Hansa Biopharma Reports Third Quarter and Interim Year to Date 2025 Financial Results

Rhea-AI Summary

Hansa Biopharma (NASDAQ: HNSA) reported interim January–September 2025 results and clinical progress on Oct 30, 2025. Key clinical milestone: imlifidase met the pivotal U.S. Phase 3 ConfIdeS primary endpoint with 12‑month mean eGFR 51.5 vs 19.3 mL/min/1.73m2 (difference 32.2; p<0.0001) and a safety profile consistent with prior studies. The company plans a BLA submission to FDA before year‑end 2025 under accelerated approval with a Priority Review request. YTD product sales rose to 143.6 MSEK (+25.4% YoY). Cash and short‑term investments were 252.1 MSEK at period end.

Positive

• ConfIdeS primary endpoint: eGFR difference +32.2 mL/min at 12 months
• Statistical strength: p<0.0001 for primary endpoint
• YTD product sales 143.6 MSEK (+25.4% YoY)
• BLA target: planned FDA submission before year‑end 2025

Negative

• Q3 product sales declined to 30.1 MSEK from 39.8 MSEK (≈24%)
• Cash and short‑term investments down to 252.1 MSEK from 553.5 MSEK
• Q3 loss from operations widened to (147.6) MSEK vs (116.9) MSEK
• Outstanding shares increased to 84,763,222 from 67,814,241 (dilution)

Insights

Clinical-regulatory and commercial strategist

Imlifidase met the Phase 3 primary endpoint and Hansa plans a BLA filing before year-end 2025, supporting near-term regulatory action.

Mean 12‑month eGFR in the treated arm was 51.5 mL/min/1.73m2 versus 19.3 mL/min/1.73m2, a difference of 32.2 mL/min/1.73m2 with p<0.0001; this is a clear, quantifiable primary endpoint outcome that underpins a regulatory submission. The company states safety was consistent with prior experience, and management intends to submit a BLA under the accelerated pathway and request Priority Review before year-end 2025.

Commercially, year-to-date product sales of 143.6 MSEK represent a 25.4% increase versus last year and approximate 102% of full-year 2024 product sales, indicating revenue momentum despite a weaker Q3 due to seasonality, a pause in a German program and regional reimbursement hurdles in Catalunya. Watch the BLA filing and FDA acceptance/Priority Review decision in the next few months, and monitor quarterly transplant volumes and reimbursement resolutions into 2026 for revenue recovery.

• Imlifidase successfully met primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation.
• First clinical data supports imlifidase ability to substantially reduce anti-AAV antibodies to allow administration of gene therapy.

LUND, Sweden, Oct. 30, 2025 /PRNewswire/ --  Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), today announced its interim report for January-September 2025.

Renée Aguiar-Lucander, CEO, Hansa Biopharma said, "A key milestone in Q3 was the highly statistically significant outcome of the ConfIdeS trial, where imlifidase met its primary endpoint of eGFR at 12 months in kidney transplantation. This marks the first time imlifidase has been evaluated in a randomized and controlled trial, and we are thrilled with the results. The data clearly demonstrate a statistically significant (p < 0.0001) and clinically meaningful benefit for the highly sensitized patients in the imlifidase arm, underscoring the urgent need for effective desensitization therapies. These findings offer real hope to patients who currently face years on dialysis and limited transplant options. Based on the strength of the data, we are targeting a Biologics License Application (BLA) submission to the FDA under the accelerated approval pathway before year-end 2025, and we intend to request Priority Review. Two gene therapy trials, one sponsored by Sarepta and the other sponsored by Genethon, the latter reported as a subsequent event, support the ability of imlifidase to substantially reduce anti-AAV antibodies to allow administration of gene therapy, which is very exciting."

Financial Performance

Year to date IDEFIRIX product sales totalled 143.6 MSEK and represented an increase of 29.1 MSEK or 25.4% compared to the same period a year ago (114.5 MSEK). Year to date product sales represent approximately 102% of total full-year product sales achieved in 2024. Product sales in the third quarter of 2025 totalled 30.1 MSEK, compared to 39.8 MSEK for the same period in 2024.  

