) 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
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
Arena Pharmaceuticals, Inc.
) Belviq, received approval in the U.S. last year. Belviq was
launched in the U.S. in Jun 2013.
Orexigen Therapeutics, Inc.
) 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
) with a Zacks Rank #2 (Buy).
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