Regeneron Pharmaceuticals (REGN) 10-K risk factor changes: FY2025 vs FY2024

[Table [removed: of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)][added: of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)]

- We are substantially dependent on the success of [removed: EYLEA,] EYLEA HD, [added: EYLEA,] and Dupixent.

- Sales of our products are dependent on the availability and extent of coverage and reimbursement [added: or copay assistance] from third-party [removed: payors,] [added: payors and other third parties,] including private payors and government programs such as Medicare and Medicaid.

- Product reimbursement and coverage policies and [removed: practices] [added: practices, pricing regulations and requirements, and our pricing strategy] could change due to various factors [added: beyond our control,] such as drug price control measures that have been or may be enacted or introduced in the United States by various federal and state authorities.

- The commercial success of our products is subject to significant competition from products or product candidates that may be superior to, or more established or cost effective than, our products or product [removed: candidates.][added: candidates, including biosimilars.]

- Drug development and obtaining and maintaining regulatory approval for drug [added: and biologic] products is costly, time-consuming, and highly uncertain.

As we increase our production in response to higher product demand or in anticipation of [removed: a] potential regulatory [removed: approval,] [added: approvals,] our current manufacturing capacity will likely not be sufficient, and our dependence on our collaborators and/or contract manufacturers may increase, to produce adequate quantities of drug material for both commercial and clinical purposes.

- Our or our collaborators' [added: or contract manufacturers'] failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales.

- Tax [removed: liabilities] [added: liabilities, tariffs] and [added: other trade restrictions, and other] risks associated with our operations outside the United States could adversely affect our business.

- Our business is dependent on our key personnel and will be harmed if we cannot recruit [removed: and] [added: or] retain key members of our senior management team, including leaders in our research, development, manufacturing, and commercial organizations.

- Public health outbreaks, epidemics, or pandemics [removed: (such as the COVID-19 pandemic)] have adversely affected and may in the future adversely affect our business.

We are substantially dependent on the success of [removed: EYLEA,] EYLEA HD, [added: EYLEA,] and Dupixent.

We are substantially dependent on the success of EYLEA [removed: and, since its August 2023 FDA approval, EYLEA HD.][added: HD and EYLEA.]

[removed: EYLEA net] [added: Net] product sales [added: of these products] have historically represented a substantial portion of our revenues, and we expect [removed: that there will continue to be a] [added: this] concentration of our net sales [removed: from] [added: to continue in] the [removed: net product sales of] [added: future with an increasing dependence on] EYLEA HD [removed: and] [added: relative to our historical dependence on] EYLEA.

For the years ended December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] our aggregate EYLEA HD and EYLEA net product sales in the United States represented [removed: 42%] [added: 31%] and [removed: 45%] [added: 42%] of our total revenues, respectively.

For the year ended December 31, [removed: 2024,] [added: 2025,] EYLEA HD U.S. net product sales represented [removed: 20%] [added: 37%] of our aggregate EYLEA HD and EYLEA U.S. net product sales.

[added: If we experience difficulty with the] commercialization of EYLEA HD or EYLEA [added: in the United States or if Bayer experiences any difficulty with the commercialization of EYLEA HD or EYLEA] outside the United States, if EYLEA [added: HD] net product sales [removed: experience a] [added: do not sufficiently offset any] sustained decline [added: of EYLEA net product sales] in or outside the United [removed: States without an offset from EYLEA HD net product sales,] [added: States,] or if we and Bayer are unable to maintain or obtain marketing approvals of these products (as applicable), we may experience a reduction in revenue and may not be able to stay profitable at the levels we previously achieved or at all, and our business, prospects, operating results, and financial condition may be materially harmed.

Commercialization of EYLEA [added: HD] and EYLEA [removed: HD] in the United States and elsewhere is subject to significant competition (as described further below under "*The commercial success of our products and product candidates is subject to significant competition*"), which we expect to continue to increase in the future.

For the year ended December 31, [removed: 2024,] [added: 2025,] EYLEA U.S. net product sales declined by [removed: 17%] [added: 42%] compared to the [removed: same] [added: corresponding] period in [removed: 2023.][added: 2024 as a result of competitive pressures and other factors described under Part II, Item 7.]

[added: "Management's Discussion and Analysis of Financial Condition and Results of Operations – Results of Operations."] Following the expiration of the U.S. regulatory exclusivity period for EYLEA [removed: (i.e., the period during which no biosimilar product can be approved by the FDA)] in May 2024, several biosimilar versions of EYLEA have been approved by the FDA, and one such product has launched in the United States.

EYLEA and/or EYLEA HD net product sales recorded by us are likely to [added: continue to] be negatively impacted by biosimilar competition in the United States, [added: including competition from additional biosimilar versions of EYLEA expected to launch in the United States in the second half of 2026,] which may have a material adverse impact on our results of operations.

In addition, we expect that competition for EYLEA [added: and/or EYLEA HD] outside the United States will [added: continue to] increase [removed: in the future when] [added: as] biosimilar versions of EYLEA (including those already approved but not yet launched) are brought to market in additional countries, which may negatively impact the amount of collaboration revenue we earn from Bayer.

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

We also are substantially dependent on our share of profits from the commercialization of Dupixent under our [removed: Antibody Collaboration] [added: collaboration] with [removed: Sanofi.][added: Sanofi (the "Antibody Collaboration").]

For the years ended December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] Sanofi collaboration revenue (most of which is attributable to our share of profits from the commercialization of Dupixent) represented [removed: 32%] [added: 41%] and [removed: 29%] [added: 32%] of our total revenues, respectively.

- sufficient coverage of, and reimbursement [added: or copay assistance] for, our marketed products by third-party [removed: payors,] [added: payors and other third parties,] including Medicare and Medicaid in the United States and other government and private payors in the United States and foreign jurisdictions, as well as U.S. and foreign payor restrictions on eligible patient populations and the reimbursement process (including drug price control measures that have been or may be enacted or introduced in the United States by various federal and state authorities);

- our ability and our collaborators' ability to maintain sales of our marketed products in the face of competitive products and to differentiate our marketed products from competitive products, including as applicable product candidates currently in clinical development; and, in the case of EYLEA [added: HD] and [removed: EYLEA HD,] [added: EYLEA,] the existing and potential new branded and biosimilar competition (discussed further under "*The commercial success of our products and product candidates is subject to significant competition -* Marketed Products" below) and the willingness of retinal specialists and patients to start or continue treatment with such products or to switch from a competitive product to one of our products;

- the safety and efficacy of our marketed products [removed: (particularly those launched recently, such as EYLEA HD)] seen in a broader patient group (i.e., real-world use);

- serious complications or side effects in connection with the use of our marketed products, as discussed under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - *Serious complications or side effects in connection with the use [added: or development] of our products [removed: and in clinical trials for our] [added: or] product candidates [removed: and new indications for our marketed products] could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation [removed: of*][added: of development of our product candidates or new indications for our marketed products, which could severely harm our business, prospects, operating results, and financial condition*" below;]

[removed: *development] [added: Serious complications or side effects in connection with the use or development] of our [added: products or] product candidates [added: could cause our regulatory approvals to be revoked] or [added: limited or lead to delay or discontinuation of development of our product candidates or] new indications for our marketed products, which could severely harm our business, prospects, operating results, and financial [removed: condition*" below;][added: condition.]

- maintaining and successfully monitoring commercial manufacturing arrangements for our marketed products with third parties who perform fill/finish [added: and bulk product manufacturing] or other steps in the manufacture of such products to ensure that they meet our standards and those of regulatory authorities, including the FDA, which extensively regulate and [removed: monitor] [added: monitor, and have been increasing their focus on,] pharmaceutical manufacturing facilities;

If we or our collaborators fail to maintain regulatory compliance or satisfy other obligations for such products' currently approved indications (including because the product does not meet the relevant endpoints of any required post-approval studies (such as those required under an accelerated approval by the FDA or other similar type of approval), or for any of the reasons discussed below under "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - *Obtaining and maintaining regulatory approval for drug [added: and biologic] products is costly, time-consuming, and highly uncertain.

If we or our collaborators do not maintain regulatory approval for our marketed products, [removed: and] [added: or] obtain regulatory approval for our product candidates or new indications [removed: for] [added: of] our marketed [removed: products, we will not be able to market or sell them, which would] [added: products (or are] materially [added: delayed in doing so), the value of our Company] and [removed: negatively impact] our business, prospects, operating results, and financial [removed: condition.*"), the applicable marketing approval] [added: condition] may be [removed: withdrawn, which would] materially [removed: harm our business, prospects, operating results, and financial condition.][added: harmed.]

See also "Risks Related to Manufacturing and Supply - *Our or our collaborators' [added: or contract manufacturers'] failure to meet the stringent requirements of governmental regulation in the manufacture of drug products or product candidates could result in incurring substantial remedial costs, delays in the development or approval of our product candidates or new indications for our marketed products and/or in their commercial launch if regulatory approval is obtained, and a reduction in sales*" below.

Sales of our marketed products are dependent on the availability and extent of coverage and reimbursement [added: and copay assistance] from third-party [removed: payors.][added: payors and other third parties.]

Sales of our marketed products in the United States are dependent, in large part, on the availability and extent of [added: coverage and] reimbursement from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies ("PBMs"), and government programs such as Medicare and Medicaid.

Our [removed: future] revenues and profitability will be [added: materially] adversely affected [removed: in a material manner] if such third-party payors [added: and other third parties] do not adequately defray or reimburse the cost of our marketed products.

If [removed: these entities] [added: third-party payors] do not provide coverage and reimbursement with respect to our marketed products or provide an insufficient level of coverage and reimbursement, such products may be too costly for many patients to afford them, and physicians may not prescribe them.

Third-party payors may also require prior authorization for reimbursement, [removed: or] require failure on another type of [removed: treatment] [added: treatment, or impose other utilization management restrictions] before covering a particular drug, particularly with respect to higher-priced drugs.

As our currently marketed products and most of our product candidates are biologics, bringing them to market may cost more than bringing traditional, small-molecule drugs to market due to the complexity [added: associated with the research, development, production, supply, and regulatory review of such products.]

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While the FDA recently approved EYLEA HD for the treatment of RVO and for an every 4-week dosing regimen across approved indications and we continue to work toward FDA approval of the EYLEA HD pre-filled syringe as discussed under Part I, Item 1.

"Business - Programs in Clinical Development - Additional Information - Clinical Development Programs - EYLEA HD," there can be no assurance that such milestones (including potential FDA approval of the EYLEA HD pre-filled syringe) will help accelerate any potential future growth of EYLEA HD net product

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sales.

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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.

Such sales are also impacted by the ability of patients to afford copays and the availability and extent of copay assistance, including copay assistance provided by other third parties (such as not-for-profit patient assistance funds).

Further, sales of our marketed products (such as EYLEA HD and EYLEA) in the United States may be adversely impacted by the lack of sufficient copay assistance from not-for-profit patient assistance funds.

For example, a loss in market share to compounded bevacizumab due to patient affordability constraints impacted U.S. net product sales of EYLEA for the year ended December 31, 2025, as further described under Part II, Item 7.

"Management's Discussion and Analysis of Financial Condition and Results of Operations – Results of Operations." If independent not-for-profit patient assistance funds that provide patient 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.

There is no certainty that we will be able

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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.

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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.

We are aware of

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For example, Lynozyfic faces significant actual and potential future competition from other bispecific antibodies and CAR-T cell therapies targeting BCMA, GPRC5D, and/or other targets that are currently approved or in development for the treatment of relapsed/refractory multiple myeloma.

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

(including bispecific antibodies, multispecific antibodies, and/or antibody-drug conjugates) and gene therapy-based products against targets that are also the targets of our early- and late-stage product candidates.

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.

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

*develop, manufacture, and commercialize certain of our products and product candidates in the time expected, or at all, may be materially harmed*" below.

In addition, there are proposals to legalize the import of pharmaceuticals from outside the United States into the United States and, as discussed above under "*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,*" an executive order from April 2025 directed the Secretary of the HHS to take appropriate steps to facilitate such importation at the state level.

In addition, we may need to further develop or acquire these capabilities as we and/or our collaborators continue to pursue the development of drugs generated by means other than our established "Trap" or *VelociSuite* technologies, such as siRNA gene silencing, genome editing, and targeted viral-based gene delivery and expression.

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

or other pharmacies (as applicable).

If we or our collaborators do not maintain regulatory approval for our marketed products, or obtain regulatory approval for our product candidates, we will not be able to market or sell them; and if we do not obtain approvals for new indications for our marketed products, we may not be able to realize the full commercial potential of such products.

A REMS may include various elements, ranging from a medication guide or patient

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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.

If we are successful in commercializing EYLEA HD, we expect that our dependence on EYLEA HD will grow relative to our historical dependence on EYLEA.

