Ligand Pharmaceuticals Inc.
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
Mark One
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the Fiscal Year Ended December 31, 2006
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to .
Commission File No. 0-20720
LIGAND PHARMACEUTICALS INCORPORATED
(Exact name of registrant as specified in its charter)
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Delaware
(State or other jurisdiction of
incorporation or organization)
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77-0160744
(IRS Employer
Identification No.) |
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10275 Science Center Drive
San Diego, CA
(Address of Principal Executive Offices)
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92121-1117
(Zip Code) |
Registrants telephone number, including area code: (858) 550-7500
Securities registered pursuant to Section 12(b) of the Act:
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Title of Each Class
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Name of Each Exchange on Which Registered |
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Common Stock, par value $.001 per share
Preferred Share Purchase Rights
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The NASDAQ Global Market of The NASDAQ Stock Market LLC
The NASDAQ Global Market of The NASDAQ Stock Market LLC |
Securities registered pursuant to Section 12(g) of the Act:
None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. Yes o No þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section
13 of Section 15(d) of the Securities Exchange Act of 1934. Yes o No þ
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation
S-K is not contained herein, and will not be contained, to the best of 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. þ
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, or a non-accelerated filer.
Large Accelerated Filer o Accelerated Filer þ Non-accelerated Filer o
Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act
Rule 12b-2 of the Exchange Act). Yes o No þ
The aggregate market value of the Registrants voting and non-voting stock held by
non-affiliates was approximately $597.4 million based on the last sales price of the Registrants
Common Stock on the NASDAQ Global Market of the NASDAQ Stock Market LLC on June 30, 2006. For
purposes of this calculation, shares of Common Stock held by directors, officers and 10%
stockholders known to the Registrant have been deemed to be owned by affiliates which should not be
construed to indicate that any such person possesses the power, direct or indirect, to direct or
cause the direction of the management or policies of the Registrant or that such person is
controlled by or under common control with the Registrant.
As of February 28, 2007, the Registrant had 101,008,348 shares of Common Stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Portions of the Proxy Statement for the Registrants 2007 Annual Meeting of Stockholders
to be filed with the Commission on or before April 30, 2007 are incorporated by reference in Part
III of this Annual Report on Form 10-K. With the exception of those portions that are specifically
incorporated by reference in this Annual Report on Form 10-K, such Proxy Statement shall not be
deemed filed as part of this Report or incorporated by reference herein.
Table of Contents
AVAILABLE INFORMATION:
We file electronically with the Securities and Exchange Commission (or SEC) our annual reports
on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K and, as necessary,
amendments to these reports, pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of
1934. The public may read or copy any materials we file with the SEC at the SECs Public Reference
Room at 100 F Street, NE, Washington, DC 20549. The public may obtain information on the operation
of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The SEC maintains an Internet
site that contains reports, proxy and information statements, and other information regarding
issuers that file electronically with the SEC. The address of that site is
<http://www.sec.gov>.
You may obtain a free copy of our annual reports on Form 10-K, quarterly reports on Form 10-Q
and current reports on Form 8-K and amendments to those reports which are posted as soon as
reasonably practicable after filing on our website at <http://www.ligand.com>, by
contacting the Investor Relations Department at our corporate offices by calling (858) 550-7500 or
by sending an e-mail message to investors@ligand.com. You may also request information via the
Investor Relations page of our website.
1
Glossary
PRODUCTS AND INDICATIONS
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AVINZA®
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Approved in March 2002 for sale in the U.S. for the
once-daily treatment of moderate-to-severe pain in
patients who require continuous, around-the-clock
opioid therapy for an extended period of time.** |
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ONTAK® (denileukin diftitox)
ONZAR
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Approved in February 1999 for sale in the U.S. for the
treatment of patients with persistent or recurrent
cutaneous T-cell lymphoma whose malignant cells express
the CD25 component of the Interleukin-2 receptor.* |
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Targretin® (bexarotene) capsules
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Approved in December 1999 for sale in the U.S. and in
March 2001 for sale in Europe for the treatment of
cutaneous manifestations of cutaneous T-cell lymphoma
in patients who are refractory to at least one prior
systemic therapy.* |
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Targretin® (bexarotene) gel 1%
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Approved in June 2000 for sale in the U.S. for the
topical treatment of cutaneous lesions in patients with
cutaneous T-cell lymphoma (Stage 1A and 1B) who have
refractory or persistent disease after other therapies
or who have not tolerated other therapies.* |
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Panretin® gel (alitretinoin) 0.1%
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Approved in February 1999 for sale in the U.S. and in
October 2000 for sale in Europe for the topical
treatment of cutaneous lesions of patients with
AIDS-related Kaposis sarcoma.* |
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CTCL
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Cutaneous T-Cell Lymphoma |
HIV
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Human Immunodeficiency Virus |
HT
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Hormone Therapy |
NSCLC
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Non-Small Cell Lung Cancer |
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SCIENTIFIC TERMS |
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AR
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Androgen Receptor |
ER
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Estrogen Receptor |
IR
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Intracellular Receptor |
PPAR
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Peroxisome Proliferation Activated Receptor |
PR
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Progesterone Receptor |
RAR
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Retinoic Acid Receptor |
RR
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Retinoid Responsive Intracellular Receptor |
RXR
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Retinoid X Receptor |
SARM
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Selective Androgen Receptor Modulator |
SERM
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Selective Estrogen Receptor Modulator |
SGRM
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Selective Glucocorticoid Receptor Modulator |
TPO
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Thrombopoietin |
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REGULATORY TERMS |
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EMEA
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European Agency for the Evaluation of Medicinal Products |
FDA
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United States Food and Drug Administration |
IND
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Investigational New Drug Application (United States) |
MAA
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Marketing Authorization Application (Europe) |
NDA
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New Drug Application (United States) |
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ONTAK, Targretin, and Panretin were acquired by Eisai, Inc. in October 2006 in the sale of the
Companys oncology product line.
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AVINZA was acquired by King Pharmaceuticals, Inc. in February 2007 in the sale of the Companys
pain product line. |
2
PART I
Item 1. Business
Caution: This discussion and analysis may contain predictions, estimates and other
forward-looking statements that involve a number of risks and uncertainties, including those
discussed in Item 1A. Risk Factors. This outlook represents our current judgment on the future
direction of our business. These statements include those related to our restructuring process,
AVINZA royalty revenues, product returns, product development, our 2005 restatement, and material
weaknesses or deficiencies in internal control over financial reporting. Actual events or results
may differ materially from Ligands expectations. For example, there can be no assurance that our
recognized revenues or expenses will meet any expectations or follow any trend(s), that our
internal control over financial reporting will be effective or produce reliable financial
information on a timely basis, or that our restructuring process will be successful or yield
preferred results. We cannot assure you that the Company will be able to successfully or timely
complete its restructuring, that we will receive expected AVINZA royalties to support our ongoing
business, or that our internal or partnered pipeline products will progress in their development,
gain marketing approval or success in the market. In addition, the Companys ongoing SEC
investigation may have an adverse effect on the Company. Such risks and uncertainties, and others,
could cause actual results to differ materially from any future performance suggested. We
undertake no obligation to release publicly the results of any revisions to these forward-looking
statements to reflect events or circumstances arising after the date of this annual report. This
caution is made under the safe harbor provisions of Section 21E of the Securities Exchange Act of
1934 as amended.
References to Ligand Pharmaceuticals Incorporated (Ligand, the Company, we or our)
include our wholly owned subsidiaries Ligand Pharmaceuticals (Canada) Incorporated; Ligand
Pharmaceuticals International, Inc.; Seragen, Inc. (Seragen); and Nexus Equity VI LLC (Nexus).
We were incorporated in Delaware in 1987. Our principal executive offices are located at
10275 Science Center Drive, San Diego, California, 92121. Our telephone number is (858) 550-7500.
Overview
We
are an early-stage biotech company that focuses on discovering and developing new
drugs that address critical unmet medical needs in the areas of thrombocytopenia, cancer, hepatitis
C, hormone-related diseases, osteoporosis and inflammatory diseases. We strive to develop drugs
that are more effective and/or safer than existing therapies, that are more convenient to
administer and that are cost effective. We plan to build a profitable company by generating income
from research, milestone, royalty and co-promotion revenues resulting from our collaborations with
pharmaceutical partners.
In October 2006, we completed the sale of our oncology product line to Eisai Co., LTD (Tokyo)
and Eisai Inc. (New Jersey) for approximately $205.0 million. Of this amount, $185.0 million was
received in cash and $20.0 million was funded into an escrow account to support any indemnification
claims made by Eisai following the closing of the sale. Such cash proceeds are exclusive of
transaction fees and costs. The sale included our four marketed oncology drugs: ONTAK, Targretin
capsules, Targretin gel and Panretin gel. In addition, certain of our employees were offered
employment by Eisai.
In February 2007, we completed the sale of our AVINZA product line to King Pharmaceuticals,
Inc (King). We received $280.4 million in net cash proceeds at the closing from King which is
net of $15.0 million that was funded into an escrow account to support any indemnification claims
made by King following the closing of the sale. The net cash amount represents a purchase price of
$246.3 million which includes certain inventory-related adjustments, plus approximately $49.1
million in reimbursement of payments to Organon and others. Such net cash proceeds are exclusive
of transaction fees and costs. We have now completed the sale of our commercial businesses, thus
allowing us to focus our business strategy on a targeted internal research and development effort.
We have what we believe are promising products through our internal development programs, including
the potential of LGD-4665, which is currently in clinical development.
We have formed research and development collaborations for our products with numerous global
pharmaceutical companies with ongoing clinical programs at GlaxoSmithKline, Wyeth, Pfizer Inc. and
TAP Pharmaceutical
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Products, Inc. (TAP). These partnered products are being studied for the treatment of large
market indications such as thrombocytopenia, osteoporosis, menopausal symptoms and frailty.
Eltrombopag (Promacta), a small-molecule TPO mimetic, is being developed by GlaxoSmithKline
for thrombocytopenia. Eltrombopag (Promacta) advanced to Phase III in February 2006, in patients
with Immune Thrombocytopenic Purpura. Additional Phase I and II studies are ongoing in patients
with hepatitis C and chemotherapy-induced thrombocytopenia.
Wyeth is developing bazedoxifene (Viviant) as a monotherapy for osteoporosis and Aprela which
is bazedoxifene in combination with Wyeths PREMARIN for osteoporosis prevention, and vasomotor
symptoms of menopause. Wyeth filed an NDA for bazedoxifene (Viviant) in June 2006. Another
partnered product, lasofoxifene (Oporia), is being developed by Pfizer for osteoporosis and vaginal
atrophy. Pfizer filed an NDA with the FDA in August 2004 for the use of lasofoxifene (Oporia) in
the prevention of osteoporosis and then filed a supplemental NDA in December 2004 for the use of
lasofoxifene (Oporia) in the treatment of vaginal atrophy. In September 2005 and February 2006,
respectively, Pfizer announced the receipt of non-approvable letters from the FDA for both
indications. However, lasofoxifene (Oporia) continues in Phase III clinical trials by Pfizer for
the treatment of osteoporosis.
In June 2005, GlaxoSmithKline commenced Phase I studies of SB-559448, a second product for
thrombocytopenia and in April 2005, TAP commenced Phase I studies for LGD-2941 for the treatment of
osteoporosis and frailty.
Internal and collaborative research and development programs are built around our proprietary
science technology, which is based on our leadership position in gene transcription technology.
LGD-4665 as well as our partnered products currently in human development, are modulators of gene
transcription, working through key cellular or intracellular receptor targets discovered using our
IR technology.
Business Strategy
We aim to create value for shareholders by advancing our internally developed programs through
early clinical development and then entering licensing agreements with larger pharmaceutical and
biotechnology companies with substantially greater development and commercialization
infrastructure. In addition to advancing our R&D programs, we expect to collect licensing and
royalties from existing and future license agreements. We aim to build a profitable company by
generating income from our corporate licenses. The principal elements of our strategy are:
Leverage Proprietary Intracellular Receptor Gene Expression Technology. We have accumulated
substantial expertise in IR gene expression technology applicable to drug discovery and
development. Building on our scientific findings about the molecular basis of hormone action, we
have created proprietary new tools to explore and manipulate hormone and growth factor action for
potential therapeutic benefit. We employ a proprietary cell-culture based assay system for small
molecules that can modulate IRs, referred to as the co-transfection assay. The co-transfection
assay system simulates the actual cellular processes controlled by IRs and is able to detect
whether a compound interacts with a particular human IR and whether this interaction mimics or
blocks the effects of the natural regulatory molecules on target gene expression.
Discover and Develop Targeted Modulators that are Promising Drug Candidates. We discover,
synthesize and test numerous compounds to identify those that are most promising for clinical
development. We perform extensive target profiling and base our selection of promising development
candidates on product characteristics such as initial indications of safety and efficacy. We
believe that this focused strategy allows us to eliminate unpromising candidates from consideration
sooner without incurring substantial clinical costs.
License Drug Candidates to Other Parties. We generally plan to advance drug candidates through
initial and/or early-stage drug development. For larger disease indications requiring complex
clinical trials, our strategy is to license drug candidates to pharmaceutical or biotechnology
partners for final development and global marketing. We believe partnerships are a good source of
development payments, license fees, future event payments and royalties. They also provide
considerable benefit regarding late-stage product development, regulatory approval, manufacturing
and marketing. We believe that focusing on discovery and early-stage drug development while
4
benefiting from our partners proven development and commercialization expertise will reduce our
internal expenses and allow us to have a larger number of drug candidates progress to later stages
of drug development. However, after establishing a lead product candidate, we are willing to
license that candidate during any stage of the development process we determine to be beneficial to
the company and to the ultimate development and commercialization of that drug candidate.
Generate Revenue through Partnerships to Fund Our Business and Drive Future Profitability. We have
multiple sources of potential license and royalty revenue from existing corporate agreements and we
may enter additional partnerships that will provide additional revenue opportunities. In
particular, in February 2007, we divested our AVINZA product line to King in exchange for cash and
ongoing royalties from product revenues. With the close of that transaction, we expect immediately
to begin generating royalty revenue based on Kings sales with the product. We have numerous
collaborations, including our agreement with GlaxoSmithKline for eltrombopag (Promacta) that has
the potential to generate future royalties for Ligand. The revenue generated from these and future
potential collaborations will fund our business and potentially provide profits to our
shareholders.
General Product Development Process
There are three general phases in product development the research phase, the preclinical
phase and the clinical trials phase. See Government Regulation for a more complete description
of the regulatory process involved in developing drugs. At Ligand, activities during the research
phase include research related to specific IR targets and the identification of lead compounds.
Lead compounds are chemicals that have been identified to meet preselected criteria in cell culture
models for activity and potency against IR targets. More extensive evaluation is then undertaken
to determine if the compound should enter preclinical development. Once a lead compound is
selected, chemical modification of the compound is undertaken to create an optimal drug candidate.
The preclinical phase includes pharmacology and toxicology testing in preclinical models (in
vitro and in vivo), formulation work and manufacturing scale-up to gather necessary data to comply
with applicable regulations prior to commencing human clinical trials. Development candidates are
lead compounds that have successfully undergone in vitro and in vivo evaluation to demonstrate that
they have an acceptable profile that justifies taking them through preclinical development with the
intention of filing an IND and initiating human clinical testing.
Clinical trials are typically conducted in three sequential phases that may overlap. In Phase
I, the initial introduction of the pharmaceutical into humans, the emphasis is on testing for
adverse effects, dosage tolerance, absorption, metabolism, distribution, excretion and clinical
pharmacology. Phase II involves studies in a representative patient population to determine the
efficacy of the pharmaceutical for specific targeted indications, to determine dosage tolerance and
optimal dosage, and to identify related adverse side effects and safety risks. Once a compound is
found to be effective and to have an acceptable safety profile in Phase II studies, Phase III
trials are undertaken to evaluate clinical efficacy further and to test further for safety.
Sometimes Phase I and II trials or Phase II and III trials are combined. In the U.S., the FDA
reviews both clinical plans and results of trials, and may discontinue trials at any time if there
are significant safety concerns. Once a product has been approved, Phase IV post-market clinical
studies may be performed to support the marketing of the product.
Ligand Product Development Programs
We are developing several proprietary products for which we have worldwide rights for a
variety of cancers, thrombocytopenia and inflammation and hormonal disorders, as summarized in the
table below. Our development programs are primarily based on products discovered through our IR
technology. See Technology for a discussion of our IR technology.
5
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Program |
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Disease/Indication |
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Development Phase |
LGD-4665
(Thrombopoietin
oral mimetic)
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Idiopathic Thrombocytopenia
Purpura; other
thrombocytopenias
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Phase I |
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Selective androgen
receptor modulators
(agonists)
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Hypogonadism, osteoporosis,
sexual dysfunction, frailty,
cachexia
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Pre-clinical |
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Selective
glucocorticoid
receptor modulators
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Inflammation, cancer
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Research |
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Selective androgen
receptor modulators
(antagonists)
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Prostate cancer Research |
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Research |
Thrombopoietin (TPO) Research Programs
In our TPO program, we seek to develop our own drug candidates that mimic the activity of
thrombopoietin for use in the treatment or prophylaxis of thrombocytopenia with indications in a
variety of conditions including Idiopathic Thrombocytopenic Purpura (ITP), cancer, hepatitis C
and other disorders of blood cell formation. These are large markets with unmet medical needs.
For example, the US prevalence of a few target diseases with thrombocytopenia is 200,000 patients
with ITP, 1.3 million cancer patients receiving chemotherapy and 2.7 million patients with
hepatitis C.
Thrombocytopenia can be caused by insufficient platelet production, splenic sequestration of
platelets or increased destruction of platelets predominantly by a patients own immune system.
Thrombocytopenia in cancer patients can be treatment-related (chemotherapy) or cancer-related.
Platelet transfusion is the standard of care for thrombocytopenia. However, repeated transfusions
can result in the development of platelet alloantibodies that could significantly reduce the
effectiveness of transfusions. In addition, patients are at increased risk of infections and
allergic reactions. Currently, there is only one approved drug (Neumega) for the prevention of
severe thrombocytopenia and the reduction of the need for platelet transfusions in patients with
nonmyeloid malignancies. However, we believe that there is a substantial medical need for improved
platelet enhancing agents for use in the treatment of thrombocytopenia due to the significant side
effects seen with current therapies. Thus, a small molecule TPO mimetic with no apparent
immunogenic potential and oral activity that may facilitate dosing may provide an attractive
therapeutic profile for a major unmet medical need.
In 1997, we formed a joint research and development alliance with SmithKline Beecham (now
GlaxoSmithKline) to focus on the discovery and development of small molecule TPO mimetics. Our
partner has two TPO mimetics that were part of our collaboration with them in clinical trials:
eltrombopag (Promacta) in Phase II and Phase III trials for multiple indications and SB-559448 in
Phase I. For a discussion of these clinical trials, see Collaborative Research and Development
Programs Thrombopoietin (TPO) Mimetics Collaborative Program GlaxoSmithKline Collaboration.
After a wash-out period following the termination of the research collaboration with
GlaxoSmithKline, each party retained rights to perform research and development of new drugs to
control hematopoiesis. This wash-out period ended in February 2003 at which time we began to
research and later selected a TPO mimetic, LGD-4665, as a clinical candidate and completed
preclinical studies in 2006. We initiated Phase I clinical studies in November 2006. We may pursue
the specialty applications emerging from our TPO mimetics internally, but may seek collaborations
with major pharmaceutical companies to exploit broader clinical applications.
Selective Androgen Receptor Modulators (SARM) Research and Development Programs
We are pioneering the development of tissue selective SARMs, a novel class of non-steroidal,
orally active molecules that selectively modulate the activity of the androgen receptor in
different tissues, providing a wide range of opportunities for the treatment of many diseases and
disorders in both men and women. Tissue-selective androgen receptor agonists may provide utility
in the treatment of patients with hypogonadism, osteoporosis, sexual dysfunction and frailty.
Tissue-selective androgen receptor antagonists may provide utility in the treatment of patients
with prostate cancer, acne, androgenetic alopecia and other diseases. The use of androgen
antagonists has shown efficacy in the treatment of prostate cancer, with three androgen antagonists
currently approved by the FDA
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for use in the treatment of the disease. However, we believe there is a substantial medical
need for improved androgen modulators for use in the treatment of prostate cancer due to the
significant side effects seen with currently available drugs.
We have assembled an extensive SARM compound library and, we believe, one of the most
experienced androgen receptor drug discovery teams in the pharmaceutical industry. We may pursue
the specialty applications emerging from SARMs internally, but may seek collaborations with major
pharmaceutical companies to exploit broader clinical applications.
Consistent with this strategy, we formed in 2001 a joint research and development alliance
with TAP Pharmaceutical Products to focus on the discovery and development of SARMs. The research
component of this collaboration ended in June 2006. TAP continues to develop the lead SARM
compound in Phase I. Please see the Selective Androgen Receptor Modulators (SARM) Collaborative
Programs section below for more details on this alliance.
As part of our alliance with TAP, we exercised an option to select for development one
compound and a back-up, LGD-3303 and LGD-3129, out of a pool of compounds available for
development. Preclinical studies we have conducted with LGD-3303 indicate that the compound may
have utility for osteoporosis, sexual dysfunction, frailty and hypogonadism. In vivo studies in
rodents indicate a favorable profile with anabolic effects on bone, but an absence of the prostatic
hypertrophy that occurs with the currently marketed androgens.
Selective Glucocorticoid Receptor Modulators (SGRM) Research and Development Program
We are developing SGRMs for inflammation, cancer indications and other therapeutic
applications. We have a library of compounds that we are optimizing with the goal to identify one
or more compounds to enter human trials. Our most advanced compound LGD-5552 was on track to enter
clinical trials in 2007; however Good Laboratory Practice studies failed to demonstrate the desired
preclinical safety characteristics for a drug to treat rheumatoid arthritis. We decided in the
first quarter of 2007 not to proceed with the development of LGD-5552.
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Collaborative Research and Development Programs
We have several major collaborative programs to further develop the research and development
of compounds based on our IR technologies. These collaborations focus on numerous large market
indications. As of December 31, 2006, several of our collaborative product candidates were in
varying stages of human development. Please see Note 15 of the consolidated financial statements
for a description of the financial terms of our key collaboration agreements. The table below
summarizes our collaborative research and development programs, but is not intended to be a
comprehensive summary of these programs.
LEADING PARTNERED DEVELOPMENT PROGRAMS
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Program |
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Disease/Indication |
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Development Phase |
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Marketing Rights |
THROMBOPOIETIN (TPO) MIMETICS |
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Eltrombopag (Promacta) (TPO
agonist)
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Thrombocytopenia (Idiopathic
Thrombocytopenic Purpura,
ITP)
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Phase III
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GlaxoSmithKline |
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Thrombocytopenia (hepatitis C)
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Phase II
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GlaxoSmithKline |
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Thrombocytopenia
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Phase II
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GlaxoSmithKline |
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(Chemotherapy-Induced, CIT) |
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Thrombocytopenia (hepatic, renal, CITs)
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Phase I
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GlaxoSmithKline |
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SB-559448 (TPO agonist)
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Thrombocytopenia
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Phase I
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GlaxoSmithKline |
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SELECTIVE ESTROGEN RECEPTOR MODULATORS (SERMs) |
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Bazedoxifene (Viviant)
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Osteoporosis
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NDA filed
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Wyeth |
Bazedoxifene CE (Aprela)
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Osteoporosis prevention
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Phase III
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Wyeth |
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Vasomotor symptoms |
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Lasofoxifene (Oporia)(1)
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Osteoporosis prevention, vaginal atrophy
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NDA and SNDA filed
(1)
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Pfizer |
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Osteoporosis treatment
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Phase III
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Pfizer |
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SELECTIVE ANDROGEN RECEPTOR MODULATORS (SARMs) |
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LGD-2941 (androgen agonist)
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Osteoporosis, frailty and
sexual dysfunction
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Phase I
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TAP |
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(1) |
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In September 2005 and February 2006, respectively, Pfizer announced receipt of
non-approvable letters from the FDA for the prevention of osteoporosis and vaginal atrophy.
Pfizer also indicated that the NDAs may be resubmitted with additional clinical data. |
Thrombopoetin (TPO) Mimetics Collaborative Program
GlaxoSmithKline Collaboration. In 1995, we entered into a research and development
collaboration with SmithKline Beecham (now GlaxoSmithKline) to use our proprietary expertise to
discover and characterize small molecule, orally bioavailable drugs to control hematopoiesis (the
formation and development of blood cells) for the treatment of a variety of blood cell
deficiencies. In 1998, we announced the discovery of the first non-peptide small molecule that
mimics in mice the activity of Granulocyte-Colony Stimulating Factor (G-CSF), a natural protein
that stimulates production of infection-fighting neutrophils (a type of white blood cell). While
this lead compound has only been shown to be active in mice, its discovery is a major scientific
milestone and suggests that orally active, small-molecule mimetics can be developed not only for
G-CSF, but for other cytokines as well.
8
A number of lead molecules have been found that mimic the activity of natural growth factors
for white cells and platelets. In 2002, we earned a $2.0 million milestone payment from
GlaxoSmithKline, in connection with the commencement of human trials of eltrombopag (Promacta), an
oral, small molecule drug that mimics the activity of thrombopoietin, a protein factor that
promotes growth and production of blood platelets. In 2005, we announced that we had earned a $1.0
million milestone payment from GlaxoSmithKline with that companys commencement of Phase II trials
of eltrombopag (Promacta). In 2005, we earned a $2.0 million milestone payment as SB-559448, a
second TPO agonist, began Phase I development. Additionally, in February 2006, we earned a $2.0
million milestone in connection with the commencement of Phase III trials of eltrombopag
(Promacta). There are no approved oral TPO mimetic agents for the treatment or prevention of
thrombocytopenias (decreased platelet count). Investigational use of injectable forms of
recombinant human TPO has been effective in raising platelet levels in cancer patients undergoing
chemotherapy, and has led to accelerated hematopoietic recovery when given to stem cell donors.
Some of these investigational treatments have not moved forward to registration due to the
development of neutralizing antibodies. Thus, a small molecule TPO mimetic with no apparent
immunogenic potential and oral activity that may facilitate dosing may provide an attractive
therapeutic profile for a major unmet medical need.
The research phase of the GlaxoSmithKline collaboration concluded in February 2001. After a
wash-out period following the termination of the research collaboration, each party has rights to
perform research and development of new drugs to control hematopoiesis. This wash-out period ended
in February 2003 at which time we began to research and later selected a TPO mimetic, LGD-4665, as
a clinical candidate and completed preclinical studies in 2006. We initiated Phase I clinical
studies in November 2006. In addition, under the collaboration we have the right to select, but
have not selected up to three compounds related to hematopoietic targets for development as
anti-cancer products other than those compounds selected for development by GlaxoSmithKline.
GlaxoSmithKline has the option to co-promote any selected products with us in North America and to
develop and market such products outside North America. We may pursue the specialty applications
emerging from our TPO mimetics internally, but may seek collaborations with major pharmaceutical
companies to exploit broader clinical applications (see Ligand Product Development Programs).
Selective Estrogen Receptor Modulators (SERM) Collaborative Programs
The primary objective of our estrogen receptor modulators collaborative programs is to develop
drugs for hormonally responsive cancers, hormone therapies, the treatment and prevention of
diseases affecting womens health, and hormonal disorders prevalent in men. Our programs, both
collaborative and internal, target development of tissue-selective modulators of the progesterone
receptor the estrogen receptor and the androgen receptor. Through our collaborations with Wyeth
and Pfizer, three SERM compounds are in development for osteoporosis, vaginal atrophy and vasomotor
symptoms of menopause.
Wyeth Collaboration. In 1994, we entered into a research and development collaboration with
Wyeth-Ayerst Laboratories (now Wyeth) to discover and develop drugs that interact with estrogen and
progesterone receptors for use in hormone therapy, anti-cancer therapy, gynecological diseases and
central nervous system disorders associated with menopause and fertility control. We granted Wyeth
exclusive worldwide rights to all products discovered in the collaboration that are agonists or
antagonists to the progesterone and estrogen receptors for application in the fields of womens
health and cancer therapy.
As part of this collaboration, we tested Wyeths extensive chemical library for activity
against a selected set of targets. In 1996, Wyeth exercised its option to include compounds we
discovered that modulate progesterone receptors, and to expand the collaboration to encompass the
treatment or prevention of osteoporosis through the estrogen receptors. Wyeth also added four
advanced chemical compound series from its internal estrogen receptor osteoporosis program to the
collaboration. The research phase of the collaboration ended in August 1998.
In December 2005, the Company entered into an Amended and Restated Agreement with Wyeth to
better define, simplify and clarify: the universe of research compounds resulting from the research
and development efforts of the parties; combine and clarify categories of those compounds as well
as related milestones, royalties and resolve a number of milestone payment issues.
9
Wyeth has ongoing clinical studies with two SERMs from the collaboration. Wyeth is developing
bazedoxifene (Viviant) and bazedoxifene in combination with PREMARIN (Aprela) for the treatment of
post-menopausal osteoporosis. We have milestone and royalty rights for Viviant and Aprela.
Portions of these royalty rights have been sold to Royalty Pharma AG. See Royalty Pharma
Agreement.
In June 2006, Wyeth announced that an NDA for bazedoxifene (Viviant) had been submitted to the
FDA. Wyeth is developing bazedoxifene CE (Aprela) as a progesterone-free treatment for menopausal
symptoms. Bazedoxifene (Viviant) is a synthetic drug that was specifically designed to increase
bone density and reduce cholesterol levels while at the same time protecting breast and uterine
tissue.
Pfizer Collaboration. We have a research and development collaboration with Pfizer to develop
therapies for osteoporosis. The collaboration produced a drug candidate, lasofoxifene (Oporia),
that Pfizer has advanced through late-stage clinical development.
Lasofoxifene (Oporia) is an estrogen partial agonist being developed for osteoporosis
prevention and other diseases. Pfizer has retained marketing rights to the drug. We have milestone
and royalty rights to lasofoxifene (Oporia). Portions of these royalty rights have been sold to
Royalty Pharma AG. See Royalty Pharma Agreement.
In 2004, Pfizer submitted an NDA to the FDA for lasofoxifene (Oporia) for the prevention of
osteoporosis in postmenopausal women. We earned a development milestone of approximately $2.0
million from Pfizer in connection with the filing. In September 2005, Pfizer announced the receipt
of a non-approvable letter from the FDA for the prevention of osteoporosis. However, lasofoxifene
(Oporia) continues in Phase III clinical trials by Pfizer for the treatment of osteoporosis.
In 2004, Pfizer filed a supplemental NDA for the use of lasofoxifene (Oporia) for the
treatment of vaginal atrophy for which no additional milestone was due. In February 2006, Pfizer
announced the receipt of a non-approval letter from the FDA for this indication.
Selective Androgen Receptor Modulators (SARM) Collaborative Programs
TAP Collaboration. In June 2001, we entered into a joint research and development alliance
with TAP Pharmaceutical Products to focus on the discovery and development of SARMs. SARMs may
contribute to the prevention and treatment of diseases including sexual dysfunction, osteoporosis
and frailty. The three-year collaboration carried an option to extend by up to two additional
one-year terms. In December 2004, we announced the second extension of this collaboration for an
additional year, which was successfully concluded in June 2006.
Under the terms of the agreement, TAP received exclusive worldwide rights to manufacture and
sell any products resulting from the collaboration in its field, which would include treatment and
prevention of male hypogonadism, male sexual dysfunction, female osteoporosis and other indications
not retained by Ligand. Ligand retained certain rights in the androgen receptor field, including
the prevention or treatment of prostate cancer, benign prostatic hyperplasia, acne and hirsutism.
Following expiration of the research collaboration, Ligand has the right to perform research and
development of new SARM drugs independently of TAP. We may also receive milestones and up to
double-digit royalties as compounds are developed and commercialized. LGD-2941, an androgen
agonist targeting osteoporosis and frailty, commenced Phase I development in April 2005.
In addition, we had an option at the expiration of the original three-year term to develop one
compound not developed by TAP in its field, with TAP retaining an option to negotiate to co-develop
and co-promote such compounds with Ligand. We exercised our option to select one compound and a
back-up for development, LGD-3303 and LGD-3129, out of a pool of compounds available for
development in the TAP field. TAP retains certain royalty rights and an option to negotiate to
co-develop and co-promote such compounds with us up to the end of Phase II development (see Ligand
Product Development Programs).
10
Metabolic and Cardiovascular Disease Collaborative Programs
We have collaborative partnerships with GlaxoSmithKline and Eli Lilly and Company (Lilly) in the
areas of cardiovascular and metabolic diseases. Multiple PPAR modulators have entered clinical
development under these partnerships. However, further studies with these compounds are either on
hold or have been discontinued.
GlaxoSmithKline Collaboration. In 1992, we entered into a research and development
collaboration with Glaxo Wellcome plc (now GlaxoSmithKline) to discover and develop drugs for the
prevention or treatment of atherosclerosis and other disorders affecting the cardiovascular system.
The research phase was successfully completed in 1997 with the identification of a novel lead
structure that activates selected PPAR subfamily members and the identification of a different lead
compound that shows activity in preclinical models for lowering LDL cholesterol by up-regulating
LDL receptor gene expression in liver cells. We retain the right to develop and commercialize
products arising from the collaboration in markets not exploited by GlaxoSmithKline, or where
GlaxoSmithKline is not developing a product for the same indication.
In 1999, several PPAR leads were advanced to exploratory development. GW501516 was selected
for clinical development and Phase II trials were initiated for cardiovascular disease and
dyslipidemia. GW501516 is currently on hold pending the review of preclinical studies.
Eli Lilly Collaboration. In 1997, we entered into a research and development collaboration
with Lilly for the discovery and development of products for metabolic disorders. The research
phase of the collaboration ended in November 2004.
Lilly selected three PPAR modulators, naveglitazar, LY929 and LY674, for clinical development.
Ligand earned milestone payments for IND filings and initiation of Phase II studies. Naveglitazar
entered Phase II studies early in 2003, resulting in a $1.5 million milestone payment. In 2004,
Lilly announced its decision to move naveglitazar into Phase III registration studies. However, in
May 2006, after review of all preclinical and clinical data including two year animal safety
studies, Lilly informed us that it had decided not to pursue further development of
naveglitazar at this time. This decision was specific with regard to naveglitazar.
In 2002, Lilly filed with the FDA an IND for LY929, a PPAR modulator for the treatment of Type
II diabetes, metabolic diseases and dyslipidemias. A third IND was filed with the FDA in November
2002 for LY674, a PPAR modulator for the treatment of atherosclerosis. In July 2005, LY674 entered
Phase II studies. In September 2006, Lilly informed us that it had suspended an ongoing mid-stage
human trial of LY674 in order to assess unexpected findings noted during animal safety studies of
the same compound and evaluate collective clinical efficacy and safety from the human data already
gathered.
Royalty Pharma Agreement
In March 2002, we announced an agreement with Royalty Pharma AG, which purchased rights to a
share of future royalty payments from our collaborative partners sales of three SERMs then in
Phase III development. The SERM products included in the transaction are Oporia, which is being
developed for osteoporosis and other indications at Pfizer, bazedoxifene (Viviant) and bazedoxifene
CE, PREMARIN combo (Aprela) which are in development at Wyeth for osteoporosis and for
vasomotor symptoms of menopause (see the detailed discussions of these products under the Pfizer
and Wyeth collaborations above). Since March 2002, and following certain amendments to the
original agreement, Royalty Pharma has acquired cumulative rights to 3.0125% of the potential
future net sales of the three SERM products for an aggregate of $63.3 million.
Under the terms of the agreements, payments from the royalty rights purchase are
non-refundable, regardless of whether the products are ever successfully registered or marketed.
Milestone payments owed by our partners as the products complete development and registration are
not included in the Royalty Pharma agreement and will be paid to us as earned.
11
Technology
In our efforts to discover new and important medicines, we and our academic collaborators and
consultants have concentrated on two areas of research: advancing the understanding of the
activities of hormones and hormone-related drugs, and making scientific discoveries related to IR
technology. We believe that our expertise in this technology will enable us to develop novel,
small-molecule drugs acting through IRs with more target-specific properties than currently
available drugs. Our efforts may result in improved therapeutic and side effect profiles and new
indications for IRs. IRs are families of transcription factors that change cell function by
selectively turning on or off particular genes in response to circulating signals that impinge on
cells.
Intracellular Receptor Technology
Hormones occur naturally within the body and control processes such as reproduction, cell
growth and differentiation. Hormones generally fall into two classes, non-peptide hormones and
peptide hormones. Non-peptide hormones include retinoids, sex steroids (estrogens, progestins and
androgens), adrenal steroids (glucocorticoids and mineralocorticoids), vitamin D and thyroid
hormone. These non-peptide hormones act by binding to their corresponding IRs to regulate the
expression of genes in order to maintain and restore balanced cellular function within the body.
Hormonal imbalances can lead to a variety of diseases. The hormones themselves and drugs that
mimic or block hormone action may be useful in the treatment of these diseases. Furthermore,
hormone mimetics (agonists) or blockers (antagonists) can be used to treat diseases in which the
underlying cause is not hormonal imbalance. The effectiveness of IRs as drug targets is clearly
demonstrated by currently available drugs acting through IRs for several diseases. However, the
use of most of these drugs has been limited by their often significant side effects.
We have accumulated substantial expertise in IRs applicable to drug discovery and development.
Building on our scientific findings about the molecular basis of hormone action, we have created
proprietary new tools to explore and manipulate non-peptide hormone action for potential
therapeutic benefit. We employ a proprietary cell-culture based assay system for small molecules
that can modulate IRs, referred to as the co-transfection assay. The co-transfection assay system
simulates the actual cellular processes controlled by IRs and is able to detect whether a compound
interacts with a particular human IR and whether this interaction mimics or blocks the effects of
the natural regulatory molecules on target gene expression.
In 1999, we invested in and exclusively licensed particular IR technology to a new
corporation, X-Ceptor Therapeutics, Inc. (X-Ceptor). X-Ceptor was subsequently acquired by
Exelixis Inc. in October 2004. Under the 1999 license agreement, we will receive a royalty on net
sales of any products that are discovered using the licensed technologies.
Fusion Protein Technology
Our fusion protein technology was developed by Seragen, which we acquired in 1998. Seragens
fusion proteins consist of a fragment of diphtheria toxin genetically fused to a ligand that binds
to specific receptors on the surface of target cells. Once bound to the cell, the fusion proteins
are designed to enter the cell and destroy the ability of the cell to manufacture proteins,
resulting in cell death. Using this platform, Seragen genetically engineered six fusion proteins,
each of which consists of a fragment of diphtheria toxin fused to a different targeting ligand,
such as a polypeptide hormone or growth factor. Fusion proteins may have utility in oncology,
dermatology, infectious diseases and autoimmune diseases.
Academic Collaborations
To date, we have licensed technology from The Salk Institute, Baylor College of Medicine and
other academic institutions and developed relationships with key scientists to further the
development of our core IR technology.
The Salk Institute of Biological Studies. In 1988, we established an exclusive relationship
with The Salk Institute, which is one of the research centers in the area of IR technology. We
amended and restated this agreement in April 2002. Under our agreement, we have an exclusive,
worldwide license to certain IR technology developed in the laboratory of Dr. Ronald Evans, a Salk
professor and Howard Hughes Medical Institute Investigator. Dr. Evans
12
cloned and characterized the first IR in 1985 and is an inventor of the co-transfection assay
we use to screen for IR modulators. Under the agreement, we are obligated to make royalty payments
based on sales of certain products developed using the licensed technology, as well as certain
minimum annual royalty payments and a percentage of milestones and certain other payments received.
The agreement also provides that we have the option of buying out future royalty payments as well
as milestone and other payment-sharing obligations on a product-by-product basis by paying the Salk
a lump sum calculated using a formula in the agreement. In March 2004, we paid The Salk Institute
$1.1 million to exercise this buyout option with respect to lasofoxifene (Oporia), a product under
development by Pfizer for the prevention of osteoporosis in postmenopausal women. In December 2004
Pfizer filed a supplemental NDA for the use of lasofoxifene (Oporia) for the treatment of vaginal
atrophy. As a result of the supplemental lasofoxifene (Oporia) NDA filing, we exercised an option
in January 2005 to pay The Salk Institute $1.1 million to buy out royalty payments due on future
sales of the product in this additional indication. See the discussion above regarding
Collaborative Research and Development Programs.
We have also entered into a consulting agreement with Dr. Evans that continues through
February 2008. Dr. Evans serves as Chairman of Ligands Scientific Advisory Board.
Baylor College of Medicine. In 1990, we established an exclusive relationship with Baylor,
which is a center of IR technology. We entered into a series of agreements with Baylor under which
we have an exclusive, worldwide license to IR technology developed at Baylor and to future
improvements made in the laboratory of Dr. Bert W. OMalley through the life of the related
patents. Dr. OMalley is a professor and the Chairman of the Department of Molecular and Cellular
Biology at the Baylor College of Medicine.
We continue to work with Dr. OMalley and Baylor in scientific IR research, particularly in
the area of sex steroids and orphan IRs. Under our agreement, we are obligated to make certain
royalty payments based on the sales of products developed using the licensed technology. Dr.
OMalley is a member of Ligands Scientific Advisory Board.
In addition to the collaborations discussed above, we also have a number of other consulting,
licensing, development and academic agreements by which we strive to advance our technology.
Manufacturing
We currently have no manufacturing facilities and, accordingly, rely on third parties,
including our collaborative partners, for clinical production of any products or compounds.
Quality Assurance
Our success depends in great measure upon customer confidence in the quality of our products
and in the integrity of the data that support their safety and effectiveness. The quality of our
products arises from our commitment to quality in all aspects of our business, including research
and development, purchasing, manufacturing and distribution. Quality assurance procedures have
been developed relating to the quality and integrity of our scientific information and production
processes.
Control of production processes involves rigid specifications for ingredients, equipment,
facilities, manufacturing methods, packaging materials and labeling. Control tests are made at
various stages of production processes and on the final product to assure that the product meets
all regulatory requirements and our standards. These tests may involve chemical and physical
testing, microbiological testing, preclinical testing, human clinical trials or a combination
thereof.
Commercial
Through September 2006, we promoted AVINZA, our pain product, with approximately 102 sales
representatives and our oncology products with approximately 32 sales representatives . On
September 7, 2006, we announced the sale of our ONTAK, Targretin capsules, Targretin gel and
Panretin products to Eisai, Inc. (Eisai). The Eisai sales transaction subsequently closed on
October 25, 2006.
13
AVINZA was also co-promoted by Organon Pharmaceuticals USA Inc. (Organon). On January 17,
2006, we signed an agreement with Organon that terminated the AVINZA co-promotion agreement between
the two companies and returned AVINZA rights to Ligand. The effective date of the termination
agreement is January 1, 2006; however, the parties agreed to continue to cooperate during a
transition period that ended September 30, 2006 to promote the product. The transition period
co-operation included a minimum number of product sales calls per quarter (100,000 for Organon and
30,000 for Ligand with an aggregate of 375,000 and 90,000, respectively, for the transition period)
as well as the transition of ongoing promotions, managed care contracts, clinical trials and key
opinion leader relationships to Ligand. During the transition period, we paid Organon an amount
equal to 23% of AVINZA net sales as reported by us. We also paid and were responsible for the
design and execution of all clinical, advertising and promotion expenses and activities.
Additionally, in consideration of the early termination and return of rights under the terms of the
agreement, we unconditionally paid Organon $37.8 million in October 2006. We further paid Organon
$10.0 million on January 16, 2007. In addition, after the termination, we agreed to make quarterly
royalty payments to Organon equal to 6.5% of AVINZA net sales through December 31, 2012 and
thereafter 6% through patent expiration, currently anticipated to be November of 2017.
On September 7, 2006 we announced the sale of AVINZA and related assets to King
Pharmaceuticals, Inc. (King) and we closed that sale on February 26, 2007. Under the asset
purchase agreement with King (the AVINZA Purchase Agreement), King acquired all of our rights in
and to AVINZA, assumed certain liabilities, and reimbursed us the $47.8 million paid to Organon.
King also assumed our co-promote termination obligation to make payments to Organon based on net
sales of AVINZA (approximately $93.3 million as of December 31, 2006). Under the agreement with
Organon, we remain liable to Organon in the event of Kings default of this royalty obligation.
On September 6, 2006, we entered into a contract sales agreement with King whereby King agreed
to perform certain minimum monthly product details (i.e. sales calls) which commenced effective
October 1, 2006 and continued until the closing of the AVINZA sales transaction. In connection
with the sales call agreement, on January 3, 2007, we executed an amendment to the AVINZA Purchase
Agreement with King whereby the parties agreed that King could make offers to the Ligand sales
representatives and its regional business managers, such offers to be contingent on the closing.
The parties agreed on certain related termination, bonus and severance terms with respect to those
employees who did not receive employment offers from King. Accordingly, 23 Ligand sales
representatives and regional business managers were informed of their termination and related
benefits on December 6, 2006. The termination was effective January 2, 2007. This contract sales
agreement terminated with the closing of the AVINZA asset sale to King.
Substantially all of our revenues were attributable to customers in the United States;
likewise, substantially all of our long-lived assets are located in the United States. For the
year ended December 31, 2006, shipments to three wholesale distributors each accounted for more
than 10% of total shipments and in the aggregate represented 79% of total shipments. These
wholesale distributors were AmerisourceBergen Corporation, Cardinal Health, Inc. and McKesson
Corporation.
For further discussion of these items, see below under Item 7. Managements Discussion and
Analysis of Financial Condition and Results of Operations.
Research and Development Expenses
Research and development expenses from continuing operations were $41.9 million, $33.1 million
and $32.7 million in 2006, 2005 and 2004, respectively, of which approximately 95%, 89% and 76%,
respectively, we sponsored, and the remainder of which was funded pursuant to collaborative
research and development arrangements.
Research and development expenses from discontinued operations were $12.9 million, $23.0
million and $32.5 million in 2006, 2005 and 2004 respectively.
14
Competition
Some of the drugs we are developing will compete with existing therapies. In addition, a
number of companies are pursuing the development of novel pharmaceuticals that target the same
diseases we are targeting. A number of pharmaceutical and biotechnology companies are pursuing
IR-related approaches to drug discovery and development. Furthermore, academic institutions,
government agencies and other public and private organizations conducting research may seek patent
protection with respect to potentially competing products or technologies and may establish
collaborative arrangements with our competitors.
Many of our existing or potential competitors, particularly large pharmaceutical companies,
have greater financial, technical and human resources than we do and may be better equipped to
develop, manufacture and market products. Many of these companies also have extensive experience
in preclinical testing and human clinical trials, obtaining FDA and other regulatory approvals and
manufacturing and marketing pharmaceutical products. For example, GlaxoSmithKline is developing
eltrombopag (Promacta), a TPO mimetic that could compete with our LGD-4665 if both were to be
approved for marketing.
Our competitive position also depends upon our ability to attract and retain qualified
personnel, obtain patent protection or otherwise develop proprietary products or processes, and
secure sufficient capital resources for the often substantial period between technological
conception and commercial sales. For a discussion of the risks associated with competition, see
below under Item 1A. Risk Factors.
Government Regulation
The manufacturing and marketing of our products, our ongoing research and development
activities and products being developed by our collaborative partners are subject to regulation for
safety and efficacy by numerous governmental authorities in the United States and other countries.
In the United States, pharmaceuticals are subject to rigorous regulation by federal and various
state authorities, including the FDA. The Federal Food, Drug and Cosmetic Act and the Public
Health Service Act govern the testing, manufacture, safety, efficacy, labeling, storage, record
keeping, approval, advertising and promotion of our products. There are often comparable
regulations that apply at the state level. Product development and approval within this regulatory
framework takes a number of years and involves the expenditure of substantial resources.
The steps required before a pharmaceutical agent may be marketed in the United States include
(1) preclinical laboratory tests, (2) the submission to the FDA of an IND, which must become
effective before human clinical trials may commence, (3) adequate and well-controlled human
clinical trials to establish the safety and efficacy of the drug, (4) the submission of a NDA to
the FDA and (5) the FDA approval of the NDA prior to any commercial sale or shipment of the drug.
A company must pay a one-time user fee for NDA submissions, and annually pay user fees for each
approved product and manufacturing establishment. In addition to obtaining FDA approval for each
product, each domestic drug-manufacturing establishment must be registered with the FDA and, in
California, with the Food and Drug Branch of California. Domestic manufacturing establishments are
subject to pre-approval inspections by the FDA prior to marketing approval, then to biennial
inspections, and must comply with current Good Manufacturing Practices (cGMP). To supply products
for use in the United States, foreign manufacturing establishments must comply with cGMP and are
subject to periodic inspection by the FDA or by regulatory authorities in such countries under
reciprocal agreements with the FDA.
For both currently marketed and future products, failure to comply with applicable regulatory
requirements after obtaining regulatory approval can, among other things, result in the suspension
of regulatory approval, as well as possible civil and criminal sanctions. In addition, changes in
existing regulations could have a material adverse effect to us.
For marketing outside the United States before FDA approval to market, we must submit an
export permit application to the FDA. We also are subject to foreign regulatory requirements
governing human clinical trials and marketing approval for drugs. The requirements relating to the
conduct of clinical trials, product licensing, pricing and reimbursement vary widely from country
to country and there can be no assurance that we or any of our partners will meet and sustain any
such requirements.
15
We are also increasingly subject to regulation by the states. A number of states now
regulate, for example, pharmaceutical marketing practices and the reporting of marketing
activities, controlled substances, clinical trials and general commercial practices. We have
developed and are developing a number of policies and procedures to ensure our compliance with
these state laws, in addition to the federal regulations described above. Significant resources
are now required on an ongoing basis to ensure such compliance. For a discussion of the risks
associated with government regulations, see below under Item 1A. Risk Factors.
Patents and Proprietary Rights
We believe that patents and other proprietary rights are important to our business. Our
policy is to file patent applications to protect technology, inventions and improvements to our
inventions that are considered important to the development of our business. We also rely upon
trade secrets, know-how, continuing technological innovations and licensing opportunities to
develop and maintain our competitive position.
As of December 31, 2006, we have filed or participated as licensee in the filing of
approximately 37 currently pending patent applications in the United States relating to our
technology, as well as foreign counterparts of certain of these applications in multiple countries.
In addition, we own or have licensed rights covered by approximately 260 patents issued or
applications, granted or allowed worldwide, including United States patents and foreign
counterparts to United States patents. Except for a few patents and applications that are not
material to our commercial success, these patents and applications will expire between 2008 and
2023. Starting in 2007, we receive royalties from King Pharmaceuticals Inc. on AVINZA representing
substantially all of our ongoing revenue. AVINZA is expected to have patent protection in the
United States until November 2017. Subject to compliance with the terms of the
respective agreements, our rights under our licenses with our exclusive licensors extend for the
life of the patents covering such developments. For a discussion of the risks associated with
patent and proprietary rights, see below under Item 1A. Risk Factors.
Human Resources
As of March 12, 2007, we had 122 full-time employees including 37 employees who will be
supporting the Company providing transitional services for various time periods throughout 2007,
following the restructuring announced in January 2007. Following the termination of the
transitional employees, we expect to have approximately 85 full time employees of whom 55 will be
involved directly in scientific research and development activities. Of these employees, 32 hold
Ph.D. or M.D. degrees.
16
ITEM 1A. RISK FACTORS
The following is a summary description of some of the many risks we face in our business. You
should carefully review these risks in evaluating our business, including the businesses of our
subsidiaries. You should also consider the other information described in this report.
Risks Related To Us and Our Business.
Failure to timely or successfully restructure our business could have adverse consequences for the
Company.
