Regeneron Pharmaceuticals (REGN) 10-K risk factor changes: FY2023 vs FY2022

[removed: - Our business] [added: The COVID-19 pandemic previously adversely affected, and the COVID-19 pandemic or other actual or threatened public health outbreaks, epidemics, or pandemics] may [removed: be further] [added: in the future] adversely [removed: affected by] [added: affect, among other things,] the [removed: effects] [added: economic and financial markets and labor resources] of the [removed: COVID-19 pandemic, including those impacting] [added: countries in which we operate;] our manufacturing and supply chain operations, research and development efforts, commercial operations and sales force, administrative personnel, third-party service providers, and business partners and [removed: customers, as well as] [added: customers; and] the demand for our marketed products.

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

- [removed: Sales of our products are dependent on the availability and extent of] [added: Product] reimbursement [removed: from third-party payors, including private payors] and [removed: government programs such as Medicare] [added: coverage policies] and [removed: Medicaid, which] [added: practices] could change due to various factors such as drug price control measures that have been or may be enacted or introduced in the United States by various federal and state authorities.

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

- We and our collaborators on which we rely to commercialize some of our marketed products may be unable to continue to successfully commercialize or co-commercialize our products, both in [added: and outside] the United [removed: States and abroad.][added: States.]

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

- Tax liabilities and risks associated with our operations outside [removed: of] the United States could adversely affect our business.

- If our collaborations with Sanofi or Bayer or other third parties are terminated or breached, our ability to develop, manufacture, and commercialize certain of our products and product candidates in the time expected, or at all, [removed: would] [added: may] be materially harmed.

- We have undertaken and may in the future undertake strategic acquisitions, and any difficulties from integrating such acquisitions [added: or failure to realize the expected benefits from such acquisitions] could adversely affect our business, operating results, and financial condition.

Other Risks [removed: Factors – Risks] Related to [removed: Employees, Information Technology, Financial Results and Liquidity,] [added: Our Business] and Our Common Stock

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

[removed: These and similar, and perhaps more severe,] [added: Such] disruptions in our operations [removed: may] [added: could] materially adversely impact our business, prospects, operating results, and financial condition.

To the extent [removed: the COVID-19] [added: a public health outbreak, epidemic, or] pandemic adversely affects our business, prospects, operating results, or financial condition, it may also have the effect of heightening many of the other risks described in this "Risk Factors" section.

Depending on the demand for our products [removed: (including any future demand for our COVID-19 monoclonal antibodies), our ability to re-establish successfully our customary manufacturing cadence,] and other relevant factors, we may not be able to replenish our inventory safety stock to the levels we deem prudent or supply our products and product candidates in sufficient [added: quantities to satisfy our commercial and development needs.]

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

For the years ended December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022, our aggregate] EYLEA [added: HD and EYLEA] net product sales in the United States represented [removed: 51%] [added: 45%] and [removed: 36%] [added: 51%] of our total revenues, [removed: respectively, with EYLEA net product sales as a percentage of our total revenues for the year ended December 31, 2021 being significantly lower due to the net product sales of REGEN-COV we recorded in that period under our agreements with the U.S. government.][added: respectively.]

If we [removed: were to experience difficulty with the commercialization of EYLEA in the United States] or [removed: if Bayer] [added: Sanofi] were to experience any difficulty with the commercialization of [removed: EYLEA outside the United States (including as a result of the COVID-19 pandemic discussed above),] [added: Dupixent] or if we [removed: and Bayer] [added: or Sanofi] are unable to maintain current marketing approvals of [removed: EYLEA,] [added: Dupixent,] we may experience a reduction in revenue and [removed: may not be able to sustain profitability, and] our business, prospects, operating results, and financial condition [removed: would] [added: may] be materially harmed.

[removed: While we have submitted a BLA for aflibercept 8 mg with the FDA, the] [added: The] degree to which [removed: any future] [added: EYLEA HD] net product sales [removed: of aflibercept 8 mg (if approved)] may offset any potential decrease in EYLEA net product [removed: sales] [added: sales, resulting from the factors discussed above or otherwise,] is [removed: highly] uncertain.

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

[removed: If we or Sanofi] [added: Bayer] were to experience any difficulty with the commercialization of [removed: Dupixent] [added: EYLEA HD] or [added: EYLEA outside the United States,] if [removed: we] [added: EYLEA net product sales experience a sustained decline in] or [removed: Sanofi] [added: outside the United States without an offset from EYLEA HD net product sales, or if we and Bayer] are unable to maintain [removed: current] [added: or obtain] marketing approvals of [removed: Dupixent,] [added: these products (as applicable),] we may experience a reduction in revenue and [added: 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 [removed: would] [added: may] be materially harmed.

- our ability and our collaborators' ability to maintain sales of our marketed products in the face of competitive products and to differentiate our marketed products from competitive products, including as applicable product candidates currently in clinical [removed: development (such as aflibercept 8 mg);] [added: development;] and, in the case of [removed: EYLEA,] [added: EYLEA and EYLEA HD,] the existing and potential new branded and biosimilar competition [removed: for EYLEA] (discussed further under "*The commercial success of our products and product candidates is subject to significant competition -* Marketed Products" below) and the willingness of retinal specialists and patients to start or continue treatment with [removed: EYLEA] [added: such products] or to switch from [removed: another] [added: a competitive] product to [removed: EYLEA;][added: one of our products;]

- the effect of existing and new health care laws and regulations currently being considered or implemented in the United [removed: States,] [added: 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;

- the outcome of the pending proceedings relating to [removed: EYLEA, Praluent,] [added: EYLEA] 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);

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, [added: Japan,] and other countries where such products are approved.

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

Sales of our marketed products are dependent on the availability and extent of [added: coverage and] reimbursement from third-party [removed: payors, and changes to such reimbursement may materially harm our business, prospects, operating results, and financial condition.][added: payors.]

Sales of our marketed products in other countries are [added: also] dependent, in large part, on [removed: similar] [added: complex coverage and] reimbursement mechanisms and programs in those countries.

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

Given cost sensitivities in many health care [removed: systems (which may continue to be exacerbated as a result of the COVID-19 pandemic),] [added: 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 [removed: Code, formulary approval by PBMs, and recognition by insurance companies and CMS.]

Some states [removed: are] [added: have] also [added: enacted or are] considering legislation [removed: that would] [added: to] control the prices and reimbursement of prescription drugs, and 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.

Further, there have been several recent U.S. Congressional inquiries and recently approved or proposed federal and state [removed: legislation] [added: legislation, regulations,] and policies (in addition to those already in effect) designed to, among other things, bring more transparency to drug pricing, review the relationship between pricing and manufacturer patient programs, reduce the out-of-pocket cost of prescription drugs, and reform government program reimbursement methodologies for drugs.

While enacted into law, it is [added: currently] unclear [removed: how] the [removed: provisions of the IRA will be implemented and the] extent to which the policy changes will ultimately impact reimbursement levels of our marketed products, including those covered under Medicare Part B (such as [removed: EYLEA)] [added: EYLEA and EYLEA HD)] or our product candidates that may [removed: in the future] be covered under Medicare Part B [removed: (such as aflibercept 8 mg).][added: or Medicare Part D in the future.]

A reduction in the availability or extent of reimbursement from U.S. government programs (including as a result of the legislation, proposals, initiatives, and developments described above) could have a material adverse effect on the sales of [added: EYLEA,] EYLEA [added: HD,] or our other marketed products.

In [removed: certain foreign countries,] [added: many countries outside the United States,] pricing, coverage, and level of reimbursement of prescription drugs are subject to governmental control, and we and our collaborators may be unable to obtain coverage, pricing, and/or reimbursement on terms that are favorable to us or necessary for us or our collaborators to successfully commercialize our marketed products in those countries.

In some [removed: foreign] [added: of these] countries, the proposed pricing for a drug must be approved before it may be lawfully marketed.

[added: The requirements] governing drug pricing and reimbursement vary widely from country to country, and may take into account the clinical effectiveness, cost, and service impact of existing, new, and emerging drugs and treatments.

Our results of operations may suffer if we or our collaborators are unable to market our products in [removed: foreign] countries [added: outside the United States] or if coverage and reimbursement for our marketed products in [removed: foreign] [added: such] countries is limited or delayed.

*EYLEA and [removed: (if approved) aflibercept 8 mg.*] EYLEA [removed: faces and, if approved, aflibercept 8 mg will face,] [added: HD.* EYLEA and EYLEA HD face] significant competition in the marketplace.

[removed: For example, EYLEA competes in one or more of its approved indications with other VEGF inhibitors, including Novartis and Genentech/Roche's Lucentis, Novartis' Beovu, and Genentech/Roche's Susvimo and Vabysmo, as well as biosimilar versions of Lucentis commercialized in the United States by Biogen Inc. and Coherus BioSciences, Inc.] 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 [added: and EYLEA HD's respective] indications, and we are aware of another company developing an ophthalmic formulation of such product.

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- Sales of our products are dependent on the availability and extent of coverage and reimbursement from third-party payors, including private payors and government programs such as Medicare and Medicaid.

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

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

EYLEA net product sales have historically represented a substantial portion of our revenues, and we expect that there will continue to be a concentration of our net sales from the net product sales of EYLEA HD and EYLEA.

For the year ended December 31, 2023, aggregate EYLEA HD U.S. and EYLEA U.S. net product sales decreased by 6%, compared to the same period in 2022.

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

If we were to experience difficulty with the commercialization of EYLEA HD or EYLEA in the United States or if

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

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If we or our collaborators do not maintain regulatory approval for our marketed products, and obtain regulatory approval for our product candidates or new indications for our marketed products, we will not be able to market or sell them, which would materially and negatively impact our business, prospects, operating results, and financial condition.*"), the applicable marketing approval may be withdrawn, which would materially harm our business, prospects, operating results, and financial condition.

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

As discussed below under "*If we are unable to establish commercial capabilities outside the United States for 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 develop commercial capabilities outside the United States (including those necessary for our successful commercialization and co-commercialization of Libtayo and Dupixent, respectively).

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

Private payor healthcare and insurance providers, health maintenance organizations, and PBMs are increasingly requiring significant discounts and rebates from manufacturers as a condition to including products on formulary with favorable coverage and copayment/coinsurance.

Notably, in 2022 the U.S. Congress passed the IRA, which includes, among other items, provisions regarding the following:

- *Implementation of a Medicare Drug Price Negotiation Program* (the "Medicare Drug Price Negotiation Program").

The Medicare Drug Price Negotiation Program requires the government to set prices for select high-expenditure drugs covered under Medicare Parts B and D.

Starting in 2023 and 2026, the government is authorized to select Part D and Part B drugs, respectively, for inclusion in the Medicare Drug Price Negotiation Program, with established prices to go into effect for selected Part D drugs in 2026 and for selected Part B drugs in 2028, in each case absent certain disqualifying events.

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- *Medicare Inflation Based Rebates*.

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

- *Medicare Part D Program Redesign*.

The IRA implements changes to the Medicare Part D benefits to limit patient out-of-pocket drug costs and shift program liabilities from patients to other stakeholders, including health plans, manufacturers, and the government.

For example, each of EYLEA and EYLEA HD competes in one or more of its approved indications with other VEGF inhibitors.

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

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

In asthma, competitors to Dupixent include antibodies against the IL-5 ligand or the IL-5 receptor, immunoglobulin E, or thymic stromal lymphopoietin

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For additional information regarding our collaborations with Bayer and Sanofi, see "Risks Related to Our Reliance on or Transactions with Third Parties - *If our collaboration with Bayer for EYLEA HD and EYLEA is terminated, or Bayer materially breaches its obligations thereunder,*

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these products to healthcare providers.

Commercialization of any of our marketed products may also be adversely impacted by vertical integration of private payor healthcare and insurance programs, health maintenance organizations, and PBMs, or further consolidation among the healthcare providers served by our distributor customers if, for example, one or more consolidated groups of healthcare providers determines not to use (or decides to switch from) such marketed product in favor of a competing product.

See also "*The commercial success of our products and product candidates is subject to significant competition -* Marketed Products" above.

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).

We must obtain and maintain similar regulatory approvals from comparable foreign regulatory authorities in order to sell drugs outside the United States.

Risks Related to the COVID-19 Pandemic

- We face risks related to the development, manufacturing, and potential future commercialization of monoclonal antibodies targeting SARS-CoV-2.