If we experience difficulty with the commercialization of EYLEA HD or EYLEA in the United States or if Bayer experiences any difficulty with the

While we anticipate several important 2025 milestones relevant to further commercialization of EYLEA HD as shown in the table under Part I, Item 1.

"Business - Programs in Clinical Development," there can be no assurance that any such milestones will be achieved or, if achieved, that they will enable us and Bayer to accelerate the ongoing launch and further commercialization of EYLEA HD.

associated with the research, development, production, supply, and regulatory review of such products.

In addition, biosimilar versions of EYLEA have been approved both in and outside the United States.

These include Amgen's Pavblu™ (aflibercept-ayyh), which recently launched in the United States.

technologies and other approaches such as RNAi, chimeric antigen receptor T cell (CAR-T cell), and gene therapy technologies.

In addition, there are proposals to legalize the import of pharmaceuticals from outside the United States into the United States.

Commercialization of any of our marketed products may

approvable.

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.

product.

For example, in August 2024, the FDA issued a CRL concerning the Company's BLA for linvoseltamab in relapsed/refractory multiple myeloma due to findings from a pre-approval inspection at a third-party fill/finish provider for another company's product candidate.

While the linvoseltamab BLA has recently been resubmitted to the FDA, this has resulted in a delay of any potential FDA approval of this product candidate.

Serious complications or side effects in connection with the use of our products and in clinical trials for our product candidates and new indications for our marketed products could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of development of our product candidates or new indications for our marketed products, which could severely harm our business, prospects, operating results, and financial condition.

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.

outcomes or patient experiences.

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).

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.

In addition, the 8mg pre-filled syringe for EYLEA HD is approved in the EU and is currently under regulatory review in the United States.

separately regulated products is made by the FDA on a case-by-case basis.

For example, the EU has had an established regulatory pathway for biosimilars since 2005.

sufficient, and our dependence on our collaborators and/or contract manufacturers may increase, to produce adequate quantities of drug material for both commercial and clinical purposes.

"Management's Discussion and Analysis of Financial Condition and Results of Operations – Liquidity and Capital Resources" for information about capital expenditures relating to this and other projects).

A judicial or regulatory decision in favor of one or more parties making such allegations could

We have previously been subject to, and may in the future be subject to, claims by patients who use our approved products, or our product candidates if those product candidates receive regulatory approval and become commercially available, that they have been injured by a side effect associated with the drug.

Even in a circumstance in which we do not believe that an adverse event is related to our products or product candidates, the related investigation may be time consuming or inconclusive and may have a negative impact on our reputation or business.

activities, and sales representatives' communications.

The FDA may take enforcement action for promoting unapproved uses of a product or other violations of its advertising laws and regulations.

The Bipartisan Budget Act of 2018 has increased the criminal and civil penalties that can be imposed for violating certain federal healthcare laws, including the federal anti-kickback statute.

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.

Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2023] [added: 2024] (filed with the SEC on February 5, [removed: 2024)] [added: 2025)] for additional discussion of our financial condition and results of operations for the year ended December 31, [removed: 2022,] [added: 2023,] as well as our financial condition and results of operations for the year ended December 31, [removed: 2023] [added: 2024] compared to the year ended December 31, [removed: 2022.*][added: 2023.*]

Our research and development efforts have led to numerous [removed: approved] products that have received marketing approval and approximately [removed: 40] [added: 45] product candidates [added: currently] in clinical development (including a number of marketed products for which we are investigating additional indications), most of which were homegrown in our laboratories.

Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the success in commercializing [added: our products, including] EYLEA [removed: HD, EYLEA,] [added: HD] and Dupixent.

[Table [removed: of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)][added: of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)]

Our collaboration agreements may require us to deliver various rights, services, and/or goods across the entire [removed: life cycle of a product or product candidate.]

- share in any profits or losses arising from the commercialization of such products, we record our share of the variable consideration, representing net product sales less cost of goods sold and shared commercialization and other expenses, in the period in which such underlying sales occur and costs are incurred by the collaborator; [added: and]

We recognize stock-based compensation expense for equity grants under our long-term incentive plans to employees and non-employee members of our board of directors [removed: (as applicable)] based on the grant-date fair value of those awards.

Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of our Common Stock price, (ii) the periods of time over which employees and members of our board of directors are expected to hold their options prior to exercise (expected lives), (iii) expected dividend yield on our Common Stock, [added: which is based on our historical practice] and [added: expectation of future dividend payments, and] (iv) risk-free interest rates, which are based on quoted U.S. Treasury rates for securities with maturities approximating the options' expected lives.

We recognize deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns, including deferred tax assets and liabilities for expected amounts of [added: Net CFC Tested Income (“NCTI”) (formerly known as] global intangible low-taxed income [removed: ("GILTI")] [added: ("GILTI"))] inclusions.

With regard to contingent consideration in an asset acquisition, the Company recognizes regulatory milestones upon achievement, royalties in the period in which the underlying sales occur, and sales-based milestones when the milestone is deemed probable by [removed: the Company of being achieved.]

| *(In millions, except per share data)* | | | [removed: 2024] [added: 2025] | | | | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | |

| Revenues | | | $ | [removed: 14,202.0] [added: 14,342.9] | | | | | $ | [removed: 13,117.2] [added: 14,202.0] | | | | | $ | [removed: 12,172.9] [added: 13,117.2] | |

| Operating expenses | | | [removed: 10,211.3] [added: 10,765.0] | | | | | | [removed: 9,070.1] [added: 10,211.3] | | | | | | [removed: 7,434.0] [added: 9,070.1] | | |

| Income from operations | | | [removed: 3,990.7] [added: 3,577.9] | | | | | | [removed: 4,047.1] [added: 3,990.7] | | | | | | [removed: 4,738.9] [added: 4,047.1] | | |

| Other income (expense) | | | [removed: 789.2] [added: 1,652.8] | | | | | | [removed: 152.2] [added: 789.2] | | | | | | [removed: 119.9] [added: 152.2] | | |

| Income before income taxes | | | [removed: 4,779.9] [added: 5,230.7] | | | | | | [removed: 4,199.3] [added: 4,779.9] | | | | | | [removed: 4,858.8] [added: 4,199.3] | | |

| Income tax expense | | | [removed: 367.3] [added: 725.8] | | | | | | [removed: 245.7] [added: 367.3] | | | | | | [removed: 520.4] [added: 245.7] | | |

| Net income | | | $ | [removed: 4,412.6] [added: 4,504.9] | | | | | $ | [removed: 3,953.6] [added: 4,412.6] | | | | | $ | [removed: 4,338.4] [added: 3,953.6] | |

| Net income per share - diluted | | | $ | [removed: 38.34] [added: 41.48] | | | | | $ | [removed: 34.77] [added: 38.34] | | | | | $ | [removed: 38.22] [added: 34.77] | |

| *(In millions)* | | | [removed: 2024] [added: 2025] | | | | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2024] [added: 2025] vs. [removed: 2023] [added: 2024] | | | | | | [removed: 2023] [added: 2024] vs. [removed: 2022] [added: 2023] | | |

| EYLEA HD - U.S. | | | $ | [removed: 1,201.1] [added: 1,636.9] | | | | | $ | [removed: 165.8] [added: 1,201.1] | | | | | $ | [removed: —] [added: 165.8] | | | | | $ | [removed: 1,035.3] [added: 435.8] | | | | | $ | [removed: 165.8] [added: 1,035.3] | |

| EYLEA - U.S. | | | [removed: 4,767.1] [added: 2,747.8] | | | | | | [removed: 5,719.6] [added: 4,767.1] | | | | | | [removed: 6,264.6] [added: 5,719.6] | | | | | | [removed: (952.5)] [added: (2,019.3)] | | | | | | [removed: (545.0)] [added: (952.5)] | | |

| Total EYLEA HD and EYLEA - U.S. | | | [removed: 5,968.2] [added: 4,384.7] | | | | | | [removed: 5,885.4] [added: 5,968.2] | | | | | | [removed: 6,264.6] [added: 5,885.4] | | | | | | [removed: 82.8] [added: (1,583.5)] | | | | | | [removed: (379.2)] [added: 82.8] | | |

| Libtayo - U.S. | | | [removed: 787.3] [added: 944.7] | | | | | | [removed: 538.8] [added: 787.3] | | | | | | [removed: 374.5] [added: 538.8] | | | | | | [removed: 248.5] [added: 157.4] | | | | | | [removed: 164.3] [added: 248.5] | | |

| Libtayo - [removed: ROW(a)] [added: ROW] | | | [removed: 429.5] [added: 507.5] | | | | | | [removed: 324.3] [added: 429.5] | | | | | | [removed: 73.0] [added: 324.3] | | | | | | [removed: 105.2] [added: 78.0] | | | | | | [removed: 251.3] [added: 105.2] | | |

| Total Libtayo - Global | | | [removed: 1,216.8] [added: 1,452.2] | | | | | | [removed: 863.1] [added: 1,216.8] | | | | | | [removed: 447.5] [added: 863.1] | | | | | | [removed: 353.7] [added: 235.4] | | | | | | [removed: 415.6] [added: 353.7] | | |

| Praluent - U.S. | | | [removed: 241.7] [added: 262.5] | | | | | | [removed: 182.4] [added: 241.7] | | | | | | [removed: 130.0] [added: 182.4] | | | | | | [removed: 59.3] [added: 20.8] | | | | | | [removed: 52.4] [added: 59.3] | | |

| Evkeeza - U.S. | | | [removed: 125.7] [added: 162.2] | | | | | | [removed: 77.3] [added: 125.7] | | | | | | [removed: 48.6] [added: 77.3] | | | | | | [removed: 48.4] [added: 36.5] | | | | | | [removed: 28.7] [added: 48.4] | | |

| Inmazeb - U.S. | | | [removed: 76.8] [added: 37.4] | | | | | | [removed: 69.8] [added: 76.8] | | | | | | [removed: 3.0] [added: 69.8] | | | | | | [removed: 7.0] [added: (39.4)] | | | | | | [removed: 66.8] [added: 7.0] | | |

| Total net product sales | | | $ | [removed: 7,629.2] [added: 6,309.1] | | | | | $ | [removed: 7,078.0] [added: 7,629.2] | | | | | $ | [removed: 6,893.7] [added: 7,078.0] | | | | | $ | [removed: 551.2] [added: (1,320.1)] | | | | | $ | [removed: 184.3] [added: 551.2] | |

| Sanofi | | | $ | [removed: 4,531.4] [added: 5,884.0] | | | | | $ | [removed: 3,799.5] [added: 4,531.4] | | | | | $ | [removed: 2,855.7] [added: 3,799.5] | | | | | $ | [removed: 731.9] [added: 1,352.6] | | | | | $ | [removed: 943.8] [added: 731.9] | |

| Bayer | | | [removed: 1,499.0] [added: 1,422.4] | | | | | | [removed: 1,487.5] [added: 1,499.0] | | | | | | [removed: 1,430.7] [added: 1,487.5] | | | | | | [removed: 11.5] [added: (76.6)] | | | | | | [removed: 56.8] [added: 11.5] | | |

| Roche | | | [removed: 1.4] [added: —] | | | | | | [removed: 211.0] [added: 1.4] | | | | | | [removed: 627.3] [added: 211.0] | | | | | | [removed: (209.6)] [added: (1.4)] | | | | | | [removed: (416.3)] [added: (209.6)] | | |

| Other | | | [removed: 26.0] [added: 24.8] | | | | | | [removed: 5.1] [added: 26.0] | | | | | | [removed: 0.4] [added: 5.1] | | | | | | [removed: 20.9] [added: (1.2)] | | | | | | [removed: 4.7] [added: 20.9] | | |

| Other revenue | | | [removed: 515.0] [added: 702.6] | | | | | | [removed: 536.1] [added: 515.0] | | | | | | [removed: 365.1] [added: 536.1] | | | | | | [removed: (21.1)] [added: 187.6] | | | | | | [removed: 171.0] [added: (21.1)] | | |

| Total revenues | | | $ | [removed: 14,202.0] [added: 14,342.9] | | | | | $ | [removed: 13,117.2] [added: 14,202.0] | | | | | $ | [removed: 12,172.9] [added: 13,117.2] | | | | | $ | [removed: 1,084.8] [added: 140.9] | | | | | $ | [removed: 944.3] [added: 1,084.8] | |

EYLEA [removed: HD was approved by the FDA in August 2023 and] net product sales [removed: in 2024 were driven] [added: have been, and are likely to continue to be, negatively impacted] by [removed: the transition of patients] [added: increased competition] from other anti-VEGF products, including [removed: EYLEA,] [added: biosimilars,] as well as [removed: new] [added: the transition of] patients [removed: naïve] [added: from EYLEA] to [removed: anti-VEGF therapy.][added: EYLEA HD.]

| Balance as of December 31, 2022 | | | [added: $ |] 353.9 | | | | | [added: $] | 111.4 | | | | | [added: $] | 81.5 | | | | | [added: $] | 546.8 | | [removed: |]

| Balance as of December 31, 2024 | | | [removed: $ |] 539.1 | | | | | [removed: $] | 127.8 | | | | | [removed: $] | 93.5 | | | | | [removed: $] | 760.4 | | [added: |]

| *(In millions)* | | | | | | [removed: 2024] [added: 2025] | | | | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | |

life cycle of a product or product candidate.

