UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): January 7, 2019 (January 2, 2019)

 

REGENERON PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

New York

(State or other jurisdiction of incorporation)

 

000-19034

 

13-3444607

(Commission
File Number)

 

(I.R.S. Employer
Identification No.)

 

777 Old Saw Mill River Road, Tarrytown, New York

 

10591-6707

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code: (914) 847-7000

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):

 

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company o

 

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

 

 

 


 

 

Item 1.01.                                        Entry into a Material Definitive Agreement.

 

On January 2, 2018, Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”) and Sanofi Biotechnology SAS (“Sanofi”) entered into an Amended and Restated Immuno-oncology Discovery and Development Agreement (the “Amended IO Discovery Agreement”), which amended and restated that certain Immuno-oncology Discovery and Development Agreement, dated as of July 1, 2015 and executed as of July 27, 2015, by and between the Company and Sanofi, as amended (the “Original IO Discovery Agreement”). The Amended IO Discovery Agreement has an effective date of December 31, 2018.

 

Pursuant to the Amended IO Discovery Agreement, the scope of the existing discovery and development activities conducted by the Company (the “IO Development Activities”) has been narrowed to developing therapeutic bi-specific antibodies targeting (i) BCMA and CD3 (the “BCMAxCD3 Program”) and (ii) MUC16 and CD3 (the “MUC16xCD3 Program”) through clinical proof of concept. The Amended IO Discovery Agreement provides for Sanofi’s payment of $462 million to the Company as consideration for (x) the termination of the Original IO Discovery Agreement, (y) the prepayment for certain IO Development Activities regarding the BCMAxCD3 Program and the MUC16xCD3 Program, and (z) the reimbursement of costs incurred by the Company under the Original IO Discovery Agreement during the fourth quarter of 2018. The Company is required to conduct the IO Development Activities with respect to (i) the BCMAxCD3 Program through the earlier of clinical proof of concept or the expenditure of $70 million (the “BCMAxCD3 Program Costs Cap”) and (ii) the MUC16xCD3 Program through the earlier of clinical proof of concept or the expenditure of $50 million (the “MUC16xCD3 Program Costs Cap”) (the BCMAxCD3 Program Costs Cap and MUC16xCD3 Program Costs Cap, collectively, the “Program Costs Caps”); provided that under certain circumstances, Sanofi will have the option to increase the MUC16xCD3 Program Costs Cap to $70 million by making a payment to the Company in the amount of $20 million. Pursuant to the Amended IO Discovery Agreement, the Company will be primarily responsible for conducting the IO Discovery Activities and, other than certain clinical trials that may be funded separately by Sanofi, will design and conduct all research activities, including antibody development, preclinical activities, toxicology studies, manufacture of preclinical and clinical supplies, filing of Investigational New Drug Applications, and clinical development through proof of concept. The Company is obligated to reimburse Sanofi for half of the development costs that are attributable to clinical development of antibody product candidates under the Amended IO Discovery Agreement from its share of future profits to the extent they are sufficient for this purpose. As the scope of the IO Development Activities has been limited, the exclusivity obligations of the parties under the Amended IO Discovery Agreement have been narrowed.

 

The Amended IO Discovery Agreement provides that Regeneron retains exclusive rights to all other immuno-oncology programs that were part of the Original IO Discovery Agreement; provided that Sanofi will receive a royalty on global sales of two product candidates currently in clinical development, REGN3767 (antibody to LAG-3 protein) and REGN4659 (antibody to CTLA4).

 

With regard to the BCMAxCD3 Program and the MUC16xCD3 Program, when clinical proof of concept is established, the applicable Program Costs Cap is reached, or in certain other limited circumstances, Sanofi will have the option to license rights to the product candidate and other antibodies targeting the same targets for immuno-oncology indications pursuant to the Immuno-oncology License and Collaboration Agreement, dated as of July 1, 2015, by and between the Company and Sanofi, as amended. If Sanofi does not exercise its option to license rights to a product candidate, the Company will retain the exclusive right to develop and commercialize such product candidate and Sanofi will receive a royalty on sales. Pursuant to the Amended IO Discovery Agreement, the parties agreed that (i) if Sanofi exercises its option with respect to a BCMAxCD3 Program antibody, Sanofi will lead the development and commercialization of such BCMAxCD3 Program antibody; and (ii) if Sanofi exercises its option with respect to a MUC16xCD3 Program antibody, (x) the Company will lead the development of such MUC16xCD3 Program antibody and commercialization of such MUC16xCD3 Program antibody within the United States and (y) Sanofi will lead the commercialization of such MUC16xCD3 Program antibody outside of the United States. The Amended IO Discovery Agreement will terminate as of the earlier of (a) Sanofi having elected to exercise or not exercise its options with respect to the BCMAxCD3 Program and the MUC16xCD3 Program in accordance with the terms of the Amended IO Discovery Agreement and (b) December 31, 2022.

 

The Amended IO Discovery Agreement contains other customary covenants and termination provisions, including for material breach by the other party.

 

2


 

The foregoing description of the Amended IO Discovery Agreement is qualified in its entirety by reference to the full text of the Amended IO Discovery Agreement, a copy of which will be filed with the United States Securities and Exchange Commission (the “SEC”) as an exhibit to the Quarterly Report on Form 10-Q to be filed by the Company for the quarterly period ending March 31, 2019.

 

Item 2.02.  Results of Operations and Financial Condition.

 

On January 7, 2019, the Company issued a press release providing a strategic business update in connection with the Company’s presentation at the 37th Annual J.P. Morgan Healthcare Conference in San Francisco, California (the “2019 J.P. Morgan Healthcare Conference”). The press release includes information regarding the Company’s preliminary (unaudited) U.S. net product sales of EYLEA® (aflibercept) Injection of approximately $4.07 billion for the full year 2018 (based on preliminary (unaudited) fourth quarter 2018 U.S. net product sales of EYLEA of approximately $1.07 billion). A copy of the press release is being furnished to the SEC as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference to this Item 2.02.

 

Item 7.01.  Regulation FD Disclosure.

 

The information set forth under Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 to this Current Report on Form 8-K is incorporated by reference herein.

 

On January 7, 2019, at the 2019 J.P. Morgan Healthcare Conference, Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron, and George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron, are providing a corporate update. A copy of the presentation is furnished as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.

 

On January 9, 2019, at a sell-side investor meeting at the 2019 J.P. Morgan Healthcare Conference, Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron, is giving a presentation entitled “2019 Financial Overview.” A copy of the presentation is furnished as Exhibit 99.3 to this Current Report on Form 8-K and is incorporated by reference herein.

 

The information included or incorporated in Item 2.02 and Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.1, 99.2, and 99.3, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall such information and exhibit be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

 

Item 9.01.                Financial Statements and Exhibits.

 

(d) Exhibits.

 

99.1

 

Press Release, dated January 7, 2019.

99.2

 

Presentation by Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron Pharmaceuticals, Inc., and George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron Pharmaceuticals, Inc., at the 37th Annual J.P. Morgan Healthcare Conference.

99.3

 

Presentation by Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron Pharmaceuticals, Inc., entitled “2019 Financial Overview.”

 

3


 

EXHIBIT INDEX

 

Number

 

Description

 

 

 

99.1

 

Press Release, dated January 7, 2019.

99.2

 

Presentation by Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron Pharmaceuticals, Inc., and George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron Pharmaceuticals, Inc., at the 37th Annual J.P. Morgan Healthcare Conference.

