
relation to the basic financial statements taken as a whole,
presents fairly in all material respects the information set
forth therein.
As discussed in Note 2 to the consolidated financial
statements, on July 1, 2005, the Company changed its method
of accounting for share-based compensation.
We also have audited, in accordance with the standards of the
Public Company Accounting Oversight Board (United States), the
effectiveness of Medicis Pharmaceutical Corporations
internal control over financial reporting as of
December 31, 2005, based on criteria established in
Internal Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission
and our report dated March 10, 2006 expressed an
unqualified opinion thereon.
Phoenix, Arizona
March 10, 2006
F-2
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Medicis
Pharmaceutical Corporation
We have audited managements assessment, included in the
accompanying Managements Report on Internal Control over
Financial Reporting, that Medicis Pharmaceutical Corporation and
subsidiaries (the Company) maintained effective internal control
over financial reporting as of December 31, 2005, based on
criteria established in Internal Control Integrated
Framework issued by the Committee of Sponsoring Organizations of
the Treadway Commission (the COSO criteria). Medicis
Pharmaceutical Corporations management is responsible for
maintaining effective internal control over financial reporting
and for its assessment of the effectiveness of internal control
over financial reporting. Our responsibility is to express an
opinion on managements assessment and an opinion on the
effectiveness of the Companys internal control over
financial reporting based on our audit.
We conducted our audit in accordance with the standards of the
Public Company Accounting Oversight Board (United States). Those
standards require that we plan and perform the audit to obtain
reasonable assurance about whether effective internal control
over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of
internal control over financial reporting, evaluating
managements assessment, testing and evaluating the design
and operating effectiveness of internal control, and performing
such other procedures as we considered necessary in the
circumstances. We believe that our audit provides a reasonable
basis for our opinion.
A companys internal control over financial reporting is a
process designed to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of
financial statements for external purposes in accordance with
generally accepted accounting principles. A companys
internal control over financial reporting includes those
policies and procedures that (1) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the
company; (2) provide reasonable assurance that transactions
are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting
principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of
management and directors of the company; and (3) provide
reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use, or disposition of the
companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over
financial reporting may not prevent or detect misstatements.
Also, projections of any evaluation of effectiveness to future
periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree
of compliance with the policies or procedures may deteriorate.
In our opinion, managements assessment that Medicis
Pharmaceutical Corporation maintained effective internal control
over financial reporting as of December 31, 2005, is fairly
stated, in all material respects, based on the COSO criteria.
Also, in our opinion, Medicis Pharmaceutical Corporation
maintained, in all material respects, effective internal control
over financial reporting as of December 31, 2005, 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, 2005 consolidated financial statements of
Medicis Pharmaceutical Corporation and subsidiaries and our
report dated March 10, 2006 expressed an unqualified
opinion thereon.
Phoenix, Arizona
March 10, 2006
F-3
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
|
December 31, | |
|
| |
|
|
2005 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands, except share amounts) | |
ASSETS |
Current assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
446,997 |
|
|
$ |
177,785 |
|
|
$ |
46,621 |
|
|
Short-term investments
|
|
|
295,535 |
|
|
|
425,783 |
|
|
|
587,419 |
|
|
Accounts receivable, less allowances:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005: $18,160; June 30, 2005:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$19,073; June 30, 2004: $15,955
|
|
|
46,697 |
|
|
|
47,220 |
|
|
|
47,858 |
|
|
Inventories, net
|
|
|
19,076 |
|
|
|
20,701 |
|
|
|
19,540 |
|
|
Deferred tax assets, net
|
|
|
12,738 |
|
|
|
11,001 |
|
|
|
14,104 |
|
|
Other current assets
|
|
|
12,241 |
|
|
|
16,435 |
|
|
|
18,321 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
833,284 |
|
|
|
698,925 |
|
|
|
733,863 |
|
Property and equipment, net
|
|
|
5,416 |
|
|
|
6,143 |
|
|
|
5,842 |
|
Intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets related to product line acquisitions and
business combinations
|
|
|
311,406 |
|
|
|
326,780 |
|
|
|
324,345 |
|
|
Other intangible assets
|
|
|
4,888 |
|
|
|
4,507 |
|
|
|
3,647 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
316,294 |
|
|
|
331,287 |
|
|
|
327,992 |
|
|
Less: accumulated amortization
|
|
|
76,458 |
|
|
|
71,749 |
|
|
|
51,961 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net intangible assets
|
|
|
239,836 |
|
|
|
259,538 |
|
|
|
276,031 |
|
Goodwill
|
|
|
63,094 |
|
|
|
64,672 |
|
|
|
55,113 |
|
Deferred financing costs, net
|
|
|
4,325 |
|
|
|
5,397 |
|
|
|
7,535 |
|
Other non-current assets
|
|
|
|
|
|
|
8,576 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,145,955 |
|
|
$ |
1,043,251 |
|
|
$ |
1,078,384 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-4
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED BALANCE SHEETS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
|
December 31, | |
|
| |
|
|
2005 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands, except share amounts) | |
|
LIABILITIES |
Current liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
57,708 |
|
|
$ |
30,832 |
|
|
$ |
13,912 |
|
|
Short-term contract obligation
|
|
|
27,407 |
|
|
|
27,407 |
|
|
|
17,891 |
|
|
Income taxes payable
|
|
|
31,521 |
|
|
|
10,236 |
|
|
|
712 |
|
|
Other current liabilities
|
|
|
24,195 |
|
|
|
30,379 |
|
|
|
34,605 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
140,831 |
|
|
|
98,854 |
|
|
|
67,120 |
|
Long-term liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent convertible senior notes
|
|
|
453,065 |
|
|
|
453,065 |
|
|
|
453,067 |
|
|
Deferred tax liability, net
|
|
|
8,572 |
|
|
|
4,986 |
|
|
|
2,894 |
|
Commitments and Contingencies
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS EQUITY |
Preferred stock, $0.01 par value; shares authorized:
5,000,000; no shares issued
|
|
|
|
|
|
|
|
|
|
|
|
|
Class A common stock, $0.014 par value; shares
authorized:
150,000,000; issued and outstanding: 67,052,326, 67,007,330,
65,419,460 at December 31, 2005, June 30, 2005 and
2004, respectively
|
|
|
938 |
|
|
|
938 |
|
|
|
916 |
|
Class B common stock, $0.014 par value; shares
authorized:
1,000,000; issued and outstanding: 0, 0 and 758,032 at
December 31, 2005, June 30, 2005 and 2004, respectively
|
|
|
|
|
|
|
|
|
|
|
10 |
|
Additional paid-in capital
|
|
|
550,006 |
|
|
|
539,443 |
|
|
|
517,468 |
|
Accumulated other comprehensive income
|
|
|
379 |
|
|
|
(606 |
) |
|
|
(1,020 |
) |
Deferred compensation
|
|
|
|
|
|
|
(697 |
) |
|
|
(1,212 |
) |
Accumulated earnings
|
|
|
334,894 |
|
|
|
288,474 |
|
|
|
230,049 |
|
Less: Treasury stock, 12,647,554, 12,620,554 and
8,681,468 shares at cost at December 31, 2005,
June 30, 2005 and 2004, respectively
|
|
|
(342,730 |
) |
|
|
(341,206 |
) |
|
|
(190,908 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
543,487 |
|
|
|
486,346 |
|
|
|
555,303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
1,145,955 |
|
|
$ |
1,043,251 |
|
|
$ |
1,078,384 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-5
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF INCOME
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended | |
|
|
|
|
December 31, | |
|
Year Ended June 30, | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(Unaudited) | |
|
|
|
|
|
|
|
|
(In thousands, except per share data) | |
Net product revenues
|
|
$ |
155,569 |
|
|
$ |
146,999 |
|
|
$ |
305,114 |
|
|
$ |
291,607 |
|
|
$ |
241,909 |
|
Net contract revenues
|
|
|
8,385 |
|
|
|
34,168 |
|
|
|
71,785 |
|
|
|
12,115 |
|
|
|
5,630 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net revenues
|
|
|
163,954 |
|
|
|
181,167 |
|
|
|
376,899 |
|
|
|
303,722 |
|
|
|
247,539 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue(1)
|
|
|
24,111 |
|
|
|
27,270 |
|
|
|
55,447 |
|
|
|
46,606 |
|
|
|
38,260 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit
|
|
|
139,843 |
|
|
|
153,897 |
|
|
|
321,452 |
|
|
|
257,116 |
|
|
|
209,279 |
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative(2)
|
|
|
89,360 |
|
|
|
65,736 |
|
|
|
135,154 |
|
|
|
118,253 |
|
|
|
91,648 |
|
|
Research and development(3)
|
|
|
22,367 |
|
|
|
45,140 |
|
|
|
65,676 |
|
|
|
16,494 |
|
|
|
29,568 |
|
|
Depreciation and amortization
|
|
|
12,420 |
|
|
|
10,222 |
|
|
|
22,350 |
|
|
|
16,794 |
|
|
|
10,125 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income
|
|
|
15,696 |
|
|
|
32,799 |
|
|
|
98,272 |
|
|
|
105,575 |
|
|
|
77,938 |
|
Other income, net
|
|
|
59,801 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
10,059 |
|
|
|
5,076 |
|
|
|
11,470 |
|
|
|
10,050 |
|
|
|
12,302 |
|
Interest expense
|
|
|
(5,333 |
) |
|
|
(5,324 |
) |
|
|
(10,640 |
) |
|
|
(10,808 |
) |
|
|
(12,580 |
) |
Loss on early extinguishment of debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(58,660 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income before income tax expense
|
|
|
80,223 |
|
|
|
32,551 |
|
|
|
99,102 |
|
|
|
46,157 |
|
|
|
77,660 |
|
Income tax expense
|
|
|
(30,502 |
) |
|
|
(11,328 |
) |
|
|
(34,112 |
) |
|
|
(15,317 |
) |
|
|
(26,404 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
$ |
30,840 |
|
|
$ |
51,256 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per common share
|
|
$ |
0.92 |
|
|
$ |
0.38 |
|
|
$ |
1.18 |
|
|
$ |
0.55 |
|
|
$ |
0.94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per common share
|
|
$ |
0.76 |
|
|
$ |
0.34 |
|
|
$ |
1.01 |
|
|
$ |
0.52 |
|
|
$ |
0.84 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash dividend declared per common share
|
|
$ |
0.06 |
|
|
$ |
0.06 |
|
|
$ |
0.12 |
|
|
$ |
0.10 |
|
|
$ |
0.025 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic common shares outstanding
|
|
|
54,323 |
|
|
|
55,972 |
|
|
|
55,196 |
|
|
|
55,618 |
|
|
|
54,376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted common shares outstanding
|
|
|
69,772 |
|
|
|
72,160 |
|
|
|
70,909 |
|
|
|
72,481 |
|
|
|
70,191 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) amounts exclude amortization of intangible assets
related to acquired products
|
|
$ |
10,899 |
|
|
$ |
8,933 |
|
|
$ |
19,620 |
|
|
$ |
14,891 |
|
|
$ |
9,166 |
|
(2) amounts include share-based compensation expense
|
|
$ |
13,947 |
|
|
$ |
258 |
|
|
$ |
515 |
|
|
$ |
515 |
|
|
$ |
365 |
|
(3) amounts include share-based compensation expense
|
|
$ |
1,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-6
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
|
|
|
|
|
|
|
|
Class A | |
|
Class B | |
|
|
|
Other | |
|
|
|
|
|
|
|
|
|
|
Common Stock | |
|
Common Stock | |
|
Additional | |
|
Comprehensive | |
|
|
|
|
|
Treasury Stock | |
|
|
|
|
| |
|
| |
|
Paid-In | |
|
Income | |
|
Deferred | |
|
Accumulated | |
|
| |
|
|
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
(Loss) | |
|
Compensation | |
|
Earnings | |
|
Shares | |
|
Amount | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Balance at June 30, 2002
|
|
|
61,552 |
|
|
$ |
862 |
|
|
|
758 |
|
|
$ |
10 |
|
|
$ |
429,515 |
|
|
$ |
790 |
|
|
$ |
(2,094 |
) |
|
$ |
154,923 |
|
|
|
(6,824 |
) |
|
$ |
(154,947 |
) |
|
$ |
429,059 |
|
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51,256 |
|
|
|
|
|
|
|
|
|
|
|
51,256 |
|
|
Net unrealized gains on available- for-sale securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,396 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,396 |
|
|
Net unrealized losses on foreign currency translation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52,866 |
|
|
Dividends declared
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,362 |
) |
|
|
|
|
|
|
|
|
|
|
(1,362 |
) |
Restricted shares issued for deferred compensation, net of
cancellations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2 |
) |
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of deferred compensation, net of award
reacquisitions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
365 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
365 |
|
|
Exercise of stock options
|
|
|
958 |
|
|
|
14 |
|
|
|
|
|
|
|
|
|
|
|
12,746 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,760 |
|
|
Tax effect of stock options exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,394 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,394 |
|
|
Purchase of treasury stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,858 |
) |
|
|
(35,961 |
) |
|
|
(35,961 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2003
|
|
|
62,510 |
|
|
|
876 |
|
|
|
758 |
|
|
|
10 |
|
|
|
445,653 |
|
|
|
2,400 |
|
|
|
(1,727 |
) |
|
|
204,817 |
|
|
|
(8,682 |
) |
|
|
(190,908 |
) |
|
|
461,121 |
|
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
30,840 |
|
|
|
|
|
|
|
|
|
|
|
30,840 |
|
|
Net unrealized gains on available- for-sale securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,452 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,452 |
) |
|
Net unrealized gains on foreign currency translation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,420 |
|
|
Conversion of contingent convertible senior notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6 |
|
|
Dividends declared
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,608 |
) |
|
|
|
|
|
|
|
|
|
|
(5,608 |
) |
|
Amortization of deferred compensation, net of award
reacquisitions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
515 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
515 |
|
|
Exercise of stock options
|
|
|
2,909 |
|
|
|
40 |
|
|
|
|
|
|
|
|
|
|
|
51,393 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
51,433 |
|
|
Tax effect of stock options exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,416 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
20,416 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2004
|
|
|
65,419 |
|
|
|
916 |
|
|
|
758 |
|
|
|
10 |
|
|
|
517,468 |
|
|
|
(1,020 |
) |
|
|
(1,212 |
) |
|
|
230,049 |
|
|
|
(8,682 |
) |
|
|
(190,908 |
) |
|
|
555,303 |
|
See accompanying notes to consolidated financial statements.
