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Hansa Biopharma (HNSA) investor relations material
Hansa Biopharma Q3 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Q3 2025 earnings summary30 Oct, 2025
Executive summary
Underwent significant transformation, including debt restructuring, two equity raises, and leadership changes to strengthen US operations and support BLA filing and prelaunch preparations.
Achieved pivotal success in the US Phase 3 CONFIDIS trial for kidney transplantation, with imlifidase showing significant improvement in eGFR at 12 months (51.5 vs. 19.3 mL/min/1.73m², p<0.0001), supporting a BLA filing before year-end.
Year-to-date IDEFIRIX product sales rose 25.4% to 143.6 MSEK, surpassing full-year 2024 sales, though Q3 sales declined due to lower transplant activity, seasonality, and reimbursement challenges in Germany and Spain.
European business faced challenges from lower transplant rates, reimbursement issues, and regional protocol gaps, especially in Germany and Spain.
U.S. market opportunity is substantial, with robust clinical data, strong KOL engagement, and high unmet need among highly sensitized patients.
Financial highlights
Q3 2025 product sales were 30.1 MSEK, down from 39.8 MSEK in Q3 2024; year-to-date product sales at 143.6 MSEK.
Q3 2025 operating loss was 147.6 MSEK; year-to-date operating loss improved to 395.8 MSEK from 463.7 MSEK a year ago.
Cash and cash equivalents at quarter-end were 252.1 MSEK; pro forma cash after October capital raise was 888 MSEK.
Gross margin for the nine months ended September 30, 2025, was 60%, up from 50% in 2024.
Net cash used in operations year-to-date was 353.3 MSEK, an improvement of 173.8 MSEK year-over-year.
Outlook and guidance
BLA submission for imlifidase in kidney transplantation planned before year-end 2025, with US commercial launch targeted for the second half of 2026, pending FDA approval.
Initiatives planned to accelerate European growth in 2026, focusing on market access, reimbursement, and improved sales visibility.
Topline data from the global Phase 3 anti-GBM trial expected in Q4 2025; EU PAES study data readout anticipated in 2026.
Imlifidase US approval and launch timeline?
What specific Q4 initiatives will boost EU sales?
What are next steps for DMD gene therapy partnership?
Do you expect an FDA AdCom for imlifidase BLA?
German program pause: spillover to other EU markets?
Anti-GBM study: specific top-line data points?
Germany Eurotransplant program reinstatement?
U.S. launch strategy for 100 clinics
HNSA-5487 clinical development plans
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Next Hansa Biopharma earnings date
KOL Event12 Nov, 2025
Next Hansa Biopharma earnings date
KOL Event12 Nov, 2025
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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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