2006 was a year of transformation for drug developer BioMarin Pharmaceuticals (NASDAQ:BMRN). It received marketing approval in the European Union for one of its key drugs, Naglazyme, and prepared the way for possible FDA approval of another drug candidate, Kuvan (formerly called Phenoptin), later this year.
Last week, BioMarin reported its fourth-quarter and year-end financial results. Revenue for 2006 was up nearly 230% to $84 million, as sales of enzyme replacement therapy Naglazyme picked up in the U.S. and EU after its marketing approvals in those regions in June 2005 and January 2006, respectively.
Even with the higher Naglazyme sales, earnings were still negative, to the tune of $29 million for the year. Guidance calls for 2007's net loss, excluding stock-option expenses, to total less than $10 million. BioMarin has been conservative with its estimates in the past, though, so don't be surprised if it beats that number. I think that if Naglazyme's sales trajectory continues tracking higher than expected, positive earnings could easily come toward the end of this year.
BioMarin also revealed last week that its only pipeline candidate in development for hypertension failed to show a statistically significant improvement in blood pressure, compared to a placebo. At the moment, management is planning to continue development of the drug, and we should get more word on its plans in the coming quarters.
Filing for marketing approval for Kuvan with the FDA and European medical authorities is still expected in the second and third quarters of this year, respectively. Assuming the drug gets a six-month priority review from the FDA, it could be on the market in the U.S. by the end of the year.
With Kuvan and Naglazyme early in their launch and sales growing rapidly, BioMarin will enter the rare club of profitable biotechs no later than early 2008. BioMarin has proven itself adept at bringing drugs through the clinic, but now management needs to prove its marketing abilities. With an empty drug pipeline, investors need Naglazyme and BioMarin's other products to continue their rapid sales pace.
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Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.
