MedinCell (MEDCL) H1 25/26 earnings summary

Executive summary

• Total income for the half-year reached €14.1 million, up 50% year-over-year, driven by strong UZEDY® royalty growth, R&D partnerships, and new development contracts, including with AbbVie and the Gates Foundation.

• UZEDY® delivered robust sales growth, received FDA approval for Bipolar I Disorder, and launched in South Korea and Canada.

• Olanzapine LAI NDA was submitted to the FDA, with potential approval and US launch expected in late 2026, and positive Phase 3 safety data with no PDSS events.

• The pipeline advanced with late-stage and global health programs, including Gates Foundation and iM4TB collaborations targeting pain, contraception, malaria, and tuberculosis.

• Strengthened governance with new board appointments and performance-based share grants.

Financial highlights

• Revenue for the half-year ended September 30, 2025, increased by 50% year-over-year to €14.1 million, with UZEDY® royalties up 50% in euro and 65% in USD, reaching €4.2 million.

• Operating expenses rose 22% year-over-year, mainly due to R&D, with 64% of costs allocated to R&D, mostly partner-funded.

• Operating loss improved by 13% to €6.6 million; net loss widened to €16.1 million, mainly due to a €6.8 million non-cash adjustment from EIB warrants and higher financial charges.

• Cash and equivalents stood at €53.5 million at September-end, providing at least 12 months of liquidity.

• Gross financial debt was €71.1 million; net financial debt at €17.6 million.

Outlook and guidance

• UZEDY® 2025 sales guidance confirmed at $190–200 million, with Q4 outlook of $55–65 million.

• Olanzapine LAI FDA review expected to conclude in Q4 2026, with European submission to follow and commercial launch anticipated before year-end 2026.

• AbbVie #1 program set to enter clinical development in 2026, with up to $315 million in milestones and low double-digit royalties.

• Return to profitability targeted for fiscal 2026–2027, though a weak USD could delay this.

• Sufficient liquidity to meet all financial commitments for at least the next 12 months.