MedinCell (MEDCL) H1 24/25 earnings summary

Executive summary

• UZEDY, approved in April 2023, saw strong commercial ramp-up with $75M in first three quarters and Teva raising 2024 sales guidance to $100M, with Medincell eligible for royalties and up to $105M in milestones.

• Olanzapine LAI (mdc-TJK) completed Phase 3 with 100% safety milestone, no PDSS observed, targeting FDA filing in H1 2025 and potential approval in H1 2026, with a faster ramp-up anticipated than UZEDY.

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

• BEPO® STAR technology migration underway, now used in all development programs, extending patent life to 2040 and broadening application scope.

• Robust R&D pipeline with multiple programs advancing toward clinical stages, including contraception and malaria candidates, and new feasibility studies launched.

Financial highlights

• Revenues rose 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 deferred for future recognition.

• Operating expenses stable at €17M; operating loss improved to €7.5M from €9M year-over-year.

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

Outlook and guidance

• Confident in achieving operating profitability by fiscal year ending March 31, 2027.

• Annual revenues expected to exceed €100M in three to four years, driven by UZEDY and olanzapine LAI.

• UZEDY revenue flow to continue quarterly; olanzapine LAI FDA filing expected H1 2025, approval H1 2026.

• 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.