F-7
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
|
|
|
|
|
|
|
|
Class A | |
|
Class B | |
|
|
|
Other | |
|
|
|
|
|
|
|
|
|
|
Common Stock | |
|
Common Stock | |
|
Additional | |
|
Comprehensive | |
|
|
|
|
|
Treasury Stock | |
|
|
|
|
| |
|
| |
|
Paid-In | |
|
Income | |
|
Deferred | |
|
Accumulated | |
|
| |
|
|
|
|
Shares | |
|
Amount | |
|
Shares | |
|
Amount | |
|
Capital | |
|
(Loss) | |
|
Compensation | |
|
Earnings | |
|
Shares | |
|
Amount | |
|
Total | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Balance at June 30, 2004
|
|
|
65,419 |
|
|
$ |
916 |
|
|
|
758 |
|
|
$ |
10 |
|
|
$ |
517,468 |
|
|
$ |
(1,020 |
) |
|
$ |
(1,212 |
) |
|
$ |
230,049 |
|
|
|
(8,682 |
) |
|
$ |
(190,908 |
) |
|
$ |
555,303 |
|
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
64,990 |
|
|
|
|
|
|
|
|
|
|
|
64,990 |
|
|
Net unrealized losses on available- for-sale securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(75 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(75 |
) |
|
Net unrealized gains on foreign currency translation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
489 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
65,404 |
|
Conversion of Class B common stock to Class A common
stock
|
|
|
758 |
|
|
|
10 |
|
|
|
(758 |
) |
|
|
(10 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of contingent convertible senior notes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 |
|
|
Dividends declared
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,565 |
) |
|
|
|
|
|
|
|
|
|
|
(6,565 |
) |
|
Restricted shares issued for deferred compensation, net of
cancellations
|
|
|
18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
298 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(18 |
) |
|
|
(298 |
) |
|
|
|
|
Amortization of deferred compensation, net of award
reacquisitions
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
515 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
515 |
|
|
Exercise of stock options
|
|
|
812 |
|
|
|
12 |
|
|
|
|
|
|
|
|
|
|
|
16,571 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,583 |
|
|
Tax effect of stock options exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,104 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,104 |
|
|
Purchase of treasury stock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,920 |
) |
|
|
(150,000 |
) |
|
|
(150,000 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2005
|
|
|
67,007 |
|
|
|
938 |
|
|
|
|
|
|
|
|
|
|
|
539,443 |
|
|
|
(606 |
) |
|
|
(697 |
) |
|
|
288,474 |
|
|
|
(12,620 |
) |
|
|
(341,206 |
) |
|
|
486,346 |
|
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
49,721 |
|
|
|
|
|
|
|
|
|
|
|
49,721 |
|
|
Net unrealized gains on available- for-sale securities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
636 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
636 |
|
|
Net unrealized gains on foreign currency translation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
349 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
349 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive income
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
50,706 |
|
Adjustment for adoption of FAS 123(R)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
827 |
|
|
|
|
|
|
|
697 |
|
|
|
|
|
|
|
|
|
|
|
(1,524 |
) |
|
|
|
|
|
Share-based compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,947 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,947 |
|
|
Dividends declared
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,301 |
) |
|
|
|
|
|
|
|
|
|
|
(3,301 |
) |
|
Restricted shares issued for deferred compensation
|
|
|
27 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(27 |
) |
|
|
|
|
|
|
|
|
|
Exercise of stock options
|
|
|
18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
430 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
430 |
|
|
Tax effect of stock options exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,641 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(5,641 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
67,052 |
|
|
$ |
938 |
|
|
|
|
|
|
$ |
|
|
|
$ |
550,006 |
|
|
$ |
379 |
|
|
$ |
|
|
|
$ |
334,894 |
|
|
|
(12,647 |
) |
|
$ |
(342,730 |
) |
|
$ |
543,487 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-8
MEDICIS PHARMACEUTICAL CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended | |
|
|
|
|
December 31, | |
|
Year Ended June 30, | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(Unaudited) | |
|
|
|
|
|
|
|
|
(In thousands) | |
Operating Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
$ |
30,840 |
|
|
$ |
51,256 |
|
Adjustments to reconcile net income to net cash provided by
operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
12,420 |
|
|
|
10,222 |
|
|
|
22,350 |
|
|
|
16,794 |
|
|
|
10,125 |
|
|
Amortization of deferred financing fees
|
|
|
1,072 |
|
|
|
1,072 |
|
|
|
2,143 |
|
|
|
2,144 |
|
|
|
2,641 |
|
|
Impairment of long-lived assets
|
|
|
9,171 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss (gain) on sale of property and equipment
|
|
|
34 |
|
|
|
39 |
|
|
|
52 |
|
|
|
(4 |
) |
|
|
|
|
|
Loss on sale of product rights
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32 |
|
|
|
|
|
|
Loss (gain) on sale of available-for-sale investments
|
|
|
599 |
|
|
|
103 |
|
|
|
882 |
|
|
|
(599 |
) |
|
|
(380 |
) |
|
Write-off of Inamed transaction costs
|
|
|
14,042 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation expense
|
|
|
14,947 |
|
|
|
258 |
|
|
|
515 |
|
|
|
515 |
|
|
|
365 |
|
|
Deferred income tax expense (benefit)
|
|
|
1,849 |
|
|
|
(3,060 |
) |
|
|
5,369 |
|
|
|
(3,634 |
) |
|
|
8,879 |
|
|
Tax benefit from exercise of stock options
|
|
|
|
|
|
|
5,058 |
|
|
|
5,104 |
|
|
|
20,416 |
|
|
|
3,394 |
|
|
Excess tax benefits from share-based payment arrangements
|
|
|
(73 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provision for doubtful accounts and returns
|
|
|
(913 |
) |
|
|
3,100 |
|
|
|
3,118 |
|
|
|
1,050 |
|
|
|
5,321 |
|
|
Accretion of (discount) premium on investments
|
|
|
(418 |
) |
|
|
5,010 |
|
|
|
6,528 |
|
|
|
7,284 |
|
|
|
3,657 |
|
|
Loss on early extinguishment of debt
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
58,660 |
|
|
|
|
|
Changes in operating assets and liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable
|
|
|
1,436 |
|
|
|
(957 |
) |
|
|
(2,480 |
) |
|
|
2,753 |
|
|
|
(11,318 |
) |
|
|
Inventories
|
|
|
1,625 |
|
|
|
2,621 |
|
|
|
(1,160 |
) |
|
|
(5,535 |
) |
|
|
(2,050 |
) |
|
|
Other current assets
|
|
|
4,194 |
|
|
|
(1,942 |
) |
|
|
1,886 |
|
|
|
(1,472 |
) |
|
|
(378 |
) |
|
|
Accounts payable
|
|
|
27,220 |
|
|
|
4,557 |
|
|
|
15,580 |
|
|
|
(4,655 |
) |
|
|
4,553 |
|
|
|
Income taxes payable
|
|
|
17,255 |
|
|
|
5,974 |
|
|
|
9,524 |
|
|
|
232 |
|
|
|
(979 |
) |
|
|
Other current liabilities
|
|
|
(6,191 |
) |
|
|
(7,813 |
) |
|
|
(4,420 |
) |
|
|
3,143 |
|
|
|
9,581 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities
|
|
|
147,990 |
|
|
|
45,465 |
|
|
|
129,981 |
|
|
|
127,964 |
|
|
|
84,667 |
|
Investing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
(748 |
) |
|
|
(1,829 |
) |
|
|
(2,913 |
) |
|
|
(4,594 |
) |
|
|
(1,367 |
) |
Proceeds from sale of property and equipment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
131 |
|
|
|
|
|
Payment of direct merger costs
|
|
|
(5,811 |
) |
|
|
(129 |
) |
|
|
(7,454 |
) |
|
|
(633 |
) |
|
|
(1,511 |
) |
Payment for purchase of product rights
|
|
|
(481 |
) |
|
|
(3,085 |
) |
|
|
(3,296 |
) |
|
|
(84,116 |
) |
|
|
(81,727 |
) |
Proceeds from sale of product rights
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,100 |
|
|
|
|
|
Purchase of available-for-sale investments
|
|
|
(203,247 |
) |
|
|
(440,602 |
) |
|
|
(762,561 |
) |
|
|
(888,152 |
) |
|
|
(712,040 |
) |
Sale of available-for-sale investments
|
|
|
159,597 |
|
|
|
489,352 |
|
|
|
846,143 |
|
|
|
622,006 |
|
|
|
566,080 |
|
Maturity of available-for-sale investments
|
|
|
174,355 |
|
|
|
32,451 |
|
|
|
70,568 |
|
|
|
123,072 |
|
|
|
138,975 |
|
Decrease (increase) in restricted cash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
53,837 |
|
|
|
(22,153 |
) |
Change in other assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8 |
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
123,665 |
|
|
|
76,158 |
|
|
|
140,487 |
|
|
|
(166,341 |
) |
|
|
(113,709 |
) |
Financing Activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment of financing costs
|
|
|
|
|
|
|
(6 |
) |
|
|
(6 |
) |
|
|
(5,276 |
) |
|
|
(142 |
) |
Payment of dividends
|
|
|
(3,295 |
) |
|
|
(3,115 |
) |
|
|
(6,370 |
) |
|
|
(5,536 |
) |
|
|
|
|
Purchase of treasury stock
|
|
|
|
|
|
|
(150,000 |
) |
|
|
(150,000 |
) |
|
|
|
|
|
|
(35,961 |
) |
Excess tax benefits from share-based payment arrangements
|
|
|
73 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from the exercise of stock options
|
|
|
430 |
|
|
|
15,674 |
|
|
|
16,583 |
|
|
|
51,433 |
|
|
|
12,760 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities
|
|
|
(2,792 |
) |
|
|
(137,447 |
) |
|
|
(139,793 |
) |
|
|
40,621 |
|
|
|
(23,343 |
) |
Effect of exchange rate on cash and cash equivalents
|
|
|
349 |
|
|
|
724 |
|
|
|
489 |
|
|
|
31 |
|
|
|
214 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
269,212 |
|
|
|
(15,100 |
) |
|
|
131,164 |
|
|
|
2,275 |
|
|
|
(52,171 |
) |
Cash and cash equivalents at beginning of period
|
|
|
177,785 |
|
|
|
46,621 |
|
|
|
46,621 |
|
|
|
44,346 |
|
|
|
96,517 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period
|
|
$ |
446,997 |
|
|
$ |
31,521 |
|
|
$ |
177,785 |
|
|
$ |
46,621 |
|
|
$ |
44,346 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to consolidated financial statements.
F-9
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
|
|
NOTE 1. |
THE COMPANY AND BASIS OF PRESENTATION |
Medicis Pharmaceutical Corporation (Medicis or the
Company) is a leading independent specialty
pharmaceutical company focusing primarily on the development and
marketing of products in the United States (U.S.)
for the treatment of dermatological, aesthetic and podiatric
conditions. Medicis also markets products in Canada for the
treatment of dermatological and aesthetic conditions. Medicis
has built its business by executing a four-part growth strategy.
This strategy consists of promoting existing core brands,
developing new products and important product line extensions,
entering into strategic collaborations, and acquiring
complementary products, technologies and businesses.
The Company offers a broad range of products addressing various
conditions including acne, fungal infections, rosacea,
hyperpigmentation, photoaging, psoriasis, eczema, skin and
skin-structure infections, seborrheic dermatitis and cosmesis
(improvement in the texture and appearance of skin). Medicis
currently offers 15 branded products. Its core brands are
DYNACIN®
(minocycline HCI),
LOPROX®
(ciclopirox),
OMNICEF®
(cefdinir),
PLEXION®
(sodium sulfacetamide/sulfur),
RESTYLANE®
(hyaluronic acid),
TRIAZ®
(benzoyl peroxide), and
VANOStm
(fluocinonide) Cream, 0.1%.
In March 2003, Medicis expanded into the dermal aesthetic market
through its acquisition of the exclusive U.S. and Canadian
rights to market, distribute and commercialize the dermal
restorative product lines known as
RESTYLANE®,
PERLANEtm
and RESTYLANE FINE
LINEStm
from Q-Med AB, a Swedish biotechnology/medical device company
and its affiliates, collectively Q-Med.
RESTYLANE®
has been approved by the Food and Drug Administration (the
FDA) for use in the U.S. as a medical device
for the correction of moderate to severe facial wrinkles and
folds, such as nasolabial folds.
RESTYLANE®,
PERLANEtm
and RESTYLANE FINE
LINEStm
have been approved for use in Canada.
The consolidated financial statements include the accounts of
Medicis Pharmaceutical Corporation 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.
Effective December 31, 2005, the Company changed its fiscal
year end from June 30 to December 31. This change is
being made in order to align the Companys fiscal year end
with other companies within the industry. The resulting
six-month period ended December 31, 2005 may be referred to
herein as the Transition Period. The six-month
period ended December 31, 2004 is unaudited. The Company
refers to the period beginning July 1, 2004 and ending
June 30, 2005 as fiscal 2005, the period
beginning July 1, 2003 and ending June 30, 2004 as
fiscal 2004 and the period beginning July 1,
2002 and ending June 30, 2003 as fiscal 2003.
|
|
NOTE 2. |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES |
|
|
|
Cash and Cash Equivalents |
At December 31, 2005, cash and cash equivalents included
highly liquid investments invested in money market accounts
consisting of government securities and high-grade commercial
paper. These investments are stated at cost, which approximates
fair value. The Company considers all highly liquid investments
purchased with a remaining maturity of three months or less to
be cash equivalents.
F-10
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Short-Term Investments
The Companys debt securities 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. On an ongoing basis, the Company
evaluates its debt securities to determine if a decline in fair
value is other-than-temporary. When a decline in fair value is
determined to be other-than-temporary, an impairment charge
would be recorded and a new cost basis in the investment is
established. The amortized cost of debt securities in this
category is adjusted for amortization of premiums and accretion
of discounts to maturity. Such amortization is included in
interest income. Realized gains and losses and interest and
dividends on securities are included in interest income. The
cost of securities sold is based upon the specific
identification method.
Inventories
The Company utilizes third parties to manufacture and package
inventories held for sale, takes title to certain inventories
once manufactured, and warehouses such goods until packaged for
final distribution and sale. Inventories consist of salable
products held at the Companys warehouses, as well as raw
materials and components at the manufacturers facilities,
and are valued at the lower of cost or market using the
first-in, first-out
method. The Company provides valuation reserves for estimated
obsolescence or unmarketable inventory in an amount equal to the
difference between the cost of inventory and the estimated
market value based upon assumptions about future demand and
market conditions.
Inventories are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
|
December 31, | |
|
| |
|
|
2005 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
Raw materials
|
|
$ |
6,436 |
|
|
$ |
5,283 |
|
|
$ |
8,785 |
|
Finished goods
|
|
|
13,925 |
|
|
|
16,518 |
|
|
|
11,105 |
|
Valuation reserve
|
|
|
(1,285 |
) |
|
|
(1,100 |
) |
|
|
(350 |
) |
|
|
|
|
|
|
|
|
|
|
|
Total inventories
|
|
$ |
19,076 |
|
|
$ |
20,701 |
|
|
$ |
19,540 |
|
|
|
|
|
|
|
|
|
|
|
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):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
|
December 31, | |
|
| |
|
|
2005 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
Furniture, fixtures and equipment
|
|
$ |
10,064 |
|
|
$ |
9,377 |
|
|
$ |
7,268 |
|
Leasehold improvements
|
|
|
1,994 |
|
|
|
1,989 |
|
|
|
2,018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,058 |
|
|
|
11,366 |
|
|
|
9,286 |
|
Less: accumulated depreciation
|
|
|
(6,642 |
) |
|
|
(5,223 |
) |
|
|
(3,444 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
5,416 |
|
|
$ |
6,143 |
|
|
$ |
5,842 |
|
|
|
|
|
|
|
|
|
|
|
Total depreciation expense for property and equipment was
approximately $1.4 million, $1.2 million (unaudited) ,
$2.6 million, $1.7 million and $0.9 million for
the Transition Period, the comparable 2004 six months, and the
fiscal years ended June 30, 2005, June 30, 2004 and
June 30, 2003, respectively.
F-11
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Goodwill
Goodwill is recorded when the purchase price paid for an
acquisition exceeds the estimated fair value of the net
identified tangible and intangible assets acquired. The Company
is required to perform an annual impairment review, and more
frequently under certain circumstances. The goodwill is
subjected to this test during the last quarter of the
Companys fiscal year. The impairment review process
compares the fair value of the reporting unit to its carrying
value. If the Company determines through the impairment process
that goodwill has been impaired, the Company will record the
impairment charge in the statement of income. As of
December 31, 2005, 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.
Goodwill was approximately $63.1 million as of
December 31, 2005, $64.7 million as of June 30,
2005 and approximately $55.1 million as of June 30,
2004. The decrease during the Transition Period reflects a
realized income tax benefit resulting from imputed interest on
the contingent purchase price payments to the former
shareholders of Ascent Pediatrics, Inc. (Ascent),
related to the Companys merger with Ascent completed in
2001. The increase during fiscal 2005 reflects the recording of
the third year contingent purchase price payment related to the
Companys merger with Ascent. See Note 10 for further
discussion.
