Regeneron Pharmaceuticals (REGN) 10-K risk factor changes: FY2020 vs FY2019

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

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

For the years ended December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] EYLEA net sales in the United States represented [removed: 59%] [added: 58%] and [removed: 61%] [added: 71%] of our total revenues, respectively.

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

[removed: | • |] [added: -] effectiveness of the commercial strategy in and outside the United States for the marketing of our products, including pricing strategy; [removed: |]

[removed: | • |] [added: -] 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 [added: have been or] may be introduced in the United States by various federal and state authorities); [removed: |]

[removed: | • |] [added: -] our ability and our collaborators' ability to maintain sales of our marketed products in the face of competitive products and to differentiate our marketed products from competitive products, including as applicable product candidates currently in clinical development; and, in the case of EYLEA, the existing and potential new 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; [removed: |]

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

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

[removed: | • |] [added: -] our ability to meet the demand for commercial supplies of our marketed products; [removed: |]

[removed: | • |] [added: -] the outcome of the pending [removed: patent infringement] proceedings relating to [removed: Dupixent] [added: EYLEA, Dupixent,] and Praluent (described further in Note [removed: 16] [added: 15] to our Consolidated Financial Statements included in this report), as well as other risks relating to our marketed products [added: 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); [removed: |]

[removed: | • |] [added: -] the outcome of the pending government [added: proceedings and] investigations [added: and other matters] described in Note [removed: 16] [added: 15] to our Consolidated Financial Statements included in this [removed: report; |][added: 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);]

[removed: | • |] [added: -] the results of post-approval studies, whether conducted by us or by others and whether mandated by regulatory agencies or voluntary, and studies of other products that could implicate an entire class of products or are perceived to do so; and [removed: |]

[removed: | • |] [added: -] the effect of existing and new health care laws and regulations currently being considered or implemented in the United States, including price reporting and other disclosure requirements of such laws and regulations and the potential impact of such requirements on physician prescribing practices and payor coverage. [removed: |]

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

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

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

Given cost sensitivities in many health care [removed: systems,] [added: systems (which will likely 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.

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

Government and other third-party payors (including [removed: pharmacy benefit management companies)] [added: PBMs)] are challenging the prices charged for healthcare products and increasingly limiting, and attempting to limit, both coverage and level of reimbursement for prescription drugs, such as by requiring outcomes-based or other pay-for-performance pricing arrangements.

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.][added: products; this trend may be further accelerated as a result of the COVID-19 pandemic.]

[added: At the federal level, some of the prior budget proposals contained] drug price control measures that may be [removed: subsequently rolled into the budget proposal for fiscal year 2021 and could be enacted during the 2021 budget process or] [added: included] in [removed: other] future legislation, including, for example, measures to permit Medicare Part D plans to negotiate the price of certain drugs under Medicare Part B (such as EYLEA); to allow some states to negotiate drug prices under Medicaid; and to eliminate cost sharing for generic drugs for low-income patients.

[removed: The Department of Health] [added: Additionally, the HHS] and [removed: Human Services has] [added: CMS have] been soliciting feedback on some of these measures and may implement others impacting our business under [removed: its] [added: their] existing authority.

CMS has also [removed: recently] sought public comment on how best to leverage its authority provided under the Competitive Acquisition Program and introduce competition into Medicare Part B by allowing CMS to bring on vendors to negotiate payment amounts for Medicare Part B drugs.

Similarly, [added: President Biden and] various members of the current U.S. Congress [removed: and potential 2020 presidential candidates] have indicated that lowering drug prices continues to be a legislative and political priority, and some have introduced proposals aimed at drug pricing.

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

In addition, [removed: pharmacy benefit management companies] [added: PBMs] often develop formularies to reduce their cost for medications.

The breadth of the products covered by formularies varies considerably from one [removed: pharmacy benefit management company] [added: PBM] to another.

Our smaller competitors may also enhance their competitive position if they acquire or discover patentable inventions, form collaborative arrangements, or [added: merge with larger pharmaceutical or biotechnology companies.]

We are also aware of a number of companies working on the development of product candidates and extended delivery devices for the potential treatment of one or more of EYLEA's indications, including those that act by blocking VEGF and VEGF receptors (including therapies designed to extend the treatment interval) and/or other targets (such as [removed: Ang2), as well as siRNAs that modulate gene expression.][added: Ang2).]

In asthma, competitors to Dupixent include antibodies against the IL-5 ligand or the IL-5 receptor or immunoglobulin E; and some of these [removed: antibodies, if] [added: antibodies are either] approved [added: or] in [removed: this indication, may] [added: development for indications that] also compete [added: or may compete in the future] with Dupixent in CRSwNP.

There are several other potentially competitive products in development that may compete with Dupixent in [removed: both the atopic dermatitis and asthma indications,] [added: asthma,] as well as potential future indications, including antibodies against thymic stromal lymphopoietin [removed: (TSLP),] [added: ("TSLP"),] the IL-33 ligand, or the IL-33 receptor (ST2).

There are several competitors that are marketing and/or developing antibodies against PD-1 and/or PDL-1, including Merck's Keytruda, Bristol-Myers Squibb's Opdivo, [removed: and] Roche's [removed: Tecentriq.][added: Tecentriq, and AstraZeneca's Imfinzi.]

There is also significant actual and potential future competition for other products marketed [added: or otherwise commercialized] by us and/or our collaborators under our collaboration agreements with them.

[removed: For example, there are several companies that are] marketing and/or developing antibodies [added: or other molecules (such as small interfering RNA molecules, or siRNAs)] against PCSK9 and IL-6 and/or IL-6R, which currently (or, for [removed: antibodies] [added: product candidates] in development, may in the future if approved) compete with Praluent and Kevzara, respectively.

Our [added: *VelocImmune®* technology, other] antibody generation [removed: technologies] [added: technologies,] and [removed: other] late-stage and earlier-stage clinical candidates face competition from many pharmaceutical and biotechnology companies using various [added: technologies, including antibody generation technologies and other approaches such as RNA interference (RNAi) and chimeric antigen receptor T cell (CAR-T cell)] technologies.

[removed: We] [added: For example, we] are aware of other pharmaceutical and biotechnology companies actively engaged in the research and development of antibody-based products against targets that are also the targets of our early- and late-stage product candidates.

Under the terms of our license and collaboration agreement with Bayer (which is terminable by Bayer at any time upon six or twelve months' advance notice, depending on the circumstances giving rise to termination), we rely on Bayer (and, in Japan, Santen pursuant to [added: a Co-Promotion and Distribution Agreement with Bayer's Japanese affiliate, as in effect from time to time) for sales, marketing, and distribution of EYLEA in countries outside the United States.]

[removed: "Business - Collaboration Agreements - *Collaborations with Sanofi*" (the "Antibody] [added: In addition, under the terms of our Antibody] Collaboration [removed: Restructuring"))] and our IO Collaboration, we and Sanofi co-commercialize Dupixent and Libtayo in the United States.

For example, Sanofi records product sales for Dupixent in the United [removed: States, serves as the Dupixent lead regulatory party (*e.g.*, is responsible for regulatory filings and negotiations relating to it) in the United States,] [added: States] and leads negotiations with payors relating to this product.

In this section, we first provide a summary of the more significant risks and uncertainties we face and then provide a full set of risk factors and discuss them in greater detail.

Summary of Risk Factors

As noted above, we are subject to a number of risks that if realized could materially harm our business, prospects, operating results, and financial condition.

Some of the more significant risks and uncertainties we face include those summarized below.

The summary below is not exhaustive and is qualified by reference to the full set of risk factors set forth in this "Risk Factors" section.

Please carefully consider all of the information in this Form 10-K, including the full set of risks set forth in this "Risk Factors" section, and in our other filings with the U.S. Securities and Exchange Commission before making an investment decision regarding Regeneron.

Risks Related to the COVID-19 Pandemic

- Our business may be further adversely affected by the effects of the COVID-19 pandemic, including those impacting 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, as well as the demand for our marketed products.

- We face risks related to the development, manufacturing, and potential commercialization of REGEN-COV.

Commercialization Risks

- 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 the recently announced "most-favored-nation" drug price control measures.

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

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

Regulatory and Development Risks

- Drug development and obtaining and maintaining regulatory approval for drug products is costly, time-consuming, and highly uncertain.

- Serious complications or side effects in connection with the use or development of our products or product candidates could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of development of our product candidates or new indications for our marketed products.

- We may be unable to formulate or manufacture our product candidates in a way that is suitable for clinical or commercial use, which would delay or prevent continued development of such candidates and/or receipt of regulatory approval or commercial sale.

- Many of our products are intended to be used in combination with drug-delivery devices, which may result in additional regulatory, commercialization, and other risks.

Intellectual Property and Market Exclusivity Risks

- Patents or proprietary rights of others may restrict our development, manufacturing, and/or commercialization efforts and subject us to patent litigation and other proceedings that could find us liable for damages.

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

Manufacturing and Supply Risks

- We rely on limited internal and contracted manufacturing and supply chain capacity, which could adversely affect our ability to commercialize our products and to advance our clinical pipeline.

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

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

- Our ability to manufacture products may be impaired if any of our or our collaborators’ manufacturing activities, or the activities of other third parties involved in our manufacture and supply chain, are found to infringe patents of others.

- If sales of our marketed products do not meet the levels currently expected, or if the launch of any of our product candidates is delayed or unsuccessful, we may face costs related to excess inventory or unused capacity at our manufacturing facilities and at the facilities of third parties or our collaborators.

- 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 chain, would adversely affect our ability to supply our products.

