10-K 0000872589-26-000008 (2026-02-04) vs 10-K 0001804220-25-000011 (2025-02-05)
| Section | Compared text | Words now | Changed |
| Risk Factors | Item 1A | 31,398 |
20.4% |
| MD&A | Item 7 | 6,802 |
20.9% |
| Legal Proceedings | Item 3, via Note 16 – Legal Matters | 4,881 |
51.4% |
| Accounting Policies | 10-K text, Note 1 – Business Overview and Summary of Significant Accounting Policies | 4,060 |
11.9% |
The redline: what was cut and what was added
In each section, the paragraph that changed most, marked against last year's 10-K:
cut words struck through, new words highlighted and underlined.
Risk Factors 348 words changed in this paragraph; it is 33% similar to last year's version.
EYLEA HD and EYLEA. EYLEA HD and EYLEA HD. EYLEA and EYLEA HD face significant competition in the marketplace. For example, each of EYLEA HD and EYLEA HD competes in one or more of its approved indications with other VEGF inhibitors. These include Genentech/Roche's Vabysmo® (faricimab-svoa) and Susvimo® (ranibizumab ocular implant); Novartis and Genentech/Roche's Lucentis® (ranibizumab); Novartis' Beovu® (brolucizumab); and a biosimilar versions version of Lucentis commercialized in the United States by Biogen Inc. and Sandoz Group AG. In addition, biosimilar versions of EYLEA have been approved and/or launched both in and outside the United States. These include States, including Amgen's Pavblu™ (aflibercept-ayyh), which recently launched in the United States. We expect that biosimilar competition for EYLEA will increase in the future when additional biosimilar versions of EYLEA are launched (aflibercept-ayyh) (launched in the United States and other countries, the timing of which will depend on, among other factors, the outcome of the pending patent litigation proceedings described in Note 16 to our Consolidated Financial Statements and the expiration of the patents protecting EYLEA (including those set forth under Part I - Item 1. "Business - Patents, Trademarks, and Trade Secrets"). Ophthalmologists are also using off-label, third-party repackaged versions of Genentech/Roche's approved VEGF antagonist, bevacizumab, for the treatment of certain of EYLEA's and EYLEA HD's respective indications, and we are aware of another company developing an ophthalmic formulation of such product that has been approved in the EU. In DME (and, in the case fourth quarter of EYLEA, also RVO), EYLEA and EYLEA HD also compete with intravitreal implants of corticosteroids. We are also aware of a number of companies working on the development of product candidates and extended delivery devices for the potential treatment of one or more of EYLEA's and EYLEA HD's respective indications, including those that act by blocking VEGF and VEGF receptors (including therapies designed to extend the treatment interval) and/or other targets. In addition, we are aware of several other companies developing biosimilar versions of EYLEA, EYLEA HD, and/or other approved anti-VEGF treatments. Other potentially competitive products in development include products for use in combination with EYLEA and/or other anti-VEGF treatments, small-molecule tyrosine kinase inhibitors, gene therapies, and other eye-drop formulations, devices, and oral therapies. There also is a risk that third parties repackage ZALTRAP for off-label use and sale for the treatment of diseases of the eye, even though ZALTRAP has not been manufactured and formulated for use in intravitreal injections. 2024). We are aware of claims by third parties, including those based on published clinical data, alleging that ZALTRAP may be safely administered to the eye.
Source: Item 1A, 10-K 0000872589-26-000008 vs Item 1A, 10-K 0001804220-25-000011
Legal Proceedings 319 words changed in this paragraph; it is 46% similar to last year's version.
In June 2021, the Company received a CID from the U.S. Department of Justice pursuant to the federal False Claims Act. The CID states that the investigation concerns allegations that the Company (i) violated the False Claims Act by paying kickbacks to distributors and ophthalmology practices to induce purchase of EYLEA, including through discounts, rebates, credit card fees, free units of EYLEA, and inventory management systems; and (ii) inflated reimbursement rates for EYLEA by excluding applicable discounts, rebates, and benefits from the average sales price reported to the Centers for Medicare & Medicaid Services. The CID covers the period from January 2011 through June 2021. On November 29, 2023, the U.S. Department of Justice informed the Company that it had filed a notice of partial intervention in this matter. On March 28, 2024, the Department of Justice and the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint intervention (the "March 2024 Civil Complaint") in the U.S. District Court for the District of Massachusetts asserting causes of action under the federal False Claims Act and a claim for unjust enrichment. Also on March 28, 2024, the U.S. District Court of for the District of Massachusetts unsealed a qui tam complaint against the Company, AmerisourceBergen, Company and Besse Medical others by two qui tam plaintiffs (known as relators) plaintiffs, purportedly on behalf of the United States and various states and municipalities, asserting causes of action under the federal False Claims Act and state and local laws, and alleging violations of the federal Anti-Kickback statute. statute related to, among other things, the alleged conduct described above. Also on March 28, 2024, the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts filed a civil complaint in partial intervention (the "March 2024 Civil Complaint") of the qui tam action, in the same court, asserting causes of action under the federal False Claims Act and a claim for unjust enrichment related to the alleged conduct described above. On June 25, 2024, the States of Colorado, Georgia, Michigan, North Carolina, Texas, and Washington filed a civil complaint in partial intervention (the "June 2024 Civil Complaint") in the U.S. District Court for the District of Massachusetts same court asserting causes of action under various state laws. laws related to the same alleged conduct. On July 18, 2024, April 29, 2025, the Company filed a court denied the Company's motion to dismiss the March 2024 Civil Complaint and the June 2024 Civil Complaint. An oral hearing on On June 18, 2025, the Company's motion to dismiss was held on December 16, 2024. States of Maine, Nebraska, Ohio, Oregon, and Wyoming intervened in the action and filed a consolidated complaint asserting causes of action under their respective state laws.
