Annual Reports

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  • 10-K (Mar 2, 2010)
  • 10-K (Feb 26, 2009)
  • 10-K (Feb 28, 2008)
  • 10-K (Feb 26, 2008)
  • 10-K (Feb 28, 2007)

 
Quarterly Reports

 
8-K

 
Other

Human Genome Sciences 10-K 2009
e10vk
 
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
Form 10-K
 
 
 
For the fiscal year ended December 31, 2008
 
Commission File Number 0-22962
HUMAN GENOME SCIENCES, INC.
 
     
Delaware   22-3178468
(State of organization)
  (I.R.S. employer
identification number)
14200 Shady Grove Road, Rockville, Maryland 20850-7464
(address of principal executive offices and zip code)
 
(301) 309-8504
(Registrant’s telephone number)
 
Securities registered pursuant to Section 12(b) of the Act:
 
     
Title of Each Class
 
Name of Each Exchange on Which Registered
 
Common stock, par value $0.01 per share
  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 or 15(d) of the Exchange Act.  Yes o     No þ
 
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.  Yes þ     No o
 
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein and will not be contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.  o
 
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
 
             
Large accelerated filer þ
  Accelerated filer o   Non-accelerated filer o
(Do not check if a smaller reporting company)
  Smaller reporting company o
 
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes o     No þ
 
The number of shares of the registrant’s common stock outstanding on January 31, 2009 was 135,745,696. As of June 30, 2008, the aggregate market value of the common stock held by non-affiliates of the registrant based on the closing price reported on the National Association of Securities Dealers Automated Quotations System was approximately $515,894,695.*
 
 
Portions of Human Genome Sciences, Inc.’s Notice of Annual Stockholder’s Meeting and Proxy Statement, to be filed within 120 days after the end of the registrant’s fiscal year, are incorporated by reference into Part III of this Annual Report.
 
Excludes 36,528,324 shares of common stock deemed to be held by officers and directors and stockholders whose ownership exceeds five percent of the shares outstanding at June 30, 2008. Exclusion of shares held by any person should not be construed to indicate that 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.
 


 

 
 
ITEM 1.   BUSINESS
 
This annual report on Form 10-K contains forward-looking statements, within the meaning of the Securities Exchange Act of 1934 and the Securities Act of 1933, that involve risks and uncertainties. In some cases, forward-looking statements are identified by words such as “believe,” “anticipate,” “expect,” “intend,” “plan,” “will,” “may” and similar expressions. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this report. All of these forward-looking statements are based on information available to us at this time, and we assume no obligation to update any of these statements. Actual results could differ from those projected in these forward-looking statements as a result of many factors, including those identified in “Risk Factors,” “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and elsewhere. We urge you to review and consider the various disclosures made by us in this report, and those detailed from time to time in our filings with the Securities and Exchange Commission, that attempt to advise you of the risks and factors that may affect our future results.
 
 
Human Genome Sciences, Inc. (HGS) is a commercially focused biopharmaceutical company advancing toward the market with three products in late-stage clinical development: Albuferon® for chronic hepatitis C, LymphoStat-B® for systemic lupus erythematosus (SLE), and ABthraxtm for inhalation anthrax. In January 2009, we achieved our Company’s first product sales when we began delivery of ABthrax to the U.S. Strategic National Stockpile.
 
Albuferon and LymphoStat-B are also progressing toward commercialization. In December 2008, we reported that Albuferon successfully met its primary endpoint in the first of two Phase 3 clinical trials in chronic hepatitis C; we expect to report results of the second Phase 3 trial in March 2009. If results in the second Phase 3 trial are also successful, we expect the filing of global marketing applications for Albuferon in fall 2009. We completed enrollment in both Phase 3 trials of LymphoStat-B in SLE in 2008, and we expect to report the results of these studies in July and November 2009, respectively. Assuming success in Phase 3, we plan to file global marketing applications for LymphoStat-B in the first half of 2010.
 
We also have substantial financial rights to two novel drugs that GlaxoSmithKline (GSK) has advanced to late-stage development. In December 2008, GSK initiated the first Phase 3 clinical trial of darapladib, which was discovered by GSK based on HGS technology, in more than 15,000 men and women with chronic coronary heart disease. GSK plans to initiate a second large Phase 3 trial of darapladib in late 2009. In February 2009, GSK initiated a Phase 3 clinical trial program for Syncria® (albiglutide) in the long-term treatment of type 2 diabetes mellitus. Syncria was created by HGS using our proprietary albumin-fusion technology, and we licensed Syncria to GSK in 2004.
 
HGS also has several novel drugs in earlier stages of clinical development for the treatment of cancer, led by our TRAIL receptor antibody HGS-ETR1 and a small-molecule antagonist of IAP (inhibitor of apoptosis) proteins.
 
Strategic partnerships are an important driver of our commercial success. We have co-development and commercialization agreements with prominent pharmaceutical companies for both of our lead products - Novartis for Albuferon and GSK for LymphoStat-B. ABthrax is being developed under a contract with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS).
 
Our strategic partnerships with leading pharmaceutical and biotechnology companies allow us to leverage our strengths and gain access to sales and marketing infrastructure, as well as complementary technologies. Some of these partnerships provide us with licensing or other fees, clinical development cost-sharing, milestone payments and rights to royalty payments as products are developed and commercialized. In some cases, we are entitled to certain commercialization, co-promotion, revenue-sharing and other product rights.
 
With a strong cash position, a management team experienced in bringing products to market, an experienced drug development organization and significant capabilities in biologicals manufacturing, HGS has the resources


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and capabilities necessary to achieve near-term commercial success while sustaining a viable pipeline that supports the long-term growth of the Company.
 
We are a Delaware corporation headquartered at 14200 Shady Grove Road, Rockville, Maryland, 20850-7464. Our telephone number is (301) 309-8504. Our website address is www.hgsi.com. Information contained on our website is not a part of, and is not incorporated into, this annual report on Form 10-K. Our filings with the SEC are available without charge on our website as soon as reasonably practicable after filing.
 
 
Over the last few years, HGS has made strategic decisions that have transformed the Company on multiple levels and created multiple paths for success. We now have three diverse products in final testing and mid-stage products emerging in our clinical pipeline. Our two lead products, Albuferon and LymphoStat-B, have significant therapeutic potential and the commercial potential to achieve leadership positions in the marketplace. Key strategies include:
 
  •  Accelerate the development and commercialization of our late-stage products.  Our priority focus is on our product candidates with the highest therapeutic and commercial potential, and accelerating the progress of our late-stage compounds toward commercialization.
 
  •  Build strong partnerships with global leaders in the pharmaceutical industry.  The co-development and commercialization agreements we have in place for our lead products — with Novartis for Albuferon and with GSK for LymphoStat-B — could help HGS assure that these products achieve their full therapeutic and commercial potential. As our mid-stage products continue to progress, we will consider each individually to assess whether similar collaborations are strategically beneficial.
 
  •  Ensure sustainable growth into the future by continuing to invest in our mid- and early-stage clinical pipeline.  We have taken a number of actions to strengthen our oncology program. In April 2008, we reacquired rights to our TRAIL receptor antibodies HGS-ETR1 (mapatumumab) and HGS-ETR2 (lexatumumab) from GSK. We have advanced HGS-ETR1 to a proof-of-concept phase that currently includes three randomized chemotherapy combination trials to evaluate its potential in the treatment of specific cancers, including multiple myeloma, non-small cell lung cancer and hepatocellular cancer. We have also acquired the rights to develop and commercialize novel small-molecule inhibitors of IAP proteins that show substantial early promise in the treatment of a number of cancers. We will remain opportunistic in our search for new product candidates, assessing the best of the therapeutic opportunities discovered by HGS alongside therapeutic opportunities discovered by other organizations.
 
  •  Pursue strategic acquisitions and collaborations.  We will pursue strategic acquisitions and collaborations to augment our capabilities, provide access to complementary technologies, and expand our portfolio of new drug candidates. We also rely on collaborations for the development of certain products discovered by HGS or others based on our technology, including those to which we have substantial financial rights in the GSK clinical pipeline. In addition, we are engaging in collaborations to leverage our extensive capabilities in protein and antibody process development and manufacturing to produce near-term revenue.
 
  •  Capitalize on our intellectual property portfolio.  We pursue patents to protect our intellectual property and have developed a significant intellectual property portfolio, with hundreds of issued U.S. patents covering genes, proteins, antibodies and proprietary technologies. We have also filed U.S. patent applications covering many additional discoveries and inventions. We will seek opportunities to monetize intellectual property assets that we do not plan to develop ourselves internally.
 
  •  Maintain a strong cash position.  HGS has finances in place that allow us to maintain a priority focus on advancing our late-stage products to commercialization, while also exploring longer-term opportunities that will drive momentum beyond our lead products. Controlling net cash burn and maintaining a strong cash position will continue to be an important ongoing priority.


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HGS has three products in late-stage clinical development: Albuferon for chronic hepatitis C, LymphoStat-B for SLE, and ABthrax for inhalation anthrax. We also have substantial financial rights to certain products in the GSK clinical pipeline; GSK has advanced two of these products to Phase 3 clinical trials, darapladib for cardiovascular disease and Syncria for type 2 diabetes. In addition, we have a portfolio of novel drugs in earlier stages of development, led by our TRAIL receptor antibody HGS-ETR1 in mid-stage development for cancer.
 
 
 
Two of our late-stage products, Albuferon for chronic hepatitis C and LymphoStat-B for SLE, are in Phase 3 clinical development. We have already begun to deliver the third lead product, ABthrax, to the U.S. Strategic National Stockpile for emergency use in the treatment of inhalation anthrax.
 
 
Albuferon is a genetic fusion of human albumin and interferon alfa that was created using the Company’s proprietary albumin-fusion technology. Research has shown that genetic fusion of therapeutic proteins to human albumin decreases clearance and prolongs the half-life of the therapeutic proteins. Albuferon is being developed by HGS and Novartis for the treatment of chronic hepatitis C under an exclusive worldwide co-development and commercialization agreement entered into in June 2006 (described below under “Lead Commercial Collaborations”).
 
Our Company has conducted two pivotal Phase 3 clinical trials of Albuferon in combination with ribavirin: ACHIEVE 2/3 in treatment-naïve patients with genotypes 2 or 3 chronic hepatitis C, and ACHIEVE 1 in treatment-naïve patients with genotype 1 chronic hepatitis C. Both trials were randomized, open-label, active-controlled, multi-center, non-inferiority trials that evaluated the efficacy, safety and impact on health-related quality of life of Albuferon in combination with ribavirin, versus Pegasys (peginterferon alfa-2a) in combination with ribavirin. The primary efficacy endpoint of both trials was sustained virologic response (SVR), defined as undetectable HCV (hepatitis C) RNA at 24 weeks following the end of treatment.
 
The total duration of therapy in ACHIEVE 2/3 was 24 weeks, with 24 weeks of follow-up. The total duration of therapy in ACHIEVE 1 was 48 weeks, with 24 weeks of follow-up. Both Phase 3 trials were designed to evaluate two doses of Albuferon, 1200-mcg and 900-mcg administered every two weeks, versus an active-control arm in which patients received Pegasys on a standard once-weekly regimen. In January 2008, our Company announced modified dosing in one arm of each of the ACHIEVE trials. Patients who had been receiving the 1200-mcg dose had their dose modified to 900 mcg. The change was based on recommendations made by the studies’ independent Data Monitoring Committee.
 
In December 2008, we reported that Albuferon met its primary endpoint of non-inferiority to peginterferon alfa-2a (Pegasys) in the ACHIEVE 2/3 study. The data showed that the rate of sustained virologic response was comparable for the 900-mcg dose of Albuferon administered every two weeks, versus the standard 180-mcg dose of peginterferon alfa-2a administered once weekly. Rates of serious adverse events, severe adverse events and discontinuations due to adverse events were also comparable.
 
The treatment phase of ACHIEVE 1, the second Albuferon Phase 3 clinical trial, was completed in July 2008, and the results of ACHIEVE 1 are expected in March 2009. Assuming success in Phase 3, we expect that global marketing applications for Albuferon will be filed in fall 2009.
 
We announced in January 2009 that our co-development and commercialization collaborator, Novartis, initiated a separate Phase 2b trial to explore various doses of Albuferon administered monthly, in combination with ribavirin, in treatment-naïve patients with genotypes 2 and 3 chronic hepatitis C. The monthly dosing study is a randomized, open-label, active-controlled, multi-center, adaptive-design dose-ranging study to evaluate the safety and efficacy of albinterferon alfa-2b administered every four weeks plus daily ribavirin in treatment-naïve patients with genotypes 2 and 3 chronic hepatitis C. Approximately 375 patients will be randomized into four treatment


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groups, including three that will receive Albuferon administered once every four weeks (900 mcg, 1200 mcg or 1500 mcg), in addition to the active-control group, which will receive peginterferon alfa-2a at the standard 180-mcg dose once every week. All patients in the study will receive 800-mg daily oral ribavirin. The total duration of treatment will be 24 weeks. The primary efficacy endpoint is sustained virologic response (SVR) at Week 48 (24 weeks following the end of treatment).
 
 
LymphoStat-B is a human monoclonal antibody that specifically recognizes and inhibits the biological activity of B-lymphocyte stimulator, or BLyS®. In lupus, rheumatoid arthritis and certain other autoimmune diseases, elevated levels of BLyS are believed to contribute to the production of autoantibodies — antibodies that attack and destroy the body’s own healthy tissues. LymphoStat-B is being developed by HGS and GSK as a potential treatment for systemic lupus erythematosus (SLE) under a co-development and commercialization agreement entered into in August 2006 (described below under “Lead Commercial Collaborations”).
 
We are currently conducting two pivotal Phase 3 clinical trials of LymphoStat-B in patients with active SLE — BLISS-52 and BLISS-76 — to evaluate the efficacy and safety of LymphoStat-B plus standard of care, versus placebo plus standard of care, in patients with serologically active SLE. BLISS-52 and BLISS-76 are the largest clinical trials ever conducted in lupus patients.
 
The design of the two studies is similar, but the duration of therapy is different, 52 weeks for BLISS-52 and 76 weeks for BLISS-76. Data from BLISS-76 will be analyzed after 52 weeks in support of potential global marketing applications. The primary efficacy endpoint of both trials is the patient response rate at Week 52, as defined by a reduction from baseline of at least 4 points in the SELENA SLEDAI disease activity scale, no worsening in Physician’s Global Assessment, and no worsening in BILAG. The Phase 3 trial protocols were agreed upon with FDA under a Special Protocol Assessment.
 
We expect to report the first Phase 3 results for LymphoStat-B in July 2009 from the BLISS-52 trial, with results from BLISS-76 anticipated in November 2009. Assuming success in Phase 3, we expect that global marketing applications for LymphoStat-B will be filed in the first half of 2010.
 
In June 2008, at the Congress of the European League Against Rheumatism (EULAR 2008), data were presented on long-term treatment with LymphoStat-B demonstrating that it was associated with sustained improvement in disease activity across multiple clinical measures, decreased frequency of disease flares, potential steroid-sparing activity, and was generally well tolerated through three years on treatment in combination with standard of care in patients with serologically active SLE. These data suggested that the significant clinical benefit observed for LymphoStat-B at Week 52 of this Phase 2 study appeared to be durable through three years — with incidence rates of adverse events, serious adverse events, malignancies, infections and laboratory abnormalities remaining similar to placebo or decreasing over time.
 
 
ABthrax is a human monoclonal antibody that specifically targets and blocks Bacillus anthracis protective antigen, which research has shown to be the key facilitator of the deadly toxicity of anthrax infection. ABthrax represents a new way to address the anthrax threat. While antibiotics can kill the anthrax bacteria, they are not effective against the deadly toxins that the bacteria produce. ABthrax targets anthrax toxins after they are released by the bacteria into the blood and tissues. In an inhalation anthrax attack, people may not know they are infected with anthrax until the toxins already are circulating in their blood, and it may be too late for antibiotics alone to be effective.
 
We are developing ABthrax under a $165.0 million contract entered into in 2006 with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), U.S. Department of Health and Human Services (HHS). In January 2009, we began delivery of 20,001 doses of ABthrax to the U.S. Strategic National Stockpile. We expect to receive at least $150.0 million in 2009 from this delivery — our Company’s first product sales — with most of the revenue expected in the first quarter. Also under the contract, we plan to file a BLA with the FDA in the second quarter of


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2009. We will receive an additional $15.0 million from the U.S. Government if we obtain FDA licensure of ABthrax.
 
In December 2007, we announced that the results of two animal studies demonstrated the life-saving potential of ABthrax. The results showed that a single dose of ABthrax, administered without concomitant antibiotics, improved survival rates by up to 64 percent when administered after animals were symptomatic for anthrax disease as a result of inhalation exposure to massively lethal doses of anthrax spores. These statistically significant findings demonstrated a survival benefit in two animal species, which is the requirement for establishing the efficacy of new drugs used to counter bioterrorism. These data are consistent with the results of previous studies in multiple animal models, which demonstrated that a single dose of ABthrax given prophylactically provided up to 100 percent protection against death.
 
We have also completed safety studies of ABthrax in more than 400 human volunteers. The clinical results to date suggest that ABthrax was generally safe and well tolerated. In addition, clinical data have demonstrated that co-administration of ABthrax with the antibiotic Cipro (ciprofloxacin) did not affect the pharmacokinetics of either Cipro or ABthrax, and suggested that ABthrax can be administered in combination with antibiotics. This is a key finding given the important role that antibiotics are expected to continue to play in the treatment of anthrax disease.
 
 
As our Company’s late-stage products are nearing commercialization, we have invested strategically to expand and advance our oncology portfolio around our leading expertise in the apoptosis, or controlled cell death, pathway. In April 2008, we reacquired rights to our TRAIL receptor antibodies from GSK. We have also expanded our clinical development program for HGS-ETR1 to demonstrate proof of concept in combination with other anticancer agents, and we have added new early-stage assets by in-licensing small-molecule IAP inhibitors for the treatment of cancer.
 
 
HGS has pioneered the development of highly targeted agonistic antibody therapies for cancer based on the TRAIL receptor apoptotic pathway. HGS-ETR1 (mapatumumab) and HGS-ETR2 (lexatumumab) are human monoclonal antibodies that specifically bind to the TRAIL receptor-1 and TRAIL receptor-2 proteins, respectively, and cause them to induce programmed cell death, or apoptosis, in cancer cells. We believe that HGS-ETR1 is the most advanced of all the products in development that target the TRAIL pathway.
 
HGS-ETR1 has moved to a proof-of-concept phase that currently includes three randomized trials to evaluate its potential in combination with chemotherapy for the treatment of specific cancers:
 
Non-small cell lung cancer: In August 2008, we completed the enrollment and initial dosing of patients in a randomized Phase 2 trial of HGS-ETR1 in combination with paclitaxel and carboplatin as first-line therapy in patients with advanced non-small cell lung cancer (NSCLC); initial data from the study are anticipated in 2009. NSCLC accounts for approximately 75-80% of all lung cancers and is currently the leading cause of cancer death in developed countries in both men and women.
 
Hepatocellular cancer: In July 2008, we initiated dosing in the safety lead-in to a randomized Phase 2 trial of HGS-ETR1 in combination with Nexavar (sorafenib) in patients with advanced hepatocellular cancer, which accounts for 80-90% of all liver cancers.
 
Multiple myeloma: In September 2008, we reported initial topline results from an ongoing Phase 2 clinical trial of HGS-ETR1 in combination with bortezomib (Velcade) in patients with advanced multiple myeloma. The initial data from the study show that HGS-ETR1 was well tolerated and suggest that disease response rates were comparable for this combination versus bortezomib alone. Patients will continue on treatment until the progression of disease, and HGS expects to have final data available from this study in late 2009 or early 2010, including data on the important secondary endpoint of progression-free survival. Multiple myeloma is a cancer of the plasma cells in bone marrow and accounts for about 10 percent of all hematologic cancers.


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These three trials, taken together, will support a decision on whether to advance HGS-ETR1 to Phase 3 development.
 
 
In December 2007, we and Aegera Therapeutics Inc. (“Aegera”) completed a licensing and collaboration agreement that provides us with exclusive worldwide rights (excluding Japan) to develop and commercialize small-molecule inhibitors of IAP (inhibitor of apoptosis) proteins in oncology (described below under “Product Collaborations and Agreements”). In May 2008, we initiated dosing in a Phase 1 clinical trial to evaluate the safety and tolerability of our lead IAP inhibitor, HGS1029, as monotherapy in patients with advanced solid tumors. Results of this study will also help identify the recommended dose for Phase 2 trials. The IAP inhibitors are a novel class of compounds that can block the activity of IAP proteins, thus allowing apoptosis to proceed and causing the cancer cells to die. When IAP proteins are over-expressed in cancer cells, they can help cancer cells resist apoptosis and resume growth and proliferation.
 
The HGS TRAIL receptor antibodies and small-molecule IAP inhibitors represent two different approaches targeting different points in the apoptosis pathway. Each is able to cause cancer cells to die selectively. Preclinical studies of HGS1029 in combination with our TRAIL receptor antibodies demonstrated dramatic synergistic activity against a number of cancer types, including prostate, breast, esophageal, colorectal and non-small cell lung. HGS1029 has also shown significant anti-tumor activity alone and in combination with other agents in a broad range of cancers. We plan to develop our TRAIL receptor antibodies and IAP inhibitors in combination with one another and in combination with other therapeutic agents.
 
 
There are three products in the GSK clinical development pipeline to which we have substantial financial rights (described below under “Lead Commercial Collaborations”). Two of these are genomics-derived small-molecule drugs discovered by GSK based on our technology: darapladib and GSK649868. The third product, Syncria (albiglutide) is an albumin-fusion protein created by HGS, which we licensed to GSK.
 
 
Darapladib was discovered by GSK based on our technology. It is a small-molecule inhibitor of lipoprotein-associated phospholipase-A2 (Lp-PLA2), an enzyme associated with the formation of atherosclerotic plaques and identified in clinical trials as an independent risk factor for coronary heart disease and ischemic stroke. GSK is developing darapladib as a treatment for atherosclerosis, and it has the potential to be an important treatment for the prevention of cardiovascular risk.
 
In December 2008, GSK initiated STABILITY, the first Phase 3 clinical trial to evaluate the efficacy of long-term treatment with darapladib in men and women with chronic coronary heart disease. More than 15,000 patients will participate in STABILITY. In its announcement, GSK said, “Despite major advances in medical treatment, coronary heart disease remains the leading cause of death worldwide and new approaches are needed to help reduce this burden to society. GSK is initiating the large STABILITY trial with darapladib as part of a Phase 3 program to determine if this novel medication could improve people’s lives by reducing the risk of cardiovascular events.”
 
GSK also indicated that it plans to initiate another large event-driven trial with darapladib in late 2009 in a post-ACS (acute coronary syndrome) patient population.
 
HGS will receive 10% royalties on worldwide sales if darapladib is commercialized, and has a 20% co-promotion option in North America and Europe.
 
 
Syncria is a biological product generated from the genetic fusion of human albumin and modified human GLP-1 peptide, and is designed to act throughout the body to help maintain normal blood-sugar levels and to control appetite. GSK is developing Syncria as a treatment for type 2 diabetes mellitus. In February 2009, GSK initiated a


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Phase 3 clinical trial program to evaluate the efficacy, safety and tolerability of Syncria (albiglutide) in the long-term treatment of type 2 diabetes mellitus.
 
Syncria was created by HGS using its proprietary albumin-fusion technology, and licensed to GSK in 2004. HGS is entitled to fees and milestone payments that could amount to as much as $183.0 million — including $24.0 million received to date — in addition to single-digit royalties on worldwide sales if Syncria is commercialized. HGS will receive an additional $9.0 million milestone payment in the first quarter of 2009 related to initiation of Phase 3 development.
 
 
GSK649868 was discovered by GSK based on HGS technology. It is a small-molecule orexin antagonist. Orexin is a hormone that plays an important role in the regulation of sleep-wake cycles.
 
 
HGS has developed core competencies in the discovery and understanding of human genes and their biological functions, and in the discovery and development of human protein and antibody drugs.
 
 
We have acquired rights to a variety of human antibody technologies, have integrated these technologies into our research and development program, and continue to collaborate with certain antibody companies. Many medical conditions are the result of an excess of a specific protein in the body, and some antibody drugs can inactivate such proteins and bring therapeutic benefits to patients. These drugs are known as antagonistic antibodies. For example, LymphoStat-B, which is in Phase 3 clinical trials for the treatment of systemic lupus erythematosus, is an antagonistic human monoclonal antibody.
 
In certain medical conditions, it may be desirable to stimulate a specific biological activity. Antibodies that stimulate biological activity are known as agonistic antibodies. HGS-ETR1 is an agonistic antibody that binds to TRAIL receptor 1 and triggers programmed cell death in cancer cells. We believe that it was the first human agonistic monoclonal antibody to enter clinical trials.
 
 
Our albumin-fusion technology allows us to create long-acting forms of protein drugs by fusing the gene that expresses human albumin to the gene that expresses a therapeutically active protein. We and our partners are actively pursuing the development of albumin-fusion drugs based on therapeutic proteins already on the market, as well as albumin-fusion versions of therapeutic proteins that we are developing ourselves. For example, Albuferon is a genetic fusion of human albumin and human interferon alfa, and Syncria results from the genetic fusion of human albumin and glucagon-like peptide-1 (GLP-1).
 
Based on preclinical and clinical results to date, we believe that albumin-fusion proteins may provide long-acting treatment options that have efficacy and safety similar to or better than that of existing protein drugs, with the potential additional benefit of considerably more convenient dosage schedules. Albumin-fusion technology also provides for efficient manufacture and purification of the product in our existing facilities.
 