Intangible Assets
The Company has in the past made acquisitions of license
agreements, product rights, and other identifiable intangible
assets. Intangible assets subject to amortization were
approximately $239.8 million, $259.5 million and
$276.0 million as of December 31, 2005, June 30,
2005 and 2004, respectively. The Company amortizes intangible
assets over their expected useful lives, which range between
five and 40 years. Total intangible assets as of
December 31, 2005, June 30, 2005 and June 30,
2004 were as follows (dollars in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 | |
|
June 30, 2005 | |
|
June 30, 2004 | |
|
|
|
|
| |
|
| |
|
| |
|
|
Weighted | |
|
|
|
Accumulated | |
|
|
|
|
|
Accumulated | |
|
|
|
|
|
Accumulated | |
|
|
|
|
Average Life | |
|
Gross | |
|
Amortization | |
|
Net | |
|
Gross | |
|
Amortization | |
|
Net | |
|
Gross | |
|
Amortization | |
|
Net | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Related to product line acquisitions
|
|
|
22.4 |
|
|
$ |
306,324 |
|
|
$ |
(73,879 |
) |
|
$ |
232,445 |
|
|
$ |
321,698 |
|
|
$ |
(69,727 |
) |
|
$ |
251,971 |
|
|
$ |
319,263 |
|
|
$ |
(50,724 |
) |
|
$ |
268,539 |
|
Related to business combinations
|
|
|
7.5 |
|
|
|
5,082 |
|
|
|
(1,824 |
) |
|
|
3,258 |
|
|
|
5,082 |
|
|
|
(1,346 |
) |
|
|
3,736 |
|
|
|
5,082 |
|
|
|
(730 |
) |
|
|
4,352 |
|
Patents and trademarks
|
|
|
17.8 |
|
|
|
4,888 |
|
|
|
(755 |
) |
|
|
4,133 |
|
|
|
4,507 |
|
|
|
(676 |
) |
|
|
3,831 |
|
|
|
3,647 |
|
|
|
(507 |
) |
|
|
3,140 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total intangible assets
|
|
|
|
|
|
$ |
316,294 |
|
|
$ |
(76,458 |
) |
|
$ |
239,836 |
|
|
$ |
331,287 |
|
|
$ |
(71,749 |
) |
|
$ |
259,538 |
|
|
$ |
327,992 |
|
|
$ |
(51,961 |
) |
|
$ |
276,031 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total amortization expense was approximately $11.0 million,
$9.0 million (unaudited), $19.8 million,
$15.1 million and $9.2 million for the Transition
Period, the comparable 2004 six months, fiscal 2005, fiscal 2004
and fiscal 2003, respectively. Based on the intangible assets
recorded at December 31, 2005, and assuming no subsequent
impairment of the underlying assets, the annual amortization
expense for each period, is expected to be as follows:
$20.5 million for the years ended December 31, 2006,
2007, and 2008, approximately $17.9 million for the year
ended December 31, 2009, and approximately
$15.3 million for the year ended December 31, 2010.
Impairment of Long-Lived Assets
The Company assesses whether indicators of impairment of
long-lived assets are present. If such indicators are present,
the Company determines whether the sum of the estimated
undiscounted cash flows attributable to the assets in question
is less than their carrying value. If less, the Company
recognizes an
F-12
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
impairment loss based on the excess of the carrying amount of
the assets over their respective fair values. Fair value is
determined by discounted future cash flows, appraisals or other
methods. If the assets determined to be impaired are to be held
and used, the Company recognizes an impairment loss through a
charge to operating results to the extent the present value of
anticipated net cash flows attributable to the asset are less
than the assets carrying value. When it is determined that
the useful lives of assets are shorter than originally
estimated, and there are sufficient cash flows to support the
carrying value of the assets, the Company will accelerate the
rate of amortization charges in order to fully amortize the
assets over their new shorter useful lives (See Note 3).
This process requires the use of estimates and assumptions,
which are subject to a high degree of judgment. If these
assumptions change in the future, the Company may be required to
record impairment charges for these assets.
During the quarter ended December 31, 2005, a long-lived
asset related to the Companys
DYNACIN®
capsule products was determined to be impaired based on the
Companys analysis of the long-lived assets carrying
value and projected future cash flows. Factors affecting the
long-lived assets future cash flows included the
Companys promotional focus on its
DYNACIN®
tablet products, and competitive pressures in the marketplace.
As a result of the impairment analysis, the Company recorded a
write-down of approximately $9.2 million related to this
long-lived asset, which is included in selling, general and
administrative expenses.
Deferred Financing Costs
Deferred financing costs represent fees and other costs incurred
in connection with the June 2002 issuance of the 2.5% Contingent
Convertible Senior Notes Due 2032 and the August 2003 issuance
of the 1.5% Contingent Convertible Senior Notes Due 2033. These
costs are being amortized on a basis that approximates the
effective interest method over the five-year period that ends on
the initial Put date of the Notes. Accumulated amortization
amounted to approximately $6.3 million as of
December 31, 2005.
Managed Care and Medicaid Reserves
The Company establishes and maintains reserves for amounts
payable to Managed Care Organizations and state Medicaid
programs for the reimbursement of a portion of the retail price
of prescriptions filled that are covered by the respective
plans. The amounts estimated to be paid relating to products
sold are recognized as revenue reductions and as additions to
accrued expenses at the time of sale based on the Companys
best estimate of the expected prescription fill rate to these
Managed Care and state Medicaid patients using historical
experience adjusted to reflect known changes in the factors that
impact such reserves.
Other Current Liabilities
Other current liabilities are as follows (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
|
December 31, | |
|
| |
|
|
2005 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
Accrued incentives
|
|
$ |
6,506 |
|
|
$ |
9,505 |
|
|
$ |
8,069 |
|
Deferred revenue
|
|
|
1,237 |
|
|
|
1,862 |
|
|
|
3,545 |
|
Managed care and Medicaid reserves
|
|
|
6,081 |
|
|
|
5,365 |
|
|
|
11,671 |
|
Other accrued expenses
|
|
|
10,371 |
|
|
|
13,647 |
|
|
|
11,320 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
24,195 |
|
|
$ |
30,379 |
|
|
$ |
34,605 |
|
|
|
|
|
|
|
|
|
|
|
F-13
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Revenue Recognition
Revenue from product sales is recognized pursuant to Staff
Accounting Bulletin No. 104 (SAB 104),
Revenue Recognition in Financial Statements.
Accordingly, revenue is recognized when all four of the
following criteria are met: (i) persuasive evidence that an
arrangement exists; (ii) delivery of the products has
occurred; (iii) the selling price is both fixed and
determinable; and (iv) collectibility is reasonably
assured. The Companys customers consist primarily of large
pharmaceutical wholesalers who sell directly into the retail
channel. Provisions for early payment discounts, and estimates
for chargebacks, managed care and Medicaid rebates, damaged
product returns, and exchanges for expired product are
established as a reduction of product sales revenues at the time
such revenues are recognized. These revenue reductions are
established by the Companys management as its best
estimate at the time of sale based on historical experience
adjusted to reflect known changes in the factors that impact
such reserves. These revenue reductions are generally reflected
either as a direct reduction to accounts receivable through an
allowance, or as an addition to accrued expenses if the payment
is due to a party other than the wholesale or retail customer.
The Company enters into licensing arrangements with other
parties whereby the Company receives contract revenue based on
the terms of the agreement. The timing of revenue recognition is
dependent on the level of the Companys continuing
involvement in the manufacture and delivery of licensed
products. If the Company has continuing involvement, the revenue
is deferred and recognized on a straight-line basis over the
period of continuing involvement. In addition, if the licensing
arrangements require no continuing involvement and payments are
merely based on the passage of time, the Company assesses such
payments for revenue recognition under the collectibility
criteria of SAB 104. Direct costs related to contract
acquisition and origination of licensing agreements are expensed
as incurred.
The Company does not provide any forms of price protection to
its wholesale customers and permits product returns if the
product is damaged, or 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.
Advertising
The Company expenses advertising as incurred. Advertising
expenses for the Transition Period and the comparable 2004 six
months were approximately $12.9 million and
$13.3 million (unaudited), respectively, and for fiscal
2005, 2004 and 2003 were approximately $24.2 million,
$22.5 million and $20.1 million, respectively.
Advertising expenses include samples of the Companys
products given to physicians for marketing to their patients.
Share-Based Compensation
At December 31, 2005, the Company had six active
share-based employee compensation plans. 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. Prior to July 1, 2005, the Company
accounted for share-based employee compensation, including stock
options, using the method prescribed in Accounting Principles
Board Opinion No. 25, Accounting for Stock Issued to
Employees and related Interpretations (APB Opinion
No. 25). Under APB Opinion No. 25, stock options
are granted at market price and no compensation cost is
recognized, and a disclosure is made regarding the pro forma
effect on net earnings assuming compensation cost had been
recognized in accordance with Statement of Financial Accounting
Standards No. 123, Accounting for Stock-Based
Compensation (SFAS No. 123). On
December 16, 2004, the FASB issued
F-14
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
SFAS No. 123R, which requires companies to measure and
recognize compensation expense for all share-based payments at
fair value. SFAS No. 123R eliminates the ability to
account for share-based compensation transactions using APB
Opinion No. 25, and generally requires that such
transactions be accounted for using prescribed fair-value-based
methods. SFAS No. 123R permits public companies to
adopt its requirements using one of two methods: (a) a
modified prospective method in which compensation
costs are recognized beginning with the effective date based on
the requirements of SFAS No. 123R for all share-based
payments granted or modified after the effective date, and based
on the requirements of SFAS No. 123 for all awards
granted to employees prior to the effective date of
SFAS No. 123R that remain unvested on the effective
date or (b) a modified retrospective method
which includes the requirements of the modified prospective
method described above, but also permits companies to restate
based on the amounts previously recognized under
SFAS No. 123 for purposes of pro forma disclosures
either for all periods presented or prior interim periods of the
year of adoption. Effective July 1, 2005, the Company
adopted SFAS No. 123R using the modified prospective
method. Other than restricted stock, no share-based employee
compensation cost has been reflected in net income prior to the
adoption of SFAS No. 123R. Results for prior periods
have not been restated.
The adoption of SFAS No. 123R reduced income before
income tax expense for the Transition Period by approximately
$14.9 million and reduced net income for the Transition
Period by approximately $11.0 million. As a result, basic
and diluted earnings per share were reduced $0.20 and $0.16,
respectively.
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, 2005, total unrecognized compensation
cost related to stock option awards was approximately
$64.4 million and the related weighted-average period over
which it is expected to be recognized is approximately
2.9 years.
Prior to the adoption of SFAS No. 123R, the Company
presented all tax benefits of deductions resulting from the
exercise of stock options as operating cash flows in the
condensed consolidated statements of cash flows.
SFAS No. 123R requires the cash flows resulting from
the tax benefits resulting from tax deductions in excess of the
compensation cost recognized for those options (excess tax
benefits) to be classified as financing cash flows. The
$0.1 million excess tax benefit classified as a financing
cash inflow in the Companys accompanying condensed
consolidated statements of cash flows for the Transition Period
would have been classified as an operating cash inflow if the
Company had not adopted SFAS No. 123R.
A summary of stock option activity within the Companys
stock-based compensation plans and changes for the Transition
Period is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted | |
|
|
|
|
|
|
Weighted | |
|
Average | |
|
|
|
|
|
|
Average | |
|
Remaining | |
|
Aggregate | |
|
|
Number of | |
|
Exercise | |
|
Contractual | |
|
Intrinsic | |
|
|
Shares | |
|
Price | |
|
Term | |
|
Value | |
|
|
| |
|
| |
|
| |
|
| |
Balance at June 30, 2005
|
|
|
13,648,378 |
|
|
$ |
26.89 |
|
|
|
|
|
|
|
|
|
Granted
|
|
|
843,550 |
|
|
$ |
32.43 |
|
|
|
|
|
|
|
|
|
Exercised
|
|
|
(17,996 |
) |
|
$ |
23.87 |
|
|
|
|
|
|
|
|
|
Terminated/expired
|
|
|
(94,596 |
) |
|
$ |
28.85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
14,379,336 |
|
|
$ |
27.21 |
|
|
|
6.5 |
|
|
$ |
87,396,722 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The intrinsic value of options exercised during the Transition
Period was $118,047. Options exercisable under the
Companys share-based compensation plans at
December 31, 2005 were 7,302,745, with an average exercise
price of $24.24, an average remaining contractual term of
5.4 years, and an aggregate intrinsic value of $60,152,809.
F-15
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
A summary of fully vested stock options and stock options
expected to vest, as of December 31, 2005, is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted | |
|
|
|
|
|
|
Weighted | |
|
Average | |
|
|
|
|
|
|
Average | |
|
Remaining | |
|
Aggregate | |
|
|
Number of | |
|
Exercise | |
|
Contractual | |
|
Intrinsic | |
|
|
Shares | |
|
Price | |
|
Term | |
|
Value | |
|
|
| |
|
| |
|
| |
|
| |
Outstanding
|
|
|
13,816,174 |
|
|
$ |
27.19 |
|
|
|
6.5 |
|
|
$ |
84,119,298 |
|
Exercisable
|
|
|
7,067,028 |
|
|
$ |
24.24 |
|
|
|
5.4 |
|
|
$ |
58,262,667 |
|
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:
|
|
|
|
|
|
|
|
|
|
|
Six Months | |
|
Six Months | |
|
|
Ended | |
|
Ended | |
|
|
December 31, | |
|
December 31, | |
|
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
|
|
|
(Unaudited) | |
Expected dividend yield
|
|
|
0.4 |
% |
|
|
0.3 |
% |
Expected stock price volatility
|
|
|
0.36 |
|
|
|
0.44 |
|
Risk-free interest rate
|
|
|
4.1% to 4.2% |
|
|
|
3.6 |
% |
Expected life of options
|
|
|
6 to 8 Years |
|
|
|
5 Years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Twelve Months | |
|
Twelve Months | |
|
Twelve Months | |
|
|
Ended | |
|
Ended | |
|
Ended | |
|
|
June 30, | |
|
June 30, | |
|
June 30, | |
|
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
Expected dividend yield
|
|
|
0.3 |
% |
|
|
0.3 |
% |
|
|
0.3 |
% |
Expected stock price volatility
|
|
|
0.44 |
|
|
|
0.49 |
|
|
|
0.49 |
|
Risk-free interest rate
|
|
|
3.6 |
% |
|
|
3.3 |
% |
|
|
2.5 |
% |
Expected life of options
|
|
|
5 Years |
|
|
|
5 Years |
|
|
|
5 Years |
|
The expected dividend yield is based on expected annual dividend
to be paid by the Company as a percentage of the market value of
the Companys stock as of the date of grant. The Company
determined that a blend of implied volatility and historical
volatility is more reflective of market conditions and a better
indicator of expected volatility than using purely historical
volatility. The risk-free interest rate is based on the
U.S. treasury security rate in effect as of the date of
grant. The expected lives of options are based on historical
data of the Company.
The weighted average fair value of stock options granted during
the Transition Period, the comparable 2004 six months, fiscal
2005, 2004 and 2003 was $14.15, $16.08 (unaudited), $11.66,
$10.17 and $9.10, respectively.
F-16
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table illustrates the effect on net income and net
income per common share as if the Company had applied the fair
value recognition provisions of SFAS No. 123 to all
outstanding stock option awards for periods presented prior to
the Companys adoption of SFAS No. 123R (amounts
in thousands, except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months | |
|
Twelve Months | |
|
Twelve Months | |
|
Twelve Months | |
|
|
Ended | |
|
Ended | |
|
Ended | |
|
Ended | |
|
|
December 31, | |
|
June 30, | |
|
June 30, | |
|
June 30, | |
|
|
2004 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(Unaudited) | |
|
|
|
|
|
|
Net income, as reported
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
$ |
30,840 |
|
|
$ |
51,256 |
|
Deduct: Total stock-based employee compensation expense
determined under fair value based method for all awards, net of
related tax effects
|
|
|
10,195 |
|
|
|
21,813 |
|
|
|
17,078 |
|
|
|
18,056 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro-forma net income
|
|
$ |
11,028 |
|
|
$ |
43,177 |
|
|
$ |
13,762 |
|
|
$ |
33,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income per common share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic, as reported
|
|
$ |
0.38 |
|
|
$ |
1.18 |
|
|
$ |
0.55 |
|
|
$ |
0.94 |
|
|
Basic, pro forma
|
|
$ |
0.20 |
|
|
$ |
0.78 |
|
|
$ |
0.25 |
|
|
$ |
0.61 |
|
|
Diluted, as reported
|
|
$ |
0.34 |
|
|
$ |
1.01 |
|
|
$ |
0.52 |
|
|
$ |
0.84 |
|
|
Diluted, pro forma
|
|
$ |
0.20 |
|
|
$ |
0.70 |
|
|
$ |
0.23 |
|
|
$ |
0.59 |
|
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 the Transition Period, 147,710 shares of
restricted stock were granted to certain employees. Share-based
compensation expense related to all restricted stock awards
outstanding during the Transition Period, the comparable 2004
six months, fiscal 2005, 2004, and 2003 was approximately
$0.7 million, $0.3 million (unaudited),
$0.5 million, $0.5 million, and $0.4 million,
respectively. As of December 31, 2005, the total amount of
unrecognized compensation cost related to nonvested restricted
stock awards was approximately $4.7 million, and the
related weighted-average period over which it is expected to be
recognized is approximately 4.3 years.
