Regeneron Pharmaceuticals (REGN) risk factors, FY2025 10-K

Regeneron Pharmaceuticals's FY2025 10-K, filed Feb 04, 2026, lists 48 risk factors in 5 groups. Against the prior year's 44: 8 new, 4 dropped, 22 substantially reworded.

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Risk factors listed
485 groups
New this year
8vs 44 last year
Dropped
4since the prior 10-K
Substantially reworded
22of those kept
Section length
32k wordsItem 1A

What the changes say

  • Regeneron faces increasing reliance on Eylea HD and Dupixent with Sanofi.
  • New risks highlight drug pricing pressure, tariffs, and AI adoption.
  • Intellectual property protections face global challenges including Russian decrees.

What changed since the prior 10-K

New

  • New

    sales. The degree to which EYLEA HD net product sales may offset further potential decreases in EYLEA net product sales, resulting from the factors discussed above or otherwise, is uncertain

    Sanofi collaboration revenue from Dupixent represented 41% of total revenues in 2025, increasing dependence on partner commercialization.

  • New

    to obtain or maintain the applicable requirements for reimbursement (including relevant formulary coverage, as discussed further below) of our current and future marketed products, which may have a material adverse effect on our business

    PBM formularies and international pricing controls may restrict market access and reimbursement for our products.

  • New

    Product reimbursement and coverage policies and practices, pricing regulations and requirements, and our pricing strategy could change due to various factors beyond our control, which may adversely impact our business, prospects, operating results, and financial condition

    Payors are increasingly demanding discounts, rebates, step therapy, and outcomes-based pricing arrangements.

  • NewRisks Related to Intellectual Property and Market Exclusivity

    competitors. Furthermore, even if the outcome is favorable to us, the enforcement of our intellectual property rights can be extremely expensive and time consuming

    Russian government decrees allow domestic entities to exploit US-owned inventions without consent or compensation.

  • NewRisks Related to Intellectual Property and Market Exclusivity

    all. The failure to obtain any such license could prevent us from developing or commercializing any one or more of our products or product candidates, which could severely harm our business

    Orphan drug exclusivity blocks similar drugs but allows competing products with different active moieties or indications.

  • NewOther Regulatory and Litigation Risks

    We face risks associated with tariffs and other trade restrictions, which may have a material adverse impact on our results of operations and financial condition

    New baseline 10% US tariffs and retaliatory trade measures could materially impact operations.

  • NewOther Regulatory and Litigation Risks

    There are inherent risks related to our increasing use of artificial intelligence-based solutions

    Increasing use of AI solutions creates risks of sensitive data disclosure, regulatory non-compliance, and unintended biases.

  • NewRisks Related to Our Reliance on or Transactions with Third Parties

    Moreover, we may need to raise additional funds through public or private debt or equity financing to acquire any businesses, products, or product candidates, which may result in dilution for shareholders or the incurrence of indebtedness

    Undetected liabilities or integration failures from business and product acquisitions could adversely affect financial results.

Dropped

  • Dropped

    Changes to product reimbursement and coverage policies and practices may materially harm our business, prospects, operating results, and financial condition

  • DroppedRisks Related to Intellectual Property and Market Exclusivity

    A number of jurisdictions outside the United States have also established abbreviated pathways for regulatory approval of biological products that are biosimilar to earlier versions of biological products. For example, the EU has had an established regulatory pathway for biosimilars since 2005

  • DroppedOther Regulatory and Litigation Risks

    The majority of states also have statutes or regulations similar to the federal anti-kickback law and false claims laws, which apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor

  • DroppedOther Regulatory and Litigation Risks

    We have obligations to report the average sales price for certain of our drugs to the Medicare program. Statutory or regulatory changes or CMS guidance could affect the average sales price calculations for our products and the resulting Medicare payment rate, and could negatively impact our results of operations

Reworded

  • 87% rewrittenOther Regulatory and Litigation Risks

    The use of social media platforms could give rise to liability, breaches of data security and privacy laws, or reputational damage

    Updated to split social media risks from AI risks and added a specific threat of brand damage from negative online posts.

