REGENERON PHARMACEUTICALS, INC. 10-Q

ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS This Quarterly Report on Form 10-Q contains forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (where applicable, together with its subsidiaries, "Regeneron," "Company," "we," "us," and "our"), and actual events or results may differ materially from these forward-looking statements. 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 impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators’ ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed by Regeneron and/or its collaborators (collectively, "Regeneron’s Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of Regeneron's Products and our product candidates and research and clinical programs now underway or planned, including without limitation EYLEA ® (aflibercept) Injection, Dupixent ® (dupilumab) Injection, Libtayo ® (cemiplimab) Injection, Praluent ® (alirocumab) Injection, Kevzara ® (sarilumab) Injection, fasinumab, evinacumab, REGN-EB3, garetosmab, pozelimab, REGN-COV2, Regeneron's oncology programs (including its costimulatory bispecific portfolio), Regeneron's earlier-stage programs, and the use of human genetics in Regeneron's research programs; the likelihood and timing of achieving any of our anticipated development milestones referenced in this report; safety issues resulting from the administration of Regeneron's Products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and product candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of our late-stage product candidates and new indications for Regeneron's Products, including without limitation EYLEA, Dupixent, Libtayo, Praluent, Kevzara, fasinumab, evinacumab, REGN-EB3, garetosmab, pozelimab, REGN-COV2, and REGN1979; the extent to which the results from the research and development programs conducted by us and/or our collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; ongoing regulatory obligations and oversight impacting Regeneron's Products (such as EYLEA, Dupixent, Libtayo, Praluent, and Kevzara), research and clinical programs, and business, including those relating to patient privacy; determinations by regulatory and administrative governmental authorities which may delay or restrict our ability to continue to develop or commercialize Regeneron's Products and product candidates; competing drugs and product candidates that may be superior to, or more cost effective than, 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; our ability to manufacture and manage supply chains for multiple products and product candidates; the ability of our collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and product candidates; the availability and extent of reimbursement of Regeneron’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; unanticipated expenses; the costs of developing, producing, and selling products; our ability to meet any of our financial projections or guidance, including without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including our agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd. (or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA, Dupixent, and Praluent described further in Note 12 to our Condensed Consolidated Financial Statements included in this report), other litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those described in Note 12 to our Condensed Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition. These statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any such statements. In evaluating such statements, shareholders and potential investors should specifically consider the various factors identified under Part II, Item 1A. "Risk Factors," which could cause actual events and results to differ materially from those indicated by such forward-looking statements. We do not undertake any obligation to update publicly any forward-looking statement, whether as a result of new information, future events, or otherwise. 26 Table of Contents Overview Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious diseases. Our commercialized medicines and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases, and rare diseases. Our core business strategy is to maintain a strong foundation in basic scientific research and discovery-enabling technologies, and to build on that foundation with our clinical development, manufacturing, and commercial capabilities. Our objective is to continue to be an integrated, multi-product biotechnology company that provides patients and medical professionals with important options for preventing and treating human diseases. Selected financial information is summarized as follows: Three Months Ended June 30, Six Months Ended June 30, (In millions, except per share data) 2020 2019 * 2020 2019 * Revenues $ 1,952.0 $ 1,577.8 $ 3,780.2 $ 2,950.4 Net income $ 897.3 $ 193.1 $ 1,521.9 $ 654.2 Net income per share - diluted $ 7.61 $ 1.68 $ 13.03 $ 5.69 * Certain revisions have been made to the previously reported June 30, 2019 revenues. See Note 1 to our Condensed Consolidated Financial Statements for further details. Marketed Products We currently have seven products that have received marketing approval, which are currently marketed by us, Bayer, and/or Sanofi: 27 Table of Contents Product Disease Area (1) Territory U.S. EU Japan ROW (6) EYLEA (aflibercept) Injection (2) - Neovascular age-related macular degeneration ("wet AMD") a a a a - Diabetic macular edema ("DME") a a a a - 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 - Myopic choroidal neovascularization ("mCNV") a a a - Diabetic retinopathy a - Neovascular glaucoma ("NVG") a Dupixent (dupilumab) Injection (3) - Atopic dermatitis (in adults and adolescents) (7) a a a a - Atopic dermatitis (in pediatrics 6–11 years of age) a - Asthma (in adults and adolescents) a a a a - Chronic rhinosinusitis with nasal polyposis ("CRSwNP") a a a a Libtayo (cemiplimab) Injection (3)(4) - Metastatic or locally advanced cutaneous squamous cell carcinoma ("CSCC") a a a Praluent (alirocumab) Injection (5) - LDL-lowering in heterozygous familial hypercholesterolemia ("HeFH") or clinical atherosclerotic cardiovascular disease ("ASCVD") (in adults) a a (9) a - Cardiovascular risk reduction in patients with established cardiovascular disease a a a Kevzara (sarilumab) Solution for Subcutaneous Injection (3) - Rheumatoid arthritis ("RA") (in adults) a a a a ARCALYST ® (rilonacept) Injection for Subcutaneous Use - 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 (8) - 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) Marketed as Libtayo (cemiplimab-rwlc) Injection in the United States (5) In collaboration with Sanofi prior to April 2020. Effective April 2020, the Company is solely responsible for the development and commercialization of Praluent in the United States, and Sanofi is solely responsible for the development and commercialization of Praluent outside of the United States. Pursuant to the April 2020 agreement, Sanofi pays us a royalty on net product sales of Praluent outside the United States. Refer to "Collaboration and License Agreements" section below for further details. (6) Rest of world. Checkmark in this column indicates that the product has received marketing approval in at least one country outside of the United States, European Union ("EU"), or Japan (7) Approval in Japan is for adults and adolescents 15 years of age and older (8) 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 product sales of ZALTRAP (9) No longer marketed by Sanofi in Japan due to injunction (see Note 12 to our Condensed Consolidated Financial Statements for further details) 28 Table of Contents Net Product Sales of Regeneron-Discovered Products Net Product Sales Recorded by Regeneron Three Months Ended June 30, 2020 2019 % Change U.S. ROW Total U.S. ROW Total (Total Sales) EYLEA (a) U.S. $ 1,113.7 $ 641.0 $ 1,754.7 $ 1,160.3 $ 715.3 $ 1,875.6 (6 %) Dupixent (b) $ 770.4 $ 174.6 $ 945.0 $ 454.7 $ 102.6 $ 557.3 70 % Libtayo (b) U.S. $ 63.3 $ 16.7 $ 80.0 $ 40.8 — $ 40.8 96 % Praluent (c) U.S. $ 47.2 $ 39.4 $ 86.6 $ 26.5 $ 47.2 $ 73.7 18 % Kevzara (b) $ 36.5 $ 31.8 $ 68.3 $ 34.2 $ 24.3 $ 58.5 17 % ZALTRAP (b) $ 1.7 $ 25.0 $ 26.7 $ 1.3 $ 25.3 $ 26.6 — % ARCALYST U.S. $ 2.7 — $ 2.7 $ 4.2 — $ 4.2 (36 %) Net Product Sales Recorded by Regeneron Six Months Ended June 30, 2020 2019 % Change U.S. ROW Total U.S. ROW Total (Total Sales) EYLEA (a) U.S. $ 2,285.7 $ 1,322.7 $ 3,608.4 $ 2,234.4 $ 1,384.7 $ 3,619.1 — % Dupixent (b) $ 1,449.4 $ 350.8 $ 1,800.2 $ 757.7 $ 173.3 $ 931.0 93 % Libtayo (b) U.S. $ 125.0 $ 29.8 $ 154.8 $ 67.6 — $ 67.6 129 % Praluent (c) U.S. $ 82.3 $ 84.1 $ 166.4 $ 49.4 $ 88.2 $ 137.6 21 % Kevzara (b) $ 71.8 $ 56.6 $ 128.4 $ 54.9 $ 37.3 $ 92.2 39 % ZALTRAP (b) $ 3.2 $ 51.5 $ 54.7 $ 1.8 $ 49.3 $ 51.1 7 % ARCALYST U.S. $ 5.7 — $ 5.7 $ 7.7 — $ 7.7 (26 %) (a) Regeneron records net product sales of EYLEA in the United States. Bayer records net product sales of EYLEA outside the United States. The Company