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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
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For the fiscal year ended December 31, 2004 |
Commission file number 1-11397
Valeant Pharmaceuticals International
(Exact name of registrant as specified in its charter)
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Delaware
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33-0628076 |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification No.) |
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3300 Hyland Avenue, Costa Mesa, California
(Address of principal executive offices) |
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92626
(Zip Code) |
Registrants telephone number, including area code:
(714) 545-0100
Securities registered pursuant to Section 12(b) of the
Act:
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Title of Each Class |
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Name of Each Exchange on Which Registered |
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Common stock, $.01 par value (Including
associated preferred stock purchase rights)
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New York Stock Exchange |
Securities registered pursuant to Section 12(g) of the
Act:
None
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, and (2) has been subject to such filing
requirements for the past
90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers
pursuant to Item 405 of Regulation S-K is not
contained herein, and will not be contained, to the best of
Registrants knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this
Form 10-K or any amendment to this
Form 10-K. o
Indicate by check mark whether the Registrant is an accelerated
filer (as defined in Rule 12b-2 of the
Act). Yes þ No o
The aggregate market value of the Registrants voting stock
held by non-affiliates of the Registrant on June 30, 2004,
the last business day of the Registrants most recently
completed second fiscal quarter based on the closing price of
the common stock on the New York Stock Exchange on such date,
was approximately $1,680,296,600.
The number of outstanding shares of the Registrants common
stock as of March 2, 2005 was 92,512,480.
DOCUMENTS INCORPORATED BY REFERENCE
Certain information contained in Valeant Pharmaceuticals
Internationals definitive Proxy Statement for the 2005
annual meeting of stockholders, to be filed not later than
120 days after the end of the fiscal year covered by this
report, is incorporated by reference into Part III hereof.
TABLE OF CONTENTS
1
PART I
Introduction
We are a global, research-based specialty pharmaceutical company
that discovers, develops, manufactures and markets a broad range
of pharmaceutical products. We are strategically focused on
three therapeutic areas: neurology, infectious diseases and
dermatology. Our greatest resources and attention are targeted
toward ten global brands in these therapeutic categories that we
believe will drive our growth in ten major markets around the
world.
Our two primary value drivers are: a specialty pharmaceutical
business with a global platform, and a research and development
infrastructure with strong discovery, clinical development and
regulatory capabilities. We believe that our global reach and
fully integrated research and development capability make us
unique among specialty pharmaceutical companies, and provide us
with the ability to take compounds from discovery through the
clinical stage and commercialize them in major markets around
the world. In addition, we receive royalties from the sale of
ribavirin by Schering-Plough and Roche, although such royalties
represent a much smaller contribution than they have in the past.
Valeant Pharmaceuticals International was incorporated as ICN
Pharmaceuticals, Inc. in Delaware in November 1994, as a result
of the merger of ICN Pharmaceuticals, Inc., SPI Pharmaceuticals,
Inc., Viratek, Inc. and ICN Biomedicals, Inc. On
November 12, 2003, we changed our name from ICN
Pharmaceuticals, Inc. to Valeant Pharmaceuticals International.
Our internet address is www.valeant.com. We post
links on our website to the following filings as soon as
reasonably practicable after they are electronically filed with
or furnished to the Securities and Exchange Commission
(SEC): annual reports on Form 10-K, quarterly
reports on Form 10-Q, current reports on Form 8-K and
any amendment to those reports filed or furnished pursuant to
Section 13(a) or 15(d) of the Securities Exchange Act of
1934. All such filings are available through our website free of
charge. Our filings may also be read and copied at the
SECs Public Reference Room at 450 Fifth Street, NW,
Washington, DC 20549. Information on the operation of the
Public Reference Room may be obtained by calling the SEC at
1-800-SEC-0330. The SEC also maintains an Internet site that
contains reports, proxy and information statements, and other
information regarding issuers that file electronically with the
SEC. The address of that site is www.sec.gov.
Company Strategy
We have undergone significant changes in our leadership,
strategic direction and operations since 2002. In an effort to
drive change, our stockholders elected new directors at our
annual meetings in 2001 and 2002, resulting in a new board
composition and the appointment of a new senior management team.
A three part plan was initiated to restructure our company,
transform the business and grow through innovation. We have made
significant progress in the execution of this plan, including
completion of our restructuring phase that entailed
restructuring management, divesting non-core businesses,
implementing strong governance protocols and strengthening our
research and development capability. Some of the key initiatives
that we have implemented to date are discussed below.
Restructuring management. Since June 2002, we have put in
place new leadership with extensive experience in the
pharmaceuticals and healthcare sectors. Robert W. OLeary
was named our Chairman in June 2002 and served as Chief
Executive Officer from June 2002 to December 2004 and has
extensive healthcare industry experience, with specialization in
corporate turnarounds and reorganizations. In November 2002,
Timothy C. Tyson was named our President and Chief Operating
Officer, and in January 2005 he succeeded Mr. OLeary
as Chief Executive Officer. In December 2002, Bary G. Bailey was
named our
2
Executive Vice President and Chief Financial Officer.
Additionally, we have replaced or hired new individuals for a
majority of our senior management positions.
Divesting non-core businesses. Since the announcement of
our repositioning program in October 2002, we have substantially
completed our planned divestitures of businesses that do not fit
our strategic growth plans. During 2003, we disposed of our
Russian pharmaceuticals segment, biomedicals segment and
photonics business. In July 2004, we disposed of one of the raw
materials businesses and a manufacturing facility in Central
Europe. We are actively marketing for sale the remaining raw
materials business and manufacturing facility in Central Europe
and are working toward disposing of these assets. See
Note 3 of notes to consolidated financial statements for
discussion of discontinued operations.
Strengthening research and development capability. As
part of our overall repositioning strategy and our strategy to
build our pipeline of new products, we re-evaluated the
ownership structure of Ribapharm, Inc. We determined that the
benefits perceived at the time of the initial public offering of
Ribapharm had diminished and that the potential advantages to us
of repurchasing the publicly held shares of Ribapharm outweighed
the advantages of continuing to maintain Ribapharm as a separate
publicly-traded entity or completing a spin-off of Ribapharm. In
August 2003, we repurchased the 20% minority interest in
Ribapharm, thereby increasing our ownership interest to 100%.
Through this transaction, we have secured control over
Ribapharms research and development assets and royalty
revenue stream.
Cost rationalization. We have reduced costs by
controlling expenses in our corporate headquarters, closing our
European headquarters in 2002 and eliminating excess
administrative expenses worldwide.
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Targeted Growth of Existing Products |
In order to drive specialty pharmaceuticals sales growth, we
focus our business on the following specific markets,
therapeutic areas and brands:
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Focus on Ten Key Geographic Regions. We have four
pharmaceutical segments comprising our pharmaceutical operations
in North America, Latin America, Europe and Asia, Africa and
Australia. Within these four pharmaceutical segments, we focus
on ten key geographic regions: the United States, Canada,
Mexico, the United Kingdom, France, Italy, Poland, Germany,
Spain and China. As we pursue acquisition opportunities and
product line extensions, we plan to focus on North America, the
largest pharmaceutical market worldwide and thus our biggest
growth opportunity. |
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Focus on Three Core Therapeutic Classes. We focus on
neurology, infectious disease and dermatology. We believe that
these three therapeutic classes are positioned for further
growth, and that it is possible for a mid-sized company to
attain a leadership position within these categories. |
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Focus on Ten Global Brands. We currently focus on ten
global brands, seven of which are currently being marketed.
Three of these brands, Viramidine, pradefovir (formerly called
remofovir) and retigabine, are currently in clinical
development. All of these ten global brands are within our three
targeted core therapeutic classes. We believe that these brands
have the potential for global penetration and growth rates above
the industry average growth rates. In addition, we intend to
continue to market and sell, and selectively pursue life cycle
management strategies for, our regional and local brands. |
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Efficient Manufacturing and Supply Chain
Organization |
Under our global manufacturing strategy announced in October
2003, we plan to reduce the number of manufacturing facilities
from 15 to five by 2006, in order to increase capacity
utilization and improve efficiencies. We have also undertaken a
major process improvement initiative, affecting all phases of
our operations, from raw material and supply logistics, to
manufacturing, warehousing and distribution.
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Development of New Products via Internal Research and
Development Activities |
We seek to discover, develop and commercialize innovative
products for the treatment of significant unmet medical needs,
principally in the areas of infectious disease and cancer. We
intend to combine our scientific expertise with advanced drug
screening techniques in order to discover and develop new
product candidates. Except as otherwise required by the terms of
our November 2000 agreement with Schering-Plough, we generally
intend to retain control of our product candidates in our major
markets in order to obtain the maximum value from our research
efforts.
We plan to selectively license or acquire product candidates,
technologies and businesses from third parties which complement
our existing business and provide for effective life cycle
management of key products. We believe that our drug development
expertise may allow us to recognize licensing opportunities and
to capitalize on research initially conducted and funded by
others.
In February 2004, we acquired from Amarin Corporation, plc its
U.S.-based subsidiary, Amarin Pharmaceuticals, Inc.
(Amarin), and all of its U.S. product rights,
which includes Permax® and a primary care portfolio with a
broad range of indications. The total consideration for Amarin
was $40,000,000 cash. We also acquired in the transaction the
rights to Zelapar®, a late-stage candidate for the
treatment of Parkinsons disease. Amarin has received an
approvable letter from the Food and Drug Administration
(FDA) for Zelapar, subject to the completion of two
safety studies. These studies were completed and we filed the
final results of these studies in late 2004. We received a
response from the FDA that requires us to provide them with
additional information. We expect to launch Zelapar in 2005.
In April 2004, we acquired the worldwide rights, excluding the
European Union, to Tasmar® (tolcapone), indicated for the
treatment of Parkinsons disease, from Roche for
$13,500,000 in cash, plus future royalty payments. In September
2004, we acquired the European Union rights to Tasmar from Roche
for $11,400,000 in cash, plus future royalties.
On March 1, 2005, we acquired Xcel Pharmaceuticals, Inc.
(Xcel), a specialty pharmaceutical company focused
on the treatment of disorders of the central nervous system, for
$280,000,000 in cash, plus expenses of approximately $5,000,000.
Xcels portfolio consists of four products that are sold
within the United States, and retigabine, a late-stage clinical
product candidate that is an adjunctive treatment for
partial-on-set seizures for patients with epilepsy, which is
being developed for commercialization in all major markets.
See Notes 2 and 17 of notes to consolidated financial
statements for a discussion of these acquisitions.
Specialty Pharmaceuticals
We develop, manufacture and distribute a broad range of
prescription and non-prescription pharmaceuticals. Although we
focus most of our efforts on neurology, infectious disease and
dermatology, our prescription pharmaceutical products also
treat, among other things, neuromuscular disorders, cancer,
cardiovascular disease, diabetes and psychiatric disorders. Our
current product portfolio comprises of approximately 575 branded
products, with approximately 2,400 stock-keeping units. We
market our products globally through a marketing and sales force
of approximately 1,400 representatives. Our products are
sold globally, through four reportable pharmaceutical segments
comprising: North America, Latin America, Europe and Asia,
Africa and Australia. See Note 14 of notes to consolidated
financial statements for further information concerning our
business segments.
Our specialty pharmaceutical business focuses its efforts on ten
global brands in our three therapeutic areas. Seven of these
global brands are currently being marketed. These seven global
brands accounted for 23%, 21% and 19% of our specialty
pharmaceutical revenues for the years ended December 31,
2004, 2003 and 2002, respectively. Sales of these global brands
increased 24% in the year ended December 31, 2004 over the
4
comparable period in 2003. We expect our future growth to be
driven primarily by growth of our existing products, the
commercialization of new products and business development.
The following table summarizes our ten largest products and
seven global brands by therapeutic class based on sales for the
years ended December 31, 2004, 2003 and 2002 (in thousands):
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Year Ended December 31, | |
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% of | |
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% of | |
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% of | |
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Total | |
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Total | |
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Total | |
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2004 | |
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Sales | |
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2003 | |
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Sales | |
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2002 | |
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Sales | |
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Neurology
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$ |
125,646 |
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21 |
% |
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Mestinon®(G)(T)
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41,631 |
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7 |
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$ |
41,879 |
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8 |
% |
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$ |
31,228 |
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7 |
% |
Librax®(T)
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16,868 |
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3 |
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11,774 |
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2 |
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18,209 |
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4 |
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Dalmane®/ Dalmadorm(T)
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12,146 |
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2 |
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10,636 |
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2 |
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10,753 |
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2 |
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Tasmar®(G)
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3,551 |
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1 |
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Other Neurology
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51,450 |
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8 |
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(a) |
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(a) |
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Infectious Disease
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58,429 |
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9 |
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Virazole®(G)(T)
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13,822 |
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2 |
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18,716 |
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4 |
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17,384 |
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4 |
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Other Infectious Disease
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44,607 |
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7 |
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(a) |
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(a) |
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Dermatology
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130,800 |
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22 |
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Efudix/ Efudex®(G)(T)
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45,453 |
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7 |
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26,821 |
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5 |
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23,085 |
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5 |
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Kinerase®(G)(T)
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15,619 |
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3 |
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12,628 |
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2 |
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10,389 |
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2 |
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Oxsoralen-Ultra®(G)(T)
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10,910 |
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2 |
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8,501 |
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2 |
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4,585 |
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1 |
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Dermatix®(G)
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7,034 |
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1 |
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2,493 |
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338 |
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Other Dermatology
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51,784 |
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9 |
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(a) |
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(a) |
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Other Therapeutic Classes Products Over
$10 Million in Annual Sales
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Bedoyecta®(T)
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30,654 |
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5 |
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26,955 |
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5 |
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29,781 |
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6 |
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Solcoseryl(T)
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14,397 |
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2 |
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16,186 |
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3 |
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(a) |
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Nyal®(T)
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11,904 |
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2 |
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8,969 |
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2 |
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5,207 |
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1 |
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Vision Care
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11,817 |
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2 |
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10,447 |
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2 |
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7,876 |
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2 |
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Bisocard
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10,613 |
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2 |
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7,267 |
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1 |
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4,717 |
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1 |
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Calcitonina
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10,420 |
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2 |
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13,638 |
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3 |
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9,448 |
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2 |
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Other Therapeutic Classes Products Under
$10 Million in Annual Sales(a)
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201,413 |
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33 |
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301,561 |
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59 |
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293,809 |
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63 |
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Total Product Sales
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$ |
606,093 |
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100 |
% |
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$ |
518,471 |
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100 |
% |
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$ |
466,809 |
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100 |
% |
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Total Top Ten Product Sales(T)
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$ |
213,404 |
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35 |
% |
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$ |
183,065 |
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35 |
% |
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$ |
150,621 |
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32 |
% |
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Total Global Product Sales(G)
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$ |
138,020 |
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23 |
% |
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$ |
111,038 |
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21 |
% |
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$ |
87,009 |
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19 |
% |
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(a) |
Other product amounts were not tracked by therapeutic class in
2003 and 2002 and are included in Other Pharmaceutical Products.
In 2004, we tracked other products by three therapeutic classes,
but not by other classes, therefore, our ability to provide
additional data by therapeutic classes is not practicable at
this time. |
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(T) |
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Indicates one of our ten largest products |
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(G) |
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Indicates on of our global brands |
5
Neurology. Total sales of our neurology products
accounted for 21% of our product sales from continuing
operations for the year ended December 31, 2004. The global
brands included in neurology are as follows:
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Mestinon: Mestinon is an orally active cholinesterase inhibitor
used in the treatment of myasthenia gravis, a chronic
neuromuscular, autoimmune disorder that causes varying degrees
of fatigable weakness involving the voluntary muscles of the
body. Its active ingredient is pyridostigmine bromide. |
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Tasmar: Tasmar is used in the treatment of Parkinsons
disease as an adjunct to levodopa/carbidopa therapy. Its active
ingredient is tolcapone, an inhibitor of
catechol-O-methyltransferase. |
Infectious Disease. Total sales of our infectious disease
products accounted for 9% of our product sales from continuing
operations for the year ended December 31, 2004. The global
brand included in Infectious Disease is as follows:
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Virazole: Virazole is our brand name for ribavirin, a synthetic
nucleoside with antiviral activity. It is indicated for the
treatment of hospitalized infants and young children with severe
lower respiratory tract infections due to respiratory syncytial
virus. Virazole has also been approved for various other
indications in countries outside the United States including
herpes zoster, genital herpes, chickenpox, hemorrhagic fever
with renal syndrome, measles and influenza. |
Dermatology. Total sales of our dermatology products
accounted for 22% of our product sales from continuing
operations for the year ended December 31, 2004. The global
brands included in Dermatology are as follows:
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Efudix/ Efudex: Efudix/ Efudex is used for the treatment of
multiple actinic or solar keratoses and superficial basal cell
carcinoma. It is sold as a topical solution and cream, and
provides effective therapy for multiple lesions. The key active
ingredient in Efudix/ Efudex is fluorinated pyrimidine
5-flouraouracil, an antineoplastic antimetabolite. |
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Kinerase: Kinerase is used to help improve the unwanted visual
effect of skin aging and photodamage. |
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Oxsoralen-Ultra: Oxsoralen-Ultra is indicated for the treatment
of severe psoriasis and mycosis fungoides and is used along with
ultraviolet light radiation. Oxsoralen-Ultra capsules contain
methoxsalen as the active ingredient. |
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Dermatix: Dermatix is used to flatten and soften scars and to
reduce scar-associated discoloration in old or new scars and is
used to prevent abnormal scar formation. It is sold in a
patented gel formulation that contains bio-inert and
biocompatible silicone compounds, namely polysiloxane, silicon
dioxide and non-volatile silicone components. |
Other Therapeutic Classes. Other therapeutic classes
encompass a broad range of ancillary products which are sold
through our existing distribution channels.
Ribavirin Royalties
Our royalties are derived from sales of ribavirin. Ribavirin is
a nucleoside analog that we discovered from our library of
nucleoside analog compounds. Ribavirin royalty revenues were
$76,427,000 and $167,482,000 for the years ended
December 31, 2004 and 2003, respectively, and accounted for
11% and 24% of our total revenues from continuing operations for
the same periods. The decreasing contribution of royalties to
our revenues had been expected with the entrance of generic
ribavirin in the United States We expect ribavirin royalties to
be somewhat stable for several years since generics are unlikely
to enter the major European countries and Japanese markets due
to certain protections in those markets through 2009 and 2010,
respectively, and would expect to see declines as a result of
alternative therapies such as Viramidine when and if approved.
In 1995, we entered into an exclusive license and supply
agreement with Schering-Plough whereby Schering-Plough licensed
from us all oral forms of ribavirin for the treatment of chronic
hepatitis C. In 2002,
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the FDA granted Schering-Plough marketing approval for
Rebetol® capsules (Schering-Ploughs brand name for
ribavirin) as a separately marketed product for use in
combination with
Peg-Introntm
(peg interferon alfa-2b), a longer lasting form of Intron A, for
use in combination with Rebetol for the treatment of chronic
hepatitis C in patients with compensated liver disease who
are at least 18 years of age.
In March 2001, the European Commission of the European Union
granted Schering-Plough centralized marketing authorization for
Peg-Introntm
and Rebetol for the treatment of both relapsed and
treatment-naïve adult patients with histologically proven
hepatitis C. European Union approval resulted in unified
labeling that was immediately valid in all 15 European Union
Member States.
In December 2004, Schering-Plough received marketing approval
from the Ministry of Health, Labor and Welfare of Japan for
ribavirin in combination with Peg-Intron for the treatment of
hepatitis C.
Schering-Plough also markets ribavirin for treatment in
combination with interferon in many other countries around the
world based on the United States and European Union regulatory
approvals.
On January 6, 2003, we reached an agreement with
Schering-Plough and Roche on a settlement of pending patent and
other disputes over Roches combination antiviral product
containing Roches version of ribavirin, known as Copegus.
Under the agreement, Roche may continue to register and
commercialize Copegus globally. The financial terms of this
settlement agreement include a license of ribavirin to Roche.
The license authorizes Roche to make, or have made, and to sell
Copegus. Roche pays royalty fees to us on its sales of Copegus
for use in combination with interferon alfa or pegylated
interferon alfa.
Approval of a generic form of oral ribavirin by the FDA in the
United States was announced on April 7, 2004, which has
resulted in a decrease in royalty revenues from the
U.S. market. With respect to Schering-Plough, effective
royalty rates increase in tiers based on increased sales levels
in the United States. As a result of reduced sales, the
likelihood of achieving the maximum effective royalty rate in
the United States is diminished. With respect to Roche, under
the license agreement, the introduction of generics in any
market eliminates the obligation of Roche to pay royalties for
sales in that market. Upon the entry of generics into the United
States, Roche ceased paying royalties on sales in the United
States. Schering-Plough announced its launch of generic version
of ribavirin. Under the license and supply agreement,
Schering-Plough is obligated to pay us royalties for sales of
their generic ribavirin.
Research and Development
We seek to discover, develop and commercialize innovative
products for the treatment of significant unmet medical needs,
principally in the areas of infectious diseases and cancer. Our
research and development activities are based upon accumulated
expertise developed through over 30 years of research
focused on the internal generation of novel molecules. These
efforts led to the discovery and development of ribavirin, an
antiviral drug that Schering-Plough and Roche market under
separate licenses from us, and which is the source of our
royalty income. We are also developing a pipeline of product
candidates, including two clinical programs, Viramidine and
pradefovir (formerly called remofovir), which target large
market opportunities. Additionally, we have identified a
potential IND candidate for the treatment of HIV.
As of December 31, 2004, there were 195 employees involved
in our research and development efforts. Our research and
development expenses for the years ended December 31, 2004,
2003 and 2002 were $92,496,000, $45,286,000 and $49,531,000,
respectively. Research and development expenses increased 104%
in 2004 due to the acceleration of clinical trials for
Viramidine and pradefovir and costs associated with the
completion of safety studies for Zelapar.
|
|
|
Products Under Development |
Viramidine: Viramidine is a nucleoside
(guanisine) analog that is converted into ribavirin by
adenosine deaminase in the liver. We intend to develop
Viramidine in oral form for the treatment of hepatitis C.
Preclinical studies indicate that Viramidine, a liver-targeting
analog of ribavirin, has antiviral and immunological activities
(properties) similar to ribavirin. In an animal model of
acute hepatitis, Viramidine
7
showed biologic activity similar to ribavirin. The
liver-targeting properties of Viramidine were also confirmed in
two animal models. Short-term toxicology studies show that
Viramidine may be safer than ribavirin at the same dosage
levels. This data suggests that Viramidine, as a liver-targeting
analog of ribavirin, may potentially be as effective and have a
lower incidence of anemia than ribavirin.
On January 20, 2005, we announced that we had completed
enrollment in VISER 2, a Phase 3 trial for Viramidine,
as well as an initial analysis of the sustained viral response
(SVR) information for our Viramidine Phase 2
proof-of-concept study compared to ribavirin. The results
validate the study design by continuing to show that Viramidine
demonstrates statistical comparable efficacy to ribavirin in SVR
and a significantly reduced incidence of anemia.
The Viramidine Phase 2 study, conducted entirely in the
United States, consisted of 180 treatment-naïve subjects
with chronic hepatitis C. The study was an open-label,
randomized, active control trial, with patients stratified by
genotype only. The study consisted of four comparable treatment
groups: Viramidine 400 mg BID (800 mg daily),
Viramidine 600 mg BID (1200 mg daily), Viramidine
800 mg BID (1600 mg daily) and ribavirin
1000/1200 mg daily, all in combination with peginterferon
alfa-2a. Treatment duration was based on genotype, with
genotypes two and three receiving 24 weeks of treatment and
genotype one receiving 48 weeks of treatment, with a
post-treatment follow-up period of 24 weeks. The 24-week
follow-up period is considered the medically therapeutic
standard evaluation of efficacy.
The final analyses of all Phase 2 data will be presented at
the European Association for the Study of the Liver Conference
in April 2005. The Phase 2 trial has met its design
objective by confirming the selection of the 600 mg BID
dose used in the two pivotal Phase 3 trials.
Pradefovir (formerly called remofovir): Pradefovir is a
compound that we licensed from Metabasis Therapeutics, Inc., or
Metabasis, in October 2001. We are developing this compound into
an oral once-a-day monotherapy for patients with chronic
hepatitis B infection. The active molecule in this compound
exhibits anti-hepatitis B activity against both the wild type
and Lamivudine drug-resistant hepatitis B. Based on biologic and
molecular modeling data, this compound binds to the active site
of the hepatitis B replication enzyme so that the virus is
prevented from utilizing the natural substrate from the host to
replicate. A prodrug modification developed by Metabasis
significantly improved the compounds physiochemical
properties and ability to target the liver. In preliminary
experiments in rodents, the active molecule was delivered in
significantly greater proportion to the targeted organ, the
liver, as compared to the non-targeted organ, the kidney. The
kidney is the organ responsible for the dose-limiting toxicity.
In these experiments, the amount of the active species,
adefovir, selectively delivered to the liver versus kidney was
approximately 10 times greater than the amount of compound
delivered by another well established process.
For pradefovir, we have completed three Phase 1 clinical
trials in a total of 87 healthy volunteers. A 48-week
dose-ranging Phase 2 study in Asia and the United States
began enrollment in July 2004 and completed enrollment in
November 2004.
Zelapar: We acquired the rights to Zelapar, a late-stage
candidate for the treatment of Parkinsons disease, in the
Amarin acquisition in February 2004. Zelapar is a late-stage
candidate under review by the FDA as an oral tablet using the
patented Zydis® fast-dissolving technology and is being
developed as an adjunct treatment in the management of patients
with Parkinsons disease being treated with
levodopa/carbidopa. We submitted a complete response to an
approvable letter from the FDA, following the successful
completion of two safety studies, in late 2004. We received a
response to our submission from the FDA that requires us to
provide them with additional information. We expect to launch
Zelapar in 2005.
Retigabine: We acquired the rights to retigabine, an
adjunctive treatment for partial-onset seizures in patients with
epilepsy, in the acquisition of Xcel Pharmaceuticals, Inc. on
March 1, 2005. Retigabine, successfully completed an
End-of-Phase 2 meeting with the FDA. The Phase 2
trials included more than 600 patients in several
dose-ranging studies compared to placebo. The results of the key
Phase 2 study indicate that the compound is potentially
efficacious with a demonstrated reduction in monthly seizure
rates of 23 to 35 percent as adjunctive therapy in patients with
partial seizures. Response rates in the two higher doses were
statistically significant compared to placebo (p<0.001). We
expect to initiate Phase 3 trials for retigabine in
8
the first half of 2005. Assuming successful completion of the
Phase 3 trials and approved by the FDA, we expect to launch
retigabine in early 2009.
Licenses and Patents (Proprietary Rights)
|
|
|
Data and Patent Exclusivity |
We rely on a combination of regulatory and patent rights to
protect the value of our investment in the discovery and
development of our products.
A patent is the grant of a property right which allows its
holder to exclude others from, among other things, selling the
subject invention in, or importing such invention into, the
jurisdiction that granted the patent. In both the United States
and the European Union, patents expire 20 years from the
date of application.
In the United States, for five years from the date of the first
United States regulatory FDA approval of a new drug compound,
only the pioneer drug company can use the data obtained at the
pioneers expense. No generic drug company may submit an
application for approval of a generic drug relying on the data
used by the pioneer for approval during this five year period.
A similar data exclusivity scheme exists in the European Union,
whereby only the pioneer drug company can use data obtained at
the pioneers expense for up to ten years from the date of
the approval of the first approval of a drug by the European
Agency for the Evaluation of Medicinal Products, or EMEA. Under
both the United States and the European Union data exclusivity
programs, products without patent protection can be marketed by
others so long as they repeat the clinical trials necessary to
show safety and efficacy.
|
|
|
Exclusivity Rights with Respect to Ribavirin |
The United States data exclusivity period for ribavirin has
expired.
Various parties are opposing our ribavirin patents in actions
before the European Patent Office, and we are responding to
these oppositions. These patents currently benefit from patent
extensions in the major European countries that provide market
protection until 2009. Should the opponents prevail, the
combination therapies marketed by Schering-Plough and Roche
would lose patent protection in Europe. Regardless of the
outcome of the oppositions, we believe these combination
therapies will continue to benefit from a period of data and
marketing protection in the major markets of the European Union
until 2009 for Schering-Plough and 2012 for Roche.
We have limited patent rights in Japan, which were extended to
2010.
|
|
|
Exclusivity Rights with Respect to Viramidine, Pradefovir
and Retigabine |
We expect to obtain five years of data exclusivity in the United
States and ten years in Europe, for Viramidine and pradefovir
upon regulatory approval.
We have a composition of matter patent on Viramidine that
expires in 2020. However, the structure of Viramidine was
disclosed many years ago, and, thus, we do not rely on
composition of matter claims. We own a United States
patent that claims Viramidine and rely on a second United States
patent that covers a mechanism of action of Viramidines
treatment of viral infection; those patents expire in 2018.
There is a patent application pending in the United States that
specifically claims the use of Viramidine to treat
hepatitis C infection, which, upon issuance, will expire in
2020. We are pursuing the foreign patent rights that are
counterparts of our United States patents to the extent
permitted in foreign jurisdictions.
We have, and rely on, exclusive rights in a United States patent
that claims pradefovir and related compounds that expires in
2019.
We own a United States patent that claims retigabine
independently of its specific form. This patent expires in 2013.
We also own two United States patents that claim specific
crystalline forms of retigabine, and these two patents expire in
2018 and 2019, respectively. In addition, we also own a number
of United States
9
patents and pending applications that claim the use of
retigabine to treat various indications. These patents have
expiration dates ranging from 2016 to 2019.
We have various issued patents or pending applications in
foreign countries. These patents or patent applications, if
issued, have expiration dates ranging from 2012 to 2023. We also
expect to obtain five years of data exclusivity in the United
States and ten years in Europe for retigabine upon regulatory
approval.
Government Regulations
We are subject to licensing and other regulatory control by the
FDA, other federal and state agencies, the EMEU and other
comparable foreign governmental agencies.
FDA approval must be obtained in the United States, EMEU
approval must be obtained for countries that are part of the
European Union and approval must be obtained from comparable
agencies in other countries prior to marketing or manufacturing
new pharmaceutical products for use by humans.
Obtaining FDA approval for new products and manufacturing
processes can take a number of years and involve the expenditure
of substantial resources. To obtain FDA approval for the
commercial sale of a therapeutic agent, the potential product
must undergo testing programs on animals, the data from which is
used to file an IND with the FDA. In addition, there are three
phases of human testing: Phase 1 consists of safety tests
for human clinical experiments, generally in normal, healthy
people; Phase 2 programs expand safety tests and are
conducted in people who are sick with the particular disease
condition that the drug is designed to treat; and Phase 3
programs are greatly expanded clinical trials to determine the
effectiveness of the drug at a particular dosage level in the
affected patient population. The data from these tests is
combined with data regarding chemistry, manufacturing and animal
toxicology and is then submitted in the form of an NDA to the
FDA. The preparation of an NDA requires the expenditure of
substantial funds and the commitment of substantial resources.
The review by the FDA can take up to several years. If the FDA
determines that the drug is safe and effective, the NDA is
approved. A similar process exists in the European Union and in
other countries. No assurance can be given that authorization
for commercial sale by us of any new drugs or compounds for any
application will be secured in the United States, the European
Union or any other country, or that, if such authorization is
secured, those drugs or compounds will be commercially
successful. The FDA in the United States the EMEU in the
European Union and other regulatory agencies in other countries
also periodically review approved drugs and inspect
manufacturing facilities.
We are subject to price control restrictions on our
pharmaceutical products in many countries in which we operate.
Future sales and gross profit could be materially affected if we
are unable to obtain price increases commensurate with the
levels of inflation.
Marketing and Customers
We market our pharmaceutical products in some of the most
developed pharmaceutical markets, as well as many developing
markets. We adjust our marketing strategies according to the
individual markets in which we operate. We believe our marketing
strategy is distinguished by flexibility, allowing us to
successfully market a wide array of pharmaceutical products
within diverse regional markets, as well as certain drugs on a
worldwide basis.
We focus on the major markets of the worldwide pharmaceutical
market share, namely the United States, the United Kingdom,
France, Canada, China, Italy, Poland, Germany, Spain and Mexico.
During the year ended December 31, 2004, we derived
approximately 74% of our specialty pharmaceutical sales from
these ten markets.
With the completion of the Xcel acquisition in March 2005,
we have a marketing and sales staff of approximately 1,500
persons who promote our pharmaceutical products. As part of our
marketing program for pharmaceuticals, we use direct mailings,
advertise in trade and medical periodicals, exhibit products at
medical conventions, sponsor medical education symposia and sell
through distributors in countries where we do not have our own
sales staff.
10
In the United States, Europe and Latin America, principally in
Mexico, Argentina and Brazil, we currently promote our
pharmaceutical products to physicians, hospitals, pharmacies and
wholesalers through our own sales force. These products are
typically distributed to drug stores and hospitals through
wholesalers. In Canada, we have our own sales force and promote
and sell directly to physicians, hospitals, wholesalers and
large drug store chains.
Competition
We operate in a highly competitive environment. Our competitors,
many of whom have substantially greater capital resources and
marketing capabilities and larger research and development
staffs and facilities, are actively engaged in marketing similar
products and developing new products similar to those we propose
to develop. We believe that many of our competitors spend
significantly more on research and development related
activities. Competitive factors vary by product line and
customer and include service, product availability and
performance, price and technical capabilities. Others may
succeed in developing products that are more effective than
those we presently market or propose for development. Progress
by other researchers in areas similar to those explored by us
may result in further competitive challenges.
We also face increased competition from manufacturers of generic
pharmaceutical products when patents covering certain of our
currently marketed products expire or are successfully
challenged. An adverse result in a patent dispute may preclude
commercialization of our products, or negatively impact sales of
existing products.
Manufacturing
We manufacture many of our pharmaceutical products at our
manufacturing plants around the world. We believe that we have
sufficient manufacturing facilities to meet our needs for the
foreseeable future. As a part of our plan to improve operational
performance, we approved a global manufacturing strategy during
the third quarter of 2003 to reduce the number of manufacturing
sites in our global manufacturing and supply chain network from
15 to five by 2006. As of December 31, 2004, we had
disposed of two of the sites and had a sale pending on an
additional site. For information about manufacturing
restructuring, see Note 4 of notes to consolidated
financial statements. All the manufacturing facilities that
require certification from the FDA or foreign agencies have
obtained such approval.
We also subcontract the manufacturing of certain of our
products, including products under the rights acquired from
other pharmaceutical companies. Generally, acquired products
continue to be produced for a specific period of time by the
selling company. During that time, we integrate the products
into our own manufacturing facilities or initiate toll
manufacturing agreements with third parties.
The principal raw materials used by us for our various products
are purchased in the open market. Most of these materials are
available from several sources. We have not experienced any
significant shortages in supplies of such raw materials.
Employees
As of December 31, 2004, we had 4,307 employees. These
employees include 2,116 in production, 1,372 persons in sales
and marketing, 195 in research and development, and 568 in
general and administrative positions. The majority of our
employees in Mexico, Spain, Holland and Hungary are covered by
collective bargaining or similar agreements. Substantially all
the employees in Europe are covered by national labor laws which
establish the rights of employees, including the amount of wages
and benefits paid and, in certain cases, severance and similar
benefits. We currently consider our relations with our employees
to be satisfactory and have not experienced any work stoppages,
slowdowns or other serious labor problems that have materially
impeded our business operations.
11
Product Liability Insurance
We do not currently have insurance with respect to most product
liability claims arising in the United States. We could be
exposed to possible claims for personal injury resulting from
allegedly defective products. In connection with the Amarin
acquisition, we acquired product liability insurance for Permax,
which we intend to maintain, as a result of this product being
subject to settled and pending product liability litigation. In
connection with the Xcel transaction, we have maintained their
product liability insurance while we evaluate the prospective
need for such coverage for Xcel products and our existing
products. While to date, no material adverse claim for personal
injury resulting from allegedly defective products has been
successfully maintained against us, a substantial claim, if
successful, could have a negative impact on our results of
operations and cash flows. We have in place clinical trial
insurance in the major markets that we conduct clinical trials.
Foreign Operations
Approximately 81% and 78% of our revenues from continuing
operations, which includes royalties, for the years ended
December 31, 2004 and 2003, respectively, were generated
from operations or earned outside the United States. All of our
foreign operations are subject to risks inherent in conducting
business abroad, including possible nationalization or
expropriation, price and currency exchange controls,
fluctuations in the relative values of currencies, political
instability and restrictive governmental actions. Changes in the
relative values of currencies occur from time to time and may,
in some instances, materially affect our results of operations.
The effect of these risks remains difficult to predict.
Our major facilities are in the following locations:
|
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|
|
|
|
|
|
|
|
|
|
Owned or | |
|
Square |
Location |
|
Purpose |
|
Leased | |
|
Footage |
|
|
|
|
| |
|
|
North America
|
|
|
|
|
|
|
|
|
Costa Mesa, California
|
|
Corporate headquarters and administrative offices and
R&D facilities |
|
|
Owned |
|
|
178,000 |
Humacao, Puerto Rico
|
|
Offices and manufacturing facility |
|
|
Owned |
|
|
415,000 |
Quebec, Canada**
|
|
Offices and manufacturing facility |
|
|
Owned |
|
|
93,519 |
|
Latin America
|
|
|
|
|
|
|
|
|
Mexico City, Mexico
|
|
Offices and manufacturing facility |
|
|
Owned |
|
|
324,308 |
|
Western Europe
|
|
|
|
|
|
|
|
|
Birsfelden, Switzerland
|
|
Offices and manufacturing facility |
|
|
Owned |
|
|
1,158,884 |
Tiszavasvari, Hungary*
|
|
Offices and manufacturing facility |
|
|
Owned |
|
|
1,417,446 |
Rzeszow, Poland
|
|
Offices and manufacturing facility |
|
|
Owned |
|
|
446,661 |
Warsaw, Poland**
|
|
Offices and manufacturing facility |
|
|
Owned |
|
|
108,790 |
|
|
* |
This facility is included in the consolidated financial
statements in discontinued operations. |
|
|
** |
We intend to dispose of these sites as part of our manufacturing
strategy. |
In our opinion, facilities occupied by us are more than adequate
for present requirements, and our current equipment is
considered to be in good condition and suitable for the
operations involved.
|
|
Item 3. |
Legal Proceedings |
See Note 13 of notes to consolidated financial statements.
12
|
|
Item 4. |
Submission of Matters to a Vote of Security Holders |
We did not submit any matters to a vote of security holders
during the quarter ended December 31, 2004.
PART II
|
|
Item 5. |
Market for Registrants Common Equity, Related
Stockholder Matters and Issuer Purchases of Equity
Securities |
Price Range of Common Stock
Our common stock is traded on the New York Stock Exchange
(Symbol: VRX). As of March 2, 2005, there were
5,584 holders of record of our common stock.
The following table sets forth the high and low sales prices of
our common stock on the New York Stock Exchange
Composite Transactions reporting system.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Fiscal Quarters |
|
High | |
|
Low | |
|
High | |
|
Low | |
|
|
| |
|
| |
|
| |
|
| |
First
|
|
$ |
26.66 |
|
|
$ |
20.95 |
|
|
$ |
12.87 |
|
|
$ |
8.35 |
|
Second
|
|
$ |
26.81 |
|
|
$ |
16.25 |
|
|
$ |
17.35 |
|
|
$ |
7.72 |
|
Third
|
|
$ |
24.49 |
|
|
$ |
16.75 |
|
|
$ |
18.99 |
|
|
$ |
14.66 |
|
Fourth
|
|
$ |
27.37 |
|
|
$ |
22.40 |
|
|
$ |
25.85 |
|
|
$ |
17.25 |
|
Dividend Policy
The Board of Directors declared cash dividends of
$0.0775 per share for each of the quarters during the years
ended December 31, 2004 and 2003.
