Medivir (MVIR) Q2 2024 earnings summary

Executive summary

• Fostrox plus Lenvima demonstrated superior efficacy in advanced/second-line HCC, with a median time to progression of 10.8 months and ORR of 24%, outperforming historical controls and Lenvima monotherapy.

• Clinical data presented at ESMO GI 2024 confirmed liver targeting and maintained normal liver function, with no deterioration in liver enzymes or ALBI score.

• The study population included patients with poor prognosis, many with metastases outside the liver and prior local therapies.

• The company is preparing for a randomized phase IIb trial with dose optimization, regulatory engagement, and aims to be first to market in a $2.5 billion and growing second-line HCC market.

• Board strengthened with two new members; focus remains on fostrox clinical development.

Financial highlights

• Q2 2024 net turnover was SEK 1.1 million, mainly from royalties, down from SEK 2.0 million in Q2 2023.

• Q2 2024 operating loss was SEK -37.3 million, higher than last year due to increased clinical and CMC costs.

• Cash and cash equivalents at end of Q2 2024 were SEK 126.7 million.

• Cash flow from operating activities for Q2 2024 was SEK -26.3 million.

• SEK 20 million was raised via a directed share issue in January 2024.

Outlook and guidance

• Cash runway is expected to last through Q1 2025, with cost estimates described as conservative and financing options under evaluation.

• IND filing and national approvals for the next phase are planned for the second half of 2024, with phase IIb study initiation targeted for early 2025.

• Next phase IIb trial will include endpoints such as ORR, PFS, DoR, DCR, safety, QoL, and OS.

• Ongoing partner discussions are expected to accelerate as mature efficacy and safety data become available at ESMO Barcelona.

• Data updates are scheduled for ESMO GI and ESMO congresses in 2024.