records its share of profits/losses in connection with sales of EYLEA outside the United States. (b) Regeneron records net product sales of Libtayo in the United States. Sanofi records net product sales of Libtayo outside the United States and global net product sales of Dupixent, Kevzara, and ZALTRAP. The Company records its share of profits/losses in connection with (i) sales of Libtayo outside the United States, and (ii) global sales of Dupixent and Kevzara. Sanofi pays the Company a percentage of net sales of ZALTRAP. (c) Effective April 1, 2020, Regeneron records net product sales of Praluent in the United States. Also effective April 1, 2020, Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales. Previously, Sanofi recorded global net product sales of Praluent and the Company recorded its share of profits/losses in connection with such sales. Refer to "Marketed Products" section above and "Collaboration and License Agreements - Sanofi" section below for further details. Programs in Clinical Development All 23 of our product candidates in clinical development, including the five U.S. Food and Drug Administration ("FDA") approved products which we are investigating in additional indications, were discovered in our research laboratories and are summarized in the table below. We believe that our ability to develop product candidates is enhanced by the application of our VelociSuite ® technology platforms. We continue to invest in the development of enabling technologies to assist in our efforts to identify, develop, manufacture, and commercialize new product candidates. There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development (including any post-approval studies), uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes to drug pricing and reimbursement regulations and requirements, and changes in the competitive landscape affecting a product candidate. The planning, execution, and results of our clinical programs are significant factors that can affect our operating and financial results. We and our collaborators conduct clinical trials in multiple countries across the world. The COVID-19 pandemic and the restrictions adopted around the globe to reduce the spread of the disease have impacted and will continue to impact our clinical development programs. We continue to evaluate the impact of the COVID-19 pandemic on an individual trial basis and are 29 Table of Contents working to ensure patient safety, provide sufficient supply of product candidates for the studies, and oversee trial management. At this time, we expect fully enrolled clinical studies to remain generally on track. While the COVID-19 pandemic and the resulting constraints on healthcare resources and local or regional restrictions initially adversely impacted new clinical studies and recruitment of new patients into open studies, enrollment in both new and ongoing clinical studies started to resume as regions relaxed their restrictions and healthcare resources started to become more available for non-COVID-19 activities. However, there has been a resurgence of COVID-19 cases in many regions across the world, and any resurgence of COVID-19 cases in the regions in which we or our collaborators conduct clinical trials may require our expectations relating to the impacted studies to adjust. The ultimate impact (including possible delays) resulting from the COVID-19 pandemic will depend, among other factors, on the extent of the pandemic in the areas with study sites for our or our collaborators' clinical programs. It is possible that the COVID-19 pandemic may cause clinical disruptions beyond those we have described. In addition, there may be delays in the timing of regulatory review and other projected milestones discussed in the table below. Refer to Part II, Item 1A. "Risk Factors" for a description of these and other risks and uncertainties that may affect our clinical programs, including those related to the COVID-19 pandemic. 30 Table of Contents Clinical Program Phase 1 Phase 2 Phase 3 Regulatory Review (i) 2020 Events to Date Select Upcoming Milestones (k) Ophthalmology EYLEA (b) - High-dose formulation in wet AMD - Retinopathy of prematurity ("ROP") (c) - Approved by Ministry of Health, Labour and Welfare ("MHLW") for NVG in Japan - High-dose formulation in wet AMD - Pre-filled syringe approved by European Commission ("EC") - High-dose formulation in DME Immunology & Inflammatory Diseases Dupixent (dupilumab) (a) Antibody to IL-4R alpha subunit - Peanut allergy - Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3) (d) - Atopic dermatitis in pediatrics (6–11 years of age) (EU) (d) - Approved by FDA for expanded atopic dermatitis indication in pediatrics (6–11 years of age) - EC decision for expanded atopic dermatitis indication in pediatrics (6–11 years of age) (second half 2020) - Asthma in pediatrics (6–11 years of age) - Auto-injector for 300 mg dose (Japan) - Approved by National Medical Products Administration ("NMPA") in China for adults with atopic dermatitis - Report results from Phase 3 study for atopic dermatitis in pediatric patients (6 months–5 years of age) (2022) - Eosinophilic esophagitis ("EoE") (c) in adults, adolescents, and pediatrics - Approved by MHLW for CRSwNP in Japan - Report results from Phase 3 study for asthma in pediatric patients (6–11 years of age) (second half 2020) - Chronic obstructive pulmonary disease ("COPD") - Approved by FDA for 300 mg auto-injector - Bullous pemphigoid (Phase 2/3) (c) - Reported that Part A of the Phase 3 trial in adult and adolescent patients with EoE met both co-primary endpoints - Resubmit supplemental Biologics License Application ("sBLA") for 200 mg auto-injector (second half 2020) - Chronic spontaneous urticaria - Prurigo nodularis - Presented results from Phase 2a trial in grass allergy - Report results from Phase 2 study in peanut allergy (second half 2020) - Initiated second confirmatory Phase 3 trial in COPD - Report results from Part B of the Phase 3 study in adults and adolescents with EoE (2022) 31 Table of Contents Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review (i) 2020 Events to Date Select Upcoming Milestones (k) - Allergic bronchopulmonary aspergillosis ("ABPA") - Initiate Phase 3 study in hand and foot atopic dermatitis (second half 2020) Kevzara (sarilumab) (a) Antibody to IL-6R - Polyarticular-course juvenile idiopathic arthritis ("pcJIA") - Hospitalized "critical" COVID-19 patients (outside the United States) - Stopped Phase 3 U.S. trial in COVID-19 patients due to study not meeting its primary and key secondary endpoints - Report results from Phase 3 study outside the United States in COVID-19 (second half 2020) - Systemic juvenile idiopathic arthritis ("sJIA") - Discontinued clinical development in polymyalgia rheumatica and giant cell arteritis REGN3500 (a) Antibody to IL-33. Studied as monotherapy and in combination with Dupixent. - Asthma - Discontinued further clinical development in atopic dermatitis due to lack of efficacy - COPD REGN1908-1909 (f) Multi-antibody therapy to Feld1 - Cat allergy - Report results from Phase 2 study in cat allergic asthmatics (first half 2021) REGN5713-5714-5715 Antibody to Betv1 - Birch allergy Oncology Libtayo (cemiplimab) (a)(h) Antibody to PD-1 - Solid tumors and advanced hematologic malignancies - Basal cell carcinoma ("BCC") (potentially pivotal study) - First-line non-small cell lung cancer ("NSCLC"), monotherapy - Reported that Phase 3 monotherapy trial in first-line NSCLC met its primary endpoint. The Independent Data Monitoring Committee ("IDMC") recommended stopping the trial early due to highly significant improvement in overall survival. - Submit sBLA and Marketing Authorization Application ("MAA") for first-line NSCLC, monotherapy (second half 2020) 32 Table of Contents Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review (i) 2020 Events to Date Select Upcoming Milestones (k) - Metastatic or locally advanced CSCC (d) - First-line NSCLC, chemotherapy combination - Reported that Phase 2 study in BCC demonstrated clinically-meaningful and durable responses - Complete patient enrollment in Phase 3 first-line NSCLC chemotherapy combination study (second half 2020) - Neoadjuvant CSCC - Second-line cervical cancer (e) - Submit sBLA and MAA for BCC (second half 2020) - Adjuvant CSCC - Interim analysis from Phase 3 study in cervical cancer (2021) REGN1979 Bispecific antibody targeting CD20 and CD3 - Certain B-cell malignancies (c) - B-cell non-Hodgkin lymphoma ("B-NHL") (potentially pivotal study) - Expanded potentially pivotal Phase 2 program with different subtypes of NHL - Report updated results from initial study in certain B-cell malignancies (second half 2020) REGN5458 (a) Bispecific antibody targeting BCMA and CD3 - Multiple myeloma - Report updated results from initial study in multiple myeloma (second half 2020) REGN5459 (a) Bispecific antibody targeting BCMA and CD3 - Multiple myeloma REGN4018 (a) Bispecific antibody targeting MUC16 