SAN DIEGO, March 9 /PRNewswire-FirstCall/ -- Orexigen(R) Therapeutics, Inc. , a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the three months and year ended December 31, 2009.
Three months ended December 31, 2009
As of December 31, 2009, Orexigen held $37.7 million in cash and cash equivalents and an additional $54.5 million in investment securities, available-for-sale. Together, these amounts total $92.2 million.
For the three months ended December 31, 2009, Orexigen reported a net loss of $15.0 million, or $0.32 per share attributable to common stockholders, as compared to a net loss of $22.1 million, or $0.64 per share attributable to common stockholders, for the same period in 2008.
Total operating expenses for the three months ended December 31, 2009 were $14.8 million compared to $22.1 million for the same period in 2008. The decreased operating expenses were due primarily to a decrease in research and development expenses of $8.7 million related to the completion of our Contrave(R) Phase 3 clinical trials and completion of our Phase 2 clinical trial for Empatic(TM), offset partly by an increase in general and administrative costs of $1.3 million due principally to increases in salaries and personnel related costs, marketing and consulting expenses and medical affairs expense.
Year ended December 31, 2009
For the year ended December 31, 2009, Orexigen reported a net loss of $66.6 million, or $1.67 per share attributable to common stockholders, as compared to a net loss of $93.2 million, or $2.76 per share attributable to common stockholders, for 2008.
Total operating expenses for the year ended December 31, 2009 were $65.6 million compared to $94.9 million for 2008. The decreased operating expenses were due primarily to a decrease in research and development expenses of $31.8 million related to the completion of our Contrave Phase 3 clinical trials and completion of our Phase 2 clinical trial for Empatic, offset partly by an increase in general and administrative costs of $2.5 million due principally to increases in salaries and personnel related costs, medical affairs expense, recruiting expense and public relations costs.
“Orexigen has made significant progress in the past year that positions us for our transformation to a commercial enterprise,” said Michael Narachi, President and CEO of Orexigen. “We completed our Contrave Phase 3 Program and our Empatic Phase 2 program, both with very positive results, and have nearly completed all sections of our New Drug Application for Contrave, which we expect to file with the FDA by the end of April. In addition, we raised additional capital which has allowed us to advance our preparations for a targeted commercial launch, and to outline the value proposition for potential partners that would enable access to the broader primary care markets.”
2009 Highlights
Contrave
Orexigen announced the results of all four of its Phase 3 trials in the Contrave Obesity Research, or COR, program in 2009. Each trial met its co-primary endpoints. Data from these trials demonstrated the following:
The results from the successfully completed COR program of more than 4,500 patients exceed the FDA categorical efficacy benchmark for clinically significant weight loss, supporting the Company’s plan to file a New Drug Application with the FDA by the end of April
Empatic
In September, Orexigen announced the data from the Phase 2b clinical trial of Empatic. The results of this trial demonstrated the following:
Corporate
Conference Call Today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss the three months and year ended December 31, 2009 financial results and recent business highlights. The live call may be accessed by phone by calling (866) 730-5769 (domestic) or (857) 350-1593 (international), participant code 19470590. The webcast can be accessed live on the investor relations section of the Orexigen web site at http://www.orexigen.com, and will be archived for 14 days following the call.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. The Company’s lead investigational product, Contrave(R), has completed Phase 3 clinical trials. The Company’s second product, Empatic(TM), has completed Phase 2 clinical development. Each product candidate is designed to act on a specific group of neurons in the central nervous system with the goal of achieving appetite suppression and sustained weight loss, through combination therapeutic approaches. Further information about the Company can be found at http://www.Orexigen.com.
Forward-Looking Statements
Orexigen cautions you that statements included in this press release and in the teleconference/webcast that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding the potential for, and timing of, filing an NDA for Contrave. The inclusion of forward-looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: risks inherent in the continued analyses of clinical trial results, including Contrave Phase 3 trials; the uncertainty of the FDA approval process and other regulatory requirements; the therapeutic and commercial value of Contrave and Empatic; reliance on third parties to assist with the development of Contrave and Empatic and the regulatory submissions related thereto; the potential for adverse safety findings relating to Contrave or Empatic; the potential to enter into and the terms of any commercial partnership or other strategic transaction relating to Contrave or Empatic; and other risks described in the Company’s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
CONTACT: Graham Cooper, Chief Financial Officer of Orexigen,
+1-858-875-8600; or Media, Liz Frank of WCG, +1-212-301-7216, for Orexigen
Web site: http://www.orexigen.com/
