Regeneron Flags FDA Delays For Eylea HD Prefilled Syringe

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) on Wednesday reported first-quarter adjusted earnings of $9.47 per share, up 15% year-over-year, beating the consensus of $8.89.

The company reported sales of $3.61 billion, up 19% year over year, beating the consensus of $3.48 billion.

Eylea HD Growth Driven By Demand, Pricing Pressure Persists

In the quarter, Eylea HD sales increased 52% to $468 million, driven by higher sales volumes and increased demand, partly offset by a lower net selling price.

In addition, Eylea HD net product sales were negatively affected by lower wholesaler inventory levels at the end of the first quarter of 2026 than at the end of the fourth quarter of 2025.

Eylea HD net product sales decreased 7% sequentially; however, physician unit demand increased 10% sequentially.

Collaboration Revenue Boosted By Dupixent Performance

Sanofi SA’s (NASDAQ:SNY) collaboration revenue increased due to an increase in the company's share of profits from the commercialization of antibodies, which were $1.45 billion.

The change in the company’s share of profits from the commercialization of antibodies was driven by higher profits primarily associated with an increase in Dupixent sales.

Regulatory Updates And Manufacturing Developments

In an investor call, Regeneron said, “We resubmitted an application seeking FDA approval for filling of the Eylea HD prefilled syringe at Catalent, Indiana, where the FDA has recently conducted a site re-inspection. In addition, the FDA did not act by the April 2026 PDUFA date for the company’s regulatory application for a second contract manufacturer for the PFS. Therefore, this application remains pending.”

Share Buyback And 2026 Outlook

In April 2026, the company authorized a new share repurchase program to repurchase up to an additional $3.0 billion, with no time limit.

Regeneron expects fiscal 2026 GAAP gross margin of 77%–78% (versus prior range of 79%–80%), with adjusted gross margin of 83%–84%.

The company forecasts adjusted R&D expenses of $5.9–$6.1 billion in 2026, and non-GAAP SG&A expenditure between $2.5 billion and $2.65 billion.

REGN Price Action: Regeneron Pharmaceuticals shares were down 6.02% at $687.71 at the time of publication on Wednesday, according to Benzinga Pro data.

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