We completed the sale of our commercial businesses in February 2007. In connection with these
sales we are also restructuring our remaining businesses, principally our research and development.
We will also be consolidating our staff and facilities. If we are unable to successfully and
timely complete this restructuring, our remaining assets could lose value, we may not be able to
retain key employees, we may not have sufficient resources to successfully manage those assets or
our business, and we may not be able to perform our obligations under various contracts and
commitments. Any of these could have substantial negative impacts on our business and our stock
price.
We are substantially dependent on AVINZA royalties for our revenues.
We recently completed the sale of our two commercial product lines, oncology and pain, which
in recent years provided substantially all of our continuing revenue. In each sale we received a
one-time upfront cash payment. The consideration for the sale of the pain (AVINZA) franchise also
included royalties that we will receive in the future from sales of AVINZA by King Pharmaceuticals,
Inc., who acquired the AVINZA rights from us. These consist of a 15% royalty on AVINZA sales for
the first 20 months, and then royalty payments ranging from 5-15% of AVINZA sales, depending on the
level of total annual sales. These royalties represent and will represent substantially all of our
ongoing revenue for the foreseeable future. Although we may also receive royalties and milestones
from our partners in various past and future collaborations, the amount of revenue from these
royalties and milestones is unknown and highly uncertain.
Thus, any setback that may occur with respect to AVINZA could significantly impair our
operating results and/or reduce the market price for our securities. Setbacks could include
problems with shipping, distribution, manufacturing, product safety, marketing, government licenses
and approvals, intellectual property rights, competition with existing or new products and
physician or patient acceptance of the product, as well as higher than expected total rebates,
returns or discounts.
AVINZA was licensed from Elan Corporation which is its sole manufacturer. Any problems with
Elans manufacturing operations or capacity could reduce sales of AVINZA, as could any licensing or
other contract disputes with Elan, raw materials suppliers, or others.
Similarly, Kings AVINZA sales efforts could be affected by a number of factors and decisions
regarding its organization, operations, and activities as well as events both related and unrelated
to AVINZA. Historically, AVINZA sales efforts, including our own and our prior co-promotion
partners, have encountered a number of difficulties, uncertainties and challenges, including sales
force reorganizations and lower than expected sales call and prescription volumes, which have hurt
and could continue to hurt AVINZA sales growth. AVINZA could also face stiffer competition from
existing or future pain products. The negative impact on the products sales growth in turn may
cause our royalties, revenues and earnings to be disappointing.
AVINZA sales also may be susceptible to higher than expected discounts (especially PBM/GPO
rebates and Medicaid rebates, which can be substantial), returns and chargebacks and/or slower than
expected market penetration that could reduce sales. Other setbacks that AVINZA could face in the
sustained-release opioid market include product safety and abuse issues, regulatory action,
intellectual property disputes and the inability to obtain sufficient quotas of morphine from the
Drug Enforcement Agency (DEA) to support production requirements.
In particular, with respect to regulatory action and product safety issues, the FDA previously
requested expanded warnings on the AVINZA label to alert doctors and patients to the dangers of
using AVINZA with alcohol.
17
Changes were made to the label, however, the FDA also requested clinical studies to
investigate the risks associated with taking AVINZA with alcohol. Any additional warnings, studies
and any further regulatory action could have significant adverse effects on AVINZA sales.
Significant returns of products we sold prior to selling our commercial businesses could harm our
operating results.
Under our agreements to sell our commercial businesses, we remain financially responsible for
returns of our products sold before those businesses were transferred to their respective buyers.
Thus if returns of those products are higher than expected, we could incur substantial expenses for
processing and issuing refunds for those returns which, in turn, could hurt our operating results.
The amount of returns could be affected by a number of factors including ongoing product demand,
product rotation at distributors and wholesalers, and product stability issues.
Return from any dividend is speculative; you may not receive a return on your securities.
We have not paid any cash dividends on our common stock to date. In general, we intend to
retain any earnings to support the expansion of our business. We have announced that our Board of
Directors is considering a special dividend of a substantial portion of the net proceeds from our
product line asset sales. However, other than this special dividend, we do not anticipate paying
cash dividends on any of our securities in the foreseeable future. The Board has not determined
the amount of any such special dividend, and the amount available for such a dividend depends on a
number of factors including our capital surplus, cash on hand and estimated cash needs for our
continuing business. In addition, such a special dividend would reduce our assets and could reduce
our stock price by a proportional amount. Because the amount of any special dividend and the
amount of any associated stock price reduction are both unknown, the investment return from such a
dividend is speculative. Thus, any returns you receive from our stock will be highly dependent on
increases in the market price for our securities, if any. The price for our common stock has been
highly volatile and may decrease.
We will have continuing obligations to indemnify the buyers of our commercial businesses, and may
be subject to other liabilities as a result of the sale of our commercial product lines.
In connection with the sale of our AVINZA product line, we have agreed to indemnify King for a
period of 16 months after the closing for a number of specified matters including the breach of our
representations, warranties and covenants contained in the asset purchase agreement, and in some
cases for a period of 30 months following the closing of the asset sale. In addition, we have
agreed to indemnify Eisai, the purchaser of our oncology product line, after the closing of the
asset sale, for damages suffered by Eisai arising for any breach of any of the representations,
warranties, covenants or obligations we have made in the asset purchase agreement. Our obligation
to indemnify Eisai survives the closing in some cases up to 18 or 36 months following the closing,
and in other cases, until the expiration of the applicable statute of limitations. In a few
instances, our obligation to indemnify Eisai survives in perpetuity. Under our agreement with
King, $15 million of the total upfront cash payment was deposited into an escrow account to secure
our indemnification obligations to King following the closing. Similarly, our agreement with Eisai
required that $20 million of the total upfront cash payment be deposited into an escrow account to
secure our indemnification obligations to Eisai after the closing.
Our indemnification obligations under the asset purchase agreements could cause us to be
liable to King or Eisai under certain circumstances, in excess of the amounts set forth in the
escrow accounts. The AVINZA asset purchase agreement also allows King, under certain
circumstances, to set off indemnification claims against the royalty payments payable to us. Under
the asset purchase agreements, our liability for any indemnification claim brought by King and
Eisai is generally limited to $40 million and $30 million, respectively. However, our obligation
to provide indemnification on certain matters is not subject to these indemnification limits. For
example, we agreed to retain, and provide indemnification without limitation to King for, all
liabilities arising under certain agreements with Cardinal Health PTS, LLC related to the
manufacture of AVINZA. Similarly, we agreed to retain, and provide indemnification without
limitation to Eisai for, all liabilities related to certain claims regarding promotional materials
for the ONTAK and Targretin drug products. We cannot predict the liabilities that may arise as a
result of these matters. Any liability claims related to these matters or any indemnification
claims made by King or Eisai could materially and adversely affect our financial condition.
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We may also be subject to other liabilities related to the products we recently sold. For
example, we received a letter in March 2007 from counsel to the Salk Institute for Biological
Studies alleging that we owe The Salk Institute royalties on prior sales of Targretin as well as a
percentage of the amounts received from Eisai. Salk alleges that
they are owed at least 25% of the consideration paid by Eisai for that
portion of our oncology product line and associated assets
attributable to Targretin. Any successful claim brought against us could cause
our stock price to fall and could decrease our cash or otherwise adversely affect our business.
Our product development involves a number of uncertainties, and we may never generate sufficient
revenues from the sale of products to become profitable.
We were founded in 1987. We have incurred significant losses since our inception. At
December 31, 2006, our accumulated deficit was approximately $862.8 million. We began generating
commercial product revenues in 1999; however, we completed the sale of all of our commercial
products in February 2007 and are now focused on our product development pipeline.
Most of our products in development will require extensive additional development, including
preclinical testing and human studies, as well as regulatory approvals, before we can market them.
We cannot predict if or when any of the products we are developing or those being developed with
our partners will be approved for marketing. For example, lasofoxifene (Oporia), a partner product
being developed by Pfizer received a non-approvable decision from the FDA. There are many
reasons why we or our collaborative partners may fail in our efforts to develop our other potential
products, including the possibility that:
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preclinical testing or human studies may show that our potential products are ineffective or cause
harmful side effects; |
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the products may fail to receive necessary regulatory approvals from the FDA or foreign
authorities in a timely manner, or at all; |
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the products, if approved, may not be produced in commercial quantities or at reasonable costs; |
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the products, if approved, may not achieve commercial acceptance; |
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regulatory or governmental authorities may apply restrictions to our products, which could
adversely affect their commercial success; or |
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the proprietary rights of other parties may prevent us or our partners from marketing the products. |
Any product development failures for these or other reasons, whether with our products or our
partners products, may reduce our expected revenues, profits, and stock price.
Our drug development programs will require substantial additional future funding which could hurt
our operational and financial condition.
Our drug development programs require substantial additional capital to successfully complete
them, arising from costs to:
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conduct research, preclinical testing and human studies; |
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establish pilot scale and commercial scale manufacturing processes and facilities; and |
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establish and develop quality control, regulatory, marketing, sales and
administrative capabilities to support these programs. |
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Our future operating and capital needs will depend on many factors, including:
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the pace of scientific progress in our research and development programs and the magnitude of these
programs; |
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the scope and results of preclinical testing and human studies; |
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the time and costs involved in obtaining regulatory approvals; |
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the time and costs involved in preparing, filing, prosecuting, maintaining and enforcing patent claims; |
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competing technological and market developments; |
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our ability to establish additional collaborations; |
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changes in our existing collaborations; |
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the cost of manufacturing scale-up; and |
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the effectiveness of our commercialization activities. |
We currently estimate our research and development expenditures over the next three years to
range between $110 million and $135 million. However, we base our outlook regarding the need for
funds on many uncertain variables. Such uncertainties include regulatory approvals, the timing of
events outside our direct control such as product launches by partners and the success of such
product launches, negotiations with potential strategic partners, possible sale of assets or other
transactions and other factors. Any of these uncertain events can significantly change our cash
requirements.
While we expect to fund our research and development activities primarily from cash generated
from AVINZA royalties to the extent possible, if we are unable to do so we may need to complete
additional equity or debt financings or seek other external means of financing. These financings
could depress our stock price. If additional funds are required to support our operations and we
are unable to obtain them on terms favorable to us, we may be required to cease or reduce further
development or commercialization of our products, to sell some or all of our technology or assets
or to merge with another entity.
Our product candidates face significant regulatory hurdles prior to marketing which could delay or
prevent sales.
Before we obtain the approvals necessary to sell any of our potential products, we must show
through preclinical studies and human testing that each product is safe and effective. We and our
partners have a number of products moving toward or currently in clinical trials, including
lasofoxifene for which Pfizer announced receipt of non-approval letters from the FDA, and two
products in Phase III trials by one of our partners involving bazedoxifene. Failure to show any
products safety and effectiveness would delay or prevent regulatory approval of the product and
could adversely affect our business. The clinical trials process is complex and uncertain. The
results of preclinical studies and initial clinical trials may not necessarily predict the results
from later large-scale clinical trials. In addition, clinical trials may not demonstrate a
products safety and effectiveness to the satisfaction of the regulatory authorities. A number of
companies have suffered significant setbacks in advanced clinical trials or in seeking regulatory
approvals, despite promising results in earlier trials. The FDA may also require additional
clinical trials after regulatory approvals are received, which could be expensive and
time-consuming, and failure to successfully conduct those trials could jeopardize continued
commercialization.
The rate at which we complete our clinical trials depends on many factors, including our
ability to obtain adequate supplies of the products to be tested and patient enrollment. Patient
enrollment is a function of many
factors, including the size of the patient population, the proximity of patients to clinical
sites and the eligibility criteria for the trial. Delays in patient enrollment for our trials may
result in increased costs and longer development times. In addition, our collaborative partners
have rights to control product development and clinical programs for products developed under the
collaborations. As a result, these collaborators may conduct these programs more
20
slowly or in a
different manner than we had expected. Even if clinical trials are completed, we or our
collaborative partners still may not apply for FDA approval in a timely manner or the FDA still may
not grant approval.
The restatement of our consolidated financial statements has had a material adverse impact on us,
including increased costs and the increased possibility of legal or administrative proceedings.
We determined that our consolidated financial statements for the years ended December 31, 2002
and 2003, and for the first three quarters of 2004, as described in more detail in our 2004 Annual
Report on Form 10-K, should be restated. As a result of these events, we have become subject to a
number of additional risks and uncertainties, including:
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We incurred substantial unanticipated costs for accounting and
legal fees in 2005 in connection with the restatement. Although the
restatement is complete, we expect to continue to incur
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The SEC has instituted a formal investigation of the Companys
restated consolidated financial statements identified above. This
investigation will likely divert more of our managements time and
attention and cause us to incur substantial costs. Such
investigations can also lead to fines or injunctions or orders with
respect to future activities, as well as further substantial costs
and diversion of management time and attention. |
Material weaknesses or deficiencies in our internal control over financial reporting could harm
stockholder and business confidence on our financial reporting, our ability to obtain financing and
other aspects of our business.
As disclosed in the Companys 2005 Annual Report on Form 10-K, managements assessment of the
Companys internal control over financial reporting identified material weaknesses in the Companys
internal controls surrounding (i) the accounting for revenue recognition; (ii) record keeping and
documentation; (iii) accounting personnel; (iv) financial statement close procedures; (v) the
inability of the Company to maintain an effective independent Internal Audit Department; (vi) the
existence of ineffective spreadsheet controls used in connection with the Companys financial
processes, including review, testing, access and integrity controls; (vii) the existence of
accounting system access rights granted to certain members of the Companys accounting and finance
department that are incompatible with the current roles and duties of such individuals (i.e.,
segregation of duties); and (viii) the inability of management to properly maintain the Companys
documentation of the internal control over financial reporting during 2005 or to substantively
commence the process to update such documentation and assessment until December 2005. As of
December 31, 2006, these material weaknesses have been fully remediated.
While no material weaknesses were identified as of December 31, 2006, we cannot assure you
that material weaknesses will not be identified in future periods. The existence of one or more
material weakness or significant deficiency could result in errors in our consolidated financial
statements, and substantial costs and resources may be required to rectify any internal control
deficiencies. If we fail to achieve and maintain the adequacy of our internal controls in
accordance with applicable standards, we may be unable to conclude on an ongoing basis that we have
effective internal controls over financial reporting. If we cannot produce reliable financial
reports, our business and financial condition could be harmed, investors could lose confidence in
our reported financial information, or the market price of our stock could decline significantly.
In addition, our ability to obtain additional financing to operate and expand our business, or
obtain additional financing on favorable terms, could be materially and adversely affected, which,
in turn, could materially and adversely affect our business, our financial condition and the market
value of our securities. Also, perceptions of us could also be adversely affected among customers,
lenders, investors, securities analysts and others. Any future weaknesses or deficiencies could
also hurt our ability to do business with these groups.
We may require additional money to run our business and may be required to raise this money on
terms which are not favorable or which reduce our stock price.
We have incurred losses since our inception and may not generate positive cash flow to fund
our operations for one or more years. As a result, we may need to complete additional equity or
debt financings to fund our operations. Our inability to obtain additional financing could
adversely affect our business. Financings may not be available at all or on favorable terms. In
addition, these financings, if completed, still may not meet our capital needs and could
21
result in
substantial dilution to our stockholders. For instance, in April 2002 and September 2003 we issued
an aggregate of 7.7 million shares of our common stock in private placement offerings. In
addition, in November 2002 we issued in a private placement $155.3 million in aggregate principal
amount of our 6% convertible subordinated notes due 2007, that converted into approximately 25.1
million shares of our common stock. The conversion of all of the notes was completed in November
2006.
If adequate funds are not available, we may be required to delay, reduce the scope of or
eliminate one or more of our research or drug development programs, or our marketing and sales
initiatives. We may also be required to liquidate our business or file for bankruptcy protection.
Alternatively, we may be forced to attempt to continue development by entering into arrangements
with collaborative partners or others that require us to relinquish some or all of our rights to
technologies or drug candidates that we would not otherwise relinquish.
We rely heavily on collaborative relationships and termination of any of these programs could
reduce the financial resources available to us, including research funding and milestone payments.
Our strategy for developing and commercializing many of our potential products, including
products aimed at larger markets, includes entering into collaborations with corporate partners,
licensors, licensees and others. These collaborations provide us with funding and research and
development resources for potential products for the treatment or control of metabolic diseases,
hematopoiesis, womens health disorders, inflammation, cardiovascular disease, cancer and skin
disease, and osteoporosis. These agreements also give our collaborative partners significant
discretion when deciding whether or not to pursue any development program. Our collaborations may
not continue or be successful.
In addition, our collaborators may develop drugs, either alone or with others, that compete
with the types of drugs they currently are developing with us. This would result in less support
and increased competition for our programs. If products are approved for marketing under our
collaborative programs, any revenues we receive will depend on the manufacturing, marketing and
sales efforts of our collaborators, who generally retain commercialization rights under the
collaborative agreements. Our current collaborators also generally have the right to terminate
their collaborations under specified circumstances. If any of our collaborative partners breach or
terminate their agreements with us or otherwise fail to conduct their collaborative activities
successfully, our product development under these agreements will be delayed or terminated.
We may have disputes in the future with our collaborators, including disputes concerning which
of us owns the rights to any technology developed. For instance, we were involved in litigation
with Pfizer, which we settled in April 1996, concerning our right to milestones and royalties based
on the development and commercialization of droloxifene. These and other possible disagreements
between us and our collaborators could delay our ability and the ability of our collaborators to
achieve milestones or our receipt of other payments. In addition, any disagreements could delay,
interrupt or terminate the collaborative research, development and commercialization of certain
potential products, or could result in litigation or arbitration. The occurrence of any of these
problems could be time-consuming and expensive and could adversely affect our business.
Challenges to or failure to secure patents and other proprietary rights may significantly hurt our
business.
Our success will depend on our ability and the ability of our licensors to obtain and maintain
patents and proprietary rights for our potential products and to avoid infringing the proprietary
rights of others, both in the United States and in foreign countries. Patents may not be issued
from any of these applications currently on file, or, if issued, may not provide sufficient
protection. In addition, disputes with licensors under our license agreements may arise which
could result in additional financial liability or loss of important technology and potential
products and related revenue, if any.
Our
patent position, like that of many biotech and pharmaceutical companies, is uncertain and involves
complex legal and technical questions for which important legal principles are unresolved. We may
not develop or obtain rights to products or processes that are patentable. Even if we do obtain
patents, they may not adequately protect the technology we own or have licensed. In addition,
others may challenge, seek to invalidate, infringe or circumvent any patents we own or license, and
rights we receive under those patents may not provide competitive advantages to us. Further, the
manufacture, use or sale of our products may infringe the patent rights of others.
22
Several drug companies and research and academic institutions have developed technologies,
filed patent applications or received patents for technologies that may be related to our business.
Others have filed patent applications and received patents that conflict with patents or patent
applications we have licensed for our use, either by claiming the same methods or compounds or by
claiming methods or compounds that could dominate those licensed to us. In addition, we may not be
aware of all patents or patent applications that may impact our ability to make, use or sell any of
our potential products. For example, US patent applications may be kept confidential while pending
in the Patent and Trademark Office and patent applications filed in foreign countries are often
first published six months or more after filing. Any conflicts resulting from the patent rights of
others could significantly reduce the coverage of our patents and limit our ability to obtain
meaningful patent protection. While we routinely receive communications or have conversations with
the owners of other patents, none of these third parties have directly threatened an action or
claim against us. If other companies obtain patents with conflicting claims, we may be required to
obtain licenses to those patents or to develop or obtain alternative technology. We may not be
able to obtain any such licenses on acceptable terms, or at all. Any failure to obtain such
licenses could delay or prevent us from pursuing the development or commercialization of our
potential products.
We have had and will continue to have discussions with our current and potential collaborators
regarding the scope and validity of our patents and other proprietary rights. If a collaborator or
other party successfully establishes that our patent rights are invalid, we may not be able to
continue our existing collaborations beyond their expiration. Any determination that our patent
rights are invalid also could encourage our collaborators to terminate their agreements where
contractually permitted. Such a determination could also adversely affect our ability to enter
into new collaborations.
We may also need to initiate litigation, which could be time-consuming and expensive, to
enforce our proprietary rights or to determine the scope and validity of others rights. If
litigation results, a court may find our patents or those of our licensors invalid or may find that
we have infringed on a competitors rights. If any of our competitors have filed patent
applications in the United States which claim technology we also have invented, the Patent and
Trademark Office may require us to participate in expensive interference proceedings to determine
who has the right to a patent for the technology.
We also rely on unpatented trade secrets and know-how to protect and maintain our competitive
position. We require our employees, consultants, collaborators and others to sign confidentiality
agreements when they begin their relationship with us. These agreements may be breached, and we
may not have adequate remedies for any breach. In addition, our competitors may independently
discover our trade secrets.
Our legacy commercial businesses exposes us to product liability risks and we may not have
sufficient insurance to cover any claims.
We completed the sale of our commercial businesses in February 2007. Nevertheless, products
we sold prior to divesting these businesses expose us to potential product liability risks. For
example, such products may need to be recalled to address regulatory issues. A successful product
liability claim or series of claims brought against us could result in payment of significant
amounts of money and divert managements attention from running our business.
In addition, some of the compounds we are investigating may be harmful to humans. For example,
retinoids as a class are known to contain compounds which can cause birth defects. We may not be
able to maintain our insurance on acceptable terms, or our insurance may not provide adequate
protection in the case of a product liability claim. To the extent that product liability
insurance, if available, does not cover potential claims, we will be required to self-insure the
risks associated with such claims. We believe that we carry reasonably adequate insurance for
product liability claims.
We use hazardous materials which requires us to incur substantial costs to comply with
environmental regulations.
In connection with our research and development activities, we handle hazardous materials,
chemicals and various radioactive compounds. To properly dispose of these hazardous materials in
compliance with environmental
23
regulations, we are required to contract with third parties at
substantial cost to us. Our annual cost of compliance with these regulations is approximately $0.7
million. We cannot completely eliminate the risk of accidental contamination or injury from the
handling and disposing of hazardous materials, whether by us or by our third-party contractors. In
the event of any accident, we could be held liable for any damages that result, which could be
significant. We believe that we carry reasonably adequate insurance for toxic tort claims.
Our shareholder rights plan and charter documents may hinder or prevent change of control
transactions.
Our shareholder rights plan and provisions contained in our certificate of incorporation and
bylaws may discourage transactions involving an actual or potential change in our ownership. In
addition, our Board of Directors may issue shares of preferred stock without any further action by
you. Such issuances may have the effect of delaying or preventing a change in our ownership. If
changes in our ownership are discouraged, delayed or prevented, it would be more difficult for our
current Board of Directors to be removed and replaced, even if you or our other stockholders
believe that such actions are in the best interests of us and our stockholders.
Item 1B. Unresolved Staff Comments
None.
Item 2. Properties
We currently lease and occupy office and laboratory facilities in San Diego, California.
These include a 52,800 square foot facility leased through July 2015 and an 82,500 square foot
facility leased through November 2021, which is a building we previously owned and sold and leased
back on November 9, 2006 (see note 21). We expect to consolidate our ongoing operations into the
82,500 square foot facility in 2007 and believe that this location will be adequate to meet our
near-term space requirements. Following this consolidation, we plan to sub-lease the 52,800 square
foot facility.
Item 3. Legal Proceedings
Securities Litigation
The Company was involved in several securities class action and shareholder derivative actions
which followed announcements by the Company in 2004 and the subsequent restatement of its financial
results in 2005. In June 2006, we announced that these lawsuits had been settled, subject to
certain conditions such as court approval.
Background
Beginning in August 2004, several purported class action stockholder lawsuits were filed in
the United States District Court for the Southern District of California against the Company and
certain of its directors and officers. The actions were brought on behalf of purchasers of the
Companys common stock during several time periods, the longest of which runs from July 28, 2003
through August 2, 2004. The complaints generally alleged that the Company violated Sections 10(b)
and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 of the Securities and Exchange
Commission by making false and misleading statements, or concealing information about the Companys
business, forecasts and financial performance, in particular statements and information related to
drug development issues and AVINZA inventory levels. These lawsuits were consolidated and lead
plaintiffs appointed. A consolidated complaint was filed by the plaintiffs in March 2005. On
September 27, 2005, the court granted the Companys motion to dismiss the consolidated complaint,
with leave for plaintiffs to file an amended complaint within 30 days. In December 2005, the
plaintiffs filed a second amended complaint again alleging claims under Section 10(b) and 20(a) of
the Securities Exchange Act against the Company, David Robinson and Paul Maier. The
amended complaint also asserted an expanded Class Period of March 19, 2001 through May 20,
2005 and included allegations arising from the Companys announcement on May 20, 2005 that it would
restate certain financial results.
Beginning on or about August 13, 2004, several derivative actions were filed on behalf of the
Company by individual stockholders in the Superior Court of California. The complaints named the
Companys directors and
24
certain of its officers as defendants and named the Company as a nominal
defendant. The complaints were based on the same facts and circumstances as the purported class
actions discussed in the previous paragraph and generally alleged breach of fiduciary duties, abuse
of control, waste and mismanagement, insider trading and unjust enrichment.
In October 2005, a shareholder derivative action was filed on behalf of the Company in the
United States District Court for the Southern District of California. The complaint named the
Companys directors and certain of its officers as defendants and the Company as a nominal
defendant. The action was brought by an individual stockholder. The complaint generally alleged
that the defendants falsified Ligands publicly reported financial results throughout 2002 and 2003
and the first three quarters of 2004 by improperly recognizing revenue on product sales. The
complaint also alleged breach of fiduciary duty by all defendants and requested disgorgement, e.g.,
under Section 304 of the Sarbanes-Oxley Act of 2002.
The Settlement Agreements
In June 2006, the Company entered into agreements to resolve all claims by the parties in each
of these matters, including those asserted against the Company and the individual defendants in
these cases. Under the agreements, the Company agreed to pay a total of $12.2 million in cash for
a release and in full settlement of all claims. $12.0 million of the settlement amount and a
portion of our total legal expenses were funded by our Directors and Officers Liability insurance
carrier while the remainder of the legal fees incurred ($1.4 million for 2006) was paid by us. Of
the $12.2 million settlement liability, $4.0 million was paid in October 2006 to us directly from
the insurance carrier and then disbursed to the claimants attorneys, while $8.0 million was paid
in July 2006 by the insurance carrier directly to an independent escrow agent responsible for
disbursing the funds to the class action suit claimants. As part of the settlement of the state
derivative action, we have agreed to adopt certain corporate governance enhancements including the
formalization of certain Board practices and responsibilities, a Board self-evaluation process,
Board and Board Committee term limits (with gradual phase-in) and one-time enhanced independent
requirements for a single director to succeed the current shareholder representatives on the Board.
Neither we nor any of our current or former directors and officers has made any admission of
liability or wrongdoing. On October 12, 2006, the Superior Court of California approved the
settlement of the state and federal derivative actions and entered final judgment of dismissal.
The United States District Court approved the settlement of the Federal class action in October
2006.
SEC Investigation and Other Matters
The SEC issued a formal order of private investigation dated September 7, 2005, which was
furnished to Ligands legal counsel on September 29, 2005, to investigate the circumstances
surrounding Ligands restatement of its consolidated financial statements for the years ended
December 31, 2002 and 2003, and for the first three quarters of 2004. The SEC has issued subpoenas
for the production of documents and for testimony pursuant to that investigation to Ligand and
others. The SECs investigation is ongoing and Ligand is cooperating with the investigation.
The Companys subsidiary, Seragen, Inc. and Ligand, were named parties to Sergio M. Oliver, et
al. v. Boston University, et al., a shareholder class action filed on December 17, 1998 in the
Court of Chancery in the State of Delaware in and for New Castle County, C.A. No. 16570NC, by
Sergio M. Oliver and others against Boston University and others, including Seragen, its subsidiary
Seragen Technology, Inc. and former officers and directors of Seragen. The complaint, as amended,
alleged that Ligand aided and abetted purported breaches of fiduciary duty by the Seragen related
defendants in connection with the acquisition of Seragen by Ligand and made certain
misrepresentations in related proxy materials and seeks compensatory and punitive damages of an
unspecified amount. On July 25, 2000, the Delaware Chancery Court granted in part and denied in
part defendants motions to dismiss. Seragen, Ligand, Seragen Technology, Inc. and the Companys
acquisition subsidiary, Knight Acquisition
Corporation, were dismissed from the action. Claims of breach of fiduciary duty remain
against the remaining defendants, including the former officers and directors of Seragen. The
court certified a class consisting of shareholders as of the date of the acquisition and on the
date of the proxy sent to ratify an earlier business unit sale by Seragen. On January 20, 2005,
the Delaware Chancery Court granted in part and denied in part the defendants motion for summary
judgment. Prior to trial, several of the Seragen director-defendants reached a settlement with the
plaintiffs. The trial in this action then went forward as to the remaining defendants and
concluded on
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February 18, 2005. On April 14, 2006, the court issued a memorandum opinion finding
for the plaintiffs and against Boston University and individual directors affiliated with Boston
University on certain claims. The opinion awards damages on these claims in the amount of
approximately $4.8 million plus interest. Judgment, however, has not been entered and the matter
is subject to appeal. While Ligand and its subsidiary Seragen have been dismissed from the action,
such dismissal is also subject to appeal and Ligand and Seragen may have possible indemnification
obligations with respect to certain defendants. As of December 31, 2006, the Company has not
accrued an indemnification obligation based on its assessment that the Companys responsibility for
any such obligation is not probable or estimable.
The Company also received a letter in March 2007 from counsel to The Salk Institute for
Biological Studies alleging the Company owes The Salk Institute royalties on prior product sales of
Targretin as well as a percentage of the amounts received from Eisai Co., Ltd. (Tokyo) and Eisai
inc. (New Jersey) in the asset sale transaction completed with Eisai
in October 2006. Salk alleges that they are owed at least 25% of
the consideration paid by Eisai for that portion of the
Companys oncology product line and associated assets
attributable to Targretin. The Company
intends to vigorously oppose any claim that Salk may bring for payment related to these matters.
In addition, the Company is subject to various lawsuits and claims with respect to matters
arising out of the normal course of business. Due to the uncertainty of the ultimate outcome of
these matters, the impact on future financial results is not subject to reasonable estimates.
Item 4. Submission of Matters to a Vote of Security Holders
There were no matters submitted to a vote of security holders in the fourth quarter ended
December 31, 2006.
Executive Officers of the Registrant
The names of the executive officers of the Company and their ages, titles and biographies as
of March 1, 2007 are set forth below.
John L. Higgins, 36, joined Ligand in January 2007 as President and Chief Executive Officer
and he was also appointed to the Board in March 2007. Prior to joining Ligand, Mr. Higgins served
as Chief Financial Officer at Connetics Corporation, a specialty pharmaceutical company, since
1997, and also served as Executive Vice President, Finance and Administration and Corporate
Development at Connetics since January 2002 until its acquisition by Stiefel Laboratories, Inc. in
December 2006. Before joining Connetics, he was a member of the executive management team at
BioCryst Pharmaceuticals, Inc., a biopharmaceutical company. Before joining BioCryst in 1994, Mr.
Higgins was a member of the healthcare banking team of Dillon, Read & Co. Inc., an investment
banking firm. Mr. Higgins is a Director of BioCryst and serves as chairperson of its Audit
Committee. He received his A.B. from Colgate University.
Martin D. Meglasson, Ph.D., 56, joined the Company in February 2004 as Vice President,
Discovery Research. Prior to joining the Company, Dr. Meglasson was Director of Preclinical
Pharmacology and the functional leader for research into urology, sexual dysfunction, and
neurological diseases at Pharmacia, Inc. from 1998 to 2003. From 1996 to 1998, Dr. Meglasson
served as Director of Endocrine and Metabolic Research and functional leader for diabetes and
obesity research at Pharmacia & Upjohn. From 1988 to 1996, he was a researcher in the fields of
diabetes and obesity at The Upjohn Co. and Assistant Professor, then Adjunct Associate Professor of
Pharmacology at the University of Pennsylvania School of Medicine. Dr. Meglasson received his Ph.D.
in pharmacology from the University of Houston.
Tod G. Mertes, CPA, 42, joined Ligand in May 2001 as Director of Finance, was elected Vice
President, Controller and Treasurer of the Company in May 2003, and was named Interim Chief
Financial Officer in January 2007. Prior to joining Ligand, Mr. Mertes was Chief Financial Officer
at Combio Corporation and prior to Combio
spent 12 years with PricewaterhouseCoopers in San Diego, California and Paris, France, most
recently as an audit senior manager. Mr. Mertes is a Certified Public Accountant and received a
B.S. in business administration from California Polytechnic State University at San Luis Obispo.
26
PART II
|
|
|
Item 5. |
|
Market for Registrants Common Equity, Related Stockholder Matters, and Issuer Purchases
of Equity Securities |
(a) Market Information
Prior to September 7, 2005, our common stock was traded on the NASDAQ National Market tier of
the NASDAQ Stock Market under the symbols LGND and LGNDE. Our common stock was delisted from
the NASDAQ National Market on September 7, 2005. Our common stock was quoted on the Pink Sheets
under the symbol LGND from September 7, 2005 through June 13, 2006. Our common stock was
relisted on the NASDAQ Global Market (formerly NASDAQ National Market) on June 14, 2006 under the
symbol LGND.
The following table sets forth the high and low intraday sales prices for our common stock on
the NASDAQ Global Market and on the Pink Sheets, as applicable, for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
Price Range |
|
|
High |
|
Low |
Year Ended December 31, 2006: |
|
|
|
|
|
|
|
|
1st Quarter |
|
$ |
13.70 |
|
|
$ |
11.16 |
|
2nd Quarter |
|
|
14.00 |
|
|
|
8.35 |
|
3rd Quarter |
|
|
10.74 |
|
|
|
7.78 |
|
4th Quarter |
|
|
11.89 |
|
|
|
9.61 |
|
Year Ended December 31, 2005: |
|
|
|
|
|
|
|
|
1st Quarter |
|
$ |
11.20 |
|
|
$ |
4.98 |
|
2nd Quarter |
|
|
7.00 |
|
|
|
4.75 |
|
3rd Quarter |
|
|
10.14 |
|
|
|
6.86 |
|
4th Quarter |
|
|
11.65 |
|
|
|
7.95 |
|
As of March 14, 2007, the closing price of our common stock on the NASDAQ Global Market was
$10.72.
(b) Holders
As of February 28, 2007, there were approximately 1,571 holders of record of the common stock.
(c) Dividends
We have never declared or paid any cash dividends on our capital stock. We have previously
announced that our Board of Directors is considering a special cash dividend in connection with our
recent asset sales, but no decision has yet been made regarding such dividend. The Board has not
determined the amount of any such special dividend, and the amount available for such a dividend
depends on a number of factors including our capital surplus, cash on hand and estimated cash needs
for our continuing business. Aside from the consideration of this special one-time dividend, we do
not intend to pay any cash dividends in the foreseeable future. We currently intend to retain
future earnings, if any, to finance future growth.
(d) Purchases of Equity Securities by the Issuer and Affiliated Purchasers
Not applicable.
27
(e) Performance Graph
The graph below shows the five-year cumulative total stockholder return assuming the
investment of $100 and the reinvestment of dividends, although dividends have not been declared on
the common stock, and is based on the returns of the component companies weighted monthly according
to their market capitalizations. The graph compares total stockholder returns of the Companys
common stock, of all companies traded on the NASDAQ Stock market, as represented by the NASDAQ
Composite® Index, and of the NASDAQ Pharmaceutical Stocks, as prepared by the Center for Research
in Security Prices (CRSP) at the University of Chicago. The NASDAQ Pharmaceutical Stocks tracks
approximately 250 domestic pharmaceutical stocks within SIC Code 2834.
On September 7, 2005, the Company was delisted from the NASDAQ National Market and was quoted
on the Pink Sheets from September 7, 2005 through June 13, 2006. The Companys common stock was
relisted on the NASDAQ Global Market (formerly National Market) on June 14, 2006.
The stockholder return shown on the graph below is not necessarily indicative of future
performance and the Company will not make or endorse any predictions as to future stockholder
returns.
PERFORMANCE GRAPH
COMPARISON OF CUMULATIVE TOTAL RETURN*
*
Assumes $100 investment in Companys common stock on December
31, 2001.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
12/31/01 |
|
|
12/31/02 |
|
|
12/31/03 |
|
|
12/31/04 |
|
|
12/31/05 |
|
|
12/31/06 |
|
|
Ligand |
|
|
|
100 |
% |
|
|
|
30.0 |
% |
|
|
|
80.4 |
% |
|
|
|
65.0 |
% |
|
|
|
62.3 |
% |
|
|
|
61.2 |
% |
|
|
NASDAQ Composite |
|
|
|
100 |
% |
|
|
|
68.4 |
% |
|
|
|
102.7 |
% |
|
|
|
111.5 |
% |
|
|
|
113.1 |
% |
|
|
|
123.8 |
% |
|
|
NASDAQ Pharmaceutical Stocks |
|
|
|
100 |
% |
|
|
|
64.6 |
% |
|
|
|
94.7 |
% |
|
|
|
100.9 |
% |
|
|
|
111.1 |
% |
|
|
|
108.8 |
% |
|
|
28
Item 6. Selected Consolidated Financial Data
The following selected historical consolidated financial and other data are qualified by
reference to, and should be read in conjunction with, our consolidated financial statements and the
related notes thereto appearing elsewhere herein and Managements Discussion and Analysis of
Financial Condition and Results of Operations. Our selected statement of operations data set
forth below for each of the five years ended December 31, 2006, 2005, 2004, 2003 and 2002 and the
balance sheet data as of December 31, 2006, 2005, 2004, 2003 and 2002 (unaudited) are derived from
our consolidated financial statements.
29
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 (6) |
|
|
2005 |
|
|
2004 |
|
|
2003 |
|
|
2002 |
|
|
|
(in thousands, except share data) |
|
Consolidated Statement of Operations Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales (1) |
|
$ |
136,983 |
|
|
$ |
112,793 |
|
|
$ |
69,470 |
|
|
$ |
16,482 |
|
|
$ |
1,114 |
|
Sale of royalty rights, net (2) |
|
|
|
|
|
|
|
|
|
|
31,342 |
|
|
|
11,786 |
|
|
|
17,600 |
|
Collaborative research and development and other
revenues |
|
|
3,977 |
|
|
|
10,217 |
|
|
|
11,300 |
|
|
|
13,698 |
|
|
|
23,533 |
|
Cost of products sold (1) |
|
|
22,642 |
|
|
|
23,090 |
|
|
|
18,264 |
|
|
|
12,383 |
|
|
|
2,579 |
|
Research and development expenses |
|
|
41,926 |
|
|
|
33,096 |
|
|
|
32,720 |
|
|
|
29,649 |
|
|
|
37,109 |
|
Selling, general and administrative expenses |
|
|
79,748 |
|
|
|
56,168 |
|
|
|
46,431 |
|
|
|
34,776 |
|
|
|
18,645 |
|
Co-promotion expense (3) |
|
|
37,455 |
|
|
|
32,501 |
|
|
|
30,077 |
|
|
|
9,360 |
|
|
|
|
|
Co-promote termination charges (3) |
|
|
131,078 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale leaseback |
|
|
3,119 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(168,770 |
) |
|
|
(21,845 |
) |
|
|
(15,380 |
) |
|
|
(44,202 |
) |
|
|
(16,086 |
) |
Loss from continuing operations |
|
|
(135,859 |
) |
|
|
(31,470 |
) |
|
|
(22,764 |
) |
|
|
(64,474 |
) |
|
|
(24,445 |
) |
Discontinued operations (4) |
|
|
104,116 |
|
|
|
(4,929 |
) |
|
|
(22,377 |
) |
|
|
(29,992 |
) |
|
|
(27,812 |
) |
Cumulative effect of changing method of accounting
for variable interest entity (5) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,005 |
) |
|
|
|
|
Net loss |
|
|
(31,743 |
) |
|
|
(36,399 |
) |
|
|
(45,141 |
) |
|
|
(96,471 |
) |
|
|
(52,257 |
) |
Basic and diluted per share amounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations |
|
$ |
(1.69 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.91 |
) |
|
$ |
(0.35 |
) |
Discontinued operations (4) |
|
|
1.30 |
|
|
|
(0.06 |
) |
|
|
(0.30 |
) |
|
|
(0.42 |
) |
|
|
(0.41 |
) |
Cumulative effect of changing method of accounting
for variable interest entity (5) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.03 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(0.39 |
) |
|
$ |
(0.49 |
) |
|
$ |
(0.61 |
) |
|
$ |
(1.36 |
) |
|
$ |
(0.76 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares |
|
|
80,618,528 |
|
|
|
74,019,501 |
|
|
|
73,692,987 |
|
|
|
70,685,234 |
|
|
|
69,118,976 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pro forma amounts assuming the changed method of
accounting for variable interest entity is applied
retroactively (5) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(64,360 |
) |
|
$ |
(24,644 |
) |
Loss from discontinued operations |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(29,992 |
) |
|
|
(27,812 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(94,352 |
) |
|
$ |
(52,456 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss from continuing operations
per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(0.91 |
) |
|
$ |
(0.36 |
) |
Basic and diluted loss from discontinued
operations per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(0.42 |
) |
|
|
(0.40 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(1.33 |
) |
|
$ |
(0.76 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
2006 |
|
2005 |
|
2004 |
|
2003 |
|
2002 |
|
|
|
|
|
|
|
|
|
|
(in thousands) |
|
|
|
|
|
(Unaudited) |
Consolidated Balance Sheet Data: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, short-term
investments and restricted cash and investments |
|
$ |
212,488 |
|
|
$ |
88,756 |
|
|
$ |
114,870 |
|
|
$ |
100,690 |
|
|
$ |
74,894 |
|
Working capital (deficit) (7) |
|
|
64,747 |
|
|
|
(102,244 |
) |
|
|
(48,505 |
) |
|
|
(16,930 |
) |
|
|
18,370 |
|
Total assets |
|
|
326,053 |
|
|
|
314,619 |
|
|
|
332,466 |
|
|
|
314,046 |
|
|
|
287,709 |
|
Current portion of deferred revenue, net |
|
|
57,981 |
|
|
|
157,519 |
|
|
|
152,528 |
|
|
|
105,719 |
|
|
|
48,609 |
|
Current portion of deferred gain |
|
|
1,964 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term obligations (excludes long-term
portions of deferred revenue, net and
deferred gain) |
|
|
85,780 |
|
|
|
173,280 |
|
|
|
174,214 |
|
|
|
173,851 |
|
|
|
162,329 |
|
Long-term portion of deferred revenue, net |
|
|
2,546 |
|
|
|
4,202 |
|
|
|
4,512 |
|
|
|
3,448 |
|
|
|
3,595 |
|
Long-term portion of deferred gain |
|
|
27,220 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock subject to conditional
redemption/repurchase |
|
|
12,345 |
|
|
|
12,345 |
|
|
|
12,345 |
|
|
|
14,595 |
|
|
|
34,595 |
|
Accumulated deficit |
|
|
(862,802 |
) |
|
|
(831,059 |
) |
|
|
(794,660 |
) |
|
|
(749,519 |
) |
|
|
(653,048 |
) |
Total stockholders equity (deficit) |
|
|
27,352 |
|
|
|
(110,419 |
) |
|
|
(75,317 |
) |
|
|
(37,554 |
) |
|
|
8,925 |
|
(footnotes on next page)
30
|
|
|
(1) |
|
AVINZA was approved by the FDA in March 2002 and subsequently launched in the U.S. in June
2002. |
|
(2) |
|
Represents the sale of rights to royalties. See Note 11 to our consolidated financial
statements included elsewhere in this annual report. |
|
(3) |
|
Represents expense related to our AVINZA co-promotion agreement with Organon Pharmaceuticals
USA, Inc. (Organon) entered into in February 2003. See Note 8 to our consolidated financial
statements included elsewhere in this annual report. On January 17, 2006, we signed an
agreement with Organon that terminated the AVINZA® co-promotion agreement between
the two companies and returned AVINZA rights to us. The termination was effective as of
January 1, 2006; however, the parties agreed to continue to cooperate during a transition
period ended September 30, 2006 to promote the product. See Managements Discussion and
Analysis of Financial Condition and Results of Operations Overview and Business
Overview. |
|
(4) |
|
On September 7, 2006, we announced the sale of ONTAK, Targretin capsules, Targretin gel, and
Panretin to Eisai, Inc. This transaction subsequently closed on October 25, 2006.
Accordingly, the results for the Oncology product line have been presented in our consolidated
statements of operations as Discontinued Operations. See Note 3 to our consolidated
financial statements included elsewhere in this annual report. |
|
(5) |
|
In December 2003, we adopted Financial Accounting Standard Board Interpretation No. 46
(revised December 2003) (FIN46(R)), Consolidation of Variable Interest Entities, an
interpretation of ARB No. 51. Under FIN 46(R), we were required to consolidate the variable
interest entity from which we leased our corporate headquarters. Accordingly, as of December
31, 2003, we consolidated assets with a carrying value of $13.6 million, debt of $12.5
million, and a non-controlling interest of $0.6 million. In connection with the adoption of
FIN 46(R), we recorded a charge of $2.0 million as a cumulative effect of the accounting
change on December 31, 2003. In April 2004, we acquired the portion of the variable interest
entity that we did not previously own. The acquisition resulted in Ligand assuming the
existing loan against the property and making a payment of approximately $0.6 million to the
entitys other shareholder. |
|
(6) |
|
Effective January 1, 2006, we adopted Statement of Financial Accounting Standards 123(R),
Share-Based Payment, (SFAS 123(R)), using the modified prospective transition method. The
implementation of SFAS123(R) resulted in additional employee stock compensation expense of
approximately $4.8 million in 2006 (see Note 2 to our consolidated financial statements
included elsewhere in this annual report). |
|
(7) |
|
Working capital (deficit) includes deferred product revenue recorded under the sell-through
revenue recognition method. |
31
Item 7. Managements Discussion and Analysis of Financial Condition and Results of Operations
Caution: This discussion and analysis may contain predictions, estimates and other
forward-looking statements that involve a number of risks and uncertainties, including those
discussed in Item 1A. Risk Factors. This outlook represents our current judgment on the future
direction of our business. These statements include those related to our restructuring process,
AVINZA royalty revenues, product returns, product development, our 2005 restatement, and material
weaknesses or deficiencies in internal control over financial reporting. Actual events or results
may differ materially from Ligands expectations. For example, there can be no assurance that our
recognized revenues or expenses will meet any expectations or follow any trend(s), that our
internal control over financial reporting will be effective or produce reliable financial
information on a timely basis, or that our restructuring process will be successful or yield
preferred results. We cannot assure you that the Company will be able to successfully or timely
complete its restructuring, that we will receive expected AVINZA royalties to support our ongoing
business, or that our internal or partnered pipeline products will progress in their development,
gain marketing approval or success in the market. In addition, the Companys ongoing SEC
investigation or future litigation may have an adverse effect on the Company. Such risks and
uncertainties, and others, could cause actual results to differ materially from any future
performance suggested. We undertake no obligation to release publicly the results of any revisions
to these forward-looking statements to reflect events or circumstances arising after the date of
this annual report. This caution is made under the safe harbor provisions of Section 21E of the
Securities Exchange Act of 1934 as amended.
Our trademarks, trade names and service marks referenced herein include Ligand. Each other
trademark, trade name or service mark appearing in this annual report belongs to its owner.
Overview
We
are an early-stage biotech company that focuses on discovering and developing new
drugs that address critical unmet medical needs in the areas of thrombocytopenia, cancer, hepatitis
C, hormone related diseases, osteoporosis and inflammatory diseases. We strive to develop drugs
that are more effective and/or safer than existing therapies, that are more convenient to
administer and that are cost effective. We plan to build a profitable company by generating income
from research, milestone and royalty and co-promotion revenues resulting from our collaborations
with pharmaceutical partners.
As of December 31, 2006, we marketed one product in the United States: AVINZA, for the relief
of chronic, moderate to severe pain. On September 7, 2006, we announced the sale of ONTAK,
Targretin capsules, Targretin gel, and Panretin to Eisai, Inc. (Eisai) and the sale of AVINZA to
King Pharmaceuticals, Inc. (King). The Eisai sales transaction subsequently closed on October
25, 2006. Accordingly, the results for the Oncology product line have been presented in our
consolidated statements of operations for 2006, 2005, and 2004 as Discontinued Operations. The
AVINZA sale transaction subsequently closed on February 26, 2007. The AVINZA sale transaction was
still subject to stockholder approval as of December 31, 2006. Accordingly, results of operations
for the AVINZA product line are included in the continuing operations of the Company as of and for
the years ended December 31, 2006, 2005 and 2004.
In February 2003, we entered into an agreement for the co-promotion of AVINZA with Organon
Pharmaceuticals USA Inc. (Organon). Under the terms of the agreement, Organon committed to a
specified minimum number of primary and secondary product calls delivered to certain high
prescribing physicians and hospitals beginning in March 2003. Organons compensation through 2005
was structured as a percentage of AVINZA net sales based on the following schedule:
|
|
|
|
|
% of Incremental Net Sales |
Annual Net Sales of AVINZA |
|
Paid to Organon by Ligand |
$0-150 million
|
|
30% (0% for 2003) |
$150-300 million
|
|
40% |
$300-425 million
|
|
50% |
> $425 million
|
|
45% |
32
In January 2006, we signed an agreement with Organon that terminated the AVINZA co-promotion
agreement between the two companies and returned AVINZA rights to Ligand. The termination was
effective as of January 1, 2006; however, the parties agreed to continue to cooperate during a
transition period that ended September 30, 2006 (the Transition Period) to promote the product.
The Transition Period co-operation included a minimum number of product sales calls per quarter
(100,000 for Organon and 30,000 for Ligand with an aggregate of 375,000 and 90,000, respectively,
for the Transition Period) as well as the transition of ongoing promotions, managed care contracts,
clinical trials and key opinion leader relationships to Ligand. During the Transition Period, we
paid Organon an amount equal to 23% of AVINZA net sales as reported. We also paid and were
responsible for the design and execution of all AVINZA clinical, advertising and promotion expenses
and activities.
Additionally, in consideration of the early termination and return of rights to AVINZA under
the terms of the agreement, we unconditionally paid Organon $37.8 million in October 2006. We also
agreed to and paid Organon $10.0 million in January 2007, in consideration of the minimum sales
calls during the Transition Period. In addition, following the Transition Period, we agreed to
make quarterly royalty payments to Organon equal to 6.5% of AVINZA net sales through December 31,
2012 and thereafter 6.0% through patent expiration, currently anticipated to be November of 2017.
The unconditional payment of $37.8 million to Organon and the estimated fair value of the
amounts to be paid to Organon after the termination ($95.2 million as of January 1, 2006), based on
the estimated net sales of the product (currently anticipated to be paid quarterly through November
2017) were recognized as liabilities and expensed as costs of the termination as of the effective
date of the agreement, January 2006. Additionally, the conditional payment of $10.0 million, which
represents an approximation of the fair value of the service element of the agreement during the
Transition Period (when the provision to pay 23% of AVINZA net sales is also considered), was
recognized ratably as additional co-promotion expense over the Transition Period. The full $10.0
million of this element of co-promotion expense was recognized in 2006.
Although the quarterly royalty payments to Organon are based on net reported AVINZA product
sales, such payments do not result in current period expense in the period upon which the payment
is based, but instead are charged against the co-promote termination liability. The liability is
adjusted at each reporting period to fair value and is recognized, utilizing the interest method,
as additional co-promote termination charges for that period at a rate of 15%, the discount rate
used to initially value this component of the termination liability. Any changes to our estimate
of future net AVINZA product sales would result in a change to the liability which is recognized as
an increase or decrease to co-promote termination charges in the period such changes are
identified. For example, in the fourth quarter of 2006, we recorded an adjustment of $15.7 million
to lower the fair value of the termination liability based on our updated estimate of future AVINZA
sales.
