WASHINGTON (dpa-AFX) - Over the past 5 years, shares of Regeneron Pharmaceuticals Inc. (REGN) have rallied from $17 to $310, returning an astounding 1,700% gain. True, the stock has had a big run. But with continuing topline growth, increased R&D activities and a couple of regulatory events coming its way, it looks like REGN could see more upside.
Regeneron has three marketed products - Eylea, approved for wet age-related macular degeneration and macular edema following central retinal vein occlusion; Arcalyst, approved to treat a rare genetic disease called cryopyrin-associated periodic syndromes, and Zaltrap, approved for colorectal cancer.
The company derives a substantial portion of its revenues from sales of Eylea. Regeneron maintains exclusive rights to Eylea in the United States while Bayer markets the product outside the U.S.
Since its launch in the U.S. in November 2011, Eylea has seen its sales rise over the years. The net sales of Eylea in the U.S. were $25 million in 2011; $838 million in 2012 and $1.4 billion in 2013. Looking ahead to 2014, the company expects net sales of Eylea in the U.S. to range between $1.7 billion and $1.8 billion.
Eylea continues to do well outside the U.S. too. The product was launched by Bayer in Europe and other international markets in the fourth quarter of 2012. Eylea sales outside the U.S. were $19 million in 2012 and $473 million in 2013 and $218 million in Q1, 2014.
Additional indications for Eylea are also being sought by Regeneron.
The supplemental Biologics License Application for Eylea for the treatment of Diabetic Macular Edema is under FDA review, with a decision date set for August 18, 2014. Another expanded use being sought for Eylea is for the treatment of macular edema following branch retinal vein occlusion (BRVO), and the FDA is scheduled to announce its decision on October 23, 2014.
The company has 2 product candidates in phase III testing.
-- Alirocumab for LDL cholesterol reduction. The global phase III program of Alirocumab is known as ODYSSEY, and it includes 14 phase 3 trials that are currently underway. Data from the phase III program are expected in mid-2014 through 3Q, 2014.
-- Sarilumab for rheumatoid arthritis. The Sarilumab phase III program, dubbed SARIL-RA, has six ongoing clinical studies. The company reported positive data from one of the phase III studies, known as MOBILITY trial, last November. The data from the other ongoing phase III studies are expected in 2015.
Yesterday, the company reported positive results from a phase 2b study of Dupilumab in patients with moderate-to-severe atopic dermatitis, a serious, chronic form of eczema. All doses of Dupilumab met the primary endpoint of a greater improvement in Eczema Area and Severity Index (EASI) scores from baseline compared to placebo.
A phase III trial of Dupilumab in patients with atopic dermatitis is expected to be initiated later this year.
All the three product candidates - Alirocumab, Sarilumab and Dupilumab - are being developed in collaboration with Sanofi. According to a recent SEC filing, Sanofi has increased its stake in Regeneron to 22.5% from 20.44%.
When we first profiled REGN in June 2011, it was trading around $57. The second time we alerted our readers to this stock, it was trading around $112. Now the stock trades around $310.
Related Reading:
A VIEW Of Regeneron Pharma (http://www.rttnews.com/1636542/a-view-of-regeneron-pharma.aspx)
Do You Have These Stocks On Your Radar? (http://www.rttnews.com/1914677/do-you-have-these-stocks-on-your-radar.aspx)
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