| HUMAN GENOME SCIENCES ANNOUNCES FIRST QUARTER 2010 FINANCIAL RESULTS AND KEY DEVELOPMENTS | |
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- Submission of BENLYSTA™ regulatory applications in the United States and Europe planned second quarter 2010 - ROCKVILLE, Maryland – April 29, 2010 – Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced financial results for the quarter ended March 31, 2010, and provided highlights of recent key developments. “In the first months of 2010, we have continued to make excellent progress toward the commercialization of BENLYSTA,” said H. Thomas Watkins, President and Chief Executive Officer. “BENLYSTA met the primary efficacy endpoint in both of its pivotal Phase 3 trials, with results that support our belief that this first-in-class treatment could become the first new approved drug for lupus in more than 50 years. For ZALBIN dosed once a month, we reported positive interim results from a Phase 2b trial that appear to support further evaluation of ZALBIN dosed monthly in a Phase 3 program. The European regulatory application for JOULFERON dosed every two weeks has been withdrawn by Novartis. Meanwhile, the U.S. regulatory application for this ZALBIN dosing regimen continues under review. We expect that the next few months will provide greater clarity regarding the optimal path forward for ZALBIN’s development.” FINANCIAL RESULTSHGS reported revenues for the quarter ended March 31, 2010 of $46.5 million, compared with revenues of $177.3 million for the same period in 2009. Revenues primarily included $27.6 million recognized from the ZALBIN agreement with Novartis and $13.5 million recognized from sales and deliveries of raxibacumab to the U.S. Strategic National Stockpile. The Company reported a net loss for the first quarter of 2010 of $47.9 million ($0.26 diluted per share), compared with net income of $129.8 million ($0.85 diluted per share) for the first quarter of 2009. The net loss for the current quarter, compared with net income reported for the same quarter last year, primarily reflected recognition of raxibacumab revenue of $13.5 million in 2010, versus raxibacumab revenue of $153.8 million in 2009, in addition to a gain in 2009 of $38.9 million on the extinguishment of debt. As of March 31, 2010, cash and investments totaled $1.1 billion, of which $1.05 billion was unrestricted and available for operations. This compares with cash and investments totaling $1.2 billion as of December 31, 2009, of which $1.1 billion was unrestricted and available for operations. “HGS continues to have a strong cash position to support the submission of regulatory applications and the commercial launch of our late-stage products,” said David P. Southwell, Executive Vice President and Chief Financial Officer. “We will also continue to invest strategically in the development of our product pipeline, including potential new indications for BENLYSTA and our oncology portfolio.” HIGHLIGHTS OF RECENT PROGRESSBENLYSTA™: Topline Secondary Endpoints Announced from BLISS-76; BLA and MAA Submissions Planned Second Quarter 2010
At Week 76 in the BLISS-76 study, BENLYSTA plus standard of care showed higher response rates compared with standard of care alone; however, this secondary endpoint did not reach statistical significance. Study results also showed that BENLYSTA continued to be generally well tolerated, with rates of overall adverse events and discontinuations due to adverse events comparable between BENLYSTA and placebo treatment groups. HGS and GSK plan to present BLISS-76 52-week and 76-week results in full at appropriate scientific meetings later in 2010. ZALBIN™: Positive Interim Results from Phase 2B Clinical Trial May Warrant Phase 3 Evaluation of Once-a-Month Dosing Regimen; European Regulatory Application Withdrawn for ZALBIN Dosed Every Two Weeks
These interim results support the continued evaluation of ZALBIN dosed monthly in a Phase 3 program. The primary efficacy endpoint is sustained virologic response (SVR) at Week 48 (24 weeks following the end of treatment). HGS expects that a full presentation of results from the monthly dosing study will take place at an appropriate scientific meeting later in 2010. ZALBIN, which is known as JOULFERON® outside the United States, is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in 2006. On April 19, 2010, HGS announced that Novartis has withdrawn its European Marketing Authorization Application for JOULFERON after receiving a preliminary response to its application indicating that additional new data would be requested by the European Medicines Agency that Novartis did not believe could reasonably be generated within the timeframe allowed under the European Centralized Procedure. The feedback included whether the therapeutic benefit offered by JOULFERON dosed once every two weeks is sufficient relative to risk. Raxibacumab: $13.5 Million in Revenue Recognized from Deliveries to the U.S. Strategic National Stockpile
HGS and BioInvent Collaborate to Co-Develop and Commercialize Therapeutic Antibodies
About Human Genome Sciences
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 (877) 822-8472. HGS, Human Genome Sciences, BENLYSTA, and ZALBIN are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners. Safe Harbor Statement
(a) Includes stock-based compensation expense of $3,844 ($0.02 per share) and $2,935 ($0.02 per share) for the three months ended March 31, 2010 and 2009, respectively.
(b) Includes $89,067 and $88,437 in restricted investments at March 31, 2010 and December 31, 2009, respectively. (c) Convertible subordinated debt is net of unamortized debt discount of $48,467 and $54,043 as of March 31, 2010 and December 31, 2009, respectively. Convertible subordinated debt at face value is $403,850 as of March 31, 2010 and December 31, 2009.
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