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

the Company of being achieved.

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

| Other products - Global | | | 10.1 | | | | | | — | | | | | | — | | | | | | 10.1 | | | | | | — | | |

Net product sales of EYLEA HD increased in 2025 compared to 2024, due to higher sales volumes, partly offset by a lower net selling price.

EYLEA HD was approved by the FDA in August 2023.

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.

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.

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

| Provisions | | | 2,751.7 | | | | | | 421.1 | | | | | | 119.7 | | | | | | 3,292.5 | | |

| Credits/payments | | | (2,659.2) | | | | | | (400.7) | | | | | | (122.2) | | | | | | (3,182.1) | | |

| Balance as of December 31, 2025 | | | $ | 631.6 | | | | | $ | 148.2 | | | | | $ | 91.0 | | | | | $ | 870.8 | |

| Regeneron's share of profits | | | | | | $ | 5,241.6 | | | | | $ | 3,923.5 | | | | | $ | 3,136.5 | |

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

| *(In millions)* | | | | | | 2025 | | | | | | 2024 | | | | | | 2023 | | |

| (a) Corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing | | | | | | | | | | | | | | | | | | | | |

| *(In millions)* | | | | | | 2025 | | | | | | 2024 | | | | | | 2023 | | |

| Regeneron's share of profits | | | | | | $ | 1,282.7 | | | | | $ | 1,403.3 | | | | | $ | 1,376.4 | |

| (a) See "Liquidity and Capital Resources - Additional Funding Requirements" below for additional details on our contingent reimbursement obligation | | | | | | | | | | | | | | | | | | | | |

The decrease in our share of profits for the year ended December 31, 2025, compared to the same period in 2024, was primarily driven by lower profits associated with a decrease in EYLEA sales outside the United States.

In 2023, total Roche collaboration revenue was $211.0 million.

| *(In millions)* | | | | | | 2025 | | | | | | 2024 | | | | | | 2023 | | |

| Royalties on sales of Novartis' Ilaris® (canakinumab)(a) | | | | | | $ | 274.8 | | | | | $ | 177.5 | | | | | $ | 153.8 | |

| Regeneron's share of profits from sales of ARCALYST(b) | | | | | | 231.2 | | | | | | 115.2 | | | | | | 60.4 | | |

| Other(c) | | | | | | 196.6 | | | | | | 222.3 | | | | | | 321.9 | | |

| Total other revenue | | | | | | $ | 702.6 | | | | | $ | 515.0 | | | | | $ | 536.1 | |

| (a) In connection with our agreement with Novartis, the tiered royalty rates start at 4% and reach 15% after annual sales exceed $1.5 billion | | | | | | | | | | | | | | | | | | | | |

| (b) In connection with our license agreement with Kiniksa Pharmaceuticals, Ltd., we are entitled to receive 50% of Kiniksa's profits from sales of ARCALYST | | | | | | | | | | | | | | | | | | | | |

| (c) Consists primarily of amounts earned in connection with manufacturing product for others; corresponding costs incurred by the Company in connection with such manufacturing is recorded within Cost of collaboration and contract manufacturing | | | | | | | | | | | | | | | | | | | | |

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

Operating expenses in 2025 and 2024 included stock-based compensation expense of $993.7 million and $982.8 million, respectively.

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

| Trevogrumab | | | | | | 73.7 | | | | | | 33.0 | | | | | | 1.5 | | | | | | 40.7 | | | | | | 31.5 | | |

| Priority review voucher | | | | | | 155.0 | | | | | | — | | | | | | — | | | | | | 155.0 | | | | | | — | | |

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

Research and development expenses in 2025 included $155.0 million related to an FDA Rare Pediatric Disease Priority Review Voucher ("PRV").

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.

| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (a) Effective July 1, 2022, we obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi ("A&R IO LCA") and, as a result, we began recording net product sales of Libtayo outside the United States as of such date. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

Total EYLEA HD and EYLEA net product sales in the U.S. increased in 2024 compared to 2023.

Net product sales of EYLEA HD and EYLEA in 2024 were adversely impacted by a lower net selling price compared to 2023.

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.

| Balance as of December 31, 2021 | | | $ | 214.6 | | | | | $ | 80.0 | | | | | $ | 67.6 | | | | | $ | 362.2 | |

| Provisions | | | 1,537.3 | | | | | | 431.1 | | | | | | 141.1 | | | | | | 2,109.5 | | |

| Credits/payments | | | (1,398.0) | | | | | | (399.7) | | | | | | (127.2) | | | | | | (1,924.9) | | |

| Antibody: | | | | | | | | | | | | | | | | | | | | |

| Other | | | | | | — | | | | | | — | | | | | | 28.7 | | |

| Total Antibody | | | | | | 4,531.4 | | | | | | 3,799.5 | | | | | | 2,844.4 | | |

| Total Immuno-oncology(b) | | | | | | — | | | | | | — | | | | | | 11.3 | | |

| (b) As the A&R IO LCA became effective July 1, 2022, the six months ended June 30, 2022 was the last period in which Sanofi collaboration revenue was recognized in connection with the Immuno-oncology collaboration. | | | | | | | | | | | | | | | | | | | | |

Antibody

| One-time payment in connection with amendment to the Antibody License and Collaboration Agreement | | | | | | — | | | | | | — | | | | | | (56.9) | | |

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.

| One-time payment in connection with change in Japan arrangement(b) | | | | | | — | | | | | | — | | | | | | 21.9 | | |

| (b) Effective January 1, 2022, the Company and Bayer commenced sharing equally in profits based on sales from Bayer to its distributor in Japan. Previously, the Company received from Bayer a tiered percentage of sales based on sales by Bayer's distributor in Japan. | | | | | | | | | | | | | | | | | | | | |

| Regeneron's share of profits | | | | | | $ | 1.4 | | | | | $ | 224.3 | | | | | $ | 627.3 | |

| Other | | | | | | — | | | | | | (13.3) | | | | | | — | | |

| Total Roche collaboration revenue | | | | | | $ | 1.4 | | | | | $ | 211.0 | | | | | $ | 627.3 | |

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.

Operating expenses in 2024 and 2023 included a total of $982.8 million and $885.0 million, respectively, of stock-based compensation expense related to equity awards granted under our long-term incentive plans.

Acquired IPR&D expense in 2023 included a $100.0 million development milestone in connection with our collaboration agreement with Alnylam Pharmaceuticals, Inc., a $45.0 million up-front payment in connection with our collaboration agreement with Sonoma, and a $30.0 million charge to extend the period for selecting targets under our collaboration agreement with Intellia Therapeutics, Inc.

Selling, general, and administrative expenses increased in 2024, compared to 2023, due to higher commercialization-related expenses to support our launch of EYLEA HD and higher headcount and headcount-related costs partly related to our international commercial expansion.

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.

Other income (expense) consists of the following:

| Unrealized gains (losses) on equity securities, net | | | | | | $ | 117.7 | | | | | $ | (237.8) | | | | | $ | (39.8) | |

| Foreign currency (losses) gains, net | | | | | | (0.5) | | | | | | (12.9) | | | | | | 50.2 | | |

| Other | | | | | | 15.8 | | | | | | (20.0) | | | | | | 8.8 | | |

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.

| | | | $ | 17,912.6 | | | | | $ | 16,241.3 | | | | | $ | 1,671.3 | |

| | | | $ | 14,716.6 | | | | | $ | 16,055.8 | | | | | $ | (1,339.2) | |

Sources and Uses of Cash for the Years Ended December 31, 2024, 2023, and 2022

We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would have resulted in [removed: approximately] a [removed: $163.0] [added: $198.3] million and [removed: $98.7] [added: $163.0] million decrease in the fair value of our investment portfolio as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] respectively.

[removed: We] [added: In addition to our investments in marketable securities, we also] have exposure to [removed: market risk for] changes in interest [removed: rates, including the interest rate risk relating to] [added: rates in connection with] our variable rate Tarrytown, New York lease (as described in Part II, Item 7.

We have an investment policy that includes guidelines on acceptable investment securities, minimum credit quality, maturity parameters, and [removed: concentration and] diversification.

Significant changes in foreign exchange rates of the countries outside the United States where our products are [removed: sold, where development expenses are incurred by us or our collaborators,] [added: sold] or where [removed: we incur] operating expenses [added: are incurred] may impact our operating results and financial condition.

[removed: As discussed further above, our] [added: Our] collaborators market certain products outside the United States, and we share in profits [removed: and losses] with these collaborators from commercialization of products.

We also incur worldwide development expenses for [removed: clinical products] [added: product candidates] we are developing independently, incur expenses outside the United States in connection with our international operations, and record product sales [removed: of Libtayo] [added: for certain products] outside the United States.

Our investments in equity securities [removed: primarily] include companies with which we have entered into collaboration [added: and other strategic] arrangements.

As of December 31, 2025 and 2024, the carrying value of our investments in equity securities was $515.8 million and $1.307 billion, respectively.

In 2024 and 2023, we did not recognize any charges for credit-related losses of our available-for-sale debt securities.

We are subject to credit risk associated with the receivables due from our collaborators, including Sanofi and Bayer.

We are also subject to credit risk in connection with trade accounts receivable due from our customers from our product sales.

As of December 31, 2024, two customers accounted on a combined basis for 79% of our net trade accounts receivables.

We have contractual payment terms with each of our collaborators and customers, and also monitor financial performance and credit worthiness so that we can properly assess and respond to any changes in collaborator and/or customer credit profiles.

In 2024 and 2023, we did not recognize any charges for write-offs and allowances of accounts receivable related to credit risk for our collaborators or customers.

As of December 31, 2024, our marketable securities included $1.095 billion of equity securities.

We recorded $117.7 million of net unrealized gains and $237.8 million of net unrealized losses on equity securities in Other income (expense), net in 2024 and 2023, respectively.

*•the nature, timing, and possible success and therapeutic applications of [removed: products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products")] [added: Regeneron's Products] and [removed: product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's] [added: Regeneron's] Product [removed: Candidates")] [added: Candidates] and research and clinical programs now underway or planned, including without limitation those discussed or referenced in this report, Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs;*

*•competing [removed: drugs] [added: products] and product candidates [added: (including biosimilar products)] that may be superior to, or more cost effective than, [removed: Regeneron's Products] [added: products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Products")] and [removed: Regeneron's] [added: product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's] Product [removed: Candidates (including biosimilar versions of Regeneron's Products);*][added: Candidates");*]

*•uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties [added: or other factors beyond Regeneron's control] on the commercial success of Regeneron's Products and Regeneron's Product Candidates;*

*•our ability to manufacture and manage supply chains for multiple products and product [removed: candidates;*][added: candidates and risks associated with tariffs and other trade restrictions;*]

*•the availability and extent of reimbursement [removed: of] [added: or copay assistance for] Regeneron's Products from third-party [removed: payors,] [added: payors and other third parties,] including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid;*

*•coverage and reimbursement determinations by such payors and [added: other third parties and] new policies and procedures adopted by such [removed: payors;*][added: payors and other third parties;*]

[removed: *•changes] [added: *•other changes] in laws, regulations, and policies affecting the healthcare industry;*

*•our ability to meet any of our financial projections or [removed: guidance, including without limitation capital expenditures,] [added: guidance] and changes to the assumptions underlying those projections or guidance;*

In evaluating such statements, shareholders and potential investors should specifically consider the [removed: various*][added: various factors identified under Part I, Item 1A.]