- We may need additional funding in the future, which may not be available to us, and which may force us to delay, reduce, or eliminate our product development programs or commercialization efforts.

Our business may be further adversely affected by the effects of the COVID-19 pandemic.

In December 2019, a novel strain of coronavirus, SARS-CoV-2, causing a disease referred to as COVID-19, was reported to have surfaced in Wuhan, China.

It has since spread around the world, evolved into multiple new variants, and caused a global pandemic.

This pandemic has adversely affected and/or has the potential to adversely affect, among other things, the economic and financial markets and labor resources of the countries in which we operate; our manufacturing and supply chain operations, research and development efforts, commercial operations and sales force, administrative personnel, third-party service providers, and business partners and customers; and the demand for our marketed products.

The COVID-19 pandemic has previously resulted and may again result in the imposition of various restrictions and mandates around the world to reduce the spread of the disease, including governmental orders that direct individuals to shelter at their places of residence, direct businesses and governmental agencies to cease non-essential operations at physical locations, prohibit certain non-essential gatherings, maintain social distancing, order cessation of non-essential travel, and require proof of vaccination and/or negative COVID-19 test results.

The COVID-19 pandemic has continued to ebb and flow, with different jurisdictions having higher levels of infections than others and new variants of the SARS-CoV-2 virus (such as the Omicron-lineage variants) emerging and spreading more easily and quickly than other variants.

The trajectory and the ultimate impact of the pandemic are highly uncertain and subject to change and we do not yet know the full extent of potential delays or impacts on our business, our clinical trials, healthcare systems, or the global economy as a whole.

These effects could have a material impact on our operations.

By way of example, continuation or re-imposition of various government-imposed or private-sector measures relating to the COVID-19 pandemic (including those we previously implemented, such as work-from-home policies for some employees) may further negatively impact productivity, disrupt our business, and delay our clinical programs and development timelines beyond the delays we have already experienced and disclosed.

Such restrictions and limitations may also further negatively impact our access to regulatory authorities (which are affected, among other things, by applicable travel restrictions and may be delayed in responding to inquiries, reviewing filings, and conducting inspections); our ability to perform regularly scheduled quality checks and maintenance; and our ability to obtain services from third-party specialty vendors and other providers or to access their expertise as fully and timely as needed.

The COVID-19 pandemic may also result in the loss of some of our key personnel, either temporarily or permanently.

We and our employees may also be subject to government vaccine mandates, which may have a negative impact on our ability to retain employees or hire new employees and could adversely impact our business.

In addition, our sales and marketing efforts were previously negatively impacted and may be further negatively impacted by postponement or cancellation of face-to-face meetings and restrictions on access by non-essential personnel to hospitals or clinics to the extent such measures slow down adoption or further commercialization of our marketed products.

The demand for our marketed products may also be adversely impacted by the restrictions and limitations adopted in response to the COVID-19 pandemic, particularly to the extent they affect the patients' ability or willingness to start or continue treatment with our marketed products.

Any of the foregoing factors may result in lower net product sales of our marketed products.

For example, net product sales of EYLEA in the United States decreased for the three months ended June 30, 2020, compared to the same period in 2019, due in part to the impact of the COVID-19 pandemic.

Demand for some or all of our marketed products may be further reduced if shelter-in-place, social distancing, or similar orders remain in effect or are re-implemented and, as a result, some of our inventory may become obsolete and may need to be written off, impacting our operating results.

Various government-imposed or private-sector measures relating to the COVID-19 pandemic (or the perception that such restrictions or limitations on the conduct of business operations could occur) previously impacted, and may impact in the future, personnel at our research and manufacturing facilities, our suppliers, and other third parties on which we rely, as well as the availability or cost of materials produced by or purchased from such parties, resulting in supply chain strains or disruptions that may become material.

While some materials and services may be obtained from more than one supplier or provider, port closures and other restrictions, whether resulting from the COVID-19 pandemic or otherwise (including any government restrictions or limitations, such as those that may be imposed under the Defense Production Act), could materially disrupt our supply chain or limit our ability to obtain sufficient materials or services (including fill/finish services) required for the development and manufacturing of our products and product candidates as well as our research efforts.

If microbial, viral (including COVID-19), or other contaminations are discovered in our products, product candidates, the materials used for their production, or in our facilities, or in the facilities of our collaborators, third-party contract manufacturers, or other providers or suppliers, the affected facilities may need to be closed or may otherwise be affected for an extended period of time, or the contamination may result in other delays or disruptions in our direct or indirect supply chain.

In addition, infections, hospitalizations, and deaths related to COVID-19 previously disrupted and may in the future disrupt the healthcare and healthcare regulatory systems in the United States and abroad.

These and other possible disruptions relating to the COVID-19 pandemic could divert healthcare resources away from, or materially delay, regulatory review and potential approval of our product candidates and new indications for our marketed products.

In addition, some of our clinical trials were previously and may in the future be affected by the COVID-19 pandemic.

This impact could result in further delays in site initiation and patient enrollment due to prioritization of hospital resources toward the COVID-19 pandemic, patients' inability to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, and restrictions on trial initiations imposed by hospitals and other trial sites as a result of the COVID-19 pandemic.

Similarly, our ability to recruit and retain patients and principal investigators and site staff who, as healthcare providers, may have heightened exposure to COVID-19, was previously and may in the future be delayed or disrupted.

Any such disruptions may further negatively impact the progress of our clinical trials, including the readouts of trial results, the timing of regulatory review, and any anticipated program milestones.

While the potential economic impact brought by, and the duration of, the COVID-19 pandemic may be difficult to assess or predict, it previously caused significant disruption of global financial markets and could cause more economic disruption in the future, making it more difficult for us to access capital if needed.

In addition, a recession or market correction resulting from the spread of COVID-19 could materially affect our business and the value of our Common Stock.

We face risks related to the development, manufacturing, and potential future commercialization of monoclonal antibodies targeting SARS-CoV-2.

In response to the COVID-19 pandemic, we developed REGEN-COV (known as Ronapreve in countries outside the United States), a novel investigational antibody cocktail treatment designed to prevent and treat infection from the SARS-CoV-2 virus.

REGEN-COV received an EUA from the FDA in November 2020 for the treatment of mild to moderate COVID-19 in certain patients, which was revised in January 2022 to exclude its use in geographic regions (currently including all U.S. states, territories, and jurisdictions) where infection or exposure is likely due to a variant such as an Omicron-lineage variant that is not susceptible to the treatment.

In December 2022, the FDA issued a complete response letter concerning our BLA for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.

In light of these developments, we cannot predict whether (if at all) or to what extent REGEN-COV may be reauthorized or approved for use by the FDA in the future.

As discussed in this report, we are progressing "next generation" monoclonal antibodies targeting SARS-CoV-2 (together with REGEN-COV referred to below as "our COVID-19 monoclonal antibodies").

There can be no assurance as to the timing or success of any of these efforts or studies evaluating "next generation" antibodies and whether any of such antibodies will retain activity against present or future variants of concern.

We also face risks related to our significant investment in the development, supply, allocation, distribution, pricing, and potential future commercialization of our COVID-19 monoclonal antibodies.

We have committed and may continue to commit significant capital and resources to fund and supply clinical trials and to accelerate and scale up the production of our COVID-19 monoclonal antibodies, which involves a complex manufacturing process that is both resource- and time-sensitive.

Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2021] [added: 2022] (filed with the SEC on February [removed: 7, 2022)] [added: 6, 2023)] for additional discussion of our financial condition and results of operations for the year ended December 31, [removed: 2020,] [added: 2021,] as well as our financial condition and results of operations for the year ended December 31, [removed: 2021] [added: 2022] compared to the year ended December 31, [removed: 2020.*][added: 2021.*]

[removed: We currently] [added: Our research and development efforts] have [removed: nine] [added: led to eleven] FDA-approved products that have received marketing approval and approximately 35 product candidates in clinical development, almost all 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 continued success in commercializing EYLEA and Dupixent, as well as [removed: on] whether we are [removed: able to obtain regulatory approval for aflibercept 8 mg and are] successful in commercializing [removed: it.][added: EYLEA HD.]

[removed: Revenue Recognition - Product] [added: Product] Revenue

[added: We] review our estimates of rebates, chargebacks, and other applicable provisions each period and record any necessary adjustments in the current period's net product sales.

In agreements involving multiple goods or services promised to be transferred to our collaborator, we [removed: must] assess, at the inception of the contract, whether each promise represents a separate obligation (i.e., is "distinct"), or whether such promises should be combined as a single unit of account.

When we have a combined unit of account which includes a license and providing research and development services to our collaborator, recognition of up-front payments and development milestones earned from our collaborator is deferred (as a liability) and recognized over the development period (i.e., over time) typically using an input method on the basis of our research and development costs incurred relative to the total expected cost which determines the extent of our progress toward [removed: completion (see "Results of Operations - Expenses - Other Operating (Income) Expense" below for further information related to amounts recognized in connection with such estimates).][added: completion.]

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

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

The expected dividend yield is zero as we have never paid dividends and do not currently [removed: anticipate paying any in the foreseeable future.][added: have plans to do so.]

We use a Monte Carlo simulation to compute the estimated fair value of performance-based restricted stock units that are subject to vesting based on the Company's attainment of pre-established [removed: performance] criteria that include a market condition.

[removed: The Company recognizes] [added: We recognize] the financial statement effects of a tax position when [removed: management's] [added: our] assessment is that there is more than a 50% probability that the position will be sustained upon examination by a taxing authority based upon its technical merits.

Significant judgment is required in making this assessment, and, therefore, we re-evaluate uncertain tax positions and consider various factors, including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, [added: the effective settlement of matters subject to audit, information obtained during in-process audit activities,] and changes in facts or circumstances related to a tax position.

Intangible assets acquired in [added: a business combination are recorded at fair value, while intangible assets acquired in] connection with an asset acquisition are recorded at cost.

[removed: Intangible] [added: Definite-lived intangible] assets are amortized over the estimated useful lives of the assets based on the pattern in which the economic benefits of the intangible assets are consumed; if that pattern cannot be reliably determined, a straight-line basis is used.

If contingent consideration is recognized subsequent to the acquisition date in an asset acquisition, the amount of such consideration is recorded as an addition to the cost basis of the [added: intangible asset with a cumulative catch-up adjustment for amortization expense as if the additional amount of consideration had been accrued from the outset of the acquisition.]

[removed: Our intangible] [added: Intangible] assets are reviewed for recoverability whenever events or changes in circumstances (e.g., changes in economic, regulatory, or legal conditions) indicate that the carrying amount of the asset may not be recoverable.

See Note [removed: 8] [added: 1] to our Consolidated Financial Statements for [removed: further information related to our intangible assets.][added: a description of recently issued accounting standards.]

