Regeneron Pharmaceuticals (REGN) 10-K risk factor changes: FY2019 vs FY2018

[removed: Risks] [added: Risks] Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed [removed: Products][added: Products]

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

For the years ended December 31, [removed: 2018] [added: 2019] and [removed: 2017,] [added: 2018,] EYLEA net sales in the United States represented [removed: 61%] [added: 59%] and [removed: 63%] [added: 61%] of our total revenues, respectively.

[removed: If] [added: If] we or our collaborators are unable to continue to successfully commercialize our products, our business, prospects, operating results, and financial condition will be materially [removed: harmed.][added: harmed.]

We expect that the [removed: continued] [added: degree of] commercial success of our marketed products [removed: (in particular, EYLEA, Dupixent, Praluent, Kevzara, and Libtayo)] will [added: continue to] depend on many factors, including the following (as applicable):

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

| • | our ability and our collaborators' ability to maintain sales of our marketed products in the face of competitive products and to differentiate our marketed products from competitive products, including as applicable product candidates currently in clinical development; and, in the case of EYLEA, the [added: 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 [removed: switch from Lucentis] [added: start] or [removed: off-label use of repackaged Avastin to] [added: continue treatment with] EYLEA or to [removed: start treatment with] [added: switch from another product to] EYLEA; |

| • | the outcome of the pending patent infringement proceedings relating to [removed: EYLEA, Dupixent,] [added: Dupixent] and Praluent (described further in Note [removed: 17] [added: 16] to our Consolidated Financial Statements included in this report), [removed: and] [added: as well as] other risks relating to our marketed products associated with intellectual property of other parties and pending or future litigation relating [removed: thereto, as] [added: thereto (as] discussed under "Risks Related to Intellectual Property and Market Exclusivity" [removed: below;] [added: below);] |

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

[removed: We] [added: We] and our collaborators are subject to significant ongoing regulatory obligations and oversight with respect to the products we or our collaborators commercialize.

If we or our collaborators fail to maintain regulatory compliance for any of such products, the applicable marketing approval may be withdrawn, which would materially harm our business, prospects, operating results, and financial [removed: condition.][added: condition.]

We and our collaborators are subject to significant ongoing regulatory obligations and oversight with respect to the products we or they commercialize [removed: (such as EYLEA, Dupixent, Praluent, Kevzara, and Libtayo)] for the products' currently approved indications in the United States, EU, and other countries where such products are approved.

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

See also "Risks Related to Manufacturing and Supply - [removed: Our] [added: *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 they obtain regulatory approval, and a reduction in [removed: sales"] [added: sales*"] below.

[removed: Serious] [added: Serious] complications or side effects in connection with the use of our [added: products and in clinical trials for our product candidates and new indications for our] marketed products could [removed: materially] [added: 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 [removed: condition.][added: condition.]

[removed: For additional information about some] [added: | • | serious complications or side effects in connection with the use] of [removed: these risks, see] [added: 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 - [removed: Serious] [added: *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 [removed: condition" below.][added: condition*" below; |]

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

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

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

Many third-party [removed: payers] [added: payors] cover only selected drugs, or may prefer selected drugs, making drugs that are not covered or preferred by such [removed: payers] [added: payors] more expensive for patients.

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

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

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

Government and other third-party [removed: payers] [added: payors] (including pharmacy benefit management companies) 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.

They are also imposing restrictions on eligible patient populations and the reimbursement process, including by means of required prior authorizations and utilization management [removed: criteria.][added: criteria, such as step therapy (*i.e.*, requiring the use of less costly medications before more costly medications are approved for coverage).]

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

[removed: At the federal level,] [added: drug price control measures that may be subsequently rolled into] the [removed: current administration's] budget proposal for fiscal year [removed: 2019 contains drug price control measures that] [added: 2021 and] could be enacted during the [removed: 2019] [added: 2021] budget process or in 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 [removed: EYLEA),] [added: EYLEA);] to allow some states to negotiate drug prices under [removed: Medicaid,] [added: Medicaid;] and to eliminate cost sharing for generic drugs for low-income patients.

On October 25, 2018, President Trump announced that CMS was evaluating a [removed: pilot] 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 [added: 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 [removed: pilot] [added: proposed] program, which is [removed: proposed] [added: contemplated] to initially cover fifty percent of Medicare Part B spending on separately payable Part B drugs (such as [removed: EYLEA).][added: 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.]

At the state level, legislatures are becoming increasingly aggressive in passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access, and [added: price and] marketing cost disclosure and transparency measures.

If our marketed products are not included within an adequate number of formularies, adequate reimbursement levels are not provided, the eligible insured patient population for our products is limited, or a key [removed: payer] [added: payor] refuses to provide reimbursement for our products in a particular jurisdiction altogether, this could have a material adverse effect on our and our collaborators' ability to commercialize the applicable product.

[removed: The] [added: The] commercial success of our products and product candidates is subject to [removed: strong competition.][added: significant competition.]

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

[removed: In addition, we] [added: We] are aware of several companies developing biosimilar versions of EYLEA.

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

[removed: In addition, ophthalmologists] [added: Ophthalmologists] are [added: also] using off-label, third-party repackaged versions of Genentech/Roche's approved VEGF antagonist, [removed: Avastin,] [added: bevacizumab,] for the treatment of [removed: wet AMD, DME,] [added: certain of EYLEA's indications,] and [removed: RVO.][added: we are aware of another company developing an ophthalmic formulation of such product.]

[removed: Finally, ZALTRAP has not been manufactured and formulated for use in intravitreal injections, and there] [added: There also] is a risk that third parties [removed: may attempt to] repackage ZALTRAP for off-label use and sale for the treatment of diseases of the eye, [removed: which would present a potential low-cost competitive threat to EYLEA] [added: even though ZALTRAP has not been manufactured and formulated] for [removed: its approved indications.][added: use in intravitreal injections.]

The market for Dupixent's current and potential future indications is [added: also] competitive.

In atopic dermatitis, [removed: Pfizer's Eucrisa, a topical ointment, competes with Dupixent and] there are several [removed: other] topical [added: ointments or] agents [added: either approved or] in development.

[removed: Orally] [added: Dupixent also faces competition from orally] administered small molecule agents [removed: may also compete with Dupixent] [added: and inhaled products] in asthma and potential future indications.

For purposes of this section, references to our products encompass products marketed by us and/or our collaborators under our collaboration agreements with them, unless otherwise stated or required by the context.

| • | the outcome of the pending government investigations described in Note 16 to our Consolidated Financial Statements included in this report; |

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

In addition, since January 1, 2019, CMS has allowed Medicare Advantage ("MA") plans to use step therapy for Part B drugs (such as EYLEA).

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.

Similarly, various members of the current U.S. Congress 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.

merge with larger pharmaceutical or biotechnology companies.

EYLEA faces significant competition in the marketplace.

For example, EYLEA competes in one or more of its approved indications with other VEGF inhibitors, including Novartis and Genentech/Roche's Lucentis and Novartis' Beovu.

In DME and RVO, EYLEA also competes with intravitreal implants of corticosteroids.

In addition, we are aware of several companies developing biosimilar versions of EYLEA and other approved anti-VEGF treatments.

Other potentially competitive products in development include products for use in combination with EYLEA and/or other anti-VEGF treatments, small-molecule tyrosine kinase inhibitors, gene therapies, and other eye-drop formulations, devices, and oral therapies.

In addition, a number of companies are developing antibodies against IL-13, IL-13Ra1, OX40, IL-31R, and/or IL-1alpha.

Several companies are also studying JAK inhibitors for atopic dermatitis.

In asthma, competitors to Dupixent include antibodies against the IL-5 ligand or the IL-5 receptor or immunoglobulin E; and some of these antibodies, if approved in this indication, may also compete with Dupixent in CRSwNP.

Libtayo also faces significant competition.

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

For example, there are several companies that are marketing and/or developing antibodies against PCSK9 and IL-6 and/or IL-6R, which currently (or, for antibodies in development, may in the future if approved) compete with Praluent and Kevzara, respectively.

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.

"Business - Collaboration Agreements - *Collaborations with Sanofi*" (the "Antibody Collaboration Restructuring")) and our IO Collaboration, we and Sanofi co-commercialize Dupixent and Libtayo in the United States.

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.

We will need to establish commercial capabilities outside the United States as a result of any exercise of our option to co-commercialize a product outside the United States.

