Message from Management
Welcome! Thank you for visiting the BioMarin Pharmaceutical website.
The year 2009 will be remembered by many as one of the most turbulent economic times in recent history. At BioMarin, however, we had the distinct fortune to not only weather the volatile economic storms, but to thrive. Increased global demand for our therapies and aggressive pipeline expansion will be the hallmarks of 2009. The year was not without its challenges, but by leveraging the confidence and security that comes with having strong cash reserves, a solid financial footing and an unwavering focus on building long term value, we further solidified our position in the rare disease arena. Throughout the coming year, we will continue to enhance our product pipeline and maximize investment opportunities to fuel long term growth.
Highlights of the year include strong sales of our three commercialized products, the acquisition of Huxley Pharmaceuticals and several promising compounds, the advancement of several clinical and nonclinical programs, and the anticipated launch of our fourth and newly acquired product, Firdapse™ (amifampridine phosphate) for LEMS in Europe. The company’s total net product revenues increased 25 percent over 2008, posting at $315.7 million. Naglazyme sales in new and existing markets exceeded our expectations with a 27 percent increase in net product sales over 2008, and third party sales of Aldurazyme showed modest gains as the number of patients on therapy continued to increase. Total annual net revenues for Kuvan were $76.8 million, compared to $46.7 million in 2008, and year end cash, cash equivalents and short and long term investments posted at $470.5 million for the year. Another important achievement was the completion of construction of our new manufacturing facility in Novato, which will more than double our manufacturing capacity.
Encouraging early data from the GALNS Phase I/II program for MPS IVA leads us to anticipate a pivotal Phase III trial by the end of 2010. As for PEG-PAL, the Phase II study is progressing and we expect to report some results in the third quarter of 2010. We continue to build important data on Kuvan therapy outcomes and we have initiated an exciting new program to develop a real time blood Phe monitoring device that will enable patients to better track and manage their PKU. Our BMN-195 small molecule upregulator of utrophin for Duchenne Muscular Dystrophy has advanced from preclinical status to Phase I clinical trials. Soon we will begin discussions with the FDA to establish development plans for Firdapse in the U.S. and we plan to submit an IND for the PARP inhibitor BMN-673 at the end of 2010.
We are pleased with our performance in 2009 and well positioned to meet our goals for 2010 as we look forward to an exciting year ahead. We are focused on carefully managing our pipeline and commercial products with the goal of continuing double-digit revenue growth in the coming years and to maximize long term value to BioMarin, patients and our shareholders.
I thank all of our employees for their expertise, passion and hard work throughout the year. I would also like thank patients and physicians for partnering with us to develop important therapeutics for rare diseases. I look forward to keeping you informed and sharing future developments with you as 2010 progresses.
Sincerely,
Jean-Jacques Bienaimé
Chief Executive Officer
