Regeneron Pharmaceuticals (REGN) 10-K risk factor changes: FY2018 vs FY2017

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

For the years ended December 31, [removed: 2017] [added: 2018] and [removed: 2016,] [added: 2017,] EYLEA net sales in the United States represented [removed: 63%] [added: 61%] and [removed: 68%] [added: 63%] of our total revenues, respectively.

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

| • | effectiveness of the commercial strategy in and outside the United States for the marketing of [removed: EYLEA,] [added: our products,] including pricing [removed: strategy and the continued effectiveness of efforts to obtain, and the timing of obtaining, adequate third-party reimbursements;] [added: strategy;] |

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

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

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

| • | sufficient coverage of, and reimbursement for, [removed: EYLEA] [added: our marketed products] by third-party payers, including Medicare and Medicaid in the United States and other government and private payers in the United States and foreign [removed: jurisdictions;] [added: jurisdictions, as well as payer restrictions on eligible patient populations and the reimbursement process, both in the United States and abroad;] |

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

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

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

More detailed information about the risks related to the commercialization of [removed: EYLEA] [added: our marketed products] is provided in the risk factors below.

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

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

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

If we or [removed: Bayer] [added: our collaborators] fail to maintain regulatory compliance for [removed: EYLEA for its] [added: such products'] currently approved indications (including [added: 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 - Obtaining and maintaining regulatory approval for drug products is costly, time-consuming, and highly uncertain"), [removed: EYLEA] [added: 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: If we fail] [added: Our or our collaborators' failure] to meet the stringent requirements of governmental regulation in the manufacture of drug products or product [removed: candidates, we] [added: candidates] could [removed: incur] [added: 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 sales" below.

Serious complications or side effects in connection with the use of [removed: EYLEA] [added: our marketed products] could materially harm our business, prospects, operating results, and financial condition.

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

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

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

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

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

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

For example, Momenta Pharmaceuticals (in partnership with Mylan) is developing M710 (currently in a [removed: Phase 3] [added: pivotal] trial in patients with [removed: wet AMD).][added: DME).]

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

[removed: For example,] Genentech/Roche is developing a [removed: Lucentis] port delivery system implant [added: for ranibizumab] (currently in a Phase [removed: 2] [added: 3] study in patients with wet AMD).

Novartis is developing RTH258 [removed: (ESBA1008),] [added: (brolucizumab),] a humanized monoclonal single-chain FV (scFv) antibody fragment targeting VEGF-A for wet [removed: AMD,] [added: AMD] and [removed: announced in June 2017 that two Phase 3 studies of RTH258 met their primary endpoint of non-inferiority to EYLEA.][added: DME.]

[removed: Additionally,] [added: 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 [removed: antibody (RG7716) targeting] [added: antibody, faricimab (RG7716), that targets] both VEGF and Ang2 for wet AMD and DME (currently in Phase [removed: 2 trials for both indications).][added: 3 non-inferiority studies comparing RG7716 against EYLEA in DME).]

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

Competitors are also developing other eye-drop formulations, devices, oral therapies, and gene/cell therapies [added: (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 [added: for EYLEA] in these indications.

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

We are aware of claims by third parties, including those based on published clinical data, [added: alleging] that ZALTRAP [removed: (ziv-aflibercept)] may be safely administered to the eye.

Therefore, termination of the Bayer collaboration [removed: agreement] [added: agreement, our Antibody Collaboration, or our IO Collaboration] would create substantial new and additional risks to the successful commercialization of [removed: EYLEA,] [added: the applicable products,] particularly outside the United States.

For additional information regarding our [removed: collaboration] [added: collaborations] with [removed: Bayer,] [added: Bayer and Sanofi,] see "Risks Related to Our Reliance on Third Parties - If our collaboration with Bayer for EYLEA is terminated, or Bayer materially breaches its obligations thereunder, our business, prospects, operating results, and financial condition, and our ability to continue to develop EYLEA and commercialize EYLEA outside the United States in the time expected, or at all, would be materially harmed" [added: below and "Risks Related to Our Reliance on Third Parties - If our Antibody Collaboration or our IO Collaboration with Sanofi is terminated, our business, prospects, operating results, and financial condition, and our ability to develop, manufacture, and commercialize our pipeline of product candidates in the time expected, or at all, would be materially harmed"] below.

Sales of [removed: EYLEA] [added: our marketed products] recorded by us and [removed: Bayer] [added: our collaborators] could be reduced by imports from countries where [removed: EYLEA] [added: such products] may be available at lower prices.

Our sales of [removed: EYLEA] [added: products we commercialize] in the United States and [removed: Bayer's] [added: our collaborators'] sales of [removed: EYLEA] [added: products they commercialize under our collaboration agreements with them] in [added: the United States and] other countries [added: (which impact our share of any profits or losses from the commercialization of these products under the relevant collaboration agreements and, therefore, our results of operations)] may be reduced if [removed: EYLEA] [added: the applicable product] is imported into those countries from lower priced markets, whether legally or illegally (a practice known as parallel trading or reimportation).

Prices for [removed: EYLEA] [added: our marketed products] in jurisdictions outside the United States are based on local market economics and competition and are likely to differ from country to country.

Further, there have been several recent U.S. Congressional inquiries and proposed federal and state legislation 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.

At the federal level, the current administration's budget proposal for fiscal year 2019 contains drug price control measures that could be enacted during the 2019 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 EYLEA), to allow some states to negotiate drug prices under Medicaid, and to eliminate cost sharing for generic drugs for low-income patients.

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

The Department of Health and Human Services has been soliciting feedback on some of these measures and may implement others impacting our business under its existing authority.

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

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.

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

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.

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 marketing cost disclosure and transparency measures.

In some cases, these measures are designed to encourage importation from other countries and bulk purchasing.

Marketed Products

EYLEA.

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.

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.

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

Dupixent.

The market for Dupixent's current and potential future indications is competitive.

In atopic dermatitis, Pfizer's Eucrisa, a topical ointment, competes with Dupixent and there are several other topical agents in development.

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.

Several companies are studying JAK inhibitors for atopic dermatitis, including AbbVie's upadacitinib, Pfizer's abrocitinib (PF-04965842), Eli Lilly's baricitinib (recently reported to have met the primary endpoints of two atopic dermatitis Phase 3 studies), and Asana BioSciences' ASN002.

In asthma and potential future indications, competitors to Dupixent include antibodies against the IL-5 ligand or the IL-5 receptor such as GSK's Nucala, AstraZeneca's Fasenra, and Teva's Cinqair, all of which are approved for asthma in the United States and other jurisdictions.

Novartis and Genentech/Roche's Xolair is also approved for asthma in multiple jurisdictions.

Orally administered small molecule agents may also compete with Dupixent in asthma and potential future indications.

For example, Novartis is developing fevipiprant, an oral prostaglandin D2 receptor 2 (CRTh2/DP2) antagonist, in multiple Phase 3 trials for asthma.

Inhaled products may also compete with Dupixent in asthma and potential future indications, including Pieris Pharmaceuticals' PRS-060 (an anticalin being developed in partnership with AstraZeneca against IL-4R) and Novartis' CSJ117 (an antibody fragment against thymic stromal lymphopoietin).

There are several other potentially competitive products in development that may compete with Dupixent in both the atopic dermatitis and asthma indications, as well as potential future indications.

For example, Amgen/AstraZeneca's tezepelumab, an antibody against thymic stromal lymphopoietin, or TSLP, is currently in Phase 3 development for asthma and Phase 2 trials in atopic dermatitis have been completed.

Antibodies against the IL-33 ligand or the IL-33 receptor (ST2) may also be competitive with Dupixent across multiple indications.

Risks Related to Commercialization of EYLEA

| | |

| --- | --- |

| • | our ability to maintain sales of EYLEA in the face of competitive products, including those currently in clinical development; |

Failure to comply may also subject us to sanctions, product recalls, or withdrawals of previously approved marketing applications.

For additional information about some of these risks, see "Risks Related to Maintaining Approval of Our Marketed Products and the Development and Obtaining Approval of Our Product Candidates and New Indications for Our Marketed Products - Serious complications or side effects in connection with the use of our products and in clinical trials for our product candidates and new indications for our marketed products could cause our regulatory approvals to be revoked or limited or lead to delay or discontinuation of development of our product candidates or new indications for our marketed products, which could severely harm our business, prospects, operating results, and financial condition" below.

In the United States, there is an increased focus from the federal government and others on analyzing the impact of various regulatory programs on the federal deficit, which could result in increased pressure on federal programs to reduce costs, including limiting federal healthcare expenditures.

For example, in September 2011 the Office of Inspector General (OIG) of the Department of Health and Human Services issued a report entitled "Review of Medicare Part B Avastin and Lucentis Treatments for Age-Related Macular Degeneration" in which the OIG details possible savings to the Medicare program by using off-label, repackaged Avastin rather than Lucentis for the treatment of wet AMD.

Economic pressure on state budgets may also have a similar impact.

In addition, other third-party payers (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.

Since EYLEA is too expensive for most patients to afford without health insurance coverage, if adequate coverage and reimbursement by third-party payers, including Medicare and Medicaid in the United States, is not available, our ability to successfully commercialize EYLEA will be materially adversely impacted.

Our sales and potential profits and our business, prospects, operating results, and financial condition would be materially harmed.

See also "Risks Related to Commercialization of Products - The successful commercialization of our marketed products, as well as our late-stage product candidates or new indications for our marketed products, if approved, will depend on obtaining and maintaining coverage and reimbursement for use of these products from third-party payers, including Medicare and Medicaid in the United States, and these payers may not cover or adequately reimburse for use of our products or may do so at levels that make our products uncompetitive and/or unprofitable, which would materially harm our business, prospects, operating results, and financial condition" below.

Allergan is developing abicipar pegol for wet AMD and related conditions (currently studied in Phase 3 trials against Lucentis as a comparator drug).

Tyrogenex is developing X-82, an orally administered small-molecule tyrosine kinase inhibitor, in a Phase 2 trial in combination with an anti-VEGF.

Furthermore, Lucentis and off-label use of repackaged Avastin present significant competitive challenges as doctors and patients have had significant experience using these medicines.

The relatively low cost of repackaged Avastin in treating patients may exacerbate the competitive challenge which EYLEA faces in the eye indications for which it is approved.

See also "Risks Related to Commercialization of Products - We may be unsuccessful in continuing the commercialization of our marketed products or in commercializing our product candidates or new indications for our marketed products, if approved, which would materially and adversely affect our business, profitability, and future prospects" below and Part I.

We rely on our collaboration with Bayer for commercializing EYLEA.

If we and Bayer are unsuccessful in continuing to commercialize EYLEA, our ability to sustain profitability would be materially impaired.

Parallel traders (who may repackage or otherwise alter the original product or sell it through alternative channels such as mail order or the Internet) take advantage of the price differentials between markets arising from factors including sales costs, market conditions (such as intermediate trading stages), tax rates, or national regulation of prices.

Parallel-trading practices also are of particular relevance to the EU, where they have been encouraged by the current regulatory framework.

In addition, there are proposals to legalize the import of pharmaceuticals from outside the United States into the United States.

Risks Related to Commercialization of Our Antibody-based Products (Dupixent, Praluent, and Kevzara)

If we or Sanofi are unable to successfully commercialize Dupixent, Praluent, or Kevzara, our business, prospects, operating results, and financial condition may be materially harmed.

We expect that the commercial success of Dupixent, Praluent, and Kevzara will depend on many factors, including the following (as applicable):

| • | effectiveness of the commercial strategy in and outside the United States for the marketing of these products, including pricing strategy and the effectiveness of efforts to obtain, and the timing of obtaining, adequate third-party reimbursements; |

| • | our and Sanofi's ability to differentiate these products from competitive products (including, in the case of Dupixent, Pfizer's Xeljanz and Eli Lilly's Olumiant; in the case of Praluent, Amgen's Repatha; and, in the case of Kevzara, Genentech/Roche's Actemra), as well as product candidates currently in clinical development (such as, in the case of Dupixent, the antibody product candidates being developed by Roche, LEO Pharma, AstraZeneca, Galderma, AnaptysBio, and Amgen); |

| • | the outcome of the pending patent infringement proceedings relating to Dupixent (described further in Note 17 to our Consolidated Financial Statements), and other risks relating to Dupixent associated with intellectual property of other parties and pending or future litigation relating thereto, as discussed under "Risks Related to Intellectual Property and Market Exclusivity" below; |

| • | the outcome of the pending patent infringement proceedings relating to Praluent initiated by Amgen against us and Sanofi (described further in Note 17 to our Consolidated Financial Statements), and other risks relating to Praluent associated with intellectual property of other parties and pending or future litigation relating thereto, as discussed under "Risks Related to Intellectual Property and Market Exclusivity" below; |

| • | sufficient coverage of, and reimbursement for, these products by third-party payers, including Medicare and Medicaid in the United States and other government and private payers in the United States and foreign jurisdictions; |

| • | payer restrictions on eligible patient populations and the reimbursement process, both in the United States and abroad; |

| • | the results of post-approval studies, whether conducted by us or by others and whether mandated by regulatory agencies or voluntary (including, in the case of Praluent, the ODYSSEY OUTCOMES trial prospectively assessing the potential of Praluent to demonstrate cardiovascular benefit), and studies of other products that could implicate an entire class of products or are perceived to do so; |

| • | our ability to meet the demand for commercial supplies of these products; |

| • | maintaining and successfully monitoring commercial manufacturing arrangements for these products with parties who perform fill/finish or other steps in the manufacture of these products to ensure that they meet our standards and those of regulatory authorities, including the FDA, which extensively regulate and monitor pharmaceutical manufacturing facilities. |

More detailed information about the risks related to the commercialization of Dupixent, Praluent, and Kevzara is provided in the risk factors below.

