SAN DIEGO, March 12 /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, 2008.
Three months ended December 31, 2008
As of December 31, 2008, Orexigen held $45.5 million in cash and cash equivalents and an additional $40.7 million in investment securities, available-for-sale.
For the three months ended December 31, 2008, Orexigen reported a net loss of $22.1 million, or $0.64 per share attributable to common stockholders, as compared to a net loss of $19.4 million, or $0.72 per share attributable to common stockholders, for the same period in 2007.
Total operating expenses for the three months ended December 31, 2008 were $22.1 million compared to $20.3 million for the same period in 2007. The increased operating expenses were due primarily to an increase in general and administrative expenses of $1.3 million due to increases in non-cash stock-based compensation expense, salaries and personnel related costs, facilities expenses and consulting activities.
Year ended December 31, 2008
For the year ended December 31, 2008, Orexigen reported a net loss of $93.2 million, or $2.76 per share attributable to common stockholders, as compared to a net loss of $57.8 million, or $3.08 per share attributable to common stockholders, for 2007.
Total operating expenses for the year ended December 31, 2008 were $94.9 million compared to $60.9 million for 2007. The increased operating expenses were due primarily to a $29.0 million increase in research and development expenses in connection with the Company's Contrave(R) Phase 3 clinical trials, related proprietary product formulation work and increased consulting activities. In addition, general and administrative expenses increased by $5.0 million due primarily to increases in non-cash stock-based compensation expense, salaries and personnel related costs, facilities expenses and consulting activities.
"Orexigen has made significant progress in the past year," said Eckard Weber, M.D., Interim President and CEO of Orexigen. "We executed a successful equity financing, completed enrollment in our four Phase 3 clinical trials for Contrave and recently disclosed what we believe are promising results in the first of our four Contrave Phase 3 clinical trials. In addition, we were issued two key patents by the U.S. Patent and Trademark Office, which we believe will extend protection for Contrave through at least 2024."
Recent Highlights
Contrave
Empatic(TM)
Other
Conference Call Today at 5:00 p.m. Eastern Time (2:00 p.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss the three months and year ended December 31, 2008 financial results and recent business highlights. The live call may be accessed by phone by calling (800) 860-2442 (domestic) or (412) 858-4600 (international). 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 development of pharmaceutical product candidates for the treatment of obesity. The Company's lead combination product candidates targeted for obesity are Contrave, which is in Phase 3 clinical trials, and Empatic, which is in the later stages of Phase 2 clinical development. Both product candidates take advantage of the Company's understanding of how the brain appears to regulate appetite and energy expenditure, as well as the mechanisms that come into play to limit weight loss over time. 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. Further information about the Company can be found at www.orexigen.com.
Forward-Looking Statements
Orexigen cautions you that statements included in this press release 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 enrollment, timing and completion of clinical trials of Contrave and Empatic, the potential to obtain regulatory approval for, and effectively treat obesity with, Contrave and Empatic, and the scope and duration of protection of issued patents relating to Contrave and Empatic. 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: the final analyses of data from the NB-302 trial and other clinical trials of Contrave may produce negative or inconclusive results, or may be inconsistent with previously conducted clinical trials, and the FDA may not agree with the Company's interpretation of efficacy and safety results; the potential that earlier clinical trials may not be predictive of future results; Contrave or Empatic may not receive regulatory approval on a timely basis or at all; the FDA may require Orexigen to complete additional clinical, non-clinical or other requirements prior to the submission or the approval of NDAs for either product candidate; the potential for adverse safety findings relating to Empatic or Contrave to delay or prevent regulatory approval or commercialization, or result in product liability claims; the third parties on whom Orexigen relies to assist with the development programs for Contrave or Empatic, including clinical investigators, contract laboratories, clinical research organizations and manufacturing organizations, may not successfully carry out their contractual duties or obligations or meet expected deadlines, and the quality or accuracy of the data or materials generated by such third parties may be of insufficient quality to include in the Company's regulatory submissions; the ability of Orexigen and its licensors to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of Contrave and 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 Therapeutics,
Inc., +1-858-875-8600; or Media, Lori Rosen of Invigorate Pharma,
+1-212-301-7173, for Orexigen Therapeutics, Inc.
Web site: http://www.orexigen.com/