[Table [removed: of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)][added: of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)]

| *(In millions, except per share data)* | | | | | | [removed: 2024] [added: 2025] | | | | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | |

| Revenues | | | | | | $ | [removed: 14,202.0] [added: 14,342.9] | | | | | $ | [removed: 13,117.2] [added: 14,202.0] | | | | | $ | [removed: 12,172.9] [added: 13,117.2] | |

| Net income | | | | | | $ | [removed: 4,412.6] [added: 4,504.9] | | | | | $ | [removed: 3,953.6] [added: 4,412.6] | | | | | $ | [removed: 4,338.4] [added: 3,953.6] | |

| Net income per share - diluted | | | | | | $ | [removed: 38.34] [added: 41.48] | | | | | $ | [removed: 34.77] [added: 38.34] | | | | | $ | [removed: 38.22] [added: 34.77] | |

| | | | | | | Macular edema following retinal vein occlusion [removed: ("RVO"), which includes macular edema following central retinal vein occlusion ("CRVO") and macular edema following branch retinal vein occlusion ("BRVO")] [added: ("RVO")] | | | | | | a | | | | | | a | | | | | | [removed: a] | | |

| Dupixent® (dupilumab) Injection(b) | | | | | | Atopic dermatitis (in [removed: adults, adolescents, and pediatrics] [added: patients] aged 6 months and older) | | | | | | a | | | | | | a | | | | | | a | | |

| [removed: Dupixent (dupilumab) Injection(b) *(continued)*] | | | | | | Asthma (in pediatrics 6–11 years of age) | | | | | | a | | | | | | a | | | | | | [added: a] | | |

| [added: Dupixent® (dupilumab) Injection(b) *(continued)*] | | | | | | Chronic rhinosinusitis with nasal polyposis ("CRSwNP") (in adults) | | | | | | a | | | | | | a | | | | | | a | | |

| | | | | | | Chronic obstructive pulmonary disease ("COPD") | | | | | | a | | | | | | a | | | | | | [added: a] | | |

| | | | | | | Eosinophilic esophagitis ("EoE") (in [removed: adults, adolescents, and pediatrics] [added: patients] aged 1 year and older) | | | | | | a | | | | | | a | | | | | | | | |

| | | | | | | Chronic spontaneous urticaria ("CSU") (in adults and adolescents) | | | | | | [added: a] | | | | | | [added: a] | | | | | | a | | |

| Libtayo® (cemiplimab) Injection | | | | | | Metastatic or locally advanced first-line non-small cell lung cancer [removed: ("NSCLC")] [added: ("NSCLC"), monotherapy and in combination with chemotherapy] | | | | | | a | | | | | | a | | | | | | [added: a] | | |

| Evkeeza® (evinacumab) [removed: Injection(e)] [added: Injection(d)] | | | | | | HoFH (in adults, adolescents, and pediatrics) | | | | | | a | | | | | | a | | | | | | a | | |

| Veopoz® (pozelimab) Injection | | | | | | CD55-deficient protein-losing enteropathy ("CHAPLE") (in [removed: adults, adolescents, and pediatrics] [added: patients] aged 1 year and older) | | | | | | a | | | | | | | | | | | | | | |

| ARCALYST® (rilonacept) [removed: Injection(f)] [added: Injection(e)] | | | | | | Cryopyrin-associated periodic syndromes ("CAPS"), including familial cold auto-inflammatory syndrome ("FCAS") and Muckle-Wells syndrome ("MWS") (in adults and adolescents) | | | | | | a | | | | | | | | | | | | | | |

| ZALTRAP® (ziv-aflibercept) Injection for Intravenous [removed: Infusion(g)] [added: Infusion(f)] | | | | | | Metastatic colorectal cancer ("mCRC") | | | | | | a | | | | | | a | | | | | | a | | |

| (c) The Company is [removed: solely] responsible for the development and commercialization of Praluent in the United States and Sanofi is responsible for the development and commercialization of Praluent outside the United [removed: States.] [added: States] | | | | | | | | | | | | | | | | | | | | | | | | | | |

| [removed: (e)] [added: (d)] The Company is [removed: solely] responsible for the development and commercialization of Evkeeza in the United States and Ultragenyx is responsible for the development and commercialization of Evkeeza outside the United [removed: States.] [added: States] | | | | | | | | | | | | | | | | | | | | | | | | | | |

| [removed: (f)] [added: (e)] Kiniksa is [removed: solely] responsible for the development and commercialization of [removed: ARCALYST.] [added: ARCALYST] | | | | | | | | | | | | | | | | | | | | | | | | | | |

| [removed: (g)] [added: (f)] Sanofi is [removed: solely] responsible for the development and commercialization of [removed: ZALTRAP.] [added: ZALTRAP] | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | [removed: 2024] [added: 2025] | | | | | | | | | | | | | | | | | | [removed: 2023] [added: 2024] | | | | | | | | | | | | | | | | | | [removed: 2022] [added: 2023] | | | | | | | | | | | | | | |

| *(In millions)* | | | | | | U.S. | | | | | | [removed: ROW(g)] [added: ROW(f)] | | | | | | Total | | | | | | U.S. | | | | | | ROW | | | | | | Total | | | | | | U.S. | | | | | | ROW | | | | | | Total | | |

| [added: Total] EYLEA HD and [removed: EYLEA(a)] [added: EYLEA] | | | | | | $ | [removed: 5,968.2] [added: 4,384.7] | | | | | $ | [removed: 3,576.8] [added: 3,506.3] | | | | | $ | [removed: 9,545.0] [added: 7,891.0] | | | | | $ | [removed: 5,885.4] [added: 5,968.2] | | | | | $ | [removed: 3,495.2] [added: 3,576.8] | | | | | $ | [removed: 9,380.6] [added: 9,545.0] | | | | | $ | [removed: 6,264.6] [added: 5,885.4] | | | | | $ | [removed: 3,382.8] [added: 3,495.2] | | | | | $ | [removed: 9,647.4] [added: 9,380.6] | |

| Dupixent(b) | | | | | | $ | [removed: 10,398.7] [added: 13,187.0] | | | | | $ | [removed: 3,749.3] [added: 4,619.7] | | | | | $ | [removed: 14,148.0] [added: 17,806.7] | | | | | $ | [removed: 8,855.6] [added: 10,398.7] | | | | | $ | [removed: 2,732.5] [added: 3,749.3] | | | | | $ | [removed: 11,588.1] [added: 14,148.0] | | | | | $ | [removed: 6,668.0] [added: 8,855.6] | | | | | $ | [removed: 2,013.2] [added: 2,732.5] | | | | | $ | [removed: 8,681.2] [added: 11,588.1] | |

| Libtayo(c) | | | | | | $ | [removed: 787.3] [added: 944.7] | | | | | $ | [removed: 429.5] [added: 507.5] | | | | | $ | [removed: 1,216.8] [added: 1,452.2] | | | | | $ | [removed: 538.8] [added: 787.3] | | | | | $ | [removed: 330.0] [added: 429.5] | | | | | $ | [removed: 868.8] [added: 1,216.8] | | | | | $ | [removed: 374.5] [added: 538.8] | | | | | $ | [removed: 203.5] [added: 330.0] | | | | | $ | [removed: 578.0] [added: 868.8] | |

| Praluent(d) | | | | | | $ | [removed: 241.7] [added: 262.5] | | | | | $ | [removed: 523.3] [added: 594.3] | | | | | $ | [removed: 765.0] [added: 856.8] | | | | | $ | [removed: 182.4] [added: 241.7] | | | | | $ | [removed: 456.5] [added: 523.3] | | | | | $ | [removed: 638.9] [added: 765.0] | | | | | $ | [removed: 130.0] [added: 182.4] | | | | | $ | [removed: 337.4] [added: 456.5] | | | | | $ | [removed: 467.4] [added: 638.9] | |

| Kevzara(b) | | | | | | $ | [removed: 270.2] [added: 371.4] | | | | | $ | [removed: 188.5] [added: 203.2] | | | | | $ | [removed: 458.7] [added: 574.6] | | | | | $ | [removed: 214.7] [added: 270.2] | | | | | $ | [removed: 171.2] [added: 188.5] | | | | | $ | [removed: 385.9] [added: 458.7] | | | | | $ | [removed: 199.7] [added: 214.7] | | | | | $ | [removed: 158.3] [added: 171.2] | | | | | $ | [removed: 358.0] [added: 385.9] | |

| [removed: (f)] [added: (e)] Included in this line item are products which are sold by us and others. Refer to Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues" for a [removed: complete] listing of net product sales recorded by us. Not included in this line item are net product sales of ARCALYST, which are recorded by Kiniksa. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| [removed: (g)] [added: (f)] Rest of world ("ROW") | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Clinical Program | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | [removed: 2024] [added: 2025] and [removed: 2025] [added: 2026] Events to Date | | | | | | Select Upcoming Milestones | | |

*•changes to drug pricing regulations and requirements and our drug pricing strategy;*

| | | | | | | RVO | | | | | | a | | | | | | a | | | | | | a | | |

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

| | | | | | | Bullous pemphigoid | | | | | | a | | | | | | | | | | | | | | |

| | | | | | | Adjuvant CSCC | | | | | | a | | | | | | a | | | | | | | | |

| Praluent® (alirocumab) Injection(c) | | | | | | Cardiovascular risk reduction in patients at increased risk of cardiovascular events | | | | | | a | | | | | | a | | | | | | | | |

| | | | | | | Hypercholesterolemia | | | | | | a | | | | | | a | | | | | | | | |

| | | | | | | Heterozygous familial hypercholesterolemia ("HeFH") (in patients aged 8 years and older) | | | | | | a | | | | | | a | | | | | | | | |

| Lynozyfic™ (linvoseltamab) | | | | | | Relapsed/refractory multiple myeloma | | | | | | a | | | | | | a | | | | | | | | |

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

| EYLEA HD(a) | | | | | | $ | 1,636.9 | | | | | $ | 932.7 | | | | | $ | 2,569.6 | | | | | $ | 1,201.1 | | | | | $ | 239.9 | | | | | $ | 1,441.0 | | | | | $ | 165.8 | | | | | $ | — | | | | | $ | 165.8 | |

| EYLEA(a) | | | | | | $ | 2,747.8 | | | | | $ | 2,573.6 | | | | | $ | 5,321.4 | | | | | $ | 4,767.1 | | | | | $ | 3,336.9 | | | | | $ | 8,104.0 | | | | | $ | 5,719.6 | | | | | $ | 3,495.2 | | | | | $ | 9,214.8 | |

| Other products(e) | | | | | | $ | 210.0 | | | | | $ | 113.3 | | | | | $ | 323.3 | | | | | $ | 202.9 | | | | | $ | 90.0 | | | | | $ | 292.9 | | | | | $ | 150.5 | | | | | $ | 686.2 | | | | | $ | 836.7 | |

| (c) We record global net product sales of Libtayo and pay Sanofi a royalty on such sales | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

| Pozelimab(f) *(antibody to C5)* \+ cemdisiran(l) *(siRNA therapeutic targeting C5)* | | | | | | | | | | | | –Geographic atrophy(q) | | | | | | | | | | | | | | | | | | –Report initial results from lead-in cohort of Phase 3 study in geographic atrophy (combination and cemdisiran monotherapy) (second half 2026) | | |

| Itepekimab(b) (REGN3500) *Antibody to IL-33* | | | | | | –Chronic rhinosinusitis without nasal polyposis ("CRSsNP") | | | | | | –COPD(e) –CRSwNP | | | | | | | | | | | | –Reported that Phase 3 trial (AERIFY-1) in COPD met its primary endpoint; second Phase 3 trial (AERIFY-2) did not meet same primary endpoint | | | | | | | | |

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

| Clinical Program (continued) | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2025 and 2026 Events to Date | | | | | | Select Upcoming Milestones | | |

| Itepekimab(b) (REGN3500) *(continued)* | | | | | | | | | | | | | | | | | | | | | | | | –Discontinued Phase 2 study in non-cystic fibrosis bronchiectasis ("NCFB") | | | | | | | | |

| REGN5713-5715 *Multi-antibody therapy to Bet v 1* | | | | | | | | | | | | –Birch allergy | | | | | | | | | | | | –Reported that Phase 3 trial in birch allergy met its primary and key secondary endpoints –Initiated second Phase 3 trial in birch allergy | | | | | | | | |

| REGN1908-1909(f) *Multi-antibody therapy to Fel d 1* | | | | | | | | | | | | –Cat allergy | | | | | | | | | | | | –Reported that Phase 3 trial in cat allergy met its primary and key secondary endpoints | | | | | | –Initiate second Phase 3 study in cat allergy (first half 2026) | | |

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

| Clinical Program (continued) | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2025 and 2026 Events to Date | | | | | | Select Upcoming Milestones | | |

| Fianlimab(f) (REGN3767) *(continued)* | | | | | | –Perioperative melanoma | | | | | | | | | | | | | | | | | | –Based on pre-planned interim analysis of two Phase 2/3 studies in first-line advanced NSCLC, Phase 2 portion of the studies will continue unchanged | | | | | | –Report Phase 2 data in first-line advanced NSCLC (first half 2026) | | |

| REGN5668(p) *Bispecific antibody targeting MUC16 and CD28* | | | | | | –Ovarian cancer | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Marlotamig (REGN7075) *Bispecific antibody targeting EGFR and CD28* | | | | | | –Solid tumors | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Pozelimab(f) *(antibody to C5) +* cemdisiran(l) *(siRNA therapeutic targeting C5)* | | | | | | | | | | | | –Paroxysmal nocturnal hemoglobinuria ("PNH")(c) | | | | | | | | | | | | | | | | | | –Report results from Phase 3 study in PNH (fourth quarter 2026/first quarter 2027) | | |

| Ordspono (odronextamab) *Bispecific antibody targeting CD20 and CD3* | | | | | | –B-cell non-Hodgkin lymphoma ("B-NHL") (pivotal study) | | | | | | –Lymphoma(c)(e) (multiple lines and settings) | | | | | | | | | | | | –FDA issued CRL for BLA for relapsed/refractory FL | | | | | | | | |

| Lynozyfic (linvoseltamab)(f) *Bispecific antibody targeting BCMA and CD3* | | | | | | –Multiple myeloma precursor and related conditions | | | | | | –Multiple myeloma(c)(e) (multiple lines and settings) | | | | | | | | | | | | –Approved by FDA and EC for relapsed/refractory multiple myeloma | | | | | | –Initiate additional Phase 3 studies in multiple myeloma and precursor conditions (2026) | | |

