Hansa Biopharma (HNSA) Q4 2025 earnings summary

Executive summary

• Q4 2025 revenue rose 135% year-over-year to 76.0 MSEK, with full-year revenue at 222.3 MSEK, up 30% from 2024.

• Product sales of Idefirix grew 46% year-over-year to 204.7 MSEK, driven by adoption in key European markets.

• Equity capital raise of 671.5 MSEK (~$71M) completed, extending cash runway into 2027 and strengthening the balance sheet.

• BLA for imlifidase submitted to FDA in December 2025; awaiting acceptance and PDUFA date, with potential US launch in late 2026.

• Organizational restructuring and new leadership appointments implemented to enhance commercial and medical affairs operations.

Financial highlights

• Q4 product sales: 61.1 MSEK (+139% YoY); full-year product sales: 204.7 MSEK (+46% YoY).

• Q4 SG&A expense: 101.6 MSEK, up 15% YoY; full-year SG&A: 357 MSEK, up 4%.

• Full-year R&D expense: 304.7 MSEK, down 19% from 2024; Q4 R&D: 74.4 MSEK, down 26%.

• Full-year operating loss: 521 MSEK, improved by 18% YoY; full-year loss for the period: 529.3 MSEK, improved from 807.2 MSEK in 2024.

• Cash and equivalents at year-end: 701 MSEK; pro-forma cash including capital raise: 888 MSEK.

Outlook and guidance

• FDA notification on BLA acceptance and PDUFA date expected in Q1 2026; potential US launch in Q4 2026 if priority review is granted.

• Readout of EU PAES confirmatory trial expected mid-2026, with anticipated impact on European performance in 2H 2026.

• Expect relatively weak Q1 2026 revenue due to change management, with stronger performance in the second half as new initiatives take effect.

• Focused on execution of strategic imperatives in 2026, including U.S. launch, PAES trial readout, and potential full approval in Europe.

• No specific revenue guidance provided for 2026.