Aldurazyme en Kuvan stimuleren omzetgroei BioMarin Pharmaceuticals in Q2 2012

‘Big Pharma’ Swoop Imminent
Op 2 augustus 2012 presenteerde BioMarin Pharmaceuticals, Inc (BMRN)  het tweede kwartaal de financiele resultaten per 30 juni 2012. Het bedrijf boekte een 12,1% stijging van de totale omzet tot $ 124m in Q2 2012 van € 110.6m in Q2 2011. GlobalData schrijft deze groei toe aan een significante toename in de verkoop van twee  producten van het bedrijf, Aldurazyme en Kuvan. Aldurazyme (laronidase), een enzym vervangende therapie voor de behandeling van mucopolysacharidose I (MPS I) vervaardigd door BioMarin en gecommercialiseerd door Genzyme Corporation, groeide wereldwijd met 26% jaar-op-jaar van $ 17,3 in Q2 2011 tot $ 21.8m in Q2 2012 . Kuvan (sapropterine hydrochloride), de eerste en enige door de FDA goedgekeurde geneesmiddel voor het verminderen van bloed-fenylalanine (Phe) niveaus bij patienten met hyperphenylalaninemia (HPA), groeide met 20,5%, van $ 28,8 miljoen in Q2 2011 tot $ 34.7m in Q2 2012. BioMarin bleef incrementele rendement te ervaren van zijn belangrijkste product, Naglazyme (galsaulfase), een enzym vervangende therapie voor de behandeling van mucopolysacharidose IV (MPS IV), die met 4,3% groeide van $ 60.3m in Q2 2011 tot $ 62.9m in Q2 2012, accounting voor 51,1% van de omzet van het bedrijf voor het kwartaal

nieuw!

On August 2, 2012, BioMarin Pharmaceuticals, Inc. (BMRN) announced its second quarter financial results ending June 30, 2012. The Company posted a 12.1% increase in total revenue to $124m in Q2 2012 from $110.6m in Q2 2011. GlobalData ascribes this growth to a significant increase in sales from two of the company’s currently marketed products, Aldurazyme and Kuvan. Aldurazyme (laronidase), an enzyme replacement therapy for the treatment of mucopolysaccharidosis I (MPS I) manufactured by BioMarin and commercialized by Genzyme Corporation, grew worldwide by 26% year-on-year from $17.3m in Q2 2011 to $21.8m in Q2 2012. Kuvan (sapropterin hydrochloride), the first and only FDA approved drug for reducing blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA), grew by 20.5% from $28.8m in Q2 2011 to $34.7m in Q2 2012. BioMarin continued to experience incremental returns from its lead product, Naglazyme (galsaulfase), an enzyme replacement therapy for the treatment of mucopolysaccharidosis IV (MPS IV), which grew by 4.3% from $60.3m in Q2 2011 to $62.9m in Q2 2012, accounting for 51.1% of the company’s revenue for the quarter.

In addition to the revenue growth, BioMarin’s gross profit grew 9.8% year-on-year, from $91.4m in Q2 2011 to $100.4m in Q2 2012. However, gross margin in Q2 2012 declined 160 basis points year-on-year from 82.6% to 81% due to a 22.5% increase in COGS to $23.6m. GlobalData attributes this increase to third-party manufacturing costs for the production of Kuvan and Firdapse, a product approved in the EU for the treatment of Lambert Eaton Myasthenic Syndrome (LEMS), and royalty payments.

The company’s operating expenses increased by 41% to $156m in Q2 2012 up from $109.9m in Q2 2011. GlobalData believes this significant growth is due to an increase in the company’s R&D expenses and SG&A. BioMarin also recorded a 47.% year-on-year increase in R&D expenses, from $52.9m in Q2 2011 to $77.8m in Q2 2012. We attribute this increase to more costly late-stage clinical pipeline advancements. In Q2 2012, the company announced that it spent about $11.8m on clean room manufacturing and expanded enrollment for ancillary studies for GANLS, an enzyme replacement therapy for the treatment of Morquio A syndrome (MPS IVA). The company also has an ongoing mid-stage clinical program for PEGylated recombinant phenylalanine ammonia lyase (PEG-PAL), a treatment for phenylketonuria (PKU). The results of the PEG-PAL and GANLS studies are expected in Q3 2012 and Q4 2012 respectively and the company intends to file for market authorization for GALNS in treating MPS IVA in Q1 2013.

The company’s SG&A expenses increased by 25% year-on-year, from $41m in Q2 2011 to $51.5m in Q2 2012. GlobalData believes this growth is as a result of increased corporate costs associated with infrastructure to support the company’s domestic and global expansion in 2012. Between Q1 2012 and Q2 2012, BioMarin’s headcount increased by 9.8% from 1,002 to 1,100. The company has also elevated its spending on sales and marketing to increase its share of the rare diseases market. In Q2 2012, the company announced that $2.4m was spent on pre-commercial activities related to GANLS and sales and marketing expenses associated with Naglazyme.

GlobalData believes BioMarin’s financial performance over the last quarter will further increase the possibility of a buy-out by GlaxoSmithKline or Shire Pharmaceuticals, two U.K companies with a strong presence in rare diseases. GSK, who recently acquired Human Genome Sciences (HGS) for about $3 billion, would likely edge out Shire in a deal that could be worth up to $7 billion (significantly more than BioMarin’s current $4.4 billion market cap). As we approach the patent cliff and many blockbuster drugs go off patent, major pharmaceutical companies such as GSK (whose Advair, a blockbuster drug responsible for 34% of its revenue in 2011, goes off patent in 2013) have resorted to mergers and acquisitions as a quick way to recoup the associated revenue loss and strengthen their product pipeline. BioMarin has a promising product pipeline with a significant number of compounds in late-stage development to reduce the company’s over-dependence on Naglazyme for over 60% of its revenue yearly. Therefore, it is unsurprising that the company is being courted by a ‘Big Pharma’ company such as GSK. In addition, BioMarin’s need for working capital and funds for R&D makes it susceptible to a buy-out. At the end of 2011, the company recorded a net loss of $53.8m due to a 45.5% increase in R&D, to $214.4m from $147.3m in 2010. In an attempt to strengthen its balance sheet after spending $130m on the purchase of Pfizer’s manufacturing plant in Cork, Ireland, and after the repurchase of the intellectual rights to Naglazyme from the Adelaide Health Authority, Australia, the company offered 6.5 million shares of its common stock through a public offering in May 2012, successfully raising a net $235m (after deductions). GlobalData believes it is only a matter of time before BioMarin becomes the latest victim of Big Pharma’s acquisition of biotechs.

Redactie Medicalfacts/ Janine Budding

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