VIVUS, Inc. (Nasdaq: VVUS), a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today reported its financial results for the second quarter and six months ended June 30, 2010.
Second Quarter Results
Product revenues from the sale of MUSE in the second quarter of 2010 were $3.8 million as compared to $4.1 million in the second quarter of 2009 due to a small decrease in U.S. shipments. Total revenue for the second quarter of 2010 was $3.9 million as compared to $14.7 million for the second quarter of 2009. The decrease in total revenue in the second quarter of 2010 compared to the second quarter last year was primarily due to the inclusion of deferred license revenue from the sale of Evamist in the second quarter of 2009. There was no deferred license revenue recognized in 2010 as the monthly Evamist deferred revenue recognition ended in May 2009.
Net loss for the second quarter of 2010 was $22.8 million, or $0.28 per share, as compared to net loss of $13.2 million, or $0.19 per share, for the second quarter of 2009. The increase in net loss in the second quarter of 2010 as compared to the second quarter of 2009 results from the completion of the recognition of the Evamist deferred revenue in 2009 and increased selling, general and administrative expenses, primarily due to Qnexa pre-commercialization expenses partially offset by decreased research and development spending due to the completion of the pivotal phase 3 clinical trials for Qnexa for the treatment of obesity.
First Half Results
Product revenues from the sale of MUSE in the first half of 2010 were $5.4 million as compared to $5.3 million for 2009. Total revenue for the first half of 2010 was $5.6 million as compared to $37.0 million for 2009. The decrease in total revenue in the second quarter of 2010 compared to the second quarter last year was primarily due to the inclusion of deferred license revenue from the sale of Evamist in the first half of 2009.
Net loss for the first six months of 2010 was $41.6 million, or $0.51 per share, as compared to net loss of $20.0 million, or $0.29 per share, for 2009. The increase in net loss in the first half of 2010 as compared to 2009 results from the completion of the recognition of the Evamist deferred revenue in 2009 and increased selling, general and administrative expenses, primarily due to Qnexa pre-commercialization expenses partially offset by decreased research and development spending due to the completion of the pivotal phase 3 clinical trials for Qnexa for the treatment of obesity.
Cash, Cash Equivalents and Available-for-Sale Securities
VIVUS had cash, cash equivalents and available-for-sale securities of $174.8 million at June 30, 2010, as compared to $207.0 million at December 31, 2009. The decrease in cash, cash equivalents and available-for-sale securities of $32.2 million is primarily due to cash used in operations and other net cash uses offset by proceeds of $1.3 million from the exercise of common stock options and ESPP purchases.
Qnexa Update
On July 15, 2010 the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted against the following question: "Based on the current available data, do you believe the overall benefit-risk assessment of PHEN/TPM (QNEXA) is favorable to support its approval for the treatment of obesity in individuals with a BMI > 30 kg/m2 or > 27 kg/m2 with weight-related co-morbidities?" The three co-morbidities included hypertension, diabetes and dyslipidemia.
The vote from the Endocrinologic and Metabolic Drugs Advisory Committee is a recommendation. The FDA will take the Committee's recommendation into consideration during its review of the NDA and will make a determination. The FDA may or may not follow the Committee's recommendation. We intend to work closely with the FDA leading up to our October 28, 2010 PDUFA date to address the labeling and safety questions raised during the proceedings. The impact of the negative vote of the Committee may delay or decrease the approvability of Qnexa.
We have conducted a one-year extension study of a subset of patients who have completed the 56-week CONQUER study. The SEQUEL study is a double-blind, placebo-controlled, 3-arm, prospective study across 36 centers comparing Qnexa to placebo over an additional 52-week treatment period. Patients in SEQUEL continued receiving the same treatment they had been receiving, in a blinded fashion, from the CONQUER study. The co-primary endpoints for this study are the differences between treatments in weight loss and percent weight loss from the beginning of the CONQUER trial to the end of the treatment period. Patients were asked to continue a hypocaloric diet representing a 500-calorie/day deficit and were advised to follow a simple lifestyle modification program.
SEQUEL enrolled approximately 650 obese or overweight patients with a BMI that equaled or exceeded 22 kg/m2 with controlled co-morbidities. Patients were followed for 52 weeks of treatment with patients continuing in their respective CONQUER treatment group receiving either once-a-day treatment with mid-dose Qnexa, full-dose Qnexa or placebo. This extension study was not required by the FDA nor did it need to be completed in support of the NDA for Qnexa for the treatment of obesity. The purpose of this study is to support the Marketing Authorization Application, or MAA, filing in Europe. The results of the SEQUEL study are expected before the end of the third quarter of 2010.
"Several presentations on Qnexa at various medical conferences continued our commitment to share our results with healthcare professionals. On the regulatory front, we continue to work with the FDA to address the items discussed at the recent Advisory Committee meeting. The two-year data from the SEQUEL study will provide information on the long-term efficacy and safety of Qnexa. We look forward to working with the FDA as we approach the PDUFA date on October 28, 2010," stated Leland Wilson, chief executive officer of VIVUS. "In the second quarter of 2010 we continued the advancement of avanafil. The results of the REVIVE-Diabetes study showed avanafil treatment was successful in improving erectile function in men with diabetes. The results were consistent with those observed in the first phase 3 study in men with ED from a general population."
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