Regeneron Pharmaceuticals (REGN) 10-K risk factor changes: FY2024 vs FY2023

[Table [removed: of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)][added: of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)]

- Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, [added: have in the past reduced and] could reduce [added: in] the [added: future the] duration of market exclusivity for our [removed: products, including EYLEA and EYLEA HD.][added: products.]

- Expanding our manufacturing capacity and establishing fill/finish capabilities [added: has been and] will [added: continue to] be costly and we may be unsuccessful in doing so in a timely manner, which could delay or prevent the launch and successful commercialization of our products approved for marketing and could jeopardize our clinical development programs.

- Changes in [removed: laws] [added: laws, regulations,] and [removed: regulations] [added: policies] affecting the healthcare industry could adversely affect our business.

We are substantially dependent on the success of [removed: our ophthalmology portfolio, which consists of] EYLEA and, since its August 2023 FDA approval, EYLEA HD.

For the years ended December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] our aggregate EYLEA HD and EYLEA net product sales in the United States represented [removed: 45%] [added: 42%] and [removed: 51%] [added: 45%] of our total revenues, respectively.

For the year ended December 31, [removed: 2023, aggregate EYLEA HD U.S. and] [added: 2024,] EYLEA U.S. net product sales [removed: decreased] [added: declined] by [removed: 6%,] [added: 17%] compared to the same period in [removed: 2022.][added: 2023.]

If we [removed: were to] experience difficulty with the commercialization of EYLEA HD or EYLEA in the United States or if [added: Bayer experiences any difficulty with the]

[removed: Bayer were to experience any difficulty with the] commercialization of EYLEA HD or EYLEA outside the United States, if EYLEA net product sales experience a sustained decline in or outside the United States without an offset from EYLEA HD net product sales, 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.

[removed: In] [added: As an EYLEA biosimilar has been launched in] the United [removed: States,] [added: States following] the [added: expiration of the U.S.] regulatory exclusivity period for EYLEA (i.e., the period during which no biosimilar product [removed: can] [added: could] be approved by the FDA) [removed: will expire after] [added: in] May [removed: 17, 2024.][added: 2024, EYLEA no longer has U.S. market exclusivity.]

[removed: See "Risks Related to Intellectual Property and Market Exclusivity - *Loss] [added: Loss] or limitation of patent rights, and regulatory pathways for biosimilar competition, [added: have in the past reduced and] could reduce [added: in] the [added: future the] duration of market exclusivity for our [removed: products*" below.][added: products.]

[removed: As a result, we face the risk of lower] EYLEA [added: and/or EYLEA HD] net product sales [removed: due] [added: recorded by us are likely] to [added: be negatively impacted by] biosimilar competition [removed: following such expiration,] [added: in the United States,] which may have a material adverse impact on our results of operations.

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

[removed: In addition, we] [added: We also] are substantially dependent on our share of profits from the commercialization of Dupixent under our Antibody Collaboration with Sanofi.

- the effect of existing and new [removed: health care] [added: healthcare] laws and regulations currently being considered or implemented in the United States and globally, including measures requiring the U.S. government in the future to negotiate the prices of certain drugs and price reporting and other disclosure requirements and the potential impact of such requirements on physician prescribing practices and payor coverage;

- 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 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 [removed: 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;][added: of*]

- the outcome of the pending proceedings relating to EYLEA [removed: and REGEN-COV] (described further in Note 16 to our Consolidated Financial Statements included in this report), as well as other risks relating to our marketed products and product candidates associated with intellectual property of other parties and pending or future litigation relating thereto (as discussed under "Risks Related to Intellectual Property and Market Exclusivity" below);

- the outcome of the pending government proceedings and investigations and other matters described in Note 16 to our Consolidated Financial Statements included in this report (including the civil [removed: complaint filed against us on June 24, 2020 in] [added: proceedings initiated or joined by] the U.S. [removed: District Court for the District] [added: Department] of [removed: Massachusetts by] [added: Justice and] the U.S. Attorney's Office for the District of Massachusetts); and

We and our collaborators are subject to significant ongoing regulatory obligations and oversight with respect to the products we or they commercialize for the products' currently approved indications in the United States, EU, Japan, and other [removed: countries where such products are approved.][added: countries.]

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 [removed: associated with the research, development, production, supply, and regulatory review of such products.]

Given cost sensitivities in many [removed: health care] [added: healthcare] systems, our currently marketed products and product candidates are likely to be subject to continued pricing pressures, which may have an adverse impact on our business, prospects, operating results, and financial condition.

In addition, in order for private insurance and governmental payors (such as Medicare and Medicaid in the United States) to reimburse the cost of our marketed products, we must maintain, among other things, our FDA registration and our National Drug [added: Code, formulary approval by PBMs, and recognition by insurance companies and CMS.]

As discussed below under "*If we are unable to establish [added: sufficient] commercial capabilities outside the United States for [removed: Libtayo, Dupixent, and any other] products we intend to commercialize or co-commercialize outside the United States, our business, prospects, operating results, and financial condition may be adversely affected,*" we will need to manage these and other commercialization-related risks in order for us to successfully [added: maintain and/or further] develop [added: sufficient] commercial capabilities outside the United States (including those necessary for our successful commercialization and co-commercialization of Libtayo and Dupixent, respectively).

[removed: Some states have also enacted or are considering legislation to control the prices and reimbursement of prescription drugs, and] [added: Additionally,] state Medicaid programs are increasingly requesting manufacturers to pay supplemental rebates and requiring prior authorization by the state program for use of any prescription drug for which supplemental rebates are not being paid.

It is likely that federal and state legislatures and health agencies will continue to focus on additional [removed: health care] [added: healthcare] reform measures in the future that will impose additional constraints on prices and reimbursements for our marketed products.

Notably, in 2022 the U.S. Congress passed the [removed: IRA,] [added: Inflation Reduction Act ("IRA"),] which includes, among other items, provisions regarding the following:

The IRA includes measures requiring manufacturers to pay rebates where [added: increases to] the average sales price or average manufacturer price of drugs covered under Medicare Parts B and D, respectively, [removed: exceeds] [added: exceed] the rate of inflation.

[removed: While enacted into law, it is currently unclear the] [added: The] extent to which the policy changes [added: described above] will ultimately impact reimbursement levels of our marketed products, including those covered under Medicare Part B (such as EYLEA and EYLEA [removed: HD)] [added: HD),] or our product candidates that may be covered under Medicare Part B or Medicare Part D in the [removed: future.][added: future, is currently unclear.]

[removed: There is] [added: We face] substantial competition [removed: in the biotechnology and pharmaceutical industries] from [removed: biotechnology, pharmaceutical,] [added: pharmaceutical] and [removed: chemical] [added: biotechnology] companies.

Many of our competitors have substantially greater research, preclinical and clinical product [removed: development] [added: development,] and manufacturing capabilities, as well as financial, marketing, and human resources, than we do.

These include Genentech/Roche's Vabysmo® (faricimab-svoa) and Susvimo® (ranibizumab ocular implant); Novartis and Genentech/Roche's Lucentis® (ranibizumab); Novartis' Beovu® (brolucizumab); [added: and] biosimilar versions of Lucentis commercialized in the United States by Biogen Inc. and [removed: Coherus BioSciences, Inc.; and Biocon Biologics Ltd's biosimilar version of EYLEA recently approved in the EU.][added: Sandoz Group AG.]

Ophthalmologists are also using off-label, third-party repackaged versions of Genentech/Roche's approved VEGF antagonist, bevacizumab, for the treatment of certain of EYLEA's and EYLEA HD's respective indications, and we are aware of another company developing an ophthalmic formulation of such [removed: product.][added: product that has been approved in the EU.]

In addition, we are aware of several other companies developing biosimilar versions of [added: EYLEA,] EYLEA [removed: and] [added: HD, and/or] other approved anti-VEGF treatments.

EYLEA HD was approved by the FDA in August 2023 for the treatment of wAMD, DME, and [removed: DR. As a newly approved product, EYLEA HD has] [added: DR and] entered the highly competitive environment described above.

Our success in commercializing EYLEA HD will depend on a number of factors, including the degree of success and relative timing of our commercial launch and uptake efforts as compared to those of relevant competition, the extent to which we and our collaborators are able to differentiate EYLEA HD from competitive [removed: products,] [added: products (such as on] the [added: basis of dosing frequency, the method of administration, or the breadth of indications in which the product is approved), the] safety and efficacy of EYLEA HD seen in a broader patient group (i.e., real-world use), the extent of payor coverage and reimbursement, and the applicability of any restrictions imposed by payors, such as step therapy.

In atopic dermatitis, there are [removed: topical and] systemic JAK inhibitors and antibodies against IL-13 [added: and IL-4Ra] approved [added: or in development] for atopic dermatitis.

In addition, a number of companies are developing antibodies against [removed: IL-4Ra, IL-13Ra1,] [added: other targets, including] OX40(L), [removed: and/or IL-31R] that may compete with Dupixent in atopic dermatitis and other indications (including asthma and/or prurigo [removed: nodularis), as applicable.][added: nodularis).]

In asthma, competitors to Dupixent include antibodies against the IL-5 ligand or the IL-5 receptor, immunoglobulin E, or thymic stromal lymphopoietin [added: ("TSLP"); and some of these antibodies are either approved or in development for indications that also compete or may compete in the future with Dupixent in CRSwNP, EoE, and COPD.]

There are several other potentially competitive products in development that may compete with Dupixent in asthma, [removed: as well as] [added: COPD, and] potential future indications, including antibodies against the IL-33 [removed: ligand.][added: ligand or receptor.]

Dupixent also faces competition from inhaled products in [removed: asthma] [added: asthma, COPD,] and potential future indications.

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For the year ended December 31, 2024, EYLEA HD U.S. net product sales represented 20% of our aggregate EYLEA HD and EYLEA U.S. net product sales.

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

Commercialization of EYLEA and EYLEA 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.

In addition, we expect that competition for EYLEA outside the United States will increase in the future when 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.

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.

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

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

*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;

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

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

In addition, in many countries outside the United States, we or our collaborators must participate in a tender process for public procurement of our products, and any failure to obtain acceptable pricing in the tender process could adversely affect our business.

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

In addition, many payors continue to adopt benefit plan changes that shift a greater portion of prescription costs to patients, including more limited benefit plan designs, higher patient co-pay or co-insurance obligations, and limitations on patients' use of commercial manufacturer co-pay payment assistance programs (including through co-pay accumulator adjustment or maximization programs).

Some states have also enacted or are considering legislation to control the prices and reimbursement of prescription drugs, including by establishing Prescription Drug Affordability Boards (or similar entities) to review high-cost drugs, setting upper payment limits, and/or implementing marketing cost disclosure and transparency measures.

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

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.

We expect that biosimilar competition for EYLEA will increase in the future when additional biosimilar versions of EYLEA are launched in the United States and other countries, the timing of which will depend on, among other factors, the outcome of the pending patent litigation proceedings described in Note 16 to our Consolidated Financial Statements and the expiration of the patents protecting EYLEA (including those set forth under Part I - Item 1.