 
We have built a drug development organization that has the expertise necessary to design and implement well focused, high-quality clinical trials of multiple compounds. We seek to gather, document and analyze clinical trial data in such a way that they can be submitted to regulatory authorities and used to support Biologics License Applications at the appropriate time. We have assembled experienced teams in key strategic areas of development, including:
 
  •  Clinical Research and Biostatistics.  The clinical research and biostatistics groups are responsible for the design, planning and analysis of clinical trials.


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  •  Clinical Operations.  The clinical operations group executes clinical trials and is responsible for managing clinical trial sites and ensuring that all proper procedures are followed during the collection of clinical data. The group includes our data management team.
 
  •  Project Management.  Our project management team oversees the process of development of a drug from the earliest stages of research through the conduct of clinical development and regulatory filings.
 
  •  Regulatory Affairs.  The regulatory affairs group manages communications with and submissions to regulatory authorities.
 
  •  Drug Safety.  As our products advance in clinical testing, our drug safety group collects and analyzes information on drug experience and safety, and ensures that accurate medical information is distributed.
 
  •  Quality Assurance.  The quality assurance group ensures compliance with all regulatory requirements for the clinical development and manufacture of our products.
 
  •  Bioanalytical Sciences.  The bioanalytical sciences group develops and performs highly specialized assays that are used during monitoring of preclinical tests and clinical trials. Other assays help to ensure the quality and consistency of our products.
 
  •  Biopharmaceutical Development.  The biopharmaceutical development group develops robust manufacturing processes and product formulations to support clinical studies and future commercial supply.
 
 
Strategic collaborations are a key aspect of the HGS business strategy. We have co-development and commercialization agreements with prominent pharmaceutical companies for two of our late-stage products, and our third late-stage product is being developed under a contract with the U.S. Government. Strategic collaborations are an important source of revenues and clinical development cost-sharing. They also allow us to leverage our strengths and gain access to sales and marketing infrastructure, international distribution, and complementary technologies.
 
Other potential collaborations may provide sources of exciting new product opportunities for in-licensing. In addition, we have assets that may be a better fit for another company than for HGS, and therefore could be out-licensed. Each of these collaborative models is of interest to HGS, and we are committed to remaining alert to new opportunities.
 
Lead Commercial Collaborations
 
 
Albuferon.  In June 2006, we entered into an exclusive worldwide agreement for the co-development and commercialization of Albuferon with Novartis, a global leader in the pharmaceutical industry. We and Novartis are working closely together to advance Albuferon to the market for use in the treatment of chronic hepatitis C. Under the agreement, we and Novartis will co-commercialize Albuferon in the United States, and will share clinical development costs, U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization in the rest of the world and will pay us a double-digit royalty on those sales. We will have primary responsibility for the bulk manufacture of Albuferon, and Novartis will have primary responsibility for commercial manufacturing of the finished drug product. Clinical development, commercial milestone and other payments to HGS could total as much as $507.5 million. To date, we have received $132.5 million in upfront and milestone payments under this agreement. We are recognizing these payments ratably over the remaining clinical development period. We recognized revenues of $28.0 million in 2007 and $35.4 million in 2008. The Novartis agreement includes cost-sharing provisions under which we and Novartis share clinical costs. We recorded cost reimbursement from Novartis of $46.5 million in 2007 and $36.1 million in 2008 under this provision, which was reflected as a reduction in expenses. This agreement will expire on the later of (i) the expiration of Novartis’ obligation to pay royalties under the agreement, which could be as early as 2023, and (ii) the date that we and Novartis cease to co-promote Albuferon in the United States. Novartis has the right to terminate the agreement (i) without cause or (ii) if there are material safety risks associated with Albuferon or Albuferon is not approved by


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the FDA or the European Medicines Agency (“EMEA”). In addition, either party may terminate if the other party commits a material breach of the agreement or if the other party is bankrupt or insolvent.
 
 
LymphoStat-B.  In August 2006, we entered into an agreement with GSK for the co-development and commercialization of LymphoStat-B. GSK is a world leader that brings global pharmaceutical development and marketing capabilities to the LymphoStat-B program. Under the LymphoStat-B agreement, we and GSK will share Phase 3 and 4 development costs, sales and marketing expenses, and profits equally. We are conducting Phase 3 clinical trials with assistance from GSK, and will have primary responsibility for bulk manufacturing. We have received an execution fee of $24.0 million under this agreement and we are recognizing this payment ratably over the estimated remaining development period. We recognized revenues of $6.5 million in 2007 and 2008. The GSK LymphoStat-B agreement includes cost-sharing provisions under which we and GSK share clinical development costs. We recorded cost reimbursement from GSK of $39.3 million in 2007 and $51.8 million in 2008 under this provision, which was reflected as a reduction in expenses. This agreement will expire three years after the later of (i) the expiration date of certain patent rights related to LymphoStat-B and (ii) a period of ten years after the first commercial sale of LymphoStat-B. These certain patent rights are expected to expire by 2023, with the potential for later expiration that may result from any issuance of additional patents and/or patent term extensions. GSK may terminate the agreement if (i) upon the basis of competent scientific evidence or data regarding commercial potential, GSK determines LymphoStat-B does not merit incurring additional development or marketing expenses or (ii) LymphoStat-B is not approved by the FDA or EMEA. In addition, either party may terminate if the other party commits a material breach of the agreement or if the other party is bankrupt or insolvent.
 
Darapladib.  In December 2008, GSK initiated Phase 3 development of darapladib, a small-molecule Lp-PLA2 inhibitor discovered by GSK based on HGS technology. GSK is developing darapladib as a treatment for atherosclerosis, and it has the potential to become an important treatment for the prevention of cardiovascular risk. We will receive a 10% royalty on worldwide sales of darapladib if it is commercialized, and we have a 20% co-promotion option in North America and Europe. We are also entitled to receive a milestone payment if darapladib moves through clinical development into registration.
 
Syncria.  In February 2009, GSK initiated a Phase 3 clinical trial program to evaluate the efficacy, safety and tolerability of Syncria in the long-term treatment of type 2 diabetes mellitus. Syncria was created by HGS using its proprietary albumin-fusion technology, and licensed to GSK in 2004. HGS is entitled to fees and milestone payments that could amount to as much as $183.0 million — including $24.0 million received to date. HGS will receive an additional $9.0 million milestone payment related to initiation of Phase 3 development in the first quarter of 2009. We are also entitled to single-digit royalties on worldwide sales if Syncria is commercialized.
 
TRAIL Receptor Antibodies.   In April 2008, we reacquired rights to the TRAIL receptor antibodies HGS-ETR1 and HGS-ETR2 from GSK, in return for a reduction in royalties due to HGS if Syncria is commercialized. The fees and milestone payments due to our Company under the original Syncria agreement, some of which have already been received, could amount to as much as $183.0 million and remain unchanged in the amended agreement.
 
 
ABthrax.  In September 2005, we entered into a two-phase contract with the Biomedical Advanced Research and Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) to supply ABthrax for inhalation anthrax. HHS is the lead agency for public health and medical response to man-made or natural disasters, including acts of bioterrorism. Under the first phase of the contract, we supplied ten grams of ABthrax to HHS for comparative in vitro and in vivo testing and received approximately $1.8 million for this work. In June 2006, under the second phase of the contract, the U.S. Government exercised its option to purchase treatment courses of ABthrax for the U.S. Strategic National Stockpile. Under the contract, we agreed to manufacture and deliver 20,001 treatment courses to the U.S. Strategic National Stockpile. We began delivery to the Stockpile in January 2009. We expect to recognize a total of approximately $165.0 million in revenues from this contract, including at least $150.0 million in early 2009. This agreement can be terminated by the U.S. Government if it determines that a termination is in its interest.


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Aegera Therapeutics.  In December 2007, we and Aegera Therapeutics, Inc. completed a licensing and collaboration agreement providing us with exclusive worldwide rights (excluding Japan) to develop and commercialize HGS1029 (formerly AEG40826) and other small-molecule inhibitors of IAP (inhibitor of apoptosis) proteins in oncology. Under the agreement, we made an upfront payment to Aegera of $20.0 million as a licensing fee and for an equity investment. Aegera will be entitled to receive up to $295.0 million in future development and commercial milestone payments, including a $5.0 million milestone paid in 2008 upon FDA clearance of an IND. Aegera will receive low double-digit royalties on net sales in the HGS territory. In North America, Aegera will have the option to co-promote, under which it will share certain expenses and profits (30%) in lieu of its royalties. Aegera retains the non-oncology rights to its IAP inhibitors that are not selected for development under this agreement.
 
CoGenesys.  In June 2006, we completed the transaction establishing CoGenesys as an independent company, established to focus on the early development of selected product opportunities and the monetization of certain HGS intellectual property and technology assets that HGS did not plan to develop internally. In February 2008, Teva Pharmaceutical Industries Ltd. (“Teva”) acquired all the outstanding shares of CoGenesys. We received a total of approximately $52.6 million for our 14% equity interest, approximately $47.3 million of which was received upon closing of the transaction in February 2008, and $5.3 million of which was received in February 2009. We are also entitled to a portion of the revenue that Teva may receive from outlicensing or sales of certain therapeutic and diagnostic products successfully developed and commercialized.
 
 
HGS has a rich heritage of scientific discovery that has produced a substantial intellectual property estate and a library of thousands of therapeutic and diagnostic targets. Over the past couple of years, we have conducted a careful review and selected approximately 50 targets for further research and potential development, with the goal of filing INDs in 2010-2011. We plan to develop the selected targets through co-development or research collaborations, as well as through our own internal research, including the application of antibody development technology from various collaborators.
 
 
Protein and antibody process development and manufacturing are core HGS competencies. We currently produce several protein and antibody drugs in two state-of-the-art cGMP-compliant process development and manufacturing facilities — totaling approximately 400,000 square feet and offering both small-scale and large-scale production in batches from 650 to 20,000 liters. We are leveraging these capabilities to produce near-term revenue by entering into strategically appropriate process development and manufacturing alliances.
 
 
We seek U.S. and foreign patent protection for the genes, proteins and antibodies that we discover, as well as patents on therapeutic and diagnostic products and processes, screening and manufacturing technologies, and other inventions based on genes, proteins and antibodies. We also seek patent protection or rely upon trade secret rights to protect certain technologies which may be used to discover and characterize genes, proteins and antibodies and which may be used to develop novel therapeutic and diagnostic products and processes. We believe that, in the aggregate, our patent applications, patents and licenses under patents owned by third parties are of material importance to our operations.
 
Important legal issues remain to be resolved as to the extent and scope of available patent protection for biotechnology products and processes in the U.S. and other important markets outside the U.S. We expect that litigation or administrative proceedings will likely be necessary to determine the validity and scope of certain of our and others’ proprietary rights. We are currently involved in a number of administrative proceedings and litigations relating to the scope of protection of our patents and those of others, and are likely to be involved in additional proceedings that may affect directly or indirectly patents and patent applications related to our products or the products of our partners. For example, we are involved in interference and opposition proceedings related to products based on TRAIL receptor 2 (such as HGS-ETR2) and interference, opposition and revocation proceedings related to products based on BLyS (such as LymphoStat-B). Any such lawsuit or proceeding may result in a significant commitment of resources in the future. In addition, changes in, or different interpretations of, patent laws


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in the U.S. and other countries may result in patent laws that allow others to use our discoveries or develop and commercialize our products. We cannot assure you that the patents we obtain or the unpatented technology we hold will afford us significant commercial protection.
 
We have filed U.S. patent applications with respect to many human genes and their corresponding proteins. We have also filed U.S. patent applications with respect to all or portions of the genomes of several infectious and non-infectious microorganisms. We have hundreds of U.S. patents covering genes, proteins, antibodies and proprietary technologies. Our remaining applications may not result in the issuance of any patents. Our applications may not be sufficient to meet the statutory requirements for patentability in all cases. In certain instances, we will be dependent upon our collaborators to file and prosecute patent applications.
 
Other companies or institutions have filed, and may in the future file, patent applications that attempt to patent genes similar to those covered in our patent applications, including applications based on our potential products. Any patent application filed by a third party may prevail over our patent applications, in which event the third party may require us to stop pursuing a potential product or to negotiate a royalty arrangement to pursue the potential product.
 
We also are aware that others, including universities and companies working in the biotechnology and pharmaceutical fields, have filed patent applications and have been granted patents in the U.S. and in other countries that cover subject matter potentially useful or necessary to our business. Some of these patents and patent applications claim only specific products or methods of making products, while others claim more general processes or techniques useful in the discovery and manufacture of a variety of products. The risk of additional patents and patent applications will continue to increase as the biotechnology industry progresses. We cannot predict the ultimate scope and validity of existing patents and patents that have been or may be granted to third parties, nor can we predict the extent to which we may wish or be required to obtain licenses to such patents, or the availability and cost of acquiring such licenses. To the extent that licenses are required, the owners of the patents could bring legal actions against us to claim damages or to stop our manufacturing and marketing of the affected products.
 
Issued patents may not provide commercially meaningful protection against competitors and may not provide us with competitive advantages. Other parties may challenge our patents or design around our issued patents or develop products providing effects similar to our products. Furthermore, patents are issued for a limited time period and may expire before the useful life of the covered product. In addition, others may discover uses for genes, proteins or antibodies other than those uses covered in our patents, and these other uses may be separately patentable. The holder of a patent covering the use of a gene, protein or antibody for which we have a patent claim could exclude us from selling a product for a use covered by its patent.
 
We rely on trade secret protection to protect our confidential and proprietary information. We believe we have developed proprietary procedures for making libraries of DNA sequences and genes. We have not sought patent protection for these procedures. We have developed a substantial database concerning genes we have identified. We have taken security measures to protect our data and continue to explore ways to further enhance the security for our data. However, we may not be able to meaningfully protect our trade secrets. While we have entered into confidentiality agreements with employees and collaborators, we may not be able to prevent their disclosure of these data or materials. Others may independently develop substantially equivalent information and techniques.
 
 
General.  We face intense competition from a wide range of pharmaceutical, biotechnology and diagnostic companies, as well as academic and research institutions and government agencies. Some of these competitors have substantially greater financial, marketing, research and development and human resources. Most large pharmaceutical companies have considerably more experience in undertaking clinical trials and in obtaining regulatory approval to market pharmaceutical products.
 
Basis of Competition.  Principal competitive factors in our industry include:
 
  •  the quality and breadth of an organization’s technology;
 
  •  the skill of an organization’s employees and ability to recruit and retain skilled employees;
 
  •  an organization’s intellectual property estate;


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  •  the range of capabilities, from target identification and validation to drug discovery and development to manufacturing and marketing; and
 
  •  the availability of substantial capital resources to fund discovery, development, manufacturing and commercialization activities.
 
We believe that the quality and breadth of our technology platform, the skill of our employees and our ability to recruit and retain skilled employees, our patent portfolio, our capabilities for research and drug development, and our capital resources are competitive strengths. However, many large pharmaceutical and biotechnology companies have significantly larger intellectual property estates than we do, more substantial capital resources than we have, and greater capabilities and experience than we do in preclinical and clinical development, sales, marketing, manufacturing and regulatory affairs.
 
Products.  We are aware of products in research or development by our competitors that address all of the diseases we are targeting. Any of these products may compete with our product candidates. Our competitors may succeed in developing their products before we do, obtaining approvals from the FDA or other regulatory agencies for their products more rapidly than we do, or developing products that are more effective than our products. These products or technologies might render our technology obsolete or noncompetitive. In addition, our albumin fusion protein products are designed to be long-acting versions of existing products. While we believe our albumin fusion protein products will be a more attractive alternative to the existing products, the existing product in many cases has an established market that may make the introduction of our product more difficult. Competition is based primarily on product efficacy, safety, timing and scope of regulatory approvals, availability of supply, marketing and sales capability, reimbursement coverage, price and patent position.
 
 
Regulations in the U.S. and other countries have a significant impact on our research, product development and manufacturing activities and will be a significant factor in the marketing of our products. All of our products require regulatory approval prior to commercialization. In particular, our products are subject to rigorous preclinical and clinical testing and other premarket approval requirements by the FDA and similar regulatory authorities in other countries. Various statutes and regulations also govern or influence the manufacturing, safety, labeling, storage, record keeping and marketing of our products. The lengthy process of seeking these approvals, and the subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining, regulatory approvals could materially adversely affect our ability to commercialize our products in a timely manner, or at all.
 
Preclinical Testing.  Before a drug may be clinically tested in the U.S., it must be the subject of rigorous preclinical testing. Preclinical tests include laboratory evaluation of product chemistry and animal studies to assess the potential safety and efficacy of the product and its formulations. The results of these studies must be submitted to the FDA as part of an investigational new drug application, which is reviewed by the FDA before clinical testing in humans can begin.
 
Clinical Testing.  Typically, clinical testing involves a three-phase process, which generally lasts four to seven years, and sometimes longer:
 
  •  Phase 1 clinical trials are conducted with a small number of subjects to determine the early safety profile and the pattern of drug distribution and metabolism.
 
  •  Phase 2 clinical trials are conducted with groups of patients afflicted with a specified disease in order to provide enough data to evaluate preliminary efficacy and optimal dosages statistically and to expand evidence of safety.
 
  •  Phase 3 clinical trials are large-scale, multi-center, comparative trials, which are designed to gather additional information for proper dosage and labeling of the drug and to demonstrate its overall safety and efficacy.
 
The FDA monitors the progress of each phase of testing, and may require the modification, suspension or termination of a trial if it is determined to present excessive risks to patients. The clinical trial process may be accompanied by substantial delay and expense and there can be no assurance that the data generated in these studies will ultimately be sufficient for marketing approval by the FDA.


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Marketing Approvals.  Before a product can be marketed and sold, the results of the preclinical and clinical testing must be submitted to the FDA for approval. This submission will be either a new drug application or a biologics license application, depending on the type of drug. In responding to a new drug application or a biologics license application, the FDA may grant marketing approval, request additional information or deny the application if it determines that the application does not provide an adequate basis for approval. We cannot assure you that any approval required by the FDA will be obtained on a timely basis, or at all.
 
In addition, the FDA may condition marketing approval on the conduct of specific post-marketing studies to further evaluate safety and efficacy (such as Phase 4 trials). Rigorous and extensive FDA regulation of pharmaceutical products continues after approval, particularly with respect to compliance with current good manufacturing practices, or cGMPs, reporting of adverse effects, advertising, promotion and marketing. Discovery of previously unknown problems or failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of a product or withdrawal of the product from the market as well as possible civil or criminal sanctions, any of which could materially adversely affect our business.
 
Other Regulation.  We are also subject to various laws and regulations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals and the use and disposal of hazardous or potentially hazardous substances used in connection with our research, including radioactive compounds and infectious disease agents. We also cannot accurately predict the extent of regulations that might result from any future legislative or administrative action.
 
In addition, ethical, social and legal concerns about genetic testing and genetic research could result in additional regulations restricting or prohibiting the processes we or our suppliers may use. Federal and state agencies, congressional committees and foreign governments have expressed interest in further regulating biotechnology. More restrictive regulations or claims that our products are unsafe or pose a hazard could prevent us from commercializing our products.
 
Foreign Regulation.  We must obtain regulatory approval by governmental agencies in other countries prior to commercialization of our products in those countries. Foreign regulatory systems may be just as rigorous, costly and uncertain as in the U.S.
 
Possible Pricing Restrictions.  The levels of revenues and profitability of biopharmaceutical companies like ours may be affected by the continuing efforts of government and third party payers to contain or reduce the costs of health care through various means. For example, in certain foreign markets, pricing or profitability of therapeutic and other pharmaceutical products is subject to governmental control. In the U.S. there have been, and we expect that there will continue to be, a number of federal and state proposals to implement similar governmental control. While we cannot predict whether any legislative or regulatory proposals will be adopted, the adoption of such proposals could have a material adverse effect on our business, financial condition and profitability. In addition, in the U.S. and elsewhere, sales of therapeutic and other pharmaceutical products depend in part on the availability of reimbursement to the consumer from third party payers, such as government and private insurance plans. Third party payers are increasingly challenging the prices charged for medical products and services. We cannot assure you that any of our products will be considered cost effective or that reimbursement to the consumer will be available or will be sufficient to allow us to sell our products on a competitive and profitable basis.
 
 
Most raw materials and other supplies required in our business are generally available from various suppliers in quantities adequate to meet our needs. Certain raw materials and other supplies required for manufacturing are currently available only from single sources. As we prepare for commercialization of our products, we intend to identify alternative sources of supply.
 
 
We are able to manufacture multiple protein and antibody drugs for use in research and clinical activities. We produce and purify these protein and antibody drugs in two process development and manufacturing facilities that total approximately 400,000 square feet and offer both small-scale and large-scale manufacturing capabilities. We completed the commissioning and validation of our large-scale manufacturing facility in 2006, and successfully manufactured our first cGMP-compliant material at commercial scale. We do not currently manufacture any


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products for commercial use. We have, however, manufactured ABthrax for supply to the U.S. Strategic National Stockpile.
 
We cannot assure you that we will be able in the future to consistently manufacture our products economically or in compliance with cGMPs and other regulatory requirements. For a description of the financing arrangements for these facilities, see “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources.”
 
In the future, we may contract with additional third party manufacturers or develop products with partners and use the partners’ manufacturing capabilities. If we use others to manufacture our products, we will depend on those parties to comply with cGMPs and other regulatory requirements, and to deliver materials on a timely basis. These parties may not perform adequately. Any failures by these third parties may delay our development of products or the submission of these products for regulatory approval.
 
 
We have a strategic marketing group to analyze the commercial value of our product portfolio and the competitive environment. The strategic marketing group also analyzes patient needs and customer preferences with respect to our product development and planning. If we develop products that can be marketed, we intend to market the products either independently or together with collaborators or strategic partners. GSK, Novartis and others have co-marketing rights with respect to certain of our products. If we decide to market any products, either independently or together with partners, we will incur significant additional expenditures and commit significant additional management resources to establish a sales and marketing organization. For any products that we market together with partners, we will rely, in whole or in part, on the marketing capabilities of those parties. We may also contract with third parties to market certain of our products. Ultimately, we and our partners may not be successful in marketing our products.
 
 
As of February 1, 2009, we had approximately 880 full-time employees. None of our employees is covered by a collective bargaining agreement and we consider relations with our employees to be good.


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ITEM 1A.   RISK FACTORS
 
There are a number of risk factors that could cause our actual results to differ materially from those that are indicated by forward-looking statements. Those factors include, without limitation, those listed below and elsewhere herein.
 
If we are unable to commercialize our Phase 3 and earlier development molecules, we may not be able to recover our investment in our product development and manufacturing efforts.
 
We have invested significant time and resources to isolate and study genes and determine their functions. We now devote most of our resources to developing proteins, antibodies and small molecules for the treatment of human disease. We are also devoting substantial resources to the maintenance of our own manufacturing capabilities, both to support clinical testing and eventual commercialization. We have made and are continuing to make substantial expenditures. Before we can commercialize a product, we must rigorously test the product in the laboratory and complete extensive human studies. We cannot assure you that the tests and studies will yield products approved for marketing by the FDA in the United States or similar regulatory authorities in other countries, or that any such products will be profitable. We will incur substantial additional costs to continue these activities. If we are not successful in commercializing our Phase 3 and earlier development molecules, we may be unable to recover the large investment we have made in research, development and manufacturing efforts.
 
Because we will be disclosing data from three Phase 3 trials on our two lead products this year, 2009 will be a pivotal year for the Company.
 
In 2009, we will be disclosing data from three ongoing Phase 3 clinical trials on our two lead products, Albuferon and LymphoStat-B. Even if we determine that the results from the trials are positive, FDA may determine that the results are insufficient either to file a BLA or to obtain marketing approval. If the results of the trials are negative for one or both of the products, we may not have sufficient data to file a BLA with the FDA and our results of operations and business will be materially adversely affected. If the results of these trials are negative for both products, we may not have sufficient resources to continue development of other products.
 
Because our product development efforts depend on new and rapidly-evolving technologies, we cannot be certain that our efforts will be successful.
 
Our work depends on new, rapidly evolving technologies and on the marketability and profitability of innovative products. Commercialization involves risks of failure inherent in the development of products based on innovative technologies and the risks associated with drug development generally. These risks include the possibility that:
 
  •  these technologies or any or all of the Phase 3 and earlier development molecules based on these technologies will be ineffective or toxic, or otherwise fail to receive necessary regulatory clearances;
 
  •  the products, even if safe and effective, will be difficult to manufacture on a large scale or uneconomical to market;
 
  •  proprietary rights of third parties will prevent us or our collaborators from exploiting technologies or marketing products; and
 
  •  third parties will market superior or equivalent products.
 
Because we are a late-stage development company, we cannot be certain that we can develop our business or achieve profitability.
 
We expect to continue to incur losses and we cannot assure you that we will ever become profitable. Although we have received U.S. Government approval for our initial order of ABthrax, we cannot assure you we will receive additional orders. A number of our products are in late-stage development, however it will be several years, if ever, before we are likely to receive continuing revenue from product sales or substantial royalty payments. We will continue to incur substantial expenses relating to research, development and manufacturing efforts and human studies. Depending on the stage of development, our products may require significant further research,


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development, testing and regulatory approvals. We may not be able to develop products that will be commercially successful or that will generate revenue in excess of the cost of development.
 
We are continually evaluating our business strategy, and may modify this strategy in light of developments in our business and other factors.
 
