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Press Release: Regeneron Reports Fourth Quarter and Full Year 2020 Financial and Operating Results

· 02/05/2021 06:30
-- The FDA accepted for priority review, with a target action date of February 28, 2021, the sBLA for Libtayo as monotherapy to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with >=50% PD-L1 expression. A regulatory application for Libtayo as monotherapy in first-line NSCLC was also submitted in the EU. -- The FDA accepted for priority review, with a target action date of March 3, 2021, the sBLA for Libtayo for the treatment of patients with locally advanced or metastatic basal cell carcinoma (BCC). A regulatory application for Libtayo in advanced BCC was also submitted in the EU.-- In November 2020, REGEN-COV received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). REGEN-COV is authorized for the treatment of mild to moderate COVID-19 in certain patients at high risk for progressing to severe COVID-19 and/or hospitalization. -- In January 2021, the Company announced a second agreement with the U.S. government to manufacture and deliver REGEN-COV. The U.S. government has agreed to acquire up to 1.25 million additional doses at the lowest treatment dose authorized or approved by the FDA for the indication authorized under the EUA, resulting in payments to the Company of up to $2.625 billion in the aggregate. The U.S. government is obligated to purchase all filled and finished doses of drug product delivered by June 30, 2021, and may accept doses through September 30, 2021 at its discretion. A number of factors may impact available filled and finished supply by June 30, 2021, including manufacturing considerations and authorized dose levels. The agreement is in addition to the July 2020 agreement with the U.S. government for approximately 300,000 doses. -- In February 2021, the European Medicines Agency (EMA) announced it had commenced a Rolling Review of data for the casirivimab and imdevimab antibody cocktail. Data on the safety, tolerability, and efficacy of the antibody cocktail will be shared with the EMA as they become available in the coming months. -- In October 2020, the Company announced additional positive results from an ongoing Phase 2/3 seamless trial in the COVID-19 outpatient setting showing that REGEN-COV significantly reduced viral load and COVID-19 medical visits (hospitalizations, emergency room, urgent care visits, and/or physician office/telemedicine visits). Initial clinical data from this trial were published in the New England Journal of Medicine (NEJM) in December 2020. -- A Phase 2 dose-ranging treatment study in non-hospitalized patients with COVID-19 was initiated and a lower 1,200 mg dose is being evaluated in the ongoing outpatient trial. -- In December 2020, the Company announced initial encouraging data from an ongoing Phase 1/2/3 trial in seronegative hospitalized COVID-19 patients requiring low-flow oxygen. The Phase 3 program in hospitalized patients will continue based on passing a futility analysis evaluating the risk of death or receiving mechanical ventilation and demonstrating positive reductions in viral load. In October 2020, the Independent Data Monitoring Committee (IDMC) for this trial recommended that, based on a potential safety signal and an unfavorable risk/benefit profile at this time, further enrollment of patients requiring high-flow oxygen or mechanical ventilation be placed on hold. -- The United Kingdom-based RECOVERY trial continues to evaluate REGEN-COV in hospitalized patients and has enrolled more than 6,000 patients in the cohort randomizing patients 1:1 to receive REGEN-COV or placebo. -- In January 2021, the Company announced positive initial results from an ongoing Phase 3 trial evaluating REGEN-COV used as a passive vaccine for the prevention of COVID-19 in people at high risk of infection (due to household exposure to a COVID-19 patient). An exploratory analysis was conducted on the first approximately 400 evaluable individuals enrolled in the trial, who were randomized to receive passive vaccination with REGEN-COV (1,200 mg via subcutaneous injections) or placebo. -- In January 2021, the Company announced that preclinical studies showed that the REGEN-COV antibody cocktail retains its potent neutralizing ability against circulating SARS-CoV-2 variants identified in the United Kingdom, South Africa, and Brazil. Both antibodies in the cocktail retained their potency against the UK variant (B.1.1.7); imdevimab retained its potency against the South African variant (B.1.351), while casirivimab potency was reduced but still comparable to that of other single antibodies in development against the original virus. The REGEN-COV antibody cocktail was prospectively designed so that if variants arose affecting one component, the other component could compensate and still allow for potent neutralizing activity. In fact, as reported in Science in June 2020, Regeneron scientists predicted the key mutation that has since appeared in the South African and Brazil variants, and further showed that this mutation would lower potency of the casirivimab component, but be compensated for by the imdevimab component.-- In November 2020, the European Commission (EC) extended the marketing authorization in the European Union (EU) to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy. -- In October 2020, the Company and Sanofi announced that a Phase 3 trial met its primary and all key secondary endpoints in children aged 6 to 11 years with uncontrolled moderate-to-severe asthma. A supplemental Biologics License Application (sBLA) was subsequently submitted and a submission in the EU is planned by the end of the first quarter of 2021. -- Phase 3 studies in chronic inducible urticaria, chronic sinusitis without nasal polyposis, and allergic fungal rhinosinusitis were initiated.Three Months Ended Year Ended December 31, December 31, ($ in millions, except per share data) 2020 2019 % Change 2020 2019 % Change Total revenues(4) $2,423 $1,864 30% $8,497 $6,558 30% GAAP net income $1,149 $792 45% $3,513 $2,116 66% GAAP net income per share - diluted $10.24 $6.93 48% $30.52 $18.46 65% Non-GAAP net income(1) $1,080 $858 26% $3,666 $2,827 30% Non-GAAP net income per share - diluted(1) $9.53 $7.50 27% $31.47 $24.67 28%-- Fourth quarter 2020 revenues increased 30% to $2.42 billion versus fourth quarter 2019(4) -- Fourth quarter 2020 EYLEA(R) U.S. net sales increased 10% to $1.34 billion versus fourth quarter 2019 and full year 2020 EYLEA U.S. net sales increased 7% versus 2019 -- Fourth quarter 2020 Dupixent(R) global net sales(2), which are recorded by Sanofi, increased 56% to $1.17 billion versus fourth quarter 2019 and full year 2020 Dupixent global net sales increased 75% versus 2019 -- Fourth quarter 2020 GAAP diluted EPS was $10.24 and non-GAAP diluted EPS(1) was $9.53 -- REGEN-COV(TM) antibody cocktail for COVID-19 received FDA Emergency Use Authorization; new agreement signed with U.S. government to purchase up to 1.25 million additional doses -- Positive interim data reported from Phase 3 trial with REGEN-COV used as passive vaccine to prevent COVID-19

