Hansa Biopharma Reports Fourth Quarter and Full-Year 2025 Financial Results

Rhea-AI Summary

Hansa Biopharma (Nasdaq: HNSA) reported strong Q4 2025 results with Q4 revenue 76.0 MSEK (up 135% YoY) and IDEFIRIX product sales of 61.1 MSEK (up 139% YoY). The company submitted a BLA for imlifidase to the FDA and completed a directed share issue raising 671.5 MSEK, leaving cash and short-term investments of 701.1 MSEK.

Full-year 2025 revenue was 222.3 MSEK (up 30% YoY); net loss narrowed to 529.3 MSEK. Hansa advances imlifidase programs and plans FDA interactions for HNSA-5487 in 1H 2026.

Positive

• Q4 revenue surged 135% YoY to 76.0 MSEK
• Q4 IDEFIRIX product sales rose 139% YoY to 61.1 MSEK
• Full-year revenue +30% YoY to 222.3 MSEK
• Submitted a BLA for imlifidase to the FDA (Priority Review requested)
• Completed directed share issue raising 671.5 MSEK, cash = 701.1 MSEK

Negative

• Net loss for 12M 2025 remained material at 529.3 MSEK
• Operating loss for 12M 2025 was 520.7 MSEK
• Shares outstanding increased to 101.76M, indicating dilution from the directed issue
• Net cash used in operations for 12M 2025 was 549.2 MSEK

Key Figures

Q4 2025 revenue: 76.0 MSEK FY 2025 revenue: 222.3 MSEK Q4 2025 product sales: 61.1 MSEK +5 more

8 metrics

Q4 2025 revenue 76.0 MSEK Up 135% vs 32.3 MSEK in Q4 2024

FY 2025 revenue 222.3 MSEK Up 30% vs 171.3 MSEK in 2024

Q4 2025 product sales 61.1 MSEK Up 139% vs 25.6 MSEK in Q4 2024

FY 2025 product sales 204.7 MSEK Up 46% vs 140.1 MSEK in prior year

FY 2025 loss for period 529.3 MSEK Improved vs 807.2 MSEK loss in 2024

Cash & short-term investments 701.1 MSEK Vs 405.3 MSEK at prior year-end

Directed share issue 671.5 MSEK (~$71.3M) Capital raise via directed share issue

FY 2025 EPS -6.52 SEK Vs -12.85 SEK in 2024

Market Reality Check

normal vol

Market Pulse Summary

This announcement combines strong revenue growth with significant strategic steps. Q4 2025 revenue r...

Analysis

This announcement combines strong revenue growth with significant strategic steps. Q4 2025 revenue reached 76.0 MSEK, with full-year revenue of 222.3 MSEK and improved losses versus 2024. The Biologics License Application for imlifidase and plans for HNSA-5487 in Guillain-Barré syndrome mark important pipeline milestones. Investors may focus on cash of 701.1 MSEK, the 671.5 MSEK directed share issue, and ongoing operating losses of 529.3 MSEK when tracking future updates.

Key Terms

biologics license application (bla), pdufa, aav, guillain-barré syndrome, +2 more

6 terms

biologics license application (bla) regulatory

"Submission of Biologics License Application (BLA) for imlifidase for highly sensitized"

A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.

pdufa regulatory

"Priority Review, which—if granted—would result in a PDUFA target date in August 2026"

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

aav medical

"showed that imlifidase rapidly and effectively removed AAV antibodies and can potentially"

AAV is a small, generally harmless virus repurposed by researchers as a delivery vehicle to insert therapeutic genes into human cells; think of it as a postal service that carries corrective DNA to specific tissues. Investors pay attention because AAV-based treatments can offer durable, potentially one-time cures that command high prices, but they also carry development, manufacturing and regulatory risks that can sharply influence a biotech company’s value.

guillain-barré syndrome medical

"next-generation enzyme, HNSA-5487, in Guillain-Barré syndrome (GBS). The company is planning"

A rare autoimmune disorder in which the body's immune system mistakenly attacks the nerves outside the brain and spinal cord, causing weakness, numbness and, in severe cases, temporary paralysis that can progress rapidly. Investors pay attention to reports of Guillain-Barré syndrome because confirmed cases linked to a drug, vaccine or device can trigger safety investigations, regulatory actions, label changes or trial delays—similar to a safety alarm that can materially affect a company’s product prospects and valuation.

