Page 1

REGENERON Regeneron Reports Second Quarter 2021 Financial and Operating Results August 5 , 2021 TARRYTOWN , N.Y. , Aug. 5 , 2021 / PRNewswire / -- . Second quarter 2021 rev nues increased 163 % to $ 5.14 billion versus second quarter 2020 including $ 2.76 billion attributable to REGEN - COV ™ M ( 2 ) ; revenues excluding REGEN - COV ( 1 ) ( 2 ) increased 22 % • Second quarter 2021 EYLEAⓇ U.S. net sales increased 28 % versus second quarter 2020 to a record $ 1.42 billion • Second quarter 2021 Dupixent global net sales ( 3 ) , which are recorded by Sanofi , increased 59 % to $ 1.50 billion versus second quarter 2020 • Second quarter 2021 GAAP diluted EPS was $ 27.97 and non - GAAP diluted EPS ( 1 ) was $ 25.80 • FDA updated REGEN - COV Emergency Use Authorization ( EUA ) with lower dose , subcutaneous administration , and post - exposure prophylaxis • REGEN - COV Phase 3 RECOVERY trial in hospitalized patients with severe COVID - 19 met primary outcome • Reported that Dupixent significantly improved itch and hives in patients with chronic spontaneous urticaria , marking the fifth disease to show positive pivotal results • Phase 3 trial of LibtayoⓇ combined with chemotherapy stopped early due to significant improvement in overall survival in patients with first - line advanced non - small cell lung cancer Regeneron Pharmaceuticals , Inc. ( NASDAQ : REGN ) today announced financial results for the second quarter of 2021 and provided a business update . " Regeneron had outstanding performance in the second quarter during which we delivered to the U.S. government the entire order for our COVID - 19 antibody cocktail and recognized record global sales from our EYLEA and Dupixent franchises , " said Leonard S. Schleifer , M.D. , Ph.D. , President and Chief Executive Officer of Regeneron . " We continue to advance Dupixent's potential to help new patient groups , with recent positive Phase 3 data in chronic spontaneous urticaria and additional late - stage read - outs expected later this year in prurigo nodularis , eosinophilic esophagitis , and pediatric atopic dermatitis . With today's positive Phase 3 results in combination with chemotherapy in non - small cell lung cancer , Libtayo yet again demonstrates its potential to be a leading checkpoint inhibitor . We also progressed our genetics medicines platform , with landmark clinical data alongside our collaborator Intellia using a CRISPR therapeutic and the discovery of a promising new obesity target from the Regeneron Genetics Center . " 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 ) Q2 2021 $ $ 5,139 3,099 $ 27.97 2,895 25.80 $ $ $ $ $ $ $ Q2 2020 1,952 897 7.61 854 7.16 % Change 163 % 245 % 268 % 239 % 260 % " Regeneron performed exceptionally well in the second quarter with the core business on a strong growth trajectory as we invest in our diverse and differentiated pipeline for long - term and sustainable growth , " said Robert E. Landry , Executive Vice President , Finance and Chief Financial Officer of Regeneron . Business Highlights Key Pipeline Progress Regeneron has approximately 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 • Enrollment in the Phase 3 studies for high - dose formulation in diabetic macular edema ( DME ) and neovascular age - related macular degeneration ( wet AMD ) was completed . • Enrollment in the Phase 3 study for retinopathy of prematurity ( ROP ) was also completed . Dupixent ( dupilumab ) • The Company and Sanofi announced 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 . The trial showed that adding Dupixent to standard - of - care antihistamines significantly reduced itch and hives for biologic - naive patients , compared to antihistamines alone in the first of two trials of this clinical program . • In June 2021 , the U.S. Food and Drug Administration ( FDA ) approved a 200 mg single - dose pre - filled pen for Dupixent .