and CD3 - Platinum-resistant ovarian cancer REGN5678 Bispecific antibody targeting PSMA and CD28 - Prostate cancer REGN5093 Bispecific antibody targeting two distinct MET epitopes - MET-altered advanced NSCLC REGN3767 (f) Antibody to LAG-3 - Solid tumors and advanced hematologic malignancies 33 Table of Contents Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review (i) 2020 Events to Date Select Upcoming Milestones (k) Cardiovascular/Metabolic Diseases Praluent (alirocumab) (j) Antibody to PCSK9 - Homozygous familial hypercholesterolemia ("HoFH") (c) in adults and pediatrics - HoFH in adults (U.S.) (c) - Reported results from Phase 3 study in adult patients with HoFH - FDA decision on sBLA for HoFH in adults (target action date of April 4, 2021) - HeFH in pediatrics Evinacumab (f) (REGN1500) Antibody to ANGPTL3 - Refractory hypercholesterolemia (both HeFH and non-FH) - HoFH (U.S.) (c)(d) - Submitted MAA for HoFH - FDA decision on BLA and EC decision on MAA for HoFH (first half 2021) - Severe hypertriglyceridemia Pozelimab (f) (REGN3918) Antibody to C5 - Paroxysmal nocturnal hemoglobinuria ("PNH") (c) - Initiate combination program with Alnylam's cemdisiran (second half 2020) - CD55-deficient protein-losing enteropathy (c) - Initiate Phase 3 program in PNH (next 12 months) Garetosmab (f) (REGN2477) Antibody to Activin A - Fibrodysplasia ossificans progressiva ("FOP") (c)(d)(e) (potentially pivotal study) - Reported results from Phase 2 study in FOP - Submit BLA and MAA for FOP (first half 2021) - Initiate Phase 3 study for FOP in pediatrics (first half 2021) REGN4461 (f) Agonist antibody to leptin receptor ("LEPR") - Generalized lipodystrophy (e) Pain Fasinumab (l)(f) (REGN475) Antibody to NGF - Osteoarthritis pain of the knee or hip (e) - Reported top-line results from Phase 3 trials in osteoarthritis pain of the knee or hip - Report additional longer-term safety results from Phase 3 studies in osteoarthritis pain of the knee or hip (first half 2021) REGN5069 Antibody to GFRα3 - Osteoarthritis pain of the knee (e) - Report results from Phase 2 study in osteoarthritis pain of the knee (second half 2020) 34 Table of Contents Clinical Program (continued) Phase 1 Phase 2 Phase 3 Regulatory Review (i) 2020 Events to Date Select Upcoming Milestones (k) Infectious Diseases REGN-EB3 (f)(g) (REGN3470-3471-3479) Multi-antibody therapy to Ebola virus infection ("Ebola") - Ebola (U.S.) (c)(d) - FDA decision on BLA for Ebola (target action date of October 25, 2020) REGN-COV2 (g) (REGN10933-10987) Multi-antibody therapy to SARS-CoV-2 virus - COVID-19 multi-dose safety study - COVID-19 treatment (Phase 2/3) - COVID-19 prevention (m) - Two papers published in Science describing REGN-COV2 - Report initial virology and biomarker results from treatment trials (September 2020) Note: For purposes of the table above, a program is classified in Phase 1, 2, or 3 clinical development after recruiting for the corresponding study or studies has commenced (a) In collaboration with Sanofi (b) In collaboration with Bayer outside of the United States (c) FDA granted orphan drug designation (d) FDA granted Breakthrough Therapy designation (e) FDA granted Fast Track designation (f) Sanofi did not opt-in to or elected not to continue to co-develop the product candidate. Under the terms of our agreement, Sanofi is entitled to receive royalties on any future sales of the product candidate. (g) We and the Biomedical Advanced Research Development Authority ("BARDA") of the U.S. Department of Health and Human Services ("HHS") are parties to agreements whereby HHS provides certain funding to support research and development of these antibodies. (h) Studied as monotherapy and in combination with other antibodies and treatments (i) Information in this column relates to U.S., EU, and Japan regulatory submissions only (j) In collaboration with Sanofi prior to April 2020. Effective April 2020, the Company is solely responsible for the development and commercialization of Praluent in the United States, and Sanofi is solely responsible for the development and commercialization of Praluent outside of the United States. Refer to "Collaboration and License Agreements" section below for further details. (k) As described in the section preceding the table above and Part II, Item 1A. "Risk Factors," development timelines may be further subject to change as a result of the impact of the COVID-19 pandemic (l) In collaboration with Teva and Mitsubishi Tanabe Pharma (m) Conducted jointly with the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the National Institutes of Health ("NIH") 35 Table of Contents General Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the continued success in commercializing EYLEA and Dupixent. We expect to continue to incur substantial expenses related to our research and development activities, a portion of which we expect to be reimbursed by our collaborators. Also, our research and development activities outside our collaborations, the costs of which are not reimbursed, are expected to expand and require additional resources. We also expect to incur substantial costs related to the commercialization of our marketed products. Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our marketed products; the scope and progress of our research and development efforts; the timing of certain expenses; the continuation of our collaborations, in particular with Sanofi and Bayer, including our share of collaboration profits or losses from sales of commercialized products and the amount of reimbursement of our research and development expenses that we receive from collaborators; and the amount of income tax expense we incur, which is partly dependent on the profits or losses we earn in each of the countries in which we operate. We cannot predict whether or when new products or new indications for marketed products will receive regulatory approval or, if any such approval is received, whether we will be able to successfully commercialize such product(s) and whether or when they may become profitable. Additional Information - Clinical Development Programs REGN-COV2 We are using our end-to-end antibody technologies to discover and develop brand new therapeutic antibodies for COVID-19. The Company is advancing REGN-COV2, a novel investigational antibody "cocktail" treatment designed to prevent and treat infection from the SARS-CoV-2 virus. The use of our two-antibody "cocktail" is intended to diminish the risk of viral escape by effectively binding to the virus's critical spike protein in two separate, non-overlapping locations. In April 2020, the Company moved its leading neutralizing antibodies into pre-clinical and clinical-scale cell production lines, and in June 2020, initiated its first clinical trial of REGN-COV2. Following a positive review from the IDMC of REGN-COV2 Phase 1 safety results in an initial cohort, the program advanced to late-stage clinical trials (see table above for further details). The REGN-COV2 clinical program consists of the following separate study populations: hospitalized COVID-19 patients, non-hospitalized symptomatic COVID-19 patients, and uninfected people with close exposure to a COVID-19 patient (such as the patient's housemate). Fasinumab In August 2020, we announced that two Phase 3 trials, FACT OA1 and FACT OA2, achieved the co-primary endpoints for fasinumab 1 mg monthly, demonstrating significant improvements in pain and physical function over placebo at week 16 and week 24, respectively. Fasinumab 1 mg monthly also showed nominally significant benefits in physical function in both trials and pain in one trial, when compared to the maximum FDA-approved prescription doses of non-steroidal anti-inflammatory drugs for osteoarthritis. The FACT OA1 trial included an additional treatment arm, fasinumab 1 mg every two months, which showed numerical benefit over placebo, but did not reach statistical significance. In initial safety analyses from the Phase 3 trials, there was an increase in arthropathies reported with fasinumab. In a sub-group of patients from one Phase 3 long-term safety trial, there was an increase in joint replacement with fasinumab 1 mg monthly treatment during the off-drug follow-up period, although this increase was not seen in the other trials to date. Additional longer-term safety data from the ongoing trials are being collected and are expected to be reported early next year. 36 Table of Contents Agreements with BARDA In the first quarter of 2020, the Company announced an expansion of its Other Transaction Agreement ("OTA") with BARDA, pursuant to which HHS is obligated to fund 80% of our costs incurred for certain research and development activities related to COVID-19 treatments. In July 2020, the Company also announced an agreement with entities acting at the direction of BARDA and the U.S. Department of Defense to manufacture and deliver filled and finished REGN-COV2 to the U.S. Government. This agreement could result in payments to