BioMarin Pharmaceutical(US:BMRN)2021-04-30 18:10Financial Performance - Total revenues for the three months ended March 31, 2021, were $486.0 million, a decrease from $502.1 million in the same period of 2020, representing a decline of approximately 3.3%[124] - Net income for the three months ended March 31, 2021, was $17.4 million, down from $81.4 million in the same period of 2020, reflecting a decrease of approximately 78.6%[124] - Total net product revenues decreased to $467.8 million for the three months ended March 31, 2021, down from $489.0 million in the same period of 2020, representing a decline of $21.2 million or 4.3%[133] - The decrease in net income was primarily due to the absence of a gain on the sale of nonfinancial assets and lower product sales for Kuvan due to generic competition[124] Research and Development - Research and development (R&D) expenses increased to $148.7 million in Q1 2021 from $142.3 million in Q1 2020, marking an increase of about 3.0%[124] - The company plans to continue its focus on research and development, acquisitions, and partnerships to advance its product candidate pipeline for rare diseases[121] - The company expects R&D expenses to increase in future periods due to heightened spending on preclinical activities and ongoing development of later-stage programs[149] - R&D expenses since inception as of March 31, 2021, totaled $750.3 million for Palynziq, $735.8 million for Valoctocogene roxaparvovec, $607.0 million for Vosoritide, and $195.3 million for BMN 307, with other approved products accounting for $1,540.4 million[173] Product Development and Regulatory Updates - Vosoritide, an investigational therapy for achondroplasia, completed enrollment in a Phase 2 study, with a cumulative height gain of 3.52 cm over two years compared to untreated children[121] - Valoctocogene roxaparvovec demonstrated an 84% reduction in Annualized Bleeding Rate (ABR) in a Phase 3 study for severe hemophilia A, with 80% of participants being bleed-free starting at week five post-treatment[123] - The FDA granted priority review designation for the New Drug Application (NDA) for vosoritide, potentially qualifying it for a Priority Review Voucher (PRV)[121] - The company anticipates submitting a Biologics License Application (BLA) for valoctocogene roxaparvovec in Q2 2022, following a two-year follow-up safety and efficacy data submission[123] Revenue Sources - Vimizim revenues increased by $21.2 million to $158.4 million, while Kuvan revenues decreased by $51.2 million to $70.8 million due to generic competition following the loss of U.S. market exclusivity[134] - Royalty revenues rose to $17.8 million for the three months ended March 31, 2021, compared to $8.7 million in the same period of 2020, an increase of $9.1 million or 104.6%[138] Cash and Liquidity - The company reported a cash, cash equivalents, and investments total of $1.41 billion as of March 31, 2021, compared to $1.35 billion as of December 31, 2020, indicating a growth of approximately 4.4%[125] - Cash and cash equivalents increased by $190.7 million to $667.3 million as of March 31, 2021, compared to $476.6 million at the end of the same period in 2020[164] - Net cash provided by operating activities increased by $128.7 million to $113.5 million for the three months ended March 31, 2021, compared to cash used in operating activities of $15.2 million in the same period of 2020[165] - Total convertible debt as of March 31, 2021 was $1.1 billion, impacting liquidity due to semi-annual cash interest payments[169] Expenses and Costs - Total SG&A expenses decreased by $13.0 million to $174.3 million for the three months ended March 31, 2021, compared to $187.3 million in the same period of 2020[152] - Interest income decreased by $2.8 million to $2.4 million for the three months ended March 31, 2021, primarily due to lower interest rates[156] - Provision for income taxes decreased by $14.1 million to $5.9 million for the three months ended March 31, 2021, compared to $20.0 million in the same period of 2020[160] - The fair value of contingent consideration increased by $2.3 million for the three months ended March 31, 2021, attributed to changes in estimated sales milestones related to PKU products[153] Future Outlook and Risks - The company anticipates continued impacts from the COVID-19 pandemic on future net product revenues, particularly for products administered in clinical settings[134] - Future capital requirements will depend on the ability to market products, develop manufacturing processes, and the success of preclinical studies and clinical trials[174] - As of March 31, 2021, contractual obligations for clinical and post-marketing services were estimated at approximately $122.9 million[178] - Contingent payments totaling approximately $654.5 million are due upon achieving certain development and regulatory activities and commercial sales milestones[178] - Market risks have not materially changed from those discussed in the previous annual report for the year ended December 31, 2020[180]