- If the testing or use of our products harms people, or is perceived to harm them even when such harm is unrelated to our products, we could be subject to costly and damaging product liability claims.

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

- If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate program or other governmental pricing programs, we could be subject to additional reimbursement requirements, penalties, sanctions, and fines.

- We face risks from the improper conduct of our employees, agents, contractors, or collaborators, including those relating to potential non-compliance with relevant laws and regulations such as the Foreign Corrupt Practices Act.

- Changes in laws and regulations affecting the healthcare industry could adversely affect our business.

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

- We face potential liability related to the personal information we collect from individuals, data brokers, or research institutions or obtain from clinical trials sponsored by us or our collaborators.

- If our collaborations with Sanofi or Bayer 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 collaborators and service providers may fail to perform adequately in their efforts to support the development, manufacture, and commercialization of our drug candidates and current and future products.

Other Risks Factors – Risks Related to Employees, Information Technology, Financial Results and Liquidity, and Our Common Stock

- Our business is dependent on our key personnel and will be harmed if we cannot recruit and retain leaders in our research, development, manufacturing, and commercial organizations.

- Significant disruptions of information technology systems or breaches of data security could adversely affect our business.

| | |

| --- | --- |

At the federal level, the current administration's prior budget proposals (including the proposal for fiscal year 2020) contained

Additionally, on May 11, 2018, President Trump laid out his administration's "Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs" to reduce the cost of prescription drugs while preserving innovation and cures.

On October 25, 2018, President Trump announced that CMS was evaluating a program that proposes to set the Medicare payment amount for Part B single-source drugs and biologics to more closely align with international drug prices (also referred to as reference or international price index ("IPI") drug pricing) and pay physicians and hospitals participating in such program a set drug add-on payment for administered drugs.

CMS also issued an advance notice of proposed rulemaking that requested public comment on the proposed program, which is contemplated to initially cover fifty percent of Medicare Part B spending on separately payable Part B drugs (such as EYLEA), with the IPI-based price for each such drug to be phased in over a period of five years; notice of proposed rulemaking on this program is pending review by the Office of Management and Budget.

In addition, in July 2019, President Trump indicated that his administration was considering an executive order to establish a "most favored nation" pricing plan.

While the scope and details of this contemplated executive action (including whether and how its mechanism may differ from that of the proposed IPI drug pricing program discussed above) are not clear, this seems to signal that the U.S. administration will continue to seek new measures to constrain drug costs and Medicare payments for drugs.

merge with larger pharmaceutical or biotechnology companies.

Several companies are also studying JAK inhibitors for atopic dermatitis.

Our other late-stage and earlier-stage clinical candidates in development are all fully human antibodies, which were generated using our *VelocImmune* technology.

a Co-Promotion and Distribution Agreement with Bayer's Japanese affiliate, as in effect from time to time) for sales, marketing, and distribution of EYLEA in countries outside the United States.

In addition, under the terms of our Antibody Collaboration (which, as previously announced, is expected to be revised to give effect to a new arrangement for Praluent and Kevzara, as described further in Part I, Item 1.

In addition, after the Antibody Collaboration Restructuring has been finalized, Sanofi is expected to obtain sole global rights to Kevzara and sole rights to Praluent outside the United States and will be solely responsible for commercialization of these products (as well as development and commercialization expenses) in the relevant jurisdictions; our rights will be limited to receiving a royalty on corresponding net product sales realized by Sanofi.

A clinical trial may fail because it did not include and retain a sufficient number of patients to detect the endpoint being measured or reach statistical significance.

The failure of clinical trials to demonstrate the safety and effectiveness of our clinical candidates

For example, in April 2018, the DMC monitoring the ongoing safety and efficacy of our Phase 3 clinical trials of fasinumab recommended that the higher dose-regimens be discontinued based on the risk-benefit assessment and that the program may continue with lower dose-regimens of fasinumab.

As a result, the osteoarthritis trials were modified accordingly and we discontinued dosing patients in the clinical study of fasinumab in chronic low back pain in patients with concomitant osteoarthritis of the knee and hip since this study was using only higher doses.

failure, heart attack, and stroke.

growth of our clinical programs, will require substantial additional expenditures, time, and various regulatory approvals and permits.

product liability claims, and insufficient inventory.

If we market and sell approved products in a way that violates federal or state healthcare laws, we may be subject to civil or criminal penalties.

The PPACA also includes various provisions designed to strengthen fraud-and-abuse enforcement, such as increased funding for enforcement efforts and the lowering of the intent requirement of the federal anti-kickback statute and criminal health care fraud statute such that a person or entity no longer needs to have actual knowledge of this statute or specific intent to violate it.

However, we could be prosecuted under HIPAA's criminal provisions either directly or under aiding-and-abetting or conspiracy principles.

There are fines, penalties, and a private right of action resulting from non-compliance with the CCPA.

We are likely to be required to expend significant capital

As a result of the amendment and restatement of our IO Discovery and Development Agreement with Sanofi (which forms part of our IO Collaboration), we have all rights to, and we fund and conduct on our own all research, development, manufacturing, and commercialization activities to support, all of our immuno-oncology product candidates other than MUC16xCD3 Program antibodies (such as REGN4018) and BCMAxCD3 Program antibodies (such as REGN5458 and REGN5459).

In July 2017, the United Kingdom regulator that regulates the London Interbank Offered Rate ("LIBOR") announced its intention to phase out LIBOR rates by the end of 2021.

No consensus exists as to what rate or rates may become accepted alternatives to LIBOR or whether LIBOR rates will cease to be published or supported before or after 2021.

For example, if a published U.S. dollar LIBOR rate is unavailable

Stock.

As of December 31, 2019, Sanofi beneficially owned 23,350,365 shares of our Common Stock, representing approximately 21.5% of the shares of Common Stock then outstanding.

Under our January 2014 amended and restated investor agreement with Sanofi, Sanofi has three demand rights to require us to use all reasonable efforts to conduct a registered underwritten offering with respect to shares of our Common Stock held by Sanofi from time to time; however, shares of our Common Stock held by Sanofi from time to time are subject to a "lock-up" and may not be sold until December 20, 2020 (other than with respect to an aggregate of up to 869,828 shares, as to which we have agreed to waive the lock-up during the term of the letter agreement with Sanofi described below under "*Our existing shareholders may be able to exert significant influence over matters requiring shareholder approval and over our management*" and which currently remain available to be sold in accordance with the letter agreement).

These restrictions on dispositions are subject to earlier termination upon the occurrence of certain events, such as the consummation of a change-of-control transaction involving us or a dissolution or liquidation of our Company.

In an amendment to its Schedule 13D filed on December 9, 2019, Sanofi disclosed that, following expiration of the "lock-up," it may in its discretion dispose of or collateralize all or a portion of the Common Stock beneficially owned by it at any time or from time to time in accordance with the terms of the amended and restated investor agreement.

Our board of directors previously authorized a share repurchase program to repurchase up to $1.0 billion of our Common Stock (of which $746.0 million remained available as of December 31, 2019).

As of December 31, 2019:

Pursuant to the January 2014 amended and restated investor agreement with us, Sanofi has agreed to vote its shares as recommended by our board of directors, except that it may elect to vote proportionally with the votes cast by all of our other shareholders with respect to certain change-of-control transactions and to vote in its sole discretion with respect to liquidation or dissolution of our Company, stock issuances equal to or exceeding 20% of the outstanding shares or voting rights of Common Stock and Class A Stock (taken together), and new equity compensation plans or amendments if not materially consistent with our historical equity compensation practices.

In addition, we are required under the amended and restated investor agreement to appoint an individual agreed upon by us and Sanofi to our board of directors.

Subject to certain exceptions, we are required to use our reasonable efforts (including recommending that our shareholders vote in favor) to cause the election of this designee at our annual shareholder meetings for so long as (other than during the term of the letter agreement described below) Sanofi maintains an equity interest in us that is the lower of (i) the highest percentage ownership Sanofi attains following its acquisition of 20% of our outstanding shares of Class A Stock and Common Stock (taken together) (which occurred in April 2014), and (ii) 25% of our outstanding shares of Class A Stock and Common Stock (taken together) (the "Highest Percentage Threshold").

*The following discussion should be read in conjunction with the consolidated financial statements and related notes included elsewhere in this report.

Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (filed with the SEC on February 7, 2020) for additional discussion of our financial condition and results of operations for the year ended December 31, 2018, as well as our financial condition and results of operations for the year ended December 31, 2019 compared to the year ended December 31, 2018.*

Overview

We are a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious diseases.

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

As described in Part I, Item 1.

"Business," we currently have eight products that have received marketing approval and approximately 30 product candidates in clinical development, almost all of which were homegrown in our laboratories.

In addition, REGEN-COV received Emergency Use Authorization from the FDA for the treatment of mild to moderate COVID-19 in certain patients at high-risk for progressing to severe COVID-19 and/or hospitalization.

Refer to Part I, Item 1.

"Business - Products" and "Business - Programs in Clinical Development" for additional information.

Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the continued success in commercializing EYLEA and Dupixent.

We expect to continue to incur substantial expenses related to our research and development activities, a portion of which we expect to be reimbursed by our collaborators.

Also, our research and development activities outside our collaborations, the costs of which are not reimbursed, are expected to expand and require additional resources.

We also expect to incur substantial costs related to the commercialization of our marketed products.

Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our marketed 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 or losses from sales of 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.

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

Critical Accounting Policies and Use of Estimates

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

The preparation of financial statements in accordance with accounting principles generally accepted in the United States of America ("GAAP") requires management to make estimates and assumptions that affect reported amounts and related disclosures in the 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.