the Company of up to $450.2 million in the aggregate for bulk manufacturing of the drug substance, beginning in the summer of 2020, as well as fill/finish and storage activities starting in the third quarter of 2020. In 2015, we and BARDA entered into an agreement pursuant to which HHS provides certain funding to develop, test, and manufacture a treatment for Ebola virus infection. In July 2020, HHS exercised its option under the existing agreement to provide up to $344.6 million of additional funding for the manufacture and supply of REGN-EB3. Contingent upon FDA approval of REGN-EB3, we expect to deliver an established number of treatment doses over the course of approximately six years. Collaboration and License Agreements Sanofi In May 2020, a secondary offering of 13,014,646 shares of our Common Stock held by Sanofi was completed. We also purchased 9,806,805 shares directly from Sanofi for an aggregate purchase amount of $5 billion. Pursuant to the offering and purchase, Sanofi disposed of all of its shares of common stock in Regeneron, other than 400,000 shares that it retained as of the closing of these transactions (which Sanofi has used, and may continue to use, for the funding of certain development costs as described below). Antibody As of June 30, 2020, we were collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and REGN3500 (the "Antibody Collaboration"). See discussion below for updates related to the development and commercialization of Praluent effective April 1, 2020. Under the terms of the Antibody License and Collaboration Agreement (the "LCA"), following receipt of the first positive Phase 3 trial results for a co-developed drug candidate, subsequent Phase 3 trial-related costs for that drug candidate are generally shared 80% by Sanofi and 20% by us. All other agreed-upon development costs incurred by both companies are funded 100% by Sanofi. We are obligated to reimburse Sanofi for 50% of worldwide development expenses that were fully funded by Sanofi and 30% of shared Phase 3 trial-related costs based on our share of collaboration profits from commercialization of collaboration products. However, we are only required to apply 10% of our share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs. In 2018, we and Sanofi entered into a letter agreement (the "Letter Agreement") amending the LCA in connection with, among other matters, the allocation of additional funds to certain proposed activities relating to dupilumab and REGN3500 (collectively, the "Dupilumab/REGN3500 Eligible Investments"). Pursuant to the Letter Agreement, we have agreed to allow Sanofi to satisfy in whole or in part its funding obligations with respect to the Dupilumab/REGN3500 Eligible Investments for the quarterly periods commencing on January 1, 2018 and ending on September 30, 2020 by selling certain shares of our Common Stock directly or indirectly owned by Sanofi. Refer to the " Immuno-Oncology " section below for further details regarding the Letter Agreement and this funding arrangement. Under our collaboration agreement, Sanofi records product sales for commercialized products, and Regeneron has the right to co-commercialize such products on a country-by-country basis. We have exercised our option to co-commercialize Dupixent in the United States and in certain countries outside the United States. We currently anticipate commencing co-commercialization of Dupixent in such countries outside the United States at the end of 2020 or early 2021. We supply certain commercial bulk product to Sanofi. We and Sanofi equally share profits and losses from sales within the United States. We and Sanofi share profits outside the United States on a sliding scale based on sales starting at 65% (Sanofi)/35% (us) and ending at 55% (Sanofi)/45% (us), and share losses outside the United States at 55% (Sanofi)/45% (us). In addition to profit and loss sharing, we are entitled to receive up to an aggregate of $250.0 million in milestone payments upon achievement of specified aggregate annual sales of antibodies outside the United States (including Praluent) on a rolling twelve-month basis. The Company will be entitled to receive the first sales milestone payment from Sanofi, in the amount of $50.0 million, when such sales outside the United States exceed $1.0 billion. In April 2020, the Company and Sanofi entered into an amendment to the LCA in connection with, among other things, the removal of Praluent from the LCA such that (i) effective April 1, 2020, the LCA no longer governs the development, manufacture, or commercialization of Praluent and (ii) the quarterly period ended March 31, 2020 was the last quarter for which Sanofi and the Company will share profits and losses for Praluent under the LCA. The parties also entered into a Praluent 37 Table of Contents Cross License & Commercialization Agreement (the "Praluent Agreement") pursuant to which, effective April 1, 2020, the Company, at its sole cost, is solely responsible for the development and commercialization of Praluent in the United States, and Sanofi, at its sole cost, is solely responsible for the development and commercialization of Praluent outside of the United States. Under the Praluent Agreement, Sanofi will pay the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032. The Company will not owe Sanofi royalties on the Company’s net product sales of Praluent in the United States. Although each party will be responsible for manufacturing Praluent for its respective territory, the parties have entered into definitive supply agreements under which, for a certain transitional period, the Company will continue to supply drug substance to Sanofi and Sanofi will continue to supply finished product to Regeneron. With respect to any intellectual property or product liability litigation relating to Praluent, the parties have agreed that, effective April 1, 2020, Regeneron and Sanofi each will be solely responsible for any such litigation (including damages and other costs and expenses thereof) in the United States and outside the United States, respectively, arising out of Praluent sales or other activities on or after April 1, 2020 (subject to Sanofi's right to set off a portion of any third-party royalty payments resulting from certain patent litigation proceedings against up to 50% of any Praluent royalty payment owed to Regeneron). The parties will each bear 50% of any damages arising out of Praluent sales or other activities prior to April 1, 2020. In December 2019, the Company and Sanofi also announced their intent to restructure their antibody collaboration for Kevzara. The companies continue to assess potential terms of this restructuring in light of the clinical program evaluating Kevzara in patients hospitalized with COVID-19 infection. Immuno-Oncology We are collaborating with Sanofi on the development and commercialization of antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration"). The IO Collaboration is governed by an Amended and Restated Immuno-oncology Discovery and Development Agreement (the "Amended IO Discovery Agreement"), and an Immuno-oncology License and Collaboration Agreement (the "IO License and Collaboration Agreement"). Effective December 31, 2018, the Company and Sanofi entered into the Amended IO Discovery Agreement, which narrowed the scope of the existing discovery and development activities conducted by the Company ("IO Development Activities") under the original 2015 Immuno-oncology Discovery and Development Agreement (the "2015 IO Discovery Agreement") to developing therapeutic bispecific 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 provided for Sanofi's payment of $461.9 million to the Company as consideration for (x) the termination of the 2015 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 2015 IO Discovery Agreement during the fourth quarter of 2018. Under the terms of the Amended IO Discovery Agreement, the Company is required to conduct development activities with respect to (i) the BCMAxCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $70.0 million (the "BCMAxCD3 Program Costs Cap") and (ii) the MUC16xCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $50.0 million (the "MUC16xCD3 Program Costs Cap"); provided that under certain circumstances, Sanofi will have the option to increase the MUC16xCD3 Program Costs Cap to $70.0 million by making a payment to the Company in the amount of $20.0 million. Pursuant to the Amended IO Discovery Agreement, we are primarily responsible for conducting the IO Development Activities (other than certain clinical trials that may be funded separately by Sanofi), including antibody development, preclinical activities, toxicology studies, manufacture of clinical supplies, filing of Investigational New Drug Applications ("INDs"), and clinical development through proof-of-concept. We are obligated to reimburse Sanofi for half of the development costs they funded that are attributable to clinical development of antibody product candidates under the Amended IO Discovery Agreement from our share of profits from commercialized IO Collaboration products. With regard to the BCMAxCD3 Program and the MUC16xCD3 Program, when (i) clinical proof-of-concept is established, (ii) the applicable Program Costs Cap is reached, or (iii) 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, with regard to BCMAxCD3, immuno-oncology indications, and with regard to MUC16xCD3, all indications, pursuant to the IO License and Collaboration Agreement, as amended. If Sanofi does not exercise its option to license rights to a product candidate, we 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 global commercialization of such BCMAxCD3 Program antibody; and (ii) if Sanofi exercises its option with respect to a MUC16xCD3 Program antibody, (x) we 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. 