A summary of restricted stock activity within the Companys
share-based compensation plans and changes for the Transition
Period is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- | |
|
|
|
|
Average | |
|
|
|
|
Grant-Date | |
Nonvested Shares |
|
Shares | |
|
Fair Value | |
|
|
| |
|
| |
Nonvested at June 30, 2005
|
|
|
92,000 |
|
|
$ |
23.41 |
|
Granted
|
|
|
147,710 |
|
|
$ |
32.41 |
|
Vested
|
|
|
(27,000 |
) |
|
$ |
23.44 |
|
Forfeited
|
|
|
(450 |
) |
|
$ |
32.41 |
|
|
|
|
|
|
|
|
Nonvested at December 31, 2005
|
|
|
212,260 |
|
|
$ |
29.65 |
|
|
|
|
|
|
|
|
The total fair value of restricted shares vested during the
Transition Period, the comparable 2004 six months and fiscal
2005 was $0.6 million, $0.4 million
(unaudited) and $0.4 million, respectively. No
restricted shares vested during fiscal 2004 or 2003.
F-17
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
See Note 18 for further discussion of the Companys
share-based employee compensation plans.
Shipping and Handling Costs
Substantially all costs of shipping and handling of products to
customers are included in selling, general and administrative
expense. Shipping and handling costs for the Transition Period,
the comparable 2004 six months, fiscal 2005, 2004 and 2003 were
approximately $1.4 million, $1.6 million (unaudited),
$3.1 million, $3.1 million and $3.5 million,
respectively.
Research and Development Costs and Accounting for Strategic
Collaborations
All research and development costs, including payments related
to products under development and research consulting
agreements, are expensed as incurred. The Company may continue
to make non-refundable payments to third parties for new
technologies and for research and development work that has been
completed. These payments may be expensed at the time of payment
depending on the nature of the payment made.
The Companys policy on accounting for costs of strategic
collaborations determines the timing of the recognition of
certain development costs. In addition, this policy determines
whether the cost is classified as development expense or
capitalized as an asset. Management is required to form
judgments with respect to the commercial status of such products
in determining whether development costs meet the criteria for
immediate expense or capitalization. For example, when the
Company acquires certain products for which there is already an
Abbreviated New Drug Application (ANDA) or a New
Drug Application (NDA) available, and there is net
realizable value based on projected sales for these products,
the Company capitalizes the amount paid as an intangible asset.
In addition, if the Company acquires product rights that are in
the development phase and as to which the Company has no
assurance that the third party is required to perform additional
research efforts, the Company expenses such payments.
Income Taxes
Income taxes are determined using an annual effective tax rate,
which is generally less than the U.S. Federal statutory
rate, primarily because of tax-exempt interest, charitable
contribution deductions and research and experimentation tax
credits available in the United States. The Companys
effective tax rate may be subject to fluctuations during the
fiscal year as new information is obtained which may affect the
assumptions it uses to estimate its annual effective tax rate,
including factors such as its mix of pre-tax earnings in the
various tax jurisdictions in which it operates, valuation
allowances against deferred tax assets, reserves for tax audit
issues and settlements, utilization of research and
experimentation tax credits and changes in tax laws in
jurisdictions where the Company conducts operations. The Company
recognizes deferred tax assets and liabilities for temporary
differences between the financial reporting basis and the tax
basis of its assets and liabilities. The Company records
valuation allowances against its deferred tax assets to reduce
the net carrying value to an amount that management believes is
more likely than not to be realized.
Legal Contingencies
In the ordinary course of business, the Company is involved in
legal proceedings involving contractual and employment
relationships, product liability claims, patent rights, and a
variety of other matters. The Company records contingent
liabilities resulting from asserted and unasserted claims
against it, when it is probable that a liability has been
incurred and the amount of the loss is reasonably estimable. The
Company discloses contingent liabilities when there is a
reasonable possibility that the ultimate loss will exceed the
recorded liability. Estimating probable losses requires analysis
of multiple factors, in some cases including judgments about the
potential actions of third-party claimants and courts.
Therefore, actual losses in any future period
F-18
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
are inherently uncertain. Currently, the Company does not
believe any of its pending legal proceedings or claims will have
a material impact on its financial position or results of
operations.
Foreign Currency Translations
The financial statements of foreign subsidiaries have been
translated into U.S. Dollars in accordance with
SFAS No. 52, Foreign Currency Translation. All
balance sheet accounts have been translated using the exchange
rates in effect at the balance sheet date. Income statement
amounts have been translated using the average exchange rate for
the year. The gains and losses resulting from the changes in
exchange rates from year to year have been reported in other
comprehensive income. The effect on the consolidated statements
of operations of transaction gains and losses is not material
for all years presented.
Earnings Per Common Share
Basic and diluted earnings per common share are calculated in
accordance with the requirements of Statement of Financial
Accounting Standards No. 128, Earnings Per
Share. Because the Company has Contingently Convertible
Debt (see Note 13), diluted net income per common share
must be calculated using the if-converted method in
accordance with
EITF 04-8,
Effect of Contingently Convertible Debt on Diluted
Earnings per Share. Diluted net income per common share is
calculated by adjusting net income for tax-effected net interest
and issue costs on the Contingent Convertible Debt, divided by
the weighted average number of common shares outstanding
assuming conversion. The Company adopted
EITF 04-8 during
fiscal 2005, all earnings per share amounts reflect the adoption
of EITF 04-8.
Use of Estimates and Risks and Uncertainties
The preparation of the consolidated financial statements in
conformity with U.S. generally accepted accounting
principles requires management to make estimates and assumptions
that affect the amounts reported in the consolidated financial
statements and accompanying notes. The accounting estimates that
require managements most significant, difficult and
subjective judgments include the assessment of recoverability of
long-lived assets; the recognition and measurement of current
and deferred income tax assets and liabilities; and the
reductions to revenue recorded at the time of sale for sales
returns. The actual results experienced by the company may
differ from managements estimates.
The Company purchases its inventory from third party
manufacturers, many of whom are the sole source of products for
the Company. The failure of such manufacturers to provide an
uninterrupted supply of products could adversely impact the
Companys ability to sell such products.
Fair Value of Financial Instruments
The carrying amount of cash and cash equivalents, short-term
investments, accounts receivable, accounts payable and accrued
liabilities reported in the consolidated balance sheets
approximates fair value because of the immediate or short-term
maturity of these financial instruments. The fair market value
of the Companys long-term debt is estimated based on
market quotations at year-end. The fair market value
approximates $472.2 million at December 31, 2005.
Supplemental Disclosure of Cash Flow Information
During the Transition Period, the comparable 2004 six months,
fiscal 2005, fiscal 2004 and fiscal 2003, the Company made
interest payments of $4.2 million, $4.2 million
(unaudited), $8.5 million, $8.8 million and
$10.0 million, respectively.
F-19
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Reclassifications
Certain prior year amounts have been reclassified to conform
with the current year presentation.
Recent Accounting Pronouncements
In October 2005, the FASB issued FASB Staff Position
(FSP)
No. 123R-2,
Practical Accommodation to the Application of Grant Date as
Defined in FASB Statement No. 123R, to provide guidance
on determining the grant date for an award as defined in
SFAS No. 123R. This FSP stipulates that assuming all
other criteria in the grant date definition are met, a mutual
understanding of the key terms and conditions of an award to an
individual employee is presumed to exist upon the awards
approval in accordance with the relevant corporate governance
requirements, provided that the key terms and conditions of an
award (a) cannot be negotiated by the recipient with the
employer because the award is a unilateral grant, and
(b) are expected to be communicated to an individual
recipient within a relatively short time period from the date of
approval. The Company has applied the principles set forth in
this FSP upon its adoption of SFAS No. 123R.
In November 2005, the FASB issued FSP
No. 123R-3,
Transition Election to Accounting for the Tax Effects of
Share-Based Payment Awards. This FSP requires an entity to
follow either the transition guidance for the
additional-paid-in-capital
pool as prescribed in SFAS No. 123R, or the
alternative transition method as described in the FSP. An entity
that adopts SFAS No. 123R using the modified
prospective application may make a one-time election to adopt
the transition method described in this FSP. This FSP became
effective in November 2005. The Company will continue to
evaluate the impact that the adoption of this FSP could have on
its financial statements as it has until one year from the later
of its initial adoption of SFAS No. 123R or the
effective date of this FSP to evaluate its available transition
alternatives and make its one-time election.
In December 2004, the FASB issued SFAS No. 153,
Exchanges of Nonmonetary Assets
(SFAS No. 153), an amendment of APB
Opinion No. 29 Accounting for Nonmonetary Transactions
(APB No. 29). SFAS No. 153
eliminates the exception from fair value measurement for
nonmonetary exchanges of similar productive assets in
paragraph 21 (b) of APB No. 29, and replaces it
with an exception for exchanges that do not have commercial
substance. SFAS No. 153 specifies that a nonmonetary
exchange has commercial substance if the future cash flows of
the entity are expected to change significantly as a result of
the exchange. SFAS No. 153 is effective for the fiscal
periods beginning after June 15, 2005 and we will adopt
this Statement in the first quarter of fiscal 2006. The Company
currently does not anticipate that the effects of the statement
will materially affect its consolidated financial position or
consolidated results of operations upon adoption.
In May 2005, the FASB issued SFAS No. 154,
Accounting Changes and Error Corrections A
Replacement of APB Opinion No. 20 and FASB Statement
No. 3 (SFAS No. 154).
SFAS No. 154 requires the retrospective application to
prior periods financial statements of changes in
accounting principle, unless it is impractical to determine
either the period-specific effects or cumulative effect of the
accounting change. SFAS No. 154 also requires that a
change in depreciation, amortization, or depletion method for
long-lived non-financial assets be accounted for as a change in
accounting estimate affected by a change in accounting
principle. SFAS No. 154 is affective for accounting
changes and corrections of errors made in fiscal years beginning
after December 15, 2005 and the Company will adopt this
provision, as applicable, during fiscal year 2006.
In November 2005, the FASB issued FSP
FAS 115-1 and
FAS 124-1, The
Meaning of Other-Than-Temporary Impairment and Its Application
to Certain Investments (FSP
115-1), which
provides guidance on determining when investments in certain
debt and equity securities are considered impaired, whether that
impairment is other-than-temporary, and on measuring such
impairment loss. FSP
115-1 also includes
accounting considerations subsequent to the recognition of
other-than temporary impairment and requires certain disclosures
about unrealized losses that have not been recognized as
other-than-temporary impair-
F-20
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
ments. FSP 115-1 is
required to be applied to reporting periods beginning after
December 15, 2005 and is required to be adopted by us in
the first quarter of fiscal 2006. The Company is currently
evaluating the effect that the adoption of FSP
115-1 will have on its
consolidated results of operations and financial condition but
does not expect it to have a material impact.
|
|
NOTE 3. |
CHANGE IN ESTIMATE |
Effective January 1, 2005, the Company changed the
estimated useful life for certain intangible assets related to
its merger with Ascent, based on managements determination
that these intangible assets appear to have shorter useful lives
than originally estimated. There is no cumulative effect for
this change. The effect of this change on net income for fiscal
2005 was to decrease net income by approximately
$1.1 million or $0.02 per diluted common share.
|
|
NOTE 4. |
SEGMENT AND PRODUCT INFORMATION |
The Company operates in one significant business segment:
Pharmaceuticals. The Companys current pharmaceutical
franchises are divided between the dermatological and
non-dermatological fields. The dermatological field represents
products for the treatment of acne and acne-related
dermatological conditions and non-acne dermatological
conditions. The non-dermatological field represents products for
the treatment of asthma (until May 2004), urea cycle disorder
and contract revenue. The acne and acne-related dermatological
product lines include core brands
DYNACIN®,
PLEXION®
and
TRIAZ®.
The non-acne dermatological product lines include core brands
LOPROX®,
OMNICEF®,
RESTYLANE®
and
VANOStm.
The non-dermatological product lines include
AMMONUL®,
BUPHENYL®
and
ORAPRED®.
ORAPRED®
was one of the Companys core brands until it was licensed
to BioMarin Pharmaceutical Inc. (BioMarin) in May
2004 (see Note 7). The non-dermatological field also
includes contract revenues associated with licensing agreements
and authorized generics.
The Companys pharmaceutical products, with the exception
of
AMMONUL®
and
BUPHENYL®,
are promoted to dermatologists, podiatrists and plastic
surgeons. Such products are often prescribed by physicians
outside these three specialties; including family practitioners,
general practitioners, primary-care physicians and OB/ GYNs, as
well as hospitals, government agencies and others. All products,
with the exception of
BUPHENYL®,
are sold primarily to wholesalers and retail chain drug stores.
BUPHENYL®
is primarily sold directly to hospitals and pharmacies. Prior to
the Companys licensing of
ORAPRED®
to BioMarin in May 2004, the Company also promoted its
pharmaceutical products to pediatricians. During the Transition
Period, the comparable 2004 six months, and the last three
fiscal years, four wholesalers accounted for the following
portions of the Companys net revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended | |
|
|
|
|
|
|
|
|
December 31, | |
|
|
|
|
|
|
|
|
| |
|
Fiscal | |
|
Fiscal | |
|
Fiscal | |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(Unaudited) | |
|
|
|
|
|
|
McKesson
|
|
|
54.9 |
% |
|
|
50.8 |
% |
|
|
51.2 |
% |
|
|
36.9 |
% |
|
|
20.2 |
% |
Cardinal
|
|
|
18.9 |
% |
|
|
19.7 |
% |
|
|
21.8 |
% |
|
|
23.8 |
% |
|
|
25.4 |
% |
Quality King
|
|
|
* |
|
|
|
* |
|
|
|
* |
|
|
|
* |
|
|
|
17.0 |
% |
AmerisourceBergen
|
|
|
* |
|
|
|
* |
|
|
|
* |
|
|
|
* |
|
|
|
15.5 |
% |
* less than 10%
McKesson is the sole distributor for the Companys
RESTYLANE®
products in the United States and Canada.
RESTYLANE®,
the Companys highest-selling product during the Transition
Period and fiscal 2005, was launched in the United States in
January 2004.
F-21
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The percentage of net revenues for each of the product
categories is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended | |
|
Fiscal Year Ended | |
|
|
December 31, | |
|
June 30, | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(Unaudited) | |
|
|
|
|
|
|
Acne and acne-related dermatological products
|
|
|
28 |
% |
|
|
33 |
% |
|
|
30 |
% |
|
|
30 |
% |
|
|
33 |
% |
Non-acne dermatological products
|
|
|
59 |
|
|
|
44 |
|
|
|
47 |
|
|
|
51 |
|
|
|
37 |
|
Non-dermatological products
|
|
|
13 |
|
|
|
23 |
|
|
|
23 |
|
|
|
19 |
|
|
|
30 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total net revenues
|
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
100 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 5. |
STRATEGIC COLLABORATIONS |
On September 26, 2002, Medicis entered into an exclusive
license and development agreement with Dow Pharmaceutical
Sciences, Inc. (Dow) for the development and
commercialization of a patented dermatologic product. Under
terms of the agreement, as amended, Medicis made an initial
payment of $5.4 million and a development milestone payment
of $8.8 million to Dow during fiscal 2003, a development
milestone payment of $2.4 million to Dow during fiscal
2004, and development milestone payments totaling
$11.9 million during the Transition Period. In accordance
with the agreement between the parties, Medicis is required to
make a potential additional payment of $1.0 million upon
the certification that a certain development milestone has
occurred. All payments were recorded as charges to research and
development expense in the periods in which the milestones were
achieved.