Source: Item 3, via Note 16 – Legal Matters, 10-K 0000872589-26-000008 vs Item 3, via Note 16 – Legal Matters, 10-K 0001804220-25-000011
MD&A 207 words changed in this paragraph; it is 34% similar to last year's version.
We have entered into various collaborative arrangements to research, develop, manufacture, and commercialize products and/or product candidates. Our collaboration agreements may require us to deliver various rights, services, and/or goods across the entire life cycle of a product or product candidate. In agreements involving multiple goods or services promised to be transferred to our collaborator, we assess, at the inception of the contract, whether each promise represents a separate obligation (i.e., is "distinct"), or whether such promises should be combined as a single unit of account. When we have a combined unit of account which includes a license and providing research and development services to our collaborator, recognition of up-front payments and development milestones earned from our collaborator is deferred (as a liability) and recognized over the development period (i.e., over time) typically using an input method on the basis of our research and development costs incurred relative to the total expected cost which determines the extent of our progress toward completion. We review our estimates each period and make revisions to such estimates as necessary. Due to the variability in the scope of activities and length of time necessary to develop a drug product, potential delays in development programs, changes to development plans and budgets as programs progress, including if we and our collaborators decide to expand or contract our clinical plans for a drug candidate in various disease indications, and uncertainty in the ultimate requirements to obtain governmental approval for commercialization, revisions to our estimates are likely to occur periodically, potentially resulting in material changes to amounts recognized.
Source: Item 7, 10-K 0000872589-26-000008 vs Item 7, 10-K 0001804220-25-000011
Accounting Policies 97 words changed in this paragraph; it is 47% similar to last year's version.
Concentrations of credit risk with respect to In addition, receivables from customers (see Note 2) and collaborators (see Note 3) are significant. In addition, concentrations of may subject the Company to credit risk with respect to customer accounts receivable are also significant. As of December 31, 2024 and 2023, two individual customers accounted for 79 % and 83 % of the Company's net trade accounts receivable balances, respectively. risk. The Company has contractual payment terms with each of its collaborators customers and customers, collaborators, and the Company monitors their financial performance and credit worthiness so that it can properly assess and respond to any changes in their credit profile. As of and for the years ended December 31, 2024 and 2023, there were no write-offs and allowances of accounts receivable related to credit risk for the Company's collaborators or customers.
Source: 10-K text, Note 1 – Business Overview and Summary of Significant Accounting Policies, 10-K 0000872589-26-000008 vs 10-K text, Note 1 – Business Overview and Summary of Significant Accounting Policies, 10-K 0001804220-25-000011
Every change, by type
Sentences and paragraphs of REGN's Risk Factors and MD&A, 10-K 2026-02-04 against 10-K 2025-02-05.
Each links to the text at sec.gov.
Quiet changes are sentences kept from last year with one to four words changed, at least one of them a hedge, a modal or a qualifier
(may, could, will, not, significant, material…). A year or date rolling forward is not counted.
The full word list
adverse, adversely, all, although, anticipate, anticipates, any, approximately, believe, believes, can, cannot, certain, could, expect, expects, generally, however, if, intend, intends, largely, likely, many, material, materially, may, might, most, must, never, no, not, possible, primarily, probable, should, significant, significantly, some, substantial, substantially, unlikely, will, would
AddedRisk Factors
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.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedRisk Factors
The full extent to which the policy changes described above will ultimately impact reimbursement levels of our marketed products, including those covered under Medicare Part B (such as EYLEA HD and EYLEA), or our product candidates that may be covered under Medicare Part B or Medicare Part D in the future, is currently unclear. In addition, the current U.S. administration is pursuing other measures to reduce the cost of drugs in the United States. For example, in May 2025, an executive order directed the U.S. Department of Health and Human Services ("HHS") and other federal agencies to take certain steps intended to, among other things, reduce the prices of drugs sold in the United States to match the lowest price available for the same drugs in comparably developed nations (commonly referred to as "most-favored-nation" ("MFN") pricing). In July 2025, as a follow-up to this executive order, President Trump sent a letter to several pharmaceutical companies (including Regeneron) requesting that within the next 60 days they, among other matters, provide their existing drugs at MFN rates to Medicaid patients, guarantee MFN pricing for newly launched drugs, and provide for direct-to-consumer and direct-to-business distribution models for high-volume, high-rebate prescription drugs. In addition, a prior executive order from April 2025 directed the HHS to take appropriate steps to, among other things, modify certain provisions of the Medicare Drug Price Negotiation Program, develop and implement a payment model to reduce the price of high-cost prescription drugs and biological products covered by Medicare, accelerate approval of generic and biosimilar products, and facilitate the ability of states to import pharmaceuticals from other countries. In response to these executive orders, in December 2025, the Center for Medicare and Medicaid Innovation proposed two mandatory Medicare payment models that, if enacted into law, would apply to certain drugs covered under Medicare Parts B and D and test whether alternative methodologies for calculating inflationary rebates based on international reference pricing would reduce Medicare spending. It is currently unclear how and to what extent the measures described in this paragraph may be implemented and what impact any such implementation would have on our Company.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedRisk Factors
