Orexigen second-quarter net loss decreases to $11.9 million

Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the second quarter of 2010.  For the quarter ended June 30, 2010, Orexigen reported a net loss of $11.9 million, or $0.25 per share attributable to common stockholders, as compared to a net loss of $17.8 million, or $0.51 per share attributable to common stockholders, for the second quarter of 2009.  As of June 30, 2010, Orexigen had $10.3 million in cash and cash equivalents and an additional $52.9 million in marketable securities, for a total of $63.2 million.

"Following FDA acceptance of our Contrave® NDA, we remain intensely focused on two key goals: Progressing the Contrave NDA through regulatory review, including preparation for our upcoming advisory panel, and securing a commercial partner," said Michael Narachi, President and CEO of Orexigen. "We continue to make progress on both fronts."

Total operating expenses for the second quarter of 2010 were $11.8 million compared to $17.6 million for second quarter of 2009.  The decrease in operating expenses primarily reflects a reduction in research and development expenses of $7.7 million, principally related to the completion of Contrave Phase 3 clinical trials and completion of the Phase 2 clinical trial for Empatic, offset partly by an increase in general and administrative costs of $1.9 million due principally to increases in salaries and personnel related costs, stock-based compensation expense and medical affairs expenses.

Recent Highlights

• Presented significant new data on Contrave at the American Diabetes Association 70th Scientific Sessions, including:
  • Results from a 24-week open-label study demonstrating that treatment with Contrave reduced depression scores and body weight in overweight and obese patients with major depression; and
  • Results from the COR-Diabetes trial demonstrating that Contrave significantly lowers weight and improves blood glucose control in overweight and obese patients with type 2 diabetes.
• Contrave NDA filing was accepted by FDA and assigned a Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011.
• Date for FDA Division of Metabolic and Endocrine Drug Products Advisory Committee meeting was tentatively set for December 7, 2010 to review the Company's NDA for Contrave.
• Published online results of COR-I Phase 3 study of Contrave in The Lancet on July 30, 2010. Published online results of COR-BMOD Phase 3 study of Contrave plus intense diet, exercise and behavior modification in the journal Obesity on June 17, 2010.

SOURCE Orexigen Therapeutics, Inc.