Management believes the current assumptions used to estimate amounts reflected in our Consolidated Financial Statements are appropriate.

However, if actual experience differs from the assumptions used in estimating amounts reflected in our Consolidated Financial Statements, the resulting changes could have a material adverse effect on our results of operations, and, in certain situations, could have a material adverse effect on our liquidity and financial condition.

The critical accounting estimates that impact our Consolidated Financial Statements are described below.

Revenue Recognition - Product Revenue

We recognize revenue from product sales at a point in time when our customer is deemed to have obtained control of the product, which generally occurs upon receipt by our customer.

The amount of revenue we recognize from product sales may vary due to rebates, chargebacks, and discounts provided under governmental and other programs, distribution-related fees, and other sales-related deductions.

In order to determine the transaction price, we estimate, utilizing the expected value method, the amount of variable consideration that we will be entitled to.

This estimate is based upon contracts with customers and government agencies, statutorily-defined discounts applicable to

government-funded programs, historical experience, estimated payor mix, and other relevant factors.

Calculating these provisions involves estimates and judgments.

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 - *Revenues* - *Net Product Sales*" section below for further details regarding our provisions, and credits/payments, for sales-related deductions.

Collaborative Arrangements

We have entered into various collaborative arrangements to research, develop, manufacture, and commercialize product candidates and utilize our technology platforms.

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

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

When we have a combined unit of account which includes a license and providing research and development services to our collaborator, recognition of up-front payments and development milestones earned from our collaborator is deferred (as a liability) and recognized over the development period (*i.e.*, over time).

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.

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, direct obligations of the U.S. government and its agencies and other debt securities guaranteed by the U.S. government, and municipal] bonds.

We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would have resulted in approximately a [removed: $48.6] [added: $48.1] million and [removed: $27.7] [added: $48.6] million decrease in the fair value of our investment portfolio as of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] respectively.

In [added: 2020,] 2019, [removed: 2018,] and [removed: 2017,] [added: 2018,] we did not record any charges for [removed: other-than-temporary] [added: credit-related] impairments of our available-for-sale debt securities.

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

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

[removed: During 2019, 2018,] [added: In 2020, 2019] and [removed: 2017,] [added: 2018,] we did not recognize any charges for write-offs [added: and allowances] of accounts receivable related to [added: credit risk for] our [removed: marketed products.][added: collaborators or customers.]

As of December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] three customers accounted on a combined basis for [removed: 97%] [added: 93%] and [removed: 99%,] [added: 97%,] respectively, of our net trade accounts receivables.

As discussed further above, Bayer [removed: markets EYLEA] [added: and Sanofi market certain products] outside the United [removed: States and Sanofi markets Dupixent, Praluent, and Kevzara worldwide,] [added: States,] and we share in profits and losses with these collaborators from commercialization of products (including the receipt of a percentage of EYLEA sales in Japan).

We recorded [removed: $118.3] [added: $196.0] million of net unrealized gains and [removed: $41.9] [added: $118.3] million of net unrealized [removed: losses] [added: gains] on equity securities in Other income (expense), net for the years ended December 31, [removed: 2019] [added: 2020] and [removed: 2018,] [added: 2019,] respectively.

These trade accounts receivable are primarily due from several distributors and specialty pharmacies, who are our customers.

[removed: These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed by us and/or our collaborators (collectively, "Regeneron's Products") and our 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, fasinumab, evinacumab, REGN-EB3, garetosmab, pozelimab, and REGN1979; the likelihood and timing of achieving any of our anticipated clinical development milestones referenced in this report; unforeseen safety issues resulting from the administration of Regeneron's Products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and product candidates in clinical trials; the likelihood and timing of possible regulatory approval and commercial launch of our late-stage product candidates and new indications for Regeneron's Products, including without limitation EYLEA, Dupixent, Libtayo, Praluent, Kevzara, fasinumab, evinacumab, REGN-EB3, garetosmab, pozelimab, and REGN1979; the extent to which the results from the research and development programs conducted by us or our collaborators may be replicated in other studies and lead to therapeutic applications; ongoing regulatory obligations and oversight impacting Regeneron's Products (such as EYLEA, Dupixent, Libtayo, Praluent, and Kevzara), 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 product candidates; competing drugs and product candidates that may be superior to Regeneron's Products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's Products and 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 product candidates; coverage and reimbursement determinations by third-party payors, including Medicare and Medicaid; 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), to be cancelled or terminated without any further product success; 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 Dupixent and Praluent described further in Note 16 to our Consolidated Financial Statements included in this report), other litigation and other proceedings and governmental 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.][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 (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 (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, Inmazeb*TM *(atoltivimab, maftivimab, and odesivimab-ebgn), REGEN-COV™ (casirivimab and imdevimab), fasinumab, Evkeeza*TM *(evinacumab), garetosmab, pozelimab, odronextamab, itepekimab, REGN5458, 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 EYLEA, Dupixent, Libtayo, Praluent, Kevzara, REGEN-COV, fasinumab, Evkeeza, garetosmab, pozelimab, odronextamab, itepekimab, REGN5458, and REGN5713-5714-5715; 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 (such as EYLEA, Dupixent, Libtayo, Praluent, and Kevzara), 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 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) 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 (including the impact of the recently issued "most-favored-nation" interim final rule); 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 REGEN-COV, 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.]

We do not undertake any obligation to update [removed: publicly] [added: (publicly or otherwise)] any forward-looking statement, whether as a result of new information, future events, or otherwise.*

| | | [added: | | | |] Year Ended December 31, | | | | | | | | | | | [added: | | | |]

| (In millions, except per share data) | | [removed: 2019] | | | | [removed: 2018] [added: 2020] | | | | [removed: 2017] | | [added: 2019*] | [added: | | | | | 2018* | | |]

| Net income | | [added: | | | |] $ | [removed: 2,115.8] [added: 3,513.2] | | | [added: | |] $ | [removed: 2,444.4] [added: 2,115.8] | | | [added: | |] $ | [removed: 1,198.5] [added: 2,444.4] | |

| Net income per share - diluted | | [added: | | | |] $ | [removed: 18.46] [added: 30.52] | | | [added: | |] $ | [removed: 21.29] [added: 18.46] | | | [added: | |] $ | [removed: 10.34] [added: 21.29] | |

[removed: Marketed Products][added: Products]

| Product | | [added: | | | |] Disease [removed: Area(1)] [added: Area] | | [added: | | | |] Territory | | | | | | | [added: | | | | | | | | | | | | | | | | | | | |]

| | | [added: | | | |] U.S. | | [added: | | | |] EU | | [added: | | | |] Japan | | [removed: ROW(6)] | | | [added: | ROW(4) | | | | | | | | | | | | | | |]

| EYLEA (aflibercept) [removed: Injection(2)] [added: Injection(1)] | [added: | |] \- | [added: | |] Neovascular age-related macular degeneration ("wet AMD") | | [added: | | | |] a | | [added: | | | |] a | | [added: | | | |] a | | [added: | | | |] a | [added: | | | | | | | |]

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

| [added: | | |] \- | [added: | |] 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") | | [added: | | | |] a | | [added: | | | |] a | | [added: | | | |] a | | [added: | | | |] a | | [added: | | | | | | |]

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

| [added: | | |] \- | [added: | |] Diabetic retinopathy | | [added: | | | |] a | | | | | | | | [added: | | | | | | | | | | | | | | | | | | |]

| Dupixent (dupilumab) [removed: Injection(3)] [added: Injection(2)] | [added: | |] \- | [added: | |] Atopic dermatitis (in adults and [removed: adolescents)(7)] [added: adolescents)(5)] | | [added: | | | |] a | | [added: | | | |] a | | [added: | | | |] a | | [added: | | | |] a | [added: | | | | | | | |]

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

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

| Libtayo (cemiplimab) [removed: Injection(3)(4)] [added: Injection(2)] | [added: | |] \- | [added: | |] Metastatic or locally advanced cutaneous squamous cell carcinoma ("CSCC") | | [added: | | | |] a | | [added: | | | |] a | | | | [added: | | | | | | | |] a | [added: | | | | | | | |]

| Praluent (alirocumab) Injection(3) | [added: | |] \- | [added: | |] LDL-lowering in heterozygous familial hypercholesterolemia ("HeFH") or clinical atherosclerotic cardiovascular disease ("ASCVD") (in adults) | | [removed: a] | | [added: | |] a | | [added: | | | |] a | | [added: | | | | (7) | | | | | |] a | [added: | | | | | | | |]