    Was: Increasing use of social media and artificial intelligence-based platforms could give rise to liability, breaches of data security and privacy laws, or reputational damage

  • 76% rewrittenOther Regulatory and Litigation Risks

    Our business activities have been, and may in the future be, challenged under U.S. federal or state and foreign healthcare laws, which may subject us to civil or criminal proceedings, investigations, or penalties

    Added reference to new US administration and FDA initiatives targeting transparency in direct-to-consumer advertising.

  • 72% rewritten

    Sales of our marketed products are dependent on the availability and extent of coverage and reimbursement and copay assistance from third-party payors and other third parties

    Added specific mention of patient copay affordability and third-party assistance funds impacting product sales.

    Was: Sales of our marketed products are dependent on the availability and extent of coverage and reimbursement from third-party payors

  • 68% rewritten

    We are substantially dependent on the success of EYLEA HD, EYLEA, and Dupixent

    Updated revenue concentration figures showing 2025 data where Eylea HD and Eylea represented 31% of total revenues.

    Was: We are substantially dependent on the success of EYLEA, EYLEA HD, and Dupixent

  • 61% rewrittenRisks Related to Our Reliance on or Transactions with Third Parties

    We have undertaken and may in the future undertake strategic acquisitions, and any difficulties from integrating such acquisitions could adversely affect our business, operating results, and financial condition

    Retained prior year acquisition examples like Checkmate, Decibel, and 2seventy bio without substantive changes.

  • 61% rewrittenOther Regulatory and Litigation Risks

    If the testing or use of our products harms people, or is perceived to harm them even when such harm is unrelated to our products, we could be subject to costly and damaging product liability claims

    Expanded product liability risk to explicitly note potential negative impacts on product and product candidate commercialization.

  • 53% rewrittenRisks Related to Intellectual Property and Market Exclusivity

    If we cannot protect the confidentiality of our trade secrets, or our patents or other means of defending our intellectual property are insufficient to protect our proprietary rights, our business and competitive position will be harmed

    Updated cross-references to point separately to the new standalone social media and AI risk factors.

  • 50% rewrittenRisks Related to Intellectual Property and Market Exclusivity

    Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, have in the past reduced and could reduce in the future the duration of market exclusivity for our products

    Added explicit mention of biosimilar versions causing rapid sales declines alongside generic versions upon market exclusivity expiration.

  • 46% rewrittenRisks Related to Our Reliance on or Transactions with Third Parties

    Significant disruptions of information technology systems or breaches of data security could adversely affect our business

  • 42% rewrittenOther Regulatory and Litigation Risks

    Changes in laws, regulations, and policies affecting the healthcare industry could adversely affect our business

  • 36% rewritten

    Successful development of our current and future product candidates is uncertain

  • 34% rewrittenRisks Related to Intellectual Property and Market Exclusivity

    We may be restricted in our development, manufacturing, and/or commercialization activities by patents or other proprietary rights of others, and could be subject to awards of damages if we are found to have infringed such patents or rights

  • 33% rewrittenRisks Related to Our Common Stock

    There can be no assurance that we will continue to repurchase shares of our Common Stock or continue to declare cash dividends

  • 30% rewritten

    If we are unable to establish sufficient commercial capabilities outside the United States for products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected

  • 29% rewrittenOther Regulatory and Litigation Risks

    Risks associated with our operations outside the United States could adversely affect our business

  • 29% rewrittenRisks Related to Manufacturing and Supply

    If sales of our marketed products do not meet the levels currently expected, or if the launch of any of our product candidates is delayed or unsuccessful, we may face costs related to excess inventory or unused capacity at our manufacturing facilities and at the facilities of third parties or our collaborators

  • 28% rewrittenRisks Related to Our Reliance on or Transactions with Third Parties

    Our investments are subject to risks and other external factors that may result in losses or affect the liquidity of these investments

  • 26% rewritten

    We may be unsuccessful in continuing the commercialization of our marketed products or in commercializing our product candidates or new indications for our marketed products, if approved, which would materially and adversely affect our business, profitability, and future prospects

