| HUMAN GENOME SCIENCES REPORTS FINANCIAL RESULTS FOR FULL YEAR AND FOURTH QUARTER 2002 | |
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ROCKVILLE, Maryland – February 14, 2003 -- Human Genome Sciences, Inc. (Nasdaq: HGSI) announced today financial results for the quarter and full year periods ended December 31, 2002 and provided guidance for the financial results anticipated for the year 2003. The Company’s pro forma net loss for the year 2002 was $173.3 million, or $1.35 per share. This compares to the pro forma net loss for 2001 of $90.9 million, or $0.72 per share. The Company’s pro forma net loss for the full year 2002 excludes a one-time, non-cash charge of $32.2 million, or $0.25 per share, relating to a write-down of the value of common shares purchased in 2000 from Cambridge Antibody Technology plc, as part of the Company’s previous antibody collaboration agreement, and a one-time charge to Research and Development of $14.2 million, or $0.11 per share, associated with the previous design of the Large Scale Manufacturing Facility, which is being modified to increase capacity and simplify the design. The modified design likely will result in a reduction in the total cost of the facility. The pro forma net loss for the full year of 2001 excludes a one-time, non-cash charge of $22.3 million, or $0.17 per share, relating to a write-down of the value of common shares received from Transgene, S.A. at the formation of a February 1998 collaboration, and debt conversion expenses of $3.9 million, or $0.03 per share, associated with the conversion of $28.6 million of convertible notes to equity. The Company’s actual net loss, in conformity with Generally Accepted Accounting Principles (GAAP), for the twelve months ended December 31, 2002, was $219.7 million, or $1.71 per share. This compares to the actual net loss for the year-earlier period of $117.2 million, or $0.92 per share. Total revenues in 2002 were $3.6 million, compared to $12.8 million for the year- earlier period. The decrease in revenues is due primarily to the expiration of the exclusive aspects of the Company’s Human Gene Therapeutic Consortium on June 30, 2001, which completed the Consortium members’ initial payment obligations. For the quarter ended December 31, 2002, the Company’s pro forma net loss was $45.6 million, or $0.35 per share, which excludes a one-time charge of $14.2 million, or $0.11 per share, noted above related to the change in the design of the Large Scale Manufacturing Facility. This compares to the pro forma net loss for the year-earlier period of $32.9 million, or $0.26 per share, which excludes a non-cash, one-time write-down of the investment in shares of Transgene, noted above, of $22.3 million, or $0.17 per share. For the quarter ended December 31, 2002, the Company’s actual net loss, in conformity with GAAP, was $59.8 million, or $0.46 per share. This compares to the actual net loss for the year-earlier period of $55.2 million, or $0.43 per share. Total revenues for the quarter ended December 31, 2002 were $0.6 million, which was the same amount as the revenue for the same period of the previous year. Human Genome Sciences’ operating costs increased during the twelve-month and three-month periods as compared to the year-earlier periods primarily due to increased manufacturing activities, increased investment in the Company’s drugs in clinical and preclinical development and increased patent-related activities. At December 31, 2002, cash and short-term investments totaled $1.49 billion, including $205.4 million of restricted investments. This compares to $1.69 billion, including $144.9 million of restricted investments at December 31, 2001. The increase in restricted investments is related to lease financing arrangements for the Company’s corporate, R&D and manufacturing facilities. As of December 31, 2002, there were approximately 128.9 million shares of Human Genome Sciences common stock outstanding. William A. Haseltine, Ph.D., Chairman and Chief Executive Officer, said, “The past year was an important year in the progress of Human Genome Sciences. We have eight drugs in clinical trials. We continue to expand our manufacturing and clinical development capabilities. We have a strong financial position. We look forward to significant clinical development milestones for a number of our products in 2003.” Steven C. Mayer, Senior Vice President and Chief Financial Officer, said, “We are pleased to end 2002 in a strong financial position. The strength of our balance sheet results from several successful financings completed in 1999 and 2000. We have no significant debt repayment obligations until 2007. We believe that the Company’s cash reserves are sufficient to cover our operating expenses over the next several years.” HIGHLIGHTS OF 2002 PRODUCTS AlbuferonTM-alpha: Results from a Phase 1 clinical trial demonstrate that Albuferon-alpha is well tolerated, has a prolonged half-life and is biologically active in patients with chronic hepatitis C. Human Genome Sciences is continuing to evaluate Albuferon-alpha’s safety, tolerability and pharmacology at higher doses under an amended protocol designed to seek the maximum biological response that can be achieved at a tolerable dose. AlbutropinTM: A Phase 1 clinical trial of Albutropin is complete. Data from this trial show that Albutropin is well tolerated and is biologically active in adult patients with growth hormone deficiency. Albutropin remains in the blood substantially longer than is reported for recombinant native human growth hormone. During 2003, the Company plans to initiate a Phase 2 trial of Albutropin in adults with growth hormone deficiency and a Phase 1/2 trial of Albutropin in children with growth retardation due to growth hormone deficiency. BLySTM: Results from a Phase 1 clinical trial to evaluate the safety and pharmacology of BLyS (B-lymphocyte stimulator) in patients with common variable immunodeficiency (CVID) demonstrate that BLyS is safe and well-tolerated. BLyS also is the subject of an ongoing Phase 1 clinical trial