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MedinCell (MEDCL) investor relations material
MedinCell Evercore ISI 8th Annual HealthCONx Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Evercore ISI 8th Annual HealthCONx Conference summary3 Dec, 2025
Key business highlights and outlook
UZEDY is experiencing strong market uptake, with continued growth expected over the next 12 months.
Long-acting olanzapine is on track for FDA submission by year-end, with approval anticipated in 2026.
The first collaboration with AbbVie is progressing, with lead formulation selected and IND expected in 18–24 months.
The next two years are projected to be transformative, driven by product launches and partnerships.
Clinical development and regulatory milestones
Long-acting olanzapine addresses PDSS risk by using a subcutaneous formulation that solidifies quickly, reducing bloodstream exposure.
Phase III trials met the FDA's bar of 3,600 PDSS-free injections, with zero PDSS cases observed.
All three olanzapine doses were included in phase III to facilitate clinician adoption and patient transition.
Efficacy improved over 52 weeks, with low discontinuation rates and a metabolic profile comparable to oral olanzapine.
Injection site reactions were mostly mild and decreased with subsequent doses.
Market opportunity and commercial strategy
LAI olanzapine is expected to capture significant market share due to unmet need and lack of competition.
Uptake of LAIs is increasing, with earlier adoption recommended by key opinion leaders and the American Psychiatric Association.
Early adoption is anticipated, especially among severe schizophrenia patients, with potential switches from other orals and LAIs.
Teva plans to market LAI olanzapine in both the US and Europe, where olanzapine use is even higher.
Peak franchise sales for UZEDY and olanzapine are guided at $1.5–2 billion, with consensus estimates for olanzapine at $1.1 billion by 2035.
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H1 25/269 Dec, 2025
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Frequently asked questions
MedinCell S.A. is a pharmaceutical company specializing in the development of long-acting injectable therapies using its proprietary BEPO technology. This technology allows for the sustained release of active pharmaceutical ingredients over several days, weeks, or months from a single, bioresorbable injection. The company's portfolio includes products targeting various therapeutic areas, with a focus on treating conditions such as schizophrenia and post-surgical pain. MedinCell collaborates with global pharmaceutical companies and organizations to advance its product pipeline. The company is headquartered in Jacou, France, and its shares are listed on the Euronext Paris.
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