We continue to evaluate our business strategy and, as a result, may modify this strategy in the future. In this regard, we may, from time to time, focus our product development efforts on different products or may delay or halt the development of various products. In addition, as a result of changes in our strategy, we may also change or refocus our existing drug discovery, development, commercialization and manufacturing activities. This could require changes in our facilities and personnel and the restructuring of various financial arrangements. We cannot assure you that changes will occur or that any changes that we implement will be successful.
 
Several years ago, we sharpened our focus on our most promising drug candidates. We reduced the number of drugs in early development and focused our resources on the drugs that address the greatest unmet medical needs with substantial growth potential. In 2006, we spun off our CoGenesys division (“CoGenesys”) as an independent company, in a transaction that was treated as a sale for accounting purposes. In 2008, CoGenesys was acquired by Teva Pharmaceuticals Industries, Ltd. (“Teva”) and became a wholly-owned subsidiary of Teva called Teva Biopharmaceuticals USA, Inc. (“Teva Bio”).
 
Our ability to discover and develop new products will depend on our internal research capabilities and our ability to acquire products. Our internal research capability was reduced when we completed the spin-off of CoGenesys. Although we continue to conduct research and development activities on products, our limited resources for new products may not be sufficient to discover and develop new drug candidates.
 
 
Because we have limited experience in developing and commercializing products, we may be unsuccessful in our efforts to do so.
 
Although we are conducting human studies with respect to a number of products, we have limited experience with these activities and may not be successful in developing or commercializing these or other products. Our ability to develop and commercialize products based on proteins, antibodies and small molecules will depend on our ability to:
 
  •  successfully complete laboratory testing and human studies;
 
  •  obtain and maintain necessary intellectual property rights to our products;
 
  •  obtain and maintain necessary regulatory approvals related to the efficacy and safety of our products;
 
  •  maintain production facilities meeting all regulatory requirements or enter into arrangements with third parties to manufacture our products on our behalf; and
 
  •  deploy sales and marketing resources effectively or enter into arrangements with third parties to provide these functions.
 
Because clinical trials for our products are expensive and protracted and their outcome is uncertain, we must invest substantial amounts of time and money that may not yield viable products.
 
Conducting clinical trials is a lengthy, time-consuming and expensive process. Before obtaining regulatory approvals for the commercial sale of any product, we must demonstrate through laboratory, animal and human studies that the product is both effective and safe for use in humans. We will incur substantial additional expense for and devote a significant amount of time to these studies.
 
Before a drug may be marketed in the U.S., a drug must be subject to rigorous preclinical testing. The results of these studies must be submitted to the FDA as part of an investigational new drug application, which is reviewed by the FDA before clinical testing in humans can begin. The results of preclinical studies do not predict clinical


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success. A number of potential drugs have shown promising results in early testing but subsequently failed to obtain necessary regulatory approvals. Data obtained from tests are susceptible to varying interpretations, which may delay, limit or prevent regulatory approval. Regulatory authorities may refuse or delay approval as a result of many other factors, including changes in regulatory policy during the period of product development.
 
Completion of clinical trials may take many years. The time required varies substantially according to the type, complexity, novelty and intended use of the product candidate. The progress of clinical trials is monitored by both the FDA and independent data monitoring committees, which may require the modification, suspension or termination of a trial if it is determined to present excessive risks to patients. Our rate of commencement and completion of clinical trials may be delayed by many factors, including:
 
  •  our inability to manufacture sufficient quantities of materials for use in clinical trials;
 
  •  variability in the number and types of patients available for each study;
 
  •  difficulty in maintaining contact with patients after treatment, resulting in incomplete data;
 
  •  unforeseen safety issues or side effects;
 
  •  poor or unanticipated effectiveness of products during the clinical trials; or
 
  •  government or regulatory delays.
 
To date, data obtained from our clinical trials may not be sufficient to support an application for regulatory approval without further studies. Studies conducted by us or by third parties on our behalf may not demonstrate sufficient effectiveness and safety to obtain the requisite regulatory approvals for these or any other potential products. For example, we will be submitting a Biologics License Application (“BLA”) to the FDA for ABthrax, but the studies we have conducted to date may not be sufficient to obtain FDA approval. In addition, based on the results of a human study for a particular product candidate, regulatory authorities may not permit us to undertake any additional clinical trials for that product candidate. The clinical trial process may also be accompanied by substantial delay and expense and there can be no assurance that the data generated in these studies will ultimately be sufficient for marketing approval by the FDA. For example, in 2005, we discontinued our clinical development of LymphoRad131, a product candidate to treat cancer. We also discontinued development of HGS-TR2J and returned all rights to Kirin Brewery Company, Ltd.
 
We are conducting Phase 3 clinical development programs for Albuferon and LymphoStat-B. Each of these development programs includes two Phase 3 clinical trials which are large-scale, multi-center trials and more expensive than our Phase 1 and Phase 2 clinical trials. The last three of these Phase 3 clinical trials will not be completed until 2009, at the earliest. In January 2008, we modified the dosing in the two Albuferon Phase 3 trials based on a recommendation from our independent Data Monitoring Committee (“DMC”). The DMC recommendation was based on the incidence rate of serious pulmonary adverse events in the high dose arm of the two trials. The DMC for Albuferon has completed the monitoring of these trials now that the dosing period has concluded in both studies. In December 2008, we announced that we had completed one of the Phase 3 studies for Albuferon; in that study, Albuferon met its primary efficacy endpoint of non-inferiority to peginterferon alfa-2a. We cannot assure you that we will be able to complete our other Phase 3 clinical trials successfully or obtain FDA approval of Albuferon or LymphoStat-B, or that FDA approval, if obtained, will not include limitations on the indicated uses for which Albuferon and/or LymphoStat-B may be marketed.
 
We face risks in connection with our ABthrax product in addition to risks generally associated with drug development.
 
The development of ABthrax presents risks beyond those associated with the development of our other products. Numerous other companies and governmental agencies are known to be developing biodefense pharmaceuticals and related products to combat anthrax. These competitors may have financial or other resources greater than ours, and may have easier or preferred access to the likely distribution channels for biodefense products. In addition, since the primary purchaser of biodefense products is the U.S. Government and its agencies, the success of ABthrax will depend on government spending policies and pricing restrictions. The funding of government biodefense programs is dependent, in part, on budgetary constraints, political considerations and


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military developments. In the case of the U.S. Government, executive or legislative action could attempt to impose production and pricing requirements on us. We have entered into a two-phase contract to supply ABthrax, a human monoclonal antibody developed for use in the treatment of anthrax disease, to the U.S. Government. Under the first phase of the contract, we supplied ten grams of ABthrax to the U.S. Department of Health and Human Services (“HHS”) for comparative in vitro and in vivo testing. Under the second phase of the contract, the U.S. Government ordered 20,001 doses of ABthrax for the Strategic National Stockpile for use in the treatment of anthrax disease. We have begun delivery of these doses and the U.S. Government has accepted our initial deliveries. We have future deliveries to make and have ongoing obligations under the contract, including the obligation to file a BLA and to obtain FDA approval. We will continue to face risks related to these future deliveries and the requirements of the contract. If we are unable to complete these deliveries or to meet our obligations associated with this contract, the U.S. Government will not be required to make future payments related to that order. In addition, we are in discussions with the U.S. Government concerning the possibility of future orders of ABthrax. We cannot assure you that we will be successful in obtaining an order for additional doses of ABthrax or, if we are successful in obtaining an order, that we will be successful in fulfilling that order.
 
Because neither we nor any of our collaboration partners have received marketing approval for any product candidate resulting from our research and development efforts, and because we may never be able to obtain any such approval, it is possible that we may not be able to generate any product revenue other than with respect to ABthrax.
 
Neither we nor any of our collaboration partners have completed development of any product based on our research and development efforts. It is possible that we will not receive FDA marketing approval for any of our product candidates. Although a number of our potential products have entered clinical trials, we cannot assure you that any of these products will receive marketing approval. All products being developed by our collaboration partners will also require additional research and development, extensive preclinical studies and clinical trials and regulatory approval prior to any commercial sales. In some cases, the length of time that it takes for our collaboration partners to achieve various regulatory approval milestones may affect the payments that we are eligible to receive under our collaboration agreements. We and our collaboration partners may need to successfully address a number of technical challenges in order to complete development of our products. Moreover, these products may not be effective in treating any disease or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining regulatory approval or prevent or limit commercial use.
 
 
Our plan to use collaborations to leverage our capabilities and to grow in part through the strategic acquisition of other companies and technologies may not be successful if we are unable to integrate our partners’ capabilities or the acquired companies with our operations or if our partners’ capabilities do not meet our expectations.
 
As part of our strategy, we intend to continue to evaluate strategic partnership opportunities and consider acquiring complementary technologies and businesses. In order for our future collaboration efforts to be successful, we must first identify partners whose capabilities complement and integrate well with ours. Technologies to which we gain access may prove ineffective or unsafe. Our current agreements that grant us access to such technology may expire and may not be renewable or could be terminated if we or our partners do not meet our obligations. These agreements are subject to differing interpretations and we and our partners may not agree on the appropriate interpretation of specific requirements. Our partners may prove difficult to work with or less skilled than we originally expected. In addition, any past collaborative successes are no indication of potential future success.
 
In order to achieve the anticipated benefits of an acquisition, we must integrate the acquired company’s business, technology and employees in an efficient and effective manner. The successful combination of companies in a rapidly changing biotechnology industry may be more difficult to accomplish than in other industries. The combination of two companies requires, among other things, integration of the companies’ respective technologies and research and development efforts. We cannot assure you that this integration will be accomplished smoothly or


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successfully. The difficulties of integration may be increased by any need to coordinate geographically separated organizations and address possible differences in corporate cultures and management philosophies. The integration of certain operations will require the dedication of management resources which may temporarily distract attention from the day-to-day operations of the combined companies. The business of the combined companies may also be disrupted by employee retention uncertainty and lack of focus during integration. The inability of management to integrate successfully the operations of the two companies, in particular, the integration and retention of key personnel, or the inability to integrate successfully two technology platforms, could have a material adverse effect on our business, results of operations and financial condition.
 
We reacquired rights to HGS-ETR1 from GSK, as well as all rights to other TRAIL Receptor 1 and 2 antibodies. We may be unsuccessful in developing and commercializing products from these antibodies without a collaborative partner.
 
As part of our September 1996 agreement with GSK, we granted a 50/50 co-development and commercialization option to GSK for certain human therapeutic products that successfully complete Phase 2a clinical trials. In August 2005, we announced that GSK had exercised its option to develop and commercialize HGS-ETR1 (mapatumumab) jointly with us. In April 2008, we announced that we had reacquired all rights to our TRAIL receptor antibodies (including rights to HGS-ETR1 and HGS-ETR2) from GSK, in return for a reduction in royalties due to us if Syncria®, a GSK product for which we would be owed royalties, is commercialized. We also announced that our agreement with the pharmaceutical division of Kirin Brewery Company, Ltd. for joint development of antibodies to TRAIL receptor 2 had been terminated. Takeda Pharmaceutical Company, Ltd. has the right to develop HGS-ETR1 in Japan. As a result of these actions, we have assumed full responsibility for the development and commercialization of products based on these antibodies, except for HGS-ETR1 in Japan.
 
Product development and commercialization are very expensive and involve a high degree of risk. We have limited experience in the clinical development, manufacturing, distribution and promotion of our products. We are exploring opportunities for a new partnership to assist in the development and commercialization of TRAIL receptor antibodies. We do not know if we will enter into any such partnership, nor do we know if we will be successful in developing and commercializing TRAIL receptor antibodies either with or without a partnership.
 
Our ability to receive revenues from the assets licensed in connection with our CoGenesys transaction will now depend on Teva’s ability to develop and commercialize those assets.
 
We will depend on Teva Bio to develop and commercialize the assets licensed as part of the spin-off of CoGenesys. If Teva Bio is not successful in its efforts, we will not receive any revenue from the development of these assets. In addition, our relationship with Teva Bio will be subject to the risks and uncertainties inherent in our other collaborations.
 
Because we currently depend on our collaboration partners for substantial revenue, we may not become profitable if we cannot increase the revenue from our collaboration partners or other sources.
 
We have received the majority of our revenue from payments made under collaboration agreements with GSK and Novartis, and to a lesser extent, other agreements. The research term of our initial GSK collaboration agreement and many of our other collaboration agreements expired in 2001. None of these collaboration agreements was renewed and we may not be able to enter into additional collaboration agreements. While our partners under our initial GSK collaboration agreement have informed us that they have been pursuing research programs involving different genes for the creation of small molecule, protein and antibody drugs, we cannot assure you that any of these programs will be continued or will result in any approved drugs.
 
Under the Novartis and GSK collaboration agreements, we are entitled to certain development and commercialization payments based on our development of the applicable product. Under our other collaboration agreements, we are entitled to certain milestone and royalty payments based on our partners’ development of the applicable product.


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We may not receive payments under these agreements if we or our collaborators fail to:
 
  •  develop marketable products;
 
  •  obtain regulatory approvals for products; or
 
  •  successfully market products.
 
Further, circumstances could arise under which one or more of our collaboration partners may allege that we breached our agreement with them and, accordingly, seek to terminate our relationship with them. Our collaboration partners may also terminate these agreements without cause. If any one of these agreements terminates, this could adversely affect our ability to commercialize our products and harm our business.
 
If one of our collaborators pursues a product that competes with our products, there could be a conflict of interest and we may not receive milestone or royalty payments.
 
Each of our collaborators is developing a variety of products, some with other partners. Our collaborators may pursue existing or alternative technologies to develop drugs targeted at the same diseases instead of using our licensed technology to develop products in collaboration with us. Our collaborators may also develop products that are similar to or compete with products they are developing in collaboration with us. If our collaborators pursue these other products instead of our products, we may not receive milestone or royalty payments. For example, GSK has been developing for the treatment of insomnia an orexin inhibitor based on our technology and to which we are entitled to milestones, royalties and co-promotion rights. In July 2008, GSK announced a collaboration with Actelion Ltd. to co-develop and co-commercialize a different orexin inhibitor. While GSK has stated publicly that it intends to continue work on the inhibitor derived from our technology, there can be no assurance that it will continue to do so or that such work will lead to a commercial product.
 
Since reimbursement payments from our collaborators will pay for approximately half of our late-phase clinical trial expenses, our ability to develop and commercialize products may be impaired if payments from our collaborators are delayed.
 
We are conducting Phase 3 clinical development programs for both Albuferon and LymphoStat-B. These development programs include four Phase 3 large-scale, multi-center clinical trials, only one of which has been completed. We rely on our collaborators to reimburse us for approximately half of the expenditures related to these programs. To execute our Phase 3 clinical trial programs, we strengthened our development organization and increased our dependence on third-party contract clinical trial providers. The collaboration agreements with our partners in the development of these two products provide for the reimbursement of approximately half of these increased expenditures. However, our collaborators may not agree with our expenses or may not perform their obligations under our agreements with them. Further, it is difficult to accurately predict or control the amount or timing of these expenditures, and uneven and unexpected spending on these programs may cause our operating results to fluctuate from quarter to quarter. As a result, if we are unable to obtain funding under these agreements on a timely basis, we may be forced to delay, curtail or terminate these Phase 3 trials, which could adversely affect our ability to commercialize our products and harm our business.
 
 
Because of our substantial indebtedness, we may be unable to adjust our strategy to meet changing conditions in the future.
 
As of December 31, 2008, we had long-term obligations of approximately $756.5 million of which $510.0 million represents convertible debt. Subsequent to December 31, 2008, we repurchased approximately $106.2 million of convertible subordinated debt. During the year ended December 31, 2008, we made interest and principal payments of $35.0 million on our indebtedness. Our substantial debt will have several important consequences for our future operations. For instance:
 
  •  payments of interest on, and principal of, our indebtedness will be substantial and may exceed then current income and available cash;


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  •  we may be unable to obtain additional future financing for continued clinical trials, capital expenditures, acquisitions or general corporate purposes;
 
  •  we may be unable to withstand changing competitive pressures, economic conditions and governmental regulations; and
 
  •  we may be unable to make acquisitions or otherwise take advantage of significant business opportunities that may arise.
 
We may not have adequate resources available to repay our convertible subordinated debt when it becomes due.
 
As of December 31, 2008, we had $510.0 million in convertible subordinated debt outstanding, with $280.0 million and $230.0 million due in 2011 and 2012, respectively. This debt is convertible into our common stock at a conversion price of approximately $15.55 and $17.78 per share, respectively. In February 2009, we repurchased approximately $82.9 million of the 2011 debt and $23.3 million of the 2012 debt at a cost of approximately $50.0 million plus accrued interest. If our stock price does not exceed the applicable conversion price when the remaining debt matures, we may need to pay the note holders in cash or restructure some or all of the debt. Since it may be several years, if ever, before we are likely to receive continuing revenue from product sales or substantial royalty payments, we may not have enough cash, cash equivalents, short-term investments and marketable securities available to repay the remaining debt in 2011 and 2012.
 
To become a successful biopharmaceutical company, we are likely to need additional funding in the future. If we do not obtain this funding on acceptable terms, we may not be able to generate sufficient revenue to repay our convertible debt, to launch and market successfully our products and to continue our biopharmaceutical discovery and development efforts.
 
We continue to expend substantial funds on our research and development programs and human studies on current and future drug candidates. If our Phase 3 programs are successful, we will begin to expend significant funds to support pre-launch and commercial marketing activities. We may need additional financing to fund our operating expenses, including pre-commercial launch activities, marketing activities, research and development and capital requirements. In addition, even if our products are successful, if our stock price does not exceed the applicable conversion price when our remaining convertible debt matures, we may need to pay the note holders in cash or restructure some or all of the debt. If we are unable to restructure the debt, we may not have enough cash, cash equivalents, short-term investments and marketable securities available to repay the remaining debt. We may not be able to obtain additional financing on acceptable terms either to fund operating expenses or to repay the convertible debt. If we raise additional funds by issuing equity securities, equity-linked securities or debt securities, the new equity securities may dilute the interests of our existing stockholders and the new debt securities may contain restrictive financial covenants.
 
Our need for additional funding will depend on many factors, including, without limitation:
 
  •  the amount of revenue or cost sharing, if any, that we are able to obtain from our collaborations, any approved products, and the time and costs required to achieve those revenues;
 
  •  the timing, scope and results of preclinical studies and clinical trials;
 
  •  the size and complexity of our development programs;
 
  •  the time and costs involved in obtaining regulatory approvals;
 
  •  the costs of launching our products;
 
  •  the costs of commercializing our products, including marketing, promotional and sales costs;
 
  •  the commercial sources of our products;
 
  •  our stock price;
 
  •  our ability to establish and maintain collaboration partnerships;


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  •  competing technological and market developments;
 
  •  the costs involved in filing, prosecuting and enforcing patent claims; and
 
  •  scientific progress in our research and development programs.
 
If we are unable to raise additional funds, we may, among other things:
 
  •  delay, scale back or eliminate some or all of our research and development programs;
 
  •  delay, scale back or eliminate some or all of our commercialization activities;
 
  •  lose rights under existing licenses;
 
  •  relinquish more of, or all of, our rights to product candidates on less favorable terms than we would otherwise seek; and
 
  •  be unable to operate as a going concern.
 
Our short-term investments, marketable securities and restricted investments are subject to certain risks which could materially adversely affect our overall financial position.
 
We invest our cash in accordance with an established internal policy and customarily in instruments which historically have been highly liquid and carried relatively low risk. However, the capital and credit markets have been experiencing extreme volatility and disruption. In recent months, the volatility and disruption have reached unprecedented levels. We maintain a significant portfolio of investments in short-term investments, marketable debt securities and restricted investments, which are recorded at fair value. Certain of these transactions expose us to credit risk in the event of default of the issuer. To minimize our exposure to credit risk, we invest in securities with strong credit ratings and have established guidelines relative to diversification and maturity with the objective of maintaining safety of principal and liquidity. We do not invest in derivative financial instruments or auction rate securities, and we generally hold our investments in debt securities until maturity. In September 2008, Lehman Brothers Holdings, Inc. (“LBHI”) filed for bankruptcy and the debt securities issued by LBHI experienced a significant decline in market value, which caused an other-than-temporary impairment of our investment in LBHI. As a result, we recorded an impairment charge of $6.3 million during 2008. In recent months, certain financial instruments, including some of the securities in which we invest, have sustained downgrades in credit ratings and some high quality short term investment securities have suffered illiquidity or events of default. Further deterioration in the credit market may have a further adverse effect on the fair value of our investment portfolio. Should any of our short-term investments, marketable securities or restricted investments lose additional value or have their liquidity impaired, it could materially and adversely affect our overall financial position by imperiling our ability to fund our operations and forcing us to seek additional financing sooner than we would otherwise. Such financing may not be available on commercially attractive terms or at all.
 
Some of our operating leases contain financial covenants, which may require us to accelerate payment under those agreements or increase the amount of our security deposits.
 
Under the leases for some of our equipment and our process development and small-scale manufacturing facility, we must maintain minimum levels of unrestricted cash, cash equivalents, marketable securities and net worth. During 2007, we amended certain of these leases to eliminate the minimum net worth covenant and adjust the minimum levels of unrestricted cash, cash equivalents and marketable securities required under the leases. We also pledged additional collateral to another lessor to satisfy the minimum net worth covenant associated with certain other leases. With respect to the small-scale manufacturing facility lease, we increased the amount of our security deposits in 2007 by approximately $1.0 million, raising the level in 2007 to $15.0 million. Under certain circumstances pertaining to this facility lease, if we do not elect to purchase the facility, we could lose either a portion or all of our restricted investments and record a charge to earnings for such a loss.


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Our insurance policies are expensive and protect us only from some business risks, which could leave us exposed to significant, uninsured liabilities.
 
We do not carry insurance for all categories of risk that our business may encounter. We currently maintain general liability, property, auto, workers’ compensation, products liability, fiduciary and directors’ and officers’ insurance policies. We do not know, however, if we will be able to maintain existing insurance with adequate levels of coverage. For example, the premiums for our directors’ and officers’ insurance policy have increased in the past and may increase in the future, and this type of insurance may not be available on acceptable terms or at all in the future. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our cash position and results of operations.
 
 
If our patent applications do not result in issued patents or if patent laws or the interpretation of patent laws change, our competitors may be able to obtain rights to and commercialize our discoveries.
 
Our pending patent applications, including those covering full-length genes and their corresponding proteins, may not result in the issuance of any patents. Our applications may not be sufficient to meet the statutory requirements for patentability in all cases or may be subject to challenge, if they do issue. Important legal issues remain to be resolved as to the extent and scope of available patent protection for biotechnology products and processes in the U.S. and other important markets outside the U.S., such as Europe and Japan. In the U.S., Congress is considering significant changes to U.S. intellectual property laws which could affect the extent and scope of existing protections for biotechnology products and processes. Foreign markets may not provide the same level of patent protection as provided under the U.S. patent system. We expect that litigation or administrative proceedings will likely be necessary to determine the validity and scope of certain of our and others’ proprietary rights. We are currently involved in a number of litigation and administrative proceedings relating to the scope of protection of our patents and those of others in both the United States and in the rest of the world.
 
We are involved in a number of interference proceedings brought by the United States Patent and Trademark Office and may be involved in other interference proceedings in the future. These proceedings determine the priority of inventions and, thus, the right to a patent for technology in the U.S. For example, we are involved in interferences in the United States with both Genentech, Inc. and Immunex Corporation, a wholly-owned subsidiary of Amgen, Inc., related to products based on TRAIL Receptor 2 (such as HGS-ETR2). In three of these interferences, we have initiated district court litigation to review adverse decisions by the United States Patent and Trademark Office. In one of these cases, we are also seeking appellate review of a jurisdictional issue decided by the district court. Additional litigation related to these TRAIL Receptor 2 interferences is likely.
 
We are also involved in proceedings in connection with foreign patent filings, including opposition and revocation proceedings and may be involved in other opposition proceedings in the future. For example, we are involved in European opposition proceedings against an issued patent of Biogen Idec. In this opposition, the European Patent Office (“EPO”) found the claims of Biogen Idec’s patent to be valid. The claims relate to a method of treating autoimmune diseases using an antibody to BLyS (such as LymphoStat-B). We and GSK have entered into a definitive license agreement with Biogen Idec that provides for an exclusive license to this European patent. This patent is still under appeal in Europe. We also are involved in an opposition proceeding brought by Eli Lilly and Company with respect to our European patent related to BLyS compositions, including antibodies. Recently, the Opposition Division of the EPO held our patent invalid. We expect to appeal this decision. In addition, Eli Lilly and Company instituted a revocation proceeding against our United Kingdom patent that corresponds to our BLyS European patent; in this proceeding the UK trial court found the patent invalid. We expect to appeal this decision.
 
We have also opposed European patents issued to Genentech, Inc. and Immunex Corporation related to products based on TRAIL Receptor 2, and Genentech, Inc. and Immunex Corporation have opposed our European patents related to products based on TRAIL Receptor 2. Genentech, Inc. also has opposed our Australian patent related to products based on TRAIL Receptor 2. In addition, Genentech, Inc. has opposed our European patent related to products based on TRAIL Receptor 1 (such as HGS-ETR1).
 
We cannot assure you that we will be successful in any of these proceedings. Moreover, any such litigation or proceeding may result in a significant commitment of resources in the future and could force us to do one or more of


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the following: cease selling or using any of our products that incorporate the challenged intellectual property, which would adversely affect our revenue; obtain a license from the holder of the intellectual property right alleged to have been infringed, which license may not be available on reasonable terms, if at all; and redesign our products to avoid infringing the intellectual property rights of third parties, which may be time-consuming or impossible to do. In addition, such litigation or proceeding may allow others to use our discoveries or develop or commercialize our products. Changes in, or different interpretations of, patent laws in the U.S. and other countries may result in patent laws that allow others to use our discoveries or develop and commercialize our products or prevent us from using or commercializing our discoveries and products. We cannot assure you that the patents we obtain or the unpatented technology we hold will afford us significant commercial protection.
 
