BioMarin Pharmaceutical(US:BMRN)2025-08-05 17:03PART I. FINANCIAL INFORMATION Item 1. Financial Statements The company presents its unaudited condensed consolidated financial statements for the periods ended June 30, 2025 Condensed Consolidated Statements of Comprehensive Income (Unaudited) | Metric | Three Months Ended June 30, 2025 ($ in thousands) | Three Months Ended June 30, 2024 ($ in thousands) | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | | :--- | :--- | :--- | :--- | :--- | | Total Revenues | $825,410 | $712,029 | $1,570,555 | $1,360,862 | | Income from Operations | $276,887 | $120,452 | $500,780 | $208,914 | | Net Income | $240,532 | $107,174 | $426,218 | $195,836 | | Diluted EPS | $1.23 | $0.55 | $2.19 | $1.01 | Condensed Consolidated Balance Sheets Highlights (Unaudited) | Metric | June 30, 2025 ($ in thousands) | December 31, 2024 ($ in thousands) | | :--- | :--- | :--- | | Total Current Assets | $3,805,332 | $3,232,427 | | Total Assets | $7,456,341 | $6,988,940 | | Total Liabilities | $1,429,228 | $1,330,950 | | Total Stockholders' Equity | $6,027,113 | $5,657,990 | Condensed Consolidated Statements of Cash Flows Highlights (Unaudited) | Metric | Six Months Ended June 30, 2025 ($ in thousands) | Six Months Ended June 30, 2024 ($ in thousands) | | :--- | :--- | :--- | | Net cash provided by operating activities | $359,665 | $165,733 | | Net cash provided by (used in) investing activities | ($40,830) | $76,244 | | Net cash used in financing activities | ($43,382) | ($30,181) | | Net increase in cash and cash equivalents | $270,974 | $217,023 | Notes to Condensed Consolidated Financial Statements (Unaudited) The notes detail accounting policies, revenue breakdowns, and significant events like the Inozyme Pharma acquisition Net Product Revenues by Product (Six Months Ended June 30) | Product | 2025 ($ in thousands) | 2024 ($ in thousands) | | :--- | :--- | :--- | | VOXZOGO | $435,145 | $336,812 | | VIMIZIM | $403,770 | $370,536 | | NAGLAZYME | $243,157 | $237,678 | | PALYNZIQ | $199,207 | $164,000 | | ALDURAZYME | $105,414 | $73,820 | | BRINEURA | $89,054 | $84,356 | | KUVAN | $52,170 | $64,461 | | ROCTAVIAN | $19,709 | $8,281 | Net Product Revenues by Geographic Region (Six Months Ended June 30) | Region | 2025 ($ in thousands) | 2024 ($ in thousands) | | :--- | :--- | :--- | | United States | $514,248 | $420,448 | | Europe | $472,716 | $416,738 | | Latin America | $186,400 | $163,012 | | Rest of world | $268,848 | $265,926 | - On July 1, 2025, the Company completed its acquisition of Inozyme Pharma, Inc in an all-cash transaction for approximately $270.0 million81 - The Company is involved in a legal matter with the U.S Department of Justice (DOJ) regarding sponsored testing programs for VIMIZIM and NAGLAZYME78 Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A) Management analyzes Q2 2025 financial performance, highlighting revenue growth and operational expense trends Results of Operations Q2 2025 revenues grew due to higher sales volumes while net income increased significantly from lower operating expenses Net Product Revenue Changes (Three Months Ended June 30, 2025 vs 2024) | Product | 2025 Revenue (M) | 2024 Revenue (M) | Change (M) | Key Driver | | :--- | :--- | :--- | :--- | :--- | | VOXZOGO | $221.4 | $183.9 | $37.5 | Higher sales volume from new patients | | VIMIZIM | $215.4 | $178.0 | $37.4 | Higher sales volume and timing of government orders | | PALYNZIQ | $105.9 | $88.3 | $17.6 | Higher sales volume from new patients | | KUVAN | $27.1 | $28.6 | ($1.5) | Increasing generic competition | - R&D expenses decreased by $22.5 million in Q2 2025 compared to Q2 2024, primarily due to lower spending on ROCTAVIAN and discontinued research programs107 - SG&A expenses decreased by $30.7 million in Q2 2025 compared to Q2 2024, driven by reduced commercial activities for ROCTAVIAN and lower G&A costs109110 Financial Condition, Liquidity and Capital Resources The company's liquidity improved with $1.94 billion in cash and investments and strong operating cash flow Cash, Cash Equivalents, and Investments | Category | June 30, 2025 ($ in millions) | December 31, 2024 ($ in millions) | | :--- | :--- | :--- | | Cash and cash equivalents | $1,213.8 | $942.8 | | Short-term investments | $218.3 | $194.9 | | Long-term investments | $508.6 | $521.2 | | Total | $1,940.7 | $1,658.9 | - The company has $600.0 million in