SNY · Sanofi

Sanofi disclosed four significant pipeline advancements across immunology, oncology, and rare diseases. Exhibit 99.1 details Dupixent's approval by Japan's Ministry of Health, Labour and Welfare on March 24, 2026, marking its seventh indication in Japan. The LIBERTY-BP-ADEPT phase 2/3 study (n=106) demonstrated superior sustained disease remission (18% vs 4%, p=0.025) at Week 36 with Dupixent plus corticosteroids tapering versus placebo, with conjunctivitis as the most common AE (4%). This expands Dupixent's label in a chronic, type 2 inflammation-driven skin disease affecting elderly patients. Exhibit 99.2 reports CHMP's positive opinion on March 27, 2026, for Sarclisa subcutaneous via on-body injector across EU multiple myeloma indications, supported by IRAKLIA phase 3 non-inferiority data and patient preference for OBI. If approved, it offers first OBI anticancer treatment flexibility. Exhibit 99.3 presents AAD late-breaker data from COAST 1, COAST 2, and SHORE phase 3 studies, showing amlitelimab's progressive efficacy (e.g., EASI-75 up to 48.1% Q4W in SHORE) without plateau at Week 24, supporting Q12W potential in atopic dermatitis. Safety was consistent, with low malignancy rates. Exhibit 99.4 confirms EU approval on March 31, 2026, for Rezurock in chronic GVHD post-two systemic therapies, with ROCKstar phase 2 ORR of 74%. These developments strengthen Sanofi's position in high-unmet-need areas, with Dupixent and Rezurock now commercially available in new markets and Sarclisa/amlitelimab advancing toward broader access.