| *(In millions, except per share data)* | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |

| Revenues | | | $ | [removed: 12,172.9] [added: 13,117.2] | | | | | $ | [removed: 16,071.7] [added: 12,172.9] | | | | | $ | [removed: 8,497.1] [added: 16,071.7] | |

| Operating expenses | | | [removed: 7,434.0] [added: 9,070.1] | | | | | | [removed: 7,124.9] [added: 7,434.0] | | | | | | [removed: 4,920.5] [added: 7,124.9] | | |

| Income from operations | | | [removed: 4,738.9] [added: 4,047.1] | | | | | | [removed: 8,946.8] [added: 4,738.9] | | | | | | [removed: 3,576.6] [added: 8,946.8] | | |

| Other income (expense) | | | [removed: 119.9] [added: 152.2] | | | | | | [removed: 379.0] [added: 119.9] | | | | | | [removed: 233.8] [added: 379.0] | | |

| Income before income taxes | | | [removed: 4,858.8] [added: 4,199.3] | | | | | | [removed: 9,325.8] [added: 4,858.8] | | | | | | [removed: 3,810.4] [added: 9,325.8] | | |

| Income tax expense | | | [removed: 520.4] [added: 245.7] | | | | | | [removed: 1,250.5] [added: 520.4] | | | | | | [removed: 297.2] [added: 1,250.5] | | |

| Net income | | | $ | [removed: 4,338.4] [added: 3,953.6] | | | | | $ | [removed: 8,075.3] [added: 4,338.4] | | | | | $ | [removed: 3,513.2] [added: 8,075.3] | |

| Net income per share - diluted | | | $ | [removed: 38.22] [added: 34.77] | | | | | $ | [removed: 71.97] [added: 38.22] | | | | | $ | [removed: 30.52] [added: 71.97] | |

| *(In millions)* | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2022] [added: 2023] vs. [removed: 2021] [added: 2022] | | | | | | [removed: 2021] [added: 2022] vs. [removed: 2020] [added: 2021] | | |

| EYLEA - U.S. | | | [removed: $] [added: 5,719.6] | [removed: 6,264.6] | | | | | [removed: $] [added: 6,264.6] | [removed: 5,792.3] | | | | | [removed: $] [added: 5,792.3] | [removed: 4,947.2] | | | | | [removed: $] [added: (545.0)] | [removed: 472.3] | | | | | [removed: $] [added: 472.3] | [removed: 845.1] | |

| Libtayo - U.S. | | | [removed: 374.5] [added: 538.8] | | | | | | [removed: 306.3] [added: 374.5] | | | | | | [removed: 270.7] [added: 306.3] | | | | | | [removed: 68.2] [added: 164.3] | | | | | | [removed: 35.6] [added: 68.2] | | |

| Libtayo - [removed: ROW] [added: ROW*] | | | [removed: 73.0] [added: 324.3] | | | | | | [removed: —] [added: 73.0] | | | | | | — | | | | | | [removed: *] [added: 251.3] | | | | | | [removed: *] [added: 73.0] | | |

| Praluent - [removed: U.S.] [added: U.S.] | | | [removed: 130.0] [added: 182.4] | | | | | | [removed: 170.0] [added: 130.0] | | | | | | [removed: 150.9] [added: 170.0] | | | | | | [removed: (40.0)] [added: 52.4] | | | | | | [removed: *] [added: (40.0)] | | |

| REGEN-COV - U.S. | | | — | | | | | | [removed: 5,828.0] [added: —] | | | | | | [removed: 185.7] [added: 5,828.0] | | | | | | [removed: (5,828.0)] [added: —] | | | | | | [removed: 5,642.3] [added: (5,828.0)] | | |

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

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

| ARCALYST - [removed: U.S.*] [added: U.S.] | | | — | | | | | | [removed: 2.2] [added: —] | | | | | | [removed: 13.1] [added: 2.2] | | | | | | [removed: *] [added: —] | | | | | | [removed: *] [added: (2.2)] | | |

| Total net product sales | | | $ | [removed: 6,893.7] [added: 7,078.0] | | | | | $ | [removed: 12,117.2] [added: 6,893.7] | | | | | $ | [removed: 5,567.6] [added: 12,117.2] | | | | | $ | [removed: (5,294.3)] [added: 184.3] | | | | | $ | [removed: 6,541.4] [added: (5,223.5)] | |

| Sanofi | | | $ | [removed: 2,855.7] [added: 3,799.5] | | | | | $ | [removed: 1,902.2] [added: 2,855.7] | | | | | $ | [removed: 1,186.4] [added: 1,902.2] | | | | | $ | [removed: 953.5] [added: 943.8] | | | | | $ | [removed: 715.8] [added: 953.5] | |

| Bayer | | | [removed: 1,430.7] [added: 1,487.5] | | | | | | [removed: 1,409.3] [added: 1,430.7] | | | | | | [removed: 1,186.1] [added: 1,409.3] | | | | | | [removed: 21.4] [added: 56.8] | | | | | | [removed: 223.2] [added: 21.4] | | |

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

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

Acquisitions

We make certain judgments to determine whether a transaction should be accounted for as a business combination or as an asset acquisition.

In a business combination, the acquisition method of accounting generally requires that the assets acquired and liabilities assumed be recorded as of the date of the acquisition at their respective fair values.

There can be significant judgment involved in determining the estimated fair values of such assets and liabilities.

Amounts allocated to acquired in-process research and development are capitalized as indefinite-lived intangible assets.

Any excess of the purchase price (consideration transferred) over the fair values of net assets acquired is recorded as goodwill.

In a business combination, 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.

The fair value of contingent consideration liabilities is determined using inputs that may include the probability of achieving certain milestones and estimated discount rates.

If it is determined that the assets acquired do not meet the definition of a business, or if substantially all of the fair value of the assets acquired are concentrated in a single identifiable asset, then the transaction is accounted for as an asset acquisition rather than a business combination.

In an asset acquisition, assets acquired are recorded at cost, goodwill is not recorded, and acquired in-process research and development with no alternative future use is charged to expense.

Payments to acquire intangible assets in an asset acquisition may include up-front payments and contingent consideration.

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

Indefinite-lived intangible assets are subject to impairment testing until completion or abandonment of the associated research and development efforts.

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

| EYLEA HD - U.S. | | | $ | 165.8 | | | | | $ | — | | | | | $ | — | | | | | $ | 165.8 | | | | | $ | — | |

| Total EYLEA HD and EYLEA - U.S. | | | 5,885.4 | | | | | | 6,264.6 | | | | | | 5,792.3 | | | | | | (379.2) | | | | | | 472.3 | | |

| Total Libtayo - Global | | | 863.1 | | | | | | 447.5 | | | | | | 306.3 | | | | | | 415.6 | | | | | | 141.2 | | |

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.

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

| Provisions | | | 2,074.5 | | | | | | 439.2 | | | | | | 155.3 | | | | | | 2,669.0 | | |

| Credits/payments | | | (1,972.7) | | | | | | (388.3) | | | | | | (157.5) | | | | | | (2,518.5) | | |

| Balance as of December 31, 2023 | | | $ | 455.7 | | | | | $ | 162.3 | | | | | $ | 79.3 | | | | | $ | 697.3 | |

Global net product sales of Dupixent and Kevzara are recorded by Sanofi in connection with the Antibody Collaboration, and we and Sanofi share profits on such sales.

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

| Regeneron's share of profits in connection with commercialization of antibodies | | | | | | $ | 3,136.5 | | | | | $ | 2,082.0 | | | | | $ | 1,363.0 | |

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

| *(In millions)* | | | | | | 2023 | | | | | | 2022 | | | | | | 2021 | | |

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

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

| *(In millions)* | | | | | | 2023 | | | | | | 2022 | | | | | | 2021 | | |

| Regeneron's share of profits in connection with commercialization of EYLEA outside the United States | | | | | | $ | 1,376.4 | | | | | $ | 1,317.4 | | | | | $ | 1,349.2 | |

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

| *(In millions)* | | | | | | 2023 | | | | | | 2022 | | | | | | 2021 | | |

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

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

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

In addition, REGEN-COV was authorized under an EUA for COVID-19 from November 2020 until January 2022 when the EUA was revised to exclude its use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment (see Part I, Item 1.

"Business - Additional Information - Clinical Development Programs").

Refer to Part I, Item 1.

"Business - Products" and "Business - Programs in Clinical Development" for additional information related to marketed products and product candidates.

We

securities with maturities approximating the options' expected lives.

intangible asset with a cumulative catch-up adjustment for amortization expense as if the additional amount of consideration had been accrued from the outset of the acquisition.

As described in Part I, Item 1.

"Business - Collaboration, License, and Other Agreements - Sanofi - Immuno-Oncology," effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under the A&R IO LCA with Sanofi.

The transaction was accounted for as an asset acquisition and amounts paid to Sanofi in connection with obtaining the worldwide rights to Libtayo, including the up-front payment and any contingent consideration, are recorded as an intangible asset.

Due to the complexity of the terms of the amendments to the collaboration agreements in contemplation of the acquisition of the worldwide rights to Libtayo, significant judgment was applied in identifying the elements of the transaction and evaluating the timing and recognition of contingent consideration.

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

| * Not meaningful | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Net product sales of Praluent in the United States were recorded by Sanofi prior to April 1, 2020. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

Net product sales of EYLEA in the United States increased in 2022, compared to 2021, due to higher sales volume partly offset by an increase in sales-related deductions.

As described in Part I, Item.

1.

"Business - Agreements Related to COVID-19 - *U.S. Government*" for further details.

| Balance as of December 31, 2019 | | | $ | 80.3 | | | | | $ | 46.4 | | | | | $ | 29.4 | | | | | $ | 156.1 | |

| Provisions | | | 762.9 | | | | | | 279.9 | | | | | | 94.1 | | | | | | 1,136.9 | | |

| Credits/payments | | | (641.0) | | | | | | (249.1) | | | | | | (78.7) | | | | | | (968.8) | | |

In addition, the amount of our share of profits we earned in connection with commercialization of antibodies outside the United States was adversely impacted in 2022 by the U.S. dollar strengthening against foreign currencies, including the Japanese yen and the euro.

| Dupixent, Praluent, and Kevzara net product sales(a) | | | | | | $ | 9,039.2 | | | | | $ | 6,536.3 | | | | | $ | 4,394.5 | |

| (a) Global net product sales of Dupixent and Kevzara are recorded by Sanofi. The quarter ended March 31, 2020 was the last quarter for which Sanofi and the Company shared profits and losses in connection with Sanofi's global net sales and the related commercialization of Praluent (see further details below); therefore, the quarter ended March 31, 2020 was the last quarter for which net product sales of Praluent were included in the table above. | | | | | | | | | | | | | | | | | | | | |

"Business - Collaboration, License, and Other Agreements - Sanofi - Antibody", effective April 1, 2020, the Company became solely responsible for the development and commercialization of Praluent in the United States.

Under the new agreement, Sanofi is solely responsible for the development and commercialization of Praluent outside of the United States, and pays the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States.

We are entitled to receive the final sales milestone payment of $50.0 million that would be earned when such sales outside the United States exceed $3.0 billion on a rolling twelve-month basis.

The amount of the share of profits we earned in connection with commercialization of EYLEA outside the United States was adversely impacted in 2022 by the U.S. dollar strengthening against foreign currencies, including the Japanese yen and the euro.

Each quarter, a single payment is due from one party to the other to true-up the global gross profits between the parties.

If Regeneron is to receive a true-up payment from Roche, such amount will be recorded to collaboration revenue.

If Regeneron is to make a true-up payment to Roche, such amount will be recorded to Cost of goods sold.

During the years ended December 31, 2022 and 2021, the Company recognized $627.3 million and $361.8 million, respectively, of global gross profit payments from Roche within collaboration revenue.

| EYLEA and aflibercept 8 mg | | | | | | 81.2 | | | | | | 102.2 | | | | | | 72.2 | | | | | | (21.0) | | | | | | 30.0 | | |

Reimbursement of research and development expenses by collaborators included reimbursements from Roche related to REGEN-COV of $128.1 million for the year ended December 31, 2021.

For the year ended December 31, 2022, such reimbursements from Roche related to REGEN-COV were not material.

"Risk Factors".

Cost of goods sold decreased in 2022, compared to 2021, primarily due to the Company recognizing REGEN-COV net product sales (and corresponding cost of goods sold) in the United States during 2021 and a 2021 payment of $259.6 million owed in connection with global gross profits under our Roche collaboration agreement; such transactions did not recur in 2022.

Cost of goods sold also decreased during 2022 since effective July 1, 2022, as a result of the A&R IO LCA described in Part I, Item 1.

"Business - Collaboration, License, and Other Agreements - Sanofi - Immuno-Oncology", we are no longer obligated to pay Sanofi for their share of Libtayo U.S. gross profits (during the six months ended June 30, 2022, Cost of goods sold included $70.1 million related to our obligation for Sanofi's share of Libtayo U.S. gross profits compared to $133.0 million for full year 2021).

We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would have resulted in approximately a [removed: $102.7] [added: $98.7] million and [removed: $120.0] [added: $102.7] million decrease in the fair value of our investment portfolio as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] respectively.

Our interest rate exposure is [removed: primarily] offset by our investments in marketable securities.

In [added: 2023,] 2022, [removed: 2021,] and [removed: 2020,] [added: 2021,] we did not record any charges for credit-related impairments of our available-for-sale debt securities.

In [added: 2023,] 2022, [removed: 2021] and [removed: 2020,] [added: 2021,] 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: 2022,] [added: 2023,] two customers accounted on a combined basis for [removed: 86%] [added: 83%] of our net trade accounts receivables.

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

Therefore, 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 [removed: can] [added: may] impact our operating results and financial condition.

Our [removed: marketable securities] [added: investments] include equity [removed: investments in publicly traded stock of companies, including common stock] [added: securities] of companies with which we have entered into collaboration arrangements.

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

We recorded [removed: $39.8] [added: $237.8] million [removed: of net unrealized losses] and [removed: $386.1] [added: $39.8] million of net unrealized [removed: gains] [added: losses] on equity securities in Other income (expense), net in [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] respectively.