EYLEA HD and EYLEA. EYLEA HD and EYLEA face significant competition in the marketplace. For example, each of EYLEA HD and EYLEA competes in one or more of its approved indications with other VEGF inhibitors. These include Genentech/Roche's Vabysmo® (faricimab-svoa) and Susvimo® (ranibizumab ocular implant); Novartis and Genentech/Roche's Lucentis® (ranibizumab); Novartis' Beovu® (brolucizumab); and a biosimilar version of Lucentis commercialized in the United States by Biogen Inc. In addition, biosimilar versions of EYLEA have been approved and/or launched both in and outside the United States, including Amgen's Pavblu™ (aflibercept-ayyh) (launched in the United States in the fourth quarter of 2024). We are aware of
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedRisk Factors
We face increasing competition from Chinese biotechnology and pharmaceutical companies, including Chinese state-owned or state-backed enterprises, with respect to both our marketed products and product candidates. China has become one of the world's leading developers of new drugs, and Chinese companies benefit from a regulatory regime that enables rapid, low-cost clinical trials that facilitate innovation. Furthermore, we compete with other large pharmaceutical companies, many of which have invested significantly in China, in acquiring or licensing Chinese product candidates, and we may not be as successful as our competitors in identifying or accessing such assets.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedRisk Factors
We sell our marketed products for which we record net product sales in the United States to several distributors and specialty pharmacies, as applicable (collectively, "distributor customers"), which generally sell the product directly to healthcare providers
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedRisk Factors
The functioning of the FDA is affected by a variety of factors, such as shifting government priorities, budgets and funding levels, authorization and payment of user fees, the ability to hire and retain key personnel, as well as other statutory, regulatory, and policy changes impacting HHS, the FDA, or other HHS agencies. U.S. policy changes have recently been implemented at a rapid pace, and additional changes may occur. For example, efforts implemented or commenced in 2025 to reduce the size and budgets of U.S. government agencies, downsize the federal workforce, and restructure parts of the executive branch of the federal government have directly or indirectly impacted agencies that support research and development activities or are otherwise important to our business, including the HHS and the FDA. If legislation, administrative action, or changes in policy prevent the FDA or other regulatory authorities from conducting routine inspections, reviews, or other regulatory activities, it could significantly impact the ability of the FDA to provide feedback on our clinical programs, meet with or engage in other informal interactions with us, and review and process our regulatory submissions (including our pending regulatory submissions) in a timely manner. These developments may also reduce the FDA's capacity to engage in pre-approval or guidance meetings or meetings to negotiate labeling or post-marketing commitments. Furthermore, changes in FDA personnel and policy (such as the 2025 reductions in communication and policymaking roles) may negatively impact the transparency of agency actions, lead to modifications in FDA approval requirements, and alter the FDA's existing guidance pertinent to the development strategy for our products and product candidates. In addition, the U.S. government has shut down multiple times in the recent past and certain regulatory agencies, such as the FDA, had to furlough employees and stop some of their activities. A prolonged government shutdown or a widespread freeze on federal funding could significantly impact the ability of the FDA to timely review and process our regulatory submissions or cause other agencies that support the FDA to slow their work. Any such factors could have a material adverse effect on our business.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedRisk Factors
If we believe we meet eligibility requirements, we may apply for various regulatory incentives in the United States, such as breakthrough therapy designation, fast track designation, accelerated approval, priority review, or the Commissioner's National Priority Voucher (CNPV) program, where potentially available, that serve to expedite drug development and/or review, and we
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AddedRisk Factors
may form the opinion after review of an application that the application is insufficient to allow approval of a drug-delivery device. For example, in October 2025, the FDA issued a CRL for the regulatory application seeking approval of the EYLEA HD pre-filled syringe, which has delayed further any potential FDA approval of the EYLEA HD pre-filled syringe. There can be no assurance that FDA approval of the EYLEA HD pre-filled syringe will be obtained in the currently anticipated time frame or at all. See Part I, Item 1. "Business - Programs in Clinical Development - Additional Information - Clinical Development Programs - EYLEA HD" for more information.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedRisk Factors
competitors. Furthermore, even if the outcome is favorable to us, the enforcement of our intellectual property rights can be extremely expensive and time consuming.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedRisk Factors
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.
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AddedRisk Factors
business and competitive position will be harmed."). Any future loss of market exclusivity for a product would likely negatively affect revenues from product sales of that product and thus our financial results and condition and could have a material negative impact on our business.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedRisk Factors
procure additional capacity in the required timeframe to meet commercial demand for our products (or product candidates if they receive regulatory approval) and to continue to meet the requirements of our clinical programs. This would interfere with our efforts to successfully commercialize our marketed products, and it could also delay or require us to discontinue one or more of our clinical development programs. As a result, our business, prospects, operating results, and financial condition could be materially harmed.