99.3

 

Presentation by Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron Pharmaceuticals, Inc., entitled “2019 Financial Overview.”

 

4


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

REGENERON PHARMACEUTICALS, INC.

 

 

 

 

 

/s/ Joseph J. LaRosa

 

Joseph J. LaRosa

 

Executive Vice President, General Counsel and Secretary

 

Date: January 7, 2019

 

5


Exhibit 99.1

 

 

Press Release

 

Regeneron Provides Update on Commercial and Pipeline Progress at J.P. Morgan Healthcare Conference

 

TARRYTOWN, N.Y. (January 7, 2019) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) will provide a strategic business update to the investor community today at the 37th Annual J.P. Morgan Healthcare Conference. Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer, and George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, will discuss commercial and pipeline progress across the company’s portfolio. Slides and a webcast from the presentation may be accessed from the “Investors & Media” page of Regeneron’s website at http://investor.regeneron.com/events.cfm.

 

“Regeneron continues to advance an innovative, homegrown portfolio of marketed and investigational therapies for patients with a range of serious diseases,” said Dr. Schleifer. “In 2018, we saw continued strong growth for EYLEA® (aflibercept) Injection in retinal diseases and Dupixent® (dupilumab) Injection in atopic dermatitis, as well as a positive initial reception to our two new launches — Libtayo® (cemiplimab-rwlc) Injection for advanced cutaneous squamous cell carcinoma and Dupixent for asthma. On the development front, we now have more than 20 investigational candidates in human clinical trials and look forward to entering several more this year, as we continue to leverage our cutting-edge science and technology to bring new hope to patients in need.”

 

EYLEA: Strengthening Market Leadership Position

 

·                  EYLEA† achieved $4.07 billion in 2018 U.S. net sales (based on preliminary, unaudited fourth quarter 2018 U.S. net sales of $1.07 billion), representing approximately 10 percent growth over 2017. (1)

·                  The U.S. Food and Drug Administration (FDA) has assigned an action date of May 13, 2019 for a new EYLEA indication in diabetic retinopathy.

·                  Regeneron is also advancing next-generation ophthalmology treatments, such as a high-dose formulation of EYLEA, which is expected to enter clinical trials in 2019.

 

Dupixent: Continued Growth and New Indications

 

·                  Dupixent*† uptake continues to accelerate in both its FDA-approved indications with positive trends in new-to-brand prescriptions following a direct-to-consumer television campaign for moderate-to-severe atopic dermatitis and the 2018 asthma launch.

·                  Additional important regulatory milestones are expected for Dupixent this year, including a March 11, 2019 FDA action date for adolescent atopic dermatitis (age 12-17), a European Medicines Association (EMA) decision for asthma and an FDA filing for chronic rhinosinusitis with nasal polyps.

·                  In 2019, Regeneron also expects to report results from a Phase 3 study of Dupixent in pediatric patients (age 6-11) with atopic dermatitis and initiate a Phase 2/3 program in Chronic Obstructive Pulmonary Disease. Phase 2 studies in grass allergy and peanut allergy are ongoing, as are combination studies with REGN3500* (IL-33 antibody) in atopic dermatitis and asthma.

 


Collaboration program with Sanofi

†  See full prescribing information

 

1


 

Immuno-Oncology Platform

 

·                  Regeneron has seen encouraging early uptake from the U.S. launch of Libtayo*† for advanced cutaneous squamous cell carcinoma (CSCC). An EMA decision on Libtayo for advanced CSCC is expected in the first half of 2019, and pivotal and earlier studies in other cancers are continuing to enroll.

·                  Regeneron’s CD20xCD3 bispecific antibody, REGN1979, continues to progress with a potentially pivotal Phase 2 study in Follicular Lymphoma anticipated to begin in the first half of 2019 and a potentially pivotal Phase 2 study in Diffuse Large B-Cell Lymphoma anticipated to begin in the second half of 2019.

·                  Supported by Regeneron’s proprietary science and technology platforms, the company is advancing a new class of costimulatory bispecific antibodies for cancer, with two candidates expected to enter human clinical studies in 2019. These therapies have the potential to be used in combination with other Regeneron immuno-oncology therapies to address difficult-to-treat cancers.

·                  Earlier today, Regeneron and Sanofi announced a restructuring of their 2015 Immuno-oncology Discovery and Development Agreement. Regeneron and Sanofi have selected two investigational bispecific antibodies (MUC16xCD3 for mucin16-expressing cancers and BCMAxCD3 for multiple myeloma) for continued collaborative development. Regeneron will retain exclusive rights to all its other immuno-oncology programs, including additional xCD3 bispecifics and the new class of costimulatory bispecific antibodies. The bispecific antibody REGN1979 (CD20xCD3) remains exclusively owned by Regeneron.

 

“Over the last few years, we’ve made excellent progress with our immuno-oncology portfolio, which includes Libtayo, the first and only approved treatment for advanced cutaneous squamous cell carcinoma, as well as our first clinical-stage bispecific antibody, REGN1979,” said Dr. Yancopoulos. “Regeneron now has one approved and five clinical-stage immuno-oncology therapies for a range of targets and modalities, which have the opportunity to be used as monotherapy or in combination with other agents. We’re particularly encouraged to be entering two new therapies into the clinic this year from our costimulatory bispecific portfolio. Building on our deep antibody engineering expertise, this new class of bispecific agents has the promise to treat certain cancers where other classes of immunotherapy have proven inadequate.”

 

Additional Research and Development Updates

 

·                  In 2018, Regeneron entered four new molecules into the clinic: REGN4018, a MUC16xCD3 bispecific antibody for cancer; REGN4461, a leptin receptor (LEPR) agonist for lipodystrophy and obesity; REGN4659, a CTLA-4 antibody for cancer; and REGN5069, a GFRa3 antibody for pain.

·                  In 2019, four to six new molecules are expected to enter clinical development, including REGN5458, the BCMAxCD3 bispecific antibody which has already initiated a Phase 1 study, as well as two costimulatory bispecific antibodies for cancer.

·                  The Regeneron Genetics Center (RGC) continues to make important discoveries, including validating the genetic role of IL-33 in asthma and identifying a new genetic variant that protects against chronic liver disease. The RGC has now sequenced over 500,000 human exomes linked to detailed patient electronic health records and anticipates sequencing up to 500,000 more exomes in 2019.

 


Collaboration program with Sanofi

†  See full prescribing information

 

2


 

2019 Financial Guidance(2)

 

Sanofi Collaboration Revenue
Reimbursement of Regeneron Commercialization-Related Expenses

 

$510 — 560 Million

Non-GAAP Unreimbursed R&D(3)(4)

 

$1,590 — 1,710 Million

Non-GAAP SG&A(3)(4)

 

$1,500 — 1,600 Million

Effective Tax Rate

 

14 — 16%

Capital Expenditures

 

$410 — 490 Million

 


(1)

 

Regeneron records net product sales of EYLEA in the United States. Outside the United States, EYLEA net product sales comprise sales by Bayer in countries other than Japan and sales by Santen Pharmaceutical Co., Ltd. in Japan under a co-promotion agreement with an affiliate of Bayer. The Company recognizes its share of the profits (including a percentage on sales in Japan) from EYLEA sales outside the United States within “Bayer collaboration revenue” in its Statements of Operations.

 

 

 

(2)

 

The Company’s 2019 financial guidance does not assume the completion of any significant business development transactions not completed as of the date of this press release.

