BioMarin Pharmaceutical Inc.
) third quarter 2013 loss (excluding debt conversion expense) of
36 cents per share was wider than the Zacks Consensus Estimate of
a loss of 28 cents per share and the year-ago loss of 4 cents per
share. The wider loss was due to higher expenses.
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Total revenues climbed 6.9% to $136.9 million in the reported
quarter but missed the Zacks Consensus Estimate of $140 million.
The year-over-year increase in total revenues was attributable to
higher net product revenues.
Net product revenues in the reported quarter surged approximately
6.3% to $134.3 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 1.1% to $63.2 million during the
quarter. The marginal rise in Naglazyme sales was due to the
delay of the centralized order from the Brazilian Ministry of
Net product revenues from Kuvan tablets, indicated for treating
mild-to-moderate forms of phenylketonuria (PKU), were up 19.8% to
$43.6 million. The impressive rise was due to higher demand for
the drug. BioMarin recorded revenues from another enzyme
replacement therapy, Aldurazyme, co-marketed by
), of $23.4 million, down 1.7%.
Net revenues from Firdapse, currently marketed in the EU, came in
at $4.1 million in the quarter, flat sequentially. 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 expenses (33.1%) and selling,
general & administrative expenses (33.4%) were on the upswing
during the quarter. Total BioMarin's efforts to develop its
pipeline contributed to the rise in R&D expenses.
Apart from announcing financial results for the third quarter of
2013, the company also maintained its outlook for 2013. BioMarin
still expects total revenues in the range of $530-$555 million.
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.
BioMarin also maintained its guidance with on cost items.
SG&A expenses are still expected in the range of $220-$240
million and R&D expenses continue to be forecasted in the
range of $340-$380 million.
Apart from the 4 marketed products, BioMarin has a robust
pipeline. The most important pipeline candidate at BioMarin is
Vimizim. The candidate is being developed for the treatment of
patients suffering from mucopolysaccharidosis Type IVA (MPS IVA)
or morquio A syndrome.
The candidate is under review in the U.S. and the EU. BioMarin is
also seeking approval of the candidate in Brazil. The target date
in the U.S. is Feb 28, 2014. BioMarin stated that prior to the
final decision an advisory panel of the U.S. Food and Drug
Administration (FDA) will review Vimizim's marketing application
on Nov 19, 2013. The European approval of Vimizim is also on
track with the European Medicines Agency (EMA) validating Vimizim
marketing authorization application and granting it accelerated
review status. Consequently, BioMarin expects the EMA's Committee
for Medicinal Products for Human Use to render an opinion on the
marketing application by year-end/early 2014.
Another interesting candidate in BioMarin's pipeline is PEG-PAL,
which is currently in phase III development for the treatment of
phenylketonuria (PKU). Top-line data from the study is expected
by the end of next year. BioMarin has other interesting
candidates like BMN 701 (Pompe disease) in its pipeline. The
successful development and commercialization of the robust
pipeline will help drive long-term growth at BioMarin.
BioMarin currently carries a Zacks Rank #3 (Hold). Companies like
Isis Pharmaceuticals, Inc.
) are well placed with a Zacks Rank #1 (Strong Buy).