Regeneron Reports Fourth Quarter and Full Year 2020 Financial and Operating Results

PR Newswire

TARRYTOWN, N.Y., Feb. 5, 2021

TARRYTOWN, N.Y., Feb. 5, 2021 /PRNewswire/ --

Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2020 and provided a business update.

"In 2020, the Regeneron team rapidly mobilized our significant scientific, development, manufacturing, and operational capabilities to bring our monoclonal antibody cocktail, REGEN-COV, to patients with COVID-19 through an Emergency Use Authorization," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "In 2021, in addition to our ongoing work on COVID-19, we expect further diversified growth driven by continued EYLEA momentum, expanded approvals and increased market penetration for Dupixent, and new launches for Libtayo in oncology. We anticipate U.S. regulatory action for Libtayo in both non-small cell lung cancer and basal cell carcinoma within the next month -- and anticipate additional readouts later this year from across our oncology pipeline, including the bispecific platform."

Financial Highlights

"In 2020, Regeneron delivered double-digit top- and bottom-line growth and significant shareholder value despite the unprecedented circumstances of a global pandemic," said Robert E. Landry, Executive Vice President, Finance and Chief Financial Officer of Regeneron. "As we look ahead into 2021 and beyond, our business momentum and strong balance sheet give us confidence as we invest in R&D for long-term growth and execute on our capital allocation priorities."

Business Highlights

Key Pipeline Progress

Regeneron has approximately 30 product candidates in clinical development, including five marketed products for which it is investigating additional indications. Updates from the clinical pipeline include:

Dupixent(R) (dupilumab)

REGEN-COV(TM) (casirivimab and imdevimab), a dual antibody cocktail to SARS-CoV-2 virus

Libtayo(R) (cemiplimab)

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February 05, 2021 06:30 ET (11:30 GMT)