About Regeneron Pharmaceuticals

Regeneron Pharmaceuticals, Inc. operates as an integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases. The company’s products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, hematologic conditions, infectious diseases, and rare diseases. The company’s core business strategy is to maintain a strong foundation in basic scientific research and discovery-enabling technologies, and to build on that foundation with the company’s clinical development, manufacturing, and commercial capabilities. Products Certain products have also received marketing approval in countries outside the United States, European Union (‘EU’), or Japan. Products that have received marketing approval are summarized as below: EYLEA HD (aflibercept) Injection 8 mg: Wet age-related macular degeneration (‘wAMD’), Diabetic macular edema (‘DME’), and Diabetic retinopathy (‘DR’). EYLEA (aflibercept) Injection: wAMD; DME; DR; 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’); Myopic choroidal neovascularization (‘mCNV’); Neovascular glaucoma (‘NVG’); and Retinopathy of prematurity (‘ROP’). Dupixent (dupilumab) Injection: Atopic dermatitis (in adults, adolescents, and pediatrics aged 6 months and older); Asthma (in adults and adolescents); Asthma (in pediatrics 6–11 years of age); Chronic rhinosinusitis with nasal polyposis (‘CRSwNP’); Eosinophilic esophagitis (‘EoE’) (in adults and adolescents); EoE (in pediatrics 1–11 years of age); and Prurigo nodularis. Libtayo (cemiplimab) Injection: Metastatic or locally advanced first-line non-small cell lung cancer (‘NSCLC’); Metastatic or locally advanced first-line NSCLC (in combination with chemotherapy); Metastatic or locally advanced basal cell carcinoma (‘BCC’); Metastatic or locally advanced cutaneous squamous cell carcinoma (‘CSCC’); and Metastatic or recurrent second-line cervical cancer. Praluent (alirocumab) Injection: LDL-lowering in heterozygous familial hypercholesterolemia (‘HeFH’) or clinical atherosclerotic cardiovascular disease (‘ASCVD’); HeFH in pediatrics and adolescents (8–17 years of age); Cardiovascular risk reduction in patients with established cardiovascular disease; and Homozygous familial hypercholesterolemia (‘HoFH’). REGEN-COV: COVID-19. Kevzara (sarilumab) Injection: Rheumatoid arthritis (‘RA’) and Polymyalgia rheumatica (‘PMR’). Evkeeza (evinacumab) Injection: HoFH (in adults, adolescents, and pediatrics aged 5 years and older). Inmazeb (atoltivimab, maftivimab, and odesivimab) Injection: Infection caused by Zaire ebolavirus. Veopoz (pozelimab) Injection: CD55-deficient protein-losing enteropathy (‘CHAPLE’) (in adults, adolescents, and pediatrics aged 1 year and older). ARCALYST (rilonacept) Injection: Cryopyrin-associated periodic syndromes (‘CAPS’), including familial cold auto-inflammatory syndrome (‘FCAS’) and Muckle-Wells syndrome (‘MWS’) (in adults and adolescents); Deficiency of interleukin-1 receptor antagonist (‘DIRA’) (in adults, adolescents, and pediatrics); and Recurrent pericarditis (in adults and adolescents). ZALTRAP (ziv-aflibercept) Injection for Intravenous Infusion: Metastatic colorectal cancer (‘mCRC’). Additional Information - Clinical Development Programs EYLEA HD (aflibercept) 8 mg In August 2023, the FDA approved the BLA for EYLEA HD for the treatment of patients with wAMD, DME, and DR. Previously, in June 2023, the FDA issued a CRL for the EYLEA HD BLA. The CRL was issued solely due to unresolved observations resulting from a May 2023 FDA inspection at a third-party contract manufacturing organization, Catalent, that the company engaged to complete vial-filling for EYLEA HD. With the approval of EYLEA HD, the pre-approval inspection issues related to the BLA had been addressed. In June 2023 and August 2023, the company announced top-line, two-year (96 weeks) data for EYLEA HD from the pivotal PHOTON trial in patients with DME and the pivotal PULSAR trial in patients with wAMD, respectively. In addition, in July 2023, the results from the PHOTON trial were presented at the American Society of Retina Specialists annual meeting. During both trials, EYLEA HD patients were initially randomized to either 12- or 16-week dosing intervals (after three initial monthly doses) and were able to shorten or extend dosing intervals if pre-specified criteria were met. The visual gains for EYLEA HD remained consistent with the first year of the trials. In both PHOTON and PULSAR, the safety of EYLEA HD also continued to be similar to EYLEA through two years and remained consistent with the