crigler–najjar syndrome medical

"gene therapy in patients with Crigler–Najjar syndrome who have pre-formed antibodies"

A rare, inherited liver condition that prevents the body from processing bilirubin, a normal breakdown product of red blood cells, causing dangerous jaundice and potential brain damage from toxin buildup. It matters to investors because it represents a small but high-need patient population where successful treatments can command premium pricing and benefit from special regulatory incentives and streamlined approval paths, making drug development outcomes especially value-driving.

immunoglobulin g (igg) medical

"imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which"

Immunoglobulin G (IgG) is the most abundant antibody the body makes to spot and neutralize germs and to remember past infections; think of it as the immune system’s long-term security cameras and memory cards. For investors, IgG matters because tests that measure IgG, medicines built from or mimicking IgG, and engineered IgG therapies are common products in diagnostics, vaccines and biopharma pipelines, influencing clinical results, regulatory decisions and potential revenues.

AI-generated analysis. Not financial advice.

• Strong Q4 with 76.0 MSEK in revenue, up 135% from Q4 2024.
• Submission of Biologics License Application (BLA) for imlifidase for highly sensitized patients awaiting kidney transplantation.
• Successfully completed a directed share issue raising 671.5 MSEK (~ $71.3M).

LUND, Sweden, Feb. 11, 2026 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), today announced its Q4 2025 and full-year financial results.

Renée Aguiar-Lucander, CEO, Hansa Biopharma, said, "Q4 capped a strong year for Hansa Biopharma. Filing our BLA with the FDA just three months after announcing Phase 3 results highlights the strength of our team and execution focus. We delivered solid growth in Europe, advanced market access efforts, and made the strategic decision to progress our next-generation enzyme HNSA-5487 in Guillain-Barré syndrome, with FDA interactions planned for the first half of 2026. As we enter 2026, our focus is clear: secure FDA approval, ensure a successful U.S. launch of imlifidase, and progress commercial adoption across Europe."

Financial Performance

Fourth-quarter IDEFIRIX product sales reached 61.1 MSEK, a 139% increase from 25.6 MSEK in Q4 2024. Revenue totalled 76.0 MSEK, representing a 135% increase compared to 32.3 MSEK in Q4 2024.

Full-year 2025 IDEFIRIX product sales amounted to 204.7 MSEK for the full year, a 46% increase from 140.1 MSEK in the previous year. Revenue totalled 222.3 MSEK, representing a 30% increase compared to 171.3 MSEK in 2024. This growth reflects continued adoption across major European markets and underscores both the clinical value of IDEFIRIX, and the momentum Hansa is building in the treatment of highly sensitized patients undergoing kidney transplantation

Pipeline Progress

Imlifidase in Kidney transplantation: In December, Hansa submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imlifidase in the desensitization of highly sensitized adult patients undergoing deceased kidney donor transplantation. The FDA is currently reviewing the BLA for acceptability and evaluating Hansa's request for Priority Review, which—if granted—would result in a PDUFA target date in August 2026.

Imlifidase in Gene therapy: Initial data from the first patient in the GNT-018-IDES trial, presented at the European Society of Gene and Cell Therapy, showed that imlifidase rapidly and effectively removed AAV antibodies and can potentially serve as a pre-treatment to enable gene therapy in patients with Crigler–Najjar syndrome who have pre-formed antibodies to the AAV vector. No severe side effects were reported.

HNSA-5487: Hansa is advancing the next-generation enzyme, HNSA-5487, in Guillain-Barré syndrome (GBS). The company is planning for FDA interactions in the first half of 2026, to reach agreement on the clinical development program.