The Board of Directors will continue to review our dividend
policy. The amount and timing of any future dividends will
depend upon our financial condition and profitability, the need
to retain earnings for use in the development of our business,
contractual restrictions and other factors. We are restricted on
the amount of dividends we can declare by covenants in the
7.0% senior notes due 2011.
Recent Sales of Unregistered Securities; Use of Proceeds from
Registered Securities
In 2004, 2003 and 2002, we issued the following equity
securities that were not registered under the Securities Act of
1933. In each instance, the securities were issued pursuant to
the private placement exemptions under Section 4(2) of the
Securities Act of 1933 and/or Regulation D promulgated
thereunder, based on the securities being issued to a limited
number of purchasers subject to restrictions on resale.
In November 2003, we issued $240.0 million aggregate
principal amount of 3.0% convertible subordinated notes due
2010 and $240.0 million aggregate principal amount of
4.0% convertible subordinated notes due 2013 for an
aggregate offering price of $480.0 million. The notes were
issued as two series of notes under a single indenture among us,
Ribapharm and the trustee. The convertible notes were sold to
the underwriters, Banc of America Securities LLC, Goldman
Sachs & Co., BNP Paribas and Wells Fargo
Securities, LLC. The Company received net cash consideration of
$423.9 million, which was net of underwriters
commissions of $13.2 million and a convertible note hedge
and written call option of $42.9 million. The notes of both
series are convertible into 15,184,128 shares of our common
stock based on a conversion rate of 31.6336 shares per
$1,000 principal amount of notes, subject to adjustment. Upon
conversion, we will have the right to satisfy our conversion
obligations by delivery, at our option, of either shares of our
common stock, cash or a combination thereof.
In connection with the offering of the 3.0% and
4.0% convertible subordinated notes, we entered into
convertible note hedge transactions with respect to our common
stock. The transaction consisted of us purchasing a call option
on 12,653,440 shares of our common stock at a strike price
of $31.61 and selling a written call option on
12,653,440 shares of our common stock at $39.52. The net
cost of the transaction was
13
$42.9 million. The convertible note hedge is expected to
reduce the potential dilution from conversion of the notes.
In January 2003, we issued 41,305 unregistered shares
valued at $0.5 million for consulting services rendered by
non-employees.
In April 2002, we acquired Circe Biomedicals, Inc., a
development stage company, for $25.9 million, of which
$5.9 million was paid in cash and the balance in 629,849
unregistered shares of our common stock. The shares were
registered under the Securities Act of 1933 in August 2002.
In February 2002, we acquired certain assets from CoolTouch
Corporation, a provider of non-ablative cosmetic lasers, for
1,492,331 unregistered shares of our common stock valued at
approximately $14.5 million. The shares were registered
under the Securities Act of 1933 in August 2002.
14
|
|
Item 6. |
Selected Financial Data |
The following table sets forth certain consolidated financial
data for the five years in the period ended December 31,
2004. The selected historical financial data for each of the
years in the five year period ended December 31, 2004 were
derived from the audited consolidated financial statements. This
information should be read in conjunction with Managements
Discussion and Analysis of Financial Condition and Results of
Operations and the Consolidated Financial Statements included
elsewhere in this Form 10-K.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
2001 | |
|
2000 | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands, except per share data) | |
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales
|
|
$ |
606,093 |
|
|
$ |
518,471 |
|
|
$ |
466,809 |
|
|
$ |
483,834 |
|
|
$ |
441,557 |
|
Royalties
|
|
|
76,427 |
|
|
|
167,482 |
|
|
|
270,265 |
|
|
|
136,989 |
|
|
|
155,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
682,520 |
|
|
|
685,953 |
|
|
|
737,074 |
|
|
|
620,823 |
|
|
|
596,657 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization)
|
|
|
200,313 |
|
|
|
184,669 |
|
|
|
157,013 |
|
|
|
149,554 |
|
|
|
143,303 |
|
Selling expenses
|
|
|
196,567 |
|
|
|
166,707 |
|
|
|
164,103 |
|
|
|
137,938 |
|
|
|
129,882 |
|
General and administrative expenses(1)
|
|
|
98,566 |
|
|
|
111,532 |
|
|
|
366,530 |
|
|
|
81,065 |
|
|
|
88,012 |
|
Research and development costs
|
|
|
92,496 |
|
|
|
45,286 |
|
|
|
49,531 |
|
|
|
28,706 |
|
|
|
16,383 |
|
Amortization expense
|
|
|
59,303 |
|
|
|
38,577 |
|
|
|
30,661 |
|
|
|
28,733 |
|
|
|
27,590 |
|
Restructuring charges(2)
|
|
|
19,344 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process research and development(3)
|
|
|
11,770 |
|
|
|
117,609 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses
|
|
|
678,359 |
|
|
|
664,380 |
|
|
|
767,838 |
|
|
|
425,996 |
|
|
|
405,170 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
4,161 |
|
|
|
21,573 |
|
|
|
(30,764 |
) |
|
|
194,827 |
|
|
|
191,487 |
|
Other income (loss), net including translation and exchange
|
|
|
141 |
|
|
|
4,727 |
|
|
|
8,707 |
|
|
|
3,084 |
|
|
|
(2,077 |
) |
Gain on sale of subsidiary stock(4)
|
|
|
|
|
|
|
|
|
|
|
261,937 |
|
|
|
|
|
|
|
|
|
Loss on early extinguishment of debt(5)
|
|
|
(19,892 |
) |
|
|
(12,803 |
) |
|
|
(25,730 |
) |
|
|
(32,916 |
) |
|
|
(4,962 |
) |
Interest income
|
|
|
12,432 |
|
|
|
8,888 |
|
|
|
5,644 |
|
|
|
9,473 |
|
|
|
12,483 |
|
Interest expense
|
|
|
(49,265 |
) |
|
|
(36,145 |
) |
|
|
(42,856 |
) |
|
|
(55,665 |
) |
|
|
(60,248 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations before income taxes,
and minority interest
|
|
|
(52,423 |
) |
|
|
(13,760 |
) |
|
|
176,938 |
|
|
|
118,803 |
|
|
|
136,683 |
|
Provision for income taxes(6)
|
|
|
83,597 |
|
|
|
39,463 |
|
|
|
74,963 |
|
|
|
42,078 |
|
|
|
34,408 |
|
Minority interest
|
|
|
233 |
|
|
|
11,763 |
|
|
|
17,730 |
|
|
|
174 |
|
|
|
(509 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations
|
|
|
(136,253 |
) |
|
|
(64,986 |
) |
|
|
84,245 |
|
|
|
76,551 |
|
|
|
102,784 |
|
Income (loss) from discontinued operations, net of taxes(7)
|
|
|
(33,544 |
) |
|
|
9,346 |
|
|
|
(197,288 |
) |
|
|
(12,417 |
) |
|
|
(12,604 |
) |
Cumulative effect of change in accounting principle(8)
|
|
|
|
|
|
|
|
|
|
|
(21,791 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss)
|
|
$ |
(169,797 |
) |
|
$ |
(55,640 |
) |
|
$ |
(134,834 |
) |
|
$ |
64,134 |
|
|
$ |
90,180 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Per share information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations basic
|
|
$ |
(1.62 |
) |
|
$ |
(0.78 |
) |
|
$ |
1.01 |
|
|
$ |
0.94 |
|
|
$ |
1.30 |
|
Discontinued operations
|
|
|
(0.40 |
) |
|
|
0.11 |
|
|
|
(2.37 |
) |
|
|
(0.15 |
) |
|
|
(0.16 |
) |
Cumulative effect of change in accounting principle
|
|
|
|
|
|
|
|
|
|
|
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per share basic
|
|
$ |
(2.02 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.62 |
) |
|
$ |
0.79 |
|
|
$ |
1.14 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations diluted
|
|
$ |
(1.62 |
) |
|
$ |
(0.78 |
) |
|
$ |
1.00 |
|
|
$ |
0.92 |
|
|
$ |
1.25 |
|
Discontinued operations
|
|
|
(0.40 |
) |
|
|
0.11 |
|
|
|
(2.35 |
) |
|
|
(0.15 |
) |
|
|
(0.15 |
) |
Cumulative effect of change in accounting principle
|
|
|
|
|
|
|
|
|
|
|
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) diluted
|
|
$ |
(2.02 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.61 |
) |
|
$ |
0.77 |
|
|
$ |
1.10 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dividends declared per share of common stock
|
|
$ |
0.31 |
|
|
$ |
0.31 |
|
|
$ |
0.31 |
|
|
$ |
0.30 |
|
|
$ |
0.29 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents(9)
|
|
$ |
222,590 |
|
|
$ |
410,019 |
|
|
$ |
202,647 |
|
|
$ |
317,011 |
|
|
$ |
155,205 |
|
Working capital
|
|
|
578,462 |
|
|
|
995,988 |
|
|
|
397,070 |
|
|
|
509,601 |
|
|
|
317,356 |
|
Net assets (liabilities) of discontinued operations(7)
|
|
|
(8,162 |
) |
|
|
8,263 |
|
|
|
153,762 |
|
|
|
267,482 |
|
|
|
240,939 |
|
Total assets(7)(8)
|
|
|
1,521,875 |
|
|
|
1,925,067 |
|
|
|
1,488,549 |
|
|
|
1,754,365 |
|
|
|
1,477,072 |
|
Total debt(5)
|
|
|
794,068 |
|
|
|
1,121,145 |
|
|
|
485,471 |
|
|
|
739,377 |
|
|
|
511,106 |
|
Stockholders equity(1)(2)(3)(4)(5)(6)(7)(8)
|
|
|
476,223 |
|
|
|
605,361 |
|
|
|
703,690 |
|
|
|
810,717 |
|
|
|
757,194 |
|
See accompanying Notes to Selected Financial Data.
15
Notes to Selected Financial Data:
|
|
(1) |
We recorded $239,965,000 and $4,034,000 of non-recurring and
other unusual charges, which are included in general and
administrative expenses, for the years ended December 31,
2002 and 2001, respectively. The non-recurring and other unusual
charges include compensation costs related to the change in
control, severance costs, expenses incurred in connection with
Ribapharms initial public offering, write-off of certain
assets, environmental clean-up costs and costs incurred in our
proxy contests in 2002 and 2001. |
|
(2) |
In the year ended December 31, 2004, we incurred an expense
of $19,344,000 related to the manufacturing and rationalization
plan. The manufacturing sites were tested for impairment in the
second quarter of 2004, resulting in an impairment of asset
value on three of the sites. Accordingly, we wrote these sites
down to their fair value and recorded impairment charges of
$18,000,000 and severance charges of $1,344,000 for the year
ended December 31, 2004. |
|
(3) |
In February 2004, we acquired from Amarin Corporation plc its
United States-based subsidiary, Amarin, and all of that
subsidiarys United States product rights. The total
consideration paid for Amarin was $40,000,000. In August 2003,
we repurchased the 20% publicly held minority interest in
Ribapharm for an aggregate total purchase price of $207,658,000.
In connection with these acquisitions, we expensed $11,770,000
and $117,609,000 in the years ended December 31, 2004 and
2003, respectively, associated with acquired in-process research
and development on projects that, as of the acquisition date,
had not yet reached technological feasibility and had no
alternative future use. |
|
(4) |
In April 2002, we completed an underwritten public offering of
29,900,000 shares of common stock, par value of
$0.01 per share, of Ribapharm, previously a wholly-owned
subsidiary, representing 19.93% of the total outstanding common
stock of Ribapharm. In connection with Ribapharms public
offering, we recorded a gain on the sale of Ribapharms
stock of $261,937,000, net of offering costs. |
|
(5) |
In May and July 2004, we repurchased $326,001,000 aggregate
principal amount of our
61/2% Convertible
Subordinated Notes due 2008. In connection with these
repurchases, we recorded a loss on early extinguishment of debt
of $19,892,000 for the year ended December 31, 2004. |
|
|
|
In November 2003, we completed an offering of
$240,000,000 aggregate principal amount of
3.0% Convertible Subordinated Notes due 2010 and
$240,000,000 aggregate principal amount of
4.0% Convertible Subordinated Notes due 2013. We used
proceeds from this offering to retire
$139,589,000 aggregate principal amount of our
61/2% Convertible
Subordinated Notes due 2008, resulting in a loss on early
extinguishment of debt of $12,803,000. In December 2003, we
issued $300,000,000 aggregate principal amount of
7.0% Senior Notes due 2011. |
|
|
In April 2002, we used the proceeds of the Ribapharm offering to
complete our tender offer and consent solicitation for all of
our outstanding
83/4% Senior
Notes due 2008. The repurchase of these notes resulted in a loss
on extinguishment of debt of $43,268,000. In July and August
2002, we repurchased $59,410,000 principal amount of our
61/2% Convertible
Subordinated Notes due 2008. In connection with these
repurchases, we recorded a gain on early extinguishment of debt
of $17,538,000. The net loss on extinguishment of debt was
$25,730,000 for the year ended December 31, 2002. |
|
|
In July 2001, we issued $525,000,000 aggregate principal
amount of
61/2% Convertible
Subordinated Notes due 2008. During 2001, we repurchased
$117,559,000 aggregate principal amount of our outstanding
83/4% Senior
Notes due 2008 and repurchased $190,645,000 aggregate
principal amount of our
91/4% Senior
Notes due 2005, resulting in a loss on early extinguishment of
debt of $32,916,000. |
|
|
During 2000, we repurchased $84,355,000 of our outstanding
91/4% Senior
Notes due 2005 and $12,830,000 of our outstanding
83/4% Senior
Notes due 2008. The repurchases generated a loss on early
extinguishment of debt of $4,962,000. |
|
|
(6) |
During the fourth quarter of 2004, we recorded a valuation
allowance of $95,648,000 against our deferred tax asset to
recognize the uncertainty of realizing the benefits of our
accumulated U.S. net operating losses and research credits. |
16
|
|
(7) |
During 2002, we made the decision to divest our Russian
pharmaceuticals segment, biomedical segment, raw materials
business and manufacturing capability in Central Europe,
photonics business and Circe unit. This decision required us to
evaluate the carrying value of the divested businesses in
accordance with the Statement of Accounting Standard
(SFAS) No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets. As a result of
the analysis, we recorded impairment charges of $160,010,000
(net of an income tax benefit of $48,193,000) in the year ended
December 31, 2002. The results of operations and the
financial position of the divested businesses have been
reflected as discontinued operations. |
|
(8) |
During 2002, we completed the transitional impairment test
required by SFAS No. 142, Goodwill and Other
Intangible Assets. As a result, we recorded an impairment
loss of $25,332,000 offset by a benefit of $3,541,000 for the
write-off of negative goodwill. The net amount of $21,791,000
has been recorded as a cumulative effect of change in accounting
principle. |
|
(9) |
We have reclassified our auction rate securities, previously
classified as cash equivalents, as short-term investments on our
consolidated balance sheet as of December 31, 2003 and
2002. This resulted in a reclassification from cash and cash
equivalents to short-term investments of $463,962,000 and
$42,537,000 as of December 31, 2003 and 2002, respectively. |
17
|
|
Item 7. |
Managements Discussion and Analysis of Financial
Condition and Results of Operations |
Overview
We are a global, research-based specialty pharmaceutical company
that discovers, develops, manufactures and markets a broad range
of pharmaceutical products. We focus our greatest resources and
attention principally on ten global brands in the therapeutic
areas of neurology, infectious disease and dermatology. Our
products are currently sold in more than 100 markets around the
world, with our primary focus on ten key geographic regions: the
United States, Canada, Mexico, the United Kingdom, France,
Italy, Poland, Germany, Spain and China.
Our two primary value drivers are: a specialty pharmaceutical
business with a global platform, and a research and development
infrastructure with strong discovery, clinical development and
regulatory capabilities. We believe that our global reach and
fully integrated research and development capability make us
unique among specialty pharmaceutical companies, and provide us
with the ability to take compounds from discovery through the
clinical stage and commercialize them in major markets around
the world. In addition, we receive royalties from the sale of
ribavirin by Schering-Plough and Roche, although such royalties
represent a much smaller contribution to our revenues than they
have in the past.
In its discussion of the material changes in our financial
condition and results of operations between the reporting
periods in the consolidated financial statements, management has
sought to identify and, in some cases, quantify, the factors
that contributed to such material changes. However, quantifying
these factors may involve the presentation of numerical measures
that exclude amounts that are included in the most directly
comparable measure calculated and presented in accordance with
accounting principles generally accepted in the United States
(GAAP). Management uses this information to assess
material changes in our financial condition and results of
operations and is providing it to assist investors and potential
investors to understand these assessments. In each instance,
such information is presented immediately following (and in
connection with an explanation of) the most directly comparable
financial measure calculated in accordance with GAAP, and
includes other material information necessary to reconcile the
information with the comparable GAAP financial measure.
Specialty Pharmaceuticals
Specialty pharmaceutical product sales accounted for 89% and 76%
of our total revenues from continuing operations for the years
ended December 31, 2004 and 2003, respectively, and
increased $87,622,000 (17%) in the year ended December 31,
2004 compared to the similar period in 2003. The increase in
specialty pharmaceutical product sales was due to approximately
a 7% increase in volume, a 6% increase due to changes in selling
prices and a 4% favorable impact from foreign exchange rate
fluctuations.
Our specialty pharmaceutical business focuses its efforts on ten
global brands in our three therapeutic areas. Seven of these
global brands are currently being marketed. Our future growth is
expected to be driven primarily by growth of our existing
products, the commercialization of new products and business
development. Our seven global brands accounted for 23% and 21%
of our specialty pharmaceutical product sales for the years
ended December 31, 2004 and 2003, respectively. Sales of
our global brands increased $26,982,000 (24%) in the year ended
December 31, 2004 compared to the similar period in 2003.
We have experienced generic challenges and other competition to
our products, as well as pricing challenges through government
imposed price controls and reductions, and expect these
challenges to continue in 2005 and beyond.
Research and Development
We seek to discover, develop and commercialize innovative
products for the treatment of significant unmet medical needs,
principally in the areas of infectious diseases and cancer. Our
research and development activities are based upon accumulated
expertise developed through over 30 years of research
focused on the internal generation of novel molecules. These
efforts led to the discovery and development of ribavirin, an
antiviral drug that Schering-Plough and Roche market under
separate licenses from us, and which is the source of our
royalty income.
18
We are also developing a pipeline of product candidates,
including three clinical stage programs, Viramidine, pradefovir
(formerly called remofovir) and retigabine, which target large
market opportunities. Viramidine is a pro-drug of ribavirin, for
the treatment of chronic hepatitis C in treatment-naive
patients in conjunction with a pegylated interferon. We are
developing pradefovir as an oral once-a-day monotherapy for
patients with chronic hepatitis B infection. With the
acquisition of Xcel Pharmaceutical, Inc. (Xcel) in
March of 2005, another product candidate, retigabine, has been
added to our pipeline. Retigabine is being developed as an
adjunctive treatment for partial-on-set seizures in patients
with epilepsy. We expect research and development expenses to
increase in 2005.
Ribavirin Royalties
Ribavirin royalty revenues decreased $91,055,000 (54%) and
accounted for 11% of our total revenues from continuing
operations for the year ended December 31, 2004 as compared
to 24% in 2003. The decline in ribavirin royalty revenues, and
the decreasing contribution of royalties to our revenues, had
been expected with the entry of generic ribavirin in the United
States. We expect ribavirin royalties to be somewhat stable for
several years since generics are unlikely to enter the major
European countries and Japanese markets due to certain
protections in those markets through 2009 and 2010,
respectively, and would expect to see declines as a result of
alternative therapies such as Viramidine when and if approved.
Company Strategy
We have undergone significant changes in our leadership,
strategic direction and operations since 2002. In an effort to
drive change, our stockholders elected new directors at our
annual meetings in 2001 and 2002, resulting in a new Board
composition and the appointment of a new senior management team.
A three-part plan was initiated to restructure our company,
transform the business and grow through innovation. We have made
significant progress in the execution of this plan, including
completion of our restructuring phase that entailed a
divestiture program, the restructuring of the management team,
the implementation of strong governance protocols and the
strengthening of our research and development capability. The
key elements of our strategy include the following:
|
|
|
Targeted Growth of Existing Products. We focus our
business on ten key geographic regions, across three core
therapeutic areas and ten global brands. We believe that our
core therapeutic areas are positioned for further growth and
that it is possible for a mid-sized company to attain a
leadership position within these categories. Furthermore, we
believe that our global brands have the potential for further
worldwide penetration and above industry average growth rates.
In addition, we intend to continue to market and sell, and
selectively pursue life cycle management strategies for, our
regional and local brands. |
|
|
Efficient Manufacturing and Supply Chain Organization.
Under our global manufacturing strategy announced in October
2003, we plan to reduce the number of manufacturing facilities
from 15 to five by 2006, in order to increase capacity
utilization and improve efficiencies. We have also undertaken a
major process improvement initiative, affecting all phases of
our operations, from raw material and supply logistics, to
manufacturing, warehousing and distribution. We have made
significant progress towards our plans of disposing of certain
manufacturing sites and are currently actively marketing the
sites to prospective buyers. The sites were tested for
impairment, resulting in impairment of asset value on three of
the sites. Accordingly, we wrote these sites down to their fair
value and recorded an impairment charge of $18,000,000 for the
year ended December 31, 2004. In addition, to the
impairment charge, we recorded $1,344,000 in restructuring and
impairment charges related to severance for the year ended
December 31, 2004. See Note 4 of notes to consolidated
financial statements for a discussion of the manufacturing
restructuring plan. |
|
|
Development of New Products via Internal Research and
Development Activities. We seek to discover, develop and
commercialize innovative products for the treatment of
significant unmet medical needs, principally in the areas of
infectious disease and cancer. We intend to combine our
scientific |
19
|
|
|
expertise with advanced drug screening techniques in order to
discover and develop new product candidates. |
|
|
Product Acquisitions. We plan to selectively license or
acquire product candidates, technologies and businesses from
third parties which complement our existing business and provide
for effective life cycle management of key products. We believe
that our drug development expertise may allow us to recognize
licensing opportunities and to capitalize on research initially
conducted and funded by others. During 2004, we acquired the
rights to three products indicated for the treatment of
Parkinsons disease. See Note 2 of notes to
consolidated financial statements for a discussion of these
acquisitions. |
Results of Operations
We have four reportable specialty pharmaceutical segments
comprising our pharmaceuticals operations in North America,
Latin America, Europe and Asia, Africa and Australia. In
addition, we have a research and development division. Certain
financial information for our business segments is set forth
below. This discussion of our results of operations should be
read in conjunction with the consolidated financial statements
included elsewhere in this document. For additional financial
information by business segment, see Note 14 of notes to
consolidated financial statements included elsewhere in this
document.
The following table compares revenues by reportable segments and
operating expenses for the years ended December 31, 2004,
2003 and 2002 (in thousands, except percentages):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
$ |
142,799 |
|
|
$ |
99,074 |
|
|
$ |
90,011 |
|
|
Latin America
|
|
|
151,726 |
|
|
|
136,008 |
|
|
|
135,527 |
|
|
Europe
|
|
|
253,748 |
|
|
|
232,031 |
|
|
|
189,925 |
|
|
Asia, Africa, Australia
|
|
|
57,820 |
|
|
|
51,358 |
|
|
|
51,346 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
606,093 |
|
|
|
518,471 |
|
|
|
466,809 |
|
Ribavirin royalties
|
|
|
76,427 |
|
|
|
167,482 |
|
|
|
270,265 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
682,520 |
|
|
|
685,953 |
|
|
|
737,074 |
|
|
|
|
|
|
|
|
|
|
|
Costs and Expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization)
|
|
|
200,313 |
|
|
|
184,669 |
|
|
|
157,013 |
|
Selling expenses
|
|
|
196,567 |
|
|
|
166,707 |
|
|
|
164,103 |
|
General and administrative expenses
|
|
|
98,566 |
|
|
|
111,532 |
|
|
|
366,530 |
|
Research and development costs
|
|
|
92,496 |
|
|
|
45,286 |
|
|
|
49,531 |
|
Acquired IPR&D
|
|
|
11,770 |
|
|
|
117,609 |
|
|
|
|
|
Restructuring charges
|
|
|
19,344 |
|
|
|
|
|
|
|
|
|
Amortization expense
|
|
|
59,303 |
|
|
|
38,577 |
|
|
|
30,661 |
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss)
|
|
$ |
4,161 |
|
|
$ |
21,573 |
|
|
$ |
(30,764 |
) |
|
|
|
|
|
|
|
|
|
|
Gross profit on product sales (excluding amortization)
|
|
$ |
405,780 |
|
|
$ |
333,802 |
|
|
$ |
309,796 |
|
|
|
|
|
|
|
|
|
|
|
Gross profit margin on product sales
|
|
|
67 |
% |
|
|
64 |
% |
|
|
66 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2004 Compared to 2003 |
Specialty Pharmaceutical Revenues: Specialty
pharmaceutical product sales increased $87,622,000 (17%) for the
year ended December 31, 2004 over 2003. The increases were
led by continued improvements
20
in sales of our global brands, which contributed $26,982,000 to
the increase in product sales for the year ended
December 31, 2004. In addition, favorable foreign currency
exchange rates contributed $20,936,000 on a net basis to the
increase in overall product sales for the year ended
December 31, 2004 primarily due to the increase in the
value of the Euro over the U.S. Dollar. Additionally, the
Amarin acquisition contributed $15,100,000 to product sales in
the year ended December 31, 2004.
In our North America pharmaceuticals segment, revenues for the
year ended December 31, 2004 were $142,799,000 compared to
$99,074,000 for 2003, an increase of $43,725,000 (44%). The
increase reflects higher sales of Efudex® of $17,753,000
primarily related to the launch of a 40 gram product and sales
of products related to the Amarin and Tasmar acquisitions of
$17,491,000. Additionally, the increase in revenues in 2004 as
compared to 2003 partially reflects depressed 2003 sales due to
the inventory reduction program at our wholesalers in 2003,
which was completed in April 2003. The increases are partially
offset by a decrease in sales of Mestinon of $4,392,000,
primarily due to generic competition.
In our Latin America pharmaceuticals segment, revenues for the
year ended December 31, 2004 were $151,726,000 compared to
$136,008,000 for 2003, an increase of $15,718,000 (12%). The
increase was primarily due to price increases and in some cases
lower discounts offered to wholesalers in the region aggregating
$17,680,000, partially offset by a decrease in the value of
currencies in the region as compared to the U.S. Dollar of
$4,406,000. Revenues from Bedoyecta, which is our highest
revenue product in Mexico, were $30,654,000 for 2004, an
increase of $3,699,000 (14%) as compared to 2003.
In our Europe pharmaceuticals segment, revenues for the year
ended December 31, 2004 were $253,748,000 compared to
$232,031,000 for 2003, an increase of $21,717,000 (9%). The
increase in the value of currencies in the region as compared to
the U.S. Dollar contributed $21,082,000 to the increase in
revenues in the region for the year ended December 31,
2004. Sales in Europe were negatively affected by government
imposed price controls primarily in Spain, Germany and Italy,
partially offset by an increase in sales in Poland and Central
Europe.
In our Asia, Africa and Australia (AAA)
pharmaceuticals segment, revenues for the year ended
December 31, 2004 were $57,820,000 compared to $51,358,000
for 2003, an increase of $6,462,000 (13%). The increase reflects
higher sales of Nyal of $2,935,000 and an increase in the value
of currencies in the region as compared to the U.S. Dollar
of $2,563,000.
Ribavirin Royalties: Ribavirin royalties represent
amounts earned under the license and supply agreements with
Schering-Plough and Roche. Under a license and supply agreement,
Schering-Plough licensed all oral forms of ribavirin for the
treatment of chronic hepatitis C. We receive royalty fees
from Roche under a license agreement on sale of Roches
version of ribavirin, Copegus, for use in combination with
interferon alfa or pegylated interferon alfa.
Ribavirin royalties from Schering-Plough and Roche for the year
ended December 31, 2004 were $76,427,000 compared to
$167,482,000 for 2003, reflecting a decrease of $91,055,000
(54%). The decrease in ribavirin royalties include the effects
of the launch of generic ribavirin in the United States and
increasing competition between Schering-Plough and Roche.
Approval of a generic form of oral ribavirin by the
U.S. Food and Drug Administration (FDA) in the
United States was announced on April 7, 2004. Competition
from generic pharmaceutical companies has had, and is expected
to continue to have, a material negative impact on our royalty
revenue. With respect to Schering-Plough, royalty rates increase
in tiers based on increased sales levels in the United States.
As a result of reduced sales, the likelihood of achieving the
maximum effective royalty rate in the United States is
diminished. With respect to Roche, under the license agreement,
the introduction of generics in any market eliminates the
obligation of Roche to pay royalties for sales in that market.
Upon the entry of generics into the United States on
April 7, 2004, Roche ceased paying royalties on sales in
the United States. Schering-Plough announced its launch of a
generic version of ribavirin. Under the license and supply
agreement, Schering-Plough is obligated to pay us royalties for
sales of their generic ribavirin.
We rely on a limited amount of financial information provided by
Schering-Plough and Roche to estimate the amounts due to us
under the royalty agreements. Based upon the information
provided by Schering-
21
Plough for the fourth quarter of 2004, Schering-Ploughs
sales of Rebetol in the United States were negative. As a result
of the uncertainty with royalties associated with sales of
Rebetol in the United States, a reserve has been established for
the potential impact of returns; however, due to the limited
information provided by Schering-Plough, there can be no
assurance that such amounts will be adequate to cover additional
negative royalty amounts in future periods.
Gross Profit Margin: Gross profit margin on product sales
for the year ended December 31, 2004 was 67% compared to
64% in 2003. The increase in gross profit margin is primarily
due to an increase in sales in the North America region, which
generates higher profit margins, and greater efficiencies in our
global manufacturing and supply chain operations, partially
offset by an increase in costs related to the manufacturing
rationalization plan.
Selling Expenses: Selling expenses were $196,567,000 for
the year ended December 31, 2004 compared to $166,707,000
for 2003, an increase of $29,860,000 (18%). As a percent of
product sales, selling expenses were 32% for the years ended
December 31, 2004 and 2003. Included in selling expenses
for the year ended December 31, 2004 were severance charges
of $3,611,000 related to a sales force reduction in Europe. The
increase in selling expenses reflects our increased promotional
efforts primarily in Europe, North America and Latin America and
includes costs related to new product launches and unified
promotional materials and campaigns for our global products.
General and Administrative Expenses: General and
administrative expenses were $98,566,000 for the year ended
December 31, 2004 compared to $111,532,000 for 2003, a
decrease of $12,966,000 (12%). As a percent of product sales,
general and administrative expenses were 16% for the year ended
December 31, 2004 compared to 22% for 2003. Included in
general and administrative expenses for the year ended
December 31, 2004 were severance charges of $651,000
related to workforce reductions in Spain and $3,225,000 related
to the settlement of a bondholder suit, partially offset by a
$2,500,000 insurance refund. The decrease in general and
administrative expenses was primarily due to reduced legal fees.
While steps continue to be taken to more effectively manage
legal costs, legal fees can vary from period to period based on
the level of activity surrounding outstanding legal challenges.
Research and Development: Research and development
expenses were $92,496,000 for the year ended December 31,
2004 compared to $45,286,000 for 2003, an increase of
$47,210,000 (104%). The increase in research and development
expenses was primarily attributable to the acceleration of
clinical trials for Viramidine and pradefovir and costs
associated with the completion of safety studies for Zelapar. We
completed enrollment of two Phase 3 studies for Viramidine
and a Phase 2 study for pradefovir. It is expected that
research and development expenses will increase in 2005 compared
to 2004 as progress continues with the clinical trials of
Viramidine, pradefovir and retigabine.
Acquired In-Process Research and Development: In the year
ended December 31, 2004, we incurred an expense of
$11,770,000 associated with IPR&D related to the acquisition
of Amarin that occurred in February 2004. In the year ended
December 31, 2003, we incurred an expense of $117,609,000
associated with IPR&D related to the acquisition of
Ribapharm. The amount expensed as IPR&D represents our
estimate of fair value of purchased in-process technology for
projects that, as of the acquisition date, had not yet reached
technological feasibility and had no alternative future use. In
connection with the Xcel acquisition we expect to expense
approximately $125,000,000 as IPR&D in the first quarter of
2005.
Restructuring and Impairment Charges: In the year ended
December 31, 2004, we incurred an expense of $19,344,000
related to the manufacturing and rationalization plan. We have
made significant progress towards our plans of disposing of the
manufacturing sites and are actively marketing the sites to
prospective buyers. The sites were reassessed for impairment in
the second quarter of 2004 because we accelerated our plan of
disposing of the sites. This impairment analysis resulted in
impairment of asset value on three of the sites. Accordingly, we
wrote these sites down to their fair value and recorded an
impairment charge of $18,000,000 for the year ended
December 31, 2004. In addition to the impairment charge, we
recorded $1,344,000 related to severance for the year ended
December 31, 2004.
22
Amortization: Amortization expense was $59,303,000 for
the year ended December 31, 2004 compared to $38,577,000
for 2003, an increase of $20,726,000 (54%). The increase was
primarily due to amortization of intangibles related to the
acquisitions of Ribapharm, Amarin and Tasmar of $16,327,000 for
the year ended December 31, 2004. Additionally, we recorded
impairment charges of $4,797,000 during the year ended
December 31, 2004, primarily related to products sold in
Italy for which the patent life was reduced by a decree by the
Italian government.
Other Income, Net, Including Translation and Exchange:
Other income, net, including translation and exchange was
$141,000 for the year ended December 31, 2004 compared to
$4,727,000 for 2003. In the year ended December 31, 2004,
translation gains principally consisted of translation and
exchange gains in Europe, AAA and Latin America of $908,000,
partially offset by translation and exchange losses in North
America of $767,000. Translation and exchange gains are
primarily related to U.S. Dollar denominated assets and
liabilities at our foreign currency denominated subsidiaries.
Loss on Early Extinguishment of Debt: Loss on early
extinguishment of debt for the years ended December 31,
2004 and 2003 were $19,892,000 and $12,803,000, respectively,
related to the repurchase of $326,001,000 and $139,589,000
aggregate principal amount of our
61/2% Convertible
Subordinated Notes due 2008, respectively.
Interest Expense and Income: Interest expense increased
$13,120,000 during the year ended December 31, 2004
compared to 2003. The increase was due to the issuance of
$480,000,000 aggregate principal amount of 3.0% and
4.0% Convertible Subordinated Notes and $300,000,000
aggregate principal amount of 7.0% Senior Notes in the
fourth quarter of 2003. We repurchased all of our
61/2% Convertible
Subordinated Notes due 2008 in July 2004, which decreased
interest expense in 2004. Interest income increased $3,544,000
during the year ended December 31, 2004 compared to 2003
due primarily to higher cash balances in our interest-bearing
accounts during those periods.
Income Taxes: Our effective income tax rate for the year
ended December 31, 2004 was a provision of 159% compared to
a provision of 287% for 2003. Our effective tax rate for the
year ended December 31, 2004 was affected significantly by
an increase of $95,648,000 in the valuation allowance to
recognize the uncertainty of realizing the benefits of the
United States net operating losses and research credits. It was
also affected by pre-tax losses resulting from restructuring and
impairment charges of $19,344,000 and from a work force
reduction in Europe of $4,262,000, for which we recorded a
minimal tax benefit of $1,451,000 (7%). This minimal tax benefit
reflects the uncertainty of the realization of tax benefits in
some of the jurisdictions in which these charges were incurred.
Additionally, we recorded a tax provision of $1,828,000 related
to the settlement of a tax dispute with Puerto Rico in the year
ended December 31, 2004. Excluding the effect of these
items, the 2004 effective tax rate would have been 43%. The
higher effective tax rate in 2004 reflects a shift in the mix of
taxable income with more income from higher tax jurisdictions.
Our effective tax rate for 2003 was affected by pre-tax losses
resulting from the write-off of acquired IPR&D expenses in
connection with the Ribapharm acquisition, which is not
deductible for tax purposes. Excluding the effect of the
acquired IPR&D write-off, the effective tax rate would have
been 38% for the year ended December 31, 2003.
A majority of our deferred tax assets represent United States
net operating losses and research credits. A valuation allowance
was recorded in the fourth quarter for the entire domestic net
deferred tax asset. The consolidated reporting group in the
United States has been operating at a loss in recent quarters
due to increased investments in research and development and
lower royalties. Several strategies have been pursued that would
enable us to utilize the net operating losses and other deferred
tax assets. However, during the fourth quarter, we determined
that one of the strategies that involved selling certain product
rights to an unrelated party did not make economic sense at
levels proposed and discontinued the effort. We believe the tax
assets will be realized through the successful commercialization
of Viramadine, however, there is insufficient objective evidence
at this time to recognize these assets for financial reporting
purposes. A minimum of $277,565,000 of future taxable income
will need to be generated to realize the net operating losses
and tax credits. Strategies that would cause the United States
assets to be utilized sooner than 2008 without reliance on
future operating income are being considered. The valuation
allowance will be reduced in the future if the forecast for
future taxable income is realized or other strategies are
implemented. Ultimate
23
realization of the benefit of the United States net operating
losses and research credits is dependent upon us generating
sufficient taxable income prior to their expiration.
Historically, there have not been significant differences
between financial reporting pretax earnings and taxable income.
Approximately, $168,800,000 of the United States net operating
loss carryforwards arose from discontinued operations and the
disposition of those operations that occurred during 2002 and
2003. Of the United States losses generated to date, $19,289,000
will expire in 2008. The remaining $231,000,000 begins to expire
in 2023.
Income (Loss) from Discontinued Operations: Income (loss)
from discontinued operations was a loss of $33,544,000 for the
year ended December 31, 2004 compared to income of
$9,346,000 for 2003. The loss in 2004 includes environmental
charges of $16,000,000 related to a former operating site of our
Biomedicals division, for which we retained the liability when
we sold this business. The remaining portion relates to losses
from our raw materials businesses and manufacturing capability
in Central Europe. The income in 2003 includes a net gain on
disposal of discontinued operations of $6,582,000 and income
from discontinued operations of $2,764,000.
|
|
|
Year Ended December 31, 2003 Compared to 2002 |
Specialty Pharmaceutical Revenues: Overall, we
experienced an increase in sales of pharmaceutical products of
$51,662,000 (11%) for the year ended December 31, 2003 over
2002. Foreign currency contributed $22,105,000 on a net basis to
the increase in overall product sales primarily due to the
increase in the value of the Euro over the U.S. Dollar.
Sales from our seven global brands increased $25,967,000 (28%)
for the year ended December 31, 2003 over 2002, with 34% of
this increase being attributed to increased sales of Mestinon
worldwide. Generic competition entered the market in 2003
against Mestinon in the United States, but we continued to
benefit by patent protection in Europe and the rest of the world.
In our North America pharmaceuticals segment, revenues for the
year ended December 31, 2003 were $99,074,000 compared to
$90,011,000 for 2002, an increase of $9,063,000 (10%). The
increase was primarily due to the completion of an inventory
reduction program at our wholesalers in 2003, which we began in
June 2002 and completed in April 2003. This resulted in higher
sales volume, especially in dermatological products and
Mestinon. The growth in revenues was also attributable to
product price increases in the U.S.