We and Sanofi are subject to significant ongoing regulatory obligations and oversight with respect to Dupixent, Praluent, and Kevzara.

If we or Sanofi fail to maintain regulatory compliance for Dupixent, Praluent, or Kevzara, the applicable marketing approval may be withdrawn, which would materially harm our business, prospects, operating results, and financial condition.

We and Sanofi are subject to significant ongoing regulatory obligations and oversight with respect to Dupixent, Praluent, and Kevzara for their currently approved indications in the United States, EU, and other countries.

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

We estimate that a 100 basis point, or 1%, unfavorable change in interest rates would have resulted in approximately a [removed: $23.2] [added: $27.7] million and [removed: $20.9] [added: $23.2] million decrease in the fair value of our investment portfolio as of December 31, [removed: 2017] [added: 2018] and [removed: 2016,] [added: 2017,] respectively.

In addition, [removed: beginning in the second quarter of 2017,] we [removed: began to] further manage our interest rate exposure through the use of derivative instruments.

All of our derivative instruments are utilized for risk management [removed: purposes,] [added: purposes] and are not used for trading or speculative purposes.

The following table summarizes the notional amounts of our outstanding interest rate swap and cap contracts as of December 31, [removed: 2017:][added: 2018:]

We are also subject to credit risk in connection with [added: trade] accounts receivable from our product [removed: sales of EYLEA and ARCALYST.][added: sales.]

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

During [added: 2018,] 2017, [removed: 2016,] and [removed: 2015,] [added: 2016,] we did not recognize any charges for write-offs of accounts receivable related to our marketed products.

As of December 31, [removed: 2017] [added: 2018] and [removed: 2016,] [added: 2017,] three customers accounted on a combined basis for 99% of our net trade accounts receivables.

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

Market Price Risk

We are exposed to price risk on equity securities included in our investment portfolio.

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

Changes in the fair value of our equity investments are included in Other income (expense), net on the Consolidated Statements of Income.

For the year ended December 31, 2018, there were $41.9 million of net unrealized losses on equity securities recognized in Other income (expense), net.

In 2017 and 2015, we recorded no charges for other-than-temporary impairments of our marketable securities, and in 2016, we recorded an other-than-temporary impairment charge of $9.8 million related to our investment in an equity security.

In addition, we may insure a portion of our accounts receivables within our overall risk management practices.

These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of our products, product candidates, and research and clinical programs now underway or planned, including without limitation EYLEA® (aflibercept) Injection, Dupixent® (dupilumab) Injection, Praluent® (alirocumab) Injection, Kevzara® (sarilumab) Injection, [removed: cemiplimab,] [added: Libtayo® (cemiplimab) Injection,] fasinumab, and evinacumab; the likelihood and timing of achieving any of our anticipated clinical development [removed: milestones;] [added: milestones 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 products and product candidates in patients, including serious complications or side effects in connection with the use of our 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 marketed products, including without limitation EYLEA, Dupixent, Praluent, Kevzara, [removed: cemiplimab,] [added: Libtayo,] fasinumab, and evinacumab; 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 our marketed products (such as EYLEA, Dupixent, Praluent, [added: Kevzara,] and [removed: Kevzara),] [added: Libtayo),] 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 our products and product candidates; competing drugs and product candidates that may be superior to our products and product candidates; uncertainty of market acceptance and commercial success of our 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 to perform filling, finishing, packaging, labeling, distribution, and other steps related to our products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; our ability to meet any of our financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including our agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto, including without limitation the patent litigation proceedings relating to [removed: Dupixent] [added: EYLEA, Dupixent,] and Praluent described further in Note 17 to our Consolidated Financial Statements included in this report.

Our commercialized medicines and product candidates in development are designed to help patients with eye [removed: disease,] [added: diseases,] allergic and inflammatory diseases, [removed: heart disease, pain,] cancer, [added: cardiovascular] and [added: metabolic diseases, neuromuscular diseases,] infectious [added: diseases,] and [removed: other serious medical conditions.][added: rare diseases.]

Refer to [removed: Part II,] Item [removed: 7.][added: 1A.]

We currently have [removed: six] [added: seven] products that have received marketing approval:

We are collaborating with Sanofi on the global development and commercialization of [removed: Dupixent.][added: various antibodies and antibody product candidates (Dupixent, Praluent, Kevzara, and REGN3500) (the Antibody Collaboration).]

[removed: Sanofi records product sales for Dupixent, and we] [added: We] and Sanofi [added: equally] share profits and losses from sales [removed: of Dupixent.][added: within the United States.]

We have [removed: exercised our option to co-promote Dupixent in the United States and] thus far [removed: have] not exercised any of our options to co-promote [removed: Dupixent] [added: these antibodies] outside the United States.

[added: | *] See Note 17 to our Consolidated Financial Statements for information regarding the patent infringement proceedings relating to [removed: Praluent, which may impact Praluent's commercial availability in certain jurisdictions.][added: EYLEA, Dupixent, and Praluent. | | | | | | | | | | |]

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

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

| Net product sales recorded by Regeneron | | $ | [removed: 3,718.4] [added: 4,106.2] | | | [added: | | | | | | | |] $ | [removed: 3,338.4] [added: 3,718.5] | | | [added: | | | | | | | |] $ | [removed: 2,689.5] [added: 3,338.4] | | [added: | | | | | | | |]

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

[removed: |] Dupixent [removed: | | 256.5 | | | | — | | | | — | | |]

[removed: |] Kevzara [removed: | | 13.3 | | | | — | | | | — | | |]

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

All [removed: 15] [added: 21] of our product candidates in clinical development were discovered in our research laboratories and are summarized below.

[removed: Refer to Part I, Item 1A,] "Risk Factors" for a description of these and other risks and uncertainties that may affect our clinical programs.

| [removed: REGN3767(a)] | | | [removed: Sarilumab(a)] | [added: Ÿ] | [added: Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3)(d)] | Ÿ | Atopic dermatitis in adolescents [removed: and pediatrics (6–17] [added: (12–17] years of age) [added: (U.S. and EU)] | [added: |]

| [added: REGN1908-1909(f)] Multi-antibody therapy to Feld1 | [added: Ÿ] | [added: Cat allergy] | | | | [removed: Fasinumab (REGN475)(b)(f)] | | [added: |]

| [removed: Ÿ | Allergic disease] [added: Fasinumab(b)(f) (REGN475) Antibody to NGF] | | | | | Ÿ | Osteoarthritis of knee and [removed: hip] [added: hip(e)] | [added: | |]

| [removed: REGN3500(a)] | [removed: | | | | |] Ÿ | [removed: Chronic] [added: Discontinued dosing in chronic] low back pain in patients with concomitant osteoarthritis of the knee and hip | [added: | |]

| [added: REGN3500(a)] Antibody to [removed: interleukin-33 (IL-33).] [added: IL-33.] Studied as monotherapy and in combination with [removed: dupilumab.] [added: Dupixent.] | | | [added: Ÿ] | [added: Asthma] | | | | [added: |]

| [added: Trevogrumab(f) (REGN1033) Antibody to myostatin (GDF8) |] Ÿ | [removed: Muscle wasting] [added: Muscle-wasting] diseases (in combination with [removed: REGN2477)] [added: garetosmab)] | | | | | | |

| [added: Pozelimab(f) (REGN3918) Antibody to C5 |] Ÿ | Paroxysmal nocturnal hemoglobinuria (PNH) | | | | | | |

| (c) [removed: FDA] [added: U.S. Food and Drug Administration (FDA)] granted orphan drug designation | | | | |

| (g) Sanofi did not opt-in to the product candidate. Under the terms of our agreement, Sanofi is entitled to receive royalties on any future sales of the product candidate. We and [removed: BARDA] [added: the Biomedical Advanced Research Development Authority (BARDA)] of the [removed: HHS] [added: U.S. Department of Health and Human Services (HHS)] are parties to agreements [removed: (including an agreement executed in September 2017 - see "Other Programs" below for further information)] whereby HHS provides certain funding to support research, development, and manufacturing of [removed: an antibody therapy for the treatment of Ebola virus infection.] [added: these antibodies.] | | | | |

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

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

Dupixent [removed: (dupilumab; IL-4R Antibody)] [added: (dupilumab)] for allergic and inflammatory conditions

[added: | | | Ÿ |] Atopic [removed: Dermatitis][added: dermatitis | | | | | |]

[added: | | Ÿ | Initiated] Phase 3 [removed: Studies] [added: pediatric studies] in [removed: Adolescent] [added: HeFH] and [removed: Pediatric Patients.][added: HoFH | | |]

[removed: In the first quarter of 2017, a] [added: | | Ÿ | Initiated] Phase [removed: 3] [added: 2/3] study in [removed: adolescent] [added: pediatric] patients [removed: (12–17] [added: (6 months–5] years of age) with [removed: moderate-to-severe] [added: severe] atopic dermatitis [removed: was initiated, and in the fourth quarter of 2017, a] [added: | Ÿ | Report results from] Phase 3 study in pediatric patients [removed: (from six years to 11] [added: (6–11] years of age) with [removed: severe] atopic dermatitis [removed: was also initiated.][added: |]

The primary [removed: endpoint of this study was] [added: endpoints were] the proportion of patients [removed: with a 75%] [added: achieving Investigator's Global Assessment (IGA) score of 0 (clear)] or [removed: greater] [added: 1 (almost clear) and 75%] improvement [removed: from baseline] in [removed: their] Eczema Area and Severity Index [removed: (EASI-75) score] [added: (EASI-75, co-primary endpoint outside of the U.S.)] at 16 weeks.

Praluent [added: (alirocumab)] for LDL cholesterol reduction

[added: |] Clinical Program [added: | | Phase 1 | | Phase 2 | | Phase 3 | | Regulatory Review(i) |]

[added: | Kevzara (sarilumab)(a) Antibody to IL-6R | | | Ÿ |] Polyarticular-course [removed: Juvenile Idiopathic Arthritis] [added: juvenile idiopathic arthritis] (pcJIA) [added: | Ÿ | Polymyalgia rheumatica | | |]

[removed: Cemiplimab (REGN2810; PD-1 Antibody)] [added: Libtayo (cemiplimab)] for cancer

Several drugs blocking either PD-1 or PD-L1 (one of the two ligands [removed: bound by] [added: that bind] PD-1) have been approved.

We are developing [removed: cemiplimab] [added: Libtayo] as a foundation for a diverse and comprehensive immuno-oncology portfolio.

[removed: Cemiplimab] [added: Libtayo] is also being studied by other companies in combination with their proprietary assets.

Selected financial information is summarized as follows:

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

| (In millions, except per share data) | | 2018 | | | | 2017 | | | | 2016 | | |

| Revenues | | $ | 6,710.8 | | | $ | 5,872.2 | | | $ | 4,860.4 | |

| Net income | | $ | 2,444.4 | | | $ | 1,198.5 | | | $ | 895.5 | |

| Net income per share - diluted | | $ | 21.29 | | | $ | 10.34 | | | $ | 7.70 | |

| Product | | Disease Area(1) | | Territory | | | | | | |

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

| EYLEA (aflibercept) Injection(2) | Ÿ | Neovascular age-related macular degeneration (wet AMD) | | a | | a | | a | | a |

| Ÿ | Diabetic macular edema (DME) | | a | | a | | a | | a | |

| Ÿ | Macular edema following retinal vein occlusion (RVO), which includes macular edema following central retinal vein occlusion (CRVO) and macular edema following branch retinal vein occlusion (BRVO) | | a | | a | | a | | a | |

| Ÿ | Myopic choroidal neovascularization (mCNV) | | | | a | | a | | a | |

| Dupixent (dupilumab) Injection(3) | Ÿ | Atopic dermatitis (in adults) | | a | | a | | a | | a |

| Ÿ | Asthma (in adults and adolescents) | | a | | | | | | | |

| Praluent (alirocumab) Injection(3) | Ÿ | Heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) (in adults) | | a | | a | | a | | a |

| Kevzara (sarilumab) Solution for Subcutaneous Injection(3) | Ÿ | Rheumatoid arthritis (RA) (in adults) | | a | | a | | a | | a |

| Libtayo (cemiplimab) Injection(3)(5) | Ÿ | Metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) | | a | | | | | | |

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

| ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion(4) | Ÿ | Metastatic colorectal cancer (mCRC) | | a | | a | | a | | a |

| (1) Refer to label information in each territory for specific indication | | | | | | | | | | |

| (2) In collaboration with Bayer (outside the United States) | | | | | | | | | | |

| (3) In collaboration with Sanofi | | | | | | | | | | |

| (4) 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 | | | | | | | | | | |

| (5) Marketed as Libtayo (cemiplimab-rwlc) Injection in the United States | | | | | | | | | | |

