10-K
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-K
|
|
|
þ |
|
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the Fiscal Year Ended December 31, 2007
OR
|
|
|
o |
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 0-12957
Enzon Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
|
|
|
Delaware
|
|
22-2372868 |
(State or other jurisdiction of incorporation or organization)
|
|
(I.R.S. Employer Identification No.) |
|
|
|
685 Route 202/206, Bridgewater, New Jersey
|
|
08807 |
(Address of principal executive offices)
|
|
(Zip Code) |
Registrants telephone number, including area code: (908) 541-8600
Securities registered pursuant to Section 12(b) of the Act:
|
|
|
Title of Class
|
|
Name of Exchange on Which Registered |
|
|
|
|
|
|
Common Stock, $0.01 par value;
|
|
NASDAQ Global Market |
Preferred Stock Purchase Rights |
|
|
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of
the Securities Act. o Yes þ No
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or
Section 15(d) of the Exchange Act. o Yes
þ No
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Exchange Act of 1934 during the preceding 12 months (or for such shorter
period that the registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
þ Yes o No
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 a large accelerated filer, an accelerated filer,
a non-accelerated filer, or a smaller reporting company. See the definitions of large accelerated filer,
accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
|
|
|
|
|
|
|
Large accelerated filer o
|
|
Accelerated filer
þ
|
|
Non-accelerated filer o
|
|
Smaller reporting company o |
|
|
|
|
(Do not check if a smaller reporting company) |
|
|
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). o Yes þ No
The aggregate market value of the Common Stock, par value $.01 per share, held by non-affiliates of
the registrant was approximately $345,966,000 as of June 29, 2007, based upon the closing sale
price on the Nasdaq Stock Market of $7.85 reported for such date. Shares of common stock held by
each officer and director and by each person who owns 10% or more of the outstanding common stock
have been excluded in that such shares may be deemed to be affiliate shares. This determination of
affiliate status is not necessarily a conclusive determination for other purposes.
There were 44,322,923 shares of the registrants common stock issued and outstanding as of February 27,
2008.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the registrants definitive Proxy Statement for the 2008 Annual Meeting of Stockholders
to be filed with the Commission not later than 120 days after the close of the registrants fiscal
year, have been incorporated by reference, in whole or in part, into Part III, Items 10, 11, 12, 13
and 14 of this Annual Report on Form 10-K.
ENZON PHARMACEUTICALS, INC.
2007 Form 10-K Annual Report
TABLE OF CONTENTS
2
Oncaspar®, Abelcet®, Adagen®, and SCA® are our
registered trademarks. Other trademarks and trade names used in this report are the property of
their respective owners.
This Annual Report contains forward-looking statements, which can be identified by the use of
forward-looking terminology such as believes, expects, may, will, should, potential or
anticipates or the negative thereof, or other variations thereof, or comparable terminology, or
by discussions of strategy. No assurance can be given that the future results covered by the
forward-looking statements will be achieved. The matters set forth in Item 1A. Risk Factors
constitute cautionary statements identifying important factors with respect to such forward-looking
statements, including certain risks and uncertainties that could cause actual results to vary
materially from the future results indicated in such forward-looking statements. Other factors
could also cause actual results to vary materially from the future results indicated in such
forward-looking statements. All information in this Annual Report on Form 10-K is as of February
29, 2008, unless otherwise indicated. The Company does not intend to update this information to
reflect events after the date of this report.
We maintain a website at www.enzon.com to provide information to the general public
and our stockholders on our products, resources and services along with general information on
Enzon and its management, career opportunities, financial results and press releases. Copies of
our most recent Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q and our other
reports filed with the Securities and Exchange Commission, or the SEC, can be obtained, free of
charge as soon as reasonably practicable after such material is electronically filed with, or
furnished to the SEC, from our Investor Relations Department by calling 908-541-8777, through an
e-mail request to investor@enzon.com, through the SECs website by clicking the SEC Filings link
from the Investors Info page on our website at
www.enzon.com or directly from the SECs website at
www.sec.gov. Our website and the information contained therein or connected thereto are
not intended to be incorporated into this Annual Report on Form 10-K.
3
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
FORM 10-K
ENZON PHARMACEUTICALS, INC.
PART I
ITEM 1. BUSINESS
GENERAL
We are a biopharmaceutical company dedicated to the development, manufacturing and
commercialization of important medicines for patients with cancer and other life-threatening
conditions. We have a portfolio of four marketed products,
Oncaspar®,
DepoCyt®,
Abelcet® and Adagen®. Our drug development programs utilize several
cutting-edge approaches, including our industry-leading PEGylation technology platform used to
create product candidates with benefits such as reduced dosing frequency and less toxicity. Our
PEGylation technology was used to develop two of our products, Oncaspar and Adagen, and has created
a royalty revenue stream from licensing partnerships for other products developed using the
technology. We continue to develop and utilize our Customized Linker TechnologyTM
PEGylation platform that uses linkers designed to release compounds at a controlled rate. We also
engage in contract manufacturing for several pharmaceutical companies to broaden our revenue base.
STRATEGY
We continue to pursue the comprehensive long-term strategic plan we developed in 2005. This
plan was designed to strengthen our business, build long-term value, and attain our goal of
becoming a premier, novel, and fully-integrated biopharmaceutical company with a focus in cancer
and other life-threatening diseases. To this end, we are executing a strategy that focuses on the
following three phases of corporate priorities for the next several years: (i) investing in our
extensive infrastructure that spans research, development, manufacturing, and sales and marketing,
(ii) improving our organizational efficiencies and (iii) becoming a recognized leader in oncology
and adjacent therapeutic areas.
Our strategy revolves around the following key imperatives:
Investing to maximize the potential of our marketed products. We have placed a significant
effort behind improving our top line performance. We are selectively investing in our
marketed brands to optimize and broaden their commercial potential. These initiatives
include effective market research, life cycle management plans, post-marketing clinical
programs, and other new programs to differentiate and extend the utility of our products.
Focusing on innovation. We are cultivating a renewed organizational commitment to innovation
by (i) investing in our technological base, (ii) growing our intellectual property estate,
and (iii) building a novel research and development pipeline of projects that are
strategically focused with promising pathways to regulatory approval. We are committed to
making targeted, disciplined investments in areas where we believe we can make a unique
contribution and achieve differentiation. For instance, we have extensive know-how and a
demonstrated track record in PEGylation, including our Customized Linker Technology
platform. PEG is a proven means of enabling or enhancing the performance of pharmaceuticals
with delivery limitations. We are committed to further evolving the potential of this
technology and bringing new PEG product development opportunities forward, both through
proprietary and externally-sourced programs.
Maximizing the return on our asset base. We are focused on leveraging our internal resources
and infrastructure as a means of broadening our revenue base, improving our operational
efficiencies, and generating value. Over the past three years, we have added personnel with
significant experience and talent throughout our business and strengthened our
cross-functional infrastructure.
4
Our management team has extensive experience in the
pharmaceutical industry, particularly in the development and commercialization of oncology
products. In addition, we will seek to increase our co-development and contract
manufacturing by leveraging our PEGylation technology platform that
has broad clinical utility in a wide array of therapeutic areas and our manufacturing
facility that has the capability of formulating complex injectable pharmaceutical products.
Maintaining a high-performance, value-focused corporate culture. We recognize that the
successful execution of our long-term plan begins with ensuring that our employees understand
the stated goals of the organization and are accountable for making meaningful contributions
to our corporate results. We are cultivating a performance-driven culture, focused on
delivering on our promises. We have also placed an increased emphasis on measuring and
rewarding performance throughout the organization.
Our key initiatives to advance these priorities include:
|
|
|
To further our goal of establishing a successful franchise of cancer therapeutics, we
are executing on a number of programs to optimize the value of our currently marketed
cancer products, Oncaspar and DepoCyt. We continue to see adoption of Oncaspar in
pediatric and adult cooperative group protocols. In 2007, DepoCyt received full approval
from the U.S. Food and Drug Administration (FDA) for lymphomatous meningitis. |
|
|
|
|
Lifecycle management is being deployed as a critical organizational practice with plans
underway for all of our marketed brands. We believe lifecycle management is an essential
tool for building sustainability and maximizing value for our products. We continue to
evaluate several new means of driving sustainable commercial success for our marketed
products, including new therapeutic areas, modes of administration, manufacturing process
and supply improvements and delivery mechanisms. Our management has aligned all of our
core functions, from research through commercialization, on maximizing the value of our
products through integrated lifecycle management programs. |
|
|
|
|
We continue to rebuild our research and development pipeline. In 2007, we advanced our
PEG-SN38 and our HIF-1 alpha antagonist into Phase I human clinical trials. We continue
to enroll our recombinant human Mannose-binding Lectin (rhMBL) Phase I/II studies. |
|
|
|
|
We continue to identify opportunities in our contract manufacturing business to (i)
foster new contract manufacturing partnerships, (ii) enhance our current processes, (iii)
broaden our manufacturing expertise and infrastructure, and (iv) expand the utilization of
our finish and fill capabilities. |
|
|
|
|
During 2007, we significantly improved our financial condition by successfully
monetizing 25% of our future royalties on the sales of PEG-INTRON for proceeds of $92.5
million. The majority of the net proceeds were placed in a restricted account for the
purpose of eliminating the outstanding 4.5% convertible subordinated
notes due July 1, 2008. |
PRODUCTS SEGMENT
Our Products segment includes the manufacturing, marketing and selling of pharmaceutical
products for patients with cancer and other life-threatening diseases. We currently sell four
therapeutics products, Oncaspar, DepoCyt, Abelcet, and Adagen, through our hospital and specialty
U.S. sales force that calls upon specialists in oncology, hematology, infectious disease, and other
critical care disciplines.
5
1) Oncaspar
Oncaspar is a PEG-enhanced version of a naturally occurring enzyme called L-asparaginase
derived from E. coli. Oncaspar is used in conjunction with other chemotherapeutics to treat
patients with acute lymphoblastic leukemia (ALL). We developed Oncaspar internally and received
U.S. marketing approval from the FDA for Oncaspar in February 1994. We licensed rights to Oncaspar
for North America and most of the Asia/Pacific region to Rhone Poulenc Rorer, now part of
Sanofi-Aventis. In June 2002, we licensed back those rights from Sanofi-Aventis.
L-asparaginase is an enzyme that depletes the amino acid asparagine, which certain leukemic
cells are dependent upon for survival. Other companies market unmodified L-asparaginase for the
treatment of ALL. The therapeutic value of unmodified L-asparaginase is limited by its short
half-life, which requires frequent injections, and its propensity to cause a high incidence of
allergic reactions. We believe that Oncaspar offers significant therapeutic advantages over
unmodified L-asparaginase, namely a significantly increased half-life in blood allowing fewer
injections, and fewer allergic reactions.
In October 2005, we amended our license agreement with Sanofi-Aventis for Oncaspar. The
amendment became effective in January 2006 and includes a significant reduction in our royalty
rate, with a single-digit royalty percentage payable by us only on those aggregate annual sales of
Oncaspar in the U.S. and Canada that are in excess of $25.0 million. Under the amended agreement
we made an upfront cash payment of $35.0 million to Sanofi-Aventis in January 2006. We are
obligated to make royalty payments through June 30, 2014, at which time all of our royalty
obligations will cease.
Since December 2004, we have been focusing on a number of new clinical initiatives designed to
potentially expand the Oncaspar label beyond its current indications. Several key initiatives are
summarized below.
In November 2005, we received approval from the FDA for a labeling change for Oncaspar
allowing for administration via the intravenous route. Intravenous administration provides
clinicians with a treatment option that will potentially reduce the number of injections for
pediatric cancer patients who require Oncaspar in their treatment regimen. Previously, Oncaspars
administration was limited to intramuscular administration, which involves injecting the drug
directly into the muscle and is often painful to patients.
In July 2006, we announced that the FDA had approved our supplemental Biologics License
Application (sBLA) for Oncaspar for use as a component of a multi-agent chemotherapeutic regimen
for the first-line treatment of patients with ALL, which we had submitted in November 2005. The
FDA approved the new first-line indication for Oncaspar based on data from two studies conducted by
the Childrens Cancer Group (CCG), CCG-1962 and CCG-1991, with safety data from over 2,000
pediatric patients. The Childrens Cancer Group is now incorporated under the Childrens Oncology
Group (COG).
In 2006, we announced that we had initiated a phase 1 clinical trial of Oncaspar to assess its
safety and potential utility in the treatment of advanced solid tumors and lymphomas in combination
with Gemzar (gemcitabine HCl for injection). Recently, we reached dose-limiting toxicities in this
trial. We are analyzing the data to better understand whether the combination of Oncaspar and
Gemzar warrants further development in solid tumors and lymphoma.
In December 2006, we secured the supply of L-asparaginase, the raw material used in the
production of Oncaspar. We are investing in the improvement of the manufacturing processes and
pharmaceutical properties of Oncaspar. This investment will primarily occur over the next few
years.
We manufacture Oncaspar in the U.S.
6
2) DepoCyt
DepoCyt is an injectable chemotherapeutic agent approved for the treatment of patients with
lymphomatous meningitis. It is a sustained release formulation of the chemotherapeutic agent,
arabinoside cytarabine or ara-C. DepoCyt gradually releases cytarabine into the cerebral spinal
fluid (CSF) resulting in a significantly extended half-life, prolonging the exposure to the therapy
and allowing for more uniform CSF distribution. This extends the dosing interval to once every two
weeks, as compared to the standard twice-weekly intrathecal chemotherapy dosing of cytarabine. We
acquired the U.S. and Canadian rights to DepoCyt from Pacira Pharmaceuticals, Inc. (Pacira),
formerly SkyePharma, in December 2002.
Lymphomatous meningitis is a debilitating form of neoplastic meningitis, a complication of
cancer that is characterized by the spread of cancer to the central nervous system and the
formation of secondary tumors within the thin membranes surrounding the brain. Lymphomatous
meningitis can affect all levels of the central nervous system, including the cerebral hemispheres,
cranial nerves, and spinal cord. Symptoms can include numbness or weakness in the extremities,
pain, sensory loss, double-vision, loss of vision, hearing problems, and headaches. Lymphomatous
meningitis is often not recognized or diagnosed in clinical practice. Autopsy studies have found
higher rates of lymphomatous meningitis than those observed in clinical practice. These autopsy
studies suggest that 5% of all cancer patients will develop neoplastic meningitis during the course
of their illness.
In a randomized, multi-center trial of patients with lymphomatous meningitis, treated either
with 50 mg of DepoCyt administered every 2 weeks or standard intrathecal chemotherapy administered
twice a week, DepoCyt achieved a complete response rate of 41% compared with a complete response
rate of 6% for unencapsulated cytarabine. In this study, complete response was prospectively
defined as (i) conversion of positive to negative CSF cytology and (ii) the absence of neurologic
progression. DepoCyt also demonstrated an increase in the time to neurologic progression of 78.5
days for DepoCyt versus 42 days for unencapsulated cytarabine; however, there are no controlled
trials that demonstrate a clinical benefit resulting from this treatment, such as improvement in
disease-related symptoms, increased time to disease progression or increased survival.
DepoCyt was originally approved under the Accelerated Approval regulations of Subpart H of the
Federal Food, Drug and Cosmetic Act, intended to make promising products for life-threatening
diseases available to the market on the basis of preliminary evidence prior to formal demonstration
of patient benefit. After completing required post-approval trials for DepoCyt, in April 2007, the
FDA granted full approval of DepoCyt for treatment of patients with lymphomatous meningitis.
Our sales and marketing programs are structured to enhance the commercial value of DepoCyt by
expanding awareness of the symptoms and benefits of treating lymphomatous meningitis, and marketing
programs that focus on the positive product attributes of DepoCyt as compared to unencapsulated
cytarabine. We are also exploring the potential role of DepoCyt in other cancers that can spread
to the central nervous system.
DepoCyt is manufactured in the U.S. by Pacira.
3) Abelcet
Abelcet is a lipid complex formulation of amphotericin B used primarily in the hospital to
treat immuno-compromised patients with invasive fungal infections. It is indicated for the
treatment of invasive fungal infections in patients who are intolerant of conventional amphotericin
B therapy or for whom conventional amphotericin B therapy has failed. Abelcet provides patients
with the broad-spectrum efficacy of conventional amphotericin B, while providing significantly
lower kidney toxicity than amphotericin B.
7
We acquired the U.S. and Canadian rights to Abelcet from Elan Pharmaceuticals PLC (Elan) in
November 2002. As part of the acquisition, we also acquired the operating assets associated with
the development, manufacture, sales and marketing of Abelcet in the U.S. and Canada, including a
56,000 square foot manufacturing facility in Indianapolis, Indiana. In addition to U.S. and Canada
distribution rights, we also acquired the rights to develop and commercialize the product in Japan.
Invasive fungal infections are life-threatening, often affecting patients with compromised
immune systems, such as those undergoing treatment for cancer, recipients of organ or bone marrow
transplants or patients infected with the Human Immunodeficiency Virus (HIV). Invasive fungal
infections can be caused by a multitude of different fungal pathogens that attack the patients
weakened immune system. Effective treatment is critical and can mean the difference between life
and death, and often must be initiated even in the absence of a specific diagnosis.
Over the past 20 years, there has been an increase in severe fungal infections largely as a
result of advances in medical treatment, such as increasingly aggressive chemotherapy procedures,
advances in organ and bone marrow transplantation procedures, and an increase in the population of
immuno-compromised patients, namely transplant patients, patients with cancer undergoing
chemotherapy, and patients with HIV/AIDS. Immuno-compromised patients are at risk from a variety
of fungal infections that are normally combated by an individuals healthy immune system. For
these patients, such infections represent a major mortality risk.
Amphotericin B, the active ingredient in Abelcet, is a broad-spectrum polyene antifungal agent
that is believed to act by penetrating the cell wall of a fungus, thereby killing it. In its
conventional form, amphotericin B is particularly toxic to the kidneys, an adverse effect that
often restricts the amount of the drug that can be administered to a patient. While still
exhibiting residual nephrotoxicity, Abelcet is able to deliver therapeutic levels of amphotericin B
while significantly reducing the kidney toxicity associated with the conventional drug.
Since 2004, we have experienced increased competitive market conditions for Abelcet, primarily
due to the introduction of newer antifungal agents. We are addressing the competitive challenges
we are facing through numerous data-driven initiatives designed to stabilize sales of Abelcet.
We manufacture Abelcet in the U.S.
4) Adagen
Adagen is a PEGylated bovine adenosine deaminase enzyme (ADA) used to treat patients afflicted
with a type of Severe Combined Immunodeficiency Disease, or SCID, also known as the Bubble Boy
Disease, which is caused by the chronic deficiency of ADA. We received U.S. marketing approval
from the FDA for Adagen in March 1990. Adagen represents the first successful application of
enzyme replacement therapy for an inherited disease. SCID results in children being born without
fully functioning immune systems, leaving them susceptible to a wide range of infectious diseases.
Currently, the only regulatory approved alternative to Adagen treatment is a well-matched
bone marrow transplant. Injections of unmodified ADA are not effective because of its short
circulating life (less than 30 minutes) and the potential for immunogenic reactions to a
bovine-sourced enzyme. The attachment of PEG to ADA allows ADA to achieve its full therapeutic
effect by increasing its circulating life and masking the ADA to avoid immunogenic reactions.
We are required to maintain a permit from the U.S. Department of Agriculture (USDA) in order
to import ADA. This permit must be renewed on an annual basis. As of October 6, 2007, the USDA
issued a permit to us to import ADA through October 6, 2008.
8
We sell Adagen on a worldwide basis. We utilize independent distributors in certain
territories including the U.S., Europe and Australia. As of December 31, 2007, approximately 90
patients in 17 countries are receiving Adagen therapy. We believe some newborns with ADA-deficient
SCID go undiagnosed and we are therefore focusing our marketing efforts for Adagen on new patient
identification.
Like Oncaspar, we are investing in the improvement of the manufacturing processes,
pharmaceutical properties, and changing the raw material from a bovine-derived source to a
recombinant source for Adagen. This investment will primarily occur over the next few years.
We manufacture Adagen in the U.S.
ROYALTIES SEGMENT
An important source of our revenue is derived from royalties that we receive on sales of
marketed products that utilize our proprietary technology. Currently, we are receiving royalties
on three marketed products that are successfully utilizing our proprietary PEGylation platform,
namely PEG-INTRON, Pegasys, and Macugen, with PEG-INTRON being the largest source of our royalty
income.
|
|
|
|
|
PRODUCT |
|
INDICATION |
|
COMPANY |
PEG-INTRON (peginterferon
alfa-2b)
|
|
chronic hepatitis C
|
|
Schering-Plough Corporation |
|
|
|
|
|
Macugen (pegaptanib sodium
injection)
|
|
neovascular (wet)
age-related macular
degeneration
|
|
OSI Pharmaceuticals, Inc.
and Pfizer Inc. |
|
|
|
|
|
Pegasys (peginterferon alfa-2a)
|
|
hepatitis C
|
|
Hoffmann-La Roche |
PEG-INTRON is a PEG-enhanced version of Schering-Ploughs alpha interferon product,
INTRON® A, which is used both as a monotherapy and in combination with
REBETOL® (ribavirin) capsules for the treatment of chronic hepatitis C. Under our
license agreement with Schering-Plough, Schering-Plough holds an exclusive worldwide license to
PEG-INTRON. We continue to receive royalties on Schering-Ploughs worldwide sales of PEG-INTRON.
Schering-Plough is responsible for all manufacturing, marketing, and development activities for
PEG-INTRON. We designed PEG-INTRON to allow for less frequent dosing and to yield greater
efficacy, as compared to INTRON A. PEG-INTRON is marketed worldwide by Schering-Plough and its
affiliates. In December 2004, Schering-Ploughs subsidiary, Schering-Plough K.K., launched
PEG-INTRON and REBETOL combination therapy in Japan. At that time, PEG-INTRON and REBETOL was the
only PEGylated interferon-based combination therapy available in Japan, where an estimated one to
two million persons are chronically infected with hepatitis C. In January 2007, Hoffmann-La Roche
announced that it received approval for its competing PEGylated interferon-based combination
therapy, Copegus (ribavirin) plus Pegasys (peginterferon alfa-2a (40KD)), following fast-track
review by the Japanese regulatory agency.
In August 2007, we monetized 25% of our future royalties from the sales of PEG-INTRON for
$92.5 million in gross proceeds.
PEG-INTRON is being evaluated in a number of ongoing clinical studies:
|
1) |
|
IDEAL Study In January 2004, Schering-Plough began recruiting patients in the IDEAL
study, which directly compares PEG-INTRON in combination with REBETOL versus Pegasys in
combination with COPEGUS in 2,880 patients in the U.S. On January 14, 2008 Schering
Plough reported preliminary IDEAL Study Results which showed similar sustained response
rates between the two treatments, however fewer patients relapsed following the PEG-INTRON
Combination Therapy. |
|
|
2) |
|
COPILOT Study PEG-INTRON is being evaluated for use as long-term maintenance
monotherapy in cirrhotic patients who have failed previous treatment. |
9
|
3) |
|
ENDURE Study In January 2006, Schering-Plough announced that it was initiating a
large multinational clinical trial, to evaluate the use of low-dose PEG-INTRON maintenance
monotherapy in preventing or delaying hepatitis disease progression. |
|
|
4) |
|
PROTECT Study In May 2006, Schering-Plough announced the initiation of a large
multicenter clinical trial in the U.S. to evaluate the safety and efficacy of PEG-INTRON
and REBETOL combination therapy in liver transplant recipients with recurrent hepatitis C
virus infection. The trial is targeted to enroll 125 patients in the U.S. |
|
|
5) |
|
EPIC3 Study In October 2006, Schering-Plough reported data from EPIC3, a large
ongoing clinical study, showing that retreatment with PEG-INTRON and REBETOL combination
therapy can result in sustained virologic response in patients with chronic hepatitis C
who failed previous treatment with any alpha interferon-based combination therapy,
including peginterferon regimens. |
|
|
6) |
|
Schering-Plough Corporation announced on January 31, 2008, that the FDA accepted the
PEG-INTRON sBLA for review and has granted Priority Review status for the adjuvant
treatment of patients with Stage III melanoma. Based on this Priority Review status, the
FDA reviews the application with the goal of taking action within six months of the
sponsors submission of the sBLA. The application will be discussed by the FDA Oncology
Drugs Advisory Committee on March 12, 2008. PEG-INTRON was also filed with the EMEA in
Europe in the fall of 2007. |
|
|
7) |
|
Finally, PEG-INTRON is being evaluated in several investigator-sponsored trials as a
potential treatment for various cancers, including several earlier stage clinical trials
for other oncology indications. |
We have out-licensed our proprietary PEG and single chain antibody, or SCA, technologies on
our own and through agreements with Nektar Therapeutics, Inc. (Nektar) and Micromet AG (Micromet).
Effective January 2007, we terminated our agreement with Nektar. Under the original 2002
agreement, Nektar had the lead role in granting sublicenses for certain of our PEG patents and we
receive royalties on sales of any approved product for which a sublicense has been granted. While
we will continue to receive royalties on sales of products already on the market, or those for
which sublicenses were previously granted, Nektar will only have the right to grant any additional
sublicenses to a limited class of our PEG technology. We have the right to use or grant licenses
to all of our PEG technology for our own proprietary products or those we may develop with
co-commercialization partners. Currently, we are aware of five third-party products for which
Nektar has granted sublicenses to our PEG technology: Hoffmann-La Roches Pegasys; OSI
Pharmaceuticals (OSI) Macugen® (pegaptanib sodium injection); Cimzia (formerly CDP870), owned by
UCB, a Belgium-based biopharmaceutical company; Affymax and Takeda Pharmaceuticals Hematide and
an undisclosed product of Pfizers that is in early-stage clinical development. Pegasys is
currently being marketed for the treatment of hepatitis C and Macugen is currently being marketed
through a collaboration between OSI and Pfizer for the treatment of neovascular (wet) age-related
macular degeneration, an eye disease associated with aging that destroys central vision.
Cimzia is an anti-TNF-alpha PEGylated antibody fragment. A Biologics License Application
(BLA) was filed with the FDA for CIMZIA for the treatment of Crohns disease on February 28, 2006.
CIMZIA was approved in Switzerland for the treatment of Crohns disease in September 2007. The
European Medicines Agency adopted a negative opinion in the treatment of patients with Crohns
disease. UCB submitted an appeal requesting re-examination of the opinion. A decision is expected
during the first half of 2008. The Marketing Authorization Application was based on the pivotal
PRECiSE studies involving over 1,500 patients with Crohns disease. The US regulatory application
for the treatment of rheumatoid arthritis was submitted and accepted in January 2008. Filing in Europe is planned
for the first half of 2008. UCB completed a Phase II re-treatment study in psoriasis with patients
who had relapsed during the off-treatment period of the initial Phase II study. Results show that
the majority of the re-treated patients are able to recapture response and the re-treatment was
well tolerated.
Hematide is a synthetic peptide-based erythropoiesis-stimulating agent being evaluated by
Affymax and Takeda Pharmaceutical in two phase 2 clinical trials for the treatment of anemia
associated with chronic kidney disease and of anemic cancer patients undergoing chemotherapy. In
October 2007, Affymax announced that the first patient was dosed in the Phase 3 clinical program to
treat anemia in chronic renal failure patients.
We receive a royalty from medac Gmbh (medac), a private company based in Germany, on sales of
Oncaspar KH recorded by medac.
10
CONTRACT MANUFACTURING SEGMENT
We utilize a portion of our excess manufacturing capacity to provide contract manufacturing
services for a number of injectable products. Currently, we manufacture Abelcet for export and
MYOCET, both for Cephalon France SAS (Cephalon), and the injectable multivitamin MVI®
for Mayne Pharma Limited (Mayne), a division of Hospira, Inc., at our facility in Indianapolis,
Indiana. We entered into two new manufacturing agreements near the end of 2006. In our
manufacture of these products, we utilize complex manufacturing processes, such as single-and
dual-chamber vial filling and lipid complex formulations.
We are currently focusing on our contract manufacturing business as a means of further
leveraging our manufacturing expertise and improving our overall profit margins.
RESEARCH AND DEVELOPMENT
Our internal pharmaceutical drug development programs focus on the development of novel
compounds for the treatment of cancer and adjacent therapeutic areas where there is an unmet
medical need. We are building a proprietary research and development pipeline both through the
application of our proprietary technologies and through strategic agreements that provide access to
promising product development opportunities within our therapeutic focus.
Our PEGylation technology, particularly our Customized Linker Technology platform that
utilizes our releasable linkers has applicability for areas beyond oncology. Our research and
development activities may yield data that supports developing our proprietary compounds in certain
non-oncology applications. Our strategy is to utilize our PEGylation platform for internal
discovery and development programs first, and then explore additional opportunities for PEGylation
outside of the oncology market through strategic alliances. We offer potential partners
substantial know-how in the area of PEGylation and an experienced management team with extensive
experience in researching, developing, marketing and selling pharmaceutical products, particularly
for the treatment of cancer.
We seek new clinical products from internal and external sources. Our internal research and
development activities focus on applying our proprietary technologies, namely our PEGylation
expertise, to internal product candidates, and developing products accessed through licensing
transactions such as our agreements with NatImmune A/S and Santaris Pharma A/S (Santaris). We
obtained the exclusive worldwide rights, excluding the Nordic countries, from NatImmune to develop,
manufacture, market and sell recombinant human Mannose-binding Lectin rhMBL. Mannose-binding
Lectin (MBL) is a naturally occurring human plasma protein that plays a key role in the immune
systems first-line defense against infections. In July 2006, we entered into a global
collaboration with Santaris to co-develop and commercialize a series of innovative ribonucleic acid
(RNA) antagonists based on the LNA® (locked nucleic acid) technology. We have licensed
two preclinical development compounds, the HIF-1 alpha antagonist and the Survivin antagonist, and
have selected six additional proprietary RNA antagonist candidates, all to be directed against
novel oncology targets.
11
PROPRIETARY PRODUCTS IN DEVELOPMENT
ONCASPAR
We are currently exploring the potential expansion of Oncaspar within the acute lymphoblastic
leukemia setting, as well as in additional cancers where the L-asparaginase enzyme may play a role.
For instance, there are a number of preclinical studies indicating that asparagine depletion may
play an important role in treating other cancers, including pancreatic, ovarian, head and neck, and
certain sub-types of non-Hodgkins lymphoma. A number of new clinical initiatives exploring
asparagines role in these additional cancers are being evaluated.
In 2006, we announced that we had initiated a phase 1 clinical trial of Oncaspar to assess its
safety and potential utility in the treatment of advanced solid tumors and lymphomas in combination
with Gemzar (gemcitabine HCl for injection). Recently, we reached dose-limiting toxicities in this
trial. We are analyzing the data to better understand whether the combination of Oncaspar and
Gemzar warrants further development in solid tumors and lymphoma.
PEG-SN38
SN38 is the active metabolite of the cancer drug irinotecan, a chemotherapeutic pro-drug
marketed as Camptosar® (CPT-11) in the U.S. Camptosar is a validated topoisomerase I
inhibitor. Unmodified SN38 is insoluble and can only be used to treat cancer by administering the
pro-drug. A pro-drug is a compound that is converted into the active drug in the body. Only a
small percentage of the pro-drug is converted into SN38 in cancer cells and the unpredictability of
conversion and metabolism in each patient may result in a variable efficacy and safety profile.
Through the use of our PEGylation technology, we designed PEG-SN38 (EZN-2208), a PEGylated
conjugate of SN38, to offer therapeutic advantages over unmodified SN38 and existing therapies.
The PEGylated version allows for parenteral delivery, increased solubility, higher exposure, and
longer apparent half-life.
We presented preclinical data on PEG-SN38 at several major medical meetings during 2007.
According to the study:
|
|
|
PEG-SN38 demonstrated potent in vitro cytotoxicity against several human cancer cell
lines and anti-tumor activity in xenograft models of human breast, colorectal and
pancreatic cancers. |
|
|
|
|
Treatment with a single or multiple small doses of PEG-SN38 led to complete cures of
animals in the breast cancer model. |
|
|
|
|
In colorectal and pancreatic preclinical models, PEG-SN38 demonstrated significantly
better therapeutic efficacy, at their respective maximum tolerated doses and equivalent
dose levels, than CPT-11. |
|
|
|
|
In mice, PEG-SN38 provided a long circulation half-life and exposure to the parent
drug, SN38. |
|
|
|
|
Biodistribution data showed high and prolonged exposure of SN38 within tumors,
supporting the Enhanced Permeation and Retention (EPR) effect. |
|
|
|
|
PEG-SN38 demonstrated antitumor activity in xenograft models of non-Hodgkins
lymphoma. |
|
|
|
|
Treatment with PEG-SN38 resulted in tumor growth inhibition in animals
resistant to CPT-11 and outperformed CPT-11 when given as second-round therapy to animals
initially responding to CPT-11. |
The FDA approved the Investigational New Drug Application (IND) for PEG-SN38 in 2007 and we
opened two Phase I human clinical studies for patients with solid tumors and lymphoma, evaluating
different dosing schedules.
12
LOCKED NUCLEIC ACID (LNA) TECHNOLOGY-BASED PROGRAMS
In July 2006, we entered into a license and collaboration agreement with Santaris for up to
eight RNA antagonists which we intend to develop. We obtained rights worldwide, other than Europe,
to develop and commercialize RNA antagonists based on LNA technology directed against the HIF-1
alpha and Survivin RNA targets. Santaris will design and synthesize RNA antagonists directed
against up to six additional gene targets selected by us, and we will have the right to develop and
commercialize those antagonists worldwide other than Europe.
LNA Technology, developed by Santaris, is based on Locked Nucleic Acid, a proprietary
synthetic analog of RNA which is fixed in the shape adopted by RNA in helical conformation. When
incorporated into a short nucleic acid chain (both deoxyribonucleic acid, or DNA, and RNA are made
up of longer chains of natural nucleic acids), the presence of LNA
results in several potential therapeutic
advantages. Because LNA resembles RNA but is more stable,
LNA-containing drugs may have both very high
binding affinity for RNA and metabolic stability. Using the antisense principle to block the
function of specific RNAs within cells and tissues, such drugs may have enhanced potency and
specificity and may provide improved efficacy at lower doses than comparable drugs based on
alternative chemistry. As a result, RNA Antagonists comprised of LNA have been demonstrated to be
100 to 1,000 times more potent in vitro than conventional antisense
compounds and have the potential to
demonstrate comparable or similar efficacy in vivo to the siRNAs (small interfering RNAs)
published to date. In particular, they can be used to switch off the synthesis of harmful
proteins, thereby potentially altering disease outcomes in cancer or other serious disorders.
|
|
|
HIF-1 alpha (hypoxia-inducible factor 1 alpha) Antagonist The HIF-1 alpha antagonist
is a highly-visible, well-validated target in many cancer types, including common solid
tumors. HIF-1 alpha is a key regulator of a large number of genes important in cancer
biology, such as angiogenesis, cell proliferation, apoptosis, glucose metabolism and cell
invasion. HIF-1 alpha protein level is low in normal cells, but reaches high
intracellular concentrations in a variety of cancers and is strongly correlated with poor
prognosis and resistance to therapy. Drugs targeting HIF-1 alpha thus have the potential
to target multiple cancer processes. In January 2007 we announced that the FDA accepted
our IND for the HIF-1 alpha antagonist. In 2007, we opened two Phase I studies for
patients with solid tumors and lymphoma evaluating different dosing schedules for the
HIF-1 alpha antagonist. |
|
|
|
|
Survivin Antagonist Survivin plays a vital regulatory role in both apoptosis and cell
division. Survivin is heavily over-expressed in many cancers and in newly formed
endothelial cells engaged in angiogenesis but almost absent in normal adult differentiated
tissue. Resistance of cancer cells to radiotherapy and cytotoxic drugs (in particular
microtubule interfering taxanes) is strongly correlated with expression levels of
Survivin. Clinically, Survivin expression is associated with poor prognosis, increased
cancer recurrence and resistance to therapy. The Survivin antagonist is currently in
preclinical development. |
RECOMBINANT HUMAN MANNOSE-BINDING LECTIN
In September 2005, we acquired the exclusive worldwide rights, excluding the Nordic countries,
to rhMBL, a protein therapeutic being developed for the prevention and treatment of severe
infections in individuals with deficient levels of MBL. MBL binds to a wide range of invading
organisms including bacteria, fungi, viruses, and parasites and activates the lectin pathway of the
complement system, an important defense mechanism of the immune system. Numerous studies have
found a strong correlation between MBL deficiency and an increased susceptibility to infections in
patients with a suppressed immune system, such as cancer patients undergoing treatment with
chemotherapy. A number of publications have highlighted a strong correlation between MBL levels
and the morbidity associated with severe infections. These studies were in a broad spectrum of
diseases, including cancer and immuno-compromised disorders in both adult and pediatric
populations.
13
In December 2004, NatImmune completed Phase I clinical trials that evaluated 28 patients for
the safety and pharmacokinetic profile of single- and multi-dose intravenous administration of
rhMBL. Results from the Phase I trials demonstrated that rhMBL replacement therapy is safe and has
an attractive
pharmacokinetic profile. NatImmune has also completed a prospective correlation study of 255
hematological cancer patients that documented that MBL-deficient patients have a significantly
higher risk of severe infections following chemotherapy compared to patients with sufficient MBL
levels.
Given the broad therapeutic potential of rhMBL, we are evaluating several potential lead
indications for this compound. To date, the FDA has accepted both of the INDs we submitted one
for the prevention and treatment of severe infections in cancer patients; and one for those who
have undergone liver transplant surgery. Phase I/II human clinical development of rhMBL for the
prevention and treatment of severe infections in patients with low levels of MBL undergoing liver
transplant and multiple myeloma is currently underway.
OTHER RESEARCH AND DEVELOPMENT PROGRAMS
We are conducting preclinical studies with respect to a number of PEG-enhanced compounds while
simultaneously seeking new opportunities to apply our PEG technology to develop and commercialize
improved versions of therapeutics of known efficacy that lack the features of a useful or effective
therapeutic. Our proprietary PEG platform has broad applicability to a variety of biologic
therapeutics, including proteins, peptides, enzymes, and oligonucleotides, as well as small
molecules. We are exploring the role of a PEG novel linker system for targeted delivery of LNA.
PEGylation TECHNOLOGY
Since our inception in 1981, our core expertise has been in engineering improved versions of
injectable therapeutics through the chemical attachment of polyethylene glycol or PEG. In some
cases, PEGylation can render a compound therapeutically effective, where the unmodified form had
only limited clinical utility. Currently, there are five marketed biologic products that utilize
our proprietary PEG platform, two of which we market, Adagen and Oncaspar, and three for which we
receive royalties, PEG-INTRON, Pegasys, and Macugen.
Specific advantages of PEG include: (i) increased efficacy, (ii) reduced dosing frequency,
(iii) reduced toxicity and immunogenicity, (iv) increased drug stability, and (v) enhanced drug
solubility. In addition, our PEG platform is further distinguished by (i) demonstrated safety and
tolerability, (ii) established clinical and commercial benefits, (iii) broad applicability to a
variety of macromolecules or biologic therapeutics, including proteins, peptides, enzymes, and
oligonucleotides, as well as small molecules, and (iv) proven commercial scale-up capability.
We continue to develop our Customized Linker Technology, which utilizes linkers designed to
release the native molecule at a controlled rate. The customized linkers expand the utility of our
existing PEGylation technology. This technology offers a choice of releasable or permanent
linkages to match each drugs requirements. It improves the pharmacokinetic and pharmacodynamic
profile of a drug.
We have also developed an intellectual property estate for a next-generation PEG platform that
utilizes releasable linkers designed to release the native molecule at a pre-defined rate. We
believe we are at the forefront of this area of PEGylation research. This platform may play an
important role in enhancing the long-standing benefits of PEG to include additional classes of
compounds where traditional permanent linkers are not feasible. We are also combining our
PEGylation platform with complementary drug delivery technologies. The novel attributes of
customized PEG linkers may offer superior therapeutic advantages, including increased activity and
substantially reduced side effects, when compared to traditional stable linkers.
14
Through the customized attachment of PEG, that covers the spectrum of stable and customized
releasable linkers, we can potentially overcome the pharmacologic limitations for a broad universe
of molecules and generate compounds with substantially enhanced therapeutic value over their
unmodified forms.
We are currently investigating numerous proprietary clinical development opportunities for
PEG-enhanced compounds. In addition, we are simultaneously augmenting our internal initiatives
through the evaluation of PEG product development collaborations.
SALES AND MARKETING
We have a sales and marketing team that includes a sales force that markets the Enzon products
in the U.S. We have provided exclusive marketing rights to Schering-Plough for PEG-INTRON
worldwide and to medac for Oncaspar in most of Europe and parts of Asia. Our marketing strategies
do not incorporate the use of any significant direct-to-consumer advertising.
Abelcet is utilized in the U.S. and Canada by hospitals, clinics and alternate care sites that
treat patients with invasive fungal infections, and is sold primarily to drug wholesalers who, in
turn, sell the product to hospitals and certain other third parties. We maintain contracts with a
majority of our customers which allows those customers to purchase product directly from
wholesalers and receive the contracted price generally based on annual purchase volumes.
We
market Oncaspar and DepoCyt in the U.S. to hospital oncology centers, oncology clinics, and
oncology physicians. We sell Adagen on a worldwide basis. We utilize independent distributors or
specialty pharmacies in certain territories, including the U.S., Europe and Australia.
MANUFACTURING AND RAW MATERIALS
In the manufacture of Abelcet, we combine amphotericin B with DMPC and DMPG (two lipid
materials) to produce an injectable lipid complex formulation of amphotericin B. We currently have
two suppliers of amphotericin B, Bristol-Myers Squibb (BMS) and Alpharma A.p.S. Our supply
agreement with BMS terminated on March 1, 2006; however, we are currently still receiving supplies
of amphotericin B from BMS. Additionally, we are seeking to qualify at least one additional source
of supply of amphotericin B.
In the manufacture of Adagen and Oncaspar, we combine activated forms of PEG with unmodified
proteins (ADA for Adagen and L-asparaginase for Oncaspar). We have supply agreements with Ovation
Pharmaceuticals, Inc. and Kyowa Hakko to produce the unmodified forms of L-asparaginase. Our
agreement with Ovation Pharmaceuticals, Inc. provides for Ovation to supply L-asparaginase to us
through 2009. We have committed to effectuate a technology transfer of the cell line and
manufacturing of the L-asparaginase to our own supplier by December 31, 2009, and then supply
L-asparaginase back to Ovation during the years 2010-2012.
We purchase the unmodified adenosine deaminase enzyme (ADA) used in the manufacturing of
Adagen from Roche Diagnostics. Roche Diagnostics, which is based in Germany, is the only
FDA-approved supplier of ADA. Our ADA supply agreement with Roche Diagnostics terminated in 2004,
although we are still receiving our supply of ADA from them. We are currently developing ADA using
a recombinant source as an alternative to the naturally-derived bovine product. Roche Diagnostics
continues to supply us with our requirements of ADA and indicated when they terminated the supply
agreement that they will continue to do so for a reasonable period of time as we work to develop
another source of ADA.
