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BioMarin Announces Fourth Quarter And Full Year 2012 Financial Results

GAAP net loss for the year ended December 31, 2012 was $114.3 million ($0.95 per share), compared to GAAP net loss of $53.8 million ($0.48 per share) for the year ended December 31, 2011. Non-GAAP adjusted EBITDA was a loss of $11.6 million for the year ended December 31, 2012, compared to non-GAAP adjusted EBITDA of $34.5 million for the year ended December 31, 2011. The increased GAAP net loss and the reduced non-GAAP adjusted EBITDA for the year ended December 31, 2012 compared to the year ended December 31, 2011 was primarily due to increased research and development expenses and increased selling, general and administrative expenses partially offset by increased net product revenue. 

As of December 31, 2012, BioMarin had cash, cash equivalents and short and long-term investments totaling $566.7 million, as compared to $533.2 million on September 30, 2012. 

"2012 was a milestone year for BioMarin. Our growing commercial portfolio helped us surpass $500 million in total revenue and the pipeline continued to advance, culminating in positive results for the pivotal Phase 3 study for Vimizim at the end of the year," said Jean-Jacques Bienaimé, Chief Executive Officer of BioMarin. "We are poised for additional clinical milestones in the first half of 2013 with key data readouts from BMN-701 for Pompe disease and BMN-673, our PARP inhibitor. We also expect to have our first regulatory approval for Vimizim by the end of 2013, which we believe will propel the company into its next stage of growth."

Net Product Revenue (in millions) 

  Three Months Ended December 31,  Twelve Months Ended December 31, 
  2012 2011 $ Change % Change 2012 2011 $ Change % Change
Naglazyme (1)  $ 63.0  $ 48.1  $ 14.9 31.0%  $ 257.0  $ 224.9  $ 32.1 14.3%
Kuvan  40.0 30.8 9.2 29.9% 143.1 116.8 26.3 22.5%
Firdapse  3.4 3.3 0.1 3.0% 14.2 13.2 1.0 7.6%
(1)  Naglazyme revenues experience quarterly fluctuations due to the timing of government ordering patterns in certain countries.
  Three Months Ended December 31,  Twelve Months Ended December 31, 
  2012 2011 $ Change % Change  2012 2011 $ Change % Change 
Aldurazyme revenue reported by Genzyme   $ 53.1  $ 48.8  $ 4.3 8.8%  $ 193.1  $ 185.2  $ 7.9 4.3%
Royalties due from Genzyme  23.9  21.0  2.9    80.4  74.2  6.2  
Incremental product transfer revenues (2)  0.7  2.8  (2.1)    1.8  8.6  (6.8)  
Total Aldurazyme net product revenues  $ 24.6  $ 23.8  $ 0.8    $ 82.2  $ 82.8  $ (0.6)  
(2) To the extent units shipped to third party customers by Genzyme exceed BioMarin inventory transfers to Genzyme, BioMarin will record a decrease in net product revenue from the royalty payable to BioMarin for the amount of previously recognized product transfer revenue. If BioMarin inventory transfers exceed units shipped to third party customers by Genzyme, BioMarin will record incremental net product transfer revenue for the period.
2013 Guidance 
Revenue Guidance ($ in millions)
Item 2013 Guidance
Total BioMarin Revenues $530 to $555
Naglazyme Net Product Revenue $265 to $285
Kuvan Net Product Revenue $155 to $170
Selected Income Statement Guidance ($ in millions)
Item 2013 Guidance
Cost of Sales (% of Total Revenue) 17% to 18%
Selling, General and Admin. Expense $220 to $250
Research and Development Expense* $340 to $380
GAAP Net Loss $(195) to $(170)
Non-GAAP Adjusted EBITDA (loss) $(75) to $(50)
Cash Balance** Over $420
* Research and Development expense guidance includes expenses associated with the Zacharon acquisition and the University of College London license agreement 
** Cash balance includes cash, cash equivalents and short and long term investments

Anticipated Upcoming Milestones

1Q 2013: File market authorization application for Vimizim (GALNS) for MPS IVA in the U.S.

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