Biotechnology firm Human Genome Sciences Inc. (HGSI) said Monday that it will reveal the progress made towards the commercialization of late-stage products and its priority goals set for 2010. This will be revealed in a presentation to financial analysts and investors by President and Chief Executive Officer Thomas Watkins at the 28th Annual JPMorgan Healthcare Conference in San Francisco. The company also provided revenue forecast for fiscal 2010, significantly below analysts' expectations. The Rockville, Maryland-based company said that it has made rapid progress toward the commercialization of its two lead drugs, Benlysta for systemic lupus treatment and Zalbin for chronic hepatitis C. Benlysta is being developed by Human Genome and GlaxoSmithKline plc (GSK) under a co-development and commercialization agreement entered into in August 2006. Benlysta met the primary efficacy point in phase 3 trials and is the first drug for Lupus to succeed in late stage trials. Submission for US and European approval by second quarter of 2010, while potential U.S. approval is expected in the fourth quarter of 2010. The company noted that Benlysta could be the first new approved drug in more than fifty years, for the autoimmune disease that occurs more often in women, characterized by acute and chronic inflammation of various tissues of the body.
Zalbin, formerly called Albuferon, is being developed in partnership with Novartis AG (NVS), under an exclusive worldwide co-development and commercialization agreement entered into in June 2006. The potential drug targets hepatitis C infection of liver that persists for than six months that are found in nearly 300 million worldwide. A Biologics License Application or BLA has been submitted for Zalbin to the U.S. FDA in November 2009, and a Marketing Authorization Application or MAA has been submitted under the brand name Joulferon by Novartis to the European Medicines Agency or EMEA in Europe in December 2009.
In a prepared statement, Watkins said, "We have the potential for regulatory approval of two major products in the U.S. before the end of this year, both directed to large and growing markets that represent significant medical need. We greatly strengthened our cash position in 2009 with two successful public offerings of common stock. Even with our expected ramp of investment in commercial build-out and pre-launch manufacturing, we expect to end 2010 with between $840 million and $890 million in cash and investments."
Another late-stage development drug Raxibacumab, is a human monoclonal antibody drug that Human Genome discovered and developed for the treatment of inhalation anthrax. In April 2009, the company completed the delivery of 20,000 doses of Raxibacumab to the U.S. Strategic National Stockpile. In July 2009, Human Genome received a second order for 45,000 doses of Raxibacumab from the U.S. Government, to be delivered over a period of three years, beginning near the end of 2009. Additionally, the company is targeting discussions with FDA regarding the Complete Response Letter for Raxibacumab in 2010.
The company has also substantial financial rights to a number of products in the GlaxoSmithKline clinical pipeline. GlaxoSmithKline has initiated Phase 3 clinical trials of Darapladib in men and women with chronic coronary heart disease, and Syncria or albiglutide in patients with type 2 diabetes mellitus.
"From a financial perspective, 2009 was another strong year for HGS. Our financial performance substantially exceeded the guidance we provided in January 2009, both for net cash burn and year-end cash. We expect year-end 2009 cash and investments to total approximately $1.2 billion," Watkins added.
Further, Human Genome will release the forecast for fiscal 2009 and fiscal 2010. The company projects cash and investments at year-end 2009 to total about $1.19 billion, including about $813 million of net proceeds from two public offerings of Human Genome common stock completed in August and December 2009. This is compared to the about $373 million of cash and investments at the end of 2008.
For fiscal 2010, Human Genome anticipates full-year revenues of at least $150 million. On average, eleven analysts polled by Thomson Reuters expect revenues of $181.63 million in fiscal 2010. Analysts' estimates typically exclude special items.
The company also anticipates net cash burn in a range of $300 million to $350 million, with cash and investments at year-end 2010 to total $840 to 890 million. The company noted that the forecast does not include potential Zalbin approval milestone payments.
In Monday's regular trading session, HGSI is currently trading at $30.30, down $0.52 or 1.69% on a volume of 0.27 million shares. In the past 52-week period, the stock has been trading in a broad range of $0.45 to $32.07.
For comments and feedback contact: editorial@rttnews.com
June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.