For example, we have recently exercised our option under the Antibody Collaboration to co-commercialize Dupixent in certain jurisdictions outside the United States.

We and our collaborators must maintain regulatory compliance for the products we or they commercialize in foreign jurisdictions.

From time to time, we may hold a product's marketing approval in a jurisdiction outside the United States where we may have less experience and where our regulatory capabilities may be more limited.

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

failure, heart attack, and stroke.

For example, the FDA recently approved the 2mg EYLEA pre-filled syringe, which has launched commercially.

As described above under "*If we cannot protect the confidentiality of our trade secrets, or our patents or other means of defending*

We rely entirely on other parties and our collaborators for filling and finishing services, including with respect to drug-delivery devices (such as a pre-filled syringe, patch pump, auto-injector, or other delivery system).

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

This also holds true for establishing fill/finish capabilities in the future, for which we have taken initial steps.

product liability claims, and insufficient inventory.

As described further in Note 16 to our Consolidated Financial Statements included in this report, we are cooperating with pending government investigations concerning certain of our business activities.

Any adverse finding, allegation, or exercise of enforcement or regulatory discretion in such investigations could harm our business, prospects, operating results, and financial condition.

Recommendations by the Organization for Economic Co-operation and Development and the European Union Anti-Tax Avoidance Directive require companies to disclose more information to tax authorities on operations around the world, which may lead to greater audit scrutiny.

Even though we regularly assess the information provided to tax authorities in determining the appropriateness of our tax reserves, such tax authorities could take a position that is contrary to our expectations, and the result could adversely affect our provision for income tax and our current rate.

There are instances where we collect and maintain sensitive personally identifiable information, which may include health information outside of the scope of HIPAA.

Serious complications or serious, unexpected side effects in connection with the use of our marketed products (such as EYLEA, Dupixent, Praluent, Kevzara, and Libtayo) could materially harm our business, prospects, operating results, and financial condition.

In addition, in August 2018, CMS issued new guidance that recognizes that Medicare Advantage (MA) plans may use step therapy (i.e., requiring the use of less costly medications before more costly medications are approved for coverage) for Part B drugs (such as EYLEA), beginning January 1, 2019, as part of a patient-centered care coordination program.

CMS will also consider rulemaking related to step therapy that might be appropriate for 2020 and future years.

Congress and the U.S. administration have each indicated that they will continue to seek new legislative and/or administrative measures to control drug costs.

EYLEA.

The market for eye disease products is very competitive.

For example, Novartis and Genentech/Roche are collaborating on the commercialization and further development of a VEGF antibody fragment, Lucentis, for the treatment of various eye indications.

Lucentis is approved in one or more jurisdictions for the treatment of wet AMD, macular edema following RVO (including CRVO and BRVO), DME, diabetic retinopathy, and mCNV.

For example, Momenta Pharmaceuticals (in partnership with Mylan) is developing M710 (currently in a pivotal trial in patients with DME).

Competitors are also exploring the development of a biosimilar version of Lucentis; in particular, Formycon (in collaboration with Bioeq) is developing FYB201 (a Phase 3 trial in patients with wet AMD has been completed), Samsung Bioepis is developing SB11 (currently in a Phase 3 trial in patients with wet AMD), and Pfenex is developing PF582 (a Phase 1b/2a trial in patients with wet AMD has been completed).

Other competitive or potentially competitive products include Allergan's Ozurdex (approved by the FDA for the treatment of macular edema following RVO and for the treatment of DME) and Alimera Sciences' Iluvien (approved by the FDA for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure), both of which are intravitreal implants of corticosteroids.

Novartis is developing RTH258 (brolucizumab), a humanized monoclonal single-chain FV (scFv) antibody fragment targeting VEGF-A for wet AMD and DME.

Novartis announced in June 2017 that two Phase 3 studies of RTH258 met their primary endpoint of non-inferiority to EYLEA and has indicated that it is targeting approval by global regulatory authorities in 2019.

Allergan is developing abicipar pegol for wet AMD and related conditions and announced in July 2018 that two Phase 3 studies of abicipar pegol met their primary endpoint of non-inferiority to Lucentis.

Chengdu Kanghong Pharmaceutical Industry Group is conducting non-inferiority Phase 3 trials in the United States and Europe comparing conbercept, an anti-VEGF fusion protein, against EYLEA in wet AMD.

Conbercept is approved in the wet AMD and myopic choroidal neovascularization indications in China.

Genentech/Roche is developing a port delivery system implant for ranibizumab (currently in a Phase 3 study in patients with wet AMD).

Kodiak Sciences is developing KSI-301, an anti-VEGF biologic therapy that is conjugated to a phosphorylcholine-based biopolymer to extend its half-life, for wet AMD, DME, and RVO.

A Phase 1 study of KSI-301 in patients with DME met its primary safety and tolerability endpoint, and Kodiak has initiated a Phase 1b open label study in patients with wet AMD, DME, and RVO.

In addition, companies are developing products (or combinations of products) to treat wet AMD that act by blocking VEGF and VEGF receptors, as well as other targets (for example, Ang2).

Genentech/Roche is developing a bi-specific antibody, faricimab (RG7716), that targets both VEGF and Ang2 for wet AMD and DME (currently in Phase 3 non-inferiority studies comparing RG7716 against EYLEA in DME).

Products that are being developed for use in combination with EYLEA and/or Lucentis may also pose a competitive threat.

Opthea is developing OPT-302, a VEGFR-3 large molecule trap in combination with Lucentis in a Phase 2 trial for wet AMD.

Santen (in partnership with TRACON ) is developing DE-122, an anti-endoglin antibody in combination with Lucentis in a Phase 2 trial for wet AMD.

Small-molecule tyrosine kinase inhibitors that have activity against VEGF may also compete against EYLEA, if approved for wet AMD and/or related conditions.

Graybug is developing GB-102, an intravitreally administered depot formulation of the small molecule tyrosine kinase inhibitor, sunitinib, in a Phase 1/2 trial for wet AMD.

PanOptica is developing PAN-90806, a topically administered tyrosine kinase inhibitor currently in a Phase 1/2 trial for wet AMD.

Competitors are also developing other eye-drop formulations, devices, oral therapies, and gene/cell therapies (such as REGENXBIO's RGX-314) for various indications that, if approved, would compete with EYLEA in one or more of its currently approved indications.

The relatively low cost of therapy with repackaged Avastin presents a significant competitive challenge for EYLEA in these indications.

Avastin is also being evaluated in eye diseases in clinical trials in certain countries.

Amgen (in collaboration with Allergan) has obtained regulatory approval of a biosimilar version of Avastin in the United States and the EU, and other competitors are also developing a biosimilar version of Avastin.

Off-label use of any such biosimilar in one or more of the eye indications for which EYLEA is approved may put further pressure on the commercialization of EYLEA.

Dupixent.

In addition, a number of companies are developing antibodies against IL-13 for the treatment of atopic dermatitis, including LEO Pharma (in collaboration with AstraZeneca) with tralokinumab (currently in several Phase 3 trials) and Dermira (in collaboration with Genentech/Roche) with lebrikizumab (currently in a Phase 2b trial).

Antibodies targeting OX40 are also in development for atopic dermatitis, with Glenmark Pharmaceuticals and Kyowa Hakko Kirin Co. conducting Phase 2 trials of their respective programs (GBR-830 and KHK4083).

Galderma has completed a Phase 2b trial of nemolizumab, an antibody against IL-31R.

XBiotech has completed a Phase 2 trial of bermekimab, an anti-IL-1alpha antibody.

Novartis, in partnership with MorphoSys, has a Phase 2 trial in atopic dermatitis underway for MOR-106, an anti-IL-17C antibody.

Kiniksa Pharmaceuticals has completed Phase 1 trials in atopic dermatitis for KPL-716, an antibody against the oncostatin M receptor beta.

Orally administered small molecules are also being developed for atopic dermatitis, and, if approved, may compete with Dupixent in atopic dermatitis and other potential future indications.

[removed: Interest] [added: Interest] Rate [removed: Risk][added: Risk]

We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would have resulted in approximately a [removed: $27.7] [added: $48.6] million and [removed: $23.2] [added: $27.7] million decrease in the fair value of our investment portfolio as of December 31, [removed: 2018] [added: 2019] and [removed: 2017,] [added: 2018,] respectively.

We have exposure to market risk for changes in interest rates, including the interest rate risk relating to our March 2017 variable rate Tarrytown, New York lease (as described in [added: Part II,] Item 7.