known safety profile of EYLEA from previous clinical trials for DME and wAMD. In May 2023, Bayer announced that it initiated a Phase 3 study to evaluate the efficacy and safety of EYLEA HD at extended dosing intervals compared to the standard of care, EYLEA, in RVO to support potential future regulatory submissions outside the United States. Dupixent COPD In March 2023, the company and Sanofi announced that the primary and all key secondary endpoints were met in the BOREAS trial (the first of two Phase 3 trials) in adults on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled COPD and evidence of type 2 inflammation. In this trial, patients receiving Dupixent experienced a 30% reduction in moderate or severe acute COPD exacerbations (rapid and acute worsening of respiratory symptoms) compared to placebo over 52 weeks, while also demonstrating significant improvements in lung function, quality of life, and COPD respiratory symptoms. In November 2023, the company and Sanofi announced that the replicate Phase 3 NOTUS trial met its primary endpoint, showing Dupixent significantly reduced exacerbations by 34% compared to placebo over 52 weeks in patients with moderate-to-severe COPD with evidence of type 2 inflammation, confirming results from the BOREAS pivotal trial. Given the overwhelming positive efficacy of the primary endpoint in the interim analysis from the NOTUS trial, the results will be considered the primary analysis of the trial. In December 2023, the company and Sanofi submitted the data from this interim analysis of the NOTUS trial, along with the results from the Phase 3 BOREAS trial, to the FDA. The safety results for the BOREAS and NOTUS trials were generally consistent with the known safety profile of Dupixent in its approved indications. CSU In October 2023, the FDA issued a CRL for the sBLA for Dupixent in CSU. The CRL states that additional efficacy data are required to support an approval; it did not identify any issues with safety or manufacturing. An ongoing Phase 3 clinical trial (in biologic-naïve patients) continues to enroll patients, with results expected in late 2024. REGN5678 In the ongoing Phase 1 study of REGN5678, the company has observed antitumor activity in combination with Libtayo as well as with REGN5678 monotherapy. Due to the emerging safety profile, including two immune-mediated Grade 5 adverse events (death), the company discontinued enrollment of patients receiving the combination of REGN5678 and full-dose Libtayo (cemiplimab). The company has since expanded enrollment in a REGN5678 monotherapy cohort and plans to explore other REGN5678 combinations. Descriptions of Marketed Products Studied in Additional Indications and Product Candidates in Late-Stage Clinical Development EYLEA HD (aflibercept) 8 mg EYLEA HD is a soluble fusion protein that acts as a vascular endothelial growth factor (‘VEGF’) inhibitor. Through a novel formulation, it is designed to deliver a concentrated dose of aflibercept to block VEGF-A and PLGF and inhibit the growth of new blood vessels and decrease vascular permeability to treat various retinal diseases, including wAMD, DME, and DR. Dupixent (dupilumab) Dupixent is a fully human monoclonal antibody that inhibits signaling of the IL-4 and IL-13 pathways, and is not an immunosuppressant. IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis, and potentially other chronic allergic and inflammatory diseases, including COPD. Kevzara (sarilumab) Kevzara is a fully human monoclonal antibody that binds specifically to the IL-6 receptor and inhibits IL-6-mediated signaling. IL-6 is an immune system protein produced in increased quantities in patients with RA and has been associated with disease activity, joint destruction, and other systemic problems. Itepekimab Itepekimab is an investigational, fully human monoclonal antibody that inhibits IL-33, a protein that is believed to play a key role in lung inflammation in COPD. REGN5713-5714-5715 REGN5713-5714-5715 is an investigational combination of three fully human monoclonal antibodies designed to treat allergic inflammatory conditions caused by the allergen Betv1, which is the main allergen responsible for birch pollen allergies. Birch pollen allergy is one of the most common causes of seasonal allergies that occur in the spring, and is also believed to trigger ‘oral allergy syndrome’ food reactions to related allergens found in nuts and fruits, such as apples, pears, and cherries. Libtayo (cemiplimab) Libtayo is a fully human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells that has been approved by regulatory authorities for five different cancers. The PD-1/PD-L1 immune checkpoint pathway is a well-known mechanism by which cancers evade immune destruction. Regeneron is studying Libtayo as monotherapy and in combination with either conventional or novel therapeutic approaches in various solid tumors and blood cancers. It is also being studied in combination with proprietary anti-cancer assets of other companies. Fianlimab Fianlimab is an investigational, fully human monoclonal antibody targeting the immune checkpoint receptor LAG-3 on T-cells. In melanoma, LAG-3 expression in the tumor microenvironment may be associated with therapeutic resistance to PD-1 inhibitors. Fianlimab is being investigated in combination with Libtayo to determine whether concurrent blockade of LAG-3 and PD-1 can help overcome this resistance and release the brakes on T-cell activation. Pozelimab Pozelimab is a fully human monoclonal antibody designed to block complement factor C5 in order to treat diseases mediated by abnormal complement pathway activity, and is approved by the FDA for CHAPLE. Pozelimab is being studied in investigational combinations with an investigational small interfering RNA (‘siRNA’) therapy, cemdisiran, in PNH and myasthenia gravis. Odronextamab Odronextamab is an investigational bispecific monoclonal antibody designed to bind to a component of the T-cell receptor (‘TCR’) complex (CD3), while also binding and bridging T-cells to a protein expressed on B-cells (CD20). The company is studying whether odronextamab may help to activate T-cells via their CD3 receptors and trigger targeted, T-cell mediated killing of cancerous cells in several types of B-cell non-Hodgkin lymphoma. Linvoseltamab Linvoseltamab is an investigational bispecific monoclonal antibody designed to bind to CD3 while also binding and bridging T-cells to the BCMA protein on multiple myeloma cells. The company is studying whether linvoseltamab may help to activate T-cells via their CD3 receptors and trigger targeted, T-cell mediated killing of multiple myeloma. NTLA-2001 NTLA-2001 is an investigational CRISPR-based therapy to be systemically delivered to edit genes inside the human body and is being studied as a treatment for ATTR amyloidosis. ATTR amyloidosis is a progressive and fatal disorder resulting from deposition of insoluble amyloid fibrils into multiple organs and tissues leading to systemic failure. Delivered with in vivo technology, NTLA-2001 offers the possibility of halting and reversing the disease by driving a deep, consistent, and potentially lifelong reduction in transthyretin (‘TTR’) protein after a single dose. Praluent (alirocumab) Praluent is a fully human monoclonal antibody that inhibits the binding of PCSK9 to the LDL receptor. Through inhibiting PCSK9, Praluent increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL cholesterol levels in the blood. Evkeeza (evinacumab) Evkeeza is a fully human monoclonal antibody that specifically binds to and blocks ANGPTL3. ANGPTL3 plays a key role in regulating plasma lipid levels, including triglycerides, LDL cholesterol, and HDL cholesterol, through inhibition of lipase enzymes (lipoprotein lipase and endothelial lipase). Garetosmab Garetosmab is an investigational, fully-human monoclonal antibody that binds to and neutralizes Activin A, which drives the abnormal bone formation that is the main pathology of the ultra-rare genetic disorder FOP. This abnormal bone formation in soft tissue outside of the normal skeleton, a process known as heterotopic ossification, leads to loss of mobility and premature death in FOP patients. Garetosmab is being investigated to determine whether it can help reduce and/or prevent the formation of heterotopic bone lesions by neutralizing the Activin A protein. Other Programs The company’s preclinical research programs include the areas of oncology/immuno-oncology, angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and disorders, inflammation and immune diseases, bone and cartilage, pain and neurobiology, auditory conditions, enzyme replacement therapy, cardiovascular diseases, infectious diseases, and diseases related to aging. These preclinical research programs include both rare diseases and those involving broader populations. Research and Development Technologies Many proteins that play an important role in biology and disease are secreted by cells or located on the cell surface. Moreover, cells communicate through secreted factors and surface molecules. The company’s scientists have developed two different technologies to make protein therapeutics that potently and specifically block, activate, or inhibit the action of specific cell surface or secreted molecules. The first technology fuses receptor components to the constant region of an antibody molecule to make a class of drugs the company call ‘Traps.’ EYLEA HD, EYLEA, ZALTRAP, and ARCALYST are drugs generated using the company’s Trap technology. VelociSuite is the company’s second technology platform, which is used for discovering, developing, and producing fully human antibodies that can address both secreted and cell-surface targets. VelociSuite VelociSuite consists of VelocImmune, VelociGene, VelociMouse, VelociMab, Veloci-Bi, VelociT, VelociHum, and other related technologies. The VelocImmune mouse platform is utilized to produce fully human antibodies. VelocImmune was generated by leveraging the company’s VelociGene technology (see below), in a process in which six megabases of mouse immunoglobulin gene loci were replaced, or ‘humanized,’ with corresponding human immunoglobulin gene loci. VelocImmune mice can be used efficiently to generate fully human antibodies to targets of therapeutic interest. VelocImmune and the company’s entire VelociSuite offer the potential to increase the speed and efficiency through which human antibody therapeutics may be discovered and validated, thereby improving the overall efficiency of the company’s early-stage drug development activities. The company is utilizing the VelocImmune technology to produce the company’s next generation of therapeutic antibody drug candidates for preclinical and clinical development. The company’s VelociGene platform allows custom and precise manipulation of very large sequences of DNA to produce highly customized alterations of a specified target gene, or genes, and accelerates the production of knock-out and transgenic expression models. In producing knock-out models, a color or fluorescent marker may be substituted in place of the actual gene sequence, allowing for high-resolution visualization of precisely where the gene is active in the body during normal body functioning, as well as in disease processes. For the optimization of preclinical development and pharmacology programs, VelociGene offers the opportunity to humanize targets by replacing the mouse gene with the human homolog or variants thereof. Thus, VelociGene allows scientists to rapidly identify the physical and biological effects of deleting or over-expressing the target gene, as well as to characterize and test potential therapeutic molecules. The company’s VelociMouse technology platform allows for the direct and immediate generation of genetically altered mice from embryonic stem cells (‘ES cells’), thereby avoiding the lengthy process involved in generating and breeding knockout mice from chimeras. Mice generated through this method are normal and healthy and exhibit a 100% germ-line transmission. Furthermore, mice developed using the company’s VelociMouse technology are suitable for direct phenotyping or other studies. The company has also developed its VelociMab platform for the rapid screening of antibodies and rapid generation of expression cell lines for the company’s Traps and its VelocImmune human antibodies. The company has utilized its VelociSuite technologies to develop a class of potential drug candidates, known as bispecific antibodies. Veloci-Bi allows for the generation of full-length bispecific antibodies similar to native antibodies that are amenable to production by standard antibody manufacturing techniques, and are likely to have favorable antibody-like pharmacokinetic properties. In the area of immunotherapies in oncology, the company is exploring the use of bispecific antibodies that target tumor antigens and the CD3 receptor on T-cells to harness the oncolytic properties of T-cells. The company is exploring additional indications and applications for the company’s bispecific technologies, including a new class of CD28 and 4-1BB costimulatory bispecifics. The company is also exploring a variety of alternative antibody formats (Altibodies) that can bring binding partners together in restrained geometries. The VelociT mouse extends the company’s research and drug discovery capabilities into cell-mediated immunity and therapeutic TCRs for oncology and other indications. VelociT was developed by using the company’s VelociGene technology to humanize genes encoding TCRa and TCRß variable sequences, CD4 and CD8 co-receptors, ß2m, and