VIVUS Inc. (NASDAQ: VVUS) is a biopharma company. The company develops and commercialises therapeutic products for underserved markets. It has two products under investigational pipeline at a late-stage. One of these products is Qnexa. It completed phase III clinical trials for obesity and phase II clinical trials for diabetes and obstructive sleep apnea.
The company submitted a new drug agreement (NDA) to the United Stated Food and Drug Administration (FDA) for Qnexa in December 2009. The other product is Avanafil. It is in Phase III trials for erectile dysfunction. The company also has a product for the treatment of hypoactive sexual desire disorder (HSDD), Luramist. Luramist is also under investigational trail. As December 31, 2009, the Company had one drug approved by the FDA, and several investigational product candidates in late stages of clinical development. These products are in obesity and related morbidities, including sleep apnea and diabetes, and sexual health segments.
VIVUS presented its second quarter results early this month. Total revenues for the second quarter were $3.9 million as against $14.7 million same quarter last year. The decrease in total revenue in the second quarter of 2010 was primarily due to the inclusion of deferred license revenue from the sale of Evamist in the second quarter of 2009.
Net loss for second quarter of 2010 was $22.8 million as against a net loss of $13.2 million in the same quarter of 2009. The earnings per share was seen at -28 cents per share as against -19 cents in the same quarter of 2009. The sharp increase in the net loss of the second quarter 2010 as compare to same quarter of 2009 was due to the recognition of the deferred revenues of Evamist and increase in operating overheads primarily due to the Qnexa pre-commercialization expenses.
FDA panel recommended against approval of Qnexa on Jul 15. The main concerns about Qnexa were:
- There was lack of safety evidence of longer than one year. The patients were going to take Qnexa for a long term period, considering a maintenance drug.
- There were also concerns about women taking Qnexa, as it might affect birth defects.
The VIVUS Inc. stock has a 52-week range of $4.69-$13.68. Year-to-date, the stock is down 39.18%.
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