If others file patent applications or obtain patents similar to ours, then the United States Patent and Trademark Office may deny our patent applications, or others may restrict the use of our discoveries.
 
We are aware that others, including universities and companies working in the biotechnology and pharmaceutical fields, have filed patent applications and have been granted patents in the U.S. and in other countries that cover subject matter potentially useful or necessary to our business. Some of these patents and patent applications claim only specific products or methods of making products, while others claim more general processes or techniques useful in the discovery and manufacture of a variety of products. The risk of third parties obtaining additional patents and filing patent applications will continue to increase as the biotechnology industry expands. We cannot predict the ultimate scope and validity of existing patents and patents that may be granted to third parties, nor can we predict the extent to which we may wish or be required to obtain licenses to such patents, or the availability and cost of acquiring such licenses. To the extent that licenses are required, the owners of the patents could bring legal actions against us to claim damages or to stop our manufacturing and marketing of the affected products. We believe that there will continue to be significant litigation in our industry regarding patent and other intellectual property rights. If we become involved in litigation, it could consume a substantial portion of our resources.
 
Because issued patents may not fully protect our discoveries, our competitors may be able to commercialize products similar to those covered by our issued patents.
 
Issued patents may not provide commercially meaningful protection against competitors and may not provide us with competitive advantages. Other parties may challenge our patents or design around our issued patents or develop products providing effects similar to our products. In addition, others may discover uses for genes, proteins or antibodies other than those uses covered in our patents, and these other uses may be separately patentable. The holder of a patent covering the use of a gene, protein or antibody for which we have a patent claim could exclude us from selling a product for a use covered by its patent.
 
We rely on our collaboration partners to seek patent protection for the products they develop based on our research.
 
A significant portion of our future revenue may be derived from royalty payments from our collaboration partners. These partners face the same patent protection issues that we and other biotechnology or pharmaceutical firms face. As a result, we cannot assure you that any product developed by our collaboration partners will be patentable, and therefore, revenue from any such product may be limited, which would reduce the amount of any royalty payments. We also rely on our collaboration partners to effectively prosecute their patent applications. Their failure to obtain or protect necessary patents could also result in a loss of royalty revenue to us.
 
If we are unable to protect our trade secrets, others may be able to use our secrets to compete more effectively.
 
We may not be able to meaningfully protect our trade secrets. We rely on trade secret protection to protect our confidential and proprietary information. We believe we have acquired or developed proprietary procedures and materials for the production of proteins and antibodies. We have not sought patent protection for these procedures. While we have entered into confidentiality agreements with employees and collaborators, we may not be able to prevent their disclosure of these data or materials. Others may independently develop substantially equivalent information and processes.


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Because we are subject to extensive changing government regulatory requirements, we may be unable to obtain government approval of our products in a timely manner.
 
Regulations in the U.S. and other countries have a significant impact on our research, product development and manufacturing activities and will be a significant factor in the marketing of our products. All of our products require regulatory approval prior to commercialization. In particular, our products are subject to rigorous preclinical and clinical testing and other premarket approval requirements by the FDA and similar regulatory authorities in other countries, such as Europe and Japan. Various statutes and regulations also govern or influence the manufacturing, safety, labeling, storage, record keeping and marketing of our products. The lengthy process of seeking these approvals, and the subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by us to obtain, or any delay in obtaining, regulatory approvals could materially adversely affect our ability to commercialize our products in a timely manner, or at all.
 
Marketing Approvals.  Before a product can be marketed and sold in the U.S., the results of the preclinical and clinical testing must be submitted to the FDA for approval. This submission will be either a new drug application or a biologics license application, depending on the type of drug. In responding to a new drug application or a biologics license application, the FDA may grant marketing approval, request additional information or deny the application if it determines that the application does not provide an adequate basis for approval. We cannot assure you that any approval required by the FDA will be obtained on a timely basis, or at all.
 
In addition, the FDA may condition marketing approval on the conduct of specific post-marketing studies to further evaluate safety and efficacy. Rigorous and extensive FDA regulation of pharmaceutical products continues after approval, particularly with respect to compliance with current good manufacturing practices, or cGMPs, reporting of adverse effects, advertising, promotion and marketing. Discovery of previously unknown problems or failure to comply with the applicable regulatory requirements may result in restrictions on the marketing of a product or withdrawal of the product from the market as well as possible civil or criminal sanctions, any of which could materially adversely affect our business.
 
Foreign Regulation.  We must obtain regulatory approval by governmental agencies in other countries prior to commercialization of our products in those countries. Foreign regulatory systems may be just as rigorous, costly and uncertain as in the U.S.
 
Because we are subject to environmental, health and safety laws, we may be unable to conduct our business in the most advantageous manner.
 
We are subject to various laws and regulations relating to safe working conditions, laboratory and manufacturing practices, the experimental use of animals, emissions and wastewater discharges, and the use and disposal of hazardous or potentially hazardous substances used in connection with our research, including radioactive compounds and infectious disease agents. We also cannot accurately predict the extent of regulations that might result from any future legislative or administrative action. Any of these laws or regulations could cause us to incur additional expense or restrict our operations.
 
OTHER RISKS RELATED TO OUR BUSINESS
 
Many of our competitors have substantially greater capabilities and resources and may be able to develop and commercialize products before we do.
 
We face intense competition from a wide range of pharmaceutical and biotechnology companies, as well as academic and research institutions and government agencies.
 
Principal competitive factors in our industry include:
 
  •  the quality and breadth of an organization’s technology;
 
  •  the skill of an organization’s employees and ability to recruit and retain skilled employees;


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  •  an organization’s intellectual property portfolio;
 
  •  the range of capabilities, from target identification and validation to drug discovery and development to manufacturing and marketing; and
 
  •  the availability of substantial capital resources to fund discovery, development and commercialization activities.
 
Many large pharmaceutical and biotechnology companies have significantly larger intellectual property estates than we do, more substantial capital resources than we have, and greater capabilities and experience than we do in preclinical and clinical development, sales, marketing, manufacturing and regulatory affairs.
 
We are aware of existing products and products in research or development by our competitors that address the diseases we are targeting. Any of these products may compete with our product candidates. Our competitors may succeed in developing their products before we do, obtaining approvals from the FDA or other regulatory agencies for their products more rapidly than we do, or developing products that are more effective than our products. These products or technologies might render our technology or drugs under development obsolete or noncompetitive. In addition, our albumin fusion protein product is designed to be longer-acting versions of existing products. The existing product in many cases has an established market that may make the introduction of our product more difficult.
 
If we lose or are unable to attract key management or other personnel, we may experience delays in product development.
 
We depend on our senior executive officers as well as other key personnel. If any key employee decides to terminate his or her employment with us, this termination could delay the commercialization of our products or prevent us from becoming profitable. Competition for qualified employees is intense among pharmaceutical and biotechnology companies, and the loss of qualified employees, or an inability to attract, retain and motivate additional highly skilled employees required for the expansion of our activities, could hinder our ability to complete human studies successfully and develop marketable products.
 
If the health care system or reimbursement policies change, the prices of our potential products may be lower than expected and our potential sales may decline.
 
The levels of revenues and profitability of biopharmaceutical companies like ours may be affected by the continuing efforts of government and third party payers to contain or reduce the costs of health care through various means. For example, in certain foreign markets, pricing or profitability of therapeutic and other pharmaceutical products is subject to governmental control. In the U.S., there have been, and we expect that there will continue to be, a number of federal and state proposals to implement similar governmental control. In addition, in the U.S., a number of proposals have been made to reduce the regulatory burden of follow-on biologics, which could affect the prices and sales of our products in the future. Additional proposals may occur as a result of a change in the presidential administration in January 2009. While we cannot predict whether any legislative or regulatory proposals will be adopted, the adoption of such proposals could have a material adverse effect on our business, financial condition and profitability. In addition, in the U.S. and elsewhere, sales of therapeutic and other pharmaceutical products depend in part on the availability of reimbursement to the consumer from third party payers, such as government and private insurance plans. Third party payers are increasingly challenging the prices charged for medical products and services. We cannot assure you that any of our products will be considered cost effective or that reimbursement to the consumer will be available or will be sufficient to allow us to sell our products on a competitive and profitable basis.
 
We may be unable to successfully establish a manufacturing capability and may be unable to obtain required quantities of our Phase 3 and earlier development molecules economically.
 
We have not yet manufactured any products approved for commercial use and have limited experience in manufacturing materials suitable for commercial use. We have only limited experience manufacturing in a large-scale manufacturing facility built to increase our capacity for protein and antibody drug production. The FDA must inspect and license our facilities to determine compliance with cGMP requirements for commercial production. We


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may not be able to successfully establish sufficient manufacturing capabilities or manufacture our products economically or in compliance with cGMPs and other regulatory requirements.
 
While we have expanded our manufacturing capabilities, we have previously contracted and may in the future contract with third party manufacturers or develop products with collaboration partners and use the collaboration partners’ manufacturing capabilities. If we use others to manufacture our products, we will depend on those parties to comply with cGMPs, and other regulatory requirements and to deliver materials on a timely basis. These parties may not perform adequately. Any failures by these third parties may delay our development of products or the submission of these products for regulatory approval.
 
We may be unable to fulfill the terms of our agreement with Hospira, Inc. and other agreements, if any, with potential customers for manufacturing process development and supply of selected biopharmaceutical products.
 
We have entered into an agreement with Hospira, Inc. (“Hospira”) for manufacturing process development and commercial supply of selected biopharmaceutical products, and may enter into similar agreements with other potential customers. We may not be able to successfully manufacture products under the agreement with Hospira or under other agreements, if any. We have not yet manufactured any products approved for commercial use and have limited experience in manufacturing materials suitable for commercial use. We have limited experience manufacturing in a large-scale manufacturing facility built to increase our capacity for protein and antibody drug production. The FDA must inspect and license our facilities to determine compliance with cGMP requirements for commercial production. We may not be able to enter into additional agreements with other customers. Hospira or any future customer may decide to discontinue the products contemplated under the agreements, and therefore we may not receive revenue from these agreements.
 
Because we currently have only a limited marketing capability, we may be unable to sell any of our products effectively.
 
We do not have any marketed products, although we have sold ABthrax to the U.S. Government. If we develop products that can be marketed, we intend to market the products either independently or together with collaborators or strategic partners. GSK, Novartis and others have co-marketing rights with respect to certain of our products. If we decide to market any products, either independently or together with partners, we will incur significant additional expenditures and commit significant additional management resources to establish a sales force. For any products that we market together with partners, we will rely, in whole or in part, on the marketing capabilities of those parties. We may also contract with third parties to market certain of our products. Ultimately, we and our partners may not be successful in marketing our products.
 
Because we depend on third parties to conduct many of our human studies, we may encounter delays in or lose some control over our efforts to develop products.
 
We are dependent on third-party research organizations to conduct most of our human studies. We have engaged contract research organizations to manage our global Phase 3 studies. If we are unable to obtain any necessary services on acceptable terms, we may not complete our product development efforts in a timely manner. If we rely on third parties for the management of these human studies, we may lose some control over these activities and become too dependent upon these parties. These third parties may not complete the activities on schedule.
 
Our certificate of incorporation and bylaws could discourage acquisition proposals, delay a change in control or prevent transactions that are in your best interests.
 
Provisions of our certificate of incorporation and bylaws, as well as Section 203 of the Delaware General Corporation Law, may discourage, delay or prevent a change in control of our company that you as a stockholder may consider favorable and may be in your best interest. Our certificate of incorporation and bylaws contain provisions that:
 
  •  authorize the issuance of up to 20,000,000 shares of “blank check” preferred stock that could be issued by our board of directors to increase the number of outstanding shares and discourage a takeover attempt;
 
  •  limit who may call special meetings of stockholders; and


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  •  establish advance notice requirements for nomination of candidates for election to the board of directors or for proposing matters that can be acted upon by stockholders at stockholder meetings.
 
Because our stock price has been and will likely continue to be volatile, the market price of our common stock may be lower or more volatile than you expected.
 
Our stock price, like the stock prices of many other biotechnology companies, has been highly volatile. For the twelve months ended December 31, 2008, the closing price of our common stock has been as low as $1.24 per share and as high as $11.79 per share. The market price of our common stock could fluctuate widely because of:
 
  •  future announcements about our company or our competitors, including the results of testing, technological innovations or new commercial products;
 
  •  negative regulatory actions with respect to our potential products or regulatory approvals with respect to our competitors’ products;
 
  •  changes in government regulations;
 
  •  developments in our relationships with our collaboration partners;
 
  •  developments affecting our collaboration partners;
 
  •  announcements relating to health care reform and reimbursement levels for new drugs;
 
  •  our failure to acquire or maintain proprietary rights to the gene sequences we discover or the products we develop;
 
  •  litigation; and
 
  •  public concern as to the safety of our products.
 
The stock market has experienced price and volume fluctuations that have particularly affected the market price for many emerging and biotechnology companies. These fluctuations have often been unrelated to the operating performance of these companies. These broad market fluctuations may cause the market price of our common stock to be lower or more volatile than you expected.


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ITEM 1B.   UNRESOLVED STAFF COMMENTS
 
None.
 
ITEM 2.   PROPERTIES
 
We currently lease and occupy approximately 900,000 square feet of laboratory, manufacturing and office space in Rockville, Maryland. Our space includes approximately 200,000 square feet of laboratory space, approximately 400,000 square feet of manufacturing and manufacturing support space and approximately 300,000 square feet of office space. In addition, we have subleased a portion of our headquarters facility.
 
In 2006, we placed a 291,000-square-foot large-scale manufacturing facility into operational service. This manufacturing facility is enabling us to produce larger quantities of our antibody drugs for both clinical development as well as later for commercial sale.
 
We anticipate that existing commercial real estate or the available land located at our laboratory and office campus will enable us to continue to expand our operations in close proximity to one another. We believe that our properties are generally in good condition, well maintained, suitable and adequate to carry on our business.
 
ITEM 3.   LEGAL PROCEEDINGS
 
We are party to various claims and legal proceedings from time to time. We are not aware of any legal proceedings that we believe could have, individually or in the aggregate, a material adverse effect on our results of operations, financial condition or liquidity.
 
ITEM 4.   SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
 
No matters were submitted to a vote of our security holders during the fourth quarter of the fiscal year ended December 31, 2008.


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ITEM 5.   MARKET FOR REGISTRANT’S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
 
Our common stock is traded on the NASDAQ Global Market under the symbol HGSI. The following table presents the quarterly high and low closing prices as quoted by NASDAQ.
 
                 
    High     Low  
 
2007
               
First Quarter
  $ 12.52     $ 10.25  
Second Quarter
  $ 11.51     $ 8.92  
Third Quarter
  $ 10.39     $ 7.06  
Fourth Quarter
  $ 11.10     $ 9.12  
2008
               
First Quarter
  $ 11.79     $ 4.86  
Second Quarter
  $ 6.79     $ 5.21  
Third Quarter
  $ 7.94     $ 5.17  
Fourth Quarter
  $ 6.06     $ 1.24  
 
As of January 31, 2009, there were approximately 676 holders of record of our common stock. We have never declared or paid any cash dividends. We do not anticipate declaring or paying cash dividends for the foreseeable future, in part because existing contractual agreements prohibit such dividends. Instead, we will retain our earnings, if any, for the future operation and expansion of our business.
 
The following graph compares the performance of our Common Stock for the periods indicated with the performance of the NASDAQ U.S. Stock Market Total Return Index (the “TRI”) and the NASDAQ Pharmaceutical Index (the “NPI”). The comparison assumes $100 was invested on December 31, 2003 in our Common Stock and in each of the foregoing indices and assumes the reinvestment of dividends, if any.
 
Comparison of 5 Year Cumulative Total Return
 
(PERFORMANCE GRAPH)
 
The performance graph and related information shall not be deemed “soliciting material” or be “filed” with the Securities and Exchange Commission, nor shall such information be incorporated by reference into any future filing under the Securities Act or the Exchange Act, except to the extent that the Company specifically incorporates it by reference into such filing.


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ITEM 6.   SELECTED CONSOLIDATED FINANCIAL DATA
 
We present below our selected consolidated financial data for the years ended December 31, 2008, 2007 and 2006, and as of December 31, 2008 and 2007, which have been derived from the audited consolidated financial statements included elsewhere herein and should be read in conjunction with such consolidated financial statements and the accompanying notes. We present below our selected financial data for the years ended December 31, 2005 and 2004, and as of December 31, 2006, 2005 and 2004, which have been derived from audited financial statements not included herein. The results of operations of prior periods are not necessarily indicative of results that may be expected for any other period. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Business.”
 
                                         
    Years Ended December 31,  
    2008     2007     2006     2005     2004  
    (In thousands, except per share and ratio data)  
 
Statement of Operations Data:
                                       
Revenue — research and development contracts
  $ 48,422     $ 41,851     $ 25,755     $ 19,113     $ 3,831  
                                         
Costs and expenses:
                                       
Research and development
    242,710       245,745       209,242       228,717       219,549  
General and administrative
    60,865       55,874       53,101       42,066       35,728  
Lease termination and restructuring charges (credits)
          (3,673 )     29,510             15,408  
                                         
Total costs and expenses
    303,575       297,946       291,853       270,783       270,685  
                                         
Income (loss) from operations
    (255,153 )     (256,095 )     (266,098 )     (251,670 )     (266,854 )
Investment income
    23,487       32,988       27,131       24,218       40,298  
Interest expense
    (39,483 )     (39,341 )     (26,965 )     (12,085 )     (19,030 )
Charge for impaired investments
    (6,284 )                        
Gain on sale of long-term equity investments
    32,518             14,759       1,302       255  
Gain (loss) on extinguishment of debt
                      (1,204 )     2,433  
                                         
Income (loss) before taxes
    (244,915 )     (262,448 )     (251,173 )     (239,439 )     (242,898 )
Provision for income taxes
                             
                                         
Net income (loss)
  $ (244,915 )   $ (262,448 )   $ (251,173 )   $ (239,439 )   $ (242,898 )
                                         
Net income (loss) per share, basic and diluted
  $ (1.81 )   $ (1.95 )   $ (1.91 )   $ (1.83 )   $ (1.87 )
Other Data:
                                       
Ratio of earnings to fixed charges
                             
Coverage deficiency
  $ (244,915 )   $ (262,448 )   $ (251,173 )   $ (239,439 )   $ (242,898 )
 


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ITEM 6.   SELECTED CONSOLIDATED FINANCIAL DATA, CONTINUED
 
                                         
    As of December 31,  
    2008     2007     2006     2005     2004  
    (In thousands)  
 
Balance Sheet Data:
                                       
Cash, cash equivalents, short-term investments, marketable securities and restricted investments(1)
  $ 372,939     $ 603,840     $ 763,084     $ 646,220     $ 952,686  
Total assets(2)
    674,164       949,105       1,149,668       997,046       1,249,385  
Total debt and lease financing, less current portion(2)
    756,477       754,099       751,526       510,000       505,131  
Accumulated deficit
    (2,127,744 )     (1,882,829 )     (1,620,381 )     (1,369,208 )     (1,129,769 )
Total stockholders’ equity (deficit)
    (241,375 )     (11,902 )     213,923       416,966       656,047  
 
 
(1) “Cash, cash equivalents, short-term investments, marketable securities and restricted investments” for 2008, 2007, 2006, 2005 and 2004 includes $69,360, $70,931, $61,165, $220,171 and $215,236 respectively, of restricted investments relating to certain leases.
 
(2) “Total assets” for 2008, 2007, 2006, 2005 and 2004 includes $69,360, $70,931, $61,165, $220,171 and $215,236 respectively, of restricted investments relating to certain leases. “Total debt and lease financing, less current portion” for 2008, 2007, 2006, 2005 and 2004 does not include any operating lease obligations under various facility and equipment lease arrangements. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations — Liquidity and Capital Resources” for additional discussion.

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ITEM 7.   MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
 
Human Genome Sciences, Inc. (“HGS”) is a commercially focused biopharmaceutical company advancing toward the market with three products in late-stage clinical development: Albuferon® for chronic hepatitis C, LymphoStat-B® for systemic lupus erythematosus (“SLE”), and ABthraxtm for inhalation anthrax. In January 2009, we achieved our first product sales when we began delivery of ABthrax to the U.S. Strategic National Stockpile.
 
Albuferon and LymphoStat-B are also progressing toward commercialization. In December 2008, we reported that Albuferon successfully met its primary endpoint in the first of two Phase 3 clinical trials in chronic hepatitis C; we expect to report results of the second Phase 3 trial in March 2009. If results in the second Phase 3 trial are also successful, we expect the filing of global marketing applications for Albuferon in fall 2009. We completed enrollment in both Phase 3 trials of LymphoStat-B in SLE in 2008, and we expect to report the results of these studies in July and November 2009, respectively. Assuming success in Phase 3, we plan to file global marketing applications for LymphoStat-B in the first half of 2010.
 
We also have substantial financial rights to two novel drugs that GlaxoSmithKline (“GSK”) has advanced to late-stage development. In December 2008, GSK initiated the first Phase 3 clinical trial of darapladib, which was discovered by GSK based on HGS technology, in more than 15,000 men and women with chronic coronary heart disease. GSK plans to initiate a second large Phase 3 trial of darapladib in late 2009. In February 2009, GSK initiated a Phase 3 clinical trial program for Syncria® (albiglutide) in the long-term treatment of type 2 diabetes mellitus. Syncria was created by HGS using our proprietary albumin-fusion technology, and we licensed Syncria to GSK in 2004.
 
HGS also has several novel drugs in earlier stages of clinical development for the treatment of cancer, led by our TRAIL receptor antibody HGS-ETR1 and a small-molecule antagonist of IAP (inhibitor of apoptosis) proteins.
 
Our strategic partnerships with leading pharmaceutical and biotechnology companies allow us to leverage our strengths and gain access to sales and marketing infrastructure, as well as complementary technologies. Some of these partnerships provide us with licensing or other fees, clinical development cost-sharing, milestone payments and rights to royalty payments as products are developed and commercialized. In some cases, we are entitled to certain commercialization, co-promotion, revenue-sharing and other product rights.
 
We have not received any significant product sales revenue or royalties from product sales through 2008 and any significant revenue from product sales or from royalties on product sales in the next several years is uncertain, other than with respect to ABthrax. To date, substantially all of our revenue relates to payments received under our collaboration and license agreements.
 
During 2006, we entered into a collaboration agreement with Novartis International Pharmaceutical, Ltd. (“Novartis”). Under this agreement, Novartis will co-develop and co-commercialize Albuferon and share development costs, sales and marketing expenses and profits of any product that is commercialized in the U.S. Novartis will be responsible for commercialization outside the U.S. and will pay HGS a royalty on these sales. We received a $45.0 million up-front fee from Novartis upon the execution of the agreement and are recognizing this payment as revenue ratably over the estimated development period ending in 2010. Including this up-front fee, we are entitled to payments aggregating $507.5 million upon the successful attainment of certain milestones. As of December 31, 2008, we have contractually earned and received payments aggregating $132.5 million. We are recognizing these milestones as revenue ratably over the estimated remaining development period.
 
In 2005, GSK exercised its option to co-develop and co-commercialize two of our products, LymphoStat-B and HGS-ETR1. In accordance with a co-development and co-commercialization agreement signed during 2006 related to LymphoStat-B, we and GSK will share Phase 3 and 4 development costs, and will share equally in sales and marketing expenses and profits of any product that is commercialized. We received a $24.0 million payment during 2006 as partial consideration for entering into this agreement with respect to LymphoStat-B and are recognizing this payment as revenue ratably over the estimated development period ending in 2010. During 2008, we reacquired GSK’s rights to TRAIL receptor antibodies (including rights to HGS-ETR1 and HGS-ETR2) from


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Overview (continued)
 
GSK, in exchange for a reduction in potential future royalties due to us for a product currently being developed by GSK.
 
In 2005, we entered into a two-phase contract to supply ABthrax, a human monoclonal antibody developed for use in the treatment of anthrax disease, with the U.S. Government. Under the first phase of the contract, we supplied ten grams of ABthrax to the U.S. Department of Health and Human Services (“HHS”) for comparative in vitro and in vivo testing. During 2006, under the second phase of the contract, the U.S. Government exercised its option to purchase 20,001 treatment courses of ABthrax for the Strategic National Stockpile. In January 2009 we began delivery of ABthrax to the U.S. Strategic National Stockpile and in February 2009 the product was accepted and we recorded revenue for the product as well as certain costs incurred to develop ABthrax.
 
We expect that any significant revenue or income for at least the next two years may be limited to ABthrax revenue, payments under collaboration agreements (to the extent milestones are met), cost reimbursements from GSK and Novartis, payments from the sale of product rights, payments under manufacturing agreements, such as our agreement with Hospira, Inc., investment income and other payments from other collaborators and licensees under existing or future arrangements, to the extent that we enter into any future arrangements. We expect to continue to incur substantial expenses relating to our research and development efforts. As a result, we expect to incur continued and significant losses over the next several years unless we are able to realize additional revenues under existing or any future agreements. The timing and amounts of such revenues, if any, cannot be predicted with certainty and will likely fluctuate sharply. Results of operations for any period may be unrelated to the results of operations for any other period. In addition, historical results should not be viewed as indicative of future operating results.
 
