Sanofi announced the availability of the aide-mémoire for its Q3FY26 results. The document is now accessible on the "Investors" page of sanofi.com to support financial analysis.

Purpose of the document

Prepared each quarter, this document is intended to support financial modelling of the quarterly results. It covers non-comparable items, foreign currency impact, and share count. These details allow analysts to adjust reported figures for a clearer view of underlying performance.

Upcoming earnings date

Sanofi's Q3FY26 results will be published on October 30, 2026. Investors are advised to review the aide-mémoire prior to this date to prepare for the official announcement.

Company profile

Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. The company applies deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world.

The first case management conference for the federal multidistrict litigation against Sanofi and Regeneron opened this past Friday. The proceedings address allegations that the drug Dupixent (dupilumab) can cause, accelerate, or unmask cutaneous T-cell lymphoma (CTCL). Weitz & Luxenberg, representing the largest group of plaintiffs, appeared at the hearing led by Judge Zahid N. Quraishi of the U.S. District Court for the District of New Jersey.

The litigation centers on claims that patients and physicians were not adequately warned about the risk of CTCL development or progression while using Dupixent. Laura Baughman, a partner at Weitz & Luxenberg leading the firm’s Dupixent litigation, stated that Sanofi’s own educational materials for doctors describe how this cancer can be mistaken for eczema and unmasked by the drug. She emphasized that if the company understood this risk, clear warnings were warranted, noting that the U.S. label still does not include a lymphoma warning.

Regulatory and scientific context

CTCL is a rare cancer of the immune system that initially appears on the skin. In its early stages, it can look almost identical to eczema, the primary condition Dupixent is prescribed to treat. The lawsuits allege that Sanofi and Regeneron failed to disclose the potential link between Dupixent use and CTCL.

In March 2025, the FDA identified CTCL as a potential signal of serious risk associated with Dupixent based on its adverse event reporting system. Additionally, a 2024 study published in the Journal of the American Academy of Dermatology found significantly higher odds of CTCL among eczema patients treated with Dupixent compared to those not treated. Sanofi has maintained that the scientific literature does not support a causal association.

Litigation timeline and claims

The initial case management conference took place one year to the day after Weitz & Luxenberg and co-counsel filed the first Dupixent lawsuit. Ellen Relkin, chair of Weitz & Luxenberg’s Drug and Medical Device Litigation practice group, stated that people were told their rash was eczema while a cancer progressed. She noted that the litigation focuses on what the companies knew, when they knew it, and why patients never heard about the risks.

Patients are advised not to stop taking any prescribed medication without consulting their doctor. Individuals diagnosed with CTCL, mycosis fungoides, or Sézary syndrome after using Dupixent are encouraged to seek further information through legal channels.

What the numbers show

The divergence between regulatory signals and labeling actions is a key point of contention. While the FDA flagged CTCL as a potential signal of serious risk in March 2025 and peer-reviewed studies reported higher odds of CTCL in treated patients, the drug’s U.S. label remains unchanged regarding lymphoma warnings. This gap between identified risk signals and consumer-facing disclosures forms the core of the plaintiffs' argument regarding negligence and failure to warn.