What the changes say
- BioMarin's risk profile now centers heavily on its aggressive M&A strategy, specifically the proposed acquisition of Amicus and completed purchase of Inozyme.
- The company is taking on substantial integration challenges, increased debt obligations including $850.0 million in 2034 notes, and new U.S. regulatory and tax pressures.
What changed since the prior 10-K
New
- NewBusiness and Operational Risks
We have in the past and may in the future pursue acquisitions of other companies or businesses, which could divert our management’s attention, fail to achieve the anticipated benefits and/or expose us to other risks or difficulties
Acquiring other companies, such as Amicus and Inozyme, may divert management attention and fail to deliver anticipated benefits.
- NewRisks Related to the Amicus Acquisition
The pending Amicus Acquisition may not be completed on the currently contemplated timeline or terms, or at all
The pending Amicus acquisition may be delayed or fail to close due to required stockholder approval and antitrust clearances under the HSR Act.
- NewRisks Related to the Amicus Acquisition
We may not realize the anticipated benefits from the pending Amicus Acquisition
Combining with Amicus and commercializing its products like Galafold and Pombiliti + Opfolda may not succeed as expected.
- NewRisks Related to the Amicus Acquisition
may require greater resources and investments than originally anticipated or may result in the assumption of unknown or contingent liabilities, which could have an adverse effect on us or our results of operations
Integrating Amicus could result in unforeseen liabilities, regulatory hurdles in new markets, and IT or internal control failures.
- NewRisks Related to the Amicus Acquisition
The pendency of the Amicus Acquisition could adversely affect our and/or Amicus’ businesses and operations
The pending Amicus deal may cause commercial partners to delay decisions and restrict Amicus from operating outside the ordinary course.
- NewRisks Related to the Amicus Acquisition
We expect to incur material expenses related to the Amicus Acquisition
BioMarin expects to incur material, hard-to-estimate expenses related to the Amicus acquisition and subsequent business integration.
- NewRisks Related to the Amicus Acquisition
We may not realize the anticipated cost savings from the Amicus Acquisition
Anticipated cost savings and operational synergies from the Amicus acquisition may not be fully realized or may cost more than expected.
- NewRisks Related to the Amicus Acquisition
Our and Amicus’ actual financial positions and results of operations may differ materially from the publicly filed unaudited pro forma condensed combined financial information
Actual financial results following the Amicus acquisition may differ materially from the unaudited pro forma financial information filed on Form 8-K.
- NewRegulatory Risks
The approval of biosimilar products referencing any of our products could have a material adverse impact on sales of our products and on our business, financial condition, results of operations and growth prospects due to increased competition and pricing pressures
U.S. administration policies resulting in FDA workforce reductions could delay regulatory reviews and approvals for product candidates.
- NewFinancial and Financing Risks
We will need cash not only to pay the ongoing interest due on the Notes during their term, but also to repay the principal amount of the 2027 Notes (if not converted) and the 2034 Notes
BioMarin will need additional cash to repay principal on 2027 Notes and 2034 Notes, and failure to raise financing could halt product development.
- NewFinancial and Financing Risks
equipment or facilities (including moving manufacturing from one of our facilities to another one of our facilities or a third-party facility, or from a third-party facility to one of our facilities) may require us to complete clinical trials to receive regulatory approval of any manufacturing modifications
Moving manufacturing between facilities or third parties may trigger requirements to complete additional clinical trials to prove product comparability.
- NewRisks Related to Ownership of Our Securities
Our ability to use net operating losses to offset future taxable income may be subject to certain limitations
Ownership changes exceeding 50 percent under Section 382 could limit BioMarin's ability to use net operating loss carryforwards to offset taxable income.
Dropped
- DroppedRegulatory Risks
regulatory 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
- DroppedRegulatory Risks
treatment by third-party payers, which may render our products not commercially viable or may adversely affect our future revenues and gross margins
- DroppedRegulatory Risks
products 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
- DroppedFinancial and Financing Risks
program, 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
- DroppedRisks Related to International Operations
In 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
- DroppedRisks Related to Ownership of Our Securities
management team, organizational structure, and corporate strategy could cause retention and morale concerns among current employees, and may create operational risks
- DroppedRisks Related to Ownership of Our Securities
In 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
Reworded
- 94% rewrittenFinancial and Financing Risks
If 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
Updated debt figures to reflect cash and investments of $2.1 billion and the issuance of $850.0 million in 2034 notes in February 2026.
- 77% rewrittenBusiness and Operational Risks
Changes 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
Added past tense reference regarding significant uncertainty around whether gene therapy would gain public and medical community acceptance.
- 76% rewrittenRisks Related to International Operations
We face credit risks from government-owned or sponsored customers outside of the U.S. that may adversely affect our results of operations
Maintained core risk regarding credit risks from foreign government-owned customers with minor formatting adjustments.
- 70% rewrittenRegulatory Risks
Government 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
Added pricing restrictions explicitly to the scope alongside coverage and reimbursement.
- 65% rewrittenRisks Related to Ownership of Our Securities
We depend upon our key personnel and our ability to attract and retain qualified employees
Expanded key personnel retention risk to explicitly include integrating employees joining through acquisitions or business combinations.
- 65% rewrittenRisks Related to International Operations
If we are unable to protect our intellectual property, we may not be able to compete effectively or preserve our market shares
Retained core intellectual property protection risks with minor structural wording refinements.
- 60% rewrittenRisks Related to Ownership of Our Securities
New 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
Updated tax risk to cite the enactment of the One Big Beautiful Bill (OBBB) Act in 2025 and its specific tax changes.