On February 26, 2007, we closed the AVINZA sale transaction pursuant to which King acquired
all of our rights in and to AVINZA, assumed certain liabilities, and reimbursed us the $47.8
million paid to Organon. King also assumed Ligands co-promote termination obligation to make
payments to Organon based on net sales of AVINZA (the fair value of which approximates $93.3
million as of December 31, 2006). As Organon has not consented to the legal assignment of the
co-promote termination obligation from us to King, we remain liable to Organon in the event of
Kings default of this obligation.
In June 2006, we concluded the research phase of a research and development collaboration with
TAP Pharmaceutical Products Inc. (TAP). Collaborations in the development phase are being
pursued by Eli Lilly and Company, GlaxoSmithKline, Pfizer, TAP, and Wyeth. We receive funding
during the research phase of the arrangements and milestone and royalty payments as products are
developed and marketed by our corporate partners. In addition, in connection with some of these
collaborations, we received non-refundable up-front payments.
We have been unprofitable since our inception on an annual basis and expect to incur net
losses in the future. To be profitable, we must successfully develop, clinically test, market and
sell our products. Even if we achieve profitability, we cannot predict the level of that
profitability or whether we will be able to sustain profitability. We expect that our operating
results will fluctuate from period to period as a result of differences in the timing and amounts
of revenues, including royalties expected to be earned in the future from King on sales of AVINZA,
expenses incurred, collaborative arrangements and other sources. Some of these fluctuations may be
significant.
33
Recent Developments
Sale of AVINZA Product
On September 6, 2006, Ligand and King entered into a purchase agreement (the AVINZA Purchase
Agreement), pursuant to which King agreed to acquire all of our rights in and to AVINZA in the
United States, its territories and Canada, including, among other things, all AVINZA inventory,
records and related intellectual property, and assume certain liabilities as set forth in the
AVINZA Purchase Agreement (collectively, the Transaction). In addition, subject to the terms and
conditions of the AVINZA Purchase Agreement, King agreed to offer employment following the closing
of the Transaction (the Closing) to certain of our existing AVINZA sales representatives or
otherwise reimburse us for certain agreed upon severance arrangements offered to any such non-hired
representatives.
Pursuant to the terms of the AVINZA Purchase Agreement, we received $280.4 million in net cash
proceeds at the Closing on February 26, 2007 (the Closing Date), which represents the purchase
price of $246.3 million, which is net of certain inventory adjustments of approximately $18.7
million as set forth in the AVINZA Purchase Agreement, as amended, plus approximately $49.1 million
in reimbursement of payments previously made to Organon and others. Additionally, the net proceeds
are less $15.0 million that was funded into an escrow account to support potential indemnity claims
by King following the Closing. Of the escrowed amounts not required for claims to King, 50% of the
then existing amount will be released on August 26, 2007 with the remaining available balance to be
released on February 26, 2008. King also assumed our co-promote termination obligation to make
payments to Organon based on net sales of AVINZA (approximately $93.3 million as of December 31,
2006). As Organon has not consented to the legal assignment of the co-promote termination
obligation from Ligand to King, we remain liable to Organon in the event of Kings default of this
obligation. We also incurred approximately $7.2 million in transaction fees and other costs
associated with the sale that are not reflected in the net cash proceeds. This amount includes
approximately $3.6 million for investment banking services and related expenses which have not yet
been paid. We are disputing that these fees are owed to the investment banking firm.
In addition to the assumption of existing royalty obligations, King will pay us a 15% royalty
on AVINZA net sales during the first 20 months after Closing. Subsequent royalty payments will be
based upon calendar year net sales. If calendar year net sales are less than $200.0 million, the
royalty payment will be 5% of all net sales. If calendar year net sales are greater than $200.0
million, the royalty payment will be 10% of all net sales less than $250.0 million, plus 15% of net
sales greater than $250.0 million.
In connection with the Transaction, King committed to loan us, at our option, $37.8 million
(the Loan) to be used to pay our co-promote termination obligation to Organon due October 15,
2006. This loan was drawn, and the $37.8 million co-promote liability settled in October 2006.
Amounts due under the loan were subject to certain market terms, including a 9.5% interest rate.
In addition, and as a condition of the $37.8 million loan received from King, $38.6 million of the
funds received from Eisai was deposited into a restricted account to be used to repay the loan to
King, plus interest. We repaid the loan plus interest on January 8, 2007. Pursuant to the AVINZA
Purchase Agreement, King refunded the interest to us on the Closing Date.
Also on September 6, 2006, we entered into a contract sales force agreement (the Sales Call
Agreement) with King, pursuant to which King agreed to conduct a sales detailing program to
promote the sale of AVINZA for an agreed upon fee, subject to the terms and conditions of the Sales
Call Agreement. Pursuant to the Sales Call Agreement, King agreed to perform certain minimum
monthly product details (i.e. sales calls), which commenced effective October 1, 2006 and continued
until the Closing Date. The amount due to King under the Sales Call Agreement as of December 31,
2006 is approximately $3.8 million.
Sale of Oncology Product Line
On September 7, 2006, we, Eisai Inc., a Delaware corporation and Eisai Co., Ltd., a Japanese
company (together with Eisai Inc., Eisai), entered into a purchase agreement (the Oncology
Purchase Agreement) pursuant to which Eisai agreed to acquire all of our worldwide rights in and
to our oncology products, including, among other things, all related inventory, equipment, records
and intellectual property, and assume certain liabilities (the Oncology Product Line) as set
forth in the Oncology Purchase Agreement. The Oncology Product Line included our four
34
marketed oncology drugs: ONTAK, Targretin capsules, Targretin gel and Panretin gel. Pursuant
to the Oncology Purchase Agreement, at closing on October 25, 2006, we received approximately
$185.0 million in net cash proceeds which is net of $20.0 million that was funded into an escrow
account to support any indemnification claims made by Eisai following the closing of the sale, and
Eisai assumed certain liabilities. Of the escrowed amounts not required for claims to Eisai, 50%
of the then existing amount will be released on April 25, 2007 with the remaining available balance
to be released on October 25, 2007. We incurred approximately $1.7 million of transaction fees and
costs associated with the sale that are not reflected in the net cash proceeds.
Additionally, $38.6 million of the proceeds received from Eisai were deposited into a
restricted account to repay a loan received from King, the proceeds of which were used to pay our
co-promote termination obligation to Organon in October 2006. Such amounts were released and the
loan repaid to King in January 2007.
In connection with the Oncology Purchase Agreement with Eisai, we entered into a transition
services agreement whereby we agreed to perform certain transition services for Eisai, in order to
effect, as rapidly as practicable, the transition of purchased assets from Ligand to Eisai. In
exchange for these services, Eisai pays us a monthly service fee. The term of the transition
services provided is generally three months; however, certain services will be provided for a
period of up to eight months. Fees earned under the transition services agreement, which were
recorded as an offset to operating expenses in the fourth quarter of 2006, were approximately $1.9
million.
The Salk Institute for Biological Studies (Salk) Allegations
In March 2007, we received a letter from legal counsel to The Salk Institute for Biological
Studies alleging that we owe Salk royalties on prior product sales of Targretin as well as a
percentage of the amounts received from Eisai Co., Ltd. (Tokyo) and Eisai Inc. (New Jersey) that
are attributable to Targretin with respect to our sale of the Oncology Product Line to Eisai that
was completed in October 2006. Salk alleges that they are owed at least 25% of the consideration
paid by Eisai for that portion of Ligands oncology product line and associated assets attributable
to Targretin. We have reviewed these matters and do not believe we have any financial obligations
to Salk pertaining to Targretin. Accordingly, we intend to vigorously oppose any Salk claim for
payment related to these matters.
Resignation of CEO and Appointment of New CEO
On July 31, 2006, we entered into a separation agreement with David Robinson providing for Mr.
Robinsons resignation as Chairman, President, and Chief Executive Officer of the Company. Under
the separation agreement, Mr. Robinson received his base salary and certain benefits for 24 months,
payable in five equal monthly installments beginning August 1, 2006 and ending December 1, 2006.
In addition, the agreement provided for the immediate vesting of Mr. Robinsons unvested stock
options and an extension of the exercise period of his options to January 15, 2007. In connection
with the resignation, we recognized expense of approximately $1.9 million in 2006, comprised of
cash payments of $1.4 million and stock-based compensation of $0.5 million associated with the
modification of the vesting and exercise period of the stock options.
On August 1, 2006, we announced that current director Henry F. Blissenbach had been named
Chairman and interim Chief Executive Officer. We agreed to pay Dr. Blissenbach $40,000 per month,
commencing August 1, 2006 for his services as Chairman and interim Chief Executive Officer. In
addition, Dr. Blissenbach was eligible to receive incentive compensation of up to 50% of his base
salary, but not more than $100,000, based upon his performance of certain objectives incorporated
within the employment agreement which we and Dr. Blissenbach entered into. Also, Dr. Blissenbach
received a stock option grant to purchase 150,000 shares of our common stock at an exercise price
of $9.20 per share. These stock options vested upon the appointment of a new chief executive
officer in January 2007 as further discussed below. Finally, we reimbursed Dr. Blissenbach for all
reasonable expenses incurred in discharging his duties as interim Chief Executive Officer,
including, but not limited to commuting costs to San Diego and living and related costs during the
time he spent in San Diego.
On January 16, 2007, we announced that John L. Higgins had joined the Company as Chief
Executive Officer and President. Mr. Higgins succeeded Dr. Blissenbach, who continued to serve as
Chairman of the Board of Directors until March 1, 2007. We agreed to pay Mr. Higgins an annual
salary of $400,000, with his employment
35
commencing as of January 10, 2007. In addition, Mr. Higgins has a performance bonus
opportunity with a target of 50% of his salary, up to a maximum of 75%, and received a restricted
stock award grant of 150,000 shares of our common stock which vests over two years. We also
provided Mr. Higgins with a lump-sum relocation benefit of $100,000. Mr. Higgins employment
agreement provides for severance payments and benefits in the event that employment is terminated
under various scenarios, such as a change in control of the Company.
Reductions in Workforce
In December 2006, and following the sale of our Oncology Product Line to Eisai, we entered
into a plan to eliminate 40 employee positions, across all functional areas, which were no longer
deemed necessary considering our decision to sell our commercial assets. Additionally, we
terminated 23 AVINZA sales representatives and regional business managers who were not offered
positions with King or declined Kings offer of employment. The affected employees were informed
of the plan in December 2006 with an effective termination date of January 2, 2007. In connection
with the termination plan, we recognized operating expenses of approximately $2.9 million in the
fourth quarter of 2006, comprised of one-time severance benefits of $2.3 million, stock
compensation of $0.3 million, and other costs of $0.3 million. The stock compensation charge
resulted from the accelerated vesting and extension of the exercise period of stock options in
accordance with severance arrangements of certain senior management members. We paid $0.5 million
in December 2006 and the remaining balance in January 2007.
On January 31, 2007 we announced an additional restructuring plan calling for the further
elimination of approximately 204 positions across all functional areas. This reduction was made in
connection with our efforts to refocus the Company, following the sale of our commercial assets, as
a smaller, highly focused research and development and royalty-driven
biotech company.
Associated with the restructuring and refocused business model, several of our executive officers
agreed to step down including our Chief Financial Officer, Chief Scientific Officer and General
Counsel. We also announced that our primary operations are expected to be consolidated into one
building with the goal to sublet unutilized space. In connection with the restructuring, we expect
to take a charge to earnings, the majority of which will be recorded in the first quarter of 2007,
of approximately $10.8 million, comprised of one-time severance benefits of $7.5 million, stock
compensation of $2.2 million, and other costs of $1.1 million. The stock compensation charge
results from the accelerated vesting and extension of the exercise period of stock options in
accordance with severance arrangements of certain senior management members.
Sale and Leaseback of Premises
On October 25, 2006, we, along with our wholly-owned subsidiary Nexus Equity VI, LLC (Nexus)
entered into an agreement with Slough Estates USA, Inc. (Slough) for the sale of our real
property located in San Diego, California for a purchase price of approximately $47.6 million.
This property, with a net book value of approximately $14.5 million, includes one building totaling
approximately 82,500 square feet, the land on which the building is situated, and two adjacent
vacant lots. As part of the sale transaction, we agreed to leaseback the building for a period of
15 years, as further described below. In connection with the sale transaction, on November 6,
2006, we also paid off the existing mortgage on the building of approximately $11.6 million. The
early payment triggered a prepayment penalty of approximately $0.4 million. The sale transaction
subsequently closed on November 9, 2006.
Under the terms of the lease, we will pay a basic annual rent of $3.0 million (subject to an
annual fixed percentage increase, as set forth in the agreement), plus a 1% annual management fee,
property taxes and other normal and necessary expenses associated with the lease such as utilities,
repairs and maintenance, etc. We will have the right to extend the lease for two five-year terms
and will have the first right of refusal to lease, at market rates, any facilities built on the
sold lots.
In accordance with SFAS 13, Accounting for Leases, we recognized an immediate pre-tax gain on
the sale transaction of approximately $3.1 million and deferred a gain of approximately $29.5
million on the sale of the building. The deferred gain will be recognized on a straight-line basis
over the 15 year term of the lease at a rate of approximately $2.0 million per year.
36
Conversion of 6% Convertible Subordinated Notes
The noteholders of our 6% convertible subordinated notes, in the aggregate principal amount of
$155.3 million, converted all of the notes into approximately 25.1 million shares of our common
stock in 2006. Accrued interest and unamortized debt issue costs related to the converted notes of
$0.5 million and $1.4 million, respectively, were recorded as additional paid-in capital.
Accounting for Stock-Based Compensation
Effective January 1, 2006, we adopted SFAS 123 (revised 2004), Share-Based Payment (SFAS
123(R)), using the modified prospective transition method. No stock-based employee compensation
cost was recognized prior to January 1, 2006, as all options granted prior to 2006 had an exercise
price equal to the market value of the underlying common stock on the date of the grant. Under the
modified prospective transition method, compensation cost recognized in 2006 includes: (a)
compensation cost for all share-based payments granted prior to, but not yet vested as of January
1, 2006, based on the grant date fair value estimated in accordance with the original provisions of
SFAS 123, and (b) compensation cost for all share-based payments granted in 2006, based on
grant-date fair value estimated in accordance with the provisions of SFAS 123(R). Results for 2005
and 2004 have not been retrospectively adjusted. For 2006, we recognized additional compensation expense of $4.8 million
due to the implementation of SFAS 123(R).
Employee Retention Agreements and Severance Arrangements
In March 2006, we entered into letter agreements with approximately 67 of our key employees,
including a number of our executive officers. In September 2006, we entered into letter agreements
with ten additional employees and modified existing agreements with two employees. These letter
agreements provided for certain retention or stay bonus payments to be paid in cash under specified
circumstances as an additional incentive to remain employed in good standing with the Company
through December 31, 2006. The Compensation Committee of the Board of Directors approved the
Companys entry into these agreements. In accordance with SFAS 146, Accounting for Costs
Associated with Exit or Disposal Activities, the cost of the plan was ratably accrued over the term
of the agreements. We recognized approximately $2.6 million of expense under the plan in 2006. As
an additional retention incentive, certain employees were also granted stock options to purchase
approximately 122,000 shares in the aggregate of our common stock at an exercise price of $11.90
per share.
In August 2006 and October 2006, the Companys Compensation Committee approved and ratified,
and began entering into additional severance agreements with certain of our officers and executive
officers as additional retention incentives and to provide severance benefits to these officers
that are more closely equivalent to severance benefits already in place for other executive
officers.
These additional agreements consist of (a) change of control severance agreements (Change of
Control Severance Agreement) and b) ordinary severance agreements that apply regardless of a
change of control (Ordinary Severance Agreement). Each Change of Control Severance Agreement
provides for a payment of certain benefits to the officer in the event his or her employment is
terminated without cause in connection with a change of control of the Company.
These benefits include one year of salary, plus the average bonus (if any) for the prior two
years and payment of health care premiums for one year. With certain exceptions, the officer must
be available for consulting services for one year and must abide by certain restrictive covenants,
including non-competition and non-solicitation of our employees. Each Ordinary Severance Agreement
provides for payment of six months salary in the event the officers employment is terminated
without cause, regardless of change of control.
Additionally, in October 2006, we implemented a 2006 Employee Severance Plan for those
employees who were not covered by another severance arrangement. The plan provides that if such an
employee is involuntarily terminated without cause, and not offered a similar or better job by one
of the purchasers of our product lines (i.e. King or Eisai) such employee will be eligible for
severance benefits. The benefits consist of two months salary, plus one week of salary for every
full year of service with the Company plus payment of COBRA health care coverage premiums for that
same period.
37
Lilly Collaboration Update
In May 2006, after review of all preclinical and clinical data including recently completed
two year animal safety studies, Lilly informed us that it had decided not to pursue further
development of LY818 (naveglitazar), a compound in Phase II development for the treatment of Type
II diabetes, at this time. Naveglitazar, a dual PPAR agonist, was developed through our collaborative research
and development agreement with Lilly. This decision was specific with regard to naveglitazar.
In September 2006, Lilly informed us that it had suspended an ongoing mid-stage human trial of
LY674 in order to assess unexpected findings noted during animal safety studies of the same
compound and evaluate collective clinical efficacy and safety from the human data already gathered.
LY674, a PPAR alpha agonist compound in Phase II development for the treatment of atherosclerosis,
was developed through our collaborative research and development agreement with Lilly. This
decision is specific with regard to LY674.
Agreements to Settle Securities Class Action and Derivative Lawsuits
On June 29, 2006, we announced that we reached agreement to settle the securities class action
litigation filed in the United States District Court for the Southern District of California
against us and certain of our directors and officers. In addition, we also reached agreement to
settle the shareholder derivative actions filed on behalf of the Company in the Superior Court of
California and the United States District Court for the Southern District of California.
The settlements resolve all claims by the parties, including those asserted against Ligand and
the individual defendants in these cases. Under the agreements, we agreed to pay a total of $12.2
million in cash in full settlement of all claims. $12.0 million of the settlement amount and a
portion of our total legal expenses was funded by our Directors and Officers Liability insurance
carrier while the remainder of the legal fees incurred ($1.4 million for 2006) was paid by us. Of
the $12.2 million settlement liability, $4.0 million was paid in October 2006 to us directly from
the insurance carrier and then disbursed to the claimants attorneys, while $8.0 million was paid
in July 2006 by the insurance carrier directly to an independent escrow agent responsible for
disbursing the funds to the class action suit claimants.
As part of the settlement of the state derivative action, we have agreed to adopt certain
corporate governance enhancements including the formalization of certain Board practices and
responsibilities, a Board self-evaluation process, Board and Board Committee term limits (with
gradual phase-in) and one-time enhanced independent requirements for a single director to succeed
the current shareholder representatives on the Board. Neither we nor any of our current or former
directors and officers has made any admission of liability or wrongdoing. On October 12, 2006, the
Superior Court of California approved the settlement of the state and federal derivative actions
and entered final judgment of dismissal. The United States District Court approved the settlement
of the Federal class action in October 2006.
The related investigation by the Securities and Exchange Commission is ongoing and is not
affected by the settlements discussed above.
Salk Royalty Buyout
In August 2006, we paid The Salk Institute $0.8 million to exercise an option to buy out
milestone payments, other payment sharing obligations and royalty payments due on future sales of
bazedoxifene, a product being developed by Wyeth. This payment resulted from a bazedoxifene new
drug application (NDA) filed by Wyeth for postmenopausal osteoporosis therapy. We recognized the
$0.8 million payment as development expense in our third quarter 2006 consolidated financial
statements.
38
Results of Continuing Operations
Total revenues for 2006 were $141.0 million compared to $123.0 million in 2005 and $112.1
million in 2004. Operating loss from continuing operations was $168.8 million in 2006 compared to
$21.9 million in 2005 and $15.4 million in 2004. Loss from continuing operations for 2006 was
$135.9 million ($1.69 per share) compared to $31.5 million ($0.43 per share) in 2005 and $22.8
million ($0.31 per share) in 2004.
Product Sales
Our product sales can be influenced by a number of factors including changes in demand,
competitive products, the timing of announced price increases, and the level of prescriptions
subject to rebates and chargebacks. AVINZA is also included on the formularies (or lists of
approved and reimbursable drugs) of many states health care plans, as well as the formulary for
certain Federal government agencies. In order to be placed on these formularies, we generally sign
contracts which provide discounts to the purchaser off the then-current list price and limit how
much of an annual price increase we can implement on sales to these groups. As a result, the
discounts off list price for these groups can be significant where we have implemented list price
increases. We monitor the portion of our sales subject to these discounts, and accrue for the cost
of these discounts at the time of the recognition of product sales.
Net Product Sales
AVINZA product sales are determined on a sell-through basis less allowances for rebates,
chargebacks, discounts, and losses to be incurred on returns from wholesalers resulting from
increases in the selling price of our products. In addition, we incur certain distributor service
agreement fees related to the management of our product by wholesalers. These fees have been
recorded within net product sales.
Sales of AVINZA were $137.0 million in 2006 compared to $112.8 million in 2005. According to
IMS data, AVINZA prescription market share for 2006 was 3.7% compared to 4.4% for 2005. The
increase in sales for 2006 reflects the full year impact of a 7% price increase effective April 1,
2005 and the partial year impact of a 6% price increase effective July 1, 2006, as well as a shift
in the mix of prescriptions to the higher doses of AVINZA. Net sales for 2006 also include $1.5
million from the release of an accrual previously recorded for billings received from and the
refund of amounts paid to the Department of Veterans Affairs under the Department of Defenses
TriCare Retail Pharmacy refund programs. In September 2006, the U.S. Court of Appeals for the
Federal Circuit struck down the TriCare program. The increase in AVINZA net sales further reflects
a reduction in Medicaid rebates of approximately $13.6 million. This reduction was partially
offset by an increase in managed care rebates of approximately $0.7 million in 2006 under contracts
with pharmacy benefit managers (PBMs), group purchasing organizations (GPOs) and health
maintenance organizations (HMOs), and under Medicare Part D.
The increase in AVINZA net sales for 2006 compared to 2005 was partially offset by a decrease
in prescriptions. Specifically, net sales for 2006 reflect an approximate 4% decrease in
prescriptions compared to 2005. These trends reflect a continuing decease in prescriptions under
Medicaid contracts as marginal contracts were terminated, partially offset by increases in
prescriptions under managed care contracts and Medicare Part D. We also believe that the decrease
in prescriptions is due in part to a lower level of co-promote activity in the third quarter of
2006, as our previous co-promotion arrangement with Organon terminated in September 2006, and the
subsequent transition of co-promote activities to King in the fourth quarter of 2006.
As discussed under Recent Developments, we entered into an agreement to sell the AVINZA
product line to King subject to Ligand stockholder approval. Stockholder approval was subsequently
obtained in February 2007, and the transaction closed on February 26, 2007. In connection with
that agreement, we entered into a Contract Sales Force Agreement (the Sales Agreement) with King,
pursuant to which King agreed to conduct a detailing program to promote the sale of AVINZA for an
agreed upon fee. Pursuant to the Sales Agreement, King agreed to perform certain minimum monthly
product details (i.e. sales calls), which commenced effective October 1, 2006 and continued through
the closing of the sale transaction. As of December 31, 2006, we owed King approximately $3.8
million for co-promotion activity during the fourth quarter of 2006.
AVINZA net sales for 2006 also reflect an approximate charge of $2.1 million for losses
expected to be incurred on product returns resulting from the 6% price increase effective July 1,
2006. This compares to a charge of $3.5
39
million recorded for the three months ended March 31, 2005 in connection with a 7% AVINZA
price increase effective April 1, 2005. Upon an announced price increase, we revalue our estimate
of deferred product revenue to be returned to recognize the potential higher credit a wholesaler
may take upon product return determined as the difference between the new price and the previous
price used to value the allowance. The decrease in the charge for 2006 reflects lower rates of
return on lots that closed out in 2006, thereby lowering the historical weighted average rate of
return used for estimating the allowance for return losses. AVINZA net sales for 2006 also
benefited from a reduction in the existing allowance for return losses of $4.3 million due to the
lower rates of return on lots that closed in 2006.
Any changes to our estimates for Medicaid prescription activity or prescriptions written under
our managed care contracts may have an impact on our rebate liability and a corresponding impact on
AVINZA net product sales. For example, a 10% variance to our estimated Medicaid and managed care
contract rebate accruals for AVINZA as of December 31, 2006 could result in adjustments to our
Medicaid and managed care contract rebate accruals and net product sales of approximately $0.1
million and $0.3 million, respectively.
Sales of AVINZA were $112.8 million in 2005 compared to $69.5 million in 2004. This increase
is due to higher prescriptions as a result of the increased level of marketing and sales activity
under our co-promotion agreement with Organon, a shift in the mix of prescriptions to the higher
doses of AVINZA, and the products success in achieving state Medicaid and commercial formulary
status. Demand for AVINZA as measured by prescription levels (or patient consumption for channels
with no prescription requirements) increased by 27% in 2005 compared to 2004, as reported by IMS
Health. Sales of AVINZA in 2005 also benefited from the full year impact of a 9.0% price increase
effective July 1, 2004 and the partial year impact of a 7% price increase effective April 1, 2005.
AVINZA sales for 2005 were negatively impacted by an increase in Medicaid rebates of
approximately $4.4 million and an increase in managed care rebates of approximately $ 3.6 million.
AVINZA sales in 2005 also reflect an approximate $3.5 million reduction in sales, recorded during
the three months ended March 31, 2005, for losses expected to be incurred on product returns
resulting from an AVINZA price increase which became effective April 1, 2005. For the year, the
impact on sales of the April 1, 2005 price increase was partially offset by a reduction in the
allowance for return losses of approximately $2.9 million recorded during the three months ended
December 31, 2005. This reduction resulted from lower rates of return on lots that closed out in
the fourth quarter of 2005, thereby lowering the historical weighted average rate of return used
for estimating the allowance for return losses. This compares to a $2.6 million loss in 2004 on
product returns, which was recorded during the three months ended June 30, 2004 for an AVINZA price
increase which became effective July 1, 2004. Additionally, product sales in 2005 and for the
second half of 2004 are net of fees paid to our wholesaler customers under fee for service
agreements entered into during the third and fourth quarters of 2004.
Sale of Royalty Rights
Revenue from the sale of royalty rights represents the sale to third parties of rights and
options to acquire future royalties we may earn from the sale of products in development with our
collaborative partners. In those instances where we have no continuing involvement in the research
or development of these products, sales of royalty rights are recognized as revenue in the period
the transaction is consummated or the options are exercised or expire. See Note 2 to our
consolidated financial statements for further discussion of our revenue recognition policy with
respect to sales of royalty rights.
Sale of royalty rights recognized in 2004 amounted to $31.3 million, net of the deferral of
offset rights of $1.4 million and the recognition in 2004 of $0.2 million of option value deferred
in previous periods. There were no sales of royalty rights in 2006 and 2005.
In March 2002, we entered into an agreement with Royalty Pharma AG (Royalty Pharma), to sell
a portion of our rights to future royalties from the net sales of three selective estrogen receptor
modulator (SERM) products now in late stage development with two of our collaborative partners,
Pfizer and Wyeth. The agreement provided for the initial sale of rights to 0.25% of such product
net sales for $6.0 million and options to acquire up to an additional 1.00% of net sales for $50.0
million. Of the initial $6.0 million sale of rights, $0.2 million was attributed to the options
and recorded as deferred revenue.
40
In July and December of 2002, the agreement was amended to replace the existing options with
new options providing for the rights to acquire an additional 1.3125% of net sales for $63.8
million. Royalty Pharma exercised each of the three available 2002 options, as amended, acquiring
rights to 0.4375% of net sales for $12.3 million. The fair value estimated for the amended
options, $0.2 million, was recorded as deferred revenue.
In October 2003, the existing royalty agreement was amended and Royalty Pharma exercised an
option for $12.5 million in exchange for 0.7% of potential future sales of the three SERM products
for 10 years. Under the revised agreement, Royalty Pharma had three additional options to purchase
up to 1.3% of such product net sales for $39.0 million.
In November 2004, Royalty Pharma agreed to purchase an additional 1.625% royalty on future
sales of the SERM products for $32.5 million and cancel its remaining two options.
Under the underlying royalty agreements, both Pfizer and Wyeth have the right to offset a
portion of any future royalty payments owed to the Company. Accordingly, we deferred a portion of
the revenue associated with each tranche of royalty right sold, including rights acquired upon the
exercise of options, equal to the pro-rata share of the potential royalty offset. Such amounts
associated with the offset rights against future royalty payments will be recognized as revenue
upon receipt of future royalties from the respective partners.
Collaborative Research and Development and Other Revenue
Collaborative research and development and other revenues for 2006 were $4.0 million compared
to $10.2 million for 2005 and $11.3 million for 2004. Collaborative research and development and
other revenues include reimbursement for ongoing research activities, earned development
milestones, and recognition of prior years up-front fees previously deferred in accordance with
Staff Accounting Bulletin (SAB) No. 101 Revenue Recognition, as amended by SAB 104 (hereinafter
referred to as SAB104). Revenue from distribution agreements includes recognition of up-front fees
collected upon contract signing and deferred over the life of the distribution arrangement and
milestones achieved under such agreements.
A comparison of collaborative research and development and other revenues is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Collaborative research and development |
|
$ |
1,678 |
|
|
$ |
3,513 |
|
|
$ |
7,843 |
|
Development milestones and other |
|
|
2,299 |
|
|
|
6,704 |
|
|
|
3,457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,977 |
|
|
$ |
10,217 |
|
|
$ |
11,300 |
|
|
|
|
|
|
|
|
|
|
|
Collaborative Research and Development. The decrease in collaborative research and
development revenue for 2006 compared to 2005 is due to the completion of the research phase of our
collaborative arrangement with TAP, which concluded in June 2006. The decrease in ongoing research
activities reimbursement revenue in 2005 compared to 2004 is due to the termination in November
2004 of our research arrangement with Lilly which contributed $4.0 million to revenue in 2004.
Development Milestones and Other. Development milestones in 2006 reflect a milestone of $2.0
million from GlaxoSmithKline in connection with the commencement of Phase III studies of Promacta
(also known as eltrombopag) and a $0.3 million milestone from Wyeth in connection with the filing
of an NDA for Viviant (also known as bazedoxifene).
Development milestones revenue in 2005 reflects net development milestones of $3.0 million
earned from GlaxoSmithKline in connection with the commencement of Phase II studies of Viviant and
Phase I studies of SB-559448 for the treatment of thrombocytopenia; $1.4 million, net for prior
milestones received from Wyeth in connection with an agreement in the fourth quarter of 2005 to
amend the research, development, and license agreement between Ligand and Wyeth; $1.2 million
earned from Lilly in connection with the commencement of
41
Phase II trials of LY674 for the treatment of atherosclerosis; and $1.1 million from TAP in
connection with TAPs filing of an IND for LGD2941.
Development milestones revenue in 2004 includes net development milestones of $2.0 million
from Pfizer as a result of Pfizers filing with the FDA of a new drug application for Oporia (also
known as lasofoxifene), $0.8 million earned from TAP in connection with TAPs selection of an
additional selective androgen receptor modulator (SARM) as a second clinical candidate for
development for the treatment of major androgen-related diseases, and $0.8 million earned from
GlaxoSmithKline.
Gross Margin
Gross margin on product sales was 83.5% in 2006 compared to 79.5% in 2005. The improvement in
the gross margin percentage in 2006 reflects the impact of a 7% price increase effective April 1,
2005. Under the sell-through revenue recognition method, changes to prices do not impact net
product sales and therefore gross margins until the product sells through the distribution channel.
Accordingly, the price increases did not have a full period impact on the margins in 2005.
Additionally, as further discussed above under Net Product Sales, net sales and therefore the
gross margin percentage in 2006 benefited from: 1) the impact of lower Medicaid rebates; 2) lower
net charges related to the impact of price increases on expected returns; and 3) the release of an
accrual in the third quarter of 2006 and the refund in the fourth quarter of 2006 of rebates
previously paid, related to a court ruling by the U.S. Court of Appeals against the Department of
Defenses TriCare Retail Pharmacy refund program. Furthermore, cost of sales in terms of absolute
dollars decreased in 2006 compared to 2005 due primarily to a 4% decrease in prescriptions in 2006
compared to 2005.
Gross margin on product sales was 79.5% in 2005 compared to 73.7% in 2004. The improvement in
the gross margin percentages in 2005 reflects price increases which became effective July 1, 2004
and April 1, 2005. This improvement was partially offset by a higher proportionate level of
rebates and the costs associated with our wholesaler distribution service agreements which were
entered into in the third and fourth quarters of 2004.
Research and Development Expenses
Research and development expenses were $41.9 million in 2006 compared to $33.1 million in 2005
and $32.7 million in 2004. The major components of research and development expenses are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Research |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research performed under collaboration agreements |
|
$ |
1,968 |
|
|
$ |
3,611 |
|
|
$ |
7,853 |
|
Internal research programs |
|
|
22,110 |
|
|
|
20,839 |
|
|
|
15,517 |
|
|
|
|
|
|
|
|
|
|
|
Total research |
|
|
24,078 |
|
|
|
24,450 |
|
|
|
23,370 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Development |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
New product development |
|
|
13,837 |
|
|
|
1,264 |
|
|
|
2,568 |
|
Existing product support (1) |
|
|
4,011 |
|
|
|
7,382 |
|
|
|
6,782 |
|
|
|
|
|
|
|
|
|
|
|
Total development |
|
|
17,848 |
|
|
|
8,646 |
|
|
|
9,350 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total research and development |
|
$ |
41,926 |
|
|
$ |
33,096 |
|
|
$ |
32,720 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Includes costs incurred to comply with post-marketing regulatory commitments. |
Spending for research expenses was $24.1 million for 2006 compared to $24.5 million for
2005. The decrease in research expenses for 2006 compared to 2005 primarily reflects decreased
research expenses incurred under our collaboration arrangement with TAP which concluded in June
2006 partially offset by increased research performed under our Selective Androgen Receptor
Modulator (SARM) program.
Spending for research expenses amounted to $24.5 million for 2005 compared to $23.4 million
for 2004. The overall increase in 2005 is due to an increased level of internal program research
in the area of thrombopoietin
42
(TPO) agonists. This increase is partially offset by a decrease in research performed under
collaboration agreements due primarily to a lower contractual level of research funding under our
agreement with TAP and lower research funding under the Lilly collaboration which concluded in
November 2004.
Spending for development expenses increased to $17.8 million for 2006 compared to $8.6 million
for 2005. These increases reflect a higher level of expense for new product development partially
offset by a lower level of expense in existing product support. The increase in spending on new
product development was primarily due to the increase in LGD4665 thrombopoietin (TPO), our lead
drug candidate in this area which was moved into Phase I clinical trials, and LGD5552
(Glucocorticoid agonist) expenses. LGD5552 was on track to enter clinical trials in 2007; however
Good Laboratory Practice studies failed to demonstrate the desired pre-clinical safety
characteristics for a drug to treat rheumatoid arthritis. We decided in the first quarter of 2007
not to proceed with the development of LGD5552. The decrease in 2006 for existing product support
is due to lower product support for our AVINZA product.
Spending for development expenses decreased to $8.6 million for 2005 compared to $9.4 million
for 2004. This decrease primarily reflects a lower level of effort in our glucocorticoid agonist
program in 2005 compared to 2004.
43
A summary of our significant internal research and development programs as of December 31, 2006 is
as follows:
|
|
|
|
|
Program |
|
Disease/Indication |
|
Development Phase |
AVINZA
|
|
Chronic,
moderate-to-severe pain
|
|
Marketed in U.S.
Phase IV |
|
|
|
|
|
LGD4665 (Thrombopoietin
oral mimetic)
|
|
Idiopathic
Thrombocytopenia
Purpura; other
thrombocytopenias
|
|
Phase I |
|
|
|
|
|
Selective androgen
receptor modulators,
(agonists)
|
|
Hypogonadism,
osteoporosis, sexual
dysfunction, frailty,
cachexia.
|
|
Pre-clinical |
|
|
|
|
|
Selective glucocorticoid
receptor modulators
|
|
Inflammation, cancer
|
|
Research |
|
|
|
|
|
Selective androgen
receptor modulators,
(antagonists)
|
|
Prostate cancer
|
|
Research |
We do not provide forward-looking estimates of costs and time to complete our ongoing research
and development projects, as such estimates would involve a high degree of uncertainty.
Uncertainties include our ability to predict the outcome of complex research, our ability to
predict the results of clinical studies, regulatory requirements placed upon us by regulatory
authorities such as the FDA and EMEA, our ability to predict the decisions of our collaborative
partners, our ability to fund research and development programs, competition from other entities of
which we may become aware in future periods, predictions of market potential from products that may
be derived from our research and development efforts, and our ability to recruit and retain
personnel or third-party research organizations with the necessary knowledge and skills to perform
certain research. We do, however, expect that research and development expenses will be
significantly lower in 2007 compared to 2006 due to the reduction of our workforce and related
restructuring activities in early 2007 as further discussed under Recent Developments above, and
the related refocusing of our research and development activities on fewer, selected programs.
Refer to Item 1A. Risks Factors for additional discussion of the uncertainties surrounding our
research and development initiatives.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were $79.7 million for 2006 compared to $56.2
million for 2005 and $46.4 million for 2004. The increase reflects higher legal costs (incurred in
connection with the ongoing SEC investigation, shareholder litigation and our strategic
alternatives process) which increased by approximately $8.1 million in 2006 compared to 2005. In
June 2006, we announced that we had reached a settlement with the plaintiffs in the Companys
shareholder litigation. The amounts paid to the plaintiffs and the plaintiffs attorneys and a
portion of our legal expenses incurred in connection with the shareholder litigation were covered
by proceeds provided under our Directors and Officers (D&O) Liability insurance.
General and administrative expenses were also higher in 2006 due to higher audit and
consultant fees in connection with the completion of the Companys assessment of internal controls
as of December 31, 2005 under the Sarbanes-Oxley Act and consultant costs incurred in 2006 in
connection with our 2006 SOX compliance program. A significant portion of the Companys 2005
assessment of internal controls was performed in 2006 due to the fact that the restatement of our
financial statements was not completed until late 2005.
In addition, AVINZA advertising and promotion expenses increased in 2006 compared to 2005 and
2004 when Ligand and Organon shared equally all AVINZA promotion expenses. As part of the AVINZA
termination and return of rights agreement entered into in January 2006, discussed under Overview
above, we were responsible for all AVINZA advertising and promotion expenses. This increase was
partially offset by lower selling expenses due to a reduction in our AVINZA primary care sales
force.
Selling, general and administrative expenses for 2006 also include stock compensation expense
of approximately $3.6 million incurred in accordance with SFAS 123(R) which we implemented in 2006
(total company expense of
44
$4.8 million) and a charge of approximately $2.3 million related to a
reduction in our workforce communicated to
employees in the fourth quarter of 2006. Furthermore, general and administrative expenses in
2006 include approximately $1.9 million of expenses in connection with the resignation of the
Companys CEO. (Refer to Recent Developments above for further discussion of each of these
items.)
The increase for 2005 compared to 2004 reflects a higher level of costs associated with
additional Ligand sales representatives hired in the second and third quarter of 2004 to promote
AVINZA and higher advertising and promotion expenses for AVINZA. Compared to 2004, 2005 also
reflects higher accounting and legal expenses incurred in connection with the Audit Committees
review of the Companys consolidated financial statements, the restatement and re-audits of the
Companys consolidated financial statements and ongoing shareholder litigation.
We expect that selling, general and administrative expenses will be significantly lower in
2007 compared to 2006 due primarily to the sales of our AVINZA and oncology product lines, and the
reduction in our workforce and related restructuring activities in early 2007, as further discussed
under Recent Developments above.
Gain on Sale Leaseback
On October 25, 2006, we, along with our wholly-owned subsidiary Nexus, entered into an
agreement with Slough for the sale of our real property located in San Diego, California for a
purchase price of approximately $47.6 million. This property, with a net book value of
approximately $14.5 million, includes one building totaling approximately 82,500 square feet, the
land on which the building is situated, and two adjacent vacant lots. As part of the sale
transaction, we agreed to lease back the building for a period of 15 years. The sale transaction
subsequently closed on November 9, 2006.
In accordance with SFAS 13, Accounting for Leases, we recognized an immediate pre-tax gain on
the sale transaction of approximately $3.1 million in the fourth quarter of 2006 and deferred a
gain of approximately $29.5 million on the sale of the building. The deferred gain is recognized
as an offset to operating expense on a straight-line basis over the 15 year term of the lease at a
rate of approximately $2.0 million per year.
Co-promotion Expense and Co-promote Termination Charges
Co-promotion expense amounted to $37.5 million in 2006 compared to $32.5 million for 2005 and
$30.1 million for 2004. As discussed under Overview above, in connection with the AVINZA
termination and return of co-promote rights agreement with Organon, we agreed to pay Organon 23% of
net AVINZA product sales through September 30, 2006 as compensation for promotion of the product
during the Transition Period. This compares to co-promote expense in the prior year periods which
was based on 30% of net sales, as per the original co-promotion agreement, determined using the
sell-in method of revenue recognition.
Co-promotion expense recognized through the nine months ended September 30, 2006 also includes
$10.0 million which represents the accrual of a $10.0 million payment we agreed to make to Organon,
provided that Organon achieved its required level of sales calls during the Transition Period. We
paid Organon the $10.0 million in January 2007. This payment represents an approximation of the
fair value of the service element under the agreement during the Transition Period (when the
provision to pay 23% of AVINZA net sales is also considered) and, therefore, was recognized as an
additional component of the Organon co-promotion expense ratably over the Transition Period.
Co-promotion expense for the fourth quarter of 2006 was $3.8 million determined under the
terms of our Sales Call Agreement with King. As further discussed under Recent Developments
above, King agreed to perform certain minimum monthly product details (i.e. sales calls), which
commenced effective October 1, 2006.
Co-promote termination charges in 2006 were $131.1 million. This expense includes a $37.8
million payment made to Organon in October 2006, and the fair value of subsequent quarterly
payments, estimated at approximately $95.2 million as of January 1, 2006, that we agreed to make to
Organon based on net product sales of AVINZA, through November 2017. The co-promote termination
charge for 2006 also includes expense of approximately $14.2 million recorded throughout the year
to reflect the fair value of the liability as of December 31, 2006. The full year expense is net
of a credit recorded in the fourth quarter of 2006, resulting from a reduction in the liability of
approximately $15.7 million, based on our updated estimate as of December 31, 2006 of future AVINZA
sales.
45
On February 26, 2007, we closed the AVINZA sale transaction pursuant to which King acquired
all of our rights in and to AVINZA. King also assumed our co-promote termination obligation to
make payments to Organon based on net sales of AVINZA. As Organon has not consented to the legal
assignment of the co-promote termination obligation from us to King, we remain liable to Organon in
the event of Kings default of this obligation.
Other Expenses, Net
Other expenses, net were $5.5 million for 2006 compared to $9.6 million for 2005 and $7.2
million for 2004.
Interest income increased to $3.8 million for 2006 compared to $1.9 million for 2005 and $1.1
million for 2004. The increase in 2006 is primarily due to higher cash balances during the fourth
quarter of 2006 following the sale of our oncology product line to Eisai in October 2006 and the
sale and leaseback of our corporate headquarters in November 2006.
Interest expense decreased to $10.6 million for 2006 compared to $12.2 million for 2005 and
$12.0 million for 2004. Interest expense in 2006, 2005, and 2004 primarily represents interest on
the $155.3 million of 6% convertible subordinated notes that we issued in November 2002. The lower
interest expense on the 6% Convertible Subordinated Notes for 2006 is due to the conversion of such
notes during 2006 as discussed further under Recent Developments. As all such notes had
converted as of December 31, 2006, interest expense for 2007 is expected to be substantially lower
than 2006.
Other, net reflects income of $1.3 million in 2006 compared to $0.7 million in 2005 and $3.7
million in 2004. In September 2004, we agreed to vote our shares of X-Ceptor in favor of the
acquisition of X-Ceptor by Exelixis Inc. (Exelixis). Exelixis acquisition of X-Ceptor was
subsequently completed in October 2004 and in connection therewith, Ligand received shares of
Exelixis common stock. Such shares were subject to certain trading restrictions for two years.
Additionally, approximately 21% of the shares were placed in escrow for up to one year to satisfy
indemnification and other obligations. We recorded a net gain on the transaction in the fourth
quarter of 2004 of approximately $3.7 million, based on the fair market value of the consideration
received. During 2005, the shares were released from escrow and the Company recognized a gain of
$0.9 million. During 2005, the Company sold approximately 247,000 shares for net proceeds of $1.9
million. During 2006, the Company sold the remaining shares for net proceeds of $3.9 million. The
Company recognized a gain of $1.2 million in 2006 and a loss of $0.2 million in 2005 on these
sales, which are included in other income (expense).
Income Taxes
We had losses from continuing operations and income from discontinued operations for 2006. In
accordance with SFAS No. 109, Accounting for Income Taxes, the income tax benefit generated by the
loss from continuing operations in 2006 was $38.4 million. This income tax benefit captures the
deemed use of losses from continuing operations used to offset the income and gain from our
Oncology Product Line that was sold in 2006.
Net income tax expense combining both continuing and discontinued operations was $0.7 million
for 2006. This expense reflects the net tax due on taxable income for 2006 that was not fully
offset by net operating loss and research and development credit carryforwards due to federal and
state alternative minimum tax requirements. There was no income tax expense for 2005. Income tax
expense was $0.2 million for 2004.
Net operating loss carryforwards for federal and state income tax purposes of $405.5 million
and $165.4 million, respectively, are available to be utilized against future taxable income. The
net operating losses begin to expire in 2007. We also have $16.4 million of federal research and
development credit carryforwards that begin to expire in 2007 and $10.0 million of California
research and development credits that have no expiration date. Due to the uncertainty of future
taxable income, deferred tax assets resulting from these net operating loss and research and
development credit carryforwards have been fully reserved.
Pursuant to Internal Revenue Code Sections 382 and 383, use of net operating loss and credit
carryforwards may be limited if there were changes in ownership of more than 50%. We completed a
Section 382 study for Ligand, excluding Glycomed and Seragen, and have determined that Ligand had
an ownership change in September 2005. As a result of this ownership change, utilization of
Ligands net operating losses and credits are subject to limitations
46
under Internal Revenue Code Sections 382 and 383. The information necessary to determine if
an ownership change related to Glycomed and Seragen occurred prior to their acquisition by Ligand
is not currently available. Accordingly, such tax net operating loss and credit carryforwards are
not reflected in our deferred tax assets. If information becomes available in the future to
substantiate the amount of these NOLs and credits, we will record the deferred tax assets at such
time. Future changes in ownership could result in additional limitations on the utilization of our
net operating losses and tax credits under Internal Revenue Code Sections 382 and 383.
Our research and development tax credits pertain to federal and California jurisdictions.
These jurisdictions require that we maintain documentation and support. We recently completed a
formal study and believe that we maintain sufficient documentation to support the amounts of the
research and development tax credits.
Discontinued Operations
On September 7, 2006, we and Eisai entered into the Oncology Purchase Agreement pursuant to
which Eisai agreed to acquire all of our worldwide rights in and to our oncology products,
including, among other things, all related inventory, equipment, records and intellectual property,
and assume certain liabilities (the Oncology Product Line) as set forth in the Oncology Purchase
Agreement. The Oncology Product Line included our four marketed oncology drugs: ONTAK, Targretin
capsules, Targretin gel and Panretin gel. Pursuant to the Oncology Purchase Agreement, at closing
on October 25, 2006, we received approximately $185.0 million in net cash proceeds, which is net of
$20.0 million that was funded into an escrow account to support any indemnification claims made by
Eisai following the closing of the sale. Eisai also assumed certain liabilities. Of the escrowed
amounts not required for claims to Eisai, 50% of the then existing amount will be released on April
25, 2007 with the remaining available balance to be released on October 25, 2007. We also recorded
approximately $1.7 million in transaction fees and costs associated with the sale that are not
reflected in net cash proceeds. We recorded a pre-tax gain on the sale of $135.8 million in the
fourth quarter of 2006.
Income from discontinued operations before income taxes was $7.5 million in 2006 compared to
losses from discontinued operations before income taxes of $4.9 million and $22.3 million,
respectively, in 2005 and 2004 respectively. The following table summarizes results from
discontinued operations for 2006, 2005 and 2004 included in the consolidated statements of
operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Product sales |
|
$ |
47,512 |
|
|
$ |
53,288 |
|
|
$ |
50,865 |
|
Collaborative research and development
and other revenues |
|
|
208 |
|
|
|
310 |
|
|
|
535 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
47,720 |
|
|
|
53,598 |
|
|
|
51,400 |
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
13,410 |
|
|
|
16,757 |
|
|
|
21,540 |
|
Research and development |
|
|
12,895 |
|
|
|
22,979 |
|
|
|
32,484 |
|
Selling, general and administrative |
|
|
13,891 |
|
|
|
18,488 |
|
|
|
19,367 |
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
40,196 |
|
|
|
58,224 |
|
|
|
73,391 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
7,524 |
|
|
|
(4,626 |
) |
|
|
(21,991 |
) |
Interest expense |
|
|
(51 |
) |
|
|
(244 |
) |
|
|
(332 |
) |
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
7,473 |
|
|
$ |
(4,870 |
) |
|
$ |
(22,323 |
) |
|
|
|
|
|
|
|
|
|
|
Product sales were $47.5 million in 2006 compared to $53.3 million and $50.9 million,
respectively, for 2005 and 2004. The decrease in product sales in 2006 compared to 2005 is
primarily due to the sale of the Oncology Product Line effective October 25, 2006. The increase in
product sales in 2005 compared to 2004 is primarily due
47
to increases in sales of Targretin capsules from increased demand and the effect of price
increases. These increases are partially offset by lower net product sales of ONTAK due to lower
demand.
Total operating costs and expenses were $40.2 million in 2006 compared to $58.2 million and
$73.4 million, respectively, for 2005 and 2004. The decrease in 2006 compared to 2005 is primarily
due to the sale of the Oncology Product Line effective October 25, 2006.
The decrease in cost of products sold in 2005 compared to 2004 is due primarily to lower costs
of ONTAK in connection with lower ONTAK demand. Additionally, cost of products sold in 2004
reflects a charge to royalty expense in the amount of $3.0 million for deferred royalties at the
end of the contracted royalty period for which we did not have offset rights. Under the sell
through revenue recognition method, royalties paid based on unit shipments to wholesalers were
deferred and recognized as royalty expense as those units were sold through and recognized as
revenue. Royalties paid to technology partners were deferred as we had the right to offset
royalties paid for product that were later returned against subsequent royalty obligations.
Royalties for which we did have the right to offset, however, (for example, at the end of the
contracted royalty period) were expensed in the period the royalty obligation became due.
The decrease in 2005 operating expenses compared to 2004 is primarily due to decreased
research expenses across several Oncology research programs, decreased development expenses for
existing Oncology product support (primarily a reduced level of spending on Phase III clinical
trials for Targretin capsules in non-small cell lung cancer (NSCLC)), and lower promotion
expenses for the Oncology products compared to the prior year period.
The net losses from discontinued operations for 2005 and 2004 reflect the significant
development costs incurred on the NSCLC trials for Targretin capsules which concluded in 2005.
Liquidity and Capital Resources
We have financed our operations through private and public offerings of our equity securities,
collaborative research and development and other revenues, issuance of convertible notes, product
sales, capital and operating lease transactions, accounts receivable factoring and equipment
financing arrangements and investment income.
