Medivir (MVIR) Q2 2025 earnings summary

Executive summary

• Fostrox plus Lenvima (lenvatinib) is positioned as a frontrunner in second-line advanced hepatocellular carcinoma (HCC), with strong phase 1b/2a results, including a median time to progression of 10.9 months and an objective response rate of 24%, outperforming other 2L HCC treatments.

• Patent protection for fostrox plus lenvatinib was extended in Japan, Europe, and Australia, providing exclusivity until April 2041 and enhancing global commercial prospects.

• Birinapant rights were returned to the company after IGM Biosciences' acquisition by Concentra Biosciences, and future options for the asset are under evaluation.

• No other drug projects in second-line liver cancer have shown stronger potential; the combination targets tumor cells in the liver, minimizing side effects and allowing prolonged treatment.

• Preparations for a pivotal phase 2b study (FOCUS-2) are underway in collaboration with Eisai.

Financial highlights

• Net turnover for Q2 2025 was SEK 1.5 million, up from SEK 1.1 million in Q2 2024; for H1 2025, SEK 2.1 million, up from SEK 1.6 million.

• Operating loss for Q2 2025 was SEK -23.2 million (improved from -37.3 million); H1 2025 operating loss was SEK -36.5 million (improved from -64.7 million).

• Cash and cash equivalents at period end were SEK 38.2 million, down from SEK 126.7 million year-over-year.

• Cash flow from operating activities for H1 2025 was SEK -53.0 million (improved from -61.3 million).

• CMC investments were made in Q2 for the planned phase II-B study.

Outlook and guidance

• Fostrox plus lenvatinib is positioned to address a large and growing 2L HCC market, projected to reach $4.0 billion globally by 2030, driven by increased incidence and longer treatment durations.

• Preparations for the phase II-B study are ongoing and can start promptly once financing is secured.

• Existing cash and loan commitments are expected to cover liquidity needs until end of Q4 2025; additional financing options are being evaluated.

• The absence of approved 2L treatments in advanced HCC supports a first-to-market opportunity for fostrox plus lenvatinib.