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

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

We have hedged a portion of our floating interest rate exposure using interest rate swap and interest rate cap [removed: contracts (see Note 6 to our Consolidated Financial Statements).][added: contracts.]

[removed: Credit] [added: Credit] Quality [removed: Risk][added: Risk]

In [added: 2019,] 2018, [removed: 2017,] and [removed: 2016,] [added: 2017,] we did not record any charges for other-than-temporary impairments of our available-for-sale debt securities.

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

During [added: 2019,] 2018, [removed: 2017,] and [removed: 2016,] [added: 2017,] we did not recognize any charges for write-offs of accounts receivable related to our marketed products.

As of December 31, [removed: 2018] [added: 2019] and [removed: 2017,] [added: 2018,] three customers accounted on a combined basis for [removed: 99%] [added: 97% and 99%, respectively,] of our net trade accounts receivables.

[removed: Foreign] [added: Foreign] Exchange [removed: Risk][added: Risk]

[removed: Market] [added: Market] Price [removed: Risk][added: Risk]

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

The following table summarizes the notional amounts of our outstanding interest rate swap and cap contracts as of December 31, 2018:

| | | | | |

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

| (In millions) | | Notional Amount | | |

| Interest rate swap contracts | | $ | 75.0 | |

| Interest rate cap contracts | | $ | 75.0 | |

[removed: This] [added: *This] Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (where applicable, together with its subsidiaries, "Regeneron," "Company," "we," "us," and "our"), and actual events or results may differ materially from these forward-looking statements.

These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of [added: products marketed by us and/or] our [removed: products,] [added: collaborators (collectively, "Regeneron's Products") and our] product [removed: candidates,] [added: candidates] and research and clinical programs now underway or planned, including without limitation [removed: EYLEA® (aflibercept)] [added: EYLEA*® *(aflibercept)] Injection, [removed: Dupixent® (dupilumab)] [added: Dupixent*® *(dupilumab)] Injection, [removed: Praluent® (alirocumab)] [added: Libtayo*® *(cemiplimab)] Injection, [removed: Kevzara® (sarilumab)] [added: Praluent*® *(alirocumab)] Injection, [removed: Libtayo® (cemiplimab)] [added: Kevzara*® *(sarilumab)] Injection, fasinumab, [added: evinacumab, REGN-EB3, garetosmab, pozelimab,] and [removed: evinacumab;] [added: REGN1979;] the likelihood and timing of achieving any of our anticipated clinical development milestones [removed: and the impact of the recent and any potential future U.S. government shutdowns on the anticipated timing of any U.S. Food and Drug Administration regulatory action] referenced in this report; unforeseen safety issues resulting from the administration of [removed: products] [added: Regeneron's Products] and product candidates in patients, including serious complications or side effects in connection with the use of [removed: our] [added: 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 [removed: marketed products,] [added: Regeneron's Products,] including without limitation EYLEA, Dupixent, [added: Libtayo,] Praluent, Kevzara, [removed: Libtayo,] fasinumab, [added: evinacumab, REGN-EB3, garetosmab, pozelimab,] and [removed: evinacumab;] [added: 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 [removed: our marketed products] [added: Regeneron's Products] (such as EYLEA, Dupixent, [added: Libtayo,] Praluent, [removed: Kevzara,] and [removed: Libtayo),] [added: 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 [removed: our products] [added: Regeneron's Products] and product candidates; competing drugs and product candidates that may be superior to [removed: our products] [added: Regeneron's Products] and product candidates; uncertainty of market acceptance and commercial success of [removed: our products] [added: 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 [added: (as applicable)] to perform [added: manufacturing,] filling, finishing, packaging, labeling, distribution, and other steps related to [removed: our products] [added: Regeneron's Products] and product candidates; coverage and reimbursement determinations by third-party [removed: payers,] [added: 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 [removed: thereto, including] [added: thereto (including] without limitation the patent litigation [added: and other related] proceedings relating to [removed: EYLEA, Dupixent,] [added: Dupixent] and Praluent described further in Note [removed: 17] [added: 16] to our Consolidated Financial Statements included in this [removed: report.][added: 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.]

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

[removed: General][added: General]

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, [removed: neuromuscular diseases,] [added: pain,] infectious diseases, and rare diseases.

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

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

| Revenues | | $ | [removed: 6,710.8] [added: 7,863.4] | | | $ | [removed: 5,872.2] [added: 6,710.8] | | | $ | [removed: 4,860.4] [added: 5,872.2] | |

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

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

[removed: Marketed Products][added: Marketed Products]

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

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

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

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

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

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

| [removed: Ÿ] [added: \-] | Diabetic retinopathy [removed: in patients with DME] | | a | | | | | | | |

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

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

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

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

| Libtayo (cemiplimab) [removed: Injection(3)(5)] [added: Injection(3)(4)] | [removed: Ÿ] [added: \-] | Metastatic or locally advanced cutaneous squamous cell carcinoma [removed: (CSCC)] [added: ("CSCC")] | | a | | [added: a] | | | | [added: a] |

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

| ZALTRAP® (ziv-aflibercept) Injection for Intravenous [removed: Infusion(4)] [added: Infusion(5)] | [removed: Ÿ] [added: \-] | Metastatic colorectal cancer [removed: (mCRC)] [added: ("mCRC")] | | a | | a | | a | | a |

| [removed: (4)] [added: (5)] 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 sales of ZALTRAP | | | | | | | | | | |

| [removed: (5)] [added: (4)] Marketed as Libtayo (cemiplimab-rwlc) Injection in the United States | | | | | | | | | | |

| [removed: Net] [added: Net] Product Sales of Regeneron-Discovered [removed: Products(2)] [added: Products(1)] | | [removed: Year] [added: Year] Ended December [removed: 31,] [added: 31,] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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

| | | [removed: U.S.] [added: U.S.] | | | | [removed: ROW(1)] [added: ROW] | | | | [removed: Total] [added: Total] | | | | [removed: U.S.] [added: U.S.] | | | | [removed: ROW(1)] [added: ROW] | | | | [removed: Total] [added: Total] | | | | [removed: U.S.] [added: U.S.] | | | | [removed: ROW(1)] [added: ROW] | | | | [removed: Total] [added: Total] | | |

| [removed: EYLEA(2)] [added: EYLEA(1)] | | $ | [removed: 4,076.7] [added: 4,644.2] | | | $ | [removed: 2,668.9] [added: 2,897.4] | | | $ | [removed: 6,745.6] [added: 7,541.6] | | | $ | [removed: 3,701.9] [added: 4,076.7] | | | $ | [removed: 2,226.9] [added: 2,668.9] | | | $ | [removed: 5,928.8] [added: 6,745.6] | | | $ | [removed: 3,323.1] [added: 3,701.9] | | | $ | [removed: 1,872.3] [added: 2,226.9] | | | $ | [removed: 5,195.4] [added: 5,928.8] | |

| [removed: Libtayo] [added: Libtayo(1)] | | [removed: 14.8] [added: 175.7] | | | | [removed: —] [added: 18.1] | | | | [removed: 14.8] [added: 193.8] | | | | [removed: —] [added: 14.8] | | | | — | | | | [removed: —] [added: 14.8] | | | | — | | | | — | | | | — | | |

| ARCALYST | | [removed: 14.7] [added: 14.5] | | | | — | | | | [removed: 14.7] [added: 14.5] | | | | [removed: 16.6] [added: 14.7] | | | | — | | | | [removed: 16.6] [added: 14.7] | | | | [removed: 15.3] [added: 16.6] | | | | — | | | | [removed: 15.3] [added: 16.6] | | |

| Net product sales recorded by Regeneron | | $ | [removed: 4,106.2] [added: 4,834.4] | | | | | | | | | | | $ | [removed: 3,718.5] [added: 4,106.2] | | | | | | | | | | | $ | [removed: 3,338.4] [added: 3,718.5] | | | | | | | | | |

| [removed: Net] [added: *Net] product sales recorded by [removed: Sanofi(2):] [added: Sanofi(1):*] | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

| Dupixent | | $ | [removed: 776.3] [added: 1,871.2] | | | $ | [removed: 145.7] [added: 444.4] | | | $ | [removed: 922.0] [added: 2,315.6] | | | $ | [removed: 253.8] [added: 776.3] | | | $ | [removed: 2.7] [added: 145.7] | | | $ | [removed: 256.5] [added: 922.0] | | | [removed: —] [added: $] | [added: 253.8] | | | [removed: —] [added: $] | [added: 2.7] | | | [removed: —] [added: $] | [added: 256.5] | |