In our Latin America pharmaceuticals segment, revenues for the
year ended December 31, 2003 were $136,008,000 compared to
$135,527,000 for 2002, an increase of $481,000. Revenues in
Latin America were affected by an 8% decrease in the value of
currencies in the region aggregating $11,316,000. Excluding the
impact of currencies compared to the U.S. Dollar, revenues
in Latin America increased by 9%, with approximately 6% of the
increase being due to price increases throughout the region.
Additionally, revenues in 2003 benefited by volume increases in
various products.
In our Europe pharmaceuticals segment, revenues for the year
ended December 31, 2003 were $232,031,000 compared to
$189,925,000 for 2002, an increase of $42,106,000 (22%). The
increase in the value of currencies in the region as compared to
the U.S. Dollar contributed $26,533,000 (63%) to the
increase in revenues in the region. Additionally, excluding the
effect of currencies, revenues in Poland increased $10,003,000
and revenues in Spain increased $3,083,000 primarily due to
price increases and new product launches. Revenues in 2003 were
negatively affected by the impact of German health care reform,
reference-pricing litigation in Spain and price controls in
Italy.
In our Asia, Africa and Australia, or AAA, pharmaceuticals
segment, revenues for the year ended December 31, 2003 were
$51,358,000 compared to $51,346,000 for 2002, an increase of
$12,000. Revenues in AAA were affected by an increase in the
value of currencies in the region of $4,202,000, offset by lower
sales volume in several products including Fefol®,
Coracten® and Reptilase®. Reptilase sales were
negatively impacted by licensing and renewal issues, which have
been resolved.
Ribavirin Royalties: Ribavirin royalties in 2002
represent amounts earned under the license and supply agreement
with Schering-Plough and for fiscal 2003, under a license
agreement with Roche in addition to the license and supply
agreement with Schering Plough. Ribavirin royalties for the year
ended December 31, 2003
24
from Schering-Plough and Roche were $167,482,000 compared to
$270,265,000 for 2002, a decrease of $102,783,000 (38%). The
decrease in royalties included the effects of increasing
competition between Schering-Plough and Roche, and
Schering-Ploughs provision for estimated rebates on its
U.S. sales of ribavirin and changes in trade inventory
levels as reported to us by Schering-Plough.
Gross Profit Margin: Gross profit margin on product sales
decreased to 64% for the year ended December 31, 2003
compared to 66% in 2002. The decrease in gross profit is
primarily due to costs related to our manufacturing
rationalization project incurred in 2003. These costs reflect
the impact of accelerated depreciation charges of $1,609,000 and
severance charges of $2,400,000 associated with the
rationalization effort.
Selling Expenses: Selling expenses were $166,707,000 for
the year ended December 31, 2003 compared to $164,103,000
for 2002, an increase of $2,604,000 (2%). The increase reflects
our increased promotional efforts, mainly in Europe of
$7,004,000 primarily related to the launch of Dermatix and the
impact of changes in currencies, partially offset by a decrease
in selling expenses in our North America pharmaceuticals segment
of $2,650,000.
General and Administrative Expenses: General and
administrative expenses were $111,532,000 for the year ended
December 31, 2003 compared to $366,530,000 for 2002, a
decrease of $254,998,000 (70%). Included in general and
administrative expenses for the year ended December 31,
2002, are non-recurring and other unusual charges of
$239,965,000, which primarily include: stock compensation costs
related to the change of control under our Option Plan
($61,400,000); severance costs ($54,216,000); incentive
compensation costs related to the accelerated vesting of
restricted stock upon the change of control under our Long-Term
Incentive Plan ($12,022,000); executive and director bonuses
paid in connection with Ribapharms public offering
($47,839,000); professional fees related to Ribapharm
($13,000,000); the write-off of ICN International AG capitalized
offering costs ($18,295,000); the write-down of certain assets
($15,045,000); costs incurred in the 2002 proxy contest
($9,850,000); and environmental related expenses ($8,298,000).
The remaining decrease of $15,033,000 reflects a reduction in
corporate general and administrative expenses of $22,458,000,
which is mainly attributable to a decrease in legal expenses in
2003 and expenses incurred in the year ended December 31,
2002 related to severance costs, stock compensation and other
charges other than those described above. The decrease was
partially offset by an increase of $7,793,000 in
Ribapharms general and administrative expenses partially
related to legal and professional fees incurred by Ribapharm in
connection with the Ribapharm acquisition.
Research and Development: Research and development
expenses for the year ended December 31, 2003 were
$45,286,000 compared to $49,531,000 for 2002. The decrease is
primarily attributable to the timing of costs associated with
the clinical trials of Viramidine and pradefovir.
Amortization Expense: Amortization expense for the year
ended December 31, 2003 was $38,577,000 compared to
$30,661,000 for 2002. The increase is primarily related to
amortization of intangibles related to the Ribapharm acquisition
of $6,911,000.
Other Income, Net, Including Translation and Exchange:
Other income, net, including translation and exchange, resulted
in a gain of $4,727,000 for the year ended December 31,
2003, compared to a gain of $8,707,000 for 2002. In 2003,
translation gains principally consisted of translation and
exchange gains in Europe and AAA of $9,028,000 partially offset
by translation and exchange losses in Canada of $4,450,000. Our
translation and exchange losses are primarily related to
U.S. Dollar denominated assets and liabilities at our
foreign currency denominated subsidiaries.
Gain on Sale of Subsidiary Stock: In April 2002, we sold,
through an underwritten public offering, 29,900,000 shares
of common stock representing 20% of the total outstanding common
stock of Ribapharm. In connection with the Ribapharm offering,
we received net cash proceeds of $276,611,000 and recorded a
gain on the sale of Ribapharms stock of $261,937,000, net
of offering costs in the year ended December 31, 2002.
Loss on Early Extinguishment of Debt: Loss on early
extinguishment of debt for the year ended December 31, 2003
was $12,803,000 compared to $25,730,000 for 2002. In 2003, the
entire loss on early
25
extinguishment of debt related to the repurchase of $139,589,000
principal amount of our
61/2% Convertible
Subordinated Notes due 2008. In 2002, we recorded a loss on
early extinguishment of debt of $43,268,000 related to a tender
and consent solicitation for all of our outstanding
83/4% Senior
Notes due 2008, partially offset by a gain on early
extinguishment of debt of $17,538,000 on the repurchase of
$59,410,000 principal amount of the
61/2% Convertible
Subordinated Notes due 2008.
Interest Expense and Income: Interest expense during the
year ended December 31, 2003 decreased $6,711,000 compared
to 2002. The decrease was due to repurchases of our
61/2% Convertible
Subordinated Notes in 2003 and 2002 and the redemption of our
83/4% Senior
Notes in 2002. Due to the completion of our offering of
$240,000,000 of 3.0% Convertible Subordinated Notes,
$240,000,000 of 4.0% Convertible Subordinated Notes and
$300,000,000 of 7.0% Senior Notes in November and December
of 2003, interest income increased $3,244,000 during the year
ended December 31, 2003 as compared to 2002. Interest
income in 2003 includes $2,287,000 of interest received from the
favorable arbitration verdict of the indigent patient dispute
with Schering-Plough.
Income Taxes: Our effective income tax rate for the year
ended December 31, 2003 was a negative 287% compared to 42%
for 2002. Our negative effective tax rate for 2003 was primarily
due to the pre-tax loss resulting from the write-off of acquired
IPR&D expenses in connection with the Ribapharm acquisition,
which is not deductible for tax purposes. Excluding the effect
of the acquired IPR&D write-off, the 2003 effective tax rate
would have been 38%, which is higher than the
U.S. statutory rate of 35% due to non-deductible expenses
primarily incurred in connection with the Ribapharm tender
offer, net operating loss adjustments, and state tax and other
items, partially off-set by lower tax rates in foreign tax
jurisdictions. The effective tax rate for 2002 includes
non-deductible expenses incurred and losses incurred by foreign
subsidiaries for which we received no tax benefit.
Minority Interest: Minority interest was $11,763,000 and
$17,730,000 for the years ended December 31, 2003 and 2002,
respectively. Minority interest primarily relates to the
minority shareholders portion of the net income of
Ribapharm. In connection with the Ribapharm acquisition,
Ribapharm became a wholly owned subsidiary of us and we no
longer record minority interest related to Ribapharm.
Income (loss) from Discontinued Operations, Net of Taxes:
Income (loss) from discontinued operations relating to our
Russian pharmaceuticals segment, biomedicals segment, raw
materials businesses and manufacturing capabilities in Central
Europe and photonics business (in 2002) was income of $9,346,000
for the year ended December 31, 2003 compared to a loss of
$197,288,000 for 2002. In the year ended December 31, 2003,
we recorded income from actual discontinued operations of
$2,764,000 primarily related to our Russian pharmaceuticals
segment and the biomedicals segment, partially offset by losses
incurred in the Central Europe businesses. The Russian
pharmaceutical segment and the biomedicals segment were sold in
2003 for a net gain on disposal of discontinued operations of
$15,450,000, partially offset by additional impairment losses on
the Central Europe businesses of $6,732,000. The loss for 2002
includes a net loss on disposal of discontinued operations of
$160,010,000 due to impairments on our Russian pharmaceuticals
business, photonics business and Circe and a net loss from
actual discontinued operations of $37,278,000.
Liquidity and Capital Resources
Cash and marketable securities totaled $461,508,000 at
December 31, 2004 compared to $873,981,000 at
December 31, 2003. Working capital was $578,462,000 at
December 31, 2004 compared to $995,988,000 at
December 31, 2003. The decrease in working capital of
$417,526,000 was primarily attributable to payments on long-term
debt and notes payable of $342,157,000, the use of cash in the
acquisition of Amarin, Tasmar and various other products rights
of $76,284,000, partially offset by cash generated from
operations of $17,918,000.
Cash provided by operating activities is expected to be our
primary recurring source of funds in 2005. During the year ended
December 31, 2004, cash provided by operating activities
totaled $17,918,000 compared to $189,148,000 for 2003. Cash flow
from operating activities for the year ended December 31,
2004 was negatively impacted by a decrease in royalty revenues
and increased spending in research and
26
development activities and cash losses incurred by our
discontinued businesses. We expect to see the effects of lower
royalty revenues and increased research and development in 2005
and 2006.
Cash provided by (used in) investing activities was $139,208,000
for the year ended December 31, 2004 compared to
($524,158,000) for 2003. In 2004, cash provided by investing
activities consisted of net proceeds from investments of
$225,880,000 and proceeds from the sale of assets of
$12,088,000, partially offset by payments for the acquisition of
Amarin, Tasmar and various other product rights of $76,284,000
and capital expenditures of $26,613,000. In 2003, net cash used
in investing activities consisted of net purchases of
investments of $419,500,000, payments for the acquisition of
license rights, product lines and businesses of $192,923,000
related to the Ribapharm acquisition and capital expenditures of
$17,606,000, partially offset by proceeds from investing
activities in discontinued operations of $104,615,000 primarily
related to net proceeds from the sale of the Russian
pharmaceuticals segment and the Biomedicals Dosimetry business.
Cash used in financing activities was $354,549,000 for the year
ended December 31, 2004, including payments on long-term
debt and notes payable of $342,157,000, principally for the
repurchase of the remaining portion of the
61/2% Convertible
Subordinated Notes due 2008, and cash dividends paid on common
stock of $25,884,000, partially offset by proceeds received from
the issuance of common stock of $13,492,000. In 2003, cash
provided by financing activities was $531,365,000, including
proceeds from the issuance of long-term debt and notes payable
of $714,926,000, partially offset by payments on long-term debt
and notes payable of $158,920,000 and cash dividends paid on
common stock of $26,005,000.
In January 2004, we entered into an interest rate swap agreement
with respect to $150,000,000 principal amount of our
7.0% Senior Notes due 2011. The interest rate on the swap
is variable at LIBOR plus 2.41%. The effect of this transaction
is to initially lower our effected interest rate by exchanging
fixed rate payments for floating rate payments. On a prospective
basis, the effective rate will float and correlate to the
variable interest earned on our cash held. We continue to expect
to retain minimum cash levels of between $100,000,000 and
$150,000,000.
We have collateral requirements on an interest rate swap
agreement and foreign currency hedges. The amount of collateral
varies monthly depending on the fair value of the underlying
swap contracts. As of December 31, 2004, we have collateral
of $13,943,000 included in marketable securities and other
assets related to these instruments.
In February 2004, we acquired from Amarin Corporation, plc
(Amarin plc) its United States-based subsidiary,
Amarin Pharmaceuticals, Inc. (Amarin), and all of
its United States product rights, which includes Permax®
and a primary care portfolio with a broad range of indications.
We also acquired in the transaction the rights to Zelapar, a
late-stage candidate for the treatment of Parkinsons
disease. The FDA issued an approvable letter for Zelapar,
subject to the completion of two safety studies. We completed
these studies and in late 2004 filed the final results of these
studies with the FDA. We paid $38,000,000 in cash at the closing
for the Amarin acquisition. Subsequent to the Amarin
acquisition, we became aware of a significant amount of dated
products in wholesaler channels. Under the terms of the original
purchase agreement, Amarin plc was responsible for any excess
inventory at wholesalers that existed at the date of
acquisition. In September 2004, we entered into an amended
purchase agreement with Amarin plc, which resolved Amarin
plcs responsibility with respect to excess inventory at
the wholesalers. Under the terms of the amended purchase
agreement, we are no longer obligated to pay up to $8,000,000 in
milestone payments, but paid an additional $2,000,000, which we
expensed as research and development in 2004 related to Amarin
plcs commitment to fund a portion of the Zelapar studies.
We remain obligated to make the $10,000,000 milestone
payment to the developer of Zelapar upon the attainment of
specified sales thresholds. All other terms of the original
purchase agreement remain substantially unchanged.
In April 2004, we acquired the worldwide rights, excluding the
European Union to Tasmar® from Roche. Tasmar is indicated
for the treatment of Parkinsons disease. Under the terms
of the agreement, we paid $13,500,000 in cash, plus future
additional royalty amounts. In September 2004, we acquired the
European Union rights to Tasmar from Roche for $11,400,000 in
cash, plus future royalties.
27
In May and July 2004, we repurchased $326,001,000 aggregate
principal amount of our
61/2% Convertible
Subordinated Notes due 2008. Upon these repurchases, our
wholly-owned subsidiary, Ribapharm, Inc., ceased being a
co-obligor under our 3.0% Convertible Subordinated Notes
due 2010, 4.0% Convertible Subordinated Notes due 2013 and
the 7.0% Senior Notes due 2011. The repurchases of these
notes resulted in a loss on extinguishment of debt of
$19,892,000 for the year ended December 31, 2004.
Subsequent to December 31, 2004, investors in auction rate
securities, were advised that under a recent interpretation of
SFAS No. 95, Statement of Cash Flows, all auction
rate securities should be classified as marketable securities
and not cash and cash equivalents. As a result, we reviewed our
investments in auction rate securities and concluded that we
were in technical non-compliance with a covenant in the
indenture governing our 7.0% Senior Notes. Upon realizing a
technical non-compliance existed, we liquidated our holdings of
auction rate securities at approximately the carrying value and
cured the technical non-compliance.
On March 1, 2005, we acquired Xcel Pharmaceuticals, Inc., a
specialty pharmaceutical company focused on the treatment of
disorders of the central nervous systems for $280,000,000 in
cash, plus expenses of approximately $5,000,000. Xcels
portfolio consists of four products that are sold within the
United States, and a late-stage clinical product candidate,
retigabine, being developed for commercialization in all major
markets. Approximately $44,000,000 of the cash consideration was
used to retire Xcels outstanding long-term debt. The
purchase price is subject to certain post-closing adjustments as
set forth in the acquisition agreement.
In February 2005, we sold 8,280,000 shares of our common
stock in a public offering, resulting in net proceeds of
$189,777,600 after underwriting commissions and discounts. We
used the proceeds to fund in part the Xcel acquisition. The
remainder of the funds required for the Xcel transaction was
provided by available cash on hand.
Management believes that our existing cash and cash equivalents
and funds generated from operations will be sufficient to meet
our operating requirements at least through December 31,
2005, and to provide cash needed to fund acquisitions, capital
expenditures and our research and development program. While we
have no current intent to issue additional debt or equity
securities, we may seek additional debt financing or issue
additional equity securities to finance future acquisitions or
for other purposes. We fund our cash requirements primarily from
cash provided by our operating activities. Our sources of
liquidity are our cash and cash equivalent balances and our cash
flow from operations.
Competition from generic pharmaceutical companies has had and is
expected to continue to have a material negative impact on our
royalty revenue. With respect to Schering-Plough, royalty rates
increase in tiers based on increased sales levels. As a result
of reduced sales, the likelihood of achieving the maximum
effective royalty rate in the United States is diminished. With
respect to Roche, under the license agreement, the introduction
of generics in any market eliminates the obligation of Roche to
pay royalties for sales in that market. Upon the entry of
generics into the United States on April 7, 2004, Roche
ceased paying royalties on sales in the United States.
While we have historically paid quarterly cash dividends, there
can be no assurance that we will continue to do so in the future.
We currently have no product liability insurance for a majority
of our products in the United States. In connection with the
Amarin acquisition, we acquired product liability insurance for
Permax, which coverage we expect to maintain, as a result of
this product being subject to settled and pending product
liability litigation. In connection with the Xcel transaction,
we have maintained their product liability insurance while we
evaluate the prospective need for such coverage for Xcel
products and our existing products. While, to date, no material
adverse claim for personal injury resulting from allegedly
defective products has been successfully maintained against it,
a substantial claim, if successful, could have a material
adverse effect on our liquidity and financial performance. We
maintain clinical trial insurance in major markets in which we
conduct clinical trials.
28
The following table sets forth our obligations as of
December 31, 2004, and the effect such obligations are
expected to have on our liquidity and cash flow in future
periods (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less Than | |
|
|
|
|
|
More Than | |
|
|
Total | |
|
1 Year | |
|
1-3 Years | |
|
3-5 Years | |
|
5 Years | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
Long-term debt obligations:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7.0% Senior Notes due 2011
|
|
$ |
298,833 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
298,833 |
|
|
3.0% Convertible Subordinated Notes due 2010
|
|
|
240,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
240,000 |
|
|
4.0% Convertible Subordinated Notes due 2013
|
|
|
240,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
240,000 |
|
|
Other long-term debt
|
|
|
14,549 |
|
|
|
243 |
|
|
|
557 |
|
|
|
486 |
|
|
|
13,263 |
|
|
Interest payments
|
|
|
276,600 |
|
|
|
37,800 |
|
|
|
75,600 |
|
|
|
75,600 |
|
|
|
87,600 |
|
Lease obligations
|
|
|
8,302 |
|
|
|
2,695 |
|
|
|
2,752 |
|
|
|
1,237 |
|
|
|
1,618 |
|
Notes payable
|
|
|
686 |
|
|
|
686 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total cash obligations
|
|
$ |
1,078,970 |
|
|
$ |
41,424 |
|
|
$ |
78,909 |
|
|
$ |
77,323 |
|
|
$ |
881,314 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We do not use special purpose entities or other off-balance
sheet financing techniques except for operating leases disclosed
in the table above. We have no material commitments for
purchases of property, plant and equipment and we expect that
for 2005, such expenditures will approximate $40 to
$50 million.
Products in Development
We expect our research and development expenses to increase in
the future, of which a large percentage will be to support the
continuing product development programs for Viramidine,
pradefovir, Zelapar and retigabine. We expect that for 2005, we
will spend approximately $60,000,000 on these product
development programs.
For Viramidine, on January 20, 2005, we announced that we
had completed enrollment in VISER 2, as well as an initial
analysis of the sustained viral response (SVR)
information for our Viramidine Phase 2 proof-of-concept
study compared to ribavirin. The results validate the study
design by continuing to show that Viramidine demonstrates
statistical comparable efficacy to ribavirin in SVR and a
significantly reduced incidence of anemia.
The Viramidine Phase 2 study, conducted entirely in the
United States, consisted of 180 treatment-naïve subjects
with chronic hepatitis C. The study was an open-label,
randomized, active control trial, with patients stratified by
genotype only. The study consisted of four comparable treatment
groups: Viramadine 400 mg BID (800 mg daily),
Viramidine 600 mg BID (1200 mg daily), Viramidine
800 mg BID (1600 mg daily) and ribavirin
1000/1200 mg daily all in combination with peginterferon
alfa-2a. Treatment duration was based on genotype, with
genotypes two and three receiving 24 weeks of treatment and
genotype one receiving 48 weeks of treatment, with a
post-treatment follow-up period of 24 weeks. The 24-week
follow-up period is considered the medically therapeutic
standard evaluation of efficacy.
The final analyses of all Phase 2 data is expected to be
presented at the European Association for the Study of the Liver
Conference in April 2005. The Phase 2 trial has met its
design objective by confirming the selection of the 600 mg
BID dose used in the two pivotal Phase 3 trials. Our
external research and development expenses for Viramidine were
$31,164,000 for the year ended December 31, 2004 and
$50,026,000 from inception through December 31, 2004.
For pradefovir, which is being developed for the treatment of
hepatitis B, we have completed three Phase 1 clinical
trials in a total of 87 healthy volunteers. A 48-week
dose-ranging Phase 2 study in Asia and the United States
began enrollment in July 2004 and completed enrollment in
November 2004. Our external
29
research and development expenses for pradefovir were $6,735,000
for the year ended December 31, 2004 and $19,857,000
(including a milestone payment of $2,100,000) from inception
through December 31, 2004.
We acquired the rights to Zelapar, a late-stage candidate being
developed as an adjunctive therapy in the treatment of
Parkinsons disease, in the Amarin acquisition in February
2004. In late 2004, we submitted a complete response to an
approvable letter from the FDA, following the completion of two
safety studies. We received a response to our submission from
the FDA that requires us to provide them with additional
information. We expect to launch Zelapar in 2005. Our external
research and development expenses for Zelapar were $4,832,000
for the year ended December 31, 2004.
We acquired the rights to retigabine, an adjunctive treatment
for partial-onset seizures in patients with epilepsy, in the
acquisition of Xcel Pharmaceuticals Inc. on March 1, 2005.
For retigabine, we are scheduled to commence Phase 3 trials
in 2005. Retigabine is believed to have a unique, dual-acting
mechanism and has undergone several Phase 2 clinical trials
in over 600 patients.
Foreign Operations
Approximately 81% and 78% of our revenues from continuing
operations, which includes royalties, for the years ended
December 31, 2004 and 2003, respectively, were generated
from operations or earned outside the United States. All of our
foreign operations are subject to risks inherent in conducting
business abroad. See Forward-Looking Statements.
Inflation and Changing Prices
We experience the effects of inflation through increases in the
costs of labor, services and raw materials. We are subject to
price control restriction on our pharmaceutical products in the
majority of countries in which we operate. While we attempt to
raise selling prices in anticipation of inflation, we operate in
some markets which have price controls that may limit our
ability to raise prices in a timely fashion. Future sales and
gross profit will be reduced if we are unable to obtain price
increases commensurate with the levels of inflation.
Recent Accounting Pronouncements
In March 2004, the EITF reached a consensus on Issue
No. 03-1, The Meaning of Other-Than-Temporary Impairment
and Its Application to Certain Investments. This Issue
establishes impairment models for determining whether to record
impairment losses associated with investments in certain equity
and debt securities. In September 2004, the Financial Accounting
Standards Board (FASB) issued FASB Staff Position
(FSP) EITF 03-1-1, which defers the effective
date of a substantial portion of EITF 03-1 until such time
as the FASB issues further implementation guidance. Adoption of
this pronouncement is not expected to have an impact on our
consolidated financial statements.
In November 2004, the FASB issued Statement of Financial
Accounting Standards (SFAS) No. 151,
Inventory Costs an amendment of Accounting
Research Bulletin (ARB) No. 43,
Chapter 4. SFAS No. 151 amends the guidance
in ARB No. 43, Chapter 4, Inventory Pricing, to
clarify the accounting for abnormal amounts of idle facility
expense, freight, handling costs, and wasted material
(spoilage). Among other provisions, the new rule requires that
items such as idle facility expense, excessive spoilage, double
freight, and rehandling costs be recognized as current-period
charges regardless of whether they meet the criterion of
so abnormal as stated in ARB No. 43.
Additionally, SFAS No. 151 requires that the
allocation of fixed production overheads to the costs of
conversion be based on the normal capacity of the production
facilities. SFAS No. 151 is effective for fiscal years
beginning after June 15, 2005. We are currently evaluating
the effect of SFAS No. 151 on our consolidated
financial statements.
In December 2004, the FASB issued FSP No. 109-2,
Accounting and Disclosure Guidance for the Foreign Earnings
Repatriation Provision within the American Jobs Creation Act of
2004. The American Jobs Creation Act of 2004 (the Jobs
Creation Act) was enacted on October 22, 2004.
FSP 109-2 states that an enterprise is allowed time
beyond the financial reporting period of enactment to evaluate
the effect of the Jobs
30
Creation Act on its plan for reinvestment or repatriation of
foreign earnings for purposes of applying
SFAS No. 109. We have not yet completed evaluating the
impact of the repatriation provisions.
In December 2004, the FASB issued SFAS No. 123
(revised 2004), Share-Based Payment
(SFAS No. 123R), which replaces
SFAS No. 123, Accounting for Stock-Based
Compensation (SFAS No. 123) and
supersedes APB Opinion No. 25, Accounting for Stock
Issued to Employees. SFAS No. 123R requires all
share-based payments to employees, including grants of employee
stock options, to be recognized in the financial statements
based on their fair values beginning with the first interim or
annual period after June 15, 2005. The pro forma
disclosures previously permitted under SFAS No. 123
will no longer be an alternative to financial statement
recognition. We are required to adopt SFAS No 123R in the
third quarter of fiscal 2005, beginning July 1, 2005. We
are evaluating the requirements of SFAS No. 123R and
expect that the adoption of SFAS No. 123R will have an
impact on our consolidated results of operations and earnings
per share. If we retain our current method of valuing and
expensing options as previously reported in our pro forma
disclosures required by SFAS No. 123, we estimate that
pretax compensation expense for fiscal 2005 will increase by
approximately $8,000,000.
Critical Accounting Estimates
The consolidated financial statements appearing elsewhere in
this document have been prepared in conformity with accounting
principles generally accepted in the United States. The
preparation of these statements requires us to make estimates
and assumptions that affect the reported amounts of assets and
liabilities, the disclosure of contingent assets and liabilities
at the date of the financial statements and the reported amounts
of revenues and expenses during the reporting periods. On an
on-going basis, we evaluate our estimates, including those
related to product returns, collectibility of receivables,
inventories, intangible assets, income taxes and contingencies
and litigation. The actual results could differ materially from
those estimates.
We believe the following critical accounting policies affect our
more significant judgments and estimates used in the preparation
of our consolidated financial statements.
We recognize revenues from product sales when title and risk of
ownership transfers to the customer. Revenues are recorded net
of provisions for rebates, discounts and returns, which are
established at the time of sale. Allowances for future returns
of products sold to our direct and indirect customers, who
include wholesalers, retail pharmacies and hospitals, are
calculated as a percent of sales based on historical return
percentages taking into account additional available information
on competitive products and contract changes. We use third-party
data to estimate the level of product inventories, expiration
dating, and product demand at our major wholesalers. Based upon
this information, adjustments are made to the accrual if deemed
necessary. Actual results could be materially different from our
estimates, resulting in future adjustments to revenue. For the
year ended December 31, 2004, returns received were less
than 3% of product sales. For the year ended December 31,
2004, the provision for sales returns was less than 4% of
product sales. We conduct a review of the current methodology
and assess the adequacy of the allowance for returns on a
quarterly basis, adjusting for changes in assumptions,
historical results and business practices, as necessary.
We earn ribavirin royalties as a result of sales of products by
third-party licensees, Schering-Plough and Roche. Ribavirin
royalties are earned at the time the products subject to the
royalty are sold by the third party and is reduced by an
estimate for discounts and rebates that will be paid in
subsequent periods for those products sold during the current
period. We rely on a limited amount of financial information
provided by Schering-Plough and Roche to estimate the amounts
due to us under the royalty agreements. While we believe the
Schering-Plough agreement specifies that we are to be reimbursed
based on net sales as determined under an accrual basis, we have
recently become aware that Schering-Plough may be calculating
reimbursements based on a method under which returns are
deducted as incurred rather than on an accrual basis. Based upon
the information provided by Schering-Plough for the fourth
quarter of 2004, Schering-Ploughs sales of Rebetol in the
United States were negative. As a result of the uncertainty with
royalties
31
associated with sales of Rebetol in the United States, a reserve
has been established for negative royalties caused by negative
sales of Rebetol in the United States; however, due to the
limited information provided by Schering-Plough, there can be no
assurance that such amounts will be adequate to cover additional
negative royalty amounts in future periods. Consistent with the
agreement, we have hired an accounting firm to audit the royalty
calculation.
We may offer sales incentives primarily in international
markets, where typically no right of return exists except for
goods damaged in transit, product recalls or for replacement of
existing products due to packaging or labeling changes. In the
United States market, our current practice is to offer sales
incentives primarily in connection with launches of new products
or changes of existing products where demand has not yet been
established. We monitor and restrict sales in the United States
market in order to limit wholesaler purchases in excess of their
ordinary-course-of-business inventory levels. However, specific
events such as the case of sales incentives described above or
seasonal demand (e.g. antivirals during an outbreak) may justify
purchases by wholesalers in excess of their ordinary course of
business. Our revenue recognition policy on these types of
purchases and on incentives in international markets is
consistent with the policies described in the revenue
recognition critical accounting policy.
We operate in numerous countries where our income tax returns
are subject to audit. Internal and external tax professionals
are employed to minimize tax audit adjustments where possible.
We consider the expected outcome of these audits in the
calculation of our tax provision.
We assess whether it is more likely than not that we will
realize the tax benefits associated with our deferred tax assets
and establish a valuation allowance for assets that are not
expected to result in a realized tax benefit. A significant
amount of judgment is used in this process, including
preparation of forecasts of future taxable income and evaluation
of tax planning initiatives. If we revise these forecasts or
determine that certain planning events will not occur, an
adjustment to the valuation allowance will be made to tax
expense in the period such determination is made. We increased
the valuation allowance significantly in the fourth quarter of
2004 to recognize the uncertainty of realizing the benefits of
the U.S. net operating losses and research credits.
Our U.S. tax returns for the period from 1997 to 2001 are
currently being reviewed by the Internal Revenue Service. While
we believe the review will not result in the returns being found
to contain any substantive and material deficiencies, there can
be no assurance that the Internal Revenue Services
findings will not have a material adverse effect on our reported
effective tax rate and after-tax cash flows.
In 1999, we restructured our operations by contributing the
stock of several non-United States subsidiaries to a wholly
owned Dutch company. At the time of the restructuring, we
intended to avail ourselves of the non-recognition provisions of
the Internal Revenue Code to avoid generating taxable income on
the inter-company transfer. One of the requirements under the
non-recognition provisions was to file Gain Recognition
Agreements with our timely filed 1999 U.S. Corporate Income
Tax Return. We have recently discovered that although it was
clearly our intent to file the Gain Recognition Agreements and
we have operated as if such filings had been submitted, former
management inadvertently omitted the Gain Recognition Agreements
from our filing. In accordance with Treasury guidelines, a
formal request has been made to the Internal Revenue Service to
rule that reasonable cause existed for the failure to provide
these agreements. While management is still evaluating the
underlying values of the stock contributed, if the requested
relief were to be denied and the matter could not otherwise be
resolved favorably with the Internal Revenue Service, management
believes the resulting cash tax obligation would be offset by a
substantial portion of our accumulated tax loss carryforwards.
During the fourth quarter of 2004, legislation was passed (The
American Jobs Creation Act of 2004). The legislation provides
for a special one-time tax deduction of 85 percent of
certain foreign earnings that are repatriated to the United
States. The range of reasonably possible amounts of unremitted
earnings that is
32
being considered for repatriation and the related potential
range of income tax effects of such repatriation cannot be
reasonably estimated at this time. We are evaluating the effects
of this law, and are expecting to complete the evaluation and
develop an appropriate plan of action during the first half of
2005.
|
|
|
Impairment of Property, Plant and Equipment |
We evaluate the carrying value of property, plant and equipment
in accordance with guidelines. In evaluating property, plant and
equipment, we determine whether there has been impairment by
comparing the anticipated undiscounted future cash flows
expected to be generated by the property, plant and equipment
with its carrying value. If the undiscounted cash flows is less
than the carrying value, the amount of the impairment, if any,
will be determined by comparing the carrying value of the
property, plant and equipment with its fair value. Fair value is
generally based on a discounted cash flows analysis, independent
appraisals or preliminary offers from prospective buyers.
|
|
|
Valuation of Intangible Assets |
We periodically review intangible assets for impairment using an
undiscounted net cash flows approach. We determine whether there
has been impairment by comparing the anticipated undiscounted
future operating income of the product line with its carrying
value. If the undiscounted operating income is less than the
carrying value, the amount of the impairment, if any, will be
determined by comparing the value of each intangible asset with
its fair value. Fair value is generally based on a discounted
cash flows analysis.
We use a discounted cash flow model to value intangible assets
acquired and for the assessment of impairment. The discounted
cash flow model requires assumptions about the timing and amount
of future cash inflows and outflows, risk, the cost of capital,
and terminal values. Each of these factors can significantly
affect the value of the intangible asset. We evaluated the
businesses included in discontinued operations by comparing the
carrying value of each intangible asset to their fair value, as
determined using discounted cash flows analysis, appraisals, and
purchase offers.
The estimates of future cash flows, based on reasonable and
supportable assumptions and projections, require
managements judgment. Any changes in key assumptions about
our businesses and their prospects, or changes in market
conditions, could result in an impairment charge. Some of the
more significant estimates and assumptions inherent in the
intangible asset impairment estimated process include: the
timing and amount of projected future cash flows; the discount
rate selected to measure the risks inherent in the future cash
flows; and the assessment of the assets life cycle and the
competitive trends impacting the asset, including consideration
of any technical, legal or regulatory.
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Purchase Price Allocation Including Acquired In-Process
Research and Development |
The purchase price for the Amarin and Ribapharm acquisitions
were allocated to the tangible and identifiable intangible
assets acquired and liabilities assumed based on their estimated
fair values at the acquisition date. Such a valuation requires
significant estimates and assumptions, including but not limited
to: determining the timing and expected costs to complete the
in-process projects; projecting regulatory approvals; estimating
future cash flows from product sales resulting from completed
products and in-process projects; and developing appropriate
discount rates and probability rates by project. We believe the
fair values assigned to the assets acquired and liabilities
assumed are based on reasonable assumptions. However, these
assumptions may be incomplete or inaccurate, and unanticipated
events and circumstances may occur. Additionally, estimates for
the purchase price allocations may change as subsequent
information becomes available.
We value in-process research and development
(IPR&D) acquired in a business combination based
on an approach consistent with the AICPA Practice Aid, Assets
Acquired in Business Combinations to be Used in Research and
Development Activities: A Focus in Software, Electronic Devices
and Pharmaceutical Industries. The amounts expensed as
acquired IPR&D represents an estimate of the fair value of
purchased in-process technology for projects that, as of the
acquisition date, had not yet reached technological feasibility
and had no alternative future use. The data used to determine
fair value requires significant judgment. The estimated fair
values were based on our use of a discounted cash flow model
(based on an estimate of future sales and an
33
average gross profit margin of 66% and 85% for Amarin and
Ribapharm, respectively). For each project, the estimated
after-tax cash flows (using a tax rate of 40% and 25% for Amarin
and Ribapharm, respectively) were probability weighted to take
account of the stage of completion and the risks surrounding the
successful development and commercialization. The assumed tax
rates are our estimate of the effective tax rate for
acquisitions of similar type of assets. These cash flows were
then discounted to a present value using a discount rate of 20%
and 15% for Amarin and Ribapharm, respectively. In addition,
solely for the purposes of estimating the fair value of these
IPR&D projects related to the acquisition of Ribapharm as of
August 25, 2003, the following assumptions were made:
(1) Future research and development costs of approximately
$150,000,000 would be incurred to complete the IPR&D
projects. These future costs are primarily for Phase III
testing of Viramidine and Phase II and III testing of
Pradefovir, and (2) the IPR&D projects, which were in
various stages of development from Phase I to Phase II
clinical trials, are expected to reach completion by the end of
2006. See Note 2 of notes to consolidated financial
statements for a discussion of acquisitions.
The major risks and uncertainties associated with the timely and
successful completion of these projects include the uncertainty
of our ability to confirm the safety and efficacy of product
candidates based on the data from clinical trials and of
obtaining necessary regulatory approvals. In addition, no
assurance can be given that the underlying assumptions we used
to forecast the cash flows or the timely and successful
completion of these projects will materialize as estimated. For
these reasons, among others, actual results may vary
significantly from the estimated results.
We are exposed to contingencies in the ordinary course of
business, such as legal proceedings and business-related claims,
which range from product and environmental liabilities to tax
matters. In accordance with SFAS No. 5, Accounting
for Contingencies, we record accruals for such contingencies
when it is probable that a liability will be incurred and the
amount of loss can be reasonably estimated. The estimates are
refined each accounting period, as additional information is
known. See Note 13 of notes to consolidated financial
statements for a discussion of contingencies.
Forward-Looking Statements
Except for the historical information contained herein, the
matters addressed in this annual report on Form 10-K
constitute forward-looking statements.
Forward-looking statements may be identified by the use of the
words anticipates, expects,
intends, plans, and variations or
similar expressions. These forward-looking statements are
subject to a variety of risks and uncertainties, including those
discussed below and elsewhere in this annual report on
Form 10-K, which could cause actual results to differ
materially from those anticipated by the Companys
management. Readers are cautioned not to place undue reliance on
any of these forward-looking statements, which speak only as of
the date of this report. We undertake no obligation to update
any of these forward-looking statements to reflect events or
circumstances after the date of this report or to reflect actual
outcomes.
Risk Factors
Our short and long-term success is subject to a variety of risks
and uncertainties, many of which are beyond our control. Our
stockholders and prospective stockholders should consider
carefully the following risk factors, in addition to other
information contained in this annual report on Form 10-K.
Our actual results could differ materially from these
anticipated in this report as a result of various factors,
including those set forth below.
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If we cannot successfully develop or obtain future
products, our growth would be delayed. |
Our future growth will depend, in large part, upon our ability
to develop or obtain and commercialize new products and new
formulations of, or indications for, current products. We are
engaged in an active research and development program involving
compounds owned by us or licensed from others which we may
34
commercially develop in the future. We are in clinical trials
for Viramidine and pradefovir. The process of successfully
commercializing products is time consuming, expensive and
unpredictable. There can be no assurance that we will be able to
develop or acquire new products, successfully complete clinical
trials, obtain regulatory approvals to use these products for
proposed or new clinical indications, manufacture our potential
products in compliance with regulatory requirements or in
commercial volumes, or gain market acceptance for such products.
In addition, changes in regulatory policy for product approval
during the period of product development and regulatory agency
review of each submitted new application may cause delays or
rejections. It may be necessary for us to enter into other
licensing arrangements, similar to our arrangements with
Schering-Plough and Roche, with other pharmaceutical companies
in order to market effectively any new products or new
indications for existing products. There can be no assurance
that we will be successful in entering into such licensing
arrangements on terms favorable to us or at all.
On January 20, 2005, we announced that we have completed
enrollment in VISER 2, a Phase 3 trial for Viramidine.
Phase 3 is the last phase in a multi-phase clinical
evaluation that may lead to the filing of a New Drug
Application. There can be no assurance that our clinical trials
for Viramidine will be successful, that we will be granted
approval to market Viramidine for the indication we are seeking
or that Viramidine will be a commercially successful product.