15
We do not have a long-term supply agreement for the raw polyethylene glycol material that we
use in the manufacturing of our PEG products or for the unmodified protein used in Adagen. We
believe we maintain a level of inventory that should provide us sufficient time to find an
alternate supplier, in the event it becomes necessary, without materially disrupting our business.
We have identified and are in the process of qualifying a second supplier in each case.
Adagen and Oncaspar use our early PEG technology, which is not as advanced as the PEG
technology used in PEG-INTRON or our products under development. Due, in part, to certain
limitations of using our earlier PEG technology, we have had certain manufacturing problems with
Adagen and Oncaspar. Manufacturing and stability problems have required us to implement voluntary
recalls or market withdrawals for certain batches of Oncaspar periodically since 2002 and as
recently as the fourth quarter of 2006. The updated products discussed above are being developed
with newer PEG linker technology and improved manufacturing processes to address these problems.
The FDA and the Medicines and Healthcare products Regulatory Agency or MHRA, the government
agency responsible for medicines and medical devices in the United Kingdom, have, in the past,
conducted follow-up inspections as well as routine inspections of our manufacturing facilities
related to Abelcet, Oncaspar and Adagen. Following certain of these inspections, the FDA has
issued Form 483 reports citing deviations from Current Good Manufacturing Practices (cGMP). Our
South Plainfield and Indianapolis facilities were inspected in January 2007 and June 2007,
respectively, with no Forms 483 being issued. An inspection by the FDAs Team Biologics in April
2007 did result in the issuance of a Form 483. We are currently working with the FDA to resolve
the matters identified therein.
In February 2007, we announced plans to consolidate our manufacturing operations from South
Plainfield, New Jersey to our facility in Indianapolis, Indiana. This consolidation is expected to
be completed in 2008.
DEVELOPMENT AND COMMERCIALIZATION AGREEMENTS
SANTARIS PHARMA A/S COLLABORATION
In July 2006, we entered into a license and collaboration agreement with Santaris for up to
eight RNA antagonists. We obtained rights worldwide, other than Europe, to develop and
commercialize RNA antagonists directed against the HIF-1 alpha and Survivin RNA targets. Santaris
will design and synthesize RNA antagonists directed against up to six additional gene targets
selected by us, and we will have the right to develop and commercialize those antagonists
worldwide, other than Europe. We made an initial payment of $8.0 million to Santaris in the third quarter of
2006 and an additional $3.0 million in the fourth quarter of 2006. We will be responsible for making additional
payments upon the successful completion of certain compound syntheses and selection, clinical
development and regulatory milestones. Santaris is also eligible to receive royalties from any
future product sales of products based on the licensed antagonists. Santaris retains the right to develop and commercialize products developed under the collaboration in Europe.
SCHERING-PLOUGH AGREEMENT
Our PEG technology was used to develop an improved version of Schering-Ploughs product INTRON
A. Schering-Plough is responsible for marketing and manufacturing the product, PEG-INTRON,
worldwide on an exclusive basis and we receive royalties on worldwide sales of PEG-INTRON for all
indications. Schering-Ploughs obligation to pay us royalties on sales of PEG-INTRON terminates,
on a country-by-country basis, upon the later of the date the last patent to contain a claim
covering PEG-INTRON expires in the country or 15 years after the first commercial sale of
PEG-INTRON in such country. Currently, expirations are expected to occur in 2016 in the U.S., 2018
in Europe and 2019 in Japan. The royalty percentage to which we are entitled will be lower in any
country where a PEGylated alpha-interferon product is being marketed by a third party in
competition with PEG-INTRON where such third party is not Hoffmann-La Roche.
16
We do not supply Schering-Plough with PEG-INTRON or any other materials and our agreement with
Schering-Plough does not obligate Schering-Plough to purchase or sell specified quantities of any
product.
During the quarter ended September 30, 2007, we sold a 25% interest in future royalties
payable to us by Schering-Plough on sales of PEG-INTRON occurring after June 30, 2007.
SANOFI-AVENTIS LICENSE AGREEMENTS
During 2002, we amended our license agreement with Sanofi-Aventis to reacquire the rights to
market and distribute Oncaspar in the U.S., Mexico, Canada and most of the Asia/Pacific region. In
return for the marketing and distribution rights, we paid Sanofi-Aventis $15.0 million and were
also obligated to pay a royalty on net sales of Oncaspar in the U.S. and Canada through 2014.
Following the expiration of the royalty obligations in 2014, all rights to Oncaspar will revert
back to us, unless the agreement is terminated earlier because we fail to make royalty payments or
cease to sell Oncaspar.
The amended license agreement prohibits Sanofi-Aventis from making, using or selling an
asparaginase product in the U.S. or a competing PEG-asparaginase product anywhere in the world
until the later of the expiration of the agreement or, if the agreement is terminated earlier, five
years after termination. If we cease to distribute Oncaspar or if we fail to make the required
royalty payments, Sanofi-Aventis has the option to distribute the product in the territories.
In October 2005, we further amended our license agreement with Sanofi-Aventis for Oncaspar.
The amendment became effective in January 2006 and included a significant reduction in our royalty
rate, with a single-digit royalty percentage now payable by us only on those aggregate annual sales
of Oncaspar in the U.S. and Canada that are in excess of $25.0 million. In consideration for the
amendment, we made an upfront cash payment of $35.0 million to Sanofi-Aventis in January 2006. In
the event combined Oncaspar net sales in the U.S and Canada exceed $30.0 million for two
consecutive calendar years, we will be obligated to make a milestone payment of $5.0 million to
Sanofi-Aventis. Net sales of Oncaspar in the U.S. and Canada in 2007 and 2006 were $33.7 million
and $26.3 million, respectively. We are obligated to make royalty payments, if any, through June
30, 2014, at which time all of our royalty obligations will cease.
MEDAC LICENSE AGREEMENT
In January 2002, we renewed an exclusive license to medac, to sell Oncaspar and any
PEG-asparaginase product developed by us or medac during the term of the agreement in most of
Europe and parts of Asia. Our supply agreement with medac provides for medac to purchase Oncaspar
from us at certain established prices and meet certain minimum purchase requirements. Medac is
responsible for obtaining additional approvals and indications in the licensed territories beyond
the currently approved indication in Germany. The agreement was for five years and automatically
renewed as of January 1, 2007 for an additional five years through December 31, 2011. Thereafter,
the agreement will automatically renew for an additional two years unless either party provides
written notice of its intent to terminate the agreement at least 12 months prior to the scheduled
expiration date. Following the expiration or termination of the agreement, all rights granted to
medac will revert back to us.
MICROMET ALLIANCE
Under our cross-license agreement and marketing agreement with Micromet, Micromet is the
exclusive marketer of the two companies combined intellectual property estate in the field of SCA
technology. Any resulting revenues from the license agreements executed by Micromet will be shared
equally by the two companies. In 2007, we recognized royalty revenue of $808 thousand related to
our share of revenues from Micromets licensing activities associated with this agreement.
17
NATIMMUNE A/S LICENSE AGREEMENT
In September 2005, we entered into a license agreement with NatImmune A/S (NatImmune) for
NatImmunes lead development compound, recombinant human Mannose-binding Lectin (rhMBL), a protein
therapeutic under development for the prevention of severe infections in MBL-deficient individuals
undergoing chemotherapy. Under the agreement, we received exclusive worldwide rights, excluding
the Nordic countries, and are responsible for the development, manufacture, and marketing of rhMBL.
The $10.0 million upfront cost of the license agreement was charged to acquired in-process
research and development during the year ended December 31, 2005. During 2007 and 2006, we paid
NatImmune $0.3 million and $2.1 million, respectively, for license milestones and will be
responsible for making additional payments upon the successful completion of certain clinical
development, regulatory, and sales-based milestones. NatImmune is also eligible to receive
royalties from any future product sales of rhMBL by Enzon and retains certain rights to develop a
non-systemic formulation of rhMBL for topical administration.
NEKTAR AGREEMENT
In January 2002, we entered into a PEG technology licensing agreement with Nektar under which
we granted Nektar the right to grant sub-licenses for a portion of our PEG technology to third
parties. However, on September 7, 2006, we gave notice to Nektar of our intention not to renew the
provisions of our agreement with them that gave Nektar the right to sub-license a portion of our
PEG technology and patents to third-parties. This right terminated in January 2007 and will not
affect any existing sub-licenses granted by Nektar. Nektar will only continue to have the right to
sub-license a limited class of our PEG technology and we will receive a royalty or a share of
Nektars profits for any products that utilize our patented PEG technology.
Currently, we are aware of five third-party products for which Nektar has granted sublicenses
to our PEG technology, Hoffmann-La Roches Pegasys (peginterferon alfa-2a), OSIs Macugen
(pegaptanib sodium injection), UCBs CimziaTM (certolizumab pegol, CDP870), Affymax and
Takeda Pharmaceuticals Hematide and an undisclosed product of Pfizers. Pegasys is currently
being marketed for the treatment of hepatitis C and Macugen is currently being marketed through a
partnership between OSI and Pfizer for the treatment of neovascular (wet) age-related macular
degeneration, an eye disease associated with aging that destroys
central vision. The BLA for Cimzia, a
PEGylated anti-TNF-alpha antibody fragment for the treatment of rheumatoid arthritis and Crohns disease is under review in
the U.S. with the FDA. Hematide, a synthetic peptide-based
erythropoiesis-stimulating agent is in two Phase II clinical trials for the treatment of anemia
associated with chronic kidney disease and in anemic cancer patients undergoing chemotherapy. We
retain all rights to use or sub-license all of our PEG technology for our own proprietary products
or those we may develop with co-commercialization partners.
PACIRA
AGREEMENT
In December 2002, we entered into a strategic alliance with Pacira, under which we licensed
the U.S. and Canadian rights to Paciras DepoCyt, an injectable chemotherapeutic approved for the
treatment of patients with lymphomatous meningitis. Under the terms of the agreement, we paid
Pacira a license fee of $12.0 million. Pacira manufactures DepoCyt and we purchase product at a
price equal to 35% of our net sales, which percentage can be reduced should a defined sales target
be exceeded. We recorded the $12.0 million license fee as an intangible asset that is being
amortized over a ten year period.
18
This agreement also included a broad technology access agreement, under which the two
companies may draw upon their combined drug delivery technology and expertise to jointly develop up
to three products for future commercialization. These products will be based on Paciras
proprietary platforms in the areas of oral, injectable and topical drug delivery, supported by
technology to enhance drug solubility and our proprietary PEG modification technology, for which we
received a $3.5 million technology access fee. Pacira will receive a $2.0 million milestone
payment for each product based on its own proprietary technology that enters Phase II clinical
development. Certain research and development costs related to the technology alliance will be
shared equally, as will future revenues generated from the commercialization of any
jointly-developed products.
Under this agreement, we are required to maintain sales levels of DepoCyt equal to $5.0
million for each calendar year (Minimum Sales) through the remaining term of the agreement. Pacira
is also entitled to a milestone payment of $5.0 million if our sales of the product exceed a $17.5
million annual run rate for four consecutive quarters and an additional milestone payment of $5.0
million if our sales exceed an annualized run rate of $25.0 million for four consecutive quarters.
For the year ended December 31, 2007, net sales of DepoCyt were approximately $8.6 million. We are
also responsible for a milestone payment of $5.0 million if the product receives approval for an
indication for use in all neoplastic meningitis.
Our license is for an initial term of ten years and is automatically renewable for successive
two-year terms thereafter. Pacira will be entitled to terminate the agreement if we fail to
satisfy our Minimum Sales.
CEPHALON MANUFACTURING AGREEMENTS
Cephalon owns the right to market Abelcet in any markets outside of the U.S., Canada and
Japan. Our manufacturing agreements with Cephalon require that we supply Cephalon with Abelcet and MYOCET
through November 22, 2011 and January 1, 2010.
PATENTS AND INTELLECTUAL PROPERTY RIGHTS
Patents are very important to us in establishing the proprietary rights to the products we
have developed or licensed. Our executive management team has been reinforcing our organizational
commitment to intellectual property. The patent position of pharmaceutical or biotechnology
companies can be uncertain and involve complex legal, scientific and factual questions. If our
intellectual property positions are challenged, invalidated or circumvented, or if we fail to
prevail in potential future intellectual property litigation, our business could be adversely
affected. We have an extensive portfolio of issued U.S. patents and filed applications, many of
which have foreign counterparts. These patents, if extensions are not granted, are expected to
expire beginning in 2009 through 2028. Under our license agreements, we have exclusively licensed
patents related to our commercial and development products. Of the patents owned or exclusively
licensed by us, 7 relate to PEG-INTRON, 17 relate to Abelcet, and 3
relate to DepoCyt. Our products, Oncaspar and Adagen, are not covered
by any unexpired patents. We have
exclusively licensed patents from NatImmune related to our rhMBL product candidate and from
Santaris Pharma related to our HIF-1 alpha antagonist and our other LNA compounds in development.
Although we believe that our patents provide certain protection from competition, we cannot assure
you that such patents will be of substantial protection or commercial benefit to us, will afford us
adequate protection from competing products, or will not be challenged or declared invalid. In
addition, we cannot assure you that additional U.S. patents or foreign patent equivalents will be
issued to us.
19
Patents for individual products extend for varying periods according to the date of patent
filing or grant and the legal term of patents in the various countries where patent protection is
obtained. The actual protection afforded by a patent, which can vary from country to country,
depends upon the type of patent, the scope of its coverage and the availability of legal remedies
in the country.
The patent covering our original PEG technology, which we had licensed from Research
Corporation Technologies, Inc., contained broad claims covering the attachment of PEG to
polypeptides. However, this U.S. patent and its corresponding foreign patents have expired. Based
upon the expiration of the Research Corporation patent, other parties may make, use, or sell
products covered by the claims of the Research Corporation patent, subject to other patents,
including those that we hold. We have obtained and intend to continue to pursue patents with
claims covering improved methods of attaching or linking PEG to therapeutic compounds. We also
have obtained patents relating to the specific composition of the PEG-modified compounds that we
have identified or created. We will continue to seek such patents as we develop additional
PEG-enhanced products. We cannot assure you that we will be able to prevent infringement by
unauthorized third parties or that competitors will not develop competitive products outside the
protection that may be afforded by our patents.
We are aware that others have also filed patent applications and have been granted patents in
the U.S. and other countries with respect to the application of PEG to proteins and other
compounds. Owners of any such patents may seek to prevent us or our collaborators from making,
using or selling our products.
In the field of SCA proteins, we have several U.S. and foreign patents and pending patent
applications, including a patent granted in August 1990 covering the genes needed to encode SCA
proteins.
Through our acquisition of Abelcet, we acquired several U.S., Canadian, and Japanese patents
claiming the use and manufacture of Abelcet.
We have obtained licenses from various parties that we deem to be necessary or desirable for
the manufacture, use, or sale of our products. These licenses generally require us to pay
royalties to the parties on product sales. In addition, other companies have filed patent
applications or have been granted patents in areas of interest to us. There can be no assurance
that any licenses required under such patents will be available to us on acceptable terms or at
all.
We sell our products under trademarks that we consider in the aggregate to be of material
importance. Trademark protection continues in some countries for as long as the mark is used and,
in other countries, for as long as it is registered. Registrations generally are for fixed, but
renewable, terms.
GOVERNMENT REGULATION
The FDA and comparable regulatory agencies in state and local jurisdictions and in foreign
countries impose substantial requirements on the clinical development, manufacture, and marketing
of pharmaceutical products. These agencies and other federal, state and local entities regulate
research and development activities and the inspection, testing, manufacture, quality assurance,
safety, effectiveness, labeling, packaging, storage, distribution, record-keeping, approval, and promotion of our
products. All of our products will require regulatory approval before commercialization. In
particular, therapeutic products for human use are subject to rigorous preclinical and clinical
testing and other requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health
Service Act, implemented by the FDA, as well as similar statutory and regulatory requirements of
foreign countries. Obtaining these marketing approvals and subsequently complying with ongoing
statutory and regulatory requirements is costly and time consuming. Any failure by us or our
collaborators, licensors or licensees to obtain, or any delay in obtaining, regulatory approval or
in complying with post-approval requirements, could adversely affect the marketing and sale of
products that we are developing and our ability to receive product or royalty revenues.
20
The steps required before a new drug or biological product may be distributed commercially in
the U.S. generally include:
|
|
|
conducting appropriate preclinical laboratory evaluations of the products chemistry,
formulation and stability, and animal studies to assess the potential safety and efficacy
of the product, |
|
|
|
|
submitting the results of these evaluations and tests to the FDA, along with
manufacturing information, analytical data and clinical investigational plan, in an IND, |
|
|
|
|
obtaining IND approval from the FDA, which may require the resolution of any safety or
regulatory concerns of the FDA, |
|
|
|
|
obtaining approval of Institutional Review Boards or IRBs, prior to introducing the
drug or biological product into humans in clinical studies and registering clinical trials in public databases such as clinicaltrials.gov, |
|
|
|
|
conducting adequate and well-controlled human clinical trials that establish the safety
and efficacy of the drug or safety, purity and potency of the biological product candidate for the intended use, in the
following three typically sequential, stages: |
Phase I. The product candidate is initially introduced into healthy human subjects or
patients and tested for safety, increased dose tolerance, and possibly absorption,
distribution, metabolism and excretion,
Phase II. The product candidate is studied in patients with the targeted condition to
gain safety experience at the proposed dosing schedules, identify possible adverse
effects and safety risks to determine the optimal dosage, and to obtain initial
information on effectiveness of the product candidate,
Phase III. The product candidate is studied in an expanded patient population at
multiple clinical study sites to determine primary efficacy and safety endpoints
identified at the start of the study,
|
|
|
submitting the results of preliminary research, preclinical studies, and clinical
studies as well as chemistry, manufacturing and control information on the drug or
biological product to the FDA in a New Drug Application or NDA, for a drug product, or a
BLA for a biological product, and |
|
|
|
|
obtaining FDA approval of the NDA or BLA prior to any commercial sale or shipment of
the drug or biological product. |
An NDA or BLA must contain, among other things, data derived from non-clinical laboratory and
clinical studies which demonstrate that the product meets prescribed standards of safety, purity
and potency, and a full description of manufacturing methods. Biological or drug products may not
be marketed in the U.S. until approval by the FDA of an NDA or BLA is received.
The approval process can take a number of years and often requires substantial financial
resources, including license application fees. The results of preclinical studies and initial
clinical trials are not necessarily predictive of the results from large-scale clinical trials, and
clinical trials may be subject to additional costs, delays or modifications due to a number of
factors, including the difficulty in obtaining enough patients, clinical investigators, drug
supply, or financial support.
21
The FDA
also may require testing and surveillance programs to monitor the effect of approved
products that have been commercialized, and the agency has the power to prevent or limit further
marketing of a product based on the results of these post-marketing programs. The FDA can impose
substantial fines if
these requirements are not carried out to the agencys full satisfaction. Upon approval, a drug
product or biological product may be marketed only in those dosage forms and for those indications
approved in the NDA or BLA, although information about off-label indications may be disseminated in
narrowly defined situations.
In addition to obtaining FDA approval for each indication for which the manufacturer may
market the drug, each domestic drug product manufacturing establishment must register with the FDA,
list its drug products with the FDA, comply with and maintain cGMP and permit and pass inspections
by the FDA and other regulatory authorities. Moreover, the submission of applications for approval
may require the preparation of large-scale production batches that can not be used commercially and
additional time to complete manufacturing stability studies. Foreign establishments manufacturing
drug products for distribution in the U.S. also must list their products with the FDA and comply
with cGMP. They also are subject to periodic inspection by the FDA or by local authorities under
agreement with the FDA.
Any products manufactured or distributed by us pursuant to FDA approvals are subject to
extensive continuing regulation by the FDA, including record-keeping requirements and a requirement
to report adverse experiences with the drug. In addition to continued compliance with standard
regulatory requirements, the FDA also may require post-marketing testing and surveillance to
monitor the safety and efficacy of the marketed product. Adverse experiences with the product must
be reported to the FDA. Product approvals may be withdrawn if compliance with regulatory
requirements is not maintained or if problems concerning safety or efficacy of the product are
discovered following approval.
The Federal Food, Drug, and Cosmetic Act also mandates that drug products be manufactured
consistent with cGMP. In complying with the FDAs regulations on cGMP, manufacturers must continue
to spend time, money and effort in production, record-keeping, quality control, quality assurance,
and auditing to ensure that the marketed product meets applicable specifications and other
requirements. The FDA periodically inspects drug product manufacturing facilities to ensure
compliance with cGMP. Failure to comply subjects the manufacturer to possible FDA action, such as:
|
|
|
untitled and warning letters, |
|
|
|
|
suspension of manufacturing, |
|
|
|
|
seizure of the product, |
|
|
|
|
voluntary recall of a product, |
|
|
|
|
injunctive actions, |
|
|
|
|
civil or criminal penalties. |
To the extent we rely on third parties to manufacture our compounds and products, those third
parties will be required to comply with cGMP as required by regulations. We have undertaken a
voluntary recall of certain lots of products in the past, and future recalls and costs associated
with deviations from cGMP are possible.
22
Even after FDA approval has been obtained, and often as a condition to expedited approval,
further studies, including post-marketing studies, are typically required by the FDA. Results of
post-marketing studies may limit or expand the further marketing of the products. If we propose
any modifications to the product, including changes in indication, manufacturing or testing
processes, manufacturing facility or labeling, an NDA or BLA supplement may be required to be
submitted to and approved by the FDA.
Products manufactured in the U.S. for distribution abroad will be subject to FDA regulations
regarding export, as well as to the requirements of the country to which they are shipped. These
latter requirements apply to products studied in clinical trials, the submission of marketing
applications, and all aspects of product manufacture and marketing. Such requirements vary
significantly from country to country. As part of our strategic relationships our collaborators
may be responsible for the foreign regulatory approval process of our products, although we may be
legally liable for noncompliance.
We cannot predict the extent of government regulation that might result from future
legislation or administrative action. Moreover, we anticipate that Congress, state legislatures
and the private sector will continue to review and assess controls on health care spending. Any
such proposed or actual changes could cause us or our collaborators to limit or eliminate spending
on development projects and may otherwise impact us. We cannot predict the likelihood, nature or
extent of adverse governmental regulation that might result from future legislative or
administrative action, either in the U.S. or abroad. Additionally, in both domestic and foreign
markets, sales of our proposed products will depend, in part, upon the availability of
reimbursement from third-party payors, such as government health administration authorities,
managed care providers, private health insurers and other organizations. Significant uncertainty
often exists as to the reimbursement status of newly approved health care products. In addition,
third-party payors are increasingly challenging the price and cost-effectiveness of medical
products and services. There can be no assurance that our proposed products will be considered
cost-effective or that adequate third-party reimbursement will be available to enable us to
maintain price levels sufficient to realize an appropriate return on our investment in product
research and development.
We are also subject to federal and state laws regulating our relationships with physicians,
hospitals, third party payors of health care, and other customers. The federal anti-kickback
statute, for example, prohibits the willful and knowing payment of any amount to another party with
the intent to induce the other party to make referrals for health care services or items payable
under any federal health care program. The Federal False Claims Act prohibits facilitating the submission of false claims
for payment to the federal government and has been used to enforce against off-label promotion. In recent years the federal government has substantially
increased enforcement and scrutiny of pharmaceutical manufacturers with regard to the anti-kickback
statute and other federal fraud and abuse rules. State laws also impose a growing compliance burden and
enforcement risk in their requirements for licensing, compliance programs and reporting of physician-directed marketing activities.
PEG-INTRON was approved in the European Union, the U.S., and Japan for the treatment of
hepatitis C in May 2000, January 2001 and December 2004, respectively. Abelcet was approved in the
U.S. in November 1995 and in Canada in September 1997. Oncaspar was approved for marketing in the
U.S. in February 1994 in Germany in November 1994, and in Canada under a Clinical Trial Agreement
in December 1997 for patients with acute lymphoblastic leukemia who are hypersensitive to native
forms of L-asparaginase, and in Russia in April 1993 for therapeutic use in a broad range of
cancers. Oncaspar was approved in the U.S. for first-line treatment for patients with ALL in July
2006. Adagen was approved by the FDA in March 1990. DepoCyt received full U.S. approval in April
2007. Except for these approvals, none of our commercial products have been approved for sale and
use in humans in the U.S. or elsewhere.
With respect to patented products, delays imposed by the government approval process may
materially reduce the period during which we will have the exclusive right to exploit them.
Our operations are also subject to federal, state and local environmental laws and regulations
concerning, among other things, the generation, handling, storage, transportation, treatment and
disposal of hazardous, toxic and radioactive substances and the discharge of pollutants into the
air and water.
23
Environmental permits and controls are required for some of our operations and
these permits are subject to modification, renewal and revocation by the issuing authorities. We
believe that our facilities are in substantial compliance with our permits and environmental laws
and regulations and do not believe that
future compliance with current environmental laws will have a material adverse effect on our
business, financial condition or results of operations. If, however, we were to become liable for
an accident, or if we were to suffer an extended facility shutdown as a result of such
contamination, we could incur significant costs, damages and penalties that could harm our
business.
COMPETITION
General
Competition in the biopharmaceutical industry is intense and based to a significant degree on
scientific and technological factors. These factors include but are not limited to the
availability of patent and other protection of technology and products, the ability to
commercialize products and technological developments, the ability to obtain governmental approval
for testing, manufacturing and marketing of products, and the ability to enter into licensing and
similar arrangements to facilitate the development of products and meet other business objectives.
We and our marketing partners compete with specialized biopharmaceutical firms and large
pharmaceutical companies in North America, Europe and elsewhere, with respect to the licensing of
and research and development of product candidates, as well as the commercialization of approved
products. These companies, as well as academic institutions, governmental agencies and private
research organizations, also compete with us in recruiting and retaining highly qualified
scientific personnel and consultants. Many of the companies we compete with are larger than us and
have substantially greater resources. Certain of these companies, especially Merck and Pfizer, are
able to compete effectively with us largely by virtue of their superior resources and the markets
familiarity with their brand names regardless of the technical advantages or disadvantages of
their products.
Products
Abelcet
The intravenous or IV antifungal market in which Abelcet competes has been facing increasingly
competitive market conditions. The products used to treat fungal infections are classified into
four classes of drugs: Conventional Amphotericin B or (CAB), lipid-based CAB formulations,
triazoles, and echinocandins. While we compete with all of these drugs, Abelcet is predominately
used in more severely ill patients.
CAB is a broad-spectrum polyene antifungal agent that is believed to act by penetrating the
cell wall of a fungus, thereby killing it. CAB is particularly toxic to the kidneys, an adverse
effect that often restricts the amount that can be administered to a patient. CAB is sold today as
a significantly lower cost generic drug. Its usage has been declining, however, due to these
toxicities.
The lipid-based formulations of CAB include Abelcet, amphotericin B liposome for injection,
which is marketed by Astellas Pharma US, Inc. (Astellas) and Gilead Sciences (Gilead) in the U.S.,
and amphotericin B cholesteryl sulfate complex for injection, which is marketed by Three Rivers
Pharmaceuticals, LLC. These formulations provide the efficacy of CAB while limiting the toxicities
that are inherent in its usage. Astellas and Gileads amphotericin B liposome for injection has
proven to be a significant competitor to Abelcet. Astellas and Gilead have reduced the price of
this lipid-based product in certain geographic markets, which has increased the competitive
pressure on Abelcet. In addition, in May 2005, Astellas launched a new systemic antifungal agent,
micafungin sodium for injection, which is a member of the echinocandin class of antifungal agents,
discussed below. To the extent we are not able to address this competitive pressure successfully
or we deem it necessary to reduce the price of Abelcet in order to address this competitive threat,
our market share, revenues or both could decrease, which could have a material adverse effect on
our business, financial condition and results of operations.
24
The triazoles, which include fluconazole (marketed generically and under the brand name
Diflucan® by Pfizer), itraconazole (marketed under the brand name Sporanox®
by Janssen Pharmaceuticals) and voriconazole (also marketed by Pfizer under the brand name
Vfend®) have the least reported incidence of side effects as compared to other classes
of antifungals. Triazoles are generally thought to be limited by a narrower spectrum of activity
and have issues with drug-to-drug interactions and acquired resistance. The majority of triazole
units sold in the U.S. are attributed to fluconazole. Fluconazole in particular is
often used in less compromised patients as prophylaxis or first-line empirical therapy.
Fluconazole patients are often switched to an amphotericin B product once a clinician is convinced
that a patient has a fungal infection. Voriconazole is a second-generation triazole approved in
May 2002 and is available in intravenous and oral formulations. Voriconazole carries a broader
spectrum of activity than first generation triazoles; however, it carries with it a narrower
spectrum of activity versus CAB and the lipid amphotericin B formulations, while also retaining the
same potential for drug-to-drug interactions and acquired resistance as the first generation
triazoles. Another triazole product, posiconazole, was approved by the FDA in September 2006 and
is marketed under the brand name Noxafil® by Schering-Plough.
The echinocandins are the newest class of products to enter the IV antifungal market. These
exhibit fewer of the CAB side effects but, like the triazoles, have a more limited spectrum of
activity and less clinical data supporting widespread use across a variety of fungal pathogens.
Caspofungin (marketed under the brand name Cancidas® by Merck) was approved in the U.S.
in January 2001 and was the first echinocandin to receive FDA approval. In March 2005, the FDA
approved the second echinocandin, micafungin sodium for injection and in May 2005, Astellas
launched this product under the brand name Mycamine® in the U.S. Caspofungin is
indicated for the treatment of invasive aspergillosis in patients who are refractory to or
intolerant of other therapies, esophageal candidiasis and candidemia. Micafungin is indicated for
the treatment of esophageal candidiasis and prophylaxis of candida infections in patients
undergoing hematopoietic stem cell transplantation. In February 2006, the FDA approved the third
echinocandin, anidulafungin, (marketed under the brand name EraxisTM by Pfizer).
Anidulafungin is indicated for the treatment of esophageal candidiasis, candidemia and other
candida infections.
Adagen
Prior to the development of Adagen, the only treatment available to patients afflicted with
adenosine deaminase or ADA-deficient SCID was a well-matched bone marrow transplant. Completing a
successful transplant depends upon finding a matched donor, the probability of which is low. At
present, researchers at various research centers worldwide have been treating ADA-deficient SCID
patients with gene therapy, which if successfully developed, could compete against Adagen. The
theory behind gene therapy is that cultured T-lymphocytes that are genetically engineered and
injected back into the patient will express the adenosine deaminase enzyme permanently and at
normal levels.
Oncaspar
Current standard treatment of patients with ALL includes administering L-asparaginase along
with the drugs vincristine, prednisone and daunomycin. Studies have shown that long-term treatment
with L-asparaginase increases the disease-free survival in high risk patients. Oncaspar, our
PEG-modified L-asparaginase product, is used to treat patients with ALL. Currently, there is one
unmodified form of L-asparaginase available in the U.S. and several available in Europe. We
believe that Oncaspar has an advantage over the unmodified forms of L-asparaginase of increased
half life resulting in fewer injections. OPi SA (France) announced in November 2006, that the FDA
accepted an IND for its product Erwinase® (Erwinia chrysanthemi L-asparaginase for
injection) as a substitute for Escherichia coli-derived L-asparaginase for the treatment of
patients with ALL. Erwinia chrysanthemi-derived L-asparaginase is immunologically distinct from E.
coli L-asparaginase, the active ingredient in Oncaspar. Erwinase® is approved in
several countries outside the U.S. for treatment of ALL and some other hematologic malignancies.
25
DepoCyt
DepoCyt competes against generic unmodified or ara-C cytarabine, as well as methotrexate,
another generic drug, in the treatment of lymphomatous meningitis. Both of these drugs have been
used for oncology treatment for decades and DepoCyt does not have the same level of clinical
experience as these drugs. Clinical trials have demonstrated, however, that DepoCyt provides
certain clinical advantages versus generic cytarabine. In a randomized, multi-center trial of
patients with lymphomatous meningitis, treated either with 50 mg of DepoCyt administered every 2
weeks or standard intrathecal chemotherapy administered twice a week, results showed that DepoCyt
achieved a complete response rate of 41% compared with a complete response rate of 6% for
unencapsulated cytarabine. In this study, complete response was prospectively defined as (i)
conversion of positive to negative CSF cytology and (ii) the absence of neurologic progression.
DepoCyt has also demonstrated an increase in the time to neurologic progression of 78.5 days for
DepoCyt versus 42 days for unencapsulated cytarabine.
Royalties
PEG-INTRON
PEG-INTRON, marketed by Schering-Plough, competes directly with Hoffmann-La Roches Pegasys.
Schering-Plough and Hoffmann-La Roche have been the major competitors in the global alfa interferon
market since the approval of their unmodified alpha interferon products, INTRON A and ROFERON-A,
respectively. Due to the December 2004 launch of PEG-INTRON combination therapy in Japan, our
PEG-INTRON royalties have increased over prior-year levels. In January 2007, Hoffmann-La Roche
announced it received approval for its Pegasys combination therapy, Copegus (ribavirin) plus
Pegasys (peginterferon alfa-2a (40KD)), by the Japanese regulatory agency. Currently in markets
outside of Japan, the PEGylated interferon-based combination therapy is a highly competitive
market. Further, Schering-Plough has reported that the overall hepatitis C market has been
contracting. We cannot assure you that this market contraction and competitive conditions will not
offset the near-term positive impact of PEG-INTRON sales in Japan, which could result in lower
PEG-INTRON royalties to us. Additionally there is much research being conducted on various
formulations of alpha interferon as well as many compounds being investigated for the treatment of
hepatitis C. While much of this research is very early, it is possible that this research could
lead to a competing product in the future.
Macugen
Macugen, marketed by OSI Pharmaceuticals, Inc. and Pfizer Inc., currently competes against
three therapies for the treatment of neovascular (wet) age-related macular degeneration (AMD):
photodynamic therapy with verteporfin, which was developed by QLT, Inc. and is marketed by Novartis
AG; thermal laser treatment; and the recently approved and launched ranibizumab, marketed under the
brand name LucentisTM by Genetech. Ranibizumab, approved in June 2006, for the
treatment of neovascular age-related macular degeneration, has provided significant competition to
Macugen, which we expect to continue. Additional treatments for AMD are in various stages of
preclinical or clinical testing. If approved, these treatments would also compete with Macugen.
Technology
PEGylation
We are aware that other companies are conducting research on chemically modified therapeutic
proteins and that certain companies are modifying pharmaceutical products, including proteins, by
attaching PEG.
26
EMPLOYEES
As of December 31, 2007, we employed 371 persons, including 41 persons with Ph.D. or M.D.
degrees. At that date, 96 employees were engaged in research and development activities, 152 were
engaged in manufacturing, 123 were engaged in sales, marketing and administration. None of our
employees are covered by a collective bargaining agreement. All of our employees are covered by
confidentiality agreements. We consider our relations with our employees to be good.
27
Item 1A. Risk Factors
Throughout this Annual Report on Form 10-K, we have made forward-looking statements in an
attempt to better enable the reader to understand our future prospects and make informed judgments.
By their nature, forward-looking statements are subject to numerous factors that may influence
outcomes or even prevent their eventual realization. Such factors may be external to Enzon and
entirely outside our control.
We cannot guarantee that our assumptions and expectations will be correct. Failure of events
to be achieved or of certain underlying assumptions to prove accurate could cause actual results to
vary materially from past results and those anticipated or projected. We do not intend to update
forward-looking statements.
Certain risks and uncertainties are discussed below. It is not possible to predict or
identify all such factors, however. Accordingly, you should not consider this recitation to be
complete.
Risks Related to Our Business
If any of these risks are realized our business, prospects, financial condition, results of
operations and our ability to service debt could be materially adversely affected.
We expect to incur losses over the next several years.
As of December 31, 2007, we had an accumulated deficit of $299.5 million. We expect to incur
losses over the next several years, including for the year ending December 31, 2008, as we expect
to make significant research and development expenditures.
Our ability to achieve long-term profitability will depend primarily on:
|
|
|
the success of our research and development programs; |
|
|
|
|
the continued sales of our marketed products and the products on which we receive
royalties; and |
|
|
|
|
our and our licensees ability to develop and obtain regulatory approvals for
additional product candidates. |
There is a high risk that our early-stage research and development might not generate successful
product candidates. Failure to develop and commercialize our product candidates could materially
harm our business.
There is a high risk of failure for pharmaceutical product candidates. Most product
candidates fail to reach the market. Our product candidates are subject to the risks inherent in
the development of new pharmaceutical products, including, but not limited to, risks that the drug
might prove ineffective or may cause harmful side-effects during preclinical testing or clinical
trials, may fail to receive necessary regulatory approvals, cannot be manufactured on a commercial
scale basis and therefore may not be economical to produce, may fail to achieve market acceptance
or that we may be precluded from commercialization by proprietary rights of third parties.
The risk of failure is increased for our product candidates that are based on new technologies
or approaches to the development of therapeutics. For example, our LNA technology is a novel
technology and there are currently no approved drugs, or even late-stage drug candidates employing
this technology. Product candidates employing these technologies may not advance to pivotal stages
of product development or demonstrate clinical safety or effectiveness. If our technologies fail
to generate products, or if we do not succeed in the development of these product candidates, our
business could be materially harmed.
28
At the present time, the vast majority of our research and development operations are focused
on the early stages of product research and development, and we are conducting or first commencing
clinical trials on our product candidates. Success in preclinical testing and early clinical trials
does not necessarily predict success in later clinical trials. A number of companies in the
pharmaceutical and biotechnology industries have suffered significant setbacks in later-stage
clinical trials due to such factors as inconclusive results and adverse medical events, even after
achieving positive results in earlier trials. If our product candidates fail in the clinical trial
stage, it could materially harm our business prospects.
From time to time, we may establish and announce certain development goals for our product
candidates and programs; however, given the complex nature of the drug discovery and development
process, it is difficult to predict accurately if and when we will achieve these goals. If we are
unsuccessful in advancing our preclinical programs into clinical testing or in obtaining regulatory
approval, our business prospects may be harmed.
We do not expect any of the drugs resulting from our current research and development efforts
to be commercially available for several years, if at all. In order to fill our pipeline of product
candidates under development, we may attempt to acquire rights to products under development by
other companies. The competition for the acquisition of rights to products that are viewed as
viable candidates for successful development and commercialization is intense, and we will be
competing for such opportunities with many companies with resources that are substantially greater
than ours.
Our financial results are heavily dependent on the continued sales of our marketed products and the
products on which we receive royalties; if revenues from these products fail to increase or
materially decline, our results of operations, financial position and prospects could be materially
harmed.
Our results of operations are heavily dependent on the revenues we derive from the sale and
marketing of our products Oncaspar, DepoCyt, Abelcet and Adagen as well as the royalty revenues we
receive on the sale of PEG-INTRON, marketed by Schering-Plough. Starting in the fourth quarter of
2007, our PEG-INTRON-related revenues were and will be reduced by our sale to a third-party of a
25% interest in those royalties. As a consequence of the significance of these products to us,
stagnation or decline in the sales of one or more of them could adversely affect our operating
results, financial position and prospects.
Sales of our products can be affected by, among other things, competition, patient demand and
manufacturing issues. We cannot assure you that Schering-Plough will continue to be successful in
marketing PEG-INTRON. The amount and timing of resources dedicated by Schering-Plough to the
marketing of PEG-INTRON is not within our control. Our royalty revenues will be negatively
affected if sales of PEG-INTRON are limited for any reason, including if Schering-Plough cannot
market PEG-INTRON as a result of manufacturing, regulatory or other issues.
Sales of PEG-INTRON and Abelcet have been adversely affected by competitive products introduced
into their respective markets and we have experienced in the past and may continue to experience in
the future a decline in sales of Abelcet, which if not reversed, will adversely affect our results
of operations, financial condition and prospects.
Products that compete with both PEG-INTRON and Abelcet have been and potentially will be
introduced by other drug manufacturers into their respective markets.
Hoffmann-La Roches Pegasys, a competing PEGylated interferon-based combination therapy, has
resulted in significant competitive pressure on PEG-INTRON sales in the U.S. and all international
markets. Pegasys has taken market share away from PEG-INTRON and the overall market for PEGylated
alpha-interferon for the treatment of hepatitis C has been contracting. As a result, sales of
PEG-INTRON in certain markets where it competes with Pegasys and the royalties we receive on those
sales have declined. We cannot assure you that Pegasys will not continue to gain market share at
the expense of PEG-INTRON which could result in lower PEG-INTRON sales and lower royalties to us.
While we receive a royalty on sales of Pegasys under our Nektar agreement, it is a smaller royalty
than that received on sales of PEG-INTRON.
29
Similarly, the continued sale of newer products from Merck, Pfizer, Schering-Plough and
Astellas Pharma in the antifungal market (where Abelcet competes) has negatively impacted Abelcet
sales as clinicians utilize these other therapeutic agents. Pfizer and Schering-Plough have each
recently obtained approval for an additional new product in the antifungal market that is expected
to further increase competition. In addition, Astellas Pharma and Gilead Sciences, Inc. are
currently marketing AmBisome, and Three Rivers Pharmaceuticals, Inc. is marketing Amphotec, each of
which is a lipid-based version of amphotericin B, for the treatment of fungal infections. AmBisome
and Amphotec each compete with Abelcet which has resulted in greater competitive pressure on
Abelcet sales. During calendar year 2007, we continued to experience increasing pricing pressure
with respect to Abelcet. In particular, Astellas Pharma and Gilead Sciences, Inc., have
aggressively lowered the price of their product in certain regions and for certain customers in the
U.S. This has resulted in the shrinkage or loss of certain of our customer accounts. While we are
developing and implementing strategies to address the competitive threats facing Abelcet, we cannot
assure you that we will be able to increase sales of Abelcet or prevent further decreases in
Abelcet sales. If we are not successful in addressing the competitive threats, it could adversely
affect our operating results, financial condition and prospects.
We will need to obtain additional financing to meet our future capital needs and our significant
debt level may adversely affect our ability to do so. Failure to do so could materially and
adversely affect our business, financial condition and operations.
Our current development projects and marketing initiatives require substantial capital. We
will continue to expend substantial resources for research and development, including costs
associated with developing our product candidates and conducting clinical trials. We believe that
our current cash and investments and our anticipated cash flow from operations will be adequate to
satisfy our capital needs for the near future, but we will likely need to increase our cash flow
from operations or obtain financing to meet our future capital needs, which we expect will be
substantial. We will require substantial additional funds to conduct research activities,
preclinical studies, clinical trials and other activities relating to the successful
commercialization of potential products. In addition, we may seek to acquire additional products,
technologies and companies, which could require substantial capital. The competitive pressures
impacting PEG-INTRON and Abelcet, and our sale of a 25% interest in the royalties we receive on
sales of PEG-INTRON, will cause our cash flow from operations to decrease rather than increase in
the future and we cannot be sure that additional funds from other sources will be available on
commercially reasonable terms, if at all. If adequate funds are unavailable from operations or
additional sources of financing, we may have to delay, reduce the scope of or eliminate one or more
of our research or development programs or one or more of our potential acquisitions of
technologies or companies, which could materially and adversely affect our business, financial
condition and operations.
