Regeneron Pharmaceuticals (REGN) 10-K risk factor changes: FY2022 vs FY2021

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

- We face risks related to the development, manufacturing, and [added: potential future] commercialization of [removed: REGEN-COV and "next generation"] monoclonal antibodies targeting SARS-CoV-2.

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

- Third-party service or supply failures, failures at our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, or failures at the facilities of any other party participating in the supply [removed: chain,] [added: chain] would adversely affect our ability to supply our products.

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

Risks Related to Our Reliance on [added: or Transactions with] Third Parties

- If our collaborations with Sanofi or Bayer [added: 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, would be materially harmed.

- Our existing shareholders may be able to exert [removed: significant] [added: substantial] influence over matters requiring shareholder approval and over our management.

It has since spread around the [removed: world] [added: world, evolved into multiple new variants,] and caused a global pandemic.

This pandemic has adversely affected [removed: or] [added: 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 [added: previously] resulted [added: 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 [removed: Omicron variant)] [added: Omicron-lineage variants)] emerging and spreading more easily and quickly than other variants.

[removed: As] [added: The trajectory and] the [removed: pandemic continues to rapidly evolve, its] ultimate impact [removed: is] [added: 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.

"Management's Discussion and Analysis of Financial Condition and Results of Operations - [removed: Results of Operations" for a discussion] [added: *Results] of [removed: our net product sales.][added: Operations*."]

Demand for some or all of our marketed products may be further reduced if shelter-in-place, social distancing, or [added: 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.]

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

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

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

We face risks related to the development, manufacturing, and [added: potential future] commercialization of [removed: REGEN-COV and "next generation"] monoclonal antibodies targeting SARS-CoV-2.

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

[removed: In] [added: For example, in] January 2022, the FDA revised the EUA [added: previously granted for REGEN-COV] to exclude its use in geographic regions [added: (currently including all U.S. states, territories, and jurisdictions)] where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as [removed: Omicron] [added: an Omicron-lineage variant] that is not susceptible to the treatment.

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

We also face risks related to our significant investment in the development, supply, allocation, distribution, pricing, and [added: potential future] commercialization of [removed: REGEN-COV and] our [removed: "next generation" monoclonal antibodies (together with REGEN-COV referred to below as "our] COVID-19 monoclonal [removed: antibodies").][added: antibodies.]

[removed: Given the severity and urgency of the COVID-19 pandemic, we] [added: We] have committed and [removed: expect to] [added: 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.

We expect our investment in the development and manufacture of our COVID-19 monoclonal antibodies to continue [removed: through 2022] [added: in 2023] and potentially beyond, although the magnitude of our investment will be subject to clinical data results, the duration of the COVID-19 pandemic, and other factors, including regulatory outcomes.

If we are unable to obtain a new EUA for any of our "next generation" monoclonal antibodies, or obtain regulatory approvals for any of the foregoing, or if we make a strategic decision to discontinue development [removed: of] [added: of, or not commercialize,] our [added: "next generation"] COVID-19 monoclonal antibodies or are otherwise not successful in their commercialization, we may be unable to recoup our significant expenses incurred to date and/or in the future related to the development and production of [removed: our COVID-19 monoclonal] [added: such] antibodies.

While we previously recognized significant revenues in connection with sales of REGEN-COV, the degree to which [added: any] future sales of our COVID-19 monoclonal antibodies will continue to impact our results of operations is highly uncertain.

EYLEA net [added: product] sales represent a substantial portion of our revenues and this concentration of our net sales in a single product makes us substantially dependent on that product.

For the years ended December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] EYLEA net [added: product] sales in the United States represented [removed: 36%] [added: 51%] and [removed: 58%] [added: 36%] of our total revenues, respectively, with EYLEA net [added: 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 [removed: in connection with deliveries of drug product] under our agreements with the U.S. government.

- [removed: the] [added: any] continued [added: or future] impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on our business and the demand for our marketed products, as well as [removed: its] [added: any] continued [added: or future] impact on, among other things, our employees, collaborators, suppliers, and other third parties on which we rely, our ability to continue to manage our supply chain, and the global economy (as further discussed above under "Risks Related to the COVID-19 Pandemic - *Our business may be further adversely affected by the effects of the COVID-19 pandemic*");

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

- our ability and our collaborators' ability to maintain sales of our marketed products in the face of competitive products and to differentiate our marketed products from competitive products, including as applicable product candidates currently in clinical [removed: development;] [added: development (such as aflibercept 8 mg);] and, in the case of EYLEA, the existing and potential new branded and biosimilar competition 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 EYLEA or to switch from another product to EYLEA;

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

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

- the outcome of the pending proceedings relating to EYLEA, [removed: Dupixent,] Praluent, and REGEN-COV (described further in Note [removed: 15] [added: 16] to our Consolidated Financial Statements included in this report), as well as other risks relating to our marketed products and product candidates associated with intellectual property of other parties and pending or future litigation relating thereto (as discussed under "Risks Related to Intellectual Property and Market Exclusivity" below);

- the outcome of the pending government proceedings and investigations and other matters described in Note [removed: 15] [added: 16] to our Consolidated Financial Statements included in this report (including the civil complaint filed against us on June 24, 2020 in the U.S. District Court for the District of Massachusetts by the U.S. Attorney's Office for the District of Massachusetts); and

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

[removed: 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.

[added: Given cost sensitivities in many health care systems (which may continue to be exacerbated as a result of the COVID-19] pandemic), 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.

It is likely that federal and state legislatures and health agencies will continue to focus on additional health care reform measures in the future that will impose additional constraints on prices and reimbursements for our marketed [removed: products; this trend may be further accelerated as a result of the COVID-19 pandemic.][added: products.]

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

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 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.

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.

For example, the impact of prioritizing certain manufacturing-related resources for our COVID-19 monoclonal antibodies has included and may in the future include, among other things, drawing down inventory safety stock levels for certain of our other products (including Dupixent and EYLEA).

Depending on the demand for our products (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

quantities to satisfy our commercial and development needs.

In the United States, the regulatory exclusivity period for EYLEA (i.e., the period during which no biosimilar product can be approved by the FDA) will expire after May 17, 2024.

See "Risks Related to Intellectual Property and Market Exclusivity - *Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, could reduce the duration of market exclusivity for our products*" below.

As a result, we face the risk of lower EYLEA net product sales due to biosimilar competition following such expiration, which may have a material adverse impact on our results of operations.

While we have submitted a BLA for aflibercept 8 mg with the FDA, the degree to which any future net product sales of aflibercept 8 mg (if approved) may offset any potential decrease in EYLEA net product sales is highly uncertain.

If these entities do not provide coverage and reimbursement with respect to

Notably, the U.S. Congress recently passed the IRA, which includes measures requiring the government to negotiate, with respect to drugs provided to Medicare patients and subject to a specified cap, the prices of a set number of certain high Medicare spending drugs and biological products per year starting in 2026 (including those covered under Medicare Part B, such as EYLEA and, potentially in the future, aflibercept 8 mg), measures penalizing manufacturers of certain Medicare Parts B and D drugs for price increases above inflation, and measures redesigning the Medicare Part D benefit to limit patient out-of-pocket drug costs and shift liabilities among stakeholders, including manufacturers.

While enacted into law, it is unclear how the 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 EYLEA) or our product candidates that may in the future be covered under Medicare Part B (such as aflibercept 8 mg).

The requirements

If approved, we expect that aflibercept 8 mg will be entering a highly competitive environment; and our success in potentially commercializing aflibercept 8 mg will depend on a number of factors, including the extent to which we and our collaborators are able to differentiate aflibercept 8 mg from competitive products and the applicability of any restrictions imposed by payors at the time, such as step therapy.

*Dupixent*.

Parallel traders (who may repackage or otherwise alter the original product or sell it through alternative channels such as mail order or the Internet) take advantage of

We expect significant customer concentration to continue for the foreseeable future.

For example, following the exercise of our option under the Antibody Collaboration to co-

In addition, in 2022, we and Sanofi amended the IO Collaboration to transfer all rights to develop, commercialize, and manufacture Libtayo exclusively to our Company, on a worldwide basis, over the course of a defined transition period, and we will need to establish certain sales, marketing, distribution, and manufacturing capabilities for Libtayo to support certain markets outside the United States.

See Part I, Item 1.

"Business - Collaboration, License, and Other Agreements - Sanofi." We will also need to obtain and/or maintain regulatory approvals for Libtayo in many jurisdictions outside of the United States.

safety information, and compliance with FDA-approved risk evaluation and mitigation strategies.

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

If we believe we meet eligibility requirements, we may apply for various regulatory incentives in the United States, such as breakthrough therapy designation, fast track designation, accelerated approval, or priority review, where available, that serve to expedite drug development and/or review, and we may also seek similar designations elsewhere in the world.

Often, regulatory agencies have broad discretion in determining whether or not product candidates qualify for such regulatory incentives and benefits, and we cannot guarantee we would be successful in obtaining beneficial regulatory designations by the FDA or other regulatory agencies.

Even if obtained, such designations may not result in faster development processes, reviews, or approvals compared to drugs considered for approval under conventional FDA procedures.

In addition, the FDA may later decide that any of our development programs no longer meets the conditions for a beneficial regulatory designation (including due to factors beyond our control, such as intervening competitive developments) or decide that the time period for FDA review or approval will not be shortened.

For example, we have recorded a charge to write down inventory related to REGEN-COV as described in Part II, Item 7.

patients to achieve a statistically significant result or the desired level of statistical significance for the endpoint in question, lack of sufficient supplies of the product candidate or comparator drug, and the failure of clinical investigators, trial monitors, contractors, consultants, or trial subjects to comply with the trial plan, protocol, or applicable regulations related to the FDA's GLPs or GCPs.

Additionally, conducting clinical trials in foreign countries presents additional risks, including political and economic risks that are not present in the United States, such as armed conflict and economic embargoes or boycotts.

For example, we and our collaborators are currently conducting and may in the future conduct or initiate clinical trials with sites in Russia and/or Ukraine.

While we currently do not expect the conflict between Russia and Ukraine and related developments to have a significant impact on our ability to obtain results from clinical trials conducted by us or our collaborators, actions taken by Russia or potentially other countries in Ukraine and surrounding areas may adversely affect our ability to adequately conduct certain clinical trials and maintain compliance with relevant protocols due to, among other reasons, the prioritization of hospital resources away from clinical trials, reallocation or evacuation of site staff and subjects, or as a result of government-imposed curfews, warfare, violence, or other governmental action or other events that restrict movement.

These developments may also result in our inability to access sites for monitoring or to obtain data from affected sites or patients going forward.

We could also experience disruptions in our supply chain or limits to our ability to provide sufficient investigational materials in Ukraine and surrounding regions.

Clinical trial sites may suspend or terminate the trials being conducted and patients could be forced to evacuate or choose to relocate, making them unavailable for initial or further participation in such trials.

Alternative sites in these areas may not be available and we may need to find other countries to conduct the relevant trials.

Furthermore, military action may prevent the FDA or other regulatory agencies from inspecting clinical sites in these countries.

We and our employees may also be subject to government vaccine mandates, such as President Biden's recent Executive Order entitled "Executive Order on Ensuring Adequate COVID Safety Protocols for Federal Contractors" applicable to certain federal contractors.

While enforcement of this mandate is currently enjoined and a similar mandate was recently struck down by the United States Supreme Court, if this mandate or any similar mandate becomes applicable to us, it may have a negative impact on our ability to retain employees or hire new employees and could adversely impact our business.

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.

We continue to evaluate the adverse impact of the COVID-19 pandemic on an individual trial basis.

REGEN-COV received an EUA from the FDA in November 2020 for the treatment of mild to moderate COVID-19 in certain patients.

However, based on laboratory data that showed markedly decreased binding to the Omicron spike protein, REGEN-COV is highly unlikely to be active against the Omicron variant.

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

In addition, there can be no assurance with respect to how long the EUA will remain in effect or whether the EUA will be further revised or revoked by the FDA based on its determination that the underlying health emergency no longer exists or warrants such authorization or other reasons.

Similar limitations on the use of REGEN-COV may also be imposed by foreign regulatory authorities in jurisdictions where REGEN-COV is currently authorized for use.

It is also possible that the FDA and certain other regulatory authorities may not grant REGEN-COV full marketing approval for the treatment or prevention of COVID-19, or that any such marketing approvals, if granted, may have similar or other significant limitations on its use.