A substantial amount of the value of Xcel Pharmaceuticals is
attributed to retigabine, which is being developed as an
adjunctive treatment for partial-onset seizures in patients with
epilepsy. Retigabine has completed Phase 2 studies and we
expect to begin Phase 3 clinical trials in 2005. There can
be no assurance that the clinical trials for retigabine will be
successful, that we will be granted approval to market
retigabine for the indication being sought or that retigabine
will be a commercially successful product. If we do not obtain
approval of retigabine, significant anticipated benefits of the
Xcel acquisition, including revenue enhancements, would not be
realized.
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The introduction of generic products has significantly
impacted ribavirin royalties and may negatively impact our
ability to finance research and development activities. |
While ribavirin royalty revenues earned by us under our
ribavirin license agreements with Schering-Plough and Roche have
declined, they still represent an important source of revenues
to us. Schering-Plough markets ribavirin for use in combination
with its interferon product under the trade name
Rebetol as a therapy for the treatment of
hepatitis C and Roche markets ribavirin for use in
combination with its interferon product under the name
Copegus. Under the terms of their license
agreements, Schering-Plough and Roche each have sole discretion
to determine the pricing of ribavirin and the amount and timing
of resources devoted to their respective marketing of ribavirin.
Competition from generic pharmaceutical companies in the
U.S. market has had a material negative impact on our
royalty revenue beginning in 2004 by significantly reducing
royalties payable to us by Schering-Plough and eliminating
royalties payable to us by Roche in the U.S. market. Our
research and development activities have historically been
funded by the royalties received from Schering-Plough and Roche.
Prospectively, substantially greater reliance on the
profitability of the specialty pharmaceutical business will be
required.
Although our financial planning has included an expectation of
the erosion of royalty revenue due to generic competition for
ribavirin in the United States, a greater-than-expected erosion
of royalties from the United States, or a significant decrease
in royalties from expected levels for markets other than the
United States, could negatively impact our ability to finance
research and development and other activities.
We rely on a limited amount of financial information provided by
Schering-Plough and Roche to estimate the amounts due to us
under the royalty agreements. While we believe the
Schering-Plough agreement specifies that we are to be reimbursed
based on net sales as determined under an accrual basis, we have
recently become aware that Schering-Plough may be calculating
reimbursements based on a method under which returns are
deducted as incurred rather than on an accrual basis. Based upon
the information provided by Schering-Plough for the fourth
quarter of 2004, Schering-Ploughs sales of Rebetol in the
United States were negative. As a result of the uncertainty with
royalties associated with sales of Rebetol in the United
35
States, a reserve has been established for negative royalties
caused by negative sales of Rebetol in the United States;
however, due to the limited information provided by
Schering-Plough, there can be no assurance that such amounts
will be adequate to cover additional negative royalty amounts in
future periods.
Various parties are opposing our ribavirin patents in actions
before the European Patent Office, and we are responding to
these oppositions. While data exclusivity for the combination
therapies marketed by Schering-Plough and Roche is scheduled to
continue in the major markets of the European Union until 2009
for Schering-Plough and 2012 for Roche, regulatory approvals and
schemes may change and/or studies regarding ribavirin in
combination with interferon may be replicated, allowing earlier
introduction of generics into such markets should the patent
opposition be successful.
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If our focus on the development of Viramidine does not
result in an approved and commercially successful product, our
business will be adversely affected. |
We focus our research and development activities on areas in
which we have particular strengths, particularly antivirals. The
outcome of any development program is highly uncertain. Although
Viramidine appears promising and has advanced to Phase 3
clinical trials, it may yet fail to yield a commercial product.
Success in preclinical and early stage clinical trials may not
necessarily translate into success in large-scale clinical
trials. Further, to be successful in clinical trials, increased
investment will be necessary, which will adversely affect
short-term profitability.
In addition, we will need to obtain and maintain regulatory
approval in order to market Viramidine. Even if Viramidine
appears promising in large-scale Phase 3 clinical trials,
regulatory approval may not be achieved. The results of clinical
trials are susceptible to varying interpretations that may
delay, limit or prevent approval or result in the need for
post-marketing studies. In addition, changes in regulatory
policy for product approval during the period of product
development and FDA review of a new application may cause delays
or rejection. Even if we receive regulatory approval, this
approval may include limitations on the indications for which we
can market the product. There is no guarantee that we will be
able to satisfy the needed regulatory requirements, and we may
suffer a significant reduction from planned revenue as a result.
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As we develop and commercialize new products, we will have
to incur a sizeable amount of research and development expenses
to advance such products through the clinical trial and
regulatory approval process. Such expenditures will have a
negative effect on earnings and cash flows when incurred. |
As of March 2005, we are in clinical trials with three products,
Viramidine, pradefovir and retigabine. These clinical trials
require significant research and development expenditures. We
completed enrollment of two Phase 3 studies being conducted
for Viramidine in January 2005 and a Phase 2 study for
pradefovir in November 2004. We expect that research and
development expenses will increase in 2005 compared to 2004 as
progress continues with the clinical trials of Viramidine and
pradefovir. The increased amount of research and development
expenses will negatively impact our earnings and cash flows.
Additionally, retigabine is expected to begin Phase 3
clinical trials in 2005. We will incur significant additional
research and development expenses in connection with
Phase 3 studies for retigabine.
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Third parties may be able to sell generic forms of our
products or block our sales of our products if our intellectual
property rights or data exclusivity rights do not sufficiently
protect us; patent rights of third parties may also be asserted
against us. |
Our success depends in part on our ability to obtain and
maintain meaningful exclusivity protection for our products and
product candidates in key markets throughout the world via
patent protection and/or data exclusivity protection. The patent
positions of pharmaceutical, biopharmaceutical and biotechnology
companies can be highly uncertain and involve complex legal and
factual questions. We will be able to protect our products from
generic substitution by third parties only to the extent that
our technologies are covered by valid and enforceable patents,
effectively maintained as trade secrets or are protected by data
exclusivity. However, our currently pending or future patent
applications may not issue as patents. Any patent issued may be
challenged, invalidated, held unenforceable or circumvented.
Furthermore, our patents may not be sufficiently
36
broad to prevent third parties from producing generic
substitutes for our products. Lastly, data exclusivity schemes
vary from country to country and may be limited or eliminated as
governments seek to reduce pharmaceutical costs by increasing
the speed and ease of approval of generic products.
In order to protect or enforce patent and/or data exclusivity
rights, we may initiate patent litigation against third parties,
and we may be similarly sued by others. We may also become
subject to interference proceedings conducted in the patent and
trademark offices of various countries to determine the priority
of inventions. The defense and prosecution, if necessary, of
intellectual property and data exclusivity actions are costly
and divert technical and management personnel from their normal
responsibilities. We may not prevail in any of these suits. An
adverse determination of any litigation or defense proceeding,
resulting in a finding of non-infringement or invalidity of our
patents, or a lack of protection via data exclusivity, may allow
entry of generic substitutes for our products.
Furthermore, because of the substantial amount of discovery
required in connection with such litigation, there is a risk
that some of our confidential information could be compromised
by disclosure during such litigation. In addition, during the
course of this kind of litigation, there could be public
announcements of the results of hearings, motions or other
interim proceedings or developments in the litigation. If
securities analysts or investors perceive these results to be
negative, it could have a substantial negative effect on the
trading price of our securities.
The existence of a patent will not necessarily protect us from
competition. Competitors may successfully challenge our patents,
produce similar drugs that do not infringe our patents or
produce drugs in countries that do not respect our patents. No
patent can protect its holder from a claim of infringement of
another patent. Therefore, our patent position cannot and does
not provide an assurance that the manufacture, sale or use of
products patented by us would not infringe a patent right of
another.
While we know of no actual or threatened claim of infringement
that would be material to us, there can be no assurance that
such a claim will not be asserted. If such a claim is asserted,
there can be no assurance that the resolution of the claim would
permit us to continue producing the relevant product on
commercially reasonable terms.
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Obtaining necessary government approvals is time consuming
and not assured. |
FDA approval must be obtained in the United States and approval
must be obtained from comparable agencies in other countries
prior to marketing or manufacturing new pharmaceutical products
for use by humans. Obtaining FDA approval for new products and
manufacturing processes can take a number of years and involves
the expenditure of substantial resources. Numerous requirements
must be satisfied, including preliminary testing programs on
animals and subsequent clinical testing programs on humans, to
establish product safety and efficacy. No assurance can be given
that we will obtain approval in the United States, or any other
country, of any application we may submit for the commercial
sale of a new or existing drug or compound. Nor can any
assurance be given that if such approval is secured, the
approved labeling will not have significant labeling
limitations, or that those drugs or compounds will be
commercially successful.
The FDA and other regulatory agencies in other countries also
periodically inspect manufacturing facilities both in the United
States and abroad. Failure to comply with applicable regulatory
requirements can result in, among other things, warning letters,
sanctions, fines, delays or suspensions of approvals, seizures
or recalls of products, operating restrictions, manufacturing
interruptions, costly corrective actions, injunctions, adverse
publicity against us and our products, refusal to renew
marketing applications, and criminal prosecutions. Furthermore,
changes in existing regulations or adoption of new regulations
could prevent or delay us from obtaining future regulatory
approvals or jeopardize existing approvals.
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Difficulties with acquisitions could have a material
adverse impact on our future growth. |
We intend to pursue a strategy of targeted expansion through the
acquisition of compatible businesses and product lines and the
formation of strategic alliances, joint ventures and other
business combinations. There can be no assurance that we will
successfully complete or finance any future acquisition or
investment
37
or that any acquisitions that we do complete will be completed
at prices or on terms that prove to be advantageous to us.
Failure in integrating the operations of companies that we have
acquired or may acquire in the future may have a material
adverse impact on our future growth and success.
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If competitors develop vaccines or more effective or less
costly drugs for our target indications, our business could be
seriously harmed. |
The biotechnology and pharmaceutical industries are intensely
competitive and subject to rapid and significant technological
change. Viramidine and many of the drugs that we are attempting
to discover will be competing with new and existing therapies.
Many companies in the United States and abroad are pursuing the
development of pharmaceuticals that target the same diseases and
conditions that we are targeting. For example, Human Genome
Sciences, Inc. submitted an investigational new drug application
with the FDA in October 2000 and is currently conducting a
Phase 2 human clinical trial of Albuferon for treatment of
hepatitis C. If Albuferon or other therapies that do not
incorporate the use of our products prove to be a more effective
treatment for hepatitis C than the combination therapy
involving ribavirin, then our royalty revenues from ribavirin
could significantly decrease, and we may not realize any
revenues from Viramidine. In addition, there are institutions
engaged in research on the development of a vaccine to prevent
hepatitis C. The availability of such a vaccine could have
a material adverse effect on our revenues from sales of products
treating hepatitis C.
Many of our competitors, particularly large pharmaceutical
companies, have substantially greater financial, technical and
human resources than we do. Many of our competitors spend
significantly more on research and development related
activities than we do. Others may succeed in developing products
that are more effective than those currently marketed or
proposed for development by us. Progress by other researchers in
areas similar to those being explored by us may result in
further competitive challenges. In addition, academic
institutions, government agencies, and other public and private
organizations conducting research may seek patent protection
with respect to potentially competitive products. They may also
establish exclusive collaborative or licensing relationships
with our competitors.
Products under development may include, but are not limited to:
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Inferferons or immunomodulators being developed by Human Genome
Sciences, Inc., InterMune, Inc., Intarcia Therapeutics, Inc.,
SciClone Pharmaceuticals, Inc., Anadys, and Coley
Pharmaceuticals Group, Inc.; |
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IMPDH inhibitors being developed by Roche and Vertex
Pharmaceuticals Incorporated; and |
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Protease or polymerase inhibitors being developed by Boehringer
Ingelheim, Vertex Pharmaceuticals Incorporated, Schering-Plough,
Wyeth/ Viropharma Inc. and Idenix Pharmaceuticals, Inc. |
In addition to the aforementioned corporations involved in HCV
research and development, other companies engaged in HCV
research activities similar to our research activities include
Abbott Laboratories, Pfizer, Inc., GlaxoSmithKline plc,
Merck & Co., Inc. and Novartis AG.
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If our products are alleged to be harmful, we may not be
able to sell them and we may be subject to product liability
claims not covered by insurance. |
The nature of our business exposes us to potential liability
risks inherent in the testing, manufacturing and marketing of
pharmaceutical products. Using our drug candidates in clinical
trials also exposes us to product liability claims. These risks
will expand with respect to drugs, if any, that receive
regulatory approval for commercial sale. Even if a drug were
approved for commercial use by an appropriate governmental
agency, there can be no assurance that users will not claim that
effects other than those intended may result from our products.
While to date no material adverse claim for personal injury
resulting from allegedly defective products, including
ribavirin, has been successfully maintained against us, a
substantial claim, if successful, could have a material negative
impact on us.
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In the event that anyone alleges that any of our products are
harmful, we may experience reduced consumer demand for our
products or our products may be recalled from the market. In
addition, we may be forced to defend lawsuits and, if
unsuccessful, to pay a substantial amount in damages. We
currently do not have insurance against product liability risks
for most of our commercially developed products. Insurance is
expensive and, if we seek such insurance in the future, it may
not be available on acceptable terms. Even if obtained,
insurance may not fully protect us against potential product
liability claims.
We currently maintain clinical trial insurance in the major
markets in which we conduct clinical trials. There is no
assurance, however, that such insurance will be sufficient to
cover all claims.
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We are involved in various legal proceedings that could
adversely affect us. |
We are involved in several legal proceedings, including those
described in Note 13 of notes to the consolidated financial
statements. Defending against claims and any unfavorable legal
decisions, settlements or orders could have a material adverse
effect on us.
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Existing and future audits by, or other disputes with,
taxing authorities may not be resolved favorably for us. |
Our income tax returns are currently subject to audit in various
jurisdictions. Existing and future audits by, or other disputes
with, taxing authorities may not be resolved favorably for us.
For instance, our U.S. tax returns for the period from 1997
to 2001 are currently being reviewed by the Internal Revenue
Service. While we believe the review will not result in a
material adjustment to reported results, there can be no
assurance that the Internal Revenue Services findings will
not have a material adverse effect on our reported effective tax
rate and after-tax cash flows.
In 1999, we restructured our operations by contributing the
stock of several non-United States subsidiaries to a wholly
owned Dutch company. At the time of the restructuring, we
intended to avail ourselves of the non-recognition provisions of
the Internal Revenue Code to avoid generating taxable income on
the inter-company transfer. One of the requirements under the
non-recognition provisions was to file Gain Recognition
Agreements with our timely filed 1999 U.S. Corporate Income
Tax Return. We recently discovered that although it was clearly
our intent to file the Gain Recognition Agreements and we have
operated as if such filings had been submitted, our former
management inadvertently omitted the Gain Recognition Agreements
from our filing. In accordance with Treasury guidelines, a
formal request has been made to the Internal Revenue Service to
rule that reasonable cause existed for the failure to provide
these agreements. While we are still evaluating the underlying
values of the stock contributed, if the requested relief were to
be denied and the matter could not otherwise be resolved
favorably with the Internal Revenue Service, we believe there
would be no near-term cash impact as the gain would likely
offset a substantial portion of our accumulated tax loss
carryforwards; however, the impact to net income in the period
such obligation became probable would be material.
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Our flexibility in maximizing commercialization
opportunities for our compounds may be limited by our
obligations to Schering-Plough. |
In November 2000, we entered into an agreement that provides
Schering-Plough with an option to acquire the rights to up to
three of our products intended to treat hepatitis C that
they designate prior to our entering into Phase 2 clinical
trials and a right for first/ last refusal to license various
compounds we may develop and elect to license to others.
Viramidine was not subject to the option of Schering-Plough, but
it would be subject to their right of first/ last refusal if we
elected to license it to a third party. In addition, the
agreement provides for certain other disclosures about our
research and development activities. The interest of potential
collaborators in obtaining rights to our compounds or the terms
of any agreements we ultimately enter into for these rights may
be impacted by our agreement with Schering-Plough. A
commercialization partner other than Schering-Plough might have
otherwise been preferable due to that potential partners
strength in a given disease area or geographic region or for
other reasons.
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We are subject to uncertainty related to health care
reform measures and reimbursement policies. |
The levels at which government authorities, private health
insurers, HMOs and other organizations reimburse the costs of
drugs and treatments related to those drugs will have an effect
on the successful commercialization of our drug candidates. We
cannot be sure that reimbursement in the United States or
elsewhere will be available for any drugs we may develop or, if
already available, will not be decreased in the future. Also, we
cannot be sure that reimbursement amounts will not reduce the
demand for, or the price of, our drugs. If reimbursement is not
available or is available only to limited levels, we may not be
able to obtain a satisfactory financial return on the
manufacture and commercialization of existing and any future
drugs. Consequently, significant uncertainty exists as to the
reimbursement status of approved health care products.
Third-party payors may not establish and maintain price levels
sufficient for us to realize an appropriate return on our
investment in product development or our continued manufacture
and sale of existing drug products.
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If our nucleoside analog library is destroyed because of
an earthquake or other disaster, our research and development
program may be seriously harmed. |
The laboratory books and the compounds that comprise our
nucleoside analog library are all located at our headquarters in
Costa Mesa, California, near areas where earthquakes have
occurred in the past.
There are duplicate copies of laboratory books off-premises, but
there are no backup copies of the product candidates we are
currently developing. No duplicate copies of our nucleoside
analog library exist because making copies would be
prohibitively expensive and the library has not been moved
off-site because our scientific staff is currently in the
process of screening it. Our ability to develop potential
product candidates from our nucleoside analog library would be
significantly impaired if these compounds were destroyed in an
earthquake, fire or other disaster. Any insurance we maintain
may not be adequate to cover our losses.
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Dependence on key personnel leaves us vulnerable to a
negative impact if they leave. |
We believe that our continued success will depend to a
significant extent upon the efforts and abilities of the key
members of management. The loss of their services could have a
negative impact on us.
In addition, our research and development effort depends upon
the principal members of our scientific staff. Our success
depends upon our ability to attract, train, motivate and retain
qualified scientific personnel. Qualified personnel are in great
demand throughout the biotechnology and pharmaceutical
industries. We may not be able to attract additional personnel
or retain existing employees.
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Our third-party manufacturers failure to comply with
FDA regulations could cause interruption of the manufacture of
our products. |
We have contracted with third parties to manufacture some of our
drug products, including products under the rights acquired from
other pharmaceutical companies. Our manufacturers are required
to adhere to current good manufacturing (cGMP)
regulations enforced by the FDA or similar regulations required
by regulatory agencies in other countries. Compliance with the
FDAs cGMP requirements applies to both drug products
seeking regulatory approval and to approved drug products. The
manufacturing facilities of our contract manufacturers must be
inspected and found to be in full compliance with cGMP standards
before approval for marketing. Contract manufacturers of our
approved products are subject to ongoing regulation by the FDA,
including compliance with cGMP requirements.
Our dependence upon others to manufacture our products may
adversely affect our profit margins and our ability to develop
and obtain approval for our products on a timely and competitive
basis, if at all. Failure for our contract manufacturers to
comply with cGMP regulations can result in enforcement action by
the FDA, including, among other things, warning letters, fines,
injunctions, civil penalties, recall or seizure of products,
total or partial suspension of production, refusal of the
government to renew marketing applications and criminal
prosecution. In addition, delays or difficulties with our
contract manufacturers in producing, packaging, or distributing
our products could adversely affect the sales of our current
products or introduction of other products.
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Schering-Plough manufactures and sells ribavirin under license
from us. In May 2002, Schering-Plough signed a consent decree of
permanent injunction with the FDA, agreeing to measures to
assure that the drug products manufactured at their Puerto Rico
plant are made in compliance with FDAs current good
manufacturing practice regulations. While Schering-Plough has
advised us that the deficiencies were not specifically
applicable to the production of ribavirin, the consent decree
covers the facility producing ribavirin. Schering-Ploughs
ability to manufacture and ship ribavirin could be affected by
temporary interruption of some production lines to install
system upgrades and further enhance compliance, and other
technical production and equipment qualification issues. If the
FDA is not satisfied with Schering-Ploughs compliance
under the consent decree, the FDA could take further regulatory
actions against Schering-Plough, including the seizure of
products, an injunction against further manufacture, a product
recall or other actions that could interrupt production of
ribavirin. Interruption of ribavirin production for a sustained
period of time could materially reduce our royalty revenue.
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Our business, financial condition and results of
operations are subject to risks arising from the international
scope of our operations. |
We conduct a significant portion of our business outside the
United States. Including ribavirin royalties, approximately 81%
and 78% of our revenue was generated outside the United States
during the year ended December 31, 2004 and 2003,
respectively. We sell our pharmaceutical products in 128
countries around the world and employ approximately 4,300
individuals in countries other than the United States. The
international scope of our operations may lead to volatile
financial results and difficulties in managing our operations
because of, but not limited to, the following:
|
|
|
|
|
difficulties and costs of staffing, severance and benefit
payments and managing international operations; |
|
|
|
exchange controls, currency restrictions and exchange rate
fluctuations; |
|
|
|
unexpected changes in regulatory requirements; |
|
|
|
the burden of complying with multiple and potentially
conflicting laws; |
|
|
|
the geographic, time zone, language and cultural differences
between personnel in different areas of the world; |
|
|
|
greater difficulty in collecting accounts receivables in and
moving cash out of certain geographic regions; |
|
|
|
the need for a significant amount of available cash from
operations to fund our business in a number of geographic and
economically diverse locations; and |
|
|
|
political, social and economic instability in emerging markets
in which we currently operate. |
|
|
|
Many of our key processes, opportunities and expenses are
a function of national and/or local government regulation.
Significant changes in regulations could have a material adverse
impact on our business. |
The process by which pharmaceutical products are approved is
lengthy and highly regulated. We have developed expertise in
managing this process in the many markets around the world. Our
multi-year clinical trials programs are planned and executed to
conform to these regulations, and once begun, can be difficult
and expensive to change should the regulations regarding
approval of pharmaceutical products significantly change.
In addition, we depend on patent law and data exclusivity to
keep generic products from reaching the market before we have
obtained our targeted return on our investment in the discovery
and development of our products. In assessing whether we will
invest in any development program, or license a product from a
third party, we assess the likelihood of patent and/or data
exclusivity under the laws and regulations then in effect. If
those schemes significantly change in a large market, or across
many smaller markets, our ability to protect our investment may
be adversely affected.
41
Appropriate tax planning requires that we consider the current
and prevailing national and local tax laws and regulations, as
well as international tax treaties and arrangements that we
enter into with various government authorities. Changes in
national/local tax regulations, or changes in political
situations may limit or eliminate the effects of our tax
planning.
|
|
|
Due to the large portion of our business conducted outside
the United States, we have significant foreign currency
risk. |
We sell products in many countries that are susceptible to
significant foreign currency risk. In some of these markets we
sell products for U.S. Dollars. While this eliminates our
direct currency risk in such markets, it increases our credit
risk because if a local currency is devalued significantly, it
becomes more expensive for customers in that market to purchase
our products in United States Dollars. In 2004, we entered into
foreign currency hedge arrangements to hedge a portion of our
exposure against variability in the Euro. We continue to
evaluate the possibility of entering into additional hedge
arrangements.
|
|
|
We are subject to price control restrictions on our
pharmaceutical products in the majority of countries in which we
operate. |
There is a risk that other jurisdictions may enact price control
restrictions, and that the restrictions that currently exist may
be increased. A significant portion of the sales of our products
are in Europe, a market in which price increases are controlled,
and in some instances, reductions are imposed. Our future sales
and gross profit could be materially adversely affected if we
are unable to obtain appropriate price increases, or if our
products are subject to price reductions.
|
|
|
Our research and development activities involve the
controlled use of potentially harmful biological materials as
well as hazardous materials, chemicals and various radioactive
compounds. |
We cannot completely eliminate the risk of accidental
contamination or injury from the use, storage, handling or
disposal of potentially harmful biological materials as well as
hazardous materials, chemicals and various radioactive
compounds. In the event of contamination or injury, we could be
held liable for damages that result. Any liability could exceed
our resources. We are subject to federal, state and local laws
and regulations governing the use, storage, handling and
disposal of these materials and specified waste products. The
cost of compliance with, or any potential violation of, these
laws and regulations could be significant. Any insurance we
maintain may not be adequate to cover our losses.
|
|
|
Our stockholder rights plan and anti-takeover provisions
of our charter documents could provide our board of directors
with the ability to delay or prevent a change in control of
us. |
Our stockholder rights plan, provisions of our certificate of
incorporation and provisions of the Delaware General Corporation
Law provides our board of directors with the ability to deter
hostile takeovers or delay, deter or prevent a change in control
of us, including transactions in which stockholders might
otherwise receive a premium for their shares over then current
market prices.
42
|
|
Item 7A. |
Quantitative and Qualitative Disclosures About Market
Risk |
Our business and financial results are affected by fluctuations
in world financial markets. We evaluate our exposure to such
risks on an ongoing basis, and seek ways to manage these risks
to an acceptable level, based on managements judgment of
the appropriate trade-off between risk, opportunity and cost. We
do not hold any significant amount of market risk sensitive
instruments whose value is subject to market price risk. Our
significant foreign currency exposure relates to the Euro, the
Mexican Peso, the Polish Zloty, the Swiss Franc and the Canadian
Dollar. We seek to manage our foreign currency exposure by
maintaining the majority of cash balances at foreign
subsidiaries in U.S. Dollars and through operational means
by managing local currency revenues in relation to local
currency costs. We are currently taking steps to mitigate the
impact of foreign currency on the income statement, which
include hedging our foreign currency exposure. In March and June
2004, we entered into foreign currency hedge transactions to
reduce our exposure to variability in the Euro.
In the normal course of business, we also face risks that are
either non-financial or non-quantifiable. Such risks principally
include country risk, credit risk and legal risk and are not
discussed or quantified in the following analysis. At
December 31, 2004, the fair value of our financial
instruments was as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets (Liabilities) | |
|
|
Notional/ | |
|
| |
|
|
Contract | |
|
Carrying | |
|
Fair | |
Description |
|
Amount | |
|
Value | |
|
Value | |
|
|
| |
|
| |
|
| |
Forward contracts
|
|
$ |
44,760 |
|
|
$ |
(5,630 |
) |
|
$ |
(5,630 |
) |
Interest rate swaps
|
|
|
150,000 |
|
|
|
(1,167 |
) |
|
|
(1,167 |
) |
Outstanding debt
|
|
|
780,000 |
|
|
|
(780,000 |
) |
|
|
(836,000 |
) |
We currently do not hold financial instruments for trading or
speculative purposes. Our financial assets are not subject to
significant interest rate risk due to their short duration. At
December 31, 2004, we had $14,548,000 of foreign
denominated variable rate debt that would subject it to both
interest rate and currency risks. In January 2004, we entered
into an interest rate swap agreement with respect to
$150,000,000 principal amount of our 7.0% Senior Notes. A
100 basis-point increase in interest rates affecting our
financial instruments would not have had a material effect on
our 2004 pretax earnings. In addition, we had $780,000,000 of
fixed rate debt as of December 31, 2004, that requires
U.S. Dollar repayment. To the extent that we require, as a
source of debt repayment, earnings and cash flow from some of
our units located in foreign countries, we are subject to risk
of changes in the value of certain currencies relative to the
U.S. Dollar. However, the increase of a 100 basis-points in
interest rates would have reduced the fair value of our
remaining fixed-rate debt instruments by approximately
$47,000,000 as of December 31, 2004.
We estimated the sensitivity of the fair value of our derivative
foreign exchange contracts to a hypothetical 10% strengthening
and 10% weakening of the spot exchange rates for the
U.S. Dollar against the Euro at December 31, 2004.
Based on a current fair value of our derivative foreign exchange
contracts of $5,630,000, the analysis showed that a 10%
strengthening of the U.S. Dollar would have resulted in a
loss from a fair value change of $1,054,000 and a 10% weakening
of the U.S. Dollar would have resulted in a loss from a
fair value change of $11,223,000 in these instruments. Losses
and gains on the underlying transactions being hedged would have
largely offset any gains and losses on the fair value of
derivative contracts. These offsetting gains and losses are not
reflected in the above analysis.
43
|
|
Item 8. |
Financial Statements and Supplementary Data |
Quarterly Financial Data
Following is a summary of quarterly financial data for the years
ended December 31, 2004 and 2003 (in thousands, except per
share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
First | |
|
Second | |
|
Third | |
|
Fourth | |
|
|
Quarter | |
|
Quarter | |
|
Quarter | |
|
Quarter | |
|
|
| |
|
| |
|
| |
|
| |
|
|
(Unaudited) | |
2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$ |
157,702 |
|
|
$ |
170,368 |
|
|
$ |
166,432 |
|
|
$ |
188,018 |
|
Gross profit on product sales
|
|
|
85,613 |
|
|
|
101,696 |
|
|
|
101,835 |
|
|
|
116,636 |
|
Income (loss) from continuing operations
|
|
|
(10,512 |
)(a) |
|
|
(27,325 |
)(c)(d) |
|
|
(8,536 |
)(c) |
|
|
(89,880 |
)(b) |
Income (loss) from discontinued operations, net
|
|
|
(3,061 |
) |
|
|
(13,966 |
)(e) |
|
|
(7,365 |
) |
|
|
(9,152 |
) |
Net income (loss)
|
|
|
(13,573 |
) |
|
|
(41,291 |
) |
|
|
(15,901 |
) |
|
|
(99,032 |
) |
Basic earnings (loss) per share from continuing operations
|
|
|
(0.12 |
) |
|
|
(0.32 |
) |
|
|
(0.10 |
) |
|
|
(1.07 |
) |
Discontinued operations, net of tax
|
|
|
(0.04 |
) |
|
|
(0.17 |
) |
|
|
(0.09 |
) |
|
|
(0.11 |
) |
Basic earnings (loss) per share net income (loss)
|
|
|
(0.16 |
) |
|
|
(0.49 |
) |
|
|
(0.19 |
) |
|
|
(1.18 |
) |
Diluted earnings (loss) per share from continuing operations
|
|
|
(0.12 |
) |
|
|
(0.32 |
) |
|
|
(0.10 |
) |
|
|
(1.07 |
) |
Discontinued operations, net of tax
|
|
|
(0.04 |
) |
|
|
(0.17 |
) |
|
|
(0.09 |
) |
|
|
(0.11 |
) |
Diluted earnings (loss) per share net income (loss)
|
|
$ |
(0.16 |
) |
|
$ |
(0.49 |
) |
|
$ |
(0.19 |
) |
|
$ |
(1.18 |
) |
2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues
|
|
$ |
158,717 |
|
|
$ |
183,487 |
|
|
$ |
167,507 |
|
|
$ |
176,242 |
|
Gross profit on product sales
|
|
|
68,896 |
|
|
|
84,212 |
|
|
|
89,651 |
|
|
|
91,043 |
|
Income (loss) from continuing operations
|
|
|
13,221 |
|
|
|
17,438 |
|
|
|
(98,511 |
)(a) |
|
|
2,866 |
(f) |
Income (loss) from discontinued operations, net
|
|
|
449 |
|
|
|
(2,567 |
) |
|
|
16,110 |
|
|
|
(4,646 |
) |
Net income (loss)
|
|
|
13,670 |
|
|
|
14,871 |
|
|
|
(82,401 |
) |
|
|
(1,780 |
) |
Basic earnings (loss) per share from continuing operations
|
|
|
0.16 |
|
|
|
0.21 |
|
|
|
(1.18 |
) |
|
|
0.04 |
|
Discontinued operations, net of tax
|
|
|
|
|
|
|
(0.03 |
) |
|
|
0.19 |
|
|
|
(0.06 |
) |
Basic earnings (loss) per share net income (loss)
|
|
|
0.16 |
|
|
|
0.18 |
|
|
|
(0.99 |
) |
|
|
(0.02 |
) |
Diluted earnings (loss) per share from continuing operations
|
|
|
0.16 |
|
|
|
0.21 |
|
|
|
(1.18 |
) |
|
|
0.03 |
|
Discontinued operations, net of tax
|
|
|
|
|
|
|
(0.03 |
) |
|
|
0.19 |
|
|
|
(0.05 |
) |
Diluted earnings (loss) per share net income (loss)
|
|
$ |
0.16 |
|
|
$ |
0.18 |
|
|
$ |
(0.99 |
) |
|
$ |
(0.02 |
) |
|
|
|
(a) |
|
In February 2004, we acquired from Amarin Corporation, plc its
United States-based subsidiary, Amarin, and all of that
subsidiarys United States product rights. The total
consideration paid for Amarin was $40,000,000. In August 2003,
we repurchased the 20% publicly held minority interest in
Ribapharm for an aggregate total purchase price of $207,658,000.
In connection with these acquisitions, we expensed $11,386,000
and $384,000 in the first and second quarter of 2004,
respectively, and $117,609,000 in the |
44
|
|
|
|
|
third quarter of 2003 associated with acquired in-process
research and development on projects that, as of the acquisition
date, had not yet reached technological feasibility and had no
alternative future use. |
|
(b) |
|
During the fourth quarter of 2004, we recorded a valuation
allowance of $95,648,000 against our deferred tax asset to
recognize the uncertainty of realizing the benefits of the
U.S. net operating losses and research credits. |
|
(c) |
|
In May and July 2004, we repurchased $326,001,000 aggregate
principal amount of our
61/2% Convertible
Subordinated Notes due 2008. In connection with these
repurchases, we recorded a loss on early extinguishment of debt
of $5,898,000 and $13,994,000 in the second and third quarter of
2004, respectively. |
|
(d) |
|
In the second quarter of 2004, we incurred an expense of
$20,185,000 related to the manufacturing and rationalization
plan. The manufacturing sites were tested for impairment in the
second quarter of 2004, resulting in impairment of asset value
on three of the sites. Accordingly, we wrote these sites down to
their fair value and recorded impairment charges of $18,000,000
and severance charges of $2,185,000 in the second quarter of
2004. |
|
(e) |
|
In the second quarter of 2004, we recorded an additional
environmental charge of $16,000,000, which is included in loss
from discontinued operations, related to environmental
contamination that has been identified in the soil under a
facility built by us that housed operations of our discontinued
Biomedicals division. |
|
(f) |
|
In November 2003, we completed an offering of $240,000,000
aggregate principal amount of 3.0% Convertible Subordinated
Notes due 2010 and $240,000,000 aggregate principal amount of
4.0% Convertible Subordinated Notes due 2013. We used
proceeds from this offering to retire $139,589,000 aggregate
principal amount of our
61/2% Convertible
Subordinated Notes due 2008, resulting in a loss on early
extinguishment of debt of $12,803,000. In December 2003, we
issued $300,000,000 aggregate principal amount of
7.0% Senior Notes due 2011. |
45
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS AND SCHEDULE
December 31, 2004
|
|
|
|
|
|
|
|
|
Page | |
|
|
| |
|
|
|
47 |
|
Financial statements:
|
|
|
|
|
|
|
|
|
49 |
|
|
For the years ended December 31, 2004, 2003 and 2002:
|
|
|
|
|
|
|
|
|
|
50 |
|
|
|
|
|
|
51 |
|
|
|
|
|
|
52 |
|
|
|
|
|
53 |
|
Financial statement schedule for the years ended
December 31, 2004, 2003 and 2002:
|
|
|
|
|
|
|
|
|
87 |
|
The other schedules have not been submitted because they are not
applicable.
46
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and
Stockholders of Valeant Pharmaceuticals International:
We have completed an integrated audit of Valeant Pharmaceuticals
Internationals 2004 consolidated financial statements and
of its internal control over financial reporting as of
December 31, 2004 and audits of its 2003 and 2002
consolidated financial statements in accordance with the
standards of the Public Company Accounting Oversight Board
(United States). Our opinions, based on our audits, are
presented below.
Consolidated financial statements and financial statement
schedule
In our opinion, the consolidated financial statements listed in
the accompanying index, present fairly, in all material
respects, the financial position of Valeant Pharmaceuticals
International and its subsidiaries at December 31, 2004 and
2003, and the results of their operations and their cash flows
for each of the three years in the period ended
December 31, 2004 in conformity with accounting principles
generally accepted in the United States of America. In addition,
in our opinion, the financial statement schedule listed in the
accompanying index presents fairly, in all material respects,
the information set forth therein when read in conjunction with
the related consolidated financial statements. These financial
statements and financial statement schedule are the
responsibility of the Companys management. Our
responsibility is to express an opinion on these financial
statements and financial statement schedule based on our audits.
We conducted our audits of these statements 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 of financial statements includes examining, on a test
basis, evidence supporting the amounts and disclosures in the
financial statements, assessing the accounting principles used
and significant estimates made by management, and evaluating the
overall financial statement presentation. We believe that our
audits provide a reasonable basis for our opinion.
As discussed in Note 1 in Notes to Consolidated Financial
Statements, the Company adopted Statement of Financial
Accounting Standard No. 142, Goodwill and Other
Intangible Assets, on January 1, 2002 and as a result
changed its method of accounting for goodwill.
Internal control over financial reporting
Also, in our opinion, managements assessment, included in
Managements Report on Internal Control Over
Financial Reporting appearing under Item 9A, that the
Company maintained effective internal control over financial
reporting as of December 31, 2004 based on criteria
established in Internal Control Integrated
Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO), is
fairly stated, in all material respects, based on those
criteria. Furthermore, in our opinion, the Company maintained,
in all material respects, effective internal control over
financial reporting as of December 31, 2004, based on
criteria established in Internal Control
Integrated Framework issued by the COSO. The
Companys 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 opinions
on managements assessment and on the effectiveness of the
Companys internal control over financial reporting based
on our audit. We conducted our audit of internal control over
financial reporting 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. An audit of internal control over financial reporting
includes 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
consider necessary in the circumstances. We believe that our
audit provides a reasonable basis for our opinions.
47
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 (i) pertain to the maintenance
of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the
company; (ii) 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 (iii) 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.