to evaluate its potential as a treatment for an immune disorder known as immunoglobulin-A (IgA) deficiency. LymphoStat-BTM: Human Genome Sciences completed patient enrollment in a Phase 1 clinical trial to evaluate the safety and pharmacology of LymphoStat-B (human monoclonal antibody to B-lymphocyte stimulator, BLyS) in patients with systemic lupus erythematosus. The Company is in the process of completing the treatment and follow-up phases of the trial and anticipates having results available during the first half of 2003. LymphoRadTM 131: The Company initiated Phase 1 clinical trials to evaluate the safety and pharmacology of LymphoRad131. The first trial is focused on patients with multiple myeloma. Enrollment is expected to continue throughout 2003 and into 2004. AlbuleukinTM: Human Genome Sciences initiated Phase 1 clinical trials to evaluate the safety and pharmacology of Albuleukin in patients with solid tumor cancers. TRAIL-R1 monoclonal antibody: Human Genome Sciences initiated Phase 1 clinical trials to evaluate the safety and pharmacology of TRAIL-R1 mAb in patients with advanced tumors. PIPELINE Human Genome Sciences’ drug candidates fall into several therapeutic areas including oncology, immunology, endocrinology/metabolism and infectious disease. In addition, Human Genome Sciences has initiated a number of research programs related to biodefense. Human Genome Sciences is using its protein and antibody drug development capabilities to develop therapeutic candidates to address microbial targets including anthrax and other infectious agents. PARTNERSHIPS GlaxoSmithKline: During 2002, the Company received a clinical milestone payment from GlaxoSmithKline, related to the initiation of Phase 1 clinical trials of a new compound, SB-462795, to evaluate its potential use in the treatment of patients with osteoporosis. This is the second genomics-derived drug discovered by GlaxoSmithKline using Human Genome Sciences’ technology to enter human trials. The first drug, announced in 2001, is an inhibitor of lipoprotein-associated phospholipase A2 (Lp-PLA2), an enzyme associated with formation of atherosclerotic plaques. Lp-PLA2 is being studied for use in cardiovascular disease and is now in Phase 2 clinical trials. Both SB-462795 and Lp-PLA2 inhibitor are small-molecule compounds. Human Genome Sciences is entitled to receive additional milestone payments if these drugs move into registration, and will receive royalties if the drugs are commercialized. The Company also has an option to co-promote commercialized drugs in North America and Europe. Schering-Plough: The Company entered into an agreement during 2002 with Schering-Plough Corporation under which Schering-Plough acquired exclusive rights to develop and commercialize two human antibodies from Human Genome Sciences’ technology. The Company will receive milestone payments and royalties on sales of products that may result from research on each of the two antibodies. Under the terms of a prior Human Gene Therapeutic Consortium agreement, Schering-Plough had options to two therapeutic proteins discovered by Human Genome Sciences. In October 2000, Human Genome Sciences announced that Schering-Plough exercised its option to develop and commercialize a novel type of interferon. Under the terms of the new agreement reached in 2002, Schering-Plough was granted exclusive rights to the use of two human antigens as targets for the development and commercialization of antibody drugs in lieu of its remaining option to exclusive rights to a second therapeutic protein. The 2002 agreement therefore satisfies the remaining Human Genome Sciences obligations to Schering-Plough. Takeda: Takeda Chemical Industries, Ltd. exercised its option to develop and commercialize TRAIL-R1 mAb in Japan. Human Genome Sciences retains development and commercialization rights to TRAIL-R1 mAb in North America, Europe and the rest of the world. As expected, Takeda has discontinued development of mirostipen in Japan. According to the terms of a June 1995 agreement, Takeda was granted an exclusive option to license a limited number of Human Genome Sciences products for development and sale in Japan. Takeda has paid Human Genome Sciences an option fee for these rights, and will pay milestone and royalty payments to Human Genome Sciences for each product developed and brought to market in Japan. In addition to Human Genome Sciences, GlaxoSmithKline, Schering-Plough and Takeda, the Human Gene Therapeutic Consortium included Merck KGaA and Sanofi-Synthelabo. The initial term of the Human Gene Therapeutic Consortium agreements expired on June 30, 2001. Under the Consortium agreements, work already initiated prior to the expiration can be continued if consortium members provide evidence of continued diligence, but no new use of Human Genome Sciences’ technology is permitted. The Company’s partners in the Human Gene Therapeutic Consortium have identified a large number of research programs for the creation of small molecule, protein and antibody drugs, involving many different genes. Cambridge Antibody Technology: Human Genome Sciences exercised two options to enter into exclusive development partnership agreements with Cambridge Antibody Technology plc (CAT). These agreements are focused on human monoclonal antibodies to TRAIL Receptor-1 (TRAIL-R1) and TRAIL Receptor-2 (TRAIL-R2). Both antibodies are being evaluated as anticancer drugs by Human Genome Sciences. TRAIL-R1 and TRAIL-R2 are found on the surface of a number of solid and hematopoietic cancer cells. Under the terms of a prior agreement, Human Genome Sciences has the right to use CAT’s antibody technology to develop and sell human antibodies for therapeutic and diagnostic purposes. In return, CAT is entitled to receive from Human Genome Sciences license fees, clinical development milestones and royalties on sales of products derived from CAT’s technology. Kirin: Human Genome Sciences signed a license agreement with the Pharmaceutical Division of Kirin Brewery Company, Ltd., under which the two companies will