On June 26, 2002, Medicis entered into an exclusive
strategic alliance with aaiPharma, Inc. (aaiPharma)
for the development, commercialization and license of a key
dermatologic product. Medicis made an initial payment of
$7.7 million to aaiPharma during fiscal 2002, a development
milestone payment of $6.0 million during fiscal 2003, and
had potential additional payments to be made to aaiPharma upon
the successful completion of various development milestones. The
$7.7 million initial payment and the $6.0 million
development milestone payment were recorded as charges to
research and development expense during fiscal 2002 and fiscal
2003, respectively. On January 28, 2005, the Company
amended its strategic alliance with aaiPharma. The consummation
of the amendment has not affected the timing of the development
project. The amendment allowed for the immediate transfer of the
work product as defined under the agreement, as well as the
products management and development, to Medicis, and
provides that aaiPharma will continue to assist Medicis with the
development of the product on a fee for services basis. Medicis
will have no future financial obligations to pay aaiPharma on
the attainment of clinical milestones, but incurred
approximately $8.3 million as a charge to research and
development expense during the third quarter of fiscal 2005, as
part of the amendment and the assumption of all liabilities
associated with the project.
In addition to the amendment, Medicis entered into a supply
agreement with aaiPharma for the eventual manufacture of the
product by aaiPharma under certain conditions. Medicis has the
right to qualify an alternate manufacturing facility, and
aaiPharma agreed to assist Medicis in obtaining these
qualifications. Upon the approval of the alternate facility and
approval of the product, Medicis will pay aaiPharma
approximately $1 million.
On December 13, 2004, the Company entered into an exclusive
development and license agreement and other ancillary agreements
with Ansata Therapeutics, Inc. (Ansata). The
development and license agreement grants Medicis the exclusive,
worldwide rights to Ansatas early stage, proprietary
antimicrobial peptide technology. In accordance with the
development and license agreement, Medicis paid $5 million
upon signing of the contract and will pay approximately
$9 million upon the successful completion of certain
developmental milestones. Should Medicis continue with the
development of this technology, the Company will incur
additional milestone payments beyond the development and license
agreement. The initial
F-22
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
$5 million payment was recorded as a charge to research and
development expense during the second quarter of fiscal 2005.
The Company also incurred approximately $0.5 million of
professional fees related to the completion of the agreements,
which was included in selling, general and administrative
expenses during the second quarter of fiscal 2005. In addition,
the Company entered into an Option Agreement with Ansata where
Medicis has the option to acquire Ansata or certain assets of
Ansata if certain financial conditions are present.
On April 19, 1999, the Company acquired 100% of the common
stock of Ucyclyd Pharma, Inc. (Ucyclyd), a privately
held pharmaceutical company based in Baltimore, Maryland, for
net cash of approximately $14.3 million. Ucyclyds
primary products,
BUPHENYL®
and
AMMONUL®,
are indicated in the treatment of Urea Cycle Disorder. Under
terms of the agreement, the Company paid $15.1 million on
April 19, 1999, and paid an additional $5.7 million in
contingent payments in April 2000. In November 2004, the Company
paid $2.7 million to the former shareholders of Ucyclyd as
the final contractual purchase price payment. This
$2.7 million payment was recorded as an addition to the
original Ucyclyd intangible asset in the Companys
consolidated balance sheets.
On July 15, 2004, the Company entered into an exclusive
license agreement and other ancillary documents with
Q-Med to market,
distribute, sell and commercialize in the United States and
Canada Q-Meds
product currently known as
SubQtm.
Q-Med has the exclusive right to manufacture
SubQtm
for Medicis.
SubQtm
is currently not approved for use in the United States or
Canada. Under terms of the license agreement, Medicis Aesthetics
Holdings Inc., a wholly owned subsidiary of Medicis, licenses
SubQtm
for approximately $80 million, due as follows:
approximately $30 million on July 15, 2004, which was
recorded as a charge to research and development expense during
the first quarter of fiscal 2005; approximately $10 million
upon completion of certain clinical milestones; approximately
$20 million upon satisfaction of certain defined regulatory
milestones; and approximately $20 million upon
U.S. launch of
SubQtm.
In addition, the Company incurred approximately
$0.7 million of professional fees related to the completion
of the agreements during the first quarter of fiscal 2005, which
was included in selling, general and administrative expenses.
The Company also will make additional milestone payments to
Q-Med upon the achievement of certain commercial milestones.
|
|
NOTE 6. |
TERMINATION OF DEFINITIVE MERGER AGREEMENT WITH INAMED
CORPORATION |
On March 20, 2005, Medicis and Inamed Corporation
(Inamed) entered into an Agreement and Plan of
Merger (the Agreement). Inamed is a global
healthcare company that develops, manufactures, and markets
breast implants for aesthetic augmentation and reconstructive
surgery following a mastectomy, a range of dermal products to
correct facial wrinkles, the
BioEnterics®
LAP-BAND®
System designed to treat severe and morbid obesity, and the
BioEnterics®
Intragastric Balloon
(BIB®)
system for the treatment of obesity. Under the terms of the
Agreement, Inamed was to merge with and into a subsidiary of
Medicis and each share of Inamed common stock would have been
converted into the right to receive 1.4205 shares of
Medicis common stock and $30.00 in cash. The completion of the
transaction was subject to several customary conditions,
including the receipt of applicable approvals from Medicis
and Inameds stockholders, the absence of any material
adverse effect on either partys business and the receipt
of regulatory approvals.
On December 13, 2005, the Company entered into a merger
termination agreement with Inamed following Allergan Inc.s
exchange offer for all outstanding shares of Inamed, which was
commenced on November 21, 2005, pursuant to which Medicis
and Inamed agreed to terminate the Agreement. In accordance with
the terms of the Agreement and the merger termination agreement,
Inamed paid Medicis a termination fee of $90.0 million,
plus $0.5 million in expense reimbursement fees on
December 13, 2005.
From the inception of the proposed transaction with Inamed
through the termination of the Agreement, the Company had
incurred approximately $14.0 million of professional and
other costs related to the transaction. These costs, which were
maintained in other long-term assets in our consolidated balance
sheet
F-23
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
during the transaction approval process, were expensed upon
termination of the Agreement. As a result of the termination,
the Company was required to pay Deutsche Bank Trust Company
Americas (Deutsche Bank) a fee pursuant to a
provision in Deutsche Banks merger engagement letter
whereby Deutsche Bank was entitled to a portion of the
termination fee. This fee is included in accounts payable in the
Companys consolidated balance sheets as of
December 31, 2005. The Company also incurred business
integration costs related to the transaction, including the
planning for and implementation of integration activities. These
costs were expensed as incurred. During the Transition Period,
the Company incurred approximately $4.4 million of business
integration planning costs. These costs were primarily
consulting and other professional fees.
During the Transition Period, the Company recognized a net
benefit related to the above items of approximately
$59.1 million. This is summarized as follows (in millions):
|
|
|
|
|
Termination fee received from Inamed, including expense
reimbursement fees
|
|
$ |
90.5 |
|
Less:
|
|
|
|
|
Transaction costs expensed, including legal and advisory fees
|
|
|
27.0 |
|
Integration planning costs
|
|
|
4.4 |
|
|
|
|
|
|
|
$ |
59.1 |
|
|
|
|
|
Approximately $0.7 million of the integration planning
costs, incurred during the three months ended September 30,
2005, were classified as selling, general and administrative
expenses during the Transition Period. Approximately
$59.8 million of the net benefit related to the above
items, including $3.7 million of integration planning costs
incurred during the three months ended December 31, 2005,
was classified as other income, net, during the Transition
Period.
The total net benefit recognized by the Company from the
inception of the proposed transaction through the termination of
the Agreement was approximately $53.8 million. This
includes the $59.1 million benefit recognized during the
Transition Period, partially offset by approximately
$5.3 million of integration planning costs incurred during
the three months ended June 30, 2005.
|
|
NOTE 7. |
LICENSE OF
ORAPRED®
TO BIOMARIN |
On May 18, 2004, the Company closed an asset purchase
agreement and license agreement and executed a securities
purchase agreement with BioMarin. The asset purchase agreement
involves BioMarins purchase of assets related to
ORAPRED®,
including assets concerning the Ascent field sales force.
ORAPRED®
and related pediatric intellectual property is owned by Ascent,
a wholly owned subsidiary of Medicis. The license agreement
granted BioMarin, among other things, the exclusive worldwide
rights to
ORAPRED®.
The securities purchase agreement granted BioMarin the option to
purchase all outstanding shares of common stock of Ascent, based
on certain conditions. As part of the transaction, the name of
Ascent Pediatrics, Inc. was changed to Medicis Pediatrics, Inc.
Under terms of the original agreements, BioMarin was to make
license payments to Ascent of approximately $93 million
payable over a five-year period as follows: approximately
$10 million as of the date of the transaction;
approximately $12.5 million per quarter for four quarters
beginning in July 2004; approximately $2.5 million per
quarter for the subsequent four quarters beginning in July 2005;
approximately $2 million per quarter for the subsequent
eight quarters beginning in July 2006; and approximately
$1.75 million per quarter for the last four quarters of the
five-year period beginning in July 2008. BioMarin was also to
make payments of $2.5 million per quarter for six quarters
beginning in July 2004 for reimbursement of certain contingent
payments as discussed in Note 10. The license agreement
will terminate in July 2009. At that time, based on certain
conditions, BioMarin would have the option to purchase all
outstanding shares of Ascent for approximately $82 million.
The payment was to consist of $62 million in cash and
$20 million in BioMarin common stock, based on the fair
value of the stock at that time. The Company
F-24
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
was responsible for the manufacture and delivery of finished
goods inventory to BioMarin, and BioMarin was responsible for
paying the Company for finished goods inventory delivered
through June 30, 2005. As a result, the Company was
required to recognize the first $60 million of license
payments ratably through June 30, 2005. The license
payments received after June 30, 2005 and the reimbursement
of contingent payments will be recognized as revenue when all
four criteria of SAB 104 have been met.
As of the closing date of the transaction, BioMarin is
responsible for all marketing and promotional efforts regarding
the sale of
ORAPRED®.
As a result, Medicis no longer advertises and promotes any oral
liquid prednisolone sodium phosphate solution product or any
related line extension. During the term of the license
agreement, Medicis will maintain ownership of the intellectual
property and, consequently, will continue to amortize the
related intangible assets. Payments received from BioMarin under
the license agreement will be treated as contract revenue, which
is included in net revenues in the consolidated statements of
income.
On January 12, 2005, BioMarin and the Company entered into
amendments to the Securities Purchase Agreement and License
Agreement entered into on May 18, 2004, a Convertible
Promissory Note (the Convertible Note) and a
Settlement and Mutual Release Agreement (collectively the
Agreements). Under the terms of the Agreements,
transaction payments from BioMarin to Medicis previously
totaling $175 million were reduced to $159 million.
Beginning with license payments relating to
ORAPRED®
to be made by BioMarin after July 2005, license payments
totaling $93 million were reduced pro rata to
$88.4 million. Consideration to be received by Medicis from
BioMarin in 2009 for the option relating to the purchase of all
outstanding shares of Ascent Pediatrics were reduced from
$82 million to $70.6 million. Medicis will take full
financial responsibility for contingent payments due to former
Ascent Pediatric shareholders without the $5 million in
offset payments that would have been paid by BioMarin to Medicis
after July 1, 2005. Contingent payments are due to former
Ascent Pediatric shareholders from Medicis only if revenue from
Ascent Pediatric products exceeds certain thresholds. In
addition, Medicis reimbursed BioMarin for actual returns, up to
certain agreed-upon limits, of
ORAPRED®
finished goods received by BioMarin during the quarters ended
December 31, 2004, March 31, 2005 and June 30,
2005.
Additionally, per the terms of the Agreements, Medicis has made
available to BioMarin the ability to draw down on a Convertible
Note up to $25 million beginning July 1, 2005. The
Convertible Note is convertible based on certain terms and
conditions including a change of control provision. Money
advanced under the Convertible Note is convertible into BioMarin
shares at a strike price equal to the BioMarin average closing
price for the 20 trading days prior to such advance. The
Convertible Note matures on the option purchase date in 2009 as
defined in the Securities Purchase Agreement but may be repaid
by BioMarin at any time prior to the option purchase date. No
monies have been advanced
to-date. In conjunction
with the Agreements, BioMarin and Medicis have entered into a
settlement and Mutual Release Agreement to forever discharge
each other from any and all claims, demands, damages, debts,
liabilities, actions and causes of action relating to the
transaction consummated by the parties other than certain
continuing obligations in accordance with the terms of the
parties agreements. As of December 31, 2005, BioMarin
had paid $74.2 million to Medicis under the license
agreement, which represents all scheduled payments due through
that date under the license agreement.
|
|
NOTE 8. |
ACQUISITION OF DERMAL AESTHETIC ENHANCEMENT PRODUCTS FROM THE
Q-MED GROUP |
On March 10, 2003, Medicis acquired all outstanding shares
of HA North American Sales AB from
Q-Med, a Swedish
biotechnology/medical device company. HA North American Sales AB
holds a license for the exclusive U.S. and Canadian rights to
market, distribute and commercialize the dermal restorative
product lines known as
RESTYLANE®,
PERLANEtm
and RESTYLANE FINE
LINEStm.
RESTYLANE®
has been approved by the FDA for use in the
U.S. RESTYLANE®,
PERLANEtm
and RESTYLANE FINE
F-25
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
LINEStm
have been approved for use in Canada. Under terms of the
agreements, a wholly owned subsidiary of Medicis acquired all
outstanding shares of HA North American Sales AB for total
consideration of approximately $160.0 million, payable upon
the successful completion of certain milestones or events.
Medicis paid $58.2 million upon closing of the transaction,
$53.3 million in December 2003 upon FDA approval of
RESTYLANE®,
$19.4 million in May 2004 upon certain cumulative
commercial milestones being achieved and will pay approximately
$29.1 million upon FDA approval of
PERLANEtm.
Payments and costs related to this acquisition are capitalized
as an intangible asset and are amortized over 15 years
beginning in March 2003.
|
|
NOTE 9. |
LICENSE AND SALE OF PRODUCTS TO TARO PHARMACEUTICAL
INDUSTRIES, LTD. |
On July 27, 2004, the Company entered into an exclusive
license and optional purchase agreement with Taro Pharmaceutical
Industries, Inc. (Taro) pursuant to which Taro will
market, distribute and sell the
LUSTRA®
family of products and two development stage products in the
U.S., Canada and Puerto Rico. The
LUSTRA®
family of products are topical therapies prescribed for the
treatment of ultraviolet-induced skin discolorations and
hyperpigmentation usually associated with the use of oral
contraceptives, pregnancy, hormone replacement therapy, sun
damage and superficial trauma. The license agreement extends
through July 1, 2007, after which Taro may purchase the
product lines.
On January 14, 2003, Taro licensed with an option to
purchase from Medicis four branded prescription product lines
for sale in the U.S. and Puerto Rico. The license agreement was
effective on January 14, 2003 and extended through
June 1, 2004, after which Taro had the option to purchase
the product lines. Medicis received quarterly license payments
from Taro during the term of the agreement. Under terms of the
agreement, Taro licensed from Medicis the following four brands:
TOPICORT®
(desoximetasone), a topical corticosteroid used for inflammatory
skin diseases; A/ T/
S®
(erythromycin), a topical antibiotic used in the treatment of
acne;
OVIDE®
(malathion), a pediculicide used in the treatment of head lice;
and
PRIMSOL®
(trimethoprim HCI), an antibiotic oral solution for children
with acute otitis media, or middle ear infections. Taro
purchased the product lines at the end of the term of the
agreement for $12.1 million. The carrying value of the
intangible assets related to these products was written off as
of the sale date, and a loss of approximately $32,000 was
recognized during fiscal 2004 and is included in selling,
general and administrative expenses in the accompanying
consolidated statements of income. The Company additionally
incurred approximately $350,000 of professional fees related to
the transaction.
|
|
NOTE 10. |
MERGER OF ASCENT PEDIATRICS, INC. |
As part of its merger with Ascent completed in November 2001,
the Company may be required to make contingent purchase price
payments (Contingent Payments) for each of the first
five years following closing based upon reaching certain sales
threshold milestones on the Ascent products for each twelve
month period through November 15, 2006, subject to certain
deductions and set-offs. From time to time the Company assesses
the probability and likelihood of payment in the coming
respective November period based on current sales trends. There
can be no assurance that such payment will ultimately be made
nor is the accrual of a liability an indication of current sales
levels. A total of approximately $27.4 million is included
in short-term contract obligation in the Companys
consolidated balance sheets as of December 31, 2005,
representing the first four years Contingent Payments.
