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VIVUS Reports First Quarter 2013 Financial Results

MOUNTAIN VIEW, Calif., May 8, 2013 (GLOBE NEWSWIRE) -- VIVUS, Inc. (Nasdaq:VVUS), a biopharmaceutical company commercializing and developing innovative, next-generation therapies to address unmet needs in obesity and sexual health, today provided a business update and reported its financial results for the first quarter ended March 31, 2013.

"The FDA's approval of the REMS modification allowing distribution of Qsymia through certified retail pharmacy locations was a significant achievement in our ongoing efforts to expand access to Qsymia," stated Leland Wilson, chief executive officer of VIVUS. "We have begun to lay the foundation and our team is working diligently to ensure availability of Qsymia in certified retail pharmacies."

Recent Highlights

  • On April 16, 2013, the FDA approved an amendment to the REMS that allows for distribution of Qsymia ® (phentermine and topiramate extended-release) capsules CIV through certified retail pharmacy locations. We intend to certify pharmacies and announce retail availability in the third quarter of 2013.  
  • In April 2013, the CHMP adopted a positive opinion recommending the granting of a marketing authorization for avanafil (SPEDRA™) for the treatment of erectile dysfunction in the EU. The CHMP recommendation has been referred to the European Commission and a final decision is expected within approximately two months.  
  • On March 25, 2013, we entered into a Purchase and Sale Agreement with BioPharma Secured Investments III Holdings Cayman LP ("BioPharma"), providing for the purchase of a debt-like instrument. At the initial closing on April 9, 2013, we received $50 million, less $1.1 million in funding and facility payments. Subject to the terms and conditions of the agreement and at our sole discretion, we may also elect prior to December 31, 2013 to receive an additional $60 million, less $600,000 in a funding payment, at the secondary closing, which is subject to customary closing conditions and which closing shall occur, if at all, no later than January 15, 2014.

First Quarter 2013 Results

In the first quarter of 2013, net product revenues from sales of Qsymia were $4.1 million. For the first quarter of 2013, we reported a net loss of $53.6 million or $0.53 net loss per share, as compared to a net loss $18.8 million or $0.20 net loss per share during the first quarter of 2012. The increased net loss in the first quarter of 2013, as compared to the first quarter of 2012, is primarily attributable to increased selling, general and administrative expenses of $32.2 million related to commercialization activities for Qsymia. Additionally, included in the net loss was a charge of $5.8 million to write off inventory in excess of demand. A substantial portion of the excess amount relates to the initial production of Qsymia, which has a shelf life of 24 months. With additional stability data to support a longer shelf life, we have submitted an application to the FDA to extend the shelf life to 36 months for current and future production.

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