Orexigen Therapeutics reports net loss of $18.6 million in Q3 2013

Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced business and financial results for the third quarter ended September 30, 2013.

For the three months ended September 30, 2013, Orexigen reported a net loss of $18.6 million, or $0.19 per share, as compared to a net loss of $30.6 million, or $0.44 per share, for the third quarter of 2012.

Total operating expenses for the third quarter of 2013 were $19.4 million compared to $31.5 million for the third quarter of 2012. This overall decrease in operating expenses reflects a decrease in research and development expenses associated with the conduct of the Light Study, the Contrave® cardiovascular outcomes trial. As of September 30, 2013, Orexigen had $48.7 million in cash and cash equivalents and an additional $34.1 million in marketable securities, for a total of $82.8 million.

Orexigen indicated that 2013 change in cash, cash equivalents, and marketable securities is trending to the lower end of the guidance range.  Orexigen now projects 2013 net decrease in cash, cash equivalents, and marketable securities to be between $70 million and $75 million.  The Company will commence certain active pharmaceutical ingredient (API) purchases after the Light Study interim analysis, in order to fulfill Contrave launch order requirements, which will be subsequently reimbursed by its North American commercial partner, Takeda Pharmaceuticals, once final product is shipped.  With this updated guidance, Orexigen expects to end the year with approximately $62-$67 million in cash, cash equivalents, and marketable securities.

"This is an exciting time at Orexigen, as we make final preparations for the Light Study interim analysis," said Michael Narachi, Chief Executive Officer of Orexigen. "We continue to expect we will receive the analysis from the DMC and complete our review by early December."

"We expect that an interim analysis that meets the pre-specified safety hurdles will enable a series of important steps in 2014 toward the global commercialization of Contrave, including potential approvals in the US and Europe, progression of partnership discussions for ex-North American Contrave rights, and the potential commercial launch of Contrave in North America by Takeda," Narachi continued.

Recent business highlights:

• In October, Orexigen submitted the Marketing Authorization Application for Contrave to the European Medicines Agency. Cardiovascular outcomes data from the Light Study are expected to be available for the Committee for Medicinal Products for Human Use (CHMP) Day 120 List of Questions.
• In preparation for the potential launch of Contrave, Takeda assumed from the Company the responsibility to package Contrave for commercial sale. The Company will continue to supply bulk tablets of Contrave to Takeda in accordance with the terms of the Collaboration Agreement.
• Orexigen entered into a commercial supply agreement with Sanofi to manufacture and supply Contrave for territories outside North America.

Product candidates:

Contrave (32 mg naltrexone sustained‐release (SR)/360 mg bupropion SR) for the treatment of obesity: In 2012, Orexigen screened more than 13,000 patients, enrolled more than 10,400 and ultimately completed recruitment of the Light Study with approximately 8,900 randomized patients. The primary objective of the double‐blind, randomized, placebo‐controlled Light Study, which Orexigen is conducting under a Special Protocol Assessment with the FDA (United States Food and Drug Administration), is to rule out excess cardiovascular risk in overweight and obese patients receiving Contrave. An interim analysis of the Light Study is anticipated by early December, enabling the potential resubmission of the Contrave New Drug Application to the FDA by year end. In October 2013, Orexigen submitted a Marketing Authorization Application for Contrave to the European Medicines Agency.

Orexigen has licensed North American Contrave commercial rights to Takeda Pharmaceuticals. Orexigen owns Contrave rights in Europe and throughout the rest of the world outside of North America and will seek a partner to commercialize Contrave in those territories.

Empatic™, a fixed dose combination of bupropion SR and zonisamide SR, for the treatment of obesity: In a series of discussions with the FDA on the continued development of Empatic, the FDA stated that Phase 3 data for Empatic may be sufficient to support submission of an NDA without data from a cardiovascular outcomes trial. The FDA indicated that as long as the placebo‐subtracted changes in body weight, blood pressure and heart rate for Empatic are similar to or more favorable than the placebo‐subtracted changes observed with Contrave, and there are no signals of cardiovascular concern in the Empatic development program, reassuring results of a cardiovascular outcomes trial with Contrave will be sufficient. In addition, while the FDA reiterated the belief that the teratogenicity potential for zonisamide is very concerning, the FDA will allow Phase 3 studies of Empatic to include women of childbearing potential who have a Body Mass Index that meets the FDA definition of overweight (>27kg/m²) in the presence of at least one weight‐related comorbidity.

Orexigen owns worldwide rights to Empatic. Prior to initiating Phase 3 studies of Empatic, the Company plans to seek a collaboration partner to help fund further clinical development and, if approved, commercialization.