38 Table of Contents In connection with the IO License and Collaboration Agreement, Sanofi made a $375.0 million non-refundable up-front payment to us. If Sanofi exercises its option to license rights to a BCMAxCD3 Program antibody or MUC16xCD3 Program antibody thereunder, it will co-develop these drug candidates with us through product approval under the terms of the IO License and Collaboration Agreement. Sanofi will fund development costs up front for a BCMAxCD3 Program antibody and we will reimburse half of the total development costs for such antibody from our share of future IO Collaboration profits to the extent they are sufficient for this purpose. In addition, we and Sanofi will share equally, on an ongoing basis, the development costs for a MUC16xCD3 Program antibody. Each party will have the right to co-commercialize licensed products in countries where it is not the lead commercialization party. The parties will share equally in profits and losses in connection with the commercialization of collaboration products. We are obligated to use commercially reasonable efforts to supply clinical requirements of each drug candidate under the IO License and Collaboration Agreement until commercial supplies of that IO drug candidate are being manufactured. Under the terms of the IO License and Collaboration Agreement, the parties are also co-developing and co-commercializing Libtayo (cemiplimab), an antibody targeting PD-1. We have principal control over the development of Libtayo, and the parties share equally, on an ongoing basis, development and commercialization expenses for Libtayo. Under the Letter Agreement, we have agreed to allow Sanofi to satisfy in whole or in part its funding obligation with respect to Libtayo development costs for the quarterly periods commencing on October 1, 2017 and ending on September 30, 2020 by selling certain shares of our Common Stock directly or indirectly owned by Sanofi. As of June 30, 2020, 279,766 shares of our Common Stock remained eligible for sale by Sanofi in order to satisfy its funding obligations with respect to Libtayo development costs and/or, as noted above, Dupilumab/REGN3500 Eligible Investments. If Sanofi desires to sell shares of our Common Stock during the term of the Letter Agreement to satisfy a portion or all of its funding obligations for the Libtayo development and/or, as noted above, Dupilumab/REGN3500 Eligible Investments, we may elect to purchase, in whole or in part, such shares from Sanofi. If we do not elect to purchase such shares, Sanofi may sell the applicable number of shares (subject to certain daily and quarterly limits) in one or more open-market transactions. Refer to the "Antibody" section above for a description of share transactions related to Dupilumab/REGN3500 Eligible Investments. With regard to Libtayo, we lead commercialization activities in the United States, while Sanofi leads commercialization activities outside of the United States and the parties equally share profits from worldwide sales. Sanofi has exercised its option to co-commercialize Libtayo in the United States. We will be entitled to a milestone payment of $375.0 million in the event that global sales of certain licensed products targeting PD-1 (including Libtayo), together with sales of any other products licensed under the IO License and Collaboration Agreement and sold for use in combination with any of such licensed products targeting PD-1, equal or exceed $2.0 billion in any consecutive twelve-month period. Bayer EYLEA outside the United States Since 2006, we and Bayer have been parties to a license and collaboration agreement for the global development and commercialization outside the United States of EYLEA. Under the agreement, we and Bayer collaborate on, and share the costs of, the development of EYLEA. Bayer markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally in profits and losses from sales of EYLEA. In Japan, we are entitled to receive a tiered percentage of between 33.5% and 40.0% of EYLEA net sales through 2021, and thereafter, the companies will share equally in profits and losses from the sales of EYLEA. We are obligated to reimburse Bayer for 50% of the development costs that it has incurred under the agreement from our share of the collaboration profits (including payments to us based on sales in Japan). The reimbursement payment in any quarter will equal 5% of the then outstanding repayment obligation, but never more than our share of the collaboration profits in the quarter unless we elect to reimburse Bayer at a faster rate. Within the United States, we retain exclusive commercialization rights to EYLEA and are entitled to all profits from such sales. 39 Table of Contents Teva Fasinumab In 2016, we entered into a collaboration agreement with Teva to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to our collaboration agreement with Mitsubishi Tanabe Pharma Corporation ("MTPC"). In connection with the agreement, Teva made a $250.0 million non-refundable up-front payment. We lead global development activities, and the parties share equally, on an ongoing basis, development costs under a global development plan. As of June 30, 2020, we had earned an aggregate of $120.0 million of development milestones from Teva and we are entitled to receive up to an aggregate of $340.0 million in additional development milestones and up to an aggregate of $1.890 billion in contingent payments upon achievement of specified annual net sales amounts. We are responsible for the manufacture and supply of fasinumab globally. Within the United States, we will lead commercialization activities, and the parties will share equally in any profits or losses in connection with commercialization of fasinumab. In the territory outside of the United States, Teva will lead commercialization activities and we will supply product to Teva at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances). Zai Lab REGN1979 In April 2020, we entered into an agreement with Zai Lab Limited to develop and commercialize REGN1979 in mainland China, Hong Kong, Taiwan, and Macau (the "Zai Territories"). In connection with the agreement, Zai made a $30.0 million non-refundable up-front payment to the Company. We will continue to lead global development activities for REGN1979, and Zai will be responsible for funding a portion of the global development costs for certain clinical trials. We are responsible for the manufacture and supply of clinical and commercial product of REGN1979 to Zai. If REGN1979 is commercialized in the Zai Territories, we will supply the product to Zai at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances), and are eligible to receive up to $160.0 million in additional regulatory and sales milestone payments. Intellia In 2016, we entered into a license and collaboration agreement with Intellia Therapeutics, Inc. to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development. In May 2020, we expanded our existing collaboration with Intellia Therapeutics, Inc. to provide us with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B. In addition, we also received non-exclusive rights to independently develop and commercialize ex vivo gene edited products. In connection with the agreement, we made a $70.0 million up-front payment and purchased 925,218 shares of Intellia common stock for an aggregate purchase price of $30.0 million. The amount paid in excess of the fair market value of the shares purchased , or $15.0 million, was recorded to Research and development expense. Corporate Information We were incorporated in the State of New York in 1988 and publicly listed in 1991. Our principal executive offices are located at 777 Old Saw Mill River Road, Tarrytown, New York 10591, and our telephone number at that address is (914) 847-7000. We make available free of charge on or through our Internet website ( http://www.regeneron.com ) our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and, if applicable, amendments to those reports filed or furnished pursuant to Section 13(a) or 15(d) of the Exchange Act, as soon as reasonably practicable after we electronically file such material with, or furnish it to, the Securities and Exchange Commission ("SEC"). Investors and other interested parties should note that we use our media and investor relations website ( http://newsroom.regeneron.com ) and our social media channels to publish important information about Regeneron, including information that may be deemed material to investors. We encourage investors and other interested parties to review the information we may publish through our media and investor relations website and the social media channels listed on our media and investor relations website, in addition to our SEC filings, press releases, conference calls, and webcasts. The information contained on our websites and social media channels is not included as a part of, or incorporated by reference into, this report. 