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

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

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

| | | U.S. | | | | ROW(1) | | | | Total | | | | U.S. | | | | ROW(1) | | | | Total | | | | U.S. | | | | ROW(1) | | | | Total | | |

| EYLEA(2) | | $ | 4,076.7 | | | $ | 2,668.9 | | | $ | 6,745.6 | | | $ | 3,701.9 | | | $ | 2,226.9 | | | $ | 5,928.8 | | | $ | 3,323.1 | | | $ | 1,872.3 | | | $ | 5,195.4 | |

| Libtayo | | 14.8 | | | | — | | | | 14.8 | | | | — | | | | — | | | | — | | | | — | | | | — | | | | — | | |

| ARCALYST | | 14.7 | | | | — | | | | 14.7 | | | | 16.6 | | | | — | | | | 16.6 | | | | 15.3 | | | | — | | | | 15.3 | | |

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

| Dupixent | | $ | 776.3 | | | $ | 145.7 | | | $ | 922.0 | | | $ | 253.8 | | | $ | 2.7 | | | $ | 256.5 | | | — | | | | — | | | | — | | |

| Praluent | | $ | 181.3 | | | $ | 125.5 | | | $ | 306.8 | | | $ | 131.4 | | | $ | 63.3 | | | $ | 194.7 | | | $ | 94.4 | | | $ | 21.9 | | | $ | 116.3 | |

| Kevzara | | $ | 74.7 | | | $ | 21.9 | | | $ | 96.6 | | | $ | 11.6 | | | $ | 1.7 | | | $ | 13.3 | | | — | | | | — | | | | — | | |

| ZALTRAP | | $ | 9.0 | | | $ | 98.8 | | | $ | 107.8 | | | $ | 10.7 | | | $ | 73.1 | | | $ | 83.8 | | | $ | 16.6 | | | $ | 55.7 | | | $ | 72.3 | |

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

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

| 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) |

Our significant 2017 business highlights include:

| | |

| --- | --- |

| • | EYLEA (aflibercept) Injection, which is approved by the U.S. Food and Drug Administration (FDA), European Union (EU), Japan, and certain other countries for use in retinal indications, delivered net sales growth of 11.4% over 2016 in the United States and net sales growth of 18.9% outside the United States. In December 2017, the supplemental Biologics License Application (sBLA) for a 12-week dosing interval of EYLEA in patients with neovascular age-related macular degeneration (wet AMD) was filed with the FDA, with a target action date of August 11, 2018. A Phase 3 study for the treatment of non-proliferative diabetic retinopathy (NPDR) in patients without diabetic macular edema (DME) completed enrollment. |

| • | Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis received regulatory approval in the United States and EU. We also reported positive results from two additional pivotal Phase 3 studies of dupilumab for the treatment of asthma, and recently submitted an sBLA with the FDA. We reported positive results in the Phase 2 study in eosinophilic esophagitis (EoE). Phase 3 studies in patients (12-17 years of age and 6-11 years of age) with atopic dermatitis and pediatric patients (6-11 years of age) with asthma were initiated. |

| • | The Phase 3 cardiovascular outcomes study of Praluent has recently been completed, and a Phase 3 study for the treatment of homozygous familial hypercholesterolemia (HoFH) was initiated. The U.S. Court of Appeals for the Federal Circuit ordered a new trial on the issues of written description and enablement and vacated the permanent injunction in the ongoing PCSK9 litigation. The sBLA for use of Praluent with apheresis was filed with the FDA, with a target action date of August 24, 2018. |

| • | Kevzara for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) received regulatory approval in the United States, EU, and Japan. |

| • | We reported positive top-line results from a pivotal Phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma (CSCC). We have commenced a rolling BLA submission to the FDA and expect to complete the submission in the first quarter of 2018. The FDA granted Breakthrough Therapy designation to cemiplimab for the treatment of adults with metastatic CSCC and adults with locally advanced and unresectable CSCC. A Phase 3 study as a first-line treatment for non-small cell lung cancer (NSCLC) and a Phase 3 study in cervical cancer were initiated. A potentially pivotal Phase 2 study in basal cell carcinoma (BCC) was also initiated. |

| • | Phase 3 efficacy studies of fasinumab in osteoarthritis of the knee or hip were initiated, while the Phase 3 long-term safety study in osteoarthritis continued patient enrollment. A Phase 3 study in chronic low back pain in patients with concomitant osteoarthritis of the knee and hip was also initiated. |

| • | The FDA granted Breakthrough Therapy designation for evinacumab for the treatment of hypercholesterolemia in patients with HoFH. |

| • | We advanced one new product candidate (REGN3918, an antibody to complement 5 (C5)) into Phase 1 clinical development. |

| • | We entered into significant new research and development license and collaboration arrangements, including agreements with the Biomedical Advanced Research Development Authority (BARDA) of the U.S. Department of Health and Human Services (HHS) to develop new treatments to combat infectious diseases; Decibel Therapeutics, Inc. to discover and develop new potential therapeutics to protect, repair, and restore hearing; and ISA Pharmaceuticals B.V. to develop ISA101, an immunotherapy targeting human papillomavirus type 16 (HPV16)-induced cancer, in combination with cemiplimab. |

| • | From a growth perspective, we hired our 6,000th employee, completed a new lease financing for our laboratory and office facilities in Tarrytown, New York, continued to expand our bulk drug product manufacturing operations in Rensselaer, New York, and continued build-out and validation activities at our Limerick, Ireland commercial manufacturing facility. |

| • | We were named the top employer in the global biotech and pharmaceutical industry by Science magazine. We have been ranked first for five of the past seven years, with second-place rankings in 2015 and 2011. |

Our total revenues were $5,872.2 million in 2017, compared to $4,860.4 million in 2016 and $4,103.7 million in 2015.

Our net income was $1,198.5 million, or $10.34 per diluted share, in 2017, compared to $895.5 million, or $7.70 per diluted share, in 2016, and $636.1 million, or $5.52 per diluted share, in 2015.

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations" below for further details of our financial results, including amounts incurred related to research and development activities.

| • | EYLEA (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, is available in the United States, EU, Japan, and certain other countries outside the United States for the treatment of wet AMD, DME, macular edema following retinal vein occlusion (RVO), which includes macular edema following central retinal vein occlusion (CRVO) and macular edema following branch retinal vein occlusion (BRVO). EYLEA is also available in the EU, Japan, and certain other countries outside the United States for the treatment of myopic choroidal neovascularization (mCNV) and in the United States for the treatment of diabetic retinopathy in patients with DME. |

We are collaborating with Bayer on the global development and commercialization of EYLEA outside the United States.

Bayer markets, and records revenue from sales of EYLEA outside the United States, where, for countries other than Japan, the companies share equally the profits and losses from sales of EYLEA.

In Japan, we are entitled to receive a percentage of the sales of EYLEA.

We maintain exclusive rights to EYLEA in the United States and are entitled to all profits from such sales.

| • | Dupixent (dupilumab) Injection. On March 28, 2017, the FDA approved Dupixent for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. The launch of Dupixent commenced in March following the FDA approval. In September 2017, the European Commission granted marketing authorization for Dupixent for use in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy and in January 2018, the 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. |

| • | Praluent (alirocumab) Injection is available in the United States where it is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of high low-density lipoprotein (LDL) cholesterol. Praluent is also available in certain European countries and in Japan. In April 2017, the FDA approved the sBLA for a once-monthly (every four weeks), 300 mg dose of Praluent. In July 2017, the FDA approved the sBLA for Praluent's time out of refrigeration, which was increased from 24 hours to 30 days. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. |

Sanofi records product sales for Praluent, and we and Sanofi share profits and losses from sales of Praluent.

We have exercised our option to co-promote Praluent in the United States and thus far have not exercised any of our options to co-promote Praluent outside the United States.

| • | Kevzara (sarilumab) Solution for Subcutaneous Injection. In January 2017, Health Canada approved Kevzara for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response to or intolerance to one or more biologic or non-biologic disease modifying anti-rheumatic drugs (DMARDs). This was the first approval of Kevzara worldwide. On May 22, 2017, the FDA approved Kevzara for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response or intolerance to one or more DMARDs. In June 2017, the European Commission granted marketing authorization for Kevzara in combination with methotrexate (MTX) for the treatment of moderately to severely active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs; Kevzara may be used as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate. In September 2017, the MHLW in Japan approved Kevzara for the treatment of adult patients with rheumatoid arthritis who have had an inadequate response to conventional treatments. |

Sanofi records product sales for Kevzara, and we and Sanofi share profits and losses from sales of Kevzara.

We have exercised our option to co-promote Kevzara in the United States and thus far have not exercised any of our options to co-promote Kevzara outside the United States.

| • | ARCALYST® (rilonacept) Injection for Subcutaneous Use is available in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children 12 years and older. CAPS are a group of rare, inherited, auto-inflammatory conditions characterized by life-long, recurrent symptoms of rash, fever/chills, joint pain, eye redness/pain, and fatigue. Intermittent, disruptive exacerbations or flares can be triggered at any time by exposure to cooling temperatures, stress, exercise, or other unknown stimuli. |

| • | ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, known in the scientific literature as VEGF Trap, is available in the United States, EU, and certain other countries for treatment, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. 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. |

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

| EYLEA in the United States | | $ | 3,701.9 | | | $ | 3,323.1 | | | $ | 2,676.0 | |

| ARCALYST | | 16.5 | | | | 15.3 | | | | 13.5 | | |

| EYLEA outside of the United States(1) | | $ | 2,226.9 | | | $ | 1,872.3 | | | $ | 1,413.3 | |

| EYLEA global | | $ | 5,928.8 | | | $ | 5,195.4 | | | $ | 4,089.3 | |

| Praluent in the United States | | $ | 131.4 | | | $ | 94.4 | | | $ | 9.5 | |

| Praluent outside of the United States | | 63.3 | | | | 21.9 | | | | 1.0 | | |

| Praluent global | | 194.7 | | | | 116.3 | | | | 10.5 | | |

| ZALTRAP | | 83.8 | | | | 72.3 | | | | 85.7 | | |

10-K 1 [removed: regn-123117x10k.htm] [added: regn-123118x10k.htm] FORM 10-K

| | For the fiscal year ended December 31, [removed: 2017] [added: 2018] | | |

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

| Indicate by check mark whether the [removed: registrant:] [added: 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 | ý | No | ¨ |

| Indicate by check mark whether the registrant has submitted electronically [removed: and posted on its corporate Web site, if any,] every Interactive Data File required to be submitted [removed: and posted] 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 [removed: and post] such files). | Yes | ý | No | ¨ |

| Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K [removed: (§232.405] [added: (§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 [removed: form] [added: Form] 10-K. | | [removed: ý] [added: ¨] | | |

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

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

| The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant was approximately [removed: $50,337,000,000,] [added: $35,741,000,000,] computed by reference to the closing sales price of the stock on NASDAQ on June [removed: 30, 2017,] [added: 29, 2018,] the last trading day of the registrant's most recently completed second fiscal quarter. For purposes of this calculation only, the registrant has assumed that all of its directors and executive officers, and no other persons, are its affiliates. This determination of affiliate status is not necessarily a determination for other purposes. | | | | |

| The number of shares outstanding of each of the registrant's classes of common stock as of [removed: February 1, 2018:] [added: January 31, 2019:] | | | | |

| Common Stock, $.001 par value | | [removed: 105,785,444] [added: 107,365,835] |

| Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its [removed: 2018] [added: 2019] Annual Meeting of Shareholders are incorporated by reference into Part III of this Form 10-K. Exhibit index is located on pages [removed: 88] [added: 78] to [removed: 95] [added: 83] of this filing. |

| [Item [removed: 1.](#sAF0C1F8139165302B6FB94A513EC0A28)] [added: 1.](#sD15D66B8E80E585D893A63FB3DD5DF77)] | | [removed: [Business](#sAF0C1F8139165302B6FB94A513EC0A28)] [added: [Business](#sD15D66B8E80E585D893A63FB3DD5DF77)] | | [removed: [2](#sAF0C1F8139165302B6FB94A513EC0A28)] [added: [2](#sD15D66B8E80E585D893A63FB3DD5DF77)] |

| [Item [removed: 1A.](#s0362781298B1575ABF30CDAEF15E4FAE)] [added: 1A.](#s245C5B1F8D9E53E2A25BD6CD3FCEA8EE)] | | [Risk [removed: Factors](#s0362781298B1575ABF30CDAEF15E4FAE)] [added: Factors](#s245C5B1F8D9E53E2A25BD6CD3FCEA8EE)] | | [removed: [30](#s0362781298B1575ABF30CDAEF15E4FAE)] [added: [30](#s245C5B1F8D9E53E2A25BD6CD3FCEA8EE)] |

| [Item [removed: 1B.](#sF6D847FCABFC5FFF8C9444002D0C6798)] [added: 1B.](#s459060903C2B51E788F5E121BCB7C590)] | | [Unresolved Staff [removed: Comments](#sF6D847FCABFC5FFF8C9444002D0C6798)] [added: Comments](#s459060903C2B51E788F5E121BCB7C590)] | | [removed: [60](#sF6D847FCABFC5FFF8C9444002D0C6798)] [added: [57](#s459060903C2B51E788F5E121BCB7C590)] |

| [Item [removed: 2.](#s40A91A17D9BC53A791A74699CF3045D5)] [added: 2.](#sA520E8B6EFF65AE9BB6571EAA0F971BE)] | | [removed: [Properties](#s40A91A17D9BC53A791A74699CF3045D5)] [added: [Properties](#sA520E8B6EFF65AE9BB6571EAA0F971BE)] | | [removed: [60](#s40A91A17D9BC53A791A74699CF3045D5)] [added: [57](#sA520E8B6EFF65AE9BB6571EAA0F971BE)] |

| [Item [removed: 3.](#s50E5A40549D557B1891B3AEAFB3FE77F)] [added: 3.](#s7D8E558471375473A229AC3F24875428)] | | [Legal [removed: Proceedings](#s50E5A40549D557B1891B3AEAFB3FE77F)] [added: Proceedings](#s7D8E558471375473A229AC3F24875428)] | | [removed: [61](#s50E5A40549D557B1891B3AEAFB3FE77F)] [added: [58](#s7D8E558471375473A229AC3F24875428)] |

