BioInvent International (BINV) Q4 2025 earnings summary

Executive summary

• Achieved strong clinical progress in 2025, with BI-1808 and BI-1206 showing promising efficacy in T-cell lymphoma, non-Hodgkin's lymphoma, and ovarian cancer, with data presented at ASH 2025.

• Initiated Phase IIa trial of BI-1206 with pembrolizumab in first-line NSCLC and uveal melanoma, under collaboration with Merck.

• BI-1808 received Orphan Drug Designation from EMA and FDA for CTCL and TCL, and Fast Track Designation from FDA.

• Nominated two new board members with significant pharma and investment experience ahead of the 2026 AGM.

• Strategic collaborations with Merck, AstraZeneca, Transgene, and Blood Cancer United advanced clinical programs and provided validation.

Financial highlights

• Full-year 2025 net sales reached SEK 226.5 million, up from SEK 44.7 million in 2024, mainly due to a USD 20 million payment from XOMA Royalty for mezagitamab rights.

• Q4 2025 net sales were SEK 3 million, down from SEK 21.4 million in Q4 2024, due to lower antibody production.

• Operating costs for 2025 were SEK 578.2 million, up from SEK 515.7 million in 2024.

• Loss after tax improved to SEK -332.9 million from SEK -429.4 million year-over-year.

• Liquid funds and investments at year-end totaled SEK 593 million, supporting operations for the next 12 months.

Outlook and guidance

• Multiple key clinical milestones expected in 2026 and 2027, including Phase IIa data readouts and potential pivotal trial initiations for BI-1808 and BI-1206.

• First readout for BI-1206 in first-line NSCLC and melanoma anticipated in H2 2026.

• Additional Phase IIa data for BI-1808 in ovarian cancer and CTCL expected mid to H2 2026.

• Sufficient cash runway to reach H2 2026 readouts, with ongoing evaluation of additional financing options.

• Active business development and partnering discussions ongoing, with possible deals in H2 2026.