BMRN

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How BMRN rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025

Text kept

65%

of sentences unchanged

Added

247

new sentences

Dropped

173

sentences removed

Length

+3,558

words, now 36,090

New in FY2025

On December 11, 2025, the European Parliament and the European Council reached a political agreement on a proposal for the revision of the EU pharmaceutical regulatory framework.
Among other things, the revision will amend the duration of the data and market exclusivity, the marketing authorization procedure, the possible post-authorization conditions, the reasons for a refusal of a marketing authorization, as well as obligations and waivers in connection with Pediatric Investigation Plans (PIPs).
In particular, the regulatory data protection period (during which generic/biosimilar companies cannot access product data) would amount to eight years, with one additional year of market protection (during which generic or biosimilar products cannot be sold), following a marketing authorization.
Pharmaceutical companies will be eligible for additional periods of market protection under certain conditions, with a cap of eleven years on the combined regulatory protection period.
Orphan medicinal products addressing a disease with no current available medicinal treatment (“breakthrough orphan medicinal products”) will benefit from up to eleven years of market exclusivity.
Moreover, with a view to ensure earlier market entry of generic and biosimilar medicinal products, the new rules clarify that the so-called “Bolar” exemption (which allows generic/biosimilar manufacturers to conduct certain activities during the patent protection period of the original product) allows the conduct of necessary studies, trials and other activities for the purposes of obtaining marketing authorizations, conducting health technology assessments, obtaining pricing and reimbursement approvals, or submitting procurement tender applications.
Foreign Corrupt Practices Act (FCPA), to which we are subject, prohibits U.S. persons, including U.S. entities and their employees, officers, and intermediaries from engaging in certain activities, directly or indirectly, to obtain or retain business or to influence a person working in an official capacity.
It is illegal to pay, provide offer to pay or authorize the provision of anything of value to any non-U.S. government official, government staff member, employee or officer of a state-owned or controlled entity, political party or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity.
Similar laws exist in other countries, such as the U.K., that restrict improper payments in the public and private sectors.
In the U.S., third-party payers carefully review and increasingly challenge the prices charged for drugs, examine their medical necessity, and review their cost effectiveness.
For many years, the total rebate amount for a unit of a drug was capped at 100% of the AMP; however, effective January 1, 2024, this cap was eliminated.
Elimination of this cap has, in some cases, required pharmaceutical manufacturers to pay more in rebates than they have received on the sale of products.
The out-of-pocket limit is $2,100 in 2026 and is to be adjusted for inflation thereafter.
In addition, CMS has selected and announced the negotiated maximum fair price for 15 additional Medicare Part D drugs which will become effective in 2027.
For 2028, CMS has selected an additional 15 drugs, comprised of drugs covered under Medicare Part D and, for the first time, drugs payable under Medicare Part B.
For 2029 and subsequent years, 20 Part B or Part D drugs will be selected.
However, as a result of a statutory amendment enacted in July 2025, beginning with the 2028 negotiated price applicability year, a drug may be designated for more than one rare disease or condition and still be excluded from price negotiation, as long as the only approved indications are for such rare diseases or conditions.
Presidential Administration is pursuing policies to reduce regulations and expenditures across government including at HHS, which include the FDA and CMS, and related agencies.
For example, on May 12, 2025, President Trump issued an executive order that, among other things, required HHS, within 30 days, to establish and communicate to drug manufacturers most favored nation (MFN) price targets designed to bring drug prices for American patients in line with those in comparably developed nations.