[removed: These] [added: *These] statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any such statements.

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

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

Our objective is to continue to [removed: be] [added: advance as] an integrated, multi-product biotechnology company that provides patients and medical professionals with important medicines for preventing and treating human diseases.

| *(In millions, except per share data)* | | | | | | [removed: 2022] [added: 2023] | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | |

| Revenues | | | | | | $ | [removed: 12,172.9] [added: 13,117.2] | | | | | $ | [removed: 16,071.7] [added: 12,172.9] | | | | | $ | [removed: 8,497.1] [added: 16,071.7] | |

| Net income | | | | | | $ | [removed: 4,338.4] [added: 3,953.6] | | | | | $ | [removed: 8,075.3] [added: 4,338.4] | | | | | $ | [removed: 3,513.2] [added: 8,075.3] | |

| Net income per share - diluted | | | | | | $ | [removed: 38.22] [added: 34.77] | | | | | $ | [removed: 71.97] [added: 38.22] | | | | | $ | [removed: 30.52] [added: 71.97] | |

| Product | | | | | | Disease | | | | | | Territory | | | | | | | | | | | | | | | [removed: | | | | | | | | | | | |]

| | | | | | | U.S. | | | | | | EU | | | | | | Japan | | | | | | [removed: ROW(e)] | | | [removed: | | | | | | | | | | | |]

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

| | | | | | | Diabetic macular edema ("DME") | | | | | | a | | | | | | a | | | | | | a | | | [removed: | | | a | | | | | | | | |]

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

| | | | | | | Myopic choroidal neovascularization ("mCNV") | | | | | | | | | | | | a | | | | | | a | | | [removed: | | | a | | | | | | | | |]

| | | | | | | Diabetic retinopathy ("DR") | | | | | | a | | | | | | | | | | | | | | | [removed: | | | | | | | | | | | |]

| | | | | | | Neovascular glaucoma ("NVG") | | | | | | | | | | | | | | | | | | a | | | [removed: | | | | | | | | | | | |]

| | | | | | | Retinopathy of prematurity ("ROP") | | | | | | [removed: | | | | | |] a | | | | | | a | | | | | | [removed: | | | | | |] [added: a] | | |

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

| | | | | | | [removed: Atopic dermatitis] [added: EoE] (in pediatrics [removed: 6–11] [added: 1–11] years of age) | | | | | | a | | | | | | [removed: a] | | | | | | | | | [removed: | | | a | | | | | | | | |]

| | | | | | | Asthma (in adults and adolescents) | | | | | | a | | | | | | a | | | | | | a | | | [removed: | | | a | | | | | | | | |]

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

| | | | | | | Chronic rhinosinusitis with nasal polyposis ("CRSwNP") | | | | | | a | | | | | | a | | | | | | a | | | [removed: | | | a | | | | | | | | |]

| Product (continued) | | | | | | Disease | | | | | | Territory | | | | | | | | | | | | | | | [removed: | | | | | | | | | | | |]

| [removed: Dupixent (dupilumab) Injection(b) *(continued)*] | | | | | | Eosinophilic esophagitis ("EoE") (in adults and adolescents) | | | | | | a | | | | | | a | | | | | | | | | [removed: | | | a | | | | | | | | |]

| | | | | | | Prurigo nodularis | | | | | | a | | | | | | a | | | | | | [removed: | | | | | |] a | | | [removed: | | | | | |]

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

| | | | | | | Metastatic or locally advanced first-line NSCLC (in combination with chemotherapy) | | | | | | a | | | | | | [removed: | | | | | | | | | | | |] [added: a] | | | | | | | | |

| | | | | | | Metastatic or locally advanced basal cell carcinoma ("BCC") | | | | | | a | | | | | | a | | | | | | | | | [removed: | | | a | | | | | | | | |]

| | | | | | | Metastatic or locally advanced cutaneous squamous cell carcinoma ("CSCC") | | | | | | a | | | | | | a | | | | | | | | | [removed: | | | a | | | | | | | | |]

| | | | | | | Metastatic or recurrent second-line cervical cancer | | | | | | | | | | | | a | | | | | | a | | | [removed: | | | a | | | | | | | | |]

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

| | | | | | | Cardiovascular risk reduction in patients with established cardiovascular disease | | | | | | a | | | | | | a | | | | | | | | | [removed: | | | a | | | | | | | | |]

| | | | | | | Homozygous familial hypercholesterolemia ("HoFH") | | | | | | a | | | | | | | | | | | | | | | [removed: | | | | | | | | | | | |]

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

| Kevzara (sarilumab) [removed: Solution for Subcutaneous] Injection(b) | | | | | | Rheumatoid arthritis ("RA") | | | | | | a | | | | | | a | | | | | | a | | | [removed: | | | a | | | | | | | | |]

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

| Inmazeb® (atoltivimab, maftivimab, and [removed: odesivimab-ebgn)] [added: odesivimab)] Injection | | | | | | Infection caused by *Zaire ebolavirus* | | | | | | a | | | | | | | | | | | | | | | [removed: | | | | | | | | | | | |]

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

| | | | | | | Deficiency of interleukin-1 receptor antagonist ("DIRA") (in [removed: adults] [added: adults, adolescents,] and pediatrics) | | | | | | a | | | | | | | | | | | | | | | [removed: | | | | | | | | | | | |]

| | | | | | | Recurrent pericarditis (in adults and adolescents) | | | | | | a | | | | | | | | | | | | | | | [removed: | | | | | | | | | | | |]

These statements concern, and these risks and uncertainties include, among others:*

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

*•the likelihood and timing of achieving any of our anticipated development milestones referenced in this report;*

*•safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials;*

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

*•the extent to which the results from the research and development programs conducted by us and/or our collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval;*

*•ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy;*

*•determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates;*

*•competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates;*

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

*•our ability to manufacture and manage supply chains for multiple products and product candidates;*

*•the ability of our collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates;*

*•the availability and extent of reimbursement of Regeneron's Products from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid;*

*•coverage and reimbursement determinations by such payors and new policies and procedures adopted by such payors;*

*•unanticipated expenses;*

*•the costs of developing, producing, and selling products; 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 potential for any license or collaboration agreement, including our agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated;*

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

*•risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings described further in Note 16 to our Consolidated Financial Statements included in this report), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described 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 of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

*factors identified under Part I, Item 1A.

Certain products have also received marketing approval in countries outside the United States, European Union ("EU"), or Japan.

| EYLEA® (aflibercept) Injection(a) | | | | | | wAMD | | | | | | a | | | | | | a | | | | | | a | | |

| | | | | | | DME | | | | | | a | | | | | | a | | | | | | a | | |

| | | | | | | DR | | | | | | a | | | | | | | | | | | | | | |

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

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

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

| | | | | | | Polymyalgia rheumatica ("PMR") | | | | | | a | | | | | | | | | | | | | | |

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

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

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

| Total EYLEA HD and EYLEA | | | | | | $ | 5,885.4 | | | | | $ | 3,495.2 | | | | | $ | 9,380.6 | | | | | $ | 6,264.6 | | | | | $ | 3,382.8 | | | | | $ | 9,647.4 | | | | | $ | 5,792.3 | | | | | $ | 3,450.9 | | | | | $ | 9,243.2 | |

| (g) Rest of world ("ROW") | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

| 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 | | | | | | | | |

| Pozelimab(f) (REGN3918) *Antibody to C5* | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Initiate Phase 3 study in combination with cemdisiran in geographic atrophy (second half 2024) | | |

| Dupixent (dupilumab)(b) *Antibody to IL-4R alpha subunit* | | | | | | | | | | | | –Ulcerative colitis –Eosinophilic gastroenteritis (Phase 2/3) | | | | | | –Chronic obstructive pulmonary disease ("COPD")(d) –Bullous pemphigoid(c) –Chronic spontaneous urticaria ("CSU") –Chronic pruritus of unknown origin | | | | | | –EoE in pediatrics (1–11 years of age) (EU) –COPD with type 2 inflammatory phenotype (U.S. and EU) –CSU in adults and adolescents (Japan) | | | | | | –Approved by EC for atopic dermatitis in pediatrics (6 months–5 years of age) –Approved by MHLW for atopic dermatitis in pediatrics and adolescents (6 months–14 years of age) –Approved by FDA for EoE in pediatrics (1–11 years of age) –Approved by EC for EoE in adults and adolescents –Approved by MHLW for prurigo nodularis | | | | | | –EC decision on regulatory submission for EoE in pediatrics (second half 2024) –FDA decision on supplemental Biologics License Application ("sBLA") (mid/second half 2024) and EC decision on regulatory submission (second half 2024) for COPD with type 2 inflammatory phenotype | | |

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators’ ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron’s Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation EYLEA®* *(aflibercept) Injection, Dupixent*® *(dupilumab) Injection, Libtayo*® *(cemiplimab) Injection, Praluent*® *(alirocumab) Injection, Kevzara*® *(sarilumab) Injection, Evkeeza®* *(evinacumab), aflibercept 8 mg, pozelimab, odronextamab, itepekimab, fianlimab, garetosmab, linvoseltamab, REGN5713-5714-5715, Regeneron's other oncology programs (including its costimulatory bispecific portfolio), Regeneron's and its collaborators' earlier-stage programs, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of our anticipated development milestones referenced in this report; safety issues resulting from the administration of Regeneron's Products and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of our late-stage product candidates and new indications for Regeneron's Products, including without limitation those listed above; the extent to which the results from the research and development programs conducted by us and/or our collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of Regeneron's Products and Regeneron's Product Candidates; our ability to manufacture and manage supply chains for multiple products and product candidates; the ability of our collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the availability and extent of reimbursement of Regeneron's Products from third-party payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and new policies and procedures adopted by such payors; unanticipated expenses; the costs of developing, producing, and selling products; 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 potential for any license or collaboration agreement, including our agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings described further in Note 16 to our Consolidated Financial Statements included in this report), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described 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.

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

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

| | | | | | | Atopic dermatitis (in pediatrics 6 months–5 years of age) | | | | | | a | | | | | | | | | | | | | | | | | | a | | | | | | | | |

| (e) Rest of world ("ROW"). A checkmark in this column indicates that the product has received marketing approval in at least one country outside of the United States, European Union ("EU"), or Japan. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| * Effective January 1, 2022, the Company and Bayer commenced sharing equally in profits and losses based on sales from Bayer to its distributor in Japan. Previously, the Company received from Bayer a tiered percentage of sales based on sales by Bayer's distributor in Japan. Consequently, the prior year net product sales amount has been revised for comparability purposes. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| EYLEA (aflibercept)(a) | | | | | | | | | | | | | | | | | | –ROP(c) | | | | | | –ROP (U.S.) | | | | | | –Granted pediatric exclusivity by U.S. Food and Drug Administration ("FDA") in connection with ROP study, extending period of EYLEA U.S. market exclusivity by six months through May 17, 2024 –Approved by European Commission ("EC") for ROP –Approved by Ministry of Health, Labour and Welfare ("MHLW") for ROP in Japan –Withdrew supplemental Biologics License Application ("sBLA") for every-16-weeks dosing regimen in patients with DR | | | | | | –FDA decision on sBLA for ROP (target action date of February 11, 2023) | | |

| Aflibercept 8 mg(a) | | | | | | | | | | | | | | | | | | –Wet AMD –DME | | | | | | –Wet AMD and DME (U.S.) | | | | | | –Reported that Phase 3 trials in wet AMD and DME met their primary endpoints | | | | | | –FDA decision on BLA for wet AMD and DME (third quarter 2023) –Submit regulatory application in the EU for wet AMD and DME (first quarter 2023) –Report two-year data from Phase 3 studies in wet AMD and DME (third quarter 2023) | | |

