$REGN earnings report

This is not a full earnings release. Regeneron states that its third-quarter 2026 results have not been finalized and provides only a preliminary expected acquired IPR&D charge. The Company expects an acquired IPR&D charge of approximately $22 million on a pre-tax basis, with an expected negative impact of approximately $0.18 on each of GAAP and non-GAAP net income per diluted share. No revenue, product-sales, margin, operating-income, net-income, or cash-flow results are reported.

The principal disclosure is the Sixth Amendment to the Antibody LCA with Sanofi. The parties will co-develop and co-commercialize four new long-acting, Regeneron-invented antibodies, while global profits from their sales will be shared equally. Sanofi will make an upfront payment to Regeneron of $1.0 billion, and Regeneron may receive up to an additional $7.0 billion upon specified development, regulatory, and commercial milestones.

The agreement extends Regeneron's development and U.S. regulatory role for the New Licensed Products, while Sanofi will lead commercialization and regulatory activities outside the United States. Development costs will be shared equally, but Regeneron will bear development costs above the budget cap for all New Licensed Products, subject to specified future recoupment rights. This allocation makes the scale and timing of development spending an important item for the finalized financial results and subsequent reporting.

The filing also gives Regeneron an asset-by-asset option, after certain ongoing clinical trials, to include Sanofi's Phase 2/3 asset lunsekimig and another Sanofi early development product. Exercising that option would require Regeneron to reimburse Sanofi for certain related development costs. Investors will need the final third-quarter release to assess the preliminary IPR&D charge in the context of operating performance and to obtain any accounting detail related to the collaboration payments.

Regeneron reported second-quarter 2026 total revenues of $4,291 million, up 17% from $3,676 million. The primary contributor was Sanofi collaboration revenue, which increased 51% to $2,174 million. The Company attributed this to a higher share of commercialization profits from antibodies, primarily associated with higher Dupixent sales. Dupixent global net sales, recorded by Sanofi, increased 38% to $6.0 billion.

Product sales were broadly flat, with total net product sales of $1,642 million versus $1,631 million. U.S. EYLEA HD sales increased 52% to $596 million on demand-led volume growth, but U.S. EYLEA sales declined 45% to $412 million amid competitive pressure, lower demand, patient migration to EYLEA HD, and lower net selling prices. Combined U.S. EYLEA HD and EYLEA sales declined 12% to $1,008 million. Libtayo was a key positive, with global sales up 30% to $489 million, primarily due to higher demand-driven sales volumes.

Profitability was mixed. Non-GAAP net income increased 8% to $1,543 million and non-GAAP diluted EPS increased 11% to $14.29. GAAP net income declined 7% to $1,297 million and GAAP diluted EPS fell 5% to $12.23. The period included $127 million of acquired IPR&D expense, while GAAP gross margin on net product sales declined to 78% from 83% because of unabsorbed manufacturing costs related to the temporary bulk-manufacturing interruption in Limerick, Ireland. The Company said production returned to normal levels by quarter end and product availability was not affected.

The Company fully repaid the Sanofi Development Balance as of the end of the second quarter. Regeneron said the obligation will no longer reduce Sanofi collaboration revenue beginning in the third quarter, making the collaboration-profit trajectory a central near-term item. Capital returns included $1.2 billion in common-stock repurchases during the quarter, with $2.5 billion remaining under repurchase programs as of June 30, 2026, alongside a declared $0.94 per-share cash dividend.

Full-year guidance shown in the filing indicates lower gross-margin ranges than the prior ranges displayed in the guidance table, with GAAP gross margin on net product sales at 78%–79% and non-GAAP gross margin at 84%–85%. The filing also shows updated ranges for R&D, SG&A, and GAAP COCM. Pipeline attention centers on the November 2026 FDA target action date for cemdisiran in generalized myasthenia gravis, while the fianlimab melanoma trial outcome was a setback because it did not achieve its primary endpoint.