Further, besides currently available therapeutic and prevention options for COVID-19, additional products for treatment or prevention of COVID-19 that are more efficacious, more easily administered, more cost-effective, or otherwise

superior may be successfully developed; and utilization of REGEN-COV previously was, and any future utilization may be, adversely impacted by other factors, such as the rollout of vaccines providing acquired immunity against COVID-19, other products for treatment or prevention of COVID-19, or the distribution model for REGEN-COV.

Any of these factors may further negatively impact any potential future uptake or commercialization of REGEN-COV, and such impact may be material.

The intense public interest, including speculation by the media, in the development and commercialization of monoclonal antibodies and other products for treatment or prevention of COVID-19 has caused or contributed to significant volatility in our stock price, which may continue as data and other information from any studies evaluating REGEN-COV (whether conducted by us or others), our "next generation" monoclonal antibodies targeting SARS-CoV-2 discussed below, and third-party product candidates for the treatment or prevention of COVID-19 as well as any other regulatory actions become public.

We are also subject to similar risks in connection with the development and potential commercialization of any such "next generation" monoclonal antibodies.

In addition to our REGEN-COV program, we are progressing "next generation" monoclonal antibodies targeting SARS-CoV-2 that are active against Omicron, Delta, and other variants of concern.

Although, pending regulatory discussions, new therapeutic candidates could enter clinical development in the coming months, there can be no assurance of the timing of commencement or completion of any such future studies or favorable results from any of them.

In addition, our internal and contracted manufacturing capacity may not be sufficient to cover any potential future demand for our COVID-19 monoclonal antibodies.

While we have entered into a collaboration agreement with Roche to develop, manufacture, and distribute outside the United States REGEN-COV, we cannot be certain that our current manufacturing and distribution capacity for REGEN-COV and the increased manufacturing and distribution capacity through our collaboration with Roche will be sufficient if there is significant future demand for REGEN-COV.

In addition, we rely entirely on third parties for filling and finishing services for REGEN-COV and, in the future, may rely entirely on such providers for filling and finishing services for our other COVID-19 monoclonal antibodies.

Our third-party fill/finish providers may not have sufficient capacity or may otherwise not be able to provide such services on a timely basis in the quantities requested (such as because they devote their capacity to other drugs or vaccines against COVID-19), which we previously experienced.

The ability of our third-party providers to deliver such services to us may further be adversely impacted by the imposition of government restrictions or limitations (including those that may be imposed under the Defense Production Act).

If we are unable to timely enter into alternative arrangements, or if such alternative arrangements are not available on satisfactory terms or at all, we may experience delays in the development, manufacturing, and distribution of our COVID-19 monoclonal antibodies.

We and Roche have faced and may in the future face additional challenges related to the allocation of supply of REGEN-COV and other COVID-19 monoclonal antibodies (as applicable), particularly with respect to geographic distribution.

For example, if supplies of REGEN-COV are constrained in response to future demand, it is possible that the U.S. government may limit or restrict our and/or Roche's ability to distribute and commercialize REGEN-COV outside the United States.

In addition, as a result of the emergency situations in many countries, there is a heightened risk that products for treatment or prevention of COVID-19 may be subject to adverse governmental actions in certain countries.

The U.S. government may exercise or assert certain rights with respect to our inventions, products, or product candidates.

For example, under the Defense Production Act, the U.S. government may, among other things, require domestic industries to provide essential goods and services needed for the national defense, such as drug material or other supplies needed to treat COVID-19 patients, which could require us to allocate manufacturing capacity in a way that impacts our regular operations.

In addition, our agreements with the U.S. government contain provisions granting the U.S. government certain rights relating to products, product candidates, and related inventions (as applicable) covered by those agreements.

For example, our July 2020 agreement with the U.S. government to manufacture and deliver REGEN-COV to the U.S. government gives the U.S. government, among other rights, the right to require us to grant a non-exclusive license to applicable inventions to a third party if such action is deemed necessary to alleviate certain health or safety needs.

This right may be triggered if we, for example, do not manufacture or supply sufficient product to address such

needs.

If the U.S. government exercises or asserts any such rights or imposes these or similar measures with respect to our products, product candidates, or related inventions (including our COVID-19 monoclonal antibodies), it may adversely impact our business and results of operations.

Foreign governments (including the government of Ireland, where we have manufacturing facilities) may have similar rights or attempt to assert any such rights.

Further, we have observed and are likely to continue to face significant public attention and scrutiny over the complex decisions made regarding the development program for our COVID-19 monoclonal antibodies, including any allocation, distribution, or pricing decisions.

If we are unable to successfully manage these risks, we could face significant reputational harm, which could, among other adverse consequences, negatively affect our stock price.

*development of our product candidates or new indications for our marketed products, which could severely harm our business, prospects, operating results, and financial condition*" below;

Given cost sensitivities in many health care systems (which will likely be exacerbated as a result of the COVID-19

President Biden and various members of his administration and the current U.S. Congress have indicated that lowering drug prices continues to be a legislative and political priority, as evidenced, for example, by the "Executive Order on Promoting Competition in the American Economy" issued by President Biden in July 2021.

The main proposal aimed at drug pricing introduced at the federal level as part of the "Build Back Better Act" includes measures that would allow the government to negotiate prices of certain prescription drugs under Medicare (including those covered under Medicare Part B, such as EYLEA) and would redesign the Medicare Part D benefit to limit patient out-of-pocket drug costs and shift liabilities among stakeholders, including manufacturers.

Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, [removed: 2020] [added: 2021] (filed with the SEC on February [removed: 8, 2021)] [added: 7, 2022)] for additional discussion of our financial condition and results of operations for the year ended December 31, [removed: 2019,] [added: 2020,] as well as our financial condition and results of operations for the year ended December 31, [removed: 2020] [added: 2021] compared to the year ended December 31, [removed: 2019.*][added: 2020.*]

Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that [removed: discovers,] invents, develops, manufactures, and commercializes medicines for [added: people with] serious diseases.

Our [removed: commercialized medicines] [added: 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.

We currently have nine FDA-approved products that have received marketing approval and [removed: over 30] [added: approximately 35] product candidates in clinical development, almost all of which were homegrown in our laboratories.

[removed: "Business -] [added: In addition,] REGEN-COV [removed: - Emergency and Temporary Use Authorizations"] [added: was authorized under an EUA] for [removed: a description of recent revisions to] [added: COVID-19 from November 2020 until January 2022 when] the EUA [added: 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 [removed: treatment).][added: treatment (see Part I, Item 1.]

[removed: Also refer to] [added: As described in] Part I, Item 1.

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 [removed: Dupixent.][added: Dupixent, as well as on whether we are able to obtain regulatory approval for aflibercept 8 mg and are successful in commercializing it.]

[removed: Also,] [added: In addition,] our research and development activities [removed: outside our collaborations, the] [added: and related] costs [removed: of] which are not [removed: reimbursed,] [added: reimbursed] are expected to expand and require additional resources.

Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our products; the scope and progress of our research and development efforts; the timing of certain expenses; the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits [removed: or losses] from sales of [added: commercialized] products and the amount of reimbursement of our research and development expenses that we receive from collaborators; and the amount of income tax expense we incur, which is partly dependent on the profits or losses we earn in each of the countries in which we operate.

Critical Accounting [removed: Policies and Use of] Estimates

[removed: 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.

Refer to the "Results of Operations - [removed: *Revenues*] [added: Revenues] - [removed: *Net] [added: Net] Product [removed: Sales*"] [added: Sales"] section below for further details regarding our provisions, and credits/payments, for sales-related deductions.

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 [removed: time).][added: time) typically using an input method on the basis of our research and development costs incurred relative to the total expected cost which determines the extent of our progress toward completion (see "Results of Operations - Expenses - Other Operating (Income) Expense" below for further information related to amounts recognized in connection with such estimates).]

If our collaborator performs research and development work or commercialization-related activities and [added: the parties] share [added: the related] costs, we also recognize, as expense (e.g., research and development expense or selling, general and administrative expense, as applicable) in the period when our collaborator incurs such expenses, the portion of the collaborator's expenses that we are obligated to reimburse.

- supply commercial product to our collaborator, we may be reimbursed for our manufacturing costs as commercial product is shipped to the [removed: collaborator; however,] [added: collaborator (however,] recognition of such cost reimbursements may be deferred until the product is sold by our collaborator to third-party [removed: customers;][added: customers);]

The estimates are revised, if necessary, in subsequent periods if our [added: actual] share of [removed: actual] profits or losses differ from those estimates.

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

Using this model, fair value is calculated based on assumptions with respect to (i) expected volatility of our Common Stock price, (ii) the periods of time over [added: 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]

Expected volatility [removed: has been] [added: is] estimated based on actual movements in our stock price over the most recent historical periods equivalent to the options' expected lives.

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

The assumptions used in computing the fair value of equity awards reflect our best estimates but involve uncertainties related to market and other conditions, many of which are outside [removed: of] our control.

[removed: Uncertain] [added: The Company recognizes the financial statement effects of a] tax [removed: positions, for which] [added: 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 [removed: merits, are subjected to certain recognition and measurement criteria.][added: merits.]

We adjust the amount of the liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain [added: tax] positions.

See Note [removed: 6] [added: 8] to our Consolidated Financial Statements for [added: further] information related to our [removed: inventory write-offs and reserves.][added: intangible assets.]

| *(In millions, except per share data)* | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| Revenues | | | $ | [removed: 16,071.7] [added: 12,172.9] | | | | | $ | [removed: 8,497.1] [added: 16,071.7] | | | | | $ | [removed: 6,557.6] [added: 8,497.1] | |

| Operating expenses | | | [removed: 7,124.9] [added: 7,434.0] | | | | | | [removed: 4,920.5] [added: 7,124.9] | | | | | | [removed: 4,347.8] [added: 4,920.5] | | |

| Income from operations | | | [removed: 8,946.8] [added: 4,738.9] | | | | | | [removed: 3,576.6] [added: 8,946.8] | | | | | | [removed: 2,209.8] [added: 3,576.6] | | |

| Other income (expense) | | | [removed: 379.0] [added: 119.9] | | | | | | [removed: 233.8] [added: 379.0] | | | | | | [removed: 219.3] [added: 233.8] | | |

| Income before income taxes | | | [removed: 9,325.8] [added: 4,858.8] | | | | | | [removed: 3,810.4] [added: 9,325.8] | | | | | | [removed: 2,429.1] [added: 3,810.4] | | |

| Income tax expense | | | [removed: 1,250.5] [added: 520.4] | | | | | | [removed: 297.2] [added: 1,250.5] | | | | | | [removed: 313.3] [added: 297.2] | | |

| Net income | | | $ | [removed: 8,075.3] [added: 4,338.4] | | | | | $ | [removed: 3,513.2] [added: 8,075.3] | | | | | $ | [removed: 2,115.8] [added: 3,513.2] | |

| Net income per share - diluted | | | $ | [removed: 71.97] [added: 38.22] | | | | | $ | [removed: 30.52] [added: 71.97] | | | | | $ | [removed: 18.46] [added: 30.52] | |

| *(In millions)* | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | | | | | [removed: 2021] [added: 2022] vs. [removed: 2020] [added: 2021] | | | | | | [removed: 2020] [added: 2021] vs. [removed: 2019] [added: 2020] | | |

| [removed: Net] [added: EYLEA net] product sales [removed: in] [added: outside] the United [removed: States: | | | | | | | | |] [added: States] | | | | | | [added: $] | [added: 3,382.8] | | | | | [added: $] | [added: 3,450.9*] | | | | | [added: $] | [added: 2,820.7*] | |

| EYLEA [added: - U.S.] | | | $ | [removed: 5,792.3] [added: 6,264.6] | | | | | $ | [removed: 4,947.2] [added: 5,792.3] | | | | | $ | [removed: 4,644.2] [added: 4,947.2] | | | | | $ | [removed: 845.1] [added: 472.3] | | | | | $ | [removed: 303.0] [added: 845.1] | |

| Libtayo [added: - U.S.] | | | [removed: 306.3] [added: 374.5] | | | | | | [removed: 270.7] [added: 306.3] | | | | | | [removed: 175.7] [added: 270.7] | | | | | | [removed: 35.6] [added: 68.2] | | | | | | [removed: 95.0] [added: 35.6] | | |

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

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

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

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

Critical accounting estimates are those estimates made in accordance with GAAP that involve a significant level of estimation uncertainty and have had or are reasonably likely to have a material impact on our results of operations or financial condition.