| [Item [removed: 4.](#s569D74E9721054C18861D645B5D0DE25)] [added: 4.](#s548F75A86F2356B5A0C77E4BB416A172)] | | [Mine Safety [removed: Disclosures](#s569D74E9721054C18861D645B5D0DE25)] [added: Disclosures](#s548F75A86F2356B5A0C77E4BB416A172)] | | [removed: [61](#s569D74E9721054C18861D645B5D0DE25)] [added: [58](#s548F75A86F2356B5A0C77E4BB416A172)] |

| [Item [removed: 5.](#s11AD5AA0D09B5CB88417D0E63EE25A47)] [added: 5.](#s706C4C8A2CBB5EF2A79B2A50F6543DC1)] | | [Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity [removed: Securities](#s11AD5AA0D09B5CB88417D0E63EE25A47)] [added: Securities](#s706C4C8A2CBB5EF2A79B2A50F6543DC1)] | | [removed: [62](#s11AD5AA0D09B5CB88417D0E63EE25A47)] [added: [59](#s706C4C8A2CBB5EF2A79B2A50F6543DC1)] |

| [Item [removed: 6.](#s417069DE33345777A4FDD2C53ED2DB46)] [added: 6.](#s43BAA987DD2655AF847896E742B82216)] | | [Selected Financial [removed: Data](#s417069DE33345777A4FDD2C53ED2DB46)] [added: Data](#s43BAA987DD2655AF847896E742B82216)] | | [removed: [65](#s417069DE33345777A4FDD2C53ED2DB46)] [added: [60](#s43BAA987DD2655AF847896E742B82216)] |

| [Item [removed: 7.](#s2DC074220F9357D29E589D7A7DA42489)] [added: 7.](#sCCE7B97F7C18589CA1CAEFFFDA49E692)] | | [Management's Discussion and Analysis of Financial Condition and Results of [removed: Operations](#s2DC074220F9357D29E589D7A7DA42489)] [added: Operations](#sCCE7B97F7C18589CA1CAEFFFDA49E692)] | | [removed: [66](#s2DC074220F9357D29E589D7A7DA42489)] [added: [61](#sCCE7B97F7C18589CA1CAEFFFDA49E692)] |

| [Item [removed: 7A.](#s2ECFF902083358A29C2D8176DBE5AB84)] [added: 7A.](#s7FB00113038F5B5992C94AC75D4901A3)] | | [Quantitative and Qualitative Disclosures About Market [removed: Risk](#s2ECFF902083358A29C2D8176DBE5AB84)] [added: Risk](#s7FB00113038F5B5992C94AC75D4901A3)] | | [removed: [85](#s2ECFF902083358A29C2D8176DBE5AB84)] [added: [76](#s7FB00113038F5B5992C94AC75D4901A3)] |

| [Item [removed: 8.](#sECAA0CAE6F4450E7B95B484F62DF3C41)] [added: 8.](#s333F6B48B1055FBC88FB51A318D2214C)] | | [Financial Statements and Supplementary [removed: Data](#sECAA0CAE6F4450E7B95B484F62DF3C41)] [added: Data](#s333F6B48B1055FBC88FB51A318D2214C)] | | [removed: [86](#sECAA0CAE6F4450E7B95B484F62DF3C41)] [added: [77](#s333F6B48B1055FBC88FB51A318D2214C)] |

| [Item [removed: 9.](#s8FD9662BA4425C8CAF0D5F00933CB586)] [added: 9.](#s91F0056134F1526C897683823E12DEBE)] | | [Changes in and Disagreements with Accountants on Accounting and Financial [removed: Disclosure](#s8FD9662BA4425C8CAF0D5F00933CB586)] [added: Disclosure](#s91F0056134F1526C897683823E12DEBE)] | | [removed: [86](#s8FD9662BA4425C8CAF0D5F00933CB586)] [added: [77](#s91F0056134F1526C897683823E12DEBE)] |

| [Item [removed: 9A.](#s829148217C7C5EDAA750B7E20AB35C19)] [added: 9A.](#s721B564F01C255F2912370614769967B)] | | [Controls and [removed: Procedures](#s829148217C7C5EDAA750B7E20AB35C19)] [added: Procedures](#s721B564F01C255F2912370614769967B)] | | [removed: [87](#s829148217C7C5EDAA750B7E20AB35C19)] [added: [77](#s721B564F01C255F2912370614769967B)] |

| [Item [removed: 9B.](#sBA78917E2921528794C5E8BF9BE0F28B)] [added: 9B.](#s8032AD10D4F059999D4401E32D565E07)] | | [Other [removed: Information](#sBA78917E2921528794C5E8BF9BE0F28B)] [added: Information](#s8032AD10D4F059999D4401E32D565E07)] | | [removed: [87](#sBA78917E2921528794C5E8BF9BE0F28B)] [added: [78](#s8032AD10D4F059999D4401E32D565E07)] |

| [PART [removed: III](#sAEA310569CE958359C8EC17259D75B12)] [added: III](#s1290A477D3B85B86B51E5C78EBD9A71F)] | | | | |

| [Item [removed: 10.](#sAEA310569CE958359C8EC17259D75B12)] [added: 10.](#s1290A477D3B85B86B51E5C78EBD9A71F)] | | [Directors, Executive Officers and Corporate [removed: Governance](#sAEA310569CE958359C8EC17259D75B12)] [added: Governance](#s1290A477D3B85B86B51E5C78EBD9A71F)] | | [removed: [88](#sAEA310569CE958359C8EC17259D75B12)] [added: [78](#s1290A477D3B85B86B51E5C78EBD9A71F)] |

| [Item [removed: 11.](#sAEA310569CE958359C8EC17259D75B12)] [added: 11.](#s1290A477D3B85B86B51E5C78EBD9A71F)] | | [Executive [removed: Compensation](#sAEA310569CE958359C8EC17259D75B12)] [added: Compensation](#s1290A477D3B85B86B51E5C78EBD9A71F)] | | [removed: [88](#sAEA310569CE958359C8EC17259D75B12)] [added: [78](#s1290A477D3B85B86B51E5C78EBD9A71F)] |

| [Item [removed: 12.](#sAEA310569CE958359C8EC17259D75B12)] [added: 12.](#s1290A477D3B85B86B51E5C78EBD9A71F)] | | [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder [removed: Matters](#sAEA310569CE958359C8EC17259D75B12)] [added: Matters](#s1290A477D3B85B86B51E5C78EBD9A71F)] | | [removed: [88](#sAEA310569CE958359C8EC17259D75B12)] [added: [78](#s1290A477D3B85B86B51E5C78EBD9A71F)] |

| [Item [removed: 13.](#sAEA310569CE958359C8EC17259D75B12)] [added: 13.](#s1290A477D3B85B86B51E5C78EBD9A71F)] | | [Certain Relationships and Related Transactions, and Director [removed: Independence](#sAEA310569CE958359C8EC17259D75B12)] [added: Independence](#s1290A477D3B85B86B51E5C78EBD9A71F)] | | [removed: [88](#sAEA310569CE958359C8EC17259D75B12)] [added: [78](#s1290A477D3B85B86B51E5C78EBD9A71F)] |

| [Item [removed: 14.](#sAEA310569CE958359C8EC17259D75B12)] [added: 14.](#s1290A477D3B85B86B51E5C78EBD9A71F)] | | [Principal Accounting Fees and [removed: Services](#sAEA310569CE958359C8EC17259D75B12)] [added: Services](#s1290A477D3B85B86B51E5C78EBD9A71F)] | | [removed: [88](#sAEA310569CE958359C8EC17259D75B12)] [added: [78](#s1290A477D3B85B86B51E5C78EBD9A71F)] |

| [Item [removed: 15.](#s4315BF7E3B025021A61273DC9DE8C67D)] [added: 15.](#s517292EDAB07577BBC3672406B6D0DFD)] | | [Exhibits and Financial Statement [removed: Schedules](#s4315BF7E3B025021A61273DC9DE8C67D)] [added: Schedules](#s517292EDAB07577BBC3672406B6D0DFD)] | | [removed: [88](#s4315BF7E3B025021A61273DC9DE8C67D)] [added: [78](#s517292EDAB07577BBC3672406B6D0DFD)] |

| [Item [removed: 16.](#sCC405DDBD4105F83B897EEFE46644AA9)] [added: 16.](#s45EDA561703855BEA3631A08800AFF50)] | | [Form 10-K [removed: Summary](#sCC405DDBD4105F83B897EEFE46644AA9)] [added: Summary](#s45EDA561703855BEA3631A08800AFF50)] | | [removed: [95](#sCC405DDBD4105F83B897EEFE46644AA9)] [added: [83](#s45EDA561703855BEA3631A08800AFF50)] |

| [SIGNATURE [removed: PAGE](#s497DA8687B605D17A8ADFD5B1C716850)] [added: PAGE](#s0D34A7291D8B5A9B9CF5B48C7E9EF550)] | | | | [removed: [96](#s497DA8687B605D17A8ADFD5B1C716850)] [added: [84](#s0D34A7291D8B5A9B9CF5B48C7E9EF550)] |

| "ARCALYST®", "EYLEA®", [removed: "ZALTRAP®", "VelocImmune®",] [added: "Libtayo®" (in the United States), "Regeneron®", "Regeneron Genetics Center®", "Veloci-BiTM",] "VelociGene®", [removed: "VelociMouse®",] "VelociMab®", [added: "VelocImmune®", "VelociMouse®",] "VelociSuite®", and [removed: "Regeneron Genetics Center®"] [added: "ZALTRAP®"] are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners. |

| [PART I](#s4382BCC179D957B18C22B3C46A04B787) | | | | |

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

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

| | | | | | | (Do not check if a smaller reporting company) | | | | | | | | | |

| [PART I](#s52A40645B2FC5600A8A6272DA5D9E1C7) | | | | |

| [PART II](#s4297A8CC5DD8527F8E758E824FFF529E) | | | | |

| [PART IV](#s4315BF7E3B025021A61273DC9DE8C67D) | | | | |

We own an office building in Sleepy Hollow, New York, consisting of approximately 383,000 square [removed: feet, which is partially occupied by Regeneron.][added: feet.]

[removed: We intend to occupy the entire building and use it] [added: This facility is being used] as additional office space to support the growth of our existing Tarrytown facilities.

We also own approximately 130 acres of land near our [removed: Rensselaer, New York location,] [added: Rensselaer facility; we developed approximately 212,000 square feet on this property in connection with expanding our warehouse space,] and [removed: began] [added: we have plans] to [added: further] develop this property in connection with expanding [removed: our existing] [added: certain] manufacturing [removed: and warehouse space.][added: activities.]

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

The facility has received certain manufacturing approvals by regulatory agencies, including the [removed: FDA, and is in the process of further validation for the manufacture of our bulk drug products.][added: FDA.]

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 lease approximately 75,000 square feet of additional laboratory and office space.

As of [removed: February 1, 2018,] [added: January 31, 2019,] there were [removed: 177] [added: 180] shareholders of record of our Common Stock and [removed: 17] [added: 18] shareholders of record of our Class A Stock.

Set forth below is a line graph comparing the cumulative total shareholder return on Regeneron's Common Stock with the cumulative total return of (i) [removed: The NQ] [added: the NASDAQ] US Benchmark [added: Pharmaceuticals Total Return Index (NQ US] Pharma TR [removed: Index,] [added: Index),] and (ii) Standard & Poor's 500 Stock Index (S&P 500) for the period from December 31, [removed: 2012] [added: 2013] through December 31, [removed: 2017.][added: 2018.]

The comparison assumes that $100 was invested on December 31, [removed: 2012] [added: 2013] in our Common Stock and in both of the foregoing indices.

[removed: ][added: ]

| | [removed: 12/31/2012 | | | |] 12/31/2013 | | | | 12/31/2014 | | | | 12/31/2015 | | | | 12/31/2016 | | | | 12/31/2017 | | | [added: | 12/31/2018 | | |]

| 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 following table sets forth, for the periods indicated, the range of high and low sales prices for our Common Stock as reported by The NASDAQ Global Select Market:

| | | | | | | | | |

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

| | | High | | | | Low | | |

| 2017 | | | | | | | | |

| First Quarter | | $ | 401.21 | | | $ | 340.09 | |

| Second Quarter | | 543.55 | | | | 360.00 | | |

| Third Quarter | | 526.12 | | | | 426.47 | | |

| Fourth Quarter | | 477.00 | | | | 353.14 | | |

| 2016 | | | | | | | | |

| First Quarter | | $ | 532.91 | | | $ | 348.96 | |

| Second Quarter | | 433.93 | | | | 329.09 | | |

| Third Quarter | | 443.99 | | | | 348.43 | | |

| Fourth Quarter | | 452.96 | | | | 325.35 | | |

| Regeneron | $ | 100.00 | | | $ | 160.89 | | | $ | 239.81 | | | $ | 317.34 | | | $ | 214.58 | | | $ | 219.77 | |

| S&P 500 | $ | 100.00 | | | $ | 129.60 | | | $ | 144.36 | | | $ | 143.31 | | | $ | 156.98 | | | $ | 187.47 | |

| NQ US Pharma TR Index | $ | 100.00 | | | $ | 135.68 | | | $ | 165.28 | | | $ | 174.27 | | | $ | 172.37 | | | $ | 207.54 | |

Issuer Purchases of Equity Securities

The following table reflects shares of Common Stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of restricted equity awards granted under one of our long-term incentive plans in the fourth quarter of 2017.

