BioMarin Pharmaceutical Inc.
) fourth quarter 2012 loss of 43 cents per share was wider than
the Zacks Consensus Estimate of a loss of 27 cents per share and
the year-ago loss of 23 cents per share. The wider loss was due
to higher operating expenses.
For full year 2012, BioMarin reported a loss of 95 cents per
share, wider than the year-ago loss of 48 cents and the Zacks
Consensus Estimate of a loss of 79 cents per share. The company's
total revenues for the year 2012 came in at $500.7 million, up
13.4%. Reported revenues beat the Zacks Consensus Estimate of
The Quarter in Details
Total revenues climbed 22.3% to $131.9 million in the reported
quarter, beating the Zacks Consensus Estimate of $129 million.
The increase in total revenues was attributable to higher net
Net product revenues in the reported quarter climbed
approximately 23.5% to $131 million. Naglazyme, approved for
treating MPS-VI, a rare genetic enzyme deficiency disorder,
accounted for a significant portion of the net product revenues
recorded in the quarter. Revenues from the drug shot up 31% to
$63 million during the quarter.
Net product revenues from Kuvan tablets, indicated for
treating mild-to-moderate forms of phenylketonuria, were up 29.9%
to $40 million. BioMarin is conducting a randomized,
placebo-controlled, 13-week outcomes study (PKU-016) in patients
treated with Kuvan. The company recently 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 $24.6 million, up 3.4%.
Net revenues from Firdapse, currently marketed in the EU, were
$3.4 million in the quarter, up 3% year over year. 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 45.7%)
and selling, general & administrative (SG&A) expenses (up
13.6%) shot up in the quarter, leading to a 38.3% rise in total
In Nov 2012, BioMarin reported positive results from the much
awaited phase III study of Vimizim (GALNS) for the treatment of
patients suffering from mucopolysaccharidosis Type IVA (MPS IVA)
or morquio A syndrome.
The company now plans to seek US approval for Vimizim soon,
with potential approval of the candidate expected by the end of
2013. BioMarin also plans to submit the EU application for the
candidate in the second quarter this year.
The company also plans to initiate two more late stage studies
this year for PEG-PAL (PKU) and BMN-673 (solid tumors). Apart
from these, BioMarin has several data readouts and trial
initiations throughout the year.
Apart from announcing financial results for the fourth quarter
and full year 2012, the company also provided its outlook for
2013. BioMarin expects total revenues in the range of $530-$555
million. The Zacks Consensus Estimate of $554 million is on the
higher end of the company's guidance.
The company expects total Naglazyme revenues in the range of
$265-$285 million and Kuvan net product sales in the range of
$155-$170 million in 2013.
Meanwhile SG&A expenses are expected in the range of
$220-$250 million and R&D expenditure are expected to be
$340-$380 million in 2013.
The company's fourth quarter financial results were
disappointing. We are, however, impressed with the company's
pipeline. Late stage candidate Vimizim can drive growth at
BioMarin. The company can swing to profitability on the back of
Vimizim. We expect investor focus to stay on the candidate's
BioMarin currently carries a Zacks Rank #3 (Hold). However,
other bio pharma stocks such as
) carry a Zacks Rank #1 (Strong Buy).
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