"Business - Patents, Trademarks, and Trade Secrets").

There is also an antibody against IL-31R approved for atopic dermatitis and prurigo nodularis.

While Libtayo is currently approved for intravenous administration only, certain of these products are also approved or in development for subcutaneous use.

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

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

While we evaluate market opportunities for our product candidates, there can be no assurance that our estimates will accurately reflect the market opportunity at the time of launch or that our product candidates will meet internal or external expectations and be successful commercially due to existing or potential future competition or otherwise.

As described in Note 16 to our Consolidated Financial Statements, we have sued Sanofi and certain of its affiliated entities (the "Antibody Collaboration Litigation") alleging that the defendants breached certain provisions of the agreement governing the Antibody Collaboration (the "Collaboration Agreement").

These provisions concern Sanofi's obligation to provide Regeneron with full access to material information relating to the commercialization of Dupixent or other products commercialized pursuant to the Collaboration Agreement and Regeneron's audit rights under the Collaboration Agreement.

It is not possible to determine what impact (if any) the Antibody Collaboration Litigation may have on the Antibody Collaboration and our business relationship with Sanofi, or whether we will be successful in the Antibody Collaboration Litigation.

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

Our marketed products and product candidates are typically delivered either by intravenous infusion or by intravitreal or subcutaneous injections.

Commercialization of any of our marketed products may

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

While we have made progress with establishing commercial capabilities in certain jurisdictions outside the United States in connection with our acquisition of the exclusive right to develop, commercialize, and manufacture Libtayo worldwide pursuant to the 2022 Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi (the "A&R IO LCA") and the exercise of our option under the Antibody Collaboration to co-commercialize Dupixent in certain jurisdictions outside the United States, our commercial capabilities and experience with commercializing products outside the United States (as well as obtaining and/or maintaining regulatory approvals and securing pricing and reimbursement for our products outside the United States) are still somewhat limited.

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

approvable.

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.

For example, in March 2024, the FDA issued CRLs concerning our BLA for odronextamab for the treatment of relapsed/refractory FL and DLBCL due to the enrollment status of confirmatory Phase 3 trials.

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

product.

Code, formulary approval by PBMs, and recognition by insurance companies and CMS.

("TSLP"); and some of these antibodies are either approved or in development for indications that also compete or may compete in the future with Dupixent in CRSwNP and EoE.

*our business, prospects, operating results, and financial condition, and our ability to continue to commercialize EYLEA HD and EYLEA outside the United States would be materially harmed*" below and "Risks Related to Our Reliance on or Transactions with Third Parties - *If our Antibody Collaboration with Sanofi is terminated, or Sanofi materially breaches its obligations thereunder, our business, prospects, operating results, and financial condition, and our ability to develop, manufacture, and commercialize certain of our products and product candidates in the time expected, or at all, may be materially harmed*" below.

these products to healthcare providers.

We have limited commercial capabilities outside the United States and have not yet fully established an organization for the sales, marketing, and distribution of marketed products outside the United States.

We are in the process of establishing these capabilities outside the United States for Libtayo in connection with the 2022 amendment to the IO Collaboration whereby all rights to develop, commercialize, and manufacture Libtayo will be transferred exclusively to our Company, on a worldwide basis, over the course of a defined transition period.

In addition to fully establishing these commercial capabilities by the end of the transition period, we will also need to obtain and/or maintain regulatory approvals and secure pricing and reimbursement for Libtayo in many jurisdictions outside the United States (including Europe and Japan).

Further, following the exercise of our option under the Antibody Collaboration to co-commercialize Dupixent in certain jurisdictions outside the United States, we have established certain co-commercialization capabilities for Dupixent in some of these jurisdictions and are in the process of establishing these capabilities in others.

insert to limitations on who may prescribe or dispense the drug, depending on what the FDA considers necessary for the safe use of the drug.

For example, in 2022, an FDA travel complication related to scheduling a routine clinical trial site inspection in eastern Europe delayed by nearly two months the FDA's approval of our sBLA for the combination treatment of Libtayo with chemotherapy in NSCLC.

For example, in June 2023, the FDA issued a CRL concerning the Company's BLA for EYLEA HD for the treatment of wAMD, DME, and DR due to unresolved observations resulting from an inspection at the contract manufacturing organization Catalent, which resulted in a delay of the FDA approval of EYLEA HD by nearly two months.

resources.

For example, we previously discontinued actively treating patients with fasinumab following a recommendation from the responsible IDMC that the program be terminated based on available evidence at that time; and we later discontinued further clinical development of fasinumab.

("IOI"), sterile and culture positive endophthalmitis, corneal decomposition, retinal detachment, retinal tear, and retinal vasculitis), which can cause injury to the eye and other complications.

For example, we are currently party to patent infringement and other proceedings relating to the EYLEA pre-filled syringe, as described in Note 16 to our Consolidated Financial Statements.

market.

For example, in 2021, anonymous parties initiated opposition proceedings in the European Patent Office ("EPO") against our European Patent No. 2,944,306 (which concerns pre-filled syringes comprising ophthalmic formulations containing VEGF antagonists such as aflibercept for intravitreal administration), as described in Note 16 to our Consolidated Financial Statements included in this report.

Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, could reduce the duration of market exclusivity for our products.

We also rely entirely

Changes of suppliers or

For example, in June 2023, the FDA issued a CRL concerning the Company's BLA for EYLEA HD for the treatment of wAMD, DME, and DR due to unresolved observations resulting from an inspection at a third-party fill/finish provider, the contract manufacturing organization Catalent, which resulted in a delay of the FDA approval of EYLEA HD by nearly two months.

We continue to dedicate significant resources to comply with these requirements and need to be prepared to comply with additional reporting obligations outside the United States.

The final regulation governing the Medicaid Drug Rebate program issued by CMS has increased and will continue to increase our costs and the complexity of compliance, has been and will continue to be time-consuming to implement, and could have a material adverse effect on our results of operations, particularly if CMS challenges the approach we have taken in our implementation of the final regulation.

On November 30, 2022, HRSA issued a notice of proposed rulemaking that proposes several changes to the ADR process; and, following the solicitation of public comments, in October 2023 HRSA submitted a final version of the rule to the White House Office of Management and Budget for review.

Manufacturers must pay refunds to Medicare for single-source drugs or biological products, or biosimilar biological products, reimbursed under Medicare Part B and packaged in single-dose containers or single-use packages for units of discarded drug reimbursed by Medicare Part B in excess of 10 percent of total allowed charges under Medicare Part B for that drug.

Manufacturers that fail to pay refunds could be subject to civil monetary penalties of 125 percent of the refund amount.

Unexpected refunds to the government, and/or response to a government investigation or enforcement

For example, the Organization for Economic Co-operation and Development ("OECD") Global Anti-Base Erosion Model Rules ("Pillar Two") have influenced tax laws in

The GDPR has a wide range of compliance obligations, including increased consent and transparency requirements and data subject rights.

Violations of the GDPR carry significant financial penalties for noncompliance (including possible fines of up to 4% of global annual turnover for the preceding financial year or €20 million (whichever is higher)).

In addition to the GDPR, certain EU Member States have issued or will be issuing their own implementation legislation.

In June 2021, the EC introduced new standard contractual clauses required to be incorporated into certain new and existing agreements within prescribed timeframes in order to continue to lawfully transfer personal data outside the EU.

Many of the countries that have comprehensive data privacy laws have modeled their requirements after the GDPR.

Compliance with these requirements has been and is expected to continue to be costly and time consuming.

This complexity has resulted in increased liability in the management of clinical trial data, as well as additional compliance, contractual, and due-diligence obligations that could lead to a delay in clinical trial site start-up.

There also has been an increase of enforcement activities in various EU countries that require evidence of compliance with local data privacy requirements.

While we continue to monitor these developments, there remains some uncertainty surrounding the legal and regulatory environment for these evolving privacy and data protection laws.

Complying with varying jurisdictional requirements could increase the costs and complexity of compliance, including the risk of substantial financial penalties for insufficient notice and consent, failure to respond to data subject rights requests, lack of a legal basis for the transfer of personal information out of the EU or other countries with localization laws (i.e., laws mandating that personal data collected in a foreign country be processed and stored within that country), or improper processing of personal data.

Failure by our collaborators to comply with the strict rules on the transfer of personal data into the U.S. could result in the imposition of criminal and administrative sanctions on such collaborators or impact the flow of personal data, which could adversely affect our business.

For example, as part of our human genetics initiative, our wholly-owned subsidiary, Regeneron Genetics Center LLC, has entered into collaborations with many research institutions, which are subject to HIPAA.

Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2022] [added: 2023] (filed with the SEC on February [removed: 6, 2023)] [added: 5, 2024)] for additional discussion of our financial condition and results of operations for the year ended December 31, [removed: 2021,] [added: 2022,] as well as our financial condition and results of operations for the year ended December 31, [removed: 2022] [added: 2023] compared to the year ended December 31, [removed: 2021.*][added: 2022.*]

Our research and development efforts have led to [removed: eleven FDA-approved] [added: numerous approved] products that have received marketing approval and approximately [removed: 35] [added: 40] product candidates in clinical [removed: development, almost all] [added: development (including a number] of [added: marketed products for] which [added: 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 [removed: continued] success in commercializing EYLEA [added: HD, EYLEA,] and [removed: Dupixent, as well as whether we are successful in commercializing EYLEA HD.][added: Dupixent.]

We expect to continue to incur substantial expenses related to our research and development activities, [removed: a portion of] [added: and our research and development activities and related costs] which [removed: we expect to be] [added: are not] reimbursed by [removed: our collaborators.][added: collaborators are expected to expand and require additional resources.]

[removed: We cannot predict] [added: There is uncertainty surrounding] whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such [removed: product(s)] [added: products] and whether or when they may become profitable.

[Table [removed: of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)][added: of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)]

This estimate is [added: reviewed at least annually and] revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.

[removed: In addition, we reassess our] [added: The] forfeiture rate [removed: assumptions at least annually,] [added: estimate is calculated by] considering both historical forfeiture experience and an estimate of [added: expected] future forfeitures for currently outstanding unvested awards.

We capitalize inventory costs associated with our products prior to regulatory approval when, based on management's judgment, future commercialization is considered probable and [removed: the] future economic benefit is expected to be realized; otherwise, such costs are expensed.

We periodically analyze our inventory levels to identify inventory that may expire prior to expected sale or has a cost basis in excess of its estimated realizable [removed: value, and write down such inventories as appropriate.][added: value.]