Critical Accounting Policies and the Use of Estimates
 
A “critical accounting policy” is one that is both important to the portrayal of our financial condition and results of operations and that requires management’s most difficult, subjective or complex judgments. Such judgments are often the result of a need to make estimates about the effect of matters that are inherently uncertain. The preparation of our financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates. See Note B, Summary of Significant Accounting Policies, of the Notes to the Consolidated Financial Statements for further discussion.
 
We currently believe the following accounting policies to be critical:
 
Investments.  We account for investments in accordance with Statement of Financial Accounting Standards (“SFAS”) No. 115, Accounting for Certain Investments in Debt and Equity Securities. We carry our investments at their respective fair values, except for our investment in Aegera Pharmaceuticals, Inc. (“Aegera”), which is carried at historical cost because it is a privately held company for which no quoted market price is available. We periodically evaluate the fair values of our investments to determine whether any declines in the fair value of investments represent an other-than-temporary impairment. This evaluation consists of a review of several factors, including but not limited to the length of time and extent that a security has been in an unrealized loss position, the existence of an event that would impair the issuer’s future repayment potential, the near term prospects for recovery of the market value of a security and our intent and ability to hold the security until the market values recover, which may be maturity. If management determines that such an impairment exists we would recognize an impairment charge. Because we may determine that market or business conditions may lead us to sell a short-term investment or marketable security prior to maturity, we classify our short-term investments and marketable securities as “available-for-sale.” Investments in securities that are classified as available-for-sale and have readily determinable fair values are measured at fair market value in the balance sheets, and unrealized holding gains and losses for these investments are reported as a separate component of stockholders’ equity until realized, or an other-than-temporary impairment is recorded. We classify those marketable securities that may be used in operations within one year as short-term investments. Those marketable securities in which we have both the ability to hold until maturity and


34


 

Critical Accounting Policies and the Use of Estimates (continued)
 
have a maturity date beyond one year from our most recent consolidated balance sheet date are classified as non-current marketable securities. We review the carrying value of the Aegera investment on a periodic basis for indicators of impairment, and adjust the value accordingly.
 
For investments carried at fair value, we disclose the level within the fair value hierarchy as prescribed by SFAS No. 157, Fair Value Measurements (“SFAS No. 157”). We evaluate the types of securities in our investment portfolios to determine the proper classification in the fair value hierarchy based on trading activity and the observability of market inputs. We generally obtain a single quote or price per instrument from independent third parties to help us determine the fair value of securities in Level 1 and Level 2 of the fair value hierarchy.
 
Leases.  We lease various real properties under operating leases that generally require us to pay taxes, insurance and maintenance. During 2006, we terminated one lease agreement (the “Traville lease”) with Wachovia Development Corporation (“WDC”), which had been structured as a synthetic lease and had been accounted for as an operating lease. In place of the Traville synthetic lease, we entered into a 20-year lease agreement with BioMed Realty Trust, Inc. (“BioMed”), which acquired the Traville facility from WDC. We account for the Traville lease with BioMed as an operating lease.
 
During 2006 and as described further in Note I, Long-Term Debt, of the Notes to the Consolidated Financial Statements, we sold our LSM facility and headquarters land to BioMed, and simultaneously agreed to lease such assets back over a period of 20 years. We accounted for this transaction in accordance with SFAS No. 98, Accounting For Leases: Sale-Leaseback Transactions Involving Real Estate. Because we have continuing involvement with the properties and an option to repurchase such assets, we recorded the sale and leaseback of these assets as a financing transaction and accordingly recorded the allocated sale proceeds as outstanding debt on our balance sheet. We account for lease payments under the related lease agreements as principal and interest payments on this debt. We retained ownership of approximately $36.5 million in equipment located at the LSM, which is required to be kept in place during the lease term or upon any expiration, termination or default.
 
Impairments of long-lived assets.  Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets might not be recoverable. Conditions that would necessitate an impairment assessment include a significant decline in the observable market value of an asset, a significant change in the extent or manner in which an asset is used, or a significant adverse change that would indicate that the carrying amount of an asset or group of assets is not recoverable. Determination of recoverability is based on an estimate of undiscounted cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount the assets, the assets are written down to their estimated fair values. Long-lived assets to be sold are carried at fair value less costs to sell. During 2006, we recorded exit and impairment charges of approximately $9.2 million and $3.5 million relating to certain space in our Traville headquarters and certain laboratory space, respectively. During 2007, we sold the laboratory space and reversed the remaining exit and impairment charges related to that space.
 
Revenue.  Our revenue recognition policies for all non-refundable up-front license fees and milestone arrangements are in accordance with the guidance provided in the Securities and Exchange Commission’s Staff Accounting Bulletin (“SAB”) No. 101, Revenue Recognition in Financial Statements, as amended by SAB No. 104, Revenue Recognition (“SAB No. 104”). In addition, we follow the provisions of Emerging Issues Task Force (“EITF”) Issue 00-21 (“EITF 00-21”), Revenue Arrangements with Multiple Deliverables, for multiple element revenue arrangements entered into or materially amended after June 30, 2003. EITF 00-21 provides guidance on when an arrangement that involves multiple revenue-generating activities or deliverables should be divided into separate units of accounting for revenue recognition purposes, and if this division is required, how the arrangement consideration should be allocated among the separate units of accounting. If the deliverables in a revenue arrangement constitute separate units of accounting according to the EITF’s separation criteria, the revenue recognition policy must be determined for each identified unit. If the arrangement is a single unit of accounting, the revenue recognition policy must be determined for the entire arrangement. Under arrangements where the license fees and research and development activities cannot be accounted for as separate units of accounting, non-refundable up-front license fees are deferred and recognized as revenue on a straight-line basis over the expected


35


 

Critical Accounting Policies and the Use of Estimates (continued)
 
term of our continued involvement in the research and development process. Revenues from the achievement of research and development milestones, if deemed substantive, are recognized as revenue when the milestones are achieved, and the milestone payments are due and collectible. If not deemed substantive, we would recognize such milestone as revenue on a straight-line basis over the remaining expected term of continued involvement in the research and development process. Milestones are considered substantive if all of the following conditions are met: (1) the milestone is non-refundable; (2) achievement of the milestone was not reasonably assured at the inception of the arrangement; (3) substantive effort is involved to achieve the milestone; and, (4) the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement and the related risk associated with the achievement of the milestone and any ongoing research and development or other services are priced at fair value. Payments received in advance of work performed are recorded as deferred revenue.
 
The up-front license fee received in 2006 from Novartis in connection with our Albuferon product is being recognized ratably over an estimated four-year clinical development period ending in 2010. To the extent we achieve the clinical development milestones set forth in the Novartis agreement, these will be recognized ratably over the remaining estimated clinical development period from the date of attainment. Our initial payment from GSK in connection with LymphoStat-B is being recognized ratably over the estimated four-year clinical development period ending in 2010. Our up-front license fee with GSK in connection with Syncria® is being recognized ratably over the estimated seven-year clinical development period. Our revenues from Teva Biopharmaceuticals USA, Inc. (“Teva Bio”), formerly CoGenesys, as they relate to the intellectual property license, are being recognized on a straight-line basis over the three-year period covered by the manufacturing services agreement, as amended. Our other revenues in 2008, 2007 and 2006 have been recognized in full upon receipt, as we have no continuing obligation.
 
During 2008, we entered into an agreement whereby we began providing contract manufacturing services. Revenue in 2008, which was not significant, was recorded as milestones were met.
 
Research and Development.  Research and development expenses primarily include related salaries, outside services, materials and supplies and allocated facility costs. Such costs are charged to research and development expense as incurred. Our drug development expenses include accruals for clinical site and clinical research organization (“CRO”) costs. Estimates of the incurred to date but not yet received invoices must be made for clinical site and CRO costs in determining the accrued balance in any accounting period. Reimbursement of research and development expenses received in connection with collaborative cost-sharing agreements is recorded as a reduction of such expenses.
 
Stock Compensation.  We have a stock incentive plan (the “Incentive Plan”) under which options to purchase shares of our common stock may be granted to employees, consultants and directors at a price no less than the quoted market value on the date of grant. The Incentive Plan also provides for awards in the form of stock appreciation rights, restricted (non-vested) or unrestricted stock awards, stock-equivalent units or performance-based stock awards.
 
We account for share-based awards to employees and non-employee directors pursuant to SFAS No. 123(R), Share-Based Payment (“SFAS No. 123(R)”).
 
The amount of compensation expense recognized using the fair value method requires us to exercise judgment and make assumptions relating to the factors that determine the fair value of our stock option grants. We use the Black-Scholes-Merton model to estimate the fair value of our option grants. The fair value calculated by this model is a function of several factors, including grant price, the risk-free interest rate, the estimated term of the option and the estimated future volatility of the option. The estimated term and estimated future volatility of the options require our judgment.
 
Exit Accruals.  In 2006, we exited certain facilities, which required us to make significant estimates in several areas including the realizable values of assets deemed redundant or excess and the ability to generate sublease income. We recorded an initial liability of approximately $9.0 million in lease-related costs with respect to our 2006 exit activities. During 2007, we sold one of the facilities that we exited in 2006 and reversed the remaining exit and impairment accrual of $2.0 million related to that space.


36


 

Results of Operations
 
Years Ended December 31, 2008 and 2007
 
Revenues.  We had revenues of $48.4 million and $41.9 million for the years ended December 31, 2008 and 2007, respectively. Revenues for the year ended December 31, 2008 consisted primarily of revenue recognized from Novartis of $35.4 million for the straight-line recognition of up-front license fees and milestones reached for Albuferon and $6.5 million from GSK related to straight-line recognition of up-front license fees for LymphoStat-B.
 
The 2007 revenues consisted primarily of $28.0 million in revenue recognized from Novartis for the straight-line recognition of up-front license fees and milestones reached for Albuferon and $6.5 million from GSK related to straight-line recognition of up-front license fees for LymphoStat-B.
 
Expenses.  Research and development expenses were $242.7 million for the year ended December 31, 2008 as compared to $245.7 million for the year ended December 31, 2007. Research and development expenses for 2007 include $16.9 million paid to Aegera in connection with a collaboration and license agreement. Our research and development expenses for the year ended December 31, 2008 are net of $36.1 million and $51.8 million of costs reimbursed by Novartis and GSK, respectively. Our research and development expenses for the year ended December 31, 2007 are net of $46.5 million and $39.3 million of costs reimbursed by Novartis and GSK respectively.
 
We track our research and development expenditures by type of cost incurred — research, pharmaceutical sciences, manufacturing and clinical development costs.
 
Our research costs amounted to $25.6 million for the year ended December 31, 2008 as compared to $34.0 million for the year ended December 31, 2007. This decrease is due to the $16.9 million paid to Aegera in 2007 in connection with our licensing and collaboration agreement and purchase price premium as compared to a $5.0 million milestone paid to Aegera in 2008, partially offset by an increase in activities supporting new target development. Our research costs for the years ended December 31, 2008 and 2007 are net of $2.4 million and $3.0 million, respectively, of cost reimbursement from Novartis and GSK under cost sharing provisions in our collaboration agreements.
 
Our pharmaceutical sciences costs, where we focus on improving formulation, process development and production methods, increased to $35.9 million for the year ended December 31, 2008 from $30.5 million for the year ended December 31, 2007. This increase is primarily due to less cost reimbursement under the Albuferon program and greater activity in other projects for which we have no cost sharing provisions. Pharmaceutical sciences costs for the years ended December 31, 2008 and 2007 are net of $1.2 million and $4.8 million, respectively, of cost reimbursement from Novartis and GSK under cost sharing provisions in our collaboration agreements.
 
Our manufacturing costs increased to $76.5 million for the year ended December 31, 2008 from $72.8 million for the year ended December 31, 2007. This increase is primarily due to increased production activities for ABthrax and LymphoStat-B, partially offset by decreased activities for HGS-ETR2 and Albuferon. Our manufacturing costs for the years ended December 31, 2008 and 2007 are net of $19.9 million and $15.1 million, respectively, of cost reimbursement from Novartis and GSK under cost sharing provisions in our collaboration agreements.
 
Our clinical development costs decreased to $104.7 million for the year ended December 31, 2008 from $108.5 million for the year ended December 31, 2007. This decrease is primarily due to reduced Phase 3 Albuferon clinical trial costs as the trials near completion, partially offset by increased Phase 3 trial costs related to LymphoStat-B. Our clinical development costs for the years ended December 31, 2008 and 2007 are net of $64.4 million and $62.9 million, respectively, of cost reimbursement from Novartis and GSK under cost sharing provisions in our collaboration agreements.
 
The research and development expenditures noted above are categorized by functional area. We evaluate and prioritize our activities according to functional area, rather than on a per-project basis. For this reason, we do not maintain a formal accounting system that captures or allocates all costs, both direct and indirect, on a per-project basis. Therefore, we do not believe that our available project-by-project information would form a reasonable basis for disclosure to investors.


37


 

Results of Operations (continued)
 
Years Ended December 31, 2008 and 2007 (continued)
 
General and administrative expenses increased to $60.9 million for the year ended December 31, 2008 from $55.9 million for the year ended December 31, 2007. This increase is primarily due to increased preparatory activities for commercialization. General and administrative expenses include approximately $2.2 million related to the settlement of certain patent proceedings, which were offset by a decrease in other legal expenses.
 
During 2008, we did not incur any lease termination or restructuring charges. Lease termination and restructuring credits in 2007 related to the reversal of a liability and the recording of a gain aggregating $3.7 million in connection with the purchase and sale of a small laboratory and office building. See Note N, Facility-Related Exit Costs, of the Notes to the Consolidated Financial Statements for additional discussion.
 
Investment income decreased to $23.5 million for the year ended December 31, 2008 from $33.0 million for the year ended December 31, 2007. The decrease is primarily due to lower average investment balances in 2008 as compared to 2007. Investment income also includes realized net gains on our short-term investments, marketable securities and restricted investments of $0.9 million for the year ended December 31, 2008 as compared to net gains of $0.1 million for the year ended December 31, 2007. The yield on our investments was approximately 4.6% for the year ended December 31, 2008, as compared to approximately 4.8% for the year ended December 31, 2007. We believe investment income will be lower in 2009 as a result of lower interest rates and lower average cash balances. A general decline in interest rates may adversely affect the interest earned from our portfolio as securities mature and may be replaced with securities having a lower interest rate.
 
Interest expense increased to $39.5 million for the year ended December 31, 2008 compared to $39.3 million for the year ended December 31, 2007. We expect interest expense to increase in 2009 as a result of the adoption of Financial Accounting Standards Board Staff Position No. APB 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement) (“FSP APB 14-1”). See Note B, Significant Accounting Policies, of the Notes to Consolidated Financial Statements for additional discussion.
 
The charge for impaired investments of $6.3 million during the year ended December 31, 2008 was due to an other-than-temporary impairment of our investment in debt securities issued by Lehman Brothers Holdings, Inc. (“LBHI”). During 2008, LBHI experienced a significant deterioration in its credit worthiness and filed a petition under Chapter 11 of the U.S. Bankruptcy Code. As a result, we determined that our investment in LBHI debt securities had incurred an other-than-temporary impairment. See Note C, Investments, of the Notes to the Consolidated Financial Statements for additional discussion.
 
Our gain on sale of long-term equity investments during the year ended December 31, 2008 of $32.5 million relates to the sale of our investment in CoGenesys. In 2006, we completed the sale of assets of our CoGenesys division and held a 14% equity interest in the newly formed company (“CoGenesys”). In 2008, CoGenesys was acquired by Teva Pharmaceuticals Industries, Ltd. (“Teva”). We received initial proceeds of $47.3 million. Our cost basis in this investment was $14.8 million. We received additional proceeds of approximately $5.3 million in February 2009 related to this transaction. See Note D, Collaboration Agreements and U.S. Government Agreement, of the Notes to the Consolidated Financial Statements for additional discussion.
 
Net Income (Loss).  We recorded a net loss of $244.9 million, or $1.81 per share, for the year ended December 31, 2008, compared to a net loss of $262.4 million, or $1.95 per share, for the year ended December 31, 2007. The decreased loss for 2008 compared to 2007 is primarily due to the gain on sale of our CoGenesys investment of $32.5 million, or $0.24 per share, and increase revenues, partially offset by a decrease in investment income and a charge for impaired investments of $6.3 million, or $0.04 per share.
 
Years Ended December 31, 2007 and 2006
 
Revenues.  We had revenues of $41.9 million and $25.8 million for the years ended December 31, 2007 and 2006, respectively. Revenues for the year ended December 31, 2007 consisted primarily of revenue recognized from Novartis of $28.0 million for the straight-line recognition of up-front license fees and milestones reached for Albuferon and $6.5 million from GSK related to straight-line recognition of up-front license fees for LymphoStat-B.


38


 

Results of Operations (continued)
 
Years Ended December 31, 2007 and 2006 (continued)
 
The 2006 revenues consisted primarily of $12.4 million in revenue recognized from GSK, consisting of $7.7 million related to Syncria, including a $6.0 million milestone received and recognized, $2.7 million related to straight-line recognition of up-front license fees for LymphoStat-B, and $2.0 million related to milestones met for two other products under GSK development, revenue recognized from Novartis of $7.1 million for the straight-line recognized of up-front license fees and a milestone reached in 2006 for Albuferon, revenue recognized from Transgene of $2.6 million and revenue recognized from CoGenesys of $1.9 million.
 
Expenses.  Research and development expenses were $245.7 million for the year ended December 31, 2007 as compared to $209.2 million for the year ended December 31, 2006. Research and development expenses for 2007 include $16.9 million paid to Aegera in connection with our licensing and collaboration agreement and purchase price premium. Our research and development expenses for the year ended December 31, 2007 are net of $46.5 million and $39.3 million of costs reimbursed or to be reimbursed by Novartis and GSK respectively. Our research and development expenses for the year ended December 31, 2006 are net of $22.9 million and $10.2 million of costs reimbursed by Novartis and GSK respectively, and $4.8 million of cost reimbursement from CoGenesys.
 
Our research costs amounted to $34.0 million for the year ended December 31, 2007 as compared to $20.0 million for the year ended December 31, 2006. This increase is due to the $16.9 million paid to Aegera in connection with our licensing and collaboration agreement and purchase price premium. Our research costs for the years ended December 31, 2007 and 2006 are net of $3.0 million and $1.4 million, respectively, of cost reimbursement from Novartis and GSK under costs sharing provisions in our collaboration agreements.
 
Our pharmaceutical sciences costs decreased to $30.5 million for the year ended December 31, 2007 from $32.0 million for the year ended December 31, 2006. This decrease is primarily due to cost reimbursement under our collaboration agreements and reduced activity in this area for our ABthrax program. Pharmaceutical sciences costs for the years ended December 31, 2007 and 2006 are net of $4.8 million and $4.1 million, respectively, of cost reimbursement from Novartis and GSK under cost sharing provisions in our collaboration agreements.
 
Our manufacturing costs decreased to $72.8 million for the year ended December 31, 2007 from $85.6 million for the year ended December 31, 2006. This decrease is primarily due to cost reimbursement under our collaboration agreements and reduced non-project activities, partially offset by increased production activities for HGS-ETR1 and HGS-ETR2. Our manufacturing costs for the years ended December 31, 2007 and 2006 are net of $15.1 million and $7.9 million, respectively, of cost reimbursement from Novartis and GSK under cost sharing provisions in our collaboration agreements.
 
Our clinical development costs increased to $108.5 million for the year ended December 31, 2007 from $71.6 million for the year ended December 31, 2006. The increase is primarily due to cost associated with the complete enrollment of Phase 3 trials for Albuferon and ongoing enrollment of Phase 3 trials for LymphoStat-B. These Phase 3 trials were just starting at the end of 2006, therefore minimal expenses were incurred in 2006 compared to 2007. Our clinical development costs for the year ended December 31, 2007 and 2006 are net of $62.9 million and $19.7 million, respectively, of cost reimbursement from Novartis and GSK under cost sharing provisions in our collaboration agreements, which began in mid-2006.
 
General and administrative expenses increased to $55.9 million for the year ended December 31, 2007 from $53.1 million for the year ended December 31, 2006. This increase is primarily due to increased legal expenses associated with patent proceedings for certain of our products, partially offset by lower stock-based compensation expense.
 
Lease termination and restructuring credits in 2007 related to the reversal of a liability and the recording of a gain aggregating $3.7 million in connection with the purchase and sale of a small laboratory and office building. The lease termination and restructuring charges of $29.5 million for the year ended December 31, 2006 consist of a lease termination charge of $16.8 million related to the BioMed financing and exit and impairment charges of approximately $12.7 million related to space no longer in use at our headquarters location and a small laboratory


39


 

Results of Operations (continued)
 
Years Ended December 31, 2007 and 2006 (continued)
 
building. See Note N, Facility-Related Exit Costs of the Notes to the Consolidated Financial Statements for additional discussion.
 
Investment income increased to $33.0 million for the year ended December 31, 2007 from $27.1 million for the year ended December 31, 2006. The increase is primarily due to higher interest rates in our portfolio in 2007, partially offset by lower average balances of cash, short-term investments and marketable securities. Investment income also includes realized net gains on our short-term investments, marketable securities and restricted investments of $0.1 million for the year ended December 31, 2007 as compared to net losses of $0.7 million for the year ended December 31, 2006. The yield on our investments was approximately 4.8% for the year ended December 31, 2007, as compared to approximately 3.9% for the year ended December 31, 2006.
 
Interest expense increased to $39.3 million for the year ended December 31, 2007 compared to $27.0 million for the year ended December 31, 2006, primarily due to interest expense on the debt associated with the sale and leaseback of the LSM facility to BioMed. Interest expense for the year ended December 31, 2006 is net of interest capitalized of $2.5 million in connection with the construction of our LSM facility. No interest expense was capitalized in the third quarter of 2006 or subsequently as we placed the LSM facility in service and ceased capitalization of interest at the end of the second quarter. Interest expense, before capitalized interest, was $29.5 million for the year ended December 31, 2006.
 
During 2007, we had no gains on sale of equity investments. During 2006 we recognized a gain sale of investment of $14.8 million related to the sale of our remaining equity interest in Cambridge Antibody Technology Ltd. (“CAT”), a long-term investment, for net proceeds of $24.1 million compared to a cost basis of $9.3 million.
 
Net Income (Loss).  We recorded a net loss of $262.4 million, or $1.95 per share, for the year ended December 31, 2007, compared to a net loss of $251.2 million, or $1.91 per share, for the year ended December 31, 2006. The increased loss for 2007 compared to 2006 is primarily due to increased clinical development costs related to our Phase 3 programs, increased research costs related to our license agreement with Aegera and increased interest expense, partially offset by increased revenue and a decrease in lease termination and restructuring charges.
 
Liquidity and Capital Resources
 
We had a working capital shortfall of $52.5 million at December 31, 2008 as compared to working capital of $47.0 million at December 31, 2007. The decrease in our working capital in 2008 is primarily due to the use of working capital to fund our operations, partially offset by receipt of $47.3 million related to the sale of our investment in CoGenesys (see Note P, Teva Biopharmaceuticals USA, Inc. (formerly CoGenesys), of the Notes to the Consolidated Financial Statements for additional discussion). Although current liabilities exceed current assets as of December 31, 2008, current liabilities include $43.7 million of deferred revenue which will be relieved through non-cash amortization. The delivery of ABthrax to the U.S. Strategic National Stockpile will generate over $150.0 million during 2009 which will improve our working capital position, net of $50.0 million used in February 2009 to extinguish approximately $106.2 million of our subordinated convertible notes. We may also receive payments under collaboration agreements, to the extent milestones are met, which would improve our working capital position.
 
We expect to continue to incur substantial expenses relating to our research and development efforts, which may increase relative to historical levels as we focus on clinical trials and manufacturing required for the development of our active product candidates. We will also incur costs related to our pre-commercial launch activities. In the event our working capital needs for 2009 exceed our available working capital, we can utilize our non-current marketable securities, which are classified as “available-for-sale”. We may improve our working capital position during 2009 through the sale of additional ABthrax product, receipt of collaboration fees or financing activities. We will be evaluating our working capital position on a continuing basis.
 
To minimize our exposure to credit risk, we invest in securities with strong credit ratings and have established guidelines relative to diversification and maturity with the objectives of maintaining safety of principal and


40


 

Liquidity and Capital Resources (continued)
 
liquidity. We do not invest in derivative financial instruments or auction rate securities, and we generally hold our investments in debt securities until maturity. However, the deterioration of the credit markets during 2008 had a detrimental effect on our investment portfolio. During 2008, we recorded a charge for impairment of debt securities issued by LBHI of $6.3 million. At December 31, 2008, we have gross unrealized losses on our available for sale investments of approximately $9.9 million. Our unrealized losses substantially relate to corporate debt securities. Our other non-current marketable securities, consisting primarily of government-sponsored enterprise securities, have not experienced any significant unrealized losses at December 31, 2008. The amortized cost and fair value of these other non-current marketable securities are approximately $125.0 million and $127.9 million, respectively, at December 31, 2008. If needed, we could liquidate some or all of these securities in order to meet our working capital needs.
 
The amounts of expenditures that will be needed to carry out our business plan are subject to numerous uncertainties, which may adversely affect our liquidity and capital resources. We are conducting multiple Phase 3 trials and have several ongoing Phase 1 and Phase 2 trials and expect to initiate additional trials in the future. Completion of these trials may extend several years or more, but the length of time generally varies considerably according to the type, complexity, novelty and intended use of the drug candidate. We estimated that the completion periods for our Phase 1, Phase 2, and Phase 3 trials could span one year, one to two years and two to four years, respectively. Some trials may take considerably longer to complete. The duration and cost of our clinical trials are a function of numerous factors such as the number of patients to be enrolled in the trial, the amount of time it takes to enroll them, the length of time they must be treated and observed, and the number of clinical sites and countries for the trial.
 