  • 25% rewritten

    Many of our products are intended to be used and, if approved, our product candidates may be used in combination with drug-delivery devices, which may result in additional regulatory, commercialization, and other risks

  • 24% rewritten

    Sales of our marketed products recorded by us and our collaborators could be reduced by imports from countries where such products may be available at lower prices

  • 23% rewrittenRisks Related to Manufacturing and Supply

    We rely on limited internal and contracted manufacturing and supply chain capacity, which could adversely affect our ability to commercialize our marketed products and, if approved, our product candidates and to advance our clinical pipeline

  • 22% rewritten

    More detailed information about the risks related to the commercialization of our marketed products is provided in the risk factors below

All 48 risk factors

Headings as the filing states them, in filing order.

Other

  1. 01We are substantially dependent on the success of EYLEA HD, EYLEA, and Dupixent68% rewritten
  2. 02sales. The degree to which EYLEA HD net product sales may offset further potential decreases in EYLEA net product sales, resulting from the factors discussed above or otherwise, is uncertainNew
  3. 03If we or our collaborators are unable to continue to successfully commercialize our products, our business, prospects, operating results, and financial condition will be materially harmed
  4. 04More detailed information about the risks related to the commercialization of our marketed products is provided in the risk factors below22% rewritten
  5. 05Sales of our marketed products are dependent on the availability and extent of coverage and reimbursement and copay assistance from third-party payors and other third parties72% rewritten
  6. 06to obtain or maintain the applicable requirements for reimbursement (including relevant formulary coverage, as discussed further below) of our current and future marketed products, which may have a material adverse effect on our businessNew
  7. 07Product reimbursement and coverage policies and practices, pricing regulations and requirements, and our pricing strategy could change due to various factors beyond our control, which may adversely impact our business, prospects, operating results, and financial conditionNew
  8. 08We rely on our collaborations with Bayer and Sanofi for commercializing some of our marketed products
  9. 09Sales of our marketed products recorded by us and our collaborators could be reduced by imports from countries where such products may be available at lower prices24% rewritten
  10. 10We may be unsuccessful in continuing the commercialization of our marketed products or in commercializing our product candidates or new indications for our marketed products, if approved, which would materially and adversely affect our business, profitability, and future prospects26% rewritten
  11. 11We are dependent upon a small number of customers for a significant portion of our revenue, and the loss of or significant reduction in sales to these customers would adversely affect our results of operations
  12. 12If we are unable to establish sufficient commercial capabilities outside the United States for products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected30% rewritten
  13. 13Successful development of our current and future product candidates is uncertain36% rewritten
  14. 14Many of our products are intended to be used and, if approved, our product candidates may be used in combination with drug-delivery devices, which may result in additional regulatory, commercialization, and other risks25% rewritten

Risks Related to Intellectual Property and Market Exclusivity

  1. 15For purposes of this subsection, references to our intellectual property (including patents, trademarks, copyrights, and trade secrets) include that of our collaborators and licensees, unless otherwise stated or required by the context
  2. 16If we cannot protect the confidentiality of our trade secrets, or our patents or other means of defending our intellectual property are insufficient to protect our proprietary rights, our business and competitive position will be harmed53% rewritten
  3. 17competitors. Furthermore, even if the outcome is favorable to us, the enforcement of our intellectual property rights can be extremely expensive and time consumingNew
  4. 18We may be restricted in our development, manufacturing, and/or commercialization activities by patents or other proprietary rights of others, and could be subject to awards of damages if we are found to have infringed such patents or rights34% rewritten
  5. 19all. The failure to obtain any such license could prevent us from developing or commercializing any one or more of our products or product candidates, which could severely harm our businessNew
  6. 20Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, have in the past reduced and could reduce in the future the duration of market exclusivity for our products50% rewritten