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

| Kevzara (sarilumab) Solution for Subcutaneous [removed: Injection(3)] [added: Injection(2)] | [added: | |] \- | [added: | |] Rheumatoid arthritis ("RA") (in adults) | | [added: | | | |] a | | [added: | | | |] a | | [added: | | | |] a | | [added: | | | |] a | [added: | | | | | | | |]

| ARCALYST® (rilonacept) Injection for Subcutaneous [removed: Use] [added: Use(8)] | [added: | |] \- | [added: | |] Cryopyrin-Associated Periodic Syndromes ("CAPS"), including Familial Cold Auto-inflammatory Syndrome ("FCAS") and Muckle-Wells Syndrome ("MWS") | | [added: | | | |] a | | | | | | | [added: | | | | | | | | | | | | | | | | | | | |]

| ZALTRAP® (ziv-aflibercept) Injection for Intravenous [removed: Infusion(5)] [added: Infusion(6)] | [added: | |] \- | [added: | |] Metastatic colorectal cancer ("mCRC") | | [added: | | | |] a | | [added: | | | |] a | | [added: | | | |] a | | [added: | | | |] a | [added: | | | | | | | |]

| [removed: (1)] [added: Note 2:] Refer to [added: product] label [removed: information] in each territory for specific [removed: indication] [added: information] | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| [removed: (2)] [added: (1)] In collaboration with Bayer (outside the United States) | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| [removed: (3)] [added: (2)] In collaboration with Sanofi | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| [removed: (5)] [added: (6)] Pursuant to a 2015 amended and restated ZALTRAP agreement, Sanofi is solely responsible for the development and commercialization of ZALTRAP, and Sanofi pays us a percentage of aggregate net [added: product] sales of ZALTRAP | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| [removed: (6)] [added: (4)] Rest of world. Checkmark in this column indicates that the product has received marketing approval in at least one country outside of the United States, European Union [removed: (EU),] [added: ("EU"),] or [removed: Japan] [added: Japan.] | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| [removed: (7)] [added: (5)] Approval in Japan is for adults and adolescents 15 years of age and older | | | | | | | | | | | [added: | | | | | | | | | | | | | | | | | | | | | | | | | | | |]

| [added: | | | | | |] Net Product Sales [removed: of Regeneron-Discovered Products(1)] [added: Recorded by Regeneron] | | [added: | | | |] Year Ended December 31, | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | | | | | |]

| [removed: (In millions)] | | [added: | | | | | | | 2020 | | | | | | | | | | | | | | | | | |] 2019 | | | | | | | | | | | | [removed: 2018] | | | | | | [added: 2018] | | | | | | [removed: 2017] | | | | | | | | | | | [added: |]

| [added: (In millions)] | | [added: | | | | | | |] U.S. | | | | [added: | |] ROW | | | | [added: | |] Total | | | | [added: | |] U.S. | | | | [added: | |] ROW | | | | [added: | |] Total | | | | [added: | |] U.S. | | | | [added: | |] ROW | | | | [added: | |] Total | | | [added: | | |]

| [removed: EYLEA(1)] [added: EYLEA(a)] | | [added: | | | | U.S. | | | | | |] $ | [removed: 4,644.2] [added: 4,947.2] | | | [added: | |] $ | [removed: 2,897.4] [added: 2,961.5] | | | [added: | |] $ | [removed: 7,541.6] [added: 7,908.7] | | | [added: | |] $ | [removed: 4,076.7] [added: 4,644.2] | | | [added: | |] $ | [removed: 2,668.9] [added: 2,897.4] | | | [added: | |] $ | [removed: 6,745.6] [added: 7,541.6] | | | [added: | |] $ | [removed: 3,701.9] [added: 4,076.7] | | | [added: | |] $ | [removed: 2,226.9] [added: 2,668.9] | | | [added: | |] $ | [removed: 5,928.8] [added: 6,745.6] | |

| [removed: Libtayo(1)] [added: Libtayo(b)] | | [removed: 175.7] | | | | [removed: 18.1] [added: U.S.] | | | | [removed: 193.8] | | [added: $] | [added: 270.7] | [removed: 14.8] | | | | [removed: —] [added: $] | [added: 77.5] | | | [removed: 14.8] | | [added: $] | [added: 348.2] | [removed: —] | | | | [removed: —] [added: $] | [added: 175.7] | | | [added: | | $ | 18.1 | | | | | $ | 193.8 | | | | | $ | 14.8 | | | | |] — | | | [added: | | | $ | 14.8 | |]

| ARCALYST | | [removed: 14.5] | | | | [added: U.S. | | | | | | $ | 13.1 | | | | |] — | | | | [removed: 14.5] | | [added: $] | [added: 13.1] | [removed: 14.7] | | | | [added: $ | 14.5 | | | | |] — | | | | [removed: 14.7] | | [added: $] | [added: 14.5] | [removed: 16.6] | | | | [added: $ | 14.7 | | | | |] — | | | | [removed: 16.6] | | [added: $] | [added: 14.7 | |]

[removed: | Net product sales recorded by Regeneron | | $ | 4,834.4 | | | | | | | | | | | $ | 4,106.2 | | | | | | | | | | | $ | 3,718.5 | | | | | | | | | |][added: Net Product Sales of Regeneron-Discovered Products]

| Dupixent | | [added: | | | | (b) | | | | | |] $ | [removed: 1,871.2] [added: 3,226.2] | | | [added: | |] $ | [removed: 444.4] [added: 818.6] | | | [added: | |] $ | [removed: 2,315.6] [added: 4,044.8] | | | [added: | |] $ | [removed: 776.3] [added: 1,871.2] | | | [added: | |] $ | [removed: 145.7] [added: 444.4] | | | [added: | |] $ | [removed: 922.0] [added: 2,315.6] | | | [added: | |] $ | [removed: 253.8] [added: 776.3] | | | [added: | |] $ | [removed: 2.7] [added: 145.7] | | | [added: | |] $ | [removed: 256.5] [added: 922.0] | |

| [removed: Praluent] [added: Praluent(c)] | | [added: | | | | U.S. | | | | | |] $ | [removed: 126.0] [added: 186.0] | | | [added: | |] $ | [removed: 162.7] [added: 172.8] | | | [added: | |] $ | [removed: 288.7] [added: 358.8] | | | [added: | |] $ | [removed: 181.3] [added: 126.0] | | | [added: | |] $ | [removed: 125.5] [added: 162.7] | | | [added: | |] $ | [removed: 306.8] [added: 288.7] | | | [added: | |] $ | [removed: 131.4] [added: 181.3] | | | [added: | |] $ | [removed: 63.3] [added: 125.5] | | | [added: | |] $ | [removed: 194.7] [added: 306.8] | |

| Kevzara | | [added: | | | | (b) | | | | | |] $ | [removed: 129.0] [added: 141.6] | | | [added: | |] $ | [removed: 77.7] [added: 128.3] | | | [added: | |] $ | [removed: 206.7] [added: 269.9] | | | [added: | |] $ | [removed: 74.7] [added: 129.0] | | | [added: | |] $ | [removed: 21.9] [added: 77.7] | | | [added: | |] $ | [removed: 96.6] [added: 206.7] | | | [added: | |] $ | [removed: 11.6] [added: 74.7] | | | [added: | |] $ | [removed: 1.7] [added: 21.9] | | | [added: | |] $ | [removed: 13.3] [added: 96.6] | |

| ZALTRAP | | [added: | | | | (b) | | | | | |] $ | [removed: 7.3] [added: 5.8] | | | [added: | |] $ | [removed: 101.1] [added: 97.9] | | | [added: | |] $ | [removed: 108.4] [added: 103.7] | | | [added: | |] $ | [removed: 9.0] [added: 7.3] | | | [added: | |] $ | [removed: 98.8] [added: 101.1] | | | [added: | |] $ | [removed: 107.8] [added: 108.4] | | | [added: | |] $ | [removed: 10.7] [added: 9.0] | | | [added: | |] $ | [removed: 73.1] [added: 98.8] | | | [added: | |] $ | [removed: 83.8] [added: 107.8] | |

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

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

| Revenues | | | | | | $ | 8,497.1 | | | | | $ | 6,557.6 | | | | | $ | 5,145.6 | |

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

| * Certain revisions have been made to the previously reported revenues for the years ended December 31, 2019 and 2018. See Note 1 to our Consolidated Financial Statements for further details. | | | | | | | | | | | | | | | | | | | | |

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

Products that have received marketing approval are summarized in the table below.

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

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

| | | | \- | | | Neovascular glaucoma ("NVG") | | | | | | | | | | | | | | | | | | a | | | | | | | | | | | | | | |

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

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

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

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

| Product (continued) | | | | | | Disease Area | | | | | | Territory | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | | | | U.S. | | | | | | EU | | | | | | Japan | | | | | | ROW(4) | | | | | | | | | | | | | | |

| Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) Injection | | | \- | | | Infection caused by *Zaire ebolavirus* | | | | | | a | | | | | | | | | | | | | | | | | | | | | | | | | | |

| | | | \- | | | Deficiency of Interleukin-1 Receptor Antagonist ("DIRA") (in adults and pediatrics) | | | | | | a | | | | | | | | | | | | | | | | | | | | | | | | | | |

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

| Note 1: Refer to "Net Product Sales of Regeneron-Discovered Products" section below for information regarding whether net product sales for a particular product are recorded by us, Bayer, or Sanofi | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (3) In collaboration with Sanofi prior to April 2020. Effective April 2020, 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 States. Pursuant to the April 2020 agreement, Sanofi pays us a royalty on net product sales of Praluent outside the United States. Refer to "Collaboration, License, and Other Agreements - Sanofi" section below for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (7) No longer marketed by Sanofi in Japan due to injunction (see Note 15 to our Consolidated Financial Statements for further details) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (8) Pursuant to a 2017 license agreement with Kiniksa Pharmaceuticals, Ltd., we granted Kiniksa the right to develop and commercialize certain new indications for ARCALYST. We currently maintain exclusive rights to ARCALYST in the United States for existing indications. Commencing with the receipt of marketing approval by Kiniksa for the first new indication of ARCALYST in the United States, we will grant U.S. commercial rights to ARCALYST for all approved indications and Kiniksa will pay us a share of ARCALYST profits. Refer to "Collaboration, License, and Other Agreements - Kiniksa" section below for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

*Additional Information - Product Updates*

Inmazeb

In October 2020, the U.S. Food and Drug Administration ("FDA") approved Inmazeb for the treatment of infection caused by *Zaire ebolavirus* in adult and pediatric patients, including newborns of mothers who have tested positive for the infection.

