BioMarin Pharmaceutical Inc.
) first quarter 2013 loss of 31 cents per share was wider than
the Zacks Consensus Estimate of a loss of 28 cents per share and
the year-ago loss of 21 cents per share. The wider loss was due
to higher operating expenses.
The Quarter in Details
Total revenues climbed 9.7% to $127.9 million in the reported
quarter but missed the Zacks Consensus Estimate of $131 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 9.6% to $127.3 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 1.2% to $69.4
million during the quarter.
Net product revenues from Kuvan tablets, indicated for
treating mild-to-moderate forms of phenylketonuria, were up 17.5%
to $37.6 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 now plans to submit data
from the study to the US Food and Drug Administration (FDA) to
include this in the Kuvan label.
BioMarin recorded revenues from another enzyme replacement
therapy, Aldurazyme, co-marketed by
), of $16.7 million, up 39.2%.
Net revenues from Firdapse, currently marketed in the EU,
remained flat at $3.6 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 since launch.
Both research & development (R&D) expenses (up 13.4%)
and selling, general & administrative (SG&A) expenses (up
12.8%) shot up in the quarter, leading to a 16.1% rise in total
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. BioMarin
expects Vimizim to be approved in the US by the end of the
BioMarin also submitted a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMA) for the candidate
earlier this month. Vimizim has been granted accelerated review
status in the EU.
The company has plans to initiate two more late stage studies
this year for PEG-PAL (PKU) and BMN-673 (solid tumors).
Management expects to initiate the PEG-PAL study by Jun 30, 2013.
The company expects to commence the BMN-673 study by the end of
this year. BioMarin also has several other pipeline related
events lined up this year.
Apart from announcing financial results for the first quarter
of 2013, the company also maintained its outlook for 2013.
BioMarin still expects total revenues in the range of $530-$555
million. The Zacks Consensus Estimate of $549 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.
SG&A expenses are still expected in the range of $220-$250
million. The company continues to expect 2013 R&D in the
range of $340-$380 million.
Though the company's first quarter financial results were
disappointing, 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
BioMarin currently carries a Zacks Rank #3 (Hold). However,
other biopharma stocks such as
) look better positioned. While, Incyte carries a Zacks Rank #1
(Strong Buy), Alkermes carries a Zacks Rank #2 (Buy).
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