We

In addition, we reassess our forfeiture rate assumptions at least annually, considering both historical forfeiture experience and an estimate of future forfeitures for currently outstanding unvested awards.

securities with maturities approximating the options' expected lives.

For performance-based restricted stock units that contain a performance condition, we recognize stock-based compensation expense if and when we determine that it is probable the performance condition will be achieved (based on the number of shares expected to be vested and issued).

We reassess the probability of achievement at each reporting period and adjust compensation cost, as necessary.

If there are any changes in our probability assessment, we recognize a cumulative catch-up adjustment in the period of the change in estimate, with the remaining unrecognized expense recognized prospectively over the remaining requisite service period.

If we subsequently determine that the performance criteria are not met or are not expected to be met, any amounts previously recognized as compensation expense are reversed in the period when such determination is made.

See Note 13 to our Consolidated Financial Statements for stock-based compensation expense and related assumptions used in determining the fair value of our awards.

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

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

Intangible Assets

Intangible assets acquired in connection with an asset acquisition are recorded at cost.

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

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.

Our 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.

If an indicator of impairment exists, we compare the projected undiscounted cash flows to be generated by the asset to the intangible asset's carrying amount.

If the projected undiscounted cash flows of the intangible asset are less than the carrying amount, the intangible asset is written down to its fair value in the period in which the impairment occurs.

"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.

| Net product sales: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Libtayo - ROW | | | 73.0 | | | | | | — | | | | | | — | | | | | | * | | | | | | * | | |

| Inmazeb - U.S. | | | 3.0 | | | | | | — | | | | | | — | | | | | | 3.0 | | | | | | — | | |

| Total net product sales | | | $ | 6,893.7 | | | | | $ | 12,117.2 | | | | | $ | 5,567.6 | | | | | $ | (5,294.3) | | | | | $ | 6,541.4 | |

| Other | | | 0.4 | | | | | | — | | | | | | — | | | | | | 0.4 | | | | | | — | | |

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

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

As described in Part I, Item.

1.

"Business - Collaboration, License, and Other Agreements - Sanofi - Immuno-oncology", effective July 1, 2022, the Company became solely responsible for the research, development, and commercialization of Libtayo worldwide and began recording net product sales of Libtayo outside the United States.

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

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

| Balance as of December 31, 2022 | | | $ | 353.9 | | | | | $ | 111.4 | | | | | $ | 81.5 | | | | | $ | 546.8 | |

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

As the A&R IO LCA became effective July 1, 2022, the three months ended June 30, 2022 was the last period in which Sanofi collaboration revenue was recognized in connection with the immuno-oncology collaborative arrangement.

Global net product sales of Dupixent and Kevzara are recorded by Sanofi.

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

In addition, REGEN-COV has not been approved by the FDA, but has been authorized under an EUA for COVID-19 (see Part I, Item 1.

A summary of the significant accounting policies that impact us is provided in Note 1 to our Consolidated Financial Statements.

Management considers an accounting estimate to be critical if:

- it requires an assumption (or assumptions) regarding a future outcome; and

- changes in the estimate or the use of different assumptions to prepare the estimate could have a material effect on our results of operations or financial condition.

In arrangements where we satisfy our obligation(s) during the development phase over time, we recognize amounts initially deferred over time typically using an input method on the basis of our research and development costs incurred relative to the total expected cost which determines the extent of our progress toward completion.

When we are entitled to reimbursement of all or a portion of the expenses (e.g., research and development expenses) that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.

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 securities with maturities approximating the options' expected lives.

The degree to which future sales of our COVID-19 monoclonal antibodies will continue is highly uncertain and will depend on, among other factors, the number of new COVID-19 cases and effectiveness of our product against variants of concern.

"Business - Products - REGEN-COV - Emergency and Temporary Use Authorizations" for additional information.

| Balance as of December 31, 2018 | | | $ | 41.1 | | | | | $ | 42.0 | | | | | $ | 8.3 | | | | | $ | 91.4 | |

| Provisions | | | 423.2 | | | | | | 242.9 | | | | | | 61.8 | | | | | | 727.9 | | |

| Credits/payments | | | (384.0) | | | | | | (238.5) | | | | | | (40.7) | | | | | | (663.2) | | |

| Immuno-oncology: | | | | | | | | | | | | | | | | | | | | |

| Reimbursement for manufacturing of commercial supplies(1) | | | | | | 60.1 | | | | | | 78.2 | | | | | | 54.2 | | |

| Regeneron's net profit as a percentage of EYLEA net product sales outside the United States | | | | | | 38% | | | | | | 37% | | | | | | 38% | | |

Other revenue decreased in 2021, compared to 2020, primarily due to lower amounts recognized in connection with our agreement with BARDA related to funding of certain development activities for COVID-19 antibodies, and, to a lesser extent, Inmazeb.

| Research and development(1) | | | | | | $ | 2,908.1 | | | | | $ | 2,735.0 | | | | | $ | 2,450.0 | | | | | $ | 173.1 | | | | | $ | 285.0 | |

| (2) Cost of goods sold primarily includes costs in connection with producing commercial supplies for products that are sold by Regeneron in the United States (i.e., for which we record net product sales), any royalties we are obligated to pay on such sales, and amounts we are obligated to pay to collaborators for their share of gross profits. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Fasinumab | | | | | | 67.7 | | | | | | 167.8 | | | | | | 203.4 | | | | | | (100.1) | | | | | | (35.6) | | |

| Up-front payments related to license and collaboration agreements | | | | | | 44.0 | | | | | | 85.0 | | | | | | 430.0 | | | | | | (41.0) | | | | | | (345.0) | | |

| Total direct research and development expenses | | | | | | 1,244.2 | | | | | | 1,395.2 | | | | | | 1,309.6 | | | | | | (151.0) | | | | | | 85.6 | | |

| Total research and development expenses | | | | | | $ | 2,908.1 | | | | | $ | 2,735.0 | | | | | $ | 2,450.0 | | | | | $ | 173.1 | | | | | $ | 285.0 | |

regulatory requirements, changes in the competitive landscape affecting a product candidate, and other risks and uncertainties described in Part I, Item 1A.

"Risk Factors" (including those relating to the disruptions caused by the COVID-19 pandemic).

Selling, general, and administrative expenses increased in 2021, compared to 2020, primarily due to an increase in commercialization-related expenses for (i) EYLEA, including direct-to-consumer advertising, (ii) REGEN-COV, including costs associated with educational campaigns related to COVID-19, and (iii) Libtayo; and higher headcount-related costs.

In addition, in 2020, we recorded a reversal of accruals for litigation-related loss contingencies as a result of the October 2020 ruling by the Technical Board of Appeal of the EPO and its impact on certain patent infringement actions in Europe relating to Praluent (see Note 15 to our Consolidated Financial Statements for additional details).

Cost of goods sold increased in 2021, compared to 2020, primarily due to the recognition of manufacturing costs in connection with the product sales of REGEN-COV.

Additionally, during the fourth quarter of 2021, the Company recorded a $231.7 million charge to write down its REGEN-COV inventory as a result of data that showed REGEN-COV was highly unlikely to be active against the Omicron variant and the FDA revision of the EUA for REGEN-COV, pursuant to which REGEN-COV was no longer authorized for use in any U.S. states, territories, or jurisdictions.

In these arrangements, we satisfy our obligation(s) during the development phase over time, and, as a result, recognize amounts initially deferred over time using an input method on the basis of our research and development costs incurred relative to the total expected cost which determines the extent of our progress toward completion.

See the Critical Accounting Policies and Use of Estimates section above for further details.

During 2020, we updated our estimate of the total research and development costs expected to be incurred (which resulted in changes to the estimate of the stage of completion) in connection with the Sanofi IO, Teva, and MTPC collaboration agreements, and therefore recorded cumulative catch-up adjustments of $99.8 million, net, as an increase to other operating income.

Other income (expense), net, was $379.0 million in 2021, compared to $233.8 million in 2020.

This change was primarily driven by an increase in unrealized gains on equity securities of $190.1 million.

Our effective tax rate for 2020 was positively impacted, compared to the U.S. federal statutory rate, primarily by stock-based compensation, and, to a lesser extent, federal tax credits for research activities and income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate.

| | | | $ | 12,532.7 | | | | | $ | 6,722.6 | | | | | $ | 5,810.1 | |

| Borrowings: | | | | | | | | | | | | | | | | | |

| | | | $ | 10,082.4 | | | | | $ | 7,081.7 | | | | | $ | 3,000.7 | |

Accounts payable, accrued expenses, and other liabilities as of December 31, 2021 included a $259.6 million fourth quarter 2021 true-up payment owed in connection with global gross profits under our Roche collaboration agreement.

2019

Our earnings and cash flows are subject to fluctuations due to changes in interest rates, principally in connection with our investments in marketable securities, which consist primarily of corporate [removed: bonds.][added: bonds and U.S. treasury securities.]

We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would have resulted in approximately a [removed: $120.0] [added: $102.7] million and [removed: $48.1] [added: $120.0] million decrease in the fair value of our investment portfolio as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] respectively.

We continue to monitor our interest rate risk and may utilize [removed: additional] derivative instruments and/or other strategies in the future to further mitigate our interest rate exposure.

In [added: 2022,] 2021, [removed: 2020,] and [removed: 2019,] [added: 2020,] we did not record any charges for credit-related impairments of our available-for-sale debt securities.

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

In [removed: 2021, 2020] [added: 2022, 2021] and [removed: 2019,] [added: 2020,] 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: 2021, three] [added: 2022, two] customers accounted on a combined basis for [removed: 91% (including 29% related to the U.S. government)] [added: 86%] of our net trade accounts receivables.

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

We recorded [removed: $386.1] [added: $39.8] million [added: of net unrealized losses] and [removed: $196.0] [added: $386.1] million of net unrealized gains on equity securities in Other income (expense), net [removed: for the years ended December 31, 2021] [added: in 2022] and [removed: 2020,] [added: 2021,] respectively.

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

In addition, we further manage our interest rate exposure related to our variable rate lease through the use of derivative instruments.

All of our derivative instruments are utilized for risk management purposes and are not used for trading or speculative purposes.

We have hedged a portion of our floating interest rate exposure using interest rate swap and interest rate cap contracts.

We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would not have a material impact on the fair value of our interest rate swap or interest rate cap contracts.

[removed: 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), Inmazeb*® *(atoltivimab, maftivimab, and odesivimab-ebgn), REGEN-COV*® *(casirivimab and imdevimab), aflibercept 8 mg, fasinumab, pozelimab, odronextamab, itepekimab, REGN5458, REGN5713-5714-5715, REGN1908-1909, 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, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), as well as Regeneron's agreement with Roche relating to the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve*™ *in other countries), 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 relating to EYLEA, Dupixent, Praluent, and REGEN-COV described further in Note 15 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 15 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.][added: 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.]

Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that [removed: discovers,] invents, develops, manufactures, and commercializes medicines for [added: people with] serious diseases.

Our [removed: commercialized medicines] [added: 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.