In connection with this approval, we were also granted a material threat medical countermeasure priority review voucher by the FDA.

REGEN-COV - Emergency Use Authorization

In November 2020, REGEN-COV (antibody cocktail casirivimab and imdevimab administered together) received Emergency Use Authorization ("EUA") from the 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.

See information regarding ongoing clinical trials of REGEN-COV below.

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| REGEN-COV(d) | | | | | | U.S. | | | | | | $ | 185.7 | | | | | — | | | | | | $ | 185.7 | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |

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| (a) Regeneron records net product sales of EYLEA in the United States. Bayer records net product sales of EYLEA outside the United States. The Company records its share of profits/losses in connection with sales of EYLEA outside the United States within Bayer collaboration revenue. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (b) Regeneron records net product sales of Libtayo in the United States. Sanofi records net product sales of Libtayo outside the United States and global net product sales of Dupixent, Kevzara, and ZALTRAP. The Company records its share of profits/losses within Sanofi collaboration revenue in connection with (i) sales of Libtayo outside the United States, and (ii) global sales of Dupixent and Kevzara. Sanofi pays the Company a percentage of net sales of ZALTRAP. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (c) Effective April 1, 2020, Regeneron records net product sales of Praluent in the United States. Also effective April 1, 2020, Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales. Previously, Sanofi recorded global net product sales of Praluent and the Company recorded its share of profits/losses in connection with such sales within Sanofi collaboration revenue. Refer to "Products" section above and "Collaboration, License, and Other Agreements - Sanofi" section below for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| Revenues | | $ | 7,863.4 | | | $ | 6,710.8 | | | $ | 5,872.2 | |

In December 2019, we and Sanofi announced our intent to restructure the antibody collaboration for Kevzara and Praluent; completion of the proposed arrangement is expected to be finalized in the first quarter of 2020.

Refer to "Collaboration Agreements - *Collaborations with Sanofi* - *Antibody*" section below for further details.

We currently have seven products that have received marketing approval, which are currently marketed by us, Bayer, and/or Sanofi:

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| (4) Marketed as Libtayo (cemiplimab-rwlc) Injection in the United States | | | | | | | | | | |

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| *Net product sales recorded by Sanofi(1):* | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| (1) Bayer records net product sales of EYLEA outside the U.S., and Sanofi records net product sales of Libtayo outside the U.S. and global net product sales of Dupixent, Praluent, Kevzara, and ZALTRAP. Refer to "Collaboration Agreements" section below for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

All 22 of our product candidates in clinical development, including the five U.S. Food and Drug Administration ("FDA") approved products which we are investigating in additional indications, were discovered in our research laboratories and are summarized in the table below.

| EYLEA | | | \- | High-dose formulation in wet AMD | \- | Retinopathy of prematurity ("ROP")(c) | | | \- | Approved by FDA for the treatment of diabetic retinopathy | \- | Initiate Phase 3 studies of a high-dose formulation of aflibercept in wet AMD and DME (mid-2020) |

| | | | | | | | | | \- | Pre-filled syringe approved by FDA | | |

| Immunology & Inflammatory Diseases | | | | | | | | | | | | |

| Dupixent (dupilumab)(a) *Antibody to IL-4R alpha subunit* | | | \- | Grass allergy | \- | Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3)(d) | \- | Atopic dermatitis in pediatrics (6–11 years of age) (U.S. and EU)(d) | \- | Approved by FDA and European Commission ("EC") for expanded atopic dermatitis indication in adolescent patients (12–17 years of age) | \- | FDA decision (target action date of May 26, 2020) on supplemental Biologics License Application ("sBLA") and EC decision (second half 2020) for expanded atopic dermatitis indication in pediatric patients (6–11 years of age) |

| | | \- | Peanut allergy | | | | | | | | | |

| | | | | | \- | Asthma in pediatrics (6–11 years of age) | \- | CRSwNP (Japan) | | | | |

| | | | | | \- | Eosinophilic esophagitis ("EOE")(c) | \- | Auto-injector for 300 mg dose (U.S. and Japan) | \- | Reported that Phase 3 study in pediatric patients (6–11 years of age) with severe atopic dermatitis met its primary and secondary endpoints | | |

| | | | | | \- | Chronic obstructive pulmonary disease ("COPD") | | | | \- | Report results from Phase 3 study for atopic dermatitis in pediatric patients (6 months–5 years of age) (2022) | |

| | | | | | \- | Bullous pemphigoid (Phase 2/3)(c) | | | \- | Approved by EC for treatment of asthma in adults and adolescents | | |

| | | | | | \- | Chronic spontaneous urticaria | | | | \- | Report results from Phase 3 study for asthma in pediatric patients (6–11 years of age) (second half 2020) | |

| | | | | | \- | Prurigo nodularis | | | \- | Approved by FDA and EC for CRSwNP | | |

| | | | | | | | | | \- | EU approval for 200 mg and 300 mg auto-injector | \- | Japan decision on application for CRSwNP (first half 2020) |

| | | | | | | | | | \- | FDA issued Complete Response Letter ("CRL") on sBLA for 200 mg auto-injector | \- | FDA decision on application for 300 mg auto-injector (target action date of March 20, 2020) |

| | | | | | | | | | \- | Completed Phase 2a trial in grass allergy | \- | Resubmit sBLA for 200 mg auto-injector (first half 2020) |

| | | | | | | | | | | | \- | Present results from Phase 2a trial in grass allergy at medical meeting (first half 2020) |

| | | | | | | | | | | | \- | Initiate Phase 3 study in pediatric patients with EOE (second half 2020) |

| | | | | | | | | | | | \- | Report results from Phase 2 portion of Phase 2/3 study in EOE (mid-2020) |

| | | | | | | | | | | | \- | Initiate Phase 3 studies in hand and foot atopic dermatitis and allergic bronchopulmonary aspergillosis ("ABPA") (first half 2020) |

| Kevzara (sarilumab)(a) *Antibody to IL-6R* | | | \- | Polyarticular-course juvenile idiopathic arthritis ("pcJIA") | \- | Polymyalgia rheumatica ("PMR") | | | | | | |

| | | \- | Systemic juvenile idiopathic arthritis ("sJIA") | \- | Giant cell arteritis ("GCA") | | | | | | | |

| REGN3500(a) *Antibody to IL-33.* *Studied as monotherapy and in combination with Dupixent.* | | | \- | Asthma | | | | | \- | Reported that Phase 2 study in asthma met its primary and key secondary endpoints | \- | Report results from Phase 2 study in atopic dermatitis (second half 2020) |

| | | \- | COPD | | | | | | | | | |

| | | \- | Atopic dermatitis | | | | | \- | Sanofi reported that Phase 2 study in COPD demonstrated reduced exacerbations in the overall study population, but results were not statistically significant | \- | Initiate Phase 2b study in asthma (second half 2020) | |

| REGN1908-1909(f) *Multi-antibody therapy to Feld1* | | | \- | Cat allergy | | | | | | | \- | Report results from Phase 2 study in cat allergic asthmatics (first half 2020) |

| Oncology | | | | | | | | | | | | |

| Libtayo (cemiplimab)(a)(h) *Antibody to PD-1* | \- | Solid tumors and advanced hematologic malignancies | \- | Basal cell carcinoma ("BCC") (potentially pivotal study) | \- | First-line non-small cell lung cancer ("NSCLC") | | | \- | Conditionally approved by EC for treatment of advanced CSCC | \- | Report results from potentially pivotal Phase 2 study in BCC (mid-2020) |

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

[removed: FORM 10-K][added: FORM 10-K]

| (Mark One) | | | | [added: | | | | | | | |]

| ☒ | [added: | |] ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | | [added: | | | | | |]

| | [added: | |] For the fiscal year ended | [added: | |] December 31, [removed: 2019] [added: 2020] | | [added: | | | |]

| ☐ | [added: | |] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | | | [added: | | | | | |]

| | [added: | |] For the transition period from __________ to __________ | | | [added: | | | | | |]

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

| New York | | [added: | | | |] 13-3444607 | [added: | |]

| *(State or other jurisdiction of incorporation or organization)* | | [added: | | | |] *(I.R.S. Employer Identification No.)* | [added: | |]

| 777 Old Saw Mill River [removed: Road] [added: Road Tarrytown, New York 10591-6707] | [removed: Tarrytown,] | [removed: New York] | [removed: 10591-6707] | [added: | | | | | | | |]

| *(Address of principal executive offices, including zip code)* | | | | [added: | | | | | | | |]

[removed: (914) 847-7000][added: (914) 847-7000]

| *Title of each class* | [added: | |] *Trading Symbol* | [added: | |] *Name of each exchange on which registered* | [added: | |]

| Common Stock - par value $.001 per share | [added: | |] REGN | [added: | |] NASDAQ Global Select Market | [added: | |]

| Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. | [added: | |] Yes | [added: | |] ☒ | [added: | |] No | [added: | |] ☐ | [added: | |]

| Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. | [added: | |] Yes | [added: | |] ☐ | [added: | |] No | [added: | |] ☒ | [added: | |]

| Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. | [added: | |] Yes | [added: | |] ☒ | [added: | |] No | [added: | |] ☐ | [added: | |]

| Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). | [added: | |] Yes | [added: | |] ☒ | [added: | |] No | [added: | |] ☐ | [added: | |]

| Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act. | | | | | [added: | | | | | | | | | |]

| Large accelerated filer | [added: | |] ☒ | | [added: | | | |] Accelerated filer | [added: | |] ☐ | | [added: | | | |] Non-accelerated filer | [added: | |] ☐ | | [added: | | | |] Smaller reporting company | [added: | |] ☐ | | [added: | | | |] Emerging growth company | [added: | |] ☐ | | | [added: | | | | | |]

| If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. | | [added: | | | | | | | | | |] ☐ | | |

| Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). | [added: | |] Yes | [added: | |] ☐ | [added: | |] No | [added: | |] ☒ | [added: | |]

