MedinCell (MEDCL) Evercore ISI 8th Annual HealthCONx Conference summary

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.