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

| Clinical Program (continued) | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2025 and 2026 Events to Date | | | | | | Select Upcoming Milestones | | |

| Lynozyfic (linvoseltamab)(f) *(continued)* | | | | | | | | | | | | | | | | | | | | | | | | –Completed enrollment in Phase 3 confirmatory trial (LINKER-MM3) in relapsed/refractory multiple myeloma | | | | | | | | |

| REGN7508 *Antibody to Factor XI (catalytic domain)* | | | | | | –Thrombosis | | | | | | –Venous thromboembolism after total knee replacement surgery | | | | | | | | | | | | | | | | | | –Initiate additional Phase 3 studies in anticoagulation (first half 2026) | | |

| REGN9933 *Antibody to Factor XI (A2 domain)* | | | | | | –Thrombosis | | | | | | | | | | | | | | | | | | | | | | | | –Initiate Phase 3 studies in anticoagulation (first half 2026) | | |

| Internal Medicine/Neurology/Rare Diseases | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Garetosmab(f) (REGN2477) *Antibody to Activin A* | | | | | | | | | | | | –Fibrodysplasia ossificans progressiva ("FOP")(c)(d)(e) | | | | | | –FOP (U.S. and EU) | | | | | | –Reported that Phase 3 trial in FOP met its primary endpoint | | | | | | –FDA decision on BLA and EC decision on Marketing Authorization Application ("MAA") for FOP (second half 2026) | | |

| Cemdisiran(l) *siRNA therapeutic targeting C5* | | | | | | | | | | | | –Myasthenia gravis(c) | | | | | | | | | | | | –Reported that Phase 3 trial in myasthenia gravis met its primary and key secondary endpoints | | | | | | –Submit New Drug Application ("NDA") for myasthenia gravis (first quarter 2026) | | |

*factors identified under Part I, Item 1A.

| | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | U.S. | | | | | | EU | | | | | | Japan | | | | | | | | |

| | | | | | | Metastatic or locally advanced first-line NSCLC (in combination with chemotherapy) | | | | | | a | | | | | | a | | | | | | | | |

| Praluent® (alirocumab) Injection(c) | | | | | | LDL-lowering in heterozygous familial hypercholesterolemia ("HeFH") or clinical atherosclerotic cardiovascular disease ("ASCVD") | | | | | | a | | | | | | a | | | | | | | | |

| | | | | | | HeFH in pediatrics and adolescents (8–17 years of age) | | | | | | a | | | | | | a | | | | | | | | |

| | | | | | | Cardiovascular risk reduction in patients with established cardiovascular disease | | | | | | a | | | | | | a | | | | | | | | |

| REGEN-COV®(d) | | | | | | COVID-19 | | | | | | | | | | | | a | | | | | | a | | |

| Product (continued) | | | | | | Disease | | | | | | | | | | | | | | | | | | | | |

| | | | | | | Territory | | | | | | | | | | | | | | | | | | | | |

| (d) In collaboration with Roche. Product is known as REGEN-COV in the United States and Ronapreve™ in other countries. | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGEN-COV(e) | | | | | | $ | — | | | | | $ | 3.5 | | | | | $ | 3.5 | | | | | $ | — | | | | | $ | 618.8 | | | | | $ | 618.8 | | | | | $ | — | | | | | $ | 1,769.6 | | | | | $ | 1,769.6 | |

| Other products(f) | | | | | | $ | 202.9 | | | | | $ | 86.5 | | | | | $ | 289.4 | | | | | $ | 150.5 | | | | | $ | 67.4 | | | | | $ | 217.9 | | | | | $ | 56.1 | | | | | $ | 69.1 | | | | | $ | 125.2 | |

| (c) We record global net product sales of Libtayo and pay Sanofi a royalty on such sales. Prior to July 1, 2022, Sanofi recorded net product sales of Libtayo outside the United States. Included in this line item for the years ended December 31, 2023 and 2022 is approximately $6 million and $34 million, respectively, of net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period). | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (e) Roche records net product sales outside the United States and we record our share of gross profits from sales, which is recorded within Collaboration revenue. Refer to Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations -Results of Operations - Revenues - Roche Collaboration Revenue" for such amounts. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Pozelimab(f) (REGN3918) *Antibody to C5* | | | | | | | | | | | | –Geographic atrophy, cemdisiran combination(l) | | | | | | | | | | | | | | | | | | | | |

| Dupixent (dupilumab)(b) *(continued)* | | | | | | | | | | | | | | | | | | | | | | | | –Approved by MHLW for CSU in adults and adolescents –Reported that second Phase 3 trial in CSU in biologic-naïve patients met its primary and key secondary endpoints –Approved by FDA, EC, and National Medical Products Administration ("NMPA") in China for uncontrolled COPD and an eosinophilic phenotype –Reported that Phase 3 NOTUS trial in COPD with evidence of type 2 inflammation met its primary and key secondary endpoints; results presented at 2024 American Thoracic Society International Conference and published in *NEJM* –Reported that Phase 3 trial in bullous pemphigoid met its primary and all key secondary endpoints –Reported that first Phase 3 trial in CPUO did not achieve statistical significance in its primary itch responder endpoint | | | | | | | | |

| Itepekimab(b) (REGN3500) *Antibody to IL-33* | | | | | | –Non-cystic fibrosis bronchiectasis ("NCFB") –Chronic rhinosinusitis without nasal polyposis ("CRSsNP") | | | | | | –COPD(e) | | | | | | | | | | | | | | | | | | –Report results from Phase 3 study in COPD (second half 2025) –Initiate additional Phase 3 studies (first half 2025) | | |

| REGN5713-5715 *Multi-antibody therapy to Bet v 1* | | | | | | | | | | | | –Birch allergy | | | | | | | | | | | | | | | | | | | | |

| REGN1908-1909(f) *Multi-antibody therapy to Fel d 1* | | | | | | | | | | | | –Cat allergy | | | | | | | | | | | | | | | | | | | | |

| REGN7075 *Bispecific antibody targeting EGFR and CD28* | | | | | | –Solid tumors | | | | | | | | | | | | | | | | | | –Presented positive results from dose escalation portion of Phase 1/2 trial (in combination with Libtayo) in advanced solid tumors at American Society of Clinical Oncology ("ASCO") 2024 Annual Meeting | | | | | | –Report additional data from study in solid tumors (2025) | | |

| Pozelimab(f) (REGN3918) *Antibody to C5* | | | | | | | | | | | | –Myasthenia gravis, cemdisiran combination(c)(l) –Paroxysmal nocturnal hemoglobinuria ("PNH"), cemdisiran combination(c)(l) | | | | | | | | | | | | –Presented positive updated data from Phase 3 trial (in combination with cemdisiran) in PNH at American Society of Hematology ("ASH") Annual Meeting | | | | | | –Report results from Phase 3 cemdisiran combination study in myasthenia gravis (second half 2025) | | |

| Ordspono (odronextamab) *Bispecific antibody targeting CD20 and CD3* | | | | | | –B-cell non-Hodgkin lymphoma ("B-NHL") (pivotal study) | | | | | | –FL(e) –DLBCL(e) | | | | | | –FL (U.S.) | | | | | | –FDA issued Complete Response Letters ("CRLs") for BLA for relapsed/refractory FL and DLBCL due to enrollment status of confirmatory Phase 3 trials; subsequently resubmitted BLA for FL –Approved by EC for relapsed/refractory FL and DLBCL –Presented new and updated data for several B-NHL subtypes across earlier lines of treatment at ASH Annual Meeting | | | | | | –FDA decision on BLA for relapsed/refractory FL (second half 2025) | | |

| Linvoseltamab(f) (REGN5458) *Bispecific antibody targeting BCMA and CD3* | | | | | | –Multiple myeloma (pivotal study)(c)(e) –Earlier (pre-malignant) multiple myeloma –Monoclonal gammopathy of undetermined significance ("MGUS") –Light chain amyloidosis ("ALA") | | | | | | –Multiple myeloma(c)(e) | | | | | | –Relapsed/refractory multiple myeloma (U.S. and EU) | | | | | | –Resubmitted BLA for relapsed/refractory multiple myeloma following resolution of third-party manufacturing issues –Presented 14-month median follow-up data from pivotal Phase 1/2 trial in multiple myeloma at European Hematology Association ("EHA") Congress 2024 and published these data in *Journal of Clinical Oncology* | | | | | | –FDA decision on BLA (mid-2025) and EC decision on regulatory application (first half 2025) for relapsed/refractory multiple myeloma | | |

| REGN9933 *Antibody to Factor XI* | | | | | | –Thrombosis | | | | | | | | | | | | | | | | | | –Reported positive results from Phase 2 trial in thrombosis | | | | | | –Initiate Phase 3 program (2025) | | |

| REGN7508 *Antibody to Factor XI* | | | | | | –Thrombosis | | | | | | | | | | | | | | | | | | –Reported positive results from Phase 2 trial in thrombosis | | | | | | –Initiate Phase 3 program (2025) | | |

| Internal Medicine/Genetic Medicines | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Garetosmab(f) (REGN2477) *Antibody to Activin A* | | | | | | | | | | | | –Fibrodysplasia ossificans progressiva ("FOP")(c)(d)(e) | | | | | | | | | | | | | | | | | | –Report results from Phase 3 study in FOP (second half 2025) | | |

| REGN5381 *Agonist antibody to NPR1* | | | | | | –Heart failure | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (f) Sanofi did not opt-in to or elected not to continue to co-develop the product candidate. Under the terms of our agreement, Sanofi is entitled to receive royalties on sales of the product, if any. | | | | | | | | | | | | | | |

| (l) Under the terms of our license agreement for cemdisiran, Alnylam is entitled to receive royalties on sales (if any), as well as sales milestones. | | | | | | | | | | | | | | |

In August 2024, the FDA issued a CRL for the BLA for linvoseltamab in relapsed/refractory multiple myeloma that has progressed after at least three prior therapies.

The sole approvability issue identified related to findings from a pre-approval inspection at a third-party fill/finish manufacturer.

In January 2025, the Company resubmitted the BLA following resolution of third-party manufacturing issues, and an FDA decision on the BLA is anticipated by mid-2025.

*Dupixent*

In September 2024, the Company and Sanofi announced that the first Phase 3 trial (Study A) of Dupixent in adults with uncontrolled and severe CPUO did not achieve statistical significance in its primary itch responder endpoint (despite favorable numerical improvements), but showed nominally significant improvements in all other itch endpoints.

The Dupixent Phase 3 program in CPUO consists of Study A and Study B.

Study B recently initiated as a subsequent pivotal trial.

