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| HUMAN GENOME SCIENCES ANNOUNCES THIRD QUARTER 2008 FINANCIAL RESULTS AND KEY DEVELOPMENTS | |
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- Treatment completed in Albuferon® Phase 3 trials; first Phase 3 data in December 2008 - - Enrollment completed in LymphoStat-B® Phase 3 trials; first Phase 3 data in mid-2009 - - HGS updates financial guidance - ROCKVILLE, Maryland – November 6, 2008 – Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced financial results and key developments for the quarter ended September 30, 2008. “Albuferon, LymphoStat-B and our oncology program all continued to make substantial progress during the third quarter. In addition, we entered into an exclusive agreement with Hospira that will enable HGS to generate revenue in the coming years by leveraging our process development and manufacturing capabilities,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “We are on track to report our first Phase 3 data for Albuferon in December 2008. We are on track to report our first Phase 3 data for LymphoStat-B by mid-2009. We have also met every milestone under our contract to supply ABthrax to the U.S. Strategic National Stockpile. We will soon complete production, and we are currently awaiting authorization to begin delivery. However, it now appears that the timing of this authorization is likely to cause the ABthrax sales we previously expected to recognize in 2008, to be recognized instead in 2009. We are updating our 2008 financial guidance accordingly. We continue to believe that ABthrax offers a significant step forward in the treatment of inhalational anthrax and could play an important role in strengthening America’s arsenal against bioterrorism.” FINANCIAL RESULTSHGS reported increased revenues for the quarter ended September 30, 2008 of $11.7 million, compared with revenues of $11.1 million for the same period in 2007. Revenues included $8.9 million recognized from the Albuferon agreement with Novartis, and $1.6 million in revenue recognized from the LymphoStat-B agreement with GlaxoSmithKline (GSK). The Company reported a net loss for the quarter ended September 30, 2008 of $68.1 million ($0.50 per share), compared with a net loss for the second quarter of 2007 of $67.3 million ($0.50 per share). The net loss for the quarter includes a charge of $6.0 million ($0.04 per share) for impaired investments, and a decrease in investment income, partially offset by decreased research and development expenses related to Phase 3 trials for Albuferon. For the first nine months of 2008, HGS reported increased revenues of $35.6 million, compared with revenues of $29.3 million for the same period of the previous year. Revenues included $26.6 million recognized from the Albuferon agreement and $4.9 million recognized from the LymphoStat-B agreement. The Company reported a net loss of $189.3 million ($1.40 per share) for the nine months ended September 30, 2008, compared with a net loss of $169.6 million ($1.26 per share) for the same period of the previous year. The increased net loss for the nine months was due primarily to increased research and development and general and administrative expenses, in addition to the $6.0 million ($0.04 per share) charge for impaired investments, partially offset by a one-time gain of $32.5 million ($0.24 per share) resulting from the sale of CoGenesys, Inc. stock to Teva Pharmaceutical Industries, Ltd. Net cash burn for the nine months ended September 30, 2008 totaled $186.9 million. (For information on the calculation of this non-GAAP financial measure, visit http://www.hgsi.com/images/Q32008results/netcashburn.pdf). As of September 30, 2008, cash and investments totaled $432.8 million, of which $360.3 million is unrestricted and available for operations. This compares with cash and investments totaling $603.8 million, of which $532.9 million was unrestricted and available for operations, as of December 31, 2007. “Our cash position remains strong and is sufficient to take us through the availability of Phase 3 data and the filing of marketing applications for our lead products, while also fueling development of our product pipeline,” said Tim Barabe, Senior Vice President and Chief Financial Officer, HGS. “We are updating our financial guidance to reflect the change in expected timing of ABthrax sales.” HIGHLIGHTS OF RECENT PROGRESSAlbuferon® on Track for First Phase 3 Data in December 2008
LymphoStat-B® on Track for First Phase 3 Data in Mid-2009
ABthrax™: Awaiting U.S. Government Authorization to Begin Delivery to Strategic National Stockpile
