VIVUS Inc.’s (VVUS) second quarter 2013 loss of 48 cents per share was slightly narrower than the Zacks Consensus Estimate of a loss of 49 cents per share but wider than the year-ago loss of 24 cents per share. The wider loss was due to higher operating expenses.
The company’s net product revenue, consisting of Qsymia sales, for the second quarter of 2013 came in at $5.5 million as compared to $4.1 million recorded in the first quarter of 2013. The company did not record any revenues during the prior-year quarter. The Zacks Consensus Estimate stood at $6 million for the second quarter of 2013.
In the second quarter of 2013 research and development expenses were $9.2 million, up 4% year over year. Selling, general and administrative expenses shot up 176.7% to $42.7 million due to increased expenditure related to the commercialization of Qsymia.
We remind investors that Qsymia was launched in the U.S. in Sep 2012. The U.S. Food and Drug Administration (FDA) cleared Qsymia in Jul 2012 as an adjunct to a healthy diet (low on calories) and increased physical activity for chronic weight management in obese (Body Mass Index, or BMI – 30 or more) or overweight (BMI – 27 or more) adults suffering from at least one weight-related co-morbid condition.
On Apr 16, 2013, the FDA approved an amendment and modification to the Risk Evaluation and Mitigation Strategy (REMS) of Qsymia.
As per the modification to the REMS, Qsymia can now be distributed through certified retail pharmacies apart from the existing certified mail-order pharmacy network. The company announced retail availability on Jul 1, 2013.
We remind investors that apart from Qsymia, another weight-loss drug, Arena Pharmaceuticals, Inc.’s (ARNA) Belviq, received approval in the U.S. last year. Belviq was launched in the U.S. in Jun 2013. Orexigen Therapeutics, Inc. (OREX) is also developing a candidate, Contrave, targeting the lucrative obesity market.
Apart from Qsymia, the company’s portfolio consists of another approved product, Stendra for erectile dysfunction (ED), which received approval in the U.S. in Apr 2012 and in the EU in Jun 2013. The company is looking for a partner in the U.S. VIVUS has entered in to a license and commercialization agreement with Menarini. As per the terms of the agreement, Menarini will get the rights to Spedra in more than 40 European countries, apart from Australia and New Zealand.
VIVUS, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Biopharma companies that currently look attractive include Jazz Pharmaceuticals (JAZZ) with a Zacks Rank #2 (Buy).
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