Financial Summary

Amounts in MSEK, unless otherwise stated	Q4 2025	Q4 2024	12M 2025	12M 2024
Revenue	76.0	32.3	222.3	171.3
- Including: Product sales	61.1	25.6	204.7	140.1
SG&A expenses	(101.6)	(89.0)	(356.6)	(344.3)
R&D expenses	(74.4)	(101.4)	(304.7)	(375.7)
Loss from operations	(124.9)	(174.2)	(520.7)	(637.9)
Loss for the period	(165.0)	(276.9)	(529.3)	(807.2)
Net cash used in operations	(177.5)	(147.8)	(549.2)	(674.9)
Cash and short-term investments	701.1	405.3	701.1	405.3
EPS before and after dilution (SEK)	(1.62)	(4.08)	(6.52)	(12.85)
Number of outstanding shares	101,763,222	67,814,241	101,763,222	67,814,241
Weighted average number of shares before and after dilution	101,763,222	67,814,241	81,200,543	62,834,848
Number of employees at period end	125	135	125	135

Conference Call Details

Hansa Biopharma will host a telephone conference today Wednesday, 11 February 2026, at 14:00 CET / 8:00 am EST.

The event will be hosted by Renée Aguiar-Lucander, CEO, Richard Philipson, CMO, Evan Ballantyne, CFO, and Maria Törnsén COO and President U.S. The call will be held in English.

Slides used in the presentation will be live on the company website during the call under Financial reports | Hansa Biopharma and will also be made available online after the call.

To participate in the telephone conference, please use the dial-in details provided below:
Participant Dial In (Toll Free): 1-833-821-3542
Participant International Dial In: 1-412-652-1248
*Please ask to be joined into the Hansa Biopharma call

Join the webcast here: Webcast | Hansa Biopharma Fourth Quarter 2025 Earnings

Contacts for more information:

Evan Ballantyne, Chief Financial Officer
IR@hansabiopharma.com

Kerstin Falck, VP Global Corporate Affairs
media@hansabiopharma.com

Notes to editors

About Hansa Biopharma

Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company developing and commercializing novel immunomodulatory therapies to transform care for patients with acute or complex immune disorders. Hansa's proprietary IgG-cleaving enzyme technology platform to address serious unmet medical needs in transplantation, gene therapy and autoimmune diseases. The company's portfolio includes imlifidase, a first-in-class immunoglobulin G (IgG) antibody-cleaving enzyme therapy, which has been shown to enable kidney transplantation in highly sensitized patients, and HNSA-5487, a next-generation IgG-cleaving molecule that will be developed for Guillain-Barré Syndrome (GBS). Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the U.S. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com and follow us on LinkedIn.

©2026 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved.

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HNSA - Q4 2025 ENG Final

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SOURCE Hansa Biopharma AB

FAQ

What did Hansa Biopharma (HNSA) report for Q4 2025 revenue and product sales?

Hansa reported Q4 revenue of 76.0 MSEK and IDEFIRIX sales of 61.1 MSEK. According to the company, these figures represent a 135% revenue increase and 139% product sales growth versus Q4 2024, driven by adoption across European markets.

Has Hansa Biopharma (HNSA) filed for U.S. approval of imlifidase and what is the timeline?

Hansa submitted a BLA for imlifidase for kidney transplantation and requested Priority Review. According to the company, if Priority Review is granted, a PDUFA target date could be in August 2026.

How much funding did Hansa Biopharma (HNSA) raise in the directed share issue and how strong is its cash position?

Hansa completed a directed share issue raising 671.5 MSEK, boosting liquidity. According to the company, cash and short-term investments stood at 701.1 MSEK at year-end 2025, supporting near-term commercialization and development plans.

What was Hansa Biopharma's (HNSA) full-year 2025 financial outcome and net loss?

Full-year 2025 revenue was 222.3 MSEK while net loss was 529.3 MSEK. According to the company, revenue rose 30% year-over-year but the company remains in a net loss position as it invests in growth and development.

Did Hansa Biopharma (HNSA) report any clinical progress besides the BLA in Q4 2025?

Yes, initial gene therapy trial data showed imlifidase removed AAV antibodies without severe side effects. According to the company, this could enable gene therapy in patients with pre-formed AAV antibodies.

What investor impact arises from Hansa Biopharma's (HNSA) increased share count after 2025 financing?

Shares outstanding increased to 101.76 million after the directed issue, implying dilution for prior holders. According to the company, the financing aimed to fund U.S. launch preparations and ongoing development programs.