We may seek to raise any necessary additional funds through equity or debt financings,
collaborative arrangements with corporate partners or other sources which may be dilutive to
existing stockholders. We cannot assure you that we will be able to obtain additional funds on
commercially reasonable terms, if at all.
As of December 31, 2007, we had $347.4 million of outstanding indebtedness related to our
outstanding 2013 convertible notes and 2008 convertible notes. Since that date, we have repurchased
$59.9 million of the 2008 notes and have restricted cash and investments set aside to repurchase or
repay the remaining $12.5 million of the 2008 notes. Our significant debt level could limit our
ability to obtain additional financing and could have other important negative consequences,
including:
|
|
|
increasing our vulnerability to general adverse economic and industry conditions; |
|
|
|
|
requiring the dedication of a substantial portion of our expected cash flow from
operations to service our indebtedness, thereby reducing the amount of our expected cash
flow available for other purposes; |
|
|
|
|
limiting our flexibility in planning for, or reacting to, changes in our business and
the industry in which we compete;
|
30
|
|
|
placing us at a possible competitive disadvantage relative to less leveraged
competitors and competitors that have better access to capital resources; and |
|
|
|
|
making it difficult or impossible for us to pay the principal amount of the 2013
notes at maturity, or the repurchase price of the 2013 notes upon a
fundamental change, including accrued and unpaid interest. |
We depend on our collaborative partners; if we lose our collaborative partners or they do not apply
adequate resources to our collaborations, our product development and financial performance may
suffer.
We rely and will depend heavily in the future on collaborations with partners, primarily
pharmaceutical and biotechnology companies, for one or more of the research, development,
manufacturing, marketing and other commercialization activities relating to most of our product
candidates. If we lose our collaborative partners, or if they do not apply adequate resources to
our collaborations, our product development and financial performance may suffer.
The amount and timing of resources dedicated by our collaborators to their collaborations with
us are not within our control. If any collaborator breaches or terminates its agreements with us,
or fails to conduct its collaborative activities in a timely manner, the commercialization of our
product candidates could be slowed or blocked completely. We cannot assure you that our
collaborative partners will not change their strategic focus or pursue alternative technologies or
develop alternative products as a means for developing treatments for the diseases targeted by
these collaborative programs. Our collaborators could develop competing products.
We cannot assure you that our collaborations will be successful. Disputes may arise between us
and our collaborators as to a variety of matters, including financing obligations under our
agreements and ownership of intellectual property rights. These disputes may be both expensive and
time-consuming and may result in delays in the development and commercialization of products. If
any of the product candidates that we are commercializing with collaborators are delayed or stopped
from coming to market or we experience increased costs as a result of our relationship with our
collaborators, our financial performance could be adversely affected.
We purchase some of the compounds utilized in our products from a single source or a limited group
of suppliers, and the partial or complete loss of one of these suppliers could cause production
delays and a substantial loss of revenues.
We purchase the unmodified compounds and bulk PEGs utilized in our approved products and
products under development from outside suppliers. In some cases, we have a limited number of
suppliers. Moreover, in some cases, we have no supply agreement. Specifically, our ability to
obtain compounds for our respective products may be limited by the following factors.
Oncaspar. We have supply agreements with Ovation Pharmaceuticals, Inc. and Kyowa Hakko to
produce the unmodified forms of L-asparaginase, the active ingredient used in the production of
Oncaspar. Our agreement with Ovation Pharmaceuticals, Inc. provides for Ovation to supply
L-asparaginase to us through 2009. We have committed to effectuate a technology transfer of the
cell line and manufacturing of the L-asparaginase to our own supplier by December 31, 2009, and
then supply L-asparaginase back to Ovation during the years 2010-2012. It is possible that we will
not be able to successfully complete the technology transfer by the deadline or at all, due to
technological, manufacturing, regulatory, clinical development or other issues. If we are unable to
effectuate the technology transfer by the deadline, we may not be able to manufacture or sell
Oncaspar, which would result in a substantial loss of revenues and damage to our business. Also,
if we are unable to supply L-asparaginase back to Ovation during the years 2010-2012, we could be
required to pay damages to Ovation in the amounts of $5.0 million in 2010, $10.0 million in 2011
and $15.0 million in 2012 in connection with a breach of our obligation to supply L-asparaginase to
them.
31
Adagen. We purchase the unmodified adenosine deaminase enzyme used in the manufacture of
Adagen from Roche Diagnostics. Roche Diagnostics, which is based in Germany, is the only
FDA-approved supplier of the adenosine deaminase enzyme, or ADA, used in Adagen. During 2002, we
obtained FDA approval of the use of the ADA enzyme obtained from bovine intestines from cattle of
New Zealand origin. New Zealand currently certifies that its cattle are bovine spongiform
encephalopathy (BSE or mad cow disease) free. Beginning in September 2002, the U.S. Department of
Agriculture (USDA) required all animal-sourced materials shipped to the U.S. from any European
country to contain a veterinary certificate that the product is BSE free, regardless of the country
of origin. Our ADA supply agreement with Roche Diagnostics terminated in 2004 although we are
still receiving our supply of ADA from them. We are currently developing ADA using a recombinant
source as an alternative to the naturally-derived bovine product. This is a difficult and expensive
undertaking as to which success cannot be assured. Roche Diagnostics continues to supply us with
our requirements of ADA and indicated when they terminated the supply agreement that they will
continue to do so for a reasonable period of time as we work to develop another source of ADA. We
may have little or no notice if Roche Diagnostics decides to stop supplying us with ADA. If we are
unable to secure an alternative source of ADA before Roche Diagnostics discontinues supplying the
material to us, may experience inventory shortages and potentially a period of product
unavailability or a long-term inability to produce Adagen. If this occurs, it will have a
measurable (and potentially material) negative impact on our business and results of operations and
it could potentially result in significant reputational harm and regulatory difficulties.
Abelcet. We have two suppliers that produce the amphotericin B used in the manufacture of
Abelcet: Bristol-Myers Squibb (BMS) and Alpharma A.p.S. Our supply agreement with BMS terminated on
March 1, 2006. However, we are currently still receiving supply of amphotericin B from BMS.
Additionally, we are seeking to qualify at least one additional source of supply. The termination
of our supply agreement by BMS may give rise to future increased costs for the acquisition of
amphotericin B, and obtaining production and regulatory approval of Abelcet incorporating the
alternative amphotericin B.
If we experience a delay in obtaining or are unable to obtain any compound for any of the
products discussed above on reasonable terms, or at all, it could have a material adverse effect on
our business, financial condition and results of operations. No assurance can be given that in any
case alternative suppliers with appropriate regulatory authorizations could be readily identified
if necessary. If we experience delays in obtaining or are unable to obtain any such compounds on
reasonable terms, it could have a material adverse effect on our business, financial condition and
results of operations.
If we are required to obtain an alternate source for an unmodified compound utilized in a
product, the FDA and relevant foreign regulatory agencies will likely require that we perform
additional testing to demonstrate that the alternate material is biologically and chemically
equivalent to the unmodified compound previously used in our clinical trials. This testing could
delay or stop development of a product, limit commercial sales of an approved product and cause us
to incur significant additional expenses. If we are unable to demonstrate that the alternate
material is chemically and biologically equivalent to the previously used unmodified compound, we
will likely be required to repeat some or all of the preclinical and clinical trials conducted for
the compound. The marketing of an FDA approved drug could be disrupted while such tests are
conducted. Even if the alternate material is shown to be chemically and biologically equivalent to
the previously used compound, the FDA or relevant foreign regulatory agency may require that we
conduct additional clinical trials with the alternate material.
Our product candidates must undergo extensive clinical testing, the results of which are uncertain
and could substantially delay or prevent us from obtaining regulatory approval.
Before we can obtain regulatory approval for a product candidate, we must undertake extensive
clinical testing in humans to demonstrate safety and efficacy to the satisfaction of the FDA and
similar foreign regulatory authorities for each indication before they can be approved for
commercialization. The preclinical testing and clinical trials of any product candidates that we
develop must comply with the regulations of numerous federal, state and local government
authorities in the U.S., principally the FDA, and by similar agencies in other countries. Clinical
trials of new product candidates sufficient to obtain regulatory marketing approval are expensive
and take years to complete, and the outcome
32
of these trials is uncertain. Clinical development of any product candidate that we determine to take into
clinical trials may be delayed or prevented at any time for some or all of the following reasons:
|
|
|
negative or ambiguous results regarding the efficacy of the product candidate; |
|
|
|
|
undesirable side effects that delay or extend the trials or make the product
candidate not medically or commercially viable; |
|
|
|
|
inability to recruit and qualify a sufficient number of patients for our trials; |
|
|
|
|
regulatory delays or other regulatory actions, including changes in regulatory
requirements; |
|
|
|
|
difficulties in obtaining sufficient quantities of the product candidate
manufactured under current good manufacturing practices; |
|
|
|
|
delays, suspension or termination of the trials imposed by us, an independent
institutional review board for a clinical trial site, or clinical holds placed upon
the trials by the FDA; and |
|
|
|
|
we may have inadequate financial resources to fund these trials. |
We rely and will continue to rely on clinical investigators, academic institutions,
third-party contract research organizations and consultants to perform some or all of the functions
associated with preclinical testing or clinical trials. While we rely heavily on these parties for
successful execution of our clinical trials, we do not control many aspects of their activities.
The failure of any of these parties to perform in an acceptable and timely manner, including in
accordance with any applicable regulatory requirements, such as good clinical and laboratory
practices, or preclinical testing or clinical trial protocols, could cause a delay or otherwise
adversely affect our preclinical testing or clinical trials and ultimately the timely advancement
of our development programs. We also depend upon third party manufacturers to qualify for FDA
approval and to comply with good manufacturing practices required by regulators. The failure of our
manufacturers and suppliers to comply with current good manufacturing practices may result in the
delay or termination of clinical studies.
If our clinical trials are not successful, if we experience significant delays in these
trails, or if we do not complete our clinical trials, we may not be able to commercialize our
product candidates, which could materially harm our business.
We depend on patents and proprietary rights, which may offer only limited protection against
potential infringement and the development by our competitors of competitive products. The U.S. and
foreign patents upon which our original PEG technology was based have expired.
The pharmaceutical industry places considerable importance on obtaining patent and trade
secret protection for new technologies, products and processes. Our success depends, in part, on
our ability to develop and maintain a strong patent position for our products and technologies both
in the U.S. and in other countries. If we are unable to obtain and enforce patent protection for
our products and product candidates, our business could be materially harmed. We have an extensive
portfolio of issued U.S. patents and filed applications, many of which have foreign counterparts.
These patents, if extensions are not granted, are expected to expire beginning in 2009 through
2028. Under our license agreements, we have exclusively licensed patents related to our commercial
and development products. Of the patents owned or exclusively licensed by us, 7 relate to
PEG-INTRON, 17 relate to Abelcet and 3 relate to DepoCyt. Our products, Oncaspar and Adagen, are
not covered by any unexpired patents. We have exclusively licensed patents from NatImmune related
to our rhMBL product candidate and from Santaris related to our HIF-1 alpha antagonist and our
other LNA compounds in development. Although we believe that our patents provide certain
protection from competition, we cannot assure you that such patents will be of substantial
protection or commercial benefit to us, will afford us adequate protection from competing products,
or will not be challenged or declared invalid. In addition, we cannot assure you that additional
U.S. patents or foreign patent equivalents will be issued to us.
33
Issued patents may be challenged, invalidated or circumvented. In addition, court decisions
may introduce uncertainty in the enforceability or scope of patents owned by biotechnology and
pharmaceutical companies. The legal systems of certain countries do not favor the aggressive
enforcement of patents, and the laws of foreign countries may not protect our rights to the same
extent as the laws of the U.S. Therefore, enforceability or scope of our patents in the U.S. or in
foreign countries cannot be predicted with certainty, and, as a result, any patents that we own or
license may not provide sufficient protection against competitors. We may not be able to obtain or
maintain patent protection for our pending patent applications, those we may file in the future, or
those we may license from third parties.
While we believe that our patent rights are enforceable, we cannot assure you that any patents
that we have issued, that we may issue or that may be licensed to us will be enforceable or valid
or will not expire prior to the commercialization of our product candidates, thus allowing others
to more effectively compete with us. Therefore, any patents that we own or license may not
adequately protect our product candidates or our future products. If we are not able to protect our
patent positions, our business could be materially harmed.
Other entities may have or obtain patents or proprietary rights that could limit our ability
to manufacture, use, sell, offer for sale or import products or impair our competitive position.
To the extent that a third party obtains patents or proprietary rights that cover our products, we
may be required to obtain licenses to those patents or proprietary rights, which licenses may not
be available or may not be available on commercially reasonable terms, if at all.
We may become aware that certain organizations are engaging in activities that infringe
certain of our patents, including our PEG and single-chain antibody, or SCA, technology patents. We
cannot assure you that we will be able to enforce our patents and other rights against such
organizations.
Legal or administrative proceedings may be necessary to defend against claims of infringement
or to enforce our intellectual property rights. We have in the past been involved in patent
litigation and other proceedings and we may likely become involved in additional patent litigation
or proceedings in the future. If we become involved in any such litigation or proceeding,
irrespective of the outcome, we may incur substantial costs, the efforts of our technical and
management personnel may be diverted, and such disputes could substantially delay or prevent our
product development or commercialization activities, which could materially harm our business,
financial condition and results of operations.
The U.S and corresponding foreign patents upon which our original PEG technology was based and
containing broad claims covering the attachment of PEG to polypeptides in 1996. Without that
patent protection, other parties are permitted to make, use or sell products covered by the claims
of those patents, subject to other patents, including those which we hold. We have obtained
numerous patents with claims covering improved methods of attaching or linking PEG to therapeutic
compounds. We cannot assure you that any of these patents will enable us to prevent competition or
that competitors will not develop alternative methods of attaching PEG to compounds potentially
resulting in competitive products outside the protection that may be afforded by our patents. We
are aware that others have also filed patent applications and have been granted patents in the U.S.
and other countries with respect to the application of PEG to proteins and other compounds.
We or our suppliers could experience delays or difficulties in manufacturing, including problems
complying with the FDAs regulations for manufacturing our products. These problems could
materially harm our business.
Manufacturers of drugs must comply with current cGMP regulations, which include quality
control and quality assurance requirements as well as the corresponding maintenance of records and
documentation. Manufacturing facilities are subject to ongoing periodic inspection by the FDA and
corresponding state agencies, including unannounced inspections of our commercial manufacturing
facilities. We or our present or future suppliers may be unable to comply with the applicable cGMP
regulations and other FDA regulatory requirements.
34
Adagen and Oncaspar, which we manufacture, use our earlier PEG technology which tends to be
less stable than the PEG technology used in PEG-INTRON and our products under development. Due, in
part, to the drawbacks in the earlier technologies we have had and may continue to have
manufacturing problems with these products.
We continue to face manufacturing and stability issues with Oncaspar. To date, we have been
unable to identify the cause of these issues. If we continue to have these issues with Oncaspar, we
may have a disruption in our ability to manufacture Oncaspar. Manufacturing and stability problems
have required us to implement voluntary recalls or market withdrawals for certain batches of
Oncaspar periodically since 2002 and as recently as the fourth quarter of 2006. Mandatory recalls
can also take place if regulators or courts require them, even if we believe our products are safe
and effective. Recalls result in lost sales of the recalled products themselves and can result in
further lost sales while replacement products are manufactured or due to customer dissatisfaction.
We cannot assure you that future product recalls or market withdrawals will not materially
adversely affect our business, our financial condition, results of operations or our reputation and
relationships with our customers. Disruption in supply or manufacturing difficulties relating to
Oncaspar could cause a disruption in our ability to market and sell Oncaspar and result in a
substantial loss of revenues.
The FDA and the MHRA, the British equivalent of the FDA, have conducted periodic inspections
of our manufacturing facilities related to Abelcet, Oncaspar and Adagen. Following certain of these
inspections, the FDA has issued Form 483 reports citing deviations from cGMP, the most recent of
which were issued in January 2006 for our New Jersey facility and August 2005 for our Indianapolis
facility. We have responded to such reports with corrective action plans.
We are aware that the FDA has conducted inspections of certain of the manufacturing facilities
of Schering-Plough, who manufactures PEG-INTRON, and Merck, who manufactures the L-asparaginase
that we receive from Ovation Pharmaceuticals for use in the production of Oncaspar, and those
inspections have resulted in the issuance of Forms 483 citing deviations from cGMP.
If we or our partners face additional manufacturing problems in the future or if we or our
licensees are unable to satisfactorily resolve current or future manufacturing problems, the FDA
could require us or our licensees to discontinue the distribution of our products or to delay
continuation of clinical trials.
Our arrangements with third-party manufacturers involve significant financial commitments and costs
that may be incurred if we terminate or delay manufacturing.
We depend on the manufacturing capabilities of third parties to manufacture drug substances
used in certain of our products. Our contractual arrangements with these manufacturers require us
to commit to planned manufacturing activities. If we were to terminate or delay these activities,
we may be required to pay termination fees or other delay-related charges and these amounts may be
significant. The need to terminate or delay planned manufacturing activities could arise from a
delay in a clinical trial or regulatory approval, an inability to transfer our technology and
complex processes to the third-party manufacturers or other reasons that may be beyond our control.
We may be subject to a variety of types of product liability or other claims based on allegations
that the use of our products has resulted in adverse effects, whether by participants in our
clinical trials or by patients using our products, and our insurance may not cover all product
liability or other claims.
We may face liability claims related to the use or misuse of our products and product
candidates in clinical trials or in commercial use. Liability claims may be expensive to defend
and may result in large judgments against us.
Although we maintain product liability insurance for claims arising from the use of our
products in clinical trials prior to FDA approval and for claims arising from the use of our
products after FDA approval at levels that we believe are appropriate, we cannot assure you that we
will
35
be able
to maintain our existing insurance coverage or obtain additional coverage on commercially reasonable terms for the use
of our other products in the future. Also, our insurance coverage and our resources may not be
sufficient to satisfy any liability resulting from product liability claims, and a product
liability claim could materially harm our business, financial condition or results of operations.
Generally,
our clinical trials are conducted in patients with serious life-threatening diseases
for whom conventional treatments have been unsuccessful, and, during the course of treatment, these
patients could suffer adverse medical effects or die for reasons that may or may not be related to
our products. Any of these events could result in a claim of liability. Any such claims against
us, regardless of their merit, could result in significant costs to defend or awards against us
that could materially harm our business, financial condition or results of operations.
We depend on key personnel and may not be able to retain these employees or recruit additional
qualified personnel, which would harm our business.
Because of the specialized scientific nature of our business, we are highly dependent upon
qualified scientific, technical and managerial personnel, including our Chief Executive Officer.
There is intense competition for qualified personnel in the pharmaceutical field. Therefore, we may
not be able to attract and retain the qualified personnel necessary for the development of our
business. Although we have employment agreements with our Chief Executive Officer, Chief Financial
Officer and Chief Scientific Officer, our ability to continue to retain such officers, as well as
other senior executives or key managers is not assured. The loss of the services of one or a
combination of our senior executives, particularly our Chief Executive Officer, Chief Financial
Officer and Chief Scientific Officer, as well as the failure to recruit additional key scientific,
technical and managerial personnel in a timely manner, would have an adverse effect on our
business.
Risks Related to Our Industry
We face rapid technological change and intense competition, which could harm our business and
results of operations.
The biopharmaceutical industry is characterized by rapid technological change. Our future
success will depend on our ability to maintain a competitive position with respect to technological
advances. Rapid technological development by others may result in our products and technologies
becoming obsolete.
We face intense competition from established biotechnology and pharmaceutical companies, as
well as academic and research institutions that are pursuing competing technologies and products.
We know that competitors are developing or manufacturing various products that are used for the
prevention, diagnosis or treatment of diseases that we have targeted for product development. For
example, PEG-INTRON faces increased competition from Hoffmann-La Roches Pegasys, Abelcet faces
increased competition from Astellas Pharma and Gilead Pharmaceuticals AmBisome and Three Rivers
Pharmaceuticals Amphotec. DepoCyt competes with the generic drugs, cytarabine and methotrexate,
and Oncaspar competes with ELSPAR® (asparaginase). In November 2006, the FDA accepted
an IND for OPi SA (France) for its product, Erwinase (Erwinia chryanthemi L-asparaginase).
Erwinase is approved in several countries outside the U.S. for treatment of ALL. Other existing
and future products, therapies and technological approaches will compete directly with our
products. Current and prospective competing products may provide greater therapeutic benefits for a
specific problem or may offer comparable performance at a lower cost. In addition, any product
candidate that we develop and that obtains regulatory approval must then compete for market
acceptance and market share.
Many of our competitors have substantially greater research and development capabilities and
experience and greater manufacturing, marketing and financial resources than we do. Accordingly,
our competitors may develop technologies and products that are superior to those we or our
collaborators are developing and render our technologies and products or those of our collaborators
obsolete and noncompetitive. In addition, many of our competitors have much more experience than we
do in preclinical
36
testing and human clinical trials of new drugs, as well as in obtaining FDA and other
regulatory approval. If we cannot compete effectively, our business and financial performance would
suffer.
The regulatory approval process is highly uncertain and we may not successfully secure approval for
new products. Failure to obtain, or delays in obtaining, regulatory approvals could materially
harm our business.
The marketing of pharmaceutical products in the U. S. and abroad is subject to stringent
governmental regulation. The sale of any new products for use in humans in the U. S. requires the
prior approval of the FDA. If our products are marketed abroad, they will also be subject to
extensive regulation by foreign governments, whether or not we have obtained FDA approval for a
given product and its uses. The FDA has established mandatory procedures and safety standards that
apply to the clinical testing and marketing of pharmaceutical products. The FDA regulates the
research, development, preclinical and clinical testing, manufacture, safety, effectiveness,
record-keeping, reporting, labeling, storage, approval, advertising, promotion, sale, distribution,
import and export of pharmaceutical and biological products. Obtaining FDA approval for a new
therapeutic product may take several years and involve substantial expenditures. Compliance with
these regulations can be costly, time consuming and subject us to unanticipated delays in
developing our products. We cannot assure you that we or our licensees will be able to obtain or
maintain FDA or other relevant marketing approval for any of our products.
Government regulation substantially increases the cost of researching, developing,
manufacturing and selling our products. The regulatory review and approval process, which includes
preclinical testing and clinical trials of each product candidate, is lengthy, expensive and
uncertain. We must obtain regulatory approval for each product we intend to market, and the
manufacturing facilities used for the products must be inspected and meet legal requirements.
Securing regulatory approval requires the submission of extensive preclinical and clinical data and
other supporting information for each proposed therapeutic indication in order to establish the
products safety, efficacy, potency and purity for each intended use. The development and approval
process takes many years, requires substantial resources and may never lead to the approval of a
product.
Even if we are able to obtain regulatory approval for a particular product, the approval may
limit the indicated uses for the product, may otherwise limit our ability to promote, sell and
distribute the product, may require that we conduct costly post-marketing surveillance and may
require that we conduct ongoing post-marketing studies. Material changes to an approved product,
such as manufacturing changes or revised labeling, may require further regulatory review and
approval. Once obtained, any approvals may be withdrawn for a number of reasons, including the
later discovery of previously unknown problems with the product, such as a safety issue. If we or
our contract manufacturers fail to comply with applicable regulatory requirements at any stage
during the regulatory process, such noncompliance could result in:
|
|
|
refusals or delays in the approval of applications or supplements to approved
applications; |
|
|
|
|
refusal of a regulatory authority, including the FDA, to review pending market
approval applications or supplements to approved applications; |
|
|
|
|
warning letters; |
|
|
|
|
fines; |
|
|
|
|
import or export restrictions; |
|
|
|
|
product recalls or seizures; |
|
|
|
|
injunctions; |
|
|
|
|
total or partial suspension of production; |
|
|
|
|
fines, civil penalties or criminal prosecutions; or |
|
|
|
|
withdrawals of previously approved marketing applications or licenses. |
In addition, any approved products are subject to continuing regulation. Among other things,
the holder of an approved biologic license application or new drug application is subject to
periodic and other FDA monitoring and reporting obligations, including obligations to monitor and
report adverse events and instances of the failure of a product to meet the specifications in the
biologic license application or new
37
drug application. Application holders must also submit advertising and other promotional
material to the FDA and report on ongoing clinical trials. Failure to meet these post-approval
requirements can result in criminal prosecution, fines or other penalties, injunctions, recall or
seizure of products, total or partial suspension of production, or denial or withdrawal of
pre-marketing product approvals.
Failure to obtain regulatory approval in foreign jurisdictions would prevent us from marketing
our products abroad. In order to market our products in the European Union and many other
jurisdictions outside the U.S., we must obtain separate regulatory approvals and comply with
numerous foreign regulatory requirements. The approval procedure varies among countries and can
involve additional testing. The time required to obtain approval may differ from that required to
obtain FDA approval. The foreign regulatory approval process may include all of the risks
associated with obtaining FDA approval. We may not obtain foreign regulatory approvals on a timely
basis, if at all. Approval by the FDA does not ensure approval by regulatory authorities in other
countries, and approval by one foreign regulatory authority does not ensure approval by regulatory
authorities in other foreign countries or by the FDA. We may not be able to file for regulatory
approvals and may not receive necessary approvals to commercialize our products in any market. The
failure to obtain these approvals could materially harm our business, financial condition and
results of operations.
If we or our licensees fail to obtain or maintain requisite governmental approvals or fail to
obtain or maintain approvals of the scope requested, it will delay or preclude us or our licensees
or marketing partners from marketing our products. It could also limit the commercial use of our
products. Any such failure or limitation may have a material adverse effect on our business,
financial condition and results of operations.
Even if we obtain regulatory approval for our products, they may not be accepted in the
marketplace.
Even if clinical trials demonstrate the safety and efficacy of our product candidates and all
regulatory approvals are obtained, our products may not gain market acceptance among physicians,
patients, third-party payors or the medical community. The degree of market acceptance will depend
on many factors, including:
|
|
|
the scope of regulatory approvals, |
|
|
|
|
establishment and demonstration of clinical efficacy and safety; |
|
|
|
|
cost-effectiveness of our products; |
|
|
|
|
alternative treatment methods and potentially competitive products; |
|
|
|
|
the availability of third-party reimbursement |
If our products do not achieve significant market acceptance, our business,
financial condition and results of operations may be materially harmed.
Our operations are subject to extensive environmental laws and regulations.
Our operations are subject to federal, state and local environmental laws and regulations
concerning, among other things, the generation, handling, storage, transportation, treatment and
disposal of hazardous, toxic and radioactive substances and the discharge of pollutants into the
air and water. Environmental permits and controls are required for some of our operations and these
permits are subject to modification, renewal and revocation by the issuing authorities. We believe
that our facilities are in substantial compliance with our permits and environmental laws and
regulations and do not believe that future compliance with current environmental law will have a
material adverse effect on our business, financial condition or results of operations. If, however,
we were to become liable for an accident, or if we were to suffer an extended facility shutdown as
a result of such contamination, we could incur significant costs, damages and penalties that could
harm our business.
38
Because of the uncertainty of pharmaceutical pricing, reimbursement and healthcare reform measures,
we may be unable to sell our products profitably in the U.S.
The availability of reimbursement by governmental and other third-party payors affects the
market for any pharmaceutical product. In recent years, there have been numerous proposals to
change the healthcare system in the U.S. and further proposals are likely. Some of these proposals
have included measures that would limit or eliminate payments for medical procedures and treatments
or subject the pricing of pharmaceuticals to government control. In addition, government and
private third-party payors are increasingly attempting to contain healthcare costs by limiting both
the coverage and the level of reimbursement of drug products. For example, under the Medicare
Prescription Drug Improvement and Modernization Act of 2003 (the Act), Medicare benefits are
provided primarily through private entities that attempt to negotiate price concessions from
pharmaceutical manufacturers. This may increase pressure to lower prescription drug prices. The Act
also includes other cost containment measures for Medicare in the event Medicare cost increases
exceed a certain level, which measures may impose limitations on prescription drug prices. These
changes in Medicare reimbursement could have a negative impact on our revenues derived from sales
of our products. Moreover, significant uncertainty exists as to the reimbursement status of
newly-approved healthcare products.
Our ability to commercialize our products will depend, in part, on the extent to which
reimbursement for the cost of the products and related treatments will be available from
third-party payors such as government health care programs and private health insurers. These
third-party payors control health care costs by limiting both coverage and the level of
reimbursement for new health care products. Third-party payors are increasingly challenging the
price and examining the cost effectiveness of medical products and services. If we or any of our
collaborators succeed in bringing one or more products to market, we cannot assure you that
third-party payors will establish and maintain price levels sufficient for realization of an
appropriate return on our investment in product development. In addition, lifetime limits on
benefits included in most private health plans may force patients to self-pay for treatment. For
example, patients who receive Adagen are expected to require injections for their entire lives.
The cost of this treatment may exceed certain plan limits and cause patients to self-fund further
treatment. Without reimbursement or with inadequate third-party coverage, the market for our
products may be limited, which could materially harm our business.
Significant changes in the healthcare system in the U.S. or elsewhere could have a material
adverse effect on our business and financial performance. In the future, the U.S. government may
institute price controls and further limits on Medicare and Medicaid spending. Moreover, medical
reimbursement systems vary internationally, with differing degrees of regulation. Pricing controls
and reimbursement limitations could affect the payments we receive from sales of our products.
These variations could harm our ability to sell our products in commercially acceptable quantities
at profitable prices.
The law or FDA policy could change and expose us to competition from generic or follow-on
versions of our products, which could adversely impact our business.
Under current U.S. law and FDA policy, generic versions of conventional chemical drug
compounds, sometimes referred to as small molecule compounds, may be approved through an
abbreviated approval process. There is no abbreviated approval process under current law for
biological products approved under the Public Health Service Act through a Biologic License
Application, such as monoclonal antibodies, cytokines, growth factors, enzymes, interferons and
certain other proteins. However, various proposals have been made to establish an abbreviated
approval process to permit approval of generic or follow-on versions of these types of biological
products under U.S. law, and the FDAs counterpart in the European Union has recently approved a
number of follow-on biologicals. It is not clear whether any proposed legislation on generic or
follow-on biologics will become law, or what form that law might take. However, if the law is
changed or if the FDA somehow extends its existing authority in new ways, and third parties are
permitted to obtain approvals of versions of our biological products through an abbreviated
approval mechanism, and without conducting full clinical studies of their own, it could adversely
affect our business.
39
Risks Related to Our Common Stock and our Convertible Notes
The price of our common stock has been, and may continue to be, volatile, which also may
significantly affect the trading price of our convertible notes.
Historically, the market price of our common stock has fluctuated over a wide range, and it is
likely that the price of our common stock will continue to be volatile in the future. The market
price of our common stock could be impacted due to a variety of factors, including, in addition to
global and industry-wide events:
|
|
|
the level of revenues we generate from our sale of products and royalties we
receive; |
|
|
|
|
the losses we incur or the profits we generate; |
|
|
|
|
the results of preclinical testing and clinical trials by us, our collaborative
partners or our competitors; |
|
|
|
|
announcements of technical innovations or new products by us, our collaborative
partners or our competitors; |
|
|
|
|
the status of corporate collaborations and supply arrangements; |
|
|
|
|
regulatory approvals; |
|
|
|
|
developments in patent or other proprietary rights; |
|
|
|
|
public concern as to the safety and efficacy of products developed by us or
others; and |
|
|
|
|
litigation. |
In addition, due to one or more of the foregoing factors in one or more future quarters, our
results of operations may fall below the expectations of securities analysts and investors. In that
event, the market price of our common stock could be materially and adversely affected. Volatility
in the price of our common stock may significantly affect the trading price of our convertible
notes.
Events with respect to our share capital could cause the shares of our common stock outstanding to
increase.
Sales of substantial amounts of our common stock in the open market, or the availability of
such shares for sale, could adversely affect the price of our common stock. We had approximately
44.2 million shares of common stock outstanding as of December 31, 2007. As of that date, the
following securities that may be exercised for, or are convertible into, shares of our common stock
were outstanding:
|
|
|
Options. Stock options to purchase 8.4 million shares of our common stock at a
weighted average exercise price of approximately $11.36 per share; |
|
|
|
|
4% convertible senior notes due 2013 (the 2013 convertible notes). Our 2013
convertible notes may be converted into 28.8 million shares of our common stock at
a conversion price of $9.55 per share. |
|
|
|
|
Restricted stock units. 1.8 million shares of our common stock issuable in
respect of outstanding restricted stock units held by officers, employees and
directors. |
The shares of our common stock that may be issued under the options, restricted stock units,
and the 2013 convertible notes are currently registered with the Securities and Exchange
Commission, and, therefore, those shares of common stock that may be issued will be eligible for
public resale.
The conversion of some or all of the convertible notes will dilute the ownership interests of
existing stockholders. Any sales in the public market of the common stock issuable upon such
conversion could adversely affect prevailing market prices of our common stock. In addition, the
existence of the notes may encourage short selling by market participants because the conversion of
the notes could depress the price of our common stock.
40
As of December 31, 2007, we also had outstanding our 4.5% convertible subordinated notes due
2008 that may be converted into 1.0 million shares of our common stock. However, the conversion
price for these notes is $70.98 per share, which makes their conversion highly unlikely.
Anti-takeover provisions in our charter documents and under Delaware law may make it more difficult
to acquire us, even though such acquisitions may be beneficial to our stockholders.
Provisions of our certificate of incorporation and bylaws, as well as provisions of Delaware
law, could make it more difficult for a third party to acquire us, even though such acquisitions
may be beneficial to our stockholders. These anti-takeover provisions include:
|
|
|
a classified board of directors whereby not all members of the board may be
elected at one
time; |
|
|
|
|
lack of a provision for cumulative voting in the election of directors, which would
otherwise
allow less than a majority of stockholders to elect director candidates; |
|
|
|
|
the ability of our board to authorize the issuance of blank check preferred stock to
increase
the number of outstanding shares and thwart a takeover attempt; |
|
|
|
|
advance notice requirements for nominations for election to the board of directors or for
proposing matters that can be acted upon by stockholders at stockholder meetings; and |
|
|
|
|
limitations on who may call a special meeting of stockholders. |
Further, we have in place a stockholder rights plan, commonly known as a poison pill. The
provisions described above, our stockholder rights plan and provisions of Delaware law relating to
business combinations with interested stockholders may discourage, delay or prevent a third party
from acquiring us. These provisions may also discourage, delay or prevent a third party from
acquiring a large portion of our securities, or initiating a tender offer, even if our stockholders
might receive a premium for their shares in the acquisition over the then current market price. We
also have agreements with our executive officers that provide for change of control severance
benefits which provides for cash severance, restricted stock and option award vesting acceleration
and other benefits in the event our employees are terminated (or, in some cases, resign for
specified reasons) following an acquisition. These agreements could discourage a third party from
acquiring us.
The issuance of preferred stock may adversely affect rights of common stockholders.
Under our certificate of incorporation, our board of directors has the authority to issue up
to three million shares of blank check preferred stock and to determine the price, rights,
preferences and privileges of those shares without any further vote or action by our stockholders.
The rights of the holders of common stock will be subject to the rights of the holders of any
shares of preferred stock that may be issued in the future. In addition to discouraging a
takeover, as discussed above, this blank check preferred stock may have rights, including
economic rights senior to the common stock, and, as a result, the issuance of such preferred stock
could have a material adverse effect on the market value of our common stock.
We may be unable to redeem our 2013 convertible notes upon a fundamental change.
We may be unable to redeem the 2013 convertible notes in the event of a fundamental change, as
defined in the related indenture. Upon a fundamental change, holders of the 2013 convertible notes
may require us to redeem all or a portion of the 2013 convertible notes. If a fundamental change
were to occur, we may not have enough funds to pay the redemption price for all tendered 2013
convertible notes. Any future credit agreements or other agreements relating to our indebtedness
may contain similar provisions, or expressly prohibit the repurchase of the 2013 convertible notes
upon a fundamental change or may provide that a fundamental change constitutes an event of default
under that agreement. If a fundamental change occurs at a time when we are prohibited from
purchasing or redeeming 2013 convertible notes, we could seek the consent of our lenders to redeem
the 2013 convertible notes or could attempt to refinance this debt. If we do not obtain a consent,
we
41
could not
purchase or redeem the 2013 convertible notes. Our failure to redeem tendered 2013 convertible notes would constitute an event of default under the
indenture governing the 2013 convertible notes.
The term fundamental change is limited to certain specified transactions as defined in the
indenture governing the 2013 convertible notes and may not include other events that might
adversely affect our financial condition or the market value of the 2013 convertible notes or our
common stock. Our obligation to offer to redeem the 2013 convertible notes upon a fundamental
change would not necessarily afford holders of the 2013 convertible notes protection in the event
of a highly leveraged transaction, reorganization, merger or similar transaction involving us.
The market for unrated debt is subject to disruptions that could have an adverse effect on the
market price of the 2013 convertible notes, or a market for our notes may fail to develop or be
sustained.
The 2013 convertible notes are not rated. As a result, holders of the notes have the risks
associated with an investment in unrated debt. Historically, the market for unrated debt has been
subject to disruptions that have caused substantial volatility in the prices of such securities and
greatly reduced liquidity for the holders of such securities. If the notes are traded, they may
trade at a discount from their initial offering price, depending on, among other things, prevailing
interest rates, the markets for similar securities, general economic conditions and our financial
condition, results of operations and prospects. The liquidity of, and trading markets for, the
notes also may be adversely affected by general declines in the market for unrated debt. Such
declines may adversely affect the liquidity of, and trading markets for, the notes, independent of
our financial performance or prospects. In addition, certain regulatory restrictions prohibit
certain types of financial institutions from investing in unrated debt, which may further suppress
demand for such securities. We cannot assure you that the market for the notes will not be subject
to similar disruptions or that any market for our notes will develop or be sustained. Any such
disruptions may have an adverse effect on the holders of the notes.
We may not have sufficient funds available to pay amounts due under our 2013 convertible notes.
We may not have sufficient funds available or may be unable to arrange for additional
financing to satisfy our obligations under our 2013 notes. Our ability to pay cash to holders of
the notes or meet our payment and other debt obligations depends on our ability to generate
significant cash flow in the future. This, to some extent, is subject to general economic,
financial, competitive, legislative and regulatory factors, as well as other factors that are
beyond our control. Also, the indenture governing our 2013 convertible notes does not contain any
financial or operating covenants or restrictions on the payments of dividends, the incurrence of
indebtedness or the issuance or repurchase of securities by us or any of our subsidiaries. We
cannot assure you that our business will generate cash flow from operations, or that future
borrowings will be available to us in an amount sufficient to enable us to meet our payment
obligations under the notes and our other obligations and to fund other liquidity needs.
42
Item 1B. Unresolved Staff Comments.
None.
Item 2. Properties
We
own a 56,000 square foot manufacturing facility in Indianapolis, Indiana, at which we
produce Abelcet, Oncaspar and Adagen for the Products segment and products we manufacture for
others on a contract basis (Contract Manufacturing segment). Our Indianapolis facility is not
subject to any mortgage.
The following are all of the facilities that we currently lease:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Approx. |
|
|
|
|
|
|
|
|
|
|
Square |
|
|
Approx. |
|
|
|
Location |
|
Principal Operations |
|
Footage |
|
|
Annual Rent |
|
Lease Expiration |
20 Kingsbridge Road Piscataway, NJ |
|
Research & Development |
|
|
56,000 |
|
$ |
640,000 |
(1) |
|
|
July 31, 2021 |
300 Corporate Ct. S. Plainfield, NJ |
|
Manufacturing |
|
|
24,000 |
|
$ |
228,000 |
|
|
|
October 31, 2012 |
685 Route 202/206 Bridgewater, NJ |
|
Administrative |
|
|
51,000 |
|
$ |
1.4 million |
(2) |
|
|
January 31, 2018 |
|
|
|
(1) |
|
Under the terms of the lease, annual rent increases over the remaining term of the
lease from $640,000 to $773,000. |
|
(2) |
|
Under the terms of the lease, annual rent increases over the remaining term of the
lease from $1.4 million to $1.5 million. |
We believe that our facilities are well maintained and generally adequate for our present and
future anticipated needs.
The research and development activities at the Piscataway facility and the manufacturing
facility in South Plainfield support the Products segment. The administrative functions in
Bridgewater support all segments.
In February 2007, our board of directors approved a plan to consolidate our manufacturing
operations in Indianapolis, Indiana from our South Plainfield, New Jersey facility. We expect this
consolidation to be completed during 2008 and that this change will help streamline operations and
eliminate certain redundancies. If we are unsuccessful in subletting the South Plainfield
facility, we will be obligated to pay the annual rent through lease expiration of October 31, 2012.
See Note 10 Restructuring to the accompanying consolidated financial statements.
Item 3. Legal Proceedings
There is no pending material litigation to which we are a party or to which any of our
property is subject.
Item 4. Submission of Matters to a Vote of Security Holders
None.
43
PART II
Item 5. Market for the Registrants Common Equity, Related Stockholder Matters, and Issuer
Purchases of Equity Securities
Market Information
Our common stock is traded on the NASDAQ Global Market under the trading symbol ENZN.
