Medivir (MVIR) Q4 2025 earnings summary

Executive summary

• SEK 151 million rights issue and SEK 45 million directed share issue strengthened the financial position, enabling advancement of MIV-711 for Osteogenesis Imperfecta and fostrox for liver cancer, both with significant market potential.

• MIV-711 received FDA Orphan Drug Designation for Osteogenesis Imperfecta; phase II proof-of-concept study underway, targeting a high unmet need with no approved systemic treatments.

• Fostrox program in liver cancer advancing, with finalized study design and collaboration with major Korean hospitals; top-line results expected in 2027.

• VBX-1000 (MIV-701) for canine periodontitis shows promising proof-of-concept data; randomized, placebo-controlled study initiated, with results expected Q4 2026.

• Out-licensing of remetinostat to Biossil, with potential milestone payments up to USD 60 million and future royalties.

Financial highlights

• Q4 net turnover was SEK 5.5 million, up from SEK 1.0 million year-over-year, mainly due to remetinostat licensing revenue and royalty income from Xerclear.

• Operating loss for Q4 was SEK -42.5 million, higher year-over-year due to a SEK 29.8 million non-cash write-down on the birinapant project.

• Cash flow from operating activities in Q4 was approximately SEK -6.3 million.

• Year-end cash balance was SEK 119.2 million, up from SEK 62.5 million, bolstered by rights and directed share issues.

• Full-year net turnover reached SEK 8.5 million, up from SEK 3.5 million in 2024.

Outlook and guidance

• Cash runway extends into 2028, sufficient to fund planned phase II studies in both liver cancer and Osteogenesis Imperfecta under current assumptions.

• MIV-711 phase II study in OI expected to enroll quickly due to pre-identified patient populations; pivotal phase to follow proof-of-concept.

• Fostrox study in Korea expected to generate top-line results in 2027.

• VBX-1000 animal health study results expected Q4 2026.

• No dividend proposed for 2025.