Working capital was $64.7 million at December 31, 2006 compared to a deficit of $102.2 million
at December 31, 2005. Cash, cash equivalents, short-term investments, and restricted cash and
investments totaled $212.5 million at December 31, 2006 compared to $88.8 million at December 31,
2005. We primarily invest our cash in United States government and investment grade corporate debt
securities. Restricted cash and investments at December 31, 2006 consist of certificates of
deposit held with a financial institution as collateral under asset financing and third-party
service provider arrangements, and funds held in an escrow account with a financial institution to
be used to repay a loan due to King. We repaid the loan plus interest on January 8, 2007.
Operating Activities
Operating activities used cash of $138.5 million in 2006 and provided cash of $8.4 million in
2005 and $5.8 million in 2004. The use of cash in 2006 reflects a net loss of $31.7 million,
adjusted by $24.1 million in items to reconcile the net loss to net cash used in operations. These
reconciling items include the gain on the sale of our oncology product line of $135.8 million and
the gain on the sale leaseback of our corporate headquarters of $3.1 million, partially offset by
non-cash co-promote termination expense of $93.3 million, depreciation and amortization of assets
of $16.2 million, and the recognition of $5.3 million of stock-based compensation expense in
connection with the adoption of SFAS 123(R), restricted stock grants to employees and option grants
to non-employees.
The use of cash for 2006 is further impacted by changes in operating assets and liabilities
due primarily to decreases in deferred revenue, net of $72.6 million, and accounts payable and
accrued liabilities of $27.6 million partially offset by decreases in accounts receivable, net of
$9.4 million; inventories of $1.6 million; and other current assets of $6.6 million. The decreases
in deferred revenue and accounts receivable are primarily due to a reduction in shipments of AVINZA
starting in September 2006. The AVINZA Purchase Agreement with King provided for a reduction in
the purchase price to the extent that product inventories in the wholesale and retail distribution
channels were in excess of specified amounts. Accordingly, we reduced shipments of AVINZA starting
48
in September 2006. The decrease in accounts payable and accrued liabilities is primarily due
to the payment of accrued fees for co-promotion services to Organon during and following the
co-promote transition period which terminated effective September 30, 2006, and lower headcount
costs and operational expenses following the sale of our Oncology Product Line to Eisai in October
2006.
Cash provided by operating activities in 2005 of $8.4 million reflects a net loss of $36.4
million, non-cash adjustments to operating activities of $18.1 million (primarily the amortization
of long-term assets of $18.7 million), and changes in operating assets and liabilities that
comprise a net cash inflow of $26.6 million. Changes in operating assets and liabilities provided
cash of $26.6 million in 2005 primarily due to increases in accounts payable and accrued
liabilities of $13.7 million, deferred revenue of $4.7 million, decreases in accounts receivable,
net of $9.9 million, and decreases in other current assets of $2.0 million, partially offset by an
increase in inventories of $3.4 million.
Cash provided by operating activities in 2004 of $5.8 million reflects a net loss of $45.1
million, non-cash adjustments to operating activities of $9.7 million, and changes in operating
assets and liabilities that comprise a net cash inflow of $41.2 million. The non-cash operating
items include the amortization of long-term assets of $15.3 million, partially offset by the gain
on sale of an equity investment of $3.7 million and a non-cash development milestone of $2.0
million. Changes in operating assets and liabilities provided cash of $41.2 million in 2004
primarily due to increases in deferred revenue of $47.9 million, and accounts payable and accrued
liabilities of $9.8 million, partially offset by increases in accounts receivable and inventories
of $11.9 million and $3.3 million, respectively.
Cash used in operating activities of $138.5 million in 2006 includes $38.3 million, net used
in discontinued operations. This compares to net cash used in discontinued operations of $6.6
million for 2005 and $10.9 million for 2004.
Investing Activities
Investing activities provided cash of $196.9 million in 2006, used cash of $33.7 million in
2005, and provided cash of $19.6 million in 2004. Cash provided by investing activities in 2006
includes net proceeds from the sale of our Oncology Product Line of $183.3 million, proceeds from
the sale leaseback of our corporate headquarters of $46.9 million, and net proceeds from the sale
of short-term investments of $7.2 million. These amounts were partially offset by an increase in
restricted cash and investments of $38.8 million, primarily from a requirement to fund $38.6
million of the funds received from the sale of our Oncology Product Line into a restricted account
to repay a loan to King in January 2007, and purchases of property and equipment of $1.8 million.
The use of cash in 2005 reflects $33.0 million of payments for the buy-down of ONTAK royalty
payments in connection with the amended royalty agreement entered into in November 2004 between the
Company and Lilly, and $2.6 million of purchases of property and equipment. The use of cash in
2005 was partially offset by net proceeds from the sale of short-term investments of $1.9 million.
Cash provided by investing activities in 2004 reflects net proceeds of $14.1 million from the
sale of short-term investments and $9.2 million from the maturing of restricted investments which
were used to pay interest on our 6% convertible subordinated notes. The use of cash for investing
activities in 2004 reflects $3.6 million for purchases of property and equipment.
Cash provided by investing activities of $196.8 million in 2006 includes $183.3 million
provided by discontinued operations from the sale of the Oncology Product Line. Cash used in
investing activities of $33.7 million in 2005 includes $33.0 used in discontinued operations for
the buy-down of the ONTAK royalty payments. None of the cash provided by investing activities of
$19.6 million in 2004 relates to discontinued operations.
Financing Activities
Financing activities provided cash of $33.3 million in 2006, used cash of $0.2 million in
2005, and provided cash of $7.9 million in 2004. Cash provided by financing activities in 2006
includes proceeds of $37.8 million from a note issued to King in connection with the AVINZA
Purchase Agreement and proceeds from the exercise of
49
employee stock options and stock purchases of $9.1 million, partially offset by the repayment
of the mortgage note payable due on our corporate headquarters of $11.8 million in connection with
the sale of that building in November 2006, and net payments under equipment financing arrangements
of $1.5 million.
Cash used in financing activities in 2005 reflects repayment of long-term debt and net
payments under equipment financing arrangements of $0.3 million and $0.8 million, respectively,
partially offset by net proceeds from the exercise of employee stock options and stock purchases
under our employee stock purchase plan of $0.9 million.
Cash provided by financing activities in 2004 includes net proceeds of $6.6 million from the
exercise of employee stock options and stock purchases under our employee stock purchase plan and
$1.8 million of net proceeds received under equipment financing arrangements.
Cash provided by financing activities of $33.3 million in 2006 includes $0.2 million used in
discontinued operations. This compares to cash used in discontinued operations for financing
activities of $0.04 million for 2005 and cash provided by financing activities of discontinued
operations of $0.2 million for 2004.
Certain of our property and equipment is pledged as collateral under various equipment
financing arrangements. As of December 31, 2006, $4.3 million was outstanding under such
arrangements with $2.2 million classified as current. Our equipment financing arrangements have
terms of three to five years with interest ranging from 7.35% to 10.11%.
The noteholders of our 6% convertible subordinated notes, in the aggregate principal amount of
$155.3 million, converted all of the notes into approximately 25.1 million shares of our common
stock in 2006. Accrued interest and unamortized debt issue costs related to the converted notes of
$0.5 million and $1.4 million, respectively, were recorded as additional paid-in capital.
Other Liquidity and Capital Resource Matters
In December 2006, following the sale of our Oncology Product Line to Eisai, we entered into a
plan to eliminate 63 employee positions. The affected employees were informed of the plan in
December 2006 with an effective termination date of January 2, 2007. In connection with the
termination plan, we expect to pay severance of approximately $2.4 million and other costs of $0.3
million in the first quarter of 2007.
On January 31, 2007, we announced an additional restructuring plan calling for the further
elimination of approximately 204 positions across all functional areas. This reduction was made in
connection with our efforts to refocus the Company, following the sale of our commercial assets, as
a smaller, highly focused research and development and royalty-driven
biotech company. In
connection with the restructuring, we expect to pay severance of approximately $7.5 million and
other costs of approximately $1.1 million in 2007.
Pursuant to the AVINZA Purchase Agreement, at closing in 2007, we received net cash proceeds
of approximately $280.4 million, which is a net of $15.0 million that was funded into an escrow
account to support any indemnification claims made by King. See further discussion above under
Recent Developments Sale of AVINZA Product.
On March 1, 2007, we entered into an indemnity fund agreement, which established in a trust
account with Dorsey & Whitney LLP, counsel to the Companys independent directors and to the Audit
Committee of our Board of Directors, a $10.0 million indemnity fund to support our existing
indemnification obligations to continuing and departing directors in connection with the ongoing
SEC investigation and related matters.
We believe our available cash, cash equivalents, short-term investments and existing sources
of funding will be sufficient to satisfy our anticipated operating and capital requirements through
at least the next 12 months. Our future operating and capital requirements will depend on many
factors including: the pace of scientific progress in our research and development programs; the
magnitude of these programs; the scope and results of preclinical testing and clinical trials; the
time and costs involved in obtaining regulatory approvals; the costs involved in preparing, filing,
prosecuting, maintaining and enforcing patent claims; competing technological and market
50
developments; and the efforts of our collaborators. We will also consider additional equipment
financing arrangements similar to arrangements currently in place.
We have never declared or paid any cash dividends on our capital stock. We have previously
announced that the Board is considering a special cash dividend in connection with our recent asset
sales, but no decision has yet been made regarding such dividend. Aside from the consideration of
this special one-time dividend, we do not intend to pay any cash dividends in the foreseeable
future. We currently intend to retain future earnings, if any, to finance future growth.
Leases and Off-Balance Sheet Arrangements
We lease certain of our office and research facilities under operating lease arrangements with
varying terms through November 2021. The agreements provide for increases in annual rents based on
changes in the Consumer Price Index or fixed percentage increases ranging from 3% to 7%.
Contractual Obligations
As of December 31, 2006, future minimum payments due under our contractual obligations are as
follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payments Due by Period |
|
|
|
Total |
|
|
Less than 1 year |
|
|
1-3 years |
|
|
3-5 years |
|
|
After 5 years |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital lease obligations (1) |
|
$ |
4,773 |
|
|
$ |
2,459 |
|
|
$ |
2,220 |
|
|
$ |
94 |
|
|
$ |
|
|
Operating lease obligations |
|
|
72,548 |
|
|
|
5,227 |
|
|
|
10,061 |
|
|
|
10,569 |
|
|
|
46,691 |
|
Loan payable to King Pharmaceuticals (2) |
|
|
38,633 |
|
|
|
38,633 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Co-promote termination liability (3) |
|
|
194,980 |
|
|
|
13,307 |
|
|
|
29,157 |
|
|
|
36,472 |
|
|
|
116,044 |
|
Retention bonus obligation |
|
|
2,654 |
|
|
|
2,654 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Severance obligation |
|
|
2,061 |
|
|
|
2,061 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Distribution service agreements |
|
|
4,818 |
|
|
|
4,818 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Consulting agreements |
|
|
1,270 |
|
|
|
1,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Manufacturing agreements (4) |
|
|
12,600 |
|
|
|
5,400 |
|
|
|
4,800 |
|
|
|
2,400 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total contractual obligations |
|
$ |
334,337 |
|
|
$ |
75,829 |
|
|
$ |
46,238 |
|
|
$ |
49,535 |
|
|
$ |
162,735 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) Includes interest payments as follows: |
|
$ |
449 |
|
|
$ |
291 |
|
|
$ |
155 |
|
|
$ |
3 |
|
|
$ |
|
|
|
(2) Includes interest payments as follows: |
|
|
883 |
|
|
|
883 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3) Includes accretion of interest as
follows: |
|
|
101,652 |
|
|
|
1,128 |
|
|
|
7,520 |
|
|
|
15,984 |
|
|
|
77,020 |
|
(4) Our AVINZA manufacturing agreement with Elan, with future minimum payments of $3.2
million as of December 31, 2006, was subsequently assumed by King in connection with the sale of
our AVINZA product line to King in February 2007. As further discussed below, our second source
AVINZA supply agreement with Cardinal was not assumed by King.
As of December 31, 2006, we have net open purchase orders (defined as total open purchase
orders at year end less any accruals or invoices charged to or amounts paid against such purchase
orders) totaling approximately $13.3 million. For the twelve months ended December 31, 2007, we
plan to spend approximately $0.6 million on capital expenditures.
In January 2006, we signed an agreement with Organon that terminated the AVINZA co-promotion
agreement between the two companies and returned AVINZA co-promotion rights to Ligand. After
termination, we agreed to make quarterly royalty payments to Organon equal to 6.5% of AVINZA net
sales through December 31, 2012 and thereafter 6.0% through patent expiration, currently
anticipated to be November 2017. In connection with the AVINZA Purchase Agreement, King assumed
our outstanding obligations to Organon. As Organon has not consented to the legal assignment of
the co-promote termination obligation for royalties from us to King, we remain liable to Organon in
the event of Kings default of this obligation.
51
In connection with the AVINZA Purchase Agreement discussed under Overview, King committed to
loan to us, at our option, $37.8 million (the Loan) to be used to pay our co-promote termination
obligation to Organon due October 15, 2006. This loan was drawn, and the $37.8 million co-promote
liability settled, in October 2006. Amounts due under the loan were subject to certain market
terms, including a 9.5% interest rate. In addition, and as a condition of the $37.8 million loan
received from King, $38.6 million of the funds received from Eisai for the sale of our Oncology
Product Line was deposited into a restricted account to be used to repay the loan to King, plus
interest. We repaid the loan plus interest in January 2007.
In May 2006, Ligand and Cardinal Health PTS, LLC (Cardinal) entered into the First Amendment
to the Manufacturing and Packaging Agreement for the manufacturing of AVINZA. The amendment
principally adjusted certain contract dates, near-term minimum commitments and contract prices.
Under the terms of the amended agreement, we committed to minimum annual purchases ranging from
$0.8 million to $1.2 million for 2006; $2.2 million to $3.3 million for 2007; and $2.4 million to
$3.6 million for 2008 through 2010. As part of the closing of the AVINZA sale transaction, we and
King agreed that the Cardinal agreement would not be assigned or transferred to King and that we
would be responsible for winding down the contract and any resulting liabilities.
In March 2006, we entered into letter agreements with approximately 67 of our key employees,
including a number of our executive officers. In September 2006, we entered into letter agreements
with ten additional key employees and modified existing agreements with two employees. These
letter agreements provided for certain retention or stay bonus payments to be paid in cash under
specified circumstances as an additional incentive to remain employed in good standing with the
Company through December 31, 2006. The Compensation Committee of the Board of Directors approved
the Companys entry into these Agreements. In accordance with SFAS 146, Accounting for Costs
Associated with Exit or Disposal Activities, the cost of the plan was ratably accrued over the term
of the agreements. We recognized approximately $3.3 million of expense under the plan in 2006.
On January 15, 2007, we announced that John L. Higgins had joined the Company as Chief
Executive Officer and President. Mr. Higgins succeeded Henry F. Blissenbach, who continues as
Chairman of the Board of Directors. We agreed to pay Mr. Higgins an annual salary of $400,000,
with his employment commencing as of January 10, 2007. In addition, Mr. Higgins has a performance
bonus opportunity with a target of 50% of his salary, up to a maximum of 75%, and received a
restricted stock grant of 150,000 shares of our common stock vesting over two years. We also
provided Mr. Higgins with a lump-sum relocation benefit of $100,000. Mr. Higgins employment
agreement provides for severance payments and benefits in the event that employment is terminated
under various scenarios, such as a change in control of the Company.
Critical Accounting Policies
Certain of our policies require the application of management judgment in making estimates and
assumptions that affect the amounts reported in the consolidated financial statements and
disclosures made in the accompanying notes. Those estimates and assumptions are based on
historical experience and various other factors deemed to be applicable and reasonable under the
circumstances. The use of judgment in determining such estimates and assumptions is by nature,
subject to a degree of uncertainty. Accordingly, actual results could differ materially from the
estimates made. Our critical accounting policies are as follows:
Revenue Recognition
Through December 31, 2006, we generated revenue from product sales, collaborative research and
development arrangements, and other activities such as distribution agreements, royalties, and
sales of technology rights. Our collaborative arrangements and distribution agreements may include
multiple elements within a single contract. Each element of the contract is separately negotiated.
Payments received may include non-refundable fees at the inception of the contract for technology
rights under collaborative arrangements or product rights under distribution agreements, fully
burdened funding for services performed during the research phase of collaborative arrangements,
milestone payments for specific achievements designated in the collaborative or distribution
agreements, royalties on sales of products resulting from collaborative arrangements, and payments
for the supply of products under distribution agreements.
52
We recognize product revenue in accordance with SAB 104 and SFAS 48 Revenue Recognition
When Right of Return Exists. SAB 104 states that revenue should not be recognized until it is
realized or realizable and earned. Revenue is realized or realizable and earned when all of the
following criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has
occurred or services have been rendered; (3) the sellers price to the buyer is fixed and
determinable; and (4) collectibility is reasonably assured. SFAS 48 states that revenue from sales
transactions where the buyer has the right to return the product shall be recognized at the time of
sale only if (1) the sellers price to the buyer is substantially fixed or determinable at the date
of sale, (2) the buyer has paid the seller, or the buyer is obligated to pay the seller and the
obligation is not contingent on resale of the product, (3) the buyers obligation to the seller
would not be changed in the event of theft or physical destruction or damage of the product, (4)
the buyer acquiring the product for resale has economic substance apart from that provided by the
seller, (5) the seller does not have significant obligations for future performance to directly
bring about resale of the product by the buyer, and (6) the amount of future returns can be
reasonably estimated.
Net Product Sales
Our AVINZA net product sales are determined on a sell-through basis whereby we do not
recognize revenue upon shipment of product to the wholesaler. For these product sales, we invoice
the wholesaler, record deferred revenue at gross invoice sales price less estimated cash discounts,
rebates and chargebacks, and classify the inventory held by the wholesaler as deferred cost of
goods sold within Other current assets. At that point, we make an estimate of units that may be
returned and record a reserve for those units against the deferred cost of goods sold account.
We recognize revenue when such inventory is sold through (as defined hereafter), on a first-in
first-out (FIFO) basis. Sell through for AVINZA is considered to be at the prescription level or
at the point of patient consumption for channels with no prescription requirements.
Additionally under the sell-through method, royalties paid based on unit shipments to
wholesalers are deferred and recognized as royalty expense as those units are sold through and
recognized as revenue. Royalties paid to technology partners are deferred as we have the right to
offset royalties paid for product that are later returned against subsequent royalty obligations.
Royalties for which we do not have the ability to offset (for example, at the end of the
contractual royalty period) are expensed in the period the royalty obligation becomes due.
We estimate sell-through based upon (1) analysis of third-party information, including
information obtained from certain wholesalers with respect to their inventory levels and
sell-through to customers, and third-party market research data, and (2) our internal product
movement information. To assess the reasonableness of third-party demand (i.e. sell-through)
information, we prepare separate demand reconciliations based on inventory in the distribution
channel. Differences identified through these reconciliations outside an acceptable range are
recognized as an adjustment to the third-party reported demand in the period those differences are
identified. This adjustment mechanism is designed to identify and correct for any material
variances between reported and actual demand over time and other potential anomalies such as
inventory shrinkage at wholesalers. Our estimates are subject to the inherent limitations of
estimates that rely on third-party data, as certain third-party information is itself in the form
of estimates. Our sales and revenue recognition under the sell-through method reflect our
estimates of actual product sold through the channel.
We use information from external sources to estimate our gross product sales under the
sell-through revenue recognition method and significant gross to net sales adjustments. Our
estimates include product information with respect to prescriptions, wholesaler out-movement and
inventory levels, and retail pharmacy stocking levels, and our own internal information. We
receive information from IMS Health, a supplier of market research to the pharmaceutical industry,
which we use to estimate sell-through demand for our products and retail pharmacy inventory levels.
We also receive wholesaler out-movement and inventory information from our wholesaler customers
that is used to support and validate our demand-based, sell-through revenue recognition estimates.
The inventory information received from wholesalers is a product of their record-keeping process
and their internal controls surrounding such processes.
53
The following summarizes the activity in the accrued liability accounts related to allowances
for loss on returns, rebates, chargebacks, and other discounts (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Managed |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Losses on |
|
|
|
|
|
|
Care |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns Due |
|
|
|
|
|
|
Rebates and |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
to Changes |
|
|
Medicaid |
|
|
Other |
|
|
Charge- |
|
|
Other |
|
|
|
|
|
|
|
|
|
In Price (1) |
|
|
Rebates |
|
|
Rebates |
|
|
backs |
|
|
Discounts |
|
|
Returns |
|
|
Total |
|
Balance at January 1, 2004 |
|
$ |
4,347 |
|
|
$ |
1,692 |
|
|
$ |
426 |
|
|
$ |
178 |
|
|
$ |
517 |
|
|
$ |
2,036 |
|
|
$ |
9,196 |
|
Provision |
|
|
5,018 |
|
|
|
14,430 |
|
|
|
5,773 |
|
|
|
3,962 |
|
|
|
6,495 |
|
|
|
3,015 |
|
|
|
38,693 |
|
Payments |
|
|
¾ |
|
|
|
(11,074 |
) |
|
|
(4,455 |
) |
|
|
(3,684 |
) |
|
|
(7,008 |
) |
|
|
¾ |
|
|
|
(26,221 |
) |
Charges |
|
|
(3,025 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(2,492 |
) |
|
|
(5,517 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2004 |
|
|
6,340 |
|
|
|
5,048 |
|
|
|
1,744 |
|
|
|
456 |
|
|
|
4 |
|
|
|
2,559 |
|
|
|
16,151 |
|
Provision |
|
|
1,801 |
|
|
|
18,852 |
|
|
|
10,592 |
|
|
|
5,874 |
|
|
|
¾ |
|
|
|
3,439 |
|
|
|
40,558 |
|
Payments |
|
|
¾ |
|
|
|
(18,552 |
) |
|
|
(8,869 |
) |
|
|
(6,130 |
) |
|
|
(4 |
) |
|
|
¾ |
|
|
|
(33,555 |
) |
Charges |
|
|
(4,103 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(3,322 |
) |
|
|
(7,425 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2005 |
|
|
4,038 |
|
|
|
5,348 |
|
|
|
3,467 |
|
|
|
200 |
|
|
|
¾ |
|
|
|
2,676 |
|
|
|
15,729 |
|
Provision |
|
|
2,324 |
|
|
|
4,515 |
|
|
|
8,131 |
|
|
|
5,624 |
|
|
|
¾ |
|
|
|
1,368 |
|
|
|
21,962 |
|
Oncology Transaction
Provision (2) |
|
|
¾ |
|
|
|
363 |
|
|
|
¾ |
|
|
|
1,913 |
|
|
|
¾ |
|
|
|
10,020 |
|
|
|
12,296 |
|
Payments |
|
|
¾ |
|
|
|
(8,820 |
) |
|
|
(8,037 |
) |
|
|
(6,457 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
(23,314 |
) |
Charges |
|
|
(5,021 |
) |
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
(6,964 |
) |
|
|
(11,985 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2006 |
|
$ |
1,341 |
|
|
$ |
1,406 |
|
|
$ |
3,561 |
|
|
$ |
1,280 |
|
|
$ |
¾ |
|
|
$ |
7,100 |
|
|
$ |
14,688 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The provision for losses on returns is net of changes in the allowance for such
losses resulting from different actual rates of return on lots of AVINZA that close out
compared to the rate of return used to initially estimate the allowance upon an announced
price increase. |
|
(2) |
|
The 2006 oncology transaction provision represents additional accruals
recorded in connection with the sale of the oncology product line to Eisai on October 25,
2006. We will maintain the obligation for returns of product that were shipped to wholesalers
prior to the close of the Eisai transaction on October 25, 2006 and chargebacks and rebates
associated with product in the distribution channel as of the closing date. See Note 3 to our
consolidated financial statements for additional information. |
Sale of Royalty Rights
Revenue from the sale of royalty rights represents the non-refundable sale to third parties of
rights for and exercise of options to acquire future royalties we may earn from the sale of
products in development with our collaborative partners. If we have no continuing involvement in
the research, development or marketing of these products, sales of royalty rights are recognized as
revenue in the period the transaction is consummated or the options are exercised or expired. If
we have significant continuing involvement in the research, development or marketing of the
product, proceeds received for the sale of royalty rights are accounted for as a financing
arrangement in accordance with EITF 88-18, Sales of Future Revenues.
Collaborative Research and Development and Other Revenues
Collaborative research and development and other revenues are recognized as services are
performed consistent with the performance requirements of the contract. Non-refundable contract
fees for which no further performance obligation exists and where we have no continuing involvement
are recognized upon the earlier of when payment is received or collection is assured. Revenue from
non-refundable contract fees where we have continuing involvement through research and development
collaborations or other contractual obligations is recognized ratably over the development period
or the period for which we continue to have a performance obligation. Revenue from performance
milestones is recognized upon the achievement of the milestones as specified in the respective
agreement. Payments received in advance of performance or delivery are recorded as deferred
revenue and subsequently recognized over the period of performance or upon delivery.
54
Allowance for Return Losses
Product sales are net of adjustments for losses resulting from price increases we may
experience on product returns from our wholesaler customers. Our policy for returns of AVINZA
allows customers to return the product six months prior to and six months after expiration. Upon
an announced price increase, typically in the quarter prior to when a price increase becomes
effective, the Company revalues its estimate of deferred product revenue to be returned to
recognize the potential higher credit a wholesaler may take upon product return determined as the
difference between the new price and the previous price used to value the allowance. Due to
estimates and assumptions inherent in determining the amount of return losses, the actual amount of
product returns may be materially different from our estimates. In addition, because of the
inherent difficulties of predicting possible changes to the estimates and assumptions used to
determine losses to be incurred on returns from price changes due to, among other factors, changes
in future prescription levels and wholesaler inventory practices, we are unable to quantify an
estimate of the reasonably likely effect of any such changes on our results of operations or
financial position. For reference purposes, a 10% to 20% variance to our estimated allowance for
return losses as of December 31, 2006 would result in an approximate $0.1 million to $0.3 million
adjustment to net product sales.
Medicaid Rebates
Our products are subject to state government-managed Medicaid programs whereby discounts and
rebates are provided to participating state governments. We account for Medicaid rebates by
establishing an accrual in an amount equal to our estimate of Medicaid rebate claims. We determine
our estimate of the Medicaid rebate accrual primarily based on historical experience regarding
Medicaid rebates, as well as current and historical prescription activity provided by external
sources, current contract prices and any expected contract changes. We additionally consider any
legal interpretations of the applicable laws related to Medicaid and qualifying federal and state
government programs and any new information regarding changes in the Medicaid programs regulations
and guidelines that would impact the amount of the rebates. We adjust the accrual periodically
throughout each period to reflect actual experience, expected changes in future prescription
volumes and any changes in business circumstances or trends. In addition, because of the inherent
difficulties of predicting the impact on our estimates and assumptions of rapidly evolving state
Medicaid programs and regulations, we are unable to quantify an estimate of the reasonably likely
effect of any such changes on our results of operations or financial position. For reference
purposes, a 10% to 20% variance to our estimated allowance for state Medicaid rebates as of
December 31, 2006 would result in an approximate $0.1 million to $0.3 million adjustment to net
product sales.
Government Chargebacks
Our products are subject to certain programs with federal government entities and other
parties whereby pricing on products is extended below wholesaler list price to participating
entities. These entities purchase products through wholesalers at the lower vendor price, and the
wholesalers charge the difference between their acquisition cost and the lower vendor price back to
us. We account for chargebacks by establishing an accrual in an amount equal to our estimate of
chargeback claims. We determine our estimate of the chargebacks primarily based on historical
experience regarding chargebacks and current contract prices under the vendor programs. We
consider vendor payments and our claim processing time lag and adjust the accrual periodically
throughout each period to reflect actual experience and any changes in business circumstances or
trends. Due to estimates and assumptions inherent in determining the amount of government
chargebacks, the actual amount of claims for chargebacks may be materially different from our
estimates. Based on our experience with government chargebacks, however, we do not believe that a
material change to our estimated allowance for chargebacks is reasonably likely.
Managed Health Care Rebates and Other Contract Discounts
We offer rebates and discounts to managed health care organizations and to other contract
counterparties such as hospitals and group purchasing organizations in the U.S. We account for
managed health care rebates and other contract discounts by establishing an accrual in an amount
equal to our estimate of managed health care rebates and other contract discounts. We determine
our estimate of the managed health care rebates and other contract discounts accrual primarily
based on historical experience regarding these rebates and discounts and current contract prices.
We also consider the current and historical prescription activity provided by external sources,
current contract prices and any expected contract changes and adjust the accrual periodically
throughout each period to reflect actual
55
experience and any changes in business circumstances or trends. Due to estimates and
assumptions inherent in determining the amount of rebates and contract discounts, the actual amount
of claims for rebates and discounts may be materially different from our estimates. In addition,
because of the inherent difficulties of predicting the impact on our estimates and assumptions of
rapidly evolving managed care programs, we are unable to quantify an estimate of the reasonably
likely effect of any such changes on our results of operations or financial position. For
reference purposes, a 10% to 20% variance to our estimated allowance for managed health care and
other contract discounts as of December 31, 2006 would result in an approximate $0.3 million to
$0.7 million adjustment to net product sales.
Oncology Product Returns
In connection with the sale of the oncology product line to Eisai Inc., we retained the
obligation for returns of product that were shipped to wholesalers prior to the close of the
transaction on October 25, 2006. The accrual for oncology product returns, which was recorded as
part of the accounting for the sales transaction, is based on historical experience. Due to the
estimates and assumptions inherent in determining the amount of wholesaler returns, we are unable
to quantify an estimate of the reasonably likely effect of any such changes on our results of
operations or financial position. For reference purposes, a 10% to 20% variance to our estimated
allowance for wholesaler returns on the oncology products would result in an approximate $0.6
million to $1.1 million adjustment to the reserve for oncology product returns.
Co-Promote Termination Accounting
As part of the termination and return of co-promotion rights agreement that we entered into
with Organon in January 2006, we agreed to make quarterly payments to Organon, effective for the
fourth quarter of 2006, equal to 6.5% of AVINZA net sales through December 31, 2012 and thereafter
6% through patent expiration, currently anticipated to be November 2017. The estimated fair value
of the amounts to be paid to Organon after the termination ($95.2 million as of January 2006),
based on the future net sales of the product, was recognized as a liability and expensed as a cost
of the termination as of the effective date of the agreement, January 2006.
Although the quarterly payments to Organon are based on net reported AVINZA product sales,
such payments do not result in current period expense in the period upon which the payment is
based, but instead are charged against the co-promote termination liability. Any changes to our
estimates of future net AVINZA product sales, however, result in a change to the liability which is
recognized as an increase or decrease to co-promote termination charges in the period such changes
are identified. We also recognize additional co-promote termination charges each period to reflect
the fair value of the termination liability. On a quarterly basis, management reviews the carrying
value of the co-promote termination liability. Due to assumptions and judgments inherent in
determining the estimates of future net AVINZA sales through November 2017, the actual amount of
net AVINZA sales used to determine the amount actually due Organon for a particular period may be
materially different from our current estimates. In addition, because of the inherent difficulties
of predicting possible changes to the estimates and assumptions used to determine the estimate of
future AVINZA product sales, we are unable to quantify an estimate of the reasonably likely effect
of any such changes on our results of operations or financial position. In accordance with the
AVINZA Purchase Agreement, King assumed our co-promote termination obligation to make payments to
Organon based on net sales of AVINZA. As Organon has not consented to the legal assignment of the
co-promote termination obligation from us to King, we remain liable to Organon in the event of
Kings default of this obligation.
Inventories
Our inventories are stated at the lower of cost or market value. Cost is determined using the
first-in, first-out method. We record reserves for estimated obsolescence to account for
unsaleable products including products that are nearing or have reached expiration, and slow-moving
inventory. If actual future demand or market conditions are less favorable than our estimates,
then additional material inventory write-downs might be required.
Acquired Technology and Product Rights
Acquired technology and product rights as of December 31, 2006 represent payments related to
our acquisition of license and product rights for AVINZA. In accordance with SFAS 142, these
amounts are amortized on a straight line basis since the pattern in which the economic benefit of
these assets are consumed (or otherwise used up) cannot
56
be reliably determined. Accordingly, acquired technology and product rights are amortized on
a straight-line basis over 15 years, which approximated the remaining patent life at the time the
assets were acquired and represents the period estimated to be benefited. Specifically, we are
amortizing AVINZA through November 2017, the expiration of its U.S. patent.
Impairment of Long-Lived Assets
We review long-lived assets, including acquired technology and product rights and property and
equipment, during the fourth quarter of each year, or whenever events or circumstances indicate
that the carrying amount of the assets may not be fully recoverable. We measure the recoverability
of assets to be held and used by comparing the carrying amount of an asset to the future
undiscounted net cash flows expected to be generated by the asset. If an asset is considered to be
impaired, the impairment to be recognized is measured as the amount by which the carrying amount of
the asset exceeds its fair value. Fair value of our long-lived assets is determined using the
expected cash flows discounted at a rate commensurate with the risk involved. Assumptions and
estimates used in the evaluation of impairment may affect the carrying value of long-lived assets,
which could result in impairment charges in future periods. As of December 31, 2006, we believe
that the future cash flows to be received from our long-lived assets will exceed the assets
carrying value.
Income Taxes
Income taxes are accounted for under the liability method. This approach requires the
recognition of deferred tax assets and liabilities for the expected future tax consequences of
differences between the tax basis of assets or liabilities and their carrying amounts in the
consolidated financial statements. A valuation allowance is provided for deferred tax assets if it
is more likely than not that these items will either expire before we are able to realize their
benefit or if future deductibility is uncertain. Developing the provision for income taxes
requires significant judgment and expertise in federal and state income tax laws, regulations and
strategies, including the determination of deferred tax assets and liabilities and, if necessary,
any valuation allowances that may be required for deferred tax assets. Our judgments and tax
strategies are subject to audit by various taxing authorities. While we believe we have provided
adequately for our income tax liabilities in our consolidated financial statements, adverse
determinations by these taxing authorities could have a material adverse effect on our consolidated
financial condition and results of operations.
Stock-Based Compensation
Effective January 1, 2006, our accounting policy related to stock option accounting changed
upon our adoption of SFAS No. 123(R), Share-Based Payment. SFAS 123(R) requires us to expense the
fair value of employee stock options and other forms of stock-based compensation. Under the fair
value recognition provisions of SFAS 123(R), stock-based compensation cost is estimated at the
grant date based on the value of the award and is recognized as expense ratably over the service
period of the award. Determining the appropriate fair value model and calculating the fair value
of stock-based awards requires judgment, including estimating stock price volatility, the risk-free
interest rate, forfeiture rates and the expected life of the equity instrument. Expected
volatility utilized in the model is based on the historical volatility of the Companys stock price
and other factors. The risk-free interest rate is derived from the U.S. Treasury yield in effect
at the time of the grant. The model incorporates forfeiture assumptions based on an analysis of
historical data. The expected life of the 2006 grants is derived in accordance with the safe
harbor expected term assumptions under SAB No. 107. We recorded $5.3 million of stock-based
compensation in 2006 for awards granted to employees and non-employee directors.
Prior to January 1, 2006, we accounted for options granted to employees in accordance with APB
No. 25, Accounting for Stock Issued to Employees, and related interpretations and followed the
disclosure requirements of SFAS No. 123, Accounting for Stock-Based Compensation. Therefore,
prior to the first quarter of 2006, we did not record any compensation cost related to stock-based
awards, as all options granted prior to 2006 had an exercise price equal to the market value of the
underlying common stock on the date of grant. Periods prior to our first quarter of 2006 were not
restated to reflect the fair value method of expensing stock options. The impact of expensing
stock awards on our earnings may be significant and is further described in Note 2 to the notes to
the consolidated financial statements.
57
New Accounting Pronouncements
In November 2005, the Financial Accounting Standards Board (FASB) issued Staff Positions
(FSPs) Nos. FSPs 115-1 and 124-1, The Meaning of Other-Than-Temporary Impairment and Its
Application to Certain Investments, in response to EITF 03-1, The Meaning of Other-Than-Temporary
Impairment and Its Application to Certain Investments (EITF 03-1). FSPs 115-1 and 124-1 provide
guidance regarding the determination as to when an investment is considered impaired, whether that
impairment is other-than-temporary, and the measurement of an impairment loss. FSPs 115-1 and
124-1 also include accounting considerations subsequent to the recognition of an
other-than-temporary impairment and requires certain disclosures about unrealized losses that have
not been recognized as other-than temporary-impairments. These requirements are effective for
annual reporting periods beginning after December 15, 2005. The adoption of the impairment
guidance contained in FSPs 115-1 and 124-1 did not have a material impact on the Companys
consolidated results of operations or financial position.
In November 2004, the FASB issued SFAS No. 151, Inventory Pricing (SFAS 151). SFAS 151
amends the guidance in ARB No. 43, Chapter 4, Inventory Pricing, to clarify the accounting for
abnormal amounts of idle facility expense, freight, handling costs, and wasted material (spoilage).
This statement requires that those items be recognized as current-period charges. In addition,
SFAS 151 requires that allocation of fixed production overheads to the costs of conversion be based
on the normal capacity of the production facilities. This statement is effective for inventory
costs incurred during fiscal years beginning after June 15, 2005. The adoption of SFAS 151 did not
have a material impact on the Companys consolidated results of operations or financial position.
In February 2006, the FASB issued SFAS No. 155, Accounting for Certain Hybrid Financial
Instruments (SFAS 155) which amends SFAS No. 133, Accounting for Derivative Instruments and
Hedging Activities (SFAS 133) and SFAS 140, Accounting for the Impairment or Disposal of
Long-Lived Assets (SFAS 140). Specifically, SFAS 155 amends SFAS 133 to permit fair value
remeasurement for any hybrid financial instrument with an embedded derivative that otherwise would
require bifurcation, provided the whole instrument is accounted for on a fair value basis.
Additionally, SFAS 155 amends SFAS 140 to allow a qualifying special purpose entity to hold a
derivative financial instrument that pertains to a beneficial interest other than another
derivative financial instrument. SFAS 155 applies to all financial instruments acquired or issued
after the beginning of an entitys first fiscal year that begins after September 15, 2006, with
early application allowed. The adoption of SFAS 155 is not expected to have a material impact on
the Companys consolidated results of operations or financial position.
In March 2006, the FASB issued SFAS No. 156, Accounting for Servicing of Financial Assets
(SFAS 156) to simplify accounting for separately recognized servicing assets and servicing
liabilities. SFAS 156 amends SFAS No. 140, Accounting for Transfers and Servicing of Financial
Assets and Extinguishments of Liabilities. Additionally, SFAS 156 applies to all separately
recognized servicing assets and liabilities acquired or issued after the beginning of an entitys
fiscal year that begins after September 15, 2006, although early adoption is permitted. The
adoption of SFAS 156 is not expected to have a material impact on the Companys consolidated
results of operations or financial position.
In July 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxes- an interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in a companys financial statements in accordance with FASB
Statement No. 109. It prescribes a recognition threshold and measurement attribute for the
financial statement recognition and measurement of a tax position taken or expected to be taken in
a tax return. Additionally, FIN 48 provides guidance on derecognition, classification, interest
and penalties, accounting in interim periods, disclosure, and transition. FIN 48 is effective for
fiscal years beginning after December 15, 2006. While the analysis of the impact of FIN 48 is not
yet complete, the Company does not expect that the adoption of FIN 48 will have a material impact
on its consolidated financial statements.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS
157 defines fair value, establishes a framework for measuring fair value under GAAP, and expands
disclosures about fair value measurements. SFAS 157 applies under other accounting pronouncements
that require or permit fair value measurements where fair value has previously been concluded to be
the relevant measurement attribute. SFAS 157 is effective for financial statements issued for
fiscal years beginning after November 15, 2007. The Company will
58
adopt SFAS 157 in the first interim period of fiscal 2008 and is evaluating the impact, if
any, that the adoption of the statement will have on its consolidated results of operations and
financial position.
In September 2006, the FASB issued SFAS No. 158, Employers Accounting for Defined Benefit
Pension and Other Postretirement Plans, an amendment of FASB Statement No. 87, 88, 106 and 132(R)
(SFAS 158). Under SFAS 158, companies must recognize a net liability or asset to report the
funded status of their defined benefit pension and other postretirement benefit plans (collectively
referred to herein as benefit plans) on their balance sheets, starting with balance sheets as of
December 31, 2006 if they are a calendar year-end public company. SFAS 158 also changed certain
disclosures related to benefit plans. The adoption of SFAS 158 did not have a material impact on
the Companys consolidated results of operations or financial position.
In September 2006, the SEC released Staff Accounting Bulletin No. 108, Considering the Effects
of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements
(SAB 108). SAB 108 provides guidance on how the effects of prior-year uncorrected financial
statement misstatements should be considered in quantifying a current year misstatement. SAB 108
requires registrants to quantify misstatements using both an income statement (rollover) and
balance sheet (iron curtain) approach and evaluate whether either approach results in a
misstatement that, when all relevant quantitative and qualitative factors are considered, is
material. If prior year errors that had been previously considered immaterial are now considered
material based on either approach, no restatement is required as long as management properly
applied its previous approach and all relevant facts and circumstances were considered. If prior
years are not restated, the cumulative effect adjustment is recorded in opening retained earnings
as of the beginning of the fiscal year of adoption. SAB 108 is effective for fiscal years ending
on or after November 15, 2006. The adoption of SAB 108 did not have a material impact on the
Companys consolidated results of operations or financial position.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities-Including an amendment of FASB Statement No. 115 (SFAS 159). SFAS 159
permits entities to choose to measure many financial instruments and certain other items at fair
value. Most of the provisions of SFAS 159 apply only to entities that elect the fair value option;
however, the amendment to FASB Statement No. 115, Accounting for Certain Investments in Debt and
Equity Securities, applies to all entities with available-for-sale and trading securities. The
Company will adopt SFAS 159 in the first interim period of fiscal 2008 and is evaluating the
impact, if any, that the adoption of this statement will have on its consolidated results of
operations and financial position.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
At December 31, 2006 and 2005, our investment portfolio included fixed-income securities of
$13.5 million and $18.5 million, respectively. These securities are subject to interest rate risk
and will decline in value if interest rates increase. However, due to the short duration of our
investment portfolio, an immediate 10% change in interest rates would have no material impact on
our financial condition, results of operations or cash flows. At December 31, 2006 and 2005, we
also have certain equipment financing arrangements with variable rates of interest. Due to the
relative insignificance of such arrangements, however, an immediate 10% change in interest rates
would have no material impact on our financial condition, results of operations, or cash flows.
Declines in interest rates over time will, however, reduce our interest income, while increases in
interest rates over time will increase our interest expense.
We do not have a significant level of transactions denominated in currencies other than U.S.
dollars and as a result we have very limited foreign currency exchange rate risk. The effect of an
immediate 10% change in foreign exchange rates would have no material impact on our financial
condition, results of operations or cash flows.
59
Item 8. Consolidated Financial Statements and Supplementary Data
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
60
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders
Ligand Pharmaceuticals Incorporated
San Diego, California
We have audited the accompanying consolidated balance sheets of Ligand Pharmaceuticals Incorporated
and subsidiaries (the Company) as of December 31, 2006 and 2005, and the related consolidated
statements of operations, stockholders equity (deficit) and comprehensive loss, and cash flows for
each of the years in the three year period ended December 31, 2006. We have also audited the
schedule listed in the accompanying Item 15. These consolidated financial statements and schedule
are the responsibility of the Companys management. Our responsibility is to express an opinion on
these consolidated financial statements and 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 consolidated financial
statements and schedule are free of material
misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and
disclosures in the consolidated financial statements and schedule, 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 and schedule referred to above present fairly, in all
material respects, the consolidated financial position of Ligand Pharmaceuticals Incorporated and
subsidiaries as of December 31, 2006 and 2005, and the consolidated results of its operations and
its cash flows for each of the years in the three year period ended December 31, 2006, in
conformity with accounting principles generally accepted in the United States of America.
As discussed in Note 2 to the consolidated financial statements, effective January 1, 2006, the
Company adopted Statement of Financial Accounting Standards No. 123R (SFAS No. 123R) Share-Based
Payment, which addresses the accounting for stock-based payment transactions in which an
enterprise receives employee services in exchange for (a) equity instruments of the enterprise or
(b) liabilities that are based on the fair value of the enterprises equity instruments or that may
be settled by the issuance of such equity instruments.
We have also audited, in accordance with the standards of the Public Company Accounting Oversight
Board (United States), the effectiveness of Ligand Pharmaceuticals Incorporateds internal control
over financial reporting as of December 31, 2006, based on criteria established in The Internal
Control Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission and our report dated March 14, 2007 expressed an unqualified opinion thereon.
/s/ BDO Seidman, LLP
Costa Mesa, California
March 14, 2007
61
LIGAND PHARMACEUTICALS INCORPORATED
CONSOLIDATED BALANCE SHEETS
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
158,401 |
|
|
$ |
66,756 |
|
Short-term investments |
|
|
13,447 |
|
|
|
20,174 |
|
Restricted cash |
|
|
38,814 |
|
|
|
|
|
Accounts receivable, net |
|
|
11,521 |
|
|
|
20,954 |
|
Current portion of inventories, net |
|
|
3,856 |
|
|
|
9,333 |
|
Other current assets |
|
|
9,518 |
|
|
|
15,750 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
235,557 |
|
|
|
132,967 |
|
Restricted investments |
|
|
1,826 |
|
|
|
1,826 |
|
Long-term portion of inventories, net |
|
|
|
|
|
|
5,869 |
|
Property and equipment, net |
|
|
5,551 |
|
|
|
22,483 |
|
Acquired technology, product rights and royalty buy-down, net |
|
|
83,083 |
|
|
|
146,770 |
|
Other assets |
|
|
36 |
|
|
|
4,704 |
|
|
|
|
|
|
|
|
Total assets |
|
$ |
326,053 |
|
|
$ |
314,619 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS EQUITY (DEFICIT) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
12,259 |
|
|
$ |
15,360 |
|
Accrued liabilities |
|
|
46,509 |
|
|
|
59,587 |
|
Current portion of deferred revenue, net |
|
|
57,981 |
|
|
|
157,519 |
|
Current portion of deferred gain |
|
|
1,964 |
|
|
|
|
|
Current portion of co-promote termination liability |
|
|
12,179 |
|
|
|
|
|
Current portion of equipment financing obligations |
|
|
2,168 |
|
|
|
2,401 |
|
Current portion of debt |
|
|
37,750 |
|
|
|
344 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
170,810 |
|
|
|
235,211 |
|
Long-term debt |
|
|
|
|
|
|
166,745 |
|
Long-term portion of co-promote termination liability |
|
|
81,149 |
|
|
|
|
|
Long-term portion of equipment financing obligations |
|
|
2,156 |
|
|
|
3,430 |
|
Long-term portion of deferred revenue, net |
|
|
2,546 |
|
|
|
4,202 |
|
Long-term portion of deferred gain |
|
|
27,220 |
|
|
|
|
|
Other long-term liabilities |
|
|
2,475 |
|
|
|
3,105 |
|
|
|
|
|
|
|
|
Total liabilities |
|
|
286,356 |
|
|
|
412,693 |
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Common stock subject to conditional redemption; 997,568 shares issued and
outstanding at December 31, 2006 and 2005, respectively |
|
|
12,345 |
|
|
|
12,345 |
|
|
|
|
|
|
|
|
Stockholders equity (deficit): |
|
|
|
|
|
|
|
|
Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; none issued |
|
|
|
|
|
|
|
|
Common stock, $0.001 par value; 200,000,000 shares authorized; 99,553,504 and 73,136,340 shares
issued at December 31, 2006 and 2005, respectively |
|
|
100 |
|
|
|
73 |
|
Additional paid-in capital |
|
|
891,446 |
|
|
|
720,988 |
|
Accumulated other comprehensive (loss) income |
|
|
(481 |
) |
|
|
490 |
|
Accumulated deficit |
|
|
(862,802 |
) |
|
|
(831,059 |
) |
|
|
|
|
|
|
|
|
|
|
28,263 |
|
|
|
(109,508 |
) |
Treasury stock, at cost; 73,842 shares |
|
|
(911 |
) |
|
|
(911 |
) |
|
|
|
|
|
|
|
Total stockholders equity (deficit) |
|
|
27,352 |
|
|
|
(110,419 |
) |
|
|
|
|
|
|
|
|
|
$ |
326,053 |
|
|
$ |
314,619 |
|
|
|
|
|
|
|
|
See accompanying notes to these consolidated financial statements.
62
LIGAND PHARMACEUTICALS INCORPORATED
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
136,983 |
|
|
$ |
112,793 |
|
|
$ |
69,470 |
|
Sale of royalty rights, net |
|
|
|
|
|
|
|
|
|
|
31,342 |
|
Collaborative research and development and other revenues |
|
|
3,977 |
|
|
|
10,217 |
|
|
|
11,300 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
140,960 |
|
|
|
123,010 |
|
|
|
112,112 |
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
22,642 |
|
|
|
23,090 |
|
|
|
18,264 |
|
Research and development |
|
|
41,926 |
|
|
|
33,096 |
|
|
|
32,720 |
|
Selling, general and administrative |
|
|
79,748 |
|
|
|
56,168 |
|
|
|
46,431 |
|
Co-promotion |
|
|
37,455 |
|
|
|
32,501 |
|
|
|
30,077 |
|
Co-promote termination charges |
|
|
131,078 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
312,849 |
|
|
|
144,855 |
|
|
|
127,492 |
|
Gain on sale leaseback |
|
|
3,119 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(168,770 |
) |
|
|
(21,845 |
) |
|
|
(15,380 |
) |
|
|
|
|
|
|
|
|
|
|
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
3,780 |
|
|
|
1,890 |
|
|
|
1,096 |
|
Interest expense |
|
|
(10,614 |
) |
|
|
(12,214 |
) |
|
|
(12,006 |
) |
Other, net |
|
|
1,331 |
|
|
|
699 |
|
|
|
3,705 |
|
|
|
|
|
|
|
|
|
|
|
Total other expense, net |
|
|
(5,503 |
) |
|
|
(9,625 |
) |
|
|
(7,205 |
) |
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(174,273 |
) |
|
|
(31,470 |
) |
|
|
(22,585 |
) |
Income tax benefit (expense) |
|
|
38,414 |
|
|
|
|
|
|
|
(179 |
) |
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations |
|
|
(135,859 |
) |
|
|
(31,470 |
) |
|
|
(22,764 |
) |
|
|
|
|
|
|
|
|
|
|
Discontinued operations: |
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from discontinued operations before income
taxes |
|
|
7,473 |
|
|
|
(4,870 |
) |
|
|
(22,323 |
) |
Gain on sale of Oncology Product Line before income taxes |
|
|
135,778 |
|
|
|
|
|
|
|
|
|
Income tax expense on discontinued operations |
|
|
(39,135 |
) |
|
|
(59 |
) |
|
|
(54 |
) |
|
|
|
|
|
|
|
|
|
|
Discontinued operations |
|
|
104,116 |
|
|
|
(4,929 |
) |
|
|
(22,377 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(31,743 |
) |
|
$ |
(36,399 |
) |
|
$ |
(45,141 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted per share amounts: |
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations |
|
$ |
(1.69 |
) |
|
$ |
(0.43 |
) |
|
$ |
(0.31 |
) |
Discontinued operations |
|
|
1.30 |
|
|
|
(0.06 |
) |
|
|
(0.30 |
) |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(0.39 |
) |
|
$ |
(0.49 |
) |
|
$ |
(0.61 |
) |
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares |
|
|
80,618,528 |
|
|
|
74,019,501 |
|
|
|
73,692,987 |
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these consolidated financial statements.