[removed: In a business combination, contingent] [added: Contingent] consideration obligations are recorded at fair value as of the acquisition date and remeasured each subsequent reporting period until the contingencies have been resolved.

| *(In millions, except per share data)* | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | |

| Revenues | | | $ | [removed: 13,117.2] [added: 14,202.0] | | | | | $ | [removed: 12,172.9] [added: 13,117.2] | | | | | $ | [removed: 16,071.7] [added: 12,172.9] | |

| Operating expenses | | | [removed: 9,070.1] [added: 10,211.3] | | | | | | [removed: 7,434.0] [added: 9,070.1] | | | | | | [removed: 7,124.9] [added: 7,434.0] | | |

| Income from operations | | | [removed: 4,047.1] [added: 3,990.7] | | | | | | [removed: 4,738.9] [added: 4,047.1] | | | | | | [removed: 8,946.8] [added: 4,738.9] | | |

| Other income (expense) | | | [removed: 152.2] [added: 789.2] | | | | | | [removed: 119.9] [added: 152.2] | | | | | | [removed: 379.0] [added: 119.9] | | |

| Income before income taxes | | | [removed: 4,199.3] [added: 4,779.9] | | | | | | [removed: 4,858.8] [added: 4,199.3] | | | | | | [removed: 9,325.8] [added: 4,858.8] | | |

| Income tax expense | | | [removed: 245.7] [added: 367.3] | | | | | | [removed: 520.4] [added: 245.7] | | | | | | [removed: 1,250.5] [added: 520.4] | | |

| Net income | | | $ | [removed: 3,953.6] [added: 4,412.6] | | | | | $ | [removed: 4,338.4] [added: 3,953.6] | | | | | $ | [removed: 8,075.3] [added: 4,338.4] | |

| Net income per share - diluted | | | $ | [removed: 34.77] [added: 38.34] | | | | | $ | [removed: 38.22] [added: 34.77] | | | | | $ | [removed: 71.97] [added: 38.22] | |

| *(In millions)* | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2023] [added: 2024] vs. [removed: 2022] [added: 2023] | | | | | | [removed: 2022] [added: 2023] vs. [removed: 2021] [added: 2022] | | |

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

| EYLEA - U.S. | | | [removed: 5,719.6] [added: 4,767.1] | | | | | | [removed: 6,264.6] [added: 5,719.6] | | | | | | [removed: 5,792.3] [added: 6,264.6] | | | | | | [removed: (545.0)] [added: (952.5)] | | | | | | [removed: 472.3] [added: (545.0)] | | |

| Total EYLEA HD and EYLEA - U.S. | | | [removed: 5,885.4] [added: 5,968.2] | | | | | | [removed: 6,264.6] [added: 5,885.4] | | | | | | [removed: 5,792.3] [added: 6,264.6] | | | | | | [removed: (379.2)] [added: 82.8] | | | | | | [removed: 472.3] [added: (379.2)] | | |

| Libtayo - U.S. | | | [removed: 538.8] [added: 787.3] | | | | | | [removed: 374.5] [added: 538.8] | | | | | | [removed: 306.3] [added: 374.5] | | | | | | [removed: 164.3] [added: 248.5] | | | | | | [removed: 68.2] [added: 164.3] | | |

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

| Total Libtayo - Global | | | [removed: 863.1] [added: 1,216.8] | | | | | | [removed: 447.5] [added: 863.1] | | | | | | [removed: 306.3] [added: 447.5] | | | | | | [removed: 415.6] [added: 353.7] | | | | | | [removed: 141.2] [added: 415.6] | | |

| Praluent - U.S. | | | [removed: 182.4] [added: 241.7] | | | | | | [removed: 130.0] [added: 182.4] | | | | | | [removed: 170.0] [added: 130.0] | | | | | | [removed: 52.4] [added: 59.3] | | | | | | [removed: (40.0)] [added: 52.4] | | |

| Evkeeza - U.S. | | | [removed: 77.3] [added: 125.7] | | | | | | [removed: 48.6] [added: 77.3] | | | | | | [removed: 18.4] [added: 48.6] | | | | | | [removed: 28.7] [added: 48.4] | | | | | | [removed: 30.2] [added: 28.7] | | |

| Inmazeb - U.S. | | | [removed: 69.8] [added: 76.8] | | | | | | [removed: 3.0] [added: 69.8] | | | | | | [removed: —] [added: 3.0] | | | | | | [removed: 66.8] [added: 7.0] | | | | | | [removed: 3.0] [added: 66.8] | | |

| Total net product sales | | | $ | [removed: 7,078.0] [added: 7,629.2] | | | | | $ | [removed: 6,893.7] [added: 7,078.0] | | | | | $ | [removed: 12,117.2] [added: 6,893.7] | | | | | $ | [removed: 184.3] [added: 551.2] | | | | | $ | [removed: (5,223.5)] [added: 184.3] | |

| Sanofi | | | $ | [removed: 3,799.5] [added: 4,531.4] | | | | | $ | [removed: 2,855.7] [added: 3,799.5] | | | | | $ | [removed: 1,902.2] [added: 2,855.7] | | | | | $ | [removed: 943.8] [added: 731.9] | | | | | $ | [removed: 953.5] [added: 943.8] | |

| Bayer | | | [removed: 1,487.5] [added: 1,499.0] | | | | | | [removed: 1,430.7] [added: 1,487.5] | | | | | | [removed: 1,409.3] [added: 1,430.7] | | | | | | [removed: 56.8] [added: 11.5] | | | | | | [removed: 21.4] [added: 56.8] | | |

| Roche | | | [removed: 211.0] [added: 1.4] | | | | | | [removed: 627.3] [added: 211.0] | | | | | | [removed: 361.8] [added: 627.3] | | | | | | [removed: (416.3)] [added: (209.6)] | | | | | | [removed: 265.5] [added: (416.3)] | | |

| Other | | | [removed: 5.1] [added: 26.0] | | | | | | [removed: 0.4] [added: 5.1] | | | | | | [removed: —] [added: 0.4] | | | | | | [removed: 4.7] [added: 20.9] | | | | | | [removed: 0.4] [added: 4.7] | | |

| Other revenue | | | [removed: 536.1] [added: 515.0] | | | | | | [removed: 365.1] [added: 536.1] | | | | | | [removed: 281.2] [added: 365.1] | | | | | | [removed: 171.0] [added: (21.1)] | | | | | | [removed: 83.9] [added: 171.0] | | |

| Total revenues | | | $ | [removed: 13,117.2] [added: 14,202.0] | | | | | $ | [removed: 12,172.9] [added: 13,117.2] | | | | | $ | [removed: 16,071.7] [added: 12,172.9] | | | | | $ | [removed: 944.3] [added: 1,084.8] | | | | | $ | [removed: (3,898.8)] [added: 944.3] | |

The following table summarizes the provisions, and credits/payments, for sales-related [removed: deductions.][added: deductions:]

| Balance as of December 31, 2021 | | | [added: $ |] 214.6 | | | | | [added: $] | 80.0 | | | | | [added: $] | 67.6 | | | | | [added: $] | 362.2 | | [removed: |]

| Balance as of December 31, 2023 | | | [removed: $ |] 455.7 | | | | | [removed: $] | 162.3 | | | | | [removed: $] | 79.3 | | | | | [removed: $] | 697.3 | | [added: |]

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

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

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

| (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.

EYLEA HD was approved by the FDA in August 2023 and net product sales in 2024 were driven by the transition of patients from other anti-VEGF products, including EYLEA, as well as new patients naïve to anti-VEGF therapy.

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

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

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.

| Provisions | | | 2,447.3 | | | | | | 462.7 | | | | | | 143.0 | | | | | | 3,053.0 | | |

| Credits/payments | | | (2,363.9) | | | | | | (497.2) | | | | | | (128.8) | | | | | | (2,989.9) | | |

| Balance as of December 31, 2024 | | | $ | 539.1 | | | | | $ | 127.8 | | | | | $ | 93.5 | | | | | $ | 760.4 | |

| Regeneron's share of profits | | | | | | $ | 3,923.5 | | | | | $ | 3,136.5 | | | | | $ | 2,082.0 | |

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

| Regeneron's share of profits | | | | | | $ | 3,923.5 | | | | | $ | 3,136.5 | | | | | $ | 2,082.0 | |

| *(In millions)* | | | | | | 2024 | | | | | | 2023 | | | | | | 2022 | | |

| Regeneron's share of profits | | | | | | $ | 1,403.3 | | | | | $ | 1,376.4 | | | | | $ | 1,317.4 | |

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

| *(In millions)* | | | | | | 2024 | | | | | | 2023 | | | | | | 2022 | | |

| Regeneron's share of profits | | | | | | $ | 1,403.3 | | | | | $ | 1,376.4 | | | | | $ | 1,317.4 | |

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

| *(In millions)* | | | | | | 2024 | | | | | | 2023 | | | | | | 2022 | | |

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

Net product sales of Ronapreve outside the United States declined as a result of new variants of the SARS-CoV-2 virus emerging that are not susceptible to the treatment.

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.

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

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

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.

Other operating expense (income), net, in 2024 reflected a charge of $53.4 million related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with our 2023 acquisition of Decibel Therapeutics, Inc.

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

| *(In millions)* | | | | | | 2024 | | | | | | 2023 | | | | | | 2022 | | |

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.

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

| *(In millions)* | | | 2024 | | | | | | 2023 | | | | | | $ Change | | |

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

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

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

In addition, payments in connection with Common Stock tendered for employee tax obligations were $1.029 billion during 2024, compared to $700.6 million during 2023 and $445.7 million during 2022.

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

| *(In millions)* | | | | | | 2024 | | | | | | 2023 | | | | | | 2022 | | |

In addition, our research and development activities and related costs which are not reimbursed are expected to expand and require additional resources.

The expected dividend yield is zero as we have never paid dividends and do not currently have plans to do so.

See "Results of Operations - Expenses - Cost of Goods Sold" below for further information related to our inventory write-offs and reserves.

| REGEN-COV - U.S. | | | — | | | | | | — | | | | | | 5,828.0 | | | | | | — | | | | | | (5,828.0) | | |

| ARCALYST - U.S. | | | — | | | | | | — | | | | | | 2.2 | | | | | | — | | | | | | (2.2) | | |

| * Effective July 1, 2022, the Company became solely responsible for the research, development, and commercialization of Libtayo worldwide and began recording net product sales of Libtayo outside the United States. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States. Previously, the Company recorded net product sales of ARCALYST in the United States. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

Net product sales of EYLEA in the United States decreased in 2023, compared to 2022, primarily due to changing market dynamics, resulting in a lower net selling price and lower volumes.

EYLEA volumes in 2023 were impacted by the August 2023 launch of EYLEA HD and subsequent transition of EYLEA patients to EYLEA HD.

During the year ended December 31, 2021, we recorded net product sales of REGEN-COV in connection with our agreements with the U.S. government.

As of December 31, 2021, the Company had completed its final deliveries of drug product under its agreements with the U.S. government; as a result, there were no net product sales of REGEN-COV in the United States recorded during the years ended December 31, 2023 and 2022.

| Balance as of December 31, 2020 | | | $ | 202.2 | | | | | $ | 77.2 | | | | | $ | 44.8 | | | | | $ | 324.2 | |

| Provisions | | | 1,047.1 | | | | | | 363.6 | | | | | | 150.4 | | | | | | 1,561.1 | | |

| Credits/payments | | | (1,034.7) | | | | | | (360.8) | | | | | | (127.6) | | | | | | (1,523.1) | | |

As described in Part I, Item 1.

