Medincell - UZEDY®: Q1 2026 Net Sales Reached $63M, Up 62% Year‑on‑Year

MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:

Medincell (Euronext Paris: MEDCL) partner, Teva Pharmaceuticals (NYSE and TASE: TEVA), announced today that UZEDY U.S. net sales reached $63 million in Q1 2026, representing a 62% increase from $39 million in Q1 2025 and a 15% increase from $55 million in Q4 2025.

Medincell receives mid‑ to high‑single-digit royalties on UZEDY net sales and is eligible for up to $105M in commercial milestone payments, subject to the achievement of annual sales thresholds.

UZEDY is a 1-Month and 2-Month subcutaneous risperidone LAI (Long-Acting Injectable). It received U.S. FDA approval for schizophrenia in April 2023 and for Bipolar I Disorder in October 2025.

Olanzapine LAI

The New Drug Application (NDA) for once‑monthly olanzapine LAI for the treatment of schizophrenia in adults was accepted by the U.S. FDA in February 2026, with a regulatory decision anticipated in Q4 2026. In Europe, acceptance of the Marketing Authorization Application (MAA) is expected in Q2 2026.

Teva Q1’26 results press release: https://ir.tevapharm.com/news-and-events/press-releases/default.aspx

Teva Q1’26 earnings conference call today at 8:00am ET: https://events.q4inc.com/attendee/621165544

About Medincell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable treatments across multiple therapeutic areas. Our innovative treatments are designed to ensure adherence to medical prescriptions, enhance the effectiveness and accessibility of medicines, and reduce their environmental impact.

These treatments combine active pharmaceutical ingredients with our proprietary BEPO^® / BEPO^® Star technologies, which enables controlled drug delivery at therapeutic levels for several days, weeks, or months following a subcutaneous or local injection of a small, fully bioresorbable depot.

Risperidone LAI was the first treatment based on BEPO^® technology to receive FDA approval, initially for schizophrenia in April 2023, and subsequently for Bipolar I Disorder in October 2025. It is marketed in the United States by Teva under the brand name UZEDY^®. Medincell’s risperidone LAI was also approved for schizophrenia in Canada and South Korea in 2025.

A New Drug Application (NDA) for Olanzapine LAI as a once-monthly treatment for schizophrenia in adults was submitted to the U.S. FDA in December 2025 by Medincell’s partner, Teva. U.S. FDA accepts Teva’s New NDA for Olanzapine LAI on February 20, 2026.

Medincell’s investigational pipeline includes numerous innovative therapeutic candidates in various stages of development, from formulation to Phase 3 clinical trials. We collaborate with leading pharmaceutical companies and foundations to advance global health through new treatment options.

Headquartered in Montpellier, France, Medincell employs over 140 people representing more than 25 nationalities.

medincell.com

UZEDY^® is a trademark of Teva Pharmaceuticals. Medincell’s BEPO^® technology is licensed to Teva as SteadyTeq™, a trademark of Teva Pharmaceuticals.

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