class-I and -II major histocompatibility complexes. As a result, VelociT mice can be utilized to produce fully human TCRs, providing for customized modeling of T-cell function in different diseases and a powerful platform for the discovery of unique TCR-based therapies. The company is also able to produce antibodies that recognize intracellular peptides bound in the groove of human leukocyte antigen (‘HLA’), enabling the targeting of intracellular proteins in cancer cells. VelociHum is the company’s immunodeficient mouse platform that can be used to accurately test human therapeutics against human immune cells and to study human tumor models. Through genetic humanizations, VelociHum mice have been optimized to allow for better development of human immune cells in vivo, as well as to allow for engraftment of primary patient-derived tumors that do not take in other commercially available mice. Regeneron Genetics Center Regeneron Genetics Center LLC (RGC), a wholly owned subsidiary of the company, leverages de-identified clinical, genomic, and other types of molecular data from properly consented human volunteers from around the world to identify medically relevant associations in a blinded fashion designed to preserve a patient's privacy while uncovering the unique characteristics of their health and wellness. The intention of RGC is to expand the use of human genetics for discovering and validating genetic factors that cause or influence a range of diseases where there are major unmet medical needs, with the prospect of improving the drug discovery and development process and to advance innovation in clinical care design. RGC is undertaking multiple collaborative approaches to study design and implementation, including large population-based efforts that engage study participants to more discrete disease specific and founder populations with data on strategic phenotypes of interest. RGC utilized laboratory automation and innovative approaches to cloud computing to achieve high-quality throughput, attaining more than 2 million samples sequenced as of December 31, 2023. Central to the work of RGC is the portfolio of collaborations with over 100 academic and clinical collaborators around the world, including the University of Colorado, Geisinger Health System, Mayo Clinic, University of Pennsylvania, UCLA Medical Center, UK Biobank, University of Oxford, University of Cambridge, and the University of Helsinki. These collaborations provide access to biological samples and associated phenotype data from properly consented patient volunteers for purposes of genomic research. RGC undertakes genetic sequencing of these samples to create a unique resource of de-identified genetic data and associated phenotype data for research. Furthermore, the RGC has deployed bulk RNA sequencing, whole genome sequencing, and an O-LINK proteomic assay to complement whole exome sequencing and genotyping. In addition, the RGC leverages organoid models, siRNA, and CRISPR knockout models to validate genetic associations that lead to new therapeutic targets. The RGC continues to publish results from its research efforts in journals and publications in partnership with its collaborators to advance the field of genomics. These efforts at the RGC have led to the identification of more than 30 novel genetic targets. Through the company’s Regeneron Genetics Medicines initiative, the company is advancing these targets using either its VelociSuite technologies or other technologies, such as siRNA gene silencing, genome editing, and targeted viral-based gene delivery and expression. Collaboration, License, and Other Agreements Sanofi Antibody The company is collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the ‘Antibody Collaboration’). The company co-commercializes Dupixent in the United States and in certain countries outside the United States. The company supply certain commercial bulk product to Sanofi. Immuno-Oncology The company previously collaborated with Sanofi for antibody-based cancer treatments in the field of immuno-oncology (the ‘IO Collaboration’). Under the terms of the Immuno-oncology License and Collaboration Agreement, the parties were co-developing and co-commercializing Libtayo. The company had principal control over the development of Libtayo and led commercialization activities in the United States, while Sanofi led commercialization activities outside the United States. Effective July 1, 2022, the company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi (the ‘A&R IO LCA’). Bayer The company and Bayer are parties to a license and collaboration agreement for the global development and commercialization of EYLEA 8 mg and EYLEA outside the United States. Agreed-upon development expenses incurred by the company and Bayer are generally shared equally. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales. Within the United States, the company retains exclusive commercialization rights and are entitled to all profits from such sales. Alnylam In 2019, the company and Alnylam Pharmaceuticals, Inc. entered into a global, strategic collaboration to discover, develop, and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system (‘CNS’), in addition to a select number of targets expressed in the liver. For CNS programs and liver programs, under a Co-Co Collaboration Agreement, the party designated as the lead party will lead development and commercialization of the program and the parties will split profits and share costs equally, subject to certain co-funding opt-outs at specified clinical trial phases or under other conditions. Alnylam is the lead party for ALN-APP, and the company is the lead party for ALN-PNP. The parties have entered into various license agreements, including for a combination consisting of cemdisiran (an siRNA therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam) and pozelimab, with the company as the licensee. Intellia In 2016, the company entered into a license and collaboration agreement with Intellia to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development. NTLA-2001, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia will lead development and commercialization activities and the parties share an agreed-upon percentage of development expenses and profits (if commercialized). In 2020, the company expanded the company’s existing collaboration with Intellia to provide the company 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, with Regeneron leading development and commercialization activities. In addition, the company received non-exclusive rights to independently develop and commercialize ex vivo gene edited products. In September 2023, the company further expanded its existing collaboration to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases. Intellia will lead the design of the editing methodology, the company will lead the design of the targeted viral vector delivery approach, and the parties share costs equally. Each company will have the opportunity to lead potential development and commercialization of product candidates for one target, and the company that is not leading development and commercialization will have the option to enter into a co-development and co-commercialization agreement for the target. In October 2023, the company elected to extend the period for selecting targets under the 2016 license and collaboration agreement for an additional two years until April 2026. Decibel In 2017, the company entered into an agreement with Decibel Therapeutics, Inc. to discover and develop new potential therapeutics to protect, repair and restore hearing (including DB-OTO, which is in clinical development, and preclinical programs for GJB2-related and stereocilin-related hearing loss). In September 2023, the company completed the acquisition of Decibel. BARDA In August 2023, the company expanded the company’s existing Other Transaction Agreement (‘OTA’) with BARDA, pursuant to which the HHS is obligated to fund up to 70% of the company’s costs incurred for certain development activities related to a next-generation COVID-19 monoclonal antibody therapy for the prevention of SARS-CoV-2 infection. Commercial The company’s medicines are marketed through its commercial group, which includes experienced professionals in the fields of marketing, sales, professional education, patient education, reimbursement and market access, trade and distribution, commercial operations, commercial analytics, and market research. In the United States, the company sells its marketed products primarily to wholesalers and specialty distributors that serve pharmacies, hospitals, government agencies, physicians, and other healthcare providers. The company had sales to two customers (Besse Medical, a subsidiary of Cencora, Inc., and McKesson Corporation) that each accounted for more than 10% of total gross product revenue for the year ended December 31, 2023. On a combined basis, the company’s product sales to these customers accounted for 76% of the company’s total gross product revenue for the year ended December 31, 