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RemovedRisk Factors
The extent to which the policy changes described above will ultimately impact reimbursement levels of our marketed products, including those covered under Medicare Part B (such as EYLEA and EYLEA HD), or our product candidates that may be covered under Medicare Part B or Medicare Part D in the future, is currently unclear.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedRisk Factors
approvable. If any of these outcomes occur, we may be forced to delay or abandon our applications for approval. For example, in October 2023, the FDA issued a CRL for the sBLA for Dupixent in CSU stating that additional efficacy data are required to support an approval. While we reported results from a confirmatory Phase 3 clinical trial of Dupixent in CSU (in biologic-naïve patients) in September 2024, there can be no assurance that such data will ultimately result in FDA or other regulatory approval. As another example of this type of risk, the FDA's request for additional analyses regarding sub-populations from the BOREAS and NOTUS pivotal studies delayed by three months the FDA's September 2024 approval of our sBLA for Dupixent as an add-on maintenance treatment of adults with inadequately controlled COPD and an eosinophilic phenotype.
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RemovedRisk Factors
Before approving a new drug or biologic product, the FDA and such comparable foreign regulatory authorities require that the facilities at which the product will be manufactured or advanced through the supply chain be in compliance with current Good Manufacturing Practices, or cGMP, requirements and regulations governing the manufacture, shipment, and storage of the
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedRisk Factors
With respect to EYLEA and EYLEA HD, there are many potential safety concerns associated with significant blockade of VEGF that may limit our ability to further successfully commercialize EYLEA and to successfully commercialize EYLEA HD. These serious and potentially life-threatening risks, based on clinical and preclinical experience of VEGF inhibitors, include bleeding, intestinal perforation, hypertension, proteinuria, congestive heart failure, heart attack, and stroke. Other VEGF blockers have reported side effects that became evident only after large-scale trials or after marketing approval when large numbers of patients were treated. There are risks inherent in the intravitreal administration of drugs like aflibercept (such as intraocular inflammation, sterile and culture positive endophthalmitis, corneal decomposition, retinal detachment, retinal tear, and retinal vasculitis), which can cause injury to the eye and other complications. The side effects previously reported for aflibercept include conjunctival hemorrhage, macular degeneration, eye pain, retinal hemorrhage, and vitreous floaters. While the safety of EYLEA HD was similar to EYLEA in clinical trials, it is possible that the use of EYLEA HD outside the clinical trial setting may yield different
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedRisk Factors
Dupixent and Libtayo are being studied in additional indications, as shown in the table under Part I, Item 1. "Business - Programs in Clinical Development." There is no guarantee that the safety data from these trials will be consistent with the known Dupixent and Libtayo safety profiles (as applicable) or that regulatory approval of Dupixent or Libtayo (as applicable) in any of these indications will be successfully obtained. The side effects previously reported for Dupixent include hypersensitivity reactions, eye problems (including conjunctivitis and keratitis), injection-site reactions, eye and eyelid inflammation, cold sores, oropharyngeal pain, eosinophilia, insomnia, toothache, gastritis, joint pain (arthralgia), parasitic (helminth) infections, and facial rash or redness; and the side effects previously reported for Libtayo include certain immune-mediated adverse reactions that may occur in any organ system or tissue, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and dermatologic reactions, as well as infusion-related reactions, cellulitis, sepsis, pneumonia, urinary tract infection, fatigue, rash, and diarrhea. These and other complications or side effects could harm further development and/or commercialization of Dupixent and Libtayo (as applicable).
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedRisk Factors
There also are risks inherent in subcutaneous injections (which are used for administering most of our antibody-based products and product candidates), such as injection-site reactions (including redness, itching, swelling, pain, and tenderness) and other side effects. In addition, there are risks inherent in intravenous administration (which are used for some of our antibody-based products and product candidates), such as infusion-related reactions (including nausea, pyrexia, rash, and dyspnea). These and other complications or side effects could harm further development and/or commercialization of our antibody-based products and product candidates utilizing this method of administration.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedRisk Factors
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.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedRisk Factors
directly or indirectly preclude the manufacture of our products to which those intellectual property rights apply on a temporary or permanent basis, which could materially harm our business, prospects, operating results, and financial condition.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedRisk Factors
The FDA regulates the marketing and promotion of our products, which must comply with the Food, Drug, and Cosmetic Act and applicable FDA implementing standards. The FDA's review of promotional activities includes healthcare provider-directed and direct-to-consumer advertising, certain communications regarding unapproved uses, industry-sponsored scientific and educational
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedRisk Factors
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.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedRisk Factors
As part of the PPACA, the federal government requires that pharmaceutical manufacturers record any "transfers of value" made to U.S. licensed physicians and teaching hospitals as well as ownership and investment interests held by physicians and their immediate family members. Information provided by companies is aggregated and posted annually on an "Open Payments" website, which is managed by CMS, the agency responsible for implementing these disclosure requirements. Applicable manufacturers also are required to report information regarding payments and transfers of value provided to physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anesthetists, anesthesiologist assistants, and certified nurse-midwives. We also have similar reporting obligations in other countries based on laws, regulations, and/or industry trade association requirements.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedRisk Factors
•general market conditions, including as a result of changes in trade, economic, and other policies of the United States or other countries;
Read it in 10-K 2025-02-05 at sec.gov ↗
RewordedRisk Factors
At the state level, legislatures are becoming increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and price and marketing cost disclosure and transparency measures. measures, and measures that could expand the applicability of the ceiling price under the federal government's 340B program (see also "Other Regulatory and Litigation Risks - If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions, and fines, which could have a material adverse effect on our business, financial condition, results of operations, and future prospects.").