63
LIGAND PHARMACEUTICALS INCORPORATED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIT) AND COMPREHENSIVE LOSS
(in thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
other |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
|
|
|
Common stock |
|
|
paid-in |
|
|
comprehensive |
|
|
Accumulated |
|
|
Treasury stock |
|
|
stockholders |
|
|
Comprehensive |
|
|
|
Shares |
|
|
Amount |
|
|
capital |
|
|
income (loss) |
|
|
deficit |
|
|
Shares |
|
|
Amount |
|
|
equity (deficit) |
|
|
loss |
|
Balance at January 1, 2004 |
|
|
72,085,399 |
|
|
$ |
72 |
|
|
$ |
712,870 |
|
|
$ |
(66 |
) |
|
$ |
(749,519 |
) |
|
|
(73,842 |
) |
|
$ |
(911 |
) |
|
$ |
(37,554 |
) |
|
|
|
|
Issuance of common stock |
|
|
885,271 |
|
|
|
1 |
|
|
|
6,618 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
6,619 |
|
|
|
|
|
Effect of common stock redemption |
|
|
|
|
|
|
|
|
|
|
294 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
294 |
|
|
|
|
|
Income tax benefits of stock
option deductions |
|
|
|
|
|
|
|
|
|
|
81 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
81 |
|
|
|
|
|
Unrealized net gains on
available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
282 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
282 |
|
|
$ |
282 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
89 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
89 |
|
|
|
|
|
Foreign currency translation
adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13 |
|
|
|
13 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(45,141 |
) |
|
|
|
|
|
|
|
|
|
|
(45,141 |
) |
|
|
(45,141 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004 |
|
|
72,970,670 |
|
|
|
73 |
|
|
|
719,952 |
|
|
|
229 |
|
|
|
(794,660 |
) |
|
|
(73,842 |
) |
|
|
(911 |
) |
|
|
(75,317 |
) |
|
$ |
(44,846 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock |
|
|
165,670 |
|
|
|
|
|
|
|
930 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
930 |
|
|
|
|
|
Unrealized net gains on
available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
184 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
184 |
|
|
$ |
184 |
|
Reclassification adjustment for
losses on sales of
available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
261 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
261 |
|
|
|
261 |
|
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
106 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
106 |
|
|
|
|
|
Foreign currency translation
adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(184 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(184 |
) |
|
|
(184 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(36,399 |
) |
|
|
|
|
|
|
|
|
|
|
(36,399 |
) |
|
|
(36,399 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005 |
|
|
73,136,340 |
|
|
|
73 |
|
|
|
720,988 |
|
|
|
490 |
|
|
|
(831,059 |
) |
|
|
(73,842 |
) |
|
|
(911 |
) |
|
|
(110,419 |
) |
|
$ |
(36,138 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Issuance of common stock upon
exercise of stock options and
restricted stock grants |
|
|
1,268,159 |
|
|
|
2 |
|
|
|
10,820 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10,822 |
|
|
|
|
|
Issuance of common stock on
conversion of debt |
|
|
25,149,005 |
|
|
|
25 |
|
|
|
154,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
154,325 |
|
|
|
|
|
Unrealized net gains on
available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
281 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
281 |
|
|
$ |
281 |
|
Reclassification adjustment for
gains on sales of
available-for-sale securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,029 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1,029 |
) |
|
|
(1,029 |
) |
Stock-based compensation |
|
|
|
|
|
|
|
|
|
|
5,338 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
5,338 |
|
|
|
|
|
Foreign currency translation
adjustments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(223 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(223 |
) |
|
|
(223 |
) |
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(31,743 |
) |
|
|
|
|
|
|
|
|
|
|
(31,743 |
) |
|
|
(31,743 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
99,553,504 |
|
|
$ |
100 |
|
|
$ |
891,446 |
|
|
$ |
(481 |
) |
|
$ |
(862,802 |
) |
|
|
(73,842 |
) |
|
$ |
(911 |
) |
|
$ |
27,352 |
|
|
$ |
(32,714 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to these consolidated financial statements.
64
LIGAND PHARMACEUTICALS INCORPORATED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(31,743 |
) |
|
$ |
(36,399 |
) |
|
$ |
(45,141 |
) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Gain on sale of Oncology Product Line |
|
|
(135,778 |
) |
|
|
|
|
|
|
|
|
Gain on sale leaseback |
|
|
(3,119 |
) |
|
|
|
|
|
|
|
|
Accretion of deferred gain on sale leaseback |
|
|
(278 |
) |
|
|
|
|
|
|
|
|
Amortization of acquired technology and royalty and license rights |
|
|
12,154 |
|
|
|
13,945 |
|
|
|
10,946 |
|
Depreciation and amortization of property and equipment |
|
|
3,227 |
|
|
|
3,724 |
|
|
|
3,355 |
|
Non-cash development milestone |
|
|
|
|
|
|
|
|
|
|
(1,956 |
) |
Amortization of debt discount and issuance costs |
|
|
836 |
|
|
|
1,038 |
|
|
|
974 |
|
Loss on asset write-offs |
|
|
998 |
|
|
|
|
|
|
|
|
|
Gain on sale of investment |
|
|
(1,205 |
) |
|
|
(713 |
) |
|
|
|
|
Gain on sale of equity investment |
|
|
|
|
|
|
|
|
|
|
(3,705 |
) |
Stock-based compensation |
|
|
5,338 |
|
|
|
106 |
|
|
|
89 |
|
Non-cash co-promote termination expense |
|
|
93,328 |
|
|
|
|
|
|
|
|
|
Non-cash interest expense |
|
|
561 |
|
|
|
|
|
|
|
|
|
Other |
|
|
(179 |
) |
|
|
29 |
|
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Accounts receivable, net |
|
|
9,433 |
|
|
|
9,893 |
|
|
|
(11,946 |
) |
Inventories, net |
|
|
1,584 |
|
|
|
(3,430 |
) |
|
|
(3,292 |
) |
Other current assets |
|
|
6,581 |
|
|
|
1,963 |
|
|
|
(1,352 |
) |
Accounts payable and accrued liabilities |
|
|
(27,640 |
) |
|
|
13,687 |
|
|
|
9,753 |
|
Other liabilities |
|
|
|
|
|
|
(159 |
) |
|
|
156 |
|
Deferred revenue, net |
|
|
(72,619 |
) |
|
|
4,681 |
|
|
|
47,873 |
|
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) operating activities |
|
|
(138,521 |
) |
|
|
8,365 |
|
|
|
5,754 |
|
|
|
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from sale of Oncology Product Line |
|
|
183,332 |
|
|
|
|
|
|
|
|
|
Proceeds from sale of building |
|
|
46,886 |
|
|
|
|
|
|
|
|
|
Purchases of short-term investments |
|
|
(18,383 |
) |
|
|
(29,456 |
) |
|
|
(26,322 |
) |
Proceeds from sale of short-term investments |
|
|
25,554 |
|
|
|
31,323 |
|
|
|
40,464 |
|
Decrease (increase) in restricted cash and investments |
|
|
(38,814 |
) |
|
|
(170 |
) |
|
|
9,204 |
|
Purchases of property and equipment |
|
|
(1,783 |
) |
|
|
(2,596 |
) |
|
|
(3,604 |
) |
Payment to buy-down ONTAK royalty obligation |
|
|
|
|
|
|
(33,000 |
) |
|
|
|
|
Other, net |
|
|
73 |
|
|
|
181 |
|
|
|
(131 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) investing activities |
|
|
196,865 |
|
|
|
(33,718 |
) |
|
|
19,611 |
|
|
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
|
|
|
|
|
Proceeds from note payable to King |
|
|
37,750 |
|
|
|
|
|
|
|
|
|
Principal payments on equipment financing obligations |
|
|
(2,537 |
) |
|
|
(2,795 |
) |
|
|
(2,650 |
) |
Proceeds from equipment financing arrangements |
|
|
1,030 |
|
|
|
2,019 |
|
|
|
4,429 |
|
Net proceeds from issuance of common stock |
|
|
9,050 |
|
|
|
930 |
|
|
|
6,619 |
|
Decrease in other long-term liabilities |
|
|
(153 |
) |
|
|
(35 |
) |
|
|
(189 |
) |
Repayment of long-term debt |
|
|
(11,839 |
) |
|
|
(320 |
) |
|
|
(294 |
) |
|
|
|
|
|
|
|
|
|
|
Net cash provided by (used in) financing activities |
|
|
33,301 |
|
|
|
(201 |
) |
|
|
7,915 |
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
91,645 |
|
|
|
(25,554 |
) |
|
|
33,280 |
|
Cash and cash equivalents at beginning of year |
|
|
66,756 |
|
|
|
92,310 |
|
|
|
59,030 |
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of year |
|
$ |
158,401 |
|
|
$ |
66,756 |
|
|
$ |
92,310 |
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information |
|
|
|
|
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
9,792 |
|
|
$ |
11,421 |
|
|
$ |
10,468 |
|
Supplemental schedule of non-cash investing and financing activities |
|
|
|
|
|
|
|
|
|
|
|
|
Receipt and retirement of common stock in settlement of Pfizer development milestone |
|
|
|
|
|
|
|
|
|
|
1,956 |
|
Receipt of Exelixis, Inc. common stock upon sale of equity investment in X- Ceptor |
|
|
|
|
|
|
|
|
|
|
3,908 |
|
Conversion of 6% convertible subordinated notes into common stock: |
|
|
|
|
|
|
|
|
|
|
|
|
Conversion of principal amount of convertible notes |
|
|
155,250 |
|
|
|
|
|
|
|
|
|
Conversion of unamortized debt issue costs |
|
|
(1,357 |
) |
|
|
|
|
|
|
|
|
Conversion of unpaid accrued interest |
|
|
(454 |
) |
|
|
|
|
|
|
|
|
Employee stock option exercises |
|
|
1,770 |
|
|
|
|
|
|
|
|
|
See accompanying notes to these consolidated financial statements.
65
LIGAND PHARMACEUTICALS INCORPORATED
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. The Company and Its Business
Ligand Pharmaceuticals Incorporated, a Delaware corporation (the Company or Ligand), is an
early-stage biotech company that focuses on discovering and developing new drugs that
address critical unmet medical needs in the areas of thrombocytopenia, cancer, hepatitis C,
hormone-related diseases, osteoporosis and inflammatory diseases. Ligand strives to develop drugs
that are more effective and/or safer than existing therapies, that are more convenient and that are
cost effective The consolidated financial statements include the Companys wholly owned
subsidiaries, Ligand Pharmaceuticals International, Inc., Ligand Pharmaceuticals (Canada)
Incorporated, Seragen, Inc. (Seragen) and Nexus Equity VI LLC (Nexus).
As further discussed in Note 3, the Company sold its oncology product line (Oncology) on
October 25, 2006. The operating results for Oncology have been presented in the accompanying
consolidated financial statements as Discontinued Operations. Additionally, as discussed in Note
24, on September 7, 2006, the Company announced plans to sell its AVINZA product line, subject to
stockholder approval to King Pharmaceuticals Inc. (King). AVINZA is a product for the relief of
chronic, moderate to severe pain which was launched in June 2002. Due to the uncertainty
surrounding stockholder approval as of December 31, 2006, the operating results for the AVINZA
product line do not qualify for discontinued operations (held for sale) presentation and therefore
are presented in the accompanying consolidated financial statements as continuing operations.
Stockholder approval was obtained on February 12, 2007 and the sales transaction with King
subsequently closed on February 26, 2007. Furthermore, as discussed in Note 21, the Company, along
with its wholly-owned subsidiary Nexus, entered into an agreement with Slough Estates USA, Inc.
(Slough) for the sale of the Companys real property located in San Diego, California. The
transaction closed in November 2006 and includes an agreement between the Company and Slough for
the Company to leaseback the building for a period of 15 years. In connection with the sale
transaction, on November 6, 2006, the Company paid off the existing mortgage on the building of
approximately $11.6 million.
The Companys other potential products are in various stages of development. Potential
products that are promising at early stages of development may not reach the market for a number of
reasons. A significant portion of the Companys revenues to date have been derived from research
and development agreements with major pharmaceutical collaborators. Prior to generating revenues
from these products, the Company or its collaborators must complete the development of the products
in the human health care market. No assurance can be given that: (1) product development efforts
will be successful, (2) required regulatory approvals for any indication will be obtained, (3) any
products, if introduced, will be capable of being produced in commercial quantities at reasonable
costs or, (4) patient and physician acceptance of these products will be achieved. There can be no
assurance that Ligand will ever achieve or sustain annual profitability.
The Company faces risks common to companies whose products are in various stages of
development. These risks include, among others, the Companys need for additional financing to
complete its research and development programs and commercialize its technologies. The Company has
incurred significant losses since its inception. At December 31, 2006, the Companys accumulated
deficit was $862.8 million. The Company expects to continue to incur substantial research and
development expenses.
The Company believes that patents and other proprietary rights are important to its business.
Its policy is to file patent applications to protect technology, inventions and improvements to its
inventions that are considered important to the development of its business. The patent positions
of pharmaceutical and biotechnology firms, including the Company, are uncertain and involve complex
legal and technical questions for which important legal principles are largely unresolved.
66
2. Significant Accounting Policies
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned
subsidiaries. Intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of consolidated financial statements in conformity with generally accepted
accounting principles requires the use of estimates and assumptions that affect the reported
amounts of assets and liabilities, including disclosure of contingent assets and contingent
liabilities, at the date of the consolidated financial statements and the reported amounts of
revenue and expenses during the reporting period. The Companys critical accounting policies are
those that are both most important to the Companys consolidated financial condition and results of
operations and require the most difficult, subjective or complex judgments on the part of
management in their application, often as a result of the need to make estimates about the effect
of matters that are inherently uncertain. Because of the uncertainty of factors surrounding the
estimates or judgments used in the preparation of the consolidated financial statements, actual
results may materially vary from these estimates.
Cash, Cash Equivalents and Short-term Investments
Cash and cash equivalents consist of cash and highly liquid securities with maturities at the
date of acquisition of three months or less. Non-restricted equity and debt security investments
with a maturity of more than three months are considered short-term investments and have been
classified by management as available-for-sale. Such investments are carried at fair value, with
unrealized gains and losses included as a separate component of stockholders deficit. The Company
determines cost based on the specific identification method.
Restricted Cash and Investments
Restricted cash and investments consist of certificates of deposit held with a financial
institution as collateral under equipment financing and third-party service provider arrangements,
and funds held in an escrow account with a financial institution to be used to repay a loan due to
King. The King loan, including accrued interest, was subsequently paid in January 2007 (see Note
24). The certificates of deposit have been classified by management as held-to-maturity and are
accounted for at amortized cost (see Note 12).
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to significant concentrations of
credit risk consist primarily of cash equivalents, investments and accounts receivable.
The Company invests its excess cash principally in United States government debt securities,
investment grade corporate debt securities and certificates of deposit. The Company has
established guidelines relative to diversification and maturities that maintain safety and
liquidity. These guidelines are periodically reviewed and modified to take advantage of trends in
yields and interest rates. The Company has not experienced any significant losses on its cash
equivalents, short-term investments or restricted investments.
Trade accounts receivable represent the Companys most significant credit risk. The Company
extends credit on an uncollateralized basis primarily to wholesale drug distributors throughout the
United States. Prior to entering into sales agreements with new customers, and on an ongoing basis
for existing customers, the Company performs credit evaluations. To date, the Company has not
experienced significant losses on customer accounts.
As more fully discussed in Note 6, the Company sells certain of its accounts receivable under
a non-recourse factoring arrangement with a finance company. The Company can transfer funds in any
amount up to a specified percentage of the net amount due from the Companys trade customers at the
time of the sale to the finance company, with the remaining funds available upon collection or
write-off of the trade receivable. As of December 31, 2006, the gross amount due from the finance
company was $1.0 million.
67
Inventories, net
Inventories, net are stated at the lower of cost or market value. Cost is determined using
the first-in-first-out method. Inventories, net consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Raw materials |
|
$ |
|
|
|
$ |
1,508 |
|
Work-in-process |
|
|
1,041 |
|
|
|
9,115 |
|
Finished goods |
|
|
2,968 |
|
|
|
6,324 |
|
Less inventory reserves |
|
|
(153 |
) |
|
|
(1,745 |
) |
|
|
|
|
|
|
|
|
|
|
3,856 |
|
|
|
15,202 |
|
Less current portion |
|
|
(3,856 |
) |
|
|
(9,333 |
) |
|
|
|
|
|
|
|
Long-term portion of inventories, net |
|
$ |
|
|
|
$ |
5,869 |
|
|
|
|
|
|
|
|
The long-term portion of inventories, net as of December 31, 2005 is comprised of oncology
product inventory which was sold in connection with the sale of our Oncology Product Line on
October 25, 2006 (see Note 3).
Property and Equipment
Property and equipment is stated at cost and consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Land |
|
$ |
|
|
|
$ |
5,176 |
|
Equipment, building, and leasehold improvements |
|
|
45,835 |
|
|
|
61,732 |
|
Less accumulated depreciation and amortization |
|
|
(40,284 |
) |
|
|
(44,425 |
) |
|
|
|
|
|
|
|
|
|
$ |
5,551 |
|
|
$ |
22,483 |
|
|
|
|
|
|
|
|
Depreciation of equipment and building is computed using the straight-line method over the
estimated useful lives of the assets which range from three to thirty years. Leasehold
improvements are amortized using the straight-line method over their estimated useful lives or
their related lease term, whichever is shorter.
Acquired Technology, Product Rights and Royalty Buy-Down
In accordance with SFAS No. 142, Goodwill and Other Intangibles, the Company amortizes
intangible assets with finite lives in a manner that reflects the pattern in which the economic
benefits of the assets are consumed or otherwise used up. If that pattern cannot be reliably
determined, the assets are amortized using the straight-line method.
Acquired technology, product rights and royalty buy-down, net as of December 31, 2006
represent payments related to the Companys acquisition of license rights for AVINZA. Because the
Company cannot reliably determine the pattern in which the economic benefits of the acquired
technology and products rights are realized, acquired technology and product rights are amortized
on a straight-line basis over 15 years, which approximated the remaining patent life at the time
the asset was acquired and otherwise represents the period estimated to be benefited.
Specifically, the AVINZA asset is being amortized through November 2017, the expiration of its U.S.
patent.
68
Acquired technology, product rights and royalty buy-down, net consist of the following (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
AVINZA |
|
$ |
114,437 |
|
|
$ |
114,437 |
|
Less accumulated amortization |
|
|
(31,354 |
) |
|
|
(23,725 |
) |
|
|
|
|
|
|
|
|
|
|
83,083 |
|
|
|
90,712 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
ONTAK |
|
|
|
|
|
|
78,312 |
|
Less accumulated amortization |
|
|
|
|
|
|
(22,254 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
56,058 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
83,083 |
|
|
$ |
146,770 |
|
|
|
|
|
|
|
|
Amortization of acquired technology, product rights and royalty buy-down, net for continuing
operations was $7.6 million for each of the years ended December 31, 2006, 2005 and 2004.
Amortization of acquired technology, product rights and royalty buy-down, net for discontinued
operations was $4.3 million, $6.0 million, and $3.0 million for the years ended December 31, 2006,
2005 and 2004, respectively. Acquired technology, product rights and royalty buy-down
related to ONTAK were sold effective October 25, 2006 in connection with the sale of the Companys
Oncology Product Line (see Note 3). Additionally, the AVINZA assets were subsequently sold as part
of the sale of the Companys AVINZA product line on February 26, 2007 (see Note 24).
Impairment of Long-Lived Assets
The Company reviews long-lived assets for impairment annually or whenever events or changes in
circumstances indicate the carrying amount of an asset may not be recoverable. Recoverability of
assets to be held and used is measured by a comparison of the carrying amount of an asset to future
undiscounted net cash flows expected to be generated by the asset. If such assets are considered
to be impaired, the impairment to be recognized is measured as the amount by which the carrying
amount of the assets exceeds the fair value of the assets. Fair value for the Companys long-lived
assets is determined using the expected cash flows discounted at a rate commensurate with the risk
involved. During the fourth quarter of 2006, the Company recorded an impairment charge of
approximately $1.1 million to reflect the discontinuation of certain operational software. As of
December 31, 2006, the Company believes that the future cash flows to be received from its
long-lived assets will exceed the assets carrying value.
Fair Value of Financial Instruments
The carrying amount of cash, cash equivalents, short-term investments, accounts receivable,
restricted investments, accounts payable, accrued liabilities and short-term debt at December 31,
2006 and 2005 are considered to be a reasonable estimate of their fair values due to the short-term
nature of those instruments. As of December 31, 2006 and 2005, the carrying amount of equipment
financing obligations represents a reasonable estimate of their fair value due to their interest
rates approximating current market rates. As of December 31, 2006, the co-promote termination
liability is recorded at fair value.
The carrying value and estimated fair value of the Companys long-term debt at December 31,
2005 is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 |
|
|
|
|
|
|
Estimated |
|
|
Carrying Value |
|
Fair Value |
6% Convertible Subordinated Notes |
|
$ |
155,250 |
|
|
$ |
280,040 |
|
Note payable to bank |
|
|
11,839 |
|
|
|
12,196 |
|
Estimated fair value amounts have been determined using available market information.
69
Revenue Recognition
The Company generates revenue from product sales, collaborative research and development
arrangements, and other activities such as distribution agreements, royalties, and sales of
technology rights. Payments received under such arrangements may include non-refundable fees at
the inception of the contract for technology rights under collaborative arrangements or product
rights under distribution agreements, fully burdened funding for services performed during the
research phase of collaborative arrangements, milestone payments for specific achievements
designated in the collaborative or distribution agreements, royalties on sales of products
resulting from collaborative arrangements, and payments for the supply of products under
distribution agreements.
The Company recognizes revenue in accordance with Staff Accounting Bulletin (SAB) No. 101
Revenue Recognition, as amended by SAB 104 (hereinafter referred to as SAB 104) and SFAS 48
Revenue Recognition When Right of Return Exists (SFAS 48). SAB 104 states that revenue should
not be recognized until it is realized or realizable and earned. Revenue is realized or realizable
and earned when all of the following criteria are met: (1)persuasive evidence of an arrangement
exists; (2)delivery has occurred or services have been rendered; (3)the sellers price to the buyer
is fixed and determinable; and (4)collectibility is reasonably assured. SFAS 48 states that
revenue from sales transactions where the buyer has the right to return the product shall be
recognized at the time of sale only if (1)the sellers price to the buyer is substantially fixed or
determinable at the date of sale, (2)the buyer has paid the seller, or the buyer is obligated to
pay the seller and the obligation is not contingent on resale of the product, (3)the buyers
obligation to the seller would not be changed in the event of theft or physical destruction or
damage of the product, (4)the buyer acquiring the product for resale has economic substance apart
from that provided by the seller, (5)the seller does not have significant obligations for future
performance to directly bring about resale of the product by the buyer, and (6)the amount of future
returns can be reasonably estimated.
Net Product Sales
The Companys AVINZA net product sales are determined on a sell-through basis whereby the
Company does not recognize revenue upon shipment of product to the wholesaler. For these product
sales, the Company invoices the wholesaler, records deferred revenue at gross invoice sales price
less estimated cash discounts, rebates and chargebacks, and classifies the inventory held by the
wholesaler as deferred cost of goods sold within Other current assets. At that point, the
Company makes an estimate of units that may be returned and records a reserve for those units
against the deferred cost of goods sold account. The Company recognizes revenue when such
inventory is sold through (as defined hereafter), on a first-in first-out (FIFO) basis. Sell
through for AVINZA is considered to be at the prescription level or at the point of patient
consumption for channels with no prescription requirements.
Additionally under the sell-through method, royalties paid based on unit shipments to
wholesalers are deferred and recognized as royalty expense as those units are sold through and
recognized as revenue. Royalties paid to technology partners are deferred as the Company has the
right to offset royalties paid for product that are later returned against subsequent royalty
obligations. Royalties for which the Company does not have the ability to offset (for example, at
the end of the contractual royalty period) are expensed in the period the royalty obligation
becomes due.
The Company estimates sell-through based upon (1) analysis of third-party information,
including information obtained from certain wholesalers with respect to their inventory levels and
sell-through to customers, and third-party market research data, and (2) the Companys internal
product movement information. To assess the reasonableness of third-party demand (i.e.
sell-through) information, the Company prepares separate demand reconciliations based on inventory
in the distribution channel. Differences identified through these reconciliations outside an
acceptable range are recognized as an adjustment to the third-party reported demand in the period
those differences are identified. This adjustment mechanism is designed to identify and correct
for any material variances between reported and actual demand over time and other potential
anomalies such as inventory shrinkage at wholesalers. The Companys estimates are subject to the
inherent limitations of estimates that rely on third-party data, as certain third-party information
is itself in the form of estimates. The Companys sales and revenue recognition under the
sell-through method reflect the Companys estimates of actual product sold through the channel.
70
The Company uses information from external sources to estimate gross product sales under the
sell-through revenue recognition method and significant gross to net sales adjustments. The
Companys estimates include product information with respect to prescriptions, wholesaler
out-movement and inventory levels, and retail pharmacy stocking levels, and internal information.
The Company receives information from IMS Health, a supplier of market research to the
pharmaceutical industry, which it uses to estimate sell-through demand for its products and retail
pharmacy inventory levels. The Company also receives wholesaler out-movement and inventory
information from its wholesaler customers that is used to support and validate the demand-based,
sell-through revenue recognition estimates. The inventory information received from wholesalers is
a product of their record-keeping process and their internal controls surrounding such processes.
The Companys total net product sales from continuing operations in 2006 were $137.0 million
compared to $112.8 million in 2005 and $69.5 million in 2004.
Sale of Royalty Rights
Revenue from the sale of royalty rights represents the sale to third parties of rights for and
exercise of options to acquire future royalties the Company may earn from the sale of products in
development with its collaborative partners. If the Company has no continuing involvement in the
research, development or marketing of these products, sales of royalty rights are recognized as
revenue in the period the transaction is consummated or the options are exercised or expire. If
the Company has significant continuing involvement in the research, development or marketing of the
product, proceeds for the sale of royalty rights are accounted for as a financing in accordance
with Emerging Issues Task Force (EITF) 88-18, Sales of Future Revenues (See Note 11).
Collaborative Research and Development and Other Revenues
Collaborative research and development and other revenues are recognized as services are
performed consistent with the performance requirements of the contract. Non-refundable contract
fees for which no further performance obligation exists and where the Company has no continuing
involvement are recognized upon the earlier of when payment is received or collection is assured.
Revenue from non-refundable contract fees where Ligand has continuing involvement through research
and development collaborations or other contractual obligations is recognized ratably over the
development period or the period for which Ligand continues to have a performance obligation.
Revenue from performance milestones is recognized upon the achievement of the milestones as
specified in the respective agreement. Payments received in advance of performance or delivery are
recorded as deferred revenue and subsequently recognized over the period of performance or upon
delivery.
The composition of collaborative research and development and other revenues is as follows (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Collaborative research and development |
|
$ |
1,678 |
|
|
$ |
3.513 |
|
|
$ |
7,843 |
|
Development milestones and other |
|
|
2,299 |
|
|
|
6,704 |
|
|
|
3,457 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
3,977 |
|
|
$ |
10,217 |
|
|
$ |
11,300 |
|
|
|
|
|
|
|
|
|
|
|
Deferred Revenue, Net
Under the sell-through revenue recognition method, the Company does not recognize revenue upon
shipment of product to the wholesaler. For these shipments, the Company invoices the wholesaler,
records deferred revenue at gross invoice sales price, and classifies the inventory held by the
wholesaler (and subsequently held by retail pharmacies as in the case of AVINZA) as deferred cost
of goods sold within other current assets. Deferred revenue is presented net of deferred cash
and other discounts. Other deferred revenue reflects certain collaborative research and
development payments and the sale of certain royalty rights.
71
The composition of deferred revenue, net is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Deferred product revenue |
|
$ |
58,562 |
|
|
$ |
158,030 |
|
Other deferred revenue |
|
|
2,546 |
|
|
|
5,296 |
|
Deferred discounts |
|
|
(581 |
) |
|
|
(1,605 |
) |
|
|
|
|
|
|
|
Deferred revenue, net |
|
$ |
60,527 |
|
|
$ |
161,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred revenue, net: |
|
|
|
|
|
|
|
|
Current, net |
|
$ |
57,981 |
|
|
$ |
157,519 |
|
Long-term, net |
|
|
2,546 |
|
|
|
4,202 |
|
|
|
|
|
|
|
|
|
|
$ |
60,527 |
|
|
$ |
161,721 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred product revenue, net (1) |
|
|
|
|
|
|
|
|
Current |
|
$ |
57,981 |
|
|
$ |
156,425 |
|
Long-term |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
57,981 |
|
|
$ |
156,425 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other deferred revenue |
|
|
|
|
|
|
|
|
Current |
|
$ |
|
|
|
$ |
1,094 |
|
Long-term |
|
|
2,546 |
|
|
|
4,202 |
|
|
|
|
|
|
|
|
|
|
$ |
2,546 |
|
|
$ |
5,296 |
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Deferred product revenue does not include other gross to net revenue
adjustments made when the Company reports net product sales. Such
adjustments include Medicaid rebates, managed health care rebates, and
government chargebacks, which are included in accrued liabilities in
the accompanying consolidated financial statements. |
Allowance for Return Losses
Product sales are net of adjustments for losses resulting from price increases the Company may
experience on product returns from its wholesaler customers. The Companys policy for returns of
AVINZA allows customers to return the product six months prior to and six months after expiration.
Upon an announced price increase, typically in the quarter prior to when a price increase becomes
effective, the Company revalues its estimate of deferred product revenue to be returned to
recognize the potential higher credit a wholesaler may take upon product return determined as the
difference between the new price and the previous price used to value the allowance.
Medicaid Rebates
The Companys products are subject to state government-managed Medicaid programs whereby
discounts and rebates are provided to participating state governments. Medicaid rebates are
accounted for by establishing an accrual in an amount equal to the Companys estimate of Medicaid
rebate claims attributable to sales recognized in that period. The estimate of the Medicaid
rebates accrual is determined primarily based on historical experience regarding Medicaid rebates,
as well as current and historical prescription activity provided by external sources, current
contract prices and any expected contract changes. The Company additionally considers any legal
interpretations of the applicable laws related to Medicaid and qualifying federal and state
government programs and any new information regarding changes in the Medicaid programs regulations
and guidelines that would impact the amount of the rebates. The Company adjusts the accrual
periodically throughout each period to reflect actual experience, expected changes in future
prescription volumes and any changes in business circumstances or trends.
Government Chargebacks
The Companys products are subject to certain programs with federal government entities and
other parties whereby pricing on products is extended below wholesaler list price to participating
entities. These entities purchase
72
products through wholesalers at the lower vendor price, and the wholesalers charge the
difference between their acquisition cost and the lower vendor price back to the Company.
Chargebacks are accounted for by establishing an accrual in an amount equal to the estimate of
chargeback claims. The Company determines estimates of the chargebacks primarily based on
historical experience regarding chargebacks and current contract prices under the vendor programs.
The Company considers vendor payments and claim processing time lags and adjusts the accrual
periodically throughout each period to reflect actual experience and any changes in business
circumstances or trends.
Oncology Product Returns
In connection with the sale of the oncology product line to Eisai Inc. (see Note 3), the
Company retained the obligation for returns of product that were shipped to wholesalers prior to
the close of the transaction on October 25, 2006. The accrual for oncology product returns, which
was recorded as part of the accounting for the sales transaction, is based on historical
experience. Any subsequent changes to the Companys estimate of oncology product returns will be
accounted for as a component of discontinued operations.
Managed Health Care Rebates and Other Contract Discounts
The Company offers rebates and discounts to managed health care organizations and to other
contract counterparties such as hospitals and group purchasing organizations in the U.S. Managed
health care rebates and other contract discounts are accounted for by establishing an accrual in an
amount equal to the estimate of managed health care rebates and other contract discounts.
Estimates of the managed health care rebates and other contract discounts accruals are determined
primarily based on historical experience regarding these rebates and discounts and current contract
prices. The Company also considers the current and historical prescription activity provided by
external sources, current contract prices and any expected contract changes and adjusts the accrual
periodically throughout each period to reflect actual experience and any changes in business
circumstances or trends.
Costs and Expenses
Cost of products sold includes manufacturing costs, amortization of acquired technology and
product rights, and royalty expenses associated with the Companys commercial products. Research
and development costs are expensed as incurred. Amounts paid for products or to buy-out product
royalty obligations for which a new drug application has been filed with the United States Food and
Drug Administration (FDA) are capitalized. Research and development expenses from continuing
operations were $41.9 million, $33.1 million, and $32.7 million in 2006, 2005, and 2004,
respectively, of which approximately 95%, 89%, and 76% were sponsored by Ligand, and the remainder
of which was funded pursuant to collaborative research and development arrangements.
Advertising Expenses
Advertising expenses, including advertising incurred through co-promotion arrangements, are
expensed as incurred.
Debt Issuance Costs
The costs related to the issuance of debt are capitalized and amortized to interest expense
using the effective interest method over the lives of the related debt.
Income Taxes
The Company recognizes liabilities or assets for the deferred tax consequences of temporary
differences between the tax bases of assets or liabilities and their reported amounts in the
financial statements in accordance with SFAS No. 109, Accounting for Income Taxes (SFAS 109).
These temporary differences will result in taxable or deductible amounts in future years when the
reported amounts of the assets or liabilities are recovered or settled. SFAS 109 requires that a
valuation allowance be established when management determines that it is more likely than not that
all or a portion of a deferred tax asset will not be realized. The Company evaluates the
realizability of its net deferred tax assets on a quarterly basis and valuation allowances are
provided, as necessary. During this
73
evaluation, the Company reviews its forecasts of income in conjunction with other positive and
negative evidence surrounding the realizability of its deferred tax assets to determine if a
valuation allowance is required. Adjustments to the valuation allowance will increase or decrease
the Companys income tax provision or benefit. The Company also applies the guidance of SFAS 109
to determine the amount of income tax expense or benefit to be allocated among continuing
operations, discontinued operations, and items charged or credited directly to stockholders equity
(deficit).
Due to the adoption of Statement of Financial Accounting Standards No. 123R, Share-Based
Payment (SFAS 123R) beginning January 1, 2006, the Company recognizes windfall tax benefits
associated with the exercise of stock options directly to stockholders equity (deficit) only when
realized. Accordingly, deferred tax assets are not recognized for net operating loss carryforwards
resulting from windfall tax benefits occurring from January 1, 2006 onward. A windfall tax benefit
occurs when the actual tax benefit realized by the Company upon an employees disposition of a
share-based award exceeds the deferred tax asset, if any, associated with the award that the
Company had recorded. When assessing whether a tax benefit relating to share-based compensation has
been realized, the Company follows the with-and-without method, excluding the indirect effects,
under which current year share-based compensation deductions are assumed to be utilized after net
operating loss carryforwards and other tax attributes.
Income (Loss) Per Share
Net loss per share is computed using the weighted average number of common shares outstanding.
Basic and diluted income (loss) per share amounts are equivalent for the periods presented as the
inclusion of potential common shares in the number of shares used for the diluted computation would
be anti-dilutive to loss per share from continuing operations. In accordance with SFAS No. 128,
Earnings Per Share, no potential common shares are included in the computation of any diluted per
share amounts, including income (loss) per share from discontinued operations, as the Company
reported a net loss from continuing operations for all periods presented. Potential common shares,
the shares that would be issued upon the conversion of convertible notes and the exercise of
outstanding warrants and stock options, were 5.8 million, 32.7 million, and 32.4 million at
December 31, 2006, 2005, and 2004, respectively. In 2006, the holders of the convertible notes
converted all of the notes into approximately 25.1 million shares of the Companys common stock.
Additionally, in 2006, all outstanding warrants to purchase 748,800 shares of the Companys common
stock expired.
Accounting for Stock-Based Compensation
Prior to January 1, 2006, the Company accounted for stock-based compensation in accordance
with Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees,
and related interpretations. The pro forma effects of employee stock options were disclosed as
required by Financial Accounting Standard Board Statement (SFAS) No. 123, Accounting for
Stock-Based Compensation (SFAS 123).
Effective January 1, 2006, the Company adopted Statement of Financial Accounting Standards
(SFAS) 123 (revised 2004), Share-Based Payment (SFAS 123(R)), using the modified prospective
transition method. No stock-based employee compensation cost was recognized prior to January 1,
2006, as all options granted prior to 2006 had an exercise price equal to the market value of the
underlying common stock on the date of the grant. In March 2005, the Securities and Exchange
Commission issued Staff Accounting Bulletin No. 107 (SAB 107) relating to SFAS 123(R). The
Company has applied the provisions of SAB 107 in its adoption of SFAS 123(R). Under the transition
method, compensation cost recognized in 2006 includes: (a) compensation cost for all share-based
payments granted prior to, but not yet vested as of January 1, 2006, based on the grant date fair
value estimated in accordance with the original provisions of SFAS 123, and (b) compensation cost
for all share-based payments granted in 2006, based on grant-date fair value estimated in
accordance with the provisions of SFAS 123(R). For 2006, the Company recognized additional
compensation expense of $4.8 million ($0.06 per share) due to the implementation of SFAS 123(R).
Additionally, the Company accounts for the fair value of options granted to non-employee
consultants under Emerging Issues Task Force (EITF) 96-18, Accounting for Equity Instruments That
Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or
Services.
74
Results for 2005 and 2004 have not been retrospectively adjusted. The fair value of the
options was estimated using a Black-Scholes option-pricing formula and amortized to expense over
the options vesting periods.
The following table illustrates the pro forma effect of share-based compensation on net loss
and loss per share for 2005 and 2004 (in thousands, except per share data):
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2005 |
|
|
2004 |
|
Net loss, as reported |
|
$ |
(36,399 |
) |
|
$ |
(45,141 |
) |
|
|
|
|
|
|
|
|
|
Stock-based employee compensation
expense included in reported net
loss |
|
|
107 |
|
|
|
89 |
|
Less: total stock-based
compensation expense determined
under fair value based method for
all awards continuing to vest |
|
|
(3,008 |
) |
|
|
(7,674 |
) |
Less: total stock-based
compensation expense determined
under fair value based method for
options accelerated in January 2005
(1) |
|
|
(12,455 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net loss, pro forma |
|
$ |
(51,755 |
) |
|
$ |
(52,726 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted per share amounts: |
|
|
|
|
|
|
|
|
Net loss per share, as reported |
|
$ |
(0.49 |
) |
|
$ |
(0.61 |
) |
|
|
|
|
|
|
|
Net loss per share, pro forma |
|
$ |
(0.70 |
) |
|
$ |
(0.72 |
) |
|
|
|
|
|
|
|
|
|
|
(1) |
|
Represents pro forma unrecognized expense for accelerated options as of the date
of acceleration. |
The estimated weighted average fair value at grant date for the options granted for 2005
and 2004 was $8.13 and $14.93, respectively.
On January 31, 2005, Ligand accelerated the vesting of certain unvested and out-of-the-money
stock options previously awarded to the executive officers and other employees under the Companys
1992 and 2002 stock option plans which had an exercise price greater than $10.41, the closing price
of the Companys stock on that date. The vesting for options to purchase approximately 1.3 million
shares of common stock (of which approximately 450,000 shares were subject to options held by the
executive officers) were accelerated. Options held by non-employee directors were not accelerated.
Holders of incentive stock options (ISOs) within the meaning of Section 422 of the Internal
Revenue Code of 1986, as amended, were given the election to decline the acceleration of their
options if such acceleration would have the effect of changing the status of such option for
federal income tax purposes from an ISO to a non-qualified stock option. In addition, the
executive officers plus other members of senior management agreed that they will not sell any
shares acquired through the exercise of an accelerated option prior to the date on which the
exercise would have been permitted under the options original vesting terms. This agreement does
not apply to a) shares sold in order to pay applicable taxes resulting from the exercise of an
accelerated option or b) upon the officers retirement or other termination of employment.
The purpose of the acceleration was to eliminate any future compensation expense the Company
would have otherwise recognized in its statement of operations with respect to these options upon
the implementation of SFAS 123(R).
The Company grants options to employees, non-employee consultants, and non-employee directors.
Additionally, the Company granted restricted stock to non-employee directors in the first quarter
of 2006. Non-employee directors are accounted for as employees under SFAS 123(R). Options and
restricted stock granted to certain directors vest in equal monthly installments over one year.
Options granted to employees vest 1/8 on the six month anniversary and 1/48 each month thereafter
for forty-two months. Options granted to non-employee consultants generally vest between 24 and 36
months. All option awards generally expire ten years from the date of the grant.
75
Stock-based compensation cost for awards to employees and non-employee directors is recognized
on a straight-line basis over the vesting period until the last tranche vests. Compensation cost
for consultant awards is recognized over each separate tranches vesting period. The Company
recognized compensation expense of approximately $5.3 million for 2006 associated with option
awards and restricted stock. Of the total compensation expense for 2006 associated with option
awards, approximately $0.3 million related to options granted to non-employee consultants and $0.2
million related to restricted stock granted. There was no deferred tax benefit recognized in
connection with this cost.
The fair-value for options that were awarded to employees and directors was estimated at the
date of grant using the Black-Scholes option valuation model with the following weighted average
assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
2006 |
|
2005 |
|
2004 |
Risk-free interest rate |
|
4.3% to 5.0% |
|
|
4.35 |
% |
|
|
3.61 |
% |
Dividend yield |
|
|
|
|
|
|
|
|
|
|
|
|
Expected volatility |
|
|
70 |
% |
|
|
72 |
% |
|
|
74 |
% |
Expected term |
|
6 years |
|
5 years |
|
5 years |
The expected term of the employee and non-employee director options is the estimated
weighted-average period until exercise or cancellation of vested options (forfeited unvested
options are not considered). SAB 107 guidance permits companies to use a safe harbor expected
term assumption for grants up to December 31, 2007 based on the mid-point of the period between
vesting date and contractual term, averaged on a tranche-by-tranche basis. The Company used the
safe harbor in selecting the expected term assumption in 2006. The expected term for consultant
awards is the remaining period to contractual expiration.
Volatility is a measure of the expected amount of variability in the stock price over the
expected life of an option expressed as a standard deviation. SFAS 123(R) requires an estimate of
future volatility. In selecting this assumption, the Company used the historical volatility of the
Companys stock price over a period equal to the expected term.
For options granted to the Companys former Chief Executive Officer (CEO) and for shares
purchased under the Companys employee stock purchase plan (ESPP), an expected volatility of 50%
was used for 2006. The expected term of the options granted to the former CEO was 5.5 months. The
expected term for shares issued under the ESPP is three months.
Employee Stock Purchase Plan
The Company also has an employee stock purchase plan (the 2002 ESPP). The 2002 ESPP was
originally adopted July 1, 2001 and amended through June 30, 2003 to allow employees to purchase a
limited amount of common stock at the end of each three month period at a price equal to the lesser
of 85% of fair market value on a) the first trading day of the period, or b) the last trading day
of the Lookback period (the Lookback Provision). The 15% discount and the Lookback Provision
make the 2002 ESPP compensatory under SFAS 123(R). Stock purchases under the 2002 ESPP in 2006
resulted in an expense of $0.1 million. Since the adoption of the 2002 ESPP in 2001, a total of
510,248 shares of common stock has been reserved for issuance by Ligand under the 2002 ESPP
(includes shares transferred from the predecessor plan). As of December 31, 2006, 387,501 shares
of common stock had been issued under the 2002 ESPP to employees and 122,747 shares are available
for future issuance. There were 24,763 shares of common stock issued under the 2002 ESPP in 2006.
Comprehensive Loss
Comprehensive loss represents net loss adjusted for the change during the periods presented in
unrealized gains and losses on available-for-sale securities less reclassification adjustments for
realized gains or losses included in net loss, as well as foreign currency translation adjustments.
The accumulated unrealized gains or losses and cumulative foreign currency translation adjustments
are reported as accumulated other comprehensive income (loss) as a separate component of
stockholders equity (deficit).
76
Segment Reporting
The Company currently operates in a single operating segment. The Company generates revenue
from various sources that result primarily from its underlying research and development activities.
In addition, financial results are prepared and reviewed by management as a single operating
segment. The Company continually evaluates the benefits of operating in distinct segments and will
report accordingly when such distinction is made.
Guarantees and Indemnifications
The Company accounts for and discloses guarantees in accordance with FASB Interpretation No.
45 (FIN 45), Guarantors Accounting and Disclosure Requirements for Guarantees Including Indirect
Guarantees of Indebtedness of Others, an interpretation of FASB Statements No. 5, 57 and 107 and
rescission of FIN 34. The following is a summary of the Companys agreements that the Company has
determined are within the scope of FIN 45:
Under its bylaws, the Company has agreed to indemnify its officers and directors for certain
events or occurrences arising as a result of the officers or directors serving in such capacity.
The term of the indemnification period is for the officers or directors lifetime. The maximum
potential amount of future payments the Company could be required to make under these
indemnification agreements is unlimited. The Company has a directors and officers liability
insurance policy that limits its exposure and enables it to recover a portion of any future amounts
paid. As a result of its insurance policy coverage, the Company believes the estimated fair value
of these indemnification agreements is minimal and has no liabilities recorded for these agreements
as of December 31, 2006 and 2005. These insurance policies, however, do not cover the ongoing
legal costs or the fines, if any, that may become due in connection with the ongoing SEC
investigation of the Company, following the use of prior directors and officers liability insurance
policy limits to settle certain shareholder litigation matters (see discussion of SEC investigation
and shareholder litigation settlements at Note 12). The SEC investigation is ongoing, and the
Company is currently unable to assess the duration, extent, and cost of such investigation.
Further, the Company is unable to assess the amount of such costs that may in turn be required to
be reimbursed to any individual director or officer under the Companys indemnification agreements
as the scope of the investigation cannot be apportioned amongst the Company and the indemnified
officers and directors. Accordingly, a liability has not been recorded for the fair value of the
ongoing and ultimate obligations, if any, related to the SEC investigation.
The Company may enter into other indemnification provisions under its agreements with other
companies in its ordinary course of business, typically with business partners, suppliers,
contractors, customers and landlords. Under these provisions the Company generally indemnifies and
holds harmless the indemnified party for direct losses suffered or incurred by the indemnified
party as a result of the Companys activities or, in some cases, as a result of the indemnified
partys activities under the agreement. The maximum potential amount of future payments the
Company could be required to make under these indemnification provisions is unlimited. The Company
has not incurred material costs to defend lawsuits or settle claims related to these
indemnification agreements. As a result, the Company believes the estimated fair value of these
agreements is minimal. Accordingly, the Company has no liabilities recorded for these agreements
as of December 31, 2006 and 2005.
3. Discontinued Operations
On September 7, 2006, the Company, Eisai Inc., a Delaware corporation and Eisai Co., Ltd., a
Japanese company (together with Eisai Inc., Eisai), entered into a purchase agreement (the
Oncology Purchase Agreement) pursuant to which Eisai agreed to acquire all of the Companys
worldwide rights in and to the Companys oncology products, including, among other things, all
related inventory, equipment, records and intellectual property, and assume certain liabilities
(the Oncology Product Line) as set forth in the Oncology Purchase Agreement. The Oncology Product
Line included the Companys four marketed oncology drugs: ONTAK, Targretin capsules, Targretin gel
and Panretin gel. Pursuant to the Oncology Purchase Agreement, at closing on October 25, 2006,
Ligand received approximately $185.0 million in net cash proceeds, net of $20.0 million that was
funded into an escrow account to support any indemnification claims made by Eisai following the
closing of the sale. Eisai also assumed certain liabilities. Of the escrowed amounts not required
for claims to Eisai, 50% of the then existing amount will be released on April 25, 2007 with the
remaining available balance to be released on October 25, 2007. The Company also incurred
approximately $1.7 million in transaction fees and costs associated
with the sale that are not reflected in net cash proceeds. The Company recorded a pre-tax
gain on the sale of $135.8 million in the fourth quarter of 2006.
77
Additionally, $38.6 million of the proceeds received from Eisai were deposited into an escrow
account to repay a loan received from King, the proceeds of which were used to pay the Companys
co-promote termination obligation to Organon in October 2006. The escrow amounts were released and
the loan repaid to King in January 2007 (see Note 24).
In connection with the Oncology Purchase Agreement with Eisai, the Company entered into a
transition services agreement whereby the Company agreed to perform certain transition services for
Eisai, in order to effect, as rapidly as practicable, the transition of purchased assets from
Ligand to Eisai. In exchange for these services, Eisai pays the Company a monthly service fee.
The term of the transition services provided is generally three months; however, certain services
will be provided for a period of up to eight months. Fees earned under the transition services
agreement, which were recorded as an offset to operating expenses in the fourth quarter of 2006,
were approximately $1.9 million.
The Company has agreed to indemnify Eisai, after the closing, for damages suffered by Eisai
arising for any breach of any of the representations, warranties, covenants or obligations the
Company made in the Oncology Purchase Agreement. The Companys obligation to indemnify Eisai
survives the closing in some cases up to 18 or 36 months following the closing, and in other cases,
until the expiration of the applicable statute of limitations. In a few instances, the Companys
obligation to indemnify Eisai survives in perpetuity. The Companys agreement with Eisai required
that $20 million of the total upfront cash payment be deposited into an escrow account to secure
the Companys indemnification obligations to Eisai after the closing. The Companys
indemnification obligations could cause the Company to be liable to Eisai, under certain
circumstances, in excess of the amounts set forth in the escrow account. The Companys liability
for any indemnification claim brought by Eisai is generally limited to $30 million. However, the
Companys obligation to provide indemnification on certain matters is not subject to these
indemnification limits. For example, the Company agreed to retain, and provide indemnification
without limitation to Eisai for, all liabilities related to certain claims regarding promotional
materials for the ONTAK and Targretin drug products. The Company cannot estimate the liabilities
that may arise as a result of these matters.
78
Assets and liabilities of the Companys Oncology Product Line on October 25, 2006 were as
follows (in thousands):
|
|
|
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Current portion of inventories, net (1) |
|
$ |
5,849 |
|
Other current assets (2) |
|
|
1,421 |
|
|
|
|
|
Total current portion of assets disposed |
|
|
7,270 |
|
|
|
|
|
Long-term portion of inventories, net (1) |
|
|
3,913 |
|
Equipment, net of accumulated depreciation (1) |
|
|
50 |
|
Acquired technology, product rights and royalty buy-down, net (1) |
|
|
51,717 |
|
Other assets (1) |
|
|
2,127 |
|
|
|
|
|
Total long-term portion of assets disposed |
|
|
57,807 |
|
|
|
|
|
Total assets disposed |
|
$ |
65,077 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
Current liabilities: |
|
|
|
|
Current portion of deferred revenue, net (2) |
|
$ |
27,116 |
|
|
|
|
|
Total current portion of liabilities disposed |
|
|
27,116 |
|
|
|
|
|
Long-term portion of deferred revenue, net (2) |
|
|
1,459 |
|
Other long-term liabilities (1) |
|
|
522 |
|
|
|
|
|
Total long-term portion of liabilities disposed |
|
|
1,981 |
|
|
|
|
|
Total liabilities disposed |
|
$ |
29,097 |
|
|
|
|
|
|
|
|
(1) |
|
Represents assets acquired or liabilities assumed by Eisai in accordance with the
terms of the Oncology Purchase Agreement. |
|
(2) |
|
Represents assets or liabilities eliminated from the Companys consolidated
balance sheet in connection with the Oncology sale transaction. |
Prior to the Oncology sale, the Company recorded accruals for rebates, chargebacks, and
other discounts related to Oncology products when product sales were recognized as revenue under
the sell-through method. Upon the Oncology sale, the Company accrued for rebates, chargebacks, and
other discounts related to Oncology products in the distribution channel which had not sold-through
at the time of the Oncology sale and for which the Company retained the liability subsequent to the
Oncology sale. The Company recorded a charge of $11.5 million reflected as a reduction to the gain
on sale for these accruals. These accruals are $7.1 million as of December 31, 2006 and are
included in accrued liabilities in the accompanying consolidated balance sheet.
