Medivir (MVIR) Q4 2024 earnings summary

Executive summary

• Fostrox, an oral liver-targeted therapy, advanced with FDA IND approval for the global phase 2b FOcuS-2 study in second-line advanced HCC, with collaboration and supply agreement with Eisai and preparations across eight countries and 40 sites for 2025 enrollment.

• Phase 1b/2a data for fostrox + Lenvima showed a median time to progression of 10.9 months and a 24% response rate, outperforming historical second-line benchmarks, with final data to be presented at EASL Liver Cancer Summit.

• Fostrox is positioned as the first-to-market oral therapy for advanced HCC, addressing a significant unmet need in second-line treatment.

• Cash position at year-end was SEK 62.5 million, with a SEK 30 million loan facility available and a projected cash runway into Q4 2025.

• Focus remains on oncology pipeline, especially fostrox, with ongoing partnering efforts for other assets and outlicensed projects generating milestone and royalty income.

Financial highlights

• Q4 2024 net turnover was SEK 1.0 million, mainly from Xerclear royalties, down from SEK 4.4 million in Q4 2023.

• Q4 operating loss was SEK -26.9 million, with net loss at SEK -26.7 million, both higher than the previous year due to increased R&D investment.

• Q4 cash flow from operating activities was SEK -29.4 million; year-end cash balance was SEK 62.5 million.

• EBITDA margin and operating margin remained negative, reflecting high clinical development costs.

• No investments in tangible or intangible assets during the year.

Outlook and guidance

• Preparations for the phase 2b FOcuS-2 study are on track, with first patient enrollment expected in 2025 and study read-out in 2027.

• Existing cash and loan facility expected to cover liquidity needs until Q4 2025, with management confident in securing additional financing.

• The study is designed to enable potential breakthrough therapy designation and accelerated approval.

• No dividend proposed for 2024.