VIVUS Inc.’s (VVUS) first quarter 2013 loss of 53 cents per share was wider than the Zacks Consensus Estimate of a loss of 51 cents per share and the year-ago loss of 20 cents per share. The wider loss was due to higher operating expenses.
The company’s net product revenue, consisting of Qsymia sales, for the first quarter of 2013 came in at $4.1 million as compared to $2 million recorded in the fourth quarter of 2012. The company did not record any revenues during the prior-year quarter. The Zacks Consensus Estimate stood at $6 million for the first quarter of 2013.
We remind investors that Qsymia was launched in the US in Sep 2012. The US 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 plans to announce retail availability in the third quarter of 2013.
We remind investors that apart from Qsymia, another weight-loss drug, Arena Pharmaceuticals, Inc.’s (ARNA) Belviq, also received approval in the US last year. 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 FDA approved product, Stendra (avanafil), for erectile dysfunction (ED), which received marketing approval in the US in Apr 2012. In Apr 2013, European Medicines Agency's (:EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Stendra (trade name: Spedra in EU) for the ED indication. The positive opinion by the CHMP will be reviewed by the European Commission, which should issue a final decision by Jun 2013.
In the first quarter of 2013 research and development expenses were $7.0 million, up 12% year over year. Selling, general and administrative expenses shot up 258.1% to $44.7 million due to increased expenditure related to the commercialization of Qsymia.
VIVUS, a biopharmaceutical company, currently carries a Zacks Rank #4 (Sell). Biopharma companies that currently look attractive include XOMA Corporation (XOMA) with a Zacks Rank #1 (Strong Buy).
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