If significant progress towards MFN pricing is not achieved, the executive order requires HHS to propose a rulemaking to implement MFN pricing.
On December 23, 2025, CMS issued proposed regulations to establish, under the Center for Medicare and Medicaid Innovation, two mandatory MFN demonstration models under Medicare Parts B and D, respectively.
This is confirmed in the CTR, the current EU legislation on clinical trials, according to which clinical trial applications and all the related documentation are uploaded and stored in the Clinical Trials Information System (CTIS) which is managed by the EMA.
Currently, once all the studies and measures agreed have been conducted in accordance with the PIP, products are eligible for a six -month extension of the protection under a supplementary protection certificate (if any is in effect at the time of approval) or, in the case of orphan medicinal products, a two -year extension of the orphan market exclusivity.
Furthermore, it is expected that these rules will be amended as a result of a reform of the EU pharmaceutical legislative package.
On December 11, 2025, the European Parliament and the European Council reached a political agreement on the proposed revision of several European legislative instruments related to medicinal products, including pediatric products.
Among other things, the revision will likely amend the PIP waivers and the possible PIP obligations.
Privacy and Security Legislation The legislative and regulatory environments regarding privacy and data protection are continually evolving and developing, in response to increasing global attention.
Numerous U.S. states have enacted comprehensive privacy laws that impose certain obligations on covered businesses, including providing specific disclosures in privacy notices and affording residents with certain rights concerning their personal data.
For example, the California Consumer Privacy Act of 2018 (CCPA) applies to personal data of consumers, business representatives, and employees who are California residents, and requires businesses to provide specific disclosures in privacy notices and honor requests of such individuals to exercise certain privacy rights.
The CCPA provides for fines and allows private litigants affected by certain data breaches to recover significant statutory damages.
Other jurisdictions have enacted or proposed similar legislation and/or regulations.
Additionally, various U.S. federal and state consumer protection laws which require us to publish statements that accurately and fairly describe how we handle personal data and choices individuals may have about their personal data.
Outside of the United States, the EU’s General Data Protection Regulation (EU GDPR) and UK's General Data Protection Regulation (UK GDPR and collectively, GDPR), which require, among other things, that personal data is only collected for specified, explicit and legal purposes as set out in the GDPR or local laws, and the data may then only be processed in a manner consistent with those purposes.
Human Capital As of December 31, 2025, we had 3,221 employees worldwide, of whom 1,518 were in operations, 692 were in research and development, 495 were in sales and marketing and 516 were in administration.
Of the 3,221 employees as of December 31, 2025, 2,026 employees were in the U.S. and Canada, and 1,195 employees were outside of North America, including 967 in Europe and the Middle East, 151 in Latin America and 77 in Asia Pacific.
Compensation, Benefits and Well-being We offer competitive compensation and benefits in order to attract, recognize and retain excellent employees and support their overall well-being.
Our total rewards compensation package includes market-competitive salary, the potential to earn bonuses or sales commissions in recognition of performance, equity in recognition of performance and potential, healthcare benefits, among other benefits.
Workplace Culture We believe that scientific breakthroughs happen when different perspectives come together to solve complex problems.
Our dedication to this work ensures that we are harnessing the full range of our talent to drive innovation at BioMarin for patients around the world.
We know that the power of different viewpoints and experiences will drive a culture of inclusion, which creates innovation and growth.

