BioMarin Pharmaceutical Inc.
) second quarter 2013 loss of 16 cents per share was narrower
than the Zacks Consensus Estimate of a loss of 28 cents per share
and the year-ago loss of 27 cents per share. The narrower loss
was due to higher revenues.
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The Quarter in Details
Total revenues climbed 10.3% to $136.8 million in the reported
quarter but missed the Zacks Consensus Estimate of $135 million.
The year-over-year increase in total revenues was attributable to
higher net product revenues.
Net product revenues in the reported quarter climbed
approximately 7.6% to $132.4 million. Naglazyme, approved for
treating MPS-VI, a rare genetic enzyme deficiency disorder,
accounted for a significant portion of product revenues recorded
in the quarter. Revenues from the drug were up 11.1% to $69.9
million during the quarter.
Net product revenues from Kuvan tablets, indicated for treating
mild-to-moderate forms of phenylketonuria (PKU), were up 17.9% to
$40.9 million. BioMarin is conducting a randomized,
placebo-controlled, 13-week outcomes study (PKU-016) in patients
treated with Kuvan. In Feb 2013, the company announced positive
results from the PKU-016 study.
BioMarin recorded revenues from another enzyme replacement
therapy, Aldurazyme, co-marketed by
), of $17.5 million, down 19.7%.
Net revenues from Firdapse, currently marketed in the EU, came in
at $4.1 million in the quarter. Firdapse was launched in Apr
2010, in the EU, for treating patients suffering from LEMS, a
rare autoimmune disorder. The drug has performed disappointingly
While research & development (R&D) expenses up were up
10.1%, selling, general & administrative (SG&A) expenses
went down 1.7% during the quarter. Total operating expenses were
up 1.2% in the reported quarter.
In Mar 2013, BioMarin submitted a Biologics License Application
(BLA) to the FDA for Vimizim (GALNS) for the treatment of
patients suffering from mucopolysaccharidosis Type IVA (MPS IVA)
or morquio A syndrome. The BLA submission was based on positive
results from a phase III study on Vimizim. Vimizim was granted a
priority review designation by the FDA and a final verdict on the
U.S approval of the candidate is expected in Feb 2014.
BioMarin also submitted a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMA) for the candidate
earlier this year. BioMarin expects the Committee for Medicinal
Products for Human Use (CHMP) of the EMA to provide its verdict
on the EU approval of Vimizim by year end.
Moreover, BioMarin initiated a phase III study on its PKU
candidate PEG-PAL during the reported quarter, with top-line data
expected by the end of next year. The company expects to commence
a phase III study on BMN-673 shortly in patients suffering from
breast cancer. BioMarin also has several other pipeline related
events lined up this year.
Apart from announcing financial results for the second quarter of
2013, the company also maintained its revenues outlook for 2013.
BioMarin still expects total revenues in the range of $530-$555
million. The Zacks Consensus Estimate of $539 million is well
within the company's guidance range.
The company also maintained total Naglazyme revenues in the range
of $265-$285 million and Kuvan net product sales in the range of
$155-$170 million for 2013.
However, BioMarin narrowed its SG&A expenses guidance to the
range of $220-$240 million from the previous range of $220-$250
million. The company meanwhile continues to expect 2013 R&D
in the range of $340-$380 million.
We are impressed with the company's progress with its pipeline.
Vimizim, on approval, is expected to drive growth at BioMarin. We
expect investor focus to stay on the candidate's regulatory
BioMarin currently carries a Zacks Rank #3 (Hold). However,
companies such as
Jazz Pharmaceuticals Public Limited Company
Cadence Pharmaceuticals Inc.
) look better positioned. While Jazz Pharma carries a Zacks Rank
#1 (Strong Buy), Cadence carries a Zacks Rank #2 (Buy).