Risks Related to Manufacturing and Supply

  1. 21We rely on limited internal and contracted manufacturing and supply chain capacity, which could adversely affect our ability to commercialize our marketed products and, if approved, our product candidates and to advance our clinical pipeline23% rewritten
  2. 22Our ability to manufacture products may be impaired if any of our or our collaborators' manufacturing activities, or the activities of other third parties involved in our manufacture and supply chain, are found to infringe patents of others
  3. 23If sales of our marketed products do not meet the levels currently expected, or if the launch of any of our product candidates is delayed or unsuccessful, we may face costs related to excess inventory or unused capacity at our manufacturing facilities and at the facilities of third parties or our collaborators29% rewritten

Other Regulatory and Litigation Risks

  1. 24If the testing or use of our products harms people, or is perceived to harm them even when such harm is unrelated to our products, we could be subject to costly and damaging product liability claims61% rewritten
  2. 25Our business activities have been, and may in the future be, challenged under U.S. federal or state and foreign healthcare laws, which may subject us to civil or criminal proceedings, investigations, or penalties76% rewritten
  3. 26Risks from the improper conduct of employees, agents, contractors, or collaborators could adversely affect our reputation and our business, prospects, operating results, and financial condition
  4. 27Our operations are subject to environmental, health, and safety laws and regulations, including those governing the use of hazardous materials. Compliance with these laws and regulations is costly, and we may incur substantial liability arising from our activities involving the use of hazardous materials
  5. 28Changes in laws, regulations, and policies affecting the healthcare industry could adversely affect our business42% rewritten
  6. 29Risks associated with our operations outside the United States could adversely affect our business29% rewritten
  7. 30We face risks associated with tariffs and other trade restrictions, which may have a material adverse impact on our results of operations and financial conditionNew
  8. 31We may incur additional tax liabilities related to our operations
  9. 32We face risks related to the personal data we collect, process, and share
  10. 33The use of social media platforms could give rise to liability, breaches of data security and privacy laws, or reputational damage87% rewritten
  11. 34There are inherent risks related to our increasing use of artificial intelligence-based solutionsNew

Risks Related to Our Reliance on or Transactions with Third Parties

  1. 35If our collaboration with Bayer for EYLEA HD and EYLEA is terminated, or Bayer materially breaches its obligations thereunder, our business, prospects, operating results, and financial condition, and our ability to continue to commercialize EYLEA HD and EYLEA outside the United States would be materially harmed
  2. 36Our collaborators and service providers may fail to perform adequately in their efforts to support the development, manufacture, and commercialization of our drug candidates and current and future products
  3. 37We have undertaken and may in the future undertake strategic acquisitions, and any difficulties from integrating such acquisitions could adversely affect our business, operating results, and financial condition61% rewritten
  4. 38Moreover, we may need to raise additional funds through public or private debt or equity financing to acquire any businesses, products, or product candidates, which may result in dilution for shareholders or the incurrence of indebtednessNew
  5. 39We are dependent on our key personnel and if we cannot recruit or retain leaders in our research, development, manufacturing, and commercial organizations, our business will be harmed
  6. 40Significant disruptions of information technology systems or breaches of data security could adversely affect our business46% rewritten
  7. 41Public health outbreaks, epidemics, or pandemics have adversely affected and may in the future adversely affect our business
  8. 42Our indebtedness could adversely impact our business
  9. 43Changes in foreign currency exchange rates could have a material adverse effect on our operating results
  10. 44Our investments are subject to risks and other external factors that may result in losses or affect the liquidity of these investments28% rewritten

Risks Related to Our Common Stock

  1. 45Our stock price is extremely volatile
  2. 46Future sales of our Common Stock by our significant shareholders or us may depress our stock price and impair our ability to raise funds in new share offerings
  3. 47There can be no assurance that we will continue to repurchase shares of our Common Stock or continue to declare cash dividends33% rewritten
  4. 48Our existing shareholders may be able to exert substantial influence over matters requiring shareholder approval and over our management

Other Regeneron Pharmaceuticals 10-Ks

  • FY2024 10-K risk factors
    44 risks

    Regeneron's risk profile is dominated by heavy revenue concentration in EYLEA, EYLEA HD, and Dupixent.

    Filed Feb 05, 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.