Regeneron (REGN) Tops Q4 EPS by 1c

February 10, 2015 6:32 AM EST

Regeneron (Nasdaq: REGN) reported Q4 EPS of $2.79, $0.01 better than the analyst estimate of $2.78. Revenue for the quarter came in at $802 million versus the consensus estimate of $775.42 million.

Pipeline Progress

Regeneron has fifteen fully human monoclonal antibodies generated using the Company's VelocImmune® technology in clinical development, including five in collaboration with Sanofi. Highlights from the antibody pipeline include:

PRALUENT (alirocumab) is the Company's antibody targeting PCSK9 to lower LDL-cholesterol (LDL-C). In January 2015, the FDA accepted for priority review the BLA for PRALUENT, with a target action date of July 24, 2015. In addition, the European Medicines Agency (EMA) recently accepted for review the Marketing Authorization Application (MAA) for PRALUENT.

In November 2014, the Company and Sanofi reported positive results from six Phase 3 ODYSSEY trials that showed that PRALUENT significantly reduced LDL-C, or "bad" cholesterol. All six trials, ODYSSEY LONG TERM, COMBO I, ALTERNATIVE, OPTIONS I, OPTIONS II, and HIGH FH, met their primary efficacy endpoint of a greater reduction in LDL-C at 24 weeks, versus either active comparator or placebo, which included standard-of-care therapy. Detailed results from these trials were presented as part of a special session on the ODYSSEY program at the American Heart Association (AHA) Scientific Sessions in Chicago, IL. The companies had previously announced in July 2014 that all six studies met their primary efficacy endpoints. Data from ten studies (ODYSSEY LONG TERM, FH I, FH II, HIGH FH, COMBO I, COMBO II, OPTIONS I, OPTIONS II, ALTERNATIVE, and MONO) formed the basis for the Company's initial global regulatory filings.

In January 2015, the Company and Sanofi announced that the ODYSSEY CHOICE I and ODYSSEY CHOICE II studies met their primary efficacy endpoints. The trials compared the reduction from baseline in LDL-C at 24 weeks with PRALUENT versus placebo in patients with hypercholesterolemia. In these monthly dosing trials, the mean percent reduction in LDL-C from baseline was consistent with that seen in previous Phase 3 trials evaluating PRALUENT in every other week dosing.

The Phase 3 ODYSSEY program remains ongoing.

Sarilumab, the Company's antibody targeting IL-6R for rheumatoid arthritis, is currently under investigation in the global Phase 3 SARIL-RA program. The Phase 3 MONARCH study, which will be a head-to-head monotherapy study comparing sarilumab against adalimumab, was recently initiated. The Company and Sanofi plan to present new Phase 3 data in 2015 and submit a BLA in the United States by the end of 2015.

Dupilumab, the Company's antibody that blocks signaling of IL-4 and IL-13, is currently being studied in atopic dermatitis, asthma, chronic sinusitis with nasal polyps, and eosinophilic esophagitis. In October 2014, the LIBERTY AD CHRONOS Phase 3 study of dupilumab in atopic dermatitis was initiated and is currently enrolling patients. In November 2014, the FDA granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.

In November 2014, the Company and Sanofi reported positive results from the interim analysis of a dose-ranging Phase 2b of dupilumab in adult patients with uncontrolled moderate-to-severe asthma. Full results of the trial will be presented at an upcoming scientific meeting.

A Phase 2 study of dupilumab in eosinophilic esophagitis was also recently initiated.

Fasinumab, an antibody targeting Nerve Growth Factor (NGF), is expected to re-enter clinical development during 2015.

REGN2222, an antibody targeting the respiratory syncytial virus (RSV), is expected to enter Phase 3 trials in 2015.

REGN2810, an antibody targeting PD-1, entered Phase 1 clinical development for the treatment of cancer in the first quarter of 2015.

For earnings history and earnings-related data on Regeneron (REGN) click here.



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