"Business - Collaboration, License, and Other Agreements - Sanofi - Antibody", on July 1, 2022, an amendment to the LCA became effective, pursuant to which the percentage of Regeneron's share of profits in any calendar quarter used to reimburse Sanofi for development costs which were funded by Sanofi increased from 10% to 20%.

| Regeneron's share of collaboration profits | | | | | | 3,596.3 | | | | | | 2,405.5 | | | | | | 1,511.5 | | |

During the year ended December 31, 2022, the Company earned two $50.0 million sales-based milestones from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $2.0 billion and $2.5 billion, respectively, on a rolling twelve-month basis.

Reimbursements for manufacturing of commercial supplies primarily relate to Dupixent and are recognized when the product is sold by Sanofi to third-party customers; such reimbursements decreased during the year ended December 31, 2023, compared to 2022, primarily due to lower manufacturing costs resulting from the transition to a higher-yielding manufacturing process.

| Regeneron's share of profits as a percentage of EYLEA net product sales outside the United States | | | | | | 39% | | | | | | 39% | | | | | | 39% | | |

| Global gross profit payment from Roche in connection with sales of REGEN-COV and Ronapreve | | | | | | $ | 224.3 | | | | | $ | 627.3 | | | | | $ | 361.8 | |

Other revenue in 2023 included the recognition of $50.4 million of revenue in connection with our August 2023 agreement with BARDA to fund certain costs for a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection.

In addition, Other revenue increased in 2023, compared to 2022, primarily due to the following:

- higher reimbursements for the manufacture of commercial supplies for Sanofi related to Praluent outside the United States;

- higher share of profits earned in connection with sales of ARCALYST pursuant to our license agreement with Kiniksa Pharmaceuticals, Ltd.; and

- royalties earned in connection with our license agreement with Novartis, under which we receive royalties on worldwide sales of Novartis' Ilaris® (canakinumab).

| REGEN-COV | | | | | | (5.6) | | | | | | 32.8 | | | | | | 309.8 | | | | | | (38.4) | | | | | | (277.0) | | |

Total research and development expenses increased in 2023, compared to 2022, partially due to the impact of the amendments to the Sanofi collaboration agreements (which were effective July 1, 2022) described above in Part I, Item 1.

"Business - "Collaboration, License, and Other Agreements - Sanofi", as (i) Sanofi is no longer reimbursing us for 50% of Libtayo development costs (such reimbursements were previously included in Reimbursement of research and development expenses by collaborators in the table above) and (ii) we recognize our 50% share of research and development expenses in connection with the Sanofi Antibody Collaboration.

Acquired IPR&D in 2023 included:

- $100.0 million charge in connection with a development milestone for the Phase 1 ALN-APP program, which is in collaboration with Alnylam;

Acquired IPR&D in 2022 included:

- $195.0 million charge related to our acquisition of Checkmate Pharmaceuticals, Inc.;

- $30.0 million up-front payment in connection with our collaboration agreement with CytomX Therapeutics, Inc.; and

- $20.0 million opt-in payment in connection with a product candidate under our collaboration agreement with Adicet Bio, Inc.

Selling, general, and administrative expenses increased in 2023, compared to 2022, primarily due to higher headcount and headcount-related costs, an increase in commercialization-related expenses for Libtayo (including acquisition and integration-related costs for Libtayo outside the United States as effective July 1, 2022, the Company became solely responsible for the commercialization of Libtayo worldwide), and, to a lesser extent, commercialization-related expenses for various other products, and higher contributions to an independent not-for-profit patient assistance organization.

Inventory write-offs and reserves were $102.3 million in 2023 compared to $258.7 million in 2022.

The inventory write-offs and reserves in 2022 were primarily related to REGEN-COV.

*Cost of Collaboration and Contract Manufacturing*

Cost of collaboration and contract manufacturing increased in 2023, compared to 2022, primarily due to the recognition of costs in connection with manufacturing commercial supplies for Sanofi related to Praluent outside the United States and for Bayer related to EYLEA outside the United States.

We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would have resulted in approximately a [removed: $98.7] [added: $163.0] million and [removed: $102.7] [added: $98.7] million decrease in the fair value of our investment portfolio as of December 31, [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] respectively.

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources - *Tarrytown, New York [removed: Leases*").][added: Corporate Headquarters Lease*").]

In [removed: 2023, 2022,] [added: 2024] and [removed: 2021,] [added: 2023,] we did not [removed: record] [added: recognize] any charges for credit-related [removed: impairments] [added: losses] of our available-for-sale debt securities.

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

We [added: 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 [removed: 2023, 2022,] [added: 2024] and [removed: 2021,] [added: 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, [removed: 2023,] [added: 2024,] two customers accounted on a combined basis for [removed: 83%] [added: 79%] of our net trade accounts receivables.

In addition, pursuant to the applicable terms of the agreements with our collaborators, we also share in certain worldwide development [added: and/or commercialization-related] expenses incurred by our collaborators.

We also incur worldwide development expenses for clinical products we are developing independently, incur expenses outside the United States in connection with our international operations, [removed: and, effective July 1, 2022, market] [added: and record product sales of] Libtayo outside the United [removed: States as a result of obtaining worldwide rights to Libtayo under an A&R IO LCA with Sanofi.][added: States.]

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

As sales outside the United States continue to grow, and as we expand our international operations, we will continue to assess [removed: potential steps,] [added: and implement strategies,] including foreign currency [removed: hedging and other strategies,] [added: hedging,] to mitigate our foreign exchange risk.

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

Changes in the fair value of our equity [removed: investments] [added: securities] are included in Other income (expense), net on the Statements of Operations.

We recorded [removed: $237.8] [added: $117.7] million [added: of net unrealized gains] and [removed: $39.8] [added: $237.8] million of net unrealized losses on equity securities in Other income (expense), net in [removed: 2023] [added: 2024] and [removed: 2022,] [added: 2023,] respectively.

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

We have contractual payment terms with each of our collaborators and customers.

*•the likelihood, timing, and scope of possible regulatory approval and commercial launch of [removed: our late-stage product candidates] [added: Regeneron's Product Candidates] and new indications for Regeneron's Products, including without limitation those discussed or referenced in this report;*

*•competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product [removed: Candidates;*][added: Candidates (including biosimilar versions of Regeneron's Products);*]

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

*•the impact of public health outbreaks, epidemics, or pandemics [removed: (such as the COVID-19 pandemic)] on our business; and*

*•risks associated with [removed: intellectual property of] [added: litigation and] other [removed: parties] [added: proceedings] and [removed: pending or future litigation] [added: government investigations] relating [removed: thereto] [added: to the Company and/or its operations] (including without limitation [removed: the patent litigation and other related proceedings] [added: those] described [removed: further] in Note 16 to our Consolidated Financial Statements included in this report), [removed: other litigation and] [added: risks associated with intellectual property of] other [removed: proceedings] [added: parties] and [removed: government investigations] [added: pending or future litigation] relating [removed: to the Company and/or its operations] [added: thereto] (including without limitation [removed: those] [added: the patent litigation and other related proceedings] described [added: further] in Note 16 to our Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition.*

[Table [removed: of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)][added: of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)]

Our products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, [added: neurological diseases,] hematologic conditions, infectious diseases, and rare diseases.

Our core business strategy is to maintain a strong foundation in [removed: basic] scientific research and [removed: discovery-enabling] [added: drug development using our proprietary] technologies, and to build on that foundation with our clinical development, manufacturing, and commercial capabilities.

| *(In millions, except per share data)* | | | | | | [removed: 2023] [added: 2024] | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | |

| Revenues | | | | | | $ | [removed: 13,117.2] [added: 14,202.0] | | | | | $ | [removed: 12,172.9] [added: 13,117.2] | | | | | $ | [removed: 16,071.7] [added: 12,172.9] | |

| Net income | | | | | | $ | [removed: 3,953.6] [added: 4,412.6] | | | | | $ | [removed: 4,338.4] [added: 3,953.6] | | | | | $ | [removed: 8,075.3] [added: 4,338.4] | |

| Net income per share - diluted | | | | | | $ | [removed: 34.77] [added: 38.34] | | | | | $ | [removed: 38.22] [added: 34.77] | | | | | $ | [removed: 71.97] [added: 38.22] | |

For purposes of this report, references to our products encompass products [removed: marketed or otherwise] commercialized by us and/or our collaborators or licensees and references to our product candidates encompass product candidates in development by us and/or our collaborators or licensees (in the case of collaborated or licensed products or product candidates under the terms of the applicable collaboration or license agreements), unless otherwise stated or required by the context.

| [removed: EYLEA® HD] [added: EYLEA HD®] (aflibercept) Injection 8 mg(a) | | | | | | Wet age-related macular degeneration ("wAMD") | | | | | | a | | | | | | a | | | | | | a | | |

| | | | | | | Chronic rhinosinusitis with nasal polyposis ("CRSwNP") [added: (in adults)] | | | | | | a | | | | | | a | | | | | | a | | |

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

| | | | | | | [removed: EoE (in] [added: HeFH in] pediatrics [removed: 1–11] [added: and adolescents (8–17] years of age) | | | | | | a | | | | | | [added: a] | | | | | | | | |

| Libtayo® (cemiplimab) [removed: Injection(c)] [added: Injection] | | | | | | Metastatic or locally advanced first-line non-small cell lung cancer ("NSCLC") | | | | | | a | | | | | | a | | | | | | | | |

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

| [removed: REGEN-COV®(e)] [added: REGEN-COV®(d)] | | | | | | COVID-19 | | | | | | | | | | | | a | | | | | | a | | |

| [removed: Kevzara] [added: Kevzara®] (sarilumab) Injection(b) | | | | | | Rheumatoid arthritis ("RA") | | | | | | a | | | | | | a | | | | | | a | | |

| | | | | | | Polymyalgia rheumatica ("PMR") | | | | | | a | | | | | | [added: a] | | | | | | | | |

| Evkeeza® (evinacumab) [removed: Injection(f)] [added: Injection(e)] | | | | | | HoFH (in adults, adolescents, and [removed: pediatrics aged 5 years and older)] [added: pediatrics)] | | | | | | a | | | | | | a | | | | | | a | | |

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

| ARCALYST® (rilonacept) [removed: Injection(g)] [added: Injection(f)] | | | | | | 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(h)] [added: Infusion(g)] | | | | | | Metastatic colorectal cancer ("mCRC") | | | | | | a | | | | | | a | | | | | | a | | |

| [removed: (d)] [added: (c)] The Company is 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 States. | | | | | | | | | | | | | | | | | | | | | | | | | | |

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

| [removed: (f)] [added: (e)] The Company is 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 States. | | | | | | | | | | | | | | | | | | | | | | | | | | |

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

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

[removed: Net] [added: The table below includes net] product sales of Regeneron-discovered [removed: products consist of the following:][added: products.]

