MOUNTAIN VIEW, Calif., Nov. 7, 2011 /PRNewswire/ -- VIVUS, Inc. (NASDAQ: VVUS), a biopharmaceutical company dedicated to the development and commercialization of novel therapeutic products, today reported its financial results for the third quarter and nine months ended September 30, 2011.
Third Quarter Results
For the third quarter ended September 30, 2011, VIVUS reported a net loss of $8.6 million, or $0.10 net loss per share, as compared to a net loss of $18.0 million, or $0.22 net loss per share for the third quarter of 2010. The net loss from continuing operations was $8.8 million, or $0.10 net loss per share, as compared to a net loss from continuing operations of $18.1 million, or $0.22 net loss per share during the third quarter of 2010. The lower net loss in 2011 as compared to 2010 primarily results from reduced research and development spending on Qnexa® and avanafil as these projects progress from the clinical trial stage to the regulatory review stage.
In the third quarter of 2011, we closed on a registered direct offering of our common stock which provided us with gross proceeds of $45.8 million before deduction of fees and expenses related to the offering.
First Nine Months Results
Net loss for the first nine months of 2011 was $34.7 million, or $0.42 net loss per share, as compared to a net loss of $59.6 million, or $0.74 net loss per share for 2010. The decrease in net loss in the first nine months of 2011 as compared to 2010 results primarily from reduced research and development spending on Qnexa and avanafil. In addition, the net loss for the first nine months last year included a $3.2 million loss from discontinued operations of the MUSE business, which was sold in the fourth quarter 2010.
Cash, Cash Equivalents and Available-for-Sale Securities
VIVUS had cash, cash equivalents and available-for-sale securities of $155.3 million at September 30, 2011, as compared to $139.2 million at December 31, 2010. The net increase in cash, cash equivalents and available-for-sale securities of $16.1 million is primarily due to net proceeds of $45.3 million from the registered direct offering of our common stock and $2.0 million from the exercise of common stock options and ESPP purchases offset by cash used in operations of $31.2 million for the first nine months.
Qnexa Update
On October 17, 2011, we resubmitted the Qnexa New Drug Application (NDA). The FDA has accepted the NDA for filing and has designated it as a Class 2 resubmission, which is expected to have a six-month review period from the date of filing. The Prescription Drug User Fee Act (PDUFA) target date is April 17, 2012. The FDA has informed us that an advisory committee of the Division of Metabolism and Endocrinology Products (DMEP) will meet to specifically discuss the Qnexa NDA in the first quarter of 2012.
The Qnexa NDA resubmission seeks approval for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients (BMI >/= 30 kg/m2), or overweight patients (BMI >/= 27 kg/m2) with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling includes a contraindication for women of childbearing potential. The resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).
The Marketing Authorization Application (MAA) for Qnexa was submitted to the European Medicines Agency (EMA) in December 2010. In May of 2011, we received the 120-day list of questions from the Committee for Medicinal Products for Human Use (CHMP) and began preparing our response. The questions and issues raised by the CHMP were consistent with those raised by the FDA. We met with representatives from the CHMP in September 2011 to seek clarification on certain questions. With this clarification, we anticipate submitting our response to the CHMP in the fourth quarter of 2011. We expect the CHMP to issue the 180-day opinion in the first quarter of 2012.
Additional analyses of results from Qnexa studies have been recently presented at various medical meetings including:
- The American Association of Diabetes Educators (AADE) meeting in Las Vegas, NV. Ronette L. Kolotkin, PhD, a clinical psychologist from Obesity and Quality of Life Consulting and Consulting Professor at Duke University Medical Center, and gave an oral presentation of efficacy and safety data that concluded that patients treated with Qnexa during the 56-week EQUIP and CONQUER trials showed statistically significant improvements in quality of life compared to placebo patients. Improvements in quality of life were measured using two validated surveys: the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) and Medical Outcomes Study Short Form-36 (SF-36);
- Multiple abstracts were presented at the 47th European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon, Portugal. The presentations highlighted the long-term efficacy and safety of Qnexa treatment in metabolically-impaired patients with prediabetes, diabetes, and metabolic syndrome;
- Finally, several abstracts were presented at the 29th Annual Scientific Meeting of The Obesity Society held in Orlando, Florida. The presentations highlighted the long-term efficacy and safety of Qnexa. Specifically, patients treated with Qnexa had significant improvement in liver function and reductions in medications used for diabetes, high blood pressure and high cholesterol. In addition, Qnexa was found effective in treating severely obese patients (BMI>35). Severely obese patients who were treated with Qnexa top dose for two years had weight loss over 12%.
The most commonly reported side effects in the Qnexa clinical studies were dry mouth, paresthesia (tingling), constipation, insomnia, dizziness and dysgeusia (altered taste).
“In the third quarter we made significant progress in advancing Qnexa towards regulatory approval with the resubmission of the Qnexa NDA in October. The Qnexa NDA has been accepted for review and we look forward to the Division of Metabolism and Endocrinology Products Advisory Committee meeting in the first quarter of 2012,” stated Leland Wilson, chief executive officer of VIVUS. “With the NDA filing, we are accelerating the commercial planning in anticipation of approval and the launch of Qnexa in the second half of 2012.”
Avanafil Update
In August 2011, the FDA accepted our NDA for avanafil, our investigational drug candidate for the treatment of erectile dysfunction (ED). The PDUFA date for the avanafil NDA is April 29, 2012. In previously announced results from the pivotal phase 3 trials, patients treated with avanafil achieved significant improvement in erectile function compared to placebo.
Recently, the positive safety and efficacy results from the avanafil phase 3 study in diabetics were presented by Dr. Irwin Goldstein, Director of Sexual Medicine at Alvarado Hospital, San Diego, CA, during the poster session at the 47th European Association for the Study of Diabetes (EASD) Annual Meeting in Lisbon, Portugal. This was the first public European presentation of avanafil safety and efficacy data in diabetic patients.
The most commonly reported side effects in the avanafil clinical studies included headache, flushing, nasopharyngitis and nasal congestion.
The MAA for avanafil is being prepared and we plan to file it with the EMA in the first quarter of 2012.
“We’ve made significant progress with the development of Qnexa and avanafil over the past 12 months, and now both NDAs have been accepted for regulatory review,” stated Peter Tam, president of VIVUS. “With the PDUFA dates for both Qnexa and avanafil in April, next year will be a very exciting time for our company.”
About VIVUS
VIVUS is a biopharmaceutical company developing therapies to address obesity, sleep apnea, diabetes and male sexual health. The company’s lead investigational product in clinical development, Qnexa, has completed phase 3 clinical trials for the treatment of obesity and is currently being considered for approval by US and EU regulators. VIVUS received a Complete Response Letter, or CRL, to the initial Qnexa NDA on October 28, 2010. We resubmitted the Qnexa NDA in October 2011, with an FDA action date of April 17, 2012. Qnexa is also in phase 2 clinical development for the treatment of type 2 diabetes and obstructive sleep apnea. In the area of sexual health, VIVUS has submitted an NDA for avanafil, a PDE5 inhibitor being studied for the treatment of erectile dysfunction, with an FDA action date of April 29, 2012. For more information about the company, please visit www.vivus.com.
