{"id":484645,"date":"2021-04-29T16:06:22","date_gmt":"2021-04-29T20:06:22","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/biomarin-announces-first-quarter-2021-financial-results-and-corporate-updates\/"},"modified":"2021-04-29T16:06:22","modified_gmt":"2021-04-29T20:06:22","slug":"biomarin-announces-first-quarter-2021-financial-results-and-corporate-updates","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/biomarin-announces-first-quarter-2021-financial-results-and-corporate-updates\/","title":{"rendered":"BioMarin Announces First Quarter 2021 Financial Results and Corporate Updates"},"content":{"rendered":"
\n

– Full-year 2021 Financial Guidance Reaffirmed<\/h2>\n

– Total Revenues Grew 9% in the First Quarter 2021 Compared to First Quarter 2020, Excluding Kuvan<\/h2>\n

– Regulatory Actions in Europe for Vosoritide and Valoctocogene Roxaparvovec Tracking as Expected; BioMarin Anticipates CHMP Opinion in June for Vosoritide and June Re-submission of MAA for Valoctocogene Roxaparvovec<\/h2>\n

– FDA Review of Vosoritide Proceeding; PDUFA Target Action Date Extended to November 20, 2021 to Provide Time for Review of Recently Submitted 2-year Phase 3 Results<\/h2>\n

PR Newswire<\/p>\n<\/p><\/div>\n

\n

\n SAN RAFAEL, Calif.<\/span>, April 29, 2021<\/span> \/PRNewswire\/ — <\/p>\n

\n

\n
\n \"BioMarin
\n <\/a>\n <\/p>\n<\/p><\/div>\n

\n Financial Highlights (in millions of U.S. dollars, except per share data, unaudited)<\/b>\n <\/p>\n

\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\n \n <\/td>\n\n \n <\/td>\n\n

\n
\n Three Months Ended March 31,<\/b>
\n <\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n
\n 2021<\/b>
\n <\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n
\n 2020<\/b>
\n <\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n
\n % Change<\/b>
\n <\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n<\/tr>\n
\n

\n Total Revenues<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 486.0<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 502.1<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n (3)<\/span>\n <\/p>\n<\/td>\n

\n

\n %<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n<\/tr>\n
\n

\n Net Product Revenues Marketed by BioMarin (1)<\/sup><\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 417.8<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 433.3<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n (4)<\/span>\n <\/p>\n<\/td>\n

\n

\n %<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n<\/tr>\n
\n

\n Vimizim Net Product Revenues<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 158.4<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 137.2<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n 15<\/span>\n <\/p>\n<\/td>\n

\n

\n %<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n Naglazyme Net Product Revenues<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 107.3<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 114.3<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n (6)<\/span>\n <\/p>\n<\/td>\n

\n

\n %<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n Kuvan Net Product Revenues<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 70.8<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 122.0<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n (42)<\/span>\n <\/p>\n<\/td>\n

\n

\n %<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n Palynziq Net Product Revenues<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 54.0<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 34.6<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n 56<\/span>\n <\/p>\n<\/td>\n

\n

\n %<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n Brineura Net Product Revenues<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 27.3<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 24.0<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n 14<\/span>\n <\/p>\n<\/td>\n

\n

\n %<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n<\/tr>\n
\n

\n Aldurazyme Net Product Revenues<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 50.0<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 55.7<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n (10)<\/span>\n <\/p>\n<\/td>\n

\n

\n %<\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n<\/tr>\n
\n

\n GAAP Net Income<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 17.4<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 81.4<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n<\/tr>\n
\n

\n GAAP Net Income per Share \u2013 Basic<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 0.10<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 0.45<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n<\/tr>\n
\n

\n GAAP Net Income per Share \u2013 Diluted<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 0.09<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 0.44<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n<\/tr>\n
\n

\n Non-GAAP Income\u00a0(2)<\/sup><\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 104.4<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 116.5<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n \n <\/td>\n<\/tr>\n<\/table><\/div>\n

\u00a0<\/p>\n

\n\n\n\n
\n \n <\/td>\n\n

\n
\n March 31,<\/b>
\n
\n 2021<\/b>
\n <\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n

\n
\n December 31,<\/b>
\n
\n 2020<\/b>
\n <\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n<\/tr>\n
\n

\n Cash, cash equivalents and investments<\/span>\n <\/p>\n<\/td>\n

\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 1,408.6<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n\n

\n $<\/span>\n <\/p>\n<\/td>\n

\n

\n 1,350.9<\/span>\n <\/p>\n<\/td>\n

\n \n <\/td>\n\n \n <\/td>\n<\/tr>\n<\/table><\/div>\n
\n\n\n\n\n
\n \n <\/td>\n\n \n <\/td>\n<\/tr>\n
\n

\n (1)<\/span>\n <\/p>\n<\/td>\n

\n

\n Net 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. In January 2020, BioMarin divested the Firdapse assets to a third party in a sale transaction. The sale is reflected in the Company’s consolidated financial statements for the first quarter ended March 31, 2020; as a result of the transaction BioMarin will not recognize Net Product Revenues from Firdapse in the future. <\/span>\n <\/p>\n<\/td>\n<\/tr>\n

\n

\n (2)<\/span>\n <\/p>\n<\/td>\n

\n

\n Non-GAAP Income is defined by the Company as reported GAAP Net Income\/Loss, excluding net interest expense, provision for (benefit from) income taxes, depreciation expense, amortization expense, stock-based compensation expense, contingent consideration expense and, in certain periods, certain other specified items. Refer to Non-GAAP Information beginning on page 11 of this press release for a complete discussion of the Company’s Non-GAAP financial information and reconciliations to the comparable information reported under U.S. GAAP.<\/span>\n <\/p>\n<\/td>\n<\/tr>\n<\/table><\/div>\n

BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (BioMarin or the Company) today announced financial results for the first quarter ended March\u00a031, 2021. <\/p>\n

“We mark the start of 2021 with strong financial results, and a number of exciting regulatory decisions ahead this year,” said Jean-Jacques Bienaim\u00e9, Chairman and Chief Executive Officer of BioMarin. “The potential approval in Europe<\/span> this summer of vosoritide, the first potential therapeutic option for children with achondroplasia, will set the stage for our next significant phase of growth, especially considering the EMEA region is 3 times larger than the U.S. market. To date, the interactions with the review team at the European Medicines Agency have been very positive. Next, we plan to re-submit the application for valoctocogene roxaparvovec gene therapy, to treat hemophilia A, to the EMA in the second quarter, to be followed by potential approval of vosoritide in the United States<\/span> later this year.” <\/p>\n

Mr. Bienaim\u00e9 continued, “We are well positioned to deliver strong results for the full-year 2021, and reaffirm our financial guidance provided early this year. This takes into consideration the uneven ordering patterns in our dynamic and global commercial business, as well as continued uncertainty outside of the United States<\/span> from COVID-19, and further underscores the essential nature of our products to the people who rely on them. Taken together, our financial strength, including positive cash flows from operations of $113.5 million<\/span> in the first quarter, combined with near-term opportunities from potential new products and a robust early-stage pipeline, we believe that 2021 will be pivotal to BioMarin’s evolution.”\u00a0 <\/p>\n

\n
\n Financial Highlights:<\/i>
\n <\/b>\n <\/p>\n