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedRisk Factors
If we or our collaborators do not maintain regulatory approval for our marketed products, and or obtain regulatory approval for our product candidates or new indications for our marketed products, candidates, we will not be able to market or sell them, which would materially them; and negatively impact if we do not obtain approvals for new indications for our business, prospects, operating results, and financial condition."), marketed products, we may not be able to realize the applicable marketing approval may be withdrawn, which would materially harm our business, prospects, operating results, and financial condition. full commercial potential of such products.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedRisk Factors
If we or our collaborators do not maintain regulatory approval for our marketed products, and or obtain regulatory approval for our product candidates or new indications for our marketed products, candidates, we will not be able to market or sell them, which would materially them; and negatively impact if we do not obtain approvals for new indications for our business, prospects, operating results, and financial condition. marketed products, we may not be able to realize the full commercial potential of such products.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedRisk Factors
For example, certain of our European patents, including those pertaining to EYLEA (as further described in and Dupixent, are subject to opposition proceedings before the European Patent Office (the "EPO") and/or patent offices of various European countries (see Note 16 to our Consolidated Financial Statements included in this report) and Dupixent, are subject to opposition proceedings before the EPO and/or patent offices of various European countries. report for additional information).
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedRisk Factors
If we or our collaborators do not maintain regulatory approval for our marketed products, and obtain regulatory approval for our product candidates or new indications for our marketed products, we will not be able to market or sell them, which would Any of the foregoing may materially and negatively impact our business, prospects, operating results, and financial condition."), the applicable marketing approval may be withdrawn, which would materially harm our business, prospects, operating results, and financial condition.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedRisk Factors
The U.S. federal or state governments could carry out other significant changes in legislation, regulation, or government policy, including with respect to government reimbursement changes or drug price control measures (such as those discussed above under "Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - Changes to product reimbursement and coverage policies and practices may materially harm our business, prospects, operating results, and financial condition") or the PPACA or other healthcare reform laws.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedRisk Factors
We may not successfully expand or establish sufficient manufacturing or any future fill/finish capabilities or manufacture our products in a cost-effective manner or in compliance with cGMPs and other regulatory requirements, and we and our collaborators or contract manufacturers may not be able to build or procure additional capacity in the required timeframe to meet commercial demand for our product candidates if they receive regulatory approval, and to continue to meet the requirements of our clinical programs.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedRisk Factors
While we have made progress with establishing commercial capabilities in certain jurisdictions outside the United States in recent years (primarily in connection with our acquisition of the exclusive right worldwide rights to develop, commercialize, and manufacture Libtayo worldwide pursuant to the in 2022 Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi (the "A&R IO LCA") and the exercise of our option under the Antibody Collaboration to co-commercialize Dupixent in certain jurisdictions outside the United States, States), our commercial capabilities and experience with commercializing products outside the United States (as well as obtaining and/or maintaining regulatory approvals and securing pricing and reimbursement for our products outside the United States) are still somewhat limited.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedRisk Factors
Department of the Treasury), other trade barriers (including further legislation or actions taken by the United States or other countries that restrict trade), and protectionist or retaliatory measures taken by the United States or other countries; countries (discussed in greater detail below under "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");
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedRisk Factors
Further, other factors may adversely affect our effective tax rate, including changes in the mix of our profitability from country to country, tax effects of stock-based compensation (which depend in part on the price of our stock and, therefore, are beyond our control), and changes in tax laws or regulations.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedRisk Factors
If we fail to realize the expected benefits from acquisitions we have consummated or may consummate in the future, whether as a result of unidentified risks or liabilities, integration difficulties, product development or regulatory setbacks (including those relating to issues that may have arisen before we completed the transaction in question), litigation with current or former employees and other events, our business, operating results, and financial condition could be adversely affected.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedRisk Factors
The use of AI solutions by our employees or third parties on which we rely may continue to increase and may lead to the impermissible use or public disclosure of confidential information (including personal data and proprietary information) in contravention of our internal policies, data protection laws, other applicable laws, or contractual requirements. sensitive data.
Read it in 10-K 2026-02-04 at sec.gov ↗
Quiet changesRisk Factors
While we exercised our option under the Antibody Collaboration to co-commercialize Dupixent in certain jurisdictions outside the United States, we will continue to rely in considerable part on Sanofi's sales and marketing organization in such jurisdictions.
Read it in 10-K 2026-02-04 at sec.gov ↗
Quiet changesRisk Factors
We cannot predict with certainty if or when we might submit for regulatory approval for any of our product candidates currently under development.
Read it in 10-K 2026-02-04 at sec.gov ↗
Quiet changesRisk Factors
If any licenses are required, we may not be able to obtain such licenses on commercially reasonable terms, if at all.