(3)

 

This press release uses non-GAAP unreimbursed R&D and non-GAAP SG&A, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). These non-GAAP financial measures are computed by excluding certain non-cash and other items from the related GAAP financial measure. Non-GAAP adjustments also include the estimated income tax effect of reconciling items.

The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company’s control (such as the Company’s stock price on the dates share-based grants are issued or changes in the fair value of the Company’s equity investments) or items that are not associated with normal, recurring operations (such as changes in applicable laws and regulations). Management uses these non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company’s core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company’s non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP.

 

 

 

(4)

 

A reconciliation of full year 2019 non-GAAP to GAAP financial guidance is included below:

 

3


 

 

 

Projected Range

 

(In millions)

 

Low

 

High

 

GAAP unreimbursed R&D (5)

 

$

1,855

 

$

2,000

 

R&D: Non-cash share-based compensation expense

 

(265

)

(290

)

Non-GAAP unreimbursed R&D

 

$

1,590

 

$

1,710

 

 

 

 

 

 

 

GAAP SG&A

 

$

1,700

 

$

1,830

 

SG&A: Non-cash share-based compensation expense

 

(200

)

(230

)

Non-GAAP SG&A

 

$

1,500

 

$

1,600

 

 


 

 

(5) Unreimbursed R&D represents R&D expenses reduced by R&D expense reimbursements from the Company’s collaborators and/or customers.

 

About Regeneron

 

Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neuromuscular diseases, infectious diseases and rare diseases.

 

Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

 

For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

 

Regeneron Forward-Looking Statements and Use of Digital Media

 

This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements.  Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words.  These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron’s 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, Libtayo® (cemiplimab-rwlc) Injection, fasinumab, evinacumab, Regeneron’s immuno-oncology programs (including its costimulatory bispecific portfolio), Regeneron’s earlier-stage product candidates, and the use of human genetics in Regeneron’s research programs; the extent to which the results from Regeneron’s research programs or preclinical testing may lead to advancement of product candidates to clinical trials or therapeutic applications; 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 Regeneron’s product candidates in clinical trials; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron’s late-stage product candidates and new indications for marketed products, including without limitation EYLEA, Dupixent, Praluent, Kevzara, Libtayo, fasinumab, and evinacumab; the likelihood and timing of achieving any of the anticipated milestones described in this press release; the extent to which the results from the research and development programs conducted by Regeneron or its collaborators may be replicated in other studies and lead to therapeutic applications; ongoing regulatory obligations and oversight impacting Regeneron’s marketed products (such as EYLEA, Dupixent, Praluent, Kevzara, and Libtayo), research and clinical programs, and

 

4


 

business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s products and product candidates; competing drugs and product candidates that may be superior to Regeneron’s products and product candidates; uncertainty of market acceptance and commercial success of Regeneron’s products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron’s products and product candidates; the availability and extent of reimbursement of the Company’s products 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; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third parties to perform filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance, including financial guidance relating to Sanofi collaboration revenue, non-GAAP unreimbursed R&D, non-GAAP SG&A, effective tax rate, and capital expenditures; risks associated with intellectual property of other parties and pending or future litigation relating thereto, including without limitation the patent litigation proceedings relating to EYLEA, Dupixent, and Praluent, the ultimate outcome of any such litigation proceeding, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition; and the potential for any license or collaboration agreement, including Regeneron’s 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. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2017 and its Form 10-Q for the quarterly period ended September 30, 2018, including in each case in the section thereof captioned “Item 1A. Risk Factors.” Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

 

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron’s media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron).

 

Non-GAAP Financial Measures

 

This press release includes amounts that are considered non-GAAP financial measures under U.S. Securities and Exchange Commission rules. Please refer to important information about these measures, as well as a reconciliation of the non-GAAP financial measures included in this press release to the most directly comparable GAAP measures, in the notes above.

 

Media Relations

Hala Mirza

Tel: +1 (914) 847-3422

hala.mirza@regeneron.com

 

Investor Relations

Mark Hudson

Tel: +1 (914) 847-3482

mark.hudson@regeneron.com

 

5


Exhibit 99.2

 

JP Morgan 2019 January 7th Leonard S. Schleifer MD, PhD President & CEO George D. Yancopoulos MD, PhD President & CSO

GRAPHIC

 

2 Note regarding FORWARD-LOOKING STATEMENTs and non-gaap financial measures This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron’s 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, Libtayo® (cemiplimab) Injection, fasinumab, evinacumab, Regeneron’s immuno-oncology programs (including its costimulatory bispecific portfolio), Regeneron’s earlier-stage product candidates, and the use of human genetics in Regeneron’s research programs; the extent to which the results from Regeneron’s research programs or preclinical testing may lead to advancement of product candidates to clinical trials or therapeutic applications; 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 Regeneron’s product candidates in clinical trials; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron’s late-stage product candidates and new indications for marketed products, including without limitation EYLEA, Dupixent, Praluent, Kevzara, Libtayo, fasinumab, and evinacumab; the likelihood and timing of achieving any of the anticipated milestones described in this presentation; the extent to which the results from the research and development programs conducted by Regeneron or its collaborators may be replicated in other studies and lead to therapeutic applications; ongoing regulatory obligations and oversight impacting Regeneron’s marketed products (such as EYLEA, Dupixent, Praluent, Kevzara, and 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 Regeneron’s ability to continue to develop or commercialize Regeneron’s products and product candidates; competing drugs and product candidates that may be superior to Regeneron’s products and product candidates; uncertainty of market acceptance and commercial success of Regeneron’s products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron's products and product candidates; the availability and extent of reimbursement of the Company’s products 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; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third parties to perform filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance, including financial guidance relating to Sanofi collaboration revenue, non-GAAP unreimbursed R&D, non-GAAP SG&A, effective tax rate, and capital expenditures; risks associated with intellectual property of other parties and pending or future litigation relating thereto, including without limitation the patent litigation proceedings relating to EYLEA, Dupixent, and Praluent, the ultimate outcome of any such litigation proceeding, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition; and the potential for any license or collaboration agreement, including Regeneron’s 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. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2017 and its Form 10-Q for the quarterly period ended September 30, 2018, including in each case in the section thereof captioned “Item 1A. Risk Factors.” Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. This presentation uses non-GAAP unreimbursed R&D and non-GAAP SG&A, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). These non-GAAP financial measures are computed by excluding certain non-cash and other items from the related GAAP financial measure. Non-GAAP adjustments also include the income tax effect of reconciling items. The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company’s control, such as the Company’s stock price on the dates share-based grants are issued. Management uses these and other non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company’s core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company’s non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. A reconciliation of the Company's full year 2019 non-GAAP to GAAP financial guidance is provided on slide 12.