| | | | | | | [removed: 2023] [added: 2024] | | | | | | | | | | | | | | | | | | [removed: 2022] [added: 2023] | | | | | | | | | | | | | | | | | | [removed: 2021] [added: 2022] | | | | | | | | | | | | | | |

| [removed: Total] EYLEA HD and [removed: EYLEA] [added: EYLEA(a)] | | | | | | $ | [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] | | | | | $ | [removed: 5,792.3] [added: 6,264.6] | | | | | $ | [removed: 3,450.9] [added: 3,382.8] | | | | | $ | [removed: 9,243.2] [added: 9,647.4] | |

| Dupixent(b) | | | | | | $ | [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] | | | | | $ | [removed: 4,713.0] [added: 6,668.0] | | | | | $ | [removed: 1,485.3] [added: 2,013.2] | | | | | $ | [removed: 6,198.3] [added: 8,681.2] | |

| Libtayo(c) | | | | | | $ | [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] | | | | | $ | [removed: 306.3] [added: 374.5] | | | | | $ | [removed: 151.9] [added: 203.5] | | | | | $ | [removed: 458.2] [added: 578.0] | |

| Praluent(d) | | | | | | $ | [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] | | | | | $ | [removed: 170.0] [added: 130.0] | | | | | $ | [removed: 251.1] [added: 337.4] | | | | | $ | [removed: 421.1] [added: 467.4] | |

| REGEN-COV(e) | | | | | | $ | — | | | | | $ | [removed: 618.8] [added: 3.5] | | | | | $ | [removed: 618.8] [added: 3.5] | | | | | $ | — | | | | | $ | [removed: 1,769.6] [added: 618.8] | | | | | $ | [removed: 1,769.6] [added: 618.8] | | | | | $ | [removed: 5,828.0] [added: —] | | | | | $ | [removed: 1,745.9] [added: 1,769.6] | | | | | $ | [removed: 7,573.9] [added: 1,769.6] | |

| Kevzara(b) | | | | | | $ | [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: 161.9] [added: 199.7] | | | | | $ | [removed: 176.1] [added: 158.3] | | | | | $ | [removed: 338.0] [added: 358.0] | |

| Other products(f) | | | | | | $ | [removed: 150.5] [added: 202.9] | | | | | $ | [removed: 67.4] [added: 86.5] | | | | | $ | [removed: 217.9] [added: 289.4] | | | | | $ | [removed: 56.1] [added: 150.5] | | | | | $ | [removed: 69.1] [added: 67.4] | | | | | $ | [removed: 125.2] [added: 217.9] | | | | | $ | [removed: 25.9] [added: 56.1] | | | | | $ | [removed: 86.4] [added: 69.1] | | | | | $ | [removed: 112.3] [added: 125.2] | |

*•changes in laws, regulations, and policies affecting the healthcare industry;*

*•the costs of developing, producing, and selling products or unanticipated expenses;*

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

| | | | | | | CRSwNP (in adolescents) | | | | | | a | | | | | | | | | | | | | | |

| | | | | | | Chronic obstructive pulmonary disease ("COPD") | | | | | | a | | | | | | a | | | | | | | | |

| | | | | | | Chronic spontaneous urticaria ("CSU") (in adults and adolescents) | | | | | | | | | | | | | | | | | | a | | |

| | | | | | | Polyarticular juvenile idiopathic arthritis ("pJIA") | | | | | | a | | | | | | a | | | | | | | | |

| Ordspono™ (odronextamab) | | | | | | Follicular lymphoma ("FL") | | | | | | | | | | | | a | | | | | | | | |

| | | | | | | Diffuse large B-cell lymphoma ("DLBCL") | | | | | | | | | | | | a | | | | | | | | |

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

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

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

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

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

Such net product sales are recorded by us or others, as further described in the footnotes to the table.

We believe the information in the table is useful to investors as it demonstrates our pipeline productivity and our ability to innovate, discover, and develop new products, and bring those products to market either alone or based on contractual arrangements with other parties, which has a direct impact on our results of operations and financial condition.

The table also shows the degree to which we, a collaborator, and/or a licensee is currently commercializing the products discovered by Regeneron.

In addition, this information allows management and investors to assess the commercial trends and developments impacting Regeneron-discovered products.

In arrangements where our collaborator or licensee is currently commercializing such products and is recording net product sales as a result, the net product sales shown in the table also are an important metric for management's review and assessment of (i) the revenues we record for our share of profits and/or royalties from such sales and (ii) the impact of our obligation to supply commercial product to certain of these collaborators or licensees.

| (b) Sanofi records global net product sales of Dupixent and Kevzara, and we record our share of profits in connection with global sales of such products 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 - Sanofi Collaboration Revenue" for such amounts. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (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. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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

| EYLEA HD (aflibercept) 8 mg(a) | | | | | | | | | | | | –RVO | | | | | | –Two-year data for wAMD and DME (U.S.) –Pre-filled syringe (U.S.) | | | | | | –Approved by European Commission ("EC") and Japan's Ministry of Health, Labour and Welfare ("MHLW") for wAMD and DME –Pre-filled syringe approved by European Medicines Agency ("EMA") –Presented positive three-year data from extension study of Phase 3 DME trial at American Academy of Ophthalmology ("AAO") Annual Meeting –Reported that Phase 3 QUASAR trial in RVO met its primary endpoint | | | | | | –U.S. Food and Drug Administration ("FDA") decision on supplemental Biologics License Application ("sBLA") with two-year data for wAMD and DME (target action date of April 20, 2025) –FDA decision for pre-filled syringe (mid-2025) –Submit sBLA for RVO (first quarter 2025) –Submit sBLA for every 4-week dosing regimen (first quarter 2025) | | |

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

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

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

| 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 | | | | | | | | |

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

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

| Clinical Program (continued) | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2024 and 2025 Events to Date | | | | | | Select Upcoming Milestones | | |

| 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) | | |

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

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

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

| Libtayo (cemiplimab)(g) *Antibody to PD-1* | | | | | | –Neoadjuvant CSCC –First-line NSCLC, BNT116(i) combination –Neoadjuvant NSCLC –Neoadjuvant hepatocellular carcinoma ("HCC") | | | | | | –Adjuvant CSCC –Early-stage CSCC (intralesional) | | | | | | –First-line NSCLC, monotherapy and chemotherapy combination (Japan) | | | | | | –Presented positive five-year survival data from Phase 3 NSCLC monotherapy trial at IASLC 2024 World Conference on Lung Cancer –Reported positive interim data from Phase 3 study in adjuvant CSCC | | | | | | –MHLW decision on regulatory submission for NSCLC, monotherapy and chemotherapy combination (second half 2025) –Submit sBLA for adjuvant CSCC (first half 2025) | | |

| Vidutolimod *Immune activator targeting TLR9* | | | | | | | | | | | | | | | | | | | | | | | | –Company discontinued Phase 2 study due to drug supply | | | | | | | | |

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

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

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Clinical Program (continued) | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2024 and 2025 Events to Date | | | | | | Select Upcoming Milestones | | |

*•unanticipated expenses;*

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

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

| (c) In collaboration with Sanofi prior to July 2022. Effective July 2022, the Company is solely responsible for the development, commercialization, and manufacturing of Libtayo. Refer to "Collaboration, License, and Other Agreements" section below for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | |

| EYLEA HD(a) | | | | | | $ | 165.8 | | | | | $ | — | | | | | $ | 165.8 | | | | | $ | — | | | | | $ | — | | | | | $ | — | | | | | $ | — | | | | | $ | — | | | | | $ | — | |

| EYLEA(a) | | | | | | $ | 5,719.6 | | | | | $ | 3,495.2 | | | | | $ | 9,214.8 | | | | | $ | 6,264.6 | | | | | $ | 3,382.8 | | | | | $ | 9,647.4 | | | | | $ | 5,792.3 | | | | | $ | 3,450.9 | | | | | $ | 9,243.2 | |

| (b) Sanofi records global net product sales of Dupixent and Kevzara. The Company records its share of profits in connection with global sales of Dupixent and Kevzara. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (e) Regeneron records net product sales of REGEN-COV in the United States and Roche records net product sales of Ronapreve outside the United States. The parties share gross profits from global sales of REGEN-COV and Ronapreve based on a pre-specified formula. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| EYLEA HD (aflibercept) 8 mg(a) | | | | | | | | | | | | | | | | | | –RVO | | | | | | | | | | | | –Approved by U.S. Food and Drug Administration ("FDA") for wAMD, DME, and DR –Approved by European Commission ("EC") and Japan's Ministry of Health, Labour and Welfare ("MHLW") for wAMD and DME –Reported positive two-year data from Phase 3 studies in wAMD and DME | | | | | | –Initiate Phase 3 study in RVO (mid-2024) to enable FDA submission | | |

| EYLEA (aflibercept)(a) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Approved by FDA for ROP | | | | | | | | |

| Dupixent (dupilumab)(b) *(continued)* | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Reported that Phase 3 BOREAS trial in COPD with evidence of type 2 inflammation met its primary and all key secondary endpoints; presented at 2023 American Thoracic Society International Conference and published in *New England Journal of Medicine* –Reported that results from interim analysis of replicate Phase 3 NOTUS trial in COPD with evidence of type 2 inflammation met its primary endpoint –FDA issued Complete Response Letter ("CRL") for sBLA for CSU due to requirement for additional efficacy data –Phase 3 trial in chronic cold induced urticaria did not meet its required efficacy endpoints –Discontinued further clinical development in allergic fungal rhinosinusitis and chronic rhinosinusitis without nasal polyposis | | | | | | –MHLW decision on regulatory submission for CSU in adults and adolescents (first half 2024) –Report results from ongoing Phase 3 trial in CSU (in biologic-naïve patients) (fourth quarter 2024) –Report results from Phase 3 trial in bullous pemphigoid (second half 2024) –Initiate Phase 1 study in severe food allergy following transient linvoseltamab treatment (2024) | | |

| Itepekimab(b) (REGN3500) *Antibody to IL-33* | | | | | | | | | | | | | | | | | | –COPD(e) | | | | | | | | | | | | –Phase 3 COPD program passed interim futility analysis conducted by Independent Data Monitoring Committee ("IDMC") | | | | | | –Report results from Phase 3 study in COPD (2025) | | |

| Libtayo (cemiplimab)(g) *Antibody to PD-1* | | | | | | | | | | | | –Neoadjuvant CSCC –First-line NSCLC, BNT116(r) combination | | | | | | –Adjuvant CSCC | | | | | | | | | | | | –Approved by EC for first-line NSCLC, chemotherapy combination | | | | | | –Conduct interim analysis from Phase 3 study in adjuvant CSCC (second half 2024) | | |

| Vidutolimod *Immune activator targeting TLR9* | | | | | | | | | | | | –Solid tumors | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGN5668(n) *Bispecific antibody targeting MUC16 and CD28* | | | | | | –Platinum-resistant ovarian cancer | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGN4336 *Bispecific antibody targeting PSMA and CD3* | | | | | | –Prostate cancer | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGN5093-M114 *Bispecific antibody-drug conjugate targeting two distinct MET epitopes* | | | | | | –MET overexpressing advanced cancer | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGN6569 *Antibody to GITR* | | | | | | –Solid tumors | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGN7075 *Bispecific antibody targeting EGFR and CD28* | | | | | | –Solid tumors | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Initiate dose-expansion cohorts (in combination with Libtayo) in EGFR-high tumors (first half 2024) | | |

