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Regeneron Pharmaceuticals' CEO Discusses Q2 2012 Results - Earnings Call Transcript

Today we are happy to report a very successful quarter as our team continues to execute on the ongoing launch of EYLEA, also known as intravitreal aflibercept injection. We saw strong quarter-over-quarter growth with U.S. net sales of $194 million, representing a 57% increase over the last quarter. Given the trajectory of the launch to date, tempered by the potential for less frequent dosing as doctors increase the interval between injections of EYLEA, we are increasing our full-year U.S. EYLEA net sales forecast to between 700 and 750 million from a prior 500 to 550 million. If we achieve this new forecast, EYLEA will become one of the best drug launches in the history of the biotechnology industry. In a few minutes, Bob Terifay will go into some more details on the launch.

Importantly, the strong EYLEA sales growth translated into even stronger earnings growth where we saw non-GAAP net income rise more than 2.5-fold from $40 million last quarter to slightly over $100 million in the second quarter of 2012, which translated into non-GAAP fully diluted earnings per share of $0.90. Obviously we are pleased by both the performance of EYLEA as well as its ability to fuel the Company’s earnings. The ability to translate sales growth into strong earnings growth while still investing heavily in our robust and internally discovered pipeline that includes 10 antibodies into addition to our three traps, highlights our relatively unique business model.

Our PDUFA date in the U.S. for our SBLA for EYLEA for CRVO is September 23, and an approval would further expand the EYLEA opportunity. As a reminder, the strong commercial results for EYLEA only reflect the launch of EYLEA in the U.S. Outside the United States, our partner Bayer Healthcare has already receiving marketing approval in two countries – Australia and Colombia – and we are awaiting regulatory decisions in the EU, Japan, and other countries. We expect the global launch to start toward the end of the year.

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