Read it in 10-K 2026-02-04 at sec.gov ↗
Quiet changesRisk Factors
For example, during each of the years ended December 31, 2022 and 2021, we recorded a substantial charge to write down inventory related to REGEN-COV. REGEN-COV®.
Read it in 10-K 2026-02-04 at sec.gov ↗
Quiet changesRisk Factors
Unexpected refunds to the government, and/or response to a government investigation or enforcement action, would could be expensive and time-consuming, and could have a material adverse effect on our business, financial condition, results of operations, and future prospects.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedMD&A
We have entered into various collaborative arrangements to research, develop, manufacture, and commercialize products and/or product candidates. Our collaboration agreements may require us to deliver various rights, services, and/or goods across the entire
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedMD&A
life cycle of a product or product candidate. In agreements involving multiple goods or services promised to be transferred to our collaborator, we assess, at the inception of the contract, whether each promise represents a separate obligation (i.e., is "distinct"), or whether such promises should be combined as a single unit of account.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedMD&A
Net product sales of EYLEA decreased in 2025 compared to 2024, due to (i) lower sales volumes as a result of continued competitive pressures (as described below), loss in market share to compounded bevacizumab due to patient affordability constraints, and the continued transition of patients to EYLEA HD, and (ii) a lower net selling price.
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AddedMD&A
EYLEA net product sales have been, and are likely to continue to be, negatively impacted by increased competition from other anti-VEGF products, including biosimilars, as well as the transition of patients from EYLEA to EYLEA HD. The magnitude and duration of such impact is presently unknown. For more information, see Part I, Item 1A. "Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - We are substantially dependent on the success of EYLEA HD, EYLEA, and Dupixent" and "The commercial success of our products and product candidates is subject to significant competition - Marketed Products." In addition, if independent not-for-profit patient assistance funds that provide copay assistance are unable to support eligible patients, this will likely have a continued negative impact on patient affordability resulting in lower utilization of higher-cost anti-VEGF agents.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedMD&A
Research and development expenses included stock-based compensation expense of $545.4 million and $543.8 million in 2025 and 2024, respectively. Research and development expenses in 2025 included $155.0 million related to an FDA Rare Pediatric Disease Priority Review Voucher ("PRV"). During the fourth quarter of 2025, we made the decision to utilize the PRV for a regulatory submission; this PRV was purchased by us, and capitalized as an intangible asset, in the second quarter of 2025.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedMD&A
Selling, general, and administrative expenses decreased in 2025, compared to 2024, primarily due to lower charitable contributions to Good Days, an independent non-profit patient assistance organization with a Retinal Vascular and Neovascular Disease Fund (the "Fund"). In July 2025, we launched a matching program for donations made to the Fund and committed to quarterly matching donations through the end of 2025. During the fourth quarter of 2025, we recognized approximately $60 million in connection with matching donations made to the Fund. We have also recently committed to matching donations for up to a total of $200 million during 2026.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedMD&A
Year Ended December 31, (In millions, except gross margin on net product sales) 2025 2024 2023 Cost of goods sold $ 1,140.8 $ 1,087.3 $ 932.1 Gross margin on net product sales(a) 82% 86% 87% (a) Gross margin on net product sales represents gross profit expressed as a percentage of total net product sales recorded by the Company. Gross profit is calculated as net product sales (see "Net Product Sales" section above) less cost of goods sold.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedMD&A
Gross margin on net product sales decreased in 2025, compared to 2024, partly due to ongoing investments to support our manufacturing operations and higher inventory write-offs and reserves. In addition, gross margin on net product sales decreased due to higher amortization expense associated with our Libtayo intangible asset as each quarter we record additions to the intangible asset related to royalties due to Sanofi.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedMD&A
Year Ended December 31, (In millions) 2025 2024* 2023* Gains (losses) on marketable and other securities, net $ 946.1 $ 118.3 $ (266.4) Interest income 716.8 711.4 495.9 Other 33.7 14.7 (4.3) Other income (expense), net 1,696.6 844.4 225.2 Interest expense (43.8) (55.2) (73.0) Total other income (expense) $ 1,652.8 $ 789.2 $ 152.2 * Certain prior year amounts have been reclassified to conform to the current year's presentation
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedMD&A
On July 4, 2025, bill H.R. 1, commonly referred to as the "One Big Beautiful Bill Act" or "OBBBA," was signed into law, with certain provisions effective in 2025 and other provisions becoming effective in 2026. The OBBBA significantly revises U.S. corporate income tax laws by, among other things, restoring the option for immediate expense recognition for U.S.-based research and development expenditures and making permanent the ability to claim first-year bonus depreciation on qualified property. The OBBBA also modifies U.S. taxation on foreign earnings by, among other things, changing the tax rates for global intangible low-taxed income (now known as Net CFC Tested Income) and foreign-derived intangible income (now known as foreign-derived deduction eligible income), modifying the allocation of expenses in calculating foreign tax credits, as well as changing foreign tax credit limitations. As a result of the OBBBA being signed into law, we recognized a charge of $44.5 million in the third quarter of 2025 related to the re-measurement of our U.S. net deferred tax assets.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedMD&A
Our effective tax rate for 2025, compared to 2024, included a lower benefit from stock-based compensation.