The following table sets forth the high and low sale prices for our common stock during the
years ended December 31, 2007 and December 31, 2006 as reported by the NASDAQ Global Market. The
quotations shown represent inter-dealer prices without adjustment for retail markups, markdowns or
commissions, and may not necessarily reflect actual transactions.
|
|
|
|
|
|
|
|
|
|
|
High |
|
Low |
Year Ended December 31, 2007 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
9.16 |
|
|
$ |
7.96 |
|
Second Quarter |
|
|
8.81 |
|
|
|
7.85 |
|
Third Quarter |
|
|
8.85 |
|
|
|
6.44 |
|
Fourth Quarter |
|
|
10.24 |
|
|
|
8.97 |
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, 2006 |
|
|
|
|
|
|
|
|
First Quarter |
|
$ |
8.35 |
|
|
$ |
6.50 |
|
Second Quarter |
|
|
9.28 |
|
|
|
7.06 |
|
Third Quarter |
|
|
8.49 |
|
|
|
7.12 |
|
Fourth Quarter |
|
|
8.73 |
|
|
|
7.84 |
|
44
Total Return To Shareholders
(Includes reinvestment of dividends)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
RETURN PERCENTAGE |
|
|
|
Periods
Ending |
|
Company / Index |
|
6/04 |
|
|
6/05 |
|
|
12/05* |
|
|
12/06 |
|
|
12/07 |
|
|
Enzon Pharmaceuticals, Inc. |
|
|
1.67 |
|
|
|
-49.22 |
|
|
|
14.20 |
|
|
|
15.00 |
|
|
|
11.99 |
|
Nasdaq U.S. Index |
|
|
27.18 |
|
|
|
-0.11 |
|
|
|
7.42 |
|
|
|
10.27 |
|
|
|
9.93 |
|
Nasdaq Pharmaceutical Index |
|
|
9.20 |
|
|
|
-3.95 |
|
|
|
20.09 |
|
|
|
0.29 |
|
|
|
-2.37 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Base |
|
INDEXED RETURNS |
|
|
|
Period |
|
Periods
Ending |
|
Company / Index |
|
6/03 |
|
6/04 |
|
|
6/05 |
|
|
12/05* |
|
|
12/06 |
|
|
12/07 |
|
|
Enzon Pharmaceuticals, Inc. |
|
100 |
|
|
101.67 |
|
|
|
51.63 |
|
|
|
58.96 |
|
|
|
67.81 |
|
|
|
75.94 |
|
Nasdaq U.S. Index |
|
100 |
|
|
127.18 |
|
|
|
127.04 |
|
|
|
136.47 |
|
|
|
150.48 |
|
|
|
165.42 |
|
Nasdaq Pharmaceutical Index |
|
100 |
|
|
109.20 |
|
|
|
104.89 |
|
|
|
125.96 |
|
|
|
126.32 |
|
|
|
123.32 |
|
* Six-month data.
45
Holders
As
of February 27, 2008, there were 1,359 holders of record of our common stock.
Dividends
We have never declared or paid any cash dividends on our common stock and do not anticipate
paying any cash dividends in the foreseeable future. We currently intend to retain future earnings
to fund the development and growth of our business.
46
Item 6. Selected Financial Data
Set forth below is our selected financial data for the years ended December 31, 2007 and 2006,
the six-month period ended December 31, 2005 and the three fiscal years ended June 30, 2005 (in
thousands, except per-share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
|
|
|
|
Year Ended |
|
|
Ended |
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
Year Ended June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 (1) |
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Consolidated Statement of Operations
Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues(2) |
|
$ |
185,601 |
|
|
$ |
185,653 |
|
|
$ |
73,699 |
|
|
$ |
166,250 |
|
|
$ |
169,571 |
|
|
$ |
146,406 |
|
Cost of product sales and contract
manufacturing |
|
|
54,978 |
|
|
|
50,121 |
|
|
|
23,216 |
|
|
|
46,023 |
|
|
|
46,986 |
|
|
|
28,521 |
|
Research and development |
|
|
56,507 |
|
|
|
43,521 |
|
|
|
13,985 |
|
|
|
36,957 |
|
|
|
34,769 |
|
|
|
20,969 |
|
Write-down of carrying value of
investment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,341 |
|
|
|
27,237 |
|
Acquired in-process research
and development |
|
|
|
|
|
|
11,000 |
|
|
|
10,000 |
|
|
|
|
|
|
|
12,000 |
|
|
|
|
|
Restructuring charge |
|
|
7,741 |
(3) |
|
|
|
|
|
|
|
|
|
|
2,053 |
|
|
|
|
|
|
|
|
|
Write-down of goodwill and
intangibles (4) |
|
|
|
|
|
|
|
|
|
|
284,101 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of royalty interest |
|
|
(88,666 |
)(5) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other operating expenses |
|
|
64,547 |
|
|
|
70,511 |
|
|
|
35,312 |
|
|
|
70,642 |
|
|
|
60,433 |
|
|
|
39,782 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
90,494 |
|
|
|
10,500 |
|
|
|
(292,915 |
) |
|
|
10,575 |
|
|
|
7,042 |
|
|
|
29,897 |
|
Investment income, net |
|
|
10,918 |
|
|
|
24,670 |
|
|
|
3,248 |
|
|
|
4,360 |
|
|
|
13,396 |
|
|
|
8,942 |
|
Interest expense |
|
|
(17,380 |
) |
|
|
(22,055 |
) |
|
|
(9,841 |
) |
|
|
(19,829 |
) |
|
|
(19,829 |
) |
|
|
(19,828 |
) |
Other, net |
|
|
954 |
|
|
|
8,952 |
|
|
|
(2,776 |
) |
|
|
(6,768 |
) |
|
|
6,776 |
|
|
|
26,938 |
|
Income tax (provision) benefit |
|
|
(1,933 |
) |
|
|
(758 |
) |
|
|
10,947 |
|
|
|
(77,944 |
) |
|
|
(3,177 |
) |
|
|
(223 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
83,053 |
|
|
$ |
21,309 |
|
|
$ |
(291,337 |
) |
|
$ |
(89,606 |
) |
|
$ |
4,208 |
|
|
$ |
45,726 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common
share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
1.89 |
|
|
$ |
0.49 |
|
|
$ |
(6.69 |
) |
|
$ |
(2.06 |
) |
|
$ |
0.10 |
|
|
$ |
1.06 |
|
Diluted |
|
$ |
1.29 |
|
|
$ |
0.46 |
|
|
$ |
(6.69 |
) |
|
$ |
(2.06 |
) |
|
$ |
0.10 |
|
|
$ |
1.05 |
|
No dividends have been declared.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
Consolidated Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current assets |
|
$ |
281,177 |
|
|
$ |
212,311 |
|
|
$ |
207,215 |
|
|
$ |
213,882 |
|
|
$ |
179,291 |
|
|
$ |
154,676 |
|
Current liabilities(6) |
|
|
105,482 |
|
|
|
59,885 |
|
|
|
31,146 |
|
|
|
37,854 |
|
|
|
31,664 |
|
|
|
34,345 |
|
Total assets(4) |
|
|
420,357 |
|
|
|
403,830 |
|
|
|
341,345 |
|
|
|
650,861 |
|
|
|
722,410 |
|
|
|
728,566 |
|
Long-term debt(6) |
|
|
275,000 |
|
|
|
397,642 |
|
|
|
394,000 |
|
|
|
399,000 |
|
|
|
400,000 |
|
|
|
400,000 |
|
Total stockholders equity (deficit)(4) |
|
|
36,573 |
|
|
|
(56,441 |
) |
|
|
(83,970 |
) |
|
|
203,502 |
|
|
|
289,091 |
|
|
|
291,584 |
|
|
|
|
(1) |
|
The Company adopted the provisions of Statement of Financial Accounting Standards
No. 123R, Share-Based Payment, effective July 1, 2005. |
|
(2) |
|
The Company modified its royalty revenue estimation process in December 2005. As a
result, there was a one-time one-quarter delay in recognition of certain significant royalty
revenues from the six months ended December 31, 2005 into the year ended December 31, 2006. |
|
(3) |
|
During 2007, the Company initiated a program to consolidate manufacturing operations
at its Indianapolis, Indiana facility. Refer to Note 10 of the accompanying consolidated
financial statements. |
47
|
|
|
(4) |
|
The Company recognized an impairment of goodwill and intangibles in the six months
ended December 31, 2005. Refer to Note 7 of the accompanying consolidated financial statements. |
|
(5) |
|
The Company sold a 25% interest in its PEG-INTRON royalty. Refer to Note 11 of the
accompanying consolidated financial statements. |
|
(6) |
|
As of December 31, 2007, $72,391 outstanding principal amount of 4.5% notes payable
is due July 1, 2008 and is classified as a current liability. |
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
The
following discussion of our financial condition and results of operations should be read together with our consolidated financial statements and notes to those statements included in Item 8 of Part II of this Form 10-K.
Overview
We are a biopharmaceutical company dedicated to the development, manufacturing and
commercialization of important medicines for patients with cancer and other life-threatening
conditions. We operate in three business segments: Products, Royalties and Contract
Manufacturing. We have a portfolio of four marketed products, Oncaspar, DepoCyt, Abelcet and
Adagen. Our drug development programs utilize several cutting-edge approaches, including our
industry-leading PEGylation technology platform used to create product candidates with benefits
such as reduced dosing frequency and less toxicity. Our PEGylation technology was used to develop
two of our products, Oncaspar and Adagen, and has created a royalty revenue stream from licensing
partnerships for other products developed using the technology. Enzon also engages in contract
manufacturing for several pharmaceutical companies to broaden the Companys revenue base.
Results of Operations
Effective December 31, 2005, we changed our fiscal year-end from June 30 to December 31. The
discussion and analysis that follows covers our results of operations and cash flows for the three
years ended December 2007, 2006 and 2005. Because of the change in fiscal year, the full-year 2005
information was compiled from our Transition Report on Form 10-K for the six months ended December
31, 2005, our Annual Report on Form 10-K for the fiscal year ended June 30, 2005 and our Quarterly
Report on Form 10-Q for quarter ended March 31, 2005. Quarterly data were not audited.
Summary-level overview year ended December 31, 2007 compared to 2006
Total revenues of $185.6 million were unchanged in 2007 compared to 2006. Products segment
revenues remained constant as a group. A reduction in 2007 fourth-quarter royalty revenues from
PEG-INTRON due to the sale of a 25% interest therein was offset by a rise in contract manufacturing
revenues for the year. Income before tax for the year ended December 31, 2007 was $85.0 million
compared to $22.1 million in 2006. Major operating factors contributing to the rise were the gain
on the sale of the royalty interest of $88.7 million partially offset by $7.7 million of
restructuring costs. Company-wide spending on research and development rose approximately $13.0
million in 2007 compared to 2006, but acquired in-process research and development expenditures of
$11.0 million experienced in 2006 were not repeated in 2007. Other major effects include: $7.0
million of legal costs related to securing the supply of Oncaspar raw material in 2006, not
incurred in 2007; a $13.8 million gain on sale of equity securities in 2006 not recurring in 2007
and lower interest expense in 2007 of $4.7 million compared to 2006, due to the refinancing and
repurchases of our debt.
Summary-level overview year ended December 31, 2006 compared to 2005
Total revenues rose $29.1 million for the year ended December 31, 2006 to $185.7 million from
$156.6 million in full year 2005. The largest component of total revenues is product sales which
grew by 7% in the year ended December 31, 2006 to $101.0 million. Total revenues reflect four full
quarters of royalties in 2006 versus approximately three quarters in 2005 contributing to a higher
increase than actual growth in royalty activity. There was a one-quarter deferral of royalty
revenue in 2005 to improve the recognition process. Income before tax for the year
48
ended December
31, 2006 was $22.1 million as compared to a loss before income tax of $312.5 million for the twelve months ended December
31, 2005. Our financial results in 2005 were significantly impacted by the write-down of
intangible assets and goodwill totaling $284.1 million. The one-quarter deferral in royalty
revenue recognition in 2005 also affected comparisons of operating results.
Further discussion of these and other revenue and profitability fluctuations is contained in
the segment analyses that follow.
The percentage changes throughout this Managements Discussion and Analysis are based on
thousands of dollars and not the rounded millions of dollars reflected throughout this section.
Following is a reconciliation of segment profitability to consolidated income (loss) before income
tax (millions of dollars):
Overview
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
|
December |
|
|
December |
|
|
December |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
Products segment profit (loss) |
|
$ |
7.6 |
|
|
$ |
20.5 |
|
|
$ |
(267.6 |
)(2) |
Royalties segment profit |
|
|
156.0 |
(1) |
|
|
70.6 |
|
|
|
48.3 |
|
Contract Manufacturing
segment profit (loss) |
|
|
4.4 |
|
|
|
2.3 |
|
|
|
(3.3 |
)(2) |
Corporate and other expenses |
|
|
(83.0 |
) |
|
|
(71.3 |
) |
|
|
(89.9 |
) |
|
|
|
|
|
|
|
|
|
|
Income (loss) before income tax |
|
$ |
85.0 |
|
|
$ |
22.1 |
|
|
$ |
(312.5 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes $88.7 million gain on sale of 25% interest in PEG-INTRON royalties. |
|
(2) |
|
Impairment losses of $277.1 million in the Products segment related to
goodwill and Abelcet intangible assets and $7.0 million in the Contract Manufacturing
segment related to goodwill were recognized in December 2005. |
We do not allocate certain corporate income and expenses not directly identifiable with the
respective segments, including exploratory and preclinical research and development expenses,
general and administrative expenses, depreciation, investment income, interest income, interest
expense or income taxes. Research and development expense is considered a corporate expense unless
it relates to an existing marketed product or a product candidate enters Phase III clinical trials
at which time related costs would be chargeable to one of our operating segments.
Products Segment
Products segment profitability (millions of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
|
December |
|
|
% |
|
|
December |
|
|
% |
|
|
December |
|
|
|
2007 |
|
|
Change |
|
|
2006 |
|
|
Change |
|
|
2005 |
|
Revenues |
|
$ |
100.7 |
|
|
|
|
|
|
$ |
101.0 |
|
|
|
7 |
|
|
$ |
94.2 |
|
Cost of sales |
|
|
41.8 |
|
|
|
9 |
|
|
|
38.3 |
|
|
|
8 |
|
|
|
35.6 |
|
Research and development |
|
|
11.0 |
|
|
|
50 |
|
|
|
7.3 |
|
|
|
304 |
|
|
|
1.8 |
|
Selling and marketing |
|
|
31.9 |
|
|
|
(6 |
) |
|
|
34.1 |
|
|
|
1 |
|
|
|
33.9 |
|
Amortization |
|
|
0.7 |
|
|
|
(5 |
) |
|
|
0.8 |
|
|
|
n.m. |
|
|
|
13.4 |
|
Write-down of goodwill
and intangibles |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
n.m. |
|
|
|
277.1 |
|
Restructuring charge |
|
|
7.7 |
|
|
|
n.m. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment profit (loss) |
|
$ |
7.6 |
|
|
|
(63 |
) |
|
$ |
20.5 |
|
|
|
n.m. |
|
|
$ |
(267.6 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
49
Revenues
Sales performance of individual products is provided below (millions of dollars):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
|
December |
|
|
% |
|
|
December |
|
|
% |
|
|
December |
|
Product |
|
2007 |
|
|
Change |
|
|
2006 |
|
|
Change |
|
|
2005 |
|
Oncaspar |
|
$ |
38.7 |
|
|
|
25 |
|
|
$ |
30.9 |
|
|
|
27 |
|
|
$ |
24.4 |
|
DepoCyt |
|
|
8.6 |
|
|
|
4 |
|
|
|
8.3 |
|
|
|
4 |
|
|
|
7.9 |
|
Abelcet |
|
|
28.9 |
|
|
|
(21 |
) |
|
|
36.5 |
|
|
|
(12 |
) |
|
|
41.5 |
|
Adagen |
|
|
24.5 |
|
|
|
(3 |
) |
|
|
25.3 |
|
|
|
25 |
|
|
|
20.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
$ |
100.7 |
|
|
|
|
|
|
$ |
101.0 |
|
|
|
7 |
|
|
$ |
94.2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2007 compared to 2006
Net product sales of $100.7 million for 2007 are largely unchanged on an aggregate basis from
the total reached in 2006, however, the composition of sales by product reflects some significant
shifts. Sales of our lead oncology agent, Oncaspar, grew $7.8 million or 25% for the year ended
December 31, 2007 to $38.7 million compared to 2006. The growth in volume of Oncaspar during 2007
was approximately 12%. The U.S. Food and Drug Administration (FDA) approved Oncaspar for the
first-line treatment of patients with acute lymphoblastic leukemia (ALL) in July 2006. The
increase in Oncaspar sales is attributable to the continued transition to its first-line use and
the adoption of protocols in pediatric and adult patients some of which call for dosage regimens
that will include a greater number of weeks of Oncaspar therapy. There was also an April 1, 2007
price increase. Sales of DepoCyt, for treatment of lymphomatous meningitis, and Adagen, for the
treatment of severe combined immuno-deficiency disease, tend to fluctuate from period to period due
to their small patient bases. Sales of DepoCyt increased to $8.6 million or 4% in 2007 from $8.3
million last year whereas sales of Adagen decreased 3% in 2007 to $24.5 million from $25.3 million
in 2006. As noted last year, Adagen sales in 2006 were somewhat elevated due to a newly negotiated
distributor contract and that distributor adjusting inventory levels in line with industry norms.
Both DepoCyt and Adagen were impacted by an April 1, 2007 price increase. In April 2007, the FDA
granted full approval of DepoCyt. Originally, DepoCyt was conditionally approved under the FDAs
Sub Part H regulation. Abelcet, our intravenous antifungal product, experienced sales in the U.S.
and Canada that were 21% lower for the year ended December 31, 2007 at $28.9 million than the $36.5
million recorded for the year ended December 31, 2006 due to continued competition from the
numerous therapeutics in the anti-fungal market.
Year ended December 31, 2006 compared to 2005
Net product sales of $101.0 million in the year ended December 31, 2006 represented 7% growth
over net product sales of $94.2 million in the year ended December 31, 2005. The growth was
primarily attributable to volume increases of approximately 20% each for Oncaspar and Adagen. The
continued decline in sales of Abelcet was more than offset by growth in our other products. Sales
of Oncaspar grew to $30.9 million or 27% for the year 2006 compared to $24.4 million in 2005. The
growth of Oncaspar was mainly attributable to its continued adoption in certain protocols by
hospitals and cooperative groups. On July 25, 2006, we announced the approval of Oncaspar for the
first line treatment of patients with ALL. Sales of DepoCyt increased to $8.3 million in 2006 from
$7.9 million in 2005 due to pricing. Abelcet sales in the U.S. and Canada declined 12% in 2006
compared to 2005 in the face of continued competition from current and new therapeutics in the
anti-fungal market. Adagen experienced growth in sales of 25% from $20.4 million in 2005 to $25.3
million in 2006. The increase was primarily the result of a newly negotiated contract with our
distributor and the distributors establishment during the fourth quarter of 2006 of inventory
levels in line with industry norms.
50
Cost of product sales
In 2007, cost of products sold rose as a percentage of net sales to approximately 41% from 38%
in 2006.
In December 2006, we entered into supply and license agreements with Ovation for the active
ingredient used in the product of Oncaspar. A resulting license fee of $17.5 million caused a $2.3
million increase in 2007 amortization expense charged to Oncaspar cost of products sold. In 2008,
the raw material component of the Oncaspar cost of goods will increase, as we start to sell product
that has been manufactured using the active ingredient purchased through the new supply agreement
with Ovation. Higher supplier costs of materials and negative production variances contributed to
lower Adagen and Abelcet margins, respectively, in 2007. Also, the ongoing transfer of production
of Oncaspar and Adagen from our South Plainfield, New Jersey facility to our Indianapolis, Indiana
facility, discussed under restructuring below, resulted in $1.9 million of cost related to required
production test batches to validate the new production processes and assure continued product
quality and stability.
In the year ended December 31, 2006, cost of products sold as a percentage of net sales
remained relatively stable overall at 38% when compared to the year ended December 31, 2005.
Oncaspar royalty costs were significantly reduced in 2006 by $5.3 million due to the January 1,
2006 negotiated lowering of royalties with Sanofi-Aventis. Offsetting this, in part, was a $4.1
million increase in amortization resulting from the intangible that arose from the $35.0 million
payment made to Sanofi-Aventis in connection with the royalty reduction. Some inventory write-offs
were also experienced in relation to Oncaspar, but other production costs were lower as a percent
of sales resulting in a net improvement in margins for the product. Abelcet costs were favorably
affected by the December 2005 write-down of related intangibles and the consequent lowering of
amortization expense in 2006 as compared to 2005. Also, Abelcet inventory write-off losses
experienced in 2005 were not repeated in 2006. These improvements in Abelcet cost of sales were
largely offset by lower margins in Adagen due to the write-off of certain batch failures. DepoCyt
margins remained relatively unchanged.
Research and development expenses
Products segment research and development spending increased by 50% in 2007 to $11.0 million
from $7.3 million in 2006. Our existing marketed products are in the later stages of their
respective life cycles. For this reason, research and development spending related to marketed
products has been directed largely towards securing and maintaining a reliable supply of the
ingredients used in their production primarily in the production of Oncaspar and Adagen. In
August 2006, we initiated a phase I clinical trial of Oncaspar to assure its safety and potential
utility in the treatment of advanced solid tumors and lymphomas in combination therapy. As
announced in February 2008, the Oncaspar solid tumor trial in combination therapy reached
dose-limiting toxicities. The data are currently being analyzed to better understand whether the
combination of Oncaspar and Gemzar warrants further development in solid tumors and lymphoma.
Research and development spending on marketed products is expected to continue.
Selling and marketing expenses
Selling and marketing expenses consist primarily of salaries and benefits for our sales and
marketing personnel, as well as other commercial expenses and marketing programs to support our
sales force. Also included in selling and marketing expenses are the costs associated with our
medical affairs function, including a medical science liaison group.
Selling and marketing expenses declined 6% to $31.9 million in 2007 when compared to $34.1
million in 2006, due primarily to lower promotional costs this year. In late 2007, we realigned
our sales territories to improve the efficiency of our sales force. We continue to make selective
investments in selling, marketing and medical affairs.
51
The aggregate spending on selling and marketing expense of $34.1 million during the year ended
December 31, 2006 remained relatively constant compared to $33.9 million in the same period of
2005. Oncaspar expansion due to the first line approval for ALL announced in July 2006 was a key
focus. We also supported a repositioning of Abelcet during 2006.
Amortization of acquired intangibles
Amortization expense of approximately $0.7 million in 2007 and $0.8 million in 2006 was
principally related to Abelcet intangible assets. During the quarter ended December 31, 2005, we
recognized an impairment write-down of nearly all Abelcet-related assets amounting to $133.1
million (see write-down of goodwill and intangibles below). This write-down significantly reduced
periodic amortization expense in the year ended December 31, 2006 from $13.4 million in the twelve
months ended December 31, 2005.
Write-down of goodwill and intangibles
The majority of our intangible assets prior to 2006 had been acquired in November 2002 with
the acquisition of Abelcet. By late 2004 and into 2005, Abelcet sales had declined from historical
levels and a long-term strategic plan completed in November 2005 indicated that it was unlikely
sales would recover to prior levels. In light of this impairment indicator, we engaged an
independent valuation specialist, Duff and Phelps, to assist us in determining the fair value of
the Abelcet asset group and test for impairment in accordance with Statement of Financial
Accounting Standards (SFAS) No. 144, Accounting for the Impairment or Disposal of Long-Lived
Assets. Initial testing disclosed that the future undiscounted net cash flows to be generated by
the asset group were insufficient to cover the carrying value of the Abelcet-related intangibles.
The fair value of these intangible assets was then calculated and a non-cash impairment charge was
recognized in the Products segment for the excess of carrying amount over fair value in the
aggregate amount of $133.1 million during the quarter ended December 31, 2005.
Effective in the quarter ended December 31, 2005, we changed the manner in which we manage and
evaluate the performance of our operations which resulted in a change to our business segmentation
and the identification of our related reporting units. This new segmentation necessitated the
allocation of our existing goodwill to the newly identified reporting units on a relative
fair-value basis. Further, we considered the historical declining performance of the Abelcet
products and the impairment recognized of the related intangible assets to be indicators that our
Products segment goodwill may be impaired. With the assistance of Duff and Phelps, we determined
the fair value of our reporting units, to assist us with the allocation of our goodwill and
estimate the fair value of currently marketed product intangibles. The allocation process resulted
in the Products segment being assigned $144.0 million of goodwill. The ensuing testing to estimate
the implied fair value of this goodwill disclosed that it was impaired in its entirety.
Accordingly, a non-cash impairment loss related to goodwill was recorded in the amount of $144.0
million in the Products segment during the quarter ended December 31, 2005.
Restructuring
During the first quarter of 2007, we announced plans to consolidate our manufacturing
operations in our Indianapolis, Indiana location. This action was taken as part of our continued
efforts to streamline operations. All operations at our South Plainfield, New Jersey facility are
expected to be transferred to our Indianapolis facility in 2008, resulting in the incurrence of
certain restructuring and exit costs. Among these costs will be employee severance and related
benefits for affected employees estimated to be $3.5 million. These amounts are expected to be
paid in 2008 upon the successful transfer of production to our Indianapolis facility and closure of
our South Plainfield facility. Severance charges and related benefits of $2.2 million have been
recognized through December 31, 2007. We expect to incur other costs during 2008 related to the
relocation of goods and equipment, which will be recognized when costs are incurred.
52
Certain assets consisting primarily of manufacturing equipment that will not be transferred to
the Indianapolis facility, nor continue to be used in manufacturing at the South Plainfield
facility were decommissioned during 2007. Accordingly, we recognized the remaining depreciation
totaling $5.1 million on these assets during 2007.
In the three months ended June 30, 2007, $1.9 million, the cost of required validation batches
at our Indianapolis facility for both Oncaspar and Adagen, was expensed and included in cost of
product sales. There were no charges for validation batches during the other quarters of 2007.
We may experience costs associated with the lease termination or the subleasing of the South
Plainfield facility. Such costs will be incurred and recognized when we cease use of the property
in 2008. However, we do not know at this time what the final use or disposition of the leased
South Plainfield facility will be.
Additionally, during 2007, we recognized $0.4 million of employee severance and related
benefits when we combined our previous two specialized sales forces into one sales team. This, in
addition to severance costs of $2.2 million and equipment write-downs of $5.1 million associated
with the manufacturing consolidation, discussed above, brought total 2007 restructuring charges to
$7.7 million.
Royalties Segment
Royalties segment profitability (millions of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
|
December |
|
|
% |
|
|
December |
|
|
% |
|
|
December |
|
|
|
2007 |
|
|
Change |
|
|
2006 |
|
|
Change |
|
|
2005 |
|
Royalty revenue |
|
$ |
67.3 |
|
|
|
(5 |
) |
|
$ |
70.6 |
|
|
|
n.m. |
|
|
$ |
48.3 |
|
Gain on sale of royalty interest |
|
|
88.7 |
|
|
|
n.m. |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment profit |
|
$ |
156.0 |
|
|
|
n.m. |
|
|
$ |
70.6 |
|
|
|
n.m. |
|
|
$ |
48.3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The majority of total royalties is comprised of royalty revenue we receive on sales of
PEG-INTRON, a PEG-enhanced version of Schering-Ploughs alpha interferon product, INTRON A, which
is used for the treatment of chronic hepatitis C. Total royalties also include other royalty
revenue and certain license revenues related to the application of our technology to other firms
products. For example, under an agreement we have with Nektar Therapeutics, Inc. (Nektar), OSI
Pharmaceuticals has sublicensed our PEGylation technology for use in Macugen for the treatment of
neovascular (wet) age-related macular degeneration, an eye disease associated with aging that
destroys central vision. Nektar also has a sublicense with Hoffmann-La Roche relating to Pegasys,
a treatment for hepatitis C. We receive a share of the royalties Nektar receives from OSI
Pharmaceuticals and Hoffmann-La Roche.
We recognize royalty revenue when it is reasonably determinable and collection is reasonably
assured which, beginning with the quarter ended December 31, 2005, is the notification from the
third-party licensee of the royalties earned under the license agreement. This information is
generally received from the licensees in the quarter subsequent to the period in which the sales
occur. The one-quarter deferral of royalty revenue recognition had no effect on our cash flows but
has inhibited period-to-period revenue comparisons. The years ended December 2007 and 2006 reflect
royalties earned on underlying sales made in the twelve-month period October 1 of the preceding
year through September 30 of the current year whereas, the year ended December 31, 2005 reflects
royalties on sales made January 1 through September 30, 2005. The impact on revenue comparisons is
discussed below.
53
Total royalty revenue of $67.3 million for the year ended December 31, 2007 was 5% lower
than
the $70.6 million reported during the year ended December 31, 2006. The decline was primarily
attributable to the fact that the Company sold a 25% interest in royalties payable to it by
Schering-Plough Corporation on net sales of PEG-INTRON occurring after June 30, 2007. In our
fourth quarter of 2007, because of the one-quarter lag in royalty revenue recognition and the sale
of 25% of the revenue stream, we reported just 75% of the total royalty revenues generated from
sales of PEG-INTRON for quarter ended September 30, 2007, compared to full recognition in all
quarters of 2006. Apart from the decrease in percentage of royalties received, there was a modest
rise in sales of PEG-INTRON. Increased Pegasys royalties were offset by the effects of competition
for Macugen in the U.S.
The gain on the sale of the 25% interest in PEG-INTRON royalties, net of related costs, was
$88.7 million. The purchaser of the royalty interest will be obligated to pay an additional $15.0
million to us in the first quarter of 2012 if it achieves a certain threshold level of royalties on
sales of PEG-INTRON occurring from July 1, 2007 through December 31, 2011. The $15.0 million
contingent gain will be recognized when and if the contingency is removed and collection is
assured, however, at this time, we do not anticipate that the threshold will be reached.
The year ended December 2006 reflected a full years revenues whereas the one-quarter deferral
of royalty revenue discussed above resulted in the year ended December 2005 representing
essentially just three quarters revenues. PEG-INTRON sales continued to grow in 2006 as a result
of its launch in Japan. However, as anticipated, Schering-Plough reported a decline in PEG-INTRON
sales in Japan in the fourth quarter of 2006 as new patient enrollment moderated as a result of
increased competition. Macugen also experienced significant competition from a newly approved
agent as anticipated.
The future revenues to be received from the use of our technology are dependent upon numerous
factors outside of our control such as competition and the effectiveness of marketing by our
licensees. These factors include the approval of new agents like Cimzia and Hematide, new uses and
geographies for PEG-INTRON and increased competition. Also, the 2007 sale of a 25% interest in
future PEG-INTRON royalties will lower royalty revenues commensurately.
Costs and expenses
Current royalty revenues do not require any material specific maintenance costs. At some
point in the future, costs associated with initiation of new outlicensing agreements that could
result in our receipt of a royalty stream and, if necessary, costs necessary to maintain the
underlying technology may be charged to the Royalties segment.
Contract Manufacturing Segment
Contract manufacturing revenues are primarily comprised of revenues from the manufacture of
MYOCET and Abelcet for Cephalon for the European market, and to a lesser extent, the manufacture of
an injectable multivitamin, MVI, for Mayne Pharma, Ltd., a division of Hospira, Inc.
Contract manufacturing segment profitability (millions of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
|
December |
|
|
% |
|
|
December |
|
|
% |
|
|
December |
|
|
|
2007 |
|
|
Change |
|
|
2006 |
|
|
Change |
|
|
2005 |
|
Revenues |
|
$ |
17.6 |
|
|
|
25 |
|
|
$ |
14.1 |
|
|
|
|
|
|
$ |
14.1 |
|
Cost of sales |
|
|
13.2 |
|
|
|
12 |
|
|
|
11.8 |
|
|
|
14 |
|
|
|
10.4 |
|
Write-down of goodwill |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
n.m. |
|
|
|
7.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment profit (loss) |
|
$ |
4.4 |
|
|
|
91 |
|
|
$ |
2.3 |
|
|
|
n.m. |
|
|
$ |
(3.3 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
54
Revenues
Contract manufacturing revenue for the year ended December 31, 2007 rose 25% to $17.6 million
over the $14.1 million recorded in 2006 reflecting, in part, managements efforts to generate
additional business in this segment and the reflection of a full year of business under two
contracts entered into near the end of 2006. The two referenced contracts entered into in 2006
involve the production of research materials. Accordingly, we cannot be certain we will be able to
sustain the level of revenue we experienced during the year ended December 31, 2007 ($3.4 million
versus $0.3 million in 2006). Also, the 2006 revenue amount was adversely affected by a $1.2
million billing adjustment.
Contract manufacturing revenue remained unchanged at $14.1 million between 2006 and 2005.
Declines in international sales of Abelcet-related revenues were largely offset by growth in MVI
and MYOCET. Abelcet international revenues were down, in part, due to declining demand but also
due to a billing adjustment that resulted in a 2006 reduction of $1.2 million.
Cost of sales
Cost of sales for contract manufacturing, as a percentage of sales, was approximately 75% for
the year ended December 31, 2007. As the above-referenced $1.2 million billing adjustment lowered
2006 sales but had no effect on that years costs, the ratio of costs to sales was negatively
affected. Without that effect, cost of sales for contract manufacturing would have been more
consistent in 2006 with the 2007 percentage and with the 74% of sales recorded in 2005.
Write-down of goodwill
In the quarter ended December 31, 2005, the Contract Manufacturing segment was allocated $7.0
million of goodwill in connection with the redefinition of segments described above in the Products
segment. A similar test, as described above, for impairment disclosed that the full amount of
goodwill allocated to Contract Manufacturing was impaired and, accordingly, was written off.
Non-U.S. Revenue
We had export sales and royalties recognized on export sales of $73.9 million, $68.5 million
and $50.9 million for the years ended December 31, 2007, 2006 and 2005, respectively. Of these
amounts, sales in Europe and royalties recognized on sales in Europe, were $45.6 million, $40.1
million and $33.7 million for the years ended December 31, 2007, 2006 and 2005, respectively. Our
non-U.S. product sales and royalties are denominated in U.S. dollars and are included in total
revenues.
55
Corporate and Other Expenses
(millions of dollars)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended |
|
|
|
December |
|
|
% |
|
|
December |
|
|
% |
|
|
December |
|
|
|
2007 |
|
|
Change |
|
|
2006 |
|
|
Change |
|
|
2005 |
|
Research and development |
|
$ |
45.5 |
|
|
|
26 |
|
|
$ |
36.2 |
|
|
|
19 |
|
|
$ |
30.4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
General and administrative |
|
|
31.9 |
|
|
|
(11 |
) |
|
|
35.7 |
|
|
|
38 |
|
|
|
25.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acquired in-process research and
development |
|
|
|
|
|
|
n.m. |
|
|
|
11.0 |
|
|
|
10 |
|
|
|
10.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restructuring |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
n.m. |
|
|
|
2.1 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
17.4 |
|
|
|
(21 |
) |
|
|
22.1 |
|
|
|
12 |
|
|
|
19.8 |
|
Investment income, net |
|
|
(10.9 |
) |
|
|
(56 |
) |
|
|
(24.7 |
) |
|
|
321 |
|
|
|
(5.9 |
) |
Other, net |
|
|
(0.9 |
) |
|
|
n.m. |
|
|
|
(9.0 |
) |
|
|
n.m. |
|
|
|
7.6 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5.6 |
|
|
|
n.m. |
|
|
|
(11.6 |
) |
|
|
n.m. |
|
|
|
21.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corporate costs |
|
$ |
83.0 |
|
|
|
16 |
|
|
$ |
71.3 |
|
|
|
(14 |
) |
|
$ |
89.9 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
Research and development expenses consist primarily of salaries and benefits; patent filing
fees; contractor and consulting fees, principally related to clinical and regulatory projects;
costs related to research and development partnerships or licenses; drug supplies for clinical and
preclinical activities; as well as other research supplies and facilities charges. Research and
development expenses related to currently marketed products are excluded from these corporate
amounts and are reported in the Products segment. Our research and development expense is
considered a corporate expense until a product candidate enters Phase III clinical trials at which
time related costs would be chargeable to one of our operating segments. We continue to invest in
research and development to build a differentiated oncology business through the continued
development of our current portfolio, reinforcing our position as a scientific leader in PEGylation
through our Customized Linker TechnologyTM platform.
For the full year of 2007, research and development spending was $45.5 million as compared to
$36.2 million in 2006. The increase was primarily due to spending in 2007 on the new programs
initiated during 2006. We filed an Investigational New Drug (IND) application and opened two Phase
I trials for PEG-SN38. Also, we opened two Phase I trials in the HIF-1 alpha antagonist subsequent
to the IND filing in the quarter ended December 31, 2006. In the fourth quarter of 2007, we
accepted two of the additional six oncology compounds licensed from Santaris Pharma A/S (Santaris)
which prompted a $2.0 million milestone payment. In addition, compensation expense was affected by
new hires and by the July 1, 2005 adoption of share-based compensation rules that required a charge
to expense for stock options and nonvested share awards. This affected 2007 to 2006 comparisons
due to the successive layering in of amortization of post-adoption grants.
56
The significant increase in research and development spending during 2006 reflected a number
of key initiatives undertaken to expand and improve our product pipeline. Expenditures rose 19% to
$36.2 million in 2006. Included in the 2005 amount was a $5.0 million payment to Tekmira
Pharmaceuticals Corporation (formerly Inex Pharmaceuticals) related to the termination of our
partnership for the development of an oncology product. Excluding these 2005 costs from the
comparison, the underlying growth in research and development spending year-over-year was even more
significant. IND applications were filed during 2006 relating to recombinant human Mannose-Binding
Lectin and the HIF-1 alpha antagonist for solid tumors. The clinical trials underlying these and
other research efforts accounted for much of the increased spending in 2006. In addition, the IND
filing in December 2006 related to HIF-1 alpha (which filing was approved by the FDA in January
2007) triggered a $5.0 million license milestone payment to Santaris. This amount was recorded in
research and development expense in 2006. One additional IND was filed during 2006. The costs
associated with this have been included in the Products segment as it relates to Oncaspar.
General and administrative
General and administrative expenses consist primarily of outside professional services for
accounting, audit, tax, legal, and financing activities; salaries and benefits for support
functions; and allocations of facilities costs.
General and administrative expenses for the year ended December 31, 2007 of $31.9 million were
lower by 11% from 2006 levels of $35.7 million whereas spending in 2006 was up 38% over the $25.9
million recorded in 2005. General and administrative expenses for the year ended December 31, 2006
included $7.0 million in legal costs incurred in connection with securing the supply of the raw
material used to produce Oncaspar. The absence of this expense in the succeeding and preceding
years largely explains the decline in general and administrative expense from 2006 to 2007 of $3.8
million and the majority of the increase from 2005 to 2006 of $9.8 million. The other significant
influence on year-to-year comparisons during this three-year interval is the earnings impact
resulting from the July 1, 2005 adoption of share-based compensation rules. The cost of officer
and director share-based compensation is recognized in the general and administrative expense
caption causing it to be felt most significantly here. For a period of three to four years after
adoption of the new rules, we will experience incrementally higher share-based compensation expense
as amortization of additional grants is layered into the computations. The effect of the new
accounting rules was greater in the 2005 2006 comparisons because they were in place for twelve
months of 2006 versus six months in 2005.
Acquired in-process research and development
Acquired in-process research and development for the year ended December 31, 2006 was
comprised of payments totaling $11.0 million to Santaris for rights to a total of eight RNA
antagonists based on LNA (locked nucleic acid) technology. Acquired in-process research and
development of $10.0 million for the twelve months ended December 31, 2005 was attributable to the
execution of a license agreement with NatImmune A/S (NatImmune) in September 2005 for the clinical
development of recombinant human Mannose-binding Lectin (rhMBL). As each of these technologies was
in the developmental stage at the time of acquisition, the payments were charged to operations.
Subsequent milestone payments related to these agreements are charged to research and development.
Other income (expense)
Other income (expense) for the three years ended December 31, 2007, 2006 and 2005 was:
expense of $5.6 million, income of $11.6 million and expense of $21.5 million, respectively. The
refinancing of a significant portion of our long-term debt in 2006 affected the year-to-year
comparisons in a number of manners (refer to Liquidity and Capital Resources below).
57
Interest expense was $17.4 million for 2007 compared to $22.1 million for 2006. The reduction
in interest expense is attributable to the lowering of the effective interest rate on our
outstanding notes payable through the refinancing in 2006 and subsequent repurchases of our 4.5%
notes. Outstanding notes payable at the beginning of 2006 in the amount of $394.0 million bore
interest at 4.5%. In 2006, $271.4 million principal amount, of these notes was repurchased using
the proceeds of our May 2006 issuance of $275.0 million 4.0% notes. The net result of these
transactions was to replace $271.4 million of 4.5% notes with $275.0 million 4.0% notes, resulting
initially in an annualized interest cost savings of approximately $1.2 million. Additional
repurchases of our 4.5% notes, including $50.2 million principal amount during 2007, have taken
place over the past year and a half, reducing the outstanding balance as of December 31, 2007 to
$72.4 million, further contributing to savings of interest expense. Additional repurchases of the
4.5% notes were made during January of 2008 reducing the outstanding balance to $12.5 million as of
January 31, 2008. The 4.5% notes will be fully repurchased or repaid on or before of July 1, 2008.
Interest expense rose during 2006 to $22.1 million from $19.8 million in 2005 due primarily to
the write-off of $2.5 million of deferred offering costs in connection with the 2006 repurchase of
a portion of our 4.5% notes.
Net investment income decreased by $13.8 million to $10.9 million for 2007 from $24.7 million
for 2006 due principally to the sale in January and February 2006 of our remaining 1,023,302 shares
of Nektar Therapeutics, Inc. common stock which resulted in a net gain of $13.8 million. Net
investment income for 2006 increased over 2005 due to the gain of $13.8 million realized in 2006 on
the sale of our remaining shares of Nektar common stock. In addition, we had more investments
outstanding in 2006 at higher interest rates than in the same period of 2005.
Other, net was income of $0.9 million for 2007, compared to income of $9.0 million for 2006.
The change resulted primarily from a $9.2 million gain on the repurchase of the 4.5% notes during
2006 (in 2007, we realized a $0.5 million gain related to repurchases of our 4.5% notes).
Concurrent with the 2006 issuance of new 4% notes due 2013, we used a portion of the proceeds to
repurchase $271.4 million principal amount of 4.5% notes due 2008 at a purchase price of $262.1
million resulting in a gain of $9.2 million reflected in other, net. During the twelve months
ended December 31, 2005, we realized a loss of $8.6 million related to the sale of NPS
Pharmaceuticals (NPS) common stock we received under a June 2003 merger termination agreement and a
financial instrument we entered into to reduce our exposure to the change in fair value associated
with such shares.
Income taxes
During 2007, we recorded a tax expense of approximately $1.9 million, which represents
federal, state and Canadian tax liabilities and includes an adjustment to taxes payable. A federal
income tax provision was recorded for 2007 representing federal alternative minimum tax primarily
related to the gain on sale of a royalty interest recognized in the third quarter of 2007. Our
adoption, as of January 1, 2007, of FASB Interpretation No. 48, Accounting for Uncertainty in
Income Taxes (FIN 48), had no effect on income tax expense. In accordance with FIN 48, as
amended, tax benefits of uncertain tax positions are recognized only if it is more likely than not
we will be able to sustain a position taken on an income tax return. We have no tax positions
relating to open income tax returns that we consider to be uncertain.
Income tax expense of $0.8 million for 2006 is comprised of certain state and Canadian taxes.
No federal income tax expense was recorded due to the utilization of deferred tax assets. For the
twelve months ended December 31, 2005, the net income tax provision was $67.5 million. This was
almost entirely the result of the establishment of a full valuation reserve against our deferred
tax assets in June 2005 based on our assessment that it was not likely we would realize a future
benefit from those assets.