/s/ PricewaterhouseCoopers
LLP
PricewaterhouseCoopers LLP
Los Angeles, California
March 16, 2005
48
VALEANT PHARMACEUTICALS INTERNATIONAL
CONSOLIDATED BALANCE SHEETS
December 31, 2004 and 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
(In thousands, except par | |
|
|
value data) | |
ASSETS |
Current Assets:
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents
|
|
$ |
222,590 |
|
|
$ |
410,019 |
|
|
Marketable securities
|
|
|
238,918 |
|
|
|
463,962 |
|
|
Accounts receivable, net
|
|
|
171,860 |
|
|
|
162,402 |
|
|
Inventories, net
|
|
|
112,250 |
|
|
|
91,906 |
|
|
Prepaid expenses and other current assets
|
|
|
25,049 |
|
|
|
29,450 |
|
|
|
|
|
|
|
|
|
|
Total current assets
|
|
|
770,667 |
|
|
|
1,157,739 |
|
Property, plant and equipment, net
|
|
|
233,258 |
|
|
|
241,016 |
|
Deferred tax assets, net
|
|
|
|
|
|
|
12,551 |
|
Goodwill
|
|
|
20,499 |
|
|
|
13,282 |
|
Intangible assets, net
|
|
|
432,277 |
|
|
|
421,747 |
|
Other assets
|
|
|
41,280 |
|
|
|
50,738 |
|
|
|
|
|
|
|
|
|
|
Total non-current assets
|
|
|
727,314 |
|
|
|
739,334 |
|
Assets of discontinued operations
|
|
|
23,894 |
|
|
|
27,994 |
|
|
|
|
|
|
|
|
|
|
$ |
1,521,875 |
|
|
$ |
1,925,067 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
Current Liabilities:
|
|
|
|
|
|
|
|
|
|
Trade payables
|
|
$ |
48,713 |
|
|
$ |
36,073 |
|
|
Accrued liabilities
|
|
|
122,297 |
|
|
|
109,373 |
|
|
Notes payable and current portion of long-term debt
|
|
|
929 |
|
|
|
1,343 |
|
|
Income taxes payable
|
|
|
20,266 |
|
|
|
14,962 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities
|
|
|
192,205 |
|
|
|
161,751 |
|
Long-term debt, less current portion
|
|
|
793,139 |
|
|
|
1,119,802 |
|
Other liabilities
|
|
|
28,252 |
|
|
|
18,422 |
|
|
|
|
|
|
|
|
|
|
Total non-current liabilities
|
|
|
821,391 |
|
|
|
1,138,224 |
|
Liabilities of discontinued operations
|
|
|
32,056 |
|
|
|
19,731 |
|
|
|
|
|
|
|
|
Commitments and contingencies
|
|
|
|
|
|
|
|
|
Stockholders Equity:
|
|
|
|
|
|
|
|
|
|
Common stock, $0.01 par value; 200,000 shares
authorized; 84,219 (2004) and 83,185 (2003) shares
outstanding (after deducting shares in treasury of 1,068 as of
December 31, 2004 and 2003)
|
|
|
842 |
|
|
|
832 |
|
|
Additional capital
|
|
|
1,004,875 |
|
|
|
976,773 |
|
|
Accumulated deficit
|
|
|
(534,205 |
) |
|
|
(338,384 |
) |
|
Accumulated other comprehensive profit (loss)
|
|
|
4,711 |
|
|
|
(33,860 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders equity
|
|
|
476,223 |
|
|
|
605,361 |
|
|
|
|
|
|
|
|
|
|
$ |
1,521,875 |
|
|
$ |
1,925,067 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated statements.
49
VALEANT PHARMACEUTICALS INTERNATIONAL
CONSOLIDATED STATEMENTS OF OPERATIONS
For the Years Ended December 31, 2004, 2003 and 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands, except per share data) | |
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales
|
|
$ |
606,093 |
|
|
$ |
518,471 |
|
|
$ |
466,809 |
|
|
Ribavirin royalties
|
|
|
76,427 |
|
|
|
167,482 |
|
|
|
270,265 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
682,520 |
|
|
|
685,953 |
|
|
|
737,074 |
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold (excluding amortization)
|
|
|
200,313 |
|
|
|
184,669 |
|
|
|
157,013 |
|
|
Selling expenses
|
|
|
196,567 |
|
|
|
166,707 |
|
|
|
164,103 |
|
|
General and administrative expenses
|
|
|
98,566 |
|
|
|
111,532 |
|
|
|
366,530 |
|
|
Research and development costs
|
|
|
92,496 |
|
|
|
45,286 |
|
|
|
49,531 |
|
|
Acquired in-process research and development
|
|
|
11,770 |
|
|
|
117,609 |
|
|
|
|
|
|
Restructuring charges
|
|
|
19,344 |
|
|
|
|
|
|
|
|
|
|
Amortization expense
|
|
|
59,303 |
|
|
|
38,577 |
|
|
|
30,661 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses
|
|
|
678,359 |
|
|
|
664,380 |
|
|
|
767,838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
4,161 |
|
|
|
21,573 |
|
|
|
(30,764 |
) |
Other income, net, including translation and exchange
|
|
|
141 |
|
|
|
4,727 |
|
|
|
8,707 |
|
Gain on sale of subsidiary stock
|
|
|
|
|
|
|
|
|
|
|
261,937 |
|
Loss on early extinguishment of debt
|
|
|
(19,892 |
) |
|
|
(12,803 |
) |
|
|
(25,730 |
) |
Interest income
|
|
|
12,432 |
|
|
|
8,888 |
|
|
|
5,644 |
|
Interest expense
|
|
|
(49,265 |
) |
|
|
(36,145 |
) |
|
|
(42,856 |
) |
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations before income taxes and
minority interest
|
|
|
(52,423 |
) |
|
|
(13,760 |
) |
|
|
176,938 |
|
Provision for income taxes
|
|
|
83,597 |
|
|
|
39,463 |
|
|
|
74,963 |
|
Minority interest, net
|
|
|
233 |
|
|
|
11,763 |
|
|
|
17,730 |
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations
|
|
|
(136,253 |
) |
|
|
(64,986 |
) |
|
|
84,245 |
|
|
Income (loss) from discontinued operations
|
|
|
(33,544 |
) |
|
|
9,346 |
|
|
|
(197,288 |
) |
|
Cumulative effect of change in accounting principle
|
|
|
|
|
|
|
|
|
|
|
(21,791 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$ |
(169,797 |
) |
|
$ |
(55,640 |
) |
|
$ |
(134,834 |
) |
|
|
|
|
|
|
|
|
|
|
Basic income (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations
|
|
$ |
(1.62 |
) |
|
$ |
(0.78 |
) |
|
$ |
1.01 |
|
|
Discontinued operations
|
|
|
(0.40 |
) |
|
|
0.11 |
|
|
|
(2.37 |
) |
|
Cumulative effect of change in accounting principle
|
|
|
|
|
|
|
|
|
|
|
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic net loss per share
|
|
$ |
(2.02 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.62 |
) |
|
|
|
|
|
|
|
|
|
|
Diluted income (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations
|
|
$ |
(1.62 |
) |
|
$ |
(0.78 |
) |
|
$ |
1.00 |
|
|
Discontinued operations
|
|
|
(0.40 |
) |
|
|
0.11 |
|
|
|
(2.35 |
) |
|
Cumulative effect of change in accounting principle
|
|
|
|
|
|
|
|
|
|
|
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
Diluted net loss per share
|
|
$ |
(2.02 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.61 |
) |
|
|
|
|
|
|
|
|
|
|
Shares used in per share computation:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic
|
|
|
83,887 |
|
|
|
83,602 |
|
|
|
83,279 |
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
|
83,887 |
|
|
|
83,602 |
|
|
|
83,988 |
|
|
|
|
|
|
|
|
|
|
|
Dividends paid per share of common stock
|
|
$ |
0.31 |
|
|
$ |
0.31 |
|
|
$ |
0.31 |
|
|
|
|
|
|
|
|
|
|
|
Dividends declared per share of common stock
|
|
$ |
0.31 |
|
|
$ |
0.31 |
|
|
$ |
0.31 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated statements.
50
VALEANT PHARMACEUTICALS INTERNATIONAL
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY
For the Years Ended December 31, 2004, 2003 and 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated | |
|
|
|
|
Preferred Stock |
|
Common Stock | |
|
|
|
|
|
Other | |
|
|
|
|
|
|
| |
|
Additional | |
|
Accumulated | |
|
Comprehensive | |
|
|
|
|
Shares | |
|
Amount |
|
Shares | |
|
Amount | |
|
Capital | |
|
Deficit | |
|
Profit (Loss) | |
|
Total | |
|
|
| |
|
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Balance at December 31, 2001
|
|
|
|
|
|
$ |
|
|
|
|
81,689 |
|
|
$ |
817 |
|
|
$ |
995,243 |
|
|
$ |
(96,055 |
) |
|
$ |
(89,288 |
) |
|
$ |
810,717 |
|
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(134,834 |
) |
|
|
|
|
|
|
(134,834 |
) |
|
Foreign currency translation adjustments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
27,906 |
|
|
|
27,906 |
|
|
Unrealized loss on marketable equity securities and other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,295 |
) |
|
|
(6,295 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(113,223 |
) |
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
860 |
|
|
|
9 |
|
|
|
13,481 |
|
|
|
|
|
|
|
|
|
|
|
13,490 |
|
Stock options exchanged for common stock
|
|
|
|
|
|
|
|
|
|
|
307 |
|
|
|
3 |
|
|
|
2,965 |
|
|
|
|
|
|
|
|
|
|
|
2,968 |
|
Tax benefit of stock options exercised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,649 |
|
|
|
|
|
|
|
|
|
|
|
6,649 |
|
Stock compensation
|
|
|
|
|
|
|
|
|
|
|
235 |
|
|
|
2 |
|
|
|
9,004 |
|
|
|
|
|
|
|
|
|
|
|
9,006 |
|
Repurchase of common stock
|
|
|
|
|
|
|
|
|
|
|
(1,146 |
) |
|
|
(11 |
) |
|
|
(31,944 |
) |
|
|
|
|
|
|
|
|
|
|
(31,955 |
) |
Issuance of common stock in connection with acquisitions
|
|
|
|
|
|
|
|
|
|
|
2,121 |
|
|
|
21 |
|
|
|
31,937 |
|
|
|
|
|
|
|
|
|
|
|
31,958 |
|
Dividends
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(25,920 |
) |
|
|
|
|
|
|
(25,920 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2002
|
|
|
|
|
|
|
|
|
|
|
84,066 |
|
|
|
841 |
|
|
|
1,027,335 |
|
|
|
(256,809 |
) |
|
|
(67,677 |
) |
|
|
703,690 |
|
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(55,640 |
) |
|
|
|
|
|
|
(55,640 |
) |
|
Foreign currency translation adjustments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
34,759 |
|
|
|
34,759 |
|
|
Unrealized loss on marketable equity securities and other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(942 |
) |
|
|
(942 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(21,823 |
) |
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
145 |
|
|
|
2 |
|
|
|
1,724 |
|
|
|
|
|
|
|
|
|
|
|
1,726 |
|
Tax effect on stock options exercised, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,657 |
) |
|
|
|
|
|
|
|
|
|
|
(3,657 |
) |
Stock compensation
|
|
|
|
|
|
|
|
|
|
|
42 |
|
|
|
|
|
|
|
1,940 |
|
|
|
|
|
|
|
|
|
|
|
1,940 |
|
Common stock received for assets
|
|
|
|
|
|
|
|
|
|
|
(895 |
) |
|
|
(9 |
) |
|
|
(15,197 |
) |
|
|
|
|
|
|
|
|
|
|
(15,206 |
) |
Common stock received in settlement of note receivable
|
|
|
|
|
|
|
|
|
|
|
(173 |
) |
|
|
(2 |
) |
|
|
(207 |
) |
|
|
|
|
|
|
|
|
|
|
(209 |
) |
Convertible note hedge
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(42,880 |
) |
|
|
|
|
|
|
|
|
|
|
(42,880 |
) |
Issuance of stock options in connection with Ribapharm
acquisition
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
7,715 |
|
|
|
|
|
|
|
|
|
|
|
7,715 |
|
Dividends
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(25,935 |
) |
|
|
|
|
|
|
(25,935 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
83,185 |
|
|
|
832 |
|
|
|
976,773 |
|
|
|
(338,384 |
) |
|
|
(33,860 |
) |
|
|
605,361 |
|
Comprehensive income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(169,797 |
) |
|
|
|
|
|
|
(169,797 |
) |
|
Foreign currency translation adjustments
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
43,343 |
|
|
|
43,343 |
|
|
Unrealized loss on marketable equity securities and other
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,772 |
) |
|
|
(4,772 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(131,226 |
) |
Exercise of stock options
|
|
|
|
|
|
|
|
|
|
|
839 |
|
|
|
8 |
|
|
|
10,611 |
|
|
|
|
|
|
|
|
|
|
|
10,619 |
|
Employee stock purchase plan
|
|
|
|
|
|
|
|
|
|
|
195 |
|
|
|
2 |
|
|
|
2,871 |
|
|
|
|
|
|
|
|
|
|
|
2,873 |
|
Tax effect on stock options exercised, net
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12,548 |
|
|
|
|
|
|
|
|
|
|
|
12,548 |
|
Stock compensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,072 |
|
|
|
|
|
|
|
|
|
|
|
2,072 |
|
Dividends
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(26,024 |
) |
|
|
|
|
|
|
(26,024 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004
|
|
|
|
|
|
$ |
|
|
|
|
84,219 |
|
|
$ |
842 |
|
|
$ |
1,004,875 |
|
|
$ |
(534,205 |
) |
|
$ |
4,711 |
|
|
$ |
476,223 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated statements.
51
VALEANT PHARMACEUTICALS INTERNATIONAL
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the Years Ended December 31, 2004, 2003 and 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Cash flows from operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations
|
|
$ |
(136,253 |
) |
|
$ |
(64,986 |
) |
|
$ |
84,245 |
|
|
Adjustments to reconcile net income (loss) to net cash provided
by (used in) operating activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization
|
|
|
87,138 |
|
|
|
64,807 |
|
|
|
53,919 |
|
|
|
Provision for losses on accounts receivable and inventory
obsolescence
|
|
|
6,371 |
|
|
|
6,856 |
|
|
|
6,011 |
|
|
|
Translation and exchange (gains) losses, net
|
|
|
(141 |
) |
|
|
(4,727 |
) |
|
|
(8,707 |
) |
|
|
Other non-cash items
|
|
|
3,416 |
|
|
|
5,360 |
|
|
|
55,961 |
|
|
|
Property, plant and equipment impairment charges
|
|
|
18,000 |
|
|
|
|
|
|
|
|
|
|
|
Write-off of acquired in-process R&D
|
|
|
11,770 |
|
|
|
117,609 |
|
|
|
|
|
|
|
Deferred income taxes
|
|
|
40,035 |
|
|
|
13,695 |
|
|
|
22,612 |
|
|
|
Minority interest
|
|
|
(233 |
) |
|
|
11,763 |
|
|
|
17,730 |
|
|
|
Gain on sale of subsidiary stock
|
|
|
|
|
|
|
|
|
|
|
(261,937 |
) |
|
|
Loss on extinguishment of debt
|
|
|
19,892 |
|
|
|
12,803 |
|
|
|
25,730 |
|
|
Change in assets and liabilities, net of effects of acquisitions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounts and notes receivable
|
|
|
(3,303 |
) |
|
|
60,167 |
|
|
|
4,263 |
|
|
|
Inventories
|
|
|
(16,293 |
) |
|
|
44 |
|
|
|
1,629 |
|
|
|
Prepaid expenses and other assets
|
|
|
1,294 |
|
|
|
(7,451 |
) |
|
|
(22,131 |
) |
|
|
Trade payables and accrued liabilities
|
|
|
5,307 |
|
|
|
(53,985 |
) |
|
|
49,874 |
|
|
|
Income taxes payable
|
|
|
4,256 |
|
|
|
28,701 |
|
|
|
(8,268 |
) |
|
|
Other liabilities
|
|
|
(5,238 |
) |
|
|
(15,051 |
) |
|
|
10,068 |
|
|
|
|
|
|
|
|
|
|
|
|
Cash flow from operating activities in continuing operations
|
|
|
36,018 |
|
|
|
175,605 |
|
|
|
30,999 |
|
|
Cash flow from operating activities in discontinued operations
|
|
|
(18,100 |
) |
|
|
13,543 |
|
|
|
(8,469 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities
|
|
|
17,918 |
|
|
|
189,148 |
|
|
|
22,530 |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital expenditures
|
|
|
(26,613 |
) |
|
|
(17,606 |
) |
|
|
(19,420 |
) |
|
Proceeds from sale of assets
|
|
|
12,088 |
|
|
|
1,256 |
|
|
|
1,526 |
|
|
Proceeds from sale of subsidiary stock
|
|
|
|
|
|
|
|
|
|
|
276,611 |
|
|
Proceeds from investments
|
|
|
1,173,251 |
|
|
|
335,534 |
|
|
|
715 |
|
|
Purchase of investments
|
|
|
(947,371 |
) |
|
|
(755,034 |
) |
|
|
(42,821 |
) |
|
Acquisition of license rights, product lines and businesses
|
|
|
(76,284 |
) |
|
|
(192,923 |
) |
|
|
(37,164 |
) |
|
|
|
|
|
|
|
|
|
|
|
Cash flow from investing activities in continuing operations
|
|
|
135,071 |
|
|
|
(628,773 |
) |
|
|
179,447 |
|
|
Cash flow from investing activities in discontinued operations
|
|
|
4,137 |
|
|
|
104,615 |
|
|
|
69 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities
|
|
|
139,208 |
|
|
|
(524,158 |
) |
|
|
179,516 |
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of long-term debt and notes payable
|
|
|
|
|
|
|
714,926 |
|
|
|
686 |
|
|
Payments on long-term debt and notes payable
|
|
|
(342,157 |
) |
|
|
(158,920 |
) |
|
|
(273,754 |
) |
|
Proceeds from issuance of stock
|
|
|
13,492 |
|
|
|
1,726 |
|
|
|
13,490 |
|
|
Repurchase of common stock
|
|
|
|
|
|
|
|
|
|
|
(31,955 |
) |
|
Dividends paid
|
|
|
(25,884 |
) |
|
|
(26,005 |
) |
|
|
(25,520 |
) |
|
|
|
|
|
|
|
|
|
|
|
Cash flow from financing activities in continuing operations
|
|
|
(354,549 |
) |
|
|
531,727 |
|
|
|
(317,053 |
) |
|
Cash flow from financing activities in discontinued operations
|
|
|
|
|
|
|
(362 |
) |
|
|
(1,021 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities
|
|
|
(354,549 |
) |
|
|
531,365 |
|
|
|
(318,074 |
) |
|
|
|
|
|
|
|
|
|
|
Effect of exchange rate changes on cash and cash equivalents
|
|
|
9,210 |
|
|
|
3,450 |
|
|
|
1,902 |
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
(188,213 |
) |
|
|
199,805 |
|
|
|
(114,126 |
) |
Cash and cash equivalents at beginning of year
|
|
|
410,932 |
|
|
|
211,127 |
|
|
|
325,253 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year
|
|
|
222,719 |
|
|
|
410,932 |
|
|
|
211,127 |
|
Cash and cash equivalents classified as part of discontinued
operations
|
|
|
(129 |
) |
|
|
(913 |
) |
|
|
(8,480 |
) |
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents of continuing operations
|
|
$ |
222,590 |
|
|
$ |
410,019 |
|
|
$ |
202,647 |
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these
consolidated statements.
52
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
December 31, 2004
|
|
1. |
Organization and Summary of Significant Accounting
Policies |
Organization: Valeant Pharmaceuticals International
(Valeant, formerly known as ICN Pharmaceuticals
Inc.) and its subsidiaries (collectively, the
Company) is a global, research-based, specialty
pharmaceutical company that discovers, develops, manufactures,
and markets a broad range of pharmaceutical products. In
addition, the Company generates royalty revenues from the sale
of ribavirin by Schering-Plough Ltd.
(Schering-Plough) and F. Hoffman-LaRoche
(Roche).
Principles of Consolidation: The accompanying
consolidated condensed financial statements include the accounts
of Valeant, its wholly owned subsidiaries and all of its
majority-owned subsidiaries. Minority interest in results of
operations of consolidated subsidiaries represents the minority
stockholders share of the income or loss of these
consolidated subsidiaries. All significant intercompany account
balances and transactions have been eliminated.
Cash and Cash Equivalents: Cash equivalents include
repurchase agreements, certificates of deposit, money market
funds and municipal debt securities which have maturities of
three months or less. For purposes of the consolidated
statements of cash flows, the Company considers highly liquid
investments with a maturity of three months or less at the time
of purchase to be cash equivalents. The carrying amount of these
assets approximates fair value due to the short-term maturity of
these investments. At December 31, 2004 and 2003, cash
equivalents totaled $179,938,000 and $158,686,000, respectively.
Marketable Securities: The Company invests in investment
grade securities and classifies these securities as
available-for-sale as they typically have maturities of one year
or less and are highly liquid. As of December 31, 2004, the
fair market value of these securities approximates cost.
Included in marketable securities is restricted cash of
$8,460,000 related to collateral on foreign currency hedges as
of December 31, 2004.
Allowance for Doubtful Accounts: The Company evaluates
the collectiblity of its receivables on a regular basis. The
allowance is based upon various factors including the financial
condition and payment history of major customers, an overall
review of collections experience on other accounts and economic
factors or events expected to affect our future collections
experience.
Inventories: Inventories, which include material, direct
labor and factory overhead, are stated at the lower of cost or
market. Cost is determined on a first-in, first-out
(FIFO) basis. The Company evaluates the carrying
value of its inventories on a regular basis, taking into account
such factors as historical and anticipated future sales compared
with quantities on hand, the price the Company expects to obtain
for its products in their respective markets compared with
historical cost and the remaining shelf life of goods on hand.
Property, Plant and Equipment: Property, plant and
equipment are stated at cost. The Company primarily uses the
straight-line method for depreciating property, plant and
equipment over their estimated useful lives. Buildings are
depreciated up to 40 years, machinery and equipment are
depreciated from 3-10 years, furniture and fixtures from
5-10 years and leasehold improvements and capital leases
are amortized over their useful lives, limited to the life of
the related lease. The Company follows the policy of
capitalizing expenditures that materially increase the lives of
the related assets and charges maintenance and repairs to
expense. Upon sale or retirement, the costs and related
accumulated depreciation or amortization are eliminated from the
respective accounts and the resulting gain or loss in included
in income. The Company, from time to time as circumstances
warrant, evaluates the carrying value of property, plant and
equipment. In evaluating property, plant and equipment, the
Company determines whether there has been impairment by
comparing the anticipated undiscounted future cash flows
expected to be generated by the property, plant and equipment
with its carrying value. If the undiscounted cash flows is less
than the carrying value, the amount of the impairment, if any,
will be determined by comparing the carrying value of the
property, plant and
53
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
equipment with its fair value. Fair value is generally based on
a discounted cash flows analysis, independent appraisals or
preliminary offers from prospective buyers. In the year ended
December 31, 2004, the Company recorded an impairment
charge of $18,000,000 on certain of its manufacturing sites. See
Note 4.
Acquired In-Process Research and Development: In the
years ended December 31, 2004 and 2003, the Company
incurred an expense of $11,770,000 and $117,609,000,
respectively, associated with acquired in-process research and
development (IPR&D) related to the acquisition
of Amarin Pharmaceuticals, Inc. (Amarin) and all of
that subsidiarys U.S. product rights in 2004 and the
acquisition of the minority interest of Ribapharm in 2003.
Amounts expensed as IPR&D represent an estimate of the fair
value of purchased in-process technology for projects that, as
of the acquisition date, had not yet reached technological
feasibility and had no alternative future use. The data used to
determine fair value requires significant judgment. Differences
in those judgments would have the impact of changing the
allocation of purchase price to goodwill, which is an
unamortizable intangible asset.
With regard to Amarin, the amount expensed as IPR&D
represents an estimate of the fair value of Zelapar® based
on the use of a discounted cash flow model (based on an estimate
of future sales and an average gross margin of 66%). The
estimated after-tax cash flows (using a tax rate of 40%) were
then discounted to a present value using a discount rate of 20%,
reflecting the Companys estimated risk adjusted after tax
weighted average cost of capital for its industry. The Zelapar
studies were completed in 2004 and, if successful, revenue for
Zelapar will commence in 2005.
With regard to Ribapharm, the estimated fair value of these
projects was based on the use of discounted cash flow model
(based on an estimate of future sales and an average gross
margin of 85%). For each project, the estimated after-tax cash
flows (using a tax rate of 25%) were probability weighted to
take account of the stage of completion and the risks
surrounding the successful development and commercialization.
The assumed tax rate of 25% is the Companys estimate of
the effective tax rate for acquisitions of similar type of
assets. These cash flows were then discounted to a present value
using a discount rate of 15%, which is the Companys after
tax weighted average cost of capital. The Company then risk
adjusted the cash flows for each project. In addition, solely
for the purposes of estimating the fair value of these IPR&D
projects as of August 25, 2003, the following assumptions
were made:
|
|
|
Future research and development costs of approximately
$150,000,000 would be incurred to complete the IPR&D
projects. These future costs are primarily for Phase 3
testing of Viramidine and Phase 2 and 3 testing of
Pradefovir (formerly referred to as remofovir). |
|
|
The IPR&D projects, which were in various stages of
development from Phase 1 to Phase 2 clinical trials,
are expected to reach completion by the end of 2006. |
The major risks and uncertainties associated with the timely and
successful completion of these projects consists of the ability
to confirm the safety and efficacy of the technology based on
the data from clinical trials and obtaining necessary regulatory
approvals. In addition, no assurance can be given that the
underlying assumptions used to forecast the cash flows or the
timely and successful completion of such projects will
materialize, as estimated. For these reasons, among others,
actual results may vary significantly from the estimated results.
Goodwill and Intangible Assets: In July 2001, the
Financial Accounting Standards Board (FASB) issued
Statement of Financial Accounting Standards (SFAS)
No. 141, Business Combinations, and
SFAS No. 142, Goodwill and Other Intangible
Assets. SFAS No. 141 requires that the purchase
method of accounting be used for all business combinations
initiated after June 30, 2001. Under
SFAS No. 142, goodwill will no longer be amortized but
will be subject to annual impairment tests in accordance with
the statement. Other intangible assets will continue to be
amortized over their useful lives. On January 1, 2002, the
Company adopted SFAS No. 142. During the second
quarter of 2002, the Company completed the transitional
impairment test required by SFAS No. 142. As a result,
the Company recorded an impairment loss of
54
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
$25,332,000, which was offset by a benefit of $3,541,000 for the
write-off of negative goodwill. The net amount of $21,791,000
has been recorded as a cumulative effect of change in accounting
principle in the year ended December 31, 2002.
During the year ended December 31, 2004, the Company
recorded impairment charges of $4,797,000 primarily related to
products sold in Italy for which the patent life was reduced by
a decree by the Italian government. The Company evaluated the
intangible assets by comparing the carrying value of each
intangible asset to their fair value, as determined using
discounted cash flows analysis.
Revenue Recognition: The Company recognizes revenues from
product sales when title and risk of ownership transfers to the
customer. Revenues are recorded net of provisions for rebates,
discounts and returns, which are established at the time of
sale. Allowances for future returns of products sold to the
Companys direct and indirect customers, who include
wholesalers, retail pharmacies and hospitals, are calculated as
a percent of sales based on historical return percentages taking
into account additional available information on competitive
products and contract changes. The Company uses third-party data
to estimate the level of product inventories, expiration dating,
and product demand at the Companys major wholesalers.
Based upon this information, adjustments are made to the accrual
if deemed necessary. Actual results could be materially
different from the Companys estimates, resulting in future
adjustments to revenue. The Company conducts a review of the
current methodology and assesses the adequacy of the allowance
for returns on a quarterly basis, adjusting for changes in
assumptions, historical results and business practices, as
necessary.
The Company earns ribavirin royalties as a result of sale of
product rights and technologies to third parties. Ribavirin
royalties are earned at the time the products subject to the
royalty are sold by the third party and is reduced by an
estimate for discounts and rebates that will be paid in
subsequent periods for those products sold during the current
period. The Company relies on a limited amount of financial
information provided by Schering-Plough and Roche to estimate
the amounts due to it under the royalty agreements. While the
Company believes the Schering-Plough agreement specifies that it
is to be reimbursed based on net sales as determined under an
accrual basis, the Company has recently become aware that
Schering-Plough may be calculating reimbursements based on a
method under which returns are deducted as incurred rather than
on an accrual basis. Based upon the information provided by
Schering-Plough for the fourth quarter of 2004,
Schering-Ploughs sales of Rebetol in the United States
were negative. A reserve has been established for negative
royalties caused by negative sales of Rebetol in the United
States; however, due to the limited information provided by
Schering-Plough, there can be no assurance that such amounts
will be adequate to cover additional negative royalty amounts in
future periods.
Foreign Currency Translation: The assets and liabilities
of the Companys foreign operations are translated at end
of period exchange rates. Revenues and expenses are translated
at the weighted average exchange rates prevailing during the
period. The effects of unrealized exchange rate fluctuations on
translating foreign currency assets and liabilities into United
States Dollars are accumulated in stockholders equity.
Income Taxes: Income taxes are calculated in accordance
with SFAS No. 109, Accounting for Income Taxes.
SFAS No. 109 is an asset and liability approach that
requires the recognition of deferred tax assets and liabilities
for the expected future tax consequence of events that have been
recognized in the Companys financial statements or tax
returns. A valuation allowance is established, when necessary,
to reduce deferred tax assets to the amount expected to be
realized. In estimating future tax consequences,
SFAS No. 109 generally considers all expected future
events other than an enactment of changes in tax laws or rates.
Derivative Financial Instruments: The Companys
accounting policies for derivative instruments are based on
whether they meet the Companys criteria for designation as
hedging transactions, either as cash flow or fair value hedges.
The Companys derivative instruments are recorded at fair
value and are included in other
55
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
current assets, other assets, accrued liabilities or debt.
Depending on the nature of the hedge, changes in the fair value
of the hedged item are either offset against the change in the
fair value of the hedged item through earnings or recognized in
other comprehensive income until the hedged item is recognized
in earnings.
Comprehensive Income: The Company has adopted the
provisions of Statement of Financial Accounting Standards
(SFAS) No. 130, Reporting Comprehensive
Income. Accumulated other comprehensive loss consists of
accumulated foreign currency translation adjustments, unrealized
losses on marketable equity securities, minimum pension
liability and changes in the fair value of derivative financial
instruments.
Per Share Information: Basic earnings per share are
computed by dividing income available to common stockholders by
the weighted-average number of common shares outstanding. In
computing diluted earnings per share, the weighted-average
number of common shares outstanding is adjusted to reflect the
effect of potentially dilutive securities including options,
warrants, and convertible debt or preferred stock; income
available to common stockholders is adjusted to reflect any
changes in income or loss that would result from the issuance of
the dilutive common shares.
The Companys Board of Directors declared a quarterly cash
dividend of $0.0775 per share for each fiscal quarter of
2004, 2003 and 2002. While the Company has historically paid
quarterly cash dividends, there can be no assurance that it will
continue to do so.
Stock-Based Compensation: The Company has adopted the
disclosure-only provision of SFAS No. 123 and
SFAS No. 148, Accounting for Stock-Based
Compensation Transition and Disclosure.
Compensation cost for stock-based compensation issued to
employees has been measured using the intrinsic value method
provided by Accounting Principles Board Opinion No. 25.
Accordingly, no compensation cost has been recognized for
options granted under the Companys 2003 Equity Incentive
Plan (the Incentive Plan), as all options granted
under the Incentive Plan had an exercise price equal to the
market value of the underlying common stock on the date of grant.
Had compensation cost for the Incentive Plan been determined
based on the fair value at the grant date for awards in 2004,
2003 and 2002 consistent with the provisions of
SFAS No. 123, the Companys net loss and loss per
share would have been the unaudited pro forma amounts indicated
below (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Net loss as reported
|
|
$ |
(169,797 |
) |
|
$ |
(55,640 |
) |
|
$ |
(134,834 |
) |
Compensation costs related to the Companys employee stock
compensation plan, net of tax
|
|
|
96 |
|
|
|
|
|
|
|
38,068 |
|
Stock based employee compensation expense determined under fair
value based method, net of related tax effects
|
|
|
(13,218 |
) |
|
|
(3,886 |
) |
|
|
(26,000 |
) |
|
|
|
|
|
|
|
|
|
|
Pro forma net loss
|
|
$ |
(182,919 |
) |
|
$ |
(59,526 |
) |
|
$ |
(122,766 |
) |
|
|
|
|
|
|
|
|
|
|
Loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic as reported
|
|
$ |
(2.02 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.62 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic pro forma
|
|
$ |
(2.18 |
) |
|
$ |
(0.71 |
) |
|
$ |
(1.47 |
) |
|
|
|
|
|
|
|
|
|
|
|
Diluted as reported
|
|
$ |
(2.02 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.61 |
) |
|
|
|
|
|
|
|
|
|
|
|
Diluted pro forma
|
|
$ |
(2.18 |
) |
|
$ |
(0.71 |
) |
|
$ |
(1.46 |
) |
|
|
|
|
|
|
|
|
|
|
Prior to April 2004, pro forma compensation expense has been
calculated using the Black-Scholes model based on a
single-option valuation approach using the straight-line method
of amortization. Beginning in April 2004, the Company has
calculated pro forma compensation expense for any stock options
granted since that
56
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
time using the accelerated amortization method prescribed in
FASB Interpretation No. 28, Accounting for Stock
Appreciation Rights and Other Variable Stock Option or Award
Plans, because it was more representative of the
Companys expected exercising behavior. This change in
accounting policy was not material to the pro forma disclosure.
Use of Estimates: The preparation of financial statements
in conformity with accounting principles generally accepted in
the United States of America requires management to make
estimates and assumptions that affect the reported amount of
assets and liabilities, the disclosure of contingent assets and
liabilities at the date of the financial statements and the
reported amounts of revenues and expenses during the reporting
periods. Actual results could differ materially from those
estimates.
Reclassifications: Certain auction rate securities have
been reclassified from cash equivalents to short-term
investments. Auction rate securities are variable rate bonds and
preferred stock tied to short-term interest rates with
maturities on the face of the securities in excess of ninety
days. Auction rate securities have interest rate resets through
a modified Dutch auction, at pre-determined short-term
intervals, usually every seven, twenty-eight or thirty-five
days. They trade at par and are callable at par on any interest
payment date at the option of the issuer. Interest paid during a
given period is based upon the interest rate determined during
the prior auction.
Although these securities are issued and rated as long-term
bonds, they are priced and traded as short-term instruments
because of the liquidity provided through the interest rate
reset. The Company had historically classified these instruments
as cash equivalents if the period between interest rate resets
was ninety days or less, which was based on our ability to
either liquidate our holdings or roll our investment over to the
next reset period.
Based upon the Companys re-evaluation of these securities,
the Company has reclassified its auction rate securities,
previously classified as cash equivalents, as short-term
investments on the accompanying consolidated balance sheet as of
December 31, 2003. This resulted in a reclassification from
cash and cash equivalents to short-term investments of
$463,962,000 on the December 31, 2003 consolidated balance
sheet. In addition, purchases of short-term and long-term
investments and sales of short-term investments, included in the
accompanying consolidated statements of cash flows, have been
revised to reflect the purchase and sale of auction rate
securities during the periods presented. The Company accounts
for its marketable securities in accordance with
SFAS No. 115, Accounting for Certain Investments
in Debt and Equity Securities. Such investments are
classified as available-for-sale and are reported at
fair value in the Companys consolidated balance sheets.
The short-term nature and structure, the frequency with which
the interest rate resets and the ability to sell auction rate
securities at par and at the Companys discretion indicates
that such securities should more appropriately be classified as
short-term investments with the intent of meeting the
Companys short-term working capital requirements.
New Accounting Pronouncements: In March 2004, the
Emerging Issues Task Force (EITF) reached a
consensus on Issue No. 03-1, The Meaning of
Other-Than-Temporary Impairment and Its Application to Certain
Investments. This Issue establishes impairment models for
determining whether to record impairment losses associated with
investments in certain equity and debt securities. In September
2004, the FASB issued FSP EITF 03-1-1, which defers the
effective date of a substantial portion of EITF 03-1 until
such time as the FASB issues further implementation guidance.
Adoption of this pronouncement is not expected to have an impact
on the Companys consolidated financial statements.
In November 2004, the FASB issued SFAS No. 151,
Inventory Costs an amendment of ARB No. 43,
Chapter 4. SFAS No. 151 amends the guidance
in ARB No. 43, Chapter 4, Inventory Pricing, to
clarify the accounting for abnormal amounts of idle facility
expense, freight, handling costs, and wasted material
(spoilage). Among other provisions, the new rule requires that
items such as idle facility expense, excessive spoilage, double
freight, and rehandling costs be recognized as current-period
charges regardless of whether
57
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
they meet the criterion of so abnormal as stated in
ARB No. 43. Additionally, SFAS No. 151 requires
that the allocation of fixed production overheads to the costs
of conversion be based on the normal capacity of the production
facilities. SFAS No. 151 is effective for fiscal years
beginning after June 15, 2005. The Company is currently
evaluating the effect of SFAS No. 151 on our
consolidated financial statements.
In December 2004, the FASB issued FSP No. 109-2,
Accounting and Disclosure Guidance for the Foreign Earnings
Repatriation Provision within the American Jobs Creation Act of
2004. The American Jobs Creation Act of 2004 (the Jobs
Creation Act) was enacted on October 22, 2004. FSP
109-2 states that an enterprise is allowed time beyond the
financial reporting period of enactment to evaluate the effect
of the Jobs Creation Act on its plan for reinvestment or
repatriation of foreign earnings for purposes of applying
SFAS No. 109. The Company has not yet completed
evaluating the impact of the repatriation provisions.
In December 2004, the FASB issued SFAS No. 123
(revised 2004), Share-Based Payment
(SFAS No. 123R), which replaces
SFAS No. 123, Accounting for Stock-Based
Compensation (SFAS No. 123) and
supersedes APB Opinion No. 25, Accounting for Stock
Issued to Employees. SFAS No. 123R requires all
share-based payments to employees, including grants of employee
stock options, to be recognized in the financial statements
based on their fair values beginning with the first interim or
annual period after June 15, 2005. The pro forma
disclosures previously permitted under SFAS No. 123
will no longer be an alternative to financial statement
recognition. The Company is required to adopt SFAS No 123R
in the third quarter of fiscal 2005, beginning July 1,
2005. The Company is evaluating the requirements of
SFAS No. 123R and expects that the adoption of
SFAS No. 123R will have an impact on its consolidated
results of operations and earnings per share. If the Company
retains its current method of valuing and expensing options as
previously reported in its pro forma disclosures required by
SFAS No. 123, the Company estimates that pretax
compensation expense for fiscal 2005 will total approximately
$8,000,000.
Amarin Pharmaceuticals, Inc.: On February 25, 2004,
the Company acquired from Amarin Corporation, plc (Amarin
plc) its U.S.-based subsidiary (Amarin) and
all of its U.S. product rights (the Amarin
Acquisition). Under the terms of the transaction, the
Company acquired the rights to Amarins product portfolio,
which includes Permax® and a primary care portfolio with a
broad range of indications. The Company also acquired in the
transaction the rights to Zelapar, a late-stage candidate for
the treatment of Parkinsons disease. Amarin has received
an approvable letter from the Food and Drug Administration
(FDA) for Zelapar, subject to the completion of two
safety studies. These studies were completed and the Company
filed the final results of these studies in late 2004. The
Company paid $38,000,000 in cash at the closing for the Amarin
acquisition.
Subsequent to the Amarin Acquisition, the Company became aware
of a significant amount of dated Amarin products in wholesaler
channels. Under the terms of the original purchase agreement,
Amarin plc was responsible for any excess inventory at
wholesalers that existed at the date of acquisition. On
September 27, 2004, the Company and Amarin plc entered into
an amended purchase agreement (the Amended Purchase
Agreement), which also revised certain milestone payments.
Under the terms of the Amended Purchase Agreement, the Company
is no longer obligated to pay up to $8,000,000 in milestone
payments, but paid an additional $2,000,000, which the Company
expensed as research and development in the third quarter of
2004 related to Amarin plcs commitment to fund a portion
of the Zelapar studies. The Company remains obligated to make
the $10,000,000 milestone payment to the developer of
Zelapar upon the attainment of specified sales thresholds. All
other terms of the original purchase agreement remain
substantially unchanged.
The Amarin Acquisition has been accounted for using the purchase
method of accounting, and Amarins results of operations
have been included in the Companys consolidated condensed
financial statements from the date of acquisition. Allocation of
the purchase price for the Amarin Acquisition is based on
estimates of the fair value of the assets acquired and
liabilities assumed at the date of acquisition. The acquired
intangible
58
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
assets are being amortized using an estimated useful life of
seven years. Amounts allocated to goodwill are deductible for
tax purposes. Pro forma results are not presented as the
acquisition did not materially affect the Companys results
of operations.
