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Regeneron Pharmaceuticals Value Stock - Dividend - Research Selection


ISIN: US75886F1075 , WKN: 881535

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Description of the company

Regeneron Pharmaceuticals, Inc. is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. We commercialize medicines for eye diseases, high low-density lipoprotein (LDL) cholesterol, and a rare inflammatory condition and have product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis (RA), asthma, atopic dermatitis, pain, cancer, and infectious diseases. Our significant 2016 business highlights include: • EYLEA (aflibercept) Injection, which is approved by the U.S. Food and Drug Administration (FDA) for use in retinal indications, delivered U.S. net sales growth of 24.2% over 2015, and continues to be the market-leading, branded anti-VEGF therapy in the United States. A Phase 3 study for the treatment of non-proliferative diabetic retinopathy (NPDR) in patients without DME was initiated. • We, along with our partner Sanofi, received regulatory approval for Praluent in additional countries outside the United States. Praluent has been launched in the United States, Europe, and other countries. We also reported positive Phase 3 data from the ODYSSEY ESCAPE study of Praluent in patients with heterozygous familial hypercholesterolemia (HeFH) and consequently, high LDL cholesterol levels who were undergoing apheresis. A Phase 3 cardiovascular outcomes study of Praluent is ongoing. • We reported positive efficacy and safety data from Phase 3 studies of Dupixent in patients with moderate-to-severe atopic dermatitis. The FDA accepted, and granted priority review for, the Biologics License Application (BLA) for Dupixent for the treatment of atopic dermatitis with a target action date of March 29, 2017. In addition, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application (MAA) for Dupixent for the treatment of atopic dermatitis. The FDA granted Breakthrough Therapy designation for Dupixent for the treatment of atopic dermatitis in pediatric patients. A Phase 3 study of dupilumab for the treatment of uncontrolled, persistent asthma completed enrollment. A Phase 3 study of dupilumab for the treatment of nasal polyps was also initiated. • A Phase 3 study of fasinumab in patients with pain due to osteoarthritis of the knee or hip was initiated. A Phase 2b study of fasinumab in chronic low back pain was also initiated and later placed on clinical hold by the FDA. We completed an unplanned analysis of this Phase 2b study in chronic low back pain which showed clear evidence of efficacy with improvement in pain scores in all fasinumab groups compared to placebo. • REGN2810 entered a potentially pivotal clinical study for the treatment of advanced cutaneous squamous cell carcinoma. • Phase 2 studies of EYLEA, in a co-formulated combination with nesvacumab, an antibody to angiopoietin-2 (ANG2), advanced in clinical development for the treatment of wet AMD and DME. • We advanced four new product candidates (REGN3500, REGN3470-3471-3479, REGN2477, and REGN3767) into Phase 1 clinical development. • We entered into significant new research and development license and collaboration arrangements: a collaboration with Bayer for a co-formulated combination therapy of the Ang2 antibody nesvacumab and aflibercept for the treatment of serious eye diseases; a collaboration with Teva for fasinumab; a license and collaboration with Intellia Therapeutics, Inc. to advance CRISPR/Cas gene-editing technology for in vivo therapeutic development; and a license and collaboration agreement with Adicet Bio, Inc. to develop next-generation engineered immune-cell therapeutics with fully human chimeric antigen receptors and T-cell receptors directed to disease-specific cell surface antigens in order to enable the precise engagement and killing of tumor cells. • Our initiatives in genomics also advanced, and we have sequenced over 150,000 exomes to date. • From a company growth perspective, we hired our 5,000th employee, purchased an office building near our Tarrytown facility, purchased land and an office building near our Rensselaer, New York facilities, continued to expand our bulk drug product manufacturing operations in Rensselaer, New York, and continued building out and hiring people for our new Limerick, Ireland commercial manufacturing facility. • We were named the top employer in the global biotech and pharmaceutical industry by Science magazine. We have been ranked first for four of the past six years, with second place rankings in 2015 and 2011. • Society for Science & the Public announced that Regeneron has become the new title sponsor of the Science Talent Search. Regeneron became only the third sponsor in 75 years of the nation's oldest and most prestigious high school science competition. Our total revenues were $4,860.4 million in 2016, compared to $4,103.7 million in 2015 and $2,819.6 million in 2014. Our net income was $895.5 million, or $7.70 per diluted share, in 2016, compared to $636.1 million, or $5.52 per diluted share, in 2015, and $338.1 million, or $2.98 per diluted share, in 2014. Refer to Part II, Item 7. "Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations" below for further details of our financial results. We currently have five products that have received marketing approval: • EYLEA (aflibercept) Injection, known in the scientific literature as VEGF Trap-Eye, which is available in the United States, European Union (EU), Japan, and certain other countries outside the United States for the treatment of neovascular age-related macular degeneration (wet AMD), diabetic macular edema (DME), macular edema following retinal vein occlusion (RVO), which includes macular edema following central retinal vein occlusion (CRVO) and macular edema following branch retinal vein occlusion (BRVO). EYLEA is also available in the EU, Japan, and certain other countries outside the United States for the treatment of myopic choroidal neovascularization (mCNV) and in the United States for the treatment of diabetic retinopathy in patients with DME. Bayer has additional regulatory applications for EYLEA for various indications pending in other countries. We are collaborating with Bayer on the development and commercialization of EYLEA outside the United States. • Praluent (alirocumab) Injection, which is available in the United States where it is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL cholesterol. Praluent is also available in certain countries in Europe for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet: (a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated dose of a statin, or (b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated. In July 2016, the Japanese Ministry of Health, Labour and Welfare (MHLW) granted marketing and manufacturing authorization for Praluent for the treatment of uncontrolled LDL cholesterol, in certain adult patients with hypercholesterolemia at high cardiovascular risk. The effect of Praluent on cardiovascular morbidity and mortality has not been determined. We are collaborating with Sanofi on the global development and commercialization of Praluent. See Part I, Item 3. "Legal Proceedings" for information regarding the patent infringement proceedings relating to Praluent, which may impact Praluent's commercial availability in the United States and other jurisdictions. • ARCALYST® (rilonacept) Injection for Subcutaneous Use, which is available in the United States for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including Familial Cold Auto-inflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS), in adults and children 12 years and older. • KevzaraTM (sarilumab) Solution for Subcutaneous Injection. In January 2017, Health Canada approved Kevraza for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have an inadequate response to or intolerance to one or more biologic or non-biologic disease modifying anti-rheumatic drugs (DMARDs). This is the first approval of Kevzara worldwide. • ZALTRAP® (ziv-aflibercept) Injection for Intravenous Infusion, known in the scientific literature as VEGF Trap, which is available in the United States, EU, and certain other countries for treatment, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), of patients with metastatic colorectal cancer (mCRC) that is resistant to or has progressed following an oxaliplatin-containing regimen. Pursuant to a 2015 amended and restated ZALTRAP agreement (Amended ZALTRAP Agreement), Sanofi is solely responsible for the development and commercialization of ZALTRAP, and Sanofi pays us a percentage of aggregate net sales of ZALTRAP. We have 16 product candidates in clinical development, all of which were discovered in our research laboratories. These consist of a Trap-based clinical program and 15 fully human monoclonal antibody product candidates, as summarized below. Each of the antibodies in the table below was generated using our VelocImmune® technology.
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