TARRYTOWN, N.Y., Feb. 10, 2015 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced financial results for the fourth quarter and full year 2014 and provided an update on development programs.
Financial Highlights | |||||||||||||||
($ in millions, except per share data) | Three Months Ended December 31, | Year Ended December 31, | |||||||||||||
2014 | 2013 | % Change | 2014 | 2013 | % Change | ||||||||||
EYLEA U.S. net product sales | $ | 518 | $ | 402 | 29% | $ | 1,736 | $ | 1,409 | 23% | |||||
Total revenues | $ | 802 | $ | 610 | 31% | $ | 2,820 | $ | 2,105 | 34% | |||||
Non-GAAP net income | $ | 328 | $ | 259 | 27% | $ | 1,175 | $ | 935 | 26% | |||||
Non-GAAP net income per share - diluted | $ | 2.79 | $ | 2.24 | 25% | $ | 10.00 | $ | 8.17 | 22% | |||||
GAAP net income | $ | 110 | $ | 97 | 13% | $ | 348 | $ | 424 | (18%) | |||||
GAAP net income per share - diluted | $ | 0.96 | $ | 0.86 | 12% | $ | 3.07 | $ | 3.81 | (19%) | |||||
"In 2015, Regeneron continues on our mission to evolve into a company with multiple, commercially-important therapies for patients," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "We look forward to another strong year of EYLEA growth, driven by expanded use in diabetic macular edema, as well as the potential regulatory approval and U.S. launch of PRALUENT for hypercholesterolemia. Regeneron also continues to advance our innovative mid-to-late stage pipeline of antibodies for people with serious diseases including rheumatoid arthritis, atopic dermatitis, asthma, chronic pain, and a life-threatening infection."
Business Highlights
EYLEA® (aflibercept) Injection for Intravitreal Injection
- In the fourth quarter of 2014, net sales of EYLEA in the United States increased 29% to $518 million from $402 million in the fourth quarter of 2013. For the full year 2014, net sales of EYLEA in the United States increased 23% to $1.736 billion from $1.409 billion for the full year 2013. Overall distributor inventory levels remained within the Company's one- to two-week targeted range.
- Bayer HealthCare commercializes EYLEA outside the United States. In the fourth quarter of 2014, net sales of EYLEA outside of the United States(1) were $297 million, compared to $184 million in the fourth quarter of 2013. In the fourth quarter of 2014, Regeneron recognized $88 million from its share of net profit from EYLEA sales outside the United States (after repayment of $14 million in development expenses), compared to $44 million in the fourth quarter of 2013 (after repayment of $15 million in development expenses). For the full year 2014, net sales of EYLEA outside of the United States(1) were $1.039 billion, compared to $472 million in 2013. For the full year 2014, Regeneron recognized $301 million from its share of net profit from EYLEA sales outside the United States (after repayment of $57 million in development expenses), compared to $102 million in 2013 (after repayment of $58 million in development expenses).
- In October 2014, the FDA approved EYLEA for the treatment of macular edema following retinal vein occlusion (RVO), which includes macular edema following branch retinal vein occlusion (BRVO) in addition to the previously-approved indication of macular edema following central retinal vein occlusion (CRVO). Bayer HealthCare has also submitted regulatory applications seeking marketing authorization in the European Union and Japan for EYLEA for the treatment of macular edema following BRVO. In January 2015, the European Committee for Medicinal Products for Human Use (CHMP) recommended EYLEA for approval for the treatment of visual impairment due to macular edema secondary to CRVO or BRVO.
- In October 2014, the Company announced that in the National Institutes of Health (NIH) sponsored, Diabetic Retinopathy Clinical Research Network comparative effectiveness study in patients with diabetic macular edema (DME), EYLEA demonstrated a significantly greater improvement in mean change in best-corrected visual acuity (BCVA) from baseline at 52 weeks compared to both bevacizumab (Avastin®) and ranibizumab injection (Lucentis®), the primary endpoint of the study. The independent, NIH-sponsored study was designed to determine if one of three different anti-VEGF therapies is superior to the others for the treatment of DME.
- In November 2014, the Japanese Ministry of Health, Labour and Welfare approved EYLEA for DME.
- In November 2014, the FDA accepted for priority review the supplemental biologics license application (sBLA) for EYLEA for the treatment of diabetic retinopathy in patients with DME, with a target action date of March 30, 2015.
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.
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