The components of the purchase price allocation for the Amarin
Acquisition is as follows (in thousands):
|
|
|
|
|
|
Purchase price:
|
|
|
|
|
|
Cash paid
|
|
$ |
38,000 |
|
|
Amount payable
|
|
|
2,000 |
|
|
Transaction costs
|
|
|
2,811 |
|
|
Less: Cash acquired
|
|
|
(601 |
) |
|
|
|
|
|
|
$ |
42,210 |
|
|
|
|
|
Allocation:
|
|
|
|
|
|
Current assets
|
|
$ |
2,642 |
|
|
Prepaid research and development
|
|
|
2,000 |
|
|
Property, plant, and equipment
|
|
|
205 |
|
|
Acquired intangible assets
|
|
|
37,113 |
|
|
Goodwill
|
|
|
7,180 |
|
|
Acquired IPR&D
|
|
|
11,770 |
|
|
Other liabilities assumed
|
|
|
(18,700 |
) |
|
|
|
|
|
|
$ |
42,210 |
|
|
|
|
|
Tasmar®: On April 22, 2004, the Company
acquired the worldwide rights, excluding the European Union, to
Tasmar® (tolcapone) from Roche. Tasmar is indicated
for the treatment of Parkinsons disease. Under the terms
of the agreement, the Company paid $13,500,000 in cash, plus
future additional royalty amounts. On September 13, 2004,
the Company acquired the European Union rights to Tasmar from
Roche for $11,400,000 in cash, plus future royalties. The
Company accounted for the acquisition of Tasmar as product
rights.
Ribapharm: In April 2002, the Company completed an
underwritten public offering of 29,900,000 shares of common
stock, par value $0.01 per share, of Ribapharm, previously
a wholly-owned subsidiary, representing 19.93% of the total
outstanding common stock of Ribapharm (the Ribapharm
Offering). In connection with the Ribapharm Offering, the
Company received net cash proceeds of $276,611,000 and recorded
a gain on the sale of Ribapharms stock of $261,937,000,
net of offering costs.
In connection with the Ribapharm Offering, the Company paid cash
bonuses to its officers, directors and employees totaling
$47,839,000 in April 2002. The Company is seeking to recover a
portion of these bonuses (See Note 13 Commitments and
Contingencies Derivative Actions). Additionally, the
Company paid other professional fees of $13,000,000 related to
the structuring of Ribapharm in April 2002. These amounts are
included in the Companys statements of income in general
and administrative expenses.
In August 2003, the Company repurchased the 20% minority
interest in its Ribapharm subsidiary for an aggregate total
purchase price of $207,658,000 (the Ribapharm
Acquisition). The Company paid $6.25 in cash for each of
the 29,900,703 outstanding publicly held shares of Ribapharm.
Additionally, the Company included the fair value of the
Companys stock options issued in exchange for outstanding
Ribapharm stock options in the purchase price. The fair value of
stock options issued were determined based on a $15.43 stock
price, the closing stock price on August 22, 2003, using
the Black-Scholes option valuation model assuming an expected
life of 4.2 years, weighted average risk-free rate of 2.3%,
volatility of 62% and dividends of $0.31. The
59
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
acquisition increased the Companys ownership of Ribapharm
to a 100% interest and was accounted for using the purchase
method of accounting. The results of operations of Ribapharm
have always been included in the consolidated income before
minority interest of the Company. Prior to the acquisition, the
minority interest in the Ribapharm income was excluded from the
Companys consolidated net income. Since the date of
acquisition on August 25, 2003, no minority interest exists
in Ribapharm and, accordingly, the consolidated net income
includes the full amount of Ribapharms results from this
date. As a result of the acquisition, minority interest included
on the Companys consolidated balance sheet relating to
Ribapharm as of the acquisition date has been eliminated. The
remaining minority interest as of December 31, 2003 relates
to foreign subsidiaries.
The components of the purchase price allocation for the
Ribapharm Acquisition is as follows (in thousands):
|
|
|
|
|
|
Purchase price:
|
|
|
|
|
|
Cash paid
|
|
$ |
186,879 |
|
|
Fair value of the Companys options issued
|
|
|
10,415 |
|
|
Transaction costs
|
|
|
10,364 |
|
|
|
|
|
|
|
$ |
207,658 |
|
|
|
|
|
Allocation:
|
|
|
|
|
|
In-process research and development
|
|
$ |
117,609 |
|
|
Ribavirin license agreements
|
|
|
67,376 |
|
|
Unearned compensation
|
|
|
2,700 |
|
|
Goodwill
|
|
|
13,065 |
|
|
Minority interest
|
|
|
33,859 |
|
|
Deferred tax liability
|
|
|
(26,951 |
) |
|
|
|
|
|
|
$ |
207,658 |
|
|
|
|
|
The aggregate purchase price was allocated to identifiable
intangible assets acquired based on estimates of fair value
using a discounted cash flow model. The intangible asset related
to the ribavirin license agreements with Schering-Plough and
Roche is amortized using an estimated useful life of five years.
Identifiable intangible assets related to Viramidine, pradefovir
(formerly referred to as remofovir) and Levovirin totaled
approximately $101,000,000, $12,000,000 and $5,000,000,
respectively, and are expensed as in-process research and
development as the technological feasibility of these assets has
not occurred and there is no alternative future use. The Company
recorded deferred compensation cost related to the unvested
intrinsic value of the Companys options issued in exchange
for unvested Ribapharm options, which will be amortized over
31/2
years. The remaining excess of the aggregate purchase price over
the fair value of the identifiable net assets acquired has been
recognized as goodwill.
60
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following unaudited pro forma financial information presents
the combined results of the Company and Ribapharm as if the
acquisition had occurred at the beginning of each year presented
(in thousands except per share information):
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
|
(Unaudited) | |
Net revenue
|
|
$ |
685,953 |
|
|
$ |
737,074 |
|
Income before discontinued operations and accounting change
|
|
|
54,592 |
|
|
|
87,472 |
|
Net income (loss)
|
|
|
63,938 |
|
|
|
(131,607 |
) |
Basic net income (loss) per share:
|
|
|
|
|
|
|
|
|
|
Income before discontinued operations and accounting change
|
|
$ |
0.65 |
|
|
$ |
1.05 |
|
Net income (loss)
|
|
$ |
0.76 |
|
|
$ |
(1.58 |
) |
Diluted net income (loss) per share:
|
|
|
|
|
|
|
|
|
|
Income before discontinued operations and accounting change
|
|
$ |
0.65 |
|
|
$ |
1.04 |
|
Net income (loss)
|
|
$ |
0.76 |
|
|
$ |
(1.57 |
) |
The above pro forma financial information excludes the acquired
in-process research and development charge of $117,609,000 noted
above and includes adjustments for interest income on cash
disbursed for the acquisition, amortization of identifiable
intangible assets and adjustments for the expenses incurred by
Ribapharm related to the exchange offer for all Ribapharm
outstanding publicly held shares. The expenses incurred by
Ribapharm amounted to $4,544,000 in the year ended
December 31, 2003.
Xcel Pharmaceuticals, Inc.: On March 1, 2005, we
acquired Xcel Pharmaceuticals, Inc. (Xcel), a
specialty pharmaceutical company focused on the treatment of
disorders of the central nervous system, for $280,000,000 plus
approximately $5,000,000 in expenses. Xcels portfolio
consists of four products that are sold within the United
States, and a late-stage clinical product candidate being
developed for commercialization in all major markets. See
Note 17 for a discussion of this acquisition.
|
|
3. |
Discontinued Operations |
In the second half of 2002, the Company made a strategic
decision to divest its Photonics business, Circe unit, Russian
Pharmaceuticals segment, biomedicals segment and raw materials
businesses and manufacturing facilities in Central Europe. The
results of the discontinued businesses have been reflected as
discontinued operations in the consolidated financial statements
in accordance with SFAS No. 144, Accounting for the
Impairment of Disposal of Long-Lived Assets. The
consolidated financial statements have been reclassified to
conform to discontinued operations presentation for all
historical periods presented.
In July 2004, the Company disposed of one of the raw materials
business and manufacturing facility in Central Europe for net
cash proceeds of $3,611,000. The Company recorded a net loss on
disposal of discontinued operations of $1,522,000 related to the
sale of this business in the year ended December 31, 2004.
The Company is actively marketing for sale the remaining raw
materials business and manufacturing facility in Central Europe.
In September 2003, the Company sold the remaining assets of its
biomedicals segment, Dosimetry, for gross cash proceeds of
$58,000,000. The Company recorded a net gain on disposal of
discontinued operations of $23,608,000, net of taxes of
$15,526,000, related to the sale of Dosimetry in the year ended
December 31, 2003.
61
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
In June 2003, the Company sold its Russian Pharmaceuticals
segment and certain assets of its biomedicals segment. The
Company received gross proceeds of $55,000,000 in cash for the
Russian Pharmaceuticals segment and received 727,990 shares
of its common stock that was held by the purchaser, which had a
fair market value of $12,369,000, for the assets of its
biomedicals segment. The Company recorded a net loss on disposal
of discontinued operations of $8,158,000, net of a tax benefit
of $10,161,000, related to the sale of these businesses in the
year ended December 31, 2003.
The Company disposed of its Photonics business in two stages.
First, it discontinued the medical services business in
September 2002. Second, the Company sold the laser device
business in March 2003 for approximately $505,000. In addition,
the Company disposed of the Circe unit in the fourth quarter of
2002 for a nominal sales price.
Summarized selected financial information for discontinued
operations including assets held for sale for the years ended
December 31, 2004, 2003 and 2002 is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Revenue
|
|
$ |
17,474 |
|
|
$ |
117,467 |
|
|
$ |
221,926 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes
|
|
$ |
(28,994 |
) |
|
$ |
4,367 |
|
|
$ |
(41,118 |
) |
Income tax provision (benefit)
|
|
|
|
|
|
|
1,603 |
|
|
|
(3,840 |
) |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from discontinued operations, net
|
|
|
(28,994 |
) |
|
|
2,764 |
|
|
|
(37,278 |
) |
|
|
|
|
|
|
|
|
|
|
Income (loss) on disposal of discontinued operations
|
|
|
(4,550 |
) |
|
|
10,474 |
|
|
|
(208,203 |
) |
Income tax provision (benefit)
|
|
|
|
|
|
|
3,892 |
|
|
|
(48,193 |
) |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) on disposal of discontinued operations, net
|
|
|
(4,550 |
) |
|
|
6,582 |
|
|
|
(160,010 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from discontinued operations
|
|
$ |
(33,544 |
) |
|
$ |
9,346 |
|
|
$ |
(197,288 |
) |
|
|
|
|
|
|
|
|
|
|
The assets and liabilities of discontinued operations including
assets held for sale are stated separately as of
December 31, 2004 and 2003 on the accompanying consolidated
balance sheets. The major assets and liabilities categories are
as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Cash
|
|
$ |
129 |
|
|
$ |
913 |
|
Accounts receivable, net
|
|
|
3,352 |
|
|
|
6,422 |
|
Inventories, net
|
|
|
12,624 |
|
|
|
10,756 |
|
Property, plant and equipment, net
|
|
|
3,659 |
|
|
|
8,671 |
|
Other assets
|
|
|
4,130 |
|
|
|
1,232 |
|
|
|
|
|
|
|
|
|
Assets of discontinued operations
|
|
$ |
23,894 |
|
|
$ |
27,994 |
|
|
|
|
|
|
|
|
Accounts payable
|
|
$ |
2,042 |
|
|
$ |
3,127 |
|
Accrued liabilities
|
|
|
22,932 |
|
|
|
13,498 |
|
Other liabilities
|
|
|
7,082 |
|
|
|
3,106 |
|
|
|
|
|
|
|
|
|
Liabilities of discontinued operations
|
|
$ |
32,056 |
|
|
$ |
19,731 |
|
|
|
|
|
|
|
|
Environmental contamination has been identified in the soil
under a facility built by the Company which housed operations of
its discontinued Biomedicals division and is currently vacant.
Remediation of the site will likely involve excavation and
disposal of the waste at appropriately licensed sites some
distance from the facility. Environmental reserves have been
provided for remediation and related costs that the Company can
62
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
reasonably estimate. Remediation costs are applied against these
environmental reserves as they are incurred. In July 2004,
preliminary supplemental site characterization information was
received. As a result of this information, the Company recorded
an additional environmental charge of $16,000,000, which is
included in loss from discontinued operations for the year ended
December 31, 2004. As assessments and remediation progress,
these liabilities will be reviewed and adjusted to reflect
additional information that becomes available. Total
environmental reserves for this site were $21,475,000 and
$5,033,000 as of December 31, 2004 and 2003, respectively,
and are included in the liabilities of discontinued operations.
Although the Company believes that its reserves are adequate,
there can be no assurance that the amount of expenditures and
other expenses, which will be required relating to remediation
actions and compliance with applicable environmental laws will
not exceed the amounts reflected in reserves or will not have a
material adverse effect on the Companys consolidated
financial condition, results of operations or cash flows. Any
possible loss that may be incurred in excess of amounts provided
for as of December 31, 2004 cannot be reasonably estimated.
|
|
4. |
Manufacturing Restructuring |
During the third quarter of 2003, the Company approved
restructuring plans to establish a global manufacturing and
supply chain network of five manufacturing sites, which will
result in the closing of ten of the Companys manufacturing
sites (the Manufacturing Restructuring Plan). The
Manufacturing Restructuring Plan includes a refocus of the
Companys international operations to improve profitability
and achieve greater operating efficiencies. The Company has made
significant progress towards its plans of disposing of certain
manufacturing sites and is currently actively marketing the
sites to prospective buyers. The sites were reassessed for
impairment in the second quarter of 2004 because we accelerated
our plan of disposing of the sites. The impairment analysis
resulted in impairment of asset value on three of the sites.
Accordingly, the Company wrote these sites down to their fair
value and recorded an impairment charge of $18,000,000 for the
year ended December 31, 2004. In addition to the impairment
charge, the Company recorded $1,344,000 in restructuring and
impairment charges related to severance for the year ended
December 31, 2004. These restructuring charges are recorded
as a component of costs and expenses in the consolidated
condensed statement of income. The Company will continue to
depreciate the remaining sites until the facility closures are
complete. The Company intends to dispose of the remaining
manufacturing plants by selling each to a buyer who we believe
will continue to operate the plant, including the assumption of
employee obligations. However, the Company may not locate a
buyer for each such manufacturing plant, which would require the
Company to close certain of these manufacturing plants and incur
additional severance charges. During the fourth quarter of 2004,
the Company sold its manufacturing site in Spain and entered
into an agreement to sell a manufacturing site in Mexico.
63
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
5. |
Non-recurring and Other Unusual Charges |
The Company recorded $239,965,000 of non-recurring and other
unusual charges, which are included in general and
administrative expenses, for the year ended December 31,
2002. There were no significant non-recurring and other unusual
charges included in general and administrative expenses in the
years ended December 31, 2004 and 2003. The following is a
summary of the non-recurring and other unusual charges (in
thousands):
|
|
|
|
|
|
|
2002 | |
|
|
| |
Compensation costs related to the Companys employee stock
compensation plan
|
|
$ |
61,400 |
|
Severance and related costs
|
|
|
54,216 |
|
Long-term incentive plan compensation costs
|
|
|
12,022 |
|
Executive and director bonuses paid in connection with the
Ribapharm Offering (Note 2)
|
|
|
47,839 |
|
Professional fees related to Ribapharm (Note 2)
|
|
|
13,000 |
|
Write-off of capitalized offering costs
|
|
|
18,295 |
|
Asset impairments
|
|
|
15,045 |
|
Costs incurred in the Companys proxy contest
|
|
|
9,850 |
|
Environmental remediation and related expenses
|
|
|
8,298 |
|
|
|
|
|
|
|
$ |
239,965 |
|
|
|
|
|
As a result of the May 29, 2002 Annual Meeting of
Stockholders, three persons nominated by Franklin Mutual
Advisors, LLC and Iridian Asset Management LLC were elected to
the Board of Directors. Under the terms of employment agreements
with some key executives, a long-term stock incentive plan and
the Option Plan, the results of the 2002 election, together with
the results of the 2001 election, constituted a change of
control (the Change of Control).
Under the terms of a long-term incentive plan, all restricted
stock awards vested immediately upon the Change of Control on
June 11, 2002. As a result, compensation expense of
$12,022,000 was recorded in the year ended December 31,
2002.
The Companys Amended and Restated 1998 Stock Option Plan
(the 1998 Option Plan) provided that all options
immediately vested and that an option holder had sixty days
following the Change of Control to elect to surrender his or her
nonqualified options to the Company for a cash payment to the
excess of the highest closing market price of the stock during
the 90 days preceding the Change of Control, which was
$32.50 per share, or the closing market price on the day
preceding the date of surrender, whichever is higher, over the
exercise price for the surrendered options. During the year
ended December 31, 2002, the Company recorded a charge of
$61,400,000 related to the cash payment obligation under the
Option Plan.
Under employment agreements the Company had with some of its
former key executives, the Company had payment obligations that
were triggered upon a termination of the executives
employment either by the Company or the executive following the
Change of Control. During the third quarter of 2002, the Company
triggered its payment obligations and recorded an obligation for
the payments to the executives totaling $15,507,000. The Company
recorded expenses of $3,201,000 for employee termination and
severance benefits in 2002 unrelated to the aforementioned
executive employment agreements. This amount primarily relates
to severance related to former employees and the restructuring
of the Companys ICN International headquarters in Basel,
Switzerland. In addition, on June 19, 2002, Mr. Milan
Panic, the Companys former Chief Executive Officer and
Chairman of the Board, resigned with immediate effect from his
positions as Chairman and Chief Executive Officer and from all
positions he held as a director or officer of any of the
Companys affiliates. Mr. Panic also resigned as one
of the Companys employees with effect from June 30,
2002 and is no
64
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
longer one of the Companys directors. In connection with
Mr. Panics termination, the Company recorded
severance expense of $12,000,000 in the year ended
December 31, 2002.
During 2002, based on a number of factors, including changes in
market conditions and changes in strategic direction, the
Company evaluated the net realizable value of certain long-lived
assets, including capitalized offering costs related to the
proposed public offering of ICN International AG, the
Companys corporate aircraft and other assets. The Company
concluded that due to the passage of time and the strategic
business review, the capitalized offering costs of ICN
International AG of $18,295,000 should be written-off. Also, an
impairment charge of $9,100,000 was recorded for the difference
between the carrying value and the fair value of the corporate
aircraft, as determined by appraisals.
The Company incurred a significant amount of professional fees
in connection with proxy contests in 2002. Proxy contest
expenses were $9,850,000 for the year ended December 31,
2002.
|
|
6. |
Concentrations of Credit Risk |
The Company is exposed to concentrations of credit risk related
to its cash deposits and marketable securities. The Company
places its cash and cash equivalents with respected financial
institutions. The Companys cash and cash equivalents and
marketable securities totaled $461,508,000 and $873,981,000, at
December 31, 2004 and 2003, respectively, which are held in
time deposits, money market funds, and municipal debt securities
through approximately ten major financial institutions. The
Company is also exposed to credit risk related to its receivable
from Schering-Plough and Roche, which totaled $17,329,000 and
$36,690,000 at December 31, 2004 and 2003, respectively.
The components of income (loss) from continuing operations
before minority interest for each of the years ended
December 31, 2004, 2003 and 2002 consists of the following
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Domestic
|
|
$ |
(143,311 |
) |
|
$ |
(102,225 |
) |
|
$ |
113,806 |
|
Foreign
|
|
|
90,888 |
|
|
|
88,465 |
|
|
|
63,132 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(52,423 |
) |
|
$ |
(13,760 |
) |
|
$ |
176,938 |
|
|
|
|
|
|
|
|
|
|
|
The income tax provision for each of the years ended
December 31, 2004, 2003 and 2002 consists of the following
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Current
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$ |
(1,956 |
) |
|
$ |
1,423 |
|
|
$ |
20,626 |
|
|
State
|
|
|
24 |
|
|
|
1,858 |
|
|
|
1,164 |
|
|
Foreign
|
|
|
32,991 |
|
|
|
33,746 |
|
|
|
24,177 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31,059 |
|
|
|
37,027 |
|
|
|
45,967 |
|
|
|
|
|
|
|
|
|
|
|
Deferred
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal
|
|
$ |
45,529 |
|
|
$ |
9,286 |
|
|
$ |
25,620 |
|
|
State
|
|
|
(292 |
) |
|
|
(1,304 |
) |
|
|
295 |
|
|
Foreign
|
|
|
7,301 |
|
|
|
(5,546 |
) |
|
|
3,081 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
52,538 |
|
|
|
2,436 |
|
|
|
28,996 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
83,597 |
|
|
$ |
39,463 |
|
|
$ |
74,963 |
|
|
|
|
|
|
|
|
|
|
|
65
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The Companys effective tax rate from continuing operations
differs from the applicable United States statutory federal
income tax rate due to the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Statutory rate
|
|
|
35 |
% |
|
|
35 |
% |
|
|
35 |
% |
Foreign source income taxed at other effective rates
|
|
|
(2 |
) |
|
|
(5 |
) |
|
|
3 |
|
Ribapharm Acquisition expenses
|
|
|
|
|
|
|
2 |
|
|
|
|
|
Change in valuation allowance
|
|
|
(209 |
) |
|
|
(1 |
) |
|
|
4 |
|
Net operating loss adjustments
|
|
|
|
|
|
|
5 |
|
|
|
|
|
State tax and other, net
|
|
|
17 |
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective rate, excluding IPR&D
|
|
|
(159 |
) |
|
|
38 |
|
|
|
42 |
|
IPR&D
|
|
|
|
|
|
|
(325 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effective rate
|
|
|
(159 |
)% |
|
|
(287 |
)% |
|
|
42 |
% |
|
|
|
|
|
|
|
|
|
|
The Companys effective tax rate for the year ended
December 31, 2004 was significantly affected by an increase
in the valuation allowance to recognize the uncertainty of
realizing the benefits of the United States net operating losses
and research credits. Pre-tax losses resulting from
restructuring and impairment charges of $19,344,000 and a
European work force reduction charge of $4,262,000, for which
the Company recorded a minimal tax benefit of $1,451,000 (6%)
also affected the effective tax rate. This minimal tax benefit
reflects uncertainty of the realization of tax benefits in some
of the jurisdictions in which these charges were incurred.
Additionally, in the year ended December 31, 2004, the
Company recorded a tax provision of $1,828,000 related to the
settlement of a tax dispute with Puerto Rico relating to tax
years 1998 and 1999.
The primary components of the Companys net deferred tax
asset at December 31, 2004 and 2003 are as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Deferred tax assets:
|
|
|
|
|
|
|
|
|
|
NOL carryforwards
|
|
$ |
111,782 |
|
|
$ |
58,815 |
|
|
Inventory and other reserves
|
|
|
11,931 |
|
|
|
15,587 |
|
|
Tax credit carryforwards
|
|
|
12,966 |
|
|
|
7,136 |
|
|
Other
|
|
|
12,136 |
|
|
|
7,572 |
|
|
Valuation allowance
|
|
|
(122,154 |
) |
|
|
(20,509 |
) |
|
|
|
|
|
|
|
|
|
Total deferred tax asset
|
|
|
26,661 |
|
|
|
68,601 |
|
|
|
|
|
|
|
|
Deferred tax liabilities:
|
|
|
|
|
|
|
|
|
|
Foreign fixed assets and other
|
|
|
(16,321 |
) |
|
|
(9,202 |
) |
|
Intangibles
|
|
|
(22,189 |
) |
|
|
(31,261 |
) |
|
|
|
|
|
|
|
|
|
Total deferred tax liability
|
|
|
(38,510 |
) |
|
|
(40,463 |
) |
|
|
|
|
|
|
|
|
|
Net deferred tax (liability) asset
|
|
$ |
(11,849 |
) |
|
$ |
28,138 |
|
|
|
|
|
|
|
|
In 2004, the valuation allowance primarily relates to United
States and foreign net operating losses. In 2003, the valuation
allowance primarily related to foreign net operating losses and
to reduce the benefit from the exercise of stock options
included in the net operating loss carryforward.
At December 31, 2004, the Company had U.S. federal,
state and foreign net operating losses of approximately
$250,295,000, $164,335,000 and $70,033,000, respectively. In
2008, $19,289,000 of the
66
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Companys U.S. federal net operating losses will
expire. The remainder will begin to expire in 2023. The state
net operating losses will begin to expire in 2013 and the
foreign net operating losses will begin to expire in 2007. The
Company also has U.S. federal and state credits of
$11,431,000 and $1,535,000 that will begin to expire in 2014.
A valuation allowance was recorded in the fourth quarter for the
entire domestic net deferred tax asset. The consolidated
reporting group in the United States has been operating at a
loss in recent quarters due to increased investments in research
and development and lower royalties. Several strategies have
been pursued that would enable the Company to utilize the net
operating losses and other deferred tax assets. However, during
the fourth quarter, the Company determined that one of the
strategies that involved selling certain product rights to an
unrelated party did not make economic sense at levels proposed
and discontinued the effort. The Company believes the tax assets
will be realized through the successful commercialization of
Viramidine, however, there is insufficient objective evidence at
this time to recognize these assets for financial reporting
purposes. A minimum of $250,295,000 of future taxable income
will need to be generated to realize the benefits of the net
operating losses. Strategies that would cause the United States
losses to be utilized sooner than 2008 without reliance on
future operating income are being considered. The valuation
allowance will be reduced in the future if the forecast for
future taxable income is realized or other strategies are
implemented. Ultimate realization of the benefit of the United
States net operating losses and research credits is dependent
upon the Company generating sufficient taxable income prior to
their expiration.
As of December 31, 2004, approximately $462,000 of the
valuation allowance related to the tax benefits of stock option
deductions and $4,247,000 related to the tax benefits of bond
interest that is included in the Companys net operating
losses. At such time as the valuation allowance is released, the
benefit will be credited to additional capital.
Historically, there have not been significant differences
between financial reporting pretax earnings and taxable income.
Approximately $168,800,000 of the United States net operating
loss carryforwards arose from discontinued operations and the
disposition of those operations that occurred during 2002 and
2003.
During 2003, no United States income or foreign withholding
taxes were provided on the undistributed earnings of the
Companys foreign subsidiaries with the exception of
Subpart F income, since management intends to reinvest those
undistributed earnings in the foreign operations. Included in
consolidated accumulated deficit at December 31, 2003 is
approximately $498,970,000 of accumulated earnings of foreign
operations that would be subject to United States income or
foreign withholdings taxes, if and when repatriated.
The Company and its domestic subsidiaries file a consolidated
United States federal income tax return. These returns have
either been audited or settled through statute expiration
through the year 1996. The Company and its consolidated
subsidiaries are currently under examination in the United
States for years 1997 through 2001. Other audits are in process
for some of the non-United States subsidiaries. While the
Company believes the review will not result in the returns being
found to contain any substantive and material deficiencies,
there can be no assurance that the Internal Revenue
Services findings will not have a material adverse effect
on the Companys reported effective tax rate.
In 1999, the Company restructured its operations by contributing
the stock of several non-United States subsidiaries to a wholly
owned Dutch company. At the time of the restructuring, the
Company intended to avail itself of the non-recognition
provisions of the Internal Revenue Code to avoid generating
taxable income on the intercompany transfer. One of the
requirements under the non-recognition provisions was to file
Gain Recognition Agreements with the Companys timely filed
1999 United States Corporate Income Tax Return. The Company has
recently discovered that although it was clearly the intent of
the Company to file the Gain Recognition Agreement and it has
operated as if such filings had been submitted, former management
67
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
inadvertently omitted the Gain Recognition Agreements from its
filings. In accordance with Treasury guidelines, a formal
request has been made to the Internal Revenue Service to rule
that reasonable cause existed for the failure to provide these
agreements. While the Company is still evaluating the underlying
values of the stock contributed, if the requested relief were to
be denied and the matter could not otherwise be resolved
favorably with the Internal Revenue Service, the Company
believes the resulting cash tax obligation would likely offset a
substantial portion of the Companys accumulated tax loss
carryforwards.
During the fourth quarter of 2004, legislation was passed (The
American Jobs Creation Act of 2004), which provides for a
special one-time tax deduction of 85 percent of certain
foreign earnings that are repatriated to the United States. The
range of reasonably possible amounts of unremitted earnings that
is being considered for repatriation and the related potential
range of income tax effects of such repatriation cannot be
reasonably estimated at this time. The Company is evaluating the
effects of this law, and is expecting to complete the evaluation
and develop an appropriate plan of action during the first half
of 2005.
The following table sets forth the computation of basic and
diluted earnings per share (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator for basic and dilutive earnings per share
income available to stockholders
|
|
$ |
(169,797 |
) |
|
$ |
(55,640 |
) |
|
$ |
(134,834 |
) |
|
|
|
|
|
|
|
|
|
|
Shares:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for basic earnings per share
weighted-average shares outstanding
|
|
|
83,887 |
|
|
|
83,602 |
|
|
|
83,279 |
|
|
Employee stock options
|
|
|
|
|
|
|
|
|
|
|
709 |
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for diluted earnings per share adjusted
weighted-average shares after assumed conversions
|
|
|
83,887 |
|
|
|
83,602 |
|
|
|
83,988 |
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$ |
(1.62 |
) |
|
$ |
(0.78 |
) |
|
$ |
1.01 |
|
|
Discontinued operations, net of taxes
|
|
|
(0.40 |
) |
|
|
0.11 |
|
|
|
(2.37 |
) |
|
Cumulative effect of change in accounting principle
|
|
|
|
|
|
|
|
|
|
|
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
Basic net loss per share
|
|
$ |
(2.02 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.62 |
) |
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations
|
|
$ |
(1.62 |
) |
|
$ |
(0.78 |
) |
|
$ |
1.00 |
|
|
Discontinued operations, net of taxes
|
|
|
(0.40 |
) |
|
|
0.11 |
|
|
|
(2.35 |
) |
|
Cumulative effect of change in accounting principle
|
|
|
|
|
|
|
|
|
|
|
(0.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
Diluted net loss per share
|
|
$ |
(2.02 |
) |
|
$ |
(0.67 |
) |
|
$ |
(1.61 |
) |
|
|
|
|
|
|
|
|
|
|
The $240,000,000 3.0% Convertible Subordinated Notes due
2010 and the $240,000,000 4.0% Convertible Subordinated
Notes due 2013, discussed in Note 10, allow the Company to
settle any conversion by remitting to the note holder the
principal amount of the note in cash, while settling the
conversion spread (the excess conversion value over the accreted
value) in the shares of the Companys common stock. The
accounting for convertible debt with such settlement features is
addressed in EITF Issue No. 90-19, Convertible Bonds
with Issuer Option to Settle for Cash Upon Conversion. It
is the Companys intent to
68
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
settle the notes conversion obligations consistent with
Instrument C of EITF 90-19. Only the conversion spread,
which will be settled in stock, will result in potential
dilution in the Companys earnings-per-share computations
as the accreted value of the notes will be settled for cash upon
the conversion.
For the years ended December 31, 2004 and 2003, options to
purchase 2,789,000 and 1,131,000 weighted-average shares of
common stock, respectively, were not included in the computation
of earnings per share because the Company incurred a loss and
the effect would have been anti-dilutive.
For the years ended December 31, 2004 and 2003, options to
purchase 2,661,000 and 3,526,000 weighted-average shares of
common stock, respectively, were also not included in the
computation of earnings per share because the options exercise
prices were greater than the average market price of the
Companys common stock and, therefore, the effect would
have been anti-dilutive.
|
|
9. |
Detail of Certain Accounts |
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
(In thousands) | |
Accounts receivable, net:
|
|
|
|
|
|
|
|
|
|
Trade accounts receivable
|
|
$ |
142,925 |
|
|
$ |
121,651 |
|
|
Royalties receivable
|
|
|
17,329 |
|
|
|
36,690 |
|
|
Other receivables
|
|
|
17,620 |
|
|
|
10,724 |
|
|
|
|
|
|
|
|
|
|
|
177,874 |
|
|
|
169,065 |
|
|
Allowance for doubtful accounts
|
|
|
(6,014 |
) |
|
|
(6,663 |
) |
|
|
|
|
|
|
|
|
|
$ |
171,860 |
|
|
$ |
162,402 |
|
|
|
|
|
|
|
|
Inventories, net:
|
|
|
|
|
|
|
|
|
|
Raw materials and supplies
|
|
$ |
42,568 |
|
|
$ |
36,288 |
|
|
Work-in-process
|
|
|
24,002 |
|
|
|
23,731 |
|
|
Finished goods
|
|
|
59,612 |
|
|
|
43,470 |
|
|
|
|
|
|
|
|
|
|
|
126,182 |
|
|
|
103,489 |
|
|
Allowance for inventory obsolescence
|
|
|
(13,932 |
) |
|
|
(11,583 |
) |
|
|
|
|
|
|
|
|
|
$ |
112,250 |
|
|
$ |
91,906 |
|
|
|
|
|
|
|
|
Property, plant and equipment, net:
|
|
|
|
|
|
|
|
|
|
Land
|
|
$ |
14,492 |
|
|
$ |
15,147 |
|
|
Buildings
|
|
|
177,254 |
|
|
|
175,701 |
|
|
Machinery and equipment
|
|
|
170,503 |
|
|
|
170,925 |
|
|
Furniture and fixtures
|
|
|
30,860 |
|
|
|
27,317 |
|
|
Leasehold improvements
|
|
|
6,521 |
|
|
|
5,491 |
|
|
|
|
|
|
|
|
|
|
|
399,630 |
|
|
|
394,581 |
|
|
Accumulated depreciation and amortization
|
|
|
(183,140 |
) |
|
|
(158,496 |
) |
|
Construction in progress
|
|
|
16,768 |
|
|
|
4,931 |
|
|
|
|
|
|
|
|
|
|
$ |
233,258 |
|
|
$ |
241,016 |
|
|
|
|
|
|
|
|
69
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
At December 31, 2004 and 2003, construction in progress
primarily includes costs incurred for plant expansion projects
in North America and Europe.
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
(In thousands) | |
Accrued liabilities:
|
|
|
|
|
|
|
|
|
|
Payroll and related items
|
|
$ |
36,244 |
|
|
$ |
36,576 |
|
|
Accrued returns and allowances
|
|
|
18,184 |
|
|
|
8,846 |
|
|
Legal and professional fees
|
|
|
11,865 |
|
|
|
17,021 |
|
|
Accrued research and development costs
|
|
|
11,850 |
|
|
|
475 |
|
|
Dividends payable
|
|
|
6,509 |
|
|
|
6,429 |
|
|
Environmental accrual
|
|
|
5,031 |
|
|
|
9,798 |
|
|
Interest
|
|
|
5,029 |
|
|
|
13,438 |
|
|
Other
|
|
|
27,585 |
|
|
|
16,790 |
|
|
|
|
|
|
|
|
|
|
$ |
122,297 |
|
|
$ |
109,373 |
|
|
|
|
|
|
|
|
Goodwill and intangible assets: As of December 31,
2004 and 2003, goodwill and intangible assets were as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
|
|
Gross | |
|
Accumulated | |
|
Gross | |
|
Accumulated | |
|
|
Amount | |
|
Amortization | |
|
Amount | |
|
Amortization | |
|
|
| |
|
| |
|
| |
|
| |
Intangible assets:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product rights
|
|
$ |
595,699 |
|
|
$ |
(206,367 |
) |
|
$ |
520,025 |
|
|
$ |
(158,743 |
) |
|
License agreement
|
|
|
67,376 |
|
|
|
(24,431 |
) |
|
|
67,376 |
|
|
|
(6,911 |
) |
|
Goodwill
|
|
|
20,499 |
|
|
|
|
|
|
|
13,282 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
|
|
$ |
683,574 |
|
|
$ |
(230,798 |
) |
|
$ |
600,683 |
|
|
$ |
(165,654 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Goodwill increased $7,217,000 for the year ended
December 31, 2004 primarily due to the Amarin Acquisition.
Amortization expense for the years ended December 31, 2004,
2003 and 2002 were $59,303,000, $38,577,000 and $30,661,000,
respectively, of which $41,783,000, $31,666,000 and $30,661,000
was related to the amortization of acquired product rights,
respectively. Estimated amortization expenses for the years
ending December 31, 2005, 2006, 2007, 2008 and 2009 are
$52,560,000, $52,552,000, $51,299,000, $45,086,000, and
$37,853,000, respectively.
70
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Long-term debt consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
61/2% Convertible
Subordinated Notes due 2008
|
|
$ |
|
|
|
$ |
326,001 |
|
3% Convertible Subordinated Notes due 2010
|
|
|
240,000 |
|
|
|
240,000 |
|
4% Convertible Subordinated Notes due 2013
|
|
|
240,000 |
|
|
|
240,000 |
|
7% Senior Notes due 2011
|
|
|
298,833 |
|
|
|
300,000 |
|
Mortgages in Swiss francs with an interest rate of LIBOR + 1.5%;
interest and principal payable semi-annually through 2030
|
|
|
14,477 |
|
|
|
13,469 |
|
Notes payable due 2005
|
|
|
686 |
|
|
|
1,660 |
|
Other
|
|
|
72 |
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
794,068 |
|
|
|
1,121,145 |
|
Less: current portion
|
|
|
(929 |
) |
|
|
(1,343 |
) |
|
|
|
|
|
|
|
|
Total long-term debt
|
|
$ |
793,139 |
|
|
$ |
1,119,802 |
|
|
|
|
|
|
|
|
On May 14 and July 21, 2004, the Company repurchased
$326,001,000 aggregate principal amount of its
61/2% Convertible
Subordinated Notes due 2008. In connection with these
repurchases, the Company recorded a loss on early extinguishment
of debt of $19,892,000 for the year ended December 31, 2004.
In December 2003, the Company issued $300,000,000 aggregate
principal amount of 7.0% Senior Notes due 2011 (the
7.0% Senior Notes). Interest on the
7% Senior Notes is payable semi-annually on June 15
and December 15 of each year. The Company may, at its
option, redeem some or all of the 7.0% Senior Notes at any
time on or after December 15, 2007, at a redemption price
of 103.50%, 101.75% and 100.00% of the principal amount during
the twelve-month period beginning December 15, 2007, 2008
and 2009 and thereafter, respectively. In addition, on or prior
to December 15, 2006, the Company may, at its option,
redeem up to 35% of the 7.0% Senior Notes with the proceeds
of certain sales of its equity at a redemption price equal to
107.0% of the principal amount provided that at least 65% of the
aggregate principal amount of the notes issued remains
outstanding after the redemption. The 7.0% Senior Notes are
senior unsecured obligations. They rank senior in right of
payment to any existing and future subordinated indebtedness of
the Company. The indenture governing the 7.0% Senior Notes
include certain covenants which may restrict the incurrence of
additional indebtedness, the payment of dividends and other
restricted payments, the creation of certain liens, the sale of
assets or the ability to consolidate or merge with another
entity, subject to qualifications and exceptions. In January
2004, the Company entered into an interest rate swap agreement
with respect to $150,000,000 in principal amount of the Senior
Notes. See Note 11 for a description of the interest rate
swap arrangement.
Subsequent to December 31, 2004, investors in auction rate
securities, were advised under a recent interpretation of SFAS
No. 95 Statement of Cash Flows, all auction rate
securities should be classified as marketable securities and not
cash equivalents. As a result, the Company reviewed its
investments in auction rate securities and concluded that it was
in technical non-compliance with a covenant in the indenture
governing the Companys 7.0% Senior notes. Upon realizing
that a technical non-compliance existed, the Company liquidated
its holdings of auction rate securities at approximately the
carrying value and cured the technical non-compliance.