| Dupixent (dupilumab)(b) *Antibody to IL-4R alpha subunit* | | | | | | | | | | | | | | | | | | –EoE in pediatrics(c) –Chronic obstructive pulmonary disease ("COPD") –Bullous pemphigoid (Phase 2/3)(c) –Chronic spontaneous urticaria ("CSU") –Chronic inducible urticaria - cold –Chronic rhinosinusitis without nasal polyposis –Allergic fungal rhinosinusitis –Chronic pruritus of unknown origin | | | | | | –Atopic dermatitis in pediatrics (6 months–5 years of age) (EU) and in pediatrics and adolescents (6 months–14 years of age (Japan) –Prurigo nodularis (Japan) –CSU in adults and adolescents (U.S.) | | | | | | –Approved by FDA for atopic dermatitis in pediatrics (6 months–5 years of age) –European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for atopic dermatitis in pediatrics (6 months–5 years of age) –Approved by EC for severe asthma in pediatrics (6–11 years of age) –Approved by FDA and EC for EoE in adults and adolescents –Reported that Phase 3 trial in EoE in pediatrics (1–11 years of age) met its primary endpoint –Approved by FDA and EC for prurigo nodularis –Stopped one of the Phase 3 trials in CSU (in patients refractory to omalizumab) due to futility, based on pre-specified interim analysis –Initiated additional Phase 3 trial in CSU (in biologic-naïve patients) –Discontinued further clinical development in peanut allergy | | | | | | –EC decision on regulatory submission for atopic dermatitis in pediatrics (6 months–5 years of age) (first half 2023) –MHLW decision on regulatory submission for atopic dermatitis in pediatrics and adolescents (6 months–14 years of age) in Japan (second half 2023) –Submit sBLA for EoE in pediatrics (mid-2023) –Report results from first Phase 3 study in COPD (first half 2023) –FDA decision on sBLA for CSU in adults and adolescents (second half 2023) –Report results from Phase 3 study in chronic inducible urticaria - cold (first half 2023) | | |

| Libtayo (cemiplimab)(n)(g) *Antibody to PD-1* | | | | | | | | | | | | –Neoadjuvant CSCC –Second-line cervical cancer, ISA101b combination | | | | | | –Adjuvant CSCC | | | | | | –First-line NSCLC, chemotherapy combination (EU) | | | | | | –Approved by FDA in combination with chemotherapy for NSCLC –Approved by EC and MHLW for cervical cancer –Voluntarily withdrew sBLA for cervical cancer due to inability to align with FDA on certain post-marketing studies –Positive data from Phase 2 trial in neoadjuvant CSCC presented at European Society for Medical Oncology ("ESMO") Congress 2022 and published in *New England Journal of Medicine* | | | | | | –EC decision on regulatory submission for NSCLC, chemotherapy combination (first half 2023) | | |

| Fianlimab(f) *(continued)* | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Positive initial data from Phase 1 trial (in combination with Libtayo) in NSCLC presented at ESMO Immuno-Oncology Congress 2022 | | | | | | –Initiate Phase 2/3 studies (in combination with Libtayo) in first-line advanced NSCLC (first half 2023) –Initiate Phase 2 study (in combination with Libtayo) in perioperative NSCLC (second half 2023) | | |

| REGN5678 *Bispecific antibody targeting PSMA and CD28* | | | | | | –Prostate cancer | | | | | | | | | | | | | | | | | | | | | | | | –Reported preliminary data from dose escalation portion of Phase 1/2 study (in combination with Libtayo) in prostate cancer | | | | | | –Report additional results from Phase 1/2 study (in combination with Libtayo) in prostate cancer (2023) | | |

| REGN9933 *Antibody to Factor XI* | | | | | | –Thrombosis | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| General Medicine | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Praluent (alirocumab) *Antibody to PCSK9* | | | | | | | | | | | | | | | | | | –HeFH in pediatrics | | | | | | | | | | | | | | | | | | –Submit sBLA for HeFH in pediatrics (mid-2023) | | |

| Evkeeza (evinacumab)(f)(l) *Antibody to ANGPTL3* | | | | | | | | | | | | | | | | | | | | | | | | –HoFH in pediatrics (5–11 years of age) (U.S.) | | | | | | –Reported that Phase 3 trial for HoFH in pediatrics (5–11 years of age) met its primary endpoint | | | | | | –FDA decision on sBLA for HoFH in pediatrics (5–11 years of age) (target action date of March 30, 2023) | | |

| Note 2: We have discontinued further clinical development of fasinumab (REGN475), an antibody to NGF, which was previously being studied in osteoarthritis pain of the knee or hip in collaboration with Teva and Mitsubishi Tanabe Pharma Corporation ("MTPC"); REGN6490, an antibody to IL-36R, which was previously being studied in palmo-plantar pustulosis; and the Phase 3 study of REGN1908-1909, a multi-antibody therapy to Fel d 1, in cat allergy, due to futility. | | | | | | | | | | | | | | |

| (i) In collaboration with Zai Lab in mainland China, Hong Kong, Taiwan, and Macau | | | | | | | | | | | | | | |

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

In September 2022, the Company announced that the primary endpoints were met in two pivotal trials investigating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with DME and wet AMD.

The PHOTON trial in DME and the PULSAR trial in wet AMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the EYLEA 8-week dosing regimen.

Furthermore, of the patients randomized to 12- and 16-week dosing intervals, 91% and 89% of DME patients, respectively, and 79% and 77% of wet AMD patients, respectively, maintained those intervals through 48 weeks.

The Company is utilizing a priority review voucher in connection with the December 2022 submission of the BLA for DME and wet AMD.

*REGEN-COV (casirivimab and imdevimab)*

REGEN-COV, a multi-antibody therapy to SARS-CoV-2 virus, previously received an EUA for use in certain post-exposure prophylaxis settings and as a treatment for people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19.

Based on laboratory data, in January 2022, the FDA revised the EUA for REGEN-COV to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as an Omicron-lineage variant that is not susceptible to the treatment.

With this EUA revision, REGEN-COV is not currently authorized for use in any U.S. states, territories, or jurisdictions, since Omicron-lineage variants are currently dominant across the United States.

In December 2022, the FDA issued a complete response letter ("CRL") on the BLA for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.

It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and PLGF, two growth factors involved in angiogenesis.

Aflibercept 8 mg is an investigational soluble fusion protein that acts as a VEGF inhibitor.

Aflibercept 8 mg is being studied in wet AMD and DME using extended dosing intervals of every 12 weeks and every 16 weeks.

EYLEA, ZALTRAP, and ARCALYST are drugs generated using our Trap technology.

Agreements Related to COVID-19

U.S. Government

In 2020, the Company also entered into an agreement with entities acting at the direction of BARDA and the U.S. Department of Defense to manufacture and deliver filled and finished drug product of REGEN-COV to the U.S. government.

The agreement, as subsequently amended, provided for payments to the Company of up to $465.9 million in the aggregate for bulk manufacturing of the drug substance, as well as fill/finish, storage, and other activities.

In January 2021, the Company entered into an agreement with the U.S. Department of Defense and HHS to manufacture and deliver additional filled and finished drug product of REGEN-COV to the U.S. government.

Pursuant to the agreement, the U.S. government was obligated to purchase 1.25 million doses of drug product, resulting in payments to the Company of $2.625 billion.

In September 2021, the Company entered into an amendment to its January 2021 agreement to supply the U.S. government with an additional 1.4 million doses of REGEN-COV.

Pursuant to the agreement, the U.S. government was obligated to purchase all filled and finished doses of such additional drug product delivered by January 31, 2022, resulting in payments to the Company of $2.940 billion in the aggregate.

| | | | For the fiscal year ended December 31, [removed: 2022] [added: 2023] | | | | | | | | |

| The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant was [removed: $62.0] [added: $76.7] billion, computed by reference to the closing sales price of the stock on NASDAQ on June 30, [removed: 2022,] [added: 2023,] 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: 26, 2023:] [added: 25, 2024:] | | | | | | | | | | | | | | |

| Common Stock, $.001 par value | | | | | | [removed: 107,507,386] [added: 107,943,750] | | |

| Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its [removed: 2023] [added: 2024] Annual Meeting of Shareholders are incorporated by reference into Part III of this Form 10-K. Exhibit index is located on pages [removed: 96] [added: 92] to [removed: 101] [added: 96] of this filing. | | |

| [Item [removed: 1.](#ic18bad8bf5314e3e9f4c348a9f859317_13)] [added: 1.](#icad69a7485714b89bcccabdab8d6701b_13)] | | | | | | [removed: [Business](#ic18bad8bf5314e3e9f4c348a9f859317_13)] [added: [Business](#icad69a7485714b89bcccabdab8d6701b_13)] | | | | | | [removed: [2](#ic18bad8bf5314e3e9f4c348a9f859317_13)] [added: [2](#icad69a7485714b89bcccabdab8d6701b_13)] | | |

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| [PART [removed: III](#ic18bad8bf5314e3e9f4c348a9f859317_82)] [added: III](#icad69a7485714b89bcccabdab8d6701b_82)] | | | | | | | | | | | | | | |

| [Item [removed: 10.](#ic18bad8bf5314e3e9f4c348a9f859317_82)] [added: 10.](#icad69a7485714b89bcccabdab8d6701b_82)] | | | | | | [Directors, Executive Officers and Corporate [removed: Governance](#ic18bad8bf5314e3e9f4c348a9f859317_82)] [added: Governance](#icad69a7485714b89bcccabdab8d6701b_82)] | | | | | | [removed: [95](#ic18bad8bf5314e3e9f4c348a9f859317_82)] [added: [91](#icad69a7485714b89bcccabdab8d6701b_82)] | | |

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| [SIGNATURE [removed: PAGE](#ic18bad8bf5314e3e9f4c348a9f859317_94)] [added: PAGE](#icad69a7485714b89bcccabdab8d6701b_94)] | | | | | | | | | | | | [removed: [102](#ic18bad8bf5314e3e9f4c348a9f859317_94)] [added: [97](#icad69a7485714b89bcccabdab8d6701b_94)] | | |

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

| If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. | | | | | | | | | | | | ☐ | | |

| Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). | | | | | | | | | | | | ☐ | | |

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

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

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

| [Item 6.](#icad69a7485714b89bcccabdab8d6701b_43) | | | | | | [\[Reserved\]](#icad69a7485714b89bcccabdab8d6701b_43) | | | | | | [73](#icad69a7485714b89bcccabdab8d6701b_43) | | |

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

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

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

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

| [PART I](#ic18bad8bf5314e3e9f4c348a9f859317_10) | | | | | | | | | | | | | | |

| [PART II](#ic18bad8bf5314e3e9f4c348a9f859317_37) | | | | | | | | | | | | | | |

| [Item 6.](#ic18bad8bf5314e3e9f4c348a9f859317_43) | | | | | | [\[R](#ic18bad8bf5314e3e9f4c348a9f859317_43)[eserved](#ic18bad8bf5314e3e9f4c348a9f859317_43)[\]](#ic18bad8bf5314e3e9f4c348a9f859317_43) | | | | | | [77](#ic18bad8bf5314e3e9f4c348a9f859317_43) | | |

| [PART IV](#ic18bad8bf5314e3e9f4c348a9f859317_88) | | | | | | | | | | | | | | |

Risk Management and Strategy

We regularly assess risks from cybersecurity threats; monitor our information systems for potential vulnerabilities; and test those systems pursuant to our cybersecurity policies, processes, and practices, which are integrated into our overall risk management program.

To protect our information systems from cybersecurity threats, we use various security tools that are designed to help identify, escalate, investigate, resolve, and recover from security incidents in a timely manner.

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 risks based on probability and potential impact to key business systems and processes.

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 reported to the Technology Risk Management Committee and tracked as part of our overall risk management program overseen by the Audit Committee of our board of directors.

We collaborate with third parties to assess the effectiveness of our cybersecurity prevention and response systems and processes.

These include cybersecurity assessors, consultants, and other external cybersecurity experts to assist in the identification, verification, and validation of cybersecurity risks, as well as to support associated mitigation plans when necessary.

We have also

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

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

Cybersecurity threats, including those resulting from any previous cybersecurity incidents, have not materially affected our Company, including our business strategy, results of operations, or financial condition.

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.

Refer to the risk factor captioned "*Significant disruptions of information technology systems or breaches of data security could adversely affect our business*" in Part I, Item 1A.

"Risk Factors" for additional description of cybersecurity risks and potential related impacts on our Company.

Governance

Our board of directors oversees our risk management process, including as it pertains to cybersecurity risks, directly and through its committees.

The Audit Committee of the board oversees our risk management program, which focuses on the most significant risks we face in the short-, intermediate-, and long-term timeframe.

Audit Committee meetings include discussions of specific risk areas throughout the year, including, among others, those relating to cybersecurity threats, and reports from the Chief Audit Executive on our enterprise risk profile on an annual basis.

The Audit Committee reviews our cybersecurity risk profile with management on a periodic basis using key performance and/or risk indicators.

These key performance indicators are metrics and measurements designed to assess the effectiveness of our cybersecurity program in the prevention, detection, mitigation, and remediation of cybersecurity incidents.