Our clinical development expenses are impacted by the clinical phase of our drug candidates. Our expenses increase as our drug candidates move to later phases of clinical development. The status of our clinical projects is as follows:
 
                 
        Clinical Trial Status as of December 31,(2)
Product Candidate (1)
 
Indication
  2008   2007   2006
 
Albuferon
  Hepatitis C   Phase 3(3)   Phase 3   Phase 3
LymphoStat-B
  Systemic Lupus Erythematosus   Phase 3   Phase 3   Phase 2(4)
LymphoStat-B
  Rheumatoid Arthritis   Phase 2(5)   Phase 2(5)   Phase 2(5)
HGS-ETR1
  Cancer   Phase 2   Phase 2   Phase 2
HGS-ETR2
  Cancer   Phase 1   Phase 1   Phase 1
ABthrax
  Anthrax   (6)   (6)   (6)
HGS1029
  Cancer   Phase 1   (7)  
 
 
(1) Includes only those candidates for which an Investigational New Drug (“IND”) application has been filed with the FDA.
 
(2) Clinical Trial Status defined as when patients are being dosed.
 
(3) Patient dosing completed during in 2008; some patients in follow up as of December 31, 2008.
 
(4) Initial Phase 2 trial completed and Phase 3 enrollment initiated in 2006; patient dosing began in 2007.
 
(5) Initial Phase 2 trial completed; extension safety study ongoing and further development under review.
 
(6) We have begun delivery of ABthrax to the U.S. Strategic National Stockpile. We anticipate filing a Biologics License Application (“BLA”) in 2009.
 
(7) IND filed in December 2007 with respect to HGS1029 (formerly AEG40826).
 
We identify our drug candidates by conducting numerous preclinical studies. We may conduct multiple clinical trials to cover a variety of indications for each drug candidate. Based upon the results from our trials, we may elect to discontinue clinical trials for certain indications or certain drugs in order to concentrate our resources on more promising drug candidates.


41


 

Liquidity and Capital Resources (continued)
 
We are advancing a number of drug candidates, including antibodies, an albumin fusion protein and a small molecule, in part to diversify the risks associated with our research and development spending. In addition, our manufacturing plants have been designed to enable multi-product manufacturing capability. Accordingly, we believe our future financial commitments, including those for preclinical, clinical or manufacturing activities, are not substantially dependent on any single drug candidate. Should we be unable to sustain a multi-product drug pipeline, our dependence on the success of a single drug candidate would increase.
 
We must receive regulatory clearance to advance each of our products into and through each phase of clinical testing. Moreover, we must receive regulatory approval to launch any of our products commercially. In order to receive such approval, the appropriate regulatory agency must conclude that our clinical data establish safety and efficacy and that our products and the manufacturing facilities meet all applicable regulatory requirements. We cannot be certain that we will establish sufficient safety and efficacy data to receive regulatory approval for any of our drugs or that our drugs and the manufacturing facilities will meet all applicable regulatory requirements.
 
Part of our business plan includes collaborating with others. For example, we entered into a collaboration agreement in 2006 with Novartis to co-develop and co-commercialize Albuferon. Under this agreement, we will co-commercialize Albuferon in the United States, and will share U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization outside the U.S. and will pay us a royalty on those sales. We and Novartis share clinical development costs. Including a non-refundable up-front license fee, we are entitled to payments aggregating approximately $507.5 million upon successful attainment of certain milestones. As of December 31, 2008, we have contractually earned and received milestones aggregating $132.5 million, including the up-front fee. In 2006, we entered into a collaboration agreement with GSK with respect to LymphoStat-B and received a payment of $24.0 million. We and GSK share Phase 3 and 4 development costs, and will share equally in sales and marketing expenses and profits of any product that is commercialized. During 2008, we recorded approximately $87.9 million of reimbursable expenses from Novartis and GSK with respect to our cost sharing agreements as a reduction of research and development expenses. We are recognizing the up-front fees and milestones received from Novartis and GSK as revenue ratably over the estimated remaining development periods.
 
We have other collaborators who have sole responsibility for product development. For example, GSK is developing other products under separate agreements as part of our overall relationship with them. We have no control over the progress of GSK’s development plans. We cannot forecast with any degree of certainty whether any of our current or future collaborations will affect our drug development.
 
Because of the uncertainties discussed above, the costs to advance our research and development projects are difficult to estimate and may vary significantly. We expect that our existing funds, payments received under the ABthrax contract and other agreements and investment income will be sufficient to fund our operations for at least the next twelve months.
 
Our future capital requirements and the adequacy of our available funds will depend on many factors, primarily including the scope and costs of our clinical development programs, the scope and costs of our manufacturing and process development activities, the magnitude of our discovery and preclinical development programs and the level of our pre-commercial launch activities. There can be no assurance that any additional financing required in the future will be available on acceptable terms, if at all.
 
Depending upon market and interest rate conditions, we are exploring, and, from time to time, may take actions to strengthen further our financial position. We may undertake financings and may repurchase or restructure some or all of our outstanding convertible debt instruments in the future depending upon market and other conditions. In February 2009 we repurchased approximately $106.2 million of our convertible subordinated debt due in 2011 and 2012 at a cost of approximately $50.0 million plus accrued interest.
 
We have certain contractual obligations which may have a future effect on our financial condition, changes in financial condition, results of operations, liquidity, capital expenditures or capital resources that are material to investors. Our operating leases, along with our unconditional purchase obligations, are not recorded on our balance sheets. Debt associated with the sale and accompanying leaseback of our LSM facility to BioMed in 2006 is recorded on our balance sheet as of December 31, 2008 and 2007. Under the LSM lease, we have an option to


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Liquidity and Capital Resources (continued)
 
purchase the property between 2009 and 2010 at prices ranging between approximately $254.9 million and $269.5 million, depending upon when we exercise this option. We have an option to purchase the Traville facility in 2016 for $303.0 million.
 
Our contractual obligations as of December 31, 2008 are summarized as follows:
 
                                         
    Payments Due by Period  
          One Year
    Two to
    Four to
    After
 
    Total     or Less     Three Years     Five Years     Five Years  
    (dollars in millions)  
 
Contractual Obligations
                                       
Long-term debt — convertible notes(1)
  $ 549.7     $ 11.5     $ 303.0     $ 235.2     $  
Long term lease commitment — BioMed(2)
    495.1       26.1       49.6       51.6       367.8  
Operating leases(3)
    398.9       21.5       43.8       45.1       288.5  
Unconditional purchase obligations(4)
    7.1       7.1                    
ABthrax milestones and royalties(5)
    10.3       10.3                    
Other long-term liabilities reflected on our balance sheets(6)
                             
                                         
Total contractual cash obligations(7)
  $ 1,461.1     $ 76.5     $ 396.4     $ 331.9     $ 656.3  
                                         
 
 
(1) Contractual interest obligations related to our convertible subordinated notes included above total $39.7 million as of December 31, 2008. Contractual interest obligations of $11.5 million, $23.0 million and $5.2 million are due in one year or less, two to three years and four to five years, respectively. In February 2009, we repurchased a portion of our convertible subordinated notes. This repurchase reduces the principal due in two to three years and four to five years by $82.9 million and $23.3 million, respectively. Contractual interest obligations due in one year or less, two to three years and four to five years are reduced by $2.1 million, $4.5 million and $0.4 million, respectively, as a result of the repurchase.
 
(2) Contractual interest obligations related to BioMed are included above and aggregate $442.1 million as of December 31, 2008. Contractual interest obligations of $26.1 million, $49.6 million, $51.6 million and $314.8 million are due in one year or less, two to three years, four to five years and after five years, respectively.
 
(3) Includes Traville headquarters operating lease with BioMed with aggregate payments of $360.9 million. Lease payments of $17.5 million, $36.1 million, $37.6 million and $269.7 million are due in one year or less, two to three years, four to five years and after five years, respectively. The operating lease obligations shown above are the gross amounts, not considering sublease income. Contractual sublease income of $4.5 million and $9.0 million is due in one year or less and two to three years, respectively. Certain of our operating leases contain financial covenants with respect to minimum levels of unrestricted cash, cash equivalents and marketable securities and minimum levels of net worth. During 2007, we amended certain of these leases to eliminate the minimum net worth covenant and adjust the minimum levels of unrestricted cash, cash equivalents and marketable securities required under the leases. We also pledged additional collateral of approximately $8.6 million to certain lessors to satisfy the minimum net worth covenant associated with certain other leases. During 2008, approximately $4.9 million of this additional collateral was released, as the lease terms of the related leases expired.
 
(4) Our unconditional purchase obligations relate to commitments for capital expenditures.
 
(5) Includes milestone payments and royalties associated with the delivery of ABthrax to the U.S. Strategic National Stockpile.
 
(6) In the event we reach certain development milestones for Albuferon and LymphoStat-B such as successful completion of Phase 3 trials or regulatory approval, we would be obligated to make payments of up to $11.5 million over the next five years. In the event we reach certain development milestones related to


43


 

Liquidity and Capital Resources (continued)
 
HGS1029, we would be obligated to pay up to $204.0 million. Our other products are in either Phase 1 or Phase 2 and would also obligate us to make certain milestone payments should they reach Phase 3 or regulatory approval. These other payments could result in aggregate milestone payments of $21.0 million. Because we cannot forecast with any degree of certainty whether any of these products will reach these milestones, we have excluded these amounts and any royalty payments from the above table.
 
(7) For additional discussion of our debt obligations and lease commitments, see Note I, Long-Term Debt and Note J, Commitments and Other Matters, of the Notes to the Consolidated Financial Statements.
 
As of December 31, 2008, we had net operating loss carry forwards for federal income tax purposes of approximately $2.0 billion, which expire, if unused, through December 31, 2028. We also have available research and development tax credit and other tax credit carry forwards of approximately $33.5 million, the majority of which will expire, if unused, through December 31, 2028.
 
Our unrestricted and restricted funds may be invested in U.S. Treasury securities, government agency obligations, high grade corporate debt securities and various money market instruments rated “A−” or better. Such investments reflect our policy regarding the investment of liquid assets, which is to seek a reasonable rate of return consistent with an emphasis on safety, liquidity and preservation of capital.
 
 
During 1997 and 1999, we entered into two long-term leases with the Maryland Economic Development Corporation (“MEDCO”) expiring January 1, 2019 for a process development and small-scale manufacturing facility aggregating 127,000 square feet and built to our specifications. We have accounted for these leases as operating leases. The facility was financed primarily through a combination of bonds issued by MEDCO (“MEDCO Bonds”) and loans issued to MEDCO by certain State of Maryland agencies. We have no equity interest in MEDCO.
 
Rent is based upon MEDCO’s debt service obligations and annual base rent under the leases currently is approximately $3.8 million. The MEDCO Bonds are secured by letters of credit issued for the account of MEDCO which expire in December 2009. MEDCO’s debt service obligations may be affected by prevailing interest rate conditions in 2009, which could in turn affect our rent and the level of our restricted investments. We have restricted investments of approximately $15.7 million and $15.0 million as of December 31, 2008 and December 31, 2007, respectively, and are required to maintain restricted investments of $15.0 million which serve as additional security for the MEDCO letters of credit reimbursement obligation. Upon default or early lease termination or in the event the letters of credit will not be renewed, the MEDCO Bond indenture trustee can draw upon the letters of credit to pay the MEDCO Bonds as they are tendered. In such an event, we could lose part or all of our restricted investments and could record a charge to earnings for a corresponding amount. Alternatively, we have an option during or at the end of the lease term to purchase this facility for an aggregate amount that declines from approximately $38.0 million in 2009 to approximately $21.0 million in 2019.
 
The lease agreements contain covenants with respect to tangible net worth, cash and cash equivalents and investment securities, restrictions on dividends, as well as other covenants.


44


 

 
Certain statements contained in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on our current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of our unproven business model, our dependence on new technologies, the uncertainty and timing of clinical trials, our ability to develop and commercialize products, our dependence on collaborators for services and revenue, our substantial indebtedness and lease obligations, our changing requirements and costs associated with facilities, intense competition, the uncertainty of patent and intellectual property protection, our dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in this filing and our other filings with the Securities and Exchange Commission. In addition, while we have begun shipment of ABthrax to the U.S. Strategic National Stockpile, we continue to face risks related to acceptance of future shipments and FDA’s approval of our Biologics License Application for ABthrax, if and when it is submitted. If we are unable to meet requirements associated with the ABthrax contract, future revenues from the sale of ABthrax to the U.S. Government will not occur. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. We undertake no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.


45


 

ITEM 7A.   QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
 
We do not have operations of a material nature that are subject to risks of foreign currency fluctuations. We do, however, have certain aspects of our global clinical studies that are subject to risks of foreign currency fluctuations. We do not use derivative financial instruments in our operations or investment portfolio. Our investment portfolio may be comprised of low-risk U.S. Treasuries, government-sponsored enterprise securities, high-grade debt having at least an “A−” rating at time of purchase and various money market instruments. The short-term nature of these securities, which currently have an average term of approximately 12 months, decreases the risk of a material loss caused by a market change related to interest rates.
 
We believe that a hypothetical 100 basis point adverse move (increase) in interest rates along the entire interest rate yield curve would adversely affect the fair value of our cash, cash equivalents, short-term investments, marketable securities and restricted investments by approximately $3.9 million, or approximately 1.04% of the aggregate fair value of $372.9 million, at December 31, 2008. For these reasons, and because these securities are generally held to maturity, we believe we do not have significant exposure to market risks associated with changes in interest rates related to our debt securities held as of December 31, 2008. We believe that any interest rate change related to our investment securities held as of December 31, 2008 is not material to our consolidated financial statements. As of December 31, 2008, the yield on comparable one-year investments was approximately 0.3%, as compared to our current portfolio yield of approximately 4.6%. However, given the short-term nature of these securities, a general decline in interest rates may adversely affect the interest earned from our portfolio as securities mature and may be replaced with securities having a lower interest rate.
 
To minimize our exposure to credit risk, we invest in securities with strong credit ratings and have established guidelines relative to diversification and maturity with the objectives of maintaining safety of principal and liquidity. We do not invest in derivative financial instruments or auction rate securities, and we generally hold our investments in debt securities until maturity. However, adverse changes in the credit markets relating to credit risks would adversely affect the fair value of our cash, cash equivalents, marketable securities and restricted investments. The deterioration of the credit markets during the year ended December 31, 2008 had a detrimental effect on our investment portfolio. During 2008, we recorded an impairment charge of $6.3 million related to our investment in debt securities issued by LBHI. During the year ended December 31, 2008, the gross unrealized losses in our portfolio increased from $3.3 million to $9.9 million. The majority of these unrealized losses related to our holdings of corporate debt securities. At December 31, 2008, the fair value of our corporate debt securities was approximately $188.0 million, or 53% of our total investment portfolio of $357.7 million. The remaining securities in our portfolio are either U.S. Treasury and agency securities or government-sponsored enterprise securities, which we believe are subject to less credit risk. In the event there is further deterioration in the credit market, the fair value of our corporate debt securities could further decline.
 
We have an equity investment in Aegera, which is a privately-held entity. We are unable to obtain a quoted market price with respect to the fair value of this investment. We paid $5.0 million for the Aegera investment in December 2007 but recorded the investment at $3.1 million based on the value per share obtained by Aegera through external financing earlier in 2007. Our investment in Aegera is denominated in Canadian dollars and is subject to foreign currency risk. The carrying value is adjusted at each reporting date based on current exchange rates, and was $2.6 million at December 31, 2008. We review the carrying value of the Agera investment on a periodic basis for indicators of impairment, and adjust the value accordingly.
 
The facility leases we entered into during 2006 require us to maintain minimum level of restricted investments of approximately $46.0 million, or $39.5 million if in the form of cash, as collateral for these facilities. Together with the requirement to maintain up to approximately $15.0 million in restricted investments with respect to our process development and manufacturing facility leases, and our additional collateral for one of our operating leases, our overall level of restricted investments is currently required to be approximately $64.5 million. Although the market value for these investments may rise or fall as a result of changes in interest rates, we will be required to maintain this level of restricted investments in either a rising or declining interest rate environment.
 
Our convertible subordinated notes bear interest at fixed rates. As a result, our interest expense on these notes is not affected by changes in interest rates.


46


 

ITEM 7A.   QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK (continued)
 
During 2002, we established a wholly-owned subsidiary, Human Genome Sciences Europe GmbH (“HGS Europe”) that is assisting in our clinical trials and clinical research collaborations in European countries. Although HGS Europe’s activities are denominated primarily in euros, we believe the foreign currency fluctuation risks to be immaterial to our operations as a whole. During 2005, we established a wholly-owned subsidiary, Human Genome Sciences Pacific Pty Ltd. (“HGS Pacific”) that is sponsoring some of our clinical trials in the Asia/Pacific region. We currently do not anticipate HGS Pacific to have any operational activity and therefore we do not believe we will have any foreign currency fluctuation risks with respect to HGS Pacific.
 
ITEM 8.   FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
 
The information required by this item is set forth on pages F-1 — F-37.
 
ITEM 9.   CHANGES AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
 
None.
 
ITEM 9A.   CONTROLS AND PROCEDURES
 
 
Our management, including our principal executive and principal financial officers, has evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2008. Our disclosure controls and procedures are designed to provide reasonable assurance that the information required to be disclosed in this annual report on Form 10-K has been appropriately recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive and principal financial officers, to allow timely decisions regarding required disclosure. Based on that evaluation, our principal executive and principal financial officers have concluded that our disclosure controls and procedures are effective at the reasonable assurance level.
 
 
Our management, including our principal executive and principal financial officers, has evaluated any changes in our internal control over financial reporting that occurred during the year ended December 31, 2008, and has concluded that there was no change that occurred during the year ended December 31, 2008 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
 
 
The management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) or 15d-15(f) promulgated under the Securities Exchange Act of 1934, as amended, as a process designed by, or under the supervision of, the Company’s principal executive and principal financial officers and effected by the Company’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
 
  •  pertain to the management of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company;
 
  •  provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures


47


 

ITEM 9A.  CONTROLS AND PROCEDURES (continued)
 
  of the Company are being made only in accordance with authorizations of management and directors of the Company; and
 
  •  provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s 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. 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. All internal control systems, no matter how well designed, have inherent limitations. Therefore, even those systems determined to be effective can provide only reasonable assurance with respect to financial statement preparation and presentation.
 
The Company’s management assessed the effectiveness of the Company’s internal control over financial reporting as of December 31, 2008. In making this assessment, the Company’s management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control-Integrated Framework.
 
Based on our assessment, management believes that, as of December 31, 2008, the Company’s internal control over financial reporting is effective based on those criteria.
 
The Company’s independent auditors have issued an audit report on internal control over financial reporting which follows herein.
 
ITEM 9B.   OTHER INFORMATION
 
None.


48


 

 
Board of Directors and Stockholders of
Human Genome Sciences, Inc.
Rockville, Maryland
 
We have audited Human Genome Sciences Inc.’s internal control over financial reporting as of December 31, 2008, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). Human Genome Sciences, Inc.’s management is responsible for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying “Management Report on Internal Control over Financial Reporting.” Our responsibility is to express an opinion on the company’s internal control over financial reporting based on our audit.
 
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
 
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s 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, Human Genome Sciences, Inc. maintained, in all material respects, effective internal control over financial reporting as of December 31, 2008, based on the COSO criteria.
 
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets of Human Genome Sciences, Inc. as of December 31, 2008 and 2007, and the related consolidated statements of operations, stockholders’ equity (deficit), and cash flows for each of the three years in the period ended December 31, 2008 and our report dated February 26, 2009 expressed an unqualified opinion thereon.
 
/s/  Ernst & Young LLP
 
Baltimore, Maryland
February 26, 2009


49


 

 
ITEM 10.   DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
 
We incorporate herein by reference the information concerning directors, executive officers and corporate governance in our Notice of Annual Stockholders’ Meeting and Proxy Statement to be filed within 120 days after the end of our fiscal year (the “2009 Proxy Statement”).
 
ITEM 11.   EXECUTIVE COMPENSATION
 
We incorporate herein by reference the information concerning executive compensation to be contained in the 2009 Proxy Statement.
 
ITEM 12.   SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
 
We incorporate herein by reference the information concerning security ownership of certain beneficial owners and management to be contained in the 2009 Proxy Statement.
 
ITEM 13.   CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
 
We incorporate herein by reference the information concerning the CoGenesys transaction set forth in Note P to our consolidated financial statements. We incorporate herein by reference the information concerning certain other relationships and related transactions to be contained in the 2009 Proxy Statement.
 
ITEM 14.   PRINCIPAL ACCOUNTING FEES AND SERVICES
 
We incorporate herein by reference the information concerning principal accounting fees and services to be contained in the 2009 Proxy Statement.


50


 

 
 
ITEM 15.   EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
 
(a) The following documents are filed as part of this Annual Report:
 
(1) Index to Consolidated Financial Statements
         
    Page
    Number
Report of Ernst & Young LLP, Independent Registered Public Accounting Firm
    F-2  
Consolidated Balance Sheets at December 31, 2008 and 2007
    F-3  
Consolidated Statements of Operations for the years ended December 31, 2008, 2007 and 2006
    F-4  
Consolidated Statements of Stockholders’ Equity (Deficit) for the years ended December 31, 2008, 2007 and 2006
    F-5  
Consolidated Statements of Cash Flows for the years ended December 31, 2008, 2007 and 2006
    F-6  
Notes to Consolidated Financial Statements
    F-8  
 
(2) Financial Statement Schedules
 
 Financial statement schedules are omitted because they are not required.
 
(3) Exhibits
 
     
Exhibit
   
No.
   
 
 3.1*
  Certificate of Incorporation of the Registrant (Filed as Exhibit 3.1 to the Registrant’s Form 10-K for the fiscal year ended December 31, 1993, Exhibit 3.3 to the Form 10-K for the fiscal year ended December 31, 1997, Exhibit 3.1 to the Form 8-K filed December 16, 1999, Exhibit 3.1 to the Form 10-Q filed July 31, 2001, and Exhibit 3.1 to the Form 8-K filed on May 8, 2008).
 3.2*
  By-laws of the Registrant (Filed as Exhibit 3.2 to the Registrant’s Form 8-K filed May 8, 2008).
 4.1*
  Form of Common Stock Certificate (Filed as Exhibit 4.1 to the Registrant’s Form S-3 Registration Statement, as amended (Commission File No. 333-45272), filed September 6, 2000).
 4.2*
  Indenture dated as of October 4, 2004 between the Registrant and The Bank of New York, as trustee, including the form of 21/4% Convertible Subordinated Notes due 2011 (Filed as Exhibit 4.1 to the Registrant’s Form 8-K filed October 4, 2004).
 4.3*
  Indenture dated as of August 9, 2005 between the Registrant and The Bank of New York, as trustee, including the form of 21/4% Convertible Subordinated Notes due 2012 (Filed as Exhibit 4.1 to the Registrant’s 8-K filed August 9, 2005).
10.1*
  Employment Agreement, dated November 21, 2004, with H. Thomas Watkins (Filed as Exhibit 10.1 to the Registrant’s Form 8-K filed November 23, 2004).
10.2*
  First Amendment to the Employment Agreement by and between Human Genome Sciences, Inc. and H. Thomas Watkins (Filed as Exhibit 10.1 to the Registrant’s Form 8-K filed December 20, 2007).
10.3*
  Form of Executive Agreement (Filed as Exhibit 10.3 to the Registrant’s Form 8-K filed December 20, 2007).
10.4*
  Human Genome Sciences, Inc. Discretionary Bonus Policy (Filed as Exhibit 10.4 to the Registrant’s Form 8-K filed December 20, 2007).
10.5*
  Form of Stock Unit Grant Agreement under the Non-Employee Director Equity Compensation Plan (Filed as Exhibit 10.5 to the Registrant’s Form 8-K filed December 20, 2007).
10.6*
  Second Amended and Restated Key Executive Severance Plan (Filed as Exhibit 10.2 to the Registrant’s Form 8-K filed December 20, 2007).
10.7*
  2000 Stock Incentive Plan, as amended (Filed as Exhibit A to the Registrant’s Definitive Proxy Statement on Schedule 14A filed April 18, 2001 and Annexes A and B to the Registrant’s Definitive Proxy Statement on Schedule 14A filed April 16, 2004).
10.8*
  Employee Stock Purchase Plan dated January 1, 2009 (Filed as Exhibit 99.1 to the Registrant’s Registration Statement on Form S-8 filed December 19, 2008).


51


 

     
Exhibit
   
No.
   