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

| *(In millions, except per share data)* | | | | | | [removed: 2021] [added: 2022] | | | | | | [removed: 2020] [added: 2021] | | | | | | [removed: 2019] [added: 2020] | | |

| Revenues | | | | | | $ | [removed: 16,071.7] [added: 12,172.9] | | | | | $ | [removed: 8,497.1] [added: 16,071.7] | | | | | $ | [removed: 6,557.6] [added: 8,497.1] | |

| Net income | | | | | | $ | [removed: 8,075.3] [added: 4,338.4] | | | | | $ | [removed: 3,513.2] [added: 8,075.3] | | | | | $ | [removed: 2,115.8] [added: 3,513.2] | |

| Net income per share - diluted | | | | | | $ | [removed: 71.97] [added: 38.22] | | | | | $ | [removed: 30.52] [added: 71.97] | | | | | $ | [removed: 18.46] [added: 30.52] | |

| | | | | | | U.S. | | | | | | EU | | | | | | Japan | | | | | | [removed: ROW(4)] [added: ROW(e)] | | | | | | | | | | | | | | |

| EYLEA (aflibercept) [removed: Injection(1)] [added: Injection(a)] | | | [removed: \-] | | | Neovascular age-related macular degeneration ("wet AMD") | | | | | | a | | | | | | a | | | | | | a | | | | | | a | | | | | | | | |

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

| | | | [removed: \-] | | | 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 | | | | | | a | | | | | | | | |

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

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

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

| Dupixent (dupilumab) [removed: Injection(2)] [added: Injection(b)] | | | [removed: \-] | | | Atopic dermatitis (in adults and adolescents) | | | | | | a | | | | | | a | | | | | | a | | | | | | a | | | | | | | | |

| | | | [removed: \-] | | | Atopic dermatitis (in pediatrics 6–11 years of age) | | | | | | a | | | | | | a | | | | | | | | | | | | a | | | | | | | | |

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

| | | | [removed: \-] | | | Asthma (in pediatrics 6–11 years of age) | | | | | | a | | | | | | [added: a] | | | | | | | | | | | | [added: a] | | | | | | | | |

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

| Libtayo (cemiplimab) [removed: Injection(2)] [added: Injection(c)] | | | [removed: \-] | | | Metastatic or locally advanced first-line non-small cell lung cancer ("NSCLC") | | | | | | a | | | | | | a | | | | | | | | | | | | a | | | | | | | | |

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

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

| Praluent (alirocumab) [removed: Injection(3)] [added: Injection(d)] | | | [removed: \-] | | | LDL-lowering in heterozygous familial hypercholesterolemia ("HeFH") or clinical atherosclerotic cardiovascular disease ("ASCVD") | | | | | | a | | | | | | a | | | | | | | | | | | | a | | | | | | | | |

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

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

| [removed: REGEN-COV(5)] [added: REGEN-COV®(f)] | | | [removed: \-] | | | COVID-19 | | | | | | | | | | | | a | | | | | | a | | | | | | a | | | | | | | | |

| Kevzara (sarilumab) Solution for Subcutaneous [removed: Injection(2)] [added: Injection(b)] | | | [removed: \-] | | | Rheumatoid arthritis ("RA") | | | | | | a | | | | | | a | | | | | | a | | | | | | a | | | | | | | | |

| Evkeeza (evinacumab) [removed: Injection(6)] [added: Injection(g)] | | | [removed: \-] | | | HoFH (in adults and adolescents) | | | | | | a | | | | | | a | | | | | | | | | | | | [added: a] | | | | | | | | |

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

| ARCALYST® (rilonacept) Injection for Subcutaneous [removed: Use(7)] [added: Use(h)] | | | [removed: \-] | | | 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 adults and pediatrics) | | | | | | a | | | | | | | | | | | | | | | | | | | | | | | | | | |

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

| ZALTRAP® (ziv-aflibercept) Injection for Intravenous [removed: Infusion(8)] [added: Infusion(i)] | | | [removed: \-] | | | Metastatic colorectal cancer ("mCRC") | | | | | | a | | | | | | a | | | | | | a | | | | | | a | | | | | | | | |

| Note: Refer to [removed: "Net Product Sales of Regeneron-Discovered Products" section] [added: table] below [added: (net product sales of Regeneron-discovered products)] for information regarding whether net product sales for a particular product are recorded by us or others. In addition, unless otherwise noted, products in the table above are [added: generally] approved for use in adults in the above-referenced diseases. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| [removed: (1)] [added: (a)] In collaboration with Bayer outside the United States | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| [removed: (2)] [added: (b)] In collaboration with Sanofi | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| [removed: (3) Pursuant to a 2020 agreement, the] [added: (d) The] Company is solely responsible for the development and commercialization of Praluent in the United States, and Sanofi is solely responsible for the development and commercialization of Praluent outside of the United [removed: States (and Sanofi pays us a royalty on net product sales of Praluent outside the United States).] [added: States.] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| [removed: (4)] [added: (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. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| [removed: (5)] [added: (f)] Known as REGEN-COV in the United States and [removed: Ronapreve] [added: Ronapreve™] in other [removed: countries] [added: countries.] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | Retinopathy of prematurity ("ROP") | | | | | | | | | | | | a | | | | | | a | | | | | | | | | | | | | | |

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

| | | | | | | U.S. | | | | | | EU | | | | | | Japan | | | | | | ROW(e) | | | | | | | | | | | | | | |

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

| | | | | | | Prurigo nodularis | | | | | | a | | | | | | a | | | | | | | | | | | | a | | | | | | | | |

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

| | | | | | | Metastatic or recurrent second-line cervical cancer | | | | | | | | | | | | a | | | | | | a | | | | | | a | | | | | | | | |

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

| (h) Kiniksa is solely responsible for the development and commercialization of ARCALYST. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| EYLEA(a) | | | | | | $ | 6,264.6 | | | | | $ | 3,382.8 | | | | | $ | 9,647.4 | | | | | $ | 5,792.3 | | | | | $ | 3,450.9 | * | | | | $ | 9,243.2 | | | | | $ | 4,947.2 | | | | | $ | 2,820.7 | * | | | | $ | 7,767.9 | |

| Other products(f) | | | | | | $ | 56.1 | | | | | $ | 69.1 | | | | | $ | 125.2 | | | | | $ | 25.9 | | | | | $ | 86.4 | | | | | $ | 112.3 | | | | | $ | 18.9 | | | | | $ | 97.9 | | | | | $ | 116.8 | |

| * 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. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (f) Included in this line item are products which are sold by the Company and others. Refer to Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues" for a complete listing of net product sales recorded by the Company. Not included in this line item are net product sales of ARCALYST subsequent to the first quarter of 2021, which are recorded by Kiniksa. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

Any of such risks and uncertainties may, among other matters, negatively impact the development timelines set forth in the table below.

| 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) | | |

| Clinical Program (continued) | | | | | | Phase 1 | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2022 and 2023 Events to Date | | | | | | Select Upcoming Milestones | | |

| 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) | | |

| Clinical Program (continued) | | | | | | Phase 1 | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2022 and 2023 Events to Date | | | | | | Select Upcoming Milestones | | |

| 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) | | |

| Vidutolimod *Immune activator targeting TLR9* | | | | | | | | | | | | –Solid tumors | | | | | | | | | | | | | | | | | | | | | | | | –Initiate Phase 2 study in melanoma | | |

| Clinical Program (continued) | | | | | | Phase 1 | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2022 and 2023 Events to Date | | | | | | Select Upcoming Milestones | | |

| Clinical Program (continued) | | | | | | Phase 1 | | | | | | Phase 2 | | | | | | Phase 3 | | | | | | Regulatory Review(h) | | | | | | 2022 and 2023 Events to Date | | | | | | Select Upcoming Milestones | | |

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

| REGN7999 *Antibody to TMPRSS6* | | | | | | –Transfusion dependent iron overload | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| "Next Generation" Covid Antibodies *Antibodies to SARS-CoV-2 variants* | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Initiate clinical development of "next generation" antibody | | |

| 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) | | |

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

| ALN-APP(k) *RNAi therapeutic targeting APP* | | | | | | –Early-onset Alzheimer’s disease | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Report results from Phase 1 study in early-onset Alzheimer’s disease (mid-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. | | | | | | | | | | | | | | |

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

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

| (o) Studied in combination with ubamatamab | | | | | | | | | | | | | | |

| (p) Alnylam elected to opt-out of the product candidate. Under the terms of our agreement, Alnylam is entitled to receive royalties on sales of the product, if any. | | | | | | | | | | | | | | |

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 safety of aflibercept 8 mg was similar to EYLEA in both trials, and consistent with the known safety profile of EYLEA from previous clinical trials.

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, 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.

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

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

*REGEN-COV - Emergency and Temporary Use Authorizations*

In November 2020, the antibody cocktail casirivimab and imdevimab administered together, known as REGEN-COV in the United States, received Emergency Use Authorization ("EUA") from the U.S. Food and Drug Administration ("FDA") for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

The EUA is temporary and does not replace a formal Biologics License Application ("BLA") submission review and approval process.

This use is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use, unless terminated or revoked sooner.

In June 2021, the FDA updated the EUA for REGEN-COV, lowering the dose to 1,200 mg (which is half the dose originally authorized) and allowing for subcutaneous injections as an alternative when intravenous ("IV") infusion is not feasible and would lead to a delay in treatment.

In July 2021, the FDA also expanded the EUA to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and who have been exposed to a SARS-CoV-2 infected individual or are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons).

Based on laboratory data that showed markedly decreased binding to the Omicron spike protein, REGEN-COV is highly unlikely to be active against the Omicron variant.

If, in the future, patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to REGEN-COV, then the limitation on use may be revised in these areas.

Emergency or temporary pandemic use authorizations are also currently in place in numerous other countries outside the United States.

| EYLEA(a) | | | | | | $ | 5,792.3 | | | | | $ | 3,592.4 | | | | | $ | 9,384.7 | | | | | $ | 4,947.2 | | | | | $ | 2,961.5 | | | | | $ | 7,908.7 | | | | | $ | 4,644.2 | | | | | $ | 2,897.4 | | | | | $ | 7,541.6 | |

| Evkeeza(f) | | | | | | $ | 18.4 | | | | | — | | | | | | $ | 18.4 | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |

| ARCALYST(g) | | | | | | $ | 2.2 | | | | | — | | | | | | $ | 2.2 | | | | | $ | 13.1 | | | | | — | | | | | | $ | 13.1 | | | | | $ | 14.5 | | | | | — | | | | | | $ | 14.5 | |

| ZALTRAP(b) | | | | | | $ | 5.3 | | | | | $ | 86.4 | | | | | $ | 91.7 | | | | | $ | 5.8 | | | | | $ | 97.9 | | | | | $ | 103.7 | | | | | $ | 7.3 | | | | | $ | 101.1 | | | | | $ | 108.4 | |

| (f) Regeneron records net product sales of Evkeeza in the United States. Pursuant to the January 2022 agreement, Ultragenyx will record net product sales of Evkeeza outside of the United States and will pay the Company a percentage of such sales. Refer to "Products" section above and "Collaboration, License, and Other Agreements - Ultragenyx" section below for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (g) Amounts reflected in the table above represent net product sales recorded by Regeneron. Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States and pays us a share of ARCALYST profits, if any. Refer to "Products" section above and "Collaboration, License, and Other Agreements - Kiniksa" section below for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

We and our collaborators conduct clinical trials in multiple countries across the world.

The COVID-19 pandemic and the restrictions adopted around the globe to reduce the spread of the disease have impacted and may continue to impact our clinical development programs.

We continue to evaluate the impact of the COVID-19 pandemic on an individual trial basis and oversee trial management while also working to ensure patient safety and provide sufficient supply of product candidates for the studies.

The ultimate impact (including possible delays in recruiting and/or obtaining data) resulting from the COVID-19 pandemic will depend, among other factors, on the extent of the pandemic in the areas with study sites and patient populations.

It is possible that the COVID-19 pandemic may cause clinical disruptions beyond those we have described.

