MedinCell (MEDCL) H1 25/26 earnings summary

Executive summary

• Total income rose 50% year-over-year to €14.1M, including €11.6M in revenue, up 35%, driven by UZEDY royalties and partnership work.

• The “Shift to Growth” strategy centers on AbbVie #1, Olanzapine LAI and Risperidone LAI (UZEDY).

• Teva submitted the Olanzapine LAI NDA to the FDA; U.S. launch is expected in late 2026, with European submission to follow.

• UZEDY received FDA approval for bipolar I disorder and approvals in South Korea and Canada; partnered and global-health programs advanced.

Financial highlights

• Revenue was €11.6M, up 35% year-over-year; total operating and other income reached €14.1M, up 50%.

• UZEDY royalties were €4.2M for the half-year, up 53% year-over-year.

• Operating expenses increased 22% to €20.8M; R&D costs rose 29% to €13.3M, nearly 64% of expenditure.

• Recurring operating loss narrowed to €6.6M from €7.6M; net loss was €16.1M versus €14.6M, including a €6.8M non-cash EIB warrant adjustment.

• Cash and cash equivalents were €49.8M and term deposits €3.7M at September 30, 2025, totaling €53.5M.

Outlook and guidance

• Teva reaffirmed UZEDY 2025 sales guidance of $190–200M and forecast Q4 sales of $55–65M.

• FDA review of Olanzapine LAI is expected to conclude in Q4 2026; U.S. launch is expected in late 2026, with European submission to follow.

• AbbVie #1 is expected to enter clinical development in 2026; collaboration terms include up to $315M in milestones and mid-single- to low-double-digit royalties.

• Operational profitability could be delayed if USD/EUR weakness persists; available cash and financial investments cover commitments over the next 12 months.