US sales of Regeneron's Eylea in first quarter best estimates

Regeneron Pharmaceuticals reported Thursday that first-quarter sales of Eylea in the US rose 15 percent year-over-year to $984 million, besting analyst estimates of around $922 million. The company's overall sales increased 15 percent to $1.5 billion, in line with forecasts, as net income surged 92 percent to $478 million.

CEO Leonard Schleifer remarked "Regeneron's commercial business continues to advance with positive sales growth for Eylea and strong underlying demand for Dupixent." In the quarter, global sales of Eylea lifted 20 percent to $1.6 billion, while Dupixent posted revenue of $131 million, missing estimates of around $168 million.

In the three-month period, sales of Praluent jumped 67 percent versus the same quarter of 2017 to $60 million, but fell short of analyst forecasts of $66 million. In October 2017, a US appeals court overturned a lower court ruling blocking Regeneron and partner Sanofi from selling the PCSK9 inhibitor in the US after a separate court determined that the companies infringed patents held by Amgen related to Repatha.

Earlier this month, Regeneron and Sanofi announced that Express Scripts is making Praluent the exclusive PCSK9 inhibitor on its national formulary as of July 1 in exchange for a lower list price. The companies had previously agreed to offer discounts of as much as 69 percent following consultation with the Institute for Clinical and Economic Review (for related analysis, see ViewPoints: Regeneron/Sanofi steal a march on Amgen with Express Scripts deal – but at what cost?).

Commenting on the results, SunTrust Robinson Humphrey analyst Yatin Suneja said "there are concerns that what happened (with Dupixent) in first quarter could happen again," adding that there may be an issue with the drug's long-term growth potential. Meanwhile, RBC Capital Markets analyst Kennen MacKay noted "there's even more competition on the horizon for Eylea, so we are looking at Dupixent as a growth driver."

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Despite the newer products missing expectations, Regeneron said it is unlikely to be undertaking deals, but will instead rely on its own drug pipeline. "Our strategy was, and continues to be, to invest heavily in our internal research capabilities rather than look externally for new products," Schleifer remarked, adding "we are not nearly as desperate as other companies are to fill up gaps in the pipeline."

Schleifer continued "our immuno-oncology portfolio is advancing rapidly, with a potential first approval for cemiplimab in advanced cutaneous squamous cell carcinoma, and a broad pivotal programme in lung cancer." Earlier this week, the FDA awarded priority review to cemiplimab for use in patients with metastatic cutaneous squamous cell carcinoma (CSCC) and those with locally advanced CSCC who are not eligible for surgery. The agency will issue a final decision regarding approval of the PD-1 antibody, which is being developed with Sanofi, by October 28 (for related analysis, see ViewPoints: Regeneron sees opportunity in world of differentiated anti-PD-(L)1s).

However, Regeneron also disclosed that higher-dose regimens of the experimental drug fasinumab will be discontinued in Phase III studies on the recommendation of an independent Data Monitoring Committee following a risk benefit assessment. The anti-NGF antibody is being studied in patients with osteoarthritis of the knee or hip and chronic low back pain in patients with concomitant osteoarthritis of the knee or hip. The company added that the trials will continue with the lower dose-regimens of fasinumab.

For further analysis, read ViewPoints: Fasinumab news sends shivers through anti-NGF universe.

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