BioInvent International (BINV) Q4 2025 earnings summary

Executive summary

• Strong clinical progress in 2025, with BI-1808 showing 46% ORR in CTCL and 24% ORR in ovarian cancer, and BI-1206 triplet achieving 80% ORR and 100% DCR in NHL, all presented at ASH 2025.

• Initiated Phase IIa trial of BI-1206 with pembrolizumab in first-line NSCLC and uveal melanoma, following promising late-line results.

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

• Additional promising data in ovarian cancer and nomination of two new board members ahead of 2026 AGM.

• Clinical focus sharpened in 2025, pausing earlier programs to accelerate BI-1808 and BI-1206.

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.

• Full-year 2025 operating costs 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.

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 uveal 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 as early as H2 2026.