In addition, there may be delays in the timing of regulatory review and other projected milestones discussed in the table below.

| EYLEA (aflibercept)(b) | | | | | | | | | | | | | | | | | | –Retinopathy of prematurity ("ROP")(c) | | | | | | –ROP (EU and Japan) | | | | | | –Initial results from National Institutes of Health ("NIH")-sponsored Protocol W trial in non-proliferative diabetic retinopathy ("NPDR") were announced; data confirmed results from Company-sponsored PANORAMA trial and demonstrated reduced risk of developing vision-threatening complications with every-16-weeks dosing regimen –Completed enrollment in Phase 3 study for ROP | | | | | | –Submit supplemental BLA ("sBLA") for every-16-weeks dosing regimen in patients with NPDR (first half 2022) –Report results from Phase 3 study in ROP (second half 2022) | | |

| Aflibercept 8 mg(b) | | | | | | | | | | | | –Wet AMD | | | | | | –Wet AMD –DME | | | | | | | | | | | | –Completed enrollment in Phase 3 studies in wet AMD and DME –Reported initial data from Phase 2 trial in wet AMD and that trial met its primary safety and efficacy endpoints | | | | | | –Report detailed results from Phase 2 trial in wet AMD (first quarter 2022) –Report results from Phase 3 studies in wet AMD and DME (second half 2022) | | |

| Dupixent (dupilumab)(a) *Antibody to IL-4R alpha subunit* | | | | | | | | | | | | –Peanut allergy –Grass allergy | | | | | | –Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3)(d) –Eosinophilic esophagitis ("EoE")(c) in adults(d), adolescents(d), and pediatrics | | | | | | –Atopic dermatitis in pediatrics (6 months–5 years of age) (U.S.) –Asthma in pediatrics (6–11 years of age) (EU) –EoE in adults and adolescents (U.S.) | | | | | | –Reported that Phase 3 trial for atopic dermatitis in pediatrics (6 months–5 years of age) met its primary and key secondary endpoints –Initiated Phase 3 study in hand and foot atopic dermatitis –Approved by FDA for asthma in pediatrics (6–11 years of age) | | | | | | –FDA decision on sBLA for atopic dermatitis in pediatric patients (6 months–5 years of age) (mid-2022) –Submit regulatory application in the EU for atopic dermatitis in pediatric patients (6 months–5 years of age) (first half 2022) | | |

| REGN1908-1909(f) *Multi-antibody therapy to Fel d 1* | | | | | | | | | | | | | | | | | | –Cat allergy | | | | | | | | | | | | –Reported that Phase 2 study in cat allergic patients with mild asthma met its primary and key secondary endpoints | | | | | | | | |

| REGN6490 *Antibody to IL-36R* | | | | | | –Palmo-plantar pustulosis | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Libtayo (cemiplimab)(a)(g) *Antibody to PD-1* | | | | | | | | | | | | –Metastatic or locally advanced CSCC(d) –Neoadjuvant CSCC –Second-line cervical cancer, ISA101b combination | | | | | | –First-line NSCLC, chemotherapy combination –Second-line cervical cancer(e) –Adjuvant CSCC | | | | | | –Second-line cervical cancer (EU) –First-line NSCLC, chemotherapy combination (U.S. and EU) | | | | | | –Approved by FDA and EC for first-line NSCLC, monotherapy –Approved by FDA and EC for BCC –Reported Phase 3 chemotherapy combination trial in NSCLC met its overall survival primary endpoint; trial stopped early based on Independent Data Monitoring Committee ("IDMC") recommendation | | | | | | –FDA decision on sBLA (target action date of September 19, 2022) and EC decision on regulatory submission for NSCLC, chemotherapy combination (second half 2022) –EC decision on regulatory submission for cervical cancer (second half 2022) | | |

| Libtayo (cemiplimab)(a)(g) *(continued)* | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Reported positive results from Phase 3 trial in cervical cancer, demonstrating an overall survival benefit; trial stopped early based on IDMC recommendation –Voluntarily withdrew sBLA for cervical cancer due to inability to align with FDA on certain post-marketing studies | | | | | | | | |

| Cemdisiran(n) *siRNA therapeutic targeting C5* | | | | | | | | | | | | –Immunoglobulin A nephropathy | | | | | | | | | | | | | | | | | | | | | | | | | | |

| REGEN-COV (casirivimab and imdevimab)(e)(k)(l) *Multi-antibody therapy to SARS-CoV-2 virus* | | | | | | | | | | | | | | | | | | –COVID-19 treatment in hospitalized patients –COVID-19 prevention | | | | | | –COVID-19 treatment and prevention (U.S.) –EUA amendment to add COVID-19 treatment for hospitalized patients and pre-exposure prophylaxis | | | | | | –Reported that Phase 3 trials in non-hospitalized COVID-19 patients met primary and key secondary endpoints –Reported that Phase 3 trial in hospitalized COVID-19 patients met its primary endpoint –Positive results reported from Phase 3 RECOVERY trial in hospitalized patients –Reported that all tested doses in Phase 2 dose-ranging study in non-hospitalized patients met its primary endpoint –FDA updated EUA, lowering dose to 1,200 mg, allowing for subcutaneous injections in certain circumstances, and to include post-exposure prophylaxis –FDA revised EUA to exclude use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment | | | | | | –FDA decision on BLA (target action date of April 13, 2022) for COVID-19 treatment of non-hospitalized patients and prevention –Submit sBLA and Marketing Authorization Application ("MAA") for COVID-19 treatment of hospitalized patients (first half 2022) | | |

| REGEN-COV (casirivimab and imdevimab)(e)(k)(l) *(continued)* | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | –Approved by EC for COVID-19 treatment of non-hospitalized patients and prevention and by Ministry of Health, Labour and Welfare ("MHLW") for COVID-19 treatment in Japan –Reported that Phase 3 prevention trial in uninfected household contacts of SARS-CoV-2 infected individuals met its primary and key secondary endpoints –Reported positive longer-term results from Phase 3 prevention trial | | | | | | | | |

| Fasinumab(j)(f) (REGN475) *Antibody to NGF* | | | | | | | | | | | | | | | | | | –Osteoarthritis pain of the knee or hip(e) | | | | | | | | | | | | | | | | | | –Continue discussions with regulatory authorities and determine next steps for the program (mid-2022) | | |

| Evkeeza (evinacumab)(f)(o) *Antibody to ANGPTL3* | | | | | | | | | | | | –Acute pancreatitis prevention | | | | | | | | | | | | | | | | | | –Approved by FDA and EC for HoFH –Completed Phase 2 study in severe hypertriglyceridemia | | | | | | | | |

| (i) As described in the section preceding the table above and Part I, Item 1A. "Risk Factors," development timelines may be further subject to change as a result of the impact of the COVID-19 pandemic. | | | | | | | | | | | | | | |

| (j) In collaboration with Teva and Mitsubishi Tanabe Pharma | | | | | | | | | | | | | | |

| (k) Certain trials conducted with the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the NIH | | | | | | | | | | | | | | |

| (o) In collaboration with Ultragenyx outside of the United States | | | | | | | | | | | | | | |

*REGEN-COV (casirivimab and imdevimab)*

The information called for by this item is incorporated herein by reference to the information set forth in Note [removed: 15] [added: 16] to our Consolidated Financial Statements included in this report.

| | | | For the fiscal year ended December 31, [removed: 2021] [added: 2022] | | | | | | | | |

| | | | Commission File Number: [removed: 0-19034] [added: 000-19034] | | | | | | | | |

| The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant was [removed: approximately $57,065,000,000,] [added: $62.0 billion,] computed by reference to the closing sales price of the stock on NASDAQ on June 30, [removed: 2021,] [added: 2022,] 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: 27, 2022:] [added: 26, 2023:] | | | | | | | | | | | | | | |

| Class A Stock, $.001 par value | | | | | | [removed: 1,823,283] [added: 1,818,146] | | |

| Common Stock, $.001 par value | | | | | | [removed: 106,715,999] [added: 107,507,386] | | |

| Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its [removed: 2022] [added: 2023] Annual Meeting of Shareholders are incorporated by reference into Part III of this Form 10-K. Exhibit index is located on pages [removed: 95] [added: 96] to 101 of this filing. | | |

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

| [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) | | | | | | | | | | | | | | |

| [PART I](#i58977c8e94dd4577b7dd02b6fd4ef00f_10) | | | | | | | | | | | | | | |

| [PART II](#i58977c8e94dd4577b7dd02b6fd4ef00f_37) | | | | | | | | | | | | | | |

| [Item 6.](#i58977c8e94dd4577b7dd02b6fd4ef00f_43) | | | | | | [\[RESERVED\]](#i58977c8e94dd4577b7dd02b6fd4ef00f_43) | | | | | | [78](#i58977c8e94dd4577b7dd02b6fd4ef00f_43) | | |

| [PART IV](#i58977c8e94dd4577b7dd02b6fd4ef00f_85) | | | | | | | | | | | | | | |

At our Tarrytown, New York location, we lease approximately 1,467,000 square feet of laboratory and office [removed: space, of which approximately 1,354,000 square feet is occupied by Regeneron.][added: space.]

We also own an approximate 100-acre parcel of [removed: undeveloped] land adjacent to our Tarrytown, New York location, which we [removed: plan to start developing] [added: are] in [removed: 2022,] [added: the process of developing,] primarily in connection with expanding our research and support facilities to accommodate our growth.

We own facilities in Rensselaer, New York totaling approximately [removed: 950,000] [added: 1,189,000] square feet of manufacturing, research, office, and warehouse space.

[removed: This includes approximately 212,000 square feet of warehouse space which we] constructed on a 130-acre parcel of land near our Rensselaer facility.

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

We are in the process of further developing this property to support our growth and expand our manufacturing capacity.

As of January [removed: 27, 2022,] [added: 26, 2023,] there were [removed: 166] [added: 161] shareholders of record of our Common Stock and [removed: 15] [added: 14] shareholders of record of our Class A Stock.

Set forth below is a line graph comparing the cumulative total shareholder return on Regeneron's Common Stock with the cumulative total return of (i) the NASDAQ US Benchmark Pharmaceuticals Total Return Index ("NQ US Pharma TR Index"), and (ii) Standard & Poor's 500 Stock Index ("S&P 500") for the period from December 31, [removed: 2016] [added: 2017] through December 31, [removed: 2021.][added: 2022.]

The comparison assumes that $100 was invested on December 31, [removed: 2016] [added: 2017] in our Common Stock and in both of the foregoing indices.

[removed: ][added: ]

| | | | [removed: 12/31/2016] [added: 12/31/2017] | | | | | | [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] | | |

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: 2021.][added: 2022.]

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

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

| (b) In [removed: November 2021,] [added: January 2023,] our board of directors authorized [removed: an additional] [added: a new] share repurchase program to repurchase up to [added: an additional] $3.0 billion of our Common Stock. [removed: | | |] [added: See Item 7. "Liquidity and Capital Resources - Share Repurchase Programs" for further details.] | | | | | | | | | | | | | | | | | | | | | | | | | | |

| 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) | | | | | |

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

| Regeneron | | | $ | 100.00 | | | | | $ | 102.42 | | | | | $ | 101.75 | | | | | $ | 102.29 | | | | | $ | 131.61 | | | | | $ | 172.03 | |

| S&P 500 | | | $ | 100.00 | | | | | $ | 119.42 | | | | | $ | 111.97 | | | | | $ | 144.31 | | | | | $ | 167.77 | | | | | $ | 212.89 | |

| NQ US Pharma TR Index | | | $ | 100.00 | | | | | $ | 120.40 | | | | | $ | 128.60 | | | | | $ | 147.25 | | | | | $ | 162.74 | | | | | $ | 202.43 | |

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

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

| 10/1/2021–10/31/2021 | | | | | | 1,195,053 | | | | | | $ | 560.51 | | | | | 1,195,053 | | | | | | $ | 27.5 | | | | |

| 11/1/2021–11/30/2021 | | | | | | 110,500 | | | | | | $ | 645.90 | | | | | 110,500 | | | | | | $ | 2,956.1 | | (b) | | |

| 12/1/2021–12/31/2021 | | | | | | 271,289 | | | | | | $ | 643.03 | | | | | 176,000 | | | | | | $ | 2,845.0 | | | | |

| Total | | | | | | 1,576,842 | | | (a) | | | | | | | | | 1,481,553 | | | (a) | | | | | | | | |

The information required by this Item is [removed: included] [added: set forth beginning] on [removed: pages] [added: page] F-1 [removed: through F-42] of this report and is incorporated herein by reference.

Our management, with the participation of our principal executive officer and principal financial officer, conducted an evaluation of the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) [removed: and] [added: or] 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act")), as of the end of the period covered by this Annual Report on Form 10-K.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) [removed: and] [added: or] 15d-15(f) under the Exchange Act.

Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, [removed: 2021] [added: 2022] 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: 2021.][added: 2022.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2021] [added: 2022] 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) [removed: and] [added: or] 15d-15(f) under the Exchange Act) during the quarter ended December 31, [removed: 2021] [added: 2022] that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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: 2022] [added: 2023] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

The full text of our code of business conduct and ethics can be found on our website (http://www.regeneron.com) under the [removed: "Corporate Governance"] [added: "Governance"] heading on the "Investors & Media" page.

