SAN DIEGO, March 8, 2012 /PRNewswire/ -- Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the three months and year ended December 31, 2011.
Three months ended December 31, 2011
For the three months ended December 31, 2011, Orexigen reported a net loss of $4.3 million, or $0.09 per share, as compared to a net loss of $11.3 million, or $0.24 per share, for the fourth quarter of 2010. As of December 31, 2011, Orexigen had $101.7 million in cash and cash equivalents and an additional $45.8 million in marketable securities, for a total of $147.5 million.
Total operating expenses for the fourth quarter of 2011 were $5.2 million compared to $12.0 million for the fourth quarter of 2010. The decrease in operating expenses primarily reflects a decrease in research and development expenses of $4.8 million principally related to decreases in salaries and personnel-related costs.
Year ended December 31, 2011
For the year ended December 31, 2011, Orexigen reported a net loss of $28.1 million, or $0.58 per share, as compared to a net loss of $51.9 million, or $1.10 per share, for 2010. Total operating expenses for the year ended December 31, 2011 were $32.3 million compared to $52.6 million for 2010. This decrease in operating expenses primarily reflects a decrease in research and development expenses of $15.3 million principally related to the decrease in expenses related to our Contrave® development program. This overall decrease in operating expenses also reflects a decrease in general and administrative costs of $5.0 million principally related to decreases in salaries and personnel-related costs and market research costs.
2011 and recent highlights
- Written feedback from the FDA’s Office of New Drugs (OND) on a feasible cardiovascular outcomes trial (CVOT) design that enables the Company to continue development of its lead program, Contrave (September 2011)
- Completion of a public offering that raised $86.9 million in net proceeds, which are expected to fund the CVOT through 2014 during which time the Company anticipates completion of the interim analysis, resubmission and potential approval of the Contrave New Drug Application (NDA) (December 2011)
- Agreement on the CVOT protocol via a Special Protocol Assessment (SPA) with the Division of Metabolic and Endocrinology Products (DMEP) of the FDA (February 2012)
“We believe the rapid progress we made with DMEP on the detailed protocol is further indication of the alignment we have reached within the FDA on the requirements for resubmission of the Contrave NDA,” said Michael Narachi, president and CEO of Orexigen. “I want to thank my colleagues at Orexigen, our key consultants and strategic partners helping us with the CVOT, and our commercialization partner, Takeda, for their outstanding efforts as we work to begin enrolling patients in this innovative large streamlined trial late in the second quarter of this year.”
Conference Call Today at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss the fourth quarter 2011 financial results and recent business highlights. The live call may be accessed by phone by calling (866) 804-6923 (domestic) or (857) 350-1669 (international), participant code 46352287. 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 product candidate is Contrave®, which has completed Phase 3 clinical trials and for which a New Drug Application has been submitted and reviewed by the FDA. The Company has also reached agreement with the FDA on a Special Protocol Assessment for the Contrave cardiovascular outcomes trial. The Company’s other product candidate, Empatic, has completed Phase 2 clinical trials. Further information about the Company can be found at www.orexigen.com.