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Proven Innovation WHERE WE ARE

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4 KEY milestones and achievements RESEARCH & DEVELOPMENT COMMERCIAL Key Regulatory Approvals* LIBTAYO Advanced CSCC DUPIXENT Moderate-to-severe Asthma EYLEA Q12 week dosing in wAMD after one year of effective therapy Key Regulatory Filings EYLEA Diabetic Retinopathy DUPIXENT Atopic Dermatitis in adolescents PRALUENT Cardiovascular Risk Reduction Clinical Trial Readouts DUPIXENT Ph3 Chronic Rhinosinusitis with Nasal Polyps LIBTAYO Ph1 Non Small Cell Lung Cancer REGN1979 (CD20xCD3) PoC in Follicular Lymphoma & Diffuse Large B-Cell Lymphoma Fasinumab (NGF) Ph3 Osteoarthritis Pozelimab (C5) Ph1 in Healthy Volunteers Ph2 and Ph3 Trial Initiations DUPIXENT Ph2/3 Eosinophilic Esophagitis Ph2 Grass Allergy Ph2 Peanut Allergy Ph2/3 AD in peds (6 mo – 5 yr) REGN3500 (IL-33) Ph2 Chronic Obstructive Pulmonary Disease Ph2 Asthma Ph2 Atopic Dermatitis KEVZARA Ph3 Polymyalgia Rheumatica Ph3 Giant Cell Arthritis INDs & Ph1 Trial Initiations REGN4018 (MUC16xCD3) Ovarian Cancer REGN5458 (BCMAxCD3) Multiple Myeloma REGN4659 (CTLA-4) Cancer REGN5069 (GFRα3) Pain REGN4461 (LEPR) Metabolic Disease Infectious Disease Delivered REGN-EB3 to the Democratic Republic of the Congo for use in Ebola patients Genetics Sequenced 500k human exomes to date New Partnerships/Collaborations UK Biobank consortium, bluebird bio, Alnylam, Zoetis US EYLEA Net sales of ~$4.07 Billion†; ~10% year-over-year growth DUPIXENT Annualizing in excess of $1.0 Billion, based on 3Q18 worldwide net sales; Atopic Dermatitis launch continues to accelerate; Asthma launch progressing well, particularly among allergists LIBTAYO Physician interest and market uptake are encouraging PRALUENT Working with payers to improve access and lower cost to patients * Please see full Prescribing Information for all approved products † Based on preliminary unaudited fiscal 2018 results; preliminary unaudited 4Q18 U.S. EYLEA net sales of $1.07 Billion This slide includes pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the disease categories described here.

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EYLEA®: Strengthening market leadership position U.S. Net Sales†, $Billion Building on leadership position in wAMD and diabetic eye disease, both of which are increasing in prevalence Label expansions and line extensions Innovating next generation therapeutics Our strategy is to maximize EYLEA growth opportunities and develop next generation therapeutics * Based on preliminary unaudited fiscal 2018 results; preliminary, unaudited 4Q18 U.S. EYLEA net sales of $1.07 Billion † Outside the United States, EYLEA net product sales comprise sales by Bayer in countries other than Japan and sales by Santen Pharmaceutical Co., Ltd. in Japan under a co-promotion agreement with an affiliate of Bayer * 5 We believe there are no near-term potential agents that can provide substantially different dosing flexibility, duration or visual gains than are already achievable with EYLEA

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EYLEA®: Leading ophthalmology innovation 6 Opportunities in Diabetic Eye Diseases Diabetic Macular Edema (DME) Targeted commercial strategy to increase anti-VEGF penetration Diabetic Retinopathy (DR) without DME – PDUFA date May 13, 2019 Phase 3 PANORAMA study shows potential to change clinical practice 65-80% of EYLEA-treated patients experienced > two-step improvement from baseline on the Diabetic Retinopathy Severity Scale (DRSS) vs. 15% sham (p<0.0001) 72-76% reduction in vision-threatening complications (VTCs) and center-involved diabetic macular edema (CI-DME): (10-11% EYLEA vs. 41% sham, p<0.001) Of the 3.5M people in the U.S. with DR without DME, ~1M individuals have moderate-to-severe disease and are at greatest risk Our strategy is to make even better treatments than our market-leading anti-VEGF therapy, EYLEA High Dose Formulation of EYLEA Other new molecular entities and gene therapies Next Generation Strategy This slide includes pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the disease categories described here.

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Dupixent ®: Building leadership in ATOPIC DERMATITIS and Launching in Asthma 7 2018 Weekly New to Brand (NBRx)* Atopic Dermatitis: Practice-Changing Advance in Management In the U.S., less than 15% of adult AD patients with the greatest need have used DUPIXENT High persistence and compliance indicate patient and physician satisfaction Ex-U.S. launch in early stage and progressing well Encouraging prescription trends following commencement of DTC TV campaign in 3Q18 Moderate-to-Severe Asthma: High Unmet Need Only asthma biologic approved for: Self administration Moderate-to-severe asthma with an eosinophilic phenotype Oral corticosteroid-dependent asthma regardless of phenotype AD patients with comorbid asthma Consistent and clinically meaningful improvements in lung function, asthma attacks and oral steroid sparing Up to 900K patients (>12 years) in the U.S. with moderate-to-severe asthma may be suitable for biologic therapy Encouraging initial prescription trends, particularly among allergists treating asthma * Source: IQVIA Please see full Prescribing Information for all approved products 0 100 200 300 400 500 600 700 800 900 1,000 Jan-18 Feb-18 Mar-18 Apr-18 May-18 Jun-18 Jul-18 Aug-18 Sep-18 Oct-18 Nov-18 Dec-18 Branded DTC TV Starts Asthma Launch

 

DUPIXENT ®: DELIVERING on The “pipeline in a product” promise 8 Atopic Dermatitis Approved in Adults Moderate-to-Severe Asthma Approved in Adults and Adolescents Pediatric Asthma (6-11 years) Ph3 ongoing Food Allergies Ph2 in Peanut Allergy initiated; more planned Airborne Allergies Ph2 in Grass Allergy initiated Combinations with REGN3500 (IL-33) Ph2 initiated in AD and Asthma APPROVED INDICATIONS NEAR-TERM OPPORTUNITIES longer-term opportunities Atopic Dermatitis in Adolescents (12-17 years) sBLA submitted, PDUFA date March 11, 2019 Atopic Dermatitis in Pediatrics (6-11 years) Ph3 readout expected in 2019 Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Two Positive Ph3 studies reported 2H18 sBLA filing expected in 1Q19 Eosinophilic Esophagitis Positive Ph2 results; Pivotal trial initiated 3Q18 Chronic Obstructive Pulmonary Disease (COPD) Initiate Ph2/3 in 2019 This slide includes pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the disease categories described here.

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9 LIBTAYO®: new hope for patients with advanced CScc LIBTAYO is now the only approved treatment option for advanced CSCC, a life-threatening condition June 2018 NEJM publication details pivotal Phase 2 study results in 59 metastatic CSCC patients: Primary endpoint: 47.5% Overall Response Rate by independent review Durable Disease Control Rate of 61% Median duration of response and progression-free survival have not been reached LIBTAYO was associated with adverse events similar to other PD-1 inhibitors An 83-year-old patient who had undergone multiple surgeries for CSCC, at baseline and after 8 weeks of treatment with LIBTAYO Cutaneous squamous cell carcinoma (CSCC) is the second most common form of skin cancer (after Basal Cell Carcinoma) and is responsible for an estimated 7,000 deaths per year in the U.S.; prior to LIBTAYO there were no approved therapies for advanced disease Please see full Prescribing Information for all approved products Despite thousands of trials by others, Regeneron is the first to identify advanced CSCC as perhaps the most responsive solid tumor to immunotherapy

