Medivir (MVIR) Q1 2025 earnings summary

Executive summary

• Final phase 1b/2a data for fostrox + Lenvima in advanced liver cancer showed median OS of 13.7 months and TTP of 10.9 months, with strong efficacy and safety compared to standard of care.

• European patent granted for fostrox + Lenvima in HCC and liver metastases, extending exclusivity until April 2041.

• Infex Therapeutics signed a licensing agreement for MET-X development in India, with Medivir entitled to future revenue share.

• No approved second-line treatments exist for liver cancer post-immunotherapy; fostrox + Lenvima could address this unmet need.

• Preparations for the phase IIb (FOcuS-2) study are ongoing, with study design approved by FDA and start planned for 2025.

Financial highlights

• Q1 2025 net turnover was SEK 0.6 million, mainly from royalty income, up from SEK 0.5 million year-over-year.

• Operating loss for Q1 2025 was SEK -13.3 million, improved from SEK -27.4 million year-over-year.

• Operating cash flow for Q1 2025 was SEK -26.8 million, reflecting study closure costs and lower clinical expenses.

• Cash position at end of Q1 2025 was SEK 35.1 million, with a projected runway into Q4 2025.

• Personnel costs increased due to a share incentive program, with no current cash impact.

Outlook and guidance

• Preparations for the global phase IIb study continue, with first patient dosing possible in 2025 if funding is secured.

• Existing cash and a loan commitment are expected to cover liquidity needs into Q4 2025.

• Company is evaluating additional financing alternatives to ensure continued operations.

• Patent protection in Europe is expected to facilitate further approvals in other key regions.