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Regeneron Reports Fourth Quarter and Full Year 2012 Financial and Operating Results
Date:2/14/2013

utive Officer of Regeneron.  "With the recent U.S. approval of EYLEA for the treatment of macular edema following central retinal vein occlusion (CRVO), and receipt of a Medicare J-Code for EYLEA in January 2013, we expect continued strong U.S. growth for EYLEA and forecast U.S. net sales of $1.2 billion to $1.3 billion in 2013.  Outside the U.S., our partner Bayer HealthCare has begun to launch EYLEA for the treatment of neovascular age-related macular degeneration (wet AMD) in Japan, Europe, Australia, and other regions, and we expect to see substantial sales growth through 2013 and beyond as pricing approvals are received." 

"Clinical development of EYLEA in additional indications continued to progress in 2012, as the Phase 3 program in diabetic macular edema (DME) was fully enrolled and a Phase 3 trial in macular edema following branch retinal vein occlusion (BRVO) was initiated," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer, and President, Regeneron Laboratories.  "Our pipeline also advanced significantly during 2012, with the roll-out of our broad Phase 3 ODYSSEY program for REGN727, an antibody targeting PCSK9 to reduce low-density lipoprotein (LDL) cholesterol, and the full enrollment of our first Phase 3 trial for sarilumab, our IL-6 receptor antibody in rheumatoid arthritis.  We are also encouraged by the potential of our IL-4R inhibitor, REGN668.  REGN668 demonstrated positive proof of concept in allergic asthma and atopic dermatitis, and data from these trials will be submitted to medical conferences for presentation later in the year.  We look forward to starting later stage, Phase 2b trials with this antibody during 2013."

Business Highlights - Fourth Quarter 2012 and 2013 to Date EYLEA® (aflibercept) Injection for Intravitreal Injection

  • The Company and Bayer HealthCare collaborate on the global development and commercialization of EYLEA outside the U
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