*Select Early-Stage Clinical Development Updates*

In 2024, a Phase 1 study of linvoseltamab, in combination with dupilumab, in severe food allergy was initiated.

| | | | For the fiscal year ended December 31, [removed: 2024] [added: 2025] | | | | | | | | |

| The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant was [removed: $113.8] [added: $54.8] billion, computed by reference to the closing sales price of the stock on NASDAQ on June [removed: 28, 2024,] [added: 30, 2025,] the last trading day of the registrant's most recently completed second fiscal quarter. For purposes of this calculation only, the registrant has assumed that all of its directors and executive officers, and no other persons, are its affiliates. This determination of affiliate status is not necessarily a determination for other purposes. | | | | | | | | | | | | | | |

| The number of shares outstanding of each of the registrant's classes of common stock as of January [removed: 23, 2025:] [added: 22, 2026:] | | | | | | | | | | | | | | |

| Common Stock, $.001 par value | | | | | | [removed: 107,507,536] [added: 103,902,660] | | |

| Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its [removed: 2025] [added: 2026] Annual Meeting of Shareholders are incorporated by reference into Part III of this Form 10-K. Exhibit index is located on pages [removed: 87 to] 91 [added: to 94] of this filing. | | |

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| [SIGNATURE [removed: PAGE](#i66ff2c03559b4ab89799d79d457200d6_100)] [added: PAGE](#idc5efe1995944548a7c87f6108cd53a5_100)] | | | | | | | | | | | | [removed: [92](#i66ff2c03559b4ab89799d79d457200d6_100)] [added: [95](#idc5efe1995944548a7c87f6108cd53a5_100)] | | |

| "Altibodies™," "ARCALYST®," "Evkeeza®," "EYLEA®," "EYLEA HD®," "Inmazeb®," "Libtayo®," [added: "Lynozyfic™,"] "Ordspono™," "Praluent®" (in the United States), "REGEN-COV®," "Regeneron®," "Regeneron Genetics Center®," "RGC®," [removed: "Veloci-Bi®," "VelociGene®," "VelociHum®," "VelociMab®," "VelocImmune®," "VelociMouse®," "VelociSuite®," "VelociT®,"] [added: "STEM-Fueled™," "*Veloci-Bi*®," "*VelociGene*®," "*VelociHum*®," "*VelociMab*®," "*VelocImmune*®," "*VelociMouse*®," "*VelociSuite*®," "*VelociT*®,"] "Veopoz®," and "ZALTRAP®" are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners. This report refers to products of Regeneron Pharmaceuticals, Inc., its collaborators, and other parties. Consult the product label in each territory for specific information about such products. | | |

[Table [removed: of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)][added: of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)]

| [PART I](#idc5efe1995944548a7c87f6108cd53a5_10) | | | | | | | | | | | | | | |

| [PART II](#idc5efe1995944548a7c87f6108cd53a5_40) | | | | | | | | | | | | | | |

| [PART IV](#idc5efe1995944548a7c87f6108cd53a5_91) | | | | | | | | | | | | | | |

| [PART I](#i66ff2c03559b4ab89799d79d457200d6_10) | | | | | | | | | | | | | | |

| [PART II](#i66ff2c03559b4ab89799d79d457200d6_40) | | | | | | | | | | | | | | |

| [PART IV](#i66ff2c03559b4ab89799d79d457200d6_91) | | | | | | | | | | | | | | |

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

[added: We have also] developed a process to conduct due diligence on third parties with which we work to oversee and identify material risks from cybersecurity threats associated with our use of those third parties' services, including those that perform cybersecurity services.

The Company's Chief Information Security Officer ("CISO"), in coordination with the Chief [removed: Information] [added: Digital & Technology] Officer and the Technology Risk Management Committee, is responsible for the establishment and maintenance of our cybersecurity program, as well as the assessment and management of cybersecurity risks.

We have also

[Table of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)

| Tarrytown, New York | | | | | | [removed: 1,500,000] [added: 1,800,000] | | | | | | Corporate headquarters, laboratory, and office space | | | | | | [removed: Leased(a)] [added: Leased or Owned(a)] | | |

| Limerick, Ireland | | | | | | [removed: 850,000] [added: 950,000] | | | | | | Manufacturing, warehouse, laboratory, and office space | | | | | | Owned | | |

| (a) [added: Approximately 1,500,000 square feet is leased pursuant to a lease financing facility and approximately 300,000 square feet is owned.] Refer to Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources - *Tarrytown, New York Corporate Headquarters Lease*" for further [removed: details.] [added: details regarding the lease financing facility.] | | | | | | | | | | | | | | | | | | | | |

| (b) Our fill/finish facility in Rensselaer, New York is currently undergoing process validation [removed: as required by regulatory authorities.] [added: and has yet to be approved for commercial production] | | | | | | | | | | | | | | | | | | | | |

In addition to the properties summarized in the table above, we own an approximate 100-acre parcel of land adjacent to our Tarrytown, New York location, which we are in the process of developing, primarily to expand our [removed: research, preclinical manufacturing,] [added: research] and support facilities to accommodate our growth.

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

In 2024, we also acquired an approximate 1,000,000 square foot facility in Saratoga Springs, New York, and we are in the process of designing and developing this property for production support activities and expanding our manufacturing capacity.

In September 2024, we also acquired an approximate 1,000,000 square foot facility in Saratoga Springs, New York.

[Table of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)

As of January [removed: 23, 2025,] [added: 22, 2026,] there were [removed: 149] [added: 150] shareholders of record of our Common Stock and 14 shareholders of record of our Class A Stock.

In [removed: February 2025,] [added: January 2026,] our board of directors [removed: approved the initiation of a quarterly cash dividend program and] declared a cash dividend of [removed: $0.88] [added: $0.94] per share on our Common Stock and Class A [removed: Stock.][added: stock, which will be payable to our shareholders in March 2026.]

Set forth below is a line graph comparing the cumulative total shareholder return on Regeneron's Common Stock with the cumulative total return of (i) the NASDAQ US Benchmark Pharmaceuticals Total Return Index ("NQ US Pharma TR Index"), and (ii) Standard & Poor's 500 Stock Index ("S&P 500") for the period from December 31, [removed: 2019] [added: 2020] through December 31, [removed: 2024.][added: 2025.]

The comparison assumes that $100 was invested on December 31, [removed: 2019] [added: 2020] in our Common Stock and in both of the foregoing indices.

[removed: ][added: ]

| | | | [removed: 12/31/2019] [added: 12/31/2020] | | | | | | [removed: 12/31/2020] [added: 12/31/2021] | | | | | | [removed: 12/31/2021] [added: 12/31/2022] | | | | | | [removed: 12/31/2022] [added: 12/31/2023] | | | | | | [removed: 12/31/2023] [added: 12/31/2024] | | | | | | [removed: 12/31/2024] [added: 12/31/2025] | | |

[Table [removed: of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)][added: of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)]

The table below reflects shares of Common Stock we repurchased under our share repurchase programs, as well as Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock granted under one of our long-term incentive plans, during the three months ended December 31, [removed: 2024.][added: 2025.]

| Period | | | | | | Total Number of Shares Purchased | | | | | | Average Price Paid per Share | | | | | | Total Number of Shares Purchased as Part of Publicly Announced Programs | | | | | | Approximate Dollar Value of Shares that May Yet Be Purchased Under the [removed: Programs(b)] [added: Programs] *(In millions)* | | |

| (a) The difference between the total number of shares purchased and the total number of shares purchased as part of publicly announced programs relates to Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock granted under one of our long-term incentive [removed: plans.] [added: plans] | | | | | | | | | | | | | | | | | | | | | | | | | | |

[removed: | (b) 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. See Part II, Item 7.] "Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources - [removed: Share Repurchase Programs"] [added: Dividends"] for further details. [removed: | | | | | | | | | | | | | | | | | | | | | | | | | | |]

Market Information

Holders

Dividends

In 2025, we initiated a quarterly cash dividend program.

We currently intend to continue to pay a quarterly cash dividend, although the amount and timing of any future dividends are subject to authorization by our board of directors and will depend on various factors.

| Regeneron | | | $ | 100.00 | | | | | $ | 130.72 | | | | | $ | 149.34 | | | | | $ | 181.80 | | | | | $ | 147.45 | | | | | $ | 159.77 | |

| S&P 500 | | | $ | 100.00 | | | | | $ | 126.89 | | | | | $ | 102.22 | | | | | $ | 126.99 | | | | | $ | 156.59 | | | | | $ | 182.25 | |

| NQ US Pharma TR Index | | | $ | 100.00 | | | | | $ | 124.39 | | | | | $ | 138.51 | | | | | $ | 143.88 | | | | | $ | 156.19 | | | | | $ | 200.89 | |

Refer to Part II, Item 7.

| 10/1/2025–10/31/2025 | | | | | | 394,828 | | | | | | $ | 592.94 | | | | | 394,828 | | | | | | $ | 1,922.3 | |

| 11/1/2025–11/30/2025 | | | | | | 330,630 | | | | | | $ | 689.69 | | | | | 325,234 | | | | | | $ | 1,697.9 | |

| 12/1/2025–12/31/2025 | | | | | | 594,493 | | | | | | $ | 735.19 | | | | | 283,758 | | | | | | $ | 1,486.0 | |

| Total(a) | | | | | | 1,319,951 | | | | | | | | | | | | 1,003,820 | | | | | | | | |

[Table of](#idc5efe1995944548a7c87f6108cd53a5_7) [Contents](#idc5efe1995944548a7c87f6108cd53a5_7)

Market for Registrant's Common Equity

Prior to 2025, no dividends on our Common Stock or Class A Stock had been declared or paid.

The cash dividend will be payable on March 20, 2025 to shareholders of record as of February 20, 2025.

| Regeneron | | | $ | 100.00 | | | | | $ | 128.66 | | | | | $ | 168.19 | | | | | $ | 192.15 | | | | | $ | 233.91 | | | | | $ | 189.71 | |

| S&P 500 | | | $ | 100.00 | | | | | $ | 116.26 | | | | | $ | 147.52 | | | | | $ | 118.84 | | | | | $ | 147.64 | | | | | $ | 182.05 | |

| NQ US Pharma TR Index | | | $ | 100.00 | | | | | $ | 110.52 | | | | | $ | 137.47 | | | | | $ | 153.08 | | | | | $ | 159.01 | | | | | $ | 172.62 | |

| 10/1/2024–10/31/2024 | | | | | | 316,483 | | | | | | $ | 982.90 | | | | | 316,431 | | | | | | $ | 2,581.9 | |

| 11/1/2024–11/30/2024 | | | | | | 404,299 | | | | | | $ | 782.08 | | | | | 395,051 | | | | | | $ | 2,273.3 | |

| 12/1/2024–12/31/2024 | | | | | | 748,201 | | | | | | $ | 744.67 | | | | | 483,956 | | | | | | $ | 1,916.7 | |

| Total | | | | | | 1,468,983 | | | (a) | | | | | | | | | 1,195,438 | | | (a) | | | | | |

Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, [removed: 2024] [added: 2025] using the framework in *Internal Control - Integrated Framework (2013)* issued by the Committee of Sponsoring Organizations of the Treadway Commission.

Based on that evaluation, our management has concluded that our internal control over financial reporting was effective as of December 31, [removed: 2024.][added: 2025.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2024] [added: 2025] has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which appears under Part IV, Item 15.

There has been no change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) or 15d-15(f) under the Exchange Act) during the quarter ended December 31, [removed: 2024] [added: 2025] that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

As disclosed in the table below, during the three months ended December 31, [removed: 2024,] [added: 2025,] certain of our directors and/or executive officers adopted plans for trading arrangements intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) of the Exchange Act.

| (a) The trading arrangement may expire on an earlier date if and when all transactions under the arrangement are [removed: completed.] [added: completed] | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Jason Pitofsky | | | | | | Senior Vice President, Controller | | | | | | 11/10/2025 | | | | | | 5/10/2026 | | | | | | 3,261 | | |

| Arthur F. Ryan | | | | | | Director | | | | | | 10/31/2025 | | | | | | 1/29/2027 | | | | | | 1,200 | | |

| Huda Y. Zoghbi, M.D. | | | | | | Director | | | | | | 11/20/2025 | | | | | | 1/3/2027 | | | | | | 2,438 | | |

| Kathryn Guarini, Ph.D. | | | | | | Director | | | | | | 11/1/2024 | | | | | | 11/14/2025 | | | | | | 1,000 | | |

The information required by this item (other than the information set forth in the next paragraph in this Item 10) will be included in our definitive proxy statement with respect to our [removed: 2025] [added: 2026] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

The information called for by this item will be included in our definitive proxy statement with respect to our [removed: 2025] [added: 2026] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

The information called for by this item will be included in our definitive proxy statement with respect to our [removed: 2025] [added: 2026] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

The information called for by this item will be included in our definitive proxy statement with respect to our [removed: 2025] [added: 2026] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