| Praluent | | $ | [removed: 181.3] [added: 126.0] | | | $ | [removed: 125.5] [added: 162.7] | | | $ | [removed: 306.8] [added: 288.7] | | | $ | [removed: 131.4] [added: 181.3] | | | $ | [removed: 63.3] [added: 125.5] | | | $ | [removed: 194.7] [added: 306.8] | | | $ | [removed: 94.4] [added: 131.4] | | | $ | [removed: 21.9] [added: 63.3] | | | $ | [removed: 116.3] [added: 194.7] | |

| Kevzara | | $ | [removed: 74.7] [added: 129.0] | | | $ | [removed: 21.9] [added: 77.7] | | | $ | [removed: 96.6] [added: 206.7] | | | $ | [removed: 11.6] [added: 74.7] | | | $ | [removed: 1.7] [added: 21.9] | | | $ | [removed: 13.3] [added: 96.6] | | | [removed: —] [added: $] | [added: 11.6] | | | [removed: —] [added: $] | [added: 1.7] | | | [removed: —] [added: $] | [added: 13.3] | |

| ZALTRAP | | $ | [removed: 9.0] [added: 7.3] | | | $ | [removed: 98.8] [added: 101.1] | | | $ | [removed: 107.8] [added: 108.4] | | | $ | [removed: 10.7] [added: 9.0] | | | $ | [removed: 73.1] [added: 98.8] | | | $ | [removed: 83.8] [added: 107.8] | | | $ | [removed: 16.6] [added: 10.7] | | | $ | [removed: 55.7] [added: 73.1] | | | $ | [removed: 72.3] [added: 83.8] | |

| [removed: (2)] [added: (1)] Bayer records net product sales of EYLEA outside the [removed: United States] [added: U.S.,] and Sanofi records [added: net product sales of Libtayo outside the U.S. and] global net product sales of Dupixent, Praluent, Kevzara, and ZALTRAP. Refer to [removed: "General" above and] "Collaboration Agreements" [added: section] below for further details. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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.

| | | U.S. | | EU | | Japan | | ROW(6) | | |

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

| (6) 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 (EU), or Japan | | | | | | | | | | |

| (7) Approval in Japan is for adults and adolescents 15 years of age and older | | | | | | | | | | |

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

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

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

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

| Ophthalmology | | | | | | | | | | | | |

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

| 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) |

| | | | | | \- | 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 | | |

| | | | | | \- | 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) |

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

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

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

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

| | | | | | | | | | | | \- | Report results from Phase 2 study in peanut allergy (first half 2021) |

| | | | | | | | | | | | \- | 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) |

| 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) | |

| REGN5713-5714-5715 *Antibody to Betv1* | \- | Birch allergy | | | | | | | | | | |

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

| | | U.S. | | EU | | Japan | | Certain other countries outside the U.S. | | |

| (1) Rest of world | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

We used our VelocImmune® technology to generate each of the antibodies in the table below.

| | | | | | | | | |

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

| Clinical Program | | Phase 1 | | Phase 2 | | Phase 3 | | Regulatory Review(i) |

| EYLEA | | | | | Ÿ | Non-proliferative diabetic retinopathy (NPDR) in patients without DME | Ÿ | Diabetic retinopathy (U.S.) |

| Dupixent (dupilumab)(a) Antibody to IL-4R alpha subunit | | | Ÿ | Grass allergy | Ÿ | Atopic dermatitis in adolescents and pediatrics (6–11 years of age)(d) | Ÿ | Asthma in adults and adolescents (EU and Japan) |

| | | | | Ÿ | Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3)(d) | Ÿ | Atopic dermatitis in adolescents (12–17 years of age) (U.S. and EU) | |

| | | | | Ÿ | Asthma in pediatrics (6–11 years of age) | Ÿ | Auto-injector for 200 mg dose (U.S. and EU) | |

| | | | | Ÿ | HeFH in pediatrics | Ÿ | First-line treatment of hyperlipidemia (U.S.) | |

| | | Ÿ | Basal cell carcinoma (BCC) (potentially pivotal study) | Ÿ | Second-line cervical cancer | | | |

| REGN3500(a) Antibody to IL-33. Studied as monotherapy and in combination with Dupixent. | | | Ÿ | Asthma | | | | |

| | | Ÿ | Chronic obstructive pulmonary disease (COPD) | | | | | |

| | | Ÿ | Atopic dermatitis | | | | | |

| Trevogrumab(f) (REGN1033) Antibody to myostatin (GDF8) | Ÿ | Muscle-wasting diseases (in combination with garetosmab) | | | | | | |

| REGN1979 Bispecific antibody against CD20 and CD3 | Ÿ | Certain B-cell malignancies (monotherapy and in combination with Libtayo)(c) | | | | | | |

| REGN-EB3(g) (REGN3470-3471-3479) Multi-antibody therapy to Ebola virus | Ÿ | Ebola virus infection(c) | | | | | | |

| REGN3048-3051(g) Multi-antibody therapy to Middle East Respiratory Syndrome (MERS) virus | Ÿ | MERS virus infection | | | | | | |

| REGN3767(f) Antibody to LAG-3 protein | Ÿ | Advanced cancers (administered alone or in combination with Libtayo) | | | | | | |

| Pozelimab(f) (REGN3918) Antibody to C5 | Ÿ | Paroxysmal nocturnal hemoglobinuria (PNH) | | | | | | |

| REGN4659(f) Antibody to CTLA4 | Ÿ | Advanced NSCLC (administered alone or in combination with Libtayo) | | | | | | |

| REGN5069 Antibody to GFRα3 | Ÿ | Pain | | | | | | |

| | | | | |

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

Our discovery platforms are designed to identify specific proteins of therapeutic interest for a particular disease or cell type and validate these targets through high-throughput production of genetically modified mice using our VelociGene® technology to understand the role of these proteins in normal physiology, as well as in models of disease.

Our human antibody technology (VelocImmune) and cell line expression technologies (VelociMab®) may then be utilized to discover and produce new product candidates directed against the disease target.

Our antibody product candidates currently in clinical trials were developed using VelocImmune.

In our clinical programs, key events in 2018 and 2019 to date were, and select 2019 milestones for the remainder of 2019 are, as follows:

| EYLEA | Ÿ | Chinese State Food and Drug Administration (CFDA) approved EYLEA for DME and wet AMD | Ÿ | FDA decision on sBLA for the treatment of diabetic retinopathy (target action date of May 13, 2019) |

| Ÿ | Reported 24-week positive top-line results from Phase 3 PANORAMA study for the treatment of NPDR in patients without DME | Ÿ | Re-submission of Prior-Approval Supplement (PAS) for pre-filled syringe | |

| | Ÿ | Initiate a study of a high dose formulation of aflibercept | | |

| Ÿ | Reported that the Phase 3 PANORAMA study met its one-year primary endpoint and key secondary endpoints | | | |

| Ÿ | Submitted sBLA for the treatment of diabetic retinopathy | | | |

| Ÿ | FDA issued Complete Response Letter (CRL) regarding the sBLA for pre-filled syringe | | | |

| Ÿ | Treat and Extend dosing regimen approved in the EU for wet AMD | | | |

| | Ÿ | FDA approved sBLA for every 12-week dosing regimen option after one year of effective therapy in patients with wet AMD | | |

| | Ÿ | FDA approved sBLA for vial-only presentation | | |

| Dupixent (dupilumab; IL-4R Antibody) | Ÿ | Ministry of Health, Labor and Welfare (MHLW) in Japan approved Dupixent for the treatment of atopic dermatitis in adults not adequately controlled with existing therapies | Ÿ | FDA decision on sBLA for expanded atopic dermatitis indication in adolescent patients (12–17 years of age) (target action date of March 11, 2019) |

| | Ÿ | Reported positive results from Phase 3 study in adolescent patients (12–17 years of age) with atopic dermatitis | Ÿ | European Medicines Agency (EMA) decision on regulatory application for asthma |

The information called for by this item is incorporated herein by reference to the information set forth in Note [removed: 17] [added: 16] to our Consolidated Financial Statements included in this report.