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2019 Goals and milestones KEY REGULATORY APPROVALS & SUBMISSIONS EYLEA FDA decision on sBLA for the treatment of Diabetic Retinopathy (PDUFA date May 13, 2019); re-submission of Prior-Approval Supplement (PAS) for pre-filled syringe DUPIXENT FDA decision on sBLA for expanded Atopic Dermatitis indication in adolescent patients 12–17 years of age (PDUFA date March 11, 2019); EMA decision on regulatory application for Asthma; file sBLA for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) LIBTAYO EMA decision for advanced cutaneous squamous cell carcinoma (CSCC) PRALUENT FDA (PDUFA date April 28, 2019) and EMA decisions on applications for Cardiovascular Risk Reduction; FDA decision on sBLA for first-line treatment of Hyperlipidemia (PDUFA date April 29, 2019) KEY DATA READOUTS DUPIXENT Report results from Ph3 study for Atopic Dermatitis in pediatric patients 6–11 years of age REGN3500 (IL-33) Report results from Ph2 Asthma study Trevogrumab (GDF8) + Garetosmab (Activin-A) Report results from multi-dose portion of Ph1 study CLINICAL PROGRESS EYLEA Initiate a study of higher dose formulations of aflibercept DUPIXENT Continue enrollment in pivotal eosinophilic esophagitis (EoE) study; Initiate Ph2/3 program in Chronic Obstructive Pulmonary Disease (COPD) LIBTAYO Continue enrollment in NSCLC and various other studies REGN1979 (CD20xCD3) Initiate potentially pivotal Ph2 study in Follicular Lymphoma (FL) and potentially pivotal Ph2 study in Diffuse Large B-Cell Lymphoma (DLBCL) Fasinumab (NGF) Continue patient enrollment in Ph3 long-term safety study and Ph3 efficacy studies in Osteoarthritis Pozelimab (C5) Initiate Ph2 in Paroxysmal Nocturnal Hemoglobinuria (PNH) NEW INDs Expect to advance 4-6 new molecules into clinical development (including more CD3 & CD28 bispecifics) 10 This slide includes pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the disease categories described here.

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11 2019 financial Guidance* * As of January 7, 2019. The guidance does not assume the completion of any significant business development transaction that had not been completed as of the date of the guidance. Regeneron does not undertake any obligation to update publicly any financial projection or guidance, whether as a result of new information, future events, or otherwise Sanofi Collaboration Revenue: Reimbursement of Regeneron Commercialization-Related Expenses $510 – 560MM Non-GAAP unreimbursed R&D† $1,590 – 1,710MM Non-GAAP SG&A† $1,500 – 1,600MM Effective Tax Rate 14 – 16% Capital Expenditures $410 – 490MM † Please refer to slide 2 for important information regarding non-GAAP financial measures and to slide 12 for a reconciliation of these measures to GAAP financial measures

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12 Reconciliation of full year 2019 Non-GAAP to GAAP Financial guidance * Unreimbursed R&D represents R&D expenses reduced by R&D expense reimbursements from the Company's collaborators and/or customers Projected Range (in millions) Low High GAAP unreimbursed R&D* $ 1,855 $ 2,000 R&D: Non-cash share-based compensation expense (265) (290) Non-GAAP unreimbursed R&D $ 1,590 $ 1,710 GAAP SG&A $ 1,700 $ 1,830 SG&A: Non-cash share-based compensation expense (200) (230) Non-GAAP SG&A $ 1,500 $ 1,600

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PORTFOLIO & pipeline PHASE 1 PHASE 2 REGN-EB3 (Ebola virus) REGN3767 (LAG-3) REGN1908-1909 (Feld1) Cemiplimab* (PD-1) Sarilumab* (IL-6R) Dupilumab* (IL-4R) Cemiplimab* (PD-1) Fasinumab† (NGF) Aflibercept (VEGF Trap) Dupilumab* (IL-4R) Alirocumab* (PCSK9) Pozelimab (C5) Cemiplimab* (PD-1) REGN4461 (LEPR) REGN3500* (IL-33) REGN3048-3051 (MERS virus) REGN4018* (MUC16xCD3 bispecific) REGN4659 (CTLA-4) REGN5069 (GFRα3) Sarilumab* (IL-6R) * IN COLLABORATION WITH SANOFI † IN COLLABORATION WITH TEVA AND MITSUBISHI TANABE Evinacumab (ANGPTL3) Trevogrumab (GDF8) + Garetosmab (Activin-A) Evinacumab (ANGPTL3) Garetosmab (Activin-A) Immunology & Inflammatory Diseases Cardiovascular/ Metabolic diseases Oncology Infectious Diseases Ophthalmology Pain Rare Diseases PHASE 3 13 REGN5458* (BCMAxCD3 bispecific) This slide includes pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the disease categories described here. REGN1979 (CD20xCD3 bispecific)

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Adolescent and pediatric atopic dermatitis – high disease burden with limited treatment options 14 Patient had significantly improved overall disease severity, skin clearing and reduced itching IGA: Investigator’s Global Assessment, EASI: Eczema Area and Severity Index Overall rate of treatment-emergent adverse events was comparable between the dupilumab group (72%) and placebo (69%). The rate of overall infections and infestations was numerically lower in the dupilumab group (11%) vs. placebo (20%) No SAEs or events leading to discontinuation in the treatment group Adolescent Atopic Dermatitis (Ages 12 – 17 years) *co-primary endpoints; p< 0.0001 Prior treatments included cycles of prednisone, oral anti-Staph antibiotics, triamcinolone and chronic daily sedating antihistamines Before DUPIXENT This slide includes pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the disease categories described here. For illustrative purposes only. Results are not representative of all patients; and individual results vary. Positive Ph3 data reported; PDUFA date March 11, 2019 DUPIXENT ®: DELIVERING on The “pipeline in a product” promise After DUPIXENT

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Driven by discovery Regeneron’s IO Strategy

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Regeneron’s IO Strategy is built on a Deep Foundation of Science and Technology 619 manuscripts published, 9,351 patent applications filed and 4,945 patents issued over the last 10 years Rapid, automated and high-scale manipulation of mouse DNA to identify and validate therapeutic targets Genetically altered mice derived from modified embryonic stem cells High-throughput screening of antibodies and rapid generation of production cell lines Genetically-humanized immune system in a mouse, producing a diverse range of fully human monoclonal antibodies Fully human T-cell receptors (TCR) against tumor and viral antigens Proprietary method that uses VelocImmune with proprietary antibody manufacturing processes to generate full-length human bispecific antibodies VELOCISUITE® 500,000 exomes sequenced by Regeneron Genetics Center (RGC) 16 ® ® ® ® VELOCI-Bi TM TM

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LIBTAYO®: the Foundation of Our IO strategy 17 Combinations DEVELOPMENT STRATEGY CSCC: THE FIRST OF MANY POTENTIAL APPROVALS Additional Solid & Liquid Tumor Indications Pediatric Glioblastoma (GBM) – Ph1/2 initiated 1L Classical Hodgkin Lymphoma – Ph1 anticipated in 2019 HPV Positive Cancers 2L Cervical Cancer – Ph3 ongoing Non Small Cell Lung Cancer (NSCLC) 1L NSCLC Monotherapy (>50% PD-L1) (n=700) – Ph3 ongoing 1L NSCLC Combination therapy (non-squamous and squamous, stratified by PD-L1 status) – Ph3 amended LIBTAYO + Chemo vs. Chemo Maximize Skin Cancer Opportunity 2L Basal Cell Carcinoma (BCC) – Ph2 (potentially pivotal) ongoing CSCC – Ph3 adjuvant trial to start in 1H19; neo-adjuvant studies to follow Melanoma – regulatory discussions anticipated in 1H19 Immune modulators, vaccines, cell therapies, kinase inhibitors, chemotherapy and bispecifics LIBTAYO is the first and only FDA-approved therapy for patients with advanced CSCC; potentially pivotal study in BCC ongoing We plan to be a major player in indications where PD-1 inhibition has shown activity We have a comprehensive and differentiated IO strategy with LIBTAYO at the core This slide includes pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the disease categories described here.