40 Table of Contents Results of Operations Three and Six Months Ended June 30, 2020 and 2019 Certain revisions have been made to the previously reported June 30, 2019 amounts below in connection with changing the presentation of certain amounts earned from collaborators; see Note 1 to our Condensed Consolidated Financial Statements for further details. Net Income Three Months Ended June 30, Six Months Ended June 30, (In millions, except per share data) 2020 2019 2020 2019 Revenues $ 1,952.0 $ 1,577.8 $ 3,780.2 $ 2,950.4 Operating expenses 1,295.6 1,262.2 2,423.7 2,154.8 Income from operations 656.4 315.6 1,356.5 795.6 Other income (expense), net 262.5 (90.9) 231.0 (24.8) Income before income taxes 918.9 224.7 1,587.5 770.8 Income tax expense 21.6 31.6 65.6 116.6 Net income $ 897.3 $ 193.1 $ 1,521.9 $ 654.2 Net income per share - diluted $ 7.61 $ 1.68 $ 13.03 $ 5.69 Revenues Three Months Ended June 30, Six Months Ended June 30, (In millions) 2020 2019 $ Change * 2020 2019 $ Change * Net product sales in the United States: EYLEA $ 1,113.7 $ 1,160.3 $ (46.6) $ 2,285.7 $ 2,234.4 $ 51.3 Libtayo 63.3 40.8 22.5 125.0 67.6 57.4 Praluent 47.2 * * 47.2 * * ARCALYST 2.7 4.2 (1.5) 5.7 7.7 (2.0) Sanofi and Bayer collaboration revenue: Sanofi 269.1 75.8 193.3 516.0 57.8 458.2 Bayer 244.2 277.2 (33.0) 525.6 541.2 (15.6) Other revenue 211.8 19.5 192.3 275.0 41.7 233.3 Total revenues $ 1,952.0 $ 1,577.8 $ 374.2 $ 3,780.2 $ 2,950.4 $ 829.8 * Net product sales of Praluent in the United States were recorded by Sanofi prior to April 1, 2020 Net Product Sales Net product sales of EYLEA in the United States decreased for the three months ended June 30, 2020, compared to the same period in 2019, due to lower sales volume primarily attributable to the COVID-19 pandemic and an increase in sales-related deductions primarily due to higher discounts. Net product sales of EYLEA in the United States increased for the six months ended June 30, 2020, compared to the same period in 2019, due to higher sales volume partly offset by an increase in sales-related deductions, primarily due to higher rebates and discounts, as well as the impact of the COVID-19 pandemic. Overall U.S. EYLEA demand was lower in April 2020 compared to the same period of 2019. While we observed an increase in U.S. EYLEA demand during the remainder of the second quarter of 2020 relative to April 2020, we are unable to predict whether there will be additional adverse impact on net product sales if shelter-in-place and social distancing orders are reintroduced or imposed in additional geographies. Effective April 1, 2020, the Company is solely responsible for the development and commercialization of Praluent in the United States and records net product sales of Praluent in the United States. Refer to "Collaboration and License Agreements - Sanofi - Antibody " section above for further details. 41 Table of Contents Sanofi Collaboration Revenue Three Months Ended June 30, Six Months Ended June 30, (In millions) 2020 2019 2020 2019 Antibody: Regeneron's share of profits in connection with commercialization of antibodies $ 171.9 $ 38.8 $ 342.8 $ 11.0 Reimbursement for manufacturing of commercial supplies (1) 100.6 43.9 180.7 58.4 Total Antibody 272.5 82.7 523.5 69.4 Immuno-oncology: Regeneron's share of losses in connection with commercialization of Libtayo outside the United States (6.4) (6.9) (12.6) (11.6) Reimbursement for manufacturing of commercial supplies (1) 3.0 — 5.1 — Total Immuno-oncology (3.4) (6.9) (7.5) (11.6) Total Sanofi collaboration revenue $ 269.1 $ 75.8 $ 516.0 $ 57.8 (1) The corresponding costs incurred by us in connection with such production is recorded within Cost of collaboration and contract manufacturing. Antibody Sanofi provides us with an estimate of our share of the profits or losses from commercialization of antibodies for the most recent fiscal quarter; these estimates are reconciled to actual results in the subsequent fiscal quarter, and our portion of the profits or losses is adjusted accordingly, as necessary. During the three and six months ended June 30, 2020, the change in our share of profits in connection with commercialization of antibodies, compared to the same period in 2019, was primarily driven by higher Dupixent profits as well as our new agreement with Sanofi under which, effective April 1, 2020, we are no longer sharing in losses with Sanofi in connection with the commercialization of Praluent (see further information below). The increase in reimbursements for manufacturing of commercial supplies is primarily driven by higher Dupixent sales, as revenue recognition for such cost reimbursements is deferred until the product is sold by Sanofi to third-party customers. Regeneron's share of profits in connection with the commercialization of Dupixent, Praluent (through March 31, 2020), and Kevzara is summarized below: Three Months Ended June 30, Six Months Ended June 30, (In millions) 2020 2019 2020 2019 Dupixent, Praluent, and Kevzara net product sales (1) $ 1,013.3 $ 689.5 $ 2,008.4 $ 1,160.8 Regeneron's share of collaboration profits $ 191.4 $ 43.0 $ 384.4 $ 15.2 Reimbursement of development expenses incurred by Sanofi in accordance with Regeneron's payment obligation 19.5 4.2 41.6 4.2 Regeneron's share of profits in connection with commercialization of antibodies $ 171.9 $ 38.8 $ 342.8 $ 11.0 Regeneron's share of collaboration profits as a percentage of Dupixent, Praluent, and Kevzara net product sales (1) 17 % 6 % 17 % 1 % (1) Global net product sales of Dupixent and Kevzara are recorded by Sanofi. The quarter ended March 31, 2020 was the last quarter for which Sanofi and the Company shared profits and losses in connection with Sanofi's global net sales and the related commercialization of Praluent (see further details below); therefore, the quarter ended March 31, 2020 was the last quarter for which net product sales of Praluent were included in the table above. 42 Table of Contents As described above under "Collaboration and License Agreements - Sanofi - Antibody ", effective April 1, 2020, the Company is solely responsible for the development and commercialization of Praluent in the United States. Under the new agreement, Sanofi is solely responsible for the development and commercialization of Praluent outside of the United States, and will pay the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States. Bayer Collaboration Revenue Three Months Ended June 30, Six Months Ended June 30, (In millions) 2020 2019 2020 2019 Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 230.9 $ 269.0 $ 484.7 $ 518.3 Reimbursement for manufacturing of commercial supplies (1) 13.3 8.2 40.9 22.9 Total Bayer collaboration revenue $ 244.2 $ 277.2 $ 525.6 $ 541.2 (1) The corresponding costs incurred by us in connection with such production is recorded within Cost of collaboration and contract manufacturing. Regeneron's net profit in connection with commercialization of EYLEA outside the United States is summarized below: Three Months Ended June 30, Six Months Ended June 30, (In millions) 2020 2019 2020 2019 EYLEA net product sales outside the United States $ 641.0 $ 715.3 $ 1,322.7 $ 1,384.7 Regeneron's share of collaboration profit from sales outside the United States $ 245.3 $ 282.9 $ 513.5 $ 546.3 Reimbursement of development expenses incurred by Bayer in accordance with Regeneron's payment obligation (14.4) (13.9) (28.8) (28.0) Regeneron's net profit in connection with commercialization of EYLEA outside the United States $ 230.9 $ 269.0 $ 484.7 $ 518.3 Regeneron's net profit as a percentage of EYLEA net product sales outside the United States 36 % 38 % 37 % 37 % Bayer records net product sales of EYLEA outside the United States. Bayer provides us with an estimate of our share of the profit, including the percentage of sales in Japan that we earned, from commercialization of EYLEA outside the United States for the most recent fiscal quarter; these estimates are reconciled to actual results in the subsequent fiscal quarter, and our portion of the profit or loss is adjusted accordingly, as necessary. Other Revenue Other revenue increased during the three and six months ended June 30, 2020, compared to the same periods of 2019, primarily due to: • recognition of revenue in connection with our agreements with BARDA related to funding of certain development activities for REGN-EB3 for the treatment of Ebola and antibodies for the treatment of COVID-19; • $30.0 million up-front payment received from Zai Lab in connection with our collaboration agreement; and • effective April 1, 2020, Sanofi's reimbursement for manufacturing commercial supplies of Praluent and royalties of 5% on Sanofi’s net product sales of Praluent outside the United States. 