The information called for by this item will be included in our definitive proxy statement with respect to our [removed: 2025] [added: 2026] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

| 3.1 | | | [Restated Certificate of Incorporation, as amended. (Incorporated by reference from the Form 10-Q for Regeneron Pharmaceuticals, Inc. (the "Registrant"), for the quarter ended June 30, [removed: 2015,] [added: 2025,] filed August [removed: 4, 2015.)](https://www.sec.gov/Archives/edgar/data/872589/000153217615000029/regn-ex_31x06302015x10q.htm)] [added: 1, 2025.)](https://www.sec.gov/Archives/edgar/data/872589/000087258925000019/regn-ex_31x06302025.htm)] | | |

| 4.1 | | | [Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000180422025000011/regn-ex_41x12312024x10k.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_41x12312025x10k.htm)] | | |

| 10.1 + | | | [removed: [R](https://www.sec.gov/Archives/edgar/data/872589/000119312514237593/d741943dex991.htm)[ege](https://www.sec.gov/Archives/edgar/data/872589/000119312514237593/d741943dex991.htm)[neron](https://www.sec.gov/Archives/edgar/data/872589/000119312514237593/d741943dex991.htm) [Pharm](https://www.sec.gov/Archives/edgar/data/872589/000119312514237593/d741943dex991.htm)[aceuticals,] [added: [Regeneron Pharmaceuticals,] Inc. [removed: 20](https://www.sec.gov/Archives/edgar/data/872589/000119312514237593/d741943dex991.htm)[1](https://www.sec.gov/Archives/edgar/data/872589/000119312514237593/d741943dex991.htm)[4] [added: 2014] Long-Term [removed: I](https://www.sec.gov/Archives/edgar/data/872589/000119312514237593/d741943dex991.htm)[ncentiv](https://www.sec.gov/Archives/edgar/data/872589/000119312514237593/d741943dex991.htm)[e Plan.](https://www.sec.gov/Archives/edgar/data/872589/000119312514237593/d741943dex991.htm) [(Incorporated] [added: Incentive Plan. (Incorporated] by reference from the Registration Statement on Form S-8 for the Registrant, filed June 16, 2014.)](https://www.sec.gov/Archives/edgar/data/872589/000119312514237593/d741943dex991.htm) | | |

| 10.1.1 + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.] [added: Plan (revised).] (Incorporated by reference from the Form 8-K for the Registrant, filed [removed: June 18, 2014.)](https://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex101.htm)] [added: November 19, 2015.)](https://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d1.htm)] | | |

| [removed: 10.1.2] [added: 10.3.9] + | | | [Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the [added: Second Amended and Restated] Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.)](https://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex103.htm)] [added: Plan (revised 202](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_1039x12312025x10xk.htm)[5](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_1039x12312025x10xk.htm)[).](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_1039x12312025x10xk.htm)] | | |

| [removed: 10.1.3] [added: 10.2.2] + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the [added: Amended and Restated] Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form [removed: 8-K] [added: 10-K] for the Registrant, [added: for the year ended December 31, 2017,] filed [removed: June 18, 2014.)](https://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex104.htm)] [added: February 8, 2018.)](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10216xar2014ltipnq.htm)] | | |

| [removed: 10.1.4] [added: 10.2.3] + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the [added: Amended and Restated] Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan [removed: (revised).] [added: (revised 2018).] (Incorporated by reference from the Form [removed: 8-K] [added: 10-K] for the Registrant, [added: for the year ended December 31, 2018,] filed [removed: November 19, 2015.)](https://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d1.htm)] [added: February 7, 2019.)](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10217xstockoptiona.htm)] | | |

| [removed: 10.1.5] [added: 10.2.6] + | | | [Form of [removed: restricted] stock [removed: award] [added: option] agreement and related notice of grant for use in connection with the grant of [removed: restricted] [added: non-qualified] stock [removed: awards] [added: options] to the Registrant's executive officers under the [added: Amended and Restated] Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan [removed: (revised).] [added: (revised 2019).] (Incorporated by reference from the Form [removed: 8-K] [added: 10-K] for the Registrant, [added: for the year ended December 31, 2019,] filed [removed: November 19, 2015.)](https://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d3.htm)] [added: February 7, 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)] | | |

| [removed: 10.1.6] [added: 10.1.2] + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2015, filed February 11, 2016.)](https://www.sec.gov/Archives/edgar/data/872589/000153217616000045/regn-ex_10210x12312015x10k.htm) | | |

| [removed: 10.2.2] [added: 10.2.5] + | | | [Form of restricted stock [added: unit] award agreement and related notice of grant for use in connection with the grant of restricted stock [removed: awards] [added: units] to the Registrant's [removed: executive officers] [added: non-employee directors] under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2017,] [added: 2018,] filed February [removed: 8, 2018.)](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10215xar2014ltiprs.htm)] [added: 7, 2019.)](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10221xar2014ltiprs.htm)] | | |

| [removed: 10.2.3] [added: 10.2.4] + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.] [added: Plan (revised 2018).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2017,] [added: 2018,] filed February [removed: 8, 2018.)](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10216xar2014ltipnq.htm)] [added: 7, 2019.)](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10220xar2014ltipnq.htm)] | | |

| [removed: 10.2.4] [added: 10.2.7] + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's [removed: executive officers] [added: non-employee directors] under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2018).] [added: 2019).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2018,] [added: 2019,] filed February 7, [removed: 2019.)](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10217xstockoptiona.htm)] [added: 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm)] | | |

| [removed: 10.2.5] [added: 10.2.8] + | | | [Form of restricted stock [added: unit] award agreement and related notice of grant for use in connection with the grant of restricted stock [removed: awards] [added: units] to the Registrant's [removed: executive officers] [added: non-employee directors] under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2018).] [added: 2019).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2018,] [added: 2019,] filed February 7, [removed: 2019.)](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10219xar2014ltiprs.htm)] [added: 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10221ar2014ltip.htm)] | | |

| [removed: 10.2.6] [added: 10.3.8] + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's [removed: non-employee directors] [added: executive officers] under the [added: Second] Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2018). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, 2019.)](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10220xar2014ltipnq.htm)] [added: 202](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_1038x12312025x10xk.htm)[5](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_1038x12312025x10xk.htm)[).](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_1038x12312025x10xk.htm)] | | |

| [removed: 10.2.7] [added: 10.3.10] + | | | [Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to the Registrant's non-employee directors under the [added: Second] Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. [removed: (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, 2019.)](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10221xar2014ltiprs.htm)] [added: (](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_10310x12312025x10xk.htm)[revised 2025).](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_10310x12312025x10xk.htm)] | | |

| 10.8.1 | | | [Restated Amendment Agreement, dated December 30, 2014 and entered into effective as of May 7, 2012, by and between Bayer HealthCare LLC and the [removed: Registrant.](https://www.sec.gov/Archives/edgar/data/872589/000180422025000011/regn-ex_1081x12312024x10k.htm)] [added: Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2024, filed February 5, 2025.)](https://www.sec.gov/Archives/edgar/data/872589/000180422025000011/regn-ex_1081x12312024x10k.htm)] | | |

| 10.9.2* | | | [Amendment No. 2 to Amended and Restated License and Collaboration Agreement, dated July 27, 2015 and entered into effective as of July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS, as successor-in-interest to Aventis Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended [removed: September] [added: June] 30, [removed: 2015,] [added: 2025,] filed [removed: November 4, 2015.)](https://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_104x09302015x10q.htm)] [added: August 1, 2025.)](https://www.sec.gov/Archives/edgar/data/872589/000087258925000019/regn-ex_101x06302025.htm)] | | |

| 10.18.1 | | | [Form of Co-Co Collaboration Agreement (Exhibit B to Master Agreement contained in Exhibit [removed: 10.1](https://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1041.htm)[8](https://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1041.htm)[).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1041.htm)] [added: 10.18).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1041.htm)] | | |

| 10.18.2 | | | [Form of License Agreement (Exhibit C to Master Agreement contained in Exhibit [removed: 10.1](https://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1042.htm)[8](https://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1042.htm)[).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1042.htm)] [added: 10.18).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1042.htm)] | | |

| 10.18.4 | | | [Amendment No. 2 to Master Agreement, dated as of March 7, 2024, by and [removed: between](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm) [the](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm) [Registrant](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm) [and] [added: between the Registrant and] Alnylam Pharmaceuticals, [removed: Inc.](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm) [](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm)[(Incorporated] [added: Inc. (Incorporated] by reference from the Form 10-Q for the Registrant, for the quarter [removed: ended](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm) [March](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm) [3](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm)[1](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm)[, 202](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm)[4](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm)[, filed](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm) [May](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm) [](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm)[2](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm)[, 202](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm)[4](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm)[.)](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm)] [added: ended March 31, 2024, filed May 2, 2024.)](https://www.sec.gov/Archives/edgar/data/872589/000180422024000017/regn-ex_101x03312024x10q.htm)] | | |

| 10.18.5 | | | [Amendment No. 3 to Master Agreement, dated as of August 1, 2024, by and [removed: between](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm) [the R](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm)[egistrant](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm) [and] [added: between the Registrant and] Alnylam Pharmaceuticals, [removed: Inc.](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm) [](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm)[(Incorporated] [added: Inc. (Incorporated] by reference from the Form 10-Q for the Registrant, for the quarter [removed: ended](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm) [September](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm) [30, 202](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm)[4](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm)[, filed](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm) [Octob](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm)[er](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm) [3](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm)[1](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm)[, 202](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm)[4](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm)[.)](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm)] [added: ended September 30, 2024, filed October 31, 2024.)](https://www.sec.gov/Archives/edgar/data/872589/000180422024000040/regn-ex_101x9302024x10q.htm)] | | |

| 19.1 | | | [removed: [I](https://www.sec.gov/Archives/edgar/data/872589/000180422025000011/regn-ex_191x12312024x10k.htm)[nsider] [added: [Insider] Trading [removed: Policy.](https://www.sec.gov/Archives/edgar/data/872589/000180422025000011/regn-ex_191x12312024x10k.htm)] [added: Policy. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2024, filed February 5, 2025.)](https://www.sec.gov/Archives/edgar/data/872589/000180422025000011/regn-ex_191x12312024x10k.htm)] | | |

| 21.1 | | | [Subsidiaries of the [removed: Registrant.](https://www.sec.gov/Archives/edgar/data/872589/000180422025000011/regn-ex_211x12312024x10k.htm)] [added: Registrant.](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_211x12312025x10k.htm)] | | |

| 23.1 | | | [Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting [removed: Firm.](https://www.sec.gov/Archives/edgar/data/872589/000180422025000011/regn-ex_231x12312024x10k.htm)] [added: Firm.](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_231x12312025x10k.htm)] | | |

| 24.1 | | | [Power of Attorney (included on the signature page of this Annual Report on Form [removed: 10-K).](#i66ff2c03559b4ab89799d79d457200d6_100)] [added: 10-K).](#idc5efe1995944548a7c87f6108cd53a5_100)] | | |

| 31.1 | | | [Certification of Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000180422025000011/regn-ex_311x12312024x10k.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_311x12312025x10k.htm)] | | |

| 31.2 | | | [Certification of Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000180422025000011/regn-ex_312x12312024x10k.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_312x12312025x10k.htm)] | | |

| 32 | | | [Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section [removed: 1350.](https://www.sec.gov/Archives/edgar/data/872589/000180422025000011/regn-ex_32x12312024x10k.htm)] [added: 1350.](https://www.sec.gov/Archives/edgar/data/872589/000087258926000008/regn-ex_32x12312025x10k.htm)] | | |

| 97.1 | | | [Clawback [removed: Policy.](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_971x12312023x10k.htm) [](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_971x12312023x10k.htm)[(Incorporated] [added: Policy. (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, 2023, filed February 5, 2024.)](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_971x12312023x10k.htm) | | |

| 101 | | | Interactive Data Files pursuant to Rule 405 of Regulation S-T formatted in Inline Extensible Business Reporting Language ("Inline XBRL"): (i) the Registrant's Consolidated Balance Sheets as of December 31, [removed: 2024] [added: 2025] and [removed: 2023;] [added: 2024;] (ii) the Registrant's Consolidated Statements of Operations and Comprehensive Income for the years ended December 31, [added: 2025,] 2024, [removed: 2023,] and [removed: 2022;] [added: 2023;] (iii) the Registrant's Consolidated Statements of Stockholders’ Equity for the years ended December 31, [added: 2025,] 2024, [removed: 2023,] and [removed: 2022;] [added: 2023;] (iv) the Registrant's Consolidated Statements of Cash Flows for the years ended December 31, [added: 2025,] 2024, [removed: 2023,] and [removed: 2022;] [added: 2023;] and (v) the notes to the Registrant's Consolidated Financial Statements. | | |

| * | | | Portions of this document have been omitted and filed separately with the SEC pursuant to requests for confidential treatment pursuant to Rule [removed: 24b-2.] [added: 24b-2] | | |

| + | | | Indicates a management contract or compensatory plan or [removed: arrangement.] [added: arrangement] | | |

| | | | | | |

| 10.2.8 + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2019). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm) | | |

| 10.2.9 + | | | [Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2019). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10219ar2014ltip.htm) | | |

| 10.2.10 + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2019). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm) | | |

| 10.2.11 + | | | [Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2019). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10221ar2014ltip.htm) | | |

| Date: | | | February [removed: 5, 2025] [added: 4, 2026] | | | | | | By: | | | /s/ LEONARD S. SCHLEIFER | | | | | |

| /s/ LEONARD S. SCHLEIFER | | | | | | *Board co-Chair, President and Chief Executive Officer (Principal Executive Officer)* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ CHRISTOPHER FENIMORE | | | | | | *Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer)* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ JASON PITOFSKY | | | | | | [removed: *Vice] [added: *Senior Vice] President, Controller (Principal Accounting Officer)* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ GEORGE D. YANCOPOULOS | | | | | | *Board co-Chair, President and Chief Scientific Officer* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ BONNIE L. BASSLER | | | | | | *Director* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ MICHAEL S. BROWN | | | | | | *Director* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ N. ANTHONY COLES | | | | | | *Director* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ JOSEPH L. GOLDSTEIN | | | | | | *Director* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ KATHRYN GUARINI | | | | | | *Director* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ CHRISTINE A. POON | | | | | | *Director* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ ARTHUR F. RYAN | | | | | | *Director* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ DAVID P. SCHENKEIN | | | | | | *Director* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ GEORGE L. SING | | | | | | *Director* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ CRAIG B. THOMPSON | | | | | | *Director* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| /s/ HUDA Y. ZOGHBI | | | | | | *Director* | | | | | | February [removed: 5, 2025] [added: 4, 2026] | | |