convertible debt due in 2027 and an undrawn $600.0 million revolving credit facility that matures in 2029126127 - As of June 30, 2025, the company had purchase obligations of approximately $585.7 million, with $236.5 million expected to be paid in 2025128 Quantitative and Qualitative Disclosures About Market Risk The company's market risk profile has not materially changed from the disclosures in its 2024 Annual Report - There have been no material changes in the company's market risks during the six months ended June 30, 2025, compared to the 2024 Form 10-K135 Controls and Procedures Management concluded that disclosure controls were effective, noting the ongoing implementation of a new ERP system - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of June 30, 2025137 - The company began deploying a new ERP system in January 2025, with a phased implementation scheduled through 2026140 PART II. OTHER INFORMATION Legal Proceedings The company reports no new legal proceedings for the period - There are no legal proceedings to report for the period141 Risk Factors The company faces risks related to strategy execution, competition, regulation, manufacturing, and global operations Business and Operational Risks Key risks include executing the new corporate strategy, competition from generics, and securing reimbursement for high-priced drugs - Success is dependent on managing growth and executing the new corporate strategy, including expanding VOXZOGO's use and integrating the Inozyme Pharma acquisition145146 - The company faces intense competition, including from generic versions of its products like KUVAN, which will continue to adversely affect revenues158 - Commercial viability depends on obtaining adequate coverage and reimbursement from third-party payers for high-priced rare disease therapies159165 Regulatory Risks The company is exposed to risks from uncertain drug approval processes, ongoing compliance requirements, and healthcare reforms - Failure or delays in receiving regulatory approval from authorities like the FDA and EMA can prevent revenue generation and increase costs173 - Approved products are subject to extensive ongoing regulatory requirements, such as the PALYNZIQ REMS program, with non-compliance risking significant penalties181183 - Government healthcare reforms, such as the Inflation Reduction Act (IRA), and international price controls could adversely affect product pricing194199 Manufacturing and International Risks Risks stem from complex manufacturing processes, reliance on single-source suppliers, and exposure to global geopolitical and economic factors - The complexity of manufacturing biologics and gene therapies may lead to insufficient production quantities at acceptable costs226227 - The company depends on single-source suppliers and a limited number of manufacturing facilities, creating vulnerability to supply interruptions235 - Significant international operations create exposure to foreign currency fluctuations, geopolitical instability, and diverse regulatory requirements244251261 General and Financial Risks Financial risks include capital needs for debt repayment, stock price volatility, new tax laws, and cybersecurity threats - The company may need to raise additional capital to fund operations and repay its $600.0 million of convertible notes due in 2027215216 - New tax laws, such as the One Big Beautiful Bill (OBBB) Act enacted in 2025, could materially affect the company's business295297 - The company is subject to stringent data privacy laws like GDPR and CCPA, with non-compliance risking significant fines and reputational harm305306 - The company is vulnerable to cybersecurity incidents that could disrupt operations and compromise sensitive data, particularly during its new ERP implementation318319320 Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities during the period - None reported336 Other Information No directors or officers adopted or terminated Rule 10b5-1 trading plans during the second quarter of 2025 - No directors or officers adopted or terminated Rule 10b5-1 trading plans during the second quarter of 2025339 Exhibits This section lists exhibits filed with the Form 10-Q, including the Inozyme Pharma merger agreement and CEO/CFO certifications - The exhibits include the Agreement of Plan and Merger with Inozyme Pharma, Inc, corporate governance documents, and CEO/CFO certifications340