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Hansa Biopharma
Hansa Biopharma (HNSA) investor relations material
Hansa Biopharma Q4 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q4 2025 earnings summary11 Feb, 2026
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.
NovaQuest loan impact on 2027 cash needs?
US launch prep for imlifidase: key challenges?
HNSA-5487 GBS: next steps after FDA talks?
Anti-GBM trial: What are next steps for pipeline?
U.S. launch: Outlier payment coverage pre-NTAP?
Germany's Eurotransplant program: Path to reinstatement?
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Next Hansa Biopharma earnings date
Piper Sandler Virtual Novel Targets in Immunology Symposium13 Feb, 2026
Hansa Biopharma
Next Hansa Biopharma earnings date
Piper Sandler Virtual Novel Targets in Immunology Symposium13 Feb, 2026
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Frequently asked questions
Hansa Biopharma AB, a biopharmaceutical company, develops immunomodulatory treatments for enabling transplants and rare immunoglobulin G (IgG)-mediated autoimmune conditions, gene therapy, and cancer using its proprietary enzyme technology platform. It develops recombinant IgG endopeptidase/CD26 in Hx-CD26 for IgG-mediated autoimmune indications; and antibody drug conjugates (ADCs) in hu2m14 that targets EGF receptor mutations. The company also develops ADCs against CD56 positive cancers in naxitamab; and multiple bispecific antibodies to meet the needs of the various target populations across hematological cancers under pre-clinical development program. In addition, it involves in developing enzyme platform technology to facilitate the development of antibody therapies by inhibiting unwanted immune reactions; and facilitates bone marrow transplantation between genetically distinct individuals.
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