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

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

| Period | | Total Number of Shares (or Units) Purchased | | | Average Price Paid per Share (or Unit) | | | | Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs | | | Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs | |

| 10/1/2017-10/31/2017 | | 184 | | | $ | 440.50 | | | — | | | — | |

| 11/1/2017-11/30/2017 | | 515 | | | $ | 405.27 | | | — | | | — | |

| 12/1/2017-12/31/2017 | | 257,850 | | | $ | 386.90 | | | — | | | — | |

| Total | | 258,549 | | | $ | 386.97 | | | — | | | — | |

The selected financial data set forth below for the years ended December 31, [added: 2018,] 2017, [removed: 2016,] and [removed: 2015] [added: 2016] and as of December 31, [removed: 2017] [added: 2018] and [removed: 2016] [added: 2017] 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: 2014] [added: 2015] and [removed: 2013] [added: 2014] and as of December 31, [added: 2016,] 2015, [removed: 2014,] and [removed: 2013] [added: 2014] are derived from our audited financial statements not included in this report.

| (In [removed: thousands,] [added: millions,] except per share data) | | [removed: 2017] [added: 2018] | | | | [removed: 2016] [added: 2017] | | | | [removed: 2015] [added: 2016] | | | | [removed: 2014] [added: 2015] | | | | [removed: 2013] [added: 2014] | | |

| Net income per share - basic | | $ | [removed: 11.27] [added: 22.65] | | | $ | [removed: 8.55] [added: 11.27] | | | $ | [removed: 6.17] [added: 8.55] | | | $ | [removed: 3.36] [added: 6.17] | | | $ | [removed: 4.23] [added: 3.36] | |

| Net income per share - diluted | | $ | [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: 3.72] [added: 2.98] | |

| (In [removed: thousands)] [added: millions)] | | [removed: 2017] [added: 2018] | | | | [removed: 2016] [added: 2017] | | | | [removed: 2015] [added: 2016] | | | | [removed: 2014] [added: 2015] | | | | [removed: 2013] [added: 2014] | | |

| Convertible senior notes (current and non-current) | | — | | | | — | | | | [removed: 10,802] [added: —] | | | | [removed: 146,773] [added: 10.8] | | | | [removed: 320,315] [added: 146.8] | | |

[removed: (1)] 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.

[removed: Refer] [added: Also refer] to [added: Part I,] Item [removed: 7.][added: 1.]

Our commercialized medicines and product candidates in development are designed to help patients with eye [removed: disease,] [added: diseases,] allergic and inflammatory diseases, [removed: heart disease, pain,] cancer, [added: cardiovascular] and [added: metabolic diseases, neuromuscular diseases,] infectious [added: diseases,] and [removed: other serious medical conditions.][added: rare diseases.]

[removed: We also] [added: "Business," we currently] have [removed: 15] [added: seven products that have received marketing approval and 21] product candidates in clinical development, all of which were discovered in our research laboratories.

[removed: In our clinical programs,] [added: "Business" for a summary of] key events in [removed: 2017 and] 2018 [added: and 2019] to [removed: date were,] [added: date,] and plans for the remainder of [removed: 2018 are, as follows:][added: 2019, related to our clinical programs.]

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

We also expect to incur substantial costs related to the commercialization of EYLEA, Dupixent, Praluent, [removed: and] Kevzara, [removed: as well as preparation for potential commercialization of cemiplimab] and [removed: other indications of dupilumab.][added: Libtayo.]

Product sales consist of U.S. sales of [removed: EYLEA] [added: EYLEA, Libtayo,] and ARCALYST.

[removed: Revenue] [added: The amount of revenue we recognize] from product sales [removed: is recorded net of applicable provisions for rebates] [added: varies due to rebates, chargebacks,] and [removed: chargebacks] [added: discounts provided] under governmental and other programs, [removed: such as Medicaid and Veterans' Administration (VA),] distribution-related fees, and other sales-related deductions.

[removed: We] [added: This] estimate [removed: reductions to product sales] [added: is] based upon contracts with customers and government agencies, statutorily-defined discounts applicable to government-funded programs, historical experience, estimated payer mix, [removed: inventory levels in the distribution channel, shelf life of the product,] and other relevant factors.

| (In millions) | [removed: Rebates & Chargebacks] [added: Rebates, Chargebacks, and Discounts] | | | | Distribution- Related Fees | | | | Other Sales- Related Deductions | | | | Total | | |

| Balance as of December 31, 2015 | [added: $ |] 6.4 | | | [added: $] | 48.4 | | | [added: $] | 0.5 | | | [added: $] | 55.3 | | [removed: |]

| Balance as of December 31, 2017 | [removed: $ |] 29.9 | | | [removed: $] | 34.1 | | | [removed: $] | 21.3 | | | [removed: $] | 85.3 | | [added: |]

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

[removed: These arrangements] [added: Our collaboration agreements] may require us to deliver various rights, services, and/or goods across the entire life cycle of a product or product candidate.

Due to the variability in the scope of activities and length of time necessary to develop a drug product, [added: potential delays in development programs,] changes to development plans [added: and budgets] as programs progress, [added: including if we] and [added: our collaborators decide to expand or contract our clinical plans for a drug candidate in various disease indications, and] uncertainty in the ultimate requirements to obtain governmental approval for commercialization, revisions to [removed: performance period] [added: our] estimates are likely to occur periodically, and could result in material changes to the amount of revenue recognized each year in the future.

Under [added: certain of] our collaboration agreements, product sales and cost of sales [removed: for products which are currently approved are] [added: may be] recorded by our [removed: collaborators.][added: collaborators as they are deemed to be the principal in the transaction.]

[removed: Our collaborators' estimates of profits or losses for such quarter are reconciled] 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.

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 [removed: non-cancelable] [added: noncancelable] obligations associated with the winding down of the clinical trial and/or penalties.

We recognize stock-based compensation expense for grants of stock [removed: option] [added: option, restricted stock awards,] and restricted stock [removed: awards] [added: units] under our long-term incentive plans to employees and non-employee members of our board of directors based on the grant-date fair value of those awards.

We recognize deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax [removed: returns.][added: returns, including deferred tax assets and liabilities for expected amounts of global intangible low-taxed income (GILTI) inclusions.]

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

As additional information becomes available, [removed: or] [added: or,] based on specific events such as the outcome of litigation or settlement of claims, we reassess the potential liability related to pending claims and litigation, and may change our estimates.

| [removed: Net Income] | Year Ended December 31, | | | | | | | | | | |

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

| Revenues | $ | [removed: 5,872.2] [added: 6,710.8] | | | $ | [removed: 4,860.4] [added: 5,872.2] | | | $ | [removed: 4,103.7] [added: 4,860.4] | |

| Operating expenses | [removed: (3,792.6] [added: (4,176.4] | | ) | | [removed: (3,529.7] [added: (3,792.6] | | ) | | [removed: (2,851.8] [added: (3,529.7] | | ) |

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

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

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

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

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

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

| Net product sales | | $ | 4,106.2 | | | $ | 3,718.5 | | | $ | 3,338.4 | | | $ | 2,689.5 | | | $ | 1,750.8 | |

| Sanofi and Bayer collaboration revenue | | 2,187.8 | | | | 1,815.3 | | | | 1,403.0 | | | | 1,339.4 | | | | 1,036.9 | | |

| | | 6,710.8 | | | | 5,872.2 | | | | 4,860.4 | | | | 4,103.7 | | | | 2,819.6 | | |

| | | 4,176.4 | | | | 3,792.6 | | | | 3,529.7 | | | | 2,851.8 | | | | 1,995.7 | | |

| Income from operations | | 2,534.4 | | | | 2,079.6 | | | | 1,330.7 | | | | 1,251.9 | | | | 823.9 | | |

| Cash, cash equivalents, and marketable securities (current and non-current) | | $ | 4,564.9 | | | $ | 2,896.0 | | | $ | 1,902.9 | | | $ | 1,677.4 | | | $ | 1,360.6 | |

| Total assets | | 11,734.5 | | | | 8,764.3 | | | | 6,973.5 | | | | 5,609.1 | | | | 3,837.7 | | |

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

| Stockholders' equity | | 8,757.3 | | | | 6,144.1 | | | | 4,449.2 | | | | 3,654.8 | | | | 2,550.3 | | |

(1) Income taxes for the year ended December 31, 2018 includes the $162.1 million net impact of the Company's sale of non-inventory related assets between foreign subsidiaries.

See Note 16 to our Consolidated Financial Statements for further details.

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

Under the terms of the new standard, revenue is measured as the amount of consideration we expect to be entitled to in exchange for transferring promised goods or providing services to a customer, and is recognized when (or as) we satisfy performance obligations under the terms of a contract.

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

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

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

We have entered into various agreements related to our activities to research, develop, manufacture, and commercialize product candidates and utilize our technology platforms.

Depending on the terms of the arrangement, we may defer the recognition of all or a portion of the consideration received because the performance obligations are satisfied over time.

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

At the inception of the contract, the transaction price reflects the amount of consideration we expect to be entitled to in exchange for transferring promised goods or services to our customer.

We review our estimate of the transaction price each period, and make revisions to such estimates as necessary.

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

We share in any profits or losses arising from the commercialization of such products, and record our share of the variable consideration, representing net product sales less cost of goods sold and shared commercialization and other expenses, as collaboration revenue in the period in which such underlying sales occur and costs are incurred by the collaborator.

Our collaborators' estimates of profits or losses for such quarter are reconciled

In arrangements where the collaborator records product sales, we may be obligated to use commercially reasonable efforts to supply commercial product to our collaborators, and may be reimbursed for our manufacturing costs as commercial product is shipped to our collaborators; however, recognition of such cost reimbursements as collaboration revenue is deferred until the product is sold by our collaborators to third-party customers.

| (In millions, except per share data) | 2018 | | | | 2017 | | | | 2016 | | |

| Other income (expense), net | 19.1 | | | | (1.1 | | ) | | (0.9 | | ) |

| Income before income taxes | 2,553.5 | | | | 2,078.5 | | | | 1,329.8 | | |

| Net income | $ | 2,444.4 | | | $ | 1,198.5 | | | $ | 895.5 | |

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

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

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

| Libtayo | 14.8 | | | | — | | | | — | | | | 14.8 | | | | — | | |

| ARCALYST | 14.7 | | | | 16.6 | | | | 15.3 | | | | (1.9 | | ) | | 1.3 | | |

| Other revenue | 416.8 | | | | 338.4 | | | | 119.0 | | | | 78.4 | | | | 219.4 | | |

In addition, on September 28, 2018, the FDA approved Libtayo for the treatment of patients with metastatic or locally advanced CSCC.

| Provisions | 223.4 | | | | 211.0 | | | | 44.5 | | | | 478.9 | | |

| Credits/payments | (212.2 | | ) | | (203.1 | | ) | | (57.5 | | ) | | (472.8 | | ) |

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

| Reimbursement of Regeneron commercialization-related expenses | | 8.9 | | | | 7.0 | | | | — | | |

| Net product sales | | $ | 3,718,463 | | | $ | 3,338,390 | | | $ | 2,689,478 | | | $ | 1,750,762 | | | $ | 1,425,839 | |

| Sanofi and Bayer collaboration revenue | | 1,815,245 | | | | 1,402,935 | | | | 1,339,361 | | | | 1,036,854 | | | | 650,400 | | |

| Other revenue | | 338,519 | | | | 119,102 | | | | 74,889 | | | | 31,941 | | | | 28,506 | | |

| | | 5,872,227 | | | | 4,860,427 | | | | 4,103,728 | | | | 2,819,557 | | | | 2,104,745 | | |

| Research and development | | 2,075,142 | | | | 2,052,295 | | | | 1,620,577 | | | | 1,271,353 | | | | 859,947 | | |

| Selling, general, and administrative | | 1,320,433 | | | | 1,177,697 | | | | 838,526 | | | | 519,267 | | | | 346,393 | | |

| Cost of goods sold | | 202,507 | | | | 194,624 | | | | 241,702 | | | | 129,030 | | | | 118,048 | | |

| Cost of collaboration and contract manufacturing | | 194,554 | | | | 105,070 | | | | 151,007 | | | | 75,988 | | | | 37,307 | | |

| | | 3,792,636 | | | | 3,529,686 | | | | 2,851,812 | | | | 1,995,638 | | | | 1,361,695 | | |

| Income from operations | | 2,079,591 | | | | 1,330,741 | | | | 1,251,916 | | | | 823,919 | | | | 743,050 | | |

| Other income (expense), net | | (1,080 | | ) | | (926 | | ) | | (26,819 | | ) | | (62,684 | | ) | | (46,668 | | ) |

| Income before income taxes | | 2,078,511 | | | | 1,329,815 | | | | 1,225,097 | | | | 761,235 | | | | 696,382 | | |

| Income tax expense (1) | | (880,000 | | ) | | (434,293 | | ) | | (589,041 | | ) | | (423,109 | | ) | | (282,644 | | ) |

| Net income | | $ | 1,198,511 | | | $ | 895,522 | | | $ | 636,056 | | | $ | 338,126 | | | $ | 413,738 | |

| Cash, cash equivalents, and marketable securities (current and non-current) | | $ | 2,896,074 | | | $ | 1,902,944 | | | $ | 1,677,385 | | | $ | 1,360,634 | | | $ | 1,083,875 | |

| Total assets | | 8,764,286 | | | | 6,973,466 | | | | 5,609,132 | | | | 3,837,672 | | | | 2,950,130 | | |

| Capital and facility lease obligations (current and non-current) | | 703,453 | | | | 481,126 | | | | 364,708 | | | | 312,291 | | | | 185,323 | | |

| Stockholders' equity | | 6,144,078 | | | | 4,449,245 | | | | 3,654,837 | | | | 2,550,251 | | | | 1,964,716 | | |

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Income Taxes" below for further details.

"Business - General," and "Business - Marketed Products," we currently have six products that have received marketing approval: EYLEA (aflibercept) Injection, Dupixent (dupilumab) Injection, Praluent (alirocumab) Injection, Kevzara (sarilumab) Solution for Subcutaneous Injection, ARCALYST (rilonacept) Injection for Subcutaneous Use, and ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion.