The information called for by this item will be included in our definitive proxy statement with respect to our [removed: 2022] [added: 2023] 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: 2022] [added: 2023] 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: 2022] [added: 2023] 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: 2022] [added: 2023] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

| 10.1.2 + | | | [Form of option agreement and related notice of grant for use in connection with the grant of [removed: performance] [added: time] based vesting stock options to the Registrant's [removed: executive officers] [added: non-employee directors] under the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive [removed: Plan.] [added: Plan (revised).] (Incorporated by reference from the Form [removed: 10-Q] [added: 10-K] for the Registrant, for the [removed: quarter] [added: year] ended [removed: March] [added: December] 31, [removed: 2009,] [added: 2011,] filed [removed: April 30, 2009.)](http://www.sec.gov/Archives/edgar/data/872589/000120677409000907/exhibit10-2.htm)] [added: February 21, 2012.)](http://www.sec.gov/Archives/edgar/data/872589/000120677412000709/exhibit10-1_9.htm)] | | |

| [removed: 10.1.3] [added: 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 [removed: Regeneron Pharmaceuticals, Inc.] Second Amended and Restated [removed: 2000] [added: Regeneron Pharmaceuticals, Inc. 2014] Long-Term Incentive [removed: Plan (revised).] [added: Plan.] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2010,] [added: 2020,] filed February [removed: 17, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000120677411000263/exhibit10_1-7.htm)] [added: 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm)] | | |

| [removed: 10.1.4] [added: 10.3.1] + | | | [Form of [added: stock] option agreement and related notice of grant for use in connection with the grant of [removed: performance based vesting] [added: non-qualified] stock options to the Registrant's executive officers under the [removed: Regeneron Pharmaceuticals, Inc.] Second Amended and Restated [removed: 2000] [added: Regeneron Pharmaceuticals, Inc. 2014] Long-Term Incentive [removed: Plan (revised).] [added: Plan.] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2010,] [added: 2020,] filed February [removed: 17, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000120677411000263/exhibit10_1-8.htm)] [added: 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm)] | | |

| [removed: 10.1.5] [added: 10.3.5] + | | | [Form of [added: stock] option agreement and related notice of grant for use in connection with the grant of [removed: time based vesting] [added: non-qualified] stock options to the Registrant's non-employee directors under the [removed: Regeneron Pharmaceuticals, Inc.] Second Amended and Restated [removed: 2000] [added: Regeneron Pharmaceuticals, Inc. 2014] Long-Term Incentive [removed: Plan (revised).] [added: Plan.] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2011,] [added: 2020,] filed February [removed: 21, 2012.)](http://www.sec.gov/Archives/edgar/data/872589/000120677412000709/exhibit10-1_9.htm)] [added: 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1035x12312020x10k.htm)] | | |

| [removed: 10.1.6] [added: 10.1.3] + | | | [Amendment No. 1 to the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2013, filed February 13, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000153217614000008/exhibit10110.htm) | | |

| [removed: 10.3.1] [added: 10.3.2] + | | | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to [removed: the Registrant's executive officers] [added: P. Roy Vagelos, M.D.] under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm)[(Incorporated] [added: Plan. (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February [removed: 8,](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm) [2021](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm)[.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1031x12312020x10k.htm)] [added: 8, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1032x12312020x10k.htm)] | | |

| [removed: 10.3.2] [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 P. Roy Vagelos, M.D. under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1032x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1032x12312020x10k.htm)[(Incorporated] [added: Plan. (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, [removed: 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1032x12312020x10k.htm)] [added: 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1034x12312020x10k.htm)] | | |

| [removed: 10.3.3] [added: 10.3.6] + | | | [Form of restricted stock [added: unit] award agreement and related notice of grant for use in connection with the grant of restricted stock [removed: awards] [added: units] to the Registrant's [removed: executive officers] [added: non-employee directors] under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm)[(Incorporated] [added: Plan. (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, [removed: 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm)] [added: 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1036x12312020x10k.htm)] | | |

| [removed: 10.3.4] [added: 10.3.7] + | | | [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: P. Roy Vagelos, M.D.] [added: Leonard S. Schleifer, M.D., Ph.D. and George D. Yancopoulos, M.D., Ph.D.] under the Second Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1034x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1034x12312020x10k.htm)[(Incorporated] [added: Plan. (Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, 2020, filed February 8, [removed: 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1034x12312020x10k.htm)] [added: 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1037x12312020x10k.htm)] | | |

| [removed: 10.10*] [added: 10.16*] | | | [removed: [Amended] [added: [ANG2 License] and [removed: Restated] Collaboration Agreement, dated as of [removed: February] [added: March] 23, [removed: 2015,] [added: 2016,] by and between [removed: Sanofi-Aventis US] [added: Bayer HealthCare] LLC and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, [removed: 2015,] [added: 2016,] filed May [removed: 7, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000020/regn-ex_101x03312015x10q.htm)] [added: 5, 2016.)](http://www.sec.gov/Archives/edgar/data/872589/000153217616000055/regn-ex_102x03312016x10q.htm)] | | |

| [removed: 10.11*] [added: 10.10*] | | | [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: 10.11.1*] [added: 10.10.1*] | | | [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: 10.11.2] [added: 10.10.2] | | | [Second Amendment Agreement, dated December 19, 2019, 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, 2019, filed February 7, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10102secondamen.htm) | | |

| [removed: 10.12] [added: 10.11.1*] | | | [removed: [License] [added: [First Amendment to Amended] and [added: Restated License and] Collaboration [removed: Agreement, dated as of January 10, 2014,] [added: Agreement] by and between [removed: Bayer HealthCare LLC and] the [removed: Registrant.] [added: Registrant and Aventis Pharmaceuticals Inc., dated May 1, 2013.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended [removed: March 31, 2014,] [added: June 30, 2013,] filed [removed: May 8, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000153217614000022/regn-ex_102x03312014x10q.htm)] [added: August 6, 2013.)](http://www.sec.gov/Archives/edgar/data/872589/000153217613000022/regn-ex_105x6302013x10q.htm)] | | |

| [removed: 10.13*] [added: 10.11*] | | | [Amended and Restated [removed: Discovery] [added: License] and [removed: Preclinical Development] [added: Collaboration] Agreement, dated as of November 10, 2009, by and [removed: between] [added: among] Aventis Pharmaceuticals [removed: Inc.] [added: 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, [removed: 2010.)](http://www.sec.gov/Archives/edgar/data/872589/000120677410001385/exhibit10-14.htm)] [added: 2010.)](http://www.sec.gov/Archives/edgar/data/872589/000120677410001385/exhibit10-15.htm)] | | |

| [removed: 10.13.1*] [added: 10.11.2*] | | | [Amendment No. [removed: 1] [added: 2] to Amended and Restated [removed: Discovery] [added: License] and [removed: Preclinical Development] [added: 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, [removed: 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_103x09302015x10q.htm)] [added: 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_104x09302015x10q.htm)] | | |

| [removed: 10.14*] [added: 10.13] | | | [Amended and Restated [removed: License and Collaboration] [added: Investor] Agreement, dated as of [removed: November 10, 2009,] [added: January 11, 2014,] by and among [added: Sanofi, sanofi-aventis US LLC,] Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant. (Incorporated by reference from the Form [removed: 10-K/A] [added: 8-K] for the Registrant, [removed: for the year ended December 31, 2009,] filed [removed: June 2, 2010.)](http://www.sec.gov/Archives/edgar/data/872589/000120677410001385/exhibit10-15.htm)] [added: January 13, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514008775/d659864dex101.htm)] | | |

| [removed: 10.14.1*] [added: 10.11.5] | | | [removed: [First] [added: [Fifth] Amendment to Amended and Restated License and Collaboration [removed: Agreement] [added: Agreement, dated as of June 1, 2022,] by and between the [removed: Registrant] [added: Registrant, Sanofi Biotechnology SAS,] and [removed: Aventis Pharmaceuticals Inc., dated May 1, 2013.] [added: Sanofi.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, [removed: 2013,] [added: 2022,] filed August [removed: 6, 2013.)](http://www.sec.gov/Archives/edgar/data/872589/000153217613000022/regn-ex_105x6302013x10q.htm)] [added: 3, 2022.)](http://www.sec.gov/Archives/edgar/data/872589/000180422022000023/regn-ex_103x6302022x10q.htm)] | | |

| [removed: 10.14.2*] [added: 10.11.3] | | | [removed: [Amendment No. 2] [added: [Third Amendment] to Amended and Restated License and Collaboration Agreement, dated [removed: July 27, 2015] [added: as of April 5, 2020,] and [removed: entered into] effective as of [removed: July] [added: April] 1, [removed: 2015,] [added: 2020,] by and between the [removed: Registrant and] [added: Registrant,] Sanofi Biotechnology SAS, [removed: as successor-in-interest to Aventis Pharmaceuticals, Inc.] [added: and Sanofi.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended [removed: September] [added: June] 30, [removed: 2015,] [added: 2020,] filed [removed: November 4, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_104x09302015x10q.htm)] [added: August 5, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000180422020000022/regn-ex103x06302020x10q.htm)] | | |

| [removed: 10.14.3] [added: 10.12] | | | [removed: [Third Amendment to Amended and Restated] [added: [Praluent Cross] License [removed: and Collaboration] [added: & Commercialization] Agreement, dated as of April 5, 2020, and effective as of April 1, 2020, by and between the [removed: Registrant,] [added: Registrant and] Sanofi Biotechnology [removed: SAS, and Sanofi.] [added: SAS.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2020, filed August 5, [removed: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000180422020000022/regn-ex103x06302020x10q.htm)] [added: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000180422020000022/regn-ex104x06302020x10q.htm)] | | |

| [removed: 10.14.4] [added: 10.11.4] | | | [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.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regen-ex_10144x12312021x10k.htm)] [added: Sanofi.](http://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regen-ex_10144x12312021x10k.htm) [(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)] | | |

| 10.15 | | | [removed: [Praluent Cross] [added: [Amended and Restated Immuno-oncology] License [removed: & Commercialization] [added: and Collaboration] Agreement, dated as of [removed: April 5, 2020, and effective as of April] [added: June] 1, [removed: 2020,] [added: 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, [removed: 2020,] [added: 2022,] filed August [removed: 5, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000180422020000022/regn-ex104x06302020x10q.htm)] [added: 3, 2022.)](http://www.sec.gov/Archives/edgar/data/872589/000180422022000023/regn-ex_102x06302022x10q.htm)] | | |

| [removed: 10.16] [added: 10.13.1] | | | [removed: [Amended] [added: [Amendment to the Amended] and Restated Investor Agreement, dated as of [removed: January 11, 2014,] [added: May 25, 2020,] by and among [added: the Registrant,] Sanofi, [removed: sanofi-aventis] [added: Sanofi-Aventis] US LLC, [removed: Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord,] and [removed: the Registrant.] [added: Aventisub LLC.] (Incorporated by reference from the Form 8-K for the Registrant, filed [removed: January 13, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514008775/d659864dex101.htm)] [added: May 29, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000110465920067752/tm2021201d1_ex10-2.htm)] | | |

| [removed: 10.16.1] [added: 10.19*] | | | [removed: [Amendment to the] [added: [Second] Amended and Restated [removed: Investor] [added: Lease and Remedies] Agreement, dated as of [removed: May 25, 2020, by and among the Registrant, Sanofi, Sanofi-Aventis US] [added: March 2, 2022, between Old Saw Mill Holdings] LLC, [added: as lessee,] and [removed: Aventisub LLC.] [added: BA Leasing BSC, LLC, as lessor.] (Incorporated by reference from the Form 8-K for the Registrant, filed [removed: May 29, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000110465920067752/tm2021201d1_ex10-2.htm)] [added: March 8, 2022.)](http://www.sec.gov/Archives/edgar/data/872589/000110465922031232/tm222431d2_ex10-2.htm)] | | |

| [removed: 10.17*] [added: 10.21] | | | [removed: [Letter Agreement] [added: [Master Agreement, dated as of April 8, 2019,] by and between the Registrant and [removed: Aventis Pharmaceuticals Inc., dated May 2, 2013.] [added: Alnylam Pharmaceuticals, Inc.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, [removed: 2013,] [added: 2019,] filed August 6, [removed: 2013.)](http://www.sec.gov/Archives/edgar/data/872589/000153217613000022/regn-ex_106x6302013x10q.htm)] [added: 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex104.htm)] | | |

| [removed: 10.18] [added: 10.14*] | | | [Credit Agreement, dated as of December [removed: 14, 2018,] [added: 19, 2022,] by and among the Registrant, as a borrower and [removed: guarantor;] [added: guarantor,] certain direct subsidiaries of the Registrant, as the initial subsidiary [removed: borrowers; JPMorgan Chase Bank, N.A., as administrative agent; Bank of America, N.A. and U.S. Bank National Association, as co-syndication agents; Barclays Bank PLC, Citibank, N.A., Fifth Third Bank, and MUFG Bank, Ltd., as co-documentation agents; JPMorgan Chase Bank, N.A., Bank of America, N.A., and U.S. Bank National Association, as] [added: borrowers,] the [added: lenders and] issuing [removed: banks;] [added: banks party thereto, and] JPMorgan Chase Bank, N.A., as [removed: the] [added: administrative agent,] swingline [removed: lender;] [added: lender,] and [removed: the other lenders party thereto from time to time.] [added: an issuing bank.] (Incorporated by reference from the Form 8-K for the Registrant, filed December [removed: 17, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000110465918073328/a18-41689_1ex10d1.htm)] [added: 20, 2022.)](http://www.sec.gov/Archives/edgar/data/872589/000110465922128613/tm2233051d1_ex10-1.htm)] | | |