58
Liquidity and Capital Resources
Aggregate cash reserves rose to $258.2 million as of December 31, 2007 from $240.6 million at
December 31, 2006. Cash reserves include cash, cash equivalents, short-term investments,
restricted investments and cash and marketable securities. Cash received on sale of a 25% interest
in PEG-INTRON royalties of $88.7 million ($92.5 million less related transaction costs),
represented the largest single cash inflow and offset expenditures to redeem a portion of the
outstanding balance of the 4.5% notes payable ($49.7 million), invest in property and equipment
($17.6 million) and make payment for Oncaspar product rights acquired in December 2006 ($17.5
million). The remaining increase in cash reserves arose principally from operating income as
adjusted for noncash items and fluctuations in working capital balances.
Total cash reserves, as of December 31, 2006 were $14.0 million greater than the $226.6
million balance as of December 31, 2005. Positive operating cash flows for the year ended December
31, 2006 and cash proceeds of $20.2 million from the sale of Nektar common stock contributed to the
increase in cash reserves. Partially offsetting these cash inflows was the January 2006 payment to
Sanofi-Aventis of $35.0 million relating to a reduction of the Oncaspar royalty rate and the $11.0
million payment to Santaris for their technology rights.
Cash provided by operating activities in 2007 of $100.4 million exceeded that in 2006 by $57.1
million. This was due primarily to the rise in operating income, as adjusted for noncash items, of
$114.6 million in 2007 compared to $32.0 million in 2006, or an increase of $82.5 million. The
largest single factor in this increase from year to year was the $88.7 million net proceeds in 2007
on the sale of future PEG-INTRON royalties referred to above. Offsetting this cash inflow, in
part, was the comparative change in operating assets and liabilities year over year aggregating to
$25.4 million. In 2007, reductions in accounts payable and increased investment in inventories
constituted uses of cash, offset by a higher level of accrued
expenses and other changes in operating assets, resulting in
a net use of cash of $14.1 million. During 2006, net changes in
operating assets and liabilities, primarily an increase in accounts
payable, had a positive
effect on operating cash of $11.3 million. Cash
used in investing activities in 2007 of $32.6 million was lower than the $100.0 million expended in
2006 due primarily to the fact that, in 2006, we made net incremental investments in marketable and
equity securities of approximately $44.3 million. We also had greater investments in 2006 in
product rights and in-process research and development ($17.5 million in 2007 versus $46.0 million
in 2006). Offsetting this trend was an increase in investments in property and equipment in 2007
of $7.9 million when compared to the prior year. Financing activities in 2007 and 2006 related
almost entirely to the repurchase and refinancing of our long-term debt as described below. The
repurchase of a portion of the 4.5% notes payable constituted a use of cash in 2007 of $49.7
million and the net result in 2006 of issuing the 4% notes and partial repurchase of the 4.5% notes
was a source of cash of $5.1 million.
Cash provided by operating activities for 2006 was $43.3 million compared to $17.7 million for
the twelve months ended December 31, 2005. The primary elements in the $25.6 million improvement
year-over-year were improved operating earnings plus net cash inflows relating to changes in
operating assets and liabilities in 2006 compared to net cash out flows relating to operating
assets in 2005. Net cash used in investing activities was $97.6 million in 2006 compared to $5.3
million in 2005. In addition to investments in short-term investments and marketable securities,
we acquired $9.7 million of property and equipment, $11.0 million of in-process research and
development and $35.0 million of product rights. Financing activities in 2006 provided a source of
cash in the amount of $6.2 million reflecting the net favorable effects of refinancing a portion of
our long-term debt as described below and $1.1 million of stock option exercises. In 2005, the
repurchase of notes payable used $5.4 million of cash.
As of December 31, 2007, we had outstanding $275.0 million of convertible senior notes payable
that bear interest at an annual rate of 4% and $72.4 million of convertible subordinated notes
payable that bear interest at an annual rate of 4.5%. Interest is payable on June 1 and December 1
for the 4% notes and January 1 and July 1 for the 4.5% notes. Accrued interest on the notes was
$2.5 million and $3.7 million, as of December 31, 2007 and 2006, respectively.
59
During 2007, we repurchased $50.3 million principal amount of 4.5% notes for $49.7 million.
The second-quarter 2006 issuance of the 4% notes generated $275.0 million of gross financing cash
inflows ($225.0 million in May and $50.0 million in June). We incurred $7.7 million of costs in
connection with the note issuances including legal, accounting and underwriting fees. The net
proceeds of the 4% note issuance were used to repurchase $271.4 million face value ($133.8 million
in May and $137.6 million in July) of 4.5% notes outstanding at a purchase price of $965 for each
$1,000 principal amount plus accrued interest. The combined purchase price was $262.1 million and
accrued interest amounted to $2.5 million. Our Board of Directors has authorized us to, and we
may, make additional privately negotiated repurchases of the notes from time to time at the
discretion of our senior management. For a more detailed description of the terms of our
convertible subordinated notes see Contractual Obligations below.
Our current sources of liquidity are our cash reserves; interest earned on such cash reserves;
sales of Oncaspar, DepoCyt, Abelcet and Adagen; royalties earned which are primarily related to
sales of PEG-INTRON; and contract manufacturing revenue. As a result of the sale in the third
quarter of 2007, of a 25% interest in future royalties payable to us on sale of PEG-INTRON
occurring after June 30, 2007, cash flows from royalties earned have been affected accordingly
beginning in the fourth quarter of 2007. Based upon our current planned research and development
activities and related costs and our current sources of liquidity, we anticipate our current cash
reserves and expected cash flow from operations will be sufficient to meet our capital and
operational requirements for the near future. As indicated above, total cash reserves include
restricted investments and cash. These dedicated funds amounted to $73.6 million at December 31,
2007 fully covering the $72.4 million principal amount of 4.5% notes payable July 1, 2008. While
we believe that our current sources of liquidity will be adequate to satisfy our capital and
operational needs for the near future, we may enter into agreements with collaborators with respect
to the development and commercialization of products that could increase our cash requirement or
seek additional financing to fund future operations and potential acquisitions. We cannot assure
you, however, that we will be able to obtain additional funds on acceptable terms, if at all. (See
Risk Factors We will need to obtain additional financing to meet our future capital needs and
our significant debt level may adversely affect our ability to do so. Failure to do so could materially and adversely affect our business, financial condition and
operations.)
Off-Balance Sheet Arrangements
As part of our ongoing business, we do not participate in transactions that generate
relationships with unconsolidated entities or financial partnerships, such as entities often
referred to as structured finance or special purpose entities (SPE), which would have been
established for the purpose of facilitating off-balance sheet arrangements or other contractually
narrow limited purposes. As of December 31, 2007, we are not involved in any off-balance sheet SPE
transactions.
Our 4% notes are convertible into shares of our common stock at a conversion price of $9.55
per share and pose a reasonable likelihood of potential significant dilution. The maximum
potential dilutive effect of conversion of the 4% notes is 28.8 million shares. The 4.5% notes
have a conversion price of $70.98 per share. Consequently, dilution related to the 4.5% notes is
remote. The notes are discussed in greater detail in Liquidity and Capital Resources above and
Contractual Obligations below.
In addition, stock options to purchase 8.4 million shares of our common stock at a weighted
average exercise price of $11.36 per share and 1.8 million restricted stock units were outstanding
at December 31, 2007, that represent additional potential dilution.
Contractual Obligations
Our major outstanding contractual obligations relate to our notes payable, including
interest, operating lease obligations, inventory purchase obligations and our license agreements
with collaborative partners.
60
As of December 31, 2007, we had $275.0 million of 4% convertible senior unsecured notes
outstanding. These notes mature on June 1, 2013 unless earlier redeemed, repurchased or converted.
They may be converted at the option of the holders into our common stock at an initial conversion
price of $9.55 per share. The 4% notes rank equal to our other senior unsecured debt and all
future senior unsecured debt.
At any time on or after June 1, 2009, if the closing price of our common stock for at least 20
trading days in the 30 consecutive trading day period ending on the date one day prior to the date
of a notice of redemption is greater than 140% of the applicable conversion price on the date of
such notice, we, at our option, may redeem the 4% notes in whole or in part, at a redemption price
in cash equal to 100% of the principal amount of the 4% notes to be redeemed, plus accrued
interest, if any, to the redemption date. The 4% notes are not redeemable prior to June 1, 2009.
Upon occurrence of a fundamental change, as defined in the indenture governing the notes, holders
of the notes may require us to redeem the notes at a price equal to 100% of the principal amount
plus accrued and unpaid interest or, in certain cases, to convert the notes at an increased
conversion rate based on the price paid per share of our common stock in the transaction
constituting the fundamental change.
In connection with our issuance of $275.0 million of the 4% senior convertible notes in May
and June 2006, we entered into a registration rights agreement whereby we agreed to file a shelf
registration statement with the U.S. Securities and Exchange Commission (SEC) to permit the public
resale of the 4% notes and the common stock issuable upon conversion of the notes. The shelf
registration was filed in a timely manner on October 2, 2006 and was declared effective by the SEC
on November 3, 2006. Failure to maintain the effectiveness of the shelf registration for a period
of two years beginning November 3, 2006 would result in additional interest of up to $1.2 million
being payable on the notes as of December 31, 2007. No amounts are owed, nor have any been
recorded for failure to maintain the effectiveness of the registration statement.
As of December 31, 2007, we had $72.4 million of 4.5% convertible subordinate notes
outstanding. Additional repurchases of the 4.5% notes were made during January of 2008 reducing
the outstanding balance to $12.5 million as of January 31, 2008. The holders may convert all or a
portion of the notes into common stock at any time on or before July 1, 2008. The notes are
convertible into our common stock at a conversion price of $70.98 per share, subject to adjustment
in certain events. The notes are subordinated to all existing and future senior indebtedness. The
4.5% notes are redeemable by us at specified redemption prices, plus accrued and unpaid interest to
the day preceding the redemption date. The notes will mature on July 1, 2008 unless earlier
converted, redeemed at our option or redeemed at the option of the note-holder upon a fundamental
change, as described in the indenture for the notes. Neither we nor any of our subsidiaries are
subject to any financial covenants under the indenture. In addition, neither we nor any of our
subsidiaries are restricted under the indenture from paying dividends, incurring debt or issuing or
repurchasing our securities.
We lease three facilities in New Jersey. Future minimum lease payments and commitments for
operating leases total $24.9 million at December 31, 2007.
Under our exclusive license for the right to sell, market and distribute Paciras DepoCyt
product, we are required to maintain sales levels of DepoCyt equal to $5.0 million for each
calendar year. Pacira is also entitled to a milestone payment of $5.0 million if our sales of the
product exceed a $17.5 million annualized run rate for four consecutive quarters and an additional
milestone payment of $5.0 million if our sales exceed an annualized run rate of $25.0 million for
four consecutive quarters. We are also responsible for a milestone payment of $5.0 million if the
product receives approval for all neoplastic meningitis. To date, no milestone payments defined
under the agreement have been generated by Pacira and no development activity is in progress.
61
In December 2006, we entered into supply and license agreements with Ovation. Pursuant to the
agreements, Ovation will supply us specified quantities of the active ingredient used in the
production of Oncaspar during calendar years 2008 and 2009. Additionally, Ovation granted to us a
non-exclusive, fully-paid, perpetual, irrevocable, worldwide license to the cell line from which
such ingredient is derived. We agreed to effectuate, at our cost, a technology transfer of the
cell line and manufacturing capabilities for the ingredient from Ovation to us no later than
December 31, 2009. We further agreed to supply specified quantities of the ingredient to Ovation,
at Ovations option, in calendar years 2010-2012. If we fail to supply the specified quantities in
2010-2012, we will be required to pay damages to Ovation in the amounts of $5.0 million in 2010,
$10.0 million in 2011 and $15.0 million in 2012.
In July 2006, we entered into a license and collaboration agreement with Santaris for up to
eight RNA antagonists. We obtained rights worldwide, other than Europe, to develop and
commercialize RNA antagonists directed against the HIF-l alpha and Survivin gene targets. Santaris
will design and synthesize RNA antagonists directed against up to six additional gene targets
selected by us, and we will have the right to develop and commercialize those antagonists
worldwide, other than Europe. We will be responsible for making additional payments upon the
successful completion of certain compound synthesis and selection, clinical development and
regulatory milestones. Santaris is also eligible to receive royalties from any future product
sales of products based on the licensed antagonists. Santaris retains the right to develop and
commercialize products developed under the collaboration in Europe.
Under our exclusive license with Sanofi-Aventis for marketing and distribution of Oncaspar in
the U.S. and Canada, we are obligated to pay $5.0 million if net sales exceed $30.0 million for two
consecutive years. Net sales of Oncaspar in 2007 and 2006 in the U.S. and Canada totaled $33.7
million and $26.3 million, respectively.
In September 2005, we entered into a license agreement with NatImmune for NatImmunes lead
development compound, rhMBL, a protein therapeutic under development for the prevention of severe
infections in MBL-deficient individuals undergoing chemotherapy. Under the agreement, we received
exclusive worldwide rights, excluding the Nordic countries, and are responsible for the
development, manufacture, and marketing of rhMBL. Upon completion of certain clinical development,
regulatory and sales-based milestones, we will be required to make payments to NatImmune pursuant
to the license agreement. NatImmune is also eligible to receive royalties from any future product
sales of rhMBL by us and retains certain rights to develop a non-systemic formulation of rhMBL for
topical administration.
Contractual obligations represent future cash commitments and liabilities under agreements
with third parties, and exclude contingent liabilities for which we cannot reasonably predict
future payment.
The following chart represents our contractual cash obligations aggregated by type as of
December 31, 2007 (in millions):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments due by period |
|
|
|
|
|
|
|
Less |
|
|
|
|
|
|
|
|
|
|
More |
|
|
|
|
|
|
|
than 1 |
|
|
2 - 3 |
|
|
4 - 5 |
|
|
than 5 |
|
Contractual Obligations and Commercial Commitments (1) |
|
Total |
|
|
Year |
|
|
Years |
|
|
Years |
|
|
years |
|
Notes payable(2) |
|
$ |
347.4 |
|
|
$ |
72.4 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
275.0 |
|
Operating lease obligations |
|
|
24.9 |
|
|
|
2.4 |
|
|
|
4.5 |
|
|
|
4.5 |
|
|
|
13.5 |
|
Inventory purchase obligations |
|
|
10.8 |
|
|
|
5.1 |
|
|
|
5.7 |
|
|
|
|
|
|
|
|
|
Interest due on notes payable |
|
|
63.7 |
|
|
|
14.2 |
|
|
|
22.0 |
|
|
|
22.0 |
|
|
|
5.5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Totals |
|
$ |
446.8 |
|
|
$ |
94.1 |
|
|
$ |
32.2 |
|
|
$ |
26.5 |
|
|
$ |
294.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The table does not include potential milestone payments of $325.3 million,
primarily comprised of; $249.0 million to Santaris that are |
62
|
|
|
|
|
only payable upon successful
development of all eight RNA antagonists selected by us, milestone payments of $55.0 million to NatImmune and $15.0 million
to Pacira, pending successful achievement of various regulatory and sales milestones. |
|
(2) |
|
Our 4.5% convertible notes are payable on July 1, 2008 and our 4.0% convertible
notes are payable on June 1, 2013. |
Critical Accounting Policies and Estimates
A critical accounting policy is one that is both important to the portrayal of a companys
financial condition and results of operations and requires managements most difficult, subjective
or complex judgments, often as a result of the need to make estimates about the effect of matters
that are inherently uncertain.
Our consolidated financial statements are presented in accordance with accounting principles
that are generally accepted in the U.S. All professional accounting standards effective as of
December 31, 2007 have been taken into consideration in preparing the consolidated financial
statements. The preparation of the consolidated financial statements requires estimates and
assumptions that affect the reported amounts of assets, liabilities, revenues, expenses and related
disclosures. Some of those estimates are subjective and complex, and, consequently, actual results
could differ from those estimates. The following accounting policies and estimates have been
highlighted as significant because changes to certain judgments and assumptions inherent in these
policies could affect our consolidated financial statements.
We base our estimates, to the extent possible, on historical experience. Historical
information is modified as appropriate based on current business factors and various assumptions
that we believe are necessary to form a basis for making judgments about the carrying value of
assets and liabilities. We evaluate our estimates on an ongoing basis and make changes when
necessary. Actual results could differ from our estimates.
Revenues
Revenues from product sales and contract manufacturing revenue are recognized when title
passes to the customer, generally at the time of shipment. We recognize revenues for Abelcet at
the time of shipment by our third-party distributor to the wholesaler. Sales are recorded when
Oncaspar and DepoCyt are shipped by our third-party distributor directly to the end-user. We
recognize revenue for Adagen upon sale to our specialty distributor. For product sales we also
record a provision at the time of shipment for estimated future credits, chargebacks, sales
discounts, rebates and returns. These sales provision accruals, except for rebates which are
recorded as a liability, are presented as a reduction of the accounts receivable balances. We
continually monitor the adequacy of the accruals by comparing the actual payments to the estimates
used in establishing the accruals.
We provide chargeback payments to the wholesalers based on their sales to members of buying
groups at prices determined under a contract between ourselves and the member. Administrative fees
are paid to buying groups based on the total amount of purchases by their members. We estimate the
amount of the chargeback that will be paid using (a) distribution channel information obtained from
certain of our wholesalers, which allows us to determine the amount and expiry of inventory in the
distribution channel, and (b) historical trends, adjusted for current changes. The settlement of
the chargebacks generally occurs within three months after the sale to the wholesaler. We
regularly analyze the historical chargeback trends and make adjustments to recorded reserves for
changes in trends.
63
In addition, state agencies that administer various programs, such as the U.S. Medicaid
programs, receive rebates. Medicaid rebates and administrative fees are recorded as a liability
and a reduction of gross sales when we record the sale of the product. In determining the
appropriate accrual amount, we use (a) channel information obtained from certain of our
wholesalers, which allows us to determine the amount and expiry of inventory in the distribution
channel, (b) our historical Medicaid rebate and administrative fee payments by product as a
percentage of our historical sales, and (c) any significant changes in sales trends. Current
Medicaid rebate laws and interpretations, and the percentage of our products that are sold to
Medicaid patients are also evaluated. Factors that complicate the rebate calculations are the
timing of the average manufacturer pricing computation, the lag time between sale and payment of a
rebate, which can range up to nine months, and the level of reimbursement by state agencies.
The following is a summary of gross-to-net sales reductions that are accrued on our
consolidated balance sheets as of December 31, 2007 and 2006 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, 2007 |
|
December 31, 2006 |
|
|
|
|
|
|
|
Accounts Receivable Reductions |
|
|
|
|
|
|
Chargebacks |
|
$ |
2,578 |
|
|
$ |
3,388 |
|
Cash Discounts |
|
|
159 |
|
|
|
168 |
|
Other (including returns) |
|
|
2,046 |
|
|
|
1,767 |
|
|
|
|
|
|
|
|
Total |
|
|
4,783 |
|
|
|
5,323 |
|
|
|
|
|
|
|
|
Accrued Liabilities |
|
|
|
|
|
|
Medicaid Rebates |
|
|
1,382 |
|
|
|
1,335 |
|
Administrative Fees |
|
|
187 |
|
|
|
205 |
|
|
|
|
|
|
|
|
Total |
|
|
1,569 |
|
|
|
1,540 |
|
|
|
|
|
|
|
|
Grand Total |
|
$ |
6,352 |
|
|
$ |
6,863 |
|
|
|
|
|
|
|
|
Royalties under our license agreements with third parties are recognized when reasonably
determinable and earned through the sale of the product by the licensee net of future credits,
chargebacks, sales discount rebates and refunds and collection is reasonably assured. Notification
from the third party licensee of the royalties earned under the license agreement is the basis for
royalty revenue recognition. This information is generally received from the licensees in the
quarter subsequent to the period in which the sales occur.
At the request of the customer, certain contract manufacturing arrangements involve the
transfer of title of the finished product to the customer prior to shipment. The product in
question is manufactured to the unique specifications of the customer and cannot be used to fill
other orders. If all necessary conditions are met, including: the product is complete and ready
for shipment, the risks of ownership have passed to the customer and the customer pays for storage
of the product at our facility, we will recognize revenue.
Non-refundable milestone payments that represent the completion of a separate earnings process
are recognized as revenue when earned, upon the occurrence of contract-specified events.
Non-refundable payments received upon entering into license and other collaborative agreements
where we have continuing involvement are recorded as deferred revenue and recognized ratably over
the estimated service period.
Income Taxes
Under the asset and liability method of SFAS No. 109, deferred tax assets and liabilities are
recognized for the estimated future tax consequences attributable to differences between the
financial statement carrying amounts of existing assets and liabilities and their respective tax
bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are
measured using enacted tax rates expected to apply to taxable income in the years in which those
temporary differences are expected to be recovered or settled. A valuation allowance on net
deferred tax assets is provided for when it is more likely than not some portion or all of the
deferred tax assets will be not realized. As of December 31, 2007, we believe that it is more
likely than not that our net deferred tax assets, including our net operating losses from operating
64
activities
and stock option exercises, will not be realized. We recognize the benefit of an uncertain tax position that we have taken or expect to take on the income tax returns we file
if it is more likely than not we will be able to sustain our position.
Long-Lived Asset Impairment Analysis
Long-lived assets, including amortizable intangible assets are tested for impairment when
impairment indicators are present. Impairment indicators are events or circumstances that may be
indicative of possible impairment such as a significant adverse change in legal factors or in
business climate, a current period operating loss combined with a history of operating losses or a
projection or forecast that demonstrates continuing losses associated with the use of a long-lived
asset or asset group.
Testing for the recoverability of amortizable intangible assets is performed initially by
comparing the carrying amount of the asset group to the future undiscounted net cash flows to be
generated by the assets. If the undiscounted net cash flow stream exceeds the carrying amount, no
further analysis is required. However, if this test shows a negative relationship, the fair value
of the assets within the asset group must be determined and we would record an impairment charge
for any excess of the carrying amount over the fair value. These evaluations involve amounts and
forecasts that are based on managements best estimates and judgment. Actual results may differ
from these estimates.
Share-Based Payments
Effective July 1, 2005, we adopted SFAS No. 123R, Share-Based Payment. SFAS No. 123R
establishes standards for the accounting for transactions in which an entity exchanges its equity
instruments for goods or services and requires that the compensation cost relating to share-based
payment transactions be recognized in the financial statements, measured by the fair value of the
equity or liability instruments issued, adjusted for estimated forfeitures. The impact such awards
will have on our results of operations will be a function of the number of shares awarded, vesting
and the trading price of our stock at date of grant, combined with the application of the
Black-Scholes valuation model discussed below.
We have elected the modified prospective transition method which requires that compensation
costs be recorded, as earned, for all unvested stock options and restricted stock awards
outstanding at June 30, 2005. Acceleration of vesting of certain stock options in April and June
2005 had the effect of reducing the amount of compensation expense that would have to be recognized
subsequent to adoption of SFAS No. 123R. The years ended December 31, 2007 and 2006, for example,
were potentially benefited by $7.6 million and $9.6 million, respectively, with potentially $4.2
million affect in the aggregate on 2008 and 2009. As of December 31, 2007, there was $8.9 million
of total unrecognized compensation cost related to unvested options that is expected to be
recognized over a weighted-average period of 21 months.
Options or stock awards issued to non-employees and consultants are recorded at their fair
value as determined in accordance with SFAS No. 123R and EITF No. 96-18, Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services, and recognized over the related vesting or service period.
Fair value of share-based payments is determined using the Black-Scholes valuation model which
employs weighted average assumptions for expected volatility of the Companys stock, expected term
until exercise of the options, the risk free interest rate, and dividends, if any. Expected
volatility is based on historical Enzon stock price information.
Recently Issued Accounting Standards
In December 2007, the FASB issued two statements that would apply prospectively to potential,
business combinations for which the acquisition date is on or after January 1, 2009. Early
application is not permitted. These pronouncements would be adopted at such time as we undertake a
business combination and will have no impact on our current and historical financial statements.
SFAS No. 141R, Business Combinations, retains the fundamental requirements of purchase accounting
but requires, among other
65
things, the recognition and measurement of any noncontrolling interest and certain previously
unrecognized intangible assets such as in-process research and development. It also calls for the
recognition of most acquisition costs as expense rather than part of the total acquisition cost and
the recognition of a gain in the event of a bargain purchase rather than negative goodwill. SFAS
No. 160, Noncontrolling Interests in Consolidated Financial Statements, establishes accounting
and reporting standards for the noncontrolling (minority) interest in a subsidiary and for the
deconsolidation of a subsidiary.
At its December 12, 2007 meeting, the FASB ratified a consensus of the Emerging Issues Task
Force regarding the accounting for collaborative agreements (EITF 07-1). Effective beginning in
2009, the consensus prohibits participants in a collaborative agreement from applying the equity
method of accounting to activities performed outside a separate legal entity and requires gross or
net presentation of revenues and expenses by the respective parties depending upon their roles in
the collaboration. The consensus will be applied to collaborative agreements in existence at the
date of adoption using a modified retrospective method that requires reclassification of all
periods presented. We are in the process of evaluating the possible impact the consensus may have
on our financial statements, but do not expect it to be material to our financial position or
results of operations.
The FASB has issued two pronouncements with effective dates primarily as of the first quarter
of 2008 relating to measuring financial instruments at fair value. We are in the process of
evaluating the new standards but do not, at this time, anticipate that either will have any
material effect on our consolidated financial position or results of operations. Certain financial
statement disclosures will be revised, however, to conform to the new guidance. SFAS No. 157,
Fair Value Measurements provides guidance on the use of fair value in such measurements and
prescribes expanded disclosures about fair value measurements contained in financial statements.
Once SFAS No. 157 is adopted, SFAS No. 159 can be adopted which allows companies the option to
measure many financial assets and financial liabilities at fair value on a contract-by-contract
basis. As it relates to certain nonfinancial assets and nonfinancial liabilities, the effective
date of SFAS No. 157 is the first quarter of 2009.
The Emerging Issues Task Force of the FASB reached a consensus in June 2007 that
non-refundable advance payments to acquire goods or pay for services that will be consumed or
performed in a future period in conducting research and development activities on behalf of the
entity should be recorded as an asset when the advance payments are made (EITF 07-3, Accounting
for Advance Payments for Goods or Services to Be Used in Future Research and Development
Activities). Capitalized amounts are to be expensed when the research and development activities
are performed, that is, when the goods without alternative future use are acquired or the service
is rendered. The consensus is to be applied prospectively to new contractual arrangements entered
into in fiscal years beginning after December 31, 2007. We are evaluating the effect of adoption
of EITF 07-3, but do not expect it to be material to our financial position or results of
operations.
Forward-Looking Information and Factors That May Affect Future Results
There are forward-looking statements contained herein which can be identified by the use of
forward-looking terminology such as the words believes, expects, may, will, should,
potential, anticipates, plans or intends and similar expressions. Such forward-looking
statements involve known and unknown risks, uncertainties and other factors that may cause actual
results, events or developments to be materially different from the future results, events or
developments indicated in such forward-looking statements. Such factors include, but are not
limited to:
|
|
|
The risk that we will not achieve success in our research and development efforts,
including clinical trials conducted by us or our collaborative partners. |
|
|
|
|
The risk that we will experience operating losses for the next several years. |
|
|
|
|
The risk that there will be a decline in sales of one or more of our marketed products
or products sold by others from which we derive royalty revenues. Such sales declines
could result from increased competition, loss of patent protection, pricing, supply
shortages and/or regulatory constraints. |
66
|
|
|
The risk that, due to limited or single sources of supply for
major products, we will be unable to obtain critical compounds used in the manufacture of
our products at economically feasible prices or at all, or one of our key suppliers will
experience manufacturing problems or delays. |
|
|
|
|
Decisions by regulatory authorities regarding whether and when to approve our
regulatory applications as well as their decisions regarding labeling and other matters
could affect the commercial potential of our products or developmental products. |
|
|
|
|
The risk that we will fail to obtain adequate financing to meet our future capital and
financing needs. |
|
|
|
|
The risk that key personnel will leave the Company. |
A more detailed discussion is contained in Risk Factors in Item 1A, Part I of this report.
These factors should be considered carefully and readers are cautioned not to place undue reliance
on such forward-looking statements. No assurance can be given that the future results covered by
the forward-looking statements will be achieved. All information contained herein is as of the
date of this report and we do not intend to update this information.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
The following discussion about our exposure to market risk of financial instruments contains
forward-looking statements. Actual results may differ materially from those described.
Our holdings of available-for-sale securities are comprised of equity and debt securities,
time deposits and auction rate securities. We do not invest in portfolio equity securities or
commodities or use financial derivatives for trading purposes. Our debt security portfolio
represents funds held temporarily pending use in our business and operations. We seek reasonable
assuredness of the safety of principal and market liquidity by investing in rated fixed income
securities while at the same time seeking to achieve a favorable rate of return. Our market risk
exposure consists principally of exposure to changes in interest rates. Our holdings are also
exposed to the risks of changes in the credit quality of issuers. We typically invest the majority
of our investments in the shorter-end of the maturity spectrum. While auction rate securities have
long stated maturities, interest rates are reset at intervals of up to 90 days at which time they
can be sold. Accordingly, they are considered to have current maturities.
The table below presents the amortized cost, fair value and related weighted average interest
rates by year of maturity for our available-for-sale securities as of December 31, 2007 excluding
primarily those related to our Executive Deferred Compensation Plan (in thousands).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2009 |
|
|
Total |
|
|
Fair Value |
|
Fixed Rate |
|
$ |
124,480 |
|
|
$ |
18,353 |
|
|
$ |
142,833 |
|
|
$ |
142,806 |
|
Average Interest Rate |
|
|
3.62 |
% |
|
|
5.36 |
% |
|
|
3.84 |
% |
|
|
|
|
Variable Rate |
|
|
54,375 |
|
|
|
|
|
|
|
54,375 |
|
|
|
54,131 |
|
Average Interest Rate |
|
|
5.80 |
% |
|
|
|
|
|
|
5.80 |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
178,855 |
|
|
$ |
18,353 |
|
|
$ |
197,208 |
|
|
$ |
196,937 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Our outstanding convertible notes have fixed interest rates. Accordingly the fair values of
the respective issuances will fluctuate as market rates of interest move up or down. Fair values
are also affected by changes in the price of our common stock.
Our 4% convertible senior unsecured notes in the principal amount of $275.0 million at
December 31, 2007 are due June 1, 2013 and have a fair value of $325.6 million at December 31,
2007.
67
Our 4.5% convertible subordinated notes in principal amount of $72.4 million at December 31,
2007 are due July 1, 2008. The fair value of these notes was approximately $72.0 million at
December 31, 2007.
Item 8. Financial Statements and Supplementary Data
Financial statements and notes thereto and the supplemental financial statement schedule
appear on pages F-1 to F-46 of this Annual Report on Form 10-K.
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
Not Applicable.
Item 9A. Controls and Procedures
(a) Evaluation of Disclosure Controls and Procedures
Our management, under the direction of our Chief Executive Officer and Chief Financial
Officer, has evaluated the effectiveness of our disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, (the Exchange
Act)) as of December 31, 2007. Based on that evaluation, our Chief Executive Officer and Chief
Financial Officer have concluded that our disclosure controls and procedures were effective as of
December 31, 2007.
(b) Changes in Internal Control over Financial Reporting and Remediation Plans
There were no changes in the Companys internal control over financial reporting, as such term
is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, during the three-month period
ended December 31, 2007 covered by this report that have materially affected, or are reasonably
likely to materially affect, the Companys internal control over financial reporting.
(c) Managements Report on Internal Control over Financial Reporting
It is the responsibility of the management of Enzon Pharmaceuticals, Inc. and subsidiaries to
establish and maintain effective internal control over financial reporting (as defined in Rule
13a-15(f) under the Exchange Act). Internal control over financial reporting is designed to provide
reasonable assurance to Enzons management and board of directors regarding the preparation of
reliable consolidated financial statements for external purposes in accordance with generally
accepted accounting principles.
Enzons 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 Enzon; (ii) provide reasonable assurance
that transactions are recorded as necessary to permit preparation of consolidated financial
statements in accordance with generally accepted accounting principles, and that receipts and
expenditures of Enzon are being made only in accordance with authorizations of management and
directors of Enzon; and (iii) provide reasonable assurance regarding the prevention or timely
detection of unauthorized acquisition, use or disposition of Enzons assets that could have a
material effect on the consolidated financial statements of Enzon.
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. Therefore, even those systems determined to be effective can provide only
reasonable assurance with respect to financial statement preparation and presentation.
68
Management has performed an assessment of the effectiveness of Enzons internal control over
financial reporting as of December 31, 2007 based upon criteria set forth in Internal Control -
Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission
(COSO). Based on this assessment, management has concluded that our internal control over
financial reporting was effective as of December 31, 2007.
Our independent auditor, KPMG LLP, an independent registered public accounting firm, has
issued an auditors report on the effectiveness of internal control over financial reporting as of
December 31, 2007. The auditors report follows.
|
|
|
/s/ Jeffrey H. Buchalter
|
|
/s/ Craig A. Tooman |
|
|
|
Jeffrey H. Buchalter
|
|
Craig A. Tooman |
Chairman, President, and Chief Executive Officer
|
|
Executive Vice President, Finance and |
(Principal Executive Officer)
|
|
Chief Financial Officer |
|
|
(Principal Financial Officer) |
|
|
|
February 29, 2008
|
|
February 29, 2008 |
69
(d) Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Enzon Pharmaceuticals, Inc.:
We have audited Enzon Pharmaceuticals, Inc.s internal control over financial reporting as of
December 31, 2007, based on criteria established in Internal
ControlIntegrated Framework issued by
the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Enzon Pharmaceuticals,
Inc.s management is responsible for maintaining effective internal control over financial
reporting and for its assessment of the effectiveness of internal control over financial reporting,
included in the accompanying Managements Report on Internal Control over Financial Reporting. Our
responsibility is to express an opinion on the Companys internal control over financial reporting
based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether effective internal control over financial reporting was maintained in all
material respects. Our audit included obtaining an understanding of internal control over financial
reporting, assessing the risk that a material weakness exists, and testing and evaluating the
design and operating effectiveness of internal control based on the assessed risk. Our audit also
included performing such other procedures as we considered necessary in the circumstances. We
believe that our audit provides a reasonable basis for our opinion.
A companys internal control over financial reporting is a process designed to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial
statements for external purposes in accordance with generally accepted accounting principles. A
companys internal control over financial reporting includes those policies and procedures that (1)
pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that
transactions are recorded as necessary to permit preparation of financial statements in accordance
with generally accepted accounting principles, and that receipts and expenditures of the company
are being made only in accordance with authorizations of management and directors of the company;
and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of the companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or
detect misstatements. Also, projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
In our opinion, Enzon Pharmaceuticals, Inc. maintained, in all material respects, effective
internal control over financial reporting as of December 31, 2007, based on criteria established in
Internal ControlIntegrated Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO).
We also have audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the consolidated balance sheets of the Company as of December 31, 2007 and December
31, 2006, and the related consolidated statements of operations, stockholders equity (deficit) and
cash flows for each of the years in the two-year period ended December 31, 2007, the six months
ended December 31, 2005 and the fiscal year ended June 30, 2005, and our report dated February 29,
2008 expressed an unqualified opinion on those consolidated financial statements.
/s/ KPMG LLP
Short Hills, New Jersey
February 29, 2008
70
Item 9B. Other Information
None.
71
PART III
The information required by Item 10 Directors, Executive Officers and Corporate Governance; Item
11 Executive Compensation; Item 12 Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters, Item 13 Certain Relationships and Related
Transactions, and Director Independence and Item 14 Principal Accountant Fees and Services is
incorporated into Part III of this Annual Report on Form 10-K by reference to the Proxy Statement
for our 2008 Annual Meeting of Stockholders.
72
PART IV
Item 15. Exhibits and Financial Statement Schedules.
(a)(1) and (2). The response to this portion of Item 15 is submitted as a separate section of
this report commencing on page F-1.
(a)(3) and (c). Exhibits (numbered in accordance with Item 601 of Regulation S-K).
|
|
|
|
|
|
|
Exhibit |
|
|
|
Reference |
Number |
|
Description |
|
No. |
3(i)
|
|
Amended and Restated Certificate of Incorporation
|
|
|
(1 |
) |
3(ii)
|
|
Amended and Restated Bylaws
|
|
|
(2 |
) |
3(iii)
|
|
Amendment dated July 31, 2007 to Amended and Restated Bylaws
|
|
|
(3 |
) |
3(iv)
|
|
Amendment dated November 21, 2007 to Amended and Restated
Bylaws
|
|
|
(4 |
) |
4.1
|
|
Rights Agreement dated May 17, 2002 between the Company and
Continental Stock Transfer & Trust Company, as rights agent
|
|
|
(5 |
) |
4.2
|
|
First Amendment to the Rights Agreement, dated as of
February 19, 2003 between the Company and Continental Stock
Transfer & Trust Company, as rights agent
|
|
|
(6 |
) |
4.3
|
|
Second Amendment to the Rights Agreement dated as of
January 7, 2008 between the Company and Continental Stock
Transfer and Trust Company, as rights agent.
|
|
|
(7 |
) |
4.4
|
|
Indenture dated as of June 26, 2001, between the Company
and Wilmington Trust Company, as trustee, including the
form of 4.5% Convertible Subordinated Note due 2008
attached as Exhibit A thereto
|
|
|
(8 |
) |
4.5
|
|
Indenture, dated May 23, 2006, between Enzon
Pharmaceuticals, Inc. and Wilmington Trust Company
|
|
|
(9 |
) |
4.6
|
|
Registration Rights Agreement, dated May 23, 2006, between
Enzon Pharmaceuticals, Inc. and Goldman, Sachs & Co.
|
|
|
(9 |
) |
10.1
|
|
Lease 300-C Corporate Court, South Plainfield, New Jersey
|
|
|
(10 |
) |
10.2
|
|
Lease dated April 1, 1995 regarding 20 Kingsbridge Road,
Piscataway, New Jersey
|
|
|
(11 |
) |
10.3
|
|
First Amendment to Lease regarding 20 Kingsbridge Road,
Piscataway, New Jersey, dated as of November 13, 2001
|
|
|
(12 |
) |
10.4
|
|
Lease 300A-B Corporate Court, South Plainfield, New Jersey
|
|
|
(13 |
) |
10.5
|
|
Modification of Lease Dated May 14, 2003 300-C Corporate
Court, South Plainfield, New Jersey
|
|
|
(14 |
) |
10.6
|
|
Lease 685 Route 202/206, Bridgewater, New Jersey
|
|
|
(15 |
) |
10.7
|
|
First Amendment of Lease 685 Route 202/206, Bridgewater,
New Jersey
|
|
|
(16 |
) |
10.8
|
|
Second Amendment to Lease 685 Route 202/206, Bridgewater,
New Jersey
|
|
|
(16 |
) |
10.9
|
|
Third Amendment to Lease 685 Route 202/206, Bridgewater,
New Jersey
|
|
|
(16 |
) |
10.10
|
|
2001 Incentive Stock Plan, as amended and restated, of
Enzon Pharmaceuticals, Inc. **
|
|
|
(1 |
) |
10.11
|
|
Development, License and Supply Agreement between the
Company and Schering Corporation; dated November 14, 1990,
as amended*
|
|
|
(17 |
) |
73
|
|
|
|
|
|
|
Exhibit |
|
|
|
Reference |
Number |
|
Description |
|
No. |
10.12
|
|
Executive Deferred Compensation Plan (2008 Restatement) **
|
|
|
(18 |
) |
10.13
|
|
Amendment dated June 10, 2005, to Employment Agreement between
the Company and Craig A. Tooman dated January 5, 2005 **
|
|
|
(19 |
) |
10.14
|
|
Form of Non-Qualified Stock Option Agreement between the Company
and Craig A. Tooman **
|
|
|
(19 |
) |
10.15
|
|
Amended and Restated Severance Agreement with Paul S. Davit dated
May 7, 2004 **
|
|
|
(19 |
) |
10.16
|
|
Amended and Restated Severance Agreement with Ralph del Campo
dated May 7, 2004 **
|
|
|
(19 |
) |
10.17
|
|
2007 Outside Director Compensation Plan, as amended **
|
|
|
(3 |
) |
10.18
|
|
Employment Agreement with Ivan D. Horak, M.D. dated September 2,
2005, along with a form of Stock Option Award Agreement and
Restricted Stock Unit Award Agreement between the Company and Mr.
Horak executed as of September 2, 2005 *, **
|
|
|
(20 |
) |
10.19
|
|
Form of Non-Qualified Stock Option Agreement for Executive
Officers **
|
|
|
(21 |
) |
10.20
|
|
Form of Restricted Stock Award Agreement for Executive Officers **
|
|
|
(21 |
) |
10.21
|
|
Form of Restricted Stock Unit Award Agreement for Executive
Officers **
|
|
|
(22 |
) |
10.22
|
|
Form of Restricted Stock Unit Award Agreement for Independent
Directors **
|
|
|
(20 |
) |
10.23
|
|
Form of Stock Option Award Agreement for Independent Directors
1987 Non-Qualified Stock Option Plan **
|
|
|
(20 |
) |
10.24
|
|
Form of Stock Option Award Agreement for Independent Directors
2001 Incentive Stock Plan **
|
|
|
(20 |
) |
10.25
|
|
Employment Agreement with Craig A. Tooman dated January 5, 2005 **
|
|
|
(21 |
) |
10.26
|
|
2007 Employee Stock Purchase Plan
|
|
|
(23 |
) |
10.27
|
|
Amended and Restated Employment Agreement with Jeffrey H.
