MOUNTAIN VIEW, Calif., Nov. 5, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS), a biopharmaceutical company commercializing Qsymia ® (phentermine and topiramate extended-release) capsules CIV for the treatment of obesity, today provided a business update and reported its financial results for the third quarter and nine months ended September 30, 2013.
- On July 1, 2013, we announced the availability of Qsymia in certified retail pharmacies. We continue to add locations and to certify additional chain and independent pharmacies. Qsymia is currently available nationwide in over 31,000 certified retail pharmacies.
- On July 5, 2013, we entered into a License and Commercialization Agreement with Menarini Group, through its subsidiary Berlin-Chemie AG, to commercialize and promote SPEDRA™ for the treatment of erectile dysfunction in over 40 European countries, plus Australia and New Zealand. Under the agreement, we are eligible to receive up to €79 million based on various approval and sales milestones, €39 million of which may be earned within the first year. In addition, we will receive royalties on SPEDRA sales.
- On September 3, 2013, Seth H. Z. Fischer joined as Chief Executive Officer and a member of the Board of Directors. Mr. Fischer has three decades of healthcare experience in the pharmaceutical and medical device industries, including 29 years with Johnson & Johnson, most recently as Company Group Chairman, Johnson & Johnson and Worldwide Franchise Chairman, Cordis Corporation from 2008 to 2012.
- On September 20, 2013, we submitted to the European Medicines Agency a request for scientific advice regarding use of a pre-specified interim analysis from the AQCLAIM cardiovascular outcomes trial. This scientific advice will provide guidance regarding the resubmission of the marketing authorization application, or MAA, for approval of Qsiva™ for obesity in Europe under the centralized procedure.
- On October 8, 2013, clinical results were published in Diabetes Care showing Qsymia reversed progression to type 2 diabetes among certain medically vulnerable patient populations. High-risk overweight or obese patients with prediabetes and/or metabolic syndrome took Qsymia over a two-year period. In addition to losing weight, these patients experienced reductions of up to 78.7% in the annualized incidence rate of type 2 diabetes.
- On October 11, 2013, we entered into a Licensing and Commercialization Agreement with Auxilium Pharmaceuticals, Inc. for the exclusive rights to market STENDRA™ in the United States and Canada. Under the Agreement, VIVUS is eligible to receive up to $300 million based on certain regulatory and sales milestones, including an upfront licensing fee of $30 million and a $15 million payment contingent upon a potential label amendment regarding time to erection, in addition to royalties on product sales.
- As part of our ongoing efforts to reduce costs by eliminating expenses that are not essential to expanding the use of Qsymia, we have implemented a cost reduction plan which will reduce our workforce by approximately 20 employees, or 17% of our workforce, excluding the sales force of 150, in the fourth quarter of 2013. We expect to complete the cost reduction plan by the end of 2013, and anticipate incurring pre-tax non-recurring charges related to employee termination costs, operating lease exit costs, and other associated costs in the range of $6 million to $8 million in the fourth quarter of 2013, including approximately $1 million to $1.5 million in non-cash share-based compensation expense related to the acceleration of the vesting and exercisability of equity awards held by the terminated employees. We expect to realize approximately $6 million to $8 million in annual net cost savings beginning in fiscal year 2014.
"Our results for this quarter were disappointing, but we have made changes to improve our performance," stated Seth H. Z. Fischer, chief executive officer. "We strengthened our balance sheet by entering into partnerships with Auxilium and Menarini for commercialization of avanafil (STENDRA/SPEDRA), our erectile dysfunction drug. We have cut costs by reducing our workforce by 17%. We have initiated a process to seek European approval for Qsiva through the centralized procedure. Net product revenue from sales of Qsymia for obesity grew modestly, but we believe that recent growth in certified retail pharmacies, expanding reimbursement coverage and a more focused selling message will allow us to increase sales in 2014."