Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported Q2 EPS of $2.47, $0.17 better than the analyst estimate of $2.30. Revenue for the quarter came in at $666 million versus the consensus estimate of $647.99 million.

EYLEA® (aflibercept) Injection for Intravitreal Injection

• In the second quarter of 2014, net sales of EYLEA in the United States increased 26% to $415 million from $330 million in the second quarter of 2013. Net sales in the second quarter of 2013 were impacted by a modest decrease in distributor inventory. Excluding these changes in inventory, underlying demand for EYLEA in the second quarter of 2014 in the United States increased by approximately 22% year over year.
• Bayer HealthCare LLC commercializes EYLEA outside the United States. In the second quarter of 2014, net sales of EYLEA outside of the United States(1) were $247 million, compared to $102 million in the second quarter of 2013. In the second quarter of 2014, Regeneron recognized $67 million from its share of net profit from EYLEA sales outside the United States, compared to $19 million in the second quarter of 2013 (each after repayment of $15 million in development expenses).
• In July 2014, the FDA approved EYLEA for the treatment of diabetic macular edema (DME).
• Applications for marketing approval in the European Union (EU) and Japan for EYLEA in DME have also been submitted. In June 2014, EYLEA was recommended for approval by the European Committee for Medicinal Products for Human Use (CHMP) for the treatment of DME. The decision of the European Commission is expected in the second half of 2014.
• In July 2014, the Company reported that two-year results from the Phase 3 VIVID-DME trial of EYLEA for the treatment of DME demonstrated sustained improvement in vision. The 52-week results (primary analyses) from this study have been previously reported.
• The target date for an FDA decision on the supplemental BLA for U.S. regulatory approval of EYLEA for the treatment of macular edema following branch retinal vein occlusion (BRVO) is October 23, 2014. In June 2014, Bayer HealthCare submitted an application to the European Medicines Agency (EMA) seeking marketing authorization in the EU for EYLEA for the treatment of macular edema following BRVO.
• In the Phase 3 SIGHT trial of EYLEA in wet age-related macular degeneration (AMD) patients in China, EYLEA 2 milligrams (mg) dosed every two months achieved the primary endpoint of a significantly greater improvement in best-corrected visual acuity (BCVA) from baseline compared to photodynamic therapy (PDT) at 28 weeks (14 letters for EYLEA vs. 3.9 letters for PDT, p less than 0.0001). The safety results were consistent with results from prior studies in wet AMD.

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