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BioMarin Announces Third Quarter 2020 Total Revenues of $477 Million
- Top-line Results from 52-week Phase 3 Study with Valoctocogene Roxaparvovec for Severe Hemophilia A Expected Early 2021 - Submission of Phase 3 Results from
About this update from Biomarin Pharmaceutical Inc.
[{"type":"text","content":"- Top-line Results from 52-week Phase 3 Study with Valoctocogene Roxaparvovec for Severe Hemophilia A Expected Early 2021\n - Submission of Phase 3 Results from 134 Subjects with 1 to 2 Years of Data with Valoctocogene Roxaparvovec for Severe Hemophilia A to the European Medicines Agency (EMA) Expected in the Second Quarter of 2021\n - Marketing Applications for Vosoritide to Treat Children with Achondroplasia under Review in Europe and the U.S.; Committee for Medicinal Products for Human Use (CHMP) Opinion Expected in the Second Half of 2021 and U.S. Prescription Drug User Fee Act (PDUFA) Target Action Date Expected August 20, 2021\n - 2020 GAAP Net Income Guidance Reflects Impact of Tax Benefit; Reduced Operating Expenses Drive Improved 2020 Non-GAAP Income Guidance; 2020 Full-year Total Revenue Guidance Revised due to Impact of the Coronavirus (COVID-19) Pandemic and Absence of Valoctocogene Roxaparvovec Revenue Contributions in 2020\n\n\nSAN RAFAEL, Calif., Nov. 5, 2020 /PRNewswire/ --\n\nFinancial Highlights (in millions of U.S. dollars, except per share data, unaudited)\nThree Months Ended September 30,\nNine Months Ended September 30,\n2020\n2019\n% Change\n2020\n2019\n% Change\nTotal Revenues\n$\n476.8\n$\n461.1\n3\n%\n$\n1,408.3\n$\n1,249.6\n13\n%\nNet Product Revenues Marketed by BioMarin (1)\n419.8\n428.1\n(2)\n%\n1,239.9\n1,150.6\n8\n%\nVimizim Net Product Revenues\n147.9\n163.5\n(10)\n%\n401.8\n412.0\n(2)\n%\nKuvan Net Product Revenues\n124.1\n120.6\n3\n%\n368.7\n340.8\n8\n%\nNaglazyme Net Product Revenues\n76.3\n94.4\n(19)\n%\n271.6\n279.5\n(3)\n%\nPalynziq Net Product Revenues\n46.1\n24.1\n91\n%\n121.4\n55.2\n120\n%\nBrineura Net Product Revenues\n25.4\n19.8\n28\n%\n75.2\n46.8\n61\n%\nAldurazyme Net Product Revenues\n40.9\n22.8\n79\n%\n128.9\n73.9\n74\n%\nGAAP Net Income (Loss)\n$\n784.8\n$\n55.0\n$\n837.0\n$\n(38.9)\nGAAP Net Income (Loss) per Share – Basic\n$\n4.33\n$\n0.31\n$\n4.63\n$\n(0.22)\nGAAP Net Income (Loss) per Share – Diluted\n$\n4.01\n$\n0.30\n$\n4.39\n$\n(0.22)\nNon-GAAP Income (2)\n$\n98.7\n$\n78.1\n$\n272.6\n$\n120.1\n \nSeptember 30,2020\nDecember 31,2019\nCash, cash equivalents and investments\n$\n1,770.8\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 ...