[added: |] The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant was approximately [removed: $32,929,000,000,] [added: $63,344,000,000,] computed by reference to the closing sales price of the stock on NASDAQ on June [removed: 28, 2019,] [added: 30, 2020,] the last trading day of the registrant's most recently completed second fiscal quarter. [added: 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. | | | | | | | | | | | | | | |]

[added: |] The number of shares outstanding of each of the registrant's classes of common stock as of January [removed: 31, 2020:][added: 29, 2021: | | | | | | | | | | | | | | |]

| Class of Common Stock | | [added: | | | |] Number of Shares | [added: | |]

| Class A Stock, $.001 par value | | [added: | | | |] 1,848,970 | [added: | |]

| Common Stock, $.001 par value | | [removed: 108,170,839] | [added: | | | 105,282,929 | | |]

| DOCUMENTS INCORPORATED BY REFERENCE | [added: | |]

| Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its [removed: 2020] [added: 2021] Annual Meeting of Shareholders are incorporated by reference into Part III of this Form 10-K. Exhibit index is located on pages [removed: 76] [added: 92] to [removed: 81] [added: 97] of this filing. | [added: | |]

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| [PART II](#i3994c168200943f68ab4a775a46b7f13_37) | | | | | | | | | | | | | | |

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| [PART IV](#i3994c168200943f68ab4a775a46b7f13_85) | | | | | | | | | | | | | | |

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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.

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| [PART I](#s0D3C0E1F50925489BE6F0EFFF13E4BA3) | | | | |

| [PART II](#s3B17C144962257A2BE00E4C2CC0ADD44) | | | | |

| [PART IV](#sD4F3E8C1BCC65E238EE94377A18EC5D2) | | | | |

At our Tarrytown, New York location, we lease approximately 1,467,000 square feet of laboratory and office space, of which approximately [removed: 1,244,000] [added: 1,354,000] square feet is occupied by Regeneron.

We also own an approximate [removed: 100\-acre] [added: 100-acre] parcel of undeveloped land adjacent to our Tarrytown, New York [removed: location; we intend to develop this property to accommodate and support our growth, primarily in connection with expanding our existing research and development and office space.][added: location.]

We own facilities in Rensselaer, New York totaling approximately [removed: 900,000] [added: 950,000] square feet of [removed: research,] manufacturing, [added: research,] office, and warehouse space.

We own a facility in Limerick, Ireland totaling approximately 555,000 square feet of manufacturing, warehouse, laboratory, and office space.

This includes approximately 110,000 square feet of recently constructed space to support our growth and increased manufacturing capacity.

We own a manufacturing facility in Limerick, Ireland, consisting of approximately 445,000 square feet, which was purchased and subsequently renovated to accommodate and support our growth and expand our manufacturing capacity.

The facility has received certain manufacturing approvals by regulatory agencies, including the FDA.

As of January [removed: 31, 2020,] [added: 29, 2021,] there were [removed: 166] [added: 162] shareholders of record of our Common Stock and 16 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: 2014] [added: 2015] through December 31, [removed: 2019.][added: 2020.]

The comparison assumes that $100 was invested on December 31, [removed: 2014] [added: 2015] in our Common Stock and in both of the foregoing indices.

[removed: ][added: ]

| | [removed: 12/31/2014] | | [added: 12/31/2015] | | [removed: 12/31/2015] | | | | 12/31/2016 | | | | [added: | |] 12/31/2017 | | | | [added: | |] 12/31/2018 | | | | [added: | |] 12/31/2019 | | | [added: | | | 12/31/2020 | | |]

The table below reflects shares of Common Stock we repurchased under [removed: our] [added: the] share repurchase [removed: program,] [added: program approved in November 2019,] as well as Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock [removed: awards or restricted stock units] granted under one of our long-term incentive plans, during the [removed: fourth quarter of 2019.][added: three months ended December 31, 2020.]

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

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

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| Regeneron | | | $ | 100.00 | | | | | $ | 67.62 | | | | | $ | 69.25 | | | | | $ | 68.80 | | | | | $ | 69.17 | | | | | $ | 88.99 | |

| S&P 500 | | | $ | 100.00 | | | | | $ | 109.54 | | | | | $ | 130.81 | | | | | $ | 122.65 | | | | | $ | 158.07 | | | | | $ | 183.77 | |

| NQ US Pharma TR Index | | | $ | 100.00 | | | | | $ | 98.91 | | | | | $ | 119.09 | | | | | $ | 127.20 | | | | | $ | 145.65 | | | | | $ | 160.97 | |

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

| 10/1/2020–10/31/2020 | | | | | | 72,870 | | | | | | $ | 556.23 | | | | | 72,870 | | | | | | $ | 332,144,883 | |

| 11/1/2020–11/30/2020 | | | | | | 596,867 | | | | | | $ | 524.36 | | | | | 596,867 | | | | | | $ | 19,172,999 | |

| 12/1/2020–12/31/2020 | | | | | | 41,636 | | | | | | $ | 516.76 | | | | | 36,854 | | | | | | — | | |

| Total | | | | | | 711,373 | | | (a) | | | | | | | | | 706,591 | | | (a) | | | | | |

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

| (b) In January 2021, our board of directors authorized a new share repurchase program to repurchase up to $1.5 billion of our Common Stock. See Item 7. "Liquidity and Capital Resources - Share Repurchase Program" for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| Regeneron | $ | 100.00 | | | $ | 132.33 | | | $ | 89.48 | | | $ | 91.64 | | | $ | 91.04 | | | $ | 91.52 | |

| S&P 500 | $ | 100.00 | | | $ | 99.27 | | | $ | 108.74 | | | $ | 129.86 | | | $ | 121.76 | | | $ | 156.92 | |

| NQ US Pharma TR Index | $ | 100.00 | | | $ | 105.43 | | | $ | 104.29 | | | $ | 125.57 | | | $ | 134.11 | | | $ | 153.57 | |

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

| 11/1/2019–11/30/2019 | | 509,365 | | | $ | 343.35 | | | 508,314 | | | $ | 825,664,565 | |

| 12/1/2019–12/31/2019 | | 214,282 | | | $ | 371.59 | | | 214,282 | | | $ | 745,967,321 | |

| Total | | 723,647 | | (a) | | | | | 722,596 | | (a) | | | |

The selected financial data set forth below for the years ended December 31, [added: 2020,] 2019, [removed: 2018,] and [removed: 2017] [added: 2018] and as of December 31, [removed: 2019] [added: 2020] and [removed: 2018] [added: 2019] are derived from and should be read in conjunction with our audited financial statements, including the notes thereto, included elsewhere in this report.

| | | [added: | | | |] Year Ended December 31, | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| *(In millions, except per share data)* | | [added: | | | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | [added: 2017] | | [removed: 2016] | | | | [removed: 2015] [added: 2016] | | |

| Statement of Operations Data: | | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | |]

| Revenues: | | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | |]

| Net product sales | | [added: | | | |] $ | [removed: 4,834.4] [added: 5,567.6] | | | [added: | |] $ | [removed: 4,106.2] [added: 4,834.4] | | | [added: | |] $ | [removed: 3,718.5] [added: 4,106.2] | | | [added: | |] $ | [removed: 3,338.4] [added: 3,718.5] | | | [added: | |] $ | [removed: 2,689.5] [added: 3,338.4] | |

| Expenses: | | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | |]

| Cost of goods sold | | [added: | | | | 491.9 | | | | | |] 362.3 | | | | [added: | |] 180.0 | | | | [removed: 202.5] | | [added: 202.5] | | [removed: 194.6] | | | | [removed: 241.7] [added: 194.6] | | |

| Income from operations | | [added: | | | | 3,576.6 | | | | | |] 2,209.8 | | | | [added: | |] 2,534.4 | | | | [removed: 2,079.6] | | [added: 2,079.6] | | [removed: 1,330.7] | | | | [removed: 1,251.9] [added: 1,330.7] | | |

| Other income (expense), net | | [added: | | | | 233.8 | | | | | |] 219.3 | | | | [added: | |] 19.1 | | | | [removed: (1.1] | | [removed: )] [added: (1.1)] | | [removed: (0.9] | | [removed: )] | | [removed: (26.8] [added: (0.9)] | | [removed: )] |

| Income before income taxes | | [added: | | | | 3,810.4 | | | | | |] 2,429.1 | | | | [added: | |] 2,553.5 | | | | [removed: 2,078.5] | | [added: 2,078.5] | | [removed: 1,329.8] | | | | [removed: 1,225.1] [added: 1,329.8] | | |

| Income tax expense(2) | | [removed: (313.3] | | [removed: )] | | [removed: (109.1] [added: 297.2] | | [removed: )] | | [removed: (880.0] | | [removed: )] [added: 313.3] | | [removed: (434.3] | | [removed: )] | | [removed: (589.0] [added: 109.1] | | [removed: )] | [added: | | | 880.0 | | | | | | 434.3 | | |]

| Net income | | [added: | | | |] $ | [removed: 2,115.8] [added: 3,513.2] | | | [added: | |] $ | [removed: 2,444.4] [added: 2,115.8] | | | [added: | |] $ | [removed: 1,198.5] [added: 2,444.4] | | | [added: | |] $ | [removed: 895.5] [added: 1,198.5] | | | [added: | |] $ | [removed: 636.1] [added: 895.5] | |