Pursuant to the merger agreement, payment of the contingent
portion of the purchase price was withheld pending the final
outcome of certain pending litigation. The Company is in the
process of distributing the accumulated Contingent Payments to
the former shareholders of Ascent as the pending litigation
matter has concluded.
F-26
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
NOTE 11. |
SHORT-TERM INVESTMENTS |
The Companys short-term investments are intended to
establish a high-quality portfolio that preserves principal,
meets liquidity needs, avoids inappropriate concentrations and
delivers an appropriate yield in relationship to the
Companys investment guidelines and market conditions.
Short-term investments consist of corporate and various
government agency and municipal debt securities. Management
classifies the Companys short-term investments as
available-for-sale. Available-for-sale securities are carried at
fair value with unrealized gains and losses reported in
stockholders equity. Realized gains and losses and
declines in value judged to be other than temporary, if any, are
included in operations. A decline in the market value of any
available-for-sale security below cost that is deemed to be
other than temporary, results in an impairment in the fair value
of the investment. The impairment is charged to earnings and a
new cost basis for the security is established. Premiums and
discounts are amortized or accreted over the life of the related
available-for-sale security. Dividend and interest income are
recognized when earned. The cost of security sold is calculated
using the specific identification method. The following is a
summary of available-for-sale securities (amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 | |
|
|
| |
|
|
|
|
Gross | |
|
Gross | |
|
Gross | |
|
|
|
|
Unrealized | |
|
Unrealized | |
|
Fair | |
|
|
Cost | |
|
Gains | |
|
Losses | |
|
Value | |
|
|
| |
|
| |
|
| |
|
| |
U.S. corporate securities
|
|
$ |
73,398 |
|
|
$ |
92 |
|
|
$ |
274 |
|
|
$ |
73,216 |
|
Other debt securities
|
|
|
222,736 |
|
|
|
2 |
|
|
|
419 |
|
|
|
222,319 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities
|
|
$ |
296,134 |
|
|
$ |
94 |
|
|
$ |
693 |
|
|
$ |
295,535 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2005 | |
|
|
| |
|
|
|
|
Gross | |
|
Gross | |
|
Gross | |
|
|
|
|
Unrealized | |
|
Unrealized | |
|
Fair | |
|
|
Cost | |
|
Gains | |
|
Losses | |
|
Value | |
|
|
| |
|
| |
|
| |
|
| |
U.S. corporate securities
|
|
$ |
144,017 |
|
|
$ |
20 |
|
|
$ |
476 |
|
|
$ |
143,561 |
|
Other debt securities
|
|
|
283,372 |
|
|
|
7 |
|
|
|
1,157 |
|
|
|
282,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities
|
|
$ |
427,389 |
|
|
$ |
27 |
|
|
$ |
1,633 |
|
|
$ |
425,783 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2004 | |
|
|
| |
|
|
|
|
Gross | |
|
Gross | |
|
Gross | |
|
|
|
|
Unrealized | |
|
Unrealized | |
|
Fair | |
|
|
Cost | |
|
Gains | |
|
Losses | |
|
Value | |
|
|
| |
|
| |
|
| |
|
| |
U.S. corporate securities
|
|
$ |
123,848 |
|
|
$ |
224 |
|
|
$ |
360 |
|
|
$ |
123,712 |
|
Other debt securities
|
|
|
465,070 |
|
|
|
164 |
|
|
|
1,527 |
|
|
|
463,707 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total securities
|
|
$ |
588,918 |
|
|
$ |
388 |
|
|
$ |
1,887 |
|
|
$ |
587,419 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Companys unrealized losses were due to fluctuations in
interest rates. The Company does not believe any of the
unrealized losses represented an other-than-temporary impairment
based on its evaluation of available evidence as of
December 31, 2005.
During the Transition Period, the comparable six month period in
2004, fiscal 2005 and fiscal 2004, the gross realized gains on
sales of available-for-sale securities totaled $658, $217,361
(unaudited), $231,766 and $1,360,154, respectively, and the
gross realized losses totaled $599,200, $320,382 (unaudited),
$1,117,366 and $236,427, respectively. Such amounts of gains and
losses are determined based on the specific identification
method. The net adjustment to unrealized gains during the
Transition Period, the comparable six month period in 2004,
fiscal 2005 and fiscal 2004 on available-for-sale securities
included in stockholders equity
F-27
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
totaled $636,777, $(107,204) (unaudited), $(75,721) and
$(3,451,343), respectively. The amortized cost and estimated
fair value of the available-for-sale securities at
December 31, 2005, by maturity, are shown below (amounts in
thousands). 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.
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 | |
|
|
| |
|
|
|
|
Estimated | |
|
|
Cost | |
|
Fair Value | |
|
|
| |
|
| |
Available-for-sale
|
|
|
|
|
|
|
|
|
|
Due in one year or less
|
|
$ |
99,662 |
|
|
$ |
99,192 |
|
|
Due after one year through five years
|
|
|
29,123 |
|
|
|
28,993 |
|
|
Due after five years through 10 years
|
|
|
4,000 |
|
|
|
4,000 |
|
|
Due after 10 years
|
|
|
163,348 |
|
|
|
163,350 |
|
|
|
|
|
|
|
|
|
|
$ |
296,133 |
|
|
$ |
295,535 |
|
|
|
|
|
|
|
|
The Company has a revolving line of credit facility of up to
$25.0 million from Wells Fargo Bank, N.A. The facility may
be drawn upon by the Company, at its discretion, and is
collateralized by certain short-term investments. The
outstanding balance of the credit facility bears interest at a
floating rate of 150 basis points in excess of the
30-day London Interbank
Offered Rate and expires in November 2006. The agreement
requires the Company to comply with certain covenants, including
covenants relating to the Companys financial condition and
results of operation; we are in compliance with such covenants.
The Company has never drawn on this credit facility.
|
|
NOTE 13. |
CONTINGENT CONVERTIBLE SENIOR NOTES |
In June 2002, the Company sold $400.0 million aggregate
principal amount of its 2.5% Contingent Convertible Notes Due
2032 (the Old Notes) in private transactions. As
discussed below, approximately $230.8 million in principal
amount of the Old Notes was exchanged for New Notes on
August 14, 2003. The Old Notes bear interest at a rate of
2.5% per annum, which is payable on June 4 and December 4
of each year, beginning on December 4, 2002. The Company
also agreed to pay contingent interest at a rate equal to
0.5% per annum during any six-month period, with the
initial six-month period commencing June 4, 2007, if the
average trading price of the Old Notes reaches certain
thresholds. The Old Notes will mature on June 4, 2032.
The Company may redeem some or all of the Old Notes at any time
on or after June 11, 2007, at a redemption price, payable
in cash, of 100% of the principal amount of the Old Notes, plus
accrued and unpaid interest, including contingent interest, if
any. Holders of the Old Notes may require the Company to
repurchase all or a portion of their Old Notes on June 4,
2007, 2012 and 2017, or upon a change in control, as defined in
the indenture governing the Old Notes, at 100% of the principal
amount of the Old Notes, plus accrued and unpaid interest to the
date of the repurchase, payable in cash.
The Old Notes are convertible, at the holders option,
prior to the maturity date into shares of the Companys
Class A common stock in the following circumstances:
|
|
|
|
|
during any quarter commencing after June 30, 2002, if the
closing price of the Companys Class A common stock
over a specified number of trading days during the previous
quarter, including the last trading day of such quarter, is more
than 110% of the conversion price of the Old Notes, or $31.96.
The Old Notes are initially convertible at a conversion price of
$29.05 per share, which is equal to a |
F-28
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
|
|
conversion rate of approximately 34.4234 shares per $1,000
principal amount of Old Notes, subject to adjustment; |
|
|
|
if the Company has called the Old Notes for redemption; |
|
|
|
during the five trading day period immediately following any
nine consecutive day trading period in which the trading price
of the Old Notes per $1,000 principal amount for each day of
such period was less than 95% of the product of the closing sale
price of the Companys Class A common stock on that
day multiplied by the number of shares of the Companys
Class A common stock issuable upon conversion of $1,000
principal amount of the Old Notes; or |
|
|
|
upon the occurrence of specified corporate transactions. |
The Old Notes, which are unsecured, do not contain any
restrictions on the payment of dividends, the incurrence of
additional indebtedness or the repurchase of the Companys
securities and do not contain any financial covenants.
The Company incurred $12.6 million of fees and other
origination costs related to the issuance of the Old Notes. The
Company is amortizing these costs over the five-year Put period,
which runs through May 2007. The Put period runs from the date
the Old Notes were issued to the date the Company may redeem
some or all of the Old Notes.
On August 14, 2003, the Company exchanged approximately
$230.8 million in principal amount of its Old Notes for
approximately $283.9 million in principal amount of its
1.5% Contingent Convertible Senior Notes Due 2033 (the New
Notes). Holders of Old Notes that accepted the
Companys exchange offer received $1,230 in principal
amount of New Notes for each $1,000 in principal amount of Old
Notes. The terms of the New Notes are similar to the terms of
the Old Notes, but have a different interest rate, conversion
rate and maturity date. Holders of Old Notes that chose not to
exchange continue to be subject to the terms of the Old Notes.
The New Notes bear interest at a rate of 1.5% per annum,
which is payable on June 4 and December 4 of each year,
beginning December 4, 2003. The Company will also pay
contingent interest at a rate of 0.5% per annum during any
six-month period, with the initial six-month period commencing
June 4, 2008, if the average trading price of the New Notes
reaches certain thresholds. The New Notes mature on June 4,
2033.
The Company may redeem some or all of the New Notes at any time
on or after June 11, 2008, at a redemption price, payable
in cash, of 100% of the principal amount of the New Notes, plus
accrued and unpaid interest, including contingent interest, if
any. Holders of the New Notes may require the Company to
repurchase all or a portion of their New Notes on June 4,
2008, 2013 and 2018, or upon a change in control, as defined in
the indenture governing the New Notes, at 100% of the principal
amount of the New Notes, plus accrued and unpaid interest to the
date of the repurchase, payable in cash.
The New Notes are convertible, at the holders option,
prior to the maturity date into shares of the Companys
Class A common stock in the following circumstances:
|
|
|
|
|
during any quarter commencing after September 30, 2003, if
the closing price of the Companys Class A common
stock over a specified number of trading days during the
previous quarter, including the last trading day of such
quarter, is more than 120% of the conversion price of the New
Notes, or $46.51. The Notes are initially convertible at a
conversion price of $38.76 per share, which is equal to a
conversion rate of approximately 25.7998 shares per $1,000
principal amount of New Notes, subject to adjustment; |
|
|
|
if the Company has called the New Notes for redemption; |
F-29
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
|
|
during the five trading day period immediately following any
nine consecutive day trading period in which the trading price
of the New Notes per $1,000 principal amount for each day of
such period was less than 95% of the product of the closing sale
price of the Companys Class A common stock on that
day multiplied by the number of shares of the Companys
Class A common stock issuable upon conversion of $1,000
principal amount of the New Notes; or |
|
|
|
upon the occurrence of specified corporate transactions. |
The New Notes, which are unsecured, do not contain any
restrictions on the incurrence of additional indebtedness or the
repurchase of the Companys securities and do not contain
any financial covenants. The New Notes require an adjustment to
the conversion price if the cumulative aggregate of all current
and prior dividend increases above $0.025 per share would
result in at least a one percent (1%) increase in the conversion
price. This threshold has not been reached and no adjustment to
the conversion price has been made.
As a result of the exchange, the outstanding principal amounts
of the Old Notes and the New Notes were $169.2 million and
$283.9 million, respectively. Both the New Notes and Old
Notes are reported in aggregate on the Companys
consolidated balance sheets. The Company incurred approximately
$5.1 million of fees and other origination costs related to
the issuance of the New Notes. The Company is amortizing these
costs over the five-year Put period, which runs through August
2008. The Put period runs from the date the New Notes were
issued to the date the Company may redeem some or all of the New
Notes.
During the quarters ended December 31, 2005,
September 30, 2005, December 31, 2004,
September 30, 2004, June 30, 2004, March 31, 2004
and December 31, 2003, the Old Notes met the criteria for
the right of conversion into shares of the Companys
Class A common stock. This right of conversion of the
holders of Old Notes was triggered by the stock closing above
$31.96 on 20 of the last 30 trading days and the last trading
day of the quarters ended December 31, 2005,
September 30, 2005, December 31, 2004,
September 30, 2004, June 30, 2004, March 31, 2004
and December 31, 2003. The holders of Old Notes have this
conversion right only until March 31, 2006. During the
quarters ended June 30, 2005 and March 31, 2005, the
Old Notes did not meet the criteria for the right of conversion.
At the end of all future quarters, the conversion rights will be
reassessed in accordance with the bond indenture agreement to
determine if the conversion trigger rights have been achieved.
During the three months ended September 30, 2004 and
March 31, 2004, outstanding principal amounts of $2,000 and
$6,000 of Old Notes, respectively, were converted into shares of
the Companys Class A common stock. As of
March 10, 2006, no other Old Notes have been converted.
|
|
NOTE 14. |
COMMITMENTS AND CONTINGENCIES |
The Company presently occupies approximately 75,000 square
feet of office space in Scottsdale, Arizona, at an average
annual expense of approximately $2.1 million, under an
amended lease agreement that expires in December 2010. The lease
contains certain rent escalation clauses and, upon expiration,
can be renewed for two additional periods of five years each.
Rent expense was approximately $1.2 million,
$1.1 million (unaudited), $2.3 million,
$2.1 million and $1.5 million for the Transition
Period, the comparable 2004 six months, fiscal 2005, 2004 and
2003, respectively. Medicis Aesthetics Canada Ltd., a wholly
owned subsidiary, presently leases approximately
3,600 square feet of office space in Toronto, Ontario,
Canada, under a lease agreement that expires in February 2008.
F-30
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
At December 31, 2005, approximate future lease payments
under the operating lease are as follows (amounts in thousands):
|
|
|
|
|
Year Ending December 31, |
|
|
|
|
|
2006
|
|
$ |
2,112 |
|
2007
|
|
|
2,079 |
|
2008
|
|
|
2,138 |
|
2009
|
|
|
2,138 |
|
2010
|
|
|
2,138 |
|
|
|
|
|
|
|
$ |
10,605 |
|
|
|
|
|
|
|
|
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, 2005, 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.
In the ordinary course of business, the Company is involved in a
number of other legal actions, both as plaintiff and defendant,
and could incur uninsured liability in any one or more of them.
Although the outcome of these actions is not presently
determinable, it is the opinion of the Companys
management, based upon the information available at this time,
that the expected outcome of these matters, individually or in
the aggregate, will not have a material adverse effect on the
results of operations or financial condition of the Company.