| [removed: 10.19*] [added: 10.17*] | | | [removed: [Amended and Restated Immuno-oncology Discovery and Development] [added: [Purchase] Agreement, [removed: executed on January 2, 2019 and effective] [added: dated] as of December [removed: 31, 2018,] [added: 30, 2016,] by and [removed: between the Registrant] [added: among BMR-Landmark at Eastview LLC] and [removed: Sanofi Biotechnology SAS.] [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: 2018,] [added: 2016,] filed February [removed: 7, 2019).](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_1017xamendedio.htm)] [added: 9, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000153217617000008/regn-ex_1035xlandmarkpsaex.htm)] | | |

| [removed: 10.20*] [added: 10.22] | | | [removed: [Immuno-oncology License and Collaboration] [added: [License] Agreement, dated [removed: July 27, 2015 and entered into effective] as of [removed: July 1, 2015,] [added: August 18, 2020,] by and [removed: between] [added: among] the [removed: Registrant] [added: Registrant, F. Hoffman-La Roche Ltd,] and [removed: Sanofi Biotechnology SAS.] [added: Genentech, Inc.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, [removed: 2015,] [added: 2020,] filed November [removed: 4, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_102x09302015x10q.htm)] [added: 5, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000180422020000030/regn-ex103x09302020x10q.htm)] | | |

| [removed: 10.25] [added: 10.18*] | | | [removed: [Amended] [added: [Second Amended] and Restated Participation Agreement, dated as of [removed: May] [added: March] 2, [removed: 2019,] [added: 2022,] by and among Old Saw Mill Holdings LLC, as [removed: lessee;] [added: lessee,] Bank of America, N.A., as administrative [removed: agent;] [added: agent,] BA Leasing BSC, LLC, as [removed: lessor;] [added: lessor,] and the [removed: lenders] [added: rent assignees] party thereto from time to time. (Incorporated by reference from the Form 8-K for the Registrant, filed [removed: May 3, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000093041319001557/c93557_ex10-1.htm)] [added: March 8, 2022.)](http://www.sec.gov/Archives/edgar/data/872589/000110465922031232/tm222431d2_ex10-1.htm)] | | |

| [removed: 10.27] [added: 10.20*] | | | [removed: [Amended] [added: [Second Amended] and Restated Guaranty, dated as of [removed: May] [added: March] 2, [removed: 2019,] [added: 2022,] made by [removed: Regeneron Pharmaceuticals, Inc.,] [added: the Registrant,] Regeneron Healthcare Solutions, Inc., and Regeneron Genetics Center LLC, as guarantors. (Incorporated by reference from the Form 8-K for the Registrant, filed [removed: May 3, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000093041319001557/c93557_ex10-3.htm)] [added: March 8, 2022.)](http://www.sec.gov/Archives/edgar/data/872589/000110465922031232/tm222431d2_ex10-3.htm)] | | |

| [removed: 10.29.1] [added: 10.21.1] | | | [Form of Co-Co Collaboration Agreement (Exhibit B to Master Agreement contained in Exhibit [removed: 10.29).](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1041.htm)] [added: 10.](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1041.htm)[21](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1041.htm)[).](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1041.htm)] | | |

| [removed: 10.29.2] [added: 10.21.2] | | | [Form of License Agreement (Exhibit C to Master Agreement contained in Exhibit [removed: 10.29).](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1042.htm)] [added: 10.](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1042.htm)[21](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1042.htm)[).](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex1042.htm)] | | |

| 21.1 | | | [Subsidiaries of the [removed: Registrant.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_211x12312021x10k.htm)] [added: Registrant.](https://www.sec.gov/Archives/edgar/data/872589/000180422023000008/regn-ex_211x12312022x10k.htm)] | | |

| 23.1 | | | [Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting [removed: Firm.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_231x12312021x10k.htm)] [added: Firm.](https://www.sec.gov/Archives/edgar/data/872589/000180422023000008/regn-ex_231x12312022x10k.htm)] | | |

| 24.1 | | | [Power of Attorney (included on the signature page of this Annual Report on Form [removed: 10-K).](#i58977c8e94dd4577b7dd02b6fd4ef00f_91)] [added: 10-K).](#ic18bad8bf5314e3e9f4c348a9f859317_94)] | | |

| 31.1 | | | [Certification of Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_311x12312021x10k.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000180422023000008/regn-ex_311x12312022x10k.htm)] | | |

| 31.2 | | | [Certification of Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_312x12312021x10k.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000180422023000008/regn-ex_312x12312022x10k.htm)] | | |

| 32 | | | [Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section [removed: 1350.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_32x12312021x10k.htm)] [added: 1350.](https://www.sec.gov/Archives/edgar/data/872589/000180422023000008/regn-ex_32x12312022x10k.htm)] | | |

| 101 | | | Interactive Data Files pursuant to Rule 405 of Regulation S-T formatted in Inline Extensible Business Reporting Language ("Inline XBRL"): (i) the Registrant's Consolidated Balance Sheets as of December 31, [removed: 2021] [added: 2022] and [removed: 2020;] [added: 2021;] (ii) the Registrant's Consolidated Statements of Operations and Comprehensive Income for the years ended December 31, [added: 2022,] 2021, [removed: 2020,] and [removed: 2019;] [added: 2020;] (iii) the Registrant's Consolidated Statements of Stockholders’ Equity for the years ended December 31, [added: 2022,] 2021, [removed: 2020,] and [removed: 2019;] [added: 2020;] (iv) the Registrant's Consolidated Statements of Cash Flows for the years ended December 31, [added: 2022,] 2021, [removed: 2020,] and [removed: 2019;] [added: 2020;] and (v) the notes to the Registrant's Consolidated Financial Statements. | | |

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

| * | | | Certain of the exhibits and/or schedules to this Exhibit have been omitted in accordance with Item 601(a)(5) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of all omitted exhibits and schedules of this Exhibit to the Securities and Exchange Commission upon its request. | | |

| | | | | | |

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

| 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.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1035x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1035x12312020x10k.htm)[(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.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1036x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1036x12312020x10k.htm)[(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.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1037x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1037x12312020x10k.htm)[(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) | | |

| 10.18.1 | | | [Amendment No. 1 to Credit Agreement, dated as of November 11, 2021, by and among the Registrant, as a borrower and guarantor; certain direct subsidiaries of the Registrant, as subsidiary borrowers; JPMorgan Chase Bank, N.A., as administrative agent; and the lenders party thereto.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_10181x12312021x10k.htm) | | |

| 10.20.1 | | | [First Amendment to Immuno-oncology License and Collaboration Agreement, dated as of October 6, 2021, by and between the Registrant and Sanofi Biotechnology SAS.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_10201x12312021x10k.htm) | | |

| 10.21* | | | [Collaboration Agreement, dated as of September 29, 2015, by and between Regeneron Ireland and Mitsubishi Tanabe Pharma Corporation. (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_107x09302015x10q.htm) | | |

| 10.22* | | | [ANG2 License and Collaboration Agreement, dated as of March 23, 2016, by and between Bayer HealthCare LLC and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2016, filed May 5, 2016.)](http://www.sec.gov/Archives/edgar/data/872589/000153217616000055/regn-ex_102x03312016x10q.htm) | | |

| 10.23* | | | [Collaboration Agreement, dated as of September 17, 2016, by and between Teva Pharmaceuticals International GmbH and Regeneron Ireland. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2016, filed November 4, 2016.)](http://www.sec.gov/Archives/edgar/data/872589/000153217616000082/regn-ex_101xteva.htm) | | |

| 10.24* | | | [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) | | |

| 10.25.1 | | | [First Amendment to Amended and Restated Participation Agreement, dated as of October 6, 2021, by and among Old Saw Mill Holdings LLC, as lessee; the Registrant, as parent guarantor; certain subsidiaries of the Registrant, as subsidiary guarantors; BA Leasing BSC, LLC, as lessor; Bank of America, N.A., as administrative agent; and the lenders party thereto.](https://www.sec.gov/Archives/edgar/data/872589/000180422022000007/regn-ex_10251x12312021x10k.htm) | | |

| 10.26 | | | [Amended and Restated Lease and Remedies Agreement, dated as of May 2, 2019, between Old Saw Mill Holdings LLC, as lessee, and BA Leasing BSC, LLC, as lessor. (Incorporated by reference from the Form 8-K for the Registrant, filed May 3, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000093041319001557/c93557_ex10-2.htm) | | |

| 10.28 | | | [Letter Agreement, dated as of January 7, 2018, by and among the Registrant, Sanofi, sanofi-aventis US LLC, Aventis Pharmaceuticals Inc., sanofi-aventis Amérique du Nord, and Sanofi Biotechnology SAS. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2018, filed May 3, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000020/regn-ex_102xletteragreemen.htm) | | |

| 10.29 | | | [Master Agreement, dated as of April 8, 2019, by and between the Registrant and Alnylam Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2019, filed August 6, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex104.htm) | | |

| 10.30 | | | [Investor Agreement, dated as of April 8, 2019, by and between the Registrant and Alnylam Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2019, filed August 6, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex105.htm) | | |

| 10.31 | | | [Stock Purchase Agreement, dated as of April 8, 2019, by and between the Registrant and Alnylam Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2019, filed August 6, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000026/regn-ex106.htm) | | |

| 10.32 | | | [Stock Repurchase Agreement, dated as of May 25, 2020, by and between the Registrant and Sanofi. (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_ex10-1.htm) | | |

| 10.33 | | | [Base Agreement, dated as of July 6, 2020, by and between the Registrant and Advanced Technology International. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2020, filed November 5, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000180422020000030/regn-ex101x09302020x10q.htm) | | |

| 10.34 | | | [Project Agreement, dated as of July 6, 2020, by and between the Registrant and Advanced Technology International.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn_exx1034-12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn_exx1034-12312020x10k.htm)[(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_exx1034-12312020x10k.htm) | | |

| 10.34.1 | | | [Modification No. 01 to Project Agreement, dated as of October 13, 2020, by and between the Registrant and Advanced Technology International.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10341x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10341x12312020x10k.htm)[(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_10341x12312020x10k.htm) | | |

| 10.34.2 | | | [Modification No. 02 to Project Agreement, dated as of November 17, 2020, by and between the Registrant and Advanced Technology International.](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10342x12312020x10k.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_10342x12312020x10k.htm)[(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_10342x12312020x10k.htm) | | |

| 10.35 | | | [License Agreement, dated as of August 18, 2020, by and among the Registrant, F. Hoffman-La Roche Ltd, and Genentech, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2020, filed November 5, 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000180422020000030/regn-ex103x09302020x10q.htm) | | |

| 10.36 | | | [Supply Agreement, dated as of January 12, 2021, by and between the Registrant and the U.S. Army Contracting Command, New Jersey. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2021, filed May 6, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000017/regn-ex_101x3312021x10q.htm) | | |

| 10.36.1 | | | [Modification P00004 to Supply Agreement, dated as of July 26, 2021, by and between the Registrant and the U.S. Army Contracting Command, New Jersey. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2021, filed November 4, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000033/regen-ex_101x9302021x10q.htm) | | |

| 10.36.2 | | | [Modification P00005 to Supply Agreement, dated as of September 14, 2021, by and between the Registrant and the U.S. Army Contracting Command, New Jersey. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2021, filed November 4, 2021.)](http://www.sec.gov/Archives/edgar/data/872589/000180422021000033/regen-ex_102x9302021x10q.htm) | | |

| Date: | | | February [removed: 7, 2022] [added: 6, 2023] | | | | | | By: | | | /s/ LEONARD S. SCHLEIFER | | | | | |