and 207 more.

Gone since FY2024

In particular, the EU pharmaceutical legislation is currently the subject of a review process, in the context of the Pharmaceutical Strategy for Europe initiative, launched by the EC in November 2020.
The EC’s proposal for a revision of several legislative instruments related to medicinal products (potentially reducing the duration of regulatory exclusivity, revising the eligibility for expedited pathways, etc.) was published on April 26, 2023.
The proposed revisions remain to be agreed and adopted by the European Parliament and European Council.
The proposals may be substantially revised before adoption.
The revisions may, however, have a significant impact on our activities in the long term.
Foreign Corrupt Practices Act (FCPA), to which we are subject, prohibits corporations and individuals from engaging in certain activities to obtain or retain business or to influence a person working in an official capacity.
It is illegal to pay, offer to pay or authorize the payment of anything of value to any non-U.S. government official, government staff member, political party or political candidate in an attempt to obtain or retain business or to otherwise influence a person working in an official capacity.
Similar laws exist in other countries, such as the U.K., that restrict improper payments to public and private parties.
Third-party payers carefully review and increasingly challenge the prices charged for drugs, examine their medical necessity, and review their cost effectiveness.
For many years, the total rebate amount for a unit of a drug was capped at 100% of the AMP; however, effective January 1, 2024, this cap was eliminated, which means that a manufacturer could pay a rebate amount on a unit of the drug that is greater than the average price the manufacturer receives for the drug.
The out-of-pocket limit is $2,000 in 2025 and is to be adjusted for inflation thereafter.
CMS has selected 15 additional Medicare Part D drugs for negotiated maximum fair pricing in 2027.
For 2028, an additional 15 drugs, which may be covered under either Medicare Part B or Part D, will be selected, and for 2029 and subsequent years, 20 Part B or Part D drugs will be selected.
This is confirmed in the CTR, the new EU legislation on clinical trials, according to which clinical trial applications and all the related documentation are uploaded and stored in the Clinical Trials Information System (CTIS) which is managed by the EMA.
Once all the studies and measures agreed have been conducted in accordance with the PIP, products are eligible for a six -month extension of the protection under a supplementary protection certificate (if any is in effect at the time of approval) or, in the case of orphan medicinal products, a two -year extension of the orphan market exclusivity.
Privacy and Security Legislation In the ordinary course of our business, we may process personal or sensitive data.
Accordingly, we are, or may become, subject to numerous data privacy and security obligations, including federal, state, local, and foreign laws, regulations, guidance, and industry standards related to data privacy, security, and protection.
Such obligations may include, without limitation, the Federal Trade Commission Act, the California Consumer Privacy Act of 2018 (CCPA), the Canadian Personal Information Protection and Electronic Documents Act, the EU’s General Data Protection Regulation 2016/679 (EU GDPR), the EU GDPR as it forms part of United Kingdom (UK) law by virtue of section 3 of the European Union (Withdrawal) Act 2018 (UK GDPR).
The legislative and regulatory environments regarding privacy and data protection are continually evolving and developing, in response to increasing global attention.
In the U.S., for example, we are subject to the CCPA along with the California Privacy Rights Act of 2020 (CPRA).
The CCPA imposes obligations on covered businesses to provide specific disclosures related to a business’s collecting, using, and disclosing personal data and to respond to certain requests from California residents related to their personal data (for example, requests to know of the business’s personal data processing activities, to delete the individual’s personal data, and to opt out of certain personal data disclosures).
Also, the CCPA provides for civil penalties and a private right of action for data breaches which may include an award of statutory damages.
In addition, the CPRA, effective January 1, 2023, expanded the CCPA.
The CPRA, among other things, gives California residents the ability to limit use of certain sensitive personal data, establish restrictions on personal data retention, expands the types of data breaches that are subject to the CCPA’s private right of action, and establishes a new California Privacy Protection Agency to implement and enforce the new law.
Other jurisdictions where we operate have enacted or proposed similar legislation and/or regulations.
Several states within the United States have enacted or proposed data privacy laws.
Additionally, we are, or may become, subject to various U.S. federal and state consumer protection laws which require us to publish statements that accurately and fairly describe how we handle personal data and choices individuals may have about the way we handle their personal data.
We are also subject to the EU’s General Data Protection Regulation GDPR, which requires that personal data is only collected for specified, explicit and legal purposes as set out in the GDPR or local laws, and the data may then only be processed in a manner consistent with those purposes.
For example, the GDPR requires us to make more detailed disclosures to data subjects, requires disclosure of the legal basis on which we can process personal data, provides for conditions under which a valid consent for processing can be obtained, requires the appointment of a data protection officer where sensitive personal data (i.e., health data) is processed on a large scale, imposes mandatory data breach notification throughout the EEA and imposes additional obligations when contracting with service providers or partners.
Human Capital As of December 31, 2024, we had 3,040 employees worldwide, of whom 1,472 were in operations, 635 were in research and development, 458 were in sales and marketing and 475 were in administration.
Of the 3,040 employees as of December 31, 2024, 1,917 employees were in the U.S. and Canada, and 1,123 employees were outside of North America, including 920 in Europe and the Middle East, 131 in Latin America and 72 in Asia Pacific.
Diversity, Equity and Inclusion At BioMarin, prejudice, racism and intolerance are unacceptable.
We are committed to removing barriers to employment and embedding fairness and opportunity across all aspects of our organization, including hiring, promotion and development practices.
At the direction of BioMarin's senior leadership team, our human resources department has implemented policies, processes, and programs to improve inclusion at all levels of the organization.
In addition, the Corporate Governance and Nominating and Compensation Committees of our Board of Directors regularly receive reports on our initiatives and offer valuable insights and recommendations to management in addition to providing appropriate oversight.
As part of our ongoing governance review, we are evaluating the potential impact of the presidential executive orders issued in early 2025 regarding diversity, equity and inclusion on our policies, processes and programs as well as our business.
As of December 31, 2024, racial and ethnic minorities represented 51% of our employees in the U.S.
Globally, 50% of our workforce were women and 50% of our positions at director-level and above were held by women.
We are committed to continuing our ongoing efforts to eliminate barriers to employment, and support diversity by expanding our talent search for all positions, including leadership.
Equality, inclusiveness and belonging are central to BioMarin's culture, and we work to make our company a place where every employee feels heard, respected and valued.

and 133 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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