| Pozelimab(f) (REGN3918) *Antibody to C5* | | | | | | | | | | | | | | | | | | –Myasthenia gravis, cemdisiran combination(c)(s) –Paroxysmal nocturnal hemoglobinuria ("PNH"), cemdisiran combination(c)(s) | | | | | | | | | | | | –Veopoz (pozelimab) approved by FDA for CHAPLE in adults and children aged 1 year and older, monotherapy | | | | | | | | |

| REGN5837(p) *Bispecific antibody targeting CD22 and CD28* | | | | | | –B-NHL | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGN5459(f) *Bispecific antibody targeting BCMA and CD3* | | | | | | –Transplant desensitization in patients with chronic kidney disease | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGN7508 *Antibody to Factor XI* | | | | | | –Thrombosis | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Praluent (alirocumab) *Antibody to PCSK9* | | | | | | | | | | | | | | | | | | –HeFH in pediatrics and adolescents | | | | | | –HeFH in pediatrics and adolescents (8–17 years of age) (U.S.) | | | | | | –Approved by EC for HeFH in pediatrics and adolescents (8–17 years of age) | | | | | | –FDA decision on sBLA for HeFH in pediatrics and adolescents (target action date of March 10, 2024) | | |

| Evkeeza(f)(l) (evinacumab) *Antibody to ANGPTL3* | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Approved by FDA and EC for HoFH in pediatrics (5–11 years of age) and MHLW for HoFH in adults, adolescents, and pediatrics | | | | | | | | |

| Garetosmab(f) (REGN2477) *Antibody to Activin A* | | | | | | | | | | | | | | | | | | –Fibrodysplasia ossificans progressiva ("FOP")(c)(d)(e) | | | | | | | | | | | | | | | | | | | | |

| Trevogrumab(f) (REGN1033) *Antibody to myostatin (GDF8)* | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Initiate Phase 2 study in combination with semaglutide with and without garetosmab (mid-2024) | | |

| REGN5381/REGN9035 *Agonist antibody to NPR1/reversal agent to REGN5381* | | | | | | –Reversal agent in healthy volunteers | | | | | | –Heart failure | | | | | | | | | | | | | | | | | | –Resumed enrollment in previously paused Phase 1 and Phase 2 studies following protocol amendments –Reported positive initial data from Phase 1 trial in healthy volunteers | | | | | | | | |

| REGN7544 *Antagonist antibody to NPR1* | | | | | | –Healthy volunteers | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| ALN-PNP(k) *RNAi therapeutic targeting PNPLA3* | | | | | | –NASH | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| ALN-APP(k) *RNAi therapeutic targeting APP* | | | | | | –Early-onset Alzheimer’s disease(q) | | | | | | | | | | | | | | | | | | | | | | | | –Reported positive interim data from single dose part of Phase 1 trial in early-onset Alzheimer’s disease | | | | | | | | |

| DB-OTO *AAV-based gene therapy* | | | | | | –Hearing loss in pediatrics(c) (Phase 1/2) | | | | | | | | | | | | | | | | | | | | | | | | –Reported preliminary, positive safety and efficacy results from first patient dosed in Phase 1/2 trial in pediatrics with hearing loss | | | | | | | | |

| "Next Generation" Covid Antibody(i) *Antibody to SARS-CoV-2 variants* | | | | | | –Healthy volunteers | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGN13335 *Antagonist antibody to PDGF-B* | | | | | | –Healthy volunteers | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (i) We and the Biomedical Advanced Research and Development Authority ("BARDA") of the U.S. Department of Health and Human Services ("HHS") are parties to an agreement whereby HHS provides certain funding to support research and development activities. | | | | | | | | | | | | | | |

| (k) In collaboration with Alnylam | | | | | | | | | | | | | | |

| (l) In collaboration with Ultragenyx outside the United States | | | | | | | | | | | | | | |

| (m) FDA granted Fast Track designation for follicular lymphoma and diffuse large B-cell lymphoma | | | | | | | | | | | | | | |

| | | | For the fiscal year ended December 31, [removed: 2023] [added: 2024] | | | | | | | | |

| The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant was [removed: $76.7] [added: $113.8] billion, computed by reference to the closing sales price of the stock on NASDAQ on June [removed: 30, 2023,] [added: 28, 2024,] 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: 25, 2024:] [added: 23, 2025:] | | | | | | | | | | | | | | |

| Class A Stock, $.001 par value | | | | | | [removed: 1,818,146] [added: 1,817,146] | | |

| Common Stock, $.001 par value | | | | | | [removed: 107,943,750] [added: 107,507,536] | | |

| Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its [removed: 2024] [added: 2025] Annual Meeting of Shareholders are incorporated by reference into Part III of this Form 10-K. Exhibit index is located on pages [removed: 92] [added: 87] to [removed: 96] [added: 91] of this filing. | | |

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| [PART [removed: III](#icad69a7485714b89bcccabdab8d6701b_82)] [added: III](#i66ff2c03559b4ab89799d79d457200d6_88)] | | | | | | | | | | | | | | |

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| [SIGNATURE [removed: PAGE](#icad69a7485714b89bcccabdab8d6701b_94)] [added: PAGE](#i66ff2c03559b4ab89799d79d457200d6_100)] | | | | | | | | | | | | [removed: [97](#icad69a7485714b89bcccabdab8d6701b_94)] [added: [92](#i66ff2c03559b4ab89799d79d457200d6_100)] | | |

| "Altibodies™," "ARCALYST®," "Evkeeza®," "EYLEA®," [removed: "EYLEA® HD,"] [added: "EYLEA HD®,"] "Inmazeb®," "Libtayo®," [added: "Ordspono™,"] "Praluent®" (in the United States), "REGEN-COV®," "Regeneron®," "Regeneron Genetics Center®," "RGC®," [removed: "*Veloci-Bi*®," "*VelociGene*®," "*VelociHum*®," "*VelociMab*®," "*VelocImmune*®," "*VelociMouse*®," "*VelociSuite*®," "*VelociT*®," "Veopoz™,"] [added: "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](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)][added: of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)]

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

| [Item 1C.](#i66ff2c03559b4ab89799d79d457200d6_28) | | | | | | [Cybersecurity](#i66ff2c03559b4ab89799d79d457200d6_28) | | | | | | [67](#i66ff2c03559b4ab89799d79d457200d6_28) | | |

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

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

| [PART I](#icad69a7485714b89bcccabdab8d6701b_10) | | | | | | | | | | | | | | |

| [I](#icad69a7485714b89bcccabdab8d6701b_1510)[tem 1C.](#icad69a7485714b89bcccabdab8d6701b_1510) | | | | | | [Cybersecurity](#icad69a7485714b89bcccabdab8d6701b_1510) | | | | | | [70](#icad69a7485714b89bcccabdab8d6701b_1510) | | |

| [PART II](#icad69a7485714b89bcccabdab8d6701b_37) | | | | | | | | | | | | | | |

| [PART IV](#icad69a7485714b89bcccabdab8d6701b_85) | | | | | | | | | | | | | | |

Our Technology Risk Management Committee, which is comprised of representatives from our business operations and support functions (e.g., legal, finance, internal audit, commercial, privacy), assesses [added: cybersecurity] risks based on probability and potential impact to key business systems and processes.

[removed: Risks] [added: Cybersecurity risks] that are considered high are incorporated into our overall risk management program.

A mitigation plan is developed for each identified high risk, with progress [added: on risk mitigation] reported to the Technology Risk Management Committee and tracked as part of our overall risk management [removed: program] [added: program, which is] overseen by the Audit Committee of our board of directors.

[Table [removed: of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)][added: of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)]

[removed: Cybersecurity] [added: To date, the Company is not aware of risks from cybersecurity] threats, including those resulting from any previous cybersecurity incidents, [added: that] have [removed: not] materially affected [added: or are reasonably likely to materially affect] our Company, including our business strategy, results of operations, or financial condition.

"Risk Factors" for additional [removed: description of] [added: information regarding] cybersecurity risks and potential related impacts on our Company.

The current CISO has over 35 years of experience in [added: technology and] information [removed: security] [added: security, including operating in the role of the CISO for several large companies in the pharmaceutical] and [added: healthcare industries, and] possesses the requisite education, skills, experience, and industry certifications expected of an individual assigned to these duties.

The CISO provides periodic updates on our cybersecurity risk profile to management's Technology Risk Management [removed: Committee,] [added: Committee and] the Audit Committee of our board of [removed: directors, and the Audit Committee chair.][added: directors.]

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.

developed a third-party cybersecurity risk management process to conduct due diligence on external entities, including those that perform cybersecurity services.

We do not believe that cybersecurity threats resulting from any previous cybersecurity incidents of which we are aware are reasonably likely to materially affect our Company.

[added: | (a) 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 [removed: Leases*"] [added: Corporate Headquarters Lease*"] for further details. [added: | | | | | | | | | | | | | | | | | | | | |]

[removed: We also] [added: 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 [removed: in connection with expanding] [added: to expand] our [removed: research] [added: research, preclinical manufacturing,] and support facilities to accommodate our growth.

[removed: In addition, we have constructed an approximately 341,000 square foot] [added: | (b) Our] fill/finish facility in Rensselaer, New York [removed: that] is [added: currently] undergoing process validation as required by regulatory authorities. [added: | | | | | | | | | | | | | | | | | | | | |]

[removed: We own a facility in] [added: |] Limerick, Ireland [removed: totaling approximately 555,000 square feet of manufacturing,] [added: | | | | | | 850,000 | | | | | | Manufacturing,] warehouse, laboratory, and office [removed: space.][added: space | | | | | | Owned | | |]

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

| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |

| Location | | | | | | Approximate Square Feet | | | | | | Use | | | | | | Leased/Owned | | |

| Tarrytown, New York | | | | | | 1,500,000 | | | | | | Corporate headquarters, laboratory, and office space | | | | | | Leased(a) | | |

| Rensselaer, New York | | | | | | 1,600,000 | | | | | | Manufacturing, warehouse, laboratory, fill/finish(b), and office space | | | | | | Owned | | |

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

Tarrytown, New York

At our Tarrytown, New York location, we lease approximately 1,467,000 square feet of laboratory and office space.

Refer to Part II, Item 7.

Rensselaer, New York

We own facilities in Rensselaer, New York totaling approximately 1,260,000 square feet of manufacturing, research, office, and warehouse space.

Limerick, Ireland

[Table [removed: of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)][added: of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_7)]

As of January [removed: 25, 2024,] [added: 23, 2025,] there were [removed: 153] [added: 149] shareholders of record of our Common Stock and 14 shareholders of record of our Class A Stock.

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: 2018] [added: 2019] through December 31, [removed: 2023.][added: 2024.]

The comparison assumes that $100 was invested on December 31, [removed: 2018] [added: 2019] in our Common Stock and in both of the foregoing indices.