The provision for income taxes consists of the following
(amounts in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended | |
|
|
|
|
December 31, | |
|
Year Ended June 30, | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(Unaudited) | |
|
|
|
|
|
|
Current
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$ |
26,780 |
|
|
$ |
13,392 |
|
|
$ |
27,516 |
|
|
$ |
15,831 |
|
|
$ |
17,123 |
|
|
State
|
|
|
1,543 |
|
|
|
822 |
|
|
|
1,215 |
|
|
|
861 |
|
|
|
1,305 |
|
|
Foreign
|
|
|
750 |
|
|
|
110 |
|
|
|
156 |
|
|
|
109 |
|
|
|
14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
29,073 |
|
|
|
14,324 |
|
|
|
28,887 |
|
|
|
16,801 |
|
|
|
18,442 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
|
1,366 |
|
|
|
(2,854 |
) |
|
|
4,456 |
|
|
|
(1,404 |
) |
|
|
7,532 |
|
|
State
|
|
|
45 |
|
|
|
(142 |
) |
|
|
787 |
|
|
|
(80 |
) |
|
|
430 |
|
|
Foreign
|
|
|
18 |
|
|
|
|
|
|
|
(18 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,429 |
|
|
|
(2,996 |
) |
|
|
5,225 |
|
|
|
(1,484 |
) |
|
|
7,962 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
30,502 |
|
|
$ |
11,328 |
|
|
$ |
34,112 |
|
|
$ |
15,317 |
|
|
$ |
26,404 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-31
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Current income tax expense does not reflect benefit of
$0.1 million, $5.1 million (unaudited),
$5.1 million, $20.4 million and $3.4 million for
the Transition Period, the comparable 2004 six months, fiscal
2005, fiscal 2004, and fiscal 2003, respectively, related to the
vesting of restricted stock and exercise of employee stock
options recorded directly to Additional
paid-in-capital
in the Companys consolidated statements of
stockholders equity. During the Transition Period, the
Company reduced Additional
paid-in-capital
by $5.7 million to properly record the amount of excess tax
benefits attributable to the prior fiscal years.
Additionally, current income tax expense does not reflect
benefits of $1.6 million resulting from interest imputed on
the contingent consideration to be paid to the former
shareholders of Ascent in connection with the merger of Ascent
during fiscal 2002. The imputed interest deducted for tax
purposes reduces the fair value of the recorded contingent
consideration. As such, the Company made a corresponding
reduction to Ascent goodwill of $1.6 million.
The reconciliations of the U.S. federal statutory rate to
the combined effective tax rate are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended | |
|
Year Ended | |
|
|
December 31, | |
|
June 30, | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(Unaudited) | |
|
|
|
|
|
|
Statutory federal income tax rate
|
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
|
|
35.0 |
% |
State tax rate, net of federal benefit
|
|
|
1.3 |
|
|
|
1.4 |
|
|
|
1.4 |
|
|
|
1.1 |
|
|
|
1.5 |
|
Share-based payments
|
|
|
1.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax-exempt interest
|
|
|
|
|
|
|
(2.4 |
) |
|
|
(1.0 |
) |
|
|
(4.2 |
) |
|
|
(2.1 |
) |
Other
|
|
|
0.1 |
|
|
|
0.8 |
|
|
|
(1.0 |
) |
|
|
1.3 |
|
|
|
(0.4 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
38.0 |
% |
|
|
34.8 |
% |
|
|
34.4 |
% |
|
|
33.2 |
% |
|
|
34.0 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-32
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
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):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, | |
|
|
|
|
|
|
| |
|
|
December 31, 2005 | |
|
2005 | |
|
2004 | |
|
|
| |
|
| |
|
| |
|
|
Current | |
|
Long-term | |
|
Current | |
|
Long-term | |
|
Current | |
|
Long-term | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
Deferred tax assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards
|
|
$ |
|
|
|
$ |
22,584 |
|
|
$ |
|
|
|
$ |
23,161 |
|
|
$ |
|
|
|
$ |
25,691 |
|
|
Reserves and liabilities
|
|
|
11,810 |
|
|
|
|
|
|
|
10,415 |
|
|
|
|
|
|
|
10,390 |
|
|
|
|
|
|
Unrealized losses on securities
|
|
|
215 |
|
|
|
|
|
|
|
586 |
|
|
|
|
|
|
|
555 |
|
|
|
|
|
|
Research and development credits
|
|
|
|
|
|
|
1,246 |
|
|
|
|
|
|
|
1,246 |
|
|
|
|
|
|
|
1,920 |
|
|
Excess of net book value over tax basis of intangible assets
|
|
|
|
|
|
|
8,885 |
|
|
|
|
|
|
|
6,613 |
|
|
|
|
|
|
|
|
|
|
Share-based payment awards
|
|
|
|
|
|
|
4,200 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign tax credit
|
|
|
713 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital loss carryover
|
|
|
|
|
|
|
892 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Charitable contributions, other
|
|
|
|
|
|
|
824 |
|
|
|
|
|
|
|
4,455 |
|
|
|
3,159 |
|
|
|
834 |
|
|
Valuation allowance
|
|
|
|
|
|
|
(17,515 |
) |
|
|
|
|
|
|
(17,473 |
) |
|
|
|
|
|
|
(17,492 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,738 |
|
|
|
21,116 |
|
|
|
11,001 |
|
|
|
18,002 |
|
|
|
14,104 |
|
|
|
10,953 |
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation on property and equipment
|
|
|
|
|
|
|
(455 |
) |
|
|
|
|
|
|
(611 |
) |
|
|
|
|
|
|
(175 |
) |
|
Bond interest
|
|
|
|
|
|
|
(29,233 |
) |
|
|
|
|
|
|
(22,377 |
) |
|
|
|
|
|
|
(9,068 |
) |
|
Excess of net book value over tax basis of intangible assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,604 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets (liabilities)
|
|
$ |
12,738 |
|
|
$ |
(8,572 |
) |
|
$ |
11,001 |
|
|
$ |
(4,986 |
) |
|
$ |
14,104 |
|
|
$ |
(2,894 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2005, the Company has a federal net
operating loss carryforward of approximately $64.5 million
that begins expiring in varying amounts in the years 2008
through 2020 if not previously utilized. The net operating loss
carryforward was acquired in connection with the Companys
merger with Ascent during fiscal 2002. As a result of the merger
and related ownership change for Ascent, the annual utilization
of the net operating loss carryforward is limited under Internal
Revenue Code Section 382. Based upon this limitation, the
Company estimates that approximately $18.0 million of the
$64.5 million net operating loss carryforward will be
realized. Accordingly, a valuation reserve has been recorded for
the remaining net operating loss carryforward that is not
expected to be realized.
At December 31, 2005, the Company had a research and
experimentation credit carryforward of approximately
$1.3 million that begins expiring in varying amounts in the
years 2008 through 2020 if not previously utilized. All of the
research and experimentation credit carryforward was acquired in
connection with the Companys merger with Ascent during
fiscal 2002 and is subject to the limitation under Internal
Revenue Code Section 383. As a result of this limitation,
the Company does not expect to realize any of the research and
experimentation credits acquired from Ascent. Accordingly, a
valuation reserve of $1.3 million has been established for
the acquired research and experimentation credits.
At December 31, 2005, the Company had a foreign tax credit
carryover of approximately $0.7 million. The foreign tax
credit will expire in 2016 if not previously utilized.
F-33
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
As a result of the limitations described above, the Company has
recorded a deferred tax asset valuation allowance of
$17.5 million related to the net operating loss and
research and experimentation credit carryforwards acquired in
the merger with Ascent. Subsequent realization of loss and
credit carryforwards in excess of the amounts estimated to be
realized as of December 31, 2005 will be applied to reduce
the valuation allowance and goodwill recorded in connection with
the merger with Ascent.
During fiscal 2004, the Internal Revenue Service issued Notice
2003-65 providing taxpayers additional guidance regarding the
computations under Internal Revenue Code Section 382. The
application of Notice 2003-65
to Ascents net operating losses resulted in an increase of
$11.9 million in the Companys estimate of the initial
recognition of Ascents net operating losses it will
utilize. As a result, the Company reclassified approximately
$4.1 million from goodwill to deferred tax assets and the
related valuation allowance to reflect the increased estimate of
the income tax benefit it will realize from utilization of
Ascents net operating loss carryforwards.
The Company recorded a deferred tax asset of approximately
$215,000, $617,000 (unaudited), $586,000 and $555,000 for the
Transition Period, the comparable 2004 six months, fiscal 2005
and fiscal 2004, respectively, relating to unrealized losses on
available-for-sale securities presented in other comprehensive
income in stockholders equity.
During the Transition Period, the comparable 2004 six months and
fiscal 2005, the Company made net tax payments of
$11.8 million, $3.1 million (unaudited) and
$13.9 million, respectively. The Company received net
refunds of $3.7 million during fiscal 2004 and made tax
payments of $16.7 million during fiscal 2003.
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 2000. The Company and its consolidated subsidiaries are
currently under examination for fiscal year ended 2003 and 2004.
The Company does not believe that the examination will have a
material effect on the financial position of the Company. The
Company continually assesses its tax filing positions and
believes that an adequate provision for taxes has been made for
all open years that may be subject to audit.
|
|
NOTE 16. |
STOCK TRANSACTIONS |
Class A common stock has one vote per share. During
September 2004, all 758,032 outstanding shares of the
Companys Class B common stock were exchanged for
758,032 shares of the Companys Class A common
stock. As of December 31, 2005, there were no shares of
Class B common stock outstanding.
During the three months ended December 31, 2004 and
September 30, 2004, Medicis purchased 2,177,286 and
1,743,800 shares of its Class A common stock in the
open market at an average price of $38.65 and $37.76 per
share, respectively. These stock purchases were made in
accordance with a stock repurchase program that was approved by
the Companys Board of Directors in August 2004. This
program provided for the repurchase of up to $150.0 million
of Class A common stock at such times as management
determined. As of December 31, 2005, the Company had
repurchased a total of approximately $150.0 million of
Class A common stock pursuant to this program, all during
the six months ended December 31, 2004. As the purchase
limit had been reached, the plan was terminated. During the
Transition Period, Medicis did not purchase any of its shares of
Class A common stock. The timing and amount of any future
payments will depend on market conditions and corporate
considerations.
On January 2, 2004, the Company announced a 2 for 1 stock
split in the form of a stock dividend payable on
January 23, 2004 to stockholders of record at the close of
business on January 12, 2004. All share and per share data
have been restated to reflect the stock split effected in the
form of a stock dividend.
F-34
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
During fiscal 2003, Medicis purchased 1,856,600 shares of
its Class A common stock in the open market at an average
price of $19.37 per share. These stock purchases were made
in accordance with a stock repurchase program that was approved
by the Companys Board of Directors in May 1999. This
program provided for the repurchase of up to $75 million of
Class A common stock at such times as management
determined. The Company had repurchased a total of approximately
$50.2 million toward the $75 million before it was
replaced by another plan in May 2003, when the Companys
Board of Directors approved a new program that authorized the
repurchase of up to $75 million of its common stock. This
plan was subsequently replaced by the August 2004 stock
repurchase program.
|
|
NOTE 17. |
DIVIDENDS DECLARED ON COMMON STOCK |
During the Transition Period and the comparable 2004 six months,
fiscal 2005 and fiscal 2004, the Company paid quarterly cash
dividends aggregating $3.3 million, $3.1 million
(unaudited), $6.4 million, $5.5 million, respectively,
on its common stock. In addition, on December 14, 2005, the
Company declared a cash dividend of $0.03 per issued and
outstanding share of common stock payable on January 31,
2006 to stockholders of record at the close of business on
January 3, 2006. The $1.6 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, 2005. Prior to these
dividends, the Company had not paid a cash dividend on our
common stock. The Company has not adopted a dividend policy.
|
|
NOTE 18. |
STOCK OPTION PLANS |
As of December 31, 2005, the Company has six active Stock
Option Plans (the 2004, 2002, 1998, 1996, 1995 and 1992 Plans
or, collectively, the Plans). As of
December 31, 2005, the 2004, 2002, 1998, 1996, 1995 and
1992 Plans had the following options outstanding: 353,050,
5,635,315, 5,320,428, 1,249,477, 1,281,968, and 539,098,
respectively. Except for the 2002 Stock Option Plan, which only
includes non-qualified incentive options, the Plans allow the
Company to designate options as qualified incentive or
non-qualified on an as-needed basis. Qualified and non-qualified
stock options vest over a period determined at the time the
options are granted, ranging from one to five years, and
generally have a maximum term of ten years. Options are granted
at the fair market value on the grant date. Options outstanding
at December 31, 2005 vary in price from $6.06 to $39.04,
with a weighted average exercise price of $27.21 as is set forth
in the following chart:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted | |
|
Weighted | |
|
|
|
Weighted | |
|
|
|
|
Average | |
|
Average | |
|
|
|
Average | |
|
|
Number | |
|
Contractual | |
|
Exercise | |
|
Number | |
|
Exercise | |
Range of Exercise Prices |
|
Outstanding | |
|
Life | |
|
Price | |
|
Exercisable | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$ 6.06 - $14.42
|
|
|
1,191,709 |
|
|
|
3.20 |
|
|
$ |
11.27 |
|
|
|
1,191,709 |
|
|
$ |
11.27 |
|
$14.50 - $18.33
|
|
|
2,284,364 |
|
|
|
6.35 |
|
|
$ |
18.22 |
|
|
|
1,035,222 |
|
|
$ |
18.08 |
|
$18.57 - $23.53
|
|
|
288,138 |
|
|
|
6.36 |
|
|
$ |
21.69 |
|
|
|
174,008 |
|
|
$ |
21.11 |
|
$23.65 - $26.95
|
|
|
2,108,662 |
|
|
|
5.62 |
|
|
$ |
26.75 |
|
|
|
1,474,284 |
|
|
$ |
26.75 |
|
$26.98 - $27.63
|
|
|
1,985,128 |
|
|
|
4.60 |
|
|
$ |
27.63 |
|
|
|
1,966,808 |
|
|
$ |
27.63 |
|
$27.70 - $29.13
|
|
|
138,410 |
|
|
|
7.01 |
|
|
$ |
28.34 |
|
|
|
44,110 |
|
|
$ |
28.20 |
|
$29.20 - $29.20
|
|
|
2,361,070 |
|
|
|
7.58 |
|
|
$ |
29.20 |
|
|
|
588,621 |
|
|
$ |
29.20 |
|
$29.25 - $36.06
|
|
|
1,330,505 |
|
|
|
7.76 |
|
|
$ |
31.76 |
|
|
|
360,945 |
|
|
$ |
30.34 |
|
$38.45 - $38.45
|
|
|
2,544,350 |
|
|
|
8.54 |
|
|
$ |
38.45 |
|
|
|
320,038 |
|
|
$ |
38.45 |
|
$39.04 - $39.04
|
|
|
147,000 |
|
|
|
8.75 |
|
|
$ |
39.04 |
|
|
|
147,000 |
|
|
$ |
39.04 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
14,379,336 |
|
|
|
6.49 |
|
|
$ |
27.21 |
|
|
|
7,302,745 |
|
|
$ |
24.24 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-35
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
A summary of stock options granted within the Plans and related
information for the Transition Period and fiscal 2005, fiscal
2004 and fiscal 2003 is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted | |
|
|
|
|
|
|
|
|
Average | |
|
|
Qualified | |
|
Non-Qualified | |
|
Total | |
|
Price | |
|
|
| |
|
| |
|
| |
|
| |
Balance at June 30, 2002
|
|
|
3,956,382 |
|
|
|
7,179,224 |
|
|
|
11,135,606 |
|
|
$ |
21.08 |
|
|
Granted
|
|
|
12,340 |
|
|
|
3,476,376 |
|
|
|
3,488,716 |
|
|
$ |
19.11 |
|
Exercised
|
|
|
(451,596 |
) |
|
|
(505,234 |
) |
|
|
(956,830 |
) |
|
$ |
13.33 |
|
Terminated/expired
|
|
|
(310,664 |
) |
|
|
(575,236 |
) |
|
|
(885,900 |
) |
|
$ |
22.32 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2003
|
|
|
3,206,462 |
|
|
|
9,575,130 |
|
|
|
12,781,592 |
|
|
$ |
21.11 |
|
|
Granted
|
|
|
10,272 |
|
|
|
3,403,248 |
|
|
|
3,413,520 |
|
|
$ |
29.32 |
|
Exercised
|
|
|
(1,383,395 |
) |
|
|
(1,526,179 |
) |
|
|
(2,909,574 |
) |
|
$ |
17.68 |
|
Terminated/expired
|
|
|
(275,772 |
) |
|
|
(985,822 |
) |
|
|
(1,261,594 |
) |
|
$ |
25.41 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2004
|
|
|
1,557,567 |
|
|
|
10,466,377 |
|
|
|
12,023,944 |
|
|
$ |
23.82 |
|
|
Granted
|
|
|
|
|
|
|
2,795,890 |
|
|
|
2,795,890 |
|
|
$ |
38.48 |
|
Exercised
|
|
|
(269,554 |
) |
|
|
(542,216 |
) |
|
|
(811,770 |
) |
|
$ |
20.43 |
|
Terminated/expired
|
|
|
(62,896 |
) |
|
|
(296,790 |
) |
|
|
(359,686 |
) |
|
$ |
28.82 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2005
|
|
|
1,225,117 |
|
|
|
12,423,261 |
|
|
|
13,648,378 |
|
|
$ |
26.89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted
|
|
|
|
|
|
|
843,550 |
|
|
|
843,550 |
|
|
$ |
32.43 |
|
Exercised
|
|
|
(9,552 |
) |
|
|
(8,444 |
) |
|
|
(17,996 |
) |
|
$ |
23.87 |
|
Terminated/expired
|
|
|
(10,626 |
) |
|
|
(83,970 |
) |
|
|
(94,596 |
) |
|
$ |
28.85 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005
|
|
|
1,204,939 |
|
|
|
13,174,397 |
|
|
|
14,379,336 |
|
|
$ |
27.21 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
NOTE 19. |
NET INCOME PER COMMON SHARE |
The following table sets forth the computation of basic and
diluted net income per common share (in thousands, except per
share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended | |
|
|
|
|
December 31, | |
|
Fiscal Year Ended June 30, | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(Unaudited) | |
|
|
|
|
|
|
BASIC
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
$ |
30,840 |
|
|
$ |
51,256 |
|
Weighted average number of common shares outstanding
|
|
|
54,323 |
|
|
|
55,972 |
|
|
|
55,196 |
|
|
|
55,618 |
|
|
|
54,376 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income per common share
|
|
$ |
0.92 |
|
|
$ |
0.38 |
|
|
$ |
1.18 |
|
|
$ |
0.55 |
|
|
$ |
0.94 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-36
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended | |
|
|
|
|
December 31, | |
|
Fiscal Year Ended June 30, | |
|
|
| |
|
| |
|
|
2005 | |
|
2004 | |
|
2005 | |
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
|
|
(Unaudited) | |
|
|
|
|
|
|
DILUTED
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
|
|
$ |
49,721 |
|
|
$ |
21,223 |
|
|
$ |
64,990 |
|
|
$ |
30,840 |
|
|
$ |
51,256 |
|
Add:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tax-effected interest expense and issue costs related to Old
Notes
|
|
|
1,677 |
|
|
|
1,675 |
|
|
|
3,347 |
|
|
|
3,884 |
|
|
|
7,901 |
|
|
Tax-effected interest expense and issue costs related to New
Notes
|
|
|
1,677 |
|
|
|
1,677 |
|
|
|
3,353 |
|
|
|
2,925 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income assuming dilution
|
|
$ |
53,075 |
|
|
$ |
24,575 |
|
|
$ |
71,690 |
|
|
$ |
37,649 |
|
|
$ |
59,157 |
|
Weighted average number of common shares
|
|
|
54,323 |
|
|
|
55,972 |
|
|
|
55,196 |
|
|
|
55,618 |
|
|
|
54,376 |
|
Effect of dilutive securities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Old Notes
|
|
|
5,823 |
|
|
|
5,823 |
|
|
|
5,823 |
|
|
|
6,777 |
|
|
|
13,770 |
|
|
New Notes
|
|
|
7,325 |
|
|
|
7,325 |
|
|
|
7,325 |
|
|
|
6,446 |
|
|
|
|
|
|
Stock options and restricted stock
|
|
|
2,301 |
|
|
|
3,040 |
|
|
|
2,565 |
|
|
|
3,640 |
|
|
|
2,045 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares assuming dilution
|
|
|
69,772 |
|
|
|
72,160 |
|
|
|
70,909 |
|
|
|
72,481 |
|
|
|
70,191 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per common share
|
|
$ |
0.76 |
|
|
$ |
0.34 |
|
|
$ |
1.01 |
|
|
$ |
0.52 |
|
|
$ |
0.84 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted net income per common share must be calculated using the
if-converted method in accordance with
EITF 04-8,
Effect of Contingently Convertible Debt on Diluted
Earnings per Share. Diluted net income per share is
calculated by adjusting net income for tax-effected net interest
and issue costs on the Old Notes and New Notes, divided by the
weighted average number of common shares outstanding assuming
conversion. All earnings per share amounts presented reflect the
adoption of EITF 04-8.
