Business
BioMarin Announces First Quarter 2020 Total Revenue Growth of 25% to $502 million
- U.S. Marketing Application for Valoctocogene Roxaparvovec for Severe Hemophilia A Accepted by FDA under Priority Review with Prescription Drug User Fee Act
About this update from Biomarin Pharmaceutical Inc.
[{"type":"text","content":"- U.S. Marketing Application for Valoctocogene Roxaparvovec for Severe Hemophilia A Accepted by FDA under Priority Review with Prescription Drug User Fee Act (PDUFA) action date of August 21, 2020\n - European Marketing Application for Valoctocogene Roxaparvovec for Severe Hemophilia A Accepted by EMA; Committee for Medicinal Products for Human Use (CHMP) Opinion Expected by Late 2020/Early 2021\n - Regulatory Submissions Planned for Marketing Authorization of Vosoritide to Treat Children with Achondroplasia in Third Quarter of 2020 in both the U.S. and Europe\n - For the Full-Year 2020 BioMarin Continues to Expect to be Profitable on a GAAP Basis for the First Time with no Guidance Change to either GAAP Net Income or Non-GAAP Income\n - 2020 Full-Year Total Revenue Guidance Reduced by 5% Due to Anticipated Impact of the Coronavirus (COVID-19) Pandemic Assuming Return to Normalized Demand Patterns in the Second Half of 2020\n\n\nSAN RAFAEL, Calif., April 29, 2020 /PRNewswire/ --\n\n \n \n \n \n \n \n\n \nFinancial Highlights (in millions of U.S. dollars, except per share data, unaudited)\nThree Months Ended March 31,\n2020\n2019\n% Change\nTotal Revenues\n$\n502.1\n$\n400.7\n25\n%\nNet Product Revenues Marketed by BioMarin (1)\n433.3\n349.2\n24\n%\nVimizim Net Product Revenues\n137.2\n125.8\n9\n%\nKuvan Net Product Revenues\n122.0\n106.9\n14\n%\nNaglazyme Net Product Revenues\n114.3\n86.9\n32\n%\nPalynziq Net Product Revenues\n34.6\n12.3\n181\n%\nBrineura Net Product Revenues\n24.0\n12.2\n97\n%\nAldurazyme Net Product Revenues\n55.7\n45.3\n23\n%\nGAAP Net Income (Loss)\n$\n81.4\n$\n(56.5)\nGAAP Net Income (Loss) per Share – Basic\n$\n0.45\n$\n(0.32)\nGAAP Net Income (Loss) per Share – Diluted\n$\n0.44\n$\n(0.32)\nNon-GAAP Income (2)\n$\n116.5\n$\n24.8\nMarch 31,\n2020\nDecember 31,\n2019\nCash, cash equivalents and investments\n$\n1,149.2\n$\n1,165.8\n(1)\nNet Product Revenues Marketed by BioMarin is the sum of revenues from Vimizim, Kuvan, Naglazyme, Palynziq, Brineura and Firdapse, each calculated in accordance with Generally Accepted Accounting Principles in the United States (U.S. GAAP). Sanofi Genzyme (Genzyme) is BioMarin's sole customer for Aldurazyme and is responsible for marketing and selling Aldurazyme to third parties. Refer to page 9 for a table showing Net Product Revenues by product, including Firdapse. In January...