43 Table of Contents Expenses Three Months Ended June 30, Six Months Ended June 30, (In millions, except headcount data) 2020 2019 $ Change 2020 2019 $ Change Research and development (1) $ 722.0 $ 885.5 $ (163.5) $ 1,305.9 $ 1,371.6 $ (65.7) Selling, general, and administrative (1) 348.3 294.6 53.7 715.6 585.7 129.9 Cost of goods sold (2) 102.5 67.0 35.5 181.3 137.9 43.4 Cost of collaboration and contract manufacturing (3) 173.0 78.8 94.2 311.5 180.0 131.5 Other operating (income) expense, net (50.2) (63.7) 13.5 (90.6) (120.4) 29.8 Total operating expenses $ 1,295.6 $ 1,262.2 $ 33.4 $ 2,423.7 $ 2,154.8 $ 268.9 Average headcount 8,254 7,649 605 8,142 7,549 593 (1) Includes costs incurred as well as cost reimbursements from collaborators who are not deemed to be our customers (2) Cost of goods sold includes costs in connection with producing commercial supplies for products that are sold by Regeneron in the United States ( i.e., for which we record net product sales) and any royalties we are obligated to pay on such sales, period costs for our Limerick manufacturing facility, and amounts we are obligated to pay to Sanofi for its share of Libtayo U.S. gross profits (3) Cost of collaboration and contract manufacturing includes costs we incur in connection with producing commercial drug supplies for collaborators and others Operating expenses included a total of $103.5 million and $105.8 million for the three months ended June 30, 2020 and 2019, respectively, and $209.3 million and $213.7 million for the six months ended June 30, 2020 and 2019, respectively, of non-cash compensation expense related to equity awards granted under our long-term incentive plans. Research and Development Expenses The following table summarizes our estimates of direct research and development expenses by clinical development program and other significant categories of research and development expenses. Direct research and development expenses are comprised primarily of costs paid to third parties for clinical and product development activities, including costs related to preclinical research activities, clinical trials, and the portion of research and development expenses incurred by our collaborators that we are obligated to reimburse. Indirect research and development expenses have not been allocated directly to each program, and primarily consist of costs to compensate personnel, overhead and infrastructure costs to maintain our facilities, and other costs related to activities that benefit multiple projects. Clinical manufacturing costs primarily consist of costs to manufacture bulk drug product for clinical development purposes as well as related external drug filling, packaging, and labeling costs. Clinical manufacturing costs also includes pre-launch commercial supplies which did not meet the criteria to be capitalized as inventory. 44 Table of Contents Three Months Ended June 30, Six Months Ended June 30, (In millions) 2020 2019 * $ Change 2020 2019 * $ Change Direct research and development expenses: Fasinumab $ 43.2 $ 59.6 $ (16.4) $ 83.7 $ 109.7 $ (26.0) Libtayo (cemiplimab) 35.4 34.4 1.0 71.4 78.4 (7.0) Dupixent (dupilumab) 31.7 19.6 12.1 66.2 45.3 20.9 REGN-COV2 14.1 — 14.1 14.1 — 14.1 EYLEA 11.2 12.2 (1.0) 28.8 25.3 3.5 Evinacumab 8.8 8.4 0.4 18.8 15.0 3.8 Up-front payments related to license and collaboration agreements 85.0 400.0 (315.0) 85.0 400.0 (315.0) Other product candidates in clinical development and other research programs 148.4 81.4 67.0 253.6 167.5 86.1 Total direct research and development expenses 377.8 615.6 (237.8) 621.6 841.2 (219.6) Indirect research and development expenses: Payroll and benefits 193.4 171.8 21.6 391.4 338.7 52.7 Lab supplies and other research and development costs 30.6 33.8 (3.2) 65.5 61.4 4.1 Occupancy and other operating costs 80.8 75.2 5.6 162.7 147.2 15.5 Total indirect research and development expenses 304.8 280.8 24.0 619.6 547.3 72.3 Clinical manufacturing costs 181.2 151.9 29.3 361.5 301.6 59.9 Reimbursement of research and development expenses by collaborators (141.8) (162.8) 21.0 (296.8) (318.5) 21.7 Total research and development expenses $ 722.0 $ 885.5 $ (163.5) $ 1,305.9 $ 1,371.6 $ (65.7) * Certain prior year amounts have been reclassified to conform to the current year's presentation. Research and development expenses for the three and six months ended June 30, 2020 included $85.0 million in aggregate up-front payments made in connection with our collaboration agreement with Intellia (see "Collaboration and License Agreements - Intellia" above). Direct research and development expenses in 2020 also include costs incurred in connection with Kevzara for the treatment of COVID-19 patients (included within "Other product candidates in clinical development and other research programs" in the table above). Research and development expenses for the three and six months ended June 30, 2019 included a $400.0 million up-front payment to Alnylam. Research and development expenses included non-cash compensation expense of $56.9 million and $59.3 million for the three months ended June 30, 2020 and 2019, respectively, and $113.6 million and $118.0 million for the six months ended June 30, 2020 and 2019, respectively. There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development, uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes in the competitive landscape affecting a product candidate, and other risks and uncertainties described in Part II, Item 1A. "Risk Factors" (including those relating to the disruptions caused by the COVID-19 pandemic). There is also variability in the duration and costs necessary to develop a pharmaceutical product, potential opportunities and/or uncertainties related to future indications to be studied, and the estimated cost and scope of the projects. The lengthy process of seeking FDA and other applicable approvals, and subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources. Any failure by us to obtain, or delay in obtaining, regulatory approvals could materially adversely affect our business. We are unable to reasonably estimate if our product candidates in clinical development will generate material product revenues and net cash inflows. 45 Table of Contents Selling, General, and Administrative Expenses Selling, general, and administrative expenses increased for the three and six months ended June 30, 2020, compared to the same periods in 2019, primarily due to higher headcount-related costs, additional accruals for loss contingencies associated with ongoing litigation, higher contributions to independent not-for-profit patient assistance organizations, and, effective April 1, 2020, no longer receiving Praluent-related cost reimbursements from Sanofi for Regeneron-incurred expenses. Selling, general, and administrative expenses also increased for the six months ended June 30, 2020, compared to the same period in 2019, due to an increase in commercialization-related expenses for EYLEA. Selling, general, and administrative expenses also included non-cash compensation expense of $38.2 million and $37.7 million for the three months ended June 30, 2020 and 2019, respectively, and $78.5 million and $81.5 million for the six months ended June 30, 2020 and 2019, respectively. Cost of Collaboration and Contract Manufacturing Cost of collaboration and contract manufacturing increased for the three and six months ended June 30, 2020, compared to the same periods in 2019, primarily due to the recognition of manufacturing costs associated with higher sales of Dupixent, process validation costs in connection with manufacturing REGN-EB3 under our BARDA agreement, and recognition of costs in connection with manufacturing ex-U.S. commercial supplies of Praluent for Sanofi under our new agreement (see "Collaboration and License Agreements - Sanofi - Antibody " above for further details). Other Operating (Income) Expense Other operating (income) expense, net, includes recognition of a portion of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with Sanofi IO, Teva, and MTPC collaborative arrangements. Other Income (Expense) Other income (expense), net, for the three and six months ended June 30, 2020, compared to the same periods in 2019, was positively impacted by the recognition of unrealized gains on equity securities. Income Taxes Three Months Ended June 30, Six Months Ended June 30, (In millions, except effective tax rate) 2020 2019 2020 