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REGENERON Regeneron Reports Third Quarter 2021 Financial and Operating Results November 4 , 2021 TARRYTOWN , N.Y. , Nov. 4 , 2021 / PRNewswire / -- • Third quarter 2021 revenues increased 51 % to $ 3.45 billion versus third quarter 2020 including $ 804 million attributable to REGEN - COVⓇ ( 2 ) • Third quarter 2021 EYLEA® U.S. net sales increased 12 % versus third quarter 2020 to $ 1.47 billion • Third quarter 2021 Dupixent global net sales ( 3 ) , which are recorded by Sanofi , increased 55 % to $ 1.66 billion versus third quarter 2020 • Third quarter 2021 GAAP diluted EPS was $ 14.33 and non - GAAP diluted EPS ( 1 ) was $ 15.37 • Positive results reported from four Phase 3 Dupixent studies ; FDA expanded approval of Dupixent to include children aged 6 to 11 years with asthma Regeneron Pharmaceuticals , Inc. ( NASDAQ : REGN ) today announced financial results for the third quarter of 2021 and provided a business update . " Regeneron had another strong quarter of core business growth , with EYLEA and Dupixent reaching more patients than ever and progress made across our diverse pipeline , " said Leonard S. Schleifer , M.D. , Ph.D. , President and Chief Executive Officer of Regeneron . " We secured a new U.S. government supply agreement and are delivering an additional 1.4 million doses of REGEN - COV . Our Biologics License Application for REGEN - COV as treatment and prophylaxis was accepted by the FDA for priority review , with a mid - April 2022 action date . During the third quarter , we announced positive data from Phase 3 trials of Dupixent in chronic spontaneous urticaria and pediatric atopic dermatitis . We also recently announced positive data from Phase 3 trials of Dupixent in eosinophilic esophagitis and prurigo nodularis , and that the FDA approval in pediatric asthma was extended to children as young as six . Finally , our abstracts that will be released today for the American Society of Hematology ( ASH ) Annual Meeting highlight programs across the hematology portfolio , including our BCMA and C5 antibodies . " Financial Highlights ( $ in millions , except per share data ) Total revenues GAAP net income GAAP net income per share diluted Non - GAAP net income ( 1 ) Non - GAAP net income per share - diluted ( 1 ) $ $ $ $ Q3 2021 3,453 1,632 14.33 1,773 $ $ Q3 2020 2,294 842 $ 7.39 $ 961 % Change 51 % 94 % 8.36 94 % 84 % $ 15.37 $ " Regeneron performed extremely well in the third quarter with strong top- and bottom - line growth driven by an increasingly diversified core business , " said Robert E. Landry , Executive Vice President , Finance and Chief Financial Officer of Regeneron . " We are approaching the end of 2021 with positive momentum as we continue to invest in our broad pipeline to drive sustained long - term growth . " Business Highlights 84 % Key Pipeline Progress Regeneron has over 30 product candidates in clinical development , including six marketed products for which it is investigating additional indications . Updates from the clinical pipeline include : EYLEAⓇ ( aflibercept ) Injection • In August 2021 , the Company announced that an ongoing Phase 2 trial evaluating an 8 mg dose of aflibercept in patients with neovascular age - related macular degeneration ( wet AMD ) met its primary safety and efficacy endpoints . The high - dose aflibercept formulation is currently also being evaluated in two large Phase 3 trials in wet AMD and diabetic macular edema ( DME ) , which are expected to report results in the second half of 2022 . Dupixent ( dupilumab ) • In October 2021 , the U.S. Food and Drug Administration ( FDA ) approved Dupixent for children aged 6 to 11 years with moderate - to - severe asthma . • In July 2021 , the Company and Sanofi announced that a Phase 3 trial in patients with moderate - to - severe chronic spontaneous urticaria ( CSU ) met its primary and all key secondary endpoints at 24 weeks . • In October 2021 , the Company and Sanofi announced that a second Phase 3 trial in adults and adolescents with eosinophilic esophagitis ( EoE ) met its co - primary endpoints in patients taking Dupixent 300 mg weekly , showing significant improvements in clinical ( Dysphagia Symptom Questionnaire ) and histologic disease measures compared to placebo . A rolling supplemental Biologics License Application ( sBLA ) has been initiated for adults and adolescents with EoE .