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LIBTAYO 18 Regeneron’s IO strategy connects multiple individual pieces Kinase Inhibitors CD3 bispecifics Costimulatory bispecifics Chemo Vaccines Tcell Rx GITR LAG-3 CTLA-4

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GITR LIBTAYO 19 Logically and rationally into a cohesive whole ...like pieces in a puzzle, bringing order to chaos Kinase Inhibitors CD3 bispecifics Costimulatory bispecifics Chemo Vaccines Tcell Rx LAG-3 Regeneron’s IO puzzle is evolving and not yet complete; based on science and experimental data, the shape, components and configuration may change CTLA-4

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20 Regeneron’s cd3 & COstimulatory Bispecifics are off-the-shelf drugs with potential to turn patients’ T cells into CAR-T-like cancer killers CAR-T CD3ζ PD-1 scFv Costim Signal 2 Signal 1 + Costimulatory bispecific CD3 bispecific PD-L1/2 Signal 1 Signal 2 + Costim Tumor Target CD3γ CD3ε CD3ε CD3δ TCRα TCRβ CD3ζ CD3ζ CAR-T Mechanism Bispecific/Costimulatory Mechanism The combination of CD3 and costimulatory bispecifics has the potential to activate T cells into highly effective, targeted cancer killers PD-1 PD-L1/2 Tumor Target Tumor Target Tumor Target T cell activation can be inhibited by PD-1 signaling T cell activation can be inhibited by PD-1 signaling

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21 CAR-T CD3ζ PD-1 scFv Costim Signal 2 Signal 1 + Costimulatory bispecific CD3 bispecific PD-L1/2 Signal 1 Signal 2 + Costim CD3γ CD3ε CD3ε CD3δ TCRα TCRβ CD3ζ CD3ζ CAR-T Mechanism Bispecific/Costimulatory Mechanism PD-1 PD-L1/2 Tumor Target Tumor Target Tumor Target LIBTAYO LIBTAYO blocks the stop signal LIBTAYO Regeneron’s cd3 & COstimulatory Bispecifics are off-the-shelf drugs with potential to turn patients’ T cells into CAR-T-like cancer killers LIBTAYO blocks the stop signal Using LIBTAYO to block PD-1 signaling can further enhance the efficacy of CD3 and costimulatory bispecifics

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anti-PD-1 22 Adding COSTIMs to cd3 BISPECIFICs or to ANTI-PD-1 shows synergy in preclinical tumor models Unlike superagonist CD28 mAbs, our CD28 bispecifics have no toxicity, and little or no activity on their own, but when clustered on cells expressing their target, activate signal 2 and synergize with signal 1 (via CD3 bispecific) and/or anti-PD-1 In 2019, Regeneron plans to advance two distinct CD28 bispecific antibodies into clinical development anti-PD-1 + TSA2xCD28 in vivo syngeneic humanized TSA2 mouse model TSA = Tumor Specific Antigen This slide includes pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the disease categories described here. TSA1xCD3 + TSA1xCD28 in vivo xenogeneic humanized TSA1 mouse model Control xCD3 TSA1xCD28 TSA1xCD3 TSA1xCD3 + TSA1xCD28 Control xCD3 TSA1xCD28 TSA1xCD3 + TSA1xCD28 TSA1xCD3 Control anti-PD-1 + TSA2xCD28 TSA2xCD28

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Anti-PD-1 Responsive Tumors TCR binds tumor MHC/peptide Anti-PD-1 Unresponsive Tumors TCR does not recognize tumor MHC/peptide Additional Strategic Opportunities Block T cell inhibition with LIBTAYO (anti-PD-1) monotherapy Enhance with combinations: chemotherapy, other immune modulators (e.g., CTLA-4, LAG-3, GITR), kinase inhibitors, vaccines, costimulatory bispecifics, etc. Initiate immune response with a CD3 bispecific targeting tumor specific antigens (e.g., neoantigens bound to MHC) or tumor associated antigens on cells that are safe to ablate (e.g., CD20) Enhance response with anti-PD-1 and/or costimulatory bispecific directed against a tumor target Major collaboration with bluebird bio to empower and extend CAR-T therapies with novel tumor targeting moieties such as TCRs or reagents that bind peptide/ MHC complexes Can complement with soluble reagents such as anti-PD-1 and CD3 or costimulatory bispecifics Regeneron’s IO Strategy is based on rational combinations Anti-PD-1 mAb monotherapy or combination CD3 bispecific alone, or in combination with PD-1 and/or costims CAR-T therapies alone or in combination 23 This slide includes pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the disease categories described here.

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Putting theory into practice: REGN1979, Our exclusively-owned cd20xcd3 bispecific antibody, demonstrates high orr/cr In our dose escalation Ph1 study, treatment with >5 mg of REGN1979 demonstrated 100% ORR and 80% CR in 10 pts with R/R FL At higher doses in R/R DLBCL we are seeing response rates that make us optimistic about achieving activity comparable to CAR-Ts At doses tested, REGN1979 was well-tolerated in B-NHL: 75% patients had Grade 3/4/5 AEs, no DLTs, 3% discontinued due to AE, no discontinuations due to CRS or immune-related events, no clinically significant neurotoxicity (no seizures/ encephalopathy), 1 death due to related AE* Safety and toxicity profile is encouraging and supports further dose escalation Relapsed/ Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) Relapsed/ Refractory Follicular Lymphoma (R/R FL) Grade 1-3a REGN1979 dose groups <5 mg (n=7) >5-<12 mg (n=5) >18-<40 mg (n=5) ORR 1/7 (14%) 5/5 (100%) 5/5 (100%) CR 1/7 (14%) 4/5 (80%) 4/5 (80%) PR 0/7 (0%) 1/5 (20%) 1/5 (20%) Responding patients who did not progress during study treatment, n/N (% of responders) 1/1 (100%) 4/5 (80%) 5/5 (100%) REGN1979 dose groups <5 mg (n=15) >5-<12 mg (n=11) >18-<40 mg (n=10) ORR 3/15 (20%) 2/11 (18%) 6/10 (60%) CR 0/15 (0%) 1/11 (9%) 2/10 (20%) PR 3/15 (20%) 1/11 (9%) 4/10 (40%) Responding patients who did not progress during study treatment, n/N (% of responders) 1/3 (33%) 1/2 (50%) 3/6 (50%) 24 Initiating potentially pivotal studies in 2019 This slide includes pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the disease categories described here. * gastric perforation in patient with gastric wall lymphoma Data presented at the 2018 American Society of Hematology (ASH) Annual Meeting

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BROADENING OUR IMMUNO-ONCOLOGY PIPELINE Approved LIBTAYO CSCC LIBTAYO Potential Indications LIBTAYO NSCLC, Cervical, BCC, Pediatric LIBTAYO + REGN1979 (CD20xCD3) B-Cell NHL Clinical Development REGN1979 (CD20xCD3) B-Cell NHL REGN5458 (BCMAxCD3) Multiple Myeloma REGN4018 (MUC16xCD3) Ovarian Cancer REGN4659 (CTLA-4) NSCLC REGN3767 (LAG-3) Solid/hematologic malignancies Pre-IND TSAxCD28 Solid Tumor TSAxCD28 B cell malignancy GITR Solid tumors And More To Come HLA/peptide (tumor and viral), etc. 25 TSA = Tumor Specific Antigen This slide includes pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and efficacy of these drug candidates have not been evaluated by any regulatory authorities for the disease categories described here.

