Nov. 3, 2009 (PR Newswire) -- MOUNTAIN VIEW, Calif., Nov. 3 /PRNewswire-FirstCall/ -- VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today reported its highlights and financial results for the third quarter ended September 30, 2009.
Third Quarter Highlights
In the third quarter of 2009, we announced positive results from two final, phase 3 pivotal 56-week studies, EQUIP (OB-302) and CONQUER (OB-303), evaluating the safety and efficacy of our investigational drug candidate Qnexa in more than 3,750 patients across 93 sites. The EQUIP and CONQUER studies met all primary endpoints by demonstrating statistically significant weight loss with all three doses of Qnexa, as compared to placebo. Patients taking Qnexa also achieved significant improvements in cardiovascular and metabolic risk factors including reductions in blood pressure, lipids, and blood sugar.
Highlights from the EQUIP and CONQUER studies include:
-- Average weight loss of 14.7% (37 lbs) was achieved by patients treated
with Qnexa for 56 weeks in the EQUIP study;
-- FDA guidance on efficacy benchmarks for weight loss agents exceeded at
all three doses of Qnexa tested in the clinical program;
-- Completion rates up to 69% were significantly higher than placebo at all
three doses of Qnexa, indicating favorable tolerability; and
-- Favorable benefit/risk safety profile for Qnexa.
In the third quarter of 2009, we closed an underwritten public offering of our common stock which provided us with gross proceeds of $108.7 million from the sale of 10,350,000 shares of our common stock at a price per share of $10.50.
"The highlight of the third quarter and the year to date was the announcement of the positive results from the year-long studies of Qnexa for the treatment of obesity. The results demonstrated that patients treated with Qnexa had weight loss up to 14.7% and significant improvement in their co-morbidities. All three doses administered in the studies exceeded the FDA guidance on efficacy endpoints. Progress on the submission of the NDA for Qnexa in obesity remains on schedule and is expected by the end of 2009," stated Leland Wilson, chief executive officer of VIVUS. "Following the announcement of the positive Qnexa results, we were able to raise $108.7 million in gross proceeds from a public offering of our common stock. With the positive results from our phase 3 trials for Qnexa and a cash and investment balance in excess of $226 million at the end of the third quarter, we believe we are well positioned to meet our goals for 2009 and beyond."
Third Quarter Results
Product revenues from the sale of MUSE in the third quarter of 2009 were $4.3 million, as compared to $4.4 million in the third quarter of 2008. License and other revenue was $115,000 and $21 million in the third quarters of 2009 and 2008, respectively. The third quarter 2008 included the recognition of deferred license revenue from Evamist. Recognition of the deferred revenue from the sale of Evamist ended in May 2009. Total revenue for the third quarter of 2009 was $4.4 million, as compared to $25.5 million for the third quarter of 2008.
Operating expenses for the third quarter of 2009 were $24.8 million as compared to $22.6 million for the same period in 2008. The difference in operating expenses for the third quarter was primarily attributable to spending related to our phase 3 clinical trials of avanafil, our orally administered investigational drug candidate for the treatment of erectile dysfunction, partially offset by reduced spending on the obesity trials for Qnexa which were completed in the third quarter of 2009.
Net loss for the third quarter of 2009 was $21.1 million, or $0.30 per share, as compared to net income of $266,000, or $0.00 per share, for the third quarter of 2008.
Nine Month Results
Product revenues from the sale of MUSE for the first nine months of 2009 were $9.7 million, as compared to $10.3 million for the same period of 2008. License and other revenue was $31.7 million for the first nine months as compared to $63.1 million for 2008. The first nine months of 2008 included recognition of deferred license revenue from Evamist. Recognition of the deferred revenue from the sale of Evamist ended in May 2009.