Enrollment and Initial Dosing Completed in Non-Small Cell Lung Cancer Trial
Darapladib Demonstrates Promise in Phase 2; GSK Confirms Plan to Initiate Phase 3 Development
In its third quarter results press release issued October 22, 2008, GSK said, “These data support our belief that Lp-PLA2 inhibition may be an important therapeutic target and we plan to begin Phase 3 clinical studies shortly.” Darapladib was discovered by GSK based on HGS technology. HGS will receive a 10% royalty on worldwide sales of darapladib Process Development and Manufacturing Alliance with Hospira will Enable HGS to Generate Revenue from Available Manufacturing Capacity In September 2008, HGS entered into an exclusive agreement with Hospira, Inc., for manufacturing process development and commercial supply of select Hospira biopharmaceutical products. In addition to the partnership with Hospira, HGS entered into a marketing services agreement with Eden Biodesign Ltd. in August 2008, under which Eden Biodesign will assist HGS in identifying other clients interested in large-scale manufacturing and late-stage process development. The Hospira alliance and similar agreements have the potential to generate $30-60 million in revenue over the next three to four years. 2008 FINANCIAL GUIDANCEHGS updated the financial guidance provided in late February 2008:
HGS is confident that it will receive $150 million in 2009 for delivery of 20,000 doses of ABthrax to the U.S. Strategic National Stockpile, with an additional $15 million expected upon FDA licensure. CONFERENCE CALLHGS management will hold a conference call to discuss this announcement today at 5 PM Eastern. Investors may listen to the call by dialing 866-550-6338 or 347-284-6930, passcode 6760480, five to 10 minutes before the start of the call. A replay of the conference call will be available within a few hours after the call ends. Investors may listen to the replay by dialing 888-203-1112 or 719-457-0820, confirmation code 6760480. Today’s conference call also will be webcast and can be accessed at www.hgsi.com. Investors interested in listening to the live webcast should log on before the conference call begins to download any software required. Both the audio replay and the archive of the conference call webcast will remain available for several days. ABOUT HUMAN GENOME SCIENCESThe mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax, cancer and other immune-mediated diseases. The Company’s primary focus is rapid progress toward the commercialization of its two key lead drugs, Albuferon® (albinterferon alfa-2b) for hepatitis C and LymphoStat-B® (belimumab) for lupus. Phase 3 clinical trials of both drugs are ongoing. ABthrax™ (raxibacumab) is in late-stage development for the treatment of inhalation anthrax, and the Company is awaiting authorization to begin the delivery of 20,000 doses of ABthrax to the Strategic National Stockpile under a contract entered into with the U.S. Government in June 2006. HGS also has three drugs in clinical development for the treatment of cancer, including two TRAIL receptor antibodies and a small-molecule antagonist of IAP (inhibitor of apoptosis) proteins. In addition, HGS has substantial financial rights to certain products in the GSK clinical development pipeline. For more information about HGS, please visit the Company’s web site at www.hgsi.com. Health professionals and patients interested in clinical trials of HGS products may inquire via e-mail to This e-mail address is being protected from spam bots, you need JavaScript enabled to view it or by calling HGS at (301) 610-5790, extension 3550. HGS, Human Genome Sciences, ABthrax, Albuferon and LymphoStat-B are trademarks of Human Genome Sciences, Inc. Safe Harbor Statement
(See selected financial data on following pages.)
(a) Includes stock-based compensation expense of $2,603 ($0.02 per share) and $3,474 ($0.03 per share) for the three months ended September 30, 2008 and 2007, respectively. Includes stock-based compensation expense of $7,837 ($0.06 per share) and $9,824 ($0.07 per share) for the nine months ended September 30, 2008 and 2007, respectively. (b) Includes stock-based compensation expense of $2,041 ($0.02 per share) and $2,261 ($0.02 per share) for the three months ended September 30, 2008 and 2007, respectively. Includes stock-based compensation expense of $6,111 ($0.05 per share) and $6,606 ($0.05 per share) for the nine months ended September 30, 2008 and 2007, respectively.
(c) Includes $72,562 and $70,931 in restricted investments at September 30, 2008 and December 31, 2007, respectively. # # #
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