Roth Comments on Regeneron's (REGN) MAA Submission for EYLEA to EU; Reaffirms 'Buy' Rating

June 11, 2014 11:27 AM EDT Send to a Friend
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Roth Capital reiterates its Buy rating and $382 target price on Regeneron Pharma (Nasdaq: REGN) after the company announced that it submitted a marketing authorization application with the EU for EYLEA.

Analyst Joseph Pantginis sees EYLEA getting approved in Europe for the BRVO indication based on positive, randomized phase III data.

Pantginis elaborated, Recall that a regulatory submission has also been made in the US for the drug for this indication. Recall that EYLEA was approved in the US in November 2011 for the treatment of wet AMD and in September 2012 for macular edema following CRVO. EYLEA is also approved in the EU for wet AMD and macular edema following CRVO. Regulatory submissions have also been made in both the US and EU for diabetic macular edema (DME). The PDUFA dates are August 18, 2014 for DME and October 23, 2014 for the BRVO indication. In 1Q14, recall that REGN noted that the lower-than-estimated sales of EYLEA in the U.S. were due to the severe weather during the winter, preventing a large population of patients from reaching their physicians. Additionally, a decrease in distributor inventory in the first quarter negatively impacted sales. REGN noted that inventory levels are back to normal at the distributor level and yearly guidance for EYLEA sales remains at $1.7-$1.8 billion. We believe the two upcoming PDUFA dates should drive EYELA growth.

For an analyst ratings summary and ratings history on Regeneron Pharma click here. For more ratings news on Regeneron Pharma click here.

Shares of Regeneron Pharma closed at $309.47 yesterday.

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