collaborate on the development and commercialization of agonistic human monoclonal antibodies to TRAIL Receptor-2. Under the terms of the agreement, the companies will work together to identify and optimize the best candidate to enter into clinical development. Kirin will develop and commercialize any resulting drug in Japan and Asia/Australasia. Human Genome Sciences will develop and commercialize any resulting drug in North America, Europe and the rest of the world. Kirin will pay milestone payments and royalties to Human Genome Sciences for any TRAIL-R2 mAb product that is developed and marketed in Japan and Asia/Australasia. Human Genome Sciences will pay royalties to Kirin for any product based on the Kirin TRAIL-R2 mAb that is developed and marketed in North America, Europe and the rest of the world. The agreement with Kirin also gives Human Genome Sciences the opportunity to study the Kirin antibodies to TRAIL-R2 alongside the Company’s own antibody to determine the optimal drug candidate to advance through clinical development. Corautus Genetics: Human Genome Sciences holds an equity interest of approximately fifteen percent in Corautus Genetics Inc. (AMEX:CAQ), a new company that resulted from the merger of Vascular Genetics Inc. (VGI) and GenStar Therapeutics. Corautus Genetics holds an exclusive license in the field of gene therapy for Human Genome Sciences’ VEGF-2 gene (a license previously held by VGI). Human Genome Sciences will be entitled to receive up to a ten percent royalty on net sales of any product brought to market by Corautus Genetics that is based on the VEGF-2 gene. FINANCES AND CAPITAL PROJECTS Financial Guidance for 2003
Actual results may vary significantly depending on various factors, including particularly, increases in the Company’s revenues and additional expenses or charges, as well as changes in shares outstanding associated with or caused by future alliances, acquisitions, financing transactions or note conversions. In addition, depending on market and interest rate conditions, the Company is exploring, and, from time to time, may take, actions to strengthen further its financial position, including the restructure of outstanding lease obligations in order to reduce its restricted cash and the repurchase or restructure of some or all of its outstanding convertible debt instruments. Facilities and Capital Projects Research Center New R&D/Corporate Campus and Large Scale Manufacturing Plant Human Genome Sciences has nearly finalized the re-design of the Large Scale Manufacturing Plant. Upon completion, it will be capable of producing novel human protein and antibody drugs and will have the capacity to produce several drugs at a time in commercial quantities. The design was modified based on an assessment of the production requirements for products currently in clinical development, reflecting an increased need for mammalian protein production capacity related to the continuing progress of the Company’s antibody product candidates. This modified design is expected to result in a $75.0 million to $100.0 million reduction in the total cost of the facility, and will delay the construction schedule. In the fourth quarter, the Company recorded a charge for construction design changes, included within Total Research and Development costs, of $14.2 million for costs associated with the previous design. Human Genome Sciences agreed to use a portion of its investment securities as collateral for the financing arrangements for these facilities. The amount of collateral will increase as funds are used to finance the construction of facilities. Because of the redesign, this amount is $75.0 million to $100.0 million less than previously estimated. The Company has the option to buy the facilities at each of the three projects at the end of the respective lease periods. In addition, the Financial Accounting Standards Board (FASB) has recently announced changes in accounting standards that may require a change in how Human Genome Sciences accounts for certain lease financings. None of these accounting changes should affect the availability of the Company’s cash and short-term investments. In light of this possibility, as well as other factors related to the improvement and construction of facilities, the Company is exploring a range of refinancing options. These may or may not result in a change of accounting treatment for these transactions. CONFERENCE CALL Human Genome Sciences will hold a conference call today to discuss this announcement. The conference call will be hosted by senior management at 11:00 am Eastern time. This conference call also will be webcast. Interested parties who wish to listen to the webcast should visit the Human Genome Sciences website at www.hgsi.com. The archive of the conference call will be available several hours after the conference call and will be available for several days. ABOUT HUMAN GENOME SCIENCES Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based drugs to patients. For additional information on Human Genome Sciences, Inc., visit the company’s web site at www.hgsi.com. HGS, Human Genome Sciences, Albuferon, Albuleukin, Albutropin, BLyS, LymphoStat-B and LymphoRad are trademarks of Human Genome Sciences, Inc. This announcement contains 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 Human Genome Sciences’ 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 the Company’s unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company’s ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company’s 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 the Company’s filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. Human Genome Sciences undertakes 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. (See selected financial information.) ####
CONTACT: Steven C. Mayer Senior Vice President & Chief Financial Officer 301/309-8504 Jerry Parrott Vice President, Corporate Communications 301/315-2777 Kate de Santis Director, Investor Relations 301/251-6003 |
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