Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced corporate and financial results for the second quarter ended June 30, 2014.
“We are making progress with the FDA discussing the alternatives for the post-marketing obligation for evaluation of cardiovascular outcomes, and we are confident that we can reach agreement on these final details of the NB32 review,” said Michael Narachi, CEO of Orexigen.
Financial results for the three months ended June 30, 2014
For the three months ended June 30, 2014, Orexigen reported a net loss of $24.5 million, or $0.21 per share, as compared to a net loss of $18.2 million, or $0.19 per share, for the second quarter of 2013.
Total operating expenses for the second quarter of 2014 were $23.7 million compared to $19.1 million for the second quarter of 2013. This overall increase in operating expenses reflects an increase in raw materials, inventory, and manufacturing-related expenses and in stock based compensation expense. While Orexigen is responsible for manufacturing NB32, Takeda Pharmaceuticals will reimburse Orexigen for manufacturing related costs, including finished goods.
As of June 30, 2014, Orexigen had $31.1 million in cash and cash equivalents and an additional $102.2 million in marketable securities, for a total of $133.3 million. Orexigen is eligible to receive cash milestone payments of $100 million from Takeda Pharmaceuticals, between US approval and first commercial sale of NB32.
NB32 program update:
NB32 (32 mg naltrexone sustained-release (SR)/360 mg bupropion SR), an investigational medicine for weight loss and the maintenance of weight loss: In June 2014, the United States Food and Drug Administration (FDA) extended its review of the resubmitted New Drug Application (NDA) for NB32. The new Prescription Drug User Fee Act (PDUFA) action date has been set for September 11, 2014. The FDA indicated that the review extension is needed to reach agreement on the post-marketing obligation related to the previously agreed upon evaluation of cardiovascular (CV) outcomes for NB32. Discussions with the Agency on the post-marketing obligation are progressing, and Orexigen is confident it can reach agreement with the FDA.
Orexigen has licensed North American NB32 rights to Takeda. Takeda is preparing a well resourced primary care U.S. launch for NB32 with approximately 900 sales representatives.
In October 2013 Orexigen submitted a Marketing Authorization Application for NB32 to the European Medicines Agency (EMA). Orexigen received the Day 180 List of Outstanding Issues from the EMA’s Committee for Medicinal Products for Human Use (CHMP) and will submit the Company’s responses in September.
Orexigen owns NB32 rights outside of North America and will seek a partner to commercialize NB32 in those territories.
Conference Call Today at 8 a.m. Eastern Time (5:00 a.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss the second quarter 2014 financial results and recent business highlights. The live call may be accessed by calling (800) 708-4540 (domestic) or (847) 619-6397 (international), participant code 37792592. The webcast can be accessed live on the Investor Relations section of the Orexigen web site at 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 NB32. Based on successful results of the Light Study, an ongoing cardiovascular outcomes trial, Orexigen’s strategy for NB32 is to pursue approvals worldwide and pharmaceutical partnerships for global commercialization. The Company has submitted applications for marketing authorization in the United States and Europe, with potential approvals in 2014. If approved, North American partner Takeda Pharmaceuticals will commercialize NB32 in the United States. 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.