MedinCell (MEDCL) H1 24/25 earnings summary

Executive summary

• UZEDY achieved $75M in U.S. net sales year-to-date, with Teva raising the 2024 forecast to $100M; Medincell recognized €2.8M in royalties and expects up to $105M in commercial milestones.

• The olanzapine LAI (mdc-TJK) program completed Phase 3 with no PDSS cases, met all primary and key secondary endpoints, and targets FDA filing in H1 2025 with potential approval and commercialization in H1 2026.

• A strategic partnership with AbbVie was signed, bringing a $35M upfront payment, €3.7M revenue recognized, and up to $1.9B in potential milestones for up to six long-acting injectable products.

• The R&D pipeline advanced with new feasibility studies, positive subgroup results for CWM (F14/celecoxib), and preclinical progress in contraception and malaria programs targeting clinical entry in 2025.

• The company targets operational profitability by fiscal year ending March 31, 2027, and aims for annual revenues exceeding €100M within 3-4 years.

Financial highlights

• Revenues rose 23% year-over-year to €8.6M for H1 2024-2025, driven by UZEDY royalties, AbbVie collaboration, and service contracts.

• Operating and other income reached €9.4M, up 15% year-over-year.

• Operating expenses were stable at €17M, with R&D accounting for over 60% but declining 8% year-over-year.

• Operating loss improved to €7.5M from €9M year-over-year; net loss widened to €14.6M from €8.2M, mainly due to negative financial adjustments and warrant revaluation.

• Cash and equivalents stood at €31.6M (plus €7.2M in term deposits) at September 30, 2024, up from €19.5M at last annual close, mainly due to the AbbVie upfront payment.

Outlook and guidance

• Operational profitability is targeted by fiscal year 2026-2027.

• Annual revenues are expected to exceed €100M in 3-4 years, driven by UZEDY and olanzapine LAI.

• Management estimates sufficient liquidity for at least the next 12 months.

• Multiple R&D programs, including contraception and malaria, are targeting clinical entry in 2025.

• Anticipates new partnerships and licensing agreements in the next 12-18 months.