We take a risk-based approach to cybersecurity and have implemented cybersecurity policies throughout our operations that are designed to address cybersecurity threats and incidents.

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

The current CISO has over 35 years of experience in information security 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 Committee, the Audit Committee of our board of directors, and the Audit Committee chair.

We own facilities in Rensselaer, New York totaling approximately [removed: 1,189,000] [added: 1,260,000] square feet of manufacturing, research, office, and warehouse space.

In addition, we have constructed an approximately 341,000 square foot fill/finish facility in Rensselaer, New York that is undergoing process validation as required by regulatory authorities.

This includes approximately 452,000 square feet of warehouse, laboratory, and office space which we

constructed on a 130-acre parcel of land near our Rensselaer facility.

We are in the process of further developing this property, primarily in connection with constructing a fill/finish facility.

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

As of January [removed: 26, 2023,] [added: 25, 2024,] there were [removed: 161] [added: 153] shareholders of record of our Common Stock and 14 shareholders of record of our Class A Stock.

We have never paid cash dividends on our Common Stock or Class A Stock and do not [removed: anticipate paying any in the foreseeable future.][added: currently have plans to do so.]

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: 2017] [added: 2018] through December 31, [removed: 2022.][added: 2023.]

The comparison assumes that $100 was invested on December 31, [removed: 2017] [added: 2018] in our Common Stock and in both of the foregoing indices.

[removed: ][added: ]

| | | | [removed: 12/31/2017] [added: 12/31/2018] | | | | | | [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] | | |

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: 2022.][added: 2023.]

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

| 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 | |

[Table of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

| 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) | | | | | |

| Regeneron | | | $ | 100.00 | | | | | $ | 99.35 | | | | | $ | 99.87 | | | | | $ | 128.50 | | | | | $ | 167.98 | | | | | $ | 191.91 | |

| S&P 500 | | | $ | 100.00 | | | | | $ | 93.76 | | | | | $ | 120.84 | | | | | $ | 140.49 | | | | | $ | 178.27 | | | | | $ | 143.61 | |

| NQ US Pharma TR Index | | | $ | 100.00 | | | | | $ | 106.80 | | | | | $ | 122.30 | | | | | $ | 135.17 | | | | | $ | 168.13 | | | | | $ | 187.21 | |

| 10/1/2022–10/31/2022 | | | | | | 48,078 | | | | | | $ | 719.10 | | | | | 48,078 | | | | | | $ | 1,151.7 | |

| 11/1/2022–11/30/2022 | | | | | | 236,526 | | | | | | $ | 737.86 | | | | | 234,834 | | | | | | $ | 978.4 | |

| 12/1/2022–12/31/2022 | | | | | | 418,427 | | | | | | $ | 737.15 | | | | | 317,470 | | | | | | $ | 745.2 | |

| Total | | | | | | 703,031 | | | (a) | | | | | | | | | 600,382 | | | (a) | | | | | |

| (b) In January 2023, our board of directors authorized a new share repurchase program to repurchase up to an additional $3.0 billion of our Common Stock. See Item 7. "Liquidity and Capital Resources - Share Repurchase Programs" for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | |

Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, [removed: 2022] [added: 2023] 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: 2022.][added: 2023.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2022] [added: 2023] 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: 2022] [added: 2023] 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, 2023, 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.

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

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

| Name | | | | | | Position | | | | | | Date of Plan Adoption | | | | | | Scheduled End Date of Trading Arrangement(a) | | | | | | Total Number of Securities to Be Sold Under the Plan | | |

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

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

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

None.

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: 2023] [added: 2024] 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: 2023] [added: 2024] 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: 2023] [added: 2024] 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: 2023] [added: 2024] 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: 2023] [added: 2024] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

All schedules for which provision is made in the applicable accounting regulations of the [removed: Securities and Exchange Commission] [added: SEC] are not required under the related instructions or are inapplicable and, therefore, have been omitted.

| [removed: 10.2.4] [added: 10.2.6] + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to [removed: P. Roy Vagelos, M.D.] [added: the Registrant's non-employee directors] under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.] [added: 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_1025x12312015x10k.htm)] [added: 2016.)](http://www.sec.gov/Archives/edgar/data/872589/000153217616000045/regn-ex_10210x12312015x10k.htm)] | | |

| [removed: 10.2.5] [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 Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d1.htm) | | |

| [removed: 10.2.6] [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 Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d3.htm) | | |

| [removed: 10.2.7] [added: 10.2.12] + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the [added: Amended and Restated] Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan [removed: (revised).] [added: (revised 2018).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2015,] [added: 2018,] filed February [removed: 11, 2016.)](http://www.sec.gov/Archives/edgar/data/872589/000153217616000045/regn-ex_10210x12312015x10k.htm)] [added: 7, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10220xar2014ltipnq.htm)] | | |

| [removed: 10.2.8] [added: 10.2.7] + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's 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, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10211xar2014ltipnq.htm) | | |

| 10.2.9 + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to [removed: P. Roy Vagelos, M.D.] [added: 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_10213xar2014ltipnq.htm)] [added: 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10216xar2014ltipnq.htm)] | | |

| [removed: 10.2.10] [added: 10.2.8] + | | | [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, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10215xar2014ltiprs.htm) | | |

| [removed: 10.2.11] [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 non-employee directors under the [added: 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, [removed: 2017,] [added: 2020,] filed February 8, [removed: 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10216xar2014ltipnq.htm)] [added: 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1035x12312020x10k.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 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, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10217xstockoptiona.htm) | | |

| [removed: 10.2.13] [added: 10.2.14] + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to [removed: P. Roy Vagelos, M.D.] [added: the Registrant's executive officers] 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_10218xstockoptiona.htm)] [added: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)] | | |

| [removed: 10.2.14] [added: 10.2.11] + | | | [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, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10219xar2014ltiprs.htm) | | |

| [removed: 10.2.15] [added: 10.2.16] + | | | [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.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm)] | | |

| [removed: 10.2.16] [added: 10.2.13] + | | | [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, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10221xar2014ltiprs.htm) | | |

| [removed: 10.2.17] [added: 10.2.15] + | | | [Form of [added: restricted] stock [removed: option] [added: award] agreement and related notice of grant for use in connection with the grant of [removed: non-qualified] [added: restricted] stock [removed: options] [added: 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-ex10217ar2014ltip.htm)] [added: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10219ar2014ltip.htm)] | | |

| [removed: 10.2.18] [added: 10.2.17] + | | | [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 [removed: P. Roy Vagelos, M.D.] [added: 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-ex10218ar2014ltip.htm)] [added: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10221ar2014ltip.htm)] | | |

| [removed: 10.2.19] [added: 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 [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-ex10219ar2014ltip.htm)] [added: 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm)] | | |

| [removed: 10.2.20] [added: 10.3.4] + | | | [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 [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-ex10220ar2014ltip.htm)] [added: 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1036x12312020x10k.htm)] | | |

| [removed: 10.2.21] [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 [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.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1037x12312020x10k.htm)] | | |

| [removed: 10.2.22] [added: 10.3.7] + | | | [Form [removed: of performance restricted] [added: of](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1037x12312023x10k.htm) [restricted] stock [removed: unit award agreement] [added: 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 [removed: of performance restricted] [added: 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 [removed: units to Leonard S. Schleifer, M.D., Ph.D., George D. Yancopoulos, M.D., Ph.D., and P. Roy Vagelos, M.D.] [added: awards](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1037x12312023x10k.htm) [to the Registrant's executive officers] under the [added: Second] Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2019, filed February 7, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10222ar2014ltip.htm)] [added: Plan (revised 2023).](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_1037x12312023x10k.htm)] | | |

| [removed: 10.3.2] [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 [removed: P. Roy Vagelos, M.D.] [added: the Registrant's executive officers] under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1032x12312020x10k.htm)] [added: 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)] | | |

| [removed: 10.5* +] [added: 10.9.2] | | | [removed: [Employment] [added: [Second Amendment] Agreement, dated [removed: as of] December [removed: 31, 1998,] [added: 19, 2019, by and] between [removed: the Registrant] [added: Bayer HealthCare LLC] and [removed: P. Roy Vagelos, M.D.] [added: the Registrant.] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2004,] [added: 2019,] filed [removed: March 11, 2005.)](http://www.sec.gov/Archives/edgar/data/872589/000095012305002979/y06183exv10w7.txt)] [added: February 7, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10102secondamen.htm)] | | |

| [removed: 10.6] [added: 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) | | |

| [removed: 10.7] [added: 10.6] + | | | [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, 2009.)](http://www.sec.gov/Archives/edgar/data/872589/000120677409000338/exhibit10-5.htm) | | |

| [removed: 10.8] [added: 10.7] + | | | [Regeneron Pharmaceuticals, Inc. Cash Incentive Bonus Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 17, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915045962/a15-14252_1ex10d1.htm) | | |

| [removed: 10.9*] [added: 10.8*] | | | [IL-1 Antibody Termination Agreement by and between Novartis Pharma AG, Novartis Pharmaceuticals Corporation and the Registrant, dated as of June 8, 2009. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2009, filed August 4, 2009.)](http://www.sec.gov/Archives/edgar/data/872589/000120677409001498/exhibit10-1.htm) | | |

| [removed: 10.10*] [added: 10.9*] | | | [License and Collaboration Agreement, dated as of October 18, 2006, by and between Bayer HealthCare LLC and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2006, filed November 6, 2006.)](http://www.sec.gov/Archives/edgar/data/872589/000095012306013527/y26593exv10w1.htm) | | |

| [removed: 10.10.1*] [added: 10.9.1*] | | | [Restated Amendment Agreement, dated December 30, 2014 and entered into effective as of May 7, 2012, by and between Bayer HealthCare LLC and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2014, filed February 12, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000008/regn-ex_10101x12312014x10k.htm) | | |

| [removed: 10.10.2] [added: 10.15*] | | | [removed: [Second Amendment] [added: [Purchase] Agreement, dated [added: as of] December [removed: 19, 2019,] [added: 30, 2016,] by and [removed: between Bayer HealthCare] [added: among BMR-Landmark at Eastview] LLC and [added: BMR-Landmark at Eastview IV LLC and] the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2019,] [added: 2016,] filed February [removed: 7, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10102secondamen.htm)] [added: 9, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000153217617000008/regn-ex_1035xlandmarkpsaex.htm)] | | |

| [removed: 10.11*] [added: 10.10*] | | | [Amended and Restated License and Collaboration Agreement, dated as of November 10, 2009, by and among Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant. (Incorporated by reference from the Form 10-K/A for the Registrant, for the year ended December 31, 2009, filed June 2, 2010.)](http://www.sec.gov/Archives/edgar/data/872589/000120677410001385/exhibit10-15.htm) | | |

| [removed: 10.11.1*] [added: 10.10.1] | | | [First Amendment to Amended and Restated License and Collaboration Agreement by and between the Registrant and Aventis Pharmaceuticals Inc., dated May 1, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, [removed: 2013,] [added: 2023,] filed August [removed: 6, 2013.)](http://www.sec.gov/Archives/edgar/data/872589/000153217613000022/regn-ex_105x6302013x10q.htm)] [added: 3, 2023.)](http://www.sec.gov/Archives/edgar/data/872589/000180422023000023/regn-ex_101x6302023x10q.htm)] | | |

| [removed: 10.11.2*] [added: 10.10.2*] | | | [Amendment No. 2 to Amended and Restated License and Collaboration Agreement, dated July 27, 2015 and entered into effective as of July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS, as successor-in-interest to Aventis Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_104x09302015x10q.htm) | | |

| [removed: 10.11.3] [added: 10.10.3] | | | [Third Amendment to Amended and Restated License and Collaboration Agreement, dated as of April 5, 2020, and effective as of April 1, 2020, by and between the Registrant, Sanofi Biotechnology SAS, and Sanofi. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2020, filed August 5, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000180422020000022/regn-ex103x06302020x10q.htm) | | |

| [removed: 10.11.4] [added: 10.10.4] | | | [Fourth Amendment to Amended and Restated License and Collaboration Agreement, dated as of October 6, 2021, by and between the Registrant, Sanofi Biotechnology SAS, and [removed: Sanofi.](http://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regen-ex_10144x12312021x10k.htm) [(Incorporated] [added: Sanofi. (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, 2021, filed February 7, 2022.)](http://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regen-ex_10144x12312021x10k.htm) | | |

