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Regeneron (REGN) Misses Q4 GAAP EPS Views on R&D, Pipeline Expansion, but EYLEA Shaping-Up Well - Roth Capital

February 11, 2015 8:54 AM

Roth Capital affirms Regeneron (Nasdaq: REGN) at Buy with a price target of $461 following Q4, FY14 results reported earlier in the week.

Analyst Joseph Pantginis noted that Q4 GAAP EPS of $0.96 compared with his estimate of $1.36. The analyst attributed the miss to continued pipeline expansion as well as growing R&D reimbursement payments to Bayer and Sanofi."

Following results, Pantginis commented, We continue to be impressed with Eylea's growth curve and as the U.S. market starts to peak in the next year or so, we expect Bayer to continue to expand ex-U.S. approvals in multiple geographies. The next major growth driver for Regeneron, in our belief, is the expected approval of Praluent (alirocumab) for the treatment of high cholesterol. Recall the PDUFA date is July 24, 2015 and we also expect E.U. approval this year as well. The drug is running essentially head to head with Amgen's (AMGN-NC) evolocumab, which has a PDUFA date of August 27, 2015. Based on the current positive regulatory environment, we believe the FDA will beat both PDUFA dates. As we look at the potential for Praluent, we believe the drug is largely priced into the stock, though investors will look to the competitive landscape and the early signs of a positive launch. Continuing to drive long term potential is the ever-growing pipeline with current focus on sarilumab and dupilumab. Additional Phase III RA data will be presented for sarilumab this year with BLA filing expected by the end of 2015. Recall dupilimab has Breakthrough Designation for atopic dermatitis (Phase III enrolling and full Phase IIb asthma data will be presented later this year.

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

Regeneron Pharma closed at $400.71 yesterday.

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