[removed: ][added: ]

| | | | [removed: 12/31/2018] [added: 12/31/2019] | | | | | | [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] | | |

This performance graph shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or incorporated by reference into any filing of ours under the Securities Act of 1933, as amended, or the Securities Exchange Act, except as shall be expressly set forth by specific reference [removed: to] [added: in] such filing.

[Table [removed: of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)][added: of](#i66ff2c03559b4ab89799d79d457200d6_7) [Contents](#i66ff2c03559b4ab89799d79d457200d6_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: 2023.][added: 2024.]

| 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] [added: Programs(b)] *(In millions)* | | |

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

In February 2025, our board of directors approved the initiation of a quarterly cash dividend program and declared a cash dividend of $0.88 per share on our Common Stock and Class A Stock.

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) | | | | | |

| (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 - Share Repurchase Programs" for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | |

We have never paid cash dividends on our Common Stock or Class A Stock and do not currently have plans to do so.

| Regeneron | | | $ | 100.00 | | | | | $ | 100.53 | | | | | $ | 129.35 | | | | | $ | 169.08 | | | | | $ | 193.17 | | | | | $ | 235.15 | |

| S&P 500 | | | $ | 100.00 | | | | | $ | 128.88 | | | | | $ | 149.83 | | | | | $ | 190.13 | | | | | $ | 153.16 | | | | | $ | 190.27 | |

| NQ US Pharma TR Index | | | $ | 100.00 | | | | | $ | 114.51 | | | | | $ | 126.56 | | | | | $ | 157.42 | | | | | $ | 175.29 | | | | | $ | 182.08 | |

| 11/1/2023–11/30/2023 | | | | | | 272,952 | | | | | | $ | 802.55 | | | | | 269,976 | | | | | | $ | 1,609.1 | |

| 12/1/2023–12/31/2023 | | | | | | 558,642 | | | | | | $ | 849.22 | | | | | 93,108 | | | | | | $ | 1,530.6 | |

| Total | | | | | | 831,594 | | | (a) | | | | | | | | | 363,084 | | | (a) | | | | | |

Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, [removed: 2023] [added: 2024] 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: 2023.][added: 2024.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2023] [added: 2024] 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: 2023] [added: 2024] 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: 2023,] [added: 2024,] 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.

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

| Robert E. Landry | | | | | | Executive Vice President, Finance and Chief Financial Officer | | | | | | 11/9/2023 | | | | | | 5/6/2024 | | | | | | 14,337 | | |

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: 2024] [added: 2025] 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: 2024] [added: 2025] 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: 2024] [added: 2025] 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: 2024] [added: 2025] 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: 2024] [added: 2025] 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, 2015, filed August 4, [removed: 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000029/regn-ex_31x06302015x10q.htm)] [added: 2015.)](https://www.sec.gov/Archives/edgar/data/872589/000153217615000029/regn-ex_31x06302015x10q.htm)] | | |

| 3.2 | | | [Amended and Restated By-Laws. (Incorporated by reference from the Form 8-K for the Registrant filed December 21, [removed: 2016.)](http://www.sec.gov/Archives/edgar/data/872589/000110465916163216/a16-23471_1ex3d2.htm)] [added: 2016.)](https://www.sec.gov/Archives/edgar/data/872589/000110465916163216/a16-23471_1ex3d2.htm)] | | |

| 3.2.1 | | | [Amendment to the Amended and Restated By-Laws effective June 9, 2023. (Incorporated by reference from the Form 8-K for the Registrant filed June 14, [removed: 2023.)](http://www.sec.gov/Archives/edgar/data/872589/000110465923071187/tm2318622d1_ex3-2.htm)] [added: 2023.)](https://www.sec.gov/Archives/edgar/data/872589/000110465923071187/tm2318622d1_ex3-2.htm)] | | |

| [removed: 4.1] [added: 10.8.2] | | | [removed: [Description of Securities Registered Pursuant to Section 12 of] [added: [Second Amendment Agreement, dated December 19, 2019, by and between Bayer HealthCare LLC and] the [removed: Securities Exchange Act of 1934.] [added: Registrant.] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, [removed: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex41xdescriptiono.htm)] [added: 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10102secondamen.htm)] | | |

| 4.2 | | | [Indenture, dated August 12, 2020, between the Registrant and U.S. Bank National Association. (Incorporated by reference from the Form 8-K for the Registrant, filed August 12, [removed: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000110465920093924/tm2027319d1_ex4-1.htm)] [added: 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000110465920093924/tm2027319d1_ex4-1.htm)] | | |

| 4.3 | | | [First Supplemental Indenture, dated August 12, 2020, between the Registrant and U.S. Bank National Association. (Incorporated by reference from the Form 8-K for the Registrant, filed August 12, [removed: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000110465920093924/tm2027319d1_ex4-2.htm)] [added: 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000110465920093924/tm2027319d1_ex4-2.htm)] | | |

| 4.4 | | | [Form of 1.750% Senior Note due 2030 (included in Exhibit [removed: 4.3).](http://www.sec.gov/Archives/edgar/data/872589/000110465920093924/tm2027319d1_ex4-2.htm)] [added: 4.3).](https://www.sec.gov/Archives/edgar/data/872589/000110465920093924/tm2027319d1_ex4-2.htm)] | | |

| 4.5 | | | [Form of 2.800% Senior Note due 2050 (included in Exhibit [removed: 4.3).](http://www.sec.gov/Archives/edgar/data/872589/000110465920093924/tm2027319d1_ex4-2.htm)] [added: 4.3).](https://www.sec.gov/Archives/edgar/data/872589/000110465920093924/tm2027319d1_ex4-2.htm)] | | |

| [removed: 10.1] [added: 10.3] + | | | [removed: [Regeneron Pharmaceuticals, Inc. Second] [added: [Second] Amended and Restated [removed: 2000] [added: Regeneron Pharmaceuticals, Inc. 2014] Long-Term Incentive Plan. (Incorporated by reference from the Registration Statement on Form S-8 for the Registrant, filed June [removed: 13, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000120677411001374/exhibit99-1.htm)] [added: 16, 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000110465920073764/tm2022552d1_ex99-1.htm)] | | |

| [removed: 10.1.1] [added: 10.3.1] + | | | [Form of [added: stock] option agreement and related notice of grant for use in connection with the grant of [removed: time based vesting] [added: non-qualified] stock options to the Registrant's [removed: non-employee directors and] executive officers under the [removed: Regeneron Pharmaceuticals, Inc.] Second Amended and Restated [removed: 2000] [added: Regeneron Pharmaceuticals, Inc. 2014] Long-Term Incentive Plan. (Incorporated by reference from the Form [removed: 10-Q] [added: 10-K] for the Registrant, for the [removed: quarter] [added: year] ended [removed: March] [added: December] 31, [removed: 2009,] [added: 2020,] filed [removed: April 30, 2009.)](http://www.sec.gov/Archives/edgar/data/872589/000120677409000907/exhibit10-1.htm)] [added: February 8, 2021.)](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm)] | | |

| [removed: 10.1.2] [added: 10.2.6] + | | | [Form of [added: stock] option agreement and related notice of grant for use in connection with the grant of [removed: time based vesting] [added: non-qualified] stock options to the Registrant's non-employee directors under the [removed: Regeneron Pharmaceuticals, Inc. Second] Amended and Restated [removed: 2000] [added: Regeneron Pharmaceuticals, Inc. 2014] Long-Term Incentive Plan [removed: (revised).] [added: (revised 2018).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2011,] [added: 2018,] filed February [removed: 21, 2012.)](http://www.sec.gov/Archives/edgar/data/872589/000120677412000709/exhibit10-1_9.htm)] [added: 7, 2019.)](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10220xar2014ltipnq.htm)] | | |

| [removed: 10.1.3] [added: 10.2] + | | | [removed: [Amendment No. 1 to the] [added: [Amended and Restated] Regeneron Pharmaceuticals, Inc. [removed: Second Amended and Restated 2000] [added: 2014] Long-Term Incentive Plan. (Incorporated by reference from the [added: Registration Statement on] Form [removed: 10-K] [added: S-8] for the Registrant, [removed: for the year ended December 31, 2013,] filed [removed: February 13, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000153217614000008/exhibit10110.htm)] [added: June 12, 2017.)](https://www.sec.gov/Archives/edgar/data/872589/000110465917038718/a17-14867_1ex99d1.htm)] | | |

| [removed: 10.2] [added: 10.1] + | | | [removed: [Amended and Restated Regeneron Pharmaceuticals,] [added: [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,] Inc. [removed: 2014] [added: 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] Long-Term [removed: Incentive Plan. (Incorporated] [added: 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] by reference from the Registration Statement on Form S-8 for the Registrant, filed June [removed: 12, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000110465917038718/a17-14867_1ex99d1.htm)] [added: 16, 2014.)](https://www.sec.gov/Archives/edgar/data/872589/000119312514237593/d741943dex991.htm)] | | |

| [removed: 10.2.1] [added: 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 Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, [removed: 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex101.htm)] [added: 2014.)](https://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex101.htm)] | | |

| [removed: 10.2.2] [added: 10.1.2] + | | | [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 Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, [removed: 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex103.htm)] [added: 2014.)](https://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex103.htm)] | | |

| [removed: 10.2.3] [added: 10.1.3] + | | | [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 non-employee directors under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, [removed: 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex104.htm)] [added: 2014.)](https://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex104.htm)] | | |

| [removed: 10.2.4] [added: 10.1.4] + | | | [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 executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, [removed: 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d1.htm)] [added: 2015.)](https://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d1.htm)] | | |

| [removed: 10.2.5] [added: 10.1.5] + | | | [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 Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, [removed: 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d3.htm)] [added: 2015.)](https://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d3.htm)] | | |

| [removed: 10.2.6] [added: 10.1.6] + | | | [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, [removed: 2016.)](http://www.sec.gov/Archives/edgar/data/872589/000153217616000045/regn-ex_10210x12312015x10k.htm)] [added: 2016.)](https://www.sec.gov/Archives/edgar/data/872589/000153217616000045/regn-ex_10210x12312015x10k.htm)] | | |

| [removed: 10.2.7] [added: 10.2.1] + | | | [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 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, 2017, filed February 8, [removed: 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10211xar2014ltipnq.htm)] [added: 2018.)](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10211xar2014ltipnq.htm)] | | |

| [removed: 10.2.8] [added: 10.2.2] + | | | [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. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, [removed: 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10215xar2014ltiprs.htm)] [added: 2018.)](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10215xar2014ltiprs.htm)] | | |

| [removed: 10.2.9] [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 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, 2017, filed February 8, [removed: 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10216xar2014ltipnq.htm)] [added: 2018.)](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10216xar2014ltipnq.htm)] | | |

| [removed: 10.2.10] [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 executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2018). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, [removed: 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10217xstockoptiona.htm)] [added: 2019.)](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10217xstockoptiona.htm)] | | |

| [removed: 10.2.11] [added: 10.2.5] + | | | [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 2018). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, [removed: 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10219xar2014ltiprs.htm)] [added: 2019.)](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10219xar2014ltiprs.htm)] | | |