2023. The company has established certain commercial capabilities outside the United States in connection with co-commercializing Dupixent in accordance with the company’s Sanofi collaboration agreement. In addition, the company is in process of building additional commercial capabilities outside the United States as a result of the company obtaining the rights, in 2022, to commercialize Libtayo outside the United States. Competition Marketed Products EYLEA HD and EYLEA: This product’s competitors are Biocon Biologics Ltd, Novartis AG, Genentech/Roche, Samsung Bioepis Co., Ltd., Biogen Inc., Xbrane Biopharma AB, Bausch + Lomb, Formycon AG, Bioeq AG, Coherus BioSciences, Inc., Teva Ltd., Allergan/AbbVie Inc., and Alimera Sciences, Inc. Dupixent: This product’s competitors are Pfizer Inc., Incyte Corporation, Eli Lilly and Company, AbbVie, LEO Pharma Inc., Almirall S.A., Japan Tobacco Inc./Torii Pharmaceutical Co., Ltd., Maruho Co., Ltd./Chugai Pharmaceutical Co., Ltd., Roche/Novartis, GlaxoSmithKline (‘GSK’), Teva, and AstraZeneca/Amgen. Libtayo: This product’s competitors are Merck & Co., Inc., Bristol-Myers Squibb, Roche, AstraZeneca, Pfizer/Merck KGaA, and GSK. Patents, Trademarks, and Trade Secrets The company’s patent portfolio includes granted patents and pending patent applications covering the company’s VelociSuite technologies, including the company’s VelocImmune mouse platform which produces fully human antibodies. The company’s issued patents covering these technologies generally expire between 2022 and 2032. The company’s patent portfolio also includes issued patents and pending applications relating to commercialized products and the company’s product candidates in clinical development. These patents cover, among other things, proteins, DNA and RNA molecules, manufacturing patents, method of use patents, and pharmaceutical compositions and formulations. The company is also the nonexclusive licensee of a number of additional patents and patent applications. These include a license agreement with Bristol-Myers Squibb, E. R. Squibb & Sons, L.L.C., and Ono Pharmaceutical Co., Ltd. to obtain a license under certain patents owned and/or exclusively licensed by one or more of these parties that includes the right to develop and sell Libtayo. ‘Altibodies,’ ‘ARCALYST,’ ‘Evkeeza,’ ‘EYLEA,’ ‘EYLEA HD,’ ‘Inmazeb,’ ‘Libtayo,’ ‘Praluent’ (in the United States), ‘REGEN-COV,’ ‘Regeneron,’ ‘Regeneron Genetics Center,’ ‘RGC,’ ‘Veloci-Bi,’ ‘VelociGene,’ ‘VelociHum,’ ‘VelociMab,’ ‘VelocImmune,’ ‘VelociMouse,’ ‘VelociSuite,’ ‘VelociT,’ ‘Veopoz,’ and ‘ZALTRAP’ are trademarks of the company. Government Regulation Following approval, the FDA and comparable regulatory authorities outside the United States regulate the marketing and promotion of the company’s products, which must comply with the Food, Drug, and Cosmetic Act and applicable FDA regulations and standards thereunder and equivalent foreign laws. In addition, the company and its third-party suppliers are required to maintain compliance with cGMP, and are subject to inspections by the FDA or comparable regulatory authorities in other jurisdictions to confirm such compliance. The company is subject to health care ‘fraud and abuse’ laws, such as the federal civil False Claims Act, the anti-kickback provisions of the federal Social Security Act, and other state and federal laws and regulations. The company is subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which the company operate, including the U.K. Bribery Act. Most health care providers, including research institutions from which the company or its collaborators obtain clinical trial data, are subject to HIPAA. To the extent the company collects California resident personal data, the company is also subject to the CCPA. Outside the United States, the company’s clinical trial programs, research collaborations, and other processing activities implicate international data protection laws, including the EU General Data Protection Regulation 2016/679 (‘GDPR’). In addition to the foregoing, the company’s business is subject to regulation under the United States Atomic Energy Act, the Clean Air Act, the Clean Water Act, the Comprehensive Environmental Response, Compensation and Liability Act, the National Environmental Policy Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act, national restrictions, and other local, state, federal, and foreign regulations. History Regeneron Pharmaceuticals, Inc. was founded in 1988. The company was incorporated in the state of New York in 1988.