MedinCell (MEDCL) H1 24/25 earnings summary

Executive summary

• UZEDY, approved in April 2023 and commercialized by Teva, saw strong ramp-up with $75M in US sales in the first three quarters of 2024 and a full-year forecast raised to $100M, with Medincell eligible for royalties and up to $105M in milestones.

• The olanzapine LAI (mdc-TJK) program completed Phase 3 with no PDSS cases, targeting FDA filing in H1 2025 and potential approval in H1 2026, with a faster sales ramp-up anticipated compared to UZEDY.

• A major partnership with AbbVie was signed in April, bringing $35M upfront and up to $1.9B in milestones for up to six long-acting injectables, with €3.7M revenue recognized and €29.3M deferred.

• The R&D pipeline remains robust, with multiple programs advancing toward clinical stages, including contraception and malaria candidates set for Phase 1 in 2025, and new feasibility studies launched.

• The company expects to reach operational profitability by fiscal year ending March 31, 2027, and targets €100M in annual revenue within 3-4 years.

Financial highlights

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

• UZEDY royalties reached €2.8M, up more than fourfold from the prior year period.

• AbbVie collaboration contributed €3.7M in revenue, with €29.3M upfront recognized as deferred income.

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

• Cash and equivalents rose to €38.8M from €19.5M at last annual close, mainly due to the AbbVie upfront payment.

Outlook and guidance

• Operational profitability targeted by fiscal year 2026-2027.

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

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

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

• Medincell anticipates further milestone payments and royalties from ongoing and new partnerships.