BioMarin Pharmaceutical(US:BMRN)2026-02-26 17:30Financial Commitments and Acquisitions - The company entered into a debt financing commitment for approximately $3.7 billion to fund the acquisition of Amicus, which was later reduced to $2.8 billion after issuing $850 million in senior unsecured notes[25]. - The company plans to enter into a senior secured term loan facility for approximately $2.8 billion and a new $600 million revolving credit facility in 2026[25]. - The company entered into a Bridge Commitment for up to approximately $3.7 billion in debt financing related to the pending acquisition of Amicus[436]. - In February 2026, the company issued $850.0 million in aggregate principal amount of the 2034 Notes to finance the pending acquisition of Amicus, reducing the Bridge Commitment from approximately $3.7 billion to $2.8 billion[437]. Revenue and Product Performance - In 2025, net product revenues for VOXZOGO reached $926.9 million, while VIMIZIM generated $792.1 million, and NAGLAZYME brought in $485.4 million[28]. - Total revenues for 2025 reached $3,221.3 million, an increase of 12.7% compared to $2,853.9 million in 2024[412]. - The company recognized net product revenues from ALDURAZYME sales, receiving payments ranging from 39.5% to 50% based on sales volume[446]. - The gross-to-net sales adjustments for the year ended December 31, 2025, included a balance at the beginning of the year of $195.0 million and an ending balance of $246.1 million[448]. Research and Development - Total R&D expense for 2025 was $921.9 million, up 23.4% from $747.2 million in 2024, driven by higher spending on later-stage clinical programs[416]. - R&D expense for later-stage clinical programs surged to $308.3 million in 2025, a significant increase from $27.6 million in 2024[416]. - The company incurred a $221.0 million In-Process Research and Development (IPR&D) charge following the Inozyme acquisition in 2025[416]. - The company reported a decrease in R&D spending on marketed products, primarily related to ROCTAVIAN, which fell to $229.9 million in 2025 from $285.6 million in 2024[416]. Market and Competitive Landscape - The biopharmaceutical industry is highly competitive, with potential competition from both larger and smaller companies in various therapeutic areas[65]. - There are currently no approved drugs for ENPP1 deficiency in the U.S. or EU, indicating a potential market opportunity for BMN 401[79]. - The commercial organization is structured around two business units: Skeletal Conditions (VOXZOGO) and Enzyme Therapies, with ongoing assessments for additional market agreements[60]. Regulatory and Compliance - The approval process for new drugs typically takes many years, involving preclinical tests and multiple phases of clinical trials[89][96]. - Clinical trials must comply with regulations and good clinical practices, with oversight from regulatory agencies and ethics committees[93][94]. - The FDA's Fast Track program allows for expedited review of drugs addressing unmet medical needs, with a determination made within 60 days of request[100]. - The FDA may approve drugs for serious conditions based on surrogate endpoints that predict clinical benefits, subject to post-marketing compliance requirements[102]. Financial Performance and Expenses - Cost of sales increased to $717.4 million in 2025, primarily due to a $119.2 million write-off of ROCTAVIAN inventory[412]. - Gross margin decreased to 77.7% in 2025 from 79.7% in 2024, largely impacted by the ROCTAVIAN inventory write-off[412]. - Total SG&A expenses for 2025 were $1,153.0 million, an increase of 14.3% from $1,009.0 million in 2024[418]. - G&A expenses rose to $622.8 million in 2025, a 17.0% increase from $532.3 million in 2024, primarily due to $118.5 million in restructuring charges related to ROCTAVIAN[419]. Legal and Intellectual Property - The company is engaged in legal actions to protect its intellectual property, particularly concerning patents related to VOXZOGO[81]. - The patent term for U.S. drugs can be extended up to five years under the Hatch-Waxman Act, providing additional market exclusivity[82]. - ALDURAZYME and NAGLAZYME patents expired in November 2020 and November 2023, respectively, with ongoing efforts to pursue additional patents and extensions[83]. Employee and Workforce - Employee count as of December 31, 2025, was 3,221, with 2,026 employees located in the U.S. and Canada[149]. - The company is committed to leveraging diverse perspectives to drive innovation and growth within its workforce[152]. Tax and Financial Obligations - Provision for income taxes increased to $133.6 million in 2025, up from $114.9 million in 2024, mainly due to non-deductible acquired IPR&D expenses[426]. - The liability for unrecognized tax benefits was $380.9 million as of December 31, 2025, with uncertain timing of future payments[443].