| [Report of Independent Registered Public Accounting Firm (PCAOB [removed: ID](#i66ff2c03559b4ab89799d79d457200d6_106) 238[)](#i66ff2c03559b4ab89799d79d457200d6_106)] [added: ID](#idc5efe1995944548a7c87f6108cd53a5_106) 238[)](#idc5efe1995944548a7c87f6108cd53a5_106)] | | | | | | [removed: [F-](#i66ff2c03559b4ab89799d79d457200d6_106)[2](#i66ff2c03559b4ab89799d79d457200d6_106)] [added: [F-](#idc5efe1995944548a7c87f6108cd53a5_106)[2](#idc5efe1995944548a7c87f6108cd53a5_106)] | | |

| [Consolidated Balance Sheets as of December 31, [removed: 202](#i66ff2c03559b4ab89799d79d457200d6_109)[4](#i66ff2c03559b4ab89799d79d457200d6_109) [and 202](#i66ff2c03559b4ab89799d79d457200d6_109)[3](#i66ff2c03559b4ab89799d79d457200d6_109)] [added: 2025 and 2024](#idc5efe1995944548a7c87f6108cd53a5_109)] | | | | | | [removed: [F-](#i66ff2c03559b4ab89799d79d457200d6_109)[4](#i66ff2c03559b4ab89799d79d457200d6_109)] [added: [F-](#idc5efe1995944548a7c87f6108cd53a5_109)[4](#idc5efe1995944548a7c87f6108cd53a5_109)] | | |

| [Consolidated Statements of Operations and Comprehensive Income for the Years Ended December 31, [removed: 202](#i66ff2c03559b4ab89799d79d457200d6_112)[4](#i66ff2c03559b4ab89799d79d457200d6_112)[, 202](#i66ff2c03559b4ab89799d79d457200d6_112)[3](#i66ff2c03559b4ab89799d79d457200d6_112)[,] [added: 2025, 2024,] and [removed: 202](#i66ff2c03559b4ab89799d79d457200d6_112)[2](#i66ff2c03559b4ab89799d79d457200d6_112)] [added: 2023](#idc5efe1995944548a7c87f6108cd53a5_112)] | | | | | | [removed: [F-](#i66ff2c03559b4ab89799d79d457200d6_112)[5](#i66ff2c03559b4ab89799d79d457200d6_112)] [added: [F-](#idc5efe1995944548a7c87f6108cd53a5_112)[5](#idc5efe1995944548a7c87f6108cd53a5_112)] | | |

| [Consolidated Statements of Stockholders' Equity for the Years Ended December 31, [removed: 202](#i66ff2c03559b4ab89799d79d457200d6_115)[4](#i66ff2c03559b4ab89799d79d457200d6_115)[, 202](#i66ff2c03559b4ab89799d79d457200d6_115)[3](#i66ff2c03559b4ab89799d79d457200d6_115)[,] [added: 2025, 2024,] and [removed: 202](#i66ff2c03559b4ab89799d79d457200d6_115)[2](#i66ff2c03559b4ab89799d79d457200d6_115)] [added: 2023](#idc5efe1995944548a7c87f6108cd53a5_115)] | | | | | | [removed: [F-](#i66ff2c03559b4ab89799d79d457200d6_115)[6](#i66ff2c03559b4ab89799d79d457200d6_115)] [added: [F-](#idc5efe1995944548a7c87f6108cd53a5_115)[6](#idc5efe1995944548a7c87f6108cd53a5_115)] | | |

| [Consolidated Statements of Cash Flows for the Years Ended December 31, [removed: 202](#i66ff2c03559b4ab89799d79d457200d6_118)[4](#i66ff2c03559b4ab89799d79d457200d6_118)[, 202](#i66ff2c03559b4ab89799d79d457200d6_118)[3](#i66ff2c03559b4ab89799d79d457200d6_118)[,] [added: 2025, 2024,] and [removed: 202](#i66ff2c03559b4ab89799d79d457200d6_118)[2](#i66ff2c03559b4ab89799d79d457200d6_118)] [added: 2023](#idc5efe1995944548a7c87f6108cd53a5_118)] | | | | | | [removed: [F-](#i66ff2c03559b4ab89799d79d457200d6_118)[8](#i66ff2c03559b4ab89799d79d457200d6_118)] [added: [F-](#idc5efe1995944548a7c87f6108cd53a5_118)[8](#idc5efe1995944548a7c87f6108cd53a5_118)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i66ff2c03559b4ab89799d79d457200d6_121)] [added: Statements](#idc5efe1995944548a7c87f6108cd53a5_121)] | | | | | | [removed: [F-](#i66ff2c03559b4ab89799d79d457200d6_121)[9](#i66ff2c03559b4ab89799d79d457200d6_121)] [added: [F-](#idc5efe1995944548a7c87f6108cd53a5_121)[9](#idc5efe1995944548a7c87f6108cd53a5_121)] to [removed: [F-](#i66ff2c03559b4ab89799d79d457200d6_175)[41](#i66ff2c03559b4ab89799d79d457200d6_175)] [added: [F-39](#idc5efe1995944548a7c87f6108cd53a5_1543)] | | |

We have audited the accompanying consolidated balance sheets of Regeneron Pharmaceuticals, Inc. and its subsidiaries (the "Company") as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] and the related consolidated statements of operations and comprehensive income, of stockholders' equity and of cash flows for each of the three years in the period ended December 31, [removed: 2024,] [added: 2025,] including the related notes (collectively referred to as the "consolidated financial statements").

We also have audited the Company's internal control over financial reporting as of December 31, [removed: 2024,] [added: 2025,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2024] [added: 2025] and [removed: 2023,] [added: 2024,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2024] [added: 2025] in conformity with accounting principles generally accepted in the United States of America.

Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2024,] [added: 2025,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

As described in Notes 1 and 15 to the consolidated financial statements, the Company's reserves for uncertain tax positions were [removed: $1,313.7] [added: $1,577.9] million as of December 31, [removed: 2024.][added: 2025.]

Management re-evaluates uncertain tax positions and considers various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, [added: the effective settlement of matters subject to audit, information obtained during in-process audit activities,] and changes in facts or circumstances related to a tax position.

| | | | [added: | | | 2025 | | | | | |] 2024 | | | | | | 2023 | | |

| Cash and cash equivalents | | | [added: | | |] $ | [added: 3,118.1 | | | | | $ |] 2,488.2 | | | | | $ | 2,730.0 | |

| Marketable securities | | | [removed: 6,524.3] [added: 5,487.1] | | | | | | [removed: 8,114.8] [added: 6,524.3] | | |

| Accounts receivable, net | | | [removed: 6,211.9] [added: 5,741.1] | | | | | | [removed: 5,667.3] [added: 6,211.9] | | |

| Inventories | | | [removed: 3,087.3] [added: 3,200.8] | | | | | | [removed: 2,580.5] [added: 3,087.3] | | |

| Prepaid expenses and other current assets | | | [removed: 349.2] [added: 474.8] | | | | | | [removed: 386.6] [added: 349.2] | | |

| Total current assets | | | [removed: 18,660.9] [added: 18,021.9] | | | | | | [removed: 19,479.2] [added: 18,660.9] | | |

| Marketable securities | | | [removed: 8,900.1] [added: 10,260.6] | | | | | | [removed: 5,396.5] [added: 8,900.1] | | |

| Property, plant, and equipment, net | | | [removed: 4,599.7] [added: 5,120.4] | | | | | | [removed: 4,146.4] [added: 4,599.7] | | |

| Intangible assets, net | | | [removed: 1,148.6] [added: 1,257.4] | | | | | | [removed: 1,038.6] [added: 1,148.6] | | |

| Deferred tax assets | | | [removed: 3,314.1] [added: 4,077.2] | | | | | | [removed: 2,575.4] [added: 3,314.1] | | |

| Other noncurrent assets | | | [removed: 1,136.0] [added: 1,821.2] | | | | | | [removed: 444.1] [added: 1,136.0] | | |

February 4, 2026

| Net income | | | | | | $ | 4,504.9 | | | | | $ | 4,412.6 | | | | | $ | 3,953.6 | |

| Dividends declared | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | 4.1 | | | | | | (380.7) | | | | | | — | | | | | | — | | | | | | — | | | | | | (376.6) | | |

| Balance, December 31, 2025 | | | | | | 1.8 | | | | | | $ | — | | | | | 137.6 | | | | | | $ | 0.1 | | | | | $ | 13,995.0 | | | | | $ | 35,797.1 | | | | | $ | 77.5 | | | | | (33.7) | | | | | | $ | (18,612.8) | | | | | $ | 31,256.9 | |

| Net income | | | | | | $ | 4,504.9 | | | | | $ | 4,412.6 | | | | | $ | 3,953.6 | |

| Other, net | | | | | | 135.5 | | | | | | 36.1 | | | | | | (0.1) | | |

| Dividends paid | | | | | | (370.3) | | | | | | — | | | | | | — | | |

In addition, receivables from customers (see Note 2) and collaborators (see Note 3) may subject the Company to credit risk.

Amounts allocated to acquired in-process research and

Outside the United States, the Company's rebates are generally contractual or legislatively mandated.

Codification ("ASC") 730-20, *Research and Development*.

| ASU 2025-06: In September 2025, the FASB issued new guidance to modernize the accounting for software costs by updating the criteria as to when entities are required to start capitalizing internal-use software (by removing all references to software development "projects stages"). | | | | | | January 1, 2028 | | | | | | Early adopted January 1, 2026; no significant impact expected | | |

| Other products | | | Global | | | | | | 10.1 | | | | | | — | | | | | | — | | |

| Customer A | | | 50 | | % | | | | 50 | | % | | | | 51 | | % |

| Customer B | | | 27 | | % | | | | 24 | | % | | | | 25 | | % |

| Provisions | | | 2,751.7 | | | | | | 421.1 | | | | | | 119.7 | | | | | | 3,292.5 | | |

| Credits/payments | | | (2,659.2) | | | | | | (400.7) | | | | | | (122.2) | | | | | | (3,182.1) | | |

| Balance as of December 31, 2025 | | | $ | 631.6 | | | | | $ | 148.2 | | | | | $ | 91.0 | | | | | $ | 870.8 | |

The Company supplies certain commercial bulk product to Sanofi.

| *(In millions)* | | | | | | 2025 | | | | | | 2024 | | |

The parties generally share equally agreed-upon development expenses as incurred.

| *(In millions)* | | | | | | 2025 | | | | | | 2024 | | |

In January 2026, the Company's collaboration agreement with Tessera Therapeutics, Inc. to develop and commercialize TSRA-196 (Tessera's investigational program for the treatment of alpha-1 antitrypsin deficiency ("AATD")) became effective.

Under the terms of the agreement, the Company made aggregate payments of $150.0 million in January 2026, consisting of an up-front payment and the purchase of Tessera preferred stock.

The portion related to the up-front payment will be recorded to Acquired IPR&D expense in the first quarter of 2026.

*Acquired IPR&D Expenses*

During the year ended December 31, 2025, the Company recorded to Acquired IPR&D expense an $80.0 million up-front payment in connection with its license agreement with Hansoh Pharmaceuticals Group Company Limited to acquire development and commercial rights outside mainland China, Hong Kong, and Macau for HS-20094 (a dual GLP-1/GIP receptor agonist currently in Phase 3 clinical development in China).

| Corporate bonds | | | | | | $ | 10,141.0 | | | | | $ | 80.9 | | | | | $ | (2.4) | | | | | $ | 10,219.5 | |

| Commercial paper | | | | | | 540.8 | | | | | | 0.3 | | | | | | — | | | | | | 541.1 | | |

| Certificates of deposit | | | | | | 265.7 | | | | | | 0.2 | | | | | | — | | | | | | 265.9 | | |

| Asset-backed securities | | | | | | 241.4 | | | | | | 1.4 | | | | | | — | | | | | | 242.8 | | |

| Sovereign bonds | | | | | | 76.3 | | | | | | 0.5 | | | | | | — | | | | | | 76.8 | | |

| | | | | | | $ | 15,617.4 | | | | | $ | 98.5 | | | | | $ | (2.5) | | | | | $ | 15,713.4 | |

| As of December 31, 2024 | | | | | | | | | | | | | | | | | | | | | | | | | | |

| *(In millions)* | | | | | | 2025 | | | | | | 2024 | | |

| | | | | | | $ | 15,713.4 | | | | | $ | 14,329.1 | |