Additionally, and pursuant to the terms of the Oncology Purchase Agreement, the Company
retained the liability for returns of product from wholesalers that had been sold by the Company
prior to the close of the transaction. Accordingly, as part of the accounting for the gain on the
sale of the Oncology Product Line, the Company recorded a reserve for Oncology product returns.
Under the sell-through revenue recognition method, the Company previously did not record a reserve
for returns from wholesalers. This reserve is $5.6 million as of December 31, 2006 and is included
in accrued liabilities in the accompanying consolidated balance sheet.
79
The following table summarizes results from discontinued operations for 2006, 2005 and 2004
included in the consolidated statements of operations (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Product sales |
|
$ |
47,512 |
|
|
$ |
53,288 |
|
|
$ |
50,865 |
|
Collaborative research and development
and other revenues |
|
|
208 |
|
|
|
310 |
|
|
|
535 |
|
|
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
47,720 |
|
|
|
53,598 |
|
|
|
51,400 |
|
|
|
|
|
|
|
|
|
|
|
Operating costs and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of products sold |
|
|
13,410 |
|
|
|
16,757 |
|
|
|
21,540 |
|
Research and development |
|
|
12,895 |
|
|
|
22,979 |
|
|
|
32,484 |
|
Selling, general and administrative |
|
|
13,891 |
|
|
|
18,488 |
|
|
|
19,367 |
|
|
|
|
|
|
|
|
|
|
|
Total operating costs and expenses |
|
|
40,196 |
|
|
|
58,224 |
|
|
|
73,391 |
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from operations |
|
|
7,524 |
|
|
|
(4,626 |
) |
|
|
(21,991 |
) |
Interest expense |
|
|
(51 |
) |
|
|
(244 |
) |
|
|
(332 |
) |
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
$ |
7,473 |
|
|
$ |
(4,870 |
) |
|
$ |
(22,323 |
) |
|
|
|
|
|
|
|
|
|
|
A comparison of sales by product for discontinued operations is as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
ONTAK |
|
$ |
26,588 |
|
|
$ |
30,996 |
|
|
$ |
32,200 |
|
Targretin capsules |
|
|
17,575 |
|
|
|
18,692 |
|
|
|
15,105 |
|
Targretin gel and Panretin gel |
|
|
3,349 |
|
|
|
3,600 |
|
|
|
3,560 |
|
|
|
|
|
|
|
|
|
|
|
Total product sales |
|
$ |
47,512 |
|
|
$ |
53,288 |
|
|
$ |
50,865 |
|
|
|
|
|
|
|
|
|
|
|
80
4. Investments
The following table summarizes the various investment categories at December 31, 2006 and 2005
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
Estimated |
|
|
|
|
|
|
|
unrealized |
|
|
unrealized |
|
|
fair |
|
|
|
Cost |
|
|
gains |
|
|
losses |
|
|
value |
|
December 31, 2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government securities |
|
$ |
2,750 |
|
|
$ |
¾ |
|
|
$ |
(4 |
) |
|
$ |
2,746 |
|
Corporate obligations |
|
|
10,681 |
|
|
|
23 |
|
|
|
(3 |
) |
|
|
10,701 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
13,431 |
|
|
|
23 |
|
|
|
(7 |
) |
|
|
13,447 |
|
Certificates of deposit restricted |
|
|
1,826 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
1,826 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total debt securities |
|
$ |
15,257 |
|
|
$ |
23 |
|
|
$ |
(7 |
) |
|
$ |
15,273 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. government securities |
|
$ |
3,538 |
|
|
$ |
1 |
|
|
$ |
(11 |
) |
|
$ |
3,528 |
|
Corporate obligations |
|
|
13,161 |
|
|
|
2 |
|
|
|
(11 |
) |
|
|
13,152 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
16,699 |
|
|
|
3 |
|
|
|
(22 |
) |
|
|
16,680 |
|
Certificates of deposit restricted |
|
|
1,826 |
|
|
|
¾ |
|
|
|
¾ |
|
|
|
1,826 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total debt securities |
|
|
18,525 |
|
|
|
3 |
|
|
|
(22 |
) |
|
|
18,506 |
|
Equity securities |
|
|
2,732 |
|
|
|
1,024 |
|
|
|
(262 |
) |
|
|
3,494 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
21,257 |
|
|
$ |
1,027 |
|
|
$ |
(284 |
) |
|
$ |
22,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
There were no material realized gains or losses on sales of available-for-sale securities for
the years ended December 31, 2006, 2005, and 2004.
The amortized cost and estimated fair value of debt security investments at December 31, 2006,
by contractual maturity, are shown below (in thousands). Expected maturities may differ from
contractual maturities because the issuers of the securities may have the right to prepay
obligations without prepayment penalties.
|
|
|
|
|
|
|
|
|
|
|
December 31, 2006 |
|
|
|
|
|
|
|
Estimated |
|
|
|
Cost |
|
|
fair value |
|
Due in one year or less |
|
$ |
6,840 |
|
|
$ |
6,839 |
|
Due after one year through three years |
|
|
8,417 |
|
|
|
8,434 |
|
|
|
|
|
|
|
|
|
|
$ |
15,257 |
|
|
$ |
15,273 |
|
|
|
|
|
|
|
|
5. Other Balance Sheet Details
Accounts receivable consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Trade accounts receivable |
|
$ |
11,018 |
|
|
$ |
1,344 |
|
Due from finance company |
|
|
1,033 |
|
|
|
20,464 |
|
Less discounts and allowances |
|
|
(530 |
) |
|
|
(854 |
) |
|
|
|
|
|
|
|
|
|
$ |
11,521 |
|
|
$ |
20,954 |
|
|
|
|
|
|
|
|
81
Other current assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Deferred royalty cost |
|
$ |
1,785 |
|
|
$ |
5,203 |
|
Deferred cost of products sold |
|
|
2,153 |
|
|
|
5,103 |
|
Other receivables |
|
|
4,066 |
|
|
|
¾ |
|
Prepaid expenses |
|
|
1,442 |
|
|
|
3,878 |
|
Other |
|
|
72 |
|
|
|
1,566 |
|
|
|
|
|
|
|
|
|
|
$ |
9,518 |
|
|
$ |
15,750 |
|
|
|
|
|
|
|
|
Other assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Prepaid royalty buyout, net |
|
$ |
¾ |
|
|
$ |
2,312 |
|
Debt issue costs, net |
|
|
¾ |
|
|
|
2,193 |
|
Other |
|
|
36 |
|
|
|
199 |
|
|
|
|
|
|
|
|
|
|
$ |
36 |
|
|
$ |
4,704 |
|
|
|
|
|
|
|
|
Accrued liabilities consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
Allowances for loss on
returns, rebates, chargebacks,
and other discounts |
|
$ |
14,688 |
|
|
$ |
15,729 |
|
Co-promotion |
|
|
14,265 |
|
|
|
24,778 |
|
Compensation |
|
|
9,330 |
|
|
|
5,746 |
|
Distribution services |
|
|
2,641 |
|
|
|
4,044 |
|
Royalties |
|
|
1,261 |
|
|
|
1,994 |
|
Seragen purchase liability |
|
|
¾ |
|
|
|
2,925 |
|
Interest |
|
|
776 |
|
|
|
1,164 |
|
Other |
|
|
3,548 |
|
|
|
3,207 |
|
|
|
|
|
|
|
|
|
|
$ |
46,509 |
|
|
$ |
59,587 |
|
|
|
|
|
|
|
|
82
The following summarizes the activity in the accrued liability accounts related to allowances
for loss on returns, rebates, chargebacks, and other discounts (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Managed |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Losses on |
|
|
|
|
|
|
Care |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Returns Due |
|
|
|
|
|
|
Rebates and |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
to Changes |
|
|
Medicaid |
|
|
Other |
|
|
Charge- |
|
|
Other |
|
|
|
|
|
|
|
|
|
In Price (1) |
|
|
Rebates |
|
|
Rebates |
|
|
backs |
|
|
Discounts |
|
|
Returns |
|
|
Total |
|
Balance at January 1, 2004 |
|
$ |
4,347 |
|
|
$ |
1,692 |
|
|
$ |
426 |
|
|
$ |
178 |
|
|
$ |
517 |
|
|
$ |
2,036 |
|
|
$ |
9,196 |
|
Provision |
|
|
5,018 |
|
|
|
14,430 |
|
|
|
5,773 |
|
|
|
3,962 |
|
|
|
6,495 |
|
|
|
3,015 |
|
|
|
38,693 |
|
Payments |
|
|
|
|
|
|
(11,074 |
) |
|
|
(4,455 |
) |
|
|
(3,684 |
) |
|
|
(7,008 |
) |
|
|
|
|
|
|
(26,221 |
) |
Charges |
|
|
(3,025 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,492 |
) |
|
|
(5,517 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2004 |
|
|
6,340 |
|
|
|
5,048 |
|
|
|
1,744 |
|
|
|
456 |
|
|
|
4 |
|
|
|
2,559 |
|
|
|
16,151 |
|
Provision |
|
|
1,801 |
|
|
|
18,852 |
|
|
|
10,592 |
|
|
|
5,874 |
|
|
|
|
|
|
|
3,439 |
|
|
|
40,558 |
|
Payments |
|
|
|
|
|
|
(18,552 |
) |
|
|
(8,869 |
) |
|
|
(6,130 |
) |
|
|
(4 |
) |
|
|
|
|
|
|
(33,555 |
) |
Charges |
|
|
(4,103 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(3,322 |
) |
|
|
(7,425 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2005 |
|
|
4,038 |
|
|
|
5,348 |
|
|
|
3,467 |
|
|
|
200 |
|
|
|
|
|
|
|
2,676 |
|
|
|
15,729 |
|
Provision |
|
|
2,324 |
|
|
|
4,515 |
|
|
|
8,131 |
|
|
|
5,624 |
|
|
|
|
|
|
|
1,368 |
|
|
|
21,962 |
|
Oncology Transaction
Provision (2) |
|
|
|
|
|
|
363 |
|
|
|
|
|
|
|
1,913 |
|
|
|
|
|
|
|
10,020 |
|
|
|
12,296 |
|
Payments |
|
|
|
|
|
|
(8,820 |
) |
|
|
(8,037 |
) |
|
|
(6,457 |
) |
|
|
|
|
|
|
|
|
|
|
(23,314 |
) |
Charges |
|
|
(5,021 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(6,964 |
) |
|
|
(11,985 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31,
2006 |
|
$ |
1,341 |
|
|
$ |
1,406 |
|
|
$ |
3,561 |
|
|
$ |
1,280 |
|
|
$ |
|
|
|
$ |
7,100 |
|
|
$ |
14,688 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
The provision for losses on returns is net of changes in the allowance for such
losses resulting from different actual rates of return on lots of AVINZA that close out
compared to the rate of return used to initially estimate the allowance upon an announced
price increase. |
|
(2) |
|
The 2006 oncology transaction provision amounts represent additional
accruals recorded in connection with the sale of the oncology product line to Eisai on October
25, 2006. The Company will maintain the obligation for returns of product that were shipped
to wholesalers prior to the close of the Eisai transaction on October 25, 2006 and chargebacks
and rebates associated with product in the distribution channel as of the closing date. See
Note 3 for additional information. |
Employment and Severance and Retention Bonus Agreements
In March 2006, the Company entered into letter agreements with approximately 67 key employees,
including a number of our executive officers. In September 2006, the Company entered into letter
agreements with ten additional employees and modified existing agreements with two employees.
These letter agreements provided for certain retention or stay bonus payments to be paid in cash
under specified circumstances as an additional incentive to remain employed in good standing with
the Company through December 31, 2006. The Compensation Committee of the Board of Directors
approved the Companys entry into these agreements. In accordance with the SFAS 146, Accounting
for Costs Associated with Exit or Disposal Activities, the cost of the plan was ratably accrued
over the term of the agreements. The Company recognized approximately $2.6 million of expense
under the plan in 2006. As an additional retention incentive, certain employees were also granted
stock options totaling approximately 122,000 shares at an exercise price of $11.90 per share.
In August 2006 and October 2006, the Companys Compensation Committee approved and ratified,
and began entering into additional severance agreements with certain of the Companys officers and
executive officers as additional retention incentives and to provide severance benefits to these
officers that are more closely equivalent to severance benefits already in place for other
executive officers.
These additional agreements consist of (a) change of control severance agreements (Change of
Control Severance Agreement) and b) ordinary severance agreements that apply regardless of a
change of control (Ordinary Severance Agreement). Each Change of Control Severance Agreement
provides for a payment of certain benefits to the officer in the event their employment is
terminated without cause in connection with a change of control of the Company.
83
These benefits include one year of salary, plus the average bonus (if any) for the prior two
years and payment of health care premiums for one year. With certain exceptions, the officer must
be available for consulting services for one year and must abide by certain restrictive covenants,
including non-competition and non-solicitation of the Companys employees. Each Ordinary Severance
Agreement provides for payment of six months salary in the event the officers employment is
terminated without cause, regardless of change of control.
Additionally, in October 2006, the Company implemented a 2006 Employee Severance Plan for
those employees who were not covered by another severance arrangement. The plan provides that if
such an employee is involuntarily terminated without cause, and not offered a similar or better job
by one of the purchasers of the product lines (i.e. King or Eisai) such employee will be eligible
for severance benefits. The benefits consist of two months salary, plus one week of salary for
every full year of service with the Company plus payment of COBRA health care coverage premiums for
that same period.
6. Accounts Receivable Factoring Arrangement
During 2003, the Company entered into a one-year accounts receivable factoring arrangement
under which eligible accounts receivable are sold without recourse to a finance company. The
agreement was renewed for a one-year period in the second quarter of 2004 and again in the second
quarter of 2005 through December 2007. Commissions on factored receivables are paid to the finance
company based on the gross receivables sold, subject to a minimum annual commission. Additionally,
the Company pays interest on the net outstanding balance of the uncollected factored accounts
receivable at an interest rate equal to the JPMorgan Chase Bank prime rate. The Company continues
to service the factored receivables. The servicing expenses for 2006, 2005 and 2004 and the
servicing liability at December 31, 2006 and 2005 were not material. There were no material gains
or losses on the sale of such receivables. The Company accounts for the sale of receivables under
this arrangement in accordance with SFAS No. 140, Accounting for Transfers and Servicing of
Financial Assets and Extinguishment of Liabilities. The gross amount due from the finance company
at December 31, 2006 and 2005 was $1.0 million and $20.5 million, respectively.
7. Elan License and Supply Agreement
In 1998, Elan Corporation, plc (Elan) agreed to exclusively license and supply to the
Company in the United States and Canada its proprietary product AVINZA, a form of morphine for
chronic, moderate-to-severe pain. In November 2002, the Company and Elan agreed to amend the terms
of the AVINZA license and supply agreement. Under the terms of the amendment, Ligand paid Elan
$100.0 million in return for a reduction in Elans product supply price on sales of AVINZA by
Ligand, rights to sublicense and obtain a co-promotion partner in its territories, and rights to
qualify and purchase AVINZA from a second manufacturing source. Elans adjusted royalty and supply
price of AVINZA is approximately 10% of the products net sales, compared to approximately 30-35%
in the prior agreement. Ligand committed to place firm purchase orders for a minimum of 40 batches
of AVINZA from Elan annually through 2005, estimated at approximately $9.2 million per year. In
addition, Elan agreed to forego its option to co-promote AVINZA in the United States and Canada.
The amount paid to Elan and related transaction costs were capitalized as acquired product rights.
In 2006, 2005, and 2004, purchases and royalties under the agreement totaled $11.9 million, $12.4
million, and $15.4 million, respectively. Ligand met its commitment for placing firm purchase
orders for 2005 and 2004.
In connection with the sale of the Companys AVINZA product line to King in February 2007 (see
Note 24), the license and supply agreement was assigned to King. In consideration of the
assignment, Ligand paid Elan $1.0 million in March 2007.
84
8. AVINZA Co-Promotion
In February 2003, Ligand and Organon Pharmaceuticals USA Inc. (Organon) announced that they
had entered into an agreement for the co-promotion of AVINZA. Under the terms of the agreement,
Organon committed to a specified minimum number of primary and secondary product calls delivered to
certain high prescribing physicians and hospitals beginning in March 2003. Organons compensation
was structured as a percentage of AVINZA net sales based on the following schedule:
|
|
|
|
|
% of Incremental Net Sales |
Annual Net Sales of AVINZA |
|
Paid to Organon by Ligand |
$0-150 million
|
|
30% (0% for 2003) |
$150-300 million
|
|
40% |
$300-425 million
|
|
50% |
> $425 million
|
|
45% |
In January 2006, Ligand signed an agreement with Organon that terminated the AVINZA
co-promotion agreement between the two companies and returned AVINZA co-promotion rights to Ligand.
The termination was effective as of January 1, 2006; however, the parties agreed to continue to
cooperate during a transition period that ended September 30, 2006 (the Transition Period) to
promote the product. The Transition Period co-operation included a minimum number of product sales
calls per quarter (100,000 for Organon and 30,000 for Ligand with an aggregate of 375,000 and
90,000, respectively, for the Transition Period) as well as the transition of ongoing promotions,
managed care contracts, clinical trials and key opinion leader relationships to Ligand. During the
Transition Period, Ligand paid Organon an amount equal to 23% of AVINZA net sales. Ligand also
paid and was responsible for the design and execution of all clinical, advertising and promotion
expenses and activities.
Additionally, in consideration of the early termination and return of rights under the terms
of the agreement, Ligand agreed to pay Organon $37.8 million in October 2006. Ligand further
agreed to and paid Organon $10.0 million in January 2007, in consideration of the minimum sales
calls during the Transition Period. In addition, following the Transition Period, Ligand agreed to
make quarterly royalty payments to Organon equal to 6.5% of AVINZA net sales through December 31,
2012 and thereafter 6.0% through patent expiration, currently anticipated to be November of 2017.
The unconditional payment of $37.8 million to Organon and the estimated fair value of the
amounts to be paid to Organon after the termination ($95.2 million as of January 1, 2006), based on
the estimated net sales of the product (currently anticipated to be paid quarterly through November
2017), were recognized as liabilities and expensed as costs of the termination as of the effective
date of the agreement, January 2006. Additionally, the conditional payment of $10.0 million, which
represents an approximation of the fair value of the service element of the agreement during the
Transition Period (when the provision to pay 23% of AVINZA net sales is also considered), was
recognized ratably as additional co-promotion expense over the Transition Period.
Although the quarterly royalty payments to Organon are based on net reported AVINZA product
sales, such payments do not result in current period expense in the period upon which the payment
is based, but instead are charged against the co-promote termination liability. The liability is
adjusted at each reporting period to fair value and is recognized, utilizing the interest method,
as additional co-promote termination charges for that period at a rate of 15%, the discount rate
used to initially value this component of the termination liability. Any changes to the Companys
estimates of future net AVINZA product sales result in a change to the liability which is
recognized as an increase or decrease to co-promote termination charges in the period such changes
are identified. For example, in the second and fourth quarters of 2006, the Company recorded
adjustments of $0.4 million and $15.7 million, respectively, to lower the fair value of the
termination liability based on updated estimates of future AVINZA sales. The adjustment recorded
in the fourth quarter of 2006 is due to lower than estimated actual net sales of AVINZA in the
fourth quarter of 2006 and the Companys lowered estimate of future AVINZA net sales.
On a quarterly basis, management reviews the carrying value of the co-promote termination
liability. Due to assumptions and judgments inherent in determining the estimates of future net
AVINZA sales through November
85
2017, the actual amount of net AVINZA sales used to determine the current fair value of the
Companys co-promote termination liability may be materially different from its current estimates.
In addition, because of the inherent difficulties of predicting possible changes to the estimates
and assumptions used to determine the estimate of future AVINZA product sales, the Company is
unable to quantify an estimate of the reasonably likely effect of any such changes on its results
of operations or financial position.
A summary of the co-promote termination liability as of December 31, 2006 is as follows (in
thousands):
|
|
|
|
|
Net present value of payments based on estimated future net
AVINZA product sales as of January 1, 2006 |
|
$ |
95,191 |
|
Fair value adjustment to payments based on estimated net
AVINZA product sales |
|
|
14,215 |
|
Reduction in net present value of liability resulting from
updated estimate of net AVINZA product sales |
|
|
(16,078 |
) |
|
|
|
|
|
|
|
93,328 |
|
Less: current portion of co-promote termination liability |
|
|
(12,179 |
) |
|
|
|
|
Long-term portion of co-promote termination liability |
|
$ |
81,149 |
|
|
|
|
|
As more fully described in Note 24, on February 26, 2007, Ligand and King closed an agreement
pursuant to which King acquired all of the Companys rights in and to AVINZA, assumed certain
liabilities, and reimbursed Ligand the $47.8 million previously paid to Organon (comprised of the
$37.8 million paid in October 2006 and the $10.0 million that the Company paid in January 2007).
King also assumed the Companys co-promote termination obligation to make payments to Organon based
on net sales of AVINZA. As Organon has not consented to the legal assignment of the co-promote
termination obligation from Ligand to King, Ligand remains liable to Organon in the event of Kings
default of this obligation.
9. Seragen
In 1998, the Company completed a merger with Seragen. Under the terms of the merger
agreement, Ligand paid merger consideration of $31.7 million at closing and $34.1 million in 1999
subsequent to final FDA approval of ONTAK. Pending resolution of final contingencies and in
accordance with the terms of the merger agreement, the Company had withheld $2.1 million from
payments made to certain Seragen stakeholders. This amount plus accrued interest of approximately
$0.8 million resulting from litigation concerning payment of the withheld amount was subsequently
paid in February 2006 (see Note 12). The total amount paid was accrued as of December 31, 2005
within accrued liabilities.
In connection with the Seragen merger, the Company acquired substantially all the assets of
Marathon Biopharmaceuticals, LLC (Marathon), which provided manufacturing services to Seragen.
In 2000, Ligand sold the contract manufacturing assets of Marathon and in connection with the sale,
entered into a three-year supply and development agreement with the acquirer for the manufacture of
ONTAK. In 2003, the Company entered into a new five-year agreement with Cambrex Bio Science
Hopkinton, Inc., the successor of Marathon, for the continued manufacturing of ONTAK. Purchases
under the agreement amounted to $1.3 million, $1.7 million, and $3.0 million in 2006, 2005, and
2004, respectively.
86
10. Debt
Debt consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
6% Convertible Subordinated Notes |
|
$ |
|
|
|
$ |
155,250 |
|
Note payable to Bank |
|
|
|
|
|
|
11,839 |
|
Note payable to King |
|
|
37,750 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
37,750 |
|
|
|
167,089 |
|
Less current portion |
|
|
(37,750 |
) |
|
|
(344 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt |
|
$ |
|
|
|
$ |
166,745 |
|
|
|
|
|
|
|
|
6% Convertible Subordinated Notes
In November 2002, the Company completed a private offering of 6% Convertible Subordinated
Notes in the aggregate principal amount of $155.3 million, receiving net proceeds of $150.1
million. The notes paid interest semi-annually at a rate of 6% and were scheduled to mature on
November 16, 2007. Holders had the option to convert the notes into shares of common stock at any
time prior to maturity at a conversion rate of 161.9905 shares per $1,000 principal amount of
notes. Of the net proceeds, $18.0 million was invested in U.S. government securities and placed
with a trustee to pay the first four scheduled interest payments. These first four interest
payments were made in 2003 and 2004 for $9.1 million and $9.3 million, respectively. The Company
paid approximately $5.2 million in debt issuance costs that were being amortized using the interest
method.
The holders converted all of the notes into approximately 25.1 million shares of common stock
in 2006. Accrued interest and unamortized debt issue costs related to the converted notes of $0.5
million and $1.4 million, respectively, were recorded as additional paid-in capital in connection
with the conversions.
Note Payable to Bank
In December 2003, Ligand implemented the provisions of FIN 46(R), Consolidation of Variable
Interest Entities, an interpretation of ARB No. 51. In connection with the implementation of FIN
46(R), the Company consolidated the entity, Nexus, from which it leased its corporate headquarter
building, including assets of $13.6 million and a note payable to bank (the Note) of $12.5
million. Ligand subsequently acquired the portion of Nexus it did not previously own in April
2004. As of December 31, 2005, the Note had a net book value of $11.8 million. The Note carried
an interest rate of 7.15% and required periodic principal and interest payments through July 2008.
The Note was secured by a lien on the subject building (including the land and tenant improvements
associated with that building).
As more fully described in Note 21, the Company entered into a purchase agreement on October
25, 2006 to sell and leaseback facilities encompassing the Companys corporate headquarter building
and two land parcels. This transaction subsequently closed on November 9, 2006. As a term of the
purchase agreement, the Company paid the outstanding principal of $11.6 million on the Note on
November 6, 2006. A prepayment penalty of $0.4 million, which is included in interest expense in
the accompanying consolidated statement of operations, was incurred in connection with the
repayment of the Note.
Note Payable to King
As more fully described in Note 24, in connection with the AVINZA Purchase Agreement, King
committed to loan the Company, at the Companys option, $37.8 million to be used to pay the
Companys co-promote termination obligation to Organon due October 15, 2006. This loan was drawn,
and the $37.8 million co-promote liability settled in October 2006. Amounts due under the loan
were subject to certain market terms, including a 9.5% interest rate. In addition, and as a
condition of the $37.8 million loan received from King, $38.6 million of the funds received from
Eisai were deposited into a restricted account to be used to repay the loan to King, plus interest.
The
87
Company repaid the loan plus interest on January 8, 2007. Pursuant to the AVINZA Purchase
Agreement, King subsequently refunded the interest to the Company.
11. Royalty Agreements
The Company has royalty obligations under various technology license agreements. During 2006,
royalties to individual licensors were accrued ranging from 1.0% to 11.0% of net sales. Royalty
expense for continuing operations for the years ended December 31, 2006, 2005 and 2004 was $5.1
million, $4.4 million and $3.0 million, respectively. Royalty expense for discontinued operations
for the years ended December 31, 2006, 2005 and 2004 was $2.5 million, $5.3 million and $12.5
million, respectively.
Sale of Royalty Rights
Revenue from the sale of royalty rights represents the sale to third parties of rights and
options to acquire future royalties the Company may earn from the sale of products in development
with its collaborative partners. If the Company has no continuing involvement in the research or
development of these products, sales of royalty rights are recognized as revenue in the period the
transaction is consummated or the options are exercised or expire.
In March 2002, the Company entered into an agreement with Royalty Pharma AG (Royalty Pharma)
to sell a portion of its rights to future royalties from the net sales of three selective estrogen
receptor modulator (SERM) products now in late stage development with two of the Companys
collaborative partners, Pfizer and Wyeth. The agreement provided for the initial sale of rights to
0.25% of such product net sales for $6.0 million and options to acquire up to an additional 1.00%
of net sales for $50.0 million. Of the initial $6.0 million sale of rights, $0.2 million was
attributed to the fair market value of the options and recorded as deferred revenue. The deferred
revenue was recognized upon exercise or expiration of the options.
In July and December of 2002, the agreement was amended to replace the existing options with
new options providing for the rights to acquire an additional 1.3125% of net sales for $63.8
million. Royalty Pharma exercised each of the three available 2002 options, as amended, acquiring
rights to 0.4375% of net sales for $12.3 million. The fair value estimated for the amended
options, $0.2 million, was recorded as deferred revenue.
In October 2003, the existing royalty agreement was amended and Royalty Pharma exercised an
option for $12.5 million in exchange for 0.7% of potential future sales of the three SERM products
for 10 years. Under the revised agreement, Royalty Pharma had three additional options to purchase
up to 1.3% of such product net sales for $39.0 million.
In November 2004, Royalty Pharma agreed to purchase an additional 1.625% royalty on future
sales of the SERM products for $32.5 million and cancel its remaining two options. Payments from
the royalty purchase are non-refundable.
Under the underlying royalty agreements, both Pfizer and Wyeth have the right to offset a
portion of any future royalty payments owed to the Company to the extent of previous milestone
payments. Accordingly, the Company deferred a portion of the revenue associated with each tranche
of royalty right sold, including rights acquired upon the exercise-of-options, equal to the
pro-rata share of the potential royalty offset. Such amounts associated with the offset rights
against future royalty payments will be recognized as revenue upon receipt of future royalties from
the respective partners.
Sale of royalty rights recognized in 2004 were $31.3 million, net of the deferral of offset
rights of $1.4 million, and the recognition of $0.2 million of option value deferred in previous
periods. There were no sales of royalty rights in 2006 and 2005.
Pfizer Collaboration Oporia (also known as lasofoxifene)
In August 2004, Pfizer submitted a new drug application (United States) (NDA) to the FDA for
Oporia (also known as lasofoxifene) for the prevention of osteoporosis in postmenopausal women. In
September 2005, Pfizer announced the receipt of a non-approvable letter from the FDA for the
prevention of osteoporosis. In December
88
2004, Pfizer filed a supplemental NDA for the use of Oporia for the treatment of vaginal
atrophy. In February 2006, Pfizer announced the receipt of a non-approval letter from the FDA for
vaginal atrophy. Oporia is also being developed by Pfizer for the treatment of osteoporosis.
Oporia is a product that resulted from the Companys collaboration with Pfizer and upon which the
Company will receive royalties if the product is approved by the FDA and subsequently marketed by
Pfizer.
Buy Out of Salk Royalty Obligations
In March 2004, the Company paid The Salk Institute (Salk) $1.1 million in connection with
the Companys exercise of an option to buy out milestone payments, other payment-sharing
obligations and royalty payments due on future sales of Oporia, a product under development by
Pfizer. This payment was recognized as a development expense for the year ended December 31, 2004
because Pfizer had not yet filed its NDA at the time of the Companys exercise.
In January 2005, Ligand paid Salk $1.1 million to exercise an option to buy out milestone
payments, other payment-sharing obligations and royalty payments due on future sales of Oporia for
vaginal atrophy. This payment resulted from a supplemental Oporia NDA filing by Pfizer. As the
Company had previously sold rights to Royalty Pharma AG of approximately 50% of any royalties to be
received from Pfizer for sales of Oporia, it recorded approximately 50% of the payment made to
Salk, approximately $0.6 million, as development expense in the first quarter of 2005. The balance
of approximately $0.5 million was capitalized to be amortized over the period any such royalties
were to be received from Pfizer for the vaginal atrophy indication. In connection with Pfizers
receipt of a non-approvable letter from the FDA for the vaginal atrophy indication in February
2006, however, the Company wrote-off the remaining capitalized balance of $0.5 million in the
fourth quarter of 2005.
In August 2006, Ligand paid Salk $0.8 million to exercise an option to buy out milestone
payments, other payment sharing obligations and royalty payments due on future sales of Viviant
(bazedoxifene), a product being developed by Wyeth. This payment resulted from a Viviant NDA filed
by Wyeth for postmenopausal osteoporosis therapy. The Company recognized the $0.8 million payment
as development expense in 2006.
Settlement of Patent Interference
In March 2005, Ligand announced that it reached a settlement agreement in a patent
interference action initiated by Ligand against two patents owned by The Burnham Institute and SRI
International, but exclusively licensed to Ligand. The settlement reduced the royalty rate on
those products while extending the royalty payment term to SRI/Burnham.
Under the agreement, Burnham has a research-only sublicense to conduct basic research under
the assigned patents and Ligand had an option on the resulting products and technology. In
addition, Burnham and SRI agreed to accept a reduction in the royalty rate paid to them on U.S.
sales of Targretin under an earlier agreement. The aggregate royalty rate owed to SRI and Burnham
by Ligand was reduced from 4% to 3% of net sales and the term of the royalty payments extended from
2012 to 2016.
This license was transferred to Eisai as part of the sale of the Oncology Product Line (see
Note 3).
12. Commitments and Contingencies
Equipment Financing
The Company has entered into capital lease and equipment agreements that require monthly
payments through September 2010 including interest ranging from 7.35% to 10.11%. The carrying
value of equipment under these agreements at December 31, 2006 and 2005 was $7.3 million and $9.6
million, respectively. At December 31, 2006 and 2005, related accumulated amortization was $3.4
million and $4.6 million, respectively. The underlying equipment is used as collateral under the
equipment financing.
89
Property Leases
As of December 31, 2003, the Company leased its corporate headquarter building from Nexus
Equity VI LLC (Nexus), a limited liability company in which Ligand held a 1% ownership interest.
No Ligand officer or employee had any financial interest with regard to this lease arrangement or
with Nexus. Ligand also had the option to either purchase the portion of Nexus that it did not
own, purchase the property from the lessor at a purchase price equal to the outstanding debt on the
property plus a calculated return on the investment made by Nexus other shareholder, sell the
property to a third party, or renew the lease arrangement.
This specific type of operating lease is commonly referred to as a synthetic lease. Prior
to the issuance of FIN 46(R), synthetic leases represented a form of off-balance sheet financing
under which they were treated as an operating lease for financial reporting purposes and as a
financing lease for tax purposes. Under FIN 46(R), a synthetic lease is evaluated to determine i)
if it qualifies as a variable interest entity (VIE) and if so, ii) the primary beneficiary
required to consolidate the VIE.
Under FIN 46(R), Ligand determined that Nexus qualified as a VIE, and that Ligand was the
primary beneficiary of the VIE, as the Company would absorb the majority of the entitys expected
losses, if any, as defined by FIN 46(R). In accordance with FIN 46(R), the Company consolidated
Nexus as of December 31, 2003.
In April 2004, the Company exercised its right to acquire the portion of Nexus that it did not
own. The acquisition resulted in Ligands assumption of the existing loan against the property and
payment to Nexus other shareholder of approximately $0.6 million.
As more fully described in Note 21, the Company entered into an agreement on October 25, 2006
to sell and lease back facilities encompassing the Companys corporate headquarter building and two
land parcels. This transaction subsequently closed on November 9, 2006. Under the terms of the
lease, the Company pays a basic annual rent of $3.0 million (subject to an annual fixed percentage
increase, as set forth in the agreement), plus a 1% annual management fee, property taxes and other
normal and necessary expenses associated with the lease such as utilities, repairs and maintenance,
etc. The Company has the right to extend the lease for two five-year terms and will have the first
right of refusal to lease, at market rates, any facilities built on the sold lots.
The Company leases its other office and research facilities under operating lease arrangements
with varying terms through July 2015. The agreements provide for increases in annual rents based
on changes in the Consumer Price Index or fixed percentage increases ranging from 3% to 7%.
The Company recognizes rent expense on a straight-line basis. Deferred rent at December 31,
2006 and 2005 was $2.5 million and $2.4 million, respectively.
Total rent expense under all office leases for 2006, 2005, and 2004 was $2.4 million, $1.7
million, and $1.9 million, respectively.
At December 31, 2006 annual minimum payments due under the Companys office, equipment and
vehicle lease obligations are as follows (in thousands):
90
|
|
|
|
|
|
|
|
|
|
|
Obligations under |
|
|
|
|
|
|
capital leases and |
|
|
|
|
|
|
equipment notes payable |
|
|
Operating leases |
|
2007 |
|
$ |
2,459 |
|
|
$ |
5,227 |
|
2008 |
|
|
1,653 |
|
|
|
5,006 |
|
2009 |
|
|
567 |
|
|
|
5,055 |
|
2010 |
|
|
94 |
|
|
|
5,206 |
|
2011 |
|
|
|
|
|
|
5,363 |
|
Thereafter |
|
|
|
|
|
|
46,691 |
|
|
|
|
|
|
|
|
Total minimum lease payments |
|
|
4,773 |
|
|
$ |
72,548 |
|
|
|
|
|
|
|
|
|
Less: amounts representing interest |
|
|
(449 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Present value of minimum lease payments |
|
|
4,324 |
|
|
|
|
|
Less: current portion |
|
|
(2,168 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
2,156 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Product Liability
The Companys business exposes it to potential product liability risks. The Companys
products also may need to be recalled to address regulatory issues. A successful product liability
claim or series of claims brought against the Company could result in payment of significant
amounts of money and divert managements attention from running the business. Some of the
compounds the Company is investigating may be harmful to humans. For example, retinoids as a class
are known to contain compounds which can cause birth defects. The Company may not be able to
maintain insurance on acceptable terms, or the insurance may not provide adequate protection in the
case of a product liability claim. To the extent that product liability insurance, if available,
does not cover potential claims, the Company would be required to self-insure the risks associated
with such claims. The Company believes that it carries reasonably adequate insurance for product
liability claims.
Distribution Service Agreements
In 2004, the Company entered into one-year fee-for-service agreements (or distribution service
agreements) for each of its products, with the majority of its wholesaler customers. These
agreements were subsequently renewed in 2005 for an additional one-year period. In exchange for a
set fee, the wholesalers agreed to provide the Company with certain information regarding product
stocking and out-movement; agreed to maintain inventory quantities within specified minimum and
maximum levels; inventory handling, stocking and management services; and certain other services
surrounding the administration of returns and chargebacks. As of December 31, 2006, the
distribution service agreements for Oncology products have been terminated as a result of the
Companys sale of its Oncology products to Eisai.
For the year ended December 31, 2006, shipments to three wholesale distributors each accounted
for more than 10% of the total shipments and in the aggregate 79% of total shipments. For the year
ended December 31, 2005, shipments to four wholesale distributors each accounted for more than 10%
of the total shipments and in the aggregate 89% of total shipments. For the year ended December 31,
2004, shipments to three wholesale distributors each accounted for more than 10% of the total
shipments and in the aggregate 77% of total shipments.
Consultant Agreements
The Company has various arrangements with consultants with terms ranging from one to three
years. Additionally, as of March 31, 2005, the Company entered into a consulting agreement with
Dr. Ronald Evans, a Salk professor and Howard Hughes Medical Institute investigator, that continues
through February 2008. The agreement provides for certain cash payments and a grant of stock
options. Dr. Evans serves as the Chairman of Ligands Scientific Advisory Board.
Manufacturing and Supply Agreements
As of December 31, 2004, Elan was the Companys only approved supplier of AVINZA. In March
2004, Ligand entered into a five-year manufacturing and packaging agreement with Cardinal Health
PTS, LLC
91
(Cardinal) under which Cardinal agreed to manufacture AVINZA. In August 2005, the FDA
approved the production of AVINZA at the Cardinal facility. Under the terms of the amended
agreement, the Company committed to minimum annual purchases ranging from $0.8 million to $1.2
million for 2006; $2.2 million to $3.3 million for 2007; and $2.4 million to $3.6 million for 2008
through 2010. In connection with the closing of the AVINZA sale transaction (see Note 24), Ligand
and King agreed that the Cardinal agreement would not be assigned or transferred to King and that
the Company would be responsible for winding down the contract and any resulting liabilities. The
Company will record a charge as a component of the gain on the sale of the AVINZA product line in
the first quarter of 2007 for any liabilities incurred in connection with the winding down of the
Cardinal agreement.
Litigation
Securities Litigation
The Company was involved in several securities class action and shareholder derivative actions
which followed announcements by the Company in 2004 and the subsequent restatement of its financial
results in 2005. In June 2006, we announced that these lawsuits had been settled, subject to
certain conditions such as court approval.
Background
Beginning in August 2004, several purported class action stockholder lawsuits were filed in
the United States District Court for the Southern District of California against the Company and
certain of its directors and officers. The actions were brought on behalf of purchasers of the
Companys common stock during several time periods, the longest of which ran from July 28, 2003
through August 2, 2004. The complaints generally alleged that the Company violated Sections 10(b)
and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 of the Securities and Exchange
Commission by making false and misleading statements, or concealing information about the Companys
business, forecasts and financial performance, in particular statements and information related to
drug development issues and AVINZA inventory levels. These lawsuits were consolidated and lead
plaintiffs appointed. A consolidated complaint was filed by the plaintiffs in March 2005. On
September 27, 2005, the court granted the Companys motion to dismiss the consolidated complaint,
with leave for plaintiffs to file an amended complaint within 30 days. In December 2005, the
plaintiffs filed a second amended complaint again alleging claims under Section 10(b) and 20(a) of
the Securities Exchange Act against the Company, David Robinson and Paul Maier. The amended
complaint also asserted an expanded Class Period of March 19, 2001 through May 20, 2005 and
included allegations arising from the Companys announcement on May 20, 2005 that it would restate
certain financial results.
Beginning on or about August 13, 2004, several derivative actions were filed on behalf of the
Company by individual stockholders in the Superior Court of California. The complaints named the
Companys directors and certain of its officers as defendants and named the Company as a nominal
defendant. The complaints were based on the same facts and circumstances as the purported class
actions discussed in the previous paragraph and generally alleged breach of fiduciary duties, abuse
of control, waste and mismanagement, insider trading and unjust enrichment.
In October 2005, a shareholder derivative action was filed on behalf of the Company in the
United States District Court for the Southern District of California. The complaint named the
Companys directors and certain of its officers as defendants and the Company as a nominal
defendant. The action was brought by an individual stockholder. The complaint generally alleged
that the defendants falsified Ligands publicly reported financial results throughout 2002 and 2003
and the first three quarters of 2004 by improperly recognizing revenue on product sales. The
complaint also alleged breach of fiduciary duty by all defendants and requested disgorgement, e.g.,
under Section 304 of the Sarbanes-Oxley Act of 2002.
The Settlement Agreements
In June 2006, the Company entered into agreements to resolve all claims by the parties in each
of these matters, including those asserted against the Company and the individual defendants in
these cases. Under the agreements, the Company agreed to pay a total of $12.2 million in cash for
a release and in full settlement of all claims. $12.0 million of the settlement amount and a
portion of the Companys total legal expenses was funded by the
92
Companys Directors and Officers Liability insurance carrier while the remainder of the legal
fees incurred ($1.4 million for 2006) was paid by the Company. Of the $12.2 million settlement
liability, $4.0 million was paid in October 2006 to Ligands insurance carrier and then disbursed
to the claimants attorneys, while $8.0 million was paid in July 2006 by the insurance carrier
directly to an independent escrow agent responsible for disbursing the funds to the class action
suit claimants. As part of the settlement of the state derivative action, the Company agreed to
adopt certain corporate governance enhancements including the formalization of certain Board
practices and responsibilities, a Board self-evaluation process, Board and Board Committee term
limits (with gradual phase-in) and one-time enhanced independent requirements for a single director
to succeed the current shareholder representatives on the Board. Neither the Company nor any of
its current or former directors and officers have made any admission of liability or wrongdoing.
On October 12, 2006, the Superior Court of California approved the settlement of the state and
federal derivative actions and entered final judgment of dismissal. The United States District
Court approved the settlement of the Federal class action in October 2006.
SEC Investigation and Other Matters
The SEC issued a formal order of private investigation dated September 7, 2005, which was
furnished to Ligands legal counsel on September 29, 2005, to investigate the circumstances
surrounding Ligands restatement of its consolidated financial statements for the years ended
December 31, 2002 and 2003, and for the first three quarters of 2004. The SEC has issued subpoenas
for the production of documents and for testimony pursuant to that investigation to Ligand and
others. The SECs investigation is ongoing and Ligand is cooperating with the investigation.
The Companys subsidiary, Seragen, Inc. and Ligand, were named parties to Sergio M. Oliver, et
al. v. Boston University, et al., a shareholder class action filed on December 17, 1998 in the
Court of Chancery in the State of Delaware in and for New Castle County, C.A. No. 16570NC, by
Sergio M. Oliver and others against Boston University and others, including Seragen, its subsidiary
Seragen Technology, Inc. and former officers and directors of Seragen. The complaint, as amended,
alleged that Ligand aided and abetted purported breaches of fiduciary duty by the Seragen related
defendants in connection with the acquisition of Seragen by Ligand and made certain
misrepresentations in related proxy materials and seeks compensatory and punitive damages of an
unspecified amount. On July 25, 2000, the Delaware Chancery Court granted in part and denied in
part defendants motions to dismiss. Seragen, Ligand, Seragen Technology, Inc. and the Companys
acquisition subsidiary, Knight Acquisition Corporation, were dismissed from the action. Claims of
breach of fiduciary duty remain against the remaining defendants, including the former officers and
directors of Seragen. The court certified a class consisting of shareholders as of the date of the
acquisition and on the date of the proxy sent to ratify an earlier business unit sale by Seragen.
On January 20, 2005, the Delaware Chancery Court granted in part and denied in part the defendants
motion for summary judgment. Prior to trial, several of the Seragen director-defendants reached a
settlement with the plaintiffs. The trial in this action then went forward as to the remaining
defendants and concluded on February 18, 2005. On April 14, 2006, the court issued a memorandum
opinion finding for the plaintiffs and against Boston University and individual directors
affiliated with Boston University on certain claims. The opinion awards damages on these claims in
the amount of approximately $4.8 million plus interest. Judgment, however, has not been entered
and the matter is subject to appeal. While Ligand and its subsidiary Seragen have been dismissed
from the action, such dismissal is also subject to appeal and Ligand and Seragen may have possible
indemnification obligations with respect to certain defendants. As of December 31, 2006, the
Company has not accrued an indemnification obligation based on its assessment that the Companys
responsibility for any such obligation is not probable or estimable.
The Company also received a letter in March 2007 from counsel to The Salk Institute for
Biological Studies alleging the Company owes The Salk Institute royalties on prior product sales of
Targretin as well as a percentage of the amounts received from Eisai Co., Ltd. (Tokyo) and Eisai
inc. (New Jersey) in the asset sale transaction completed with Eisai
in October 2006. Salk alleges that they are owed at least 25% of
the consideration paid by Eisai for that portion of Ligands oncology
product line and associated assets attributable to Targretin. The Company
intends to vigorously oppose any claim that Salk may bring for payment related to these matters.
In addition, the Company is subject to various lawsuits and claims with respect to matters
arising out of the normal course of business. Due to the uncertainty of the ultimate outcome of
these matters, the impact on future financial results is not subject to reasonable estimates.
93
13. Common Stock Subject to Conditional Redemption Pfizer Settlement Agreement
In April 1996, the Company and Pfizer entered into a settlement agreement with respect to a
lawsuit filed in December 1994 by the Company against Pfizer. In connection with a collaborative
research agreement the Company entered into with Pfizer in 1991, Pfizer purchased shares of the
Companys common stock. Under the terms of the settlement agreement, at the option of either the
Company or Pfizer, milestone and royalty payments owed to the Company can be satisfied by Pfizer by
transferring to the Company shares of the Companys common stock at the exchange ratio of $12.375
per share. In accordance with EITF D-98, the remaining common stock issued and outstanding to
Pfizer following the settlement was reclassified as common stock subject to conditional redemption
(between liabilities and equity) since Pfizer has the option to settle milestone and royalties
payments owed to the Company with the Companys shares, and such option is not within the Companys
control.
In 2004, Ligand earned a development milestone of approximately $2.0 million from Pfizer in
connection with Pfizers filing with the FDA of a new drug application for Oporia (also known as
lasofoxifene). The milestone is recorded as Other revenue in the accompanying Consolidated
Statement of Operations. Pfizer elected to pay the milestone in stock and subsequently tendered
181,818 shares to the Company. Ligand retired the tendered shares in 2004. The difference between
the fair value of the shares tendered and the carrying value of such shares based on the exchange
ratio, approximately $0.3 million, was credited to additional paid-in capital. At December 31,
2006 and 2005, respectively, the remaining shares of the Companys common stock that could be
redeemed totaled approximately 998,000, which are reflected at the exchange ratio price of $12.375
for a total of $12.3 million.
14. Stockholders Equity (Deficit)
Stock Issuances
At its annual meeting of stockholders held on June 11, 2004, the Companys stockholders
approved an increase in the authorized number of shares of Common Stock from 130,000,000 to
200,000,000.
Shares of common stock issued for stock options exercised and restricted stock grants issued
under the Companys stock option/stock issuance plans during the years ended December 31, 2006,
2005, and 2004 were 1,243,396; 109,225; and 582,176, respectively.
Shares of common stock issued under the Companys employee stock purchase plan during the
years ended December 31, 2006, 2005, and 2004 were 24,763; 56,445; and 101,895, respectively.
Shares of common stock issued upon conversion of convertible notes during the year ended
December 31, 2006 were 25,149,005.
Warrants
At December 31, 2005, there were outstanding warrants to purchase 748,800 shares of the
Companys common stock. The warrants had an exercise price of $10.00 per share and expired on
October 6, 2006.
During 2004, warrants to purchase 201,200 shares of common stock were exercised.
Stock Plans
The 2002 Stock Incentive Plan contains four separate equity programs Discretionary Option
Grant Program, Automatic Option Grant Program, Stock Issuance Program, and Director Fee Option
Grant Program (the 2002 Plan). Since its adoption, a total of 8,325,529 shares of common stock
have been reserved for issuance under the 2002 Plan (including shares transferred from the
predecessor plan). As of December 31, 2006, options for 5,766,386 shares of common stock were
outstanding under the 2002 Plan, 797,639 shares remained available for future option grant or
direct issuance, and 1,745,938 shares have been issued under the 2002 Plan.
94
Following is a summary of the Companys stock option plan activity and related information:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
Weighted |
|
Remaining |
|
Aggregate |
|
|
|
|
|
|
Average |
|
Contractual |
|
Intrinsic |
|
|
|
|
|
|
Exercise |
|
Term in |
|
Value |
|
|
Shares |
|
Price |
|
Years |
|
(In thousands) |
|
|
|
Balance at January 1, 2004 |
|
|
6,163,522 |
|
|
$ |
11.27 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,430,639 |
|
|
|
14.93 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(581,759 |
) |
|
|
9.59 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(236,305 |
) |
|
|
13.03 |
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
(62,028 |
) |
|
|
13.63 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2004 |
|
|
6,714,069 |
|
|
$ |
12.11 |
|
|
|
6.39 |
|
|
$ |
7,955 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2004 |
|
|
4,320,643 |
|
|
$ |
11.68 |
|
|
|
5.04 |
|
|
$ |
5,222 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2005 |
|
|
6,714,069 |
|
|
$ |
12.11 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
966,280 |
|
|
|
8.13 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(109,225 |
) |
|
|
6.32 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(158,731 |
) |
|
|
8.82 |
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
(410,736 |
) |
|
|
11.61 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2005 |
|
|
7,001,657 |
|
|
$ |
11.76 |
|
|
|
5.95 |
|
|
$ |
8,014 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2005 |
|
|
5,696,035 |
|
|
$ |
12.50 |
|
|
|
5.31 |
|
|
$ |
4,507 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at January 1, 2006 |
|
|
7,001,657 |
|
|
$ |
11.76 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,268,696 |
|
|
|
10.88 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(1,227,830 |
) |
|
|
8.66 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(404,654 |
) |
|
|
9.89 |
|
|
|
|
|
|
|
|
|
Cancelled |
|
|
(871,483 |
) |
|
|
13.00 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2006 |
|
|
5,766,386 |
|
|
$ |
12.17 |
|
|
|
6.04 |
|
|
$ |
4,602 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable at December 31, 2006 |
|
|
4,403,462 |
|
|
$ |
12.85 |
|
|
|
5.15 |
|
|
$ |
2,802 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options expected to vest as of
December 31, 2006 |
|
|
4,554,902 |
|
|
$ |
13.08 |
|
|
|
5.69 |
|
|
$ |
1,749 |
|
|
|
|
The weighted-average grant-date fair value of all stock options granted during 2006 was $7.07
per share. The total intrinsic value of all options exercised during 2006 was approximately $3.1
million. As of December 31, 2006, there was approximately $7.0 million of total unrecognized
compensation cost related to nonvested stock options. That cost is expected to be recognized over
a weighted average period of 2.32 years.
