Biomarin Pharmaceutical (BMRN) risk factors, FY2024 10-K

Business and Operational Risks

1. 01Our success depends on our ability to manage our growth and execute our corporate strategy
2. 02If we fail to develop new products and product candidates or compete successfully with respect to acquisitions, joint ventures, licenses or other collaboration opportunities, our ability to continue to expand our product pipeline and our growth and development would be impaired
3. 03If we do not achieve our projected development goals in the timeframes we announce or fail to achieve such goals, the commercialization of our product candidates may be delayed or never occur and the credibility of our management may be adversely affected and, as a result, our stock price may decline
4. 04If we fail to compete successfully with respect to product sales, we may be unable to generate sufficient sales to recover our expenses related to the development of a product program or to justify continued marketing of a product and our revenues could be adversely affected
5. 05If we fail to obtain and maintain an adequate level of coverage and reimbursement for our products by third-party payers, the sales of our products would be adversely affected or there may be no commercially viable markets for our products
6. 06Because the target patient populations for our products are relatively small, we must achieve significant market share and maintain high per-patient prices for our products to achieve and maintain profitability
7. 07Changes in methods of treatment of disease or failure of our products to gain acceptance by patients or the medical community could negatively impact demand for our products and adversely affect revenues
8. 08We have in the past entered and may in the future enter into licensing arrangements, and we may not realize the benefits of such licensing arrangements
9. 09Activist investor actions threatened or commenced against us have and could in the future cause us to incur substantial costs, divert management's attention and resources, cause uncertainty about the strategic direction of our business and adversely affect our business, financial position and results of operations

Regulatory Risks

1. 10regulatory approvals on a timely basis, if at all. We may not be able to file for regulatory approvals and even if we file, we may not receive necessary approvals to commercialize our product candidates in any market
2. 11Government price controls or other changes in pricing regulation could restrict the amount that we are able to charge for our current and future products, which would adversely affect our revenues and results of operations
3. 12treatment by third-party payers, which may render our products not commercially viable or may adversely affect our future revenues and gross margins
4. 13Government healthcare reform could increase our costs and adversely affect our revenues and results of operations
5. 14If we fail to obtain or maintain orphan drug exclusivity for some of our products, our competitors may obtain approval to sell the same drugs to treat the same conditions and our revenues will be reduced
6. 15products that has secured orphan drug exclusivity, our competitors may then sell the same drug to treat the same condition and our revenues will be reduced
7. 16We may face competition from biosimilars approved through an abbreviated regulatory pathway

Financial and Financing Risks

1. 17If we fail to obtain the capital necessary to fund our operations, our financial results and financial condition will be adversely affected and we will have to delay or terminate some or all of our product development programs
2. 18We have incurred substantial indebtedness that may decrease our business flexibility, access to capital, and/or increase our borrowing costs, which may adversely affect our operations and financial results
3. 19In addition, our ability to refinance our indebtedness will depend on the capital markets and our financial condition at such time
4. 20If we fail to comply with manufacturing regulations, our financial results and financial condition will be adversely affected
5. 21program, or if we are unable to produce sufficient quantities of our products at acceptable costs, we may be unable to meet commercial demand, lose potential revenue, have reduced margins or be forced to terminate a program
6. 22Supply interruptions may disrupt our inventory levels and the availability of our products and product candidates and cause delays in obtaining regulatory approval for our product candidates, or harm our business by reducing our revenues
7. 23Any interruption in the supply of finished products could hinder our ability to distribute finished products to meet commercial demand and adversely affect our financial results and financial condition
8. 24If our Manufacturing, Marketing and Sales Agreement with Sanofi were terminated, we could be prevented from continuing to commercialize ALDURAZYME or our ability to successfully commercialize ALDURAZYME would be delayed or diminished

Risks Related to International Operations

1. 25We conduct a significant amount of our operations and generate a significant percentage of our sales outside of the U.S., which subjects us to additional business risks that could adversely affect our revenues and results of operations
2. 26A significant portion of our international sales are made based on special access programs, and changes to these programs could adversely affect our product sales and revenues in these countries
3. 27Our international operations pose currency risks, which may adversely affect our operating results and net income
4. 28Failure to comply with applicable anti-corruption legislation could result in fines, criminal penalties and materially adversely affect our business, financial condition and results of operations
5. 29We face credit risks from government-owned or sponsored customers outside of the U.S. that may adversely affect our results of operations
6. 30If we are unable to protect our intellectual property, we may not be able to compete effectively or preserve our market shares
7. 31In addition, we have pursued, and may in the future pursue, litigation, administrative challenges or other types of proceedings to protect our patents and intellectual property rights. Such proceedings are often protracted and expensive, and have an unpredictable outcome
8. 32Competitors and other third parties may have developed intellectual property that could limit our ability to market and commercialize our products and product candidates, if approved

Risks Related to Ownership of Our Securities

1. 33Our stock price has been and may in the future be volatile, and an investment in our stock could suffer a decline in value
2. 34Conversion of the 2027 Notes will dilute the ownership interest of existing stockholders, including holders who had previously converted their 2027 Notes, or may otherwise depress the price of our common stock
3. 35The fundamental change repurchase feature of the 2027 Notes may delay or prevent an otherwise beneficial attempt to take us over
4. 36Anti-takeover provisions in our charter documents and under Delaware law may make an acquisition of us, which may be beneficial to our stockholders, more difficult
5. 37We depend upon our key personnel and our ability to attract and retain qualified employees
6. 38management team, organizational structure, and corporate strategy could cause retention and morale concerns among current employees, and may create operational risks
7. 39New tax laws or regulations that are enacted or existing tax laws and regulations that are interpreted, modified or applied adversely to us or our customers may have a material adverse effect on our business and financial condition
8. 40If we are found in violation of healthcare laws, we may be required to pay penalties, be subjected to scrutiny by regulators or governmental entities, or be suspended from participation in government healthcare programs, which may adversely affect our business, reputation, financial condition and results of operations
9. 41We are subject to new laws governing the privacy of consumer health data, including reproductive, sexual orientation, and gender identity privacy rights that provide consumers certain rights with respect to their health data and create a private right of action to allow individuals to sue for violations
10. 42If product liability lawsuits are successfully brought against us, we may incur substantial liabilities
11. 43We rely significantly on our information technology systems, including enterprise resource planning (ERP), production management, and other information systems, to effectively manage and maintain our operations, inventory and internal reports, to manufacture and ship products to customers and to timely invoice them
12. 44In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive information about us from public sources, data brokers, or other means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage or market position
13. 45Our business is affected by macroeconomic conditions