Buchalter dated April 27, 2007**
|
|
|
(24 |
) |
10.28
|
|
Amendment dated February 21, 2008 to Amended and Restated
Employment Agreement with Jeffrey H. Buchalter**
|
|
|
+ |
|
10.29
|
|
Purchase Agreement between the Company and Drug Royalty LP1 dated
as of August 19, 2007
|
|
|
(25 |
) |
10.30
|
|
Amendment to Amended and Restated Severance Agreement with Paul
S. Davit dated November 6, 2007**
|
|
|
(26 |
) |
10.31
|
|
Amendment to Amended and Restated Severance Agreement with Ralph
del Campo dated November 6, 2007**
|
|
|
(26 |
) |
12.1
|
|
Computation of Ratio of Earnings to Fixed Charges
|
|
|
+ |
|
21.1
|
|
Subsidiaries of Registrant
|
|
|
+ |
|
23.0
|
|
Consent of Independent Registered Public Accounting Firm
|
|
|
+ |
|
31.1
|
|
Certification of Principal Executive Officer pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
+ |
|
31.2
|
|
Certification of Principal Financial Officer pursuant to Section
302 of the Sarbanes-Oxley Act of 2002
|
|
|
+ |
|
32.1
|
|
Certification of Principal Executive Officer pursuant to
Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
+ |
|
32.2
|
|
Certification of Principal Financial Officer pursuant to Section
906 of the Sarbanes-Oxley Act of 2002
|
|
|
+ |
|
99.1
|
|
Consent of Independent Valuation Firm
|
|
|
+ |
|
+ Filed herewith
Referenced exhibit was previously filed with the Commission as an exhibit to the Companys filing
indicated below
74
and is incorporated herein by reference to that filing:
|
|
|
|
|
|
(1 |
) |
|
Current Report on Form 8-K filed May 19, 2006 |
|
|
|
|
|
|
(2 |
) |
|
Quarterly Report on Form 10-Q for the quarter ended June 30, 2006 filed August 3, 2006 |
|
|
|
|
|
|
(3 |
) |
|
Quarterly Report on Form 10-Q for the quarter ended June 30, 2007 filed August 2, 2007. |
|
|
|
|
|
|
(4 |
) |
|
Current Report on Form 8-K filed November 26, 2007. |
|
|
|
|
|
|
(5 |
) |
|
Form 8-A12G (File No. 000-12957) filed May 22, 2002 |
|
|
|
|
|
|
(6 |
) |
|
Form 8-A12G/A (File No. 000-12957) filed February 20, 2003 |
|
|
|
|
|
|
(7 |
) |
|
Current Report on Form 8-K filed January 8, 2008 |
|
|
|
|
|
|
(8 |
) |
|
Registration Statement on Form S-3 (File No. 333-67509) filed August 14, 2001 |
|
|
|
|
|
|
(9 |
) |
|
Current Report on Form 8-K filed May 25, 2006 |
|
|
|
|
|
|
(10 |
) |
|
Registration Statement on Form S-18 (File No. 2-88240-NY) |
|
|
|
|
|
|
(11 |
) |
|
Quarterly Report on Form 10-Q for the quarter ended March 31, 1995 filed May 12, 1995 |
|
|
|
|
|
|
(12 |
) |
|
Transition Report on Form 10-K for the six months ended December 31, 2005. |
|
|
|
|
|
|
(13 |
) |
|
Annual Report on Form 10-K for the fiscal year ended June 30, 1993 |
|
|
|
|
|
|
(14 |
) |
|
Annual Report on Form 10-K for the fiscal year ended June 30, 2003 |
|
|
|
|
|
|
(15 |
) |
|
Quarterly Report on Form 10-Q for the quarter ended March 31, 2002 filed May 15, 2002 |
|
|
|
|
|
|
(16 |
) |
|
Quarterly Report on Form 10-Q for the quarter ended September 30, 2006 filed November 2, 2006 |
|
|
|
|
|
|
(17 |
) |
|
Annual Report on Form 10-K for the fiscal year ended June 30, 2002 |
|
|
|
|
|
|
(18 |
) |
|
Quarterly Report on Form 10-Q for the quarter ended September 30, 2007 filed November 1, 2007 |
|
|
|
|
|
|
(19 |
) |
|
Annual Report on Form 10-K for the fiscal year ended June 30, 2005 |
|
|
|
|
|
|
(20 |
) |
|
Quarterly Report on Form 10-Q for the quarter ended September 30, 2005 filed November 9, 2005 |
|
|
|
|
|
|
(21 |
) |
|
Quarterly Report on Form 10-Q for the quarter ended December 31, 2004 filed February 9, 2005 |
|
|
|
|
|
|
(22 |
) |
|
Quarterly Report on Form 10-Q for the quarter ended March 31, 2005 filed May 10, 2005 |
|
|
|
|
|
|
(23 |
) |
|
Form S-8 (File No. 333-140282) filed January 29, 2007 |
|
|
|
|
|
|
(24 |
) |
|
Quarterly Report on Form 10Q for the quarter ended March 31, 2007 filed May 4, 2007 |
|
|
|
|
|
|
(25 |
) |
|
Current Report on Form 8-K filed August 20, 2007 |
|
|
|
|
|
|
(26 |
) |
|
Current Report on Form 8-K filed November 13, 2007 |
|
|
|
|
|
|
* |
|
|
Portions of this exhibit have been redacted and filed separately with the Commission pursuant
to a confidential treatment request. |
|
|
|
|
|
|
** |
|
|
Management contracts or compensatory plans and arrangements required to be filed pursuant to
Item 601(b)(10)(ii)(A) or (iii) of Regulation S-K. |
75
SIGNATURES
Pursuant to the requirements of section 13 or 15(d) of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
|
|
|
|
|
ENZON PHARMACEUTICALS, INC.
(Registrant)
|
|
Dated: February 29, 2008 |
/s/Jeffrey H. Buchalter
|
|
|
Jeffrey H. Buchalter |
|
|
Chairman, President and
Chief Executive Officer
(Principal Executive Officer) |
|
|
|
|
|
Dated: February 29, 2008 |
/s/Craig A. Tooman
|
|
|
Craig A. Tooman |
|
|
Executive Vice President, Finance and
Chief Financial Officer
(Principal Financial Officer) |
|
|
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 |
|
|
|
|
|
|
|
Executive Vice President, Finance
|
|
February 29, 2008 |
Craig A. Tooman
|
|
and Chief Financial Officer
(Principal Financial Officer) |
|
|
|
|
|
|
|
|
|
Chairman of the Board
|
|
February 29, 2008 |
Jeffrey H. Buchalter |
|
|
|
|
|
|
|
|
|
|
|
Director
|
|
February 29, 2008 |
Goran Ando |
|
|
|
|
|
|
|
|
|
|
|
Director
|
|
February 29, 2008 |
Rolf A. Classon |
|
|
|
|
|
|
|
|
|
|
|
Director
|
|
February 29, 2008 |
Robert LeBuhn |
|
|
|
|
|
|
|
|
|
|
|
Director
|
|
February 29, 2008 |
Victor P. Micati |
|
|
|
|
|
|
|
|
|
|
|
Director
|
|
February 29, 2008 |
Phillip M. Renfro |
|
|
|
|
|
|
|
|
|
|
|
Director
|
|
February 29, 2008 |
Robert C. Salisbury |
|
|
|
|
76
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Index
|
|
|
|
|
|
|
Page |
|
|
|
F-2 |
|
Consolidated Financial Statements: |
|
|
|
|
|
|
|
F-3 |
|
|
|
|
F-4 |
|
|
|
|
F-5 |
|
|
|
|
F-7 |
|
|
|
|
F-8 |
|
Consolidated Financial Statement Schedule: |
|
|
|
|
|
|
|
F-46 |
|
F-1
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Enzon Pharmaceuticals, Inc.:
We have audited the accompanying consolidated balance sheets of Enzon Pharmaceuticals, Inc. and
subsidiaries (the Company) as of December 31, 2007 and 2006, and the related consolidated
statements of operations, stockholders equity (deficit) and cash flows for each of the years in
the two-year period ended December 31, 2007, the six months ended December 31, 2005 and the fiscal
year ended June 30, 2005. In connection with our audits of the consolidated financial statements,
we also have audited the related financial statement schedule. These consolidated financial
statements and financial statement schedule are the responsibility of the Companys management. Our
responsibility is to express an opinion on these consolidated financial statements and financial
statement schedule based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain reasonable
assurance about whether the financial statements are free of material misstatement. An audit
includes examining, on a test basis, evidence supporting the amounts and disclosures in the
financial statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall financial statement
presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present fairly, in all
material respects, the financial position of Enzon Pharmaceuticals, Inc. and subsidiaries as of
December 31, 2007 and 2006, and the results of their operations and their cash flows for each of
the years in the two-year period ended December 31, 2007, the six months ended December 31, 2005
and the fiscal year ended June 30, 2005, in conformity with U.S. generally accepted accounting
principles. Also in our opinion, the related financial statement schedule, when considered in
relation to the basic consolidated financial statements taken as a whole, presents fairly, in all
material respects, the information set forth therein.
As discussed in Note 2 to the consolidated financial statements, the Company adopted Statement of
Financial Accounting Standards No. 123R, Share-Based Payment, effective July 1, 2005.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the Companys internal control over financial reporting as of December 31, 2007,
based on criteria established in Internal ControlIntegrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission (COSO), and our report dated February 29, 2008
expressed an unqualified opinion on the effectiveness of the Companys internal control over
financial reporting.
/s/ KPMG LLP
Short Hills, New Jersey
February 29, 2008
F-2
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(In thousands, except share amounts)
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
40,053 |
|
|
$ |
20,706 |
|
Short-term investments |
|
|
123,907 |
|
|
|
152,838 |
|
Restricted investments and cash |
|
|
73,592 |
|
|
|
|
|
Accounts receivable, net |
|
|
14,927 |
|
|
|
15,259 |
|
Inventories |
|
|
22,297 |
|
|
|
17,618 |
|
Other current assets |
|
|
6,401 |
|
|
|
5,890 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
281,177 |
|
|
|
212,311 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
45,312 |
|
|
|
39,491 |
|
Marketable securities |
|
|
20,653 |
|
|
|
67,061 |
|
Amortizable intangible assets, net |
|
|
68,141 |
|
|
|
78,510 |
|
Other assets |
|
|
5,074 |
|
|
|
6,457 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
420,357 |
|
|
$ |
403,830 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
9,441 |
|
|
$ |
24,918 |
|
Notes payable |
|
|
72,391 |
|
|
|
|
|
Accrued expenses |
|
|
21,105 |
|
|
|
31,276 |
|
Accrued interest |
|
|
2,545 |
|
|
|
3,691 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
105,482 |
|
|
|
59,885 |
|
|
|
|
|
|
|
|
|
|
Notes payable |
|
|
275,000 |
|
|
|
397,642 |
|
Other liabilities |
|
|
3,302 |
|
|
|
2,744 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
383,784 |
|
|
|
460,271 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity (deficit): |
|
|
|
|
|
|
|
|
Preferred stock $.01 par value, authorized 3,000,000 shares; no shares
issued and outstanding at December 31, 2007 and 2006 |
|
|
|
|
|
|
|
|
Common stock $.01 par value, authorized 170,000,000 shares;
issued and outstanding: 44,199,831 shares
and 43,999,031 shares at December 31, 2007 and 2006, respectively |
|
|
442 |
|
|
|
440 |
|
Additional paid-in capital |
|
|
335,318 |
|
|
|
326,099 |
|
Accumulated other comprehensive income (loss) |
|
|
326 |
|
|
|
(414 |
) |
Accumulated deficit |
|
|
(299,513 |
) |
|
|
(382,566 |
) |
|
|
|
|
|
|
|
Total stockholders equity (deficit) |
|
|
36,573 |
|
|
|
(56,441 |
) |
|
|
|
|
|
|
|
Total liabilities and stockholders equity (deficit) |
|
$ |
420,357 |
|
|
$ |
403,830 |
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-3
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
Year |
|
|
|
|
|
|
|
|
|
|
|
Ended |
|
|
Ended |
|
|
|
Year Ended December 31, |
|
|
December 31, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2005 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
100,686 |
|
|
$ |
101,024 |
|
|
$ |
49,436 |
|
|
$ |
99,192 |
|
Royalties |
|
|
67,305 |
|
|
|
70,562 |
|
|
|
17,804 |
|
|
|
51,414 |
|
Contract manufacturing |
|
|
17,610 |
|
|
|
14,067 |
|
|
|
6,459 |
|
|
|
15,644 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
185,601 |
|
|
|
185,653 |
|
|
|
73,699 |
|
|
|
166,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sales and contract manufacturing |
|
|
54,978 |
|
|
|
50,121 |
|
|
|
23,216 |
|
|
|
46,023 |
|
Research and development |
|
|
56,507 |
|
|
|
43,521 |
|
|
|
13,985 |
|
|
|
36,957 |
|
Selling, general and administrative |
|
|
63,840 |
|
|
|
69,768 |
|
|
|
28,617 |
|
|
|
57,195 |
|
Amortization of acquired intangible assets |
|
|
707 |
|
|
|
743 |
|
|
|
6,695 |
|
|
|
13,447 |
|
Write-down of goodwill and intangible assets |
|
|
|
|
|
|
|
|
|
|
284,101 |
|
|
|
|
|
Acquired in-process research and development |
|
|
|
|
|
|
11,000 |
|
|
|
10,000 |
|
|
|
|
|
Restructuring charge |
|
|
7,741 |
|
|
|
|
|
|
|
|
|
|
|
2,053 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total costs and expenses |
|
|
183,773 |
|
|
|
175,153 |
|
|
|
366,614 |
|
|
|
155,675 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of royalty interest |
|
|
88,666 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
90,494 |
|
|
|
10,500 |
|
|
|
(292,915 |
) |
|
|
10,575 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investment income, net |
|
|
10,918 |
|
|
|
24,670 |
|
|
|
3,248 |
|
|
|
4,360 |
|
Interest expense |
|
|
(17,380 |
) |
|
|
(22,055 |
) |
|
|
(9,841 |
) |
|
|
(19,829 |
) |
Other, net |
|
|
954 |
|
|
|
8,952 |
|
|
|
(2,776 |
) |
|
|
(6,768 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income tax provision (benefit) |
|
|
84,986 |
|
|
|
22,067 |
|
|
|
(302,284 |
) |
|
|
(11,662 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision (benefit) |
|
|
1,933 |
|
|
|
758 |
|
|
|
(10,947 |
) |
|
|
77,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
83,053 |
|
|
$ |
21,309 |
|
|
$ |
(291,337 |
) |
|
$ |
(89,606 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per common share basic |
|
$ |
1.89 |
|
|
$ |
0.49 |
|
|
$ |
(6.69 |
) |
|
$ |
(2.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per common share diluted |
|
$ |
1.29 |
|
|
$ |
0.46 |
|
|
$ |
(6.69 |
) |
|
$ |
(2.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares basic |
|
|
43,927 |
|
|
|
43,600 |
|
|
|
43,520 |
|
|
|
43,486 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares diluted |
|
|
72,927 |
|
|
|
61,379 |
|
|
|
43,520 |
|
|
|
43,486 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-4
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT)
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Additional |
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Par |
|
|
Paid-in |
|
|
Comprehensive |
|
|
Deferred |
|
|
Accumulated |
|
|
|
|
|
|
Shares |
|
|
Value |
|
|
Capital |
|
|
Income (Loss) |
|
|
Compensation |
|
|
Deficit |
|
|
Total |
|
Balance, June 30, 2004 |
|
|
43,751 |
|
|
$ |
438 |
|
|
$ |
322,486 |
|
|
$ |
(7,330 |
) |
|
$ |
(3,571 |
) |
|
$ |
(22,932 |
) |
|
$ |
289,091 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(89,606 |
) |
|
|
(89,606 |
) |
Other comprehensive income,
net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gain on
available-for-sale
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,803 |
|
|
|
|
|
|
|
|
|
|
|
2,803 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(86,803 |
) |
Exercise of stock options |
|
|
73 |
|
|
|
|
|
|
|
461 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
461 |
|
Issuance of restricted stock |
|
|
116 |
|
|
|
2 |
|
|
|
4,772 |
|
|
|
|
|
|
|
(4,774 |
) |
|
|
|
|
|
|
|
|
Forfeiture of restricted stock |
|
|
(158 |
) |
|
|
(2 |
) |
|
|
(1,894 |
) |
|
|
|
|
|
|
1,896 |
|
|
|
|
|
|
|
|
|
Amortization of deferred
compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
753 |
|
|
|
|
|
|
|
753 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, June 30, 2005 |
|
|
43,782 |
|
|
$ |
438 |
|
|
$ |
325,825 |
|
|
$ |
(4,527 |
) |
|
$ |
(5,696 |
) |
|
|
($112,538 |
) |
|
$ |
203,502 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(291,337 |
) |
|
|
(291,337 |
) |
Other comprehensive income,
net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gain on
available-for-sale
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,437 |
|
|
|
|
|
|
|
|
|
|
|
3,437 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(287,900 |
) |
Exercise of stock options |
|
|
5 |
|
|
|
|
|
|
|
19 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
19 |
|
Share-based payment
expense, net |
|
|
|
|
|
|
|
|
|
|
409 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
409 |
|
Elimination of deferred
compensation upon adoption
of SFAS No. 123R |
|
|
|
|
|
|
|
|
|
|
(5,696 |
) |
|
|
|
|
|
|
5,696 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2005 |
|
|
43,787 |
|
|
$ |
438 |
|
|
$ |
320,557 |
|
|
$ |
(1,090 |
) |
|
$ |
|
|
|
$ |
(403,875 |
) |
|
$ |
(83,970 |
) |
(Continued)
F-5
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT)
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Additional |
|
|
Other |
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Par |
|
|
Paid-in |
|
|
Comprehensive |
|
|
Deferred |
|
|
Accumulated |
|
|
|
|
|
|
Shares |
|
|
Value |
|
|
Capital |
|
|
Income (Loss) |
|
|
Compensation |
|
|
Deficit |
|
|
Total |
|
Balance, December 31, 2005 |
|
|
43,787 |
|
|
$ |
438 |
|
|
$ |
320,557 |
|
|
$ |
(1,090 |
) |
|
$ |
|
|
|
$ |
(403,875 |
) |
|
$ |
(83,970 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,309 |
|
|
|
21,309 |
|
Other comprehensive income,
net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gain on
available-for-sale
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
676 |
|
|
|
|
|
|
|
|
|
|
|
676 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21,985 |
|
Exercise of stock options |
|
|
230 |
|
|
|
2 |
|
|
|
1,088 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,090 |
|
Share-based payment
expense, net |
|
|
(18 |
) |
|
|
|
|
|
|
4,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2006 |
|
|
43,999 |
|
|
$ |
440 |
|
|
$ |
326,099 |
|
|
$ |
(414 |
) |
|
$ |
|
|
|
$ |
(382,566 |
) |
|
$ |
(56,441 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
83,053 |
|
|
|
83,053 |
|
Other comprehensive income,
net of tax: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net unrealized gain on
available-for-sale
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
519 |
|
|
|
|
|
|
|
|
|
|
|
519 |
|
Currency translation
adjustment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
221 |
|
|
|
|
|
|
|
|
|
|
|
221 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
83,793 |
|
Exercise of stock options |
|
|
114 |
|
|
|
1 |
|
|
|
576 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
577 |
|
Share-based payment
expense, net |
|
|
23 |
|
|
|
|
|
|
|
8,099 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,099 |
|
Issuance of stock for employee
stock purchase plan |
|
|
64 |
|
|
|
1 |
|
|
|
544 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
545 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance, December 31, 2007 |
|
|
44,200 |
|
|
$ |
442 |
|
|
$ |
335,318 |
|
|
$ |
326 |
|
|
$ |
|
|
|
$ |
(299,513 |
) |
|
$ |
36,573 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-6
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
Year |
|
|
|
|
|
|
|
|
|
|
|
Ended |
|
|
Ended |
|
|
|
Year Ended December 31, |
|
|
December 31, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2005 |
|
Cash flows from operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
83,053 |
|
|
$ |
21,309 |
|
|
$ |
(291,337 |
) |
|
$ |
(89,606 |
) |
Adjustments to reconcile net income (loss) to net cash
provided by operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
16,874 |
|
|
|
13,290 |
|
|
|
11,405 |
|
|
|
22,681 |
|
Write-off of equipment |
|
|
5,124 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization of debt securities premium/discount |
|
|
28 |
|
|
|
689 |
|
|
|
355 |
|
|
|
2,555 |
|
Write-off and amortization of debt issuance costs |
|
|
1,776 |
|
|
|
4,304 |
|
|
|
941 |
|
|
|
1,829 |
|
(Gain) loss on sale of equity investment |
|
|
|
|
|
|
(13,844 |
) |
|
|
3,470 |
|
|
|
12,913 |
|
(Gain) loss on sale of assets |
|
|
(26 |
) |
|
|
35 |
|
|
|
148 |
|
|
|
(5 |
) |
Gain on redemption of notes payable |
|
|
(519 |
) |
|
|
(9,212 |
) |
|
|
(406 |
) |
|
|
(151 |
) |
Deferred income taxes |
|
|
|
|
|
|
|
|
|
|
(10,966 |
) |
|
|
79,380 |
|
Acquired in-process research and development |
|
|
|
|
|
|
11,000 |
|
|
|
10,000 |
|
|
|
|
|
Share-based compensation |
|
|
8,268 |
|
|
|
4,454 |
|
|
|
409 |
|
|
|
753 |
|
Non-cash write down of goodwill and intangibles |
|
|
|
|
|
|
|
|
|
|
284,101 |
|
|
|
|
|
Change in fair value of derivative |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,463 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decrease (increase) in accounts receivable, net |
|
|
332 |
|
|
|
(1,172 |
) |
|
|
11,551 |
|
|
|
339 |
|
Increase in inventories |
|
|
(4,679 |
) |
|
|
(1,604 |
) |
|
|
(335 |
) |
|
|
(4,464 |
) |
(Increase) decrease in other current assets |
|
|
(902 |
) |
|
|
244 |
|
|
|
138 |
|
|
|
(9,507 |
) |
(Decrease) increase in accounts payable |
|
|
(15,340 |
) |
|
|
14,879 |
|
|
|
165 |
|
|
|
1,211 |
|
Increase (decrease) in accrued expenses |
|
|
6,442 |
|
|
|
(955 |
) |
|
|
(5,767 |
) |
|
|
3,873 |
|
Decrease in other, net |
|
|
|
|
|
|
(110 |
) |
|
|
(476 |
) |
|
|
(1,003 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by operating activities |
|
|
100,431 |
|
|
|
43,307 |
|
|
|
13,396 |
|
|
|
22,261 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(17,563 |
) |
|
|
(9,694 |
) |
|
|
(4,444 |
) |
|
|
(3,106 |
) |
Purchase of acquired in-process research and
development |
|
|
|
|
|
|
(11,000 |
) |
|
|
(10,000 |
) |
|
|
|
|
Purchase of product rights |
|
|
(17,500 |
) |
|
|
(35,000 |
) |
|
|
|
|
|
|
|
|
Proceeds from sale of investments in equity securities |
|
|
|
|
|
|
20,209 |
|
|
|
7,481 |
|
|
|
30,647 |
|
Proceeds from sale of marketable securities |
|
|
205,618 |
|
|
|
193,250 |
|
|
|
30,525 |
|
|
|
33,000 |
|
Purchase of marketable securities |
|
|
(412,887 |
) |
|
|
(611,743 |
) |
|
|
(174,887 |
) |
|
|
(219,855 |
) |
Maturities of marketable securities |
|
|
209,727 |
|
|
|
353,962 |
|
|
|
163,448 |
|
|
|
115,694 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by investing activities |
|
|
(32,605 |
) |
|
|
(100,016 |
) |
|
|
12,123 |
|
|
|
(43,620 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
1,122 |
|
|
|
1,090 |
|
|
|
19 |
|
|
|
229 |
|
Employee stock purchase plan |
|
|
131 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from issuance of notes payable |
|
|
|
|
|
|
275,000 |
|
|
|
|
|
|
|
|
|
Redemption of notes payable |
|
|
(49,732 |
) |
|
|
(262,146 |
) |
|
|
(4,594 |
) |
|
|
(849 |
) |
Cash payment for debt issuance costs |
|
|
|
|
|
|
(7,726 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net cash (used in) provided by financing activities |
|
|
(48,479 |
) |
|
|
6,218 |
|
|
|
(4,575 |
) |
|
|
(620 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
19,347 |
|
|
|
(50,491 |
) |
|
|
20,944 |
|
|
|
(21,979 |
) |
Cash and cash equivalents at beginning of period |
|
|
20,706 |
|
|
|
71,197 |
|
|
|
50,253 |
|
|
|
72,232 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
40,053 |
|
|
$ |
20,706 |
|
|
$ |
71,197 |
|
|
$ |
50,253 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these consolidated financial statements.
F-7
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements
(1) Company Overview
Enzon Pharmaceuticals, Inc. (Enzon or the Company) is a biopharmaceutical company dedicated to
the development and commercialization of important medicines for patients with cancer and other
life-threatening conditions. The Company operates in three business segments: Products, Royalties
and Contract Manufacturing. Product sales revenues are comprised of sales of four U.S. Food and
Drug Administration (FDA) approved products, Oncaspar, DepoCyt, Abelcet and Adagen. The Company
derives income from royalties on sales of products by other companies that use its proprietary
PEGylation technology, including PEG-INTRON, marketed by Schering-Plough Corporation
(Schering-Plough) and Macugen, marketed by OSI Pharmaceuticals, Inc. and Pfizer Inc. The Company
manufactures products for third parties in its contract manufacturing operations. Expenditures
include the development of additional products under various stages of development, as well as
costs related to the sales and manufacture of products.
Effective December 31, 2005, the Company changed its fiscal year end from June 30 to December
31 in order to better align with its industry. Accordingly, the information contained herein
relating to the results of operations and cash flows is for the years ended December 31, 2007 and
2006, the six months ended December 31, 2005 and the fiscal year ended June 30, 2005.
The Companys business is subject to significant risks and uncertainties including, but not
limited to:
|
|
|
The risk that the Company will not achieve success in its research and
development efforts, including clinical trials conducted by it or its
collaborative partners. |
|
|
|
|
The risk that the Company will experience operating losses for the next
several years. |
|
|
|
|
The risk that there will be a decline in sales of one or more of the Companys
marketed products or products sold by others from which the Company derives
royalty revenues. Such sales declines could result from increased competition,
loss of patent protection, pricing, supply shortages and/or regulatory
constraints. |
|
|
|
|
The risk, due to limited or single sources of supply for major products, that
the Company will be unable to obtain critical compounds used in the manufacture
of its products at economically feasible prices or at all, or that one of its
key suppliers will experience manufacturing problems or delays. |
|
|
|
|
Decisions by regulatory authorities regarding whether and when to approve the
Companys regulatory applications as well as their decisions regarding labeling
and other matters could affect the commercial potential of its products or
developmental products. |
|
|
|
|
The risk that the Company will fail to obtain adequate financing to meet its
future capital and financing needs. |
|
|
|
|
The risk that key personnel will leave the Company. |
(2) Summary of Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned
subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.
Assets and liabilities of the Companys Canadian operations are translated into U.S. dollar
equivalents at rates in effect at the balance sheet date. Translation adjustments are recorded in
stockholders equity in accumulated other comprehensive income (loss).
F-8
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States of America (U.S.) requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent
assets and liabilities at the date of the financial statements and the reported amounts of revenues
and expenses during the reporting period. Actual results could differ from those estimates.
Financial Instruments
The carrying values of cash, cash equivalents, short-term investments, restricted investments
and cash, accounts receivable, other current assets, accounts payable, accrued expenses and accrued
interest, included in the Companys consolidated balance sheets approximated their fair values at
December 31, 2007 and 2006 due to their short-term nature. Marketable securities are carried on
the consolidated balance sheets at fair value based primarily on quoted market prices. The
carrying values of the Companys 4% convertible senior unsecured notes outstanding at December 31,
2007 and 2006 was $275.0 million and the fair value of these notes was $325.6 million and $290.8
million at December 31, 2007 and 2006, respectively. The 4.5% convertible subordinated notes were
carried at $72.4 million and $122.6 million as of December 31, 2007 and 2006, respectively, and had
fair values of $72.0 million and $117.4 million as of each of those dates, respectively. Fair
value of the Companys notes payable is based on quoted market prices.
Cash
Equivalents
The Company considers all highly liquid debt instruments with remaining maturities at the date
acquired not exceeding three months to be cash equivalents. Cash equivalents consist primarily of
money market funds. As of December 31, 2007 and 2006 the Company held $19.1 million and $14.4
million of cash equivalents, respectively.
Investments and Marketable Securities
The Company classifies its investments in debt and equity securities as either short-term or
long-term based upon their stated maturities and the Companys intent and ability to hold them.
Investments with stated maturities of one year or less are classified as current assets.
Investments in debt securities with stated maturities greater than one year and marketable equity
securities are classified as noncurrent assets when the Company has the intent and ability to hold
such securities for at least one year. Short-term investments are further classified as restricted
or unrestricted with restricted investments and cash being held exclusively for the repayment or
repurchase of the Companys 4.5% convertible subordinated notes due July 1, 2008.
Investments in marketable equity securities and debt securities, including auction rate
securities are classified as available-for-sale. Debt and marketable equity securities are carried
at fair value, with the unrealized gains and losses (which are deemed to be temporary), net of
related tax effect, when appropriate, included in the determination of other comprehensive income
(loss) and reported in stockholders equity (deficit). The fair value of almost all securities is
determined by quoted market prices.
The cost of the debt securities is adjusted for amortization of premiums and accretion of
discounts to maturity. The amortization and accretion, along with realized gains and losses, is
included in investment income, net. The cost of securities is based on the specific identification
method.
F-9
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
The amortized cost, gross unrealized holding gains or losses, and fair value for securities
available-for-sale by major security type at December 31, 2007 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Holding Gains |
|
|
Holding Losses |
|
|
Value* |
|
U.S. Government and GSE debt |
|
$ |
9,796 |
|
|
$ |
2 |
|
|
$ |
(19 |
) |
|
$ |
9,779 |
|
U.S. corporate debt |
|
|
136,037 |
|
|
|
83 |
|
|
|
(97 |
) |
|
|
136,023 |
|
Auction rate securities |
|
|
51,375 |
|
|
|
|
|
|
|
(240 |
) |
|
|
51,135 |
|
Other |
|
|
2,308 |
|
|
|
333 |
|
|
|
|
|
|
|
2,641 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
199,516 |
|
|
$ |
418 |
|
|
$ |
(356 |
) |
|
$ |
199,578 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Included in short-term investments $123,907, restricted investments $55,018 and marketable
securities $20,653 at December 31, 2007. |
The amortized cost, gross unrealized holding gains or losses, and fair value for securities
available-for-sale by major security type at December 31, 2006 were as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Fair |
|
|
|
Cost |
|
|
Holding Gains |
|
|
Holding Losses |
|
|
Value* |
|
U.S. Government and GSE debt |
|
$ |
36,003 |
|
|
$ |
|
|
|
$ |
(260 |
) |
|
$ |
35,743 |
|
U.S. corporate debt |
|
|
133,904 |
|
|
|
7 |
|
|
|
(230 |
) |
|
|
133,681 |
|
Auction rate securities |
|
|
48,075 |
|
|
|
|
|
|
|
|
|
|
|
48,075 |
|
Other |
|
|
2,374 |
|
|
|
26 |
|
|
|
|
|
|
|
2,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
220,356 |
|
|
$ |
33 |
|
|
$ |
(490 |
) |
|
$ |
219,899 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Included in short-term investments $152,838 and marketable securities $67,061 at December 31,
2006. |
The Company holds auction rate securities for which interest or dividend rates are generally
reset for periods of up to 90 days at which time, the Company has the option of selling the
securities. The auction rate securities outstanding at December 31, 2007 and 2006 were investments
in state government bonds and corporate securities. As of January 31, 2008, the Companys holdings
of auction rate securities was reduced to $22.0 million through the planned liquidation of
restricted investments in order to repurchase outstanding debt.
Restricted investments and cash are held in a separate account for the sole purpose of
repayment or repurchase of the Companys 4.5% convertible subordinated notes due July 1, 2008. As
of December 31, 2007, restricted investments amounted to $55.0 million of which $29.0 million was
held in auction rate securities and restricted cash amounted to $18.6 million. By the end of
January 2008, all auction rate securities in the restricted funds had been liquidated.
F-10
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
Other securities include investments of participants in the Companys Executive Deferred
Compensation Plan (predominantly mutual fund shares) totaling $2.3 million as of December 31, 2007
and $1.8 million as of December 31, 2006. The assets of the deferred compensation plan also
include cash ($0.6 million and $0.3 million at December 31, 2007 and 2006, respectively). There is
a non-current liability that offsets the aggregate deferred compensation plan assets. In addition,
other securities include $0.3 million of corporate equity securities as of December 31, 2007.
Maturities of marketable debt securities, excluding $2.6 million, the majority of which is
related to the Companys Executive Deferred Compensation Plan, at December 31, 2007 were as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Maturing During the Year |
|
|
|
|
|
|
|
|
|
|
ended December 31, |
|
|
|
|
|
Amortized Cost |
|
|
Fair Value |
|
2008 |
|
|
|
|
|
$ |
178,855 |
|
|
$ |
178,583 |
|
2009 |
|
|
|
|
|
|
18,353 |
|
|
|
18,354 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
197,208 |
|
|
$ |
196,937 |
|
|
|
|
|
|
|
|
|
|
|
|
Net realized gains (losses) from the sale of short-term investments, marketable securities and
equity securities included in net income (loss) for the years ended December 31, 2007 and 2006, the
six months ended December 31, 2005 and the fiscal year ended June 30, 2005 were a gain of $0.1
million, a gain of $13.8 million, a loss of $3.5 million and a loss of $12.9 million, respectively.
Pursuant to Financial Accounting Standards Board Staff Position (FSP) FAS 115-1, The Meaning
of Other-Than-Temporary Impairment and Its Application to Certain Investments, impairment
assessments are made at the individual security level each reporting period. When the fair value
of an investment is less than its cost at the balance sheet date, a determination is made as to
whether the impairment is other than temporary and, if it is other than temporary, an impairment
loss is recognized in earnings equal to the difference between the investments cost and fair value
at such date. The Company has determined that there were no other-than-temporary declines in the
fair values of its marketable securities and short-term investments as of December 31, 2007. The
following table shows the gross unrealized losses and fair values of the Companys
available-for-sale securities (both short-term and long-term) aggregated by investment category and
length of time that individual securities have been in a continuous loss position at December 31,
2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than 12 months |
|
|
12 Months or Greater |
|
|
|
Fair |
|
|
Unrealized |
|
|
Fair |
|
|
Unrealized |
|
|
|
value |
|
|
loss |
|
|
value |
|
|
loss |
|
|
|
|
|
|
U.S. corporate debt(1) |
|
$ |
49,951 |
|
|
$ |
(81 |
) |
|
$ |
15,466 |
|
|
$ |
(16 |
) |
U.S.
Government and GSE debt(2) |
|
|
3,283 |
|
|
|
(13 |
) |
|
|
3,994 |
|
|
|
(6 |
) |
Auction rate securities(3) |
|
|
1,260 |
|
|
|
(240 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
54,494 |
|
|
$ |
(334 |
) |
|
$ |
19,460 |
|
|
$ |
(22 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
U.S. corporate debt. The unrealized losses of $97,000 on the U.S. corporate debt
were attributable to increases in interest rates, as well as bond pricing. The Company invests in
bonds that are rated A1 or better, as dictated by its investment policy. Since the changes in the
market value of these investments are due to changes in interest rates and not the credit quality
of the issuer, and the Company has the ability and intent to hold these investments until recovery
of the cost, the Company does not consider its investments in U.S. corporate debt to be
other-than-temporarily impaired at December 31, 2007. |
F-11
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
|
|
|
(2) |
|
U.S. Government and GSE debt. The unrealized losses of $19,000 in the U.S.
Government and government-sponsored enterprise, or GSE mortgage-backed securities were attributable
to increases in interest rates. These holdings do not permit the issuer to settle the securities
at a price less than the amortized cost. Further, because the declines in market value are due to
increases in interest rates and not the credit quality of the issuer, and the Company has the
ability and the intent to hold these investments until recovery of the cost, the Company does not
consider its investments in U.S. Government and GSE debt to be other-than-temporarily impaired at
December 31, 2007. |
|
(3) |
|
The Companys investments in auction rate securities are AAA or AA rated.
During the latter portion of 2007, auctions for one such security, having a cost basis of $1.5
million, were not successful. When the auctions are not successful, the interest rates on these
investments increase as does the risk associated with their illiquidity. The Company has reported
these securities at their estimated fair value as provided by its investment advisers and
recognized the unrealized loss in other comprehensive income. The Company has the intent and
ability to hold these investments until recovery of the cost and does not believe the impairment to
be other than temporary. The Company will continue to monitor these securities and will recognize
an impairment loss in earnings at such time as it is determined to be permanent. Auctions
generally occur at regular intervals of up to 90 days. |
Investments in Equity Securities
During the year ended December 31, 2006, the Company sold its remaining 1,023,302 shares of
common stock of Nektar Therapeutics, Inc. (Nektar). The disposition of the shares resulted in cash
proceeds of $20.2 million and a gain of $13.8 million reported in investment income, net in the
year ended December 31, 2006. For the six months ended December 31, 2005 and the fiscal year ended
June 30, 2005, cash inflows from the sale of equity securities were $7.5 million and $30.6 million,
respectively. These cash flows related primarily to the sale by the Company of its holdings in NPS
Pharmaceuticals common stock resulting in losses of $3.5 million and $12.9 million in the six
months ended December 31, 2005 and the year ended June 30, 2005, respectively.
Revenue Recognition
The Company ships product to customers primarily FOB shipping point and utilizes the following
criteria to determine appropriate revenue recognition: persuasive evidence of an arrangement
exists, delivery has occurred, selling price is fixed and determinable and collection is reasonably
assured. Revenues from product sales and contract manufacturing are recognized when title passes
to the customer, generally at the time of shipment. For product sales, a provision is made at the
time of shipment for estimated future credits, chargebacks, sales discounts, rebates, returns
(estimates of these adjustments are based on historical trends) and distribution service fees. See
below for further information regarding these sales provisions.
Royalty revenue from the Companys agreements with third parties is recognized when the
Company can reasonably determine the amounts earned. In most cases, this will be upon notification
from the third-party licensee, which is typically the quarter following the quarter in which the
sales occurred. The Company does not participate in the selling or marketing of products for which
it receives royalties.
F-12
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
At the request of the customer, certain contract manufacturing arrangements involve the
transfer of title of the finished product to the customer prior to shipment. The product in
question is manufactured to the unique specifications of the customer and cannot be used to fill
other orders. If all necessary conditions are met, including: the product is complete and ready
for shipment, the risks of ownership have passed to the customer and the customer pays for storage
of the product at the Companys facility, the Company will recognize revenue.
In accordance with Staff Accounting Bulletin (SAB) No. 104, Revenue Recognition, up-front
nonrefundable fees associated with license and development agreements where the Company has
continuing involvement in the agreement, are recorded as deferred revenue and recognized over the
estimated service period. If the estimated service period is subsequently modified, the period
over which the up-front fee is recognized is modified accordingly on a prospective basis.
Accounts Receivable
The Company records its allowance for doubtful accounts by applying historical collection
percentages to its aged accounts receivable balances and by analyzing the collectibility of known
risks. The Company ages its accounts receivable based on its terms of sales. The allowance for
doubtful accounts was $280,000 and $245,000 at December 31, 2007 and 2006, respectively.
Historically, bad debts have been minimal.
Accruals for Medicaid Rebates, Returns, Chargebacks and Distribution Service Fees
With respect to accruals for estimated Medicaid rebates, the Company evaluates its historical
rebate payments by product as a percentage of historical sales. This information is used to
estimate the proportion of revenue that will result in a rebate. At the time of rebate payments,
which occur after the related sales, the Company records a reduction to accrued expenses and, at
the end of each quarter, adjusts accrued expenses for any differences between estimated and actual
payments. Product returns are accrued based on historical experience, projected future
prescriptions of the products using historical prescription data and the amount and expiry of
inventory estimated to be in the distribution channel, based on information obtained from the
Companys major customers. Chargeback accruals are based on an estimate of claims not yet
submitted by customers, using historical trends and market share data as well as the Companys
estimate of inventory in the distribution channel based on information obtained from its major
customers. In all cases, judgment is required in estimating these reserves and actual claims for
rebates, returns and chargebacks could be materially different from the estimates. The Company has
entered into distribution service agreements with three of its largest customers. The Company pays
these customers a fixed percentage of revenues in exchange for certain distribution-related
services. This expense is accrued at the time of sale to the customer and results in a reduction
of the net revenues recorded by the Company.
These sales provision accruals, except for rebates which are recorded as a liability, are
presented as a reduction of the accounts receivable balance and totaled $4.6 million, including
$2.6 million in reserves for chargebacks, as of December 31, 2007. At December 31, 2006 these
sales provision accruals totaled $5.1 million, including $3.4 million in reserves for chargebacks.
The Company continually monitors the adequacy of the accrual by comparing the actual payments to
the estimates used in establishing the accrual.
Inventories
Inventories are carried at the lower of cost or market. Cost is determined using the
first-in, first-out (FIFO) method and includes the cost of raw materials, labor and overhead.
F-13
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
Property and Equipment
Property and equipment are stated at cost. Depreciation of fixed assets is provided by the
straight-line method over the estimated useful lives of the assets. When assets are retired or
otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts,
and any resulting gain or loss is recognized in operations for the period. Amortization of
leasehold improvements is calculated using the straight-line method over the remaining term of the
lease or the life of the asset, whichever is shorter. The cost of repairs and maintenance is
charged to operations as incurred; significant renewals and improvements are capitalized.
Long-Lived Assets
Long-lived assets, including amortizable intangible assets, are tested for impairment in
accordance with the provisions of SFAS No. 144, Accounting for the Impairment or Disposal of
Long-Lived Assets. This testing is performed when impairment indicators are present. Impairment
indicators are events or circumstances that may be indicative of possible impairment such as a
significant adverse change in legal factors or in business climate, a current period operating loss
combined with a history of operating losses or a projection or forecast that demonstrates
continuing losses associated with the use of a long-lived asset or asset group. SFAS No. 144
testing for the recoverability of an asset group is performed initially by comparing the carrying
amount of the asset group to the future undiscounted net cash flows to be generated by the assets.
If the undiscounted net cash flow stream exceeds the carrying amount, no further analysis is
required. However, if this test shows a negative relationship, the fair value of the asset group
must be determined and the Company would record an impairment charge for any excess of the carrying
amount over the fair value. These evaluations involve amounts that are based on managements best
estimates and judgment. Actual results may differ from these estimates. Refer to Note 7 regarding
a December 2005 impairment write-down.
Deferred Financing Costs
Costs incurred in issuing the Companys notes payable have been recorded as deferred financing
costs and are included within the balances of other assets and other current assets in the
accompanying consolidated balance sheets. Such amounts are being amortized using the straight-line
method, which approximates the effective interest method, over the terms of the related financing.
The amortization of deferred financing costs is included in interest expense in the accompanying
consolidated statements of operations.
Acquired In-Process Research and Development
Costs to acquire in-process research and development projects and technologies that have no
alternative future use at the date of acquisition are expensed as incurred.
Research and Development
All research and development costs are expensed as incurred. These include the following
types of costs incurred in performing research and development activities: salaries and benefits,
allocated overhead and occupancy costs, clinical trials and related clinical manufacturing costs,
contract services, and other outside costs.
F-14
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
Income Taxes
Income taxes are accounted for under the asset and liability method. Deferred tax assets and
liabilities are recognized for the estimated future tax consequences attributable to differences
between the financial statement carrying amounts of existing assets and liabilities and their
respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and
liabilities are measured using enacted tax rates expected to apply to taxable income in the years
in which those temporary differences are expected to be recovered or settled. The effect of a
change in tax rates or laws on deferred tax assets and liabilities is recognized in operations in
the period that includes the enactment date of the rate change. A valuation allowance is
established to reduce the deferred tax assets to the amounts that are more likely than not to be
realized.