[removed: UNITED STATES][added: UNITED STATES]

[removed: SECURITIES] [added: SECURITIES] AND EXCHANGE [removed: COMMISSION][added: COMMISSION]

[removed: Washington,] [added: Washington,] D.C. [removed: 20549][added: 20549]

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

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

| | [removed: For] [added: For] the fiscal year [removed: ended December 31, 2018] [added: ended] | [added: December 31, 2019] | |

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

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

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

[removed: REGENERON] [added: REGENERON] PHARMACEUTICALS, [removed: INC.][added: INC.]

[removed: (Exact] [added: *(Exact] name of registrant as specified in its [removed: charter)][added: charter)*]

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

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

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

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

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

[removed: (Registrant's] [added: *(Registrant's] telephone number, including area [removed: code)][added: code)*]

[removed: Securities] [added: Securities] registered pursuant to Section 12(b) of the [removed: Act:][added: Act:]

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

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

[removed: Securities] [added: Securities] registered pursuant to section 12(g) of the Act: [removed: None][added: None]

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

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

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

[removed: |] The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant was approximately [removed: $35,741,000,000,] [added: $32,929,000,000,] computed by reference to the closing sales price of the stock on NASDAQ on June [removed: 29, 2018,] [added: 28, 2019,] the last trading day of the registrant's most recently completed second fiscal quarter. [removed: 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. | | | | |]

[removed: |] The number of shares outstanding of each of the registrant's classes of common stock as of January 31, [removed: 2019: | | | | |][added: 2020:]

| Class A Stock, $.001 par value | | [removed: 1,911,354] [added: 1,848,970] |

| Common Stock, $.001 par value | | [removed: 107,365,835] [added: 108,170,839] |

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

| Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its [removed: 2019] [added: 2020] Annual Meeting of Shareholders are incorporated by reference into Part III of this Form 10-K. Exhibit index is located on pages [removed: 78] [added: 76] to [removed: 83] [added: 81] of this filing. |

[removed: ANNUAL] [added: ANNUAL] REPORT ON FORM [removed: 10-K][added: 10-K]

[removed: TABLE] [added: TABLE] OF [removed: CONTENTS][added: CONTENTS]

| | | | | [removed: Page Numbers] [added: Page Numbers] |

[removed: | [PART I](#s4382BCC179D957B18C22B3C46A04B787) | | | | |][added: PART I]

| [Item [removed: 1.](#sD15D66B8E80E585D893A63FB3DD5DF77)] [added: 1.](#sF3AB65842110596596C77763B37B084D)] | | [removed: [Business](#sD15D66B8E80E585D893A63FB3DD5DF77)] [added: [Business](#sF3AB65842110596596C77763B37B084D)] | | [removed: [2](#sD15D66B8E80E585D893A63FB3DD5DF77)] [added: [2](#sF3AB65842110596596C77763B37B084D)] |

| [Item [removed: 1A.](#s245C5B1F8D9E53E2A25BD6CD3FCEA8EE)] [added: 1A.](#s53891C1F8DAA5D45AE82EA7ACAEC1AFB)] | | [Risk [removed: Factors](#s245C5B1F8D9E53E2A25BD6CD3FCEA8EE)] [added: Factors](#s53891C1F8DAA5D45AE82EA7ACAEC1AFB)] | | [removed: [30](#s245C5B1F8D9E53E2A25BD6CD3FCEA8EE)] [added: [27](#s53891C1F8DAA5D45AE82EA7ACAEC1AFB)] |

| | OR | | |

| | | | |

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

| | | | |

| | | | |

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

| | | | |

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.

REGENERON PHARMACEUTICALS, INC.

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

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

10-K 1 regn-123118x10k.htm FORM 10-K

| |

| --- |

| | OR | | |

| | | |

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

| | | | | |

| Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. | | ¨ | | |

| [PART II](#s680A90DEEA6D5330B496DFFE68416814) | | | | |

| [PART IV](#s517292EDAB07577BBC3672406B6D0DFD) | | | | |

[removed: Tarrytown,] [added: Tarrytown,] New [removed: York][added: York]

At our Tarrytown, New York location, we lease approximately 1,467,000 square feet of laboratory and office space, of which approximately [removed: 1,180,000] [added: 1,244,000] square feet is occupied by Regeneron.

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

[removed: Sleepy Hollow,] [added: Rensselaer,] New [removed: York][added: York]

We own facilities in Rensselaer, New York totaling approximately [removed: 565,000] [added: 900,000] square feet of research, manufacturing, office, and warehouse space.

[removed: Limerick, Ireland][added: Limerick, Ireland]

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

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

We own an office building in Sleepy Hollow, New York, consisting of approximately 383,000 square feet.

This facility is being used as additional office space to support the growth of our existing Tarrytown facilities.

Rensselaer, New York

In 2018, we also purchased approximately 124,000 square feet of research and office space near our Rensselaer facility, a portion of which we had previously leased.

We also own approximately 130 acres of land near our Rensselaer facility; we developed approximately 212,000 square feet on this property in connection with expanding our warehouse space, and we have plans to further develop this property in connection with expanding certain manufacturing activities.

Troy, New York

We own an office building in Troy, New York, consisting of approximately 217,000 square feet, which we are utilizing as additional office space to support the growth of our existing Rensselaer facilities.

[removed: PART II][added: PART II]

[removed: Market] [added: Market] for Registrant's Common [removed: Equity][added: Equity]

As of January 31, [removed: 2019,] [added: 2020,] there were [removed: 180] [added: 166] shareholders of record of our Common Stock and [removed: 18] [added: 16] shareholders of record of our Class A Stock.

[removed: STOCK] [added: STOCK] PERFORMANCE [removed: GRAPH][added: GRAPH]

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 [removed: (NQ] [added: ("NQ] US Pharma TR [removed: Index),] [added: Index"),] and (ii) Standard & Poor's 500 Stock Index [removed: (S&P 500)] [added: ("S&P 500")] for the period from December 31, [removed: 2013] [added: 2014] through December 31, [removed: 2018.][added: 2019.]

The comparison assumes that $100 was invested on December 31, [removed: 2013] [added: 2014] in our Common Stock and in both of the foregoing indices.

[removed: ][added: ]

| | [removed: 12/31/2013] [added: 12/31/2014] | | | | [removed: 12/31/2014] [added: 12/31/2015] | | | | [removed: 12/31/2015] [added: 12/31/2016] | | | | [removed: 12/31/2016] [added: 12/31/2017] | | | | [removed: 12/31/2017] [added: 12/31/2018] | | | | [removed: 12/31/2018] [added: 12/31/2019] | | |

| 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 | |

Issuer Purchases of Equity Securities

The table below reflects shares of Common Stock we repurchased under our share repurchase program, as well as Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted stock awards or restricted stock units granted under one of our long-term incentive plans, during the fourth quarter of 2019.

Refer to Part II, Item 7.

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Liquidity and Capital Resources - *Share Repurchase Program*" for further details of the share repurchase program.

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

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

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

| Period | | Total Number of Shares Purchased | | | Average Price Paid per Share | | | | Total Number of Shares Purchased as Part of a Publicly Announced Program | | | Approximate Dollar Value of Shares that May Yet Be Purchased Under the Program | | |

| 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) | | | |

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

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

| Regeneron | $ | 100.00 | | | $ | 149.05 | | | $ | 197.24 | | | $ | 133.37 | | | $ | 136.59 | | | $ | 135.70 | |

| S&P 500 | $ | 100.00 | | | $ | 111.39 | | | $ | 110.58 | | | $ | 121.13 | | | $ | 144.65 | | | $ | 135.63 | |

| NQ US Pharma TR Index | $ | 100.00 | | | $ | 121.82 | | | $ | 128.44 | | | $ | 127.04 | | | $ | 152.96 | | | $ | 163.37 | |

The selected financial data set forth below for the years ended December 31, [added: 2019,] 2018, [removed: 2017,] and [removed: 2016] [added: 2017] and as of December 31, [removed: 2018] [added: 2019] and [removed: 2017] [added: 2018] are derived from and should be read in conjunction with our audited financial statements, including the notes thereto, included elsewhere in this report.

The selected financial data for the years ended December 31, [removed: 2015] [added: 2016] and [removed: 2014] [added: 2015] and as of December 31, [added: 2017,] 2016, [removed: 2015,] and [removed: 2014] [added: 2015] are derived from our audited financial statements not included in this report.