95
Cash received from options exercised in 2006 and 2005 was approximately $8.9 million and $0.7
million, respectively. As of December 31, 2006, there were approximately $1.8 million of
receivables related to stock option exercises which were subsequently received in the first week of
January 2007. There is no current tax benefit related to options exercised because of net
operating losses (NOLs) for which a full valuation allowance has been established.
Following is a further breakdown of the options outstanding as of December 31, 2006:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options Outstanding |
|
|
Options exercisable |
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
average |
|
|
Weighted |
|
|
|
|
|
|
|
|
|
Options |
|
|
remaining life |
|
|
average |
|
|
Number |
|
|
Weighted average |
|
Range of exercise prices |
|
outstanding |
|
|
in years |
|
|
exercise price |
|
|
exercisable |
|
|
exercise price |
|
$ 1.82 - $9.31 |
|
|
1,254,581 |
|
|
|
6.70 |
|
|
$ |
7.7238 |
|
|
|
785,459 |
|
|
$ |
7.6747 |
|
9.50 - 11.35 |
|
|
1,171,608 |
|
|
|
6.62 |
|
|
|
10.5966 |
|
|
|
660,479 |
|
|
|
10.7128 |
|
11.38 - 12.75 |
|
|
1,159,150 |
|
|
|
5.99 |
|
|
|
11.9718 |
|
|
|
780,739 |
|
|
|
11.9617 |
|
13.00 - 15.24 |
|
|
1,194,593 |
|
|
|
4.74 |
|
|
|
14.1976 |
|
|
|
1,194,593 |
|
|
|
14.1976 |
|
15.53 - 20.70 |
|
|
986,454 |
|
|
|
6.17 |
|
|
|
17.4663 |
|
|
|
982,192 |
|
|
|
17.4742 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1.82 - 20.70 |
|
|
5,766,386 |
|
|
|
6.04 |
|
|
$ |
12.1692 |
|
|
|
4,403,462 |
|
|
$ |
12.8458 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restricted Stock Activity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-Average |
|
|
|
Shares |
|
|
Stock Price |
|
Balance at December 31, 2005 |
|
|
|
|
|
$ |
|
|
Granted |
|
|
15,566 |
|
|
|
11.56 |
|
Vested |
|
|
(14,269 |
) |
|
|
11.56 |
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at December 31, 2006 |
|
|
1,297 |
|
|
$ |
11.56 |
|
|
|
|
|
|
|
|
Preferred Stock
The Company has authorized 5,000,000 shares of preferred stock, of which 1,600,000 are
designated Series A Participating Preferred Stock (the Preferred Stock). The Board of Directors
of Ligand has the authority to issue the Preferred Stock in one or more series and to fix the
designation, powers, preferences, rights, qualifications, limitations and restrictions of the
shares of each such series, including the dividend rights, dividend rate, conversion rights, voting
rights, rights and terms of redemption (including sinking fund provisions), liquidation preferences
and the number of shares constituting any such series, without any further vote or action by the
stockholders. The rights and preferences of Preferred Stock may in all respects be superior and
prior to the rights of the common stock. The issuance of the Preferred Stock could decrease the
amount of earnings and assets available for distribution to holders of common stock or adversely
affect the rights and powers, including voting rights, of the holders of the common stock and could
have the effect of delaying, deferring or preventing a change in control of Ligand. As of December
31, 2006 and 2005, there are no preferred shares issued or outstanding.
Shareholder Rights Plan
In October 2006, the Companys Board of Directors renewed the Companys stockholder rights
plan, which was originally adopted and has been in place since September 2002, and which expired on
September 13, 2006, through the adoption of a new 2006 Stockholder Rights Plan (the 2006 Rights
Plan). The 2006 Rights Plan provides for a dividend distribution of one preferred share purchase
right (a Right) on each outstanding share of the Companys common stock. Each Right entitles
stockholders to buy 1/1000th of a share of Ligand Series A Participating Preferred Stock at an
exercise price of $100. The Rights will become exercisable if a person or group announces an
acquisition of 20% or more of the Companys common stock, or announces commencement of a tender
offer for 20% or more of the common stock. In that event, the Rights permit stockholders, other
than the acquiring person, to
96
purchase the Companys common stock having a market value of twice the exercise price of the
Rights, in lieu of the Preferred stock. In addition, in the event of certain business
combinations, the Rights permit the purchase of the common stock of an acquiring person at a 50%
discount. Rights held by the acquiring person become null and void in each case. The 2006 Rights
Plan expires in 2016.
15. Collaborative Research and Development Agreements
The Company is party to various research and development collaborations with large
pharmaceutical companies including Eli Lilly and Company (Lilly), GlaxoSmithKline, Pfizer, Inc.,
TAP Pharmaceutical Products Inc., and Wyeth (formerly American Home Products). These arrangements
generally provide for the license of certain technologies and a collaborative research period
ranging from one to five years. Drugs resulting from these collaborations are then developed,
manufactured and marketed by the corporate partners. The arrangements may provide for the Company
to receive revenue from the transfer of technology rights at contract inception, collaborative
research revenue during the research phase, milestone revenue for compounds moving through clinical
development, and royalty revenue from the sale of drugs developed through the collaborative
efforts.
The following are details regarding significant collaborative arrangements that were in the
research phase during the years ended December 31, 2006, 2005, and 2004.
Eli Lilly & Company
In November 1997, the Company entered into a research and development collaboration with Lilly
for the discovery and development of products based on Ligands Intracellular Receptor technology.
Under the agreement, Lilly provided funding for a minimum of 31 to 40 Ligand scientists over the
research term of the contract. The initial five year research term concluded in November 2002.
Lilly had the option to extend the initial term by up to three additional years. In April 2002,
the companies announced the first extension of the collaboration through November 2003. In May
2003, the companies announced the second and final extension of the collaboration through November
2004.
Collaborative research revenues recognized under the agreement in 2004 were $4.0 million.
Research expenses incurred by the Company in support of the Lilly collaboration in 2004 were $3.6
million. The agreement further provides for milestones moving through the development stage and
royalties ranging from 5.0% to 12.0% on annual net sales of drugs resulting from the collaboration.
Net milestone revenue of $1.2 million was earned in 2005. No milestone revenue was earned in 2006
and 2004.
In May 2006, after review of all preclinical and clinical data including recently completed
two year animal safety studies, Lilly informed us that it had decided not to pursue further
development of LY818 (naveglitazar), a compound in Phase II development for the treatment of Type
II diabetes, at this time. Naveglitazar, a dual PPAR agonist, was developed through our collaborative research
and development agreement with Lilly. This decision was specific with regard to naveglitazar.
In September 2006, Lilly informed us that it had suspended an ongoing mid-stage human trial of
LY674 in order to assess unexpected findings noted during animal safety studies of the same
compound and evaluate collective clinical efficacy and safety from the human data already gathered.
LY674, a PPAR alpha agonist compound in Phase II development for the treatment of atherosclerosis,
was developed through our collaborative research and development agreement with Lilly. This
decision is specific with regard to LY674.
TAP
In June 2001, the Company entered into a research and development collaboration with TAP
Pharmaceutical Products Inc. (TAP) to focus on the discovery and development of selective
androgen receptor modulators (SARMs). SARMs contribute to the prevention and treatment of
certain diseases, including hypogonadism, male and female sexual dysfunction, male and female
osteoporosis, frailty, and hormone therapy. Under the agreement, TAP provided funding for a
minimum of 12 to 19 Ligand scientists over the initial term of the contract, which concluded in
June 2004. TAP had the option to extend the initial term by up to two additional years. In
December
97
2003, the companies announced the first extension of the collaboration through June 2005. In
December 2004, the companies announced the second and final extension of the collaboration through
June 2006.
Collaborative research revenues recognized under the agreement for the years ended December
31, 2006, 2005, and 2004 were $1.7 million, $3.5 million, and $3.8 million, respectively. Research
expenses incurred by the Company in support of the TAP collaboration for the years ended December
31, 2006, 2005, and 2004 were $2.1 million, $3.6 million, and $2.9 million, respectively. The
agreement further provides for milestones moving through the development stage and royalties
ranging from 6.0% to 12.0% on annual net sales of drugs resulting from the collaboration. The
Company did not earn milestone revenue under the agreement in 2006. The Company earned net
milestone revenue under the agreement of $1.1 million and $0.8 million in 2005 and 2004,
respectively.
16. X-Ceptor Therapeutics, Inc.
In June 1999, Ligand became a minority equity investor in a new private corporation, X-Ceptor
Therapeutics, Inc. (X-Ceptor). Ligand invested $6.0 million in X-Ceptor through the acquisition
of convertible preferred stock.
On September 29, 2004, Ligand announced that the Company had agreed to vote its shares in
favor of the proposed acquisition of X-Ceptor by Exelixis Inc. (Exelixis). Exelixis acquisition
of X-Ceptor was subsequently completed in October 2004, and in connection therewith, Ligand
received 618,165 shares of Exelixis common stock. Ligand recorded a net gain on the transaction in
October 2004 of $3.7 million, based on the fair market value of the consideration received, which
is included in other income (expense) in the accompanying consolidated statement of operations.
The shares received by Ligand had certain trading restrictions for which a resale registration
statement has been filed. Additionally, approximately 130,000 of the shares (21% of the total
shares) were placed in escrow for up to one year to satisfy indemnification and other obligations.
During 2005, such shares were released from escrow and the Company recognized a gain of $0.9
million, which is included in other income (expense) in the accompanying consolidated statement of
operations.
Shares of Exelixis as of December 31, 2005 were classified as available for sale investments.
These shares were carried at fair value, with unrealized gains and losses included as a separate
component of stockholders deficit. The net unrealized gain on these shares as of December 31,
2005 was $0.8 million. During 2005, the Company sold approximately 247,000 shares for net proceeds
of $1.9 million. During 2006, the Company sold the remaining shares for net proceeds of $3.9
million. The Company recognized a gain of $1.2 million in 2006 and a loss of $0.2 million in 2005
on these sales, which are included in other income (expense) in the accompanying consolidated
statements of operations.
17. Income Taxes
At December 31, 2006, the Company has both federal and state net operating loss carryforwards
of approximately $405.5 million and $165.4 million, respectively, which will begin expiring in
2007. The Company has $16.4 million of federal research and development credits carryforwards,
which will begin expiring in 2007 and $10.0 million of California research and development credits
that have no expiration date.
Pursuant to Internal Revenue Code Sections 382 and 383, use of net operating loss and credit
carryforwards may be limited if there were changes in ownership of more than 50%. The Company has
completed a Section 382 study for Ligand, excluding Glycomed and Seragen, and has determined that
Ligand had an ownership change in September 2005. As a result of this ownership change, utilization
of Ligands net operating losses and credits are subject to limitations under Internal Revenue Code
Sections 382 and 383. The information necessary to determine if an ownership change related to
Glycomed and Seragen occurred prior to their acquisition by Ligand is not currently available.
Accordingly, such tax net operating loss and credit carryforwards are not reflected in the
Companys deferred tax assets. If information becomes available in the future to substantiate the
amount of these net operating losses and credits not limited by Section 382 and 383, the Company
will record the deferred tax assets at such time.
The Companys research and development credits pertain to federal and California
jurisdictions. These jurisdictions require that the Company create minimum documentation and
support. The Company has recently
98
completed a formal study and believes that it maintains sufficient documentation to support
the amounts of the research and development credits.
Overall, the Companys 2006 net income tax expense (continuing and discounted operations) of
$0.7 million is comprised of $0.6 million, $0.05 million and $0.07 million for federal, state and
foreign, respectively. Reflected in the income tax expense of $0.7 million is income tax expense
of $39.1 million from discontinued operations offset by income tax benefit of $38.4 million from
continuing operations reflecting the utilization of losses from continuing operations against
income from discontinued operations. The net tax expense reflects the net tax due on taxable
income for 2006 that was not fully offset by net operating losses and research and development
credit carryforwards due to federal and state alternative minimum tax requirements.
The components of the income tax benefit (provision) for continuing operations are as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Current Benefit (Provision): |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
$ |
33,203 |
|
|
$ |
|
|
|
$ |
(81 |
) |
State |
|
|
5,211 |
|
|
|
|
|
|
|
(98 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
38,414 |
|
|
|
|
|
|
|
(179 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred Benefit
(Provision): |
|
|
|
|
|
|
|
|
|
|
|
|
Federal |
|
|
|
|
|
|
|
|
|
|
|
|
State |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
38,414 |
|
|
$ |
|
|
|
$ |
(179 |
) |
|
|
|
|
|
|
|
|
|
|
Significant components of the Companys deferred tax assets and liabilities as of December 31,
2006 and 2005 are shown below. A valuation allowance has been recognized to fully offset the net
deferred tax assets as of December 31, 2006 and 2005 as realization of such assets is uncertain.
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
|
(in thousands) |
|
Deferred liabilities: |
|
|
|
|
|
|
|
|
Purchased intangible assets |
|
$ |
|
|
|
$ |
(7,184 |
) |
|
|
|
|
|
|
|
Total deferred tax liabilities |
|
|
|
|
|
|
(7,184 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deferred assets: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net operating loss carryforwards |
|
|
143,386 |
|
|
|
192,274 |
|
Research and AMT credit carryforwards |
|
|
23,629 |
|
|
|
35,736 |
|
Capitalized research and development |
|
|
1,524 |
|
|
|
8,028 |
|
Fixed assets and intangibles |
|
|
4,288 |
|
|
|
5,610 |
|
Accrued expenses |
|
|
16,450 |
|
|
|
36,130 |
|
Deferred revenue |
|
|
9,825 |
|
|
|
29,968 |
|
Oncology sale escrow |
|
|
7,469 |
|
|
|
|
|
Organon termination liability |
|
|
34,852 |
|
|
|
|
|
Deferred sale leaseback |
|
|
10,898 |
|
|
|
|
|
Other |
|
|
1,326 |
|
|
|
68 |
|
|
|
|
|
|
|
|
|
|
|
253,647 |
|
|
|
307,814 |
|
|
|
|
|
|
|
|
|
|
Valuation allowance for deferred tax assets |
|
|
(253,647 |
) |
|
|
(300,630 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net deferred tax assets |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
As of December 31, 2006, approximately $6.9 million of the valuation allowance for deferred
tax assets related to benefits of stock option deductions which, when recognized, will be allocated
directly to paid-in capital. For the
99
year ended December 31, 2006, stock option deductions did not impact the valuation allowance
through paid-in capital. For the years ended December 31, 2005 and 2004, approximately $0.1
million and $1.3 million, respectively, of the change in the valuation allowance is related to
benefits of stock option deductions. Additionally, other changes to the valuation allowance
allocated directly to accumulated other comprehensive income (loss) are related to unrealized gains
and losses on foreign currency transactions of $0.4 million, $(0.2) million, and $(0.1) million for
the years ended December 31, 2006, 2005, and 2004, respectively.
A reconciliation of income tax benefit (expense) for continuing operations to the amount
computed by applying the statutory federal income tax rate to loss from continuing operations is
summarized as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Amounts computed at statutory federal rate |
|
$ |
59,253 |
|
|
$ |
10,700 |
|
|
$ |
7,679 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
State taxes net of federal benefit |
|
|
7,462 |
|
|
|
1,535 |
|
|
|
194 |
|
Meals & entertainment |
|
|
(113 |
) |
|
|
(134 |
) |
|
|
(171 |
) |
Stock-based compensation |
|
|
(306 |
) |
|
|
|
|
|
|
|
|
Adjustment to NOLs and R&D tax credits |
|
|
(49,227 |
) |
|
|
|
|
|
|
|
|
Federal research and development credits |
|
|
353 |
|
|
|
513 |
|
|
|
1,253 |
|
Nexus LLC acquisition |
|
|
|
|
|
|
|
|
|
|
1,159 |
|
Change in valuation allowance |
|
|
20,992 |
|
|
|
(12,603 |
) |
|
|
(10,291 |
) |
Other |
|
|
|
|
|
|
(11 |
) |
|
|
(2 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
38,414 |
|
|
$ |
|
|
|
$ |
(179 |
) |
|
|
|
|
|
|
|
|
|
|
A reconciliation of income tax expense for discontinued operations to the amount computed by
applying the statutory federal income tax rate to income or loss from discontinued operations is
summarized as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Amounts computed at statutory federal rate |
|
$ |
(48,705 |
) |
|
$ |
1,655 |
|
|
$ |
7,662 |
|
State taxes net of federal benefit |
|
|
(2,769 |
) |
|
|
237 |
|
|
|
191 |
|
Effect of foreign operations |
|
|
(70 |
) |
|
|
(59 |
) |
|
|
(54 |
) |
Stock-based compensation |
|
|
(102 |
) |
|
|
|
|
|
|
|
|
Change in valuation allowance |
|
|
12,511 |
|
|
|
(1,892 |
) |
|
|
(7,853 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(39,135 |
) |
|
$ |
(59 |
) |
|
$ |
(54 |
) |
|
|
|
|
|
|
|
|
|
|
18. New Accounting Pronouncements
In November 2005, the FASB issued Staff Positions (FSPs) Nos. FSPs 115-1 and 124-1, The
Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments, in response
to EITF 03-1, The Meaning of Other-Than-Temporary Impairment and Its Application to Certain
Investments (EITF 03-1). FSPs 115-1 and 124-1 provide guidance regarding the determination as to
when an investment is considered impaired, whether that impairment is other-than-temporary, and the
measurement of an impairment loss. FSPs 115-1 and 124-1 also include accounting considerations
subsequent to the recognition of an other-than-temporary impairment and requires certain
disclosures about unrealized losses that have not been recognized as other-than
temporary-impairments. These requirements are effective for annual reporting periods beginning
after December 15, 2005. The adoption of the impairment guidance contained in FSPs 115-1 and 124-1
did not have a material impact on the Companys consolidated results of operations or financial
position.
In November 2004, the FASB issued SFAS No. 151, Inventory Pricing (SFAS 151). SFAS 151
amends the guidance in ARB No. 43, Chapter 4, Inventory Pricing, to clarify the accounting for
abnormal amounts of idle facility expense, freight, handling costs, and wasted material (spoilage).
This statement requires that those items be
100
recognized as current-period charges. In addition, SFAS 151 requires that allocation of fixed
production overheads to the costs of conversion be based on the normal capacity of the production
facilities. This statement is effective for inventory costs incurred during fiscal years beginning
after June 15, 2005. The adoption of SFAS 151 did not have a material impact on the Companys
consolidated results of operations or financial position.
In February 2006, the FASB issued SFAS No. 155, Accounting for Certain Hybrid Financial
Instruments (SFAS 155) which amends SFAS No. 133, Accounting for Derivative Instruments and
Hedging Activities (SFAS 133) and SFAS 140, Accounting for the Impairment or Disposal of
Long-Lived Assets (SFAS 140). Specifically, SFAS 155 amends SFAS 133 to permit fair value
remeasurement for any hybrid financial instrument with an embedded derivative that otherwise would
require bifurcation, provided the whole instrument is accounted for on a fair value basis.
Additionally, SFAS 155 amends SFAS 140 to allow a qualifying special purpose entity to hold a
derivative financial instrument that pertains to a beneficial interest other than another
derivative financial instrument. SFAS 155 applies to all financial instruments acquired or issued
after the beginning of an entitys first fiscal year that begins after September 15, 2006, with
early application allowed. The adoption of SFAS 155 is not expected to have a material impact on
the Companys consolidated results of operations or financial position.
In March 2006, the FASB issued SFAS No. 156, Accounting for Servicing of Financial Assets
(SFAS 156) to simplify accounting for separately recognized servicing assets and servicing
liabilities. SFAS 156 amends SFAS No. 140, Accounting for Transfers and Servicing of Financial
Assets and Extinguishments of Liabilities. Additionally, SFAS 156 applies to all separately
recognized servicing assets and liabilities acquired or issued after the beginning of an entitys
fiscal year that begins after September 15, 2006, although early adoption is permitted. The
adoption of SFAS 156 is not expected to have a material impact on the Companys consolidated
results of operations or financial position.
In July 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxes- an interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the accounting for
uncertainty in income taxes recognized in a companys financial statements in accordance with FASB
Statement No. 109. It prescribes a recognition threshold and measurement attribute for the
financial statement recognition and measurement of a tax position taken or expected to be taken in
a tax return. Additionally, FIN 48 provides guidance on derecognition, classification, interest
and penalties, accounting in interim periods, disclosure, and transition. FIN 48 is effective for
fiscal years beginning after December 15, 2006. While the analysis of the impact of FIN 48 is not
yet complete, the Company does not expect that the adoption of FIN 48 will have a material impact
on its consolidated financial statements.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS
157 defines fair value, establishes a framework for measuring fair value under GAAP, and expands
disclosures about fair value measurements. SFAS 157 applies under other accounting pronouncements
that require or permit fair value measurements where fair value has previously been concluded to be
the relevant measurement attribute. SFAS 157 is effective for financial statements issued for
fiscal years beginning after November 15, 2007. The Company will adopt SFAS 157 in the first
interim period of fiscal 2008 and is evaluating the impact, if any, that the adoption of this
statement will have on its results of consolidated operations and financial position.
In September 2006, the FASB issued SFAS No. 158, Employers Accounting for Defined Benefit
Pension and Other Postretirement Plans, an amendment of FASB Statement No. 87, 88, 106 and 132(R)
(FAS S158). Under SFAS 158, companies must recognize a net liability or asset to report the
funded status of their defined benefit pension and other postretirement benefit plans (collectively
referred to herein as benefit plans) on their balance sheets, starting with balance sheets as of
December 31, 2006 if they are a calendar year-end public company. SFAS 158 also changed certain
disclosures related to benefit plans. The adoption of SFAS 158 did not have a material impact on
the Companys consolidated results of operations or financial position.
In September 2006, the SEC released Staff Accounting Bulletin No. 108, Considering the Effects
of Prior Year Misstatements when Quantifying Misstatements in Current Year Financial Statements
(SAB 108). SAB 108 provides guidance on how the effects of prior-year uncorrected financial
statement misstatements should be considered in quantifying a current year misstatement. SAB 108
requires registrants to quantify misstatements using both an income statement (rollover) and
balance sheet (iron curtain) approach and evaluate whether either approach results in a
misstatement that, when all relevant quantitative and qualitative factors are considered, is
material. If
101
prior year errors that had been previously considered immaterial are now considered material
based on either approach, no restatement is required as long as management properly applied its
previous approach and all relevant facts and circumstances were considered. If prior years are not
restated, the cumulative effect adjustment is recorded in opening retained earnings as of the
beginning of the fiscal year of adoption. SAB 108 is effective for fiscal years ending on or after
November 15, 2006. The adoption of SAB 108 did not have a material impact on the Companys
consolidated results of operations or financial position.
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities-Including an amendment of FASB Statement No. 115 (SFAS 159). SFAS 159
permits entities to choose to measure many financial instruments and certain other items at fair
value. Most of the provisions of SFAS 159 apply only to entities that elect the fair value option;
however, the amendment to FASB Statement No. 115, Accounting for Certain Investments in Debt and
Equity Securities, applies to all entities with available-for-sale and trading securities. The
Company will adopt SFAS 159 in the first interim period of fiscal 2008 and is evaluating the
impact, if any, that the adoption of this statement will have on its consolidated results of
operations and financial position.
19. Summary of Unaudited Quarterly Financial Information
The following is a summary of the unaudited quarterly results of operations for the years
ended December 31, 2006 and 2005 (in thousands, except per share amounts).
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter ended |
|
|
March 31 |
|
June 30 |
|
September 30 |
|
December 31 |
2006 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
32,495 |
|
|
$ |
33,651 |
|
|
$ |
36,707 |
|
|
$ |
34,130 |
|
Collaborative research and development and
other revenues |
|
|
2,914 |
|
|
|
1,063 |
|
|
|
|
|
|
|
|
|
Total revenues |
|
|
35,409 |
|
|
|
34,714 |
|
|
|
36,707 |
|
|
|
34,130 |
|
Cost of products sold |
|
|
5,594 |
|
|
|
5,374 |
|
|
|
5,800 |
|
|
|
5,874 |
|
Research and development costs |
|
|
8,325 |
|
|
|
10,220 |
|
|
|
10,468 |
|
|
|
12,913 |
|
Selling, general and administrative |
|
|
17,683 |
|
|
|
20,309 |
|
|
|
20,085 |
|
|
|
21,671 |
|
Co-promotion |
|
|
10,957 |
|
|
|
10,923 |
|
|
|
11,776 |
|
|
|
3,799 |
|
Co-promotion termination charges |
|
|
136,241 |
|
|
|
3,096 |
|
|
|
3,643 |
|
|
|
(11,902 |
) |
Total operating costs and expenses |
|
|
178,800 |
|
|
|
49,922 |
|
|
|
51,772 |
|
|
|
32,355 |
|
Gain on sale leaseback |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,119 |
|
Other expense, net |
|
|
(1,786 |
) |
|
|
(1,425 |
) |
|
|
(1,904 |
) |
|
|
(388 |
) |
Income tax benefit |
|
|
1,186 |
|
|
|
276 |
|
|
|
828 |
|
|
|
36,124 |
|
Income (loss) from continuing operations |
|
|
(143,991 |
) |
|
|
(16,357 |
) |
|
|
(16,141 |
) |
|
|
40,630 |
|
Discontinued operations |
|
|
1,762 |
|
|
|
397 |
|
|
|
1,223 |
|
|
|
100,734 |
|
Net income (loss) |
|
$ |
(142,229 |
) |
|
$ |
(15,960 |
) |
|
$ |
(14,918 |
) |
|
$ |
141,364 |
|
Basic per share amounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations |
|
|
(1.86 |
) |
|
|
(0.21 |
) |
|
|
(0.21 |
) |
|
|
0.46 |
|
Discontinued operations |
|
|
0.02 |
|
|
|
0.01 |
|
|
|
0.02 |
|
|
|
1.15 |
|
Net income (loss) |
|
$ |
(1.84 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.19 |
) |
|
$ |
1.61 |
|
Weighted average number of common shares |
|
|
77,497 |
|
|
|
78,540 |
|
|
|
78,670 |
|
|
|
87,678 |
|
Diluted per share amounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) from continuing operations |
|
|
(1.86 |
) |
|
|
(0.21 |
) |
|
|
(0.21 |
) |
|
|
0.42 |
|
Discontinued operations |
|
|
0.02 |
|
|
|
0.01 |
|
|
|
0.02 |
|
|
|
1.00 |
|
Net income (loss) |
|
$ |
(1.84 |
) |
|
$ |
(0.20 |
) |
|
$ |
(0.19 |
) |
|
$ |
1.42 |
|
Weighted average number of common shares |
|
|
77,497 |
|
|
|
78,540 |
|
|
|
78,670 |
|
|
|
100,460 |
|
102
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarter ended |
|
|
March 31 |
|
June 30 |
|
September 30 |
|
December 31 |
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
21,997 |
|
|
$ |
27,462 |
|
|
$ |
29,908 |
|
|
$ |
33,426 |
|
Collaborative research and development and
other revenues |
|
|
1,862 |
|
|
|
3,987 |
|
|
|
2,095 |
|
|
|
2,273 |
|
Total revenues |
|
|
23,859 |
|
|
|
31,449 |
|
|
|
32,003 |
|
|
|
35,699 |
|
Cost of products sold |
|
|
5,525 |
|
|
|
6,040 |
|
|
|
6,422 |
|
|
|
5,103 |
|
Research and development costs |
|
|
8,216 |
|
|
|
7,651 |
|
|
|
7,920 |
|
|
|
9,309 |
|
Selling, general and administrative |
|
|
13,698 |
|
|
|
14,951 |
|
|
|
14,484 |
|
|
|
13,035 |
|
Co-promotion |
|
|
7,740 |
|
|
|
6,966 |
|
|
|
7,766 |
|
|
|
10,029 |
|
Total operating costs and expenses |
|
|
35,179 |
|
|
|
35,608 |
|
|
|
36,592 |
|
|
|
37,476 |
|
Other expense, net |
|
|
(2,668 |
) |
|
|
(2,386 |
) |
|
|
(2,695 |
) |
|
|
(1,876 |
) |
Income tax expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations |
|
|
(13,988 |
) |
|
|
(6,545 |
) |
|
|
(7,284 |
) |
|
|
(3,653 |
) |
Discontinued operations |
|
|
(4,484 |
) |
|
|
(2,379 |
) |
|
|
1,003 |
|
|
|
931 |
|
Net loss |
|
$ |
(18,472 |
) |
|
$ |
(8,924 |
) |
|
$ |
(6,281 |
) |
|
$ |
(2,722 |
) |
Basic and diluted per share amounts: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from continuing operations |
|
|
(0.19 |
) |
|
|
(0.09 |
) |
|
|
(0.10 |
) |
|
|
(0.05 |
) |
Discontinued operations |
|
|
(0.06 |
) |
|
|
(0.03 |
) |
|
|
0.02 |
|
|
|
0.01 |
|
Net loss |
|
$ |
(0.25 |
) |
|
$ |
(0.12 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.04 |
) |
Weighted average number of common
shares |
|
|
73,916 |
|
|
|
74,037 |
|
|
|
74,041 |
|
|
|
74,058 |
|
20. NASDAQ Relisting
On June 12, 2006, NASDAQ approved the Companys application for relisting its common stock on
the NASDAQ Global Market (formerly NASDAQ National Market). The Company commenced trading on the
NASDAQ Global Market on June 14, 2006, under the symbol LGND. The Companys common stock was
previously delisted from the NASDAQ National Market on September 7, 2005.
21. Sale Leaseback
On October 25, 2006, the Company, along with its wholly-owned subsidiary Nexus, entered into
an agreement with Slough for the sale of the Companys real property located in San Diego,
California for a purchase price of approximately $47.6 million. This property, with a net book
value of approximately $14.5 million, included one building totaling approximately 82,500 square
feet, the land on which the building is situated, and two adjacent vacant lots. As part of the
sale transaction, the Company agreed to leaseback the building for a period of 15 years, as further
described below. In connection with the sale transaction, on November 6, 2006, the Company also
paid off the existing mortgage on the building of approximately $11.6 million (see Note 10). The
early payment triggered a prepayment penalty of approximately $0.4 million. The sale transaction
subsequently closed on November 9, 2006.
Under the terms of the lease, the Company pays a basic annual rent of $3.0 million (subject to
an annual fixed percentage increase, as set forth in the agreement), plus a 1% annual management
fee, property taxes and other normal and necessary expenses associated with the lease such as
utilities, repairs and maintenance, etc. The Company has the right to extend the lease for two
five-year terms and will have the first right of refusal to lease, at market rates, any facilities
built on the sold lots.
In accordance with SFAS 13, Accounting for Leases, the Company recognized an immediate pre-tax
gain on the sale transaction of approximately $3.1 million and deferred a gain of approximately
$29.5 million on the sale of the building. The deferred gain is recognized on a straight-line
basis over the 15 year term of the lease at a rate of approximately $2.0 million per year; the
amount of the deferred gain recognized in 2006 was $0.3 million.
103
22. Resignation of CEO and Appointment of New CEO
On July 31, 2006, the Company entered into a separation agreement with David Robinson
providing for Mr. Robinsons resignation as Chairman, President, and Chief Executive Officer of the
Company. Under the separation agreement, Mr. Robinson received his base salary and certain
benefits for 24 months, payable in five equal monthly installments beginning August 1, 2006 and
ending December 1, 2006. In addition, the agreement provided for the immediate vesting of Mr.
Robinsons unvested stock options and an extension of the exercise period of his options to January
15, 2007. In connection with the resignation, the Company recognized expense of approximately $1.9
million in 2006, comprised of cash payments of $1.4 million and stock-based compensation of $0.5
million associated with the modification of the vesting and exercise period of the stock options.
On August 1, 2006, the Company announced that current director Henry F. Blissenbach had been
named Chairman and interim Chief Executive Officer. The Company agreed to pay Dr. Blissenbach
$40,000 per month, commencing August 1, 2006 for his services as Chairman and interim Chief
Executive Officer. In addition, Dr. Blissenbach was eligible to receive incentive compensation of
up to 50% of his base salary, but not more than $100,000, based upon his performance of certain
objectives incorporated within the employment agreement which the Company and Dr. Blissenbach
entered into. Also, Dr. Blissenbach received a stock option grant to purchase 150,000 shares of
the Companys common stock at an exercise price of $9.20 per share. These stock options vested
upon the appointment of a new chief executive officer in January 2007 as further discussed below.
Finally, the Company reimbursed Dr. Blissenbach for all reasonable expenses incurred in discharging
his duties as interim Chief Executive Officer, including, but not limited to commuting costs to San
Diego and living and related costs during the time he spent in San Diego.
On January 15, 2007, the Company announced that John L. Higgins had joined the Company as
Chief Executive Officer and President. Mr. Higgins succeeded Dr. Blissenbach, who continues as
Chairman of the Board of Directors. The Company has agreed to pay Mr. Higgins an annual salary of
$400,000, with his employment commencing as of January 10, 2007. In addition, Mr. Higgins has a
performance bonus opportunity with a target of 50% of his salary, up to a maximum of 75%, and
received a restricted stock grant of 150,000 shares of the Companys common stock vesting over two
years. The Company also provided Mr. Higgins with a lump-sum relocation benefit of $100,000. Mr.
Higgins employment agreement provides for severance payments and benefits in the event that
employment is terminated under various scenarios, such as a change in control of the Company.
23. Reductions in Workforce
In December 2006, and following the sale of the Companys oncology product line to Eisai, the
Company entered into a plan to eliminate 40 employee positions, across all functional areas, which
were no longer deemed necessary considering the Companys decision to sell its commercial assets.
Additionally, the Company terminated 23 AVINZA sales representatives and regional business managers
who were not offered positions with King or declined Kings offer of employment. The affected
employees were informed of the plan in December 2006 with an effective termination date of January
2, 2007. In connection with the termination plan, the Company recognized operating expenses of
approximately $2.9 million in the fourth quarter of 2006, comprised of one-time severance benefits
of $2.3 million, stock compensation of $0.3 million, and other costs of $0.3 million. The stock
compensation charge resulted from the accelerated vesting and extension of the exercise period of
stock options in accordance with severance arrangements of certain senior management members. The
Company paid $0.5 million in December 2006 and the remaining balance in January 2007.
As more fully discussed in Note 24, the Company announced another restructuring plan on
January 31, 2007 calling for the elimination of an additional 204 positions.
24. Subsequent Events (Unaudited)
Appointment of New CEO
As more fully discussed in Note 22, in January 2007 the Company announced the appointment of
John L. Higgins as Chief Executive Officer and President.
104
Reduction in Workforce
On January 31, 2007, the Company announced an additional restructuring plan calling for the elimination
of approximately 204 positions across all functional areas. This reduction was made in connection
with the efforts to refocus the Company, following the sale of the Companys commercial assets, as
a smaller, highly focused research and development and royalty-driven biotech company.
Associated with the restructuring and refocused business model, several of the Companys executive
officers agreed to step down including the Chief Financial Officer, Chief Scientific Officer and
General Counsel. The Company also announced that primary operations are expected to be
consolidated into one building with the goal to sublet un-utilized space. In connection with the
restructuring, the Company expects to take a charge to earnings, the majority of which will be
recorded in the first quarter of 2007, of approximately $10.8 million, comprised of one-time
severance benefits of $7.5 million, stock compensation of $2.2 million, and other costs of $1.1
million. The stock compensation charge results from the accelerated vesting and extension of the
exercise period of stock options in accordance with severance arrangements of certain senior
management members.
Sale of AVINZA Product Line
On September 6, 2006, Ligand and King Pharmaceuticals, Inc. (King), entered into a purchase
agreement (the AVINZA Purchase Agreement), pursuant to which King agreed to acquire all of the
Companys rights in and to AVINZA in the United States, its territories and Canada, including,
among other things, all AVINZA inventory, records and related intellectual property, and assume
certain liabilities as set forth in the AVINZA Purchase Agreement (collectively, the
Transaction). In addition, King, subject to the terms and conditions of the AVINZA Purchase
Agreement, agreed to offer employment following the closing of the Transaction (the Closing) to
certain of the Companys existing AVINZA sales representatives or otherwise reimburse the Company
for agreed upon severance arrangements offered to any such non-hired representatives.
Pursuant to the AVINZA Purchase Agreement, at Closing on February 26, 2007 (the Closing
Date), the Company received $280.4 million in net cash proceeds, which is net of $15.0 million
that was funded into an escrow account to support potential indemnification claims made by King
following the Closing. The net cash received includes the purchase price of $246.3 million which
is net of an adjustment of approximately $12.7 million due to estimated retail inventory levels of
AVINZA at the Closing Date exceeding targeted levels. This adjustment is subject to the outcome of
final studies and review by King which could therefore result in a subsequent adjustment to the net
purchase price. The purchase price also reflects a reduction of $6.0 million for anticipated
higher cost of goods for King related to the Cardinal Health PTS, LLC (Cardinal) manufacturing
and packaging agreement (see Note 12). At the closing, Ligand agreed to not assign the Cardinal
agreement to King, wind down the contract, and remain responsible for any resulting liabilities.
The Company will record a charge as a reduction to the gain on the sale of the AVINZA product line
in the first quarter of 2007 for any liabilities incurred in connection with the winding down of
the Cardinal agreement.
105
The net cash received also includes reimbursement of $47.8 million for co-promote termination
payments which had previously been paid to Organon, $0.9 million of interest Ligand paid King on a
loan that was repaid in January 2007, and $0.5 million of severance expense for AVINZA sales
representatives not offered positions with King. A summary of the net cash proceeds is as follows
(in thousands):
|
|
|
|
|
Purchase price |
|
$ |
265,000 |
|
Reimbursement of Organon payments |
|
|
47,750 |
|
Repayment of interest on King loan |
|
|
883 |
|
Reimbursement of sales representative severance costs |
|
|
453 |
|
|
|
|
|
|
|
|
314,086 |
|
|
|
|
|
|
Less retail pharmacy inventory adjustment |
|
|
(12,687 |
) |
Less cost of goods manufacturing adjustment |
|
|
(6,000 |
) |
|
|
|
|
|
|
|
295,399 |
|
Less funds placed into escrow |
|
|
(15,000 |
) |
|
|
|
|
|
|
|
|
|
Net cash proceeds |
|
$ |
280,399 |
|
|
|
|
|
King also assumed Ligands co-promote termination obligation to make payments to Organon based
on net sales of AVINZA (approximately $93.3 million as of December 31, 2006). As Organon has not
consented to the legal assignment of the co-promote termination obligation from Ligand to King,
Ligand remains liable to Organon in the event of Kings default of this obligation. The Company
also incurred approximately $7.2 million in transaction fees and other costs associated with the
sale that are not reflected in the net cash proceeds. This amount includes approximately $3.6
million for investment banking services and related expenses which have not yet been paid. The
Company is disputing that these fees are owed to the investment banking firm.
In addition to the assumption of existing royalty obligations, King will pay Ligand a 15%
royalty on AVINZA net sales during the first 20 months after Closing. Subsequent royalty payments
will be based upon calendar year net sales. If calendar year net sales are less than $200.0
million, the royalty payment will be 5% of all net sales. If calendar year net sales are greater
than $200.0 million, the royalty payment will be 10% of all net sales less than $250.0 million,
plus 15% of net sales greater than $250.0 million.
In connection with the sale, the Company has agreed to indemnify King for a period of 16
months after the closing for a number of specified matters including the breach of the Companys
representations, warranties and covenants contained in the asset purchase agreement, and in some
cases for a period of 30 months following the closing of the asset sale. Under the Companys
agreement with King, $15.0 million of the total upfront cash payment was deposited into an escrow
account to secure the Companys indemnification obligations to King following the closing.
The Companys indemnification obligations under the asset purchase agreements could cause
Ligand to be liable to King under certain circumstances, in excess of the amount set forth in the
escrow account. The AVINZA asset purchase agreement also allows King, under certain circumstances,
to set off indemnification claims against the royalty payments payable to the Company. Under the
asset purchase agreement, the Companys liability for any indemnification claim brought by King is
generally limited to $40.0 million. However, the Companys obligation to provide indemnification
on certain matters is not subject to this indemnification limit. For example, the Company agreed
to retain, and provide indemnification without limitation to King for all liabilities arising under
certain agreements with Cardinal Health PTS, LLC related to the manufacture of AVINZA. The Company
cannot predict the liabilities that may arise as a result of these matters. Any liability claims
related to these matters or any indemnification claims made by King could materially and adversely
affect the Companys financial condition.
In connection with the Transaction, King loaned the Company, at the Companys option, $37.8
million (the Loan) which was used to pay the Companys co-promote termination obligation to
Organon due October 15, 2006. This loan was drawn, and the $37.8 million co-promote liability
settled in October 2006. Amounts due under
106
the loan were subject to certain market terms, including a 9.5% interest rate. In addition,
and as a condition of the loan, $38.6 million of the funds received from Eisai was deposited into a
restricted account to be used to repay the loan to King, plus interest. The Company repaid the
loan plus interest in January 2007. As noted above, King refunded the interest to the Company on
the Closing Date.
Also on September 6, 2006, the Company entered into a contract sales force agreement (the
Sales Call Agreement) with King, pursuant to which King agreed to conduct a sales detailing
program to promote the sale of AVINZA for an agreed upon fee, subject to the terms and conditions
of the Sales Call Agreement. Pursuant to the Sales Call Agreement, King agreed to perform certain
minimum monthly product details (i.e. sales calls), which commenced effective October 1, 2006 and
continued until the Closing Date. The amount due to King under the Sales Call Agreement as of
December 31, 2006 is approximately $3.8 million.
The following table summarizes product sales and cost of products sold information for AVINZA
for 2006, 2005 and 2004 included in the consolidated statements of operations (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2004 |
|
Product sales |
|
$ |
136,983 |
|
|
$ |
112,793 |
|
|
$ |
69,470 |
|
Cost of products sold |
|
|
(22,642 |
) |
|
|
(23,090 |
) |
|
|
(18,264 |
) |
|
|
|
|
|
|
|
|
|
|
Gross margin |
|
$ |
114,341 |
|
|
$ |
89,703 |
|
|
$ |
51,206 |
|
|
|
|
|
|
|
|
|
|
|
Potential Dividend/Modification to 2002 Stock Incentive Plan
The Companys Board of Directors is evaluating the distribution of a substantial portion of
the net cash proceeds from the asset sales transactions to the Companys stockholders in the form
of a special dividend following the consummation of the AVINZA sale transaction. The Board has not
determined the amount of any such special dividend, and the amount available for such a dividend
depends on a number of factors including the Companys capital surplus, cash on hand and estimated
cash needs for the Companys continuing business. Additionally, in February 2007 the Companys
stockholders approved a modification to the 2002 Stock Incentive Plan (the 2002 Plan) to allow
equitable adjustments to be made to options outstanding under the 2002 Plan in the event of a
special cash dividend. Given that such modification was made in contemplation of the special
dividend under consideration, any such adjustments to outstanding options would result in the
recognition of compensation expense in the Companys consolidated statement of operations under the
requirements of Statement of Financial Accounting Standard No 123(R) Share-Based Payment (SFAS
123(R)). Any such expense could be material.
Change in Board of Directors/Funding of Legacy Director Indemnity Fund
On March 1, 2007, the Company announced the resignation of directors John Groom, Irving S.
Johnson, Ph.D., Daniel Loeb, Carl C. Peck, M.D. and Brigette Roberts, M.D. and the appointment of
four new directors, John L. Higgins, our President and Chief Executive Officer, Todd C. Davis,
Elizabeth M. Greetham and David M. Knott. Also, on March 1, 2007, the Company entered into an
indemnity fund agreement, which established in a trust account with Dorsey & Whitney LLP, counsel
to Companys independent directors and to the Audit Committee of the Companys Board of Directors,
a $10.0 million indemnity fund to support the Companys existing indemnification obligations to
continuing and departing directors in connection with the ongoing SEC investigation and related
matters.
The Salk Institute for Biological Studies (Salk) Allegations
In March 2007, the Company received a letter from legal counsel to The Salk Institute for
Biological Studies (Salk) alleging that the Company owes Salk royalties on prior product sales of
Targretin as well as a percentage of the amounts received from Eisai Co., Ltd. (Tokyo) and Eisai
Inc. (New Jersey) that are attributable to Targretin with respect to the Companys sale of its
Oncology Product Line to Eisai that was completed in October 2006. Salk
107
alleges that they are owed at least 25% of the consideration paid by Eisai for that portion of
Ligands oncology product line and associated assets attributable to Targretin. The Company has
reviewed these matters and does not believe it has any financial obligations to Salk pertaining to
Targretin. Accordingly, the Company intends to vigorously oppose any Salk claim for payment
related to these matters.
Subsequent Stock Issuance
Subsequent to December 31, 2006 and through February 28, 2006, the Company has issued 457,276
additional shares of common stock, consisting of 150,000 shares pursuant to the restricted stock
grant relating to the hiring of the CEO and 307,276 shares relating to the exercises of stock options.
108
Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
None.
Item 9A. Controls and Procedures
(a) Disclosure Controls and Procedures
The Company is required to maintain disclosure controls and procedures that are designed to
ensure that information required to be disclosed in its reports under the Exchange Act is recorded,
processed, summarized and reported within the time periods specified in the SECs rules and forms,
and that such information is accumulated and communicated to management, including the Companys
Chief Executive Officer (CEO) and Chief Financial Officer (CFO) as appropriate, to allow timely
decisions regarding required disclosure.
In connection with the preparation of this Form 10-K for the year ended December 31, 2006,
management, under the supervision of the CEO and CFO, conducted an evaluation of disclosure
controls and procedures. Based on that evaluation, the CEO and CFO concluded that the Companys
disclosure controls and procedures were effective as of December 31, 2006.
(b) Managements Report on Internal Control over Financial Reporting
Management is responsible for establishing and maintaining adequate internal control over
financial reporting for the Company. Internal control over financial reporting is a process to
provide reasonable assurance regarding the reliability of the Companys financial reporting for
external purposes in accordance with accounting principles generally accepted in the United States
of America. Internal control over financial reporting includes maintaining records that in
reasonable detail accurately and fairly reflect the Companys transactions; providing reasonable
assurance that transactions are recorded as necessary for preparation of the Companys financial
statements; providing reasonable assurance that receipts and expenditures of company assets are
made in accordance with management authorization; and providing reasonable assurance that
unauthorized acquisition, use or disposition of company assets that could have a material effect on
the Companys financial statements would be prevented or detected on a timely basis. Because of its
inherent limitations, internal control over financial reporting is not intended to provide absolute
assurance that a misstatement of the Companys financial statements would be prevented or detected.
Management conducted an evaluation of the effectiveness of the Companys internal control over
financial reporting based on the framework in Internal Control Integrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission. Based on this evaluation,
management concluded that the Companys internal control over financial reporting was effective as
of December 31, 2006.
There were no changes in the Companys internal control over financial reporting during the
quarter ended December 31, 2006, except as noted in (c) and (d) below, that have materially
affected, or are reasonably likely to materially affect, the Companys internal control over
financial reporting.
BDO Seidman LLP, the Companys independent registered public accountants, has audited this
assessment of the Companys internal control over financial reporting; their report is included in
Item 9A.
(c) Changes in Internal Control over Financial Reporting
As disclosed in the Companys 2005 Annual Report on Form 10-K, the Company reported the
following material weaknesses in internal control over financial reporting:
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Revenue Recognition. The Company previously reported that it did not have effective
controls and procedures to ensure that revenues were recognized in accordance with
generally accepted accounting principles. As further discussed below, the Company
implemented new revenue recognition models and related internal controls to remediate this
weakness. Such remediation efforts, however, were not fully implemented until the fourth
quarter of 2005. Management believes the controls with respect to revenue |
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recognition were appropriately designed and effective at June 30, 2006 and continued to be
effective at December 31, 2006, as further discussed in Item (d) below. |
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Record Keeping and Documentation. The Company previously reported that it did not have
adequate record keeping and documentation supporting the decisions made and the accounting
for complex transactions. As further discussed below, the Company implemented new
procedures and controls to remediate this weakness. Such remediation efforts, however,
were not fully implemented until the fourth quarter of 2005. Management believes the
controls with respect to record keeping were appropriately designed and effective at June
30, 2006 and continued to be effective at December 31, 2006, as further discussed in Item
(d) below. |
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Lack of Sufficient Qualified Accounting Personnel. The Company previously reported that
it did not have adequate manpower in its accounting and finance department and lacked
sufficient qualified accounting personnel to identify and resolve complex accounting issues
in accordance with generally accepted accounting principles. As further discussed below,
the Company appropriately designed the organization structure of its accounting and finance
department and staffed key positions to remediate this weakness. Such remediation efforts,
however, were not fully implemented until the second and third quarters of 2006.
Management believes the controls, with respect to qualified accounting personnel, were
appropriately designed and effective at September 30, 2006 and continued to be effective at
December 31, 2006, as further discussed in Item (d) below. |
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Financial Statement Close Procedures. The Company previously reported that it did not
have adequate financial reporting and close procedures. As further discussed below, the
Company implemented new procedures and controls to remediate this weakness. Such
remediation efforts, however, were not fully implemented until the fourth quarter of 2005.