These consist of a Trap-based clinical program and 14 fully human antibody product candidates, as summarized in Part I, Item 1.

"Business - General."

The planning, execution, and results of our clinical programs are significant factors that can affect our operating and financial results.

| | | | | |

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

| Trap-based Clinical Program: | | | | |

| | | 2017 and 2018 Events to Date | | 2018 Plans |

| EYLEA | Ÿ | Bayer received regulatory approval for EYLEA for various indications and continued to pursue regulatory applications for marketing approval in additional countries | Ÿ | FDA decision on sBLA for every 12-week dosing interval in wet AMD |

| | Ÿ | Submit sBLA for pre-filled syringe | | |

| Ÿ | Completed patient enrollment in Phase 3 study for the treatment of NPDR in patients without DME | Ÿ | Bayer to submit for additional regulatory approvals outside the United States for various indications | |

| | Ÿ | sBLA for every 12-week dosing interval in wet AMD filed with FDA, with a target action date of August 11, 2018 | Ÿ | Regulatory agency decisions on applications outside the United States for various indications, including wet AMD and DME in China |

| | | | Ÿ | Report data from Phase 3 PANORAMA study for the treatment of NPDR in patients without DME, and submit sBLA |

| Antibody-based Clinical Programs: | | | | |

| Dupixent (dupilumab; IL-4R Antibody) | Ÿ | Presented detailed results from one-year Phase 3 CHRONOS study at the Annual Meeting of the American Academy of Dermatology | Ÿ | Submit for additional regulatory approvals in atopic dermatitis outside the United States |

| | Ÿ | FDA approved Dupixent for the treatment of adults with moderate-to-severe atopic dermatitis | Ÿ | Regulatory agency decisions on atopic dermatitis applications outside the United States |

| | Ÿ | Initiated Phase 3 studies in adolescent patients (12–17 years of age) and pediatric patients (6–11 years of age) with atopic dermatitis | Ÿ | Report data from Phase 3 study in adolescent patients (12–17 years of age) with atopic dermatitis |

| | Ÿ | Initiated Phase 2/3 study in pediatric patients (6 months–5 years of age) with severe atopic dermatitis | Ÿ | FDA filing and decision on sBLA for asthma in adult/adolescent patients |

| | Ÿ | Regulatory applications submitted for atopic dermatitis in various jurisdictions outside the United States | Ÿ | Submit for EU and Japan regulatory approval in asthma in adult/adolescent patients |

| | Ÿ | Reported positive results from the LIBERTY AD CAFÉ study in atopic dermatitis | Ÿ | Report data from Phase 3 studies in nasal polyps |

| | Ÿ | European Commission granted marketing approval for Dupixent for the treatment of adults with moderate-to-severe atopic dermatitis | Ÿ | Initiate Phase 3 study in eosinophilic esophagitis |

The financial statements required by this Item are included on pages F-1 through [removed: F-46] [added: F-47] of this report.

The supplementary financial information required by this Item is included at page [removed: F-46] [added: F-47] of this report.

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

Our management conducted an evaluation of the effectiveness of our internal control over financial reporting as of December 31, [removed: 2017] [added: 2018] using the framework in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission.

Based on that evaluation, our management has concluded that our internal control over financial reporting was effective as of December 31, [removed: 2017.][added: 2018.]

The effectiveness of the Company's internal control over financial reporting as of December 31, [removed: 2017] [added: 2018] has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which appears under Item 15.

There has been no change in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, [removed: 2017] [added: 2018] that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

The information required by this item (other than the information set forth in the next paragraph in this Item 10) will be included in our definitive proxy statement with respect to our [removed: 2018] [added: 2019] 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: 2018] [added: 2019] 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: 2018] [added: 2019] 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: 2018] [added: 2019] 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: 2018] [added: 2019] Annual Meeting of Shareholders to be filed with the SEC, and is incorporated herein by reference.

| [removed: 10.2.11] [added: 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 [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10211xar2014ltipnq.htm)] [added: Plan (revised).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10217xstockoptiona.htm)] |

| 10.2.12 + | [Form of stock option agreement and related notice of grant for use in connection with the grant of incentive stock options to the Registrant's executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10212xar2014ltipis.htm)] [added: 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_10212xar2014ltipis.htm)] |

| [removed: 10.2.13] [added: 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 [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10213xar2014ltipnq.htm)] [added: Plan (revised).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10218xstockoptiona.htm)] |

| 10.2.14 + | [Form of stock option agreement and related notice of grant for use in connection with the grant of incentive stock options to P. Roy Vagelos, M.D. under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10214xar2014ltipis.htm)] [added: 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_10214xar2014ltipis.htm)] |

| [removed: 10.2.15] [added: 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 [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10215xar2014ltiprs.htm)] [added: Plan (revised).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10219xar2014ltiprs.htm)] |

| [removed: 10.2.16] [added: 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 [removed: Plan.](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10216xar2014ltipnq.htm)] [added: Plan (revised).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10220xar2014ltipnq.htm)] |

| [removed: 10.12] [added: 10.22*] | [removed: [Lease,] [added: [Purchase Agreement,] dated as of December [removed: 21, 2006,] [added: 30, 2016,] by and [removed: between] [added: among] BMR-Landmark at Eastview LLC and [added: BMR-Landmark at Eastview IV LLC and] the Registrant. (Incorporated by reference from the Form [removed: 8-K] [added: 10-K] for the Registrant, [removed: filed] [added: for the year ended] December [removed: 22, 2006.)](http://www.sec.gov/Archives/edgar/data/872589/000095012306015550/y28268exv99w1.htm)] [added: 31, 2016, filed February 9, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000153217617000008/regn-ex_1035xlandmarkpsaex.htm)] |

| [removed: 10.12.1*] [added: 10.18*] | [removed: [First Amendment to Lease, by] [added: [Immuno-oncology License] and [removed: between BMR-Landmark at Eastview LLC] [added: Collaboration Agreement, dated July 27, 2015] and [removed: the Registrant,] entered into [added: effective] as of [removed: September 14, 2007.] [added: July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, [removed: 2007,] [added: 2015,] filed November [removed: 7, 2007.)](http://www.sec.gov/Archives/edgar/data/872589/000095012307015042/y41903exv10w1.htm)] [added: 4, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_102x09302015x10q.htm)] |

| [removed: 10.12.2] [added: 10.19*] | [removed: [Second Amendment to Lease,] [added: [Collaboration Agreement, dated as of September 29, 2015,] by and between [removed: BMR-Landmark at Eastview LLC] [added: Regeneron Ireland] and [removed: the Registrant, entered into as of September 30, 2008.] [added: Mitsubishi Tanabe Pharma Corporation.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, [removed: 2008,] [added: 2015,] filed November [removed: 5, 2008.)](http://www.sec.gov/Archives/edgar/data/872589/000095012308014408/y72322exv10w3.htm)] [added: 4, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_107x09302015x10q.htm)] |

| [removed: 10.12.3] [added: 10.20*] | [removed: [Third Amendment to Lease,] [added: [ANG2 License and Collaboration Agreement, dated as of March 23, 2016,] by and between [removed: BMR-Landmark at Eastview] [added: Bayer HealthCare] LLC and the [removed: Registrant, entered into as of April 29, 2009.] [added: Registrant.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, [removed: 2009,] [added: 2016,] filed [removed: April 30, 2009.)](http://www.sec.gov/Archives/edgar/data/872589/000120677409000907/exhibit10-3.htm)] [added: May 5, 2016.)](http://www.sec.gov/Archives/edgar/data/872589/000153217616000055/regn-ex_102x03312016x10q.htm)] |

| [removed: 10.12.10] [added: 10.15*] | [removed: [Tenth Amendment to Lease,] [added: [Letter Agreement] by and between [removed: BMR-Landmark at Eastview LLC and] the [removed: Registrant, entered into as of October 25, 2012.] [added: Registrant and Aventis Pharmaceuticals Inc., dated May 2, 2013.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, [removed: 2015,] [added: 2013,] filed August [removed: 4, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000029/regn-ex_102x06302015x10q.htm)] [added: 6, 2013.)](http://www.sec.gov/Archives/edgar/data/872589/000153217613000022/regn-ex_106x6302013x10q.htm)] |

| [removed: 10.12.11] [added: 10.13.1*] | [removed: [Eleventh] [added: [First] Amendment to [removed: Lease] [added: Amended and Restated License and Collaboration Agreement] by and between [removed: BMR-Landmark at Eastview LLC and] the [removed: Registrant, entered into as of April 3,] [added: Registrant and Aventis Pharmaceuticals Inc., dated May 1,] 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, [removed: 2013.)](http://www.sec.gov/Archives/edgar/data/872589/000153217613000022/regn-ex_102x6302013x10q.htm)] [added: 2013.)](http://www.sec.gov/Archives/edgar/data/872589/000153217613000022/regn-ex_105x6302013x10q.htm)] |

| [removed: 10.12.14] [added: 10.13.2*] | [removed: [Fourteenth Amendment] [added: [Amendment No. 2] to [removed: Lease, by] [added: Amended] and [removed: between BMR-Landmark at Eastview LLC] [added: Restated License] and [removed: the Registrant,] [added: Collaboration Agreement, dated July 27, 2015 and] entered into [added: effective] as of [removed: October 25, 2013.] [added: July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS, as successor-in-interest to Aventis Pharmaceuticals, Inc.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended [removed: June] [added: September] 30, 2015, filed [removed: August] [added: November] 4, [removed: 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000029/regn-ex_103x06302015x10q.htm)] [added: 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_104x09302015x10q.htm)] |

| [removed: 10.12.15] [added: 10.12.1*] | [removed: [Fifteenth Amendment] [added: [Amendment No. 1] to [removed: Lease, by] [added: Amended] and [removed: between BMR-Landmark at Eastview LLC] [added: Restated Discovery] and [removed: the Registrant,] [added: Preclinical Development Agreement, dated July 27, 2015 and] entered into [added: effective] as of [removed: June 12, 2014.] [added: July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS, as successor-in-interest to Aventis Pharmaceuticals, Inc.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended [removed: June] [added: September] 30, 2015, filed [removed: August] [added: November] 4, [removed: 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000029/regn-ex_104x06302015x10q.htm)] [added: 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_103x09302015x10q.htm)] |

| [removed: 10.12.17] [added: 10.21*] | [removed: [Seventeenth Amendment to Lease,] [added: [Collaboration Agreement, dated as of September 17, 2016,] by and between [removed: BMR-Landmark at Eastview LLC] [added: Teva Pharmaceuticals International GmbH] and [removed: the Registrant, entered into as of August 10, 2015.] [added: Regeneron Ireland.] (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, [removed: 2015,] [added: 2016,] filed November 4, [removed: 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_106x09302015x10q.htm)] [added: 2016.)](http://www.sec.gov/Archives/edgar/data/872589/000153217616000082/regn-ex_101xteva.htm)] |

| [removed: 10.15*] [added: 10.12*] | [Amended and Restated Discovery and Preclinical Development Agreement, dated as of November 10, 2009, by and between Aventis Pharmaceuticals Inc. and the Registrant. (Incorporated by reference from the Form 10-K/A for the Registrant, for the year ended December 31, 2009, filed June 2, 2010.)](http://www.sec.gov/Archives/edgar/data/872589/000120677410001385/exhibit10-14.htm) |

| [removed: 10.15.1*] [added: 10.13*] | [removed: [Amendment No. 1 to Amended] [added: [Amended] and Restated [removed: Discovery] [added: License] and [removed: Preclinical Development] [added: Collaboration] Agreement, dated [removed: July 27, 2015 and entered into effective] as of [removed: July 1, 2015,] [added: November 10, 2009,] by and [removed: between the Registrant and Sanofi Biotechnology SAS, as successor-in-interest to] [added: among] Aventis [removed: Pharmaceuticals, Inc.] [added: Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant.] (Incorporated by reference from the Form [removed: 10-Q] [added: 10-K/A] for the Registrant, for the [removed: quarter] [added: year] ended [removed: September 30, 2015,] [added: December 31, 2009,] filed [removed: November 4, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_103x09302015x10q.htm)] [added: June 2, 2010.)](http://www.sec.gov/Archives/edgar/data/872589/000120677410001385/exhibit10-15.htm)] |

| [removed: 10.16*] [added: 10.14] | [Amended and Restated [removed: License and Collaboration] [added: Investor] Agreement, dated as of [removed: November 10, 2009,] [added: January 11, 2014,] by and among [added: Sanofi, sanofi-aventis US LLC,] Aventis Pharmaceuticals Inc., sanofi-aventis Amerique du Nord, and the Registrant. (Incorporated by reference from the Form [removed: 10-K/A] [added: 8-K] for the Registrant, [removed: for the year ended December 31, 2009,] filed [removed: June 2, 2010.)](http://www.sec.gov/Archives/edgar/data/872589/000120677410001385/exhibit10-15.htm)] [added: January 13, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514008775/d659864dex101.htm)] |

| [removed: 10.16.1*] [added: 10.26 +] | [removed: [First Amendment to Amended and Restated License and Collaboration Agreement] [added: [Retirement Agreement, effective as of January 5, 2018,] by and between [removed: the Registrant] [added: Regeneron Pharmaceuticals, Inc.] and [removed: Aventis Pharmaceuticals Inc., dated May 1, 2013.] [added: Robert J. Terifay.] (Incorporated by reference from the Form 10-Q for the Registrant, [removed: for the quarter ended June 30, 2013,] filed [removed: August 6, 2013.)](http://www.sec.gov/Archives/edgar/data/872589/000153217613000022/regn-ex_105x6302013x10q.htm)] [added: May 3, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000020/regn-ex_101xretirementagre.htm)] |