| [removed: 10.11.5] [added: 10.10.5] | | | [Fifth Amendment to Amended and Restated License and Collaboration Agreement, dated as of June 1, 2022, by and between the Registrant, Sanofi Biotechnology SAS, and Sanofi. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2022, filed August 3, 2022.)](http://www.sec.gov/Archives/edgar/data/872589/000180422022000023/regn-ex_103x6302022x10q.htm) | | |

| [removed: 10.12] [added: 10.11] | | | [Praluent Cross License & Commercialization Agreement, dated as of April 5, 2020, and effective as of April 1, 2020, by and between the Registrant and Sanofi Biotechnology SAS. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2020, filed August 5, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000180422020000022/regn-ex104x06302020x10q.htm) | | |

| [removed: 10.13] [added: 10.12] | | | [Amended and Restated Investor Agreement, dated as of January 11, 2014, by and among Sanofi, sanofi-aventis US LLC, Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant, filed January 13, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514008775/d659864dex101.htm) | | |

| [removed: 10.13.1] [added: 10.12.1] | | | [Amendment to the Amended and Restated Investor Agreement, dated as of May 25, 2020, by and among the Registrant, Sanofi, Sanofi-Aventis US LLC, and Aventisub LLC. (Incorporated by reference from the Form 8-K for the Registrant, filed May 29, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000110465920067752/tm2021201d1_ex10-2.htm) | | |

| [removed: 10.14*] [added: 10.13*] | | | [Credit Agreement, dated as of December 19, 2022, by and among the Registrant, as a borrower and guarantor, certain direct subsidiaries of the Registrant, as the initial subsidiary borrowers, the lenders and issuing banks party thereto, and JPMorgan Chase Bank, N.A., as administrative agent, swingline lender, and an issuing bank. (Incorporated by reference from the Form 8-K for the Registrant, filed December 20, 2022.)](http://www.sec.gov/Archives/edgar/data/872589/000110465922128613/tm2233051d1_ex10-1.htm) | | |

| [removed: 10.15] [added: 10.14] | | | [Amended and Restated Immuno-oncology License and Collaboration Agreement, dated as of June 1, 2022, by and between the Registrant and Sanofi Biotechnology SAS. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2022, filed August 3, 2022.)](http://www.sec.gov/Archives/edgar/data/872589/000180422022000023/regn-ex_102x06302022x10q.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, 2023.)](http://www.sec.gov/Archives/edgar/data/872589/000110465923071187/tm2318622d1_ex3-2.htm) | | |

| 10.7.1 + | | | [First Amendment to Cash Incentive Bonus Plan. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2023, filed May 4, 2023.)](http://www.sec.gov/Archives/edgar/data/872589/000180422023000016/regn-ex_101x3312023x10q.htm) | | |

| 97.1 | | | [Cl](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_971x12312023x10k.htm)[awback Policy.](https://www.sec.gov/Archives/edgar/data/872589/000180422024000009/regn-ex_971x12312023x10k.htm) | | |

| | | | | | |

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

| 10.3.3 + | | | [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, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm) | | |

| 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 P. Roy Vagelos, M.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, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1034x12312020x10k.htm) | | |

| 10.3.5 + | | | [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 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, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1035x12312020x10k.htm) | | |

| 10.3.6 + | | | [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 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, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1036x12312020x10k.htm) | | |

| 10.3.7 + | | | [Form of performance restricted stock unit award agreement and related notice of grant for use in connection with the grant of performance restricted stock units to 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, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1037x12312020x10k.htm) | | |

| 10.17* | | | [Purchase Agreement, dated as of December 30, 2016, by and among BMR-Landmark at Eastview LLC and BMR-Landmark at Eastview IV LLC and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2016, filed February 9, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000153217617000008/regn-ex_1035xlandmarkpsaex.htm) | | |

| Date: | | | February [removed: 6, 2023] [added: 5, 2024] | | | | | | By: | | | /s/ LEONARD S. SCHLEIFER | | | | | |

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

[removed: Landry, Executive Vice President, Finance] [added: Schleifer] and [removed: Chief Financial Officer,] [added: Christopher Fenimore,] and each of them, his or her true and lawful attorney-in-fact and agent, with the full power of substitution and resubstitution, for him or her and in his or her name, place, and stead, in any and all capacities therewith, to sign any and all amendments to this Annual Report on Form 10-K, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto each said attorney-in-fact and agent full power and authority to do and perform each and every act and thing requisite and necessary to be done, as fully to all intents and purposes as such person might or could do in person, hereby ratifying and confirming all that each said attorney-in-fact and agent, or either of them, or their or his substitute or substitutes, may lawfully do or cause to be done by virtue hereof.

| /s/ [removed: LEONARD S. SCHLEIFER] [added: ROBERT E. LANDRY] | | | | | | [removed: *President, Chief Executive Officer,] [added: *Executive Vice President, Finance] and [removed: Director] [added: Chief Financial Officer] (Principal [removed: Executive] [added: Financial] Officer)* | | | | | | February [removed: 6, 2023] [added: 5, 2024] | | |

| /s/ CHRISTOPHER [removed: R.] FENIMORE | | | | | | *Senior Vice President, Controller (Principal Accounting Officer)* | | | | | | February [removed: 6, 2023] [added: 5, 2024] | | |

| Christopher [removed: R.] Fenimore | | | | | | | | | | | | | | |

| /s/ GEORGE D. YANCOPOULOS | | | | | | [removed: *President,] [added: *Board Co-Chair, President and] Chief Scientific [removed: Officer, and Director*] [added: Officer*] | | | | | | February [removed: 6, 2023] [added: 5, 2024] | | |

| /s/ BONNIE L. BASSLER | | | | | | *Director* | | | | | | February [removed: 6, 2023] [added: 5, 2024] | | |

| /s/ MICHAEL S. BROWN | | | | | | *Director* | | | | | | February [removed: 6, 2023] [added: 5, 2024] | | |

| /s/ N. ANTHONY COLES | | | | | | *Director* | | | | | | February [removed: 6, 2023] [added: 5, 2024] | | |

| /s/ JOSEPH L. GOLDSTEIN | | | | | | *Director* | | | | | | February [removed: 6, 2023] [added: 5, 2024] | | |

| /s/ CHRISTINE A. POON | | | | | | *Director* | | | | | | February [removed: 6, 2023] [added: 5, 2024] | | |

| /s/ ARTHUR F. RYAN | | | | | | *Director* | | | | | | February [removed: 6, 2023] [added: 5, 2024] | | |

| /s/ GEORGE L. SING | | | | | | *Director* | | | | | | February [removed: 6, 2023] [added: 5, 2024] | | |

| /s/ CRAIG B. THOMPSON | | | | | | *Director* | | | | | | February [removed: 6, 2023] [added: 5, 2024] | | |

| /s/ HUDA Y. ZOGHBI | | | | | | *Director* | | | | | | February [removed: 6, 2023] [added: 5, 2024] | | |

| [Report of Independent Registered Public Accounting Firm (PCAOB [removed: ID](#ic18bad8bf5314e3e9f4c348a9f859317_100) 238[)](#ic18bad8bf5314e3e9f4c348a9f859317_100)] [added: ID](#icad69a7485714b89bcccabdab8d6701b_100) 238[)](#icad69a7485714b89bcccabdab8d6701b_100)] | | | | | | [removed: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_100)[2](#ic18bad8bf5314e3e9f4c348a9f859317_100)] [added: [F-](#icad69a7485714b89bcccabdab8d6701b_100)[2](#icad69a7485714b89bcccabdab8d6701b_100)] | | |

| [Consolidated Balance Sheets as of December 31, [removed: 2022 and 2021](#ic18bad8bf5314e3e9f4c348a9f859317_103)] [added: 202](#icad69a7485714b89bcccabdab8d6701b_103)[3](#icad69a7485714b89bcccabdab8d6701b_103) [and 202](#icad69a7485714b89bcccabdab8d6701b_103)[2](#icad69a7485714b89bcccabdab8d6701b_103)] | | | | | | [removed: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_103)[4](#ic18bad8bf5314e3e9f4c348a9f859317_103)] [added: [F-](#icad69a7485714b89bcccabdab8d6701b_103)[4](#icad69a7485714b89bcccabdab8d6701b_103)] | | |

| [Consolidated Statements of Operations and Comprehensive Income for the Years Ended December 31, [removed: 2022, 2021,] [added: 202](#icad69a7485714b89bcccabdab8d6701b_106)[3](#icad69a7485714b89bcccabdab8d6701b_106)[, 202](#icad69a7485714b89bcccabdab8d6701b_106)[2](#icad69a7485714b89bcccabdab8d6701b_106)[,] and [removed: 2020](#ic18bad8bf5314e3e9f4c348a9f859317_106)] [added: 202](#icad69a7485714b89bcccabdab8d6701b_106)[1](#icad69a7485714b89bcccabdab8d6701b_106)] | | | | | | [removed: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_106)[5](#ic18bad8bf5314e3e9f4c348a9f859317_106)] [added: [F-](#icad69a7485714b89bcccabdab8d6701b_106)[5](#icad69a7485714b89bcccabdab8d6701b_106)] | | |

| [Consolidated Statements of Stockholders' Equity for the Years Ended December 31, [removed: 2022, 2021,] [added: 202](#icad69a7485714b89bcccabdab8d6701b_109)[3](#icad69a7485714b89bcccabdab8d6701b_109)[, 202](#icad69a7485714b89bcccabdab8d6701b_109)[2](#icad69a7485714b89bcccabdab8d6701b_109)[,] and [removed: 2020](#ic18bad8bf5314e3e9f4c348a9f859317_109)] [added: 202](#icad69a7485714b89bcccabdab8d6701b_109)[1](#icad69a7485714b89bcccabdab8d6701b_109)] | | | | | | [removed: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_109)[6](#ic18bad8bf5314e3e9f4c348a9f859317_109)] [added: [F-](#icad69a7485714b89bcccabdab8d6701b_109)[6](#icad69a7485714b89bcccabdab8d6701b_109)] | | |

| [Consolidated Statements of Cash Flows for the Years Ended December 31, [removed: 2022, 2021,] [added: 202](#icad69a7485714b89bcccabdab8d6701b_112)[3](#icad69a7485714b89bcccabdab8d6701b_112)[, 202](#icad69a7485714b89bcccabdab8d6701b_112)[2](#icad69a7485714b89bcccabdab8d6701b_112)[,] and [removed: 2020](#ic18bad8bf5314e3e9f4c348a9f859317_112)] [added: 202](#icad69a7485714b89bcccabdab8d6701b_112)[1](#icad69a7485714b89bcccabdab8d6701b_112)] | | | | | | [removed: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_112)[8](#ic18bad8bf5314e3e9f4c348a9f859317_112)] [added: [F-](#icad69a7485714b89bcccabdab8d6701b_112)[8](#icad69a7485714b89bcccabdab8d6701b_112)] | | |

| [Notes to Consolidated Financial [removed: Statements](#ic18bad8bf5314e3e9f4c348a9f859317_115)] [added: Statements](#icad69a7485714b89bcccabdab8d6701b_115)] | | | | | | [removed: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_115)[9](#ic18bad8bf5314e3e9f4c348a9f859317_115)] [added: [F-](#icad69a7485714b89bcccabdab8d6701b_115)[9](#icad69a7485714b89bcccabdab8d6701b_115)] to [removed: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_166)[44](#ic18bad8bf5314e3e9f4c348a9f859317_166)] [added: [F-](#icad69a7485714b89bcccabdab8d6701b_169)[46](#icad69a7485714b89bcccabdab8d6701b_169)] | | |

We have audited the accompanying consolidated balance sheets of Regeneron Pharmaceuticals, Inc. and its subsidiaries (the "Company") as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] and the related consolidated statements of operations and comprehensive income, of stockholders' equity and of cash flows for each of the three years in the period ended December 31, [removed: 2022,] [added: 2023,] including the related notes (collectively referred to as the "consolidated financial statements").

We also have audited the Company's internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2022] [added: 2023] and [removed: 2021,] [added: 2022,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2022] [added: 2023] in conformity with accounting principles generally accepted in the United States of America.

Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2022,] [added: 2023,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

[removed: As described in Notes 1, 3, and 8 to the consolidated financial statements, in] [added: Effective] July [added: 1,] 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under [removed: an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi.][added: the A&R IO LCA.]

The [added: Company makes a determination whether a] transaction [removed: was] [added: should be] accounted for as [added: a business combination or as] an asset acquisition.