 
10.9*
  Lease Agreement between Maryland Economic Development Corporation and Human Genome Sciences, Inc., dated December 1, 1997 (Filed as Exhibit 10.67 to the Registrant’s Form 10-K for the fiscal year ended December 31, 1997).
10.10*
  Lease Agreement between Maryland Economic Development Corporation and Human Genome Sciences, Inc. dated December 1, 1999 (Filed as Exhibit 10.43 to the Registrant’s Form 10-K for the fiscal year ended December 31, 1999).
10.11*
  Omnibus Agreement between Maryland Economic Development Corporation, Wells Fargo Bank Northwest, National Association, Human Genome Sciences, Inc., Allfirst Bank, a division of M&T Bank and the other parties named therein dated June 26, 2003 (Filed as Exhibit 10.1 to the Registrant’s Form 10-Q filed August 11, 2003).
10.12*
  Lease Agreement between Wells Fargo Bank Northwest, National Association as Trustee under Trust Agreement and Human Genome Sciences, Inc. dated October 25, 2001 (Filed as Exhibit 10.22 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2001 and amended by Exhibit 10.15 hereto).
10.13*
  Cash Collateral Pledge Agreement between Human Genome Sciences, Inc., Allfirst Bank and Allfirst Trust Company National Association dated October 25, 2001 (Filed as Exhibit 10.23 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2001).
10.14*
  Guarantee by Human Genome Sciences, Inc. as Guarantor in favor of Allfirst Bank, as Agent dated October 25, 2001 (Filed as Exhibit 10.24 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2001 and amended by Exhibit 10.15 hereto).
10.15*
  Amendment No. 1 dated March 29, 2002 to Lease Agreement between Wells Fargo Bank Northwest, National Association as Trustee under Trust Agreement and Human Genome Sciences, Inc. dated October 25, 2001 (Filed as Exhibit 10.25 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2001).
10.16*
  Amendment No. 1 dated March 29, 2002 to Guarantee by Human Genome Sciences, Inc. as Guarantor in favor of Allfirst Bank, as Agent dated October 25, 2001 (Filed as Exhibit 10.26 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2001).
10.17*
  Form of Restricted Stock Agreement (Filed as Exhibit 10.20 to the Registrant’s Form 10-Q filed August 1, 2005).
10.18*
  Form of Stock Option Agreement (Filed as Exhibit 10.2 to the Registrant’s Form 8-K filed September 20, 2004).
10.19*†
  Asset Purchase Agreement dated December 12, 2005 by and between TriGenesys, Inc. and the Registrant (Filed as Exhibit 10.22 to the Registrant’s Form 10-K for the fiscal year ended December 31, 2005).
10.20*†
  Co-development and Commercialization Agreement between Novartis International Pharmaceutical Ltd. and Human Genome Sciences, Inc., dated June 5, 2006 (Filed as Exhibit 10.1 to the Registrant’s Form 10-Q filed August 9, 2006).
10.21*
  Purchase and Sale Agreement between BioMed Realty, L.P. and Human Genome Sciences, Inc., dated May 2, 2006 (Filed as Exhibit 10.2 to the Registrant’s Form 10-Q filed August 9, 2006).
10.22*
  Lease Agreement between BMR-Belward Campus Drive LSM LLC and Human Genome Sciences, Inc., dated May 24, 2006 (Filed as Exhibit 10.3 to the Registrant’s Form 10-Q filed August 9, 2006).
10.23*
  Lease Agreement between BMR-Shady Grove Road HQ LLC and Human Genome Sciences, Inc., dated May 24, 2006 (Filed as Exhibit 10.4 to the Registrant’s Form 10-Q filed August 9, 2006).
10.24*†
  Solicitation (as amended) and Modification of Contract awarded by the Department of Health and Human Services to Human Genome Sciences, Inc. dated June 24, 2006 (Filed as Exhibit 10.5 to the Registrant’s Amended Form 10-Q filed September 27, 2007).
10.25†
  Co-development and Commercialization Agreement between Glaxo Group Limited and Human Genome Sciences, Inc., dated August 1, 2006.
10.26
  Second Amendment to the Employment Agreement by and between Human Genome Sciences, Inc. and H. Thomas Watkins.
10.27
  Form of First Amendment to Executive Agreement.


52


 

     
Exhibit
   
No.
   
 
10.28
  Form of First Amendment to the Registrant’s Second Amended and Restated Key Executive Severance Plan.
12.1
  Ratio of Earnings to Fixed Charges.
21.1
  Subsidiaries.
23.1
  Consent of Ernst & Young LLP, Independent Registered Public Accounting Firm.
31i.1
  Rule 13a-14(a) Certification of Principal Executive Officer.
31i.2
  Rule 13a-14(a) Certification of Principal Financial Officer.
32.1
  Section 1350 Certification of Chief Executive Officer.
32.2
  Section 1350 Certification of Chief Financial Officer.
 
 
* Incorporated by reference.
 
Confidential treatment requested for certain portions of this Exhibit pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended, which portions are omitted and filed separately with the Securities and Exchange Commission.


53


 

 
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.
 
HUMAN GENOME SCIENCES, INC.
 
    BY: 
/s/  H. Thomas Watkins
H. Thomas Watkins
President and Chief Executive Officer
 
Dated: February 26, 2009
 
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 the dates indicated:
 
             
Signature
 
Title
 
Date
 
         
/s/  H. Thomas Watkins

H. Thomas Watkins
  President, Chief Executive Officer and Director
(Principal Executive Officer)
  February 26, 2009
         
/s/  Timothy C. Barabe

Timothy C. Barabe
  Senior Vice President and
Chief Financial Officer
(Principal Financial Officer and
Principal Accounting Officer)
  February 26, 2009
         
/s/  Argeris N. Karabelas, Ph.D.

Argeris N. Karabelas, Ph.D.
  Chairman of the Board   February 26, 2009
         
/s/  Richard J. Danzig

Richard J. Danzig
  Director   February 26, 2009
         
/s/  Jürgen Drews, M.D.

Jürgen Drews, M.D.
  Director   February 26, 2009
         
/s/  Maxine Gowen, Ph.D.

Maxine Gowen, Ph.D.
  Director   February 26, 2009
         
/s/  Tuan Ha-Ngoc

Tuan Ha-Ngoc
  Director   February 26, 2009
         
/s/  John LaMattina, Ph.D.

John LaMattina
  Director   February 26, 2009
         
/s/  Augustine Lawlor

Augustine Lawlor
  Director   February 26, 2009
         
/s/  David Southwell

David Southwell
  Director   February 26, 2009
         
/s/  Robert C. Young

Robert C. Young, M.D.
  Director   February 26, 2009


54


 


 

 
 
Board of Directors and Stockholders of
Human Genome Sciences, Inc.
Rockville, Maryland
 
We have audited the accompanying consolidated balance sheets of Human Genome Sciences, Inc. as of December 31, 2008 and 2007, and the related consolidated statements of operations, stockholders’ equity (deficit), and cash flows for each of the three years in the period ended December 31, 2008. These financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these financial statements based on our audits.
 
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
 
In our opinion, the financial statements referred to above present fairly, in all material respects, the consolidated financial position of Human Genome Sciences, Inc. at December 31, 2008 and 2007, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 2008, in conformity with U.S. generally accepted accounting principles.
 
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Human Genome Sciences, Inc.’s internal control over financial reporting as of December 31, 2008, based on criteria established in Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission and our report dated February 26, 2009 expressed an unqualified opinion thereon.
 
/s/  Ernst & Young LLP
 
Baltimore, Maryland
February 26, 2009


F-2


 

HUMAN GENOME SCIENCES, INC.
 
 
                 
    December 31,  
    2008     2007  
    (dollars in thousands, except share and per share amounts)  
 
ASSETS
               
Current assets:
               
Cash and cash equivalents
  $ 15,248     $ 34,815  
Short-term investments
    22,691       93,952  
Collaboration receivables
    24,880       38,672  
Prepaid expenses and other current assets
    5,347       5,687  
                 
Total current assets
    68,166       173,126  
Marketable securities
    265,640       404,142  
Long-term equity investments
    2,606       18,245  
Property, plant and equipment (net of accumulated depreciation and amortization)
    259,269       268,804  
Restricted investments
    69,360       70,931  
Other assets
    9,123       13,857  
                 
TOTAL ASSETS
  $ 674,164     $ 949,105  
                 
LIABILITIES AND STOCKHOLDERS’ DEFICIT
               
Current liabilities:
               
Accounts payable and accrued expenses
  $ 55,434     $ 62,876  
Accrued payroll and related taxes
    18,574       14,448  
Accrued exit expenses
    2,952       3,627  
Deferred revenues
    43,746       45,219  
                 
Total current liabilities
    120,706       126,170  
Convertible subordinated debt
    510,000       510,000  
Lease financing
    246,477       244,099  
Deferred revenues, net of current portion
    29,563       73,049  
Accrued exit expenses, net of current portion
    2,075       3,017  
Other liabilities
    6,718       4,672  
                 
Total liabilities
    915,539       961,007  
                 
Stockholders’ deficit:
               
Preferred stock — $0.01 par value; shares authorized — 20,000,000; no shares issued or outstanding
           
Common stock — $0.01 par value; shares authorized — 400,000,000; shares issued and outstanding of 135,739,978 and 134,936,512 at December 31, 2008 and 2007, respectively
    1,357       1,349  
Additional paid-in capital
    1,889,502       1,866,426  
Accumulated other comprehensive income (loss)
    (4,490 )     3,152  
Accumulated deficit
    (2,127,744 )     (1,882,829 )
                 
Total stockholders’ deficit
    (241,375 )     (11,902 )
                 
TOTAL LIABILITIES AND STOCKHOLDERS’ DEFICIT
  $ 674,164     $ 949,105  
                 
 
The accompanying Notes to Consolidated Financial Statements are an integral part hereof.


F-3


 

HUMAN GENOME SCIENCES, INC.
 
 
                         
    Year Ended December 31,  
    2008     2007     2006  
    (dollars in thousands, except share and per share amounts)  
 
Revenue — research and development contracts
  $ 48,422     $ 41,851     $ 25,755  
                         
Costs and expenses:
                       
Research and development
    242,710       245,745       209,242  
General and administrative
    60,865       55,874       53,101  
Lease termination and restructuring charges (credits)
          (3,673 )     29,510  
                         
Total costs and expenses
    303,575       297,946       291,853  
                         
Income (loss) from operations
    (255,153 )     (256,095 )     (266,098 )
Investment income
    23,487       32,988       27,131  
Interest expense
    (39,483 )     (39,341 )     (26,965 )
Charge for impaired investments
    (6,284 )            
Gain on sale of long-term equity investment
    32,518             14,759  
                         
Income (loss) before taxes
    (244,915 )     (262,448 )     (251,173 )
Provision for income taxes
                 
                         
Net income (loss)
  $ (244,915 )   $ (262,448 )   $ (251,173 )
                         
Basic and diluted net income (loss) per share
  $ (1.81 )   $ (1.95 )   $ (1.91 )
                         
Weighted average shares of common stock outstanding, basic and diluted
    135,406,642       134,333,418       131,815,414  
                         
 
The accompanying Notes to Consolidated Financial Statements are an integral part hereof.


F-4


 

HUMAN GENOME SCIENCES, INC.
 
 
                                                 
                      Accumulated
             
                Additional
    Other
             
    Common Stock     Paid-In
    Comprehensive
    Accumulated
       
    Shares     Amount     Capital     Income (Loss)     Deficit     Total  
    (dollars in thousands, except share amounts)  
 
Balance — December 31, 2005
    131,049,798     $ 1,310     $ 1,786,549     $ (1,685 )   $ (1,369,208 )   $ 416,966  
Comprehensive income (loss):
                                               
Net loss
                            (251,173 )     (251,173 )
Unrealized loss on investments
                      (1,927 )           (1,927 )
Cumulative translation adjustment
                      18             18  
                                                 
Comprehensive loss
                                            (253,082 )
Shares of common stock issued pursuant to stock-based compensation plans
    2,770,255       28       23,405                   23,433  
Stock-based compensation expense
                26,606                   26,606  
                                                 
Balance — December 31, 2006
    133,820,053       1,338       1,836,560       (3,594 )     (1,620,381 )     213,923  
Comprehensive income (loss):
                                               
Net loss
                            (262,448 )     (262,448 )
Unrealized gain on investments
                      6,724             6,724  
Cumulative translation adjustment
                      22             22  
                                                 
Comprehensive loss
                                            (255,702 )
Shares of common stock issued pursuant to stock-based compensation plans
    1,116,459       11       8,175                   8,186  
Stock-based compensation expense
                21,691                   21,691  
                                                 
Balance — December 31, 2007
    134,936,512       1,349       1,866,426       3,152       (1,882,829 )     (11,902 )
Comprehensive income (loss):
                                               
Net loss
                            (244,915 )     (244,915 )
Unrealized loss on investments
                      (7,052 )           (7,052 )
Cumulative translation adjustment
                      (590 )           (590 )
                                                 
Comprehensive loss
                                            (252,557 )
Shares of common stock issued pursuant to stock-based compensation plans
    803,466       8       4,589                   4,597  
Stock-based compensation expense
                18,487                   18,487  
                                                 
Balance — December 31, 2008
    135,739,978     $ 1,357     $ 1,889,502     $ (4,490 )   $ (2,127,744 )   $ (241,375 )
                                                 
 
The accompanying Notes to Consolidated Financial Statements are an integral part hereof.


F-5


 

HUMAN GENOME SCIENCES, INC.
 
 
                         
    Year Ended December 31,  
    2008     2007     2006  
    (dollars in thousands)  
 
Cash flows from operating activities:
                       
Net income (loss)
  $ (244,915 )   $ (262,448 )   $ (251,173 )
Adjustments to reconcile net income (loss) to net cash used in operating activities:
                       
Stock-based compensation
    18,593       21,691       26,606  
Depreciation and amortization
    21,350       22,114       20,105  
Gain on sale of long-term equity investment
    (32,518 )           (14,759 )
Charge for impaired investments
    6,284              
Charge (credit) for lease termination and restructuring
          (1,969 )     28,953  
Gain on sale of building
          (1,704 )      
Accrued interest on short-term investments, marketable securities and restricted investments
    581       (4,631 )     (5,607 )
Non-cash expense and other
    1,981       2,995       5,307  
Non-cash reimbursement of CoGenesys expenses
                (4,818 )
Changes in operating assets and liabilities:
                       
Collaboration receivables
    13,792       25,807       (16,279 )
Prepaid expenses and other assets
    2,760       (366 )     5,292  
Accounts payable and accrued expenses
    (7,247 )     25,770       9,281  
Accrued payroll and related taxes
    4,126       (930 )     1,539  
Accrued exit expenses
    (2,083 )     (2,376 )     (5,006 )
Deferred revenues
    (44,959 )     (633 )     54,591  
Other liabilities
    1,992       2,021       (1,162 )
                         
Net cash used in operating activities
    (260,263 )     (174,659 )     (147,130 )
                         
Cash flows from investing activities:
                       
Purchase of short-term investments and marketable securities
    (15,065 )     (160,379 )     (538,314 )
Proceeds from sale and maturities of short-term investments and marketable securities
    211,722       278,031       504,970  
Proceeds from sale of long-term equity investments
    47,336             24,127  
Capital expenditures — property, plant and equipment
    (9,724 )     (3,042 )     (9,719 )
Release of restricted investments
    4,877              
Proceeds from sale of building, net of transaction costs
          14,824        
Purchase of building, net of transaction costs
          (13,120 )      
Purchase of long-term equity investment
          (3,148 )      
Capitalized interest
                (2,527 )
                         
Net cash provided by (used in) investing activities
    239,146       113,166       (21,463 )
                         
Cash flows from financing activities:
                       
Payments on long-term debt
                (3,120 )
Proceeds from sale and maturities of restricted investments
    26,120       17,857       57,670  
Purchase of restricted investments
    (28,897 )     (26,642 )     (44,968 )
Proceeds from issuance of common stock
    4,432       8,151       23,433  
Treasury stock (net of expense)
    (105 )            
Proceeds from sale-leaseback of property, plant and equipment
                220,252  
                         
Net cash provided by (used in) financing activities
    1,550       (634 )     253,267  
                         
Net increase (decrease) in cash and cash equivalents
    (19,567 )     (62,127 )     84,674  
Cash and cash equivalents — beginning of year
    34,815       96,942       12,268  
                         
Cash and cash equivalents — end of year
  $ 15,248     $ 34,815     $ 96,942  
                         


F-6


 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION, NON-CASH OPERATING, INVESTING AND FINANCING ACTIVITIES
 
                         
    Year Ended December 31,  
    2008     2007     2006  
    (dollars in thousands)  
 
Cash paid during the year for:
                       
Interest
  $ 34,729     $ 34,319     $ 25,540  
Income taxes
  $     $     $  
 
During the years ended December 31, 2008 and 2007, the Company recorded non-cash accretion of $466 and $653, respectively, related to its exit accrual for certain exited space.
 
During the years ended December 31, 2008, 2007 and 2006, lease financing increased as a result of non-cash accretion with respect to the Company’s leases with BioMed Realty Trust, Inc. (“BioMed”) by $2,378, $2,573 and $1,526 respectively. Because the lease payments are less than the amount of calculated interest expense for the first nine years of the leases, the lease balance will increase during this period.
 
During the year ended December 31, 2007, the Company completed a purchase and sale of a laboratory building and has no further obligations with respect to this space. Accordingly, the Company recorded a non-cash reversal of the lease termination liability for this building of $1,969. See Note N, Facility-Related Exit Costs for additional discussion.
 
During the year ended December 31, 2006, the Company transferred securities with maturities of less than one year from its Restricted investments to Short-term investments with an aggregate market value of approximately $65,115 in exchange for securities from its Marketable securities portfolio having an aggregate market value of approximately $60,857.
 
During the year ended December 31, 2006, the Company released restricted investments with a cost of $162,121 in connection with reduced collateral requirements arising from the termination of the lease and the execution of a new lease for its headquarters facility.
 
During the year ended December 31, 2006, the Company obtained equity in CoGenesys, Inc. (“CoGenesys”) with a value of $10,000 in exchange for an intellectual property license, equipment, and assumed liabilities. The Company obtained additional equity in CoGenesys with a value of $4,818 as reimbursement of research and development expenses incurred during 2006.
 
During the year ended December 31, 2006, the Company recorded a receivable and deferred revenue of $47,500 related to achievement of a milestone. The Company received payment of this receivable during January 2007.
 
The accompanying Notes to Consolidated Financial Statements are an integral part hereof.


F-7


 

HUMAN GENOME SCIENCES, INC.
 
(dollars in thousands, except share and per share data)
 
(NOTE A) — The Company
 
Human Genome Sciences, Inc. (the “Company”) was incorporated and commenced operations on June 26, 1992. The Company is a commercially focused biopharmaceutical company advancing toward the market with three products in late-stage clinical development. The Company also has a pipeline of novel compounds in earlier stages of clinical development in oncology, immunology and infectious disease. Additional products are in clinical development by companies with which the Company is collaborating.
 
The Company has developed and continues to enhance the resources necessary to achieve its goal of becoming a fully integrated global biopharmaceutical company. The Company has expanded its manufacturing facilities to allow it to produce larger quantities of therapeutic protein and antibody drugs for clinical development and for initial commercial activity. The Company completed construction and validation of a large-scale manufacturing facility and placed the facility into operational service in 2006. The Company is strengthening its commercial operations staff, and its intent is to add marketing and sales staff as needed as the Company’s products approach commercialization.
 
The Company has entered into relationships with a number of leading pharmaceutical and biotechnology companies to leverage its strengths and to gain access to complementary technologies and sales and marketing infrastructure. Some of these partnerships provide the Company, and have provided the Company, with research funding, licensing fees, milestone payments and royalty payments as products are developed and commercialized. In some cases, the Company also is entitled to certain commercialization, co-development, revenue sharing and other product rights. The Company’s revenues were derived from license fees and milestone payments under collaboration agreements through 2008. The Company generated its first product sales in January 2009 when it began delivery of ABthrax to the U.S. Strategic National Stockpile. The Company, which operates primarily in the United States, operates in a single business segment.
 
(NOTE B) — Summary of Significant Accounting Policies
 
Use of Estimates
 
The preparation of financial statements in conformity with U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Such estimates are based on historical experience and on various other assumptions that the Company believes to be reasonable under the circumstances. Actual results could differ from these estimates under different assumptions or conditions.
 
Principles of Consolidation
 
The consolidated financial statements include the accounts of Human Genome Sciences, Inc. and its subsidiaries, all of which are wholly-owned. All significant intercompany accounts and transactions have been eliminated.
 
Cash Equivalents, Short-term Investments, Marketable Securities, Long-term Equity Investments and Restricted Investments
 
The Company considers all highly liquid investment instruments purchased with a maturity of three months or less to be cash equivalents.
 
The Company classifies its short-term investments, marketable securities and long-term equity investments with readily determinable fair values as “available-for-sale.” Investments in securities that are classified as available- for-sale are measured at fair market value in the balance sheets, and unrealized holding gains and losses on investments that the Company has the ability and intent to hold until the market values recover are reported as a separate component of stockholders’ equity until realized. Investments for which the Company is unable to obtain readily available fair value information are carried at cost. The Company reviews the carrying value of such investments on a periodic basis for indicators of impairment. Additionally, certain of the Company’s investments are held as


F-8


 

 
HUMAN GENOME SCIENCES, INC.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(dollars in thousands, except share and per share data)
 
(NOTE B) — Summary of Significant Accounting Policies (continued)
 

Cash Equivalents, Short-term Investments, Marketable Securities, Long-term Equity Investments and Restricted Investments (continued)
 
restricted investments. Restricted investments with maturities less than three months are not classified as cash in the Company’s consolidated balance sheets. See Note C, Investments, for additional information.
 
Investment Risk
 
The Company has invested its cash in obligations of the U.S. Government, government agencies and in high-grade debt securities and various money market instruments. The Company’s investment policy limits investments to certain types of instruments issued by institutions with credit ratings of “A−” or better, and places restrictions on maturities and concentrations in certain industries and by issuer. The Company does not hold auction rate securities, loans held for sale or mortgage-backed securities backed by sub-prime or Alt-A collateral.
 
Other-Than-Temporary Impairment of Investments
 
Periodically, the Company evaluates whether any investments have incurred an other-than-temporary impairment, based on the criteria established in Financial Accounting Standards Board (“FASB”) Staff Position No. 115-1, The Meaning of Other-Than-Temporary Impairment and Its Application to Certain Investments. This evaluation consists of a review of several factors, including but not limited to the length of time and extent that a security has been in an unrealized loss position, the existence of an event that would impair the issuer’s future repayment potential, the near term prospects for recovery of the market value of a security and the intent and ability of the Company to hold the security until the market value recovers. If the Company determines that such impairment exists, the Company will recognize a charge in the consolidated statement of operations equal to the amount of such impairment. In 2008, the Company recorded an impairment charge relating to certain of its investments. See Note C, Investments, for additional discussion.
 
Depreciation and Amortization
 
Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets as follows:
 
     
Buildings
  30 years
Land improvements
  lesser of the lease term or the useful life
Production equipment
  5-10 years
Laboratory equipment
  3-10 years
Computer equipment and software
  3-5 years
Furniture and office equipment
  3-5 years
Leasehold improvements
  lesser of the lease term or the useful life
 
Impairment of Long-Lived Assets
 
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable based on the criteria established in Statement of Financial Accounting Standards (“SFAS”) No. 144, Accounting for the Impairment or Disposal of Long-Lived Assets. In 2006 the Company recorded an impairment charge relating to certain equipment and leasehold improvements. See Note N, Facility-Related Exit Costs, for additional discussion.
 
Fair Value of Financial Instruments
 
The fair value of the Company’s collaboration receivables, other assets, accounts payable and accrued expenses approximate their carrying amount due to the relatively short maturity of these items.


F-9


 

 
HUMAN GENOME SCIENCES, INC.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(dollars in thousands, except share and per share data)
 
(NOTE B) — Summary of Significant Accounting Policies (continued)
 

Fair Value of Financial Instruments (continued)
 
The carrying amounts of the Company’s investments in the consolidated balance sheets at December 31, 2008 and 2007 approximate their respective fair values. The fair value of the Company’s investments is based on quoted market prices, except for privately-held equity investments for which fair value information is not readily available. See Note O, Fair Value Measurements, for additional discussion.
 
The fair value of the Company’s convertible debt is based on quoted market prices. The fair value of the Company’s lease financing is determined using a discounted cash flow analysis and current rates for corporate debt having similar characteristics and companies with similar credit worthiness. See Note I, Long-Term Debt, for additional discussion.
 
Leases
 
The Company accounts for its leases under SFAS No. 13, Accounting for Leases, and other related guidance. The Company has a number of operating leases and has entered into sale-leaseback transactions for equipment, land and facilities. See Note J, Commitments and Other Matters, for additional discussion.
 
Stock-Based Compensation
 
The Company has a stock incentive plan (the “Incentive Plan”) under which options to purchase shares of the Company’s common stock may be granted to employees, consultants and directors with an exercise price no less than the quoted market value on the date of grant. The Incentive Plan also provides for the issuance of non-vested common stock (restricted stock) and other share-based compensation. The Company recognizes stock-based compensation expense in accordance with SFAS No. 123(R), Share-Based Payment (“SFAS No. 123(R)”). See Note K, Stockholders’ Equity, for additional discussion.
 
Revenue Recognition
 
Collaborative research and development agreements can provide for one or more of up-front license fees, research payments and milestone payments. Agreements with multiple components (“deliverables” or “items”) are evaluated to determine if the deliverables can be divided into more than one unit of accounting. An item can generally be considered a separate unit of accounting if all of the following criteria are met: (1) the delivered item(s) has value to the customer on a stand-alone basis; (2) there is objective and reliable evidence of the fair value of the undelivered item(s); and (3) if the arrangement includes a general right of return relative to the delivered item(s), delivery or performance of the undelivered item(s) is considered probable and substantially in control of the Company. Items that cannot be divided into separate units are combined with other units of accounting, as appropriate. Consideration received is allocated among the separate units based on their respective fair values or based on the residual value method and is recognized in full when the following criteria are met: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the sales price is fixed or determinable; and (4) collectibility is probable. The Company deems service to have been rendered if no continuing obligation exists on the part of the Company.
 