Management believes the controls with respect to financial statement close procedures were
appropriately designed and effective at September 30, 2006 and continued to be effective at
December 31, 2006, as further discussed in Item (d) below. |
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Internal Audit. The Company previously reported that it did not maintain an independent
effective Internal Audit department. As further discussed below, in the second and third
quarters of 2006, the Company staffed an internal audit department, including a Director of
Internal Audit, and received Audit Committee approval for its internal audit plan and the
internal audit charter. Effective the third quarter of 2006, the Companys internal audit
department was operating in accordance with the approved charter and began executing the
approved internal audit plan. Accordingly, management believes that controls with respect
to the existence of an independent, effective internal audit department were in place and
operating at September 30, 2006 and continued to be effective at December 31, 2006, as
further discussed in Item (d) below. |
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Spreadsheet Controls. In connection with the change in the Companys revenue recognition
for product sales from the sell-in method to the sell-through method in 2005, the use of
spreadsheets became a pervasive and integral part of the Companys financial accounting,
quarter-end close, and financial reporting processes. As previously reported, the Company
did not have effective end user general controls over the access, change management and
validation of spreadsheets used in its financial processes, nor did the Company have formal
policies and procedures in place relating to the use of spreadsheets. As more fully
discussed below, management completed the implementation of policies and procedures
relating to spreadsheet management which are designed to ensure that adequate control
activities exist surrounding significant spreadsheets. These policies and procedures,
which include controls relating to data integrity, version control, and restricted access
to such spreadsheets, were implemented and considered to be operating effectively for the
Companys key revenue recognition spreadsheets as of September 30, 2006 and continued to be
effective at December 31, 2006. These policies and procedures were fully implemented for
all other key (non-revenue recognition) spreadsheets in the third quarter of 2006 and are
considered to be effective at December 31, 2006. |
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Segregation of Duties. Management identified certain members of the Companys
accounting and finance department who had accounting system access rights that were
incompatible with the current roles and duties of such individuals. This control
deficiency was identified as of December 31, 2004. However, when considered in conjunction
with the material weaknesses identified in 2005 surrounding internal audit and monitoring
controls discussed herein, this control deficiency was elevated to a material weakness as
of |
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December 31, 2005. In 2006, the Company terminated access rights for those individuals who
were determined to have system access incompatible with their job functions. Management
believes the controls with respect to segregation of duties were appropriately designed and
effective at September 30, 2006 and continued to be effective at December 31, 2006. |
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Monitoring Controls. As a result of the demands placed on the Companys accounting and
finance department with respect to the Companys accounting restatement in 2005, management
did not properly maintain the Companys documentation of internal control over financial
reporting during 2005 to reflect changes in internal control over financial reporting and
as a result did not substantively commence the process to update such documentation and
complete its assessment until December 2005. Further, the restatement process which
occurred in 2005 resulted in the delayed performance of certain control procedures in the
period-end close process. Accordingly, management determined that this control deficiency
constituted a material weakness as of December 31, 2005. As discussed below, management
believes it has implemented procedures and controls in 2006 to ensure more timely
maintenance of internal control documentation and execution of its monitoring controls over
its internal controls over financial reporting and that such controls continued to be
effective at December 31, 2006. |
d) Remediation Steps to Address Material Weaknesses Identified in 2005
The following describes the remediation steps taken by management in 2006 to address material
weaknesses identified and disclosed in the Companys 2005 Annual Report on Form 10-K:
Revenue Recognition
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During 2005, the Companys finance and accounting department, with the assistance of
outside expert consultants, developed accounting models to recognize sales of its domestic
products, except Panretin, under the sell-through revenue recognition method in accordance
with generally accepted accounting principles. In connection with the development of these
models, the Company also implemented a number of new and enhanced controls and procedures
to support the sell-through revenue recognition accounting models. These controls and
procedures include approximately 35 revenue models used in connection with the sell-through
revenue recognition method including related contra-revenue models and demand
reconciliations to support and assess the reasonableness of the data and estimates, which
includes information and estimates obtained from third-parties. |
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During the fourth quarter of 2005, the accounting and finance department completed the
implementation of procedures surrounding the month-end close process to ensure that the
information and estimates necessary for reporting product revenues under the sell-through
method to facilitate a timely period-end close were available. |
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A training program for employees and consultants involved in the revenue recognition
accounting was developed and took place during the fourth quarter of 2005. In 2006,
additional training was provided and updated as considered necessary. |
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The Company staffed the position of Senior Revenue Recognition Analyst in the second
quarter of 2006 and implemented additional reviews over the revenue recognition area by
senior accounting and finance personnel. The Company has not filled the position of
Manager of Revenue Recognition. However, given the sale of the Companys revenue-producing
assets, the Company does not contemplate filling this position. Management believes that
the measures identified above are sufficient to address the control considerations
surrounding revenue recognition. |
Record Keeping and Documentation
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The Company has implemented improved procedures for analyzing, reviewing, and
documenting the support for significant and complex transactions. Documentation for all
complex transactions is now maintained by the Corporate Controller. |
111
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The Companys accounting and finance and legal departments developed a formal internal
policy during the fourth quarter of 2005 entitled Documentation of Accounting Decisions,
regarding the preparation and maintenance of contemporaneous documentation supporting
accounting transactions and contractual interpretations. The formal policy provides for
enhanced communication between the Companys finance and legal personnel. |
Lack of Sufficient Qualified Accounting Personnel
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The Companys previous Director of Internal Audit resigned effective December 2, 2005.
In December 2005, the Company retained a nationally recognized external consulting firm to
assist the Internal Audit department and oversee the Companys ongoing compliance effort
under Section 404 of the Sarbanes Oxley Act of 2002 until a permanent replacement for the
Companys Director of Internal Audit was hired. During the second quarter of 2006, the
Company hired a Director of Internal Audit, who is a certified public accountant and who
commenced employment in May 2006. |
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During 2005, the Company engaged expert accounting consultants to assist the Companys
accounting and finance department with a number of activities, including the management and
implementation of controls surrounding the Companys new sell-through revenue recognition
models, the administration of existing controls and procedures, preparation of the
Companys SEC filings and the documentation of complex accounting transactions. |
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During the second quarter of 2006, the Company hired additional senior accounting
personnel who are certified public accountants including, a Director of Corporate
Accounting, a Senior Accounting Manager, and a Director of Internal Audit, as discussed
above. The Company also staffed the position of Senior Revenue Recognition Analyst through
an internal transfer in the second quarter of 2006 and hired a senior internal auditor and
internal audit staff member in the third quarter of 2006. Additionally, the Company hired
a Director of Budget and Financial Analysis in August 2006 to replace the Senior Manager,
Budget and Financial Analysis who left the Company in June 2006. Lastly, other open
positions below the manager level have been sufficiently staffed with qualified consulting
personnel. |
Financial Statement Close Procedures
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The Company has designed and implemented process improvements concerning the Companys
financial reporting and close procedures. A training session for all finance department
employees and consultants involved in the financial statement close process took place
during the fourth quarter of 2005. Additionally, an ongoing periodic training
update/program has been implemented to conduct training sessions on a regular basis to
provide training to its finance and accounting personnel and to review procedures for
timely and accurate preparation and management review of documentation and schedules to
support the Companys financial reporting and period-end close process. As discussed
above, the additional management personnel hired by the finance department will also help
ensure that all documentation necessary for the financial reporting and period-end close
procedures is properly prepared and reviewed. |
Internal Audit
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As discussed under the caption Lack of Sufficient Qualified Accounting Personnel above,
the Company hired a Director of Internal Audit, who commenced employment in the second
quarter of 2006 and staffed an internal audit department in the third quarter of 2006.
Additionally, prior to the Director of Internal Audit commencing employment, the Company
engaged and continues to use a nationally recognized external consulting firm to assist
with internal audit services. |
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The internal audit charter and the internal audit plan for 2006 were approved by the
Companys Audit Committee during the third quarter of 2006. The Companys internal audit
department commenced execution of the approved internal audit plan during the third quarter
of 2006. |
112
Spreadsheet Controls
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Revenue Spreadsheet Controls. The Company implemented new revenue recognition models
and related internal controls to remediate this weakness. Such remediation efforts,
however, were not fully implemented until the fourth quarter of 2005. Since June 30, 2006,
the Company believes that the controls surrounding the revenue spreadsheets were
appropriately designed and have been effective. |
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Non-Revenue Spreadsheet Controls. In 2006, management identified and categorized
significant spreadsheets using qualitative measures of financial risk and complexity.
After being inventoried, the spreadsheets were subject to standardized control activity
testing, ensuring that any deficiencies in such spreadsheets relating to security, change
management, input validation, documentation, and segregation of duties were addressed.
Management completed the implementation of policies and procedures relating to spreadsheet
management which are designed to ensure that adequate control activities exist surrounding
significant spreadsheets. These policies and procedures, which include controls relating
to data integrity, version control, and restricted access to such spreadsheets were fully
implemented in the third quarter of 2006. |
Segregation of Duties
In 2006, management identified those members of the Companys accounting and finance
department who had accounting system access rights that were incompatible with the current roles
and duties of such individuals and subsequently terminated the access rights for those individuals.
On a quarterly basis, commencing with the first quarter of 2006, management monitors the
accounting system access rights of those employees with access to the accounting software systems
to identify any grants of incompatible user access rights or any user access rights resulting from
subsequent changes or modifications to the Companys internal control structure.
Monitoring Controls
As discussed under the caption Internal Audit above, the Company hired a Director of Internal
Audit, who commenced employment in the second quarter of 2006. Additionally, prior to the Director
of Internal Audit commencing employment, the Company engaged and continues to use a nationally
recognized external consulting firm to assist with internal audit services. As part of this
service, these consultants are responsible for assisting management with updating and maintaining
the Companys documentation of internal control over financial reporting. The consultants are also
assisting with the testing of such internal controls and in monitoring the progress of any ongoing
and newly identified remediation efforts to help ensure the timely completion of the Companys 2006
monitoring program.
113
Report of Independent Registered Public Accounting Firm on Internal Control over Financial Reporting
To the Board of Directors and Stockholders
Ligand Pharmaceuticals Incorporated
San Diego, California
We have audited managements assessment, included in the accompanying Managements Report on
Internal Control over Financial Reporting, that Ligand Pharmaceuticals Incorporated and
subsidiaries (the Company) maintained effective internal control over financial reporting as of
December 31, 2006, based on criteria established in Internal ControlIntegrated Framework issued by
the Committee of Sponsoring Organizations of the Treadway Commission. The Companys management is
responsible for maintaining effective internal control over financial reporting and for its
assessment of the effectiveness of internal control over financial reporting. Our responsibility is
to express an opinion on managements assessment and an opinion on the effectiveness of the
Companys internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting
Oversight Board (United States). Those standards require that we plan and perform the audit to
obtain reasonable assurance about whether effective internal control over financial reporting was
maintained in all material respects. Our audit included obtaining an understanding of internal
control over financial reporting, evaluating managements assessment, testing and evaluating the
design and operating effectiveness of internal control, and performing such other procedures as we
considered necessary in the circumstances. We believe that our audit provides a reasonable basis
for our opinions.
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 accounting principles generally
accepted in the United States of America. A companys internal control over financial reporting
includes those policies and procedures that (i) pertain to the maintenance of records that, in
reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of
the Company; (ii) provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with accounting principles generally
accepted in the United States of America, and that receipts and expenditures of the Company are
being made only in accordance with authorizations of management and directors of the Company; and
(iii) provide reasonable assurance regarding prevention or timely detection of unauthorized
acquisition, use, or disposition of the Companys assets that could have a material effect on the
financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
In our opinion, managements assessment that the Company maintained effective internal control
over financial reporting as of December 31, 2006, is fairly stated, in all material respects, based
on the criteria established in Internal ControlIntegrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission. Also in our opinion, the Company maintained,
in all material respects, effective internal control over financial reporting as of December 31,
2006, based on the criteria established in Internal ControlIntegrated Framework issued by the
Committee of Sponsoring Organizations of the Treadway Commission.
We have also audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the Companys consolidated balance sheets as of December 31, 2006
and 2005, and the related consolidated statements of operations, stockholders equity (deficit) and
comprehensive loss, and cash flows for each of the years in the three year period ended December
31, 2006 and the schedule listed in the accompanying Item 15 and our report dated March 14, 2007 expressed an unqualified opinion on those consolidated
financial statements and schedule.
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/s/ BDO Seidman, LLP |
Costa Mesa, California |
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March 14, 2007 |
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114
Item 9B. Other Information
None.
Part III
Item 10. Directors, Executive Officers and Corporate Governance
Code of Conduct
The Board of Directors has adopted a Code of Conduct and Ethics Policy (Code of Conduct)
that applies to all officers, directors and employees. The Company will promptly disclose any
material amendment or waiver to the Code of Conduct which affects any corporate officer. The Code
of Conduct was filed with the SEC as an exhibit to our report on Form 10-K for the year ended
December 31, 2003, and can be accessed via our website (http://www.ligand.com), Corporate Overview
page. You may also request a free copy by writing to: Investor Relations, Ligand Pharmaceuticals
Incorporated, 10275 Science Center Drive, San Diego, CA 92121.
The other information under Item 10 is hereby incorporated by reference from Ligands
Definitive Proxy Statement to be filed with the Securities and Exchange Commission on or prior to
April 30, 2007. See also the identification of the executive officers following Item 4 of this
Annual Report on Form 10-K.
Item 11. Executive Compensation
Item 11 is hereby incorporated by reference from Ligands Definitive Proxy Statement to be
filed with the Securities and Exchange Commission on or prior to April 30, 2007.
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters
Item 12 is hereby incorporated by reference from Ligands Definitive Proxy Statement to be
filed with the Securities and Exchange Commission on or prior to April 30, 2007.
Item 13. Certain Relationships and Related Transactions, and Director Independence
Item 13 is hereby incorporated by reference from Ligands Definitive Proxy Statement to be
filed with the Securities and Exchange Commission on or prior to April 30, 2007.
Item 14. Principal Accountant Fees and Services
Item 14 is hereby incorporated by reference from Ligands Definitive Proxy Statement to be
filed with the Securities and Exchange Commission on or prior to April 30, 2007.
115
PART IV
Item 15. Exhibits and Financial Statement Schedules
(a) The following documents are included as part of this Annual Report on Form 10-K.
(1) Financial statements
Index to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
Consolidated Balance Sheets
Consolidated Statements of Operations
Consolidated Statements of Stockholders Equity (Deficit)
Consolidated Statements of Cash Flows
Notes to Consolidated Financial Statements
(2) Schedules not included herein have been omitted because they are not applicable or the required
information is in the consolidated financial statements or notes thereto.
(3) The following exhibits are filed as part of this Form 10-K and this list includes the Exhibit
Index.
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Exhibit Number |
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Description |
2.1(1)
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Agreement and Plan of Reorganization dated May 11, 1998, by and among the Company,
Knight Acquisition Corp. and Seragen, Inc. (Filed as Exhibit 2.1). |
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2.2 (1)
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Option and Asset Purchase Agreement, dated May 11, 1998, by and among the Company,
Marathon Biopharmaceuticals, LLC, 520 Commonwealth Avenue Real Estate Corp. and 660
Corporation. (Filed as Exhibit 10.3). |
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2.3 (19)
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Asset Purchase Agreement among CoPharma, Inc., Marathon Biopharmaceuticals, Inc.,
Seragen, Inc. and the Company dated January 7, 2000. (The schedules referenced in this
agreement have not been included because they are either disclosed in such agreement or
do not contain information which is material to an investment decision (with certain
confidential portions omitted). The Company agrees to furnish a copy of such schedules
to the Commission upon request). |
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2.5 (1)
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Form of Certificate of Merger for acquisition of Seragen, Inc. (Filed as Exhibit 2.2). |
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3.1 (1)
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Amended and Restated Certificate of Incorporation of the Company. (Filed as Exhibit 3.2). |
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3.2 (1)
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Bylaws of the Company, as amended. (Filed as Exhibit 3.3). |
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3.3 (2)
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Amended Certificate of Designation of Rights, Preferences and Privileges of Series A
Participating Preferred Stock of the Company. |
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3.4 (31)
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Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the
Company dated June 14, 2000. |
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3.5 (3)
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Certificate of Amendment of the Amended and Restated Certificate of Incorporation of the
Company dated September 30, 2004. |
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3.6 (46)
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Amendment to the Bylaws of the Company dated November 13, 2005. (Filed as Exhibit
3.1). |
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4.1 (4)
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Specimen stock certificate for shares of Common Stock of the Company. |
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Exhibit Number |
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Description |
4.2 (38)
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Indenture dated November 26, 2002, between Ligand Pharmaceuticals Incorporated and J.P.
Morgan Trust Company, National Association, as trustee, with respect to the 6%
convertible subordinated notes due 2007. (Filed as Exhibit 4.3). |
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4.3 (38)
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Form of 6% Convertible Subordinated Note due 2007. (Filed as Exhibit 4.4). |
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4.4 (38)
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Pledge Agreement dated November 26, 2002, between Ligand Pharmaceuticals Incorporated
and J.P. Morgan Trust Company, National Association. (Filed as Exhibit 4.5). |
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4.5 (38)
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Control Agreement dated November 26, 2002, among Ligand Pharmaceuticals Incorporated,
J.P. Morgan Trust Company, National Association and JP Morgan Chase Bank. (Filed as
Exhibit 4.6). |
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4.6 (61)
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2006 Preferred Shares Rights Agreement, by and between Ligand Pharmaceuticals
Incorporated and Mellon Investor Services LLC, dated as of October 13, 2006. (Filed as
Exhibit 4.1) |
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10.1 (52)
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Second Amendment to Non-Qualified Deferred Compensation Plan. |
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10.2 (52)
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Letter Agreement by and between the Company and Tod G. Mertes dated as of December 8,
2005. |
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10.3 (4)
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Form of Stock Issuance Agreement. |
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10.30 (4)
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Form of Proprietary Information and Inventions Agreement. |
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10.31 (4)
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Agreement, dated March 9, 1992, between the Company and Baylor College of Medicine (with
certain confidential portions omitted). |
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10.33 (4)
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License Agreement, dated November 14, 1991, between the Company and Rockefeller
University (with certain confidential portions omitted). |
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10.34 (4)
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License Agreement and Bailment, dated July 22, 1991, between the Company and the Regents
of the University of California (with certain confidential portions omitted). |
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10.35 (4)
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Agreement, dated May 1, 1991, between the Company and Pfizer Inc (with certain
confidential portions omitted). |
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10.36 (4)
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License Agreement, dated July 3, 1990, between the Company and the Brigham and Womans
Hospital, Inc. (with certain confidential portions omitted). |
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10.38 (4)
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License Agreement, dated January 5, 1990, between the Company and the University of
North Carolina at Chapel Hill (with certain confidential portions omitted). |
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10.41 (4)
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License Agreement, dated October 1, 1989, between the Company and Institute Pasteur
(with certain confidential portions omitted). |
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10.43 (4)
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License Agreement, dated June 23, 1989, between the Company and La Jolla Cancer Research
Foundation (with certain confidential portions omitted). |
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10.46 (4)
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Form of Indemnification Agreement between the Company and each of its directors. |
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10.47 (4)
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Form of Indemnification Agreement between the Company and each of its officers. |
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10.58 (4)
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Stock Purchase Agreement, dated September 9, 1992, between the Company and Glaxo, Inc. |
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10.59 (4)
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Research and Development Agreement, dated September 9, 1992, between the Company and
Glaxo, Inc. (with certain confidential portions omitted). |
117
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Exhibit Number |
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Description |
10.60 (4)
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Stock Transfer Agreement, dated September 30, 1992, between the Company and the
Rockefeller University. |
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10.61 (4)
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Stock Transfer Agreement, dated September 30, 1992, between the Company and New York
University. |
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10.62 (4)
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License Agreement, dated September 30, 1992, between the Company and the Rockefeller
University (with certain confidential portions omitted). |
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10.67 (4)
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Letter Agreement, dated September 11, 1992, between the Company and Mr. Paul Maier. |
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10.73 (21)
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Supplementary Agreement, dated October 1, 1993, between the Company and Pfizer, Inc. to
Agreement, dated May 1, 1991. |
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10.78 (23)
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Research, Development and License Agreement, dated July 6, 1994, between the Company and
Abbott Laboratories (with certain confidential portions omitted). (Filed as Exhibit
10.75). |
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10.83 (23)
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Option Agreement, dated September 2, 1994, between the Company and American Home
Products Corporation, as represented by its Wyeth-Ayerst Research Division (with certain
confidential portions omitted). (Filed as Exhibit 10.80). |
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10.93 (6)
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Indemnity Agreement, dated June 3, 1995, between the Company, Allergan, Inc. and
Allergan Ligand Retinoid Therapeutics, Inc. |
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10.97 (6)
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Research, Development and License Agreement, dated December 29, 1994, between SmithKline
Beecham Corporation and the Company (with certain confidential portions omitted). |
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10.98 (6)
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Stock and Note Purchase Agreement, dated February 2, 1995, between SmithKline Beecham
Corporation, S.R. One, Limited and the Company (with certain confidential portions
omitted). |
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10.140 (28)
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Promissory Notes, General Security Agreements and a Credit Terms and Conditions letter
dated March 31, 1995, between the Company and Imperial Bank (Filed as Exhibit 10.101). |
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10.148 (24)
|
|
Lease, dated July 6, 1994, between the Company and Chevron/Nexus partnership, First
Amendment to lease dated July 6, 1994. |
|
|
|
10.149 (25)
|
|
Successor Employment Agreement, signed May 1, 1996, between the Company and David E.
Robinson. |
|
|
|
10.150 (7)
|
|
Master Lease Agreement, signed May 30, 1996, between the Company and USL Capital
Corporation. |
|
|
|
10.151 (25)
|
|
Settlement Agreement and Mutual Release of all Claims, signed April 20, 1996, between
the Company and Pfizer, Inc. (with certain confidential portions omitted). |
|
|
|
10.152 (25)
|
|
Letter Amendment to Abbott Agreement, dated March 14, 1996, between the Company and
Abbott Laboratories (with certain confidential portions omitted). |
|
|
|
10.153 (26)
|
|
Letter Agreement, dated August 8, 1996, between the Company and Dr. Andres Negro-Vilar. |
|
|
|
10.155 (7)
|
|
Letter Agreement, dated November 4, 1996, between the Company and William Pettit. |
|
|
|
10.157 (7)
|
|
Master Lease Agreement, signed February 13, 1997, between the Company and Lease
Management Services. |
|
|
|
10.158 (7)
|
|
Lease, dated March 7, 1997, between the Company and Nexus Equity VI LLC. |
118
|
|
|
Exhibit Number |
|
Description |
10.161 (29)
|
|
Settlement Agreement, License and Mutual General Release between Ligand Pharmaceuticals
and SRI/LJCRF, dated August 23, 1995 (with certain confidential portions omitted). |
|
|
|
10.163 (30)
|
|
Extension of Master Lease Agreement between Lease Management Services and Ligand
Pharmaceuticals dated July 29, 1997. |
|
|
|
10.165 (8)
|
|
Amended and Restated Technology Cross License Agreement, dated September 24, 1997, among
the Company, Allergan, Inc. and Allergan Ligand Retinoid Therapeutics, Inc. |
|
|
|
10.167 (8)
|
|
Development and License Agreement, dated November 25, 1997, between the Company and Eli
Lilly and Company (with certain confidential portions omitted). |
|
|
|
10.168 (8)
|
|
Collaboration Agreement, dated November 25, 1997, among the Company, Eli Lilly and
Company, and Allergan Ligand Retinoid Therapeutics, Inc. (with certain confidential
portions omitted). |
|
|
|
10.169 (8)
|
|
Option and Wholesale Purchase Agreement, dated November 25, 1997, between the Company
and Eli Lilly and Company (with certain confidential portions omitted). |
|
|
|
10.171 (8)
|
|
First Amendment to Option and Wholesale Purchase Agreement dated February 23, 1998,
between the Company and Eli Lilly and Company (with certain confidential portions
omitted). |
|
|
|
10.172 (8)
|
|
Second Amendment to Option and Wholesale Purchase Agreement, dated March 16, 1998,
between the Company and Eli Lilly and Company (with certain confidential portions
omitted). |
|
|
|
10.176 (10)
|
|
Secured Promissory Note, dated March 7, 1997, in the face amount of $3,650,000, payable
to the Company by Nexus Equity VI LLC. (Filed as Exhibit 10.1). |
|
|
|
10.177 (10)
|
|
Amended memorandum of Lease effective March 7, 1997, between the Company and Nexus
Equity VI LLC. (Filed as Exhibit 10.2). |
|
|
|
10.178 (10)
|
|
First Amendment to Lease, dated March 7, 1997, between the Company and Nexus Equity VI
LLC. (Filed as Exhibit 10.3). |
|
|
|
10.179 (10)
|
|
First Amendment to Secured Promissory Note, date March 7, 1997, payable to the Nexus
Equity VI LLC. (Filed as Exhibit 10.4). |
|
|
|
10.184 (11)
|
|
Letter agreement, dated May 11, 1998, by and among the Company, Eli Lilly and Company
and Seragen, Inc. (Filed as Exhibit 99.6). |
|
|
|
10.185 (1)
|
|
Amendment No. 3 to Option and Wholesale Purchase Agreement, dated May 11, 1998, by and
between Eli Lilly and Company and the Company. (Filed as Exhibit 10.6). |
|
|
|
10.186 (1)
|
|
Agreement, dated May 11, 1998, by and among Eli Lilly and Company, the Company and
Seragen, Inc. (Filed as Exhibit 10.7). |
|
|
|
10.188 (11)
|
|
Settlement Agreement, dated May 1, 1998, by and among Seragen, Inc., Seragen
Biopharmaceuticals Ltd./Seragen Biopharmaceutique Ltee, Sofinov Societe Financiere
DInnovation Inc., Societe Innovatech Du Grand Montreal, MDS Health Ventures Inc.,
Canadian Medical Discoveries Fund Inc., Royal Bank Capital Corporation and Health Care
and Biotechnology Venture Fund (Filed as Exhibit 99.2). |
|
|
|
10.189 (11)
|
|
Accord and Satisfaction Agreement, dated May 11, 1998, by and among Seragen, Inc.,
Seragen Technology, Inc., Trustees of Boston University, Seragen LLC, Marathon
Biopharmaceuticals, LLC, United States Surgical Corporation, Leon C. Hirsch, Turi
Josefsen, Gerald S.J. and Loretta P. Cassidy, Reed R. Prior, Jean C. Nichols, Elizabeth
C. Chen, Robert W. Crane, Shoreline Pacific Institutional Finance, Lehman Brothers Inc.,
520 Commonwealth Avenue Real Estate Corp. and 660 Corporation (Filed as Exhibit 99.4). |
119
|
|
|
Exhibit Number |
|
Description |
10.191 (10)
|
|
Letter of Agreement dated September 28, 1998 among the Company, Elan Corporation, plc
and Elan International Services, Ltd. (with certain confidential portions omitted),
(Filed as Exhibit 10.5). |
|
|
|
10.198 (14)
|
|
Stock Purchase Agreement by and between the Company and Warner-Lambert Company dated
September 1, 1999 (with certain confidential portions omitted). (Filed as Exhibit 10.2). |
|
|
|
10.200 (14)
|
|
Nonexclusive Sublicense Agreement, effective September 8, 1999, by and among Seragen,
Inc., Hoffmann-La Roche Inc. and F. Hoffmann-La Roche Ltd. (with certain confidential
portions omitted). (Filed as Exhibit 10.4). |
|
|
|
10.203 (14)
|
|
License Agreement effective June 30, 1999 by and between the Company and X-Ceptor
Therapeutics, Inc. (with certain confidential portions omitted). (Filed as Exhibit
10.7). |
|
|
|
10.218 (18)
|
|
Royalty Stream Purchase Agreement dated as of December 31, 1999 among Seragen, Inc., the
Company, Pharmaceutical Partners, L.L.C., Bioventure Investments, Kft, and
Pharmaceutical Royalties, LLC. (with certain confidential portions omitted). |
|
|
|
10.220 (19)
|
|
Research, Development and License Agreement by and between Organon Company and Ligand
Pharmaceuticals Incorporated dated February 11, 2000 (with certain confidential portions
omitted). |
|
|
|
10.224 (20)
|
|
Research, Development and License Agreement by and between Bristol Myers Squibb Company
and Ligand Pharmaceuticals Incorporated dated May 19, 2000 (with certain confidential
portions omitted). |
|
|
|
10.230 (31)
|
|
Amended and Restated Registration Rights Agreement, dated as of June 29, 2000 among the
Company and certain of its investors. |
|
|
|
10.231 (2)
|
|
Marketing and Distribution Agreement with Ferrer Internacional S.A. to market and
distribute Ligand Pharmaceuticals Incorporated products in Spain, Portugal and Greece.
(Filed as Exhibit 10.3). |
|
|
|
10.232 (2)
|
|
Marketing and Distribution Agreement with Ferrer Internacional S.A. to market and
distribute Ligand Pharmaceuticals Incorporated products in Central and South America.
(Filed as Exhibit 10.4). |
|
|
|
10.235 (32)
|
|
Distributorship Agreement, dated February 29, 2001, between the Company and Elan Pharma
International Limited (with certain confidential portions omitted). |
|
|
|
10.238 (33)
|
|
Letter Agreement, dated May 17, 2001, between the Company and Gian Aliprandi. |
|
|
|
10.239 (33)
|
|
Research, Development and License Agreement by and between the Company and TAP
Pharmaceutical Products Inc. dated June 22, 2001 (with certain confidential portions
omitted). |
|
|
|
10.240 (34)
|
|
Letter Agreement, dated December 13, 2001, between the Company and Warner R. Broaddus,
Esq. |
|
|
|
10.242 (34)
|
|
First Addendum to Amended and Restated Registration Rights Agreement dated June 29,
2000, effective as of December 20, 2001. |
|
|
|
10.244 (35)
|
|
Second Addendum to Amended and Restated Registration Rights Agreement dated June 29,
2000, effective as of March 28, 2002. |
|
|
|
10.245 (35)
|
|
Purchase Agreement, dated March 6, 2002, between the Company and Pharmaceutical
Royalties International (Cayman) Ltd. |
|
|
|
10.246 (36)
|
|
Amended and Restated License Agreement Between The Salk Institute for Biological Studies
and the Company (with certain confidential portions omitted). |
120
|
|
|
Exhibit Number |
|
Description |
10.247 (37)
|
|
Amendment Number 1 to Purchase Agreement, dated July 29, 2002, between the Company and
Pharmaceutical Royalties International (Cayman) Ltd. |
|
|
|
10.250 (40)
|
|
Amended and Restated License and Supply Agreement, dated December 6, 2002, between the
Company, Elan Corporation, plc and Elan Management Limited (with certain confidential
portions omitted). |
|
|
|
10.252 (40)
|
|
Amendment Number 1 to Amended and Restated Registration Rights Agreement, dated November
12, 2002, between the Company and Elan Corporation plc and Elan International Services,
Ltd. |
|
|
|
10.253 (40)
|
|
Second Amendment to Purchase Agreement, dated December 19, 2002, between the Company and
Pharmaceuticals Royalties International (Cayman) Ltd. |
|
|
|
10.254 (40)
|
|
Amendment Number 3 to Purchase Agreement, dated December 30, 2002, between the Company
and Pharmaceuticals Royalties International (Cayman) Ltd. (with certain confidential
portions omitted). |
|
|
|
10.255 (40)
|
|
Purchase Agreement, dated December 30, 2002, between the Company and Pharmaceuticals
Royalties International (Cayman) Ltd. (with certain confidential portions omitted). |
|
|
|
10.256 (41)
|
|
Co-Promotion Agreement, dated January 1, 2003, by and between the Company and Organon
Pharmaceuticals USA Inc. (with certain confidential portions omitted). |
|
|
|
10.257 (42)
|
|
Letter Agreement, dated June 26, 2002, between the Company and James J. LItalien, Ph.D. |
|
|
|
10.258 (42)
|
|
Letter Agreement, dated May 20, 2003, between the Company and Tod G. Mertes. |
|
|
|
10.259 (42)
|
|
Amendment No. 2 to Amended and Restated Registration Rights Agreement, dated June 25,
2003. |
|
|
|
10.261 (43)
|
|
Letter Agreement, dated July 1, 2003, between the Company and Paul V. Maier. |
|
|
|
10.262 (43)
|
|
Letter Agreement, dated July 1, 2003, between the Company and Ronald C. Eld. |
|
|
|
10.263 (43)
|
|
Separation Agreement and General Release, effective July 10, 2003, between the Company
and Thomas H. Silberg (with certain confidential portions omitted). |
|
|
|
10.264 (44)
|
|
Option Agreement Between Investors Trust & Custodial Services (Ireland) Ltd., as Trustee
for Royalty Pharma, Royalty Pharma Finance Trust and the Company, dated October 1, 2003
(with certain confidential portions omitted). |
|
|
|
10.265 (44)
|
|
Amendment to Purchase Agreement Between Royalty Pharma Finance Trust and the Company,
dated October 1, 2003 (with certain confidential portions omitted). |
|
|
|
10.266 (44)
|
|
Manufacture and Supply Agreement between Seragen and Cambrex Bio Science Hopkinton,
Inc., dated October 11, 2003 (with certain confidential portions omitted). |
|
|
|
10.267 (53)
|
|
2002 Stock Incentive Plan (as amended and restated through March 9, 2006). |
|
|
|
10.268 (44)
|
|
2002 Employee Stock Purchase Plan, dated July 1, 2002 (as amended through June 30, 2003). |
|
|
|
10.269 (44)
|
|
Form of Stock Option Agreement. |
|
|
|
10.270 (44)
|
|
Form of Employee Stock Purchase Plan Stock Purchase Agreement. |
121
|
|
|
Exhibit Number |
|
Description |
10.271 (44)
|
|
Form of Automatic Stock Option Agreement. |
|
|
|
10.272 (44)
|
|
Form of Director Fee Stock Option Agreement. |
|
|
|
10.273 (45)
|
|
Letter Agreement, dated as of February 26, 2004, between the Company and Martin
Meglasson. |
|
|
|
10.274 (45)
|
|
Adoption Agreement for Smith Barney Inc. Execchoice (R) Nonqualified Deferred
Compensation Plan. |
|
|
|
10.275 (45)
|
|
Commercial Supply Agreement, dated February 27, 2004, between Seragen Incorporated and
Holister-Stier Laboratories LLC (with certain confidential portions omitted). |
|
|
|
10.276 (45)
|
|
Manufacturing and Packaging Agreement, dated February 13, 2004 between Cardinal Health
PTS, LLC and the Company (with certain confidential portions omitted). |
|
|
|
10.277 (45)
|
|
Letter Agreement, dated July 1, 2003 between the Company and William A. Pettit. |
|
|
|
10.278 (47)
|
|
Letter Agreement, dated as of October 1, 2004, between the Company and Eric S. Groves |
|
|
|
10.279 (47)
|
|
Form of Distribution, Storage, Data and Inventory Management Services Agreement. |
|
|
|
10.280 (47)
|
|
Amendment Number 1 to the Option Agreement between Investors Trust & Custodial Services
(Ireland) Ltd., solely in its capacity as Trustee for Royalty Pharma, Royalty Pharma
Finance Trust and Ligand Pharmaceuticals Incorporated dated November 5, 2004. |
|
|
|
10.281 (47)
|
|
Amendment to Agreement among Ligand Pharmaceuticals Incorporated, Seragen, Inc. and Eli
Lilly and Company dated November 8, 2004. |
|
|
|
10.282 (47)
|
|
Amendment to Purchase Agreement between Royalty Pharma Finance Trust, Ligand
Pharmaceuticals Incorporated & Investors Trust and Custodial Services (Ireland) Ltd.,
solely in its capacity as Trustee of Royalty Pharma dated November 5, 2004. |
|
|
|
10.283 (49)
|
|
Form of Management Lockup Agreement. |
|
|
|
10.284 (49)
|
|
Letter Agreement, dated March 11, 2005, between the Company and Andres Negro Vilar. |
|
|
|
10.285 (49)
|
|
Confidential Interference Settlement Agreement dated March 11, 2005, by and between the
Company, SRI International and The Burnham Institute. |
|
|
|
10.286 (50)
|
|
Letter Agreement dated as of July 28, 2005 between the Company and Taylor J. Crouch. |
|
|
|
10.287 (53)
|
|
Amended and Restated Research, Development and License Agreement dated as of December 1,
2005 between the Company and Wyeth (formerly American Home Products Corporation) (with
certain confidential portions omitted). |
|
|
|
10.288 (48)
|
|
Settlement Agreement dated as of December 2, 2005 by and among Ligand Pharmaceuticals
Incorporated and Third Point LLC, Third Point Offshore Fund, Ltd., Third Point Partners
LP, Third Point Ultra Ltd., Lyxor/Third Point Fund Ltd., and Third Point Partners
Qualified LP. (Filed as Exhibit 10.1). |
|
|
|
10.289 (53)
|
|
Form of Stock Issuance Agreement for non-employee directors. |
|
|
|
10.290 (53)
|
|
Form of Amended and Restated Director Fee Stock Option Agreement for 2005 award to
Alexander Cross. |
|
|
|
10.291 (53)
|
|
Form of Amended and Restated Director Fee Stock Option Agreement for 2005 award to Henry
Blissenbach, John Groom, Irving Johnson, John Kozarich, Daniel Loeb, Carl Peck, Jeffrey
Perry, Brigette Roberts and Michael Rocca. |
122
|
|
|
Exhibit Number |
|
Description |
10.292 (54)
|
|
Termination and Return of Rights Agreement between Ligand Pharmaceuticals Incorporated
and Organon USA Inc. dated as of January 1, 2006 |
|
|
|
10.292A (55)
|
|
Form of Letter Agreement between the Company and certain of its officers dated as of
March 1, 2006 (Filed as Exhibit 10.292). |
|
|
|
10.293 (57)
|
|
First Amendment to the Manufacturing and Packaging Agreement between Cardinal Health
PTS, LLC and Ligand Pharmaceuticals Incorporated (with certain confidential portions
omitted). |
|
|
|
10.294 (59)
|
|
Purchase Agreement, by and between Ligand Pharmaceuticals Incorporated, King
Pharmaceuticals, Inc. and King Pharmaceuticals Research and Development, Inc., dated as
of September 6, 2006. |
|
|
|
10.295 (60)
|
|
Contract Sales Force Agreement, by and between Ligand Pharmaceuticals Incorporated and
King Pharmaceuticals, Inc. dated as of September 6, 2006. |
|
|
|
10.296 (59)
|
|
Purchase Agreement, by and among Ligand Pharmaceuticals Incorporated, Seragen, Inc.,
Eisai Inc. and Eisai Co., Ltd., dated as of September 7, 2006. |
|
|
|
10.297 (56)
|
|
Separation Agreement dated as of July 31, 2006 by and between the Company and David E.
Robinson. |
|
|
|
10.298 (64)
|
|
Offer letter/employment agreement by and between the Company and Henry F. Blissenbach,
dated as of August 1, 2006. |
|
|
|
10.299 (58)
|
|
Form of Letter Agreement (Change of Control Severance Agreement) by and between the
Company and certain officers dated as of August 25, 2006. |
|
|
|
10.300 (58)
|
|
Form of Letter Agreement (Ordinary Severance Agreement) by and between the Company and
certain officers dated as of August 25, 2006. |
|
|
|
10.301
|
|
Stipulation of Settlement by and among Plaintiffs and Ligand Pharmaceuticals, Inc. et
al., In re Ligand Pharmaceuticals Inc. Securities Litigation, United States District
Court, District of Southern California, dated as of June 28, 2006, approved by Order
dated October 16, 2006. |
|
|
|
10.302
|
|
Stipulation of Settlement by and among Plaintiffs and Ligand Pharmaceuticals, Inc. et
al., In re Ligand Pharmaceuticals Inc. Derivative Litigation, Superior Court of
California, County of San Diego, dated as of September 19, 2006, approved by Order dated
October 12, 2006. |
|
|
|
10.303
|
|
Loan Agreement by and between Ligand Pharmaceuticals Incorporated and King
Pharmaceuticals, 303 Inc. dated as of October 12, 2006. |
|
|
|
10.304 (66)
|
|
Letter Agreement by and between Ligand and King Pharmaceuticals, Inc. effective as of
December 29, 2006. |
|
|
|
10.305 (66)
|
|
Amendment Number 1 to Purchase Agreement, Contract Sales Force Agreement and
Confidentiality Agreement by and between Ligand and King Pharmaceuticals, Inc. effective
as of November 30, 2006. |
|
|
|
10.306 (63)
|
|
Purchase Agreement and Escrow Instructions by and between Nexus Equity VI, LLC, a
California Limited Liability Company, and Ligand Pharmaceuticals Incorporated, a
Delaware Corporation and Slough Estates USA Inc., a Delaware corporation dated October
25, 2006. |
|
|
|
10.307 (65)
|
|
Amendment No. 1 to the Stockholders Agreement effective as of December 12, 2006, by and
among Ligand Pharmaceutical Incorporated and Third Point LLC, Third Point Offshore Fund,
Ltd., Third Point Partners LP, Third Point Ultra Ltd., Lyxor/Third Point Fund Ltd., and
Third Point Partners Qualified LP. |
123
|
|
|
Exhibit Number |
|
Description |
10.308
|
|
2006 Employee Severance Plan dated as of October 4, 2006. |
|
|
|
10.309
|
|
Form of Letter Agreement regarding Change of Control Severance Benefits between the
Company and its officers. |
|
|
|
10.310 (62)
|
|
Form of Letter Agreement by and between the Company and Tod G. Mertes dated as of
October 19, 2006. |
|
|
|
10.311(67)
|
|
Letter Agreement by and between the Company and John L. Higgins dated as of January 10,
2007. |
|
|
|
10.312(68)
|
|
Amendment Number 2 to Purchase Agreement, by and between the Company and King
Pharmaceuticals, Inc. effective as of February 26, 2007. |
|
|
|
10.313(69)
|
|
Indemnity Fund Agreement. |
|
|
|
14.1 (44)
|
|
Code of Business Conduct and Ethics |
|
|
|
21.1
|
|
Subsidiaries of Registrant (See Business). |
|
|
|
24.1
|
|
Power of Attorney (See page II-15). |
|
|
|
31.1
|
|
Certification by Principal Executive Officer, Pursuant to Rules 13a-14(a) and 15d-14(a),
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
31.2
|
|
Certification by Principal Financial Officer, Pursuant to Rules 13a-14(a) and 15d-14(a),
as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.1
|
|
Certification by Principal Executive Officer, Pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
32.2
|
|
Certification by Principal Financial Officer, Pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
|
|
|
(1) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Registration Statement on Form S-4 (No. 333-58823)
filed on July 9, 1998. |
|
(2) |
|
This exhibit was previously filed as part of and is hereby incorporated by reference to same
numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period ended
March 31, 1999. |
|
(3) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended September 30, 2004. |
|
(4) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Registration Statement on Form S-1 (No.
33-47257) filed on April 16, 1992 as amended. |
|
(5) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Form 8-A 12G/A, filed on April 6, 2004. |
124
|
|
|
(6) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Registration Statement on Form S-1/S-3 (No. 33-87598 and
33-87600) filed on December 20, 1994, as amended. |
|
(7) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Annual Report on Form 10-K for the period ended
December 31, 1996. |
|
(8) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Annual Report on Form 10-K for the period ended
December 31, 1997. |
|
(10) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period ended
September 30, 1998. |
|
(11) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Current Report on Form 8-K of Seragen, Inc. filed on May 15,
1998. |
|
(12) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Annual Report on Form 10-K for the period ended
December 31, 1998. |
|
(13) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Registration Statement on Form 8-A/A Amendment No. 1 (No.
0-20720) filed on November 10, 1998. |
|
(14) |
|
This exhibit was previously filed as part of and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period ended
September 30, 1999. |
|
(15) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Schedule 13D of Elan Corporation, plc, filed on January 6,
1999, as amended. |
|
(16) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Registration Statement on Form S-3 (No. 333-12603)
filed on September 25, 1996, as amended. |
|
(17) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Registration Statement on Form 8-A/A Amendment No. 2 (No.
0-20720) filed on December 24, 1998. |
|
(18) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Annual Report on Form 10-K for the period ended
December 31, 1999. |
|
(19) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended March 31, 2000. |
|
(20) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended June 30, 2000. |
|
(21) |
|
This exhibit was previously filed as part of, and are hereby incorporated by reference to the
same numbered exhibit filed with the Companys Annual Report on Form 10-K for the year ended
December 31, 1993. |
|
(23) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period ended
September 30, 1994. |
|
(24) |
|
This exhibit was previously filed, and is hereby incorporated by reference to the same
numbered exhibit filed with the Companys Annual Report on Form 10-K for the year ended
December 31, 1995. |
|
(25) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly report on Form 10-Q for the period
ended June 30, 1996. |
125
|
|
|
(26) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference at the
same numbered exhibit filed with the Companys Quarterly report on Form 10-Q for the period
ended September 30, 1996. |
|
(28) |
|
This exhibit was previously filed as part of, and are hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly report on Form 10-Q for the period
ended September 30, 1995. |
|
(29) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended March 31, 1997. |
|
(30) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended June 30, 1997. |
|
(31) |
|
This exhibit was previously filed as part of, and are hereby incorporated by reference to the
same numbered exhibit filed with the Companys Annual Report on Form 10-K for the year ended
December 31, 2000. |
|
(32) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended March 31, 2001. |
|
(33) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended June 30, 2001. |
|
(34) |
|
This exhibit was previously filed as part of, and are hereby incorporated by reference to the
same numbered exhibit filed with the Companys Annual Report on Form 10-K for the year ended
December 31, 2001. |
|
(35) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended March 31, 2002. |
|
(36) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended June 30, 2002. |
|
(37) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended September 30, 2002. |
|
(38) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Registration Statement on Form S-3 (No. 333-102483)
filed on January 13, 2003, as amended. |
|
(40) |
|
This exhibit was previously filed as part of, and are hereby incorporated by reference to the
same numbered exhibit filed with the Companys Annual Report on Form 10-K for the year ended
December 31, 2002. |
|
(41) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended March 31, 2003. |
|
(42) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended June 30, 2003. |
|
(43) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended September 30, 2003. |
|
(44) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Annual Report on Form 10-K for the year ended
December 31, 2003. |
|
(45) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended March 31, 2004. |
|
(46) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Current Report on Form 8-K filed on November 14,
2005. |
126
|
|
|
(47) |
|
This exhibit was previously filed as part of, and are hereby incorporated by reference to
the same numbered exhibit filed with the Companys Annual Report on Form 10-K for the year
ended December 31, 2004. |
|
(48) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Current Report on Form 8-K filed on December 5,
2005. |
|
(49) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended March 31, 2005. |
|
(50) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended September 30, 2005. |
|
(51) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Current Report on Form 8-K filed on December 13,
2005. |
|
(52) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Current Report on Form 8-K filed on December
14, 2005. |
|
(53) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Registration Statement on Form S-1 (no.
333-131029) filed on January 13, 2006 as amended. |
|
(54) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with an Amendment to the Companys Registration Statement on Form S-1
(No. 333-1031029) filed on February 10, 2006. |
|
(55) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended March 31, 2006. |
|
(56) |
|
This exhibit was previously filed as part of, and is being incorporated by reference to the
numbered exhibit filed with the Companys Current Report Form 8-K filed on August 4, 2006. |
|
(57) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended June 30, 2006. |
|
(58) |
|
This exhibit was previously filed as part of, and is being incorporated by reference to the
numbered exhibit filed with the Companys Current Report Form 8-K filed on August 30, 2006. |
|
(59) |
|
This exhibit was previously filed as part of, and is being incorporated by reference to the
numbered exhibit filed with the Companys Current Report Form 8-K filed on September 11, 2006. |
|
(60) |
|
This exhibit was previously filed as part of, and is being incorporated by reference to the
numbered exhibit filed with the Companys Current Report Form 8-K filed on September 12, 2006. |
|
(61) |
|
This exhibit was previously filed as part of, and is being incorporated by reference to the
numbered exhibit filed with the Companys Current Report Form 8-K filed on October 17, 2006. |
|
(62) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Current Report on Form 8-K filed on October 20,
2006. |
|
(63) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Current Report on Form 8-K filed on October 31,
2006. |
|
(64) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
same numbered exhibit filed with the Companys Quarterly Report on Form 10-Q for the period
ended September 30, 2006. |
127
|
|
|
(65) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Current Report on Form 8-K filed on December 14,
2006. |
|
(66) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to the
numbered exhibit filed with the Companys Current Report on Form 8-K filed on January 5, 2007. |
|
(67) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to
the numbered exhibit filed with the Companys Current Report on Form 8-K filed on January 16,
2007. |
|
(68) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to
the numbered exhibit filed with the Companys Current Report on Form 8-K filed on February 28,
2007. |
|
(69) |
|
This exhibit was previously filed as part of, and is hereby incorporated by reference to
the numbered exhibit filed with the Companys Current Report on Form 8-K filed on March 5,
2007. |
128
(4)(d) Financial Statement Schedules
Schedules not included herein have been omitted because they are not applicable or the
required information is in the consolidated financial statements or notes thereto.
Schedule II Valuation and Qualifying Accounts (in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at |
|
|
Beginning of |
|
|
|
|
|
|
|
|
|
|
|
|
|
End of |
|
|
Period |
|
Charges |
|
Deductions |
|
Other |
|
Period |
December 31, 2006: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful
accounts and cash discounts |
|
$ |
854 |
|
|
$ |
4,167 |
|
|
$ |
4,491 |
|
|
$ |
|
|
|
$ |
530 |
|
Reserve for inventory valuation |
|
|
1,745 |
|
|
|
1,842 |
|
|
|
2,382 |
|
|
|
(1,052 |
)(A) |
|
|
153 |
|
Valuation allowance on
deferred tax assets |
|
|
300,630 |
|
|
|
|
|
|
|
47,363 |
(B) |
|
|
380 |
|
|
|
253,647 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2005: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful
accounts and cash discounts |
|
$ |
1,097 |
|
|
$ |
4,778 |
|
|
$ |
5,021 |
|
|
$ |
|
|
|
$ |
854 |
|
Reserve for inventory valuation |
|
|
1,027 |
|
|
|
1,387 |
|
|
|
669 |
|
|
|
|
|
|
|
1,745 |
|
Valuation allowance on
deferred tax assets |
|
|
286,225 |
|
|
|
14,495 |
|
|
|
|
|
|
|
(90 |
) |
|
|
300,630 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2004: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allowance for doubtful
accounts and cash discounts |
|
$ |
942 |
|
|
$ |
4,612 |
|
|
$ |
4,457 |
|
|
$ |
|
|
|
$ |
1,097 |
|
Reserve for inventory valuation |
|
|
1,177 |
|
|
|
1,179 |
|
|
|
1,329 |
|
|
|
|
|
|
|
1,027 |
|
Valuation allowance on
deferred tax assets |
|
|
266,935 |
|
|
|
18,144 |
|
|
|
|
|
|
|
1,146 |
|
|
|
286,225 |
|
|
|
|
(A) |
|
This reserve was adjusted in connection with the accounting for the sale of the
Oncology Product Line on October 25, 2006. |
|
(B) |
|
Pursuant to Internal Revenue Code Sections 382 and 383, use of net operating loss
and credit carryforwards may be limited if there were changes in ownership of more than 50%. The
Company has completed a Section 382 study for Ligand, excluding Glycomed and Seragen, and has
determined that Ligand had an ownership change in September 2005. As a result of this ownership
change, utilization of Ligands net operating losses and credits are subject to limitations under
Internal Revenue Code Sections 382 and 383. The information necessary to determine if an ownership
change related to Glycomed and Seragen occurred prior to their acquisition by Ligand is not
currently available. Accordingly, this amount includes an adjustment to reduce deferred tax assets
and the related valuation allowance for such tax net operating loss and credit carryforwards. If
information becomes available in the future to substantiate the amount of these net operating
losses and credits not limited by Section 382 and 383, the Company will record the deferred tax
assets at such time. |
129
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.
|
|
|
|
|
|
LIGAND PHARMACEUTICALS INCORPORATED
|
|
|
By: |
/s/ JOHN L. HIGGINS
|
|
|
|
John L. Higgins, |
|
|
|
President and Chief Executive Officer |
|
|
Date: March 16, 2007
POWER OF ATTORNEY
Know all men by these presents, that each person whose signature appears below constitutes and
appoints John L. Higgins or Tod G. Mertes, his or her attorney-in-fact, with power of substitution
in any and all capacities, to sign any amendments to this Annual Report on Form 10-K, and to file
the same with exhibits thereto, and other documents in connection therewith, with the Securities
and Exchange Commission, hereby ratifying and confirming all that the attorney-in-fact or his or
her substitute or substitutes may do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the registrant and in the capacities and on the
dates indicated.
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ JOHN L. HIGGINS
|
|
President, Chief Executive Officer and Director |
|
|
|
|
(Principal
Executive Officer )
|
|
March 16, 2007 |
|
|
|
|
|
/s/ TOD G. MERTES
|
|
Vice President, Interim Chief Financial Officer |
|
|
|
|
(Principal
Financial and Accounting Officer)
|
|
March 16, 2007 |
|
|
|
|
|
/s/ JASON M. ARYEH
|
|
Director
|
|
March 16, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ HENRY F. BLISSENBACH
|
|
Director
|
|
March 16, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ ALEXANDER D. CROSS
|
|
Director
|
|
March 16, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ TODD C. DAVIS
|
|
Director
|
|
March 16, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ ELIZABETH M.
GREETHAM
|
|
Director
|
|
March 16, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ DAVID M. KNOTT
|
|
Director
|
|
March 16, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ JOHN W. KOZARICH
|
|
Director
|
|
March 16, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ JEFFREY R. PERRY
|
|
Director
|
|
March 16, 2007 |
|
|
|
|
|
|
|
|
|
|
/s/ MICHAEL A. ROCCA
|
|
Director
|
|
March 16, 2007 |
|
|
|
|
|
130