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REGENERON Regeneron Reports First Quarter 2021 Financial and Operating Results May 6 , 2021 TARRYTOWN , N.Y. , May 6 , 2021 / PRNewswire / -- • First quarter 2021 revenues increased 38 % to $ 2.53 billion versus first quarter 2020 ; revenues excluding REGEN - COVTM ( 1 ) increased 20 % • First quarter 2021 EYLEA® U.S. net sales increased 15 % to $ 1.35 billion versus first quarter 2020 • First quarter 2021 Dupixent global net sales ( 2 ) , which are recorded by Sanofi , increased 48 % to $ 1.26 billion versus first quarter 2020 • First quarter 2021 GAAP diluted EPS was $ 10.09 and non - GAAP diluted EPS ( 1 ) was $ 9.89 • Three FDA approvals received : Libtayo® for first - line advanced non - small cell lung cancer ( NSCLC ) and advanced basal cell carcinoma ( BCC ) , and EvkeezaTM for homozygous familial hypercholesterolemia ( HoFH ) • Positive data reported from Phase 3 trials with REGEN - COV used to treat and prevent COVID - 19 Regeneron Pharmaceuticals , Inc. ( NASDAQ : REGN ) today announced financial results for the first quarter of 2021 and provided a business update . " Regeneron had a strong first quarter highlighting our continued evolution into a company with multiple durable product lines helping people with a range of serious diseases including COVID - 19 , " said Leonard S. Schleifer , M.D. , Ph.D. , President and Chief Executive Officer of Regeneron . " We recently reported positive Phase 3 results for REGEN - COV in both the COVID - 19 outpatient treatment and prevention settings and are working with national and state authorities to improve access . We expect continued growth with EYLEA in retinal diseases , as well as with Dupixent through further penetration in existing indications and a broad Phase 3 development program . In oncology , we are in the early days of launching Libtayo for advanced basal cell carcinoma and non - small cell lung cancer and recently announced positive pivotal data in cervical cancer with regulatory submissions planned for later this year . " 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 ) Q1 2021 2,529 1,115 10.09 1,109 $ 9.89 $ $ $ $ $ $ $ Q1 2020 1,828 625 5.43 $ 771 $ 6.60 % Change 38 % 78 % 86 % 44 % 50 % " Our business is off to a strong start in 2021 with double - digit top- and bottom - line growth , " said Robert E. Landry , Executive Vice President , Finance and Chief Financial Officer of Regeneron . " Our financial strength and solid execution across the business continue to position the Company for sustainable long - term growth . " 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 • In March 2021 , JAMA Ophthalmology announced initial results from the National Institutes of Health - sponsored Protocol W trial evaluating EYLEA in patients with moderate to severe non - proliferative diabetic retinopathy ( NPDR ) . The two - year data confirmed results from the Company - sponsored PANORAMA trial and demonstrated that EYLEA significantly reduced the risk of developing vision - threatening complications with an every - 16 - weeks dosing regimen . The Company plans to submit a supplemental Biologics License Application ( SBLA ) for an every - 16 - weeks dosing regimen in patients with NPDR later this year . Dupixent ( dupilumab ) • The U.S. Food and Drug Administration ( FDA ) accepted for review , with a target action date of October 21 , 2021 , the SBLA for Dupixent for children aged 6 to 11 years with moderate - to - severe asthma . A regulatory application for Dupixent for children aged 6 to 11 years with severe asthma was also submitted in the European Union ( EU ) . REGEN - COV ™ M ( casirivimab with imdevimab ) , a dual antibody cocktail to SARS - CoV - 2 virus • In March 2021 , the Company announced positive top - line results from the Phase 3 treatment trial in high - risk COVID - 19 outpatients . The trial met its primary endpoint , showing that REGEN - COV significantly reduced the risk of hospitalization or death by approximately 70 % with both REGEN - COV doses ( 1,200 mg and 2,400 mg ) compared to placebo . The trial also met key secondary endpoints , including the ability to reduce symptom duration . Based on these results , the Company submitted a request to the FDA to update the Emergency Use Authorization ( EUA ) to the lower 1,200 mg dose . • In April 2021 , the National Institutes of Health ( NIH ) COVID - 19 Treatment Guidelines were updated to strongly recommended that REGEN - COV be used in non - hospitalized COVID - 19 patients at high risk of clinical progression . • In April 2021 , the Company announced positive results from the Phase 3 COVID - 19 prevention trial in uninfected household contacts of SARS - CoV - 2 infected individuals . The trial met its primary and key secondary endpoints , showing that REGEN - COV 1,200 mg administered subcutaneously reduced the risk of symptomatic infections by 81 % . The Company has shared this data with the FDA and requested that the EUA be expanded to include COVID - 19 prevention for appropriate populations . • In April 2021 , the Company also announced positive data from a Phase 3 treatment trial in recently infected asymptomatic COVID - 19