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PD-1/L1 PD-1/L1 MANY COMPANIES CAN DO ONE THING... CD3 bispecifics Costimulatory bispecifics CTLA-4, LAG-3, GITR 26

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PD-1/L1 PD-1/L1 few can do many things is one of the few CD3 bispecifics Costimulatory bispecifics CTLA-4, LAG-3, GITR 27

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Thank you

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Exhibit 99.3

 

2019 Financial Overview January 9th Executive Vice President of Finance – Chief Financial Officer Robert Landry

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Note regarding FORWARD-LOOKING STATEMENTs and non-gaap financial measures 2 This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron’s 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, Libtayo® (cemiplimab) Injection, fasinumab, evinacumab, Regeneron’s immuno-oncology programs (including its costimulatory bispecific portfolio), Regeneron’s earlier-stage product candidates, and the use of human genetics in Regeneron’s research programs; the extent to which the results from Regeneron’s research programs or preclinical testing may lead to advancement of product candidates to clinical trials or therapeutic applications; 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 Regeneron’s product candidates in clinical trials; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron’s late-stage product candidates and new indications for marketed products, including without limitation EYLEA, Dupixent, Praluent, Kevzara, Libtayo, fasinumab, and evinacumab; the likelihood and timing of achieving any of the anticipated milestones described in this presentation; the extent to which the results from the research and development programs conducted by Regeneron or its collaborators may be replicated in other studies and lead to therapeutic applications; ongoing regulatory obligations and oversight impacting Regeneron’s marketed products (such as EYLEA, Dupixent, Praluent, Kevzara, and 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 Regeneron’s ability to continue to develop or commercialize Regeneron’s products and product candidates; competing drugs and product candidates that may be superior to Regeneron’s products and product candidates; uncertainty of market acceptance and commercial success of Regeneron’s products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron's products and product candidates; the availability and extent of reimbursement of the Company’s products 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; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; the ability of Regeneron’s collaborators, suppliers, or other third parties to perform filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s products and product candidates; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance, including financial guidance relating to Sanofi collaboration revenue, non-GAAP unreimbursed R&D, non-GAAP SG&A, effective tax rate, and capital expenditures; risks associated with intellectual property of other parties and pending or future litigation relating thereto, including without limitation the patent litigation proceedings relating to EYLEA, Dupixent, and Praluent, the ultimate outcome of any such litigation proceeding, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition; and the potential for any license or collaboration agreement, including Regeneron’s 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. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the fiscal year ended December 31, 2017 and its Form 10-Q for the quarterly period ended September 30, 2018, including in each case in the section thereof captioned “Item 1A. Risk Factors.” Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. This presentation uses non-GAAP unreimbursed R&D and non-GAAP SG&A, which are financial measures that are not calculated in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”). These non-GAAP financial measures are computed by excluding certain non-cash and other items from the related GAAP financial measure. Non-GAAP adjustments also include the income tax effect of reconciling items. The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance. For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company’s control, such as the Company’s stock price on the dates share-based grants are issued. Management uses these and other non-GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. Additionally, such non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company’s core business operations. However, there are limitations in the use of these and other non-GAAP financial measures as they exclude certain expenses that are recurring in nature. Furthermore, the Company’s non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies. Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP. A reconciliation of the Company's full year 2019 non-GAAP to GAAP financial guidance is provided at the end of this presentation.

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2019 financial overview TAX OVERVIEW COGS & COCM LIBTAYO® ACCOUNTING REGENERON/SANOFI RESTRUCTURE IO COLLABORATION INTERACTIVE ANALYST CENTER 2018 tax review & 2019 and beyond guidance Review Cost of Goods Sold (COGS) & Cost of Collaboration and Contract Manufacturing (COCM) Review of accounting for net sales and profits/losses Overview of the changes to the IO Discovery and Development Agreement Introduction to the Interactive Analyst Center - a repository of financial information and operational data 3

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Tax overview: 2018 review 4 * as of November 6, 2018 Given the uncertainty due to the passage of the Tax Cuts and Jobs Act (TCJA) late in 2017 and the need for significant regulatory guidance from the U.S. Treasury, we have updated our effective tax rate guidance throughout 2018. The primary driver of lowering our guidance has been various one-time items: Tax planning including the acceleration of tax deductions and deferral of taxable income in response to TCJA, secured with the filing of our 2017 tax return Increase in our federal R&D and Orphan tax credits for both 2017 and 2018 In response to changes in the global tax environment, Regeneron internally restructured how it holds its intellectual property overseas in 4Q18. In accordance with GAAP, we recorded a net tax benefit related to the transaction We will treat this tax benefit as a non-GAAP adjustment for 4Q18 earnings We believe the new structure will allow us to maintain tax benefits associated with Regeneron’s Irish operations in the foreseeable future GAAP Prior:* 11 - 13% Revised: 0 - 2% 2018 Full Year Effective Tax Rate Guidance Period GAAP 1Q18 18.3% 2Q18 16.0% 3Q18 6.5% YTD 3Q18 13.5% Effective Tax Rate

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Tax Overview: 2019 and beyond 5 Tax Strategy and Longer-Term Rate Guidance 2019 Effective Tax Rate (ETR) Guidance 14 – 16% Positively impacted, as compared to 21% federal statutory rate, by: R&D and Orphan tax credits, foreign-derived intangible income (FDII) deduction, and deductions related to share-based compensation Forecasted increased profitability of non-U.S. operations, now subject to global intangible low taxed income (GILTI) tax Negatively impacted by: Non-deductible prescription drug fee and limitations on deductibility of executive compensation Tax benefit associated with share-based compensation will continue to cause volatility in our tax rate on a quarterly basis Longer-term tax rate should remain consistent with 2019 levels until GILTI/FDII deductions change under Tax Cuts and Jobs Act We continue to monitor regulatory guidance from U.S. Treasury under the Tax Cuts and Jobs Act, which could impact our ETR guidance We do not believe that currently anticipated changes in the global tax environment will have a material impact on our go-forward tax rate ETR could fluctuate based on geographic mix of earnings

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LIBTAYO was approved in the U.S. on Sept 28, 2018 and approval is expected in the EU in 1H19 LIBTAYO® ACCOUNTING REVIEW 6 Aflibercept is an investigational medicine for the indications listed here. The safety and efficacy of this drug candidate has not been fully evaluated by any regulatory authority for the disease categories indicated here. U.S. LIBTAYO Ex-U.S. LIBTAYO* Revenue – Net Product Sales U.S. sales of LIBTAYO will be recorded in the Net Product Sales line on Regeneron’s Income Statement Revenue – Collaboration Revenue Regeneron will record its share of profits or losses within the Sanofi Collaboration Revenue line item Regeneron will record reimbursements from Sanofi related to Regeneron’s incurred ex-U.S. commercialization expenses and related manufacturing costs COGS / COCM U.S. COGS will include product-related COGS, royalties on U.S. net sales, and the Regeneron payment of Sanofi’s share of gross profit on U.S. sales of LIBTAYO Ex-U.S. COCM will include product-related costs for product manufactured for Sanofi SG&A Outflow: Regeneron-incurred U.S. commercialization expenses Outflow: Regeneron reimbursement of 50% of Sanofi-incurred U.S. commercialization expenses Inflow: Sanofi reimbursement of 50% of Regeneron-incurred U.S. commercialization expenses Regeneron-incurred ex-U.S. commercialization expenses * Ex-U.S. sales of LIBTAYO will be recorded by Sanofi