In accordance with FASB Interpretation No. 48, Accounting for Uncertainty in Income Taxes
(FIN 48), tax benefits of uncertain tax positions are recognized only if it is more likely than not
that the Company will be able to sustain a position taken on an income tax return. Upon adoption
of FIN 48, as amended, as of January 1, 2007, the Company had no tax positions relating to open
income tax returns that were considered to be uncertain. Accordingly, the Company had no liability
for such uncertain positions nor did it establish such a liability upon adoption of FIN 48 nor
during the year ended December 31, 2007. Interest and penalties, if any, related to unrecognized
tax benefits, would be recognized as income tax expense.
Foreign Currency Transactions
Gains and losses from foreign currency transactions, such as those resulting from the
translation and settlement of receivables and payables denominated in foreign currencies, are
included in the consolidated statements of operations. The Company does not currently use
derivative financial instruments to manage the risks associated with foreign currency fluctuations.
The Company recorded the impact of foreign currency transaction gains of $368,000, losses of
$20,000, gains of $110,000 and gains of $39,000 for the years ended December 31, 2007 and 2006, the
six months ended December 31, 2005 and the year ended June 30, 2005, respectively. Gains and
losses from foreign currency transactions are included as a component of other income (expense).
Concentrations of Risk
The Companys holdings of financial instruments are comprised principally of debt securities,
auction rate securities and time deposits. The Company does not invest in portfolio equity
securities or commodities or use financial derivatives for trading purposes. The Company seeks
reasonable assuredness of the safety of principal and market liquidity by investing in rated
securities while at the same time seeking to achieve a favorable rate of return. The Companys
market risk exposure consists principally of exposure to changes in interest rates. The Companys
holdings also are exposed to the risks of changes in the credit quality of issuers. The Company
typically invests the majority of its investments in the shorter-end of the maturity spectrum, and
at December 31, 2007 all of its holdings were in instruments maturing in two years or less, or
having a market that enables flexibility in terms of timing of disposal.
F-15
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
A significant portion of the Companys product sales are to wholesalers in the pharmaceutical
industry. The Company monitors the creditworthiness of customers to whom it grants credit terms
and has not experienced significant credit losses. The Company does not normally require
collateral or any other security to support credit sales. However, the Company maintains limited
credit insurance to mitigate potential losses.
The Companys top three wholesalers accounted for 38%, 41%, 50% and 59% of gross product sales
for the years ended December 31, 2007 and 2006, the six months ended December 31, 2005 and the year
ended June 30, 2005, respectively, and 46% and 28% of the gross accounts receivable balance at
December 31, 2007 and 2006, respectively.
Share-Based Compensation Plans
The Company adopted SFAS No. 123R, Share-Based Payment (Revised 2004), effective July 1,
2005, which requires that the costs resulting from all share-based payment transactions be
recognized in the financial statements at their fair values. The Company adopted SFAS No. 123R
using the modified prospective application method under which the provisions of SFAS No. 123R apply
to new awards and to awards modified, repurchased, or cancelled after the adoption date.
Additionally, compensation cost for the portion of the awards for which the requisite service has
not been rendered that are outstanding as of the adoption date is recognized in the consolidated
statement of operations in research and development and selling, general and administrative
expenses over the remaining service period after the adoption date
based on the awards original estimate of fair value (in the case of options, based on the Companys
original estimate of fair value, and in the case of restricted stock and restricted stock units
(RSUs), based on the closing price of the Companys common stock on the date of issuance).
Compensation costs for option and share awards to employees associated with the manufacturing
process are largely embodied in product standard costs and production variances and consequently
flow through to cost of products sold and contract manufacturing as inventory is sold. Results for
prior periods have not been restated. In connection with the adoption of SFAS No. 123R, the
deferred stock compensation at June 30, 2005 of $5.7 million relating to previous grants of
restricted stock was offset against additional paid-in capital (APIC).
The Company elected to apply the short-cut method to determine the hypothetical APIC pool
provided by FSP FAS 123(R)-3, Transition Election Related to Accounting for the Tax Effects of
Share-Based Payment Awards, pursuant to which, excess tax benefits resulting from stock option
exercises will be recognized as additions to APIC in the period the benefit is realized. In the
event of a shortfall (i.e., the tax benefit realized is less than the amount previously recognized
through periodic stock compensation expense recognition and related deferred tax accounting), the
shortfall would be charged against APIC to the extent of previous excess benefits, including the
hypothetical APIC pool, and then to tax expense. The Company does not anticipate experiencing a
charge to tax expense for shortfalls in the foreseeable future. The cash flows resulting from
excess tax benefits are classified as financing cash flows. For the years ended December 31, 2007
and 2006 and the six months ended December 31, 2005, there was no tax benefit resulting from
share-based compensation cost due to the Companys net operating loss position.
Prior to the adoption of SFAS No. 123R, the Company applied the intrinsic-value-based method
of accounting prescribed by APB 25, and related interpretations, to account for its stock options
granted to employees. As permitted by prior rules (i.e., SFAS No. 123, Accounting for Stock-Based
Compensation), under the intrinsic-value-based method, compensation cost was recorded only if the
market price of the underlying stock on the date of grant exceeded the exercise price. As an
alternative to fair value expense recognition of stock-based compensation, the Company adopted the
disclosure-only requirements of SFAS No. 123, as amended.
F-16
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
The following table illustrates the pro forma effect on the Companys net loss and net loss
per share as if the Company had adopted the fair-value-based method of accounting for stock-based
compensation under SFAS No. 123 for the fiscal year ended June 30, 2005 (in thousands except
per-share amounts). In computing the pro forma amounts, forfeitures were accounted for as they
occurred and no amounts of compensation expense have been capitalized into inventory or other
assets, but instead are considered period expenses in the pro forma amounts:
|
|
|
|
|
|
|
Year ended |
|
|
|
June 30, 2005 |
|
Net loss |
|
|
|
|
As reported |
|
$ |
(89,606 |
) |
Add stock-based employee compensation expense included in
reported net loss, net of tax (1) |
|
|
755 |
|
Deduct total stock-based employee compensation expense
determined under fair-value-based method for all awards,
net of tax (1) |
|
|
(27,680 |
) |
|
|
|
|
|
Pro forma net loss |
|
$ |
(116,531 |
) |
|
|
|
|
Net loss per common share-basic: |
|
|
|
|
As reported |
|
$ |
(2.06 |
) |
Pro forma |
|
$ |
(2.68 |
) |
Net loss per common share-diluted: |
|
|
|
|
As reported |
|
$ |
(2.06 |
) |
Pro forma |
|
$ |
(2.68 |
) |
|
|
|
(1) |
|
Information has not been tax-effected as a result of the Companys net operating
loss position and related valuation allowance in that year. |
The weighted-average fair value per share was $5.75 for stock options, as if accounted for
under SFAS No. 123 and granted in fiscal year ended June 30, 2005. The fair value of stock options
was estimated using the Black-Scholes option-pricing model. The Black-Scholes model considers a
number of variables, including the exercise price and the expected life of the option, and the
current price of common stock. In addition, the model used to compute the fiscal year ended June
30, 2005 proforma charge employs an expected risk-free interest rate of 3.63%, an expected weighted
average volatility of 58%, an expected weighted average term until exercise of 5.18 years and no
dividends.
Expected volatility is based on historical volatility of the Companys common stock; the
expected term until exercise represents the weighted average period of time that options granted
are expected to be outstanding giving consideration to vesting schedules and the Companys
historical exercise patterns; and the risk-free interest rate is based on the U.S. Treasury yield
curve in effect at the time of grant for periods corresponding with the expected life of the
option.
F-17
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
Cash Flow Information
Cash payments for interest were approximately $16.8 million and $22.9 million for the years
ended December 31, 2007 and 2006, respectively, $9.0 million for the six months ended December 31,
2005 and $18.0 million for the year ended June 30, 2005. There were $509,000, $118,000, $182,000
and $632,000 of income tax payments made for the years ended December 31, 2007 and 2006, the six
months ended December 31, 2005 and the year ended June 30, 2005, respectively.
In December 2006, the Company entered into a supply agreement with Ovation Pharmaceuticals,
Inc. (Ovation) related to the active ingredient used in the production of Oncaspar. The agreement
required the Company to pay, among other things, a $17.5 million license fee in February 2007.
The
Company has revised its previously reported 2006 cash and cash
equivalents and short-term investments to reflect a change in
classification of auction rate securities. Cash and cash equivalents
as of December 31, 2006, December 31, 2005 and
June 30, 2005, was reduced and short-term investments was
increased by $7.7 million, $5.3 million and
$5.3 million, respectively. The Company also reduced the
beginning-of-period cash and cash equivalents balance in the June
2005 statement of cash flows by $5.3 million. The Company
revised its purchases of marketable securities in the 2006 statement
of cash flows from $609.3 million to $611.7 million to
reflect the increased balance that year of these auction rate
securities of $2.4 million (from $5.3 million to
$7.7 million). The effect of these revisions on the Company's previously
reported financial statements was immaterial.
Reclassifications
Certain amounts previously reported have been reclassified to conform to the year ended
December 31, 2007 presentation.
(3) Comprehensive Income
Comprehensive income consists of net income (loss) and net unrealized gain (loss) on
available-for-sale securities and is presented in the consolidated statements of stockholders
equity (deficit).
The following table reconciles net income (loss) to comprehensive income (loss) (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
Year |
|
|
|
|
|
|
|
|
|
|
|
Ended |
|
|
Ended |
|
|
|
Year Ended December 31, |
|
|
December 31, |
|
|
June 30 |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2005 |
|
Net income (loss) |
|
$ |
83,053 |
|
|
$ |
21,309 |
|
|
$ |
(291,337 |
) |
|
$ |
(89,606 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain (loss) on securities that
arose during the year, net of tax(1) |
|
|
624 |
|
|
|
14,520 |
|
|
|
6,897 |
|
|
|
(5,886 |
) |
Currency translation adjustment |
|
|
221 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(Loss) gain
included in net income (loss), net of tax
(1) |
|
|
(105 |
) |
|
|
(13,844 |
) |
|
|
(3,460 |
) |
|
|
8,689 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
740 |
|
|
|
676 |
|
|
|
3,437 |
|
|
|
2,803 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total comprehensive income (loss) |
|
$ |
83,793 |
|
|
$ |
21,985 |
|
|
$ |
(287,900 |
) |
|
$ |
(86,803 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Information for the years ended December 31, 2007 and 2006, the six months ended
December 31, 2005 and the fiscal year ended June 30, 2005 has not been tax-effected as a
result of the Companys net operating loss position and related valuation allowance in those
periods. |
F-18
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
(4) Earnings Per Common Share
Basic earnings per share is computed by dividing the net income (loss) available to common
stockholders, by the weighted average number of shares of common stock outstanding during the
period. Restricted stock awards and restricted stock units (collectively, nonvested shares) are
not considered to be outstanding shares until the service vesting period has been completed.
For purposes of calculating diluted earnings (loss) per share, the denominator includes both
the weighted average number of shares of common stock outstanding and the number of common stock
equivalents if the inclusion of such common stock equivalents is dilutive. Dilutive common stock
equivalents potentially include non-qualified stock options, nonvested shares, shares issuable
under the employee stock purchase plan (ESPP) and the number of shares issuable upon conversion of
the Companys convertible subordinated notes and/or convertible senior notes payable. In the case
of notes payable, the diluted earnings per share calculation is further affected by an add-back of
interest to the numerator under the assumption that the interest would not have been incurred if
the notes were converted into common stock.
The dilutive effect of stock options and nonvested shares takes into account a number of
treasury shares calculated using assumed proceeds. Assumed proceeds include compensation costs to
be attributed to future service and not yet recognized, the cash paid by the holders of stock
options to exercise, withholding and contributions pursuant to the ESPP and the excess, if any, of
tax benefits that would be credited to APIC, related to share-based compensation.
F-19
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
The following table represents the reconciliation of the numerators and denominators of the
basic and diluted earnings (loss) per share computations for net income (loss) available for common
stockholders for the years ended December 31, 2007 and 2006, the six months ended December 31, 2005
and the year ended June 30, 2005 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
Year |
|
|
|
|
|
|
|
|
|
|
|
Ended |
|
|
ended |
|
|
|
Year Ended December 31, |
|
|
December 31, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2005 |
|
Earnings Per Common Share Basic: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
83,053 |
|
|
$ |
21,309 |
|
|
$ |
(291,337 |
) |
|
$ |
(89,606 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares outstanding |
|
|
43,927 |
|
|
|
43,600 |
|
|
|
43,520 |
|
|
|
43,486 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per share |
|
$ |
1.89 |
|
|
$ |
0.49 |
|
|
$ |
(6.69 |
) |
|
$ |
(2.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings Per Common Share Diluted: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
83,053 |
|
|
$ |
21,309 |
|
|
$ |
(291,337 |
) |
|
$ |
(89,606 |
) |
Add back interest expense on 4% convertible
notes, net of tax |
|
|
11,000 |
|
|
|
6,661 |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjusted net income |
|
$ |
94,053 |
|
|
$ |
27,970 |
|
|
$ |
(291,337 |
) |
|
$ |
(89,606 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding |
|
|
43,927 |
|
|
|
43,600 |
|
|
|
43,520 |
|
|
|
43,486 |
|
Weighted-average incremental shares related to
ESPP and vesting of nonvested shares |
|
|
204 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average incremental shares assuming
conversion of 4% notes |
|
|
28,796 |
|
|
|
17,779 |
|
|
|
N/A |
|
|
|
N/A |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average number of common shares
outstanding and common share equivalents |
|
|
72,927 |
|
|
|
61,379 |
|
|
|
43,520 |
|
|
|
43,486 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted earnings (loss) per share |
|
$ |
1.29 |
|
|
$ |
0.46 |
|
|
$ |
(6.69 |
) |
|
$ |
(2.06 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
The 4.5% convertible subordinated notes have had no dilutive effect due to the fact that their
historically relatively high conversion price influences the denominator of the earning-per-share
computation less significantly than does the add-back of interest to the numerator.
As of December 31, 2007, 2006, 2005 and June 30, 2005, the Company had potentially dilutive
common stock equivalents, other than those related to the 4% convertible notes in 2007 and 2006,
excluded from the computation of diluted earnings per share,
amounting to 9.4 million, 9.7
million, 12.5 million and 11.7 million shares, respectively. These common stock equivalents would
have been anti-dilutive.
F-20
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
(5) Inventories
Inventories, net of reserves consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Raw materials |
|
$ |
9,809 |
|
|
$ |
7,321 |
|
Work in process |
|
|
5,419 |
|
|
|
4,444 |
|
Finished goods |
|
|
7,069 |
|
|
|
5,853 |
|
|
|
|
|
|
|
|
|
|
$ |
22,297 |
|
|
$ |
17,618 |
|
|
|
|
|
|
|
|
(6) Property and Equipment
Property and equipment consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
Estimated |
|
|
|
2007 |
|
|
2006 |
|
|
Useful lives |
|
Land |
|
$ |
1,500 |
|
|
$ |
1,500 |
|
|
|
|
|
Building |
|
|
4,800 |
|
|
|
4,800 |
|
|
27 years |
Leasehold improvements |
|
|
32,672 |
|
|
|
27,202 |
|
|
3-15 years* |
Equipment |
|
|
38,867 |
|
|
|
28,967 |
|
|
3-7 years |
Furniture and fixtures |
|
|
4,440 |
|
|
|
3,497 |
|
|
7 years |
Vehicles |
|
|
64 |
|
|
|
31 |
|
|
7 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
82,343 |
|
|
|
65,997 |
|
|
|
|
|
Less: Accumulated depreciation |
|
|
37,031 |
|
|
|
26,506 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
45,312 |
|
|
$ |
39,491 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
Shorter of the lease term or lives indicated |
Depreciation charged to operations relating to property and equipment totaled $6.5 million,
$5.1 million, $2.5 million and $4.8 million for the years ended December 31, 2007 and 2006, the six
months ended December 31, 2005 and the fiscal year ended June 30, 2005, respectively.
In connection with the announced planned closure of the Companys South Plainfield
manufacturing facility, the Company accelerated the remaining depreciation on certain assets,
primarily manufacturing equipment, located there. The acceleration amounted to $5.1 million and
was reported in restructuring charge on the consolidated statement of operations for the year ended
December 31, 2007. The affected equipment was decommissioned as a result of decisions regarding
validation of manufacturing processes at the Companys facility in Indianapolis, Indiana, and as a
result, such equipment will not be transferred to Indianapolis. (Refer to Note 10).
F-21
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
(7) Intangible Assets
Intangible assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
December 31, |
|
|
December 31, |
|
|
Remaining |
|
|
|
2007 |
|
|
2006 |
|
|
Useful lives |
|
Product acquisition costs |
|
$ |
78,694 |
|
|
$ |
78,694 |
|
|
6.6 years |
Product patented technology |
|
|
6,000 |
|
|
|
6,000 |
|
|
7.0 years |
Manufacturing patent |
|
|
9,000 |
|
|
|
9,000 |
|
|
7.0 years |
Patent |
|
|
1,875 |
|
|
|
1,875 |
|
|
|
* |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
95,569 |
|
|
|
95,569 |
|
|
6.7 years |
Less: Accumulated amortization |
|
|
27,428 |
|
|
|
17,059 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
68,141 |
|
|
$ |
78,510 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangibles amortization for the year ended December 31, 2007 was $10.4 million of which $9.7
million was charged to cost of products sold and $0.7 million to amortization expense. Intangibles
amortization charges totaled $8.1 million for the year ended December 31, 2006 ($7.4 million to
cost of products sold and $0.7 million amortization expense). For the six months ended December
31, 2005, total amortization of $8.9 million was allocated $2.2 million to cost of products sold
and $6.7 million to amortization expense. For the fiscal year ended June 30, 2005, total
amortization of $17.9 million was incurred, of which $4.5 million was charged to cost of products
sold and $13.4 million to amortization expense.
Estimated future annual amortization expense for the years 2008 through 2012 is $10.3 million
per year, approximately $9.7 million of which will be charged to cost of products sold.
Amortization expense decreased significantly in 2007 and 2006, respectively, due to the December
2005 impairment of Abelcet intangibles discussed below. The Company does not have intangibles with
indefinite useful lives.
During the quarter ended December 31, 2005, the Company identified an impairment indicator
related to declining revenues of Abelcet. Subsequent analysis of Abelcet-related intangible assets
resulted in recognizing an impairment charge in the Products segment of $133.1 million. At the
same time, the Company changed the basis upon which it reported its business segments. This
necessitated the allocation of then-existing goodwill to the newly identified reporting units on a
relative fair value basis. An impairment test then revealed that the goodwill was impaired in its
entirety. The $151.0 million write-off resulted in $144.0 million and $7.0 million being charged
to the Products and Contract Manufacturing reporting units, respectively. The aggregate goodwill
and intangibles impairment write-down recognized in December 2005 amounted to $284.1 million.
F-22
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
(8) Accrued Expenses
Accrued expenses consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Accrued compensation |
|
$ |
12,731 |
|
|
$ |
8,289 |
|
Accrued Medicaid rebates |
|
|
1,382 |
|
|
|
1,335 |
|
Accrued professional and consulting fees |
|
|
348 |
|
|
|
389 |
|
Accrued clinical trial costs |
|
|
281 |
|
|
|
17 |
|
Accrued insurance and taxes |
|
|
2,659 |
|
|
|
859 |
|
Product acquisition |
|
|
|
|
|
|
17,500 |
|
Other |
|
|
3,704 |
|
|
|
2,887 |
|
|
|
|
|
|
|
|
|
|
$ |
21,105 |
|
|
$ |
31,276 |
|
|
|
|
|
|
|
|
(9) Notes Payable
The table below reflects the composition of the notes payable balances as of December 31, 2007
and 2006 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
4.5% Convertible Subordinated Notes
due July 1, 2008 |
|
$ |
72,391 |
* |
|
$ |
122,642 |
|
4% Convertible Senior Notes due
June 1, 2013 |
|
|
275,000 |
|
|
|
275,000 |
|
|
|
|
|
|
|
|
|
|
$ |
347,391 |
|
|
$ |
397,642 |
|
|
|
|
|
|
|
|
|
|
|
* |
|
Classified as current liabilities as of December 31, 2007. |
The 4.5% notes mature on July 1, 2008 and are convertible, at the option of the holders, into
common stock of the Company at a conversion price of $70.98 per share at any time on or before July
1, 2008. The 4.5% notes are subordinated to all existing and future senior indebtedness. Upon
occurrence of a fundamental change, as defined in the indenture governing the notes, holders of
the notes may require the Company to redeem the notes at a price equal to 100% of the principal
amount plus accrued and unpaid interest. The Company may redeem any or all of the 4.5% notes at
specified redemption prices, plus accrued and unpaid interest to the day preceding the redemption
date. Because the 4.5% notes mature in less than twelve months from December 31, 2007, they are
classified as current liabilities in the Companys consolidated balance sheet as of December 31,
2007. Approximately $73.6 million needed for repayment or repurchase of the remaining balance of
the 4.5% notes payable outstanding as of December 31, 2007 was set aside and stated separately on
the consolidated balance sheet as restricted investments and cash. The assets in this segregated
account may be used only for purposes of retiring the 4.5% notes. In January 2008, the outstanding
balance of the 4.5% notes payable was reduced to $12.5 million through further repurchases, at a
net discount of $0.4 million to par, thereby also reducing the balance of restricted investments
and cash.
F-23
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
The 4% notes mature on June 1, 2013 unless earlier redeemed, repurchased or converted. The 4%
notes are senior unsecured obligations and rank equal to other senior unsecured debt of the Company
and all future senior unsecured debt of the Company. The 4% notes may be converted at the option
of the holders into the Companys common stock at an initial conversion price of $9.55 per share.
At any time on or after June 1, 2009, if the closing price of the Companys common stock for at
least 20 trading days in the 30-consecutive-trading-day period ending on the date one day prior to
the date of a notice of redemption is greater than 140% of the applicable conversion price on the
date of such notice, the Company, at its option, may redeem the 4% notes in whole or in part, at a
redemption price in cash equal to 100% of the principal amount of the 4% notes to be redeemed,
plus accrued and unpaid interest, if any, to the redemption date. The 4% notes are not redeemable
prior to June 1, 2009. Upon occurrence of a fundamental change, as defined in the indenture
governing the 4% notes, holders of the notes may require the Company to redeem the notes at a price
equal to 100% of the principal amount plus accrued and unpaid interest or, in certain cases, to
convert the notes at an increased conversion rate based on the price paid per share of the
Companys common stock in the transaction constituting the fundamental change.
In connection with the Companys second-quarter 2006 issuance of $275.0 million of the 4%
notes, the Company entered into a registration rights agreement whereby it agreed to file a shelf
registration statement with the U.S. Securities and Exchange Commission (SEC) to permit the
registered resale of the 4% notes and the common stock issuable upon conversion of the notes. The
shelf registration was filed in a timely manner on October 2, 2006 and was declared effective by
the SEC on November 3, 2006. Failure to maintain its effectiveness for a period of two years
beginning November 3, 2006 would result in additional interest of up to $1.2 million being payable
on the 4% notes as of December 31, 2007. No amounts are owed, nor have any been recorded for
failure to maintain the effectiveness of the registration statement.
Repurchases in 2007 totaled $50.3 million in principal amount for cash expenditures of $49.7
million generating a small gain. Concurrent with the issuance of the 4% notes in 2006, a portion
of the proceeds was used to repurchase $271.4 million of principal amount of 4.5% notes outstanding
at a purchase price of approximately $262.1 million, yielding a gain in nonoperating income of $9.2
million. In addition, deferred interest of $0.2 million and $2.5 million was written off in 2007
and 2006, respectively, and included in interest expense on the consolidated statement of
operations.
Interest on the 4.5% notes is payable January 1 and July 1 of each year. Accrued interest on
the 4.5% notes was $1.6 million and $2.7 million as of December 31, 2007 and 2006, respectively.
Interest on the 4% notes is payable on June 1 and December 1 of each year, commencing on December
1, 2006. Accrued interest on the 4% notes amounted to $1.0 million as of each year end December
31, 2007 and 2006.
The Company incurred $7.7 million of costs in connection with the issuance of the 4% notes
including legal, accounting and underwriting fees. These costs have been capitalized as a
component of other assets and are being amortized over the approximately 84-month term of the 4%
notes.
The Company evaluates the accounting for the conversion feature of its 4.5% and 4% convertible
notes in accordance with EITF Issue No. 00-19, Accounting for Derivative Financial Instruments
Indexed to and Potentially Settled in, a Companys Own Stock. The Company concluded that no
beneficial conversion feature existed at the inception of the notes. If the conversion features
are required to be bifurcated in the future, changes in the fair value of the conversion features
would be included in operations in each period.
F-24
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
(10) Restructuring
During the first quarter of 2007, the Company announced plans to consolidate manufacturing
operations in its Indianapolis, Indiana location. This action was taken as part of the Companys
continued efforts to streamline operations. All operations at the Companys South Plainfield, New
Jersey facility are expected to be transferred to the Companys Indianapolis facility in 2008,
resulting in the incurrence of certain restructuring and exit costs. Among these costs will be
employee severance and related benefits for affected employees of approximately $3.5 million all of
which relate to the Products segment. These amounts will be paid in 2008 upon the successful
transfer of production to the Companys Indianapolis facility and closure of the South Plainfield
facility. The Company has recognized severance costs of $2.2 million in 2007.
In addition, the Company has recognized approximately $7.0 million during 2007 in equipment
write-downs and cost of validation batches related to the restructuring. Certain assets consisting
primarily of manufacturing equipment that will not be transferred to the Indianapolis facility, nor
continue to be used in manufacturing at the South Plainfield facility were decommissioned during
2007. Accordingly, the Company fully recognized the remaining depreciation totaling $5.1 million
on these assets and reported it as a restructuring charge. In the three months ended June 30,
2007, $1.9 million, being the cost of validation batches at the Indianapolis facility for Oncaspar
and Adagen, was expensed and included in cost of product sales.
The Company may experience additional costs associated with lease termination or sublease of
the South Plainfield facility. Such costs will be incurred and recognized when the Company ceases
use of the property in 2008. However, the Company does not know at this time what the final use or
disposition of the leased South Plainfield facility will be.
During 2007, the Company recognized $0.4 million of employee severance and related benefits
when it combined its previous two specialized sales forces into one sales team. This, in addition
to severance costs and equipment write-downs associated with the manufacturing consolidation
brought total 2007 restructuring charges to $7.7 million.
(11) Gain on Sale of Royalty Interest
During 2007, the Company sold a 25% interest in future royalties payable to it by
Schering-Plough on net sales of PEG-INTRON occurring after June 30, 2007. The purchaser of the 25%
interest will be obligated to pay an additional $15.0 million to the Company in the first quarter
of 2012 if it receives a certain threshold level of royalties on sales of PEG-INTRON occurring from
July 1, 2007 through December 31, 2011. The gain on the sale of the royalty interest, net of
related costs, was $88.7 million. The $15.0 million contingent gain will be recognized when and if
the contingency is removed and collection is assured.
F-25
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
(12) Stockholders Equity
Preferred Stock
The Company has authorized 3,000,000 shares of preferred stock in one or more series of which
600,000 are designated as Series B in connection with the Shareholder Rights Plan.
Common Stock
As of December 31, 2007, the Company has reserved shares of its common stock for the purposes
detailed below (in thousands):
|
|
|
|
|
Non-Qualified and Incentive Stock Plans |
|
|
12,071 |
|
Shares issuable upon conversion of 4.5% Notes due 2008 |
|
|
1,020 |
|
Shares issuable upon conversion of 4% Notes due 2013 |
|
|
28,796 |
|
Employee Stock Purchase Plan |
|
|
936 |
|
|
|
|
|
|
|
|
|
42,823 |
|
|
|
|
|
|
Shareholder Rights Plan
During May 2002, the Company adopted a shareholder rights plan (Rights Plan). The Rights Plan
involves the distribution of one preferred share purchase right (Right) as a dividend on each
outstanding share of the Companys common stock to each holder of record on June 3, 2002. Each
Right shall entitle the holder to purchase one-thousandth of a share of Series B Preferred Stock
(Preferred Shares) of the Company at a price of $190.00 per one-thousandth of a Preferred Share.
The Rights are not immediately exercisable and will become exercisable only upon the occurrence of
certain events. If a person or group acquires, or announces a tender or exchange offer that would
result in the acquisition of 15 percent or more of the Companys common stock while the Rights Plan
remains in place, then, unless (i) the Rights are redeemed by the Company for $0.01 per right or
(ii) the Board of Directors determines that a tender or exchange offer for all of the outstanding
common stock of the Company is in the best interest of the Company and the stockholders, the Rights
will be exercisable by all Rights holders except the acquiring person or group for one share of the
Company or in certain circumstances, shares of the third party acquirer, each having a value of
twice the Rights then-current exercise price. Pursuant to an amendment to the Rights Plan dated
January 7, 2008, stockholders who report beneficial ownership of the Companys common stock on
Schedule 13G under the Securities Exchange Act of 1934, as amended, may beneficially own less than
20% of the outstanding shares of common stock of the Company without becoming an acquiring person
and thereby triggering the rights under the Rights Plan. The Rights will expire on May 16, 2012.
(13) Stock Options
Through the Compensation Committee of the Board of Directors, the Company administers the 2001
Incentive Stock Plan which provides incentive and non-qualified stock option benefits for
employees, officers, directors and consultants. Options granted to employees generally vest over
four years from date of grant and options granted to directors vest after one year. The exercise
price of the options granted must be at least 100% of the fair value of the Companys common stock
at the time the options are granted. Options may be exercised for a period of up to ten years from
the date they are granted. As of December 31, 2007, 12.1 million shares of common stock were
reserved for issuance pursuant to options and awards under the plan.
F-26
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
The 2001 Incentive Stock Plan was adopted by the Board of Directors in October 2001 and
approved by the stockholders in December 2001. This Plan, as amended, had 10,000,000 shares of
common stock issuable for the grant of stock options and other stock-based awards to employees,
officers, directors, consultants, and independent contractors providing services to Enzon and its
subsidiaries as determined by the Board of Directors or by a committee of directors designated by
the Board of Directors to administer the plan.
A 1987 Non-Qualified Stock Option Plan was adopted by the Companys Board of Directors in
November 1987 and expired effective November 2007. Accordingly no additional grants of stock
options are to be made from this plan although previously awarded option grants remain outstanding.
In April 2007, the Board of Directors adopted a new compensation plan for non-employee
directors (the 2007 Outside Director Compensation Plan or the 2007 Plan). Under the 2007 Plan,
each non-employee director is to receive options to purchase shares of common stock annually on the
first trading day of the calendar year. Using the Black-Scholes option pricing model, each
eligible participant may purchase that number of shares that aggregates $75,000 in value. These
grants are made under the 2001 Incentive Stock Plan. The exercise price of the annual grant is
equal to the closing price of the common stock on the date of grant; it vests in one tranche on the
first anniversary date; and expires on the tenth anniversary date of the grant. In addition, upon
election of a new non-employee director to the Board, such newly elected director is to receive a
grant of options with a Black-Scholes value of $75,000 to purchase shares of common stock (the
exercise price of which is equal to the closing price of the common stock on the date of grant).
These options vest in three equal tranches on each of the first three anniversaries of the date of
grant, if the recipient director remains on the Board on each such date. Furthermore, for the
Chairperson of the Board, if not an employee of the Company, the number of options granted annually
and upon election is twice the number mentioned above.
The following is a summary of the activity in the Companys Stock Option Plans which include
the 2001 Incentive Stock Plan and the 1987 Non-Qualified Stock Option Plan (options in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
Weighted |
|
|
|
|
|
|
|
|
Average |
|
Average |
|
|
|
|
|
|
|
|
Exercise |
|
Remaining |
|
Aggregate |
|
|
|
|
|
|
Price Per |
|
Contractual |
|
Intrinsic |
|
|
Options |
|
Option |
|
Term (years) |
|
Value ($000) |
|
|
|
Outstanding at January 1, 2007 |
|
|
6,708 |
|
|
$ |
12.36 |
|
|
|
|
|
|
|
|
|
Granted at exercise prices which equaled
the fair value on the date of grant |
|
|
2,070 |
|
|
$ |
8.52 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(114 |
) |
|
$ |
5.08 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(40 |
) |
|
$ |
8.06 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
(239 |
) |
|
$ |
18.38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at December 31, 2007 |
|
|
8,385 |
|
|
$ |
11.36 |
|
|
|
7.44 |
|
|
$ |
4,636 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest at
December 31, 2007 |
|
|
7,599 |
|
|
$ |
11.71 |
|
|
|
7.31 |
|
|
$ |
4,216 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2007 |
|
|
5,184 |
|
|
$ |
13.38 |
|
|
|
6.68 |
|
|
$ |
3,110 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The weighted-average grant-date fair value of options granted during the years ended December
31, 2007 and 2006 and the six months ended December 31, 2005 was $3.57, $3.46 and $3.57,
respectively. The total intrinsic value of options exercised during the years ended December 31,
2007, 2006 and the six months ended December 31, 2005 was $505,000, $869,000 and $21,000,
respectively.
F-27
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
In the years ended December 31, 2007 and 2006, the Company recorded share-based compensation
of $4.8 and $2.7 million respectively, related to stock options, which was included in the
Companys net income for the period, predominantly in selling, general and administrative expense.
In the six months ended December 31, 2005, share-based compensation cost related to stock options
was $442,000. No compensation costs were capitalized into inventory during either period nor did
the Company realize a net tax benefit related to share-based compensation expense. The Companys
policy is to use newly issued shares to satisfy the exercise of stock options.
Cash received from share option exercise for the years ended December 31, 2007 and 2006, the
six months ended December 31, 2005 and the fiscal year ended June 30, 2005 was $0.6 million, $1.1
million, $19,000 and $229,000, respectively.
The Company uses the Black-Scholes option-pricing model to determine the fair value of stock
options. The Companys weighted average assumptions for expected volatility, expected term until
exercise and risk-free interest rate are shown in the table below. Expected volatility is based on
historical volatility of the Companys common stock. The expected term of options is estimated
based on the Companys historical exercise pattern. The risk-free interest rate is based on U.S.
Treasury yields for securities in effect at the time of grant with terms approximating the expected
term until exercise of the option. No dividend payments were factored into the valuations.
Forfeiture rates, used for determining the amount of compensation cost to be recognized over the
service period, are estimated based on stratified historical data. As of December 31, 2007, there
was $8.9 million of total unrecognized compensation cost related to unvested options that the
Company expects to recognize over a weighted-average period of 21 months. During the year ended
December 31, 2007, the grant-date fair value of options that vested was $3.4 million.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
Year Ended |
|
Year Ended |
|
Ended |
|
|
December 31, |
|
December 31, |
|
December 31, |
|
|
2007 |
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
4.7 |
% |
|
|
4.8 |
% |
|
|
4.2 |
% |
Expected volatility |
|
|
37 |
% |
|
|
43 |
% |
|
|
56 |
% |
Expected term (in years) |
|
|
5.5 |
|
|
|
5.2 |
|
|
|
4.7 |
|
On April 7, 2005, the Board of Directors accelerated the vesting of all of the Companys
unvested stock options awarded to officers, directors and employees under the 1987 Non-Qualified
Stock Option Plan and the 2001 Incentive Stock Plan, all of which had an exercise price greater
than $10.07 per share, the closing price of the Companys common stock on the NASDAQ National
Market on April 7, 2005. As a result of the acceleration, options to acquire approximately 4.2
million shares (with exercise prices ranging from $10.10 to $73.22 per share), of the Companys
common stock, which otherwise would have vested from time to time over four years, became
immediately exercisable.
On June 20, 2005, the Board of Directors accelerated the vesting of all of the Companys
then-outstanding unvested stock options awarded to officers under the 1987 Non-Qualified Stock
Option Plan and the 2001 Incentive Stock Plan. Options having exercise prices of $6.95 and $5.73
per share, the closing price of common stock on the NASDAQ National Market on May 12, 2005 and June
10, 2005, respectively, were accelerated. As a result, of the acceleration, options to acquire
approximately 1.1 million shares of the Companys common stock, which otherwise would have vested
from time to time over four years, became immediately exercisable.
F-28
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
The Boards decision to accelerate the vesting of these options was in response to a review of
the Companys long-term incentive compensation programs in light of changes in market practices,
current market prices of the Companys stock and recently issued changes in accounting rules
resulting from the issuance of SFAS No. 123R, which the Company was required to adopt effective
July 1, 2005. Management believed that accelerating the vesting of these options prior to the
adoption of SFAS No. 123R may have resulted in the Company not having to recognize compensation
expense in the years ended December 31, 2007 and 2006 and six months ended December 31, 2005 in the
amounts of $7.6 million, $9.6 million and $5.0 million, respectively, or in subsequent years
through 2009 in the aggregate amount of $4.2 million.
(14) Restricted Stock and Restricted Stock Units (Nonvested Shares)
The 2001 Incentive Stock Plan also provides for the issuance of restricted stock and
restricted stock units to employees, officers and directors (collectively referred to in SFAS No.
123R as nonvested shares). These awards effectively are the issuance by the Company to the
recipient of shares of the Companys common stock at either the date of the grant, in the case of a
restricted stock award, or upon vesting, in the case of a restricted stock unit. The recipient
pays no cash to receive the shares other than the $0.01 par value in some cases. These awards have
vesting periods of three to five years.
Pursuant to the 2007 Outside Director Compensation Plan, each non-employee director is to
receive a grant of restricted stock units for shares of common stock with a value of $75,000
annually on the first trading day after June 30. This grant is made under the 2001 Incentive Stock
Plan. The number of shares covered by the annual grant is equal to $75,000 divided by the closing
price of the common stock on the date of grant; it vests in three equal tranches on each of the
first three anniversaries of the date of the grant if the recipient director remains on the Board
on each such date. In addition, upon election of a new non-employee director to the Board, such
newly elected director is to receive a grant of restricted stock units for shares of common stock
in the amount of $75,000 (the number of shares covered by such grant being equal to $75,000 divided
by the closing price of the common stock on the date of grant). These restricted stock units vest
in three equal tranches on each of the first three anniversaries of the date of grant, if the
recipient director remains on the Board on each such date. Furthermore, for the Chairperson of the
Board, if not an employee of the Company, the number of restricted stock units granted annually and
upon election is twice the number mentioned above.
All nonvested shares are valued at fair value under SFAS No. 123R. The market price of the
Companys stock at grant date is factored by an expected vesting period forfeiture rate based on
stratified historical data. This amount is then amortized over the vesting period on a
straight-line basis.
F-29
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
A summary of nonvested shares as of December 31, 2007 and changes during the year ended
December 31, 2007 is provided below (shares in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Average |
|
|
Number of |
|
Grant Date |
|
|
Nonvested |
|
Fair Value |
|
|
Shares |
|
Per Share |
Nonvested at January 1, 2007 |
|
|
1,458 |
|
|
$ |
8.18 |
|
Granted |
|
|
522 |
|
|
$ |
8.47 |
|
Vested |
|
|
(88 |
) |
|
$ |
10.98 |
|
Forfeited |
|
|
(118 |
) |
|
$ |
7.98 |
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2007 |
|
|
1,774 |
|
|
$ |
8.14 |
|
|
|
|
|
|
|
|
|
|
As of December 31, 2007, there was $10.1 million of total unrecognized compensation cost
related to nonvested shares that the Company expects to be recognized over weighted average periods
of 30 months. The total grant-date fair value of nonvested shares that vested during the year
ended December 31, 2007 was $762,000.
In the years ended December 31, 2007 and 2006, the Company recorded share-based compensation
expense of $3.3 and $1.7 million related to nonvested share awards, which is included in the
Companys net income for the period, predominantly in selling, general and administrative expenses.
In the six-months ended December 31, 2005, the cost recorded for nonvested share awards was
$423,000. No compensation costs were capitalized into inventory during the period. The Companys
policy is to use newly issued shares to satisfy nonvested share awards. There has been no tax
benefit realized to date related to tax deductions for nonvested shares.
(15) Employee Stock Purchase Plan
In January 2007, the Board of Directors adopted the 2007 Employee Stock Purchase Plan (ESPP) which
was approved by the Companys stockholders in May 2007. An initial one million shares were
reserved for issuance under the plan. All benefit-eligible employees of the Company may
participate in the ESPP other than those who own shares or hold options or nonvested shares
representing a combined 5% or more of the voting power of the Companys outstanding stock. The
ESPP permits eligible employees to purchase common stock through payroll deductions which may not
exceed 15% of the employees compensation, as defined, at a price equal to 85% of the fair market
value of the shares at the beginning of the offering period (grant date) or at the end of the
offering period (purchase date), whichever is lower. There are two six-month offering periods in
each plan fiscal year, beginning April 1 and October 1. The ESPP is intended to qualify under
section 423 of the Internal Revenue Code. Individual participant purchases within a given calendar
year are limited to $25,000 ($21,250 based on the 15% discount) and no more than 2,500 shares on
any single purchase date. Unless terminated sooner, the ESPP will terminate on January 25, 2017.
F-30
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
The fair value of shares to be issued under the ESPP is estimated at the grant date and is
comprised of two components: the 15% discount to fair value of the shares at grant date and the
value of the option granted to participants pursuant to which they may purchase shares at the lower
of either the grant date or the purchase date fair value. The option component is valued using the
Black-Scholes option pricing model.
The initial assumptions used in the valuation for each offering period are reflected in the
following table (no dividends were assumed).
|
|
|
|
|
|
|
|
|
|
|
April 1, 2007 |
|
October 1, 2007 |
Risk-free interest rate |
|
|
4.50 |
% |
|
|
4.50 |
% |
Expected volatility |
|
|
20.00 |
% |
|
|
30.73 |
% |
Expected term (in years) |
|
|
0.5 |
|
|
|
0.5 |
|
Increases in individual withholding rates within the offering period could have the effect of
establishing a new measurement date for that individuals future contributions. Compensation
expense recognized for the ESPP was approximately $0.2 million for the year ended December 31,
2007, which was recorded in the same expense categories in the consolidated statement of operations
as the underlying employee compensation. Amounts withheld from participants are classified as cash
from financing activities in the cash flow statement and as a liability in the balance sheet until
such time as shares are purchased. There was one stock purchase under the ESPP during the year
ended December 31, 2007. Based upon the purchase price established as of September 30, 2007, the
end of the Plans first offering period, 63,960 shares were allocated under the plan in October
2007.
(16) Income Taxes
Under the asset and liability method of SFAS No. 109, deferred tax assets and liabilities are
recognized for the estimated future tax consequences attributable to differences between financial
statement carrying amounts of existing assets and liabilities and their respective tax bases.
Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to
taxable income in the years in which those temporary differences are expected to be recovered or
settled. Under SFAS No. 109, the effect on deferred tax assets and liabilities of a change in tax
rates is recognized in income in the period that includes the enactment date.