| Net income per share - basic | | [added: | | | |] $ | [removed: 19.38] [added: 32.65] | | | [added: | |] $ | [removed: 22.65] [added: 19.38] | | | [added: | |] $ | [removed: 11.27] [added: 22.65] | | | [added: | |] $ | [removed: 8.55] [added: 11.27] | | | [added: | |] $ | [removed: 6.17] [added: 8.55] | |

| Net income per share - diluted | | [added: | | | |] $ | [removed: 18.46] [added: 30.52] | | | [added: | |] $ | [removed: 21.29] [added: 18.46] | | | [added: | |] $ | [removed: 10.34] [added: 21.29] | | | [added: | |] $ | [removed: 7.70] [added: 10.34] | | | [added: | |] $ | [removed: 5.52] [added: 7.70] | |

| | | [added: | | | |] As of December 31, | | | | | | | | | | | | | | | | | | | [added: | | | | | | | |]

| *(In millions)* | | [added: | | | | 2020 | | | | | |] 2019 | | | | [added: | |] 2018 | | | | [removed: 2017] | | [added: 2017] | | [removed: 2016] | | | | [removed: 2015] [added: 2016] | | |

| Balance Sheet Data: | | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | |]

| Cash, cash equivalents, and marketable securities (current and non-current) | | [added: | | | |] $ | [removed: 6,471.1] [added: 6,722.6] | | | [added: | |] $ | [removed: 4,564.9] [added: 6,471.1] | | | [added: | |] $ | [removed: 2,896.0] [added: 4,564.9] | | | [added: | |] $ | [removed: 1,902.9] [added: 2,896.0] | | | [added: | |] $ | [removed: 1,677.4] [added: 1,902.9] | |

| Total assets | | [added: | | | |] $ | [removed: 14,805.2] [added: 17,163.3] | | | [added: | |] $ | [removed: 11,734.5] [added: 14,805.2] | | | [added: | |] $ | [removed: 8,764.3] [added: 11,734.5] | | | [added: | |] $ | [removed: 6,973.5] [added: 8,764.3] | | | [added: | |] $ | [removed: 5,609.1] [added: 6,973.5] | |

| Finance lease liabilities | | [added: | | | |] $ | [removed: 713.9] [added: 717.2] | | | [added: | |] $ | [removed: 708.5] [added: 713.9] | | | [added: | |] $ | [removed: 703.5] [added: 708.5] | | | [added: | |] $ | [removed: 481.1] [added: 703.5] | | | [added: | |] $ | [removed: 364.7] [added: 481.1] | |

| Stockholders' equity | | [added: | | | |] $ | [removed: 11,089.7] [added: 11,025.3] | | | [added: | |] $ | [removed: 8,757.3] [added: 11,089.7] | | | [added: | |] $ | [removed: 6,144.1] [added: 8,757.3] | | | [added: | |] $ | [removed: 4,449.2] [added: 6,144.1] | | | [added: | |] $ | [removed: 3,654.8] [added: 4,449.2] | |

| (1) Research and development expenses for the year ended December 31, 2019 includes a $400.0 million up-front payment to Alnylam in connection with our collaboration agreement. See Part I, Item 1. [removed: "Collaboration] [added: "Collaboration, License, and Other] Agreements - [removed: *Collaboration with Alnylam*")] [added: Alnylam")] for further details. | | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | |]

| (2) [removed: Income taxes for the year ended December 31, 2018 includes a $162.1 million income tax benefit related to the Company's sale of non-inventory related assets between foreign subsidiaries.] As a result of the Tax Cuts and Jobs Act being signed into law in December 2017, income taxes for the year ended December 31, 2017 included a charge of $326.2 million related to the re-measurement of our U.S. net deferred tax assets at the lower enacted corporate tax rate. See Note [removed: 15] [added: 14] to our Consolidated Financial Statements for further details. | | | | | | | | | | | | | | | | | | | | | [added: | | | | | | | | | | | |]

| Sanofi and Bayer collaboration [removed: revenue:] [added: revenue] | | | | | | [added: 2,372.5] | | | | | | [added: 1,549.2] | | | | | | [added: 910.4] | | [added: | | | | 456.3 | | | | | | 223.9 | | |]

[removed: *Selling, General,] [added: | Selling, general,] and [removed: Administrative Expenses*][added: administrative | | | | | | 1,346.0 | | | | | | 1,341.9 | | | | | | 1,127.2 | | | | | | 940.0 | | | | | | 860.9 | | |]

[removed: *Cost] [added: | Cost] of [removed: Collaboration] [added: collaboration] and [removed: Contract Manufacturing*][added: contract manufacturing | | | | | | 628.0 | | | | | | 402.8 | | | | | | 237.5 | | | | | | 169.4 | | | | | | 82.6 | | |]

Certain prior year amounts have been reclassified to conform to the current year's presentation, including revisions related to the change in presentation for certain amounts received from collaborators who are not deemed to be our customers; see Note 1 to our Consolidated Financial Statements for further details.

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

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

| Other revenue | | | | | | 557.0 | | | | | | 174.0 | | | | | | 129.0 | | | | | | 82.7 | | | | | | 68.3 | | |

| | | | | | | 8,497.1 | | | | | | 6,557.6 | | | | | | 5,145.6 | | | | | | 4,257.5 | | | | | | 3,630.6 | | |

| Research and development(1) | | | | | | 2,735.0 | | | | | | 2,450.0 | | | | | | 1,468.8 | | | | | | 1,180.5 | | | | | | 1,297.4 | | |

| Other operating (income) expense, net | | | | | | (280.4) | | | | | | (209.2) | | | | | | (402.3) | | | | | | (314.5) | | | | | | (135.6) | | |

| | | | | | | 4,920.5 | | | | | | 4,347.8 | | | | | | 2,611.2 | | | | | | 2,177.9 | | | | | | 2,299.9 | | |

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

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

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

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

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

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

| Long-term debt(3) | | | | | | $ | 1,978.5 | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |

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

| (3) In 2020, the Company issued and sold senior unsecured notes. See Item 7. "Liquidity and Capital Resources - Issuance of Senior Notes" for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

The selected financial data for the years ended December 31, 2016 and 2015 and as of December 31, 2017, 2016, and 2015 are derived from our audited financial statements not included in this report.

Certain prior year amounts have been reclassified to conform to the current year's presentation.

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

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

| Sanofi and Bayer collaboration revenue | | 2,615.6 | | | | 2,187.8 | | | | 1,815.3 | | | | 1,403.0 | | | | 1,339.4 | | |

| Other revenue | | 413.4 | | | | 416.8 | | | | 338.4 | | | | 119.0 | | | | 74.8 | | |

| | | 7,863.4 | | | | 6,710.8 | | | | 5,872.2 | | | | 4,860.4 | | | | 4,103.7 | | |

| Research and development(1) | | 3,036.6 | | | | 2,186.1 | | | | 2,075.1 | | | | 2,052.3 | | | | 1,620.6 | | |

| Selling, general, and administrative | | 1,834.8 | | | | 1,556.2 | | | | 1,320.4 | | | | 1,177.7 | | | | 838.5 | | |

| Cost of collaboration and contract manufacturing | | 419.9 | | | | 254.1 | | | | 194.6 | | | | 105.1 | | | | 151.0 | | |

| | | 5,653.6 | | | | 4,176.4 | | | | 3,792.6 | | | | 3,529.7 | | | | 2,851.8 | | |

| | |

| --- | --- |

| ITEM 7. | MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |

*The following discussion should be read in conjunction with the consolidated financial statements and related notes included elsewhere in this report.

Refer to Part II, Item 7 in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (filed with the SEC on February 7, 2019) for additional discussion of our financial condition and results of operations for the year ended December 31, 2017, as well as our financial condition and results of operations for the year ended December 31, 2018 compared to the year ended December 31, 2017.*

Overview

We are a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious diseases.

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

As described in Part I, Item 1.

"Business," we currently have seven products that have received marketing approval and 22 product candidates in clinical development, all of which were discovered in our research laboratories.

Refer to Part I, Item 1.

"Business" for a summary of our clinical programs.

Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the continued success in commercializing EYLEA and Dupixent.

We expect to continue to incur substantial expenses related to our research and development activities, a portion of which we expect to be reimbursed by our collaborators.

Also, our research and development activities outside our collaborations, the costs of which are not reimbursed, are expected to expand and require additional resources.

We also expect to incur substantial costs related to the commercialization of EYLEA, Dupixent, and Libtayo.

Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our marketed 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 or losses from sales of 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.

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

Critical Accounting Policies and Use of Estimates

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

The preparation of financial statements in accordance with accounting principles generally accepted in the United States of America ("GAAP") requires management to make estimates and assumptions that affect reported amounts and related disclosures in the 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. |

Management believes the current assumptions used to estimate amounts reflected in our Consolidated Financial Statements are appropriate.

However, if actual experience differs from the assumptions used in estimating amounts reflected in our Consolidated Financial Statements, the resulting changes could have a material adverse effect on our results of operations, and, in certain situations, could have a material adverse effect on our liquidity and financial condition.

The critical accounting estimates that impact our Consolidated Financial Statements are described below.

Revenue Recognition

During the first quarter of 2018, we adopted Accounting Standards Codification ("ASC") 606, *Revenue from Contracts with Customers*.

The financial statements required by this Item are included on pages F-1 through [removed: F-44] [added: F-47] of this report.

The supplementary financial information required by this Item is included at page [removed: F-44] [added: F-47] of this report.

Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, [removed: 2019] [added: 2020] 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: 2019.][added: 2020.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2019] [added: 2020] 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) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, [removed: 2019] [added: 2020] 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: 2020] [added: 2021] 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: "Investors & Media"] [added: "Corporate Governance"] heading on the [removed: "Corporate Governance"] [added: "Investors & Media"] page.

The information called for by this item will be included in our definitive proxy statement with respect to our [removed: 2020] [added: 2021] 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: 2020] [added: 2021] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

The information [removed: required] [added: called for] by this item will be included in our definitive proxy statement with respect to our [removed: 2020] [added: 2021] 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: 2020] [added: 2021] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

| Exhibit Number | [added: | |] Description | [added: | |]

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

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

| 4.1 | [added: | |] [Description of Securities Registered Pursuant to Section 12 of the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex41xdescriptiono.htm)] [added: 1934.](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex41xdescriptiono.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex41xdescriptiono.htm)[(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-ex41xdescriptiono.htm)] | [added: | |]

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

| 10.1.1 + | [added: | |] [Form of option agreement and related notice of grant for use in connection with the grant of [added: time based vesting stock] options to the Registrant's non-employee directors and [removed: named] executive officers under the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan. (Incorporated by reference from the Form [removed: 8-K] [added: 10-Q] for the Registrant, [added: for the quarter ended March 31, 2009,] filed [removed: December 16, 2005.)](http://www.sec.gov/Archives/edgar/data/872589/000095012305014882/y15671exv10w01.htm)] [added: April 30, 2009.)](http://www.sec.gov/Archives/edgar/data/872589/000120677409000907/exhibit10-1.htm)] | [added: | |]

| 10.1.2 + | [added: | |] [Form of option agreement and related notice of grant for use in connection with the grant of [added: performance based vesting stock] options to the Registrant's executive officers [removed: other than the named executive officers] under the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive Plan. (Incorporated by reference from the Form [removed: 8-K] [added: 10-Q] for the Registrant, [added: for the quarter ended March 31, 2009,] filed [removed: December 16, 2005.)](http://www.sec.gov/Archives/edgar/data/872589/000095012305014882/y15671exv10w02.htm)] [added: April 30, 2009.)](http://www.sec.gov/Archives/edgar/data/872589/000120677409000907/exhibit10-2.htm)] | [added: | |]

| 10.1.3 + | [added: | |] [Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. Second Amended and Restated 2000 Long-Term Incentive [removed: Plan.] [added: Plan (revised).] (Incorporated by reference from the Form [removed: 8-K] [added: 10-K] for the Registrant, [removed: filed] [added: for the year ended] December [removed: 13, 2004.)](http://www.sec.gov/Archives/edgar/data/872589/000095012304014716/y69569exv10w03.htm)] [added: 31, 2010, filed February 17, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000120677411000263/exhibit10_1-7.htm)] | [added: | |]

| 10.1.5 + | [added: | |] [Form of option agreement and related notice of grant for use in connection with the grant of time based vesting stock options to the Registrant's non-employee directors [removed: and executive officers] 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/exhibit10-1.htm)] [added: February 21, 2012.)](http://www.sec.gov/Archives/edgar/data/872589/000120677412000709/exhibit10-1_9.htm)] | [added: | |]

| [removed: 10.1.6] [added: 10.1.4] + | [added: | |] [Form of option agreement and related notice of grant for use in connection with the grant of performance based vesting stock options to the Registrant's executive officers 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: 2010,] filed [removed: April 30, 2009.)](http://www.sec.gov/Archives/edgar/data/872589/000120677409000907/exhibit10-2.htm)] [added: February 17, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000120677411000263/exhibit10_1-8.htm)] | [added: | |]

| [removed: 10.1.7] [added: 10.2.14] + | [added: | |] [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 Plan [removed: (revised).] [added: (revised 2018).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2010,] [added: 2018,] filed February [removed: 17, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000120677411000263/exhibit10_1-7.htm)] [added: 7, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10219xar2014ltiprs.htm)] | [added: | |]

| [removed: 10.1.8] [added: 10.2.12] + | [added: | |] [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 Plan [removed: (revised).] [added: (revised 2018).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2010,] [added: 2018,] filed February [removed: 17, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000120677411000263/exhibit10_1-8.htm)] [added: 7, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10217xstockoptiona.htm)] | [added: | |]

| [removed: 10.1.9] [added: 10.2.15] + | [added: | |] [Form of [added: stock] option agreement and related notice of grant for use in connection with the grant of [removed: time based vesting] [added: non-qualified] stock options to the Registrant's non-employee directors under the [removed: Regeneron Pharmaceuticals, Inc. Second] Amended and Restated [removed: 2000] [added: Regeneron Pharmaceuticals, Inc. 2014] Long-Term Incentive Plan [removed: (revised).] [added: (revised 2018).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2011,] [added: 2018,] filed February [removed: 21, 2012.)](http://www.sec.gov/Archives/edgar/data/872589/000120677412000709/exhibit10-1_9.htm)] [added: 7, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10220xar2014ltipnq.htm)] | [added: | |]

| [removed: 10.1.10] [added: 10.1.6] + | [added: | |] [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) | [added: | |]

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

| 10.2.1 + | [added: | |] [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex101.htm) | [added: | |]

| 10.2.2 + | [added: | |] [Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex103.htm) | [added: | |]

| 10.2.3 + | [added: | |] [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex104.htm) | [added: | |]

| 10.2.4 + | [added: | |] [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to P. Roy Vagelos, M.D. under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2015, filed February 11, 2016.)](http://www.sec.gov/Archives/edgar/data/872589/000153217616000045/regn-ex_1025x12312015x10k.htm) | [added: | |]

| 10.2.5 + | [added: | |] [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d1.htm) | [added: | |]

| 10.2.6 + | [added: | |] [Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d3.htm) | [added: | |]

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

| 10.2.8 + | [added: | |] [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10211xar2014ltipnq.htm) | [added: | |]

| 10.2.9 + | [added: | |] [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to P. Roy Vagelos, M.D. under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10213xar2014ltipnq.htm) | [added: | |]

| 10.2.10 + | [added: | |] [Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10215xar2014ltiprs.htm) | [added: | |]

| 10.2.11 + | [added: | |] [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10216xar2014ltipnq.htm) | [added: | |]

| [removed: 10.2.12] [added: 10.2.13] + | [added: | |] [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 Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised 2018). (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, [removed: 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10217xstockoptiona.htm)] [added: 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10218xstockoptiona.htm)] | [added: | |]

| [removed: 10.2.13] [added: 10.2.18] + | [added: | |] [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to P. Roy Vagelos, M.D. under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2018). (Incorporated] [added: 2019).](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10218ar2014ltip.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10218ar2014ltip.htm)[(Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2018,] [added: 201](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10218ar2014ltip.htm)[9](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10218ar2014ltip.htm)[,] filed February 7, [removed: 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10218xstockoptiona.htm)] [added: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10218ar2014ltip.htm)] | [added: | |]

| [removed: 10.2.14] [added: 10.2.19] + | [added: | |] [Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2018). (Incorporated] [added: 2019).](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10219ar2014ltip.htm) [(Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2018,] [added: 2019,] filed February 7, [removed: 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10219xar2014ltiprs.htm)] [added: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10219ar2014ltip.htm)] | [added: | |]

| [removed: 10.2.15] [added: 10.2.20] + | [added: | |] [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2018). (Incorporated] [added: 2019).](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm)[(Incorporated] by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2018,] [added: 2019,] filed February 7, [removed: 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10219xar2014ltiprs.htm)] [added: 2020.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm)] | [added: | |]

| 10.2.16 + | [added: | |] [Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2018, filed February 7, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10221xar2014ltiprs.htm) | [added: | |]

| 10.2.17 + | [added: | |] [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2019).](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)] [added: 2019).](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)[(Incorporated by reference from the](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm) [F](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)[orm 10-K for the Registrant, for the year ended December 31, 201](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)[9](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)[, filed February 7, 20](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)[20](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)[.)](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)] | [added: | |]

| [removed: 10.2.18] [added: 10.3.2] + | [added: | |] [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to P. Roy Vagelos, M.D. under the [added: Second] Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan (revised 2019).](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10218ar2014ltip.htm)] [added: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1032x12312020x10k.htm)] | [added: | |]

| [removed: 10.2.19] [added: 10.3.3] + | [added: | |] [Form of restricted stock award agreement and related notice of grant for use in connection with the grant of restricted stock awards to the Registrant's executive officers under the [added: Second] Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan (revised 2019).](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10219ar2014ltip.htm)] [added: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1033x12312020x10k.htm)] | [added: | |]

| [removed: 10.2.20] [added: 10.3.5] + | [added: | |] [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the [added: Second] Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan (revised 2019).](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm)] [added: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1035x12312020x10k.htm)] | [added: | |]

| 10.2.21 + | [added: | |] [Form of restricted stock unit award agreement and related notice of grant for use in connection with the grant of restricted stock units to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised [removed: 2019).](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10221ar2014ltip.htm)] [added: 2019).](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10221ar2014ltip.htm) [](http://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10221ar2014ltip.htm)[(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-ex10221ar2014ltip.htm)] | [added: | |]

| [removed: 10.2.22] [added: 10.3.7] + | [added: | |] [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., [removed: Ph.D.,] [added: Ph.D. and] George D. Yancopoulos, M.D., [removed: Ph.D., and P. Roy Vagelos, M.D.] [added: Ph.D.] under the [added: Second] Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10222ar2014ltip.htm)] [added: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000180422021000008/regn-ex_1037x12312020x10k.htm)] | [added: | |]