- Regeneron Pharmaceuticals Inc (NASDAQ: REGN) reported fourth-quarter earnings of $9.53 per share, which beat the analyst consensus estimate of $8.39. Quarterly sales of $2.42 billion increased 30% year-on-year, which was in line with expectations. The current quarter earnings benefited from a recovery in demand for its flagship eye drug (Eylea) and a jump in sales of its eczema drug, Dupixent (collaboration with Sanofi).
- Physician-administered macular degeneration drug Eylea sales were hurt during the pandemic’s peak last year as patients were reluctant to visit doctors’ offices. Eylea sales were up 10% to $2,202 million during the quarter.
- Sales from Dupixent increased 56% to $1,172 million after the European Commission extended the marketing authorization for Dupixent in the EU to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy, resulting in incremental sales from this label expansion.
- The company recorded sales of $145.5 million from REGEN-COV, its antibody cocktail for COVID-19, for which the company received FDA Emergency Use Authorization from the FDA in November 2020. Last month, the company inked a second agreement with the U.S. government for 1.25M additional REGEN-COV doses, resulting in $2.625B payments.
- Other products include Libtayo: $97.3M (+30%); Praluent: $100.9M (+24%); Kevzara: $71.5M (+20%).
Select milestones of 2021:
- Additional data from REGEN-COV Phase 3 portion of COVID-19 study in non-hospitalized patients.
- Dupixent: FDA decision on sBLA and MAA submission for asthma in pediatrics (6–11 years of age).
- Libtayo: FDA decision on marketing application (target action date of February 28 and March 3) and European Commission decision on regulatory submission for first-line advanced or metastatic non-small cell lung cancer, monotherapy, and advanced or metastatic basal cell carcinoma.
- Price Action: REGN shares gained 3.4% at $516 in premarket trading on the last check Friday.