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

| [removed: (In] [added: *(In] millions, except per share [removed: data)] [added: data)*] | | [removed: 2018] [added: 2019] | | | | [removed: 2017] [added: 2018] | | | | [removed: 2016] [added: 2017] | | | | [removed: 2015] [added: 2016] | | | | [removed: 2014] [added: 2015] | | |

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

| Net product sales | | $ | [removed: 4,106.2] [added: 4,834.4] | | | $ | [removed: 3,718.5] [added: 4,106.2] | | | $ | [removed: 3,338.4] [added: 3,718.5] | | | $ | [removed: 2,689.5] [added: 3,338.4] | | | $ | [removed: 1,750.8] [added: 2,689.5] | |

| Sanofi and Bayer collaboration revenue | | [removed: 2,187.8] [added: 2,615.6] | | | | [removed: 1,815.3] [added: 2,187.8] | | | | [removed: 1,403.0] [added: 1,815.3] | | | | [removed: 1,339.4] [added: 1,403.0] | | | | [removed: 1,036.9] [added: 1,339.4] | | |

| Other revenue | | [removed: 416.8] [added: 413.4] | | | | [removed: 338.4] [added: 416.8] | | | | [removed: 119.0] [added: 338.4] | | | | [removed: 74.8] [added: 119.0] | | | | [removed: 31.9] [added: 74.8] | | |

| | | [removed: 6,710.8] [added: 7,863.4] | | | | [removed: 5,872.2] [added: 6,710.8] | | | | [removed: 4,860.4] [added: 5,872.2] | | | | [removed: 4,103.7] [added: 4,860.4] | | | | [removed: 2,819.6] [added: 4,103.7] | | |

| Research and [removed: development] [added: development(1)] | | [removed: 2,186.1] [added: 3,036.6] | | | | [removed: 2,075.1] [added: 2,186.1] | | | | [removed: 2,052.3] [added: 2,075.1] | | | | [removed: 1,620.6] [added: 2,052.3] | | | | [removed: 1,271.4] [added: 1,620.6] | | |

| Selling, general, and administrative | | [removed: 1,556.2] [added: 1,834.8] | | | | [removed: 1,320.4] [added: 1,556.2] | | | | [removed: 1,177.7] [added: 1,320.4] | | | | [removed: 838.5] [added: 1,177.7] | | | | [removed: 519.3] [added: 838.5] | | |

| Cost of goods sold | | [removed: 180.0] [added: 362.3] | | | | [removed: 202.5] [added: 180.0] | | | | [removed: 194.6] [added: 202.5] | | | | [removed: 241.7] [added: 194.6] | | | | [removed: 129.0] [added: 241.7] | | |

| Cost of collaboration and contract manufacturing | | [removed: 254.1] [added: 419.9] | | | | [removed: 194.6] [added: 254.1] | | | | [removed: 105.1] [added: 194.6] | | | | [removed: 151.0] [added: 105.1] | | | | [removed: 76.0] [added: 151.0] | | |

| | | [removed: 4,176.4] [added: 5,653.6] | | | | [removed: 3,792.6] [added: 4,176.4] | | | | [removed: 3,529.7] [added: 3,792.6] | | | | [removed: 2,851.8] [added: 3,529.7] | | | | [removed: 1,995.7] [added: 2,851.8] | | |

| Income from operations | | [removed: 2,534.4] [added: 2,209.8] | | | | [removed: 2,079.6] [added: 2,534.4] | | | | [removed: 1,330.7] [added: 2,079.6] | | | | [removed: 1,251.9] [added: 1,330.7] | | | | [removed: 823.9] [added: 1,251.9] | | |

| Other income (expense), net | | [removed: 19.1] [added: 219.3] | | | | [removed: (1.1] [added: 19.1] | | [removed: )] | | [removed: (0.9] [added: (1.1] | | ) | | [removed: (26.8] [added: (0.9] | | ) | | [removed: (62.7] [added: (26.8] | | ) |

| Income before income taxes | | [removed: 2,553.5] [added: 2,429.1] | | | | [removed: 2,078.5] [added: 2,553.5] | | | | [removed: 1,329.8] [added: 2,078.5] | | | | [removed: 1,225.1] [added: 1,329.8] | | | | [removed: 761.2] [added: 1,225.1] | | |

| Income tax [removed: expense (1)] [added: expense(2)] | | [removed: (109.1] [added: (313.3] | | ) | | [removed: (880.0] [added: (109.1] | | ) | | [removed: (434.3] [added: (880.0] | | ) | | [removed: (589.0] [added: (434.3] | | ) | | [removed: (423.1] [added: (589.0] | | ) |

| Net income | | $ | [removed: 2,444.4] [added: 2,115.8] | | | $ | [removed: 1,198.5] [added: 2,444.4] | | | $ | [removed: 895.5] [added: 1,198.5] | | | $ | [removed: 636.1] [added: 895.5] | | | $ | [removed: 338.1] [added: 636.1] | |

| Net income per share - basic | | $ | [removed: 22.65] [added: 19.38] | | | $ | [removed: 11.27] [added: 22.65] | | | $ | [removed: 8.55] [added: 11.27] | | | $ | [removed: 6.17] [added: 8.55] | | | $ | [removed: 3.36] [added: 6.17] | |

| Net income per share - diluted | | $ | [removed: 21.29] [added: 18.46] | | | $ | [removed: 10.34] [added: 21.29] | | | $ | [removed: 7.70] [added: 10.34] | | | $ | [removed: 5.52] [added: 7.70] | | | $ | [removed: 2.98] [added: 5.52] | |

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

| [removed: (In millions)] [added: *(In millions)*] | | [removed: 2018] [added: 2019] | | | | [removed: 2017] [added: 2018] | | | | [removed: 2016] [added: 2017] | | | | [removed: 2015] [added: 2016] | | | | [removed: 2014] [added: 2015] | | |

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

| Cash, cash equivalents, and marketable securities (current and non-current) | | $ | [removed: 4,564.9] [added: 6,471.1] | | | $ | [removed: 2,896.0] [added: 4,564.9] | | | $ | [removed: 1,902.9] [added: 2,896.0] | | | $ | [removed: 1,677.4] [added: 1,902.9] | | | $ | [removed: 1,360.6] [added: 1,677.4] | |

| Total assets | | [removed: 11,734.5] [added: $] | [added: 14,805.2] | | | [removed: 8,764.3] [added: $] | [added: 11,734.5] | | | [removed: 6,973.5] [added: $] | [added: 8,764.3] | | | [removed: 5,609.1] [added: $] | [added: 6,973.5] | | | [removed: 3,837.7] [added: $] | [added: 5,609.1] | |

| Stockholders' equity | | [removed: 8,757.3] [added: $] | [added: 11,089.7] | | | [removed: 6,144.1] [added: $] | [added: 8,757.3] | | | [removed: 4,449.2] [added: $] | [added: 6,144.1] | | | [removed: 3,654.8] [added: $] | [added: 4,449.2] | | | [removed: 2,550.3] [added: $] | [added: 3,654.8] | |

[removed: (1)] [added: | (2)] Income taxes for the year ended December 31, 2018 includes [removed: the] [added: a] $162.1 million [removed: net impact of] [added: income tax benefit related to] the Company's sale of non-inventory related assets between foreign subsidiaries. [added: 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 15 to our Consolidated Financial Statements for further details. | | | | | | | | | | | | | | | | | | | | |]

As a result of the [removed: Tax Cuts and Jobs] Act being signed into [removed: law in December 2017, income taxes for the year ended December 31, 2017 included] [added: law, we recognized] a [added: provisional] charge of $326.2 million [added: in the fourth quarter of 2017] related to the re-measurement of our U.S. net deferred tax assets at the lower enacted corporate tax rate.

See Note [removed: 16] [added: 15] to our Consolidated Financial [removed: Statements for further details.][added: Statements.]

| [removed: ITEM 7.] [added: ITEM 7.] | [removed: MANAGEMENT'S] [added: MANAGEMENT'S] DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF [removed: OPERATIONS] [added: OPERATIONS] |

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

[removed: Overview][added: Overview]

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, [removed: neuromuscular diseases,] [added: pain,] infectious diseases, and rare diseases.

"Business," we currently have seven products that have received marketing approval and [removed: 21] [added: 22] product candidates in clinical development, all of which were discovered in our research laboratories.

[removed: Also refer] [added: Refer] to Part I, Item 1.

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

We also expect to incur substantial costs related to the commercialization of EYLEA, Dupixent, [removed: Praluent, Kevzara,] and Libtayo.

Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our marketed [removed: products,] [added: products;] the scope and progress of our research and development [removed: efforts,] [added: efforts;] the timing of certain [removed: expenses,] [added: 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 [removed: collaborators,] [added: 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.

[removed: Critical] [added: Critical] Accounting Policies and Use of [removed: Estimates][added: Estimates]

| Finance lease liabilities | | $ | 713.9 | | | $ | 708.5 | | | $ | 703.5 | | | $ | 481.1 | | | $ | 364.7 | |

| (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. "Collaboration Agreements - *Collaboration with Alnylam*") for further details. | | | | | | | | | | | | | | | | | | | | |

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.*

"Business" for a summary of our clinical programs.

| Income from operations | 2,209.8 | | | | 2,534.4 | | | | 2,079.6 | | |

| | Year Ended December 31, | | | | | | | | | | | | $ Change | | | | | | |

Revenue from product sales is recorded net of applicable provisions for rebates, chargebacks, and discounts; distribution-related fees; and other sales-related deductions.

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

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

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

| Reimbursement for manufacturing of commercial supplies(2) | | 206.7 | | | | 127.6 | | | | 35.1 | | |

| Other | | (1.5 | | ) | | (24.1 | | ) | | 84.0 | | |

| Amounts recognized in connection with up-front payments received | | 92.7 | | | | 243.8 | | | | 80.0 | | |

| Other | | (11.3 | | ) | | (12.4 | | ) | | (3.5 | | ) |

| (1) The corresponding commercialization-related costs incurred by us are recorded within Selling, general and administrative expense. | | | | | | | | | | | | |

| (2) The corresponding costs incurred by us in connection with such production is recorded within Cost of collaboration and contract manufacturing. | | | | | | | | | | | | |

*Antibody*

Regeneron's share of profits (losses) in connection with the commercialization of Dupixent, Praluent, and Kevzara is summarized below:

| Dupixent, Praluent, and Kevzara net product sales* | | $ | 2,811.0 | | | $ | 1,325.4 | | | $ | 464.5 | |

| Regeneron's share of collaboration profits (losses) | | 233.0 | | | | (227.0 | | ) | | (442.6 | | ) |

| Reimbursement of development expenses incurred by Sanofi in accordance with Regeneron's payment obligation | | (23.7 | | ) | | — | | | | — | | |

| Regeneron's share of profits (losses) in connection with commercialization of antibodies | | $ | 209.3 | | | $ | (227.0 | ) | | $ | (442.6 | ) |

| Regeneron's share of collaboration profits as a percentage of Dupixent, Praluent, and Kevzara net product sales | | 7 | | % | | | | | | | | |

| * Global net product sales of Dupixent, Praluent, and Kevzara are recorded by Sanofi | | | | | | | | | | | | |

| Percentage not meaningful | | | | | | | | | | | | |

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.

"Business - Collaboration Agreements - *Collaborations with Sanofi* - *Antibody*" for further details.

"Business - Collaboration Agreements - *Collaborations with Sanofi* - *Immuno-Oncology* for further details).

| (In millions) | | 2019 | | | | 2018 | | | | 2017 | | |

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

| | | Year Ended December 31, | | | | | | | | | | |

| (In millions) | | 2019 | | | | 2018 | | | | 2017 | | |

| Regeneron's net profit in connection with commercialization of EYLEA outside the United States | | $ | 1,091.4 | | | $ | 992.3 | | | $ | 802.3 | |

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

| Regeneron's net profit as a percentage of EYLEA net product sales outside the United States | | 38 | | % | | 37 | | % | | 36 | | % |

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

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

| | | Year Ended December 31, | | | | | | | | | | |

| (In millions) | | 2019 | | | | 2018 | | | | 2017 | | |

| • | recognition of revenue in connection with our agreements with BARDA related to REGN-EB3 for the treatment of Ebola; |

| Convertible senior notes (current and non-current) | | — | | | | — | | | | — | | | | 10.8 | | | | 146.8 | | |

| Capital and facility lease obligations (current and non-current) | | 708.5 | | | | 703.5 | | | | 481.1 | | | | 364.7 | | | | 312.3 | | |

| | |

| --- | --- |

"Business" for a summary of key events in 2018 and 2019 to date, and plans for the remainder of 2019, related to our clinical programs.

Developing and commercializing new medicines entails significant risk and expense.

Before significant revenues from the commercialization of our antibody candidates or new indications for our marketed products can be realized, we (or our collaborators) must overcome a number of hurdles which include successfully completing research and development and obtaining regulatory approval from the FDA and regulatory authorities in other countries.

In addition, the biotechnology and pharmaceutical industries are rapidly evolving and highly competitive, and new developments may render our products and technologies uncompetitive or obsolete.

We earn collaboration revenue in connection with collaboration agreements to utilize our technology platforms and develop and/or commercialize product candidates.

to actual profits or losses in the subsequent fiscal quarter, and our share of the profit or loss is adjusted on a prospective basis accordingly, as necessary.

Clinical Trial Expenses

Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors.

We outsource a substantial portion of our clinical trial activities, utilizing external entities such as CROs, independent clinical investigators, and other third-party service providers to assist us with the execution of our clinical studies.

For each clinical trial that we conduct, certain clinical trial costs are expensed immediately, while others are expensed over time based on the expected total number of patients in the trial, the rate at which patients enter the trial, and/or the period over which clinical investigators or CROs are expected to provide services.

Clinical activities which relate principally to clinical sites and other administrative functions to manage our clinical trials are performed primarily by CROs.

CROs typically perform most of the start-up activities for our trials, including document preparation, site identification, screening and preparation, pre-study visits, training, and program management.

On a budgeted basis, these start-up costs are typically 10% to 20% of the total contract value.

On an actual basis, this percentage range can be significantly wider, as many of our contracts with CROs are either expanded or reduced in scope compared to the original budget, while start-up costs for the particular trial may not change materially.

These start-up costs usually occur within a few months after the contract has been executed and are event-driven in nature.

The remaining activities and related costs, such as patient monitoring and administration, generally occur ratably throughout the life of the individual contract or study.

In the event of early termination of a clinical trial, we accrue and recognize expenses in an amount based on our estimate of the remaining noncancelable obligations associated with the winding down of the clinical trial and/or penalties.

For clinical study sites, where payments are made periodically on a per-patient basis to the institutions performing the clinical study, we accrue expenses on an estimated cost-per-patient basis, based on subject enrollment and activity in each quarter.

The amount of clinical study expense recognized in a quarter may vary from period to period based on the duration and progress of the study, the activities to be performed by the sites each quarter, the required level of patient enrollment, the rate at which patients actually enroll in and drop-out of the clinical study, and the number of sites involved in the study.

Clinical trials that bear the greatest risk of change in estimates are typically those that have a significant number of sites, require a large number of patients, have complex patient screening requirements, and span multiple years.

During the course of a trial, we adjust our rate of clinical expense recognition if actual results differ from our estimates.

Our estimates and assumptions for clinical expense recognition could differ significantly from our actual results, which could cause material increases or decreases in research and development expenses in future periods when the actual results become known.

| Balance as of December 31, 2015 | $ | 6.4 | | | $ | 48.4 | | | $ | 0.5 | | | $ | 55.3 | |

| Provisions | 93.4 | | | | 154.4 | | | | 30.4 | | | | 278.2 | | |

| Credits/payments | (87.1 | | ) | | (173.3 | | ) | | (27.3 | | ) | | (287.7 | | ) |

| Other | | 103.5 | | | | 119.1 | | | | 28.4 | | |

| Other | | 231.4 | | | | 76.5 | | | | 80.0 | | |

Antibodies

In addition, the lower reimbursement of antibody research and development costs during 2018 compared to 2017 was primarily related to the timing of recognition of revenue related to clinical manufacturing for Dupixent and a lower proportion of development reimbursements for Dupixent that Sanofi is required to fund under our License and Collaboration Agreement (for example, following receipt of positive Phase 3 results or U.S. regulatory approval).

The lower reimbursement of antibody research and development costs under our License and Collaboration Agreement in 2017, compared to 2016, was also primarily due to a lower proportion of development reimbursements for Dupixent as described above.

In 2017, the FDA and the European Commission approved Dupixent for the treatment of adult patients with moderate-to-severe atopic dermatitis.

In October 2018, the FDA also approved Dupixent as an add-on maintenance therapy in patients with moderate-to-severe asthma aged 12 years and older.