| [removed: 10.17] [added: 10.27] | [removed: [Amended and Restated Investor] [added: [Letter] Agreement, dated as of January [removed: 11, 2014,] [added: 7, 2018,] by and among [added: the Registrant,] Sanofi, sanofi-aventis US LLC, Aventis Pharmaceuticals Inc., sanofi-aventis [removed: Amerique] [added: Amérique] du Nord, and [removed: the Registrant.] [added: Sanofi Biotechnology SAS.] (Incorporated by reference from the Form [removed: 8-K] [added: 10-Q] for the Registrant, filed [removed: January 13, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000119312514008775/d659864dex101.htm)] [added: May 3, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000020/regn-ex_102xletteragreemen.htm)] |

| [removed: 10.29] [added: 10.16] | [Credit Agreement, dated as of [removed: March 19, 2015,] [added: December 14, 2018,] by and among the Registrant, as a borrower and guarantor; certain direct [removed: and indirect] subsidiaries of the Registrant, as the initial subsidiary borrowers; JPMorgan Chase Bank, N.A., as administrative agent; Bank of America, N.A. and U.S. Bank National Association, as co-syndication agents; Barclays Bank PLC, Citibank, N.A., [removed: Credit Suisse AG, Cayman Islands Branch,] Fifth Third [removed: Bank] [added: Bank,] and [removed: Morgan Stanley] MUFG [removed: Loan Partners, LLC,] [added: Bank, Ltd.,] as co-documentation agents; JPMorgan Chase Bank, N.A., Bank of America, [removed: N.A.] [added: N.A.,] and U.S. Bank National Association, as the issuing banks; JPMorgan Chase Bank, N.A., as the swingline lender; and the other lenders party thereto from time to time. (Incorporated by reference from the Form 8-K for the Registrant, filed [removed: March 23, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000110465915021521/a15-7353_1ex10d1.htm)] [added: December 17, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000110465918073328/a18-41689_1ex10d1.htm)] |

| [removed: 10.29.1] [added: 10.25] | [removed: [Consent and Amendment No. 1 Memorandum,] [added: [Guaranty,] dated as of [removed: February 2,] [added: March 3,] 2017, [added: made] by [removed: and among] the Registrant, [removed: as a borrower and guarantor;] Regeneron Healthcare Solutions, [removed: Inc.,] [added: Inc. and] Regeneron Genetics Center LLC, [removed: Regeneron International Unlimited Company, Regeneron Ireland Holdings Unlimited Company, Regeneron Ireland Unlimited Company, and Regeneron Capital International B.V.,] as [removed: subsidiary borrowers; JPMorgan Chase Bank, N.A., as administrative agent; and] the [removed: lenders party thereto.] [added: initial guarantors.] (Incorporated by reference from the Form 8-K for the Registrant, filed [removed: February 7, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000110465917006777/a17-3908_1ex10d1.htm)] [added: March 9, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000110465917015313/a17-7791_1ex10d3.htm)] |

| [removed: 10.36] [added: 10.23] | [Participation Agreement, dated as of March 3, 2017, 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 March 9, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000110465917015313/a17-7791_1ex10d1.htm) |

| [removed: 10.37] [added: 10.24] | [Lease and Remedies Agreement, dated as of March 3, 2017, between Old Saw Mill Holdings LLC, as lessee, and BA Leasing BSC, LLC, as lessor. (Incorporated by reference from the Form 8-K for the Registrant, filed March 9, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000110465917015313/a17-7791_1ex10d2.htm) |

| 21.1 | [Subsidiaries of the [removed: Registrant.](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_211x12312017x10k.htm)] [added: Registrant.](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_211x12312018x10k.htm)] |

| 23.1 | [Consent of PricewaterhouseCoopers LLP, Independent Registered Public Accounting [removed: Firm.](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_231x12312017x10k.htm)] [added: Firm.](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_231x12312018x10k.htm)] |

| 24.1 | [Power of Attorney (included on the signature page of this Annual Report on Form [removed: 10-K).](#s497DA8687B605D17A8ADFD5B1C716850)] [added: 10-K).](#s0D34A7291D8B5A9B9CF5B48C7E9EF550)] |

| 31.1 | [Certification of Principal Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_311x12312017x10k.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_311x12312018x10k.htm)] |

| 31.2 | [Certification of Principal Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of [removed: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_312x12312017x10k.htm)] [added: 1934.](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_312x12312018x10k.htm)] |

| 32 | [Certification of Principal Executive Officer and Principal Financial Officer pursuant to 18 U.S.C. Section [removed: 1350.](https://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_32x12312017x10k.htm)] [added: 1350.](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_32x12312018x10k.htm)] |

| 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 executive officers under the Amended and Restated Regeneron Pharmaceuticals, Inc. 2014 Long-Term Incentive Plan. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2017, filed February 8, 2018.)](http://www.sec.gov/Archives/edgar/data/872589/000153217618000013/regn-ex_10211xar2014ltipnq.htm) |

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

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

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

| 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 (revised).](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_10221xar2014ltiprs.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 SAS.](https://www.sec.gov/Archives/edgar/data/872589/000153217619000009/regn-ex_1017xamendedio.htm) |

| | |

| --- | --- |

| 4.1 | [Indenture, dated as of October 21, 2011, relating to 1.875% Convertible Senior Notes due October 1, 2016, between the Registrant and Wells Fargo Bank, National Association, as Trustee. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000119312511278786/d245760dex41.htm) |

| 4.2 | [Form of 1.875% Convertible Senior Note due October 1, 2016. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000119312511278786/d245760dex42.htm) |

| 10.12.4 | [Fourth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of December 3, 2009. (Incorporated by reference from the Form 8-K for the Registrant, filed December 8, 2009.)](http://www.sec.gov/Archives/edgar/data/872589/000120677409002305/exhibit99-1.htm) |

| 10.12.5 | [Fifth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of February 11, 2010. (Incorporated by reference from the Form 8-K for the Registrant, filed February 16, 2010.)](http://www.sec.gov/Archives/edgar/data/872589/000120677410000283/exhibit99-1.htm) |

| 10.12.6 | [Sixth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of June 4, 2010. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2010, filed July 28, 2010.)](http://www.sec.gov/Archives/edgar/data/872589/000120677410001689/exhibit10-1.htm) |

| 10.12.7 | [Seventh Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of December 22, 2010. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2010, filed February 17, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000120677411000263/exhibit10_11-7.htm) |

| 10.12.8 | [Eighth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of August 1, 2011. (Incorporated by reference from the Form 10-Q for the Registrant for the quarter ended September 30, 2011, filed October 27, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000120677411002300/exhibit10-1.htm) |

| 10.12.9 | [Ninth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of September 30, 2011. (Incorporated by reference from the Form 10-Q for the Registrant for the quarter ended September 30, 2011, filed October 27, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000120677411002300/exhibit10-2.htm) |

| 10.12.12 | [Twelfth Amendment to Lease by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of May 31, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)](http://www.sec.gov/Archives/edgar/data/872589/000153217613000022/regn-ex_103x6302013x10q.htm) |

| 10.12.13 | [Thirteenth Amendment to Lease by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of May 31, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)](http://www.sec.gov/Archives/edgar/data/872589/000153217613000022/regn-ex_104x6302013x10q.htm) |

| 10.12.16 | [Sixteenth Amendment to Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of June 30, 2015. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2015, filed August 4, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000029/regn-ex_105x06302015x10q.htm) |

| 10.13 | [Mt. Pleasant Lease by and between BMR-Landmark at Eastview LLC and the Registrant, dated April 3, 2013. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2013, filed August 6, 2013.)](http://www.sec.gov/Archives/edgar/data/872589/000153217613000022/regn-ex_101x6302013x10q.htm) |

| 10.13.1 | [First Amendment to Mt. Pleasant Lease, by and between BMR-Landmark at Eastview LLC and the Registrant, entered into as of June 30, 2015. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2015, filed August 4, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000029/regn-ex_106x06302015x10q.htm) |

| 10.14* | [Non Exclusive License and Material Transfer Agreement, dated as of March 30, 2007, by and between Astellas Pharma Inc. and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2007, filed May 4, 2007.)](http://www.sec.gov/Archives/edgar/data/872589/000095012307006735/y34395exv10w1.htm) |

| 10.14.1* | [Amendment to the Non Exclusive License and Material Transfer Agreement, dated as of March 30, 2007 by and between Astellas Pharma Inc. and the Registrant, dated as of July 28, 2010. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2010, filed October 28, 2010.)](http://www.sec.gov/Archives/edgar/data/872589/000120677410002228/exhibit10-1.htm) |

| 10.16.2* | [Amendment No. 2 to Amended and Restated License and Collaboration Agreement, dated July 27, 2015 and entered into effective as of July 1, 2015, by and between the Registrant and Sanofi Biotechnology SAS, as successor-in-interest to Aventis Pharmaceuticals, Inc. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended September 30, 2015, filed November 4, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000037/regn-ex_104x09302015x10q.htm) |

| 10.18 | [Purchase Agreement, dated as of October 18, 2011, between the Registrant and Goldman, Sachs & Co. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000119312511278786/d245760dex11.htm) |

| 10.19 | [Master Terms and Conditions for Convertible Note Hedging Transactions, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Goldman, Sachs & Co. and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000119312511278786/d245760dex101.htm) |

| 10.20 | [Master Terms and Conditions for Base Warrants, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Goldman, Sachs & Co. and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000119312511278786/d245760dex102.htm) |

| 10.20.1 | [Amendment, dated as of May 15, 2014, to the Master Terms and Conditions for Warrants, between Goldman, Sachs & Co. and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2014, filed August 5, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000153217614000035/regn-ex_108xamendmentxgold.htm) |

| 10.20.2 | [Second Amendment, dated as of November 25, 2014, to the Master Terms and Conditions for Warrants, between Goldman, Sachs & Co. and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2014, filed February 12, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000008/regn-ex_10212x12312014x10k.htm) |

| 10.20.3 | [Third Amendment, dated as of February 27, 2015, to the Master Terms and Conditions for Warrants, between Goldman, Sachs & Co. and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2015, filed May 7, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000020/regn-ex_102x03312015x10q.htm) |

| 10.20.4 | [Termination Agreement, dated as of November 23, 2016, between Goldman, Sachs & Co. and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2016, filed February 9, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000153217617000008/regn-ex_10204xgoldmansachs.htm) |

| 10.21 | [Master Terms and Conditions for Convertible Note Hedging Transactions, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Citibank, N.A. and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000119312511278786/d245760dex103.htm) |

| 10.22 | [Master Terms and Conditions for Base Warrants, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Citibank, N.A. and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000119312511278786/d245760dex104.htm) |

| 10.22.1 | [Amendment, dated as of May 13, 2014, to the Master Terms and Conditions for Warrants, between Citibank, N.A. and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2014, filed August 5, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000153217614000035/regn-ex_106xamendemntxciti.htm) |

| 10.22.2 | [Second Amendment, dated as of February 22, 2016, to the Master Terms and Conditions for Warrants, between Citibank, N.A. and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended March 31, 2016, filed May 5, 2016.)](http://www.sec.gov/Archives/edgar/data/872589/000153217616000055/regn-ex_101x03312016x10q.htm) |

| 10.22.3 | [Third Amendment, dated as of November 10, 2016, to the Master Terms and Conditions for Warrants, between Citibank, N.A. and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2016, filed February 9, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000153217617000008/regn-ex_10223xciti3rdwarra.htm) |

| 10.22.4 | [Termination Agreement, dated as of November 14, 2016, between Citibank, N.A. and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2016, filed February 9, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000153217617000008/regn-ex_10224xcititerminat.htm) |

| 10.23 | [Master Terms and Conditions for Convertible Note Hedging Transactions, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Credit Suisse International and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000119312511278786/d245760dex105.htm) |

| 10.24 | [Master Terms and Conditions for Base Warrants, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Credit Suisse International and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000119312511278786/d245760dex106.htm) |

| 10.24.1 | [Amendment, dated as of May 14, 2014, to the Master Terms and Conditions for Warrants, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant. (Incorporated by reference from the Form 10-Q for the Registrant, for the quarter ended June 30, 2014, filed August 5, 2014.)](http://www.sec.gov/Archives/edgar/data/872589/000153217614000035/regn-ex_107xamendmentxcred.htm) |

| 10.24.2 | [Second Amendment, dated as of November 18, 2014, to the Master Terms and Conditions for Warrants, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2014, filed February 12, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000008/regn-ex_10252x12312014x10k.htm) |

| 10.24.3 | [Third Amendment, dated as of November 24, 2014, to the Master Terms and Conditions for Warrants, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2014, filed February 12, 2015.)](http://www.sec.gov/Archives/edgar/data/872589/000153217615000008/regn-ex_10253x12312014x10k.htm) |

| 10.24.4 | [Fourth Amendment, dated as of November 15, 2015, to the Master Terms and Conditions for Warrants, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant. (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_10264x12312015x10k.htm) |

| 10.24.5 | [Termination Agreement, dated as of November 15, 2016, between Credit Suisse Capital LLC (as assignee of Credit Suisse International) and the Registrant. (Incorporated by reference from the Form 10-K for the Registrant, for the year ended December 31, 2016, filed February 9, 2017.)](http://www.sec.gov/Archives/edgar/data/872589/000153217617000008/regn-ex_10245xcreditsuisse.htm) |

| 10.25 | [Master Terms and Conditions for Convertible Note Hedging Transactions, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Morgan Stanley & Co. International plc and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000119312511278786/d245760dex107.htm) |

| 10.26 | [Master Terms and Conditions for Base Warrants, dated as of October 18, 2011, as supplemented by a confirmation dated October 18, 2011, between Morgan Stanley & Co. International plc and the Registrant. (Incorporated by reference from the Form 8-K for the Registrant filed October 24, 2011.)](http://www.sec.gov/Archives/edgar/data/872589/000119312511278786/d245760dex108.htm) |

| Date: | February [removed: 8, 2018] [added: 7, 2019] | | By: | /s/ LEONARD S. SCHLEIFER | |