Read it in 10-K 2026-02-04 at sec.gov ↗
AddedMD&A
In 2025, Other, net included a $155.0 million charge in connection with a fourth quarter 2025 decision to utilize a PRV for a regulatory submission; such amount was previously capitalized as an intangible asset as described in the "Cash Flows from Investing Activities" section below.
Read it in 10-K 2026-02-04 at sec.gov ↗
RemovedMD&A
We have entered into various collaborative arrangements to research, develop, manufacture, and commercialize products and/or product candidates. Our collaboration agreements may require us to deliver various rights, services, and/or goods across the entire life cycle of a product or product candidate. In agreements involving multiple goods or services promised to be transferred to our collaborator, we assess, at the inception of the contract, whether each promise represents a separate obligation (i.e., is "distinct"), or whether such promises should be combined as a single unit of account. When we have a combined unit of account which includes a license and providing research and development services to our collaborator, recognition of up-front payments and development milestones earned from our collaborator is deferred (as a liability) and recognized over the development period (i.e., over time) typically using an input method on the basis of our research and development costs incurred relative to the total expected cost which determines the extent of our progress toward completion. We review our estimates each period and make revisions to such estimates as necessary. Due to the variability in the scope of activities and length of time necessary to develop a drug product, potential delays in development programs, changes to development plans and budgets as programs progress, including if we and our collaborators decide to expand or contract our clinical plans for a drug candidate in various disease indications, and uncertainty in the ultimate requirements to obtain governmental approval for commercialization, revisions to our estimates are likely to occur periodically, potentially resulting in material changes to amounts recognized.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedMD&A
Total EYLEA HD and EYLEA net product sales for the fourth quarter of 2024 were favorably impacted by approximately $85 million as a result of higher wholesaler inventory levels for EYLEA, partially offset by lower wholesaler inventory levels for EYLEA HD, at the end of the fourth quarter of 2024 compared to the end of the third quarter of 2024.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedMD&A
During the year ended December 31, 2023, we earned the final $50.0 million sales-based milestone from Sanofi upon aggregate annual sales of antibodies outside the United States exceeding $3.0 billion on a rolling twelve-month basis.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedMD&A
Other revenue in 2024 and 2023 included $328.6 million and $247.6 million, respectively, of royalties and share of profits earned in connection with license agreements.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedMD&A
Cost of goods sold increased in 2024, compared to 2023, primarily due to higher start-up costs for our Rensselaer, New York fill/finish facility.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedMD&A
Certain countries in which we have operations, including Ireland, have adopted legislation influenced by the Organization for Economic Co-operation and Development ("OECD") Global Anti-Base Erosion Model Rules ("Pillar Two") framework, including a minimum tax rate of 15%. The adoption of the Pillar Two framework did not have a material impact on our effective tax rate for the year ended December 31, 2024. It is uncertain whether the United States will enact legislation to adopt the Pillar Two framework. We continue to evaluate additional guidance released by the OECD, along with the pending legislative adoption by additional countries.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedMD&A
Acquisitions, net of cash acquired, of $54.9 million and $230.3 million in 2023 and 2022 was related to our acquisitions of Decibel Therapeutics, Inc. and Checkmate Pharmaceuticals, Inc., respectively.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedMD&A
As set forth in the Credit Agreement, we have the option to amend the Credit Agreement to establish environmental, social, and governance targets which will be used to adjust pricing under the Credit Facility, subject to parameters to be provided in the Credit Agreement.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedMD&A
In November 2021, our board of directors authorized a share repurchase program to repurchase up to $3.0 billion of our Common Stock. As of June 30, 2023, the Company had repurchased the entire $3.0 billion of its Common Stock it was authorized to repurchase under the program.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedMD&A
The table below summarizes the shares of our Common Stock that we repurchased and the cost of such shares, which were recorded as Treasury Stock.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedMD&A
As of December 31, 2024, $1.917 billion remained available for share repurchases under the April 2024 program.
Read it in 10-K 2025-02-05 at sec.gov ↗
RemovedMD&A
In February 2025, our board of directors authorized a share repurchase program to repurchase up to an additional $3.0 billion of our Common Stock. The share repurchase program was approved under terms substantially similar to the repurchase programs described above.