The diluted net income per common share computation for the
Transition Period excludes 6,120,755 shares of stock that
represented outstanding stock options that were anti-dilutive.
The diluted net income per common share computation for the six
months ended December 31, 2004 excludes 2,459,862
(unaudited) shares of stock that represented outstanding
stock options whose exercise price were greater than the average
market price of the common shares during the period and were
anti-dilutive.
The dilutive net income per common share computation for fiscal
2005, fiscal 2004 and fiscal 2003 excludes 2,734,600, 5,393 and
3,098163 shares of stock, respectively, which represented
outstanding stock options whose exercise prices were greater
than the average market price of the common shares during the
respective fiscal years and were anti-dilutive.
|
|
NOTE 20. |
FINANCIAL INSTRUMENTS CONCENTRATIONS OF CREDIT
AND OTHER RISKS |
Financial instruments that potentially subject the Company to
significant concentrations of credit risk consist principally of
cash, cash equivalents, short-term investments and accounts
receivable.
The Company maintains cash, cash equivalents and short-term
investments primarily with two financial institutions that
invest funds in short-term, interest-bearing, investment-grade,
marketable securities. Financial instruments that potentially
subject the Company to concentrations of credit risk consist
primarily of investments in debt securities and trade
receivables. The Company generally places its investments with
high-
F-37
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
credit quality counterparties. Investments in debt securities
with original maturities of greater than six months consist
primarily of AAA rated financial instruments and counterparties.
The Companys investments are primarily in direct
obligations of the United States government or its agencies and
municipal auction-rate securities.
At December 31, 2005, and at the end of fiscal 2005 and
fiscal 2004, three customers comprised approximately 83.2%,
86.3% and 88.8%, 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, 2005.
The Companys inventory is contract manufactured. The
Company and the manufacturers of its products rely on suppliers
of raw materials used in the production of its products. Some of
these materials are available from only one source and others
may become available from only one source. Any disruption in the
supply of raw materials or an increase in the cost of raw
materials to these manufacturers could have a significant effect
on their ability to supply the Company with its products. The
failure of any such suppliers to meet its commitment on schedule
could have a material adverse effect on the Companys
business, operating results and financial condition. If a
sole-source supplier were to go out of business or otherwise
become unable to meet its supply commitments, the process of
locating and qualifying alternate sources could require up to
several months, during which time the Companys production
could be delayed. Such delays could have a material adverse
effect on the Companys business, operating results and
financial condition.
|
|
NOTE 21. |
FAIR VALUE OF FINANCIAL INSTRUMENTS |
The carrying amount of cash equivalents approximates fair value
because their maturity is less than three months. The carrying
amount of short-term investments approximates fair value because
the longer-term instruments have interest rate reset features
that regularly adjust to current market rates. The carrying
amount of accounts receivable, accounts payable and accrued
liabilities approximates fair value due to the short-term
maturity of the amounts. The fair value of capital lease
obligations, long-term debt and lines of credit approximate
their carrying value as they are estimated by discounting the
future cash flows at rates currently offered to the Company for
similar debt instruments.
|
|
NOTE 22. |
DEFINED CONTRIBUTION PLAN |
The Company has a defined contribution plan (the
Contribution Plan) that is intended to qualify under
Section 401(k) of the Internal Revenue Code. All employees,
except those who have not attained the age of 21, are
eligible to participate in the Contribution Plan. Participants
may contribute, through payroll deductions, up to 20.0% of their
basic compensation, not to exceed Internal Revenue Code
limitations. Although the Contribution Plan provides for profit
sharing contributions by the Company, the Company had not made
any such contributions since its inception until April 2002.
Beginning in April 2002, the Company began matching employee
contributions at 50% of the first 3% of basic compensation
contributed by the participants, and during the Transition
Period and during fiscal 2005 made a discretionary contribution
to the plan. During the Transition Period, the comparable 2004
six months, fiscal 2005, fiscal 2004 and fiscal 2003, the
Company recognized expense related to matching and discretionary
contributions under the Contribution Plan of $442,000, $162,000
(unaudited), $803,000, $340,000 and $307,000, respectively.
F-38
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
NOTE 23. |
QUARTERLY FINANCIAL INFORMATION (UNAUDITED) |
The tables below list the quarterly financial information for
the Transition Period, fiscal 2005 and 2004. All figures are in
thousands, except per share amounts, and certain amounts do not
total the annual amounts due to rounding.
Six Months Ended December 31, 2005
|
|
|
|
|
|
|
|
|
|
|
(For the Quarters Ended) | |
|
|
| |
|
|
September 30, | |
|
December 31, | |
|
|
2005(a) | |
|
2005(b) | |
|
|
| |
|
| |
Net revenues
|
|
$ |
83,264 |
|
|
$ |
80,690 |
|
Gross profit(1)
|
|
|
71,240 |
|
|
|
68,603 |
|
Net income
|
|
|
12,460 |
|
|
|
37,261 |
|
Basic net income per common share
|
|
$ |
0.23 |
|
|
$ |
0.69 |
|
Diluted net income per common share
|
|
$ |
0.20 |
|
|
$ |
0.56 |
|
Year Ended June 30, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(For the Quarters Ended) | |
|
|
| |
|
|
September 30, | |
|
December 31, | |
|
March 31, | |
|
June 30, | |
|
|
2004(c) | |
|
2004(d) | |
|
2005(e) | |
|
2005(f) | |
|
|
| |
|
| |
|
| |
|
| |
Net revenues
|
|
$ |
88,818 |
|
|
$ |
92,349 |
|
|
$ |
95,188 |
|
|
$ |
100,544 |
|
Gross profit(1)
|
|
|
74,985 |
|
|
|
78,911 |
|
|
|
81,274 |
|
|
|
86,282 |
|
Net income
|
|
|
1,023 |
|
|
|
20,201 |
|
|
|
19,371 |
|
|
|
24,395 |
|
Basic net income per common share
|
|
$ |
0.02 |
|
|
$ |
0.37 |
|
|
$ |
0.36 |
|
|
$ |
0.45 |
|
Diluted net income per common share
|
|
$ |
0.02 |
|
|
$ |
0.31 |
|
|
$ |
0.30 |
|
|
$ |
0.38 |
|
Year Ended June 30, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(For the Quarters Ended) | |
|
|
| |
|
|
September 30, | |
|
December 31, | |
|
March 31, | |
|
June 30, | |
|
|
2003 | |
|
2003(g) | |
|
2004 | |
|
2004 | |
|
|
| |
|
| |
|
| |
|
| |
Net revenues
|
|
$ |
63,295 |
|
|
$ |
70,633 |
|
|
$ |
81,839 |
|
|
$ |
87,954 |
|
Gross profit(1)
|
|
|
53,114 |
|
|
|
59,396 |
|
|
|
68,721 |
|
|
|
75,885 |
|
Loss on early extinguishment of debt
|
|
|
(58,660 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income
|
|
|
(27,164 |
) |
|
|
13,627 |
|
|
|
20,671 |
|
|
|
23,705 |
|
Basic net (loss) income per common share
|
|
$ |
(0.50 |
) |
|
$ |
0.25 |
|
|
$ |
0.37 |
|
|
$ |
0.42 |
|
Diluted net (loss) income per common share
|
|
$ |
(0.50 |
) |
|
$ |
0.21 |
|
|
$ |
0.31 |
|
|
$ |
0.34 |
|
|
|
(1) |
Gross profit does not include amortization of the related
intangibles. |
Quarterly results were impacted by the following items:
|
|
|
|
(a) |
Operating expenses included approximately $7.7 million of
compensation expense related to stock options and restricted
stock, and approximately $0.7 million of business
integration planning costs related to the proposed merger with
Inamed. |
|
(b) |
Operating expenses included approximately $11.9 million
paid to Dow related to a research and development collaboration,
a charge of approximately $9.2 million for the write-down
of a long-lived asset and approximately $7.3 million of
compensation expense related to stock options and restricted
stock. Other income included approximately $60.0 million
related to a termination fee received from |
F-39
MEDICIS PHARMACEUTICAL CORPORATION
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
|
|
Inamed related to the termination of the proposed merger with
Inamed, net of the expensing of accumulated transaction costs
and business integration planning costs incurred. |
|
(c) |
Operating expenses included approximately $30.0 million
paid to Q-Med related to an exclusive license agreement for the
development of
SubQtm,
and approximately $0.7 million of professional fees related
to the agreement. |
|
(d) |
Operating expense included approximately $5.0 million paid
to Ansata related to an exclusive development and license
agreement, and approximately $0.5 million of professional
fees related to the agreement. |
|
(e) |
Operating expenses included approximately $8.3 million paid
to aaiPharma related to a research and development
collaboration. Effective January 1, 2005, the Company
changed the estimated useful life for certain intangible assets
related to its merger with Ascent. This change increased
amortization expense by approximately $0.8 million during
the quarter ended March 31, 2005. |
|
|
|
|
(f) |
Operating expenses included approximately $5.3 million of
business integration planning costs related to the proposed
merger with Inamed. Effective January 1, 2005, the Company
accelerated the estimated useful life for certain intangible
assets related to its merger with Ascent. This change increased
amortization expense by approximately $0.8 million during
the quarter ended June 30, 2005. |
|
|
|
|
(g) |
Operating expenses included approximately $2.4 million paid
to Dow for a research and development collaboration. |
F-40
SCHEDULE II VALUATION AND QUALIFYING
ACCOUNTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at | |
|
Charged to | |
|
Charged to | |
|
|
|
|
|
|
Beginning | |
|
Costs and | |
|
Other | |
|
|
|
Balance at End | |
Description |
|
of Year | |
|
Expenses | |
|
Accounts | |
|
Deductions | |
|
of Year | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Six Months Ended December 31, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted from Asset Accounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances
|
|
$ |
19,073 |
|
|
$ |
42,755 |
|
|
|
|
|
|
$ |
(43,668 |
) |
|
$ |
18,160 |
|
Year Ended June 30, 2005
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted from Asset Accounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances
|
|
$ |
15,955 |
|
|
$ |
95,979 |
|
|
|
|
|
|
$ |
(92,861 |
) |
|
$ |
19,073 |
|
Year Ended June 30, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted from Asset Accounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances
|
|
$ |
15,079 |
|
|
$ |
96,263 |
|
|
|
|
|
|
$ |
(95,387 |
) |
|
$ |
15,955 |
|
Year Ended June 30, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deducted from Asset Accounts:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts Receivable:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowances
|
|
$ |
10,628 |
|
|
$ |
78,044 |
|
|
|
|
|
|
$ |
(73,593 |
) |
|
$ |
15,079 |
|
S-1
Index to Exhibits
|
|
|
|
|
Exhibit No. | |
|
Description |
| |
|
|
|
12+ |
|
|
Computation of Ratios of Earnings to Fixed Charges |
|
21 |
.1+ |
|
Subsidiaries |
|
23 |
.1+ |
|
Consent of Ernst & Young LLP, Independent Registered
Public Accounting Firm |
|
24 |
.1 |
|
Power of Attorney See signature page |
|
31 |
.1+ |
|
Certification of Chief Executive Officer pursuant to
Rule 13a-14(a) and Rule 15d-14(a) of the Securities
Exchange Act, as amended |
|
31 |
.2+ |
|
Certification of Chief Financial Officer pursuant to
Rule 13a-14(a) and Rule 15d-14(a) of the Securities
Exchange Act, as amended |
|
32 |
.1+ |
|
Certification of Chief Executive Officer pursuant to
18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 |
|
32 |
.2+ |
|
Certification of Chief Financial Officer pursuant to
18 U.S.C. Section 1350, as adopted pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002 |