Medivir (MVIR) Q3 2024 earnings summary

Executive summary

• Fostrox, an oral, liver-targeted therapy, demonstrated a median time to progression of 10.9 months and a 24% overall response rate in second-line advanced liver cancer, positioning it as a potential first approved therapy in this indication.

• Collaboration and supply agreement with Eisai for the phase 2b study provides drug supply, $15–20 million in cost savings, and validates the combination's potential, with Medivir retaining full global rights.

• Monotherapy data for Fostrox published, confirming proof of concept, safety, and tumor selectivity as a liver-targeted cancer treatment.

• Cash position at period end was SEK 92.6 million, with a SEK 30 million loan facility available, providing liquidity until Q4 2025.

• The second-line liver cancer market is projected to exceed $2.5 billion by 2030, with high unmet need and no approved therapies.

Financial highlights

• Q3 net turnover was SEK 0.9 million, mainly from royalty income.

• Q3 operating loss was SEK -35.7 million, reflecting increased clinical and CMC costs.

• Cash flow from operating activities in Q3 was SEK -33.4 million, in line with forecasts.

• Cash and cash equivalents at period end were SEK 92.6 million, with a SEK 30 million loan facility available.

• Directed share issue in January 2024 raised SEK 20 million before transaction costs.

Outlook and guidance

• Preparations for the global phase 2b study are on track, with IND filing in the US expected before year-end and study start in H1 2025.

• Existing cash and loan facility are expected to cover liquidity needs until Q4 2025.

• Management is confident in securing additional financing within 12 months to support continued operations and development.

• End-of-treatment data from the ongoing phase 2a study expected early next year.

• The company is exploring both equity financing and partnering options to fund the next phase.