MedinCell (MEDCL) TD Cowen 45th Annual Healthcare Conference summary

Key product and technology updates

• Lead products are long-acting injectables, including UZEDY (risperidone) and an olanzapine LAI, both targeting schizophrenia, with UZEDY approved in April 2023 and showing strong commercial uptake.

• UZEDY generated $117 million in 2024 U.S. sales, with projections to become a billion-dollar product; royalties and milestones from commercialization are significant revenue drivers.

• Olanzapine LAI completed phase three, showing efficacy and quality of life improvements; NDA filing expected late 2024, with potential approval in first half of 2026.

• BEPO technology underpins current products, with BEPO-STAR in development to expand to large hydrophilic molecules, potentially multiplying addressable market size.

• Pipeline includes intra-articular celecoxib, a six-month contraceptive (Gates Foundation), and malaria program (UnitAid), with additional undisclosed programs and AbbVie partnership for up to six LAIs.

Market and competitive landscape

• UZEDY competes in a $4.5 billion global LAI risperidone market, targeting the U.S. $3.5 billion segment.

• UZEDY's subcutaneous delivery, prefilled syringes, and immediate therapeutic levels differentiate it from Janssen and other competitors.

• Competitors Indivior (Perseris) and Rovi withdrew from the U.S. market, reinforcing UZEDY's position.

• Teva's schizophrenia portfolio, including Austedo, leverages a strong sales force for UZEDY and olanzapine LAI, with global expansion potential.

• Teva is pursuing a bipolar disorder indication for UZEDY, with FDA review underway and a potential 10-month timeline.

Financial performance and outlook

• Fiscal year ending March 31, 2025, is expected to see a threefold revenue increase and improved EBITDA.

• $60 million in debt, with $40 million from EIB, is being renegotiated for later maturity to align with product milestones.

• Recent capital raise attracted top-tier U.S. investors, strengthening the balance sheet.

• Operational profitability targeted for fiscal year ending March 31, 2027, with midterm revenue goal of $100 million and EBITDA exceeding 50%.

• Analysts estimate $300 million in revenue by 2030, driven by waves one and two, with further upside from pipeline and technology expansion.