Regeneron Pharmaceuticals, Inc., is a fully integrated biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions.
Bayer believes that Xarelto (blood thinner) and Eylea (eye), which is developed by Regeneron (REGN), will hit peak revenues in 5-6 years. Bayer holds the license to sell Eylea outside the U.S.
Bayer has increased its combined peak annual sales forecast for its five most important drugs - Adempas (lung), Stivarga (cancer) and Xofigo (cancer), as well as Eylea and Xarelto - to at least €7.5B from a prior forecast of €5.5B. The treatments generated sales of €1.52B in 2013.
The FDA has accepted Regeneron's (REGN +3.3%) application to expand the use of its Eylea therapy to treat Macular Edema Following Branch Retinal Vein Occlusion, a common vascular disease among the elderly that is caused by a blockage of one of the small veins that carry blood away from the retina.
Regeneron's (REGN) 7.4% gain topped today's S&P leader board following Q4 earnings which featured good news on the company’s blockbuster-to-be, Eylea.
Q4 U.S. sales of the sight-saving drug rose 46% Y/Y to $402M, and REGN forecasts U.S. sales to reach $1.7B-$1.8B this year as it expects the drug to win approval for newer uses.
RBC Capital thinks Eylea sales could be better than forecast, given that management is typically viewed as conservative when it comes to guidance.
Brean Capital raises its price on shares to $380 from $367, as it looks to several Phase 3 trials for alirocumab - part of a new class of injectable cholesterol medicines - reading out around mid-2014; the firm views the drug as the next major value driver.
Regeneron's (REGN +3.15%) Eylea treatment improved vision and maintained that improvement over two years in a Phase III trial of patients with diabetic macular edema (DME).
DME is a leading cause of blindness in younger and middle-aged adults; Eylea could potentially treat over 6M sufferers globally.
Regeneron and partner Bayer (BAYRY) are waiting for U.S. and EU approval of Eylea to treat DME; the therapy has already been authorized for other indications, including wet age-related macular edema. (PR)
Here's analyst Joseph Pantginis, commenting: "Preclinical studies have suggested that blocking both PDGFR-beta and vascular endothelial growth factor (VEGF) can provide additional benefit over anti-VEGF treatment (such as EYLEA) alone in wet AMD."
Buy rating maintained.
Price target is $362.
In other company news, REGN has announced a collaboration with Geisinger Health System under which the companies will "study the genetic determinants of human disease." Additionally, Sanofi (SNY) has amended its investor agreement with REGN and retains the right to "acquire up to 30% of REGN's outstanding common stock and Class A stock [while gaining] the right to nominate a single independent director to the Regeneron Board of Directors upon reaching 20% ownership [stake]."
IQWiG, Germany's cost gatekeeper, struck a blow to Regeneron (REGN -0.5%) and Bayer's (BAYZF -4.1%) Eylea Thursday, saying it could not determine whether the drug is superior to Lucentis (NVS -2.1%) in treating macular edema.
As Reuters notes, the institute's position "could affect the level of reimbursement by public insurers for Eylea in Germany."