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Libtayo® accounting illustrative example 7 PLEASE NOTE ALL NUMBERS ARE ILLUSTRATIVE AND ARE NOT TO BE USED AS GUIDANCE Regeneron and Sanofi entered into a license agreement with Bristol-Myers Squibb Company, E. R. Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd. and will pay royalties of 8.0% on worldwide sales of LIBTAYO through December 31, 2023, and royalties of 2.5% from January 1, 2024 through December 31, 2026. Regeneron will pay the royalties on U.S. net sales and Sanofi will pay the royalties on ex-U.S. net sales. LIBTAYO Alliance Product P&L U.S. Ex-U.S. Net Sales 500 A 250 Cost of Goods Sold (includes royalty) 100 B 75 F Gross Profit 400 C 175 SG&A REGN Expenses 200 D 25 G Sanofi Expenses 50 E 100 Total SG&A 250 125 Net Profit / (Loss) 150 50 REGN Share of Net Profit / (Loss) 75 25 H Regeneron Income Statement U.S. Ex-U.S. Net Product Sales 500 A Collaboration Revenue Profit Split 25 H Other Revenue 75 F Reimbursement of REGN SG&A 25 G Total Collaboration Revenue 125 Cost of Goods Sold (COGS) Product Supply Cost/Royalties 100 B Sanofi Share of U.S. Gross Profit 200 50% * C Total COGS 300 Cost of Collaboration and Contract Manufacturing (COCM) Product Supply Cost/Royalties 75 F SG&A REGN Incurred SG&A 200 D 25 G REGN Reimbursement of Sanofi SG&A 25 50% * E Sanofi Reimbursement of REGN SG&A -100 50% * D Total SG&A 125 REGN Share of Net Profit / (Loss) 75 25

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Cost of Goods sold (COGS) & Cost of Collaboration and Contract manufacturing (COCM) 8 Cost of Collaboration and Contract Manufacturing Cost of Goods Sold Costs related to products for which we record product sales (e.g., U.S. EYLEA®, ARCALYST®, U.S. LIBTAYO®): costs to manufacture commercial supplies royalties on products sold Starting in 4Q18, payment of Sanofi’s share of gross profit on U.S. sales of LIBTAYO Start-up costs and unabsorbed overhead costs in connection with our Limerick, Ireland manufacturing facility Costs related to product revenues recorded by our collaborators (e.g., Ex-U.S. EYLEA, DUPIXENT®, PRALUENT®, KEVZARA®, Ex-U.S. LIBTAYO): costs Regeneron incurs to manufacture Drug Product for products that are sold by our collaborators royalties Regeneron is contractually obligated to pay to third parties based on sales of product by our collaborators Costs associated with validation activities for collaborated products at our Limerick manufacturing facility Regeneron’s reimbursement of COCM by Sanofi and Bayer are recorded within the “Other Revenue” line item in the respective related collaboration revenue summary table in our MD&A

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REGENERON/SANOFI RESTRUCTURE IO COLLABORATION 9 Key Terms of Restructured Agreement Sanofi will pay Regeneron $462 million – its funding obligation for the remainder of the term of the agreement. This payment includes Sanofi’s share of 4Q18 costs, up to $120 million in dedicated development funding for BCMAxCD3 and MUC16xCD3, and a termination payment. Regeneron will commit up to $70 million to further develop BCMAxCD3 and up to $50 million to further develop MUC16xCD3. Sanofi secures the right to opt-in to each program when the earlier of proof of concept is achieved or when the allocated funding is expended. BCMAxCD3 – Post opt-in, Sanofi will lead development and commercialization and fund 100% of development costs, with Regeneron reimbursing up to 50% out of its share of collaboration profits. Sanofi and Regeneron will share global profits equally. MUC16xCD3 – Post opt-in, Regeneron will lead development and lead commercialization in the U.S. The companies will share development costs and global profits equally. Sanofi will lead commercialization outside the U.S. The companies’ ongoing collaboration for the development and commercialization of LIBTAYO is unaffected by the amended IO Discovery and Development Agreement. Regeneron retains full rights to its other immuno-oncology programs that were previously in the immuno-oncology discovery program. Regeneron and Sanofi announce restructuring of the IO Collaboration for Discovery and Development Agreement Regeneron retains exclusive rights to its other immuno-oncology discovery and development programs The original 2015 IO Agreement was scheduled to end in approximately mid-2020 and this revision focuses ongoing development on two clinical-stage bispecific antibody programs (BCMAxCD3 and MUC16xCD3)

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The Interactive Analyst Center is a repository of Regeneron’s historical reported financials and key operational data maintained by a third party This tool is meant to facilitate data gathering and to make researching Regeneron easier Access the Interactive Analyst Center via the Regeneron IR website: https://investor.regeneron.com/financial-information* Regeneron’s Interactive Analyst Center 10 Aflibercept is an investigational medicine for the indications listed here. The safety and efficacy of this drug candidate has not been fully evaluated by any regulatory authority for the disease categories indicated here. Available data includes GAAP financials, historic non-GAAP Measures, Reconciliation of non-GAAP Measures, Net Product Sales of Regeneron Discovered Products, Collaboration Revenues, and Other Revenues * The link and access to the Interactive Analyst Center are provided for convenience and should not be used as the sole basis of any analysis. Please refer to Regeneron’s reports filed with the U.S. Securities and Exchange Commission for further information.

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11 2019 financial Guidance* * As of January 7, 2019. The guidance does not assume the completion of any significant business development transaction that had not been completed as of the date of the guidance. Regeneron does not undertake any obligation to update publicly any financial projection or guidance, whether as a result of new information, future events, or otherwise Sanofi Collaboration Revenue: Reimbursement of Regeneron Commercialization-Related Expenses $510 – 560MM Non-GAAP unreimbursed R&D† $1,590 – 1,710MM Non-GAAP SG&A† $1,500 – 1,600MM Effective Tax Rate 14 – 16% Capital Expenditures $410 – 490MM † Please refer to slide 2 for important information regarding non-GAAP financial measures and to slide 12 for a reconciliation of these measures to GAAP financial measures

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12 Reconciliation of full year 2019 Non-GAAP to GAAP Financial guidance * Unreimbursed R&D represents R&D expenses reduced by R&D expense reimbursements from the Company's collaborators and/or customers Projected Range (in millions) Low High GAAP unreimbursed R&D* $ 1,855 $ 2,000 R&D: Non-cash share-based compensation expense (265) (290) Non-GAAP unreimbursed R&D $ 1,590 $ 1,710 GAAP SG&A $ 1,700 $ 1,830 SG&A: Non-cash share-based compensation expense (200) (230) Non-GAAP SG&A $ 1,500 $ 1,600

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13 Aflibercept is an investigational medicine for the indications listed here. The safety and efficacy of this drug candidate has not been fully evaluated by any regulatory authority for the disease categories indicated here. Q&A

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