- 57% rewrittenRisks Related to Ownership of Our Securities
Activist 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
Kept activist investor risk referencing the expired Elliott Investment Management Cooperation Agreement unchanged.
- 55% rewrittenRegulatory Risks
We may face competition from biosimilars approved through an abbreviated regulatory pathway
- 53% rewrittenRisks Related to Ownership of Our Securities
The fundamental change repurchase feature of the 2027 Notes and the change of control repurchase feature of the 2034 Notes may delay or prevent an otherwise beneficial attempt to take us over
Was: The fundamental change repurchase feature of the 2027 Notes may delay or prevent an otherwise beneficial attempt to take us over
- 43% rewrittenBusiness and Operational Risks
Our success depends on our ability to manage our growth and execute our corporate strategy
- 43% rewrittenRegulatory Risks
If 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
- 37% rewrittenRegulatory Risks
Government healthcare reform could increase our costs and adversely affect our revenues and results of operations
- 36% rewrittenFinancial and Financing Risks
If we fail to comply with manufacturing regulations, our financial results and financial condition will be adversely affected
- 33% rewrittenFinancial and Financing Risks
We have incurred in the past and may in the future incur 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
Was: We 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
- 26% rewrittenFinancial and Financing Risks
In addition, our ability to refinance our indebtedness will depend on the capital markets and our financial condition at such time
All 50 risk factors
Headings as the filing states them, in filing order.
Business and Operational Risks
- 01Our success depends on our ability to manage our growth and execute our corporate strategy43% rewritten
- 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
- 03We have in the past and may in the future pursue acquisitions of other companies or businesses, which could divert our management’s attention, fail to achieve the anticipated benefits and/or expose us to other risks or difficultiesNew
- 04If 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
- 05If 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
- 06If 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
- 07Because 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
- 08Changes 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 revenues77% rewritten
- 09We 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
Risks Related to the Amicus Acquisition
- 10The pending Amicus Acquisition may not be completed on the currently contemplated timeline or terms, or at allNew
- 11We may not realize the anticipated benefits from the pending Amicus AcquisitionNew
- 12may require greater resources and investments than originally anticipated or may result in the assumption of unknown or contingent liabilities, which could have an adverse effect on us or our results of operationsNew
- 13The pendency of the Amicus Acquisition could adversely affect our and/or Amicus’ businesses and operationsNew
- 14We expect to incur material expenses related to the Amicus AcquisitionNew
- 15We may not realize the anticipated cost savings from the Amicus AcquisitionNew
- 16Our and Amicus’ actual financial positions and results of operations may differ materially from the publicly filed unaudited pro forma condensed combined financial informationNew
Regulatory Risks
- 17Government 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 operations70% rewritten
- 18Government healthcare reform could increase our costs and adversely affect our revenues and results of operations37% rewritten
- 19If 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 reduced43% rewritten
- 20We may face competition from biosimilars approved through an abbreviated regulatory pathway55% rewritten
- 21The approval of biosimilar products referencing any of our products could have a material adverse impact on sales of our products and on our business, financial condition, results of operations and growth prospects due to increased competition and pricing pressuresNew
Financial and Financing Risks
- 22If 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 programs94% rewritten
- 23We will need cash not only to pay the ongoing interest due on the Notes during their term, but also to repay the principal amount of the 2027 Notes (if not converted) and the 2034 NotesNew
- 24We have incurred in the past and may in the future incur 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 results33% rewritten
- 25In addition, our ability to refinance our indebtedness will depend on the capital markets and our financial condition at such time26% rewritten
- 26If we fail to comply with manufacturing regulations, our financial results and financial condition will be adversely affected36% rewritten
- 27equipment or facilities (including moving manufacturing from one of our facilities to another one of our facilities or a third-party facility, or from a third-party facility to one of our facilities) may require us to complete clinical trials to receive regulatory approval of any manufacturing modificationsNew
- 28Supply 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
- 29Any 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
- 30If 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
- 31We 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
- 32A 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
- 33Our international operations pose currency risks, which may adversely affect our operating results and net income
- 34Failure 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
- 35We face credit risks from government-owned or sponsored customers outside of the U.S. that may adversely affect our results of operations76% rewritten
- 36If we are unable to protect our intellectual property, we may not be able to compete effectively or preserve our market shares65% rewritten
- 37Competitors 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
- 38Our stock price has been and may in the future be volatile, and an investment in our stock could suffer a decline in value
- 39Conversion 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
- 40The fundamental change repurchase feature of the 2027 Notes and the change of control repurchase feature of the 2034 Notes may delay or prevent an otherwise beneficial attempt to take us over53% rewritten
- 41Anti-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
- 42We depend upon our key personnel and our ability to attract and retain qualified employees65% rewritten
- 43New 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 condition60% rewritten
- 44Our ability to use net operating losses to offset future taxable income may be subject to certain limitationsNew
- 45If 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
- 46We 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
- 47If product liability lawsuits are successfully brought against us, we may incur substantial liabilities
- 48We 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
- 49Activist 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 operations57% rewritten
- 50Our business is affected by macroeconomic conditions
Other Biomarin Pharmaceutical 10-Ks
- FY2024 10-K risk factors45 risks
BioMarin's risk profile centers on managing $1.7 billion in cash and $600 million in 2027 Notes while executing a new 2024 corporate growth strategy. Key threats include reliance on small patient populations for products like BRINEURA and VIMIZIM, single-source manufacturing vulnerabilities, and international pricing pressures.
Filed Feb 24, 2025
About this page
The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.