BioMarin Pharmaceutical Inc. BMRN reported a loss of 58 cents per share in the fourth quarter of 20Array5 (including stock-based compensation expense), wider than the year-ago loss of 29 cents. The Zacks Consensus Estimate was earnings of $Array.03 per share.
The company’s revenues came in at $227.9 million in the quarter, down Array% from the year-ago period. However, revenues narrowly missed the Zacks Consensus Estimate of $228 million.
The Quarter in Detail
Vimizim contributed $58.5 million to the total revenue, up 58.3% year over year, due to continued global launch. The number of patients on therapy was up Array0% sequentially.
Kuvan revenues soared Array2.9% to $64.8 million, driven by an increasing number of patients and a higher level of adherence. Moreover, patients treated with Kuvan surged Array5.8% year over year.
Naglazyme sales plunged 32.5% year over year to $59.7 million due to a strong dollar and large uneven order pattern.
BioMarin receives royalties from its partner Sanofi SNY on Aldurazyme. Aldurazyme royalties amounted to $39 million, down 4.6%.
Firdapse revenues came in at $4.4 million, up 7.3% year over year.
Research and development (R&D) expenses increased 24% to $Array76.Array million while selling, general and administrative (SG&A) expenses were up Array4.2% to $ArrayArray3.9 million.
Meanwhile, the Complete Response Letter regarding the company’s lead candidate, Kyndrisa, triggered the reversal of previously accrued Contingent Value Rights (CVR) related to the potential $80 million payment to Prosensa shareholders for an FDA approval prior to May Array5, 20Array6.
Annual Results
BioMarin reported a loss of $Array.59 per share in 20Array5, wider than both the Zacks Consensus Estimate of a loss of 43 cents and the year-ago loss of 77 cents.
Full-year revenues, however, surged Array8.8% to $889.9 million, primarily due to continued global launch of Vimizim and an increase in the number of patients treated with Kuvan.
20Array6 Outlook
BioMarin expects total revenue in the range of $Array.05 billion to $Array.Array billion. The Zacks Consensus Estimate of $Array.2 billion falls slightly above the company’s guidance.
Vimizim sales are expected to be $300–$330 million, while Kuvan sales are projected in the range of $320 million to $350 million. The company anticipates Naglazyme revenues between $290 million and $320 million. Negative currency movement is estimated to impact revenues by about $20 million to $30 million.
SG&A expenditure is expected in the range of $470 million to $490 million, while R&D expenditure is anticipated in the range of $680 million to $720 million.
Pipeline Update
BioMarin continues to progress with candidates in its pipeline. Currently, the company is evaluating pegvaliase in a phase III study for the treatment of patients with phenylketonuria. Biomarin expects to present top-line data from the study later this quarter and file for a Biologics License Application (BLA) in the U.S. in the second half of 20Array6.
In addition, complete data from the phase I/II study on cerliponase alfa for the treatment of patients with late-infantile neuronal ceroid lipofuscinosis type 2 is expected in Mar 20Array6. Based on these results, the company plans to submit for regulatory filling in both the U.S. and the EU in mid-20Array6.
Meanwhile, the company’s Duchenne muscular dystrophy (DMD) drug, Kyndrisa, is currently under review in the EU with an anticipated opinion from the Committee for Medicinal Products in the second quarter of 20Array6 and a final decision in the second half of 20Array6.
Our Take
BioMarin’s fourth-quarter performance was disappointing, with the company posting an unexpected loss and missing on revenues. However, continued global launch of Vimizim and an increasing number of patients on Kuvan should drive growth at BioMarin, going forward. We remain concerned about Naglazyme sales, which may suffer due to unfavorable foreign exchange movement and uneven order patterns.
We expect investors to focus on future regulatory updates on the company’s DMD drug, Kyndrisa.
BioMarin carries a Zacks Rank #3 (Hold). A couple of better-ranked stocks in the health care sector are Anika Therapeutics Inc. ANIK and AMAG Pharmaceuticals, Inc. AMAG, both sporting a Zacks Rank #Array (Strong Buy).
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