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

| /s/ LEONARD S. SCHLEIFER | | President, Chief Executive Officer, and Director (Principal Executive Officer) | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ ROBERT E. LANDRY | | [removed: Senior] [added: Executive] Vice President, Finance and Chief Financial Officer (Principal Financial Officer) | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ CHRISTOPHER R. FENIMORE | | Vice President, Controller (Principal Accounting Officer) | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ GEORGE D. YANCOPOULOS | | President, Chief Scientific Officer, and Director | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ P. ROY VAGELOS | | Chairman of the Board | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ BONNIE L. BASSLER | | Director | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ MICHAEL S. BROWN | | Director | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ N. ANTHONY COLES | | Director | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ JOSEPH L. GOLDSTEIN | | Director | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ CHRISTINE A. POON | | Director | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ ARTHUR F. RYAN | | Director | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ GEORGE L. SING | | Director | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ MARC TESSIER-LAVIGNE | | Director | | February [removed: 8, 2018] [added: 7, 2019] |

| /s/ HUDA Y. ZOGHBI | | Director | | February [removed: 8, 2018] [added: 7, 2019] |

| [Report of Independent Registered Public Accounting [removed: Firm](#s5010B7AF6054589BA1227E9064DA6215)] [added: Firm](#sDAB7167D93175FCE8608634D17999871)] | | [F- [removed: 2](#s5010B7AF6054589BA1227E9064DA6215)] [added: 2](#sDAB7167D93175FCE8608634D17999871)] |

| [Consolidated Balance Sheets at December 31, [removed: 2017] [added: 2018] and [removed: 2016](#s2BFE7E23032450E88604A76CCE8B27C1)] [added: 2017](#s07495BDF1A965D579CFF6C2337A0C8EC)] | | [F- [removed: 4](#s2BFE7E23032450E88604A76CCE8B27C1)] [added: 4](#s07495BDF1A965D579CFF6C2337A0C8EC)] |

| [Consolidated Statements of Operations and Comprehensive Income for the Years Ended December 31, [added: 2018,] 2017, [removed: 2016,] and [removed: 2015](#s92F1CBBE72425B7F90028508F883B06B)] [added: 2016](#s7BF04B2484E2502EA794822BAE4ACF4B)] | | [F- [removed: 5](#s92F1CBBE72425B7F90028508F883B06B)] [added: 5](#s7BF04B2484E2502EA794822BAE4ACF4B)] |

| [Consolidated Statements of Stockholders' Equity for the Years Ended December 31, [added: 2018,] 2017, [removed: 2016,] and [removed: 2015](#s1BA1265FA84459AFB49060E7D1D20EA7)] [added: 2016](#s8AC1ADD56B3956BD940FDC96B3826390)] | | [F- [removed: 6](#s1BA1265FA84459AFB49060E7D1D20EA7)] [added: 6](#s8AC1ADD56B3956BD940FDC96B3826390)] |

| [Consolidated Statements of Cash Flows for the Years Ended December 31, [added: 2018,] 2017, [removed: 2016,] and [removed: 2015](#s70CD9BA65CDD5C5BBBAB041717AD48A7)] [added: 2016](#s6A8E95F047545CE7B8325DDD7E68759B)] | | [F- [removed: 8](#s70CD9BA65CDD5C5BBBAB041717AD48A7)] [added: 8](#s6A8E95F047545CE7B8325DDD7E68759B)] |

[removed: | [Notes to Consolidated Financial Statements](#sBE5AC65ADC1A5A85A1E2FB947360E8CE) | | [F- 9](#sBE5AC65ADC1A5A85A1E2FB947360E8CE) to [F- 46](#s5E059876E2EA511B8083F6AC5FFD158B) |][added: NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)]

We have audited the accompanying consolidated balance sheets of Regeneron Pharmaceuticals, Inc. and its subsidiaries [added: (the "Company")] as of December 31, [removed: 2017] [added: 2018] and [removed: 2016,] [added: 2017,] and the related consolidated statements of operations and comprehensive income; stockholders' equity and cash flows for each of the three years in the period ended December 31, [removed: 2017,] [added: 2018,] including the related notes (collectively referred to as the [removed: “consolidated] [added: "consolidated] financial [removed: statements”).][added: statements").]

We also have audited the Company's internal control over financial reporting as of December 31, [removed: 2017,] [added: 2018,] based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, [removed: 2017] [added: 2018] and [removed: 2016,] [added: 2017,] and the results of its operations and its cash flows for each of the three years in the period ended December 31, [removed: 2017] [added: 2018] in conformity with accounting principles generally accepted in the United States of America.

Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, [removed: 2017,] [added: 2018,] based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.

We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) [removed: ("PCAOB")] [added: (PCAOB)] and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

A company's internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being [removed: made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.]

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

| | [added: | 2018 | | | |] 2017 | | | | 2016 | | |

| Accounts receivable - trade, net | [removed: 1,538,642] [added: 1,723.7] | | | | [removed: 1,343,368] [added: 1,538.6] | | |

| Accounts receivable from Sanofi | [removed: 193,684] [added: 226.4] | | | | [removed: 92,989] [added: 193.7] | | |

| Accounts receivable from Bayer | [removed: 242,014] [added: 293.1] | | | | [removed: 175,263] [added: 242.0] | | |

| Prepaid expenses and other current assets | [removed: 224,972] [added: 243.3] | | | | [removed: 130,528] [added: 225.1] | | |

| Property, plant, and equipment, net | [removed: 2,358,605] [added: 2,575.8] | | | | [removed: 2,083,421] [added: 2,358.6] | | |

| Capital and facility lease obligations | [removed: —] [added: 708.5] | | | | [removed: 129,557] [added: 703.5] | | |

| Deferred revenue from Sanofi | [removed: 379,936] [added: 246.7] | | | | [removed: 503,474] [added: 177.7] | | |

| Preferred Stock, $.01 par value; [removed: 30,000,000] [added: 30,0000,000] shares authorized; issued and outstanding - none | — | | | | — | | |

| Class A Stock, convertible, $.001 par value; 40,000,000 shares authorized; shares issued and outstanding - 1,911,354 in [removed: 2017] [added: 2018] and [removed: 1,911,456 in 2016] [added: 2017] | [removed: 2] [added: —] | | | | [removed: 2] [added: —] | | |

| Common Stock, $.001 par value; 320,000,000 shares authorized; shares issued - [removed: 109,477,222] [added: 111,084,951] in [removed: 2017] [added: 2018] and [removed: 107,860,567] [added: 109,477,222] in [removed: 2016] [added: 2017] | [removed: 110] [added: 0.1] | | | | [removed: 108] [added: 0.1] | | |

| [Notes to Consolidated Financial Statements](#s06BA7C42B421546EAB37161B5DE209C5) | | [F- 9](#s06BA7C42B421546EAB37161B5DE209C5) to [F- 47](#s8E5448BC6DF0510D8C814A93EFAF4AFC) |

Change in Accounting Principle

As discussed in Note 1 to the consolidated financial statements, the Company changed the manner in which it accounts for revenues from contracts with customers in 2018.

made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company's assets that could have a material effect on the financial statements.

February 7, 2019

| | 2018 | | | | 2017 | | |

| Cash and cash equivalents | $ | 1,467.7 | | | $ | 812.7 | |

| Marketable securities | 1,342.2 | | | | 596.8 | | |

| Inventories | 1,151.2 | | | | 726.1 | | |

| Total current assets | 6,447.6 | | | | 4,335.0 | | |

| Marketable securities | 1,755.0 | | | | 1,486.5 | | |

| Deferred tax assets | 828.7 | | | | 506.3 | | |

| Other noncurrent assets | 127.4 | | | | 77.9 | | |

| Total assets | $ | 11,734.5 | | | $ | 8,764.3 | |

| Accounts payable | $ | 218.2 | | | $ | 178.2 | |

| Accrued expenses and other current liabilities | 772.1 | | | | 637.2 | | |

| Deferred revenue - other | 205.8 | | | | 142.4 | | |

| Total current liabilities | 1,442.8 | | | | 1,135.5 | | |

| Deferred revenue from Sanofi | 279.3 | | | | 379.9 | | |

| Deferred revenue - other | 184.9 | | | | 249.3 | | |

| Other noncurrent liabilities | 361.7 | | | | 152.0 | | |

| Total liabilities | 2,977.2 | | | | 2,620.2 | | |

| Additional paid-in capital | 3,911.6 | | | | 3,512.9 | | |

| Retained earnings | 5,254.3 | | | | 2,946.7 | | |

| Total stockholders' equity | 8,757.3 | | | | 6,144.1 | | |

| Net product sales | | $ | 4,106.2 | | | $ | 3,718.5 | | | $ | 3,338.4 | |

| Sanofi collaboration revenue | | 1,111.1 | | | | 877.2 | | | | 658.7 | | |

| Bayer collaboration revenue | | 1,076.7 | | | | 938.1 | | | | 744.3 | | |

| Other revenue | | 416.8 | | | | 338.4 | | | | 119.0 | | |

| | | 6,710.8 | | | | 5,872.2 | | | | 4,860.4 | | |

| Research and development | | 2,186.1 | | | | 2,075.1 | | | | 2,052.3 | | |

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

| Cost of goods sold | | 180.0 | | | | 202.5 | | | | 194.6 | | |

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

| | | 4,176.4 | | | | 3,792.6 | | | | 3,529.7 | | |

| Income from operations | | 2,534.4 | | | | 2,079.6 | | | | 1,330.7 | | |

| Interest expense | | (28.2 | | ) | | (25.1 | | ) | | (7.2 | | ) |

| | | 19.1 | | | | (1.1 | | ) | | (0.9 | | ) |

| Income before income taxes | | 2,553.5 | | | | 2,078.5 | | | | 1,329.8 | | |

| Income tax expense | | (109.1 | | ) | | (880.0 | | ) | | (434.3 | | ) |

| /s/ CHARLES A. BAKER | | Director | | February 8, 2018 |

| Charles A. Baker | | | | |

February 8, 2018

| Cash and cash equivalents | $ | 812,733 | | | $ | 535,203 | |

| Marketable securities | 596,847 | | | | 503,481 | | |

| Inventories | 726,138 | | | | 399,356 | | |

| Total current assets | 4,335,030 | | | | 3,180,188 | | |

| Marketable securities | 1,486,494 | | | | 864,260 | | |

| Deferred tax assets | 506,291 | | | | 825,303 | | |

| Other assets | 77,866 | | | | 20,294 | | |

| Total assets | $ | 8,764,286 | | | $ | 6,973,466 | |

| Accounts payable and accrued expenses | $ | 815,078 | | | $ | 879,096 | |

| Deferred revenue from Sanofi, current portion | 177,746 | | | | 115,267 | | |

| Deferred revenue - other, current portion | 142,392 | | | | 116,397 | | |

| Other current liabilities | 267 | | | | 1,178 | | |

| Total current liabilities | 1,135,483 | | | | 1,241,495 | | |

| Capital and facility lease obligations | 703,453 | | | | 351,569 | | |

| Deferred revenue - other | 249,263 | | | | 327,298 | | |

| Other long-term liabilities | 152,073 | | | | 100,385 | | |

| Total liabilities | 2,620,208 | | | | 2,524,221 | | |

| Additional paid-in capital | 3,512,833 | | | | 3,029,993 | | |

| Retained earnings | 2,946,733 | | | | 1,748,222 | | |

| Total stockholders' equity | 6,144,078 | | | | 4,449,245 | | |

| Net product sales | | $ | 3,718,463 | | | $ | 3,338,390 | | | $ | 2,689,478 | |

| Sanofi collaboration revenue | | 877,193 | | | | 658,665 | | | | 758,873 | | |

| Bayer collaboration revenue | | 938,052 | | | | 744,270 | | | | 580,488 | | |

| Other revenue | | 338,519 | | | | 119,102 | | | | 74,889 | | |

| | | 5,872,227 | | | | 4,860,427 | | | | 4,103,728 | | |

| Research and development | | 2,075,142 | | | | 2,052,295 | | | | 1,620,577 | | |

| Selling, general, and administrative | | 1,320,433 | | | | 1,177,697 | | | | 838,526 | | |

| Cost of goods sold | | 202,507 | | | | 194,624 | | | | 241,702 | | |

| Cost of collaboration and contract manufacturing | | 194,554 | | | | 105,070 | | | | 151,007 | | |

| | | 3,792,636 | | | | 3,529,686 | | | | 2,851,812 | | |

| Income from operations | | 2,079,591 | | | | 1,330,741 | | | | 1,251,916 | | |

| Interest expense | | (25,119 | | ) | | (7,195 | | ) | | (14,241 | | ) |

| | | (1,080 | | ) | | (926 | | ) | | (26,819 | | ) |

| Income before income taxes | | 2,078,511 | | | | 1,329,815 | | | | 1,225,097 | | |

| Income tax expense | | (880,000 | | ) | | (434,293 | | ) | | (589,041 | | ) |

| Net income | | $ | 1,198,511 | | | $ | 895,522 | | | $ | 636,056 | |

| Weighted average shares outstanding - basic | | 106,338 | | | | 104,719 | | | | 103,061 | | |