| /s/ LEONARD S. SCHLEIFER | | | | | | *President, Chief Executive Officer, and Director (Principal Executive Officer)* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ ROBERT E. LANDRY | | | | | | *Executive Vice President, Finance and Chief Financial Officer (Principal Financial Officer)* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ CHRISTOPHER R. FENIMORE | | | | | | *Senior Vice President, Controller (Principal Accounting Officer)* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ GEORGE D. YANCOPOULOS | | | | | | *President, Chief Scientific Officer, and Director* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ P. ROY VAGELOS | | | | | | *Chair of the Board of Directors* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ BONNIE L. BASSLER | | | | | | *Director* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ MICHAEL S. BROWN | | | | | | *Director* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ N. ANTHONY COLES | | | | | | *Director* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ JOSEPH L. GOLDSTEIN | | | | | | *Director* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ CHRISTINE A. POON | | | | | | *Director* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ ARTHUR F. RYAN | | | | | | *Director* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ GEORGE L. SING | | | | | | *Director* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ MARC TESSIER-LAVIGNE | | | | | | *Director* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| /s/ HUDA Y. ZOGHBI | | | | | | *Director* | | | | | | February [removed: 7, 2022] [added: 6, 2023] | | |

| [Report of Independent Registered Public Accounting Firm (PCAOB [removed: ID](#i58977c8e94dd4577b7dd02b6fd4ef00f_97) 238[)](#i58977c8e94dd4577b7dd02b6fd4ef00f_97)] [added: ID](#ic18bad8bf5314e3e9f4c348a9f859317_100) 238[)](#ic18bad8bf5314e3e9f4c348a9f859317_100)] | | | | | | [removed: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_97)[2](#i58977c8e94dd4577b7dd02b6fd4ef00f_97)] [added: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_100)[2](#ic18bad8bf5314e3e9f4c348a9f859317_100)] | | |

| [Consolidated Balance Sheets as of December 31, [removed: 2021] [added: 2022] and [removed: 2020](#i58977c8e94dd4577b7dd02b6fd4ef00f_100)] [added: 2021](#ic18bad8bf5314e3e9f4c348a9f859317_103)] | | | | | | [removed: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_100)[4](#i58977c8e94dd4577b7dd02b6fd4ef00f_100)] [added: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_103)[4](#ic18bad8bf5314e3e9f4c348a9f859317_103)] | | |

| [Consolidated Statements of Operations and Comprehensive Income for the Years Ended December 31, [added: 2022,] 2021, [removed: 2020,] and [removed: 2019](#i58977c8e94dd4577b7dd02b6fd4ef00f_103)] [added: 2020](#ic18bad8bf5314e3e9f4c348a9f859317_106)] | | | | | | [removed: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_103)[5](#i58977c8e94dd4577b7dd02b6fd4ef00f_103)] [added: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_106)[5](#ic18bad8bf5314e3e9f4c348a9f859317_106)] | | |

| [Consolidated Statements of Stockholders' Equity for the Years Ended December 31, [added: 2022,] 2021, [removed: 2020,] and [removed: 2019](#i58977c8e94dd4577b7dd02b6fd4ef00f_106)] [added: 2020](#ic18bad8bf5314e3e9f4c348a9f859317_109)] | | | | | | [removed: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_106)[6](#i58977c8e94dd4577b7dd02b6fd4ef00f_106)] [added: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_109)[6](#ic18bad8bf5314e3e9f4c348a9f859317_109)] | | |

| [Consolidated Statements of Cash Flows for the Years Ended December 31, [added: 2022,] 2021, [removed: 2020,] and [removed: 2019](#i58977c8e94dd4577b7dd02b6fd4ef00f_109)] [added: 2020](#ic18bad8bf5314e3e9f4c348a9f859317_112)] | | | | | | [removed: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_109)[8](#i58977c8e94dd4577b7dd02b6fd4ef00f_109)] [added: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_112)[8](#ic18bad8bf5314e3e9f4c348a9f859317_112)] | | |

| [Notes to Consolidated Financial [removed: Statements](#i58977c8e94dd4577b7dd02b6fd4ef00f_112)] [added: Statements](#ic18bad8bf5314e3e9f4c348a9f859317_115)] | | | | | | [removed: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_112)[9](#i58977c8e94dd4577b7dd02b6fd4ef00f_112)] [added: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_115)[9](#ic18bad8bf5314e3e9f4c348a9f859317_115)] to [removed: [F-](#i58977c8e94dd4577b7dd02b6fd4ef00f_166)[42](#i58977c8e94dd4577b7dd02b6fd4ef00f_166)] [added: [F-](#ic18bad8bf5314e3e9f4c348a9f859317_166)[44](#ic18bad8bf5314e3e9f4c348a9f859317_166)] | | |

We have audited the accompanying consolidated balance sheets of Regeneron Pharmaceuticals, Inc. and its subsidiaries (the "Company") as of December 31, [removed: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] 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: 2021,] [added: 2022,] 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: 2021,] [added: 2022,] 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: 2021] [added: 2022] and [removed: 2020,] [added: 2021,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2021] [added: 2022] 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: 2021,] [added: 2022,] based on criteria established in *Internal Control - Integrated Framework* (2013) issued by the COSO.

[removed: *Accounting for Other Operating Income related to Research and Development Up-front] [added: | Amounts recognized in connection with up-front] and [removed: Milestone Payments*][added: development milestone payments received | | | | | | Other operating income | | | | | | $ | 33.3 | | | | | $ | 26.2 | | | | | $ | 47.2 | |]

(In millions, except [added: per] share data)

| | | | [added: | | | 2022 | | | | | |] 2021 | | | | | | 2020 | | |

| Cash and cash equivalents | | | [added: | | |] $ | [added: 3,105.9 | | | | | $ |] 2,885.6 | | | | | $ | 2,193.7 | |

| Marketable securities | | | [removed: 2,809.1] [added: 4,636.4] | | | | | | [removed: 1,393.3] [added: 2,809.1] | | |

| Accounts receivable, net | | | [removed: 6,036.5] [added: 5,328.7] | | | | | | [removed: 4,114.7] [added: 6,036.5] | | |

| Inventories | | | [removed: 1,951.3] [added: 2,401.9] | | | | | | [removed: 1,916.6] [added: 1,951.3] | | |

| Prepaid expenses and other current assets | | | [removed: 332.4] [added: 411.2] | | | | | | [removed: 160.8] [added: 332.4] | | |

| Total current assets | | | [removed: 14,014.9] [added: 15,884.1] | | | | | | [removed: 9,779.1] [added: 14,014.9] | | |

| Marketable securities | | | [removed: 6,838.0] [added: 6,591.8] | | | | | | [removed: 3,135.6] [added: 6,838.0] | | |

| Property, plant, and equipment, net | | | [removed: 3,482.2] [added: 3,763.0] | | | | | | [removed: 3,221.6] [added: 3,482.2] | | |

| Deferred tax assets | | | [removed: 876.9] [added: 1,723.7] | | | | | | [removed: 858.9] [added: 876.9] | | |

| Other noncurrent assets | | | [removed: 222.8] [added: 336.4] | | | | | | [removed: 168.1] [added: 216.1] | | |

| Total assets | | | $ | [removed: 25,434.8] [added: 29,214.5] | | | | | $ | [removed: 17,163.3] [added: 25,434.8] | |

| Accounts payable | | | $ | [removed: 564.0] [added: 589.2] | | | | | $ | [removed: 475.5] [added: 564.0] | |

| /s/ CRAIG B. THOMPSON | | | | | | *Director* | | | | | | February 6, 2023 | | |

| Craig B. Thompson, M.D. | | | | | | | | | | | | | | |

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

As described in Notes 1, 3, and 8 to the consolidated financial statements, in July 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi.

The transaction was accounted for as an asset acquisition.

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.

The principal considerations for our determination that performing procedures relating to the accounting for the acquisition of the worldwide rights to Libtayo is a critical audit matter are (i) the significant judgment by management in identifying the elements of the transaction and in evaluating the timing and recognition of contingent consideration, (ii) a high degree of auditor judgment, subjectivity, and effort in performing procedures and evaluating audit evidence related to the accounting for the transaction and related disclosures, and (iii) the audit effort involved the use of professionals with specialized skill and knowledge.

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.

Professionals with specialized skill and knowledge were used to assist in evaluating the identification of the elements of the transaction.

| | | | 2022 | | | | | | 2021 | | |

| Intangible assets, net | | | 915.5 | | | | | | 6.7 | | |

| Research and development | | | | | | 3,592.5 | | | | | | 2,860.1 | | | | | | 2,647.0 | | |

| Acquired in-process research and development | | | | | | 255.1 | | | | | | 48.0 | | | | | | 88.0 | | |

| Net income | | | | | | $ | 4,338.4 | | | | | $ | 8,075.3 | | | | | $ | 3,513.2 | |

| Balance, December 31, 2022 | | | | | | 1.8 | | | | | | $ | — | | | | | 130.4 | | | | | | $ | 0.1 | | | | | $ | 9,949.3 | | | | | $ | 23,306.7 | | | | | $ | (238.8) | | | | | (22.6) | | | | | | $ | (10,353.3) | | | | | $ | 22,664.0 | |

| Net income | | | | | | $ | 4,338.4 | | | | | $ | 8,075.3 | | | | | $ | 3,513.2 | |

| Acquired in-process research and development in connection with asset acquisition | | | | | | 195.0 | | | | | | — | | | | | | — | | |

| Payments for Libtayo intangible asset | | | | | | (1,026.8) | | | | | | — | | | | | | — | | |

| Asset acquisition, net of cash acquired | | | | | | (230.3) | | | | | | — | | | | | | — | | |

In addition, REGEN-COV® was authorized under an Emergency Use Authorization ("EUA") 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; with this EUA revision, REGEN-COV is not currently authorized for use in any U.S. states, territories, or jurisdictions.

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.

*Intangible Assets*

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

If it is determined that substantially all of the fair value of gross assets acquired in a transaction are concentrated in a single identifiable asset, then the transaction is accounted for as an asset acquisition.

Intangible assets acquired in connection with an asset acquisition are recorded at cost.

Such amounts may include up-front payments and contingent consideration.

With regard to contingent consideration, 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.

Intangible assets are amortized to Cost of goods sold 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 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.

The Company's intangible assets are reviewed for recoverability whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable.

If an indicator of impairment exists, the Company compares the projected undiscounted cash flows to be generated by the asset to the intangible asset's carrying amount.

If the projected undiscounted cash flows of the intangible asset are less than the carrying amount, the intangible asset is written down to its fair value in the period in which the impairment occurs.

promises should be combined as a single unit of account.

In addition, the Company reassesses its forfeiture rate assumptions at least annually, considering both historical forfeiture experience and an estimate of future forfeitures for currently outstanding unvested awards.

For performance-based restricted stock units that contain a performance condition, the Company recognizes stock-based compensation expense if and when the Company determines that it is probable the performance condition will be achieved (based on the number of shares expected to be vested and issued).

As described in Note 1 to the consolidated financial statements, other operating income related to collaboration arrangements where the Company satisfies obligations during the development phase over time is typically recognized using an input method on the basis of research and development costs incurred relative to the total expected costs which determines the extent of progress towards completion of the obligation.

Other operating income for non-refundable up-front payments and development milestones for which management used an input method, was $42.5 million for the year ended December 31, 2021.

As of December 31, 2021, $322.5 million was included in other liabilities representing the amount of previously deferred non-refundable up-front and development milestones expected to be recognized in other operating income over time.

Management has disclosed that there is variability in the scope of activities and length of time necessary to develop a drug product, potential delays in development programs, changes to development plans and budgets as programs progress, and uncertainty in the ultimate requirements to obtain governmental approval for commercialization related to these estimates.

The principal considerations for our determination that performing procedures relating to the accounting for other operating income related to research and development up-front and milestone payments is a critical audit matter are the significant judgment by management when determining the estimate of total expected research and development costs to complete the obligation, which in turn led to a high degree of auditor judgment, subjectivity and effort in performing procedures and evaluating evidence to assess the reasonableness of the estimates of the costs to complete.

These procedures included testing the effectiveness of controls relating to the accounting for other operating income related to research and development up-front and milestone payments, including controls over the determination of the estimate of total expected research and development costs to complete the obligation.

These procedures also included, among others, evaluating and testing management’s process for determining the estimate of total expected research and development costs at completion for a sample of contracts, which included evaluating the reasonableness of actual costs incurred and estimated costs to complete.

Evaluating the reasonableness of estimated costs to complete involved assessing management’s ability to reasonably estimate costs to complete the obligation by (i) obtaining supporting evidence for expected development activities; (ii) evaluating the identification of circumstances that may warrant a modification to estimated costs to complete; and (iii) agreeing estimates of total budgeted costs to contracts or other agreements with collaboration partners.