In 2017, the FDA and the European Commission approved Kevzara for the treatment of rheumatoid arthritis in adult patients.

These increases in collaboration revenue were partly offset by an increase in the collaborations' Dupixent commercialization expenses for atopic dermatitis and the launch in asthma.

In 2017, Sanofi collaboration revenues in connection with commercialization of antibodies were positively impacted, compared to 2016, by higher sales of collaboration antibody products, higher reimbursements of Dupixent commercialization-related expenses, and a decrease in the collaborations' Praluent commercialization expenses, which were partially offset by an increase in the collaborations' Kevzara commercialization expenses.

Other Sanofi antibody revenue in the table above primarily includes reimbursement of commercial supplies which were manufactured by the Company, and, in 2017, an acceleration of the recognition of deferred revenue from an $85.0 million up-front payment and other payments in connection with Sanofi's decision to end our Antibody Discovery Agreement.

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

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

[removed: Evaluation] [added: Evaluation] of Disclosure Controls and [removed: Procedures][added: Procedures]

[removed: Management] [added: Management's] Report on Internal Control over Financial [removed: Reporting][added: Reporting]

Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, [removed: 2018] [added: 2019] using the framework in [removed: Internal] [added: *Internal] Control - Integrated Framework [removed: (2013)] [added: (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: 2018.][added: 2019.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2018] [added: 2019] has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which appears under [added: Part IV,] Item 15.

[removed: Changes] [added: Changes] in Internal Control over Financial [removed: Reporting][added: Reporting]

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: 2018] [added: 2019] that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

[removed: PART III][added: PART III]

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: 2019] [added: 2020] 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: 2019] [added: 2020] 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: 2019] [added: 2020] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

The information required by this item will be included in our definitive proxy statement with respect to our [removed: 2019] [added: 2020] 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: 2019] [added: 2020] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

[removed: PART IV][added: PART IV]

Financial [removed: Statements][added: Statements*]

Financial Statement [removed: Schedules][added: Schedules*]

[removed: Exhibits][added: Exhibits*]

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

| 10.2.2 + | [Form of [added: restricted] stock [removed: option] [added: award] agreement and related notice of grant for use in connection with the grant of [removed: incentive] [added: restricted] stock [removed: options] [added: awards] to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, [removed: 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex102.htm)] [added: 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex103.htm)] |

| 10.2.3 + | [Form of [removed: restricted] stock [removed: award] [added: option] agreement and related notice of grant for use in connection with the grant of [removed: restricted] [added: non-qualified] stock [removed: awards] [added: options] to the Registrant's [removed: executive officers] [added: non-employee directors] under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 8-K for the Registrant, filed June 18, [removed: 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex103.htm)] [added: 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex104.htm)] |

| [removed: 10.2.4] [added: 10.2.11] + | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the [added: Amended and Restated] Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form [removed: 8-K] [added: 10-K] for the Registrant, [added: for the year ended December 31, 2017,] filed [removed: June 18, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514240075/d741250dex104.htm)] [added: February 8, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10216xar2014ltipnq.htm)] |

| [removed: 10.2.5] [added: 10.2.4] + | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to 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) |

| [removed: 10.2.6] [added: 10.2.9] + | [Form of stock option agreement and related notice of grant for use in connection with the grant of [removed: incentive] [added: non-qualified] stock options to P. Roy Vagelos, M.D. under the [added: Amended and Restated] Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2015,] [added: 2017,] filed February [removed: 11, 2016.)](http://www.sec.gov/Archives/edgar/data/872589/000153217616000045/regn-ex_1026x12312015x10k.htm)] [added: 8, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10213xar2014ltipnq.htm)] |

| [removed: 10.2.7] [added: 10.2.5] + | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d1.htm) |

| [removed: 10.2.8] [added: 10.2.6] + | [Form of [added: restricted] stock [removed: option] [added: award] agreement and related notice of grant for use in connection with the grant of [removed: incentive] [added: restricted] stock [removed: options] [added: awards] to the Registrant's executive officers under the Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan (revised). (Incorporated by reference from the Form 8-K for the Registrant, filed November 19, [removed: 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d2.htm)] [added: 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d3.htm)] |

| [removed: 10.2.9] [added: 10.2.14] + | [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: Amended and Restated] Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan [removed: (revised).] [added: (revised 2018).] (Incorporated by reference from the Form [removed: 8-K] [added: 10-K] for the Registrant, [added: for the year ended December 31, 2018,] filed [removed: November 19, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915080234/a15-23696_1ex10d3.htm)] [added: February 7, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10219xar2014ltiprs.htm)] |

| [removed: 10.2.10] [added: 10.2.7] + | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's 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) |

| [removed: 10.2.11] [added: 10.2.8] + | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (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) |

| [removed: 10.2.12] [added: 10.2.10] + | [Form of [added: restricted] stock [removed: option] [added: award] agreement and related notice of grant for use in connection with the grant of [removed: incentive] [added: restricted] stock [removed: options] [added: awards] to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, [removed: 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10212xar2014ltipis.htm)] [added: 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10215xar2014ltiprs.htm)] |

| 10.2.13 + | [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 [removed: Plan.] [added: Plan (revised 2018).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2017,] [added: 2018,] filed February [removed: 8, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10213xar2014ltipnq.htm)] [added: 7, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10218xstockoptiona.htm)] |

| [removed: 10.2.14] [added: 10.2.12] + | [Form of stock option agreement and related notice of grant for use in connection with the grant of [removed: incentive] [added: non-qualified] stock options to [removed: P. Roy Vagelos, M.D.] [added: the Registrant's executive officers] under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.] [added: Plan (revised 2018).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2017,] [added: 2018,] filed February [removed: 8, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10214xar2014ltipis.htm)] [added: 7, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10217xstockoptiona.htm)] |

| [removed: 10.2.15] [added: 10.2.16] + | [Form of restricted stock [added: unit] award agreement and related notice of grant for use in connection with the grant of restricted stock [removed: awards] [added: units] to the Registrant's [removed: executive officers] [added: non-employee directors] under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2017,] [added: 2018,] filed February [removed: 8, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10215xar2014ltiprs.htm)] [added: 7, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10221xar2014ltiprs.htm)] |

| [removed: 10.2.16] [added: 10.2.15] + | [Form of stock option agreement and related notice of grant for use in connection with the grant of non-qualified stock options to the Registrant's non-employee directors under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.] [added: Plan (revised 2018).] (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, [removed: 2017,] [added: 2018,] filed February [removed: 8, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10216xar2014ltipnq.htm)] [added: 7, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10219xar2014ltiprs.htm)] |

| 10.2.17 + | [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 [removed: (revised).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10217xstockoptiona.htm)] [added: (revised 2019).](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10217ar2014ltip.htm)] |

| 10.2.18 + | [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 [removed: (revised).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10218xstockoptiona.htm)] [added: (revised 2019).](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10218ar2014ltip.htm)] |

| 10.2.19 + | [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 [removed: (revised).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10219xar2014ltiprs.htm)] [added: (revised 2019).](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10219ar2014ltip.htm)] |

| 10.2.20 + | [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 [removed: (revised).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10220xar2014ltipnq.htm)] [added: (revised 2019).](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10220ar2014ltip.htm)] |

| 10.2.21 + | [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 [removed: (revised).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10221xar2014ltiprs.htm)] [added: (revised 2019).](https://www.sec.gov/Archives/edgar/data/872589/000153217620000008/regn-ex10221ar2014ltip.htm)] |

| 10.17* | [Amended and Restated Immuno-oncology Discovery and Development Agreement, executed on January 2, 2019 and effective as of December 31, 2018, by and between the Registrant and Sanofi Biotechnology [removed: SAS.](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_1017xamendedio.htm)] [added: SAS. (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_1017xamendedio.htm)] |

| 10.23 | [removed: [Participation] [added: [Amended and Restated Participation] Agreement, dated as of [removed: March 3, 2017,] [added: May 2, 2019,] by and among Old Saw Mill Holdings LLC, as lessee; Bank of America, N.A., as administrative agent; BA Leasing BSC, LLC, as lessor; and the lenders party thereto from time to time. (Incorporated by reference from the Form 8-K for the Registrant, filed [removed: March 9, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000110465917015313/a17-7791_1ex10d1.htm)] [added: May 3, 2019.)](http://www.sec.gov/Archives/edgar/data/872589/000093041319001557/c93557_ex10-1.htm)] |