2019 Income tax expense $ 21.6 $ 31.6 $ 65.6 $ 116.6 Effective tax rate 2.4 % 14.1 % 4.1 % 15.1 % Our effective tax rate for the three and six months ended June 30, 2020 was positively impacted, compared to the U.S. federal statutory rate, primarily by stock-based compensation, and, to a lesser extent, income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate and federal tax credits for research activities. Our effective tax rate for the three and six months ended June 30, 2019 was positively impacted, compared to the U.S. federal statutory rate, primarily by income earned in foreign jurisdictions with tax rates lower than the U.S. federal statutory rate, stock-based compensation, federal tax credits for research activities, and, to a lesser extent, the foreign-derived intangible income deduction, partly offset by the taxation of certain global intangible low-taxed income and the non-deductible Branded Prescription Drug Fee. 46 Table of Contents Liquidity and Capital Resources Our financial condition is summarized as follows: June 30, December 31, (In millions) 2020 2019 $ Change Financial assets: Cash and cash equivalents $ 1,992.2 $ 1,617.8 $ 374.4 Marketable securities - current 1,152.0 1,596.5 (444.5) Marketable securities - noncurrent 2,587.6 3,256.8 (669.2) $ 5,731.8 $ 6,471.1 $ (739.3) Working capital: Current assets $ 7,860.2 $ 7,689.1 $ 171.1 Current liabilities 3,702.4 2,096.6 1,605.8 $ 4,157.8 $ 5,592.5 $ (1,434.7) As of June 30, 2020, we also had borrowing availability of $750.0 million under a revolving credit facility. Sources and Uses of Cash for the Six Months Ended June 30, 2020 and 2019 June 30, June 30, (In millions) 2020 2019 $ Change Cash flows provided by operating activities $ 1,641.4 $ 1,085.3 $ 556.1 Cash flows provided by (used in) investing activities $ 1,010.2 $ (1,612.1) $ 2,622.3 Cash flows (used in) provided by financing activities $ (2,277.2) $ 104.6 $ (2,381.8) Cash Flows from Operating Activities Our net income for the six months ended June 30, 2020 included up-front payments of $85.0 million made to Intellia and a $30.0 million up-front payment received from Zai Lab pursuant to our collaboration agreements. Our net income for the six months ended June 30, 2020 also included $171.3 million related to unrealized gains (net) on equity securities (included in other non-cash items). Deferred taxes as of June 30, 2020 decreased by $118.0 million, compared to December 31, 2019, primarily due to non-cash compensation expense and unrealized gains (net) on equity securities as described above. Cash Flows from Investing Activities Sales of marketable securities during the six months ended June 30, 2020 included proceeds in connection with funding our stock repurchase from Sanofi (as described below). Capital expenditures during the six months ended June 30, 2020 included costs associated with (i) the expansion of our manufacturing facilities in Rensselaer, New York and Limerick, Ireland, including construction of a fill/finish facility and related equipment, and (ii) laboratory expansion and renovations at our Tarrytown, New York facilities. We expect to incur capital expenditures of $540 million to $590 million for the full year of 2020 primarily in connection with these projects. Cash Flows from Financing Activities During the six months ended June 30, 2020, we paid an aggregate of $5.4 billion to purchase shares of our Common Stock, a portion of which was funded with the proceeds from a $1.5 billion senior unsecured 364-day bridge loan facility. See further descriptions under " Share Repurchase Program, " " Sanofi Funding of Certain Development Costs, " and " Dispositions of Regeneron Common Stock Held by Sanofi " below. Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $2.2 billion during the six months ended June 30, 2020 compared to $155.1 million during the six months ended June 30, 2019. 47 Table of Contents Share Repurchase Program In November 2019, our board of directors authorized a share repurchase program to repurchase up to $1.0 billion of our Common Stock. The share repurchase program permits the Company to effect repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act. Repurchases may be made from time to time at management’s discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors. The program has no time limit and can be discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases in the future. We plan to finance the share repurchase program with available cash. During the six months ended June 30, 2020, we repurchased 719,167 shares of our Common Stock under the program and recorded the cost of the shares received, or $272.8 million, as Treasury Stock. As of June 30, 2020, the Company had $473.1 million which remained available for share repurchases under the program. Sanofi Funding of Certain Development Costs As described above in "Collaboration and License Agreements - Sanofi," effective January 7, 2018, we have agreed to allow Sanofi to satisfy in whole or in part its funding obligations with respect to Libtayo development and/or Dupilumab/REGN3500 Eligible Investments by selling shares (of which 279,766 shares remain available to be sold as of June 30, 2020) of our Common Stock directly or indirectly owned by Sanofi. During the six months ended June 30, 2020, Sanofi elected to sell, and we elected to purchase (by issuing a credit towards the amount owed by Sanofi), 77,677 shares of the Company's Common Stock to satisfy Sanofi's funding obligation related to Libtayo development costs. Consequently, we recorded $41.7 million related to the shares received as Treasury Stock during the six months ended June 30, 2020. In addition, during the six months ended June 30, 2020, Sanofi elected to sell, and we elected to purchase (in cash), 171,471 shares of the Company's Common Stock in connection with Sanofi's funding obligation for Dupilumab/REGN3500 Eligible Investments. Consequently, we recorded the cost of the shares received, or $93.3 million, as Treasury Stock during the six months ended June 30, 2020. Secondary Offering and Purchase of Regeneron Common Stock Held by Sanofi As described above in "Collaboration and License Agreements - Sanofi," in May 2020, a secondary offering of 13,014,646 shares of our Common Stock (the "Secondary Offering") held by Sanofi was completed. In connection with the Secondary Offering, we also purchased 9,806,805 shares of our Common Stock directly from Sanofi for an aggregate purchase amount of $5 billion (the "Stock Purchase"). As a result of the Secondary Offering and the Stock Purchase, Sanofi disposed of all of its shares of our Common Stock, other than 400,000 shares that it retained as of the closing of the Secondary Offering and the Stock Purchase (which Sanofi has used, and may continue to use, for the funding of certain Libtayo development costs and/or Dupilumab/REGN3500 Eligible Investments as described above). We funded the Stock Purchase with a combination of cash on hand, proceeds from the sale of marketable securities, and proceeds from loans under a $1.5 billion senior unsecured 364-day bridge loan facility (the "Bridge Facility") which was entered into in May 2020. The loans under the Bridge Facility bear interest at a variable interest rate based on either the London Interbank Offered Rate or the alternate base rate, plus an applicable margin that varies with our debt rating and total leverage ratio. The Bridge Facility will mature, and all amounts outstanding thereunder will become due and payable, in May 2021. We intend to refinance the Bridge Facility prior to its maturity by entering into new debt financing arrangements. Amounts borrowed under the Bridge Facility may be prepaid at any time without premium or penalty. As of June 30, 2020, $1.5 billion remained outstanding under the Bridge Facility. The credit agreement governing the Bridge Facility (the “Bridge Credit Agreement”) contains financial and operating covenants, which are substantially similar to the covenants set forth in our existing $750.0 million senior unsecured five-year revolving credit facility. Financial covenants include a maximum total leverage ratio and a minimum interest expense coverage ratio. We were in compliance with all covenants of the Bridge Credit Agreement as of June 30, 2020. Critical Accounting Policies and Use of Estimates A summary of our critical accounting policies and use of estimates are presented in Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 (filed February 7, 2020). Except as described in Note 1 to our Condensed Consolidated Financial Statements included in this report, there were no material changes to our critical accounting policies and use of estimates during the six months ended June 30, 2020. 48 Table of Contents Future Impact of Recently Issued Accounting Standards As of June 30, 2020, the future adoption of recently issued accounting standards is not expected to have a material impact on the Company's financial position or results of operations.