| [removed: 10.2.12] [added: 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 [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.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10220xar2014ltipnq.htm)] [added: 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm)] | | |

| [removed: 10.2.13] [added: 10.2.7] + | | | [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. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, [removed: 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10221xar2014ltiprs.htm)] [added: 2019.)](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10221xar2014ltiprs.htm)] | | |

| [removed: 10.2.14] [added: 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, [removed: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)] [added: 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)] | | |

| [removed: 10.2.15] [added: 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, [removed: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10219ar2014ltip.htm)] [added: 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10219ar2014ltip.htm)] | | |

| [removed: 10.2.16] [added: 10.2.11] + | | | [Form of [added: restricted] stock [removed: option] [added: unit award] agreement and related notice of grant for use in connection with the grant of [removed: non-qualified] [added: restricted] stock [removed: options] [added: 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, [removed: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm)] [added: 2020.)](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10221ar2014ltip.htm)] | | |

| [removed: 10.2.17] [added: 10.3.4] + | | | [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 [removed: Plan (revised 2019).] [added: Plan.] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2019,] [added: 2020,] filed February [removed: 7, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10221ar2014ltip.htm)] [added: 8, 2021.)](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1036x12312020x10k.htm)] | | |

| [removed: 10.3] [added: 10.6] + | | | [removed: [Second Amended and Restated Regeneron] [added: [Regeneron] Pharmaceuticals, Inc. [removed: 2014 Long-Term] [added: Cash] Incentive [added: Bonus] Plan. (Incorporated by reference from the [removed: Registration Statement on] Form [removed: S-8] [added: 8-K] for the Registrant, filed June [removed: 16, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000110465920073764/tm2022552d1_ex99-1.htm)] [added: 17, 2015.)](https://www.sec.gov/Archives/edgar/data/872589/000110465915045962/a15-14252_1ex10d1.htm)] | | |

| [removed: 10.3.1] [added: 10.3.3] + | | | [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 [removed: executive officers] [added: non-employee directors] under the Second 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, 2020, filed February 8, [removed: 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm)] [added: 2021.)](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1035x12312020x10k.htm)] | | |

| 10.3.2 + | | | [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 Second 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, 2020, filed February 8, [removed: 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm)] [added: 2021.)](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm)] | | |

| [removed: 10.3.3] [added: 10.3.6] + | | | [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 Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.] [added: Plan (revised 2023).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2020,] [added: 2023,] filed February [removed: 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1035x12312020x10k.htm)] [added: 5, 2024.)](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1036x12312023x10k.htm)] | | |

| [removed: 10.3.4] [added: 10.3.5] + | | | [Form of [added: performance] restricted stock unit award agreement and related notice of grant for use in connection with the grant of [added: performance] restricted stock units to [removed: the Registrant's non-employee directors] [added: Leonard S. Schleifer, M.D., Ph.D. and George D. Yancopoulos, M.D., Ph.D.] under the Second 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, 2020, filed February 8, [removed: 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1036x12312020x10k.htm)] [added: 2021.)](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1037x12312020x10k.htm)] | | |

| [removed: 10.3.5] [added: 10.3.7] + | | | [Form of [removed: performance] restricted stock [removed: unit] award agreement and related notice of grant for use in connection with the grant of [removed: performance] restricted stock [removed: units] [added: awards] to [removed: Leonard S. Schleifer, M.D., Ph.D. and George D. Yancopoulos, M.D., Ph.D.] [added: the Registrant's executive officers] under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.] [added: Plan (revised 2023).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2020,] [added: 2023,] filed February [removed: 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1037x12312020x10k.htm)] [added: 5, 2024.)](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1037x12312023x10k.htm)] | | |

| 10.4 + | | | [Amended and Restated Employment Agreement, dated as of November 14, 2008, between the Registrant and Leonard S. Schleifer, M.D., Ph.D. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2008, filed February 26, [removed: 2009.)](http://www.sec.gov/Archives/edgar/data/872589/000120677409000338/exhibit10-3.htm)] [added: 2009.)](https://www.sec.gov/Archives/edgar/data/872589/000120677409000338/exhibit10-3.htm)] | | |

| 10.4.1 + | | | [Waiver and Consent, dated as of April 14, 2023, pursuant to the Amended and Restated Employment Agreement, dated as of November 14, 2008, between the Registrant and Leonard S. Schleifer, M.D., [removed: Ph.D.](http://www.sec.gov/Archives/edgar/data/872589/000180422023000023/regn-ex_103x6302023x10q.htm) [(Incorporated] [added: Ph.D. (Incorporated] by reference from the Form 10-Q for the [removed: Registrant,](http://www.sec.gov/Archives/edgar/data/872589/000180422023000023/regn-ex_103x6302023x10q.htm) [for] [added: Registrant, for] the quarter ended [removed: June](http://www.sec.gov/Archives/edgar/data/872589/000180422023000023/regn-ex_103x6302023x10q.htm) [30, 2023,](http://www.sec.gov/Archives/edgar/data/872589/000180422023000023/regn-ex_103x6302023x10q.htm) [filed](http://www.sec.gov/Archives/edgar/data/872589/000180422023000023/regn-ex_103x6302023x10q.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422023000023/regn-ex_103x6302023x10q.htm)[August] [added: June 30, 2023, filed August] 3, [removed: 2023](http://www.sec.gov/Archives/edgar/data/872589/000180422023000023/regn-ex_103x6302023x10q.htm)[.)](http://www.sec.gov/Archives/edgar/data/872589/000180422023000023/regn-ex_103x6302023x10q.htm)] [added: 2023.)](https://www.sec.gov/Archives/edgar/data/872589/000180422023000023/regn-ex_103x6302023x10q.htm)] | | |

| [removed: 10.6] [added: 10.5] + | | | [Regeneron Pharmaceuticals, Inc. Change in Control Severance Plan, amended and restated effective as of November 14, 2008. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2008, filed February 26, [removed: 2009.)](http://www.sec.gov/Archives/edgar/data/872589/000120677409000338/exhibit10-5.htm)] [added: 2009.)](https://www.sec.gov/Archives/edgar/data/872589/000120677409000338/exhibit10-5.htm)] | | |

| [removed: 10.7] [added: 10.6.1] + | | | [removed: [Regeneron Pharmaceuticals, Inc.] [added: [First Amendment to] Cash Incentive Bonus Plan. (Incorporated by reference from the Form [removed: 8-K] [added: 10-Q] for the Registrant, [added: for the quarter ended March 31, 2023,] filed [removed: June 17, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915045962/a15-14252_1ex10d1.htm)] [added: May 4, 2023.)](https://www.sec.gov/Archives/edgar/data/872589/000180422023000016/regn-ex_101x3312023x10q.htm)] | | |

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

| 10.18.4 | | | [Amendment No. 2 to Master Agreement, dated as of March 7, 2024, by and 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 Alnylam Pharmaceuticals, 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 by reference from the Form 10-Q for the Registrant, for the quarter 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) | | |

| | | | | | |

| --- | --- | --- | --- | --- | --- |

| 10.3.6 + | | | [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 Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1036x12312023x10k.htm) [(revised 2023)](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1036x12312023x10k.htm)[.](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1036x12312023x10k.htm) | | |

| 10.3.7 + | | | [Form of](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1037x12312023x10k.htm) [restricted stock award](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1037x12312023x10k.htm) [agreement and related notice of grant for use in connection with the grant of](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1037x12312023x10k.htm) [restric](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1037x12312023x10k.htm)[ted stock awards](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1037x12312023x10k.htm) [to the Registrant's executive officers under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2023).](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1037x12312023x10k.htm) | | |

| 10.5 + | | | [Offer Letter for Robert E. Landry effective September 9, 2013. (Incorporated by reference from the Form 8-K for the Registrant, filed September 12, 2013.)](http://www.sec.gov/Archives/edgar/data/872589/000119312513365438/d596986dex101.htm) | | |

| Date: | | | February 5, [removed: 2024] [added: 2025] | | | | | | By: | | | /s/ LEONARD S. SCHLEIFER | | | | | |

| /s/ LEONARD S. SCHLEIFER | | | | | | *Board [removed: Co-Chair,] [added: co-Chair,] President and Chief Executive Officer (Principal Executive Officer)* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ [removed: ROBERT E. LANDRY] [added: CHRISTOPHER FENIMORE] | | | | | | *Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer)* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ [removed: CHRISTOPHER FENIMORE] [added: JASON PITOFSKY] | | | | | | [removed: *Senior Vice] [added: *Vice] President, Controller (Principal Accounting Officer)* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ GEORGE D. YANCOPOULOS | | | | | | *Board [removed: Co-Chair,] [added: co-Chair,] President and Chief Scientific Officer* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ BONNIE L. BASSLER | | | | | | *Director* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ MICHAEL S. BROWN | | | | | | *Director* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ N. ANTHONY COLES | | | | | | *Director* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ JOSEPH L. GOLDSTEIN | | | | | | *Director* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ KATHRYN GUARINI | | | | | | *Director* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ CHRISTINE A. POON | | | | | | *Director* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ ARTHUR F. RYAN | | | | | | *Director* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ DAVID P. SCHENKEIN | | | | | | *Director* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ GEORGE L. SING | | | | | | *Director* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ CRAIG B. THOMPSON | | | | | | *Director* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| /s/ HUDA Y. ZOGHBI | | | | | | *Director* | | | | | | February 5, [removed: 2024] [added: 2025] | | |

| [Report of Independent Registered Public Accounting Firm (PCAOB [removed: ID](#icad69a7485714b89bcccabdab8d6701b_100) 238[)](#icad69a7485714b89bcccabdab8d6701b_100)] [added: ID](#i66ff2c03559b4ab89799d79d457200d6_106) 238[)](#i66ff2c03559b4ab89799d79d457200d6_106)] | | | | | | [removed: [F-](#icad69a7485714b89bcccabdab8d6701b_100)[2](#icad69a7485714b89bcccabdab8d6701b_100)] [added: [F-](#i66ff2c03559b4ab89799d79d457200d6_106)[2](#i66ff2c03559b4ab89799d79d457200d6_106)] | | |

| [Consolidated Balance Sheets as of December 31, [removed: 202](#icad69a7485714b89bcccabdab8d6701b_103)[3](#icad69a7485714b89bcccabdab8d6701b_103)] [added: 202](#i66ff2c03559b4ab89799d79d457200d6_109)[4](#i66ff2c03559b4ab89799d79d457200d6_109)] [and [removed: 202](#icad69a7485714b89bcccabdab8d6701b_103)[2](#icad69a7485714b89bcccabdab8d6701b_103)] [added: 202](#i66ff2c03559b4ab89799d79d457200d6_109)[3](#i66ff2c03559b4ab89799d79d457200d6_109)] | | | | | | [removed: [F-](#icad69a7485714b89bcccabdab8d6701b_103)[4](#icad69a7485714b89bcccabdab8d6701b_103)] [added: [F-](#i66ff2c03559b4ab89799d79d457200d6_109)[4](#i66ff2c03559b4ab89799d79d457200d6_109)] | | |