) fourth quarter 2013 loss (excluding one-time items) of 9 cents
per share was much narrower than the Zacks Consensus Estimate of
a loss of 43 cents and the year-ago loss of 56 cents.
The company's total revenue for the fourth quarter of 2013 came
in at $44.1 million as compared to $2.0 million recorded in the
year-ago period. The fourth quarter 2013 revenues included $34.8
million of license fee received from
Auxilium Pharmaceuticals Inc.
) for the erectile dysfunction (ED) drug, Stendra (EU trade name:
Spedra). The Zacks Consensus Estimate stood at $25 million for
the fourth quarter of 2013.
VIVUS' 2013 loss (excluding one-time items but including
stock-based compensation) of $1.54 per share was also narrower
than the Zacks Consensus Estimate of $1.95. The year-ago loss was
$1.42 per share. The company's total revenue for 2013 came in at
$81.1 million as compared to $2.0 million recorded in the
year-ago period. The Zacks Consensus Estimate stood at $60
million for 2013.
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
Net product sales of Qsymia in the reported quarter were $7.7
million, up 20.3% sequentially. Qsymia prescriptions
(approximately 124,000) witnessed a 14% sequential jump in the
reported quarter. Prescription volume was negatively impacted by
the holiday season (in Nov and Dec).
At the fourth quarter conference call, the company stated that
Qsymia was available at over 37,000 certified retail pharmacies
in the U.S., reflecting an increase of 6,000 sequentially. The
company further stated that reimbursement trends for the drug are
Apart from Qsymia, the company's portfolio consists of another
approved product, Spedra, which received approval in the U.S. in
Apr 2012 and in the EU in Jun 2013. In the reported quarter, the
drug generated revenues of approximately $1.5 million.
VIVUS is collaborating with several companies for the
commercialization of Stendra. It has inked a licensing and
commercialization deal with Sanofi for Stendra. As per the terms
of the deal, Sanofi will undertake the responsibility of
obtaining regulatory approval and commercializing the drug in
Africa, the Middle East, Turkey, and the Commonwealth of
Independent States (CIS) including Russia. VIVUS has also entered
into a license and commercialization agreement with Menarini (40
European countries and Australia and New Zealand) and Auxilium
(the U.S. and Canada).
While Auxilium launched the drug in the U.S. last December,
Menarini is expected to launch the drug in the EU in the first
half of 2014. Meanwhile, Auxilium has submitted a supplemental
New Drug Application (sNDA) for Stendra. The company is looking
to incorporate data from a study (in which Stendra was found to
be effective within 15 minutes of ingestion) in its label. The
FDA is expected to render a decision by Sep 20, 2014. We believe
Stendra's fast action could help the drug gain share.
In the fourth quarter of 2013, research and development expenses
were $5.0 million, down 35.6% year over year. Selling, general
and administrative expenses were down 27.3% to $36.6 million
benefiting from the company's restructuring efforts.
We are concerned about the competitive nature of the obesity
market given the presence of Belviq among others, keeps us
concerned. The successful commercialization of Qsymia is crucial
for the financial performance of VIVUS as it can drive the
company to profitability.
VIVUS, a biopharmaceutical company, currently carries a Zacks
Rank #3 (Hold). Some better-ranked biopharma stocks, worth
Alexion Pharmaceuticals, Inc.
) with a Zacks Rank #1 (Strong Buy).
ALEXION PHARMA (ALXN): Free Stock Analysis
AUXILIUM PHARMA (AUXL): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
VIVUS INC (VVUS): Free Stock Analysis Report
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