Revenue associated with non-refundable up-front license fees under arrangements where the license fees and research and development activities cannot be accounted for as separate units of accounting are deferred and recognized as revenue on a straight-line basis over the expected term of the Company’s continued involvement in the research and development process. Revenues from the achievement of research and development milestones, if deemed substantive, are recognized as revenue when the milestones are achieved, and the milestone payments are due and collectible. If not deemed substantive, the Company would recognize such milestone as revenue on a straight-line basis over the remaining expected term of continued involvement in the research and development process. Milestones are considered substantive if all of the following conditions are met: (1) the milestone is non-refundable; (2) achievement of the milestone was not reasonably assured at the inception of the arrangement;


F-10


 

 
HUMAN GENOME SCIENCES, INC.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(dollars in thousands, except share and per share data)
 
(NOTE B) — Summary of Significant Accounting Policies (continued)
 

Revenue Recognition (continued)
 
(3) substantive effort is involved to achieve the milestone; and, (4) the amount of the milestone appears reasonable in relation to the effort expended, the other milestones in the arrangement and the related risk associated with the achievement of the milestone and any ongoing research and development or other services are priced at fair value. Payments received in advance of work performed are recorded as deferred revenue.
 
During 2008, the Company entered into an agreement whereby it began providing contract manufacturing services. Revenue in 2008, which was not significant, was recorded as milestones were met.
 
Research and Development
 
Research and development costs are charged to expense as incurred, unless otherwise capitalized pursuant to Emerging Issues Task Force (“EITF”) No. 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services Received for Use in Future Research and Development Activities. Research and development costs include salaries and related benefits, outside services, licensing fees or milestones, materials and supplies, building costs and allocations of certain support costs. Research and development direct expenditures were $242,710, $245,745 and $209,242 for 2008, 2007 and 2006, respectively. Reimbursement of research and development expenses received in connection with collaborative cost-sharing agreements is recorded as a reduction of such expenses.
 
Financing Costs Related to Long-term Debt
 
Costs associated with obtaining long-term debt are deferred and amortized over the term of the related debt on a straight-line basis which approximates the effective interest method.
 
Patent Application Costs
 
Patent application costs are charged to expense as incurred.
 
Capitalization of Interest
 
Interest costs associated with the construction of significant facilities are capitalized as part of the cost of the facilities using the Company’s weighted-average borrowing rate. No interest was capitalized in 2008 or 2007. Capitalized interest costs were $2,527 for 2006.
 
Net Income (Loss) Per Share
 
The Company follows the provisions of SFAS No. 128, Earnings Per Share, which requires the Company to present basic and diluted earnings per share. The Company’s basic and diluted income (loss) per share is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding during all periods presented. Options or other awards to acquire stock and shares issuable upon the conversion of the Company’s convertible subordinated debt are excluded from diluted earnings per share calculations for the years ended December 31, 2008, 2007 and 2006 because the effects are anti-dilutive.
 
Foreign Currency
 
Assets and liabilities of the Company’s international operations are translated into U.S. dollars at exchange rates that are in effect as of the balance sheet date, and equity accounts are translated at historical rates. Revenue and expenses are translated at average exchange rates that are in effect during the year. Translation adjustments are accumulated in other comprehensive income (loss) as a separate component of stockholders’ equity in the consolidated balance sheet. Transaction gains and losses are included in investment income in the consolidated statement of operations.


F-11


 

 
HUMAN GENOME SCIENCES, INC.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(dollars in thousands, except share and per share data)
 
(NOTE B) — Summary of Significant Accounting Policies (continued)
 
Comprehensive Income (Loss)
 
SFAS No. 130, Reporting Comprehensive Income, requires unrealized gains and losses on the Company’s available-for-sale short-term investments, marketable securities and long-term equity investments and the activity for the cumulative translation adjustment to be included in other comprehensive income.
 
The components of accumulated other comprehensive income (loss) are as follows:
 
                         
    December 31,  
    2008     2007     2006  
 
Net unrealized gains (losses) on:
                       
Short-term investments and marketable securities
  $ (4,077 )   $ 2,882     $ (3,036 )
Long-term equity investment in VIA Pharmaceuticals
    38       279       619  
Restricted investments
    108       (39 )     (1,185 )
Foreign currency translation
    (559 )     30       8  
                         
Accumulated other comprehensive income (loss)
  $ (4,490 )   $ 3,152     $ (3,594 )
                         
 
Accumulated other comprehensive income (loss) excludes net realized gains included in net loss of $33,619, $55 and $14,121 for the years ended December 31, 2008, 2007 and 2006, respectively. The effect of income taxes on items in other comprehensive income is $0 for all periods presented.
 
During 2008, the Company recorded an impairment charge relating to its investment in debt securities issued by Lehman Brothers Holdings, Inc. (“LBHI”) of $6,284 due to the significant reduction in the market value of LBHI’s debt securities that the Company believes may not be temporary as a result of LBHI’s bankruptcy. This impairment charge is included in the net loss of $244,915 for the year ended December 31, 2008. See Note C, Investments, for additional discussion.
 
During 2006, the Company sold its remaining 988,387 shares of Cambridge Antibody Technology (“CAT”), a long-term equity investment, for net proceeds of $24,127, and realized a gain of $14,759.
 
Recent Accounting Pronouncements
 
In December 2007, the FASB ratified EITF No. 07-1, Accounting for Collaborative Agreements (“EITF No. 07-1”). EITF No. 07-1 provides guidance regarding financial statement presentation and disclosure of collaborative arrangements, as defined, which includes arrangements the Company has entered into regarding development and commercialization of products. EITF No. 07-1 is effective for the Company as of January 1, 2009. The Company does not believe the adoption of this statement will have a material effect on its consolidated results of operations, financial position or liquidity.
 
In February 2008, the FASB issued a one-year deferral for non-financial assets and liabilities to comply with SFAS No. 157, Fair Value Measurements (“SFAS No. 157”). The Company adopted SFAS No. 157 for financial assets and liabilities effective January 1, 2008 (see Note O, Fair Value Measurements, for further details). There was no material effect upon adoption of this accounting pronouncement on the Company’s consolidated results of operations, financial position or liquidity. The Company does not expect the adoption of SFAS No. 157 as it pertains to non-financial assets and liabilities to have a material impact on its consolidated results of operations, financial position or liquidity.
 
In May 2008, the FASB issued Staff Position No. APB 14-1, Accounting for Convertible Debt Instruments That May Be Settled in Cash upon Conversion (Including Partial Cash Settlement) (“FSP APB 14-1”). FSP APB 14-1 requires that the liability and equity components of convertible debt instruments that may be settled in cash upon conversion (including partial cash settlement) be separately accounted for in a manner that reflects an issuer’s non-convertible debt borrowing rate. The resulting debt discount is amortized over the period the convertible debt is expected to be


F-12


 

 
HUMAN GENOME SCIENCES, INC.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(dollars in thousands, except share and per share data)
 
(NOTE B) — Summary of Significant Accounting Policies (continued)
 

Recent Accounting Pronouncements (continued)
 
outstanding as additional non-cash interest expense. FSP APB 14-1 is effective for the Company as of January 1, 2009 and retroactive application to all periods presented is required. The Company is currently finalizing the impact of the provisions of FSP APB 14-1 on its consolidated statements of operations and consolidated balance sheets. The Company expects to record an increase to stockholders’ equity (deficit) of $169,651 and a non-cash cumulative effect of a change in accounting principle of approximately $18,681 upon adoption of FSP APB 14-1 and will restate its 2007 and 2008 financial statements. The Company expects to record additional non-cash interest expense of approximately $26,400 in 2009 as a result of the adoption of FSP APB 14-1. Additional non-cash interest expense will continue to be recorded each year for the remaining term of the debt.
 
In June 2008, the FASB ratified EITF Issue No. 07-5, Determining Whether an Instrument (or Embedded Feature) Is Indexed to an Entity’s Own Stock (“EITF No. 07-5”). EITF No. 07-5 mandates a two-step process for evaluating whether an equity-linked financial instrument or embedded feature is indexed to the entity’s own stock. It is effective for the Company as of January 1, 2009. The Company is currently evaluating the impact of EITF No. 07-5, and has not yet determined whether the adoption of EITF No. 07-5 will have a material effect on its consolidated results of operations, financial position or liquidity.
 
Sources of Supply
 
The Company is currently able to obtain most of its raw materials, supplies and equipment from various sources, and therefore, has no dependence upon a single supplier. Certain raw materials and other supplies required for manufacturing are currently available only from single sources. As the Company prepares for commercialization of its products, it intends to identify alternative sources of supply.


F-13


 

 
HUMAN GENOME SCIENCES, INC.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(dollars in thousands, except share and per share data)
 
(NOTE C) — Investments
 
Available for sale investments, including accrued interest, at December 31, 2008 and 2007 were as follows:
 
                                 
    December 31, 2008  
          Gross
    Gross
       
    Amortized
    Unrealized
    Unrealized
    Fair
 
    Cost     Gains     Losses     Value  
 
U.S. Treasury and agencies
  $ 755     $ 27     $     $ 782  
Government-sponsored enterprise securities
    10,507       271       (22 )     10,756  
Corporate debt securities
    11,421       29       (297 )     11,153  
                                 
Subtotal — Short-term investments
    22,683       327       (319 )     22,691  
                                 
U.S. Treasury and agencies
    16,150       368       (455 )     16,063  
Government-sponsored enterprise securities
    108,877       3,229       (262 )     111,844  
Corporate debt securities
    145,621       263       (8,151 )     137,733  
                                 
Subtotal — Marketable securities
    270,648       3,860       (8,868 )     265,640  
                                 
Investment in VIA Pharmaceuticals
          19             19  
                                 
Cash and cash equivalents
    5,773                   5,773  
U.S. Treasury and agencies
    6,044       95             6,139  
Government-sponsored enterprise securities
    18,145       403       (11 )     18,537  
Corporate debt securities
    39,289       299       (677 )     38,911  
                                 
Subtotal — Restricted investments
    69,251       797       (688 )     69,360  
                                 
Total
  $ 362,582     $ 5,003     $ (9,875 )   $ 357,710  
                                 
 
                                 
    December 31, 2007  
          Gross
    Gross
       
    Amortized
    Unrealized
    Unrealized
    Fair
 
    Cost     Gains     Losses     Value  
 
U.S. Treasury and agencies
  $ 2,028     $ 12     $     $ 2,040  
Government-sponsored enterprise securities
    27,554       1,065       (127 )     28,492  
Corporate debt securities
    64,072       12       (664 )     63,420  
                                 
Subtotal — Short-term investments
    93,654       1,089       (791 )     93,952  
                                 
U.S. Treasury and agencies
    29,417       689             30,106  
Government-sponsored enterprise securities
    174,937       2,766       (608 )     177,095  
Corporate debt securities
    197,205       1,381       (1,645 )     196,941  
                                 
Subtotal — Marketable securities
    401,559       4,836       (2,253 )     404,142  
                                 
Investment in VIA Pharmaceuticals
          259             259  
                                 
Cash and cash equivalents
    10,158                   10,158  
U.S. Treasury and agencies
    7,049       38             7,087  
Government-sponsored enterprise securities
    19,030       51       (51 )     19,030  
Corporate debt securities
    34,732       101       (177 )     34,656  
                                 
Subtotal — Restricted investments
    70,969       190       (228 )     70,931  
                                 
Total
  $ 566,182     $ 6,374     $ (3,272 )   $ 569,284  
                                 


F-14


 

 
HUMAN GENOME SCIENCES, INC.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(dollars in thousands, except share and per share data)
 
(NOTE C) — Investments (continued)
 
The Company’s restricted investments with respect to its headquarters (“Traville”) and large-scale manufacturing (“LSM”) leases and for the small-scale manufacturing facility leases will serve as collateral for a security deposit for the duration of the leases, although the Company has the ability to reduce the restricted investments that are in the form of securities for the Traville and LSM facility leases by substituting cash security deposits.
 
For the Traville and LSM leases, the Company is required to maintain restricted investments of at least $46,000, or $39,500 if in the form of cash, in order to satisfy the security deposit requirements of these leases. In addition, the Company is also required to maintain $15,000 in restricted investments with respect to leases for its small-scale manufacturing facility. During 2007 the Company pledged collateral of $7,585 to another lessor related to equipment leases. During 2008, approximately $4,877 of this collateral was released, as the lease terms of the related leases expired and the Company exercised its purchase option. The Company’s restricted investments were $69,360 and $70,931 as of December 31, 2008 and December 31, 2007, respectively.
 
Short-term investments, Marketable securities and Restricted investments — unrealized losses
 
The Company’s gross unrealized losses and fair value of investments with unrealized losses were as follows:
 
                                                 
    December 31, 2008  
    Loss Position
    Loss Position
       
    for Less Than
    for Greater Than
       
    Twelve Months     Twelve Months     Total  
    Fair
    Unrealized
    Fair
    Unrealized
    Fair
    Unrealized
 
    Value     Losses     Value     Losses     Value     Losses  
 
Government-sponsored enterprise securities
  $     $     $ 962     $ 22     $ 962     $ 22  
Corporate debt securities
    6,543       284       145       13       6,688       297  
                                                 
Subtotal — Short-term investments
    6,543       284       1,107       35       7,650       319  
                                                 
U.S. Treasury and agencies
    7,540       455                   7,540       455  
Government-sponsored enterprise securities
    1,714       4       11,259       258       12,973       262  
Corporate debt securities
    77,637       4,597       39,334       3,554       116,971       8,151  
                                                 
Subtotal — Marketable securities
    86,891       5,056       50,593       3,812       137,484       8,868  
                                                 
Government-sponsored enterprise securities
    2,975       5       337       6       3,312       11  
Corporate debt securities
    19,002       637       4,016       40       23,018       677  
                                                 
Subtotal — Restricted investments
    21,977       642       4,353       46       26,330       688  
                                                 
Total
  $ 115,411     $ 5,982     $ 56,053     $ 3,893     $ 171,464     $ 9,875  
                                                 
 


F-15


 

 
HUMAN GENOME SCIENCES, INC.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(dollars in thousands, except share and per share data)
 
(NOTE C) — Investments (continued)
 

Short-term investments, Marketable securities and Restricted investments — unrealized losses (continued)
 
                                                 
    December 31, 2007  
    Loss Position
    Loss Position
       
    for Less Than
    for Greater Than
       
    Twelve Months     Twelve Months     Total  
    Fair
    Unrealized
    Fair
    Unrealized
    Fair
    Unrealized
 
    Value     Losses     Value     Losses     Value     Losses  
 
Government-sponsored enterprise securities
  $     $     $ 4,211     $ 127     $ 4,211     $ 127  
Corporate debt securities
                57,293       664       57,293       664  
                                                 
Subtotal — Short-term investments
                61,504       791       61,504       791  
                                                 
Government-sponsored enterprise securities
                24,366       608       24,366       608  
Corporate debt securities
    53,674       1,523       12,498       122       66,172       1,645  
                                                 
Subtotal — Marketable securities
    53,674       1,523       36,864       730       90,538       2,253  
                                                 
Government-sponsored enterprise securities
                11,685       51       11,685       51  
Corporate debt securities
    1,951       29       15,583       148       17,534       177  
                                                 
Subtotal — Restricted investments
    1,951       29       27,268       199       29,219       228  
                                                 
Total
  $ 55,625     $ 1,552     $ 125,636     $ 1,720     $ 181,261     $ 3,272  
                                                 
 
The deterioration of the credit markets during 2008 had a detrimental effect on the Company’s investment portfolio. During 2008, LBHI experienced a significant deterioration in its credit worthiness and filed a petition under Chapter 11 of the U.S. Bankruptcy Code. As a result, the Company determined that its investment in LBHI debt securities had incurred an other-than-temporary impairment, and accordingly, recorded an impairment charge of $6,284 which is reflected on the consolidated statements of operations. Further deterioration in the credit markets may have an additional adverse effect on the fair value of the Company’s investment portfolio. The Company has the ability and intent to hold these investments until a recovery of the unrealized losses.
 
The Company owned 152 available-for-sale U.S Treasury obligations, government-sponsored enterprise securities and corporate debt securities at December 31, 2008. Of these 152 securities, 79 had unrealized losses at December 31, 2008.
 
The Company’s equity investments in privately-held companies for which no readily available fair value information is available are carried at cost. Long-term equity investments of publicly-traded companies are carried at market value based on quoted market prices and unrealized gains and losses for these investments are reported as a separate component of stockholders’ equity until realized.

F-16


 

 
HUMAN GENOME SCIENCES, INC.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(dollars in thousands, except share and per share data)
 
(NOTE C) — Investments (continued)
 
Other Information
 
The following table summarizes maturities of the Company’s short-term investments, marketable securities and restricted investment securities at December 31, 2008:
 
                                                 
    Short-term
    Marketable
    Restricted
 
    Investments     Securities     Investments  
    Amortized
    Fair
    Amortized
    Fair
    Amortized
    Fair
 
Maturities
  Cost     Value     Cost     Value     Cost     Value  
 
Less than one year
  $ 22,683     $ 22,691     $     $     $ 23,580     $ 23,666  
Due in year two through year three
                258,119       253,103       38,150       38,058  
Due in year four through year five
                7,697       7,671       6,425       6,451  
Due after five years
                4,832       4,866       1,096       1,185  
                                                 
Total
  $ 22,683     $ 22,691     $ 270,648     $ 265,640     $ 69,251     $ 69,360  
                                                 
 
The Company’s short-term investments include mortgage-backed securities with an aggregate cost of $6,434 and an aggregate fair value of $6,576 at December 31, 2008. The Company’s marketable securities include mortgage-backed securities with an aggregate cost of $75,321 and an aggregate fair value of $76,983 at December 31, 2008. The Company’s restricted investments include mortgage-backed securities with an aggregate cost of $4,953 and an aggregate fair value of $5,043 at December 31, 2008. These securities have no single maturity date and, accordingly, have been allocated on a pro rata basis to each maturity range based on each maturity range’s percentage of the total value.
 
The Company’s net proceeds, realized gains and realized losses from its investments are as follows:
 
                         
    Year Ended December 31,  
    2008     2007     2006  
 
Net proceeds on sale of investments prior to maturity
  $ 237,861     $ 123,522     $ 334,250  
Realized gains
    34,113       494       14,888  
Realized losses
    (494 )     (439 )     (767 )
 
Realized gains and losses related to the Company’s short-term investments, marketable securities and restricted investments are included in investment income in the consolidated statement of operations. The cost of the securities sold is based on the specific identification method. Realized gains shown above also include gains related to the sale of long-term equity investments, which are shown separately on the consolidated statement of operations.
 
During 2008, 2007 and 2006, the Company recognized interest income of $22,406, $32,983 and $27,316 respectively, in investment income.
 
(NOTE D) — Collaborations and U.S. Government Agreement
 
Principal Agreements
 
 
During 2006, the Company entered into an agreement with Novartis International Pharmaceutical Ltd. (“Novartis”) for the co-development and commercialization of Albuferon®. Under the agreement, the Company and Novartis will co-commercialize Albuferon in the United States, and will share U.S. commercialization costs and U.S. profits equally. Novartis will be responsible for commercialization outside the U.S. and will pay the Company a royalty on those sales. The Company will have primary responsibility for the bulk manufacture of Albuferon, and Novartis will have primary responsibility for commercial manufacturing of the finished drug product. The Company is entitled to payments aggregating approximately $507,500, including a non-refundable up-front license fee, upon the


F-17


 

 
HUMAN GENOME SCIENCES, INC.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(dollars in thousands, except share and per share data)
 
(NOTE D) — Collaborations and U.S. Government Agreement (continued)
 

Principal Agreements (continued)
 

Agreement with Novartis (continued)
 
successful attainment of certain milestones. The Company and Novartis will share clinical development costs. The Company is recognizing a 2006 up-front license fee of $45,000 as revenue over the clinical development period, estimated to end in 2010. Including the up-front fee, as of December 31, 2008, the Company has contractually earned and received payments aggregating $132,500. The Company is recognizing these payments as revenue ratably over the estimated remaining development period. The Company recognized revenue of $35,408, $28,039 and $7,090 in 2008, 2007 and 2006, respectively, under this agreement.
 
 
During 2006, the Company entered into a license agreement with GlaxoSmithKline (“GSK”) for the co-development and commercialization of LymphoStat-B arising from an option GSK exercised in 2005, relating to an earlier collaboration agreement, described more fully below. The agreement grants GSK a co-development and co-commercialization license, under which both companies will jointly conduct activities related to the development and sale of products in the United States and abroad. The Company and GSK will share Phase 3 and 4 development costs, sales and marketing expenses and profits of any product commercialized under the agreement. The Company is conducting Phase 3 clinical trials with assistance from GSK, and will have primary responsibility for bulk manufacturing. In partial consideration of the rights granted to GSK in this agreement, the Company received a non-refundable payment of $24,000 during 2006 and is recognizing this payment as revenue over the remaining clinical development period, estimated to end in 2010. The Company recognized revenue of $6,545, $6,545 and $2,727 in 2008, 2007 and 2006, respectively, relating to this payment.
 
The LymphoStat-B agreement arises from a 1993 agreement, as amended, in which the Company entered into a collaboration agreement providing GSK a first right to develop and market products in human and animal health care (“GSK Products”), based upon human genes identified by the Company. In June 1996, this agreement was substantially amended (the “1996 GSK Agreement”).
 
With respect to the Company’s rights under the 1996 GSK Agreement, the Company is entitled to (1) royalties on the net sales of certain GSK Products developed pursuant to the agreement, (2) product development milestones and (3) the option to co-promote up to 20% of any product developed by GSK under the collaboration agreement. If the Company were to exercise its option to co-promote any GSK Products, it would be entitled to receive additional amounts from GSK in proportion to its level of co-promotion. The Company has been informed that GSK is pursuing research programs involving specific genes for the creation of small molecule, protein and antibody drugs. The Company cannot provide any assurance that any of these programs will be continued or result in any approved drugs.
 
During 2005, GSK exercised its option under an earlier collaboration agreement to develop and commercialize HGS-ETR1 jointly with the Company. During 2008, the Company reacquired GSK’s rights to TRAIL Receptor antibodies (including rights to HGS-ETR1 and HGS-ETR2) from GSK, in exchange for a reduction in potential future royalties due to the Company for a product currently being developed by GSK. The Company determined the fair value of the rights reacquired by estimating a probability-weighted net present value of the future cash stream of such rights. The transaction was accounted for in accordance with Accounting Principles Board Opinion No. 29, Accounting for Nonmonetary Transactions, as amended by SFAS No. 153, Exchanges of Nonmonetary Assets, an amendment to APB Opinion No. 29. Both the rights reacquired and the royalty concessions related to in-process research and development projects. Therefore, no assets or liabilities were recorded as part of this transaction and no gain or loss was recorded.
 
In 2004, the Company entered into an agreement with GSK under which GSK acquired exclusive worldwide rights to develop and commercialize Syncria®, a drug that had been in late-stage preclinical development by the Company


F-18


 

 
HUMAN GENOME SCIENCES, INC.
 
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(dollars in thousands, except share and per share data)
 
(NOTE D) — Collaborations and U.S. Government Agreement (continued)
 

Principal Agreements (continued)
 

Agreements with GlaxoSmithKline (formerly SmithKline Beecham Corporation) (continued)
 
for potential use in the treatment of diabetes. In 2004, the Company received an up-front fee and is recognizing this revenue ratably over the clinical development period, which is estimated to be seven years. With respect to this fee, the Company recognized $741 as revenue each year in the three year period ended December 31, 2008. In 2006, the Company received and recognized as revenue $6,000 from GSK in connection with development milestones met by GSK during the year. The Company also received and recognized $1,000 as revenue in 2006 in connection with the sale of clinical material to GSK. Subsequent to December 31, 2008, GSK announced initiation of a Phase 3 trial of Syncria. The Company will receive a $9,000 milestone payment under this agreement related to this milestone.
 
 
In 2008, Teva Pharmaceuticals Industries, Ltd. (“Teva”) acquired all of the outstanding stock of CoGenesys and CoGenesys became a wholly-owned subsidiary of Teva called Teva Biopharmaceuticals USA, Inc. (“Teva Bio”). The Company sold its CoGenesys division in 2006 and entered into a license agreement, as amended, that is now with Teva Bio. This agreement provides the Company with various milestone and royalty rights on certain products, the option to reestablish development rights to certain licensed products and the option to have Teva Bio conduct certain drug development activities on the Company’s behalf. Teva Bio can obtain additional product rights by extending the initial seven-year research term upon the payment of additional consideration. In addition, the Company entered into a three-year manufacturing services agreement, as amended, that is now with Teva Bio to provide certain services. The Company allocated, based on estimated fair values, $7,575 of its consideration received upon the initial sale of CoGenesys to the product license and manufacturing services agreement, which is being recognized ratably over the term of the manufacturing services agreement, as amended. The Company recognized license revenue of $2,525, $2,525 and $1,473 during the years ended December 31, 2008, 2007 and 2006, respectively, and manufacturing services revenue of $367, $278 and $437 during the years ended December 31, 2008, 2007 and 2006, respectively, relating to these agreements, which represents related party revenue in 2007 and 2006. See Note P, Teva Biopharmaceuticals USA, Inc. (formerly CoGenesys), for additional discussion.
 
 
The Company’s research and development expenses in 2008 of $242,710 are net of $36,104 and $51,783 of costs reimbursed by Novartis and GSK, respectively. Research and development expenses of $245,745 in 2007 were net of $46,508 and $39,301 of costs reimbursed by Novartis and GSK, respectively. Research and development expenses of $209,242 in 2006 were net of $22,926 and $10,199 reimbursed by Novartis and GSK, respectively. The Company shares certain research and development costs including personnel costs, outside services, manufacturing, and overhead with Novartis and GSK under cost sharing provisions in the collaboration agreements. See Note E, Collaboration Receivables, for additional discussion.
 
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