Read it in 10-K 2025-02-05 at sec.gov ↗
RewordedMD&A
Year Ended December 31, Change (In millions, except headcount data) 2025 2024 2023 2022 2025 vs. 2024 2024 vs. 2023 2023 vs. 2022 Research and development(a) $ 5,850.2 $ 5,132.0 $ 4,439.0 $ 3,592.5 718.2 $ 693.0 $ 846.5 Acquired in-process research and development 124.1 101.0 186.1 255.1 23.1 (85.1) (69.0) Selling, general, and administrative(a) 2,700.0 2,954.4 2,631.3 2,115.9 (254.4) 323.1 515.4 Cost of goods sold 1,140.8 1,087.3 932.1 800.0 53.5 155.2 132.1 Cost of collaboration and contract manufacturing(b) 959.9 883.2 883.7 760.4 76.7 (0.5) 123.3 Other operating expense (income), (income) expense, net (10.0) 53.4 (2.1) (89.9) (63.4) 55.5 87.8 Total operating expenses $ 10,765.0 $ 10,211.3 $ 9,070.1 $ 7,434.0 553.7 $ 1,141.2 $ 1,636.1 Average headcount 15,261 14,383 12,698 11,115 878 1,685 1,583 (a) Includes costs incurred net of any cost reimbursements from collaborators (b) Includes costs incurred in connection with manufacturing drug supplies for collaborators and others
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedMD&A
Year Ended December 31, (In millions) 2025 2024 2023 Regeneron's share of profits $ 5,241.6 $ 3,923.5 $ 3,136.5 $ 2,082.0 Sales-based milestones earned — — 50.0 100.0 Reimbursement for manufacturing of commercial supplies(a) 642.4 607.9 613.0 633.7 Other — — 28.7 Total Antibody 4,531.4 3,799.5 2,844.4 Total Immuno-oncology(b) — — 11.3 Total Sanofi collaboration revenue $ 5,884.0 $ 4,531.4 $ 3,799.5 $ 2,855.7 (a) Corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing. manufacturing
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedMD&A
Year Ended December 31, (In millions) 2025 2024 2023 2022 Regeneron's share of profits $ 1,403.3 $ 1,376.4 $ 1,317.4 1,282.7 $1,403.3 $1,376.4 Reimbursement for manufacturing of ex-U.S. commercial supplies(a) 139.7 95.7 111.1 91.4 One-time payment in connection with change in Japan arrangement(b) — — 21.9 Total Bayer collaboration revenue $ 1,499.0 $ 1,487.5 $ 1,430.7 1,422.4 $1,499.0 $1,487.5 (a) Corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing. manufacturing
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedMD&A
Year Ended December 31, (In millions) 2025 2024 2023 2022 Dupixent and Kevzara net product sales $ 18,381.3 $ 14,606.7 $ 11,974.0 $ 9,039.2 Regeneron's share of collaboration profits in connection with commercialization of antibodies 6,171.3 4,527.2 3,596.3 2,405.5 Reimbursement of development expenses incurred by Sanofi in accordance with Regeneron's payment obligation(a) (929.7) (603.7) (459.8) (266.6) One-time payment in connection with amendment to the Antibody License and Collaboration Agreement — — (56.9) Regeneron's share of profits $ 5,241.6 $ 3,923.5 $ 3,136.5 $ 2,082.0 Regeneron's share of profits as a percentage of Dupixent and Kevzara net product sales 29% 27% 26% 23% (a) See "Liquidity and Capital Resources - Additional Funding Requirements" below for additional details on our contingent reimbursement obligation. obligation
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedMD&A
We expect to incur capital expenditures of $850 million $1.100 billion to $975 million $1.300 billion in 2025, 2026, including in connection with the continued expansion of our facilities in Tarrytown, New York. York and developing our property in Saratoga Springs, New York for production support activities and additional manufacturing capacity.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedMD&A
The increase decrease in our share of profits during for the year ended December 31, 2024, 2025, compared to 2023, the same period in 2024, was primarily driven by higher lower profits associated with Dupixent sales. a decrease in EYLEA sales outside the United States.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedMD&A
Net product sales of EYLEA HD and EYLEA increased in 2024 were adversely impacted 2025 compared to 2024, due to higher sales volumes, partly offset by a lower net selling price compared to 2023. price.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedMD&A
In April 2024, our Our board of directors has authorized share repurchase programs, including a share repurchase program to repurchase for up to an additional $3.0 billion of our Common Stock. Stock which was authorized in February 2025.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedMD&A
Acquired IPR&D expense expenses in 2024 2025 included a $45.0 an $80.0 million development milestone up-front payment in connection with our collaboration license agreement with Sonoma Biotherapeutics, Inc. Hansoh Pharmaceuticals Group Company Limited.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedMD&A
Our effective tax rate for 2024 and 2023 2025 was positively impacted, compared to the U.S. federal statutory rate, primarily by stock-based compensation, income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate, rate and federal tax credits for research activities. activities, partially offset by the impact of the OBBBA being signed into law.
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedMD&A
Year Ended December 31, (In millions) 2025 2024 2023 2022 EYLEA 8 mg and EYLEA net product sales outside the United States $ 3,576.8 3,506.3 $3,576.8 $3,495.2 $3,382.8 Regeneron's share of collaboration profit from sales outside the United States $ 1,469.7 1,347.3 $1,469.7 $1,436.1 $1,375.1 Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation(a) (64.6) (66.4) (59.7) (57.7) Regeneron's share of profits $ 1,403.3 1,282.7 $1,403.3 $1,376.4 $1,317.4 Regeneron's share of profits as a percentage of EYLEA 8 mg and EYLEA net product sales outside the United States 39% 37% 39% 39% (a) See "Liquidity and Capital Resources - Additional Funding Requirements" below for additional details on our contingent reimbursement obligation. obligation
Read it in 10-K 2026-02-04 at sec.gov ↗
RewordedMD&A
Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $635.9 million during 2025, compared to $1.465 billion during 2024, compared to 2024 and $1.146 billion during 2023 and $1.520 billion during 2022. 2023.
Read it in 10-K 2026-02-04 at sec.gov ↗