F-31
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
The components of the income tax provision (benefit) are summarized as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
|
|
|
|
Year Ended |
|
|
Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2005 |
|
Current: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
1,331 |
|
|
$ |
127 |
|
|
$ |
|
|
|
$ |
|
|
State |
|
|
194 |
|
|
|
456 |
|
|
|
(75 |
) |
|
|
340 |
|
Foreign |
|
|
408 |
|
|
|
175 |
|
|
|
93 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total current |
|
|
1,933 |
|
|
|
758 |
|
|
|
18 |
|
|
|
340 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
|
|
|
|
|
|
|
|
(9,395 |
) |
|
|
66,785 |
|
State |
|
|
|
|
|
|
|
|
|
|
(1,570 |
) |
|
|
10,819 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total deferred |
|
|
|
|
|
|
|
|
|
|
(10,965 |
) |
|
|
77,604 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision (benefit) |
|
$ |
1,933 |
|
|
$ |
758 |
|
|
$ |
(10,947 |
) |
|
$ |
77,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table represents a reconciliation between the reported income taxes and the
income taxes that would be computed by applying the federal statutory rate (35%) to income before
taxes (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
|
|
|
|
Year Ended |
|
|
Ended |
|
|
Year Ended |
|
|
|
December 31, |
|
|
December 31, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2005 |
|
Income tax provision (benefit) computed at
federal statutory rate |
|
$ |
29,745 |
|
|
$ |
7,723 |
|
|
$ |
(105,799 |
) |
|
$ |
(4,082 |
) |
Nondeductible expenses |
|
|
414 |
|
|
|
265 |
|
|
|
105 |
|
|
|
284 |
|
Add (deduct) effect of: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
State income taxes (including sale and
purchase of state net operating loss
carryforwards), net of federal tax* |
|
|
4,393 |
|
|
|
1,950 |
|
|
|
(16,350 |
) |
|
|
(414 |
) |
Federal research and development tax credits |
|
|
(1,105 |
) |
|
|
(1,395 |
) |
|
|
549 |
|
|
|
(1,654 |
) |
Foreign income taxes |
|
|
408 |
|
|
|
175 |
|
|
|
93 |
|
|
|
|
|
Increase (decrease) in beginning of
period valuation allowance |
|
|
(31,922 |
) |
|
|
(7,960 |
) |
|
|
110,455 |
|
|
|
83,810 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax provision (benefit) |
|
$ |
1,933 |
|
|
$ |
758 |
|
|
$ |
(10,947 |
) |
|
$ |
77,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Amount includes state net operating loss carryforwards and research and development credit carryforwards.
During the six months ended December 31, 2005 and the fiscal year ended June 30, 2005, the
Company recognized a tax benefit of $244,000 and $280,000, respectively, from the sale of certain
state net operating loss carryforwards. No state net operating loss carryforwards were purchased
or sold during the years ended December 31, 2007 nor 2006.
F-32
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
At December 31, 2007 and 2006, the tax effects of temporary differences that give rise to the
deferred tax assets and deferred tax liabilities are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Inventories |
|
$ |
747 |
|
|
$ |
874 |
|
Accrued compensation |
|
|
5,410 |
|
|
|
2,499 |
|
Returns and allowances |
|
|
3,811 |
|
|
|
2,899 |
|
Research and development credits carryforward |
|
|
19,690 |
|
|
|
16,876 |
|
Federal AMT credits |
|
|
3,044 |
|
|
|
1,718 |
|
Capital loss carryforwards |
|
|
|
|
|
|
3,988 |
|
Write-down of carrying value of investment |
|
|
3,407 |
|
|
|
3,407 |
|
Federal and state net operating loss carryforwards |
|
|
29,827 |
|
|
|
57,792 |
|
Acquired in-process research and development |
|
|
11,107 |
|
|
|
12,005 |
|
Unrealized loss on securities |
|
|
20 |
|
|
|
187 |
|
Goodwill |
|
|
40,433 |
|
|
|
44,545 |
|
Intangible assets |
|
|
50,619 |
|
|
|
53,880 |
|
Share-based compensation |
|
|
728 |
|
|
|
2,047 |
|
Other |
|
|
1,593 |
|
|
|
1,633 |
|
Tax basis in excess of book basis of acquired assets |
|
|
207 |
|
|
|
|
|
|
|
|
|
|
|
|
Total gross deferred tax assets |
|
|
170,643 |
|
|
|
204,350 |
|
Less valuation allowance |
|
|
(170,643 |
) |
|
|
(202,565 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,785 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred tax liabilities: |
|
|
|
|
|
|
|
|
Book basis in excess of tax basis of acquired assets |
|
|
|
|
|
|
(1,785 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,785 |
) |
|
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
A valuation allowance is provided when it is more likely than not that some portion or all of
the deferred tax assets will not be realized. At December 31, 2007, the Company had federal net
operating loss carryforwards of approximately $76.2 million that will expire in the years 2021
through 2026 and combined state net operating loss carryforwards of approximately $67.4 million
that will expire in the years 2009 through 2025. The Company also has federal research and
development tax credit carryforwards of approximately $15.2 million for tax reporting purposes,
which expire in the years 2008 through 2027. In addition, the Company has $4.5 million of state
research and development tax credit carryforwards, which will expire in the years 2016 through
2022. The Companys ability to use the net operating loss and research and development tax credit
carryforwards is subject to certain limitations due to ownership changes, as defined by rules
pursuant to Section 382 of the Internal Revenue Code of 1986, as amended.
F-33
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
As of December 31, 2007, management believes that it is more likely than not that the net
deferred tax assets will not be realized, based on future operations, consideration of tax
strategies and the reversal of deferred tax liabilities. As of December 31, 2007 and 2006, the
Company had deferred tax assets of $170.6 million and $204.4 million, respectively. The Company
has maintained a valuation allowance of $170.6 million and $202.6 million at December 31, 2007 and
2006, respectively. The net decrease in the valuation allowance for 2006 was due to the
utilization of deferred tax assets to offset taxes payable associated with taxable income.
The Company files income tax returns in the U.S. federal jurisdiction, various state
jurisdictions and Canada. The Company is currently not under examination by the U.S. Internal
Revenue Service, however, the tax years 2004 through 2006 remain open to examination. State income
tax returns for the states of New Jersey and Indiana are generally subject to examination for a
period of 3-4 years after filing of the respective returns. The Companys state income tax returns
for the State of New Jersey are currently under examination. The Companys Indiana state income
tax returns are not currently under examination. Income tax returns for Canada are generally
subject to examination for a period of 3-5 years after filing of the respective return. The
Companys income tax returns are currently not under examination by Revenue Canada.
(17) Significant Agreements
Santaris Pharma A/S Collaboration
In July 2006, the Company entered into a license and collaboration agreement with Santaris
Pharma A/S (Santaris) for up to eight RNA antagonists which the Company intends to develop. The
Company obtained rights worldwide, other than Europe, to develop and commercialize RNA antagonists
directed against the HIF-1 alpha and Survivin RNA targets. Santaris will design and synthesize RNA
antagonists directed against up to six additional gene targets selected by the Company, and the
Company will have the right to develop and commercialize those antagonists worldwide other than
Europe. The Company made an initial payment of $8.0 million in the third quarter of 2006 and an
additional $3.0 million in the fourth quarter of 2006 to Santaris for the rights to the HIF-1 alpha
and Survivin antagonists and for identification of the six additional gene targets, respectively.
The $11.0 million aggregate payment is reported as acquired in-process research and development in
the consolidated statements of operations for the year ended December 31, 2006. The Company will
be responsible for making additional payments upon the successful completion of certain compound
syntheses and selection, clinical development and regulatory milestones. Santaris is also eligible
to receive royalties from any future product sales from products based on the licensed antagonists.
Santaris retains the right to develop and commercialize products developed under the collaboration
in Europe.
Schering-Plough Agreement
As a result of a November 1990 agreement between the Company and Schering-Plough, the
Companys PEG technology was used to develop an improved version of Schering-Ploughs product
INTRON A. Schering-Plough is responsible for marketing and manufacturing the product, PEG-INTRON,
worldwide on an exclusive basis and the Company receives royalties on worldwide sales of PEG-INTRON
for all indications. Schering-Ploughs obligation to pay the Company royalties on sales of
PEG-INTRON terminates, on a country-by-country basis, upon the later of the date the last patent to
contain a claim covering PEG-INTRON expires in the country or 15 years after the first commercial
sale of PEG-INTRON in such country. Currently, expirations are expected to occur in 2016 in the
U.S., 2018 in Europe and 2019 in Japan. The royalty percentage to which the Company is entitled
will be lower in any country where a PEGylated alpha-interferon product is being
F-34
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
marketed by a
third party in competition with PEG-INTRON where such third party is not Hoffmann-La Roche. Either party may terminate the agreement upon a
material breach of the agreement by the other party that is not cured within 60 days of written
notice from the non-breaching party or upon declaration of bankruptcy by the other party.
The Company does not supply Schering-Plough with PEG-INTRON or any other materials and our
agreement with Schering-Plough does not obligate Schering-Plough to purchase or sell specified
quantities of any product.
During the quarter ended September 30, 2007, the Company sold a 25% interest in future
royalties payable to it by Schering-Plough Corporation on net sales of PEG-INTRON occurring after
June 30, 2007. The purchaser of the 25% interest will be obligated to pay an additional $15.0
million to the Company in the first quarter of 2012 if it receives a certain threshold level of
royalties on sales of PEG-INTRON occurring from July 1, 2007 through December 31, 2011. The gain
on sale of the royalty interest, net of related costs, was $88.7 million. The $15.0 million
contingent gain will be recognized when and if the contingency is removed and collection is
assured.
Sanofi-Aventis License Agreements
The Company reacquired the rights to market and distribute Oncaspar in the U.S., Mexico,
Canada and most of the Asia/Pacific region from Sanofi-Aventis in 2002. In return for the
marketing and distribution rights, the Company paid Sanofi-Aventis $15.0 million and was also
obligated to pay a royalty on net sales of Oncaspar in the U.S. and Canada through 2014. The $15.0
million payment is being amortized on a straight-line basis over 14 years. The license agreement
may be terminated earlier by Sanofi-Aventis upon 60 days notice if the Company fails to make the
required royalty payments or the Company decides to cease selling Oncaspar. Following the
expiration of the agreement in 2014, all rights will revert back to the Company, unless the
agreement is terminated earlier. The Company amended the license agreement effective January 2006,
significantly reducing the royalty rate, with a single-digit royalty percentage payable by Enzon
only on those aggregate annual sales of Oncaspar in the U.S. and Canada that are in excess of $25.0
million. In consideration for the amendment, Enzon made an upfront cash payment of $35.0 million
to Sanofi-Aventis in January 2006. The $35.0 million payment is being amortized on a straight-line
basis over its economic life of 8.5 years. In the event combined Oncaspar net sales in the U.S.
and Canada exceed $30.0 million for two consecutive calendar years, the Company will be obligated
to make a milestone payment of $5.0 million to Sanofi-Aventis. Net sales of Oncaspar in the U.S.
and Canada in 2007 and 2006 were $33.7 million and $26.3 million, respectively. The Company
continues to be obligated to make royalty payments through June 30, 2014. The amortization and
royalty payments to Sanofi-Aventis are included in cost of sales of the product.
Medac License Agreement
In January 2002, the Company renewed an exclusive license to medac Gmbh (medac), a private
company based in Germany, to sell Oncaspar and any PEG-asparaginase product developed by the
Company or medac during the term of the agreement in most of Europe and parts of Asia. The
Companys supply agreement with medac provides for medac to purchase Oncaspar from the Company at
certain established prices and meet certain minimum purchase requirements. Medac is responsible
for obtaining additional approvals and indications in the licensed territories beyond the currently
approved indication in Germany. The initial term of the agreement was for five years and
automatically renewed for an additional five years through the end of 2011. Thereafter, the
agreement will automatically renew for an additional two years unless either party provides written
notice of its intent to terminate the agreement at least 12 months prior to the scheduled
expiration date. Following the expiration or termination of the agreement, all rights granted to
medac will revert back to the Company.
F-35
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
Micromet
Alliance
In November 2005, the Company agreed to pay Micromet $2.5 million to end the collaboration
formed in June 2002 to identify and develop antibody-based therapeutics for the treatment of
inflammatory and autoimmune diseases. Under the termination agreement, Micromet received rights to
the lead compound (MT203) generated within the scope of the collaboration and the Company will
receive royalties on any future sales of this product.
The termination of the research and development collaboration with Micromet does not affect
the Companys other agreements with Micromet, including a cross-license agreement between the
parties and a marketing agreement under which Micromet is the exclusive marketer of the two
companies combined intellectual property estate in the field of single-chain antibody (SCA)
technology. Micromet is the exclusive marketing partner and has instituted a comprehensive
licensing program on behalf of the partnership. Any resulting revenues from the license agreements
executed by Micromet on behalf of the partnership will be shared equally by the two companies. In
2007 and 2006, the Company recorded $0.8 and $0.7 million, respectively related to its share of
revenues from Micromets licensing activities, compared to $1.5 million during the six months ended
December 31, 2005.
NatImmune A/S License Agreement
In September 2005, the Company entered into a license agreement with NatImmune A/S (NatImmune)
for NatImmunes lead development compound, recombinant human
Mannose-binding Lectin (rhMBL), a
protein therapeutic under development for the prevention of severe infections in MBL-deficient
individuals undergoing chemotherapy. Under the agreement, the Company received exclusive worldwide
rights, excluding the Nordic countries, and is responsible for the development, manufacture, and
marketing of rhMBL. The $10.0 million upfront cost of the license agreement was charged to
acquired in-process research and development in the six months ended December 31, 2005. During
2007 and 2006, the Company paid NatImmune $0.3 million and $2.1 million, respectively, for license
milestones that was charged to research and development expense and will be responsible for making
additional payments upon the successful completion of certain clinical development, regulatory, and
sales-based milestones. NatImmune is also eligible to receive royalties from any future product
sales of rhMBL by Enzon and retains certain rights to develop a non-systemic formulation of rhMBL
for topical administration.
Nektar Agreement
In January 2002, the Company entered into a PEG technology licensing agreement with Nektar
under which the Company granted Nektar the right to grant sub-licenses for a portion of its PEG
technology and patents to third parties. Nektar had the right to sub-license Enzons patents that
were defined in the January 2002 agreement and the Company will receive a royalty or a share of
Nektars profits for any products that utilize the Companys patented PEG technology. However, on
September 7, 2006, the Company gave notice to Nektar of its intention not to renew the provisions
of its agreement with them that give Nektar the right to sub-license a portion of the Companys PEG
technology and patents to third-parties. This right terminated in January 2007. Nektar will only
have the right to grant any additional sublicense to a limited class of our PEG technology.
Existing sublicenses granted by Nektar are unaffected.
F-36
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
Currently, the Company is aware of five third-party products for which Nektar has granted
sublicenses to our PEG technology, including Hoffmann-La Roches Pegasys (peginterferon alfa-2a),
OSI Pharmaceuticals Macugen (pegaptanib sodium injection), UCBs CimziaTM (certolizumab
pegol, CDP870), Affymax and Takeda Pharmaceuticals HematideTM and an undisclosed
product of Pfizers. Pegasys is currently being marketed for the treatment of hepatitis C and
Macugen is currently being marketed through a partnership between OSI Pharmaceuticals and Pfizer
for the treatment of neovascular (wet) age-related macular degeneration, an eye disease associated
with aging that destroys central vision. Cimzia, a PEGylated anti-TNF-alpha antibody fragment is
currently in Phase III development for the treatment of rheumatoid arthritis and Crohns disease.
Hematide, a synthetic peptide-based erythropoiesis-stimulating agent is in two Phase II clinical
trials for the treatment of anemia associated with chronic kidney disease and in anemic cancer
patients undergoing chemotherapy.
In January 2002, as part of a patent infringement lawsuit settlement agreement, the Company
purchased $40.0 million of newly issued Nektar convertible preferred stock. During the year ended
June 30, 2004, the Company converted approximately 50% of the preferred stock into common stock and
sold approximately 50% of the Companys investment in Nektar, which resulted in a net gain on
investments of $11.0 million and cash proceeds of $17.4 million. In January 2006, the remainder of
the Companys Nektar preferred stock automatically converted into 1,023,292 common stock and in
January and February 2006, the Company sold all shares of Nektar common stock it held, resulting in
a net gain of $13.8 million and cash proceeds of $20.2 million.
Pacira Agreement
In December 2002, the Company entered into an agreement with Pacira (formerly known as
SkyePharma PLC), under which the Company licensed the U.S. and Canadian rights to Paciras DepoCyt,
an injectable chemotherapeutic approved for the treatment of patients with lymphomatous meningitis.
Under the terms of the agreement, the Company paid Pacira a license fee of $12.0 million. Pacira
manufactures DepoCyt and the Company purchases finished product at 35% of the Companys net sales
price, which percentage can be reduced should a defined sales target be exceeded. The Company has
recorded the $12.0 million license fee as an intangible asset that is being amortized over a
ten-year period.
Under this agreement, the Company is required to maintain sales levels equal to $5.0
million for each calendar year (Minimum Sales) through the remaining term
of the agreement. Pacira is also entitled to a milestone payment of $5.0 million if the Companys
sales of the product exceed a $17.5 million annual run rate for four consecutive quarters and an
additional milestone payment of $5.0 million if the Companys sales exceed an annualized run rate
of $25.0 million for four consecutive quarters. For the year December 31, 2007, net sales of
DepoCyt were approximately $8.6 million. The Company is also responsible for a milestone payment
of $5.0 million if the product receives approval for use in all neoplastic meningitis.
F-37
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
The Companys license is for an initial term of ten years and is automatically renewable for
successive two-year terms thereafter. Either party may terminate the agreement early upon a
material breach by the other party, which breach the other party fails to cure within 60 days after
receiving notice thereof. Further, Pacira will be entitled to terminate the agreement early if the
Company fails to satisfy its Minimum Sales. In addition, the Company will be entitled
to terminate the agreement early if a court or government agency renders a decision or issues an
order that prohibits the manufacture, use or sale of the product in the U.S. If a therapeutically
equivalent generic product enters the market and DepoCyts market share decreases, the Company will
enter into good faith discussions in an attempt to agree on a reduction in its payment obligations
to Pacira and a fair allocation of the economic burdens resulting from the market entry of the
generic product. If the Company is unable to reach an agreement within 30 days, then either party
may terminate the agreement, which termination will be effective 180 days after giving notice
thereof. After termination of the agreement, the companies will have no further obligation to each
other, except the fulfillment of obligations that accrued prior thereto (e.g., deliveries,
payments, etc.). In addition, for six months after any such termination, the Company will have the
right to distribute any quantity of product it purchased from Pacira prior to termination.
Cephalon
Manufacturing Agreements
Cephalon France SAS (Cephalon) owns the right to market Abelcet in any markets outside of the
U.S., Canada and Japan. The Companys manufacturing agreements with Cephalon require that the Company
supply Cephalon with Abelcet and MYOCET through November 22,
2011 and January 1, 2010,
respectively. The Company had supplied these products on a cost-plus basis. Effective July 1, 2007,
the selling price became fixed, subject to an annual Producer Price Index adjustment.
Ovation
Pharmaceuticals, Inc. Agreements
In December 2006, the Company entered into supply and license agreements with Ovation.
Pursuant to the agreements, Ovation will supply to the Company specified quantities of the active
ingredient used in the production of Oncaspar during calendar years 2008 and 2009. Additionally,
Ovation granted to the Company, in exchange for $17.5 million, a non-exclusive, fully-paid,
perpetual, irrevocable, worldwide license to the cell line from which such ingredient is derived.
The intangible asset is being amortized on a straight-line basis through June 30, 2014. The
Company has agreed to effectuate, at Enzons cost, a technology transfer of the cell line and
manufacturing capabilities for the ingredient from Ovation to the Company (or a third party
manufacturer on behalf of the Company) no later than December 31, 2009. The Company further agreed
to supply specified quantities of the ingredient to Ovation, at Ovations option, in calendar years
2010-2012. Refer to Note 19, Commitments and Contingencies, below.
(18) Recent Accounting Pronouncements
In December 2007, the FASB issued two statements that would apply prospectively to potential
business combinations for which the acquisition date is on or after January 1, 2009. Early
application is not permitted. These pronouncements would be adopted at such time as the Company
undertakes a business combination and will have no impact on the Companys current and historical
financial statements. SFAS No. 141R, Business Combinations, retains the fundamental requirements
of purchase accounting but requires, among other things, the recognition and measurement of any
noncontrolling interest and certain previously unrecognized intangible assets such as in-process
research and development. It also calls for the recognition of most acquisition costs as expense
rather than part of the total acquisition cost and the recognition of a gain in the event of a
bargain purchase rather than negative goodwill. SFAS No. 160, Noncontrolling Interests in
F-38
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
Consolidated Financial Statement establishes accounting and
reporting standards for the noncontrolling (minority) interest in a subsidiary and for the deconsolidation of
a subsidiary.
At its December 12, 2007 meeting, the FASB ratified a consensus of the Emerging Issues Task
Force regarding the accounting for collaborative agreements (EITF 07-1). Effective January 1,
2009, the consensus prohibits participants in a collaborative agreement from applying the equity
method of accounting to activities performed outside a separate legal entity and requires gross or
net presentation of revenues and expenses by the respective parties depending upon their roles in
the collaboration. The consensus will be applied to collaborative agreements in existence at the
date of adoption using a modified retrospective method that requires reclassification of all
periods presented. The Company is in the process of evaluating the possible impact the consensus
may have on its financial statements, but does not expect it to be material to its financial
position or results of operations.
The FASB also has issued two pronouncements with effective dates primarily as of January 1,
2008 relating to measuring financial instruments at fair value. The Company is in the process of
evaluating the new standards but does not, at this time, anticipate that either will have any
material effect on its consolidated financial position or results of operations. Certain financial
statement disclosures will be revised, however, to conform to the new guidance. SFAS No. 157,
Fair Value Measurements provides guidance on the use of fair value in such measurements and
prescribes expanded disclosures about fair value measurements contained in financial statements.
Once SFAS No. 157 is adopted, SFAS No. 159 The Fair Value Option for Financial Assets and
Financial Liabilities, can be adopted which allows companies the option to measure many financial
assets and financial liabilities at fair value on a contract-by-contract basis. As it relates to
certain nonfinancial assets and nonfinancial liabilities, the effective date of SFAS No. 157 is the
first quarter of 2009.
The Emerging Issues Task Force of the FASB reached a consensus in June 2007 that
non-refundable advance payments to acquire goods or pay for services that will be consumed or
performed in a future period in conducting research and development activities on behalf of the
entity should be recorded as an asset when the advance payments are made (EITF 07-3, Accounting
for Advance Payments for Goods or Services to Be Used in Future Research and Development
Activities). Capitalized amounts are to be recognized as expense when the research and
development activities are performed, that is, when the goods without alternative future use are
acquired or the service is rendered. The consensus is to be applied prospectively to new
contractual arrangements entered into in fiscal years beginning after December 31, 2007. The
Company is evaluating the effect of adoption of EITF 07-3, but does not expect it to be material to
our financial position or results of operations.
(19) Commitments and Contingencies
In connection with the Companys December 2006 license and supply agreements with Ovation for
the active ingredient used in the production of Oncaspar, the Company has committed to effectuate a
technology transfer of the manufacturing capabilities for that ingredient from Ovation by no later
than December 31, 2009 and to supply specified quantities of the active ingredient to Ovation, at
Ovations option, for up to three years thereafter. In the event the Company fails to deliver all
such quantities ordered by Ovation in 2010, 2011 or 2012, the Company will be required to pay
liquidated damages to Ovation in the amounts of $5.0 million in 2010, $10.0 million in 2011 and
$15.0 million in 2012. Also, pursuant to the supply agreement, the Company is committed to certain
minimum quantity purchases of active ingredient in 2008 and 2009. As of December 31, 2007, future
commitments related to this supply arrangement total $9.3 million.
F-39
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
The Company has agreements with certain members of its upper management, which provide for
severance payments and payments following a termination of employment occurring after a change in
control of the Company.
The Company has been involved in various claims and legal actions arising in the ordinary
course of business. In the opinion of management, the ultimate disposition of these matters will
not have a material effect on the Companys consolidated financial position, results of operations
or liquidity.
(20) Leases
The Company has several leases for office, warehouse, production and research facilities and
equipment. The non-cancelable lease terms for the operating leases expire at various dates between
2008 and 2021 and each agreement includes renewal options.
Future minimum lease payments, for non-cancelable operating leases with initial or remaining
lease terms in excess of one year as of December 31, 2007 are (in thousands):
|
|
|
|
|
|
|
Operating |
|
Year ending December 31, |
|
Leases |
|
2008 |
|
$ |
2,319 |
|
2009 |
|
|
2,285 |
|
2010 |
|
|
2,253 |
|
2011 |
|
|
2,230 |
|
2012 |
|
|
2,227 |
|
Thereafter |
|
|
13,558 |
|
|
|
|
|
Total minimum lease payments |
|
$ |
24,872 |
|
|
|
|
|
Rent expense amounted to $2.3 million for the year ended December 31, 2007, $1.6 million, for
the year ended December 31, 2006, $795,000 for the six months ended December 31, 2005 and $1.4
million for the fiscal year ended June 30, 2005. Total rent expense, inclusive of scheduled
increases and rent holidays, is recognized on a straight-line basis over the term of the lease.
(21) Retirement Plans
The Company maintains a defined contribution 401(k) pension plan for substantially all of its
employees. The Company currently matches 50% of the employees contribution of up to 6% of
compensation, as defined. Total Company contributions for the years ended December 31, 2007 and
2006, the six months ended December 31, 2005 and the fiscal year ended June 30, 2005 were $929,000,
$764,000, $338,000 and $631,000, respectively.
In November 2003, the Board of Directors adopted the Executive Deferred Compensation Plan (the
Plan) which has subsequently been amended. The Plan is intended to aid the Company in attracting
and retaining key employees by providing a non-qualified funded compensation deferral vehicle. At
December 31, 2007 and 2006, $3.0 million and $2.7 million of deferred compensation was included in
other liabilities, respectively. Refer to Note 2 to consolidated financial statements relating to
the investment of participants assets.
F-40
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
(22) Business and Geographical Segments
The Company operates in the following three business and reportable segments:
Products The Products segment performs the manufacturing, marketing and selling of
pharmaceutical products for patients with cancer or other life-threatening diseases. Currently,
the Company has developed or acquired four therapeutic, FDA-approved products focused primarily in
oncology and other life-threatening diseases. The Company currently markets its products through
its specialized U.S. sales force that calls upon specialists in oncology, hematology, infectious
disease and other critical care disciplines. The Companys four proprietary marketed brands are
Oncaspar, DepoCyt, Abelcet and Adagen.
Royalties The Company receives royalties on the manufacture and sale of products that
utilize its proprietary technology. Royalty revenues are currently derived from sales of three
products that use the Companys PEGylation platform, namely PEG-INTRON marketed by Schering-Plough,
Pegasys marketed by OSI Pharmaceuticals, Inc. and Pfizer Inc. and Macugen marketed by Hoffmann-La
Roche. Through an agreement with Nektar, the Company shares in Nektars royalties on sales of
Pegasys and Macugen.
Contract Manufacturing The Company contract manufactures products for third parties;
primarily Abelcet for export and MYOCET, each for Cephalon and the injectable multivitamin,
MVI®, for Mayne Pharma, Ltd.
The performance of each of the Companys segments is monitored by the Companys chief
operating decision maker, the President and Chief Executive Officer. Segment profit (loss) is
measured based on operating results, excluding investment income, interest expense and income
taxes. The Companys research and development expense is considered a corporate expense until a
product candidate enters Phase III clinical trials at which time related costs would be chargeable
to one of the Companys operating segments. The Company does not identify or allocate property and
equipment by operating segment, and does not allocate depreciation, to the operating segments.
Operating segments do not have intersegment revenue, and accordingly, there is none to be reported.
F-41
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
The following tables present segment revenue, profitability and certain asset information for
the years ended December 31, 2007 and 2006, the six months ended December 31, 2005 and the fiscal
year ended June 30, 2005 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contract |
|
|
|
|
Segment |
|
|
|
Products |
|
Royalties |
|
Manufacturing |
|
Corporate(1) |
|
Consolidated |
|
|
|
|
|
Revenues |
|
December 31, 2007 |
|
$ |
100,686 |
|
|
$ |
67,305 |
|
|
$ |
17,610 |
|
|
$ |
|
|
|
$ |
185,601 |
|
|
|
December 31, 2006 |
|
|
101,024 |
|
|
|
70,562 |
|
|
|
14,067 |
|
|
|
|
|
|
|
185,653 |
|
|
|
December 31, 2005 |
|
|
49,436 |
|
|
|
17,804 |
|
|
|
6,459 |
|
|
|
|
|
|
|
73,699 |
|
|
|
June 30, 2005 |
|
|
99,192 |
|
|
|
51,414 |
|
|
|
15,644 |
|
|
|
|
|
|
|
166,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Segment |
|
December 31, 2007 |
|
|
7,604 |
|
|
|
155,971 |
(2) |
|
|
4,360 |
|
|
|
(77,441 |
) |
|
|
90,494 |
|
Profit (Loss) |
|
December 31, 2006 |
|
|
20,582 |
|
|
|
70,562 |
|
|
|
2,280 |
|
|
|
(82,924 |
) |
|
|
10,500 |
|
|
|
December 31, 2005 |
|
|
(268,885 |
)(3) |
|
|
17,804 |
|
|
|
(5,614 |
)(3) |
|
|
(36,220 |
) |
|
|
(292,915 |
) |
|
|
June 30, 2005 |
|
|
13,153 |
|
|
|
51,414 |
|
|
|
4,421 |
|
|
|
(58,413 |
) |
|
|
10,575 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets |
|
December 31, 2007 |
|
|
97,485 |
|
|
|
292 |
|
|
|
7,588 |
|
|
|
314,992 |
|
|
|
420,357 |
|
|
|
December 31, 2006 |
|
|
106,760 |
(4) |
|
|
178 |
|
|
|
4,449 |
|
|
|
292,443 |
|
|
|
403,830 |
|
|
|
December 31, 2005 |
|
|
58,304 |
(3) |
|
|
2,265 |
|
|
|
3,686 |
(3) |
|
|
277,090 |
|
|
|
341,345 |
|
|
|
June 30, 2005 |
|
|
342,342 |
|
|
|
15,949 |
|
|
|
10,153 |
|
|
|
282,417 |
|
|
|
650,861 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amortization |
|
December 31, 2007 |
|
|
10,369 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,369 |
|
|
|
December 31, 2006 |
|
|
8,144 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,144 |
|
|
|
December 31, 2005 |
|
|
8,873 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8,873 |
|
|
|
June 30, 2005 |
|
|
17,925 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
17,925 |
|
|
|
|
(1) |
|
Corporate expenses include operating income (loss) components that are not directly
attributable to an operating segment, including general and administrative expenses,
exploratory and preclinical research and development expenses and treasury activities.
Corporate assets consist principally of cash, short-term investments, restricted investments
and cash, marketable securities, property and equipment and certain working capital items.
The Company does not identify or allocate property and equipment by operating segment, and as
such does not allocate depreciation to the operating segments, nor does the chief operating
decision maker evaluate operating segments on these criteria. The Company does not allocate
interest income, interest expenses or incomes taxes to operating segments. |
|
(2) |
|
Royalty segment profit for the year ended December 31, 2007 includes a gain of $88.7
million resulting from the third-quarter 2007 sale of a 25% interest in future royalty
revenues. The subject royalties are those payable by Schering-Plough to Enzon on sales of
PEG-INTRON occurring after June 30, 2007. The impact of the 25% reduction in royalties on
sales of PEG-INTRON was first realized in the fourth quarter of 2007. |
|
(3) |
|
During the quarter ended December 31, 2005, the Company recognized impairment
write-downs of goodwill of $151.0 million and the Product segments intangible assets of
$133.1 million. The goodwill write-off was charged to the Products segment ($144.0 million)
and Contract Manufacturing ($7.0 million). |
|
(4) |
|
Assets of the Products segment increased by $48.5 million in 2006, net of
amortization, related to a payment of $35.0 million to Sanofi-Aventis for a negotiated
reduction in royalty rates to be paid by the Company on sales of Oncaspar and $17.5 million
for the Companys license of the cell line owned by Ovation Pharmaceuticals, Inc. and from
which the active ingredient in Oncaspar is derived. |
F-42
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
Following is a reconciliation of segment profit (loss) to consolidated income (loss) before
income tax (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
Year |
|
|
|
|
|
|
|
|
|
|
|
Ended |
|
|
Ended |
|
|
|
Year Ended December 31, |
|
|
December 31, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2005 |
|
Segment profit (loss) |
|
$ |
167,935 |
|
|
$ |
93,424 |
|
|
$ |
(256,695 |
) |
|
$ |
68,988 |
|
Unallocated corporate operating expense |
|
|
(77,441 |
) |
|
|
(82,924 |
) |
|
|
(36,220 |
) |
|
|
(58,413 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating income (loss) |
|
|
90,494 |
|
|
|
10,500 |
|
|
|
(292,915 |
) |
|
|
10,575 |
|
Other corporate income and expense |
|
|
(5,508 |
) |
|
|
11,567 |
|
|
|
(9,369 |
) |
|
|
(22,237 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income tax |
|
$ |
84,986 |
|
|
$ |
22,067 |
|
|
$ |
(302,284 |
) |
|
$ |
(11,662 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenues consisted of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
Year |
|
|
|
|
|
|
|
|
|
|
|
Ended |
|
|
Ended |
|
|
|
Year Ended December 31, |
|
|
December 31, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2005 |
|
Product sales, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oncaspar |
|
$ |
38,711 |
|
|
$ |
30,881 |
|
|
$ |
13,005 |
|
|
$ |
21,216 |
|
DepoCyt |
|
|
8,628 |
|
|
|
8,273 |
|
|
|
4,459 |
|
|
|
7,446 |
|
Abelcet |
|
|
28,843 |
|
|
|
36,526 |
|
|
|
21,076 |
|
|
|
51,229 |
|
Adagen |
|
|
24,504 |
|
|
|
25,344 |
|
|
|
10,896 |
|
|
|
19,301 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total product sales, net |
|
|
100,686 |
|
|
|
101,024 |
|
|
|
49,436 |
|
|
|
99,192 |
|
Royalties |
|
|
67,305 |
|
|
|
70,562 |
|
|
|
17,804 |
|
|
|
51,414 |
|
Contract manufacturing |
|
|
17,610 |
|
|
|
14,067 |
|
|
|
6,459 |
|
|
|
15,644 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
185,601 |
|
|
$ |
185,653 |
|
|
$ |
73,699 |
|
|
$ |
166,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outside the U.S., the Company principally sells: Oncaspar in Germany, DepoCyt in Canada,
Abelcet in Canada and Adagen in Europe. Information regarding revenues attributable to the U.S.
and to all foreign countries collectively is provided below. The geographic classification of
product sales was based upon the location of the customer. The geographic classification of all
other revenues is based upon the domicile of the entity from which the revenues were earned.
Following information is in thousands:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ended |
|
|
Year Ended |
|
|
|
Year Ended December 31, |
|
|
December 31, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2005 |
|
|
2005 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. |
|
$ |
111,683 |
|
|
$ |
117,161 |
|
|
$ |
52,650 |
|
|
$ |
113,891 |
|
Europe |
|
|
45,624 |
|
|
|
40,118 |
|
|
|
14,079 |
|
|
|
36,667 |
|
Other |
|
|
28,294 |
|
|
|
28,374 |
|
|
|
6,970 |
|
|
|
15,692 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
$ |
185,601 |
|
|
$ |
185,653 |
|
|
$ |
73,699 |
|
|
$ |
166,250 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-43
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
(23) Quarterly Results of Operations (Unaudited)
The following tables present summarized unaudited quarterly financial data (in thousands,
except per-share amounts). Gross profit presented in these tables is calculated as the aggregate
of product sales, net and contract manufacturing revenue, less cost of product sales and contract
manufacturing.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
June 30, |
|
|
September 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2007 |
|
|
2007 |
|
|
2007 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
22,649 |
|
|
$ |
25,019 |
|
|
$ |
24,874 |
|
|
$ |
28,144 |
|
Royalties |
|
|
16,344 |
|
|
|
18,290 |
|
|
|
18,206 |
|
|
|
14,465 |
|
Contract manufacturing |
|
|
2,495 |
|
|
|
5,903 |
|
|
|
3,761 |
|
|
|
5,451 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
41,488 |
|
|
|
49,212 |
|
|
|
46,841 |
|
|
|
48,060 |
|
Gross profit |
|
|
13,680 |
|
|
|
15,653 |
(2) |
|
|
14,517 |
|
|
|
19,468 |
|
Tax (benefit) provision |
|
|
(193 |
) |
|
|
261 |
|
|
|
1,987 |
|
|
|
(122 |
) |
Net (loss) income |
|
|
(2,786 |
)(1) |
|
|
(1,959 |
)(2) |
|
|
87,530 |
|
|
|
268 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.06 |
)(1) |
|
$ |
(0.04 |
)(2) |
|
$ |
1.99 |
|
|
$ |
0.01 |
|
Diluted |
|
$ |
(0.06 |
)(1) |
|
$ |
(0.04 |
)(2) |
|
$ |
1.23 |
|
|
$ |
0.01 |
|
Weighted average number of shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
43,862 |
|
|
|
43,884 |
|
|
|
43,925 |
|
|
|
44,039 |
|
Weighted average number of shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
43,862 |
|
|
|
43,884 |
|
|
|
74,344 |
|
|
|
44,708 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
June 30, |
|
|
September 30, |
|
|
December 31, |
|
|
|
2006 |
|
|
2006 |
|
|
2006 |
|
|
2006 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
24,275 |
|
|
$ |
24,537 |
|
|
$ |
25,295 |
|
|
$ |
26,917 |
|
Royalties |
|
|
17,248 |
|
|
|
17,936 |
|
|
|
18,705 |
|
|
|
16,673 |
|
Contract manufacturing |
|
|
3,206 |
|
|
|
5,131 |
|
|
|
1,856 |
|
|
|
3,874 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
44,729 |
|
|
|
47,604 |
|
|
|
45,856 |
|
|
|
47,464 |
|
Gross profit |
|
|
16,932 |
|
|
|
17,316 |
|
|
|
15,010 |
|
|
|
15,712 |
|
Tax provision |
|
|
136 |
|
|
|
288 |
|
|
|
127 |
|
|
|
207 |
|
Net income (loss) |
|
|
21,708 |
|
|
|
10,987 |
|
|
|
2,238 |
|
|
|
(13,624 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
0.50 |
|
|
$ |
0.25 |
|
|
$ |
0.05 |
|
|
$ |
(0.31 |
) |
Diluted |
|
$ |
0.50 |
|
|
$ |
0.25 |
|
|
$ |
0.05 |
|
|
$ |
(0.31 |
) |
Weighted average number of shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
43,524 |
|
|
|
43,539 |
|
|
|
43,590 |
|
|
|
43,730 |
|
Weighted average number of shares |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted |
|
|
43,524 |
|
|
|
43,539 |
|
|
|
43,590 |
|
|
|
43,730 |
|
|
|
|
(1) |
|
Net loss for the three months ended March 31, 2007 was revised in the third
quarter of 2007 from $1,853 (thousand) or $0.04 per share to $2,786 (thousand) or $0.06 per
share to correct a misstatement of share-based compensation expense. Share-based compensation
was understated by approximately $0.9 million for the three months ended March 31, 2007,
understating selling, general and administrative |
F-44
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Notes to Consolidated Financial Statements (Continued)
|
|
|
|
|
|
expense with an offsetting understatement of
APIC. The misstatement resulted from application of an incorrect amortization schedule to certain newly issued option awards. Due
to the Companys net operating loss position, there would have been no income tax effect
related to the revision. The effect of the misstatement on the results as previously reported
for the first quarter of 2007 was quantitatively and qualitatively immaterial. |
|
(2) |
|
Net loss for the three months ended June 30, 2007 was revised in the third quarter
of 2007 from $3,044 (thousand), or $0.07 per share to $1,959 (thousand) or $0.04 per share
primarily to correct a misstatement of cost of product sales. Cost of product sales in the
Products segment had been overstated by approximately $1.0 million with a corresponding
understatement of inventory and overstatement of net loss. The misstatement resulted from a
failure to capitalize certain purchase price variances in inventory as of June 30, 2007.
Further reducing net loss was a $61 (thousand) effect in the second quarter related to the
adjustment of share-based compensation in the first quarter. Due to the Companys net
operating loss position, there would have been no income tax effect related to the revisions.
The effect of the misstatement on the results as previously reported for the first quarter of
2007 was quantitatively and qualitatively immaterial. |
F-45
ENZON PHARMACEUTICALS, INC. AND SUBSIDIARIES
Schedule II Valuation and Qualifying Accounts
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additions |
|
|
|
|
|
|
|
|
Balance at |
|
Charged to |
|
|
|
|
|
|
|
|
|
Balance |
|
|
beginning |
|
costs and |
|
Charged to |
|
|
|
|
|
at end of |
|
|
of period |
|
expenses |
|
other accounts |
|
Deductions |
|
period |
Year ended December 31, 2007: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for chargebacks,
returns and cash discounts |
|
$ |
5,078 |
|
|
$ |
|
|
|
$ |
27,552 |
(2) |
|
$ |
(28,127 |
) |
|
$ |
4,503 |
|
Allowance for doubtful accounts |
|
|
245 |
|
|
|
352 |
(1) |
|
|
|
|
|
|
(317 |
) |
|
|
280 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for chargebacks,
returns and cash discounts |
|
$ |
5,152 |
|
|
$ |
|
|
|
$ |
30,859 |
(2) |
|
$ |
(30,933 |
) |
|
$ |
5,078 |
|
Allowance for doubtful accounts |
|
|
71 |
|
|
|
245 |
(1) |
|
|
|
|
|
|
(71 |
) |
|
|
245 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six months ended December 31, 2005: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for chargebacks,
returns and cash discounts |
|
$ |
7,242 |
|
|
$ |
|
|
|
$ |
14,943 |
(2) |
|
$ |
(17,033 |
) |
|
$ |
5,152 |
|
Allowance for doubtful accounts |
|
|
|
|
|
|
71 |
(1) |
|
|
|
|
|
|
|
|
|
|
71 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year ended June 30, 2005: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for chargebacks,
returns and cash discounts |
|
$ |
8,785 |
|
|
|
|
|
|
$ |
37,982 |
(2) |
|
$ |
(39,525 |
) |
|
$ |
7,242 |
|
|
|
|
(1) |
|
Amounts are recognized as bad debt expense. |
|
(2) |
|
Amounts are recognized as reductions from gross sales. |
F-46
[This page intentionally left blank]
685 Route 202/206, Bridgewater, NJ 08807
(908) 541-8600
FAX: (908) 575-9457
http://www.enzon.com