In November 2003, the Company issued $240,000,000 aggregate
principal amount of 3.0% Convertible Subordinated Notes due
2010 (the 3.0% Notes) and $240,000,000
aggregate principal amount of 4.0% Convertible Subordinated
Notes due 2013 (the 4.0% Notes), which were
issued as two series of notes under a single indenture among the
Company and the trustee. Interest on the 3.0% Notes is
payable semi-
71
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
annually on February 16 and August 16 of each year. Interest on
the 4.0% Notes is payable semi-annually on May 15 and
November 15 of each year. The Company has the right to redeem
the 3.0% Notes, in whole or in part, at their principal
amount on or after May 20, 2011. The 3.0% Notes and
4.0% Notes are convertible into the Companys common
stock at a conversion rate of 31.6336 shares per $1,000
principal amount of notes, subject to adjustment. Upon
conversion, the Company will have the right to satisfy its
conversion obligations by delivery, at its option of either
shares of its common stock, cash or a combination thereof. It is
the Companys intent to settle the principal amount of the
3.0% Notes and 4.0% Notes in cash. The 3.0% Notes
and 4.0% Notes are subordinated unsecured obligations of
the Company, ranking in right of payment behind the
Companys senior debt, including the 7.0% Senior
Notes. In connection with the above note offerings, the Company
used a portion of the proceeds to retire $139,589,000 aggregate
principal amount of its
61/2% Notes,
resulting in a loss on early extinguishment of debt of
$12,803,000 for the year ended December 31, 2003.
In connection with the offering of the 3.0% Notes and the
4.0% Notes, the Company entered into convertible note hedge
and written call option transactions with respect to the
Companys common stock (the Convertible
Note Hedge). The Convertible Note Hedge
consisted of the Company purchasing a call option on
12,653,440 shares of the Companys common stock at a
strike price of $31.61 and selling a written call option on the
identical number of shares at $39.52. The number of shares
covered by the Hedge is the same number of shares underlying the
conversion of $200,000,000 principal amount of the
3.0% Notes and $200,000,000 principal amount of the
4.0% Notes. The Convertible Note Hedge is expected to
reduce the potential dilution from conversion of the notes. The
written call option sold offset, to some extent, the cost of the
written call option purchased. The net cost of the Convertible
Note Hedge of $42,880,000 was recorded as the sale of a
permanent equity instrument pursuant to guidance in
EITF 00-19.
In April 2002, the Company used a portion of the proceeds of the
Ribapharm Offering to complete its tender offer and consent
solicitation for all of its outstanding
83/4% Senior
Notes due 2008. The redemption of these notes resulted in a loss
on extinguishment of debt of $43,268,000. In July and August
2002, the Company repurchased $59,410,000 principal amount of
its
61/2% Notes.
In connection with these repurchases, the Company recorded a
gain on early extinguishment of debt of $17,538,000. The net
loss on extinguishment of debt was $25,730,000 for the year
ended December 31, 2002.
The Company has mortgages totaling $14,477,000 payable in
U.S. Dollars and Swiss francs collateralized by certain
real property of the Company.
Aggregate annual maturities of long-term debt are as follows (in
thousands):
|
|
|
|
|
|
2005
|
|
$ |
929 |
|
2006
|
|
|
306 |
|
2007
|
|
|
251 |
|
2008
|
|
|
243 |
|
2009
|
|
|
243 |
|
Thereafter
|
|
|
792,096 |
|
|
|
|
|
|
Total
|
|
$ |
794,068 |
|
|
|
|
|
The estimated fair value of the Companys public debt,
based on quoted market prices or on current interest rates for
similar obligations with like maturities, was approximately
$836,000,000 and $1,182,000,000 compared to its carrying value
of $778,833,000 and $1,106,001,000 at December 31, 2004 and
2003, respectively.
The Company has short and long-term lines of credit of
$7,129,000 in the aggregate under which no borrowings were
outstanding at December 31, 2004. The lines of credit
provide for short-term borrowings and bear interest at variable
rates based upon LIBOR or other indices.
72
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
11. |
Derivatives and Hedging Activities |
The Company uses derivative financial instruments to hedge
foreign currency and interest rate exposures. The Company does
not speculate in derivative instruments in order to profit from
foreign currency exchange or interest rate fluctuations; nor
does the Company enter into trades for which there is no
underlying exposure.
Interest Rate Swap Agreement: In January 2004, the
Company entered into an interest rate swap agreement with
respect to $150,000,000 principal amount of the 7.0% Senior
Notes due 2011 (the Interest Rate Swap), with the
objective of initially lowering the Companys effective
interest rate by exchanging fixed rate payments for floating
rate payments. The agreement provides that the Company will
exchange its 7.0% fixed-rate payment obligation for variable
rate payments of six-month LIBOR plus 2.409% (5.692% as of
December 31, 2004). The Interest Rate Swap is designated as
a fair value hedge and is deemed perfectly effective. At
December 31, 2004, the fair value of the Interest Rate Swap
was $1,167,000 and is included in other long-term assets with an
offsetting credit included in long-term debt as a fair value
adjustment. In support of the Companys obligation under
the Interest Rate Swap, the Company is required to maintain a
minimum level of cash and investment collateral depending on the
fair market value of the Interest Rate Swap. As of
December 31, 2004, $5,483,000 is recorded on the balance
sheet in other assets related to collateral on the Interest Rate
Swap.
Foreign Currency Hedge Transactions: In March and June
2004, the Company entered into a series of forward contracts to
reduce its exposure to variability in the Euro compared to the
U.S. Dollar (the Hedges). The Hedges will cover
the Euro denominated royalty payments on forecasted Euro royalty
revenue. The Hedges are designated and qualify as cash flow
hedges. The Hedges are consistent with the Companys risk
management policy, which allows for the hedging of risk
associated with fluctuations in foreign currency for anticipated
future transactions. The Hedges are determined to be fully
effective as a hedge in reducing the risk of the underlying
transaction. An unrealized loss of $5,630,000 has been recorded
in other comprehensive income for the year ended
December 31, 2004. This unrealized loss will be
reclassified into earnings as the forward contracts are settled
on a monthly basis through December 30, 2005. As of
December 31, 2004, the notional amount of Hedges remaining
is $45,397,000. In connection with the Hedges, the Company is
required to maintain a margin account with a minimum level of
cash and investment collateral depending on the fair market
value of the Hedges. As of December 31, 2004, $8,460,000 is
recorded on the balance sheet in marketable securities related
to collateral on the Hedges.
In April 2003, the Company implemented its 2003 Equity Incentive
Plan (the Incentive Plan), which is an amendment and
restatement of its 1998 Option Plan. The Incentive Plan
increases the number of shares of common stock available for
issuance from 11,604,000 to 18,104,000 in the aggregate. The
Incentive Plan provides for the grant of incentive stock
options, nonqualified stock options, stock appreciation rights,
restricted stock awards, phantom stock and stock bonuses
(collectively, awards) to key employees, officers,
directors, consultants and advisors of the Company. Options
granted under the Incentive Plan must have an exercise price
that is not less than 85% of the fair market value of the common
stock on the date of grant and a term not exceeding
10 years. Under the Incentive Plan, 500,000 shares may
be issued as phantom stock awards or restricted stock awards for
which a participant pays less than the fair market value of the
common stock on the date of grant. Options vest ratably over a
four year period from the date of grant.
73
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table sets forth information relating to the
Incentive Plan during the years ended December 31, 2004 and
2003 and Stock Option Plan during the year ended
December 31, 2002 (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted | |
|
|
|
|
Average | |
|
|
Number of | |
|
Exercise | |
|
|
Shares | |
|
Price | |
|
|
| |
|
| |
Shares under option, December 31, 2001
|
|
|
10,721 |
|
|
$ |
23.40 |
|
|
Granted
|
|
|
4,047 |
|
|
|
15.59 |
|
|
Exercised
|
|
|
(1,748 |
) |
|
|
17.54 |
|
|
Surrendered
|
|
|
(6,606 |
) |
|
|
22.81 |
|
|
Canceled
|
|
|
(864 |
) |
|
|
26.00 |
|
|
|
|
|
|
|
|
Shares under option, December 31, 2002
|
|
|
5,550 |
|
|
|
19.81 |
|
|
Granted
|
|
|
5,691 |
|
|
|
15.62 |
|
|
Assumed in mergers with subsidiaries (Note 2)
|
|
|
2,234 |
|
|
|
18.63 |
|
|
Exercised
|
|
|
(145 |
) |
|
|
11.89 |
|
|
Canceled
|
|
|
(1,029 |
) |
|
|
30.12 |
|
|
|
|
|
|
|
|
Shares under option, December 31, 2003
|
|
|
12,301 |
|
|
|
16.89 |
|
|
Granted
|
|
|
2,668 |
|
|
|
23.39 |
|
|
Exercised
|
|
|
(838 |
) |
|
|
12.66 |
|
|
Canceled
|
|
|
(795 |
) |
|
|
25.86 |
|
|
|
|
|
|
|
|
Shares under option, December 31, 2004
|
|
|
13,336 |
|
|
$ |
17.93 |
|
|
|
|
|
|
|
|
Exercisable at December 31, 2002
|
|
|
2,931 |
|
|
$ |
29.43 |
|
|
|
|
|
|
|
|
Exercisable at December 31, 2003
|
|
|
3,770 |
|
|
$ |
23.38 |
|
|
|
|
|
|
|
|
Exercisable at December 31, 2004
|
|
|
4,799 |
|
|
$ |
19.56 |
|
|
|
|
|
|
|
|
Options available for grant at December 31, 2003
|
|
|
4,084 |
|
|
|
|
|
|
|
|
|
|
|
|
Options available for grant at December 31, 2004
|
|
|
2,211 |
|
|
|
|
|
|
|
|
|
|
|
|
The schedule below reflects the number of outstanding and
exercisable options as of December 31, 2004 segregated by
price range (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding | |
|
Exercisable | |
|
|
|
|
| |
|
| |
|
|
|
|
|
|
Weighted | |
|
|
|
Weighted | |
|
Weighted | |
|
|
|
|
Average | |
|
|
|
Average | |
|
Average | |
|
|
Number of | |
|
Exercise | |
|
Number of | |
|
Exercise | |
|
Remaining | |
Range of Exercise Prices |
|
Shares | |
|
Price | |
|
Shares | |
|
Price | |
|
Life (years) | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
$ 8.10 to $13.08
|
|
|
5,334 |
|
|
$ |
10.52 |
|
|
|
1,953 |
|
|
$ |
9.95 |
|
|
|
7.99 |
|
$13.67 to $23.92
|
|
|
5,893 |
|
|
$ |
20.34 |
|
|
|
1,132 |
|
|
$ |
18.63 |
|
|
|
9.09 |
|
$24.00 to $46.25
|
|
|
2,109 |
|
|
$ |
29.92 |
|
|
|
1,714 |
|
|
$ |
31.12 |
|
|
|
6.36 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,336 |
|
|
|
|
|
|
|
4,799 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
74
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
SFAS No. 123 Assumptions and Fair Value: The
fair value of options granted in 2004, 2003 and 2002 reported in
Note 1 were estimated at the date of grant using the
Black-Scholes option-pricing model with the following
assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Weighted-average life (years)
|
|
|
4.2 |
|
|
|
4.2 |
|
|
|
4.2 |
|
Volatility
|
|
|
63 |
% |
|
|
56 |
% |
|
|
94 |
% |
Expected dividend per share
|
|
$ |
0.31 |
|
|
$ |
0.31 |
|
|
$ |
0.36 |
|
Risk-free interest rate
|
|
|
3.71 |
% |
|
|
2.90 |
% |
|
|
2.55 |
% |
Weighted-average fair value of options
|
|
$ |
11.26 |
|
|
$ |
6.94 |
|
|
$ |
10.33 |
|
2003 Employee Stock Purchase Plan: In May 2003, the
Companys Stockholders approved the Valeant Pharmaceuticals
International 2003 Employee Stock Purchase Plan (the
Purchase Plan). The Purchase Plan provides employees
with an opportunity to purchase common stock through payroll
deductions. There are 7,000,000 shares of common stock
reserved for issuance under the Purchase Plan, plus an annual
increase on the first day of the Companys fiscal year for
a period of ten years, commencing on January 1, 2005 and
ending on January 1, 2015, equal to the lower of
(i) 1.5% of the shares of common stock outstanding on each
calculation date, (ii) 1,500,000 shares of common
stock, or (iii) a number of shares that may be determined
by the Compensation Committee. During fiscal 2004, the Company
issued 194,803 shares of its common stock for proceeds of
$2,873,000 under the Purchase Plan.
Stock Repurchase Plan: In 1998, the Companys Board
of Directors authorized two stock repurchase programs. The first
repurchase program authorized the Company to repurchase up to
$10,000,000 of its outstanding common stock. The second
authorized the Company to initiate a long-term repurchase
program that allows the Company to repurchase up to
3,000,000 shares of its common stock. In April and May
2002, the Company repurchased an aggregate 1,146,000 shares
of its common stock for $31,955,000 in open market transactions
with approval from the Board of Directors. There is no longer an
authorization to purchase shares under the stock repurchase
program.
Stockholder Rights Plan: The Company has adopted a
Stockholder Rights Plan to protect stockholders rights in
the event of a proposed or actual acquisition of 15% or more of
the outstanding shares of the Companys common stock. As
part of this plan, each share of the Companys common stock
carries a right to purchase one one-hundredth (1/100) of a share
of Series A Preferred Stock (the Rights), par
value $0.01 per share, of the Company at a price of
$83 per one one-hundredth of a share, subject to
adjustment, which becomes exercisable only upon the occurrence
of certain events. The Rights are subject to redemption at the
option of the Board of Directors at a price of $0.01 per
right until the occurrence of certain events. On October 5,
2004, the Company amended its Stockholder Rights Plan. The
amendment to the Stockholder Rights Plan changes certain
provisions in the Stockholder Rights Plan including extending
the expiration date from November 1, 2004 to
November 1, 2009 and increasing the exercise price of the
Rights to $100 per right, subject to adjustment.
Additionally, in connection with the amendment, the Company
increased the number of shares designated as Series A
Participating Preferred Stock from 1,000,000 shares to
2,000,000 shares.
Long-term Incentive Plan: The Company had a long-term
incentive plan, which provided for the issuance of shares of the
Companys common stock to senior executives. Shares issued
under the long-term incentive plan were restricted and vested
over a four-year period. In 2002, approximately
445,000 shares of the Companys common stock having a
value of $14,100,000 were issued under this plan. In 2001 and
2000, no shares were issued under the plan. Upon the Change of
Control, all restricted stock awards under the long-term
incentive plan vested immediately. As of December 31, 2004
and 2003, there were no shares outstanding in the plan and no
compensation expense was recorded. During 2002, the Company
recorded an other non-cash charge relating to the compensation
expense of $14,295,000. The long-term incentive plan was
terminated on December 19, 2003.
75
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Other: During 2004 and 2003, pursuant to the
Companys approved director compensation plan, the Company
granted its non-employee directors 51,476 and 69,653 shares
of phantom stock, respectively, with a fair market value of
$971,000 and $840,000, respectively. Each share of phantom stock
vests over one year, is entitled to dividend equivalent shares
and is exchanged for a share of the Companys common stock
one year after the director ceases to serve as a member of the
Companys Board. During 2004 and 2003, the Company recorded
non-cash charges related to the vesting of phantom stock of
$899,000 and $515,000, respectively. As of December 31,
2004, there were 97,635 shares of phantom stock outstanding.
During the second quarter of 2003, the Company sold the
corporate aircraft for 166,980 shares of the Companys
common stock held by the purchaser with a fair market value of
$2,837,000, which was the carrying value of this asset.
In January 2003, the Company issued 41,305 shares of its
common stock valued at $484,000 for consulting services rendered
by non-employees.
In 2003, the Company recorded a non-cash charge relating to the
modification of the term of options of $672,000.
|
|
13. |
Commitments and Contingencies |
We are involved in several legal proceedings, including the
following matters.
Ribapharm Tender Offer Litigation: In June 2003, seven
purported class actions were filed against the Company,
Ribapharm and certain directors and officers of Ribapharm in the
Delaware Court of Chancery. Six of these complaints were
consolidated under the caption In re Ribapharm Inc.
Shareholders Litigation, Consol. C.A. No. 20337 and the
seventh suit proceeded in coordination with the consolidated
case in which the plaintiffs alleged, among other things, that
the Company breached its fiduciary duties as a controlling
stockholder of Ribapharm in connection with its tender offer for
the shares of Ribapharm it did not already own. On
August 4, 2003, the Company and the plaintiffs reached an
agreement in principle to settle these lawsuits for a nominal
amount.
In June 2003, a purported class action on behalf of certain
stockholders of Ribapharm was filed against the Company in the
Delaware Court of Chancery seeking a declaration that the
shareholders rights plan is valid and enforceable. The Company
and the plaintiffs reached an agreement in principle to settle
this lawsuit which will be completed in combination with the
settlement In re Ribapharm Inc. Shareholders Litigation,
Consol. C.A. No. 20337.
In June 2003, a purported class action was filed in the Superior
Court of Orange County, California, against the Company,
Ribapharm and certain of Ribapharms officers and directors
asserting the same claims, on behalf of the same class of
plaintiffs and against the same defendants as in the seven
lawsuits filed in Delaware that are described above. The
settlement of the Delaware tender offer litigation has been
designed to release the claims brought in this lawsuit, although
the decision as to the effect of that release will be subject to
the discretion of the California court.
At a hearing held on December 2, 2004, the Delaware Court
entered an order approving the settlement and awarded
plaintiffs counsel $375,000 in fees and expenses. Pursuant
to the terms of the Delaware settlement, on January 18,
2005, the plaintiff in the California action filed a notice of
request for voluntary dismissal of the case, seeking to dismiss
the case with prejudice. On January 20, 2005, the
California court entered an order dismissing the California
action with prejudice.
On February 28, 2005, after receiving no objections to the
settlement agreement and no opt-outs by class members, the court
gave final approval to the settlement and entered an order and
judgment dismissing the action with prejudice.
76
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
Securities Class Actions: |
Section 10b-5 Litigation: Since July 25, 2002,
multiple class actions have been filed against the Company and
some of its current and former executive officers alleging that
the defendants violated Sections 10(b) and 20(a) of
the Securities Exchange Act of 1934, and Rule 10b-5
promulgated thereunder, by issuing false and misleading
financial results to the market during different class periods
ranging from May 3, 2001 to July 10, 2002, thereby
artificially inflating the price of the Companys stock.
The lawsuits generally claim that the Company issued false and
misleading statements regarding its earnings prospects and sales
figures (based upon channel stuffing allegations),
its operations in Russia, the marketing of Efudex, and the
earnings and sales of its Photonics division. The plaintiffs
generally seek to recover compensatory damages, including
interest.
All the actions have been consolidated to the Central District
of California. On June 24, 2004, the court dismissed the
Second Amended Complaint as to the channel stuffing claim. The
plaintiffs then stipulated to a dismissal of all the claims
against the Company. The plaintiffs have filed a notice of
appeal to the United States Court of Appeals for the Ninth
Circuit seeking review of the dismissal of the claims against
the Company. The plaintiffs filed their opening brief in the
Ninth Circuit on February 7, 2005. Although a schedule for
deciding the appeal has not yet been set by the court, the
Company expects a ruling on this matter by late fall 2005.
Valuepoint Bondholders Litigation: On May 9,
2003, a bondholder filed a class action lawsuit in Orange County
Superior Court against the Company and some of its current and
former directors and former executive officers. The lawsuit
alleges that the defendants violated Sections 11 and 15 of
the Securities Act of 1933 by making false and misleading
statements in connection with an offering of
61/2% Convertible
Subordinated Notes due 2008 in November 2001, thereby
artificially inflating the market price of the Notes. The
plaintiffs generally sought to recover compensatory damages,
including interest. On December 20, 2004, the court granted
preliminary approval of the settlement under which the company
will pay the plaintiffs $3,200,000.
Derivative Actions: The Company is a nominal defendant in
a shareholder derivative lawsuit pending in state court in
Orange County, California, styled James Herrig, IRA v.
Milan Panic et al. This lawsuit, which was filed on
June 6, 2002, purports to assert derivative claims on
behalf of the Company against certain current and/or former
officers and directors of the Company. The lawsuit asserts
claims for breach of fiduciary duties, abuse of control, gross
mismanagement and waste of corporate assets. The plaintiff
seeks, among other things, damages and a constructive trust over
cash bonuses paid to the officer and director defendants in
connection with the Ribapharm offering, or the Ribapharm Bonuses.
On October 1, 2002, several former and current directors of
the Company, as individuals, as well as the Company, as a
nominal defendant, were named as defendants in a second
shareholders derivative complaint filed in the Delaware
Court of Chancery, styled Paul Gerstley v. Norman
Barker, Jr. et al. The original complaint in the
Delaware action purported to state causes of action for
violation of Delaware General Corporation Law Section 144,
breach of fiduciary duties and waste of corporate assets in
connection with the defendants management of the Company.
The allegations in the Delaware action were similar to those
contained in the derivative lawsuit filed in Orange County,
California, but included additional claims asserting that the
defendants breached their fiduciary duties by disseminating
materially misleading and inaccurate information.
The Company established a Special Litigation Committee to
evaluate the plaintiffs claims in both derivative actions.
The Special Litigation Committee concluded that it would not be
in the best interest of the Companys shareholders to
pursue many of the claims in these two lawsuits, but decided to
pursue, through litigation or settlement, claims arising from
the April 2002 decision of the Board to approve the payment of
approximately $50,000,000 in bonuses to various members of the
Board and management arising from the
77
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
initial public offering of Ribapharm. The Court granted the
Companys motion to stay the California proceedings in
favor of the similar Delaware proceedings. On June 27,
2003, the Company filed a motion in the Delaware derivative
action to (a) realign itself as plaintiff in the Delaware
proceedings, (b) pursue the primary derivative claims
relating to the Ribapharm Bonuses, (c) seek dismissal of
the secondary derivative claims, and (d) settle certain
claims with respect to certain of the defendants. The Court
granted the Companys motion for realignment on
October 27, 2003; additional aspects of the Companys
motion are still pending. The Company filed an amended complaint
in the Delaware action on September 17, 2003.
The Company has agreed to settle the litigation with respect to
ten of the defendants, nine of whom each received Ribapharm
Bonuses of $330,500, and one who received a Ribapharm Bonus of
$500,000. Three of the settling defendants were first elected to
the Companys Board of Directors in 2001 (the
2001 Directors), only one of whom currently
serves on the Board of Directors. The 2001 Directors have
entered into settlement agreements, as amended, whereby they
forfeited their 2003 annual Board of Directors stipend and all
of their restricted stock units in exchange for a release from
further liability in the lawsuit. The 2001 Director
Settlement further provides that, in the event the Company
negotiates a settlement with certain defendants on financial
terms that are materially better than those set forth in the
settlement agreements with the 2001 Directors, the Company
agrees to adjust the 2001 Directors settlement
payment by a comparable proportion. Following court-sponsored
mediation in the Delaware Court of Chancery, the Company entered
into settlement agreements with seven other defendants, which
have been executed by the parties and the mediator. Pursuant to
these settlements, six of these defendants (the Outside
Director Defendants) will each pay to the Company
$150,000, in exchange for a release from further liability in
the lawsuit. The Outside Director Defendants will receive an
offset credit of $50,000 for release of their claimed right to
payments for the automatic conversion of the Companys
stock options that were not issued to them in 2002. The terms of
the mediated settlement with the other settling former director
requires that he pay $80,000 to the Company in exchange for a
release from further liability in the lawsuit. None of the
settlements will be effective unless approved by the Delaware
Court of Chancery. Following the mediated settlement agreements,
counsel for the 2001 Directors notified the Company that,
in the 2001 Directors opinion, the settlement
agreements with the Outside Director Defendants are on financial
terms that are materially better than those set forth in the
settlements with the 2001 Directors and have demanded that
the Company pay to the 2001 Directors the sum of $50,000
each. The Company has advised the 2001 Directors that the
settlement agreements reached with the other defendants do not
trigger this provision. If it is deemed that the financial terms
of the settlement with the Outside Director Defendants are on
financial terms that are materially better than those set forth
in the settlement with the 2001 Directors, the
2001 Directors settlement payment will be adjusted by
a comparable proportion. Mediation was unsuccessful and has
terminated with respect to defendants Milan Panic and Adam
Jerney, who received Ribapharm Bonuses of $33,000,000 and
$3,000,000, respectively. Discovery in the case is proceeding.
Patents: Various parties are opposing our ribavirin
patents in actions before the European Patent Office, and the
Company is responding to these oppositions. These patents
currently benefit from patent extensions in the major European
countries, that provide market protection until 2009.
Should the opponents prevail, the combination therapies marketed
by Schering-Plough would lose patent protection in Europe, but
the Company believes that these products will continue to enjoy
data exclusivity until 2009. Regardless of the outcome of the
oppositions, the Company believes the combination therapies
marketed by Roche will continue to benefit from a period of data
and marketing protection in the major markets of the European
Union until 2012.
Serbia & Montenegro: In March 1999, arbitration
was initiated in the following matters before the International
Chamber of Commerce International Court of Arbitration:
(a) State Health Fund of Serbia v. ICN
Pharmaceuticals, Inc., Case No. 10 373/ AMW/ BDW/ SPB/ JNK,
and (b) ICN Pharmaceuticals, Inc. v. Federal Republic
of Yugoslavia and Republic of Serbia, Case No. 10 439/ BWD/
SPB/ JNK. At issue
78
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
in these matters were the parties respective rights and
obligations with respect to ICN Yugoslavia, a joint venture
formed by the parties predecessors-in-interest in 1990. In
these proceedings, the Company asserted claims against the
Federal Republic of Yugoslavia (FRY) and the
Republic of Serbia, and counterclaims against the State Health
Fund of Serbia (Health Fund) for, inter alia,
unlawful seizure of the Companys majority interest in the
joint venture and failure to pay obligations to the joint
venture in excess of $176,000,000. The Company sought damages in
excess of $277,000,000. The Health Fund asserted claims against
the Company for breach of the joint venture agreement based on
the Companys alleged failure to make its required capital
contributions, and the Companys alleged mismanagement of
the joint venture. The Health Fund sought damages in excess of
$270,000,000. Early in the proceedings the arbitral tribunal
dismissed the FRY from these proceedings for lack of
jurisdiction. In November 2004 the arbitral tribunal issued a
final award in the case. The tribunal ruled that the Company had
complied with its capital contribution obligations, that the
Health Fund and Republic of Serbia had committed a de facto
expropriation of the Companys interest in the joint
venture, and that the Company was entitled to a return of its
capital contributions, including rights to certain
pharmaceutical compounds and $50,000,000 in cash. The tribunal
dismissed the remaining claims by the Company and by the Health
Fund for lack of jurisdiction. The tribunal ordered the Health
Fund and Republic of Serbia to liquidate the joint venture
within three months to repay Valeants $50,000,000 in cash,
and held that if such liquidation was not initiated in timely
fashion the Health Fund and the Republic of Serbia would be
jointly and severally liable for the return of these funds. The
deadline to liquidate the joint venture passed in February 2005,
but it appears that no liquidation of the joint venture has been
initiated. The Company accordingly intends to press forward with
enforcement efforts. The Company has seen press reports in
Serbia that the Republic of Serbia and the Health Fund have
filed one or more court actions in Serbia seeking to annul the
arbitral awards, but the Company has not been formally served
with process in such actions. The Health Fund has also
threatened to reassert in court some or all of the claims that
the tribunal did not reach on the merits. The Company intends to
vigorously contest such claims if they are asserted.
Argentina Antitrust Matter: In July 2004, the Company was
advised that the Argentine Antitrust Agency had issued a notice
unfavorable to the Company in a proceeding against its Argentine
subsidiary. The proceeding involves allegations that the
subsidiary in Argentina abused a dominant market position in
1999 by increasing its price on Mestinon in Argentina and not
supplying the market for approximately two months. The
subsidiary filed documents with the agency offering an
explanation justifying its actions, but the agency has now
rejected the explanation. The agency is collecting evidence
prior to issuing a new decision. Argentinean law permits a fine
to be levied of up to $5,000,000 plus 20% of profits realized
due to the alleged wrongful conduct. Counsel in the matter
advises that the size of the transactions alleged to have
violated the law will unlikely draw the maximum penalty.
Permax Product Liability Cases: In February 2004, the
Company purchased the shares of Amarin Pharmaceuticals Inc. At
that time a case captioned Debra Ann Blackstone v.
Amarin Pharmaceuticals, Inc., Amarin International Company, Eli
Lilly & Company, Health Net, Inc., Blue Shield of
California, Inc., Walgreen Co., Gaye Swenn, R.Ph., and John
Lowhon, R.Ph. Case No. 017 201332 03 was
already pending in the District Court of Tarrant County, Texas.
On February 15, 2005 Valeant was served in a case captioned
Jerry G. Miller and Karren M. Miller v. Eli Lilly and
Company, Elan Pharmaceuticals, Inc., Valeant Pharmaceuticals
International, Amarin Corporation PLC, Amarin Pharmaceuticals,
Inc., Reasors, Inc., Reasors LLC and Athena
Neurosciences, Inc., Case No. CJ-2004-6757 in the
District Court of Tulsa County, Oklahoma. On February 23,
2005 Valeant was served in a case captioned Jimmy Ruth
Carson v. Eli Lilly and Company, Elan Pharmaceuticals,
Inc., and Valeant Pharmaceuticals International, Case
No., 05CV106 in the United States District Court for
the Northern District of Oklahoma. In general these cases allege
that use of Permax, a drug for the treatment of Parkinsons
Disease marketed and sold by Amarin, caused valvular heart
disease. The Company has also received from time to time other
claims alleging that the use of Permax caused congestive heart
failure and other coronary-related damage, including a letter
from an attorney purporting to
79
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
represent 5 persons with such claims. Eli Lilly, holder of the
right granted by the FDA to market and sell Permax in the United
States, though such right was licensed to Amarin and the source
of the manufactured product, has also been named in the suits.
Under an agreement between the Company and Eli Lilly, Eli Lilly
will bear a portion of the liability associated with these
claims. Product liability insurance exists with respect to these
claims. Although it is expected that the insurance proceeds will
be sufficient to cover existing claims against the Company,
there can be no assurance that defending against any future
similar claims and any resulting settlements or judgments will
not, individually or in the aggregate, have a material adverse
affect on the Companys consolidated financial position,
results of operation or liquidity.
Kali litigation: In March 2004, Kali Laboratories, Inc.
submitted Abbreviated New Drug Application (ANDA)
No. 76-843 with the FDA seeking approval for a generic
version of Diastat® (a diazepam rectal gel). In July of
2004, Xcel Pharmaceuticals, Inc., which we acquired on
March 1, 2005, filed a complaint against Kali for patent
infringement of U.S. Patent No. 5,462,740
Civil Case No. 04-3238 (JCL) pending in the United States
District Court of New Jersey. The complaint alleges that
Kalis filing of ANDA No. 76-843 is an infringement
under 35 U.S.C. § 271(e)(4) of one or more
claims of U.S. Patent No. 5,462,740. Kali has filed an
answer and counterclaims, denying all allegations of the
complaint and asserting affirmative defenses and counterclaims
for non-infringement, invalidity and unenforceability under the
doctrine of patent misuse due to improper filing of the lawsuit.
Xcel filed a reply to the counterclaims, denying all allegations
thereof. Discovery is proceeding. The pretrial conference is set
for November 15, 2005. No trial date has been set.
Xcel filed this suit within forty-five days of Kalis
Paragraph IV certification. As a result, The Drug Price
Competition and Patent Restoration Act of 1984 (the
Hatch-Waxman Act) provides an automatic stay on the
FDAs approval of Kalis ANDA for thirty months. If
Xcel prevails in the lawsuit, then Kalis ANDA cannot be
effective until after the expiration of U.S. Patent
No. 5,462,740 in 2013. If Kali prevails in the lawsuit at
the district court level, then the FDA may approve Kalis
ANDA at such time, even if prior to the expiration of the
thirty-month stay period.
Trademark litigation: Altana Pharma AG filed oppositions
to the Companys registration of the VALEANT trademark in
Romania and in France. The French opposition has been denied.
The Company and Altana have entered into a coexistence agreement
pursuant to which Altana will withdraw any pending oppositions
that it has filed against the registration of the VALEANT mark
and will file no further oppositions.
Valent U.S.A. Corporation and its wholly owned subsidiary Valent
Biosciences Corporation (together Valent
Biosciences) have expressed concerns regarding the
possible confusion between Valent Biosciences VALENT
trademark registered in connection with various chemical and
agricultural products and the companys VALEANT trademark.
Valent Biosciences has opposed the registration of the VALEANT
trademark by the Company in certain jurisdictions, including
Argentina, Australia, Chile, Colombia, Czech Republic, France,
Germany, New Zealand, Spain, Switzerland, Turkey, Venezuela and
the United States. Valent Biosciences oppositions in
France and Spain have been denied. While Valent
Biosciences opposition in Chile has been sustained, the
Company has appealed that decision. The Company has responded or
will respond to the opposition proceedings that have been filed
and discovery is ongoing in the opposition proceeding in the
United States. If any of the opposition proceedings are
successful, the Company would have no trademark registration for
the VALEANT mark in that particular jurisdiction and, in
addition, in those jurisdictions where trademark rights accrue
solely through the registration process, may have no trademark
rights in those particular jurisdictions.
Other: The Company is a party to other pending lawsuits
and subject to a number of threatened lawsuits. While the
ultimate outcome of pending and threatened lawsuits or pending
violations cannot be predicted with certainty, and an
unfavorable outcome could have a negative impact on the Company,
at this
80
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
time in the opinion of management, the ultimate resolution of
these matters will not have a material effect on the
Companys consolidated financial position, results of
operations or liquidity.
The Companys four reportable specialty pharmaceutical
segments are comprised of its pharmaceutical operations in North
America, Latin America, Europe and Asia, Africa and Australia.
In addition, the Company has a research and development
division. The segment reporting has been reclassified to conform
to discontinued operations presentation for all periods
presented. See Note 3 for discussion of discontinued
operations.
The following tables set forth the amounts of segment revenues
and operating income of the Company for the years ended
December 31, 2004, 2003 and 2002 (in thousands):
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|
Year Ended December 31, | |
|
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| |
|
|
2004 | |
|
2003 | |
|
2002 | |
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| |
|
| |
|
| |
Revenues
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals
|
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|
|
North America
|
|
$ |
142,799 |
|
|
$ |
99,074 |
|
|
$ |
90,011 |
|
|
Latin America
|
|
|
151,726 |
|
|
|
136,008 |
|
|
|
135,527 |
|
|
Europe
|
|
|
253,748 |
|
|
|
232,031 |
|
|
|
189,925 |
|
|
Asia, Africa, Australia
|
|
|
57,820 |
|
|
|
51,358 |
|
|
|
51,346 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
606,093 |
|
|
|
518,471 |
|
|
|
466,809 |
|
Ribavirin royalties
|
|
|
76,427 |
|
|
|
167,482 |
|
|
|
270,265 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated revenues
|
|
$ |
682,520 |
|
|
$ |
685,953 |
|
|
$ |
737,074 |
|
|
|
|
|
|
|
|
|
|
|
Operating Income (Loss)
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
$ |
44,438 |
|
|
$ |
29,972 |
|
|
$ |
15,483 |
|
|
Latin America
|
|
|
46,124 |
|
|
|
42,671 |
|
|
|
48,535 |
|
|
Europe
|
|
|
31,347 |
|
|
|
24,425 |
|
|
|
10,625 |
|
|
Asia, Africa, Australia
|
|
|
3,103 |
|
|
|
3,570 |
|
|
|
(760 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
125,012 |
|
|
|
100,638 |
|
|
|
73,883 |
|
|
Restructuring charges(1)
|
|
|
(19,344 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
105,668 |
|
|
|
100,638 |
|
|
|
73,883 |
|
Research and development division
|
|
|
(38,860 |
) |
|
|
95,151 |
|
|
|
203,981 |
|
IPR&D(1)
|
|
|
(11,770 |
) |
|
|
(117,609 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated segment operating income
|
|
|
55,038 |
|
|
|
78,180 |
|
|
|
277,864 |
|
Corporate expenses
|
|
|
(50,877 |
) |
|
|
(56,607 |
) |
|
|
(308,628 |
) |
Interest income
|
|
|
12,432 |
|
|
|
8,888 |
|
|
|
5,644 |
|
Interest expense
|
|
|
(49,265 |
) |
|
|
(36,145 |
) |
|
|
(42,856 |
) |
Other, net
|
|
|
(19,751 |
) |
|
|
(8,076 |
) |
|
|
244,914 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations before provision for
income taxes and minority interest
|
|
$ |
(52,423 |
) |
|
$ |
(13,760 |
) |
|
$ |
176,938 |
|
|
|
|
|
|
|
|
|
|
|
81
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Depreciation and Amortization
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
$ |
21,878 |
|
|
$ |
15,887 |
|
|
$ |
15,850 |
|
|
Latin America
|
|
|
8,604 |
|
|
|
7,426 |
|
|
|
6,195 |
|
|
Europe
|
|
|
26,229 |
|
|
|
22,860 |
|
|
|
20,148 |
|
|
Asia, Africa, Australia
|
|
|
5,793 |
|
|
|
4,551 |
|
|
|
4,371 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
62,504 |
|
|
|
50,724 |
|
|
|
46,564 |
|
Corporate
|
|
|
3,176 |
|
|
|
3,647 |
|
|
|
4,510 |
|
Research and development division
|
|
|
21,458 |
|
|
|
10,436 |
|
|
|
2,845 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
87,138 |
|
|
$ |
64,807 |
|
|
$ |
53,919 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
Restructuring charges and IPR&D are not included in the
applicable segments as management excludes these items in
assessing the financial performance of these segments, primarily
due to their non-operational nature. For the year ended
December 31, 2004, restructuring charges of $17,978,000 and
$1,366,000 were incurred in the Europe and Latin America
pharmaceutical segments, respectively. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Capital Expenditures
|
|
|
|
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
|
|
|
|
North America
|
|
$ |
7,139 |
|
|
$ |
2,094 |
|
|
$ |
2,083 |
|
|
Latin America
|
|
|
3,523 |
|
|
|
3,220 |
|
|
|
4,925 |
|
|
Europe
|
|
|
9,435 |
|
|
|
5,616 |
|
|
|
7,788 |
|
|
Asia, Africa, Australia
|
|
|
2,252 |
|
|
|
250 |
|
|
|
106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total specialty pharmaceuticals
|
|
|
22,349 |
|
|
|
11,180 |
|
|
|
14,902 |
|
Corporate
|
|
|
2,156 |
|
|
|
3,548 |
|
|
|
1,575 |
|
Research and development division
|
|
|
2,108 |
|
|
|
2,878 |
|
|
|
2,943 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
26,613 |
|
|
$ |
17,606 |
|
|
$ |
19,420 |
|
|
|
|
|
|
|
|
|
|
|
82
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table sets forth the total assets and long-lived
assets of the Company by segment as of December 31, 2004
and 2003 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
|
| |
|
| |
Total Assets
|
|
|
|
|
|
|
|
|
Specialty pharmaceuticals
|
|
|
|
|
|
|
|
|
|
North America
|
|
$ |
439,084 |
|
|
$ |
400,265 |
|
|
Latin America
|
|
|
153,050 |
|
|
|
105,333 |
|
|
Europe
|
|
|
375,086 |
|
|
|
353,776 |
|
|
Asia, Africa, Australia
|
|
|
60,221 |
|
|
|
21,999 |
|
|
|
|
|
|
|
|
|
|
Total pharmaceuticals
|
|
|
1,027,441 |
|
|
|
881,373 |
|
Corporate
|
|
|
270,777 |
|
|
|
801,846 |
|
Research and development division
|
|
|
199,763 |
|
|
|
213,854 |
|
Discontinued operations
|
|
|
23,894 |
|
|
|
27,994 |
|
|
|
|
|
|
|
|
|
|
$ |
1,521,875 |
|
|
$ |
1,925,067 |
|
|
|
|
|
|
|
|
Long-lived Assets
|
|
|
|
|
|
|
|
|
North America
|
|
$ |
144,884 |
|
|
$ |
150,965 |
|
Latin America
|
|
|
15,244 |
|
|
|
15,580 |
|
Europe
|
|
|
111,860 |
|
|
|
124,743 |
|
Asia, Africa, Australia
|
|
|
2,550 |
|
|
|
466 |
|
|
|
|
|
|
|
|
|
|
$ |
274,538 |
|
|
$ |
291,754 |
|
|
|
|
|
|
|
|
83
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
The following table summarizes the Companys ten largest
products and seven global brands by therapeutic class based on
sales for the years ended December 31, 2004, 2003 and 2002
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, | |
|
|
| |
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Dermatology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Efudix/ Efudex®(G)(T)
|
|
$ |
45,453 |
|
|
$ |
26,821 |
|
|
$ |
23,085 |
|
|
Kinerase®(G)(T)
|
|
|
15,619 |
|
|
|
12,628 |
|
|
|
10,389 |
|
|
Oxsoralen-Ultra®(G)(T)
|
|
|
10,910 |
|
|
|
8,501 |
|
|
|
4,585 |
|
|
Dermatix®(G)
|
|
|
7,034 |
|
|
|
2,493 |
|
|
|
338 |
|
Infectious Disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Virazole®(G)(T)
|
|
|
13,822 |
|
|
|
18,716 |
|
|
|
17,384 |
|
Neurology
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mestinon®(G)(T)
|
|
|
41,631 |
|
|
|
41,879 |
|
|
|
31,228 |
|
|
LIbrax®(T)
|
|
|
16,868 |
|
|
|
11,774 |
|
|
|
18,209 |
|
|
Dalmane®/ Dalmadorm(T)
|
|
|
12,146 |
|
|
|
10,636 |
|
|
|
10,753 |
|
|
Tasmar®(G)
|
|
|
3,551 |
|
|
|
|
|
|
|
|
|
Other Therapeutic Classes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bedoyecta®(T)
|
|
|
30,654 |
|
|
|
26,955 |
|
|
|
29,781 |
|
|
Solcoseryl(T)
|
|
|
14,397 |
|
|
|
16,186 |
|
|
|
3,811 |
|
|
Nyal®(T)
|
|
|
11,904 |
|
|
|
8,969 |
|
|
|
5,207 |
|
|
Other products
|
|
|
382,104 |
|
|
|
332,913 |
|
|
|
312,039 |
|
|
|
|
|
|
|
|
|
|
|
Total product sales
|
|
$ |
606,093 |
|
|
$ |
518,471 |
|
|
$ |
466,809 |
|
|
|
|
|
|
|
|
|
|
|
Total top ten product sales(T)
|
|
$ |
213,404 |
|
|
$ |
183,065 |
|
|
$ |
154,432 |
|
|
|
|
|
|
|
|
|
|
|
Total global product sales(G)
|
|
$ |
138,020 |
|
|
$ |
111,038 |
|
|
$ |
87,009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(T) |
|
Indicates ten largest product |
|
(G) |
|
Indicates global brand |
Schering-Plough: In 1995, the Company entered into an
exclusive license and supply agreement with Schering-Plough (the
License Agreement). Under the License Agreement,
Schering-Plough licensed all oral forms of ribavirin for the
treatment of chronic hepatitis C. The FDA granted
Schering-Plough marketing approval for Rebetol® capsules
(Schering-Ploughs brand name for ribavirin) as a
separately marketed product for use only in combination with
Intron A injection for the treatment of hepatitis C in
patients with compensated liver disease previously untreated
with alfa interferon (commonly referred to as
treatment-naïve patients) or who have relapsed following
alfa interferon therapy. The FDA also granted Schering-Plough
approval for
Peg-Introntm
(peginterferon alfa-2b), a longer lasting form of Intron A, for
use in Combination Therapy with Rebetol for the treatment of
chronic hepatitis C in patients with compensated liver
disease who are at least 18 years of age. Schering-Plough
markets the Combination Therapy in the United States, Europe,
Japan, and many other countries around the world based on the
U.S. and European Union regulatory approvals.