The principal considerations for our determination that performing procedures relating to the [removed: accounting] [added: reserve] for [removed: the acquisition of the worldwide rights to Libtayo] [added: an uncertain tax position] is a critical audit matter are (i) the significant judgment by management [removed: in identifying the elements of] [added: when determining] the [removed: transaction and in evaluating] [added: reserve for] the [removed: timing and recognition of contingent consideration,] [added: uncertain tax position;] (ii) a high degree of auditor judgment, [removed: subjectivity,] [added: subjectivity] and effort in performing procedures and evaluating [added: management's determination of the reserve for the uncertain tax position; (iii) the assessment and evaluation of] audit evidence [removed: related] [added: available] to [added: support] the [removed: accounting] [added: reserve] for the [removed: transaction and related disclosures,] [added: uncertain tax position is complex,] and [removed: (iii)] [added: (iv)] the audit effort involved the use of professionals with specialized skill and knowledge.

Professionals with specialized [removed: skill] [added: skills] and knowledge were used to assist in evaluating the [removed: identification of] [added: technical merits and] the [removed: elements of] [added: tax benefit expected to be sustained and] the [removed: transaction.][added: application of relevant tax laws.]

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

| Cash and cash equivalents | | | [added: | | |] $ | [added: 2,730.0 | | | | | $ |] 3,105.9 | | | | | $ | 2,885.6 | |

| Marketable securities | | | [removed: 4,636.4] [added: 8,114.8] | | | | | | [removed: 2,809.1] [added: 4,636.4] | | |

| Accounts receivable, net | | | [removed: 5,328.7] [added: 5,667.3] | | | | | | [removed: 6,036.5] [added: 5,328.7] | | |

| Inventories | | | [removed: 2,401.9] [added: 2,580.5] | | | | | | [removed: 1,951.3] [added: 2,401.9] | | |

| Prepaid expenses and other current assets | | | [removed: 411.2] [added: 386.6] | | | | | | [removed: 332.4] [added: 411.2] | | |

| Total current assets | | | [removed: 15,884.1] [added: 19,479.2] | | | | | | [removed: 14,014.9] [added: 15,884.1] | | |

| Marketable securities | | | [removed: 6,591.8] [added: 5,396.5] | | | | | | [removed: 6,838.0] [added: 6,591.8] | | |

| Property, plant, and equipment, net | | | [removed: 3,763.0] [added: 4,146.4] | | | | | | [removed: 3,482.2] [added: 3,763.0] | | |

| Intangible assets, net | | | [removed: 915.5] [added: 1,038.6] | | | | | | [removed: 6.7] [added: 915.5] | | |

| /s/ KATHRYN GUARINI | | | | | | *Director* | | | | | | February 5, 2024 | | |

| Kathryn Guarini, Ph.D. | | | | | | | | | | | | | | |

| /s/ DAVID P. SCHENKEIN | | | | | | *Director* | | | | | | February 5, 2024 | | |

| David P. Schenkein, M.D. | | | | | | | | | | | | | | |

*Reserve for an Uncertain Tax Position*

As described in Notes 1 and 15 to the consolidated financial statements, the Company's reserves for uncertain tax positions were $696.4 million as of December 31, 2023.

A reserve for an individual uncertain tax position represents a portion of the consolidated balance.

These procedures included testing the effectiveness of controls relating to the recognition of reserves for uncertain tax positions.

These procedures also included, among others, (i) testing the information used in the calculation of the reserve for the individual uncertain tax position, such as international and federal filing positions, and the related final tax returns; (ii) testing the calculation of the reserve for the uncertain tax position; and (iii) evaluating management's assessment of the technical merits of tax positions and estimates of the amount of tax benefit expected to be sustained, as well as the likelihood of the possible outcome.

February 5, 2024

| | | | 2023 | | | | | | 2022 | | |

| Collaboration revenue | | | | | | 5,503.1 | | | | | | 4,914.1 | | | | | | 3,673.3 | | |

| Net income | | | | | | $ | 3,953.6 | | | | | $ | 4,338.4 | | | | | $ | 8,075.3 | |

| Loss on foreign currency translation | | | | | | (0.3) | | | | | | — | | | | | | — | | |

| Balance, December 31, 2023 | | | | | | 1.8 | | | | | | $ | — | | | | | 133.1 | | | | | | $ | 0.1 | | | | | $ | 11,354.0 | | | | | $ | 27,260.3 | | | | | $ | (80.9) | | | | | (25.5) | | | | | | $ | (12,560.4) | | | | | $ | 25,973.1 | |

| Net income | | | | | | $ | 3,953.6 | | | | | $ | 4,338.4 | | | | | $ | 8,075.3 | |

| Effect of exchange rate changes on cash, cash equivalents, and restricted cash | | | | | | (0.4) | | | | | | — | | | | | | — | | |

[Table](#icad69a7485714b89bcccabdab8d6701b_7) [of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

(expense), net.

[Table](#icad69a7485714b89bcccabdab8d6701b_7) [of](#icad69a7485714b89bcccabdab8d6701b_7) [Contents](#icad69a7485714b89bcccabdab8d6701b_7)

Lease liabilities are recognized at the lease commencement date based on the present value of the remaining lease payments, discounted using the rate implicit in the lease.

*Acquisitions*

In a business combination, the acquisition method of accounting generally requires that the assets acquired and liabilities assumed be recorded as of the date of the acquisition at their respective fair values.

Amounts allocated to acquired in-process research and development are capitalized as indefinite-lived intangible assets.

Any excess of the purchase price (consideration transferred) over the fair values of net assets acquired is recorded as goodwill.

In a business combination, 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, with any changes in fair value recorded in Other operating (income) expense, net.

In an asset acquisition, assets acquired are recorded at cost, goodwill is not recognized, and acquired in-process research and development with no alternative future use is charged to expense.

Indefinite-lived intangible assets are subject to impairment testing until completion or abandonment of the associated research and development efforts.

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and other relevant factors.

In general, the presentation of such amounts is summarized below.

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Research and development expenses include costs attributable to the conduct of research and development programs, including the cost of salaries, payroll taxes, employee benefits, materials, supplies, depreciation on and maintenance of research equipment,

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Deferred tax assets and liabilities are determined as the difference between the tax basis of assets and liabilities and their respective financial reporting amounts ("temporary differences") at enacted tax rates in effect for the years in which the differences are expected to reverse.

The Company recognizes the financial statement effects of a tax position when management's assessment is that there is more than a 50% probability that the position will be sustained upon examination by a taxing authority based upon its technical merits.

Uncertain tax positions are recorded based upon certain recognition and measurement criteria.

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

The Company adjusts the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain tax positions.

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

| /s/ ROBERT E. LANDRY | | | | | | *Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer)* | | | | | | February 6, 2023 | | |

| /s/ P. ROY VAGELOS | | | | | | *Chair of the Board of Directors* | | | | | | February 6, 2023 | | |

| P. Roy Vagelos, M.D. | | | | | | | | | | | | | | |

| /s/ MARC TESSIER-LAVIGNE | | | | | | *Director* | | | | | | February 6, 2023 | | |

| Marc Tessier-Lavigne, Ph.D. | | | | | | | | | | | | | | |

*Accounting for the Acquisition of the Worldwide Rights to Libtayo*

Amounts paid in connection with obtaining the worldwide rights to Libtayo, which included an up-front payment of $900 million, offset by the remaining up-front payments of $241 million previously received under the Immuno-oncology License and Collaboration Agreement, were recorded as an intangible asset.

The Company recorded additions to the Libtayo intangible asset primarily related to contingent consideration due to Sanofi in connection with obtaining the worldwide rights to Libtayo.

As disclosed by management, due to the complexity of the terms of the amendments to the collaboration agreements in contemplation of the acquisition of the worldwide rights to Libtayo, significant judgment was applied by management in identifying the elements of the transaction and evaluating the timing and recognition of contingent consideration including the following: royalties, which are recorded in the period in which the underlying sales occur; sales-based milestones up to an aggregate of $100 million, which are recorded when the milestone is deemed probable by the Company of being achieved; a regulatory milestone of $100 million, which is recorded upon achievement; and a portion of the value associated with the increase in the reimbursement percentage pursuant to the amendment to the Company's Antibody License and Collaboration Agreement.

These procedures included testing the effectiveness of controls over management's accounting for the amendments to the collaboration agreements including controls over the identification of the elements of the transaction and evaluating the timing and recognition of contingent consideration.

These procedures also included, among others (i) reviewing the Amended and Restated Immuno-oncology License and Collaboration Agreement and the amended Antibody License and Collaboration Agreement and other agreements related to the transaction; (ii) evaluating management's identification of the elements of the transaction; and (iii) evaluating the timing and recognition of contingent consideration.

February 6, 2023

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| Sanofi collaboration revenue | | | | | | 2,855.7 | | | | | | 1,902.2 | | | | | | 1,186.4 | | |

| Balance, December 31, 2019 | | | | | | 1.8 | | | | | | $ | — | | | | | 113.3 | | | | | | $ | 0.1 | | | | | $ | 4,428.6 | | | | | $ | 7,379.8 | | | | | $ | 21.1 | | | | | (4.9) | | | | | | $ | (739.9) | | | | | $ | 11,089.7 | |

| Proceeds from issuance of long-term debt | | | | | | — | | | | | | — | | | | | | 1,981.9 | | |

| Proceeds from bridge loan facility | | | | | | — | | | | | | — | | | | | | 1,500.0 | | |

| Repayment of bridge loan facility | | | | | | — | | | | | | — | | | | | | (1,500.0) | | |

Beginning with the first quarter of 2022, the Company added a new line item, Acquired in-process research and development, to its Consolidated Statements of Operations and Comprehensive Income.

This line item includes in-process research and development acquired in connection with asset acquisitions as well as up-front/opt-in payments related to license and collaboration agreements.

Amounts recorded in this line item during the year ended December 31, 2022 would have historically been recorded to Research and development expenses.

Three individual customers accounted for 91% (including 29% related to the U.S. government) of the Company's net trade accounts receivable balances as of December 31, 2021.

Right-of-use assets and lease liabilities are recognized at the lease commencement date based on the present value of lease payments over the lease term, unless there is a transfer of title or purchase option the Company is reasonably certain to exercise.

The Company makes a determination of whether an asset or set of assets acquired constitute a business.

promises should be combined as a single unit of account.

| (e) 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. | | | | | | | | | | | | | | | | | | | | | | | |

| Balance as of December 31, 2019 | | | $ | 80.3 | | | | | $ | 46.4 | | | | | $ | 29.4 | | | | | $ | 156.1 | |

| Provisions | | | 762.9 | | | | | | 279.9 | | | | | | 94.1 | | | | | | 1,136.9 | | |

| Credits/payments | | | (641.0) | | | | | | (249.1) | | | | | | (78.7) | | | | | | (968.8) | | |

a.

The Company's contingent reimbursement

In April 2020, the Company and Sanofi entered into an amendment to the LCA in connection with, among other things, the removal of Praluent from the LCA such that (i) effective April 1, 2020, the LCA no longer governs the development, manufacture, or commercialization of Praluent and (ii) the quarterly period ended March 31, 2020 was the last quarter for which Sanofi and the Company shared profits and losses for Praluent under the LCA.

The parties also entered into a Praluent Cross License & Commercialization Agreement (the "Praluent Agreement") pursuant to which, effective April 1, 2020, the Company, at its sole cost, became solely responsible for the development and commercialization of Praluent in the United States, and Sanofi, at its sole cost, became solely responsible for the development and commercialization of Praluent outside of the United States.

Under the Praluent Agreement, Sanofi pays the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032.

The Company does not owe Sanofi royalties on the Company’s net product sales of Praluent in the United States.

Although each party is responsible for manufacturing Praluent for its respective territory, the parties have entered into definitive supply agreements under which, for a certain transitional period, the Company continues to supply drug substance to Sanofi and Sanofi continues to supply finished product to Regeneron.

With respect to any intellectual property or product liability litigation relating to Praluent, the parties have agreed that, effective April 1, 2020, Regeneron and Sanofi each are solely responsible for any such litigation (including damages and other costs and expenses thereof) in the United States and outside the United States, respectively, arising out of Praluent sales or other activities on or after April 1, 2020 (subject to Sanofi's right to set off a portion of any third-party royalty payments resulting from certain patent litigation proceedings against up to 50% of any Praluent royalty payment owed to Regeneron).