Buoyed by the U.S. Food and Drug Administration’s (FDA) approval of Vimizim for treating mucopolysaccharidosis type IVA (MPS IVA), BioMarin Pharmaceutical Inc. (BMRN) announced that it expects its total revenues in 2014 to increase by more than 20% over 2013 levels ($548.5 million). The biopharmaceutical company expects 2014 revenues in the range of $650–$680 million.
BioMarin expects 2014 Vimizim sales in the range of $60–$70 million. Vimizim is the fifth member of BioMarin’s product portfolio. The other marketed products of the company are Naglazyme, Kuvan, Aldurazyme and Firdapse. BioMarin co-markets Aldurazyme with Sanofi (SNY).
The company is looking to get Vimizim approved in other markets as well including the EU. BioMarin expects an opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on Vimizim shortly.
Within a couple of months of the CHMP’s opinion, a final decision from the EC should be out. European approval of the drug would boost its sales potential as the U.S. market accounts for only approximately 15% of the total MPS IVA market according to the company.
BioMarin said that the list price associated with each Vimizim vial is $1068. The company is leaving no stone unturned to launch Vimizim effectively. Strong Vimizim sales are expected to help the company record total revenues in excess of $1 billion for the next few years.
BioMarin, which will release its fourth quarter and full year financial (audited) results shortly, also came out with preliminary results. Total revenues in the final quarter of 2013 climbed 11.4% to $146.9 million driven by strong product sales.
Naglazyme sales climbed 9% to $68.7 million. Kuvan registered fourth quarter sales of $45.3 million, up 13.3%. Aldurazyme and Firdapse recorded sales of $25.9 million and $4.3 million, respectively, in the final quarter of 2013.
BioMarin maintained its 2013 guidance on cost items. Selling, general & administrative expenses are still expected in the range of $220–$240 million and research & development expenses continue to be forecasted in the range of $340–$380 million.
Apart from the strong product portfolio, BioMarin has a robust pipeline with several data readouts expected this year. We expect investor focus to remain on Vimizim’s commercialization as well as BioMarin’s pipeline going forward.
BioMarin currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biopharma space include Alexion Pharmaceuticals, Inc. (ALXN) and Emergent BioSolutions, Inc. (EBS). Both stocks carry a Zacks Rank #1 (Strong Buy).
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