Regeneron Flags $22 Million IPR&D Charge for Third Quarter
The biopharmaceutical company said the pre-tax charge is expected to cut GAAP and non-GAAP diluted earnings by about $0.18 a share.
Regeneron Pharmaceuticals (REGN) said it currently expects third-quarter 2026 GAAP and non-GAAP results to include an acquired in-process research and development charge of approximately $22 million on a pre-tax basis, which is expected to reduce both GAAP and non-GAAP diluted earnings by about $0.18 a share.
The charge may include IPR&D acquired in asset acquisitions as well as up-front, opt-in, and development milestone payments and premiums on equity securities tied to collaboration and licensing agreements. Regeneron does not forecast such charges because of the uncertainty of their future occurrence, magnitude, and timing. Third-quarter results had not been finalized and remained subject to closing procedures.
The preliminary item followed a second quarter in which the Tarrytown, New York, biopharmaceutical company posted total revenues of $4.291 billion, up 17% from $3.676 billion a year earlier. That year-over-year increase slowed from the first quarter, when revenue of $3.605 billion rose 19% from $3.029 billion.
GAAP net income in the second quarter was $1.297 billion, down 7% from $1.392 billion a year earlier, and GAAP diluted earnings were $12.23 a share, down 5% from $12.81, including a $1.02 IPR&D drag. Non-GAAP net income was $1.543 billion, up 8% from $1.424 billion, and non-GAAP diluted earnings were $14.29 a share, up 11% from $12.89, including a $0.99 IPR&D drag. Chief Financial Officer Christopher Fenimore said the 17% revenue increase and 11% non-GAAP earnings increase marked a second consecutive quarter of double-digit growth on both measures.
Dupixent global net sales, recorded by Sanofi, rose 38% to an all-time high of $6.0 billion in the second quarter, after a 33% increase to $4.9 billion in the first quarter. EYLEA HD U.S. net sales increased 52% to an all-time high of $596 million, matching the 52% year-over-year increase to $468 million reported for the first quarter. Libtayo global net sales increased 30% to an all-time high of $489 million.
In the first quarter, total EYLEA HD and EYLEA U.S. net sales decreased 10% to $941 million.
Regeneron had fully repaid the Sanofi Development Balance as of the end of the second quarter, the outstanding amount due to Sanofi for funding of prior collaboration development activities. The repayment will drive a meaningful step-up in collaboration profits beginning in the third quarter.
The company deployed nearly $3.0 billion in the first half of 2026 to share repurchases, dividends, capital expenditures, and business development. It continues to invest in its pipeline, U.S. manufacturing, and external innovation while returning capital to shareholders.
Pipeline updates in the second-quarter release included FDA and European Commission approvals in April 2026 of Dupixent for chronic spontaneous urticaria in children aged 2 to 11 who remain symptomatic despite antihistamine treatment, and an FDA approval extending EYLEA HD dosing intervals up to every 20 weeks for wet age-related macular degeneration and diabetic macular edema after one year of successful response. The European Medicines Agency accepted for review, under accelerated assessment, a marketing authorization application for Otarmeni for biallelic OTOF variant-associated hearing loss. The company also announced Phase 3 results for fianlimab in combination with cemiplimab as first-line treatment for unresectable locally advanced or metastatic melanoma.
Regeneron has approximately 50 product candidates in clinical development, including marketed products for which it is investigating additional indications.