Lower sales numbers in the third quarter are largely driven by fewer than expected kidney transplants during the summer period, the pause in the German Eurotransplant Prioritized Program and reimbursement challenges in Catalunya, one of the largest regions in Spain. Several corporate initiatives will be rolled out during Q4 to capture the existing market potential and support enhanced growth in 2026 and beyond

Pipeline Progress

U.S. ConfIdeS trial: Imlifidase successfully achieved its primary endpoint in the U.S. Phase 3 pivotal ConfIdeS study in kidney transplantation. At 12 months, mean eGFR was 51.5 mL/min/1.73m² in the imlifidase arm compared to 19.3 mL/min/1.73m² in the control arm demonstrating a statistically significant and clinically meaningful difference of 32.2 mL/min/1.73m² (p<0.0001).  Imlifidase was generally well tolerated with a safety profile consistent with previous clinical trial experience. Hansa plans to file a BLA submission with the FDA before year-end 2025.

SRP-9001-104 in Duchenne muscular dystrophy (DMD): Topline results were reported for three patients with DMD treated with imlifidase prior to administration of Sarepta's ELEVIDYS in the trial. After a single dose of imlifidase, patients experienced a rapid reduction of IgG antibodies, to levels ≥95% less than baseline. In addition, pre-existing anti-AAV antibodies were reduced below a titre of 1:400, enabling treatment with ELEVIDYS. No new safety signals were observed in the trial. These first clinical data support the ability of imlifidase to substantially reduce anti-AAV antibodies to allow administration of gene therapies.

Financial Summary

Amounts in MSEK, unless otherwise stated	Q3 2025	Q3 2024	YTD 2025	YTD 2024
Revenue	30.8	48.7	146.3	139.0
- thereof: Product sales	30.1	39.8	143.6	114.5
SG&A expenses	(88.4)	(75.8)	(254.9)	(255.3)
R&D expenses	(70.2)	(79.6)	(230.3)	(274.3)
Loss from operations	(147.6)	(116.9)	(395.8)	(463.7)
Loss for the period	(148.3)	(103.8)	(364.2)	(530.3)
Net cash used in operations	(99.2)	(148.8)	(353.3)	(527.1)
Cash and short-term investments	252.1	553.5	252.1	553.5
EPS before and after dilution (SEK)	(1.75)	(1.53)	(4.90)	(8.67)
Number of outstanding shares	84,763,222	67,814,241	84,763,222	67,814,241
Weighted average number of shares before and after dilution	84,763,222	67,814,241	74,270,996	61,162,934
Number of employees at period end	133	135	133	135

Conference Call Details

Hansa Biopharma will host a telephone conference today Thursday, 30 October 2025, at 13:00 CET / 8:00 am EDT.

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 Third Quarter 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 on a mission to develop and commercialize innovative, lifesaving and life-altering treatments for patients with rare immunological conditions. The company has a rich and expanding research and development program based on its proprietary IgG-cleaving enzyme technology platform, to address serious unmet medical needs in autoimmune diseases, gene therapy and transplantation. 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 with redosing potential. 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.

©2025 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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SOURCE Hansa Biopharma AB

FAQ

What were the ConfIdeS Phase 3 results for HNSA announced Oct 30, 2025?

At 12 months mean eGFR was 51.5 vs 19.3 mL/min/1.73m2, a difference of 32.2 with p<0.0001.

When will Hansa Biopharma (HNSA) submit a BLA for imlifidase to the FDA?

Hansa plans to file a BLA before year‑end 2025 under the accelerated approval pathway and intends to request Priority Review.

How did HNSA product sales perform in January–September 2025?

Year‑to‑date product sales were 143.6 MSEK, an increase of 25.4% versus the same period in 2024.

What caused lower Q3 2025 product sales for HNSA (HNSA)?

Q3 sales decline to 30.1 MSEK was attributed to fewer transplants in summer, a pause in the German Eurotransplant Prioritized Program, and reimbursement challenges in Catalunya.

What is HNSA's cash position reported Oct 30, 2025?

Cash and short‑term investments were reported at 252.1 MSEK at period end.

Do the gene therapy trial data mention imlifidase enabling AAV treatment for HNSA?

Early data reported reductions of anti‑AAV antibodies (≥95% IgG reduction), enabling administration of gene therapies in the reported trials.

When and how can investors access Hansa Biopharma's Oct 30, 2025 conference call?

The telephone conference was held on Oct 30, 2025 at 13:00 CET / 8:00 AM EDT with a live webcast and slides available on the company website.