In November 2000, the Company entered into an agreement that
provides Schering-Plough with certain rights to license various
products the Company may develop. Under the terms of the
agreement, Schering-
84
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
Plough has the option to exclusively license on a worldwide
basis up to three compounds that the Company may develop for the
treatment of hepatitis C on terms specified in the
agreement. The option does not apply to
Levovirintm
or
Viramidinetm.
The option is exercisable as to a particular compound at any
time prior to the start of Phase II clinical studies for
that compound. Once it exercises the option with respect to a
compound, Schering-Plough is required to take over all
developmental costs and responsibility for regulatory approval
for that compound. Under the agreement, the Company would
receive royalty revenues based on the sales of licensed products.
Under the terms of the agreement, the Company also granted
Schering-Plough and an affiliate rights of first/last refusal to
license compounds relating to the treatment of infectious
diseases (other than hepatitis C) or cancer or other
oncology indications as well as rights of first/last refusal
with respect to
Levovirintm
and
Viramidinetm
(collectively, the Refusal Rights). Under the terms
of the Refusal Rights, if the Company intends to offer a license
or other rights with respect to any of these compounds to a
third party, the Company is required to notify Schering-Plough.
At Schering-Ploughs request, the Company is required to
negotiate in good faith with Schering-Plough on an exclusive
basis the terms of a mutually acceptable exclusive worldwide
license or other form of agreement on commercial terms to be
mutually agreed upon. If the Company cannot reach an agreement
with Schering-Plough, the Company is permitted to negotiate a
license agreement or other arrangement with a third party. Prior
to entering into any final arrangement with the third party, the
Company is required to offer substantially similar terms to
Schering-Plough, which terms Schering-Plough has the right to
match.
If Schering-Plough does not exercise its option or Refusal
Rights as to a particular compound, the Company may continue to
develop that compound or license that compound to other third
parties. The agreement with Schering-Plough will terminate the
later of 12 years from the date of the agreement or the
termination of the 1995 license agreement with Schering-Plough.
The agreement was entered into as part of the resolution of
claims asserted by Schering-Plough against the Company,
including claims regarding the Companys alleged improper
hiring of former Schering-Plough research and development
personnel and claims that the Company was not permitted to
conduct hepatitis C research.
Roche: On January 6, 2003, the Company entered into
a license agreement with Roche (the Roche License
Agreement) which authorizes Roche to make, have made and
to sell its own version of ribavirin, known as Copegus, under
the Companys patents for use in combination therapy with
Roches version of pegylated interferon, known as Pegasys,
for the treatment of hepatitis C. Under the Roche License
Agreement, Roche will register and commercialize Copegus
globally. Roche will pay royalty fees to the Company on its
sales of the combination product containing Copegus.
Approval of a generic form of oral ribavirin by the FDA in the
United States was announced on April 7, 2004. With respect
to Schering-Plough, effective royalty rates increase in tiers
based on increased sales levels in the United States. As a
result of reduced sales, the likelihood of achieving the maximum
effective royalty rate in the United States is diminished. With
respect to Roche, under the license agreement, the introduction
of generics in any market eliminates the obligation of Roche to
pay royalties for sales in that market. Upon the entry of
generics into the United States on April 7, 2004, Roche
ceased paying royalties on sales in the United States.
Schering-Plough announced its launch of generic version of
ribavirin. Under the license and supply agreement,
Schering-Plough is obligated to pay the Company royalties for
sales of their generic ribavirin.
85
VALEANT PHARMACEUTICALS INTERNATIONAL
NOTES TO CONSOLIDATED FINANCIAL
STATEMENTS (Continued)
|
|
16. |
Supplemental Cash Flow Disclosures |
The following table sets forth the amounts of interest and
income taxes paid during 2004, 2003 and 2002 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2004 | |
|
2003 | |
|
2002 | |
|
|
| |
|
| |
|
| |
Interest paid
|
|
$ |
54,892 |
|
|
$ |
36,396 |
|
|
$ |
42,254 |
|
|
|
|
|
|
|
|
|
|
|
Income taxes paid
|
|
$ |
31,841 |
|
|
$ |
34,011 |
|
|
$ |
53,090 |
|
|
|
|
|
|
|
|
|
|
|
Appointment of New Chief Executive Officer: On
January 1, 2005, Timothy C. Tyson was appointed President
and Chief Executive Officer of the Company. Mr. Tyson
previously served as the Companys President and Chief
Operating Officer and succeeds Robert W. OLeary, who was
the Companys former Chief Executive Officer, will continue
as the Companys Chairman of the Board.
Acquisition of Xcel Pharmaceuticals, Inc.: On
March 1, 2005, the Company acquired Xcel Pharmaceuticals,
Inc. (Xcel), a specialty pharmaceutical company
focused on the treatment of disorders of the central nervous
system for $280,000,000 in cash, plus expenses of approximately
$5,000,000. Xcels portfolio consists of four products that
are sold within the United States, and a late-stage clinical
product candidate being developed for commercialization in all
major markets. Approximately $44,000,000 of the cash
consideration was used to retire Xcels outstanding
long-term debt. The purchase price is subject to certain
post-closing adjustments as set forth in the acquisition
agreement.
In connection with the Xcel acquisition, the Company completed
an offering of 8,280,000 shares of its common stock in
February 2005. The Company received net proceeds, after
underwriting discounts and commissions, of $189,777,600, which
was used to partially fund the Xcel acquisition. The remainder
of the funds required for the Xcel acquisition was provided by
available cash on hand.
The Xcel acquisition has been accounted for using the purchase
method of accounting. Allocation of the purchase price is based
on estimates of the fair value of the assets acquired and
liabilities assumed at the date of acquisition. However, these
estimates maybe incomplete, and unanticipated events and
circumstances may occur. Of the $285,000,000 total purchase
price, we estimated approximately $125,000,000 will be allocated
to IPR&D, which represents an estimate of the fair value of
purchased in-process technology for projects that, as of the
acquisition date, had not yet reached technological feasibility
and had no alternative future use, and is therefore expensed;
and approximately $100,000,000 will be allocated to identifiable
intangible assets which will be amortized over their estimated
useful life of ten years. The Company will record the IPR&D
charge in the first quarter of 2005. The Company estimates that
the balance of the purchase price of approximately $16,000,000
will be allocated to the net assets acquired. Estimates for the
purchase price allocation may change as subsequent information
become available.
86
SCHEDULE II VALUATION AND QUALIFYING
ACCOUNTS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions | |
|
|
|
|
|
|
|
|
| |
|
|
|
|
|
|
Balance at | |
|
Charged to | |
|
Charged to | |
|
|
|
Balance | |
|
|
Beginning | |
|
Costs and | |
|
Other | |
|
|
|
at End | |
|
|
of Year | |
|
Expenses | |
|
Accounts | |
|
Deductions | |
|
of Year | |
|
|
| |
|
| |
|
| |
|
| |
|
| |
|
|
(In thousands) | |
Year ended December 31, 2004
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts
|
|
$ |
6,663 |
|
|
$ |
823 |
|
|
$ |
(1,325 |
) |
|
$ |
(147 |
) |
|
$ |
6,014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for inventory obsolescence
|
|
$ |
11,583 |
|
|
$ |
5,568 |
|
|
$ |
(4,047 |
) |
|
$ |
828 |
|
|
$ |
13,932 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax asset valuation allowance
|
|
$ |
20,509 |
|
|
|
101,645 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
122,154 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2003
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts
|
|
$ |
7,646 |
|
|
$ |
170 |
|
|
$ |
249 |
|
|
$ |
(1,402 |
) |
|
$ |
6,663 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for inventory obsolescence
|
|
$ |
11,060 |
|
|
$ |
6,686 |
|
|
$ |
582 |
|
|
$ |
(6,745 |
) |
|
$ |
11,583 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax asset valuation allowance
|
|
$ |
21,250 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(741 |
) |
|
$ |
20,509 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2002
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful accounts
|
|
$ |
8,172 |
|
|
$ |
761 |
|
|
$ |
209 |
|
|
$ |
(1,496 |
) |
|
$ |
7,646 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for inventory obsolescence
|
|
$ |
10,143 |
|
|
$ |
5,250 |
|
|
$ |
(1,735 |
) |
|
$ |
(2,598 |
) |
|
$ |
11,060 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax asset valuation allowance
|
|
$ |
21,429 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
(179 |
) |
|
$ |
21,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Item 9. |
Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure |
None.
|
|
Item 9A. |
Controls and Procedures |
The Company maintains disclosure controls and procedures that
are designed to ensure that information required to be disclosed
in the Companys Exchange Act reports is recorded,
processed, summarized and reported within the time periods
specified in the SECs rules and forms, and that such
information is accumulated and communicated to the
Companys management, including its Chief Executive Officer
and Chief Financial Officer, as appropriate, to allow timely
decisions regarding required disclosure. In designing and
evaluating the disclosure controls and procedures, management
recognizes that any controls and procedures, no matter how well
designed and operated, can provide only reasonably assurance of
achieving the desired control objectives, and management
necessarily is required to apply its judgment in evaluating the
cost-benefit relationship of possible controls and procedures.
As of December 31, 2004, the Company conducted an
evaluation of the effectiveness of the design and operation of
the Companys disclosure controls and procedures. This
evaluation was carried out under the supervision and with the
participation of the Companys management, including the
Companys Chief Executive Officer and Chief Financial
Officer. Based upon the foregoing, the Companys Chief
Executive Officer and Chief Financial Officer concluded that the
Companys disclosure controls and procedures were effective
in making known to them material information relating to the
Company (including its consolidated subsidiaries) required to be
included in this report.
There has been no significant change in the Companys
internal controls over financial reporting, known to the Chief
Executive Officer or the Chief Financial Officer, that occurred
during the quarter ended December 31, 2004 that has
materially affected, or is reasonably likely to materially
affect, the Companys internal controls over financial
reporting.
87
|
|
|
Management Responsibility for Financial Statements |
Management is responsible for the preparation of the
Companys consolidated financial statements and related
information appearing in this report. Management believes that
the consolidated financial statements fairly reflect the form
and substance of transactions and that the financial statements
reasonably present the Companys financial position and
results of operations in conformity with generally accepted
accounting principles. Management also has included in the
Companys consolidated financial statements amounts that
are based on estimates and judgments which it believes are
reasonable under the circumstances.
The independent registered public accounting firm audits the
Companys consolidated financial statements in accordance
with the standards of the Public Company Accounting Oversight
Board and provides an objective, independent review of the
fairness of reported operating results and financial position.
The Board of Directors of the Company has a Finance and Audit
Committee composed of three non-management Directors. The
committee meets periodically with financial management, the
internal auditors and the independent registered public
accounting firm to review accounting, control, auditing and
financial reporting matters.
|
|
|
Managements Annual Report on Internal Control Over
Financial Reporting |
Our management is responsible for establishing and maintaining
adequate internal control over financial reporting, as such term
is defined in Exchange Act Rule 13A-15(f). Our management,
with the participation of our principal executive officer and
principal financial officer, conducted an evaluation of the
effectiveness, as of December 31, 2004, of our internal
control over financial reporting based on the framework in
Internal Control Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway
Commission.
Based on such evaluation, our management concluded that our
internal control over financial reporting was effective as of
December 31, 2004. PricewaterhouseCoopers, LLC, the
independent registered public accounting firm that audited the
financial statements contained in this annual report of
Form 10-K, has issued an attestation report on
managements assessment, which attestation appears in
Item 8.
|
|
Item 9B. |
Other Information |
None.
PART III
|
|
Item 10. |
Directors and Executive Officers of the Registrant |
The information required under this Item is set forth in the
Companys definitive proxy statement to be filed in
connection with the Companys 2005 annual meeting of
stockholders (the Proxy Statement) and is
incorporated by reference.
The Company has adopted a code of ethics that applies to the
Companys principal executive officer, principal financial
officer and principal accounting controller. The code of ethics
has been posted on the Companys internet website found at
www.valeant.com. The Company intends to satisfy
disclosure requirements regarding amendments to, or waivers
from, any provisions of its code of ethics on its website.
|
|
Item 11. |
Executive Compensation |
The information required under this Item is set forth in the
Proxy Statement and is incorporated by reference.
88
|
|
Item 12. |
Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters |
The information required under this Item is set forth in the
Proxy Statement and is incorporated by reference.
|
|
Item 13. |
Certain Relationships and Related Transactions |
The information required under this Item is set forth in the
Proxy Statement and is incorporated by reference.
|
|
Item 14. |
Principal Accounting Fees and Services |
The information required under this Item is set forth in the
Proxy Statement and is incorporated by reference.
PART IV
|
|
Item 15. |
Exhibits and Financial Statement Schedules |
1. Financial Statements
Financial Statements of the Registrant are listed in the index
to Consolidated Financial Statements and filed under
Item 8, Financial Statements and Supplementary
Data, in this Form 10-K.
2. Financial Statement Schedule
Financial Statement Schedule of the Registrant is listed in the
index to Consolidated Financial Statements and filed under
Item 8, Financial Statements and Supplementary
Data, in this Form 10-K.
Schedules not listed have been omitted because the information
required therein is not applicable or is shown in the financial
statements and the notes thereto.
3. Exhibits
|
|
|
|
|
Exhibit | |
|
|
Number | |
|
Description |
| |
|
|
|
3.1 |
|
|
Restated Certificate of Incorporation, as amended to date,
previously filed as Exhibit 3.1 to Valeant Pharmaceuticals
Internationals Form 10-Q for the quarter ended
September 30, 2003, which is incorporated herein by
reference. |
|
3.2 |
|
|
Bylaws of the Registrant previously filed as Exhibit 3.2 to
Registration Statement No. 33-84534 on Form S-4, which
is incorporated herein by reference. |
|
4.1 |
|
|
Form of Rights Agreement, dated as of November 2, 1994,
between the Registrant and American Stock Transfer &
Trust Company, as trustee, previously filed as Exhibit 4.3
to the Companys Registration Statement on Form 8-A,
dated November 10, 1994, which is incorporated herein by
reference. |
|
4.2 |
|
|
Amended Rights Agreement, dated as of October 5, 2004,
previously filed as Exhibit 4.1 to the Companys
Current Report on Form 8-K, dated October 5, 2004,
which is incorporated herein by reference. |
|
10.7 |
|
|
Valeant Pharmaceuticals International 1992 Non-Qualified Stock
Plan, previously filed as Exhibit 10.57 to Valeant
Pharmaceuticals Internationals Annual Report on
Form 10-K for the year ended December 31, 1992, which
is incorporated herein by reference. |
|
10.8 |
|
|
Valeant Pharmaceuticals International 1994 Stock Option Plan,
previously filed as Exhibit 10.30 to the Registrants
Form 10-K for the year ended December 31, 1995, which
is incorporated herein by reference. |
89
|
|
|
|
|
Exhibit | |
|
|
Number | |
|
Description |
| |
|
|
|
10.9 |
|
|
Valeant Pharmaceuticals International 1998 Stock Option Plan,
previously filed as Exhibit 10.20 to the Registrants
Form 10-K for the year ended December 31, 1998, which
is incorporated herein by reference. |
|
10.10 |
|
|
Valeant Pharmaceuticals International 2003 Equity Incentive
Plan, previously filed as Annex B to the Proxy Statement
filed on Schedule 14A on April 25, 2003, which is
incorporated herein by reference. |
|
10.11 |
|
|
Exclusive License and Supply Agreement between Valeant
Pharmaceuticals International and Schering-Plough Ltd. dated
July 28, 1995 previously filed as Exhibit 10 to
Valeant Pharmaceuticals Internationals Amendment 3 to the
Quarterly Report on Form 10-Q for the quarter ended
September 30, 1996, which is incorporated herein by
reference. Portions of this exhibit have been omitted pursuant
to an application for confidential treatment pursuant to
Rule 24b-2 under the Securities and Exchange Act of 1934,
as amended. |
|
**10.13 |
|
|
Amendment to Exclusive License and Supply Agreement between
Valeant Pharmaceuticals International and Schering-Plough Ltd.,
previously filed as exhibit 10.32 to Valeant
Pharmaceuticals Internationals Annual Report on
Form 10-K for the year ended December 31, 2000, as
amended by Form 10-K/ A, which is incorporated herein by
reference. |
|
**10.14 |
|
|
Amendment to Exclusive License and Supply Agreement between
Valeant Pharmaceuticals International and Schering-Plough Ltd.
Dated July 16, 1998, previously filed as exhibit 10.33
to Valeant Pharmaceuticals Internationals Annual Report on
Form 10-K for the year ended December 31, 2000,
as amended by Form 10-K/ A, which is incorporated
herein by reference. |
|
**10.15 |
|
|
Agreement among Schering Corporation, Valeant Pharmaceuticals
International and Ribapharm Inc. dated as of November 14,
2000, previously filed as exhibit 10.34 to Valeant
Pharmaceuticals Internationals Annual Report on
Form 10-K for the year ended December 31, 2000, as
amended by Form 10-K/ A, which is incorporated herein by
reference. |
|
**10.16 |
|
|
Agreement among Valeant Pharmaceuticals International, Ribapharm
Inc., Hoffmann-La Roche, and F. Hoffmann-La Roche Ltd,
dated January 3, 2003, previously filed as
Exhibit 10.19 to Valeant Pharmaceuticals
Internationals Annual Report on Form 10-K for the
year ended December 31, 2002, which is incorporated herein
by reference. |
|
10.17 |
|
|
Indenture, dated as of December 12, 2003, among Valeant
Pharmaceuticals International as issuer, Ribapharm Inc. as
co-obligor and The Bank of New York as Trustee, previously filed
as Exhibit 4.1 to Valeant Pharmaceuticals International,
Registration Statement No. 333-112906 on Form S-4 and
incorporated herein by reference. |
|
10.18 |
|
|
Form of 7.0% Senior Notes due 2011, previously filed as
Exhibit A-1 to Exhibit 4.1 to Valeant Pharmaceuticals
Internationals Registration Statement No. 333-112906
on Form S-4 and incorporated herein by reference. |
|
10.19 |
|
|
Registration Rights Agreement, dated December 12, 2003,
between Valeant Pharmaceuticals, International and Ribapharm
Inc., on the one hand, and Bear Stearns & Co. on the
other hand, previously filed as Exhibit 4.3 to Valeant
Pharmaceuticals Internationals Registration Statement
No. 333-112906 on Form S-4 and incorporated herein by
reference. |
|
10.20 |
|
|
Indenture, dated as of November 19, 2003, among Valeant
Pharmaceuticals International as issuer, Ribapharm Inc. as
co-obligor and The Bank of New York as Trustee, previously filed
as to Exhibit 4.1 to our Current Report on Form 8-K
dated November 25, 2003 and incorporated by reference. |
|
10.21 |
|
|
Form of 3.0% Convertible Subordinated Notes due 2010,
previously filed as Exhibit A-1 to Exhibit 4.1 to our
Current Report on Form 8-K dated November 25, 2003 and
incorporated herein by reference. |
|
10.22 |
|
|
Form of 4.0% Convertible Subordinated Notes due 2013,
previously filed as Exhibit A-2 to Exhibit 4.1 to our
Current Report on Form 8-K dated November 25, 2003 and
incorporated herein by reference. |
90
|
|
|
|
|
Exhibit | |
|
|
Number | |
|
Description |
| |
|
|
|
10.23 |
|
|
Registration Rights Agreement, dated November 19, 2003,
between Valeant Pharmaceuticals, International and Ribapharm
Inc., on the one hand, and Banc of America Securities LLC and
Goldman Sachs & Co. on the other hand, previously filed
as to Exhibit 10.26 to our Current Report on Form 8-K
dated November 25, 2003 and incorporated by reference. |
|
10.24 |
|
|
Amended and Restated Certificate of Incorporation of Registrant,
previously filed as Exhibit 3.1 to Registration
Statement 33-84534 on Form S-4, which is incorporated
herein by reference, as amended by the Certificate of Merger,
dated November 10, 1994, of ICN Pharmaceuticals, Inc., SPI
Pharmaceuticals, Inc. and Viratek, Inc. with and into ICN Merger
Corp. previously filed as Exhibit 4.1 to Registration
Statement No. 333-08179 on Form S-3, which is
incorporated herein by reference. |
|
10.25 |
|
|
Valeant Pharmaceuticals International 2003 Equity Incentive
Plan, previously filed as Annex B to the Proxy Statement
filed on Schedule 14A on April 25, 2003, which is
incorporated herein by reference. |
|
10.26 |
|
|
Valeant Pharmaceuticals International 2003 Employee Stock
Purchase Plan, previously filed as Annex C to the Proxy
Statement filed on Schedule 14A on April 25, 2003,
which is incorporated herein by reference. |
|
10.28 |
|
|
Agreement between Valeant Pharmaceuticals International and Bary
G. Bailey, dated October 22, 2002, previously filed as
exhibit 10.21 to Valeant Pharmaceuticals
Internationals Annual Report on Form 10-K for the
year ended December 31, 2002, as amended by Form 10-K/
A, which is incorporated herein by reference. |
|
10.29 |
|
|
Agreement between Valeant Pharmaceuticals International and
Timothy C. Tyson, dated October 24, 2002, previously filed
as exhibit 10.22 to Valeant Pharmaceuticals
Internationals Annual Report on Form 10-K for the
year ended December 31, 2002, as amended by Form 10-K/
A, which is incorporated herein by reference. |
|
10.30 |
|
|
Agreement between Valeant Pharmaceuticals International and
Robert W. OLeary, dated November 4, 2002, amended and
restated on October 2, 2003, previously filed as
exhibit 10.30 to Valeant Pharmaceuticals
Internationals Annual Report on Form 10-K for
the year ended December 31, 2003, which is incorporated
herein by reference. |
|
10.31 |
|
|
Agreement between Valeant Pharmaceuticals International and
Eileen Pruette, dated March 3, 2003, previously filed as
exhibit 10.31 to Valeant Pharmaceuticals
Internationals Annual Report on Form 10-K for the
year ended December 31, 2003, which is incorporated herein
by reference. |
|
10.32 |
|
|
Agreement and plan of merger between Valeant Pharmaceuticals
International and Xcel Pharmaceuticals, Inc., previously filed
as Exhibit 99.1 to our Current Report on Form 8-K
dated February 1, 2005, which is incorporated herein by
reference. |
|
10.33 |
|
|
Valeant Pharmaceuticals International Executive Incentive Plan,
previously filed as Exhibit 10.1 to our Current Report on
Form 8-K dated February 22, 2005, which is
incorporated herein by reference. |
|
21. |
|
|
Subsidiaries of the Registrant. |
|
23. |
|
|
Consent of PricewaterhouseCoopers LLP. |
|
31.1 |
|
|
Certification of Chief Executive Officer pursuant to
Rule 13a-14(a) under the Exchange Act and Section 302
of the Sarbanes-Oxley Act of 2002. |
|
31.2 |
|
|
Certification of Chief Financial Officer pursuant to
Rule 13a-14(a) under the Exchange Act and Section 302
of the Sarbanes-Oxley Act of 2002. |
|
32.1 |
|
|
Certification of Chief Executive Officer and Chief Financial
Officer of Periodic Financial Reports pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002,
18 U.S.C. § 1350 |
|
|
* |
None of the other indebtedness of the Registrant exceeds 10% of
its total consolidated assets. The Registrant will furnish
copies of the instruments relating to such other indebtedness
upon request. |
|
** |
Portions of this exhibit have been omitted pursuant to a request
for confidential treatment. |
|
|
|
Management contract or compensatory plan or arrangement. |
91
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.
|
|
|
Valeant Pharmaceuticals
International
|
|
|
|
|
|
Timothy C. Tyson
|
|
President and Chief Executive Officer |
Date: March 16, 2005
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 and in the capacities and on the
dates indicated.
|
|
|
|
|
|
|
Name |
|
Title |
|
Date |
|
|
|
|
|
|
/s/ Timothy C. Tyson
Timothy
C. Tyson |
|
President and Chief Executive Officer (Principal Executive
Officer) |
|
Date: March 16, 2005 |
|
/s/ Bary G. Bailey
Bary
G. Bailey |
|
Executive Vice President and Chief Financial Officer (Principal
Financial Officer) |
|
Date: March 16, 2005 |
|
/s/ Robert W.
OLeary
Robert
W. OLeary |
|
Chairman of the Board |
|
Date: March 16, 2005 |
|
/s/ Edward A. Burkhardt
Edward
A. Burkhardt |
|
Director |
|
Date: March 16, 2005 |
|
/s/ Richard H. Koppes
Richard
H. Koppes |
|
Director |
|
Date: March 16, 2005 |
|
/s/ Lawrence N.
Kugelman
Lawrence
N. Kugelman |
|
Director |
|
Date: March 16, 2005 |
|
/s/ Elaine Ullian
Elaine
Ullian |
|
Director |
|
Date: March 16, 2005 |
|
/s/ Theo Melas-Kyriazi
Theo
Melas-Kyriazi |
|
Director |
|
Date: March 16, 2005 |
|
/s/ Randy H. Thurman
Randy
H. Thurman |
|
Director |
|
Date: March 16, 2005 |
|
/s/ Robert A. Ingram
Robert
A. Ingram |
|
Director |
|
Date: March 16, 2005 |
92
EXHIBIT INDEX
|
|
|
|
|
Exhibit | |
|
|
Number | |
|
Description |
| |
|
|
|
3.1 |
|
|
Restated Certificate of Incorporation, as amended to date,
previously filed as Exhibit 3.1 to Valeant Pharmaceuticals
Internationals Form 10-Q for the quarter ended
September 30, 2003, which is incorporated herein by
reference. |
|
3.2 |
|
|
Bylaws of the Registrant previously filed as Exhibit 3.2 to
Registration Statement No. 33-84534 on Form S-4, which
is incorporated herein by reference. |
|
4.1 |
|
|
Form of Rights Agreement, dated as of November 2, 1994,
between the Registrant and American Stock Transfer &
Trust Company, as trustee, previously filed as Exhibit 4.3
to the Companys Registration Statement on Form 8-A,
dated November 10, 1994, which is incorporated herein by
reference. |
|
4.2 |
|
|
Amended Rights Agreement, dated as of October 5, 2004,
previously filed as Exhibit 4.1 to the Companys
Current Report on Form 8-K, dated October 5, 2004,
which is incorporated herein by reference. |
|
10.7 |
|
|
Valeant Pharmaceuticals International 1992 Non-Qualified Stock
Plan, previously filed as Exhibit 10.57 to Valeant
Pharmaceuticals Internationals Annual Report on
Form 10-K for the year ended December 31, 1992, which
is incorporated herein by reference. |
|
10.8 |
|
|
Valeant Pharmaceuticals International 1994 Stock Option Plan,
previously filed as Exhibit 10.30 to the Registrants
Form 10-K for the year ended December 31, 1995, which
is incorporated herein by reference. |
|
10.9 |
|
|
Valeant Pharmaceuticals International 1998 Stock Option Plan,
previously filed as Exhibit 10.20 to the Registrants
Form 10-K for the year ended December 31, 1998, which
is incorporated herein by reference. |
|
10.10 |
|
|
Valeant Pharmaceuticals International 2003 Equity Incentive
Plan, previously filed as Annex B to the Proxy Statement
filed on Schedule 14A on April 25, 2003, which is
incorporated herein by reference. |
|
10.11 |
|
|
Exclusive License and Supply Agreement between Valeant
Pharmaceuticals International and Schering-Plough Ltd. dated
July 28, 1995 previously filed as Exhibit 10 to
Valeant Pharmaceuticals Internationals Amendment 3 to the
Quarterly Report on Form 10-Q for the quarter ended
September 30, 1996, which is incorporated herein by
reference. Portions of this exhibit have been omitted pursuant
to an application for confidential treatment pursuant to
Rule 24b-2 under the Securities and Exchange Act of 1934,
as amended. |
|
**10.13 |
|
|
Amendment to Exclusive License and Supply Agreement between
Valeant Pharmaceuticals International and Schering-Plough Ltd.,
previously filed as exhibit 10.32 to Valeant
Pharmaceuticals Internationals Annual Report on
Form 10-K for the year ended December 31, 2000, as
amended by Form 10-K/A, which is incorporated herein by
reference. |
|
**10.14 |
|
|
Amendment to Exclusive License and Supply Agreement between
Valeant Pharmaceuticals International and Schering-Plough Ltd.
Dated July 16, 1998, previously filed as exhibit 10.33
to Valeant Pharmaceuticals Internationals Annual Report on
Form 10-K for the year ended December 31, 2000, as
amended by Form 10-K/A, which is incorporated herein by
reference. |
|
**10.15 |
|
|
Agreement among Schering Corporation, Valeant Pharmaceuticals
International and Ribapharm Inc. dated as of November 14,
2000, previously filed as exhibit 10.34 to Valeant
Pharmaceuticals Internationals Annual Report on
Form 10-K for the year ended December 31, 2000, as
amended by Form 10-K/A, which is incorporated herein by
reference. |
|
**10.16 |
|
|
Agreement among Valeant Pharmaceuticals International, Ribapharm
Inc., Hoffmann-La Roche, and F. Hoffmann-La Roche Ltd,
dated January 3, 2003, previously filed as
Exhibit 10.19 to Valeant Pharmaceuticals
Internationals Annual Report on Form 10-K for the
year ended December 31, 2002, which is incorporated herein
by reference. |
|
10.17 |
|
|
Indenture, dated as of December 12, 2003, among Valeant
Pharmaceuticals International as issuer, Ribapharm Inc. as
co-obligor and The Bank of New York as Trustee, previously filed
as Exhibit 4.1 to Valeant Pharmaceuticals International,
Registration Statement No. 333-112906 on Form S-4 and
incorporated herein by reference. |
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Exhibit | |
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Number | |
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Description |
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10.18 |
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Form of 7.0% Senior Notes due 2011, previously filed as
Exhibit A-1 to Exhibit 4.1 to Valeant Pharmaceuticals
Internationals Registration Statement No. 333-112906
on Form S-4 and incorporated herein by reference. |
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10.19 |
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Registration Rights Agreement, dated December 12, 2003,
between Valeant Pharmaceuticals, International and Ribapharm
Inc., on the one hand, and Bear Stearns & Co. on the
other hand, previously filed as Exhibit 4.3 to Valeant
Pharmaceuticals Internationals Registration Statement
No. 333-112906 on Form S-4 and incorporated herein by
reference. |
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10.20 |
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Indenture, dated as of November 19, 2003, among Valeant
Pharmaceuticals International as issuer, Ribapharm Inc. as
co-obligor and The Bank of New York as Trustee, previously filed
as to Exhibit 4.1 to our Current Report on Form 8-K
dated November 25, 2003 and incorporated by reference. |
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10.21 |
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Form of 3.0% Convertible Subordinated Notes due 2010,
previously filed as Exhibit A-1 to Exhibit 4.1 to our
Current Report on Form 8-K dated November 25, 2003 and
incorporated herein by reference. |
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10.22 |
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Form of 4.0% Convertible Subordinated Notes due 2013,
previously filed as Exhibit A-2 to Exhibit 4.1 to our
Current Report on Form 8-K dated November 25, 2003 and
incorporated herein by reference. |
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10.23 |
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Registration Rights Agreement, dated November 19, 2003,
between Valeant Pharmaceuticals, International and Ribapharm
Inc., on the one hand, and Banc of America Securities LLC and
Goldman Sachs & Co. on the other hand, previously filed
as to Exhibit 10.26 to our Current Report on Form 8-K
dated November 25, 2003 and incorporated by reference. |
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10.24 |
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Amended and Restated Certificate of Incorporation of Registrant,
previously filed as Exhibit 3.1 to Registration
Statement 33-84534 on Form S-4, which is incorporated
herein by reference, as amended by the Certificate of Merger,
dated November 10, 1994, of ICN Pharmaceuticals, Inc., SPI
Pharmaceuticals, Inc. and Viratek, Inc. with and into ICN Merger
Corp. previously filed as Exhibit 4.1 to Registration
Statement No. 333-08179 on Form S-3, which is
incorporated herein by reference. |
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10.25 |
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Valeant Pharmaceuticals International 2003 Equity Incentive
Plan, previously filed as Annex B to the Proxy Statement
filed on Schedule 14A on April 25, 2003, which is
incorporated herein by reference. |
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10.26 |
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Valeant Pharmaceuticals International 2003 Employee Stock
Purchase Plan, previously filed as Annex C to the Proxy
Statement filed on Schedule 14A on April 25, 2003,
which is incorporated herein by reference. |
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10.28 |
|
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Agreement between Valeant Pharmaceuticals International and Bary
G. Bailey, dated October 22, 2002, previously filed as
exhibit 10.21 to Valeant Pharmaceuticals
Internationals Annual Report on Form 10-K for the
year ended December 31, 2002, as amended by
Form 10-K/A, which is incorporated herein by reference. |
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10.29 |
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Agreement between Valeant Pharmaceuticals International and
Timothy C. Tyson, dated October 24, 2002, previously filed
as exhibit 10.22 to Valeant Pharmaceuticals
Internationals Annual Report on Form 10-K for the
year ended December 31, 2002, as amended by
Form 10-K/A, which is incorporated herein by reference. |
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10.30 |
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Agreement between Valeant Pharmaceuticals International and
Robert W. OLeary, dated November 4, 2002, amended and
restated on October 2, 2003, previously filed as
exhibit 10.30 to Valeant Pharmaceuticals
Internationals Annual Report on Form 10-K for the
year ended December 31, 2003, which is incorporated herein
by reference. |
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10.31 |
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Agreement between Valeant Pharmaceuticals International and
Eileen Pruette, dated March 3, 2003, previously filed as
exhibit 10.31 to Valeant Pharmaceuticals
Internationals Annual Report on Form 10-K for the
year ended December 31, 2003, which is incorporated herein
by reference. |
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10.32 |
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Agreement and plan of merger between Valeant Pharmaceuticals
International and Xcel Pharmaceuticals, Inc., previously filed
as Exhibit 99.1 to our Current Report on Form 8-K
dated February 1, 2005, which is incorporated herein by
reference. |
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10.33 |
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Valeant Pharmaceuticals International Executive Incentive Plan,
previously filed as Exhibit 10.1 to our Current Report on
Form 8-K dated February 22, 2005, which is
incorporated herein by reference. |
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Exhibit | |
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Number | |
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Description |
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21. |
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Subsidiaries of the Registrant. |
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23. |
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Consent of PricewaterhouseCoopers LLP. |
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31.1 |
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Certification of Chief Executive Officer pursuant to
Rule 13a-14(a) under the Exchange Act and Section 302
of the Sarbanes-Oxley Act of 2002. |
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31.2 |
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Certification of Chief Financial Officer pursuant to
Rule 13a-14(a) under the Exchange Act and Section 302
of the Sarbanes-Oxley Act of 2002. |
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32.1 |
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Certification of Chief Executive Officer and Chief Financial
Officer of Periodic Financial Reports pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002,
18 U.S.C. § 1350 |
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* |
None of the other indebtedness of the Registrant exceeds 10% of
its total consolidated assets. The Registrant will furnish
copies of the instruments relating to such other indebtedness
upon request. |
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** |
Portions of this exhibit have been omitted pursuant to a request
for confidential treatment. |
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Management contract or compensatory plan or arrangement. |