Hansa Biopharma Reports Second Quarter and Interim January-June 2025 Financial Results

Rhea-AI Summary

Hansa Biopharma (NASDAQ:HNSA) reported Q2 2025 financial results, highlighting a 76% year-over-year increase in IDEFIRIX product sales to 47.8 MSEK. The company secured a directed cash share issue of 232 MSEK (US $24.3M) and restructured its NovaQuest debt, with US $14.9M of outstanding debt converted to equity.

First half 2025 IDEFIRIX sales reached 113.5 MSEK, representing a 52% increase over 1H 2024. The company's pipeline progress includes upcoming data readouts from two Phase 3 programs in kidney transplantation and anti-GBM, with a planned BLA submission to FDA in second half 2025. The secured financing extends cash runway into Q2 2026.

Positive

• IDEFIRIX Q2 product sales grew 76% year-over-year to 47.8 MSEK
• Successful capital raise of 232 MSEK (US $24.3M)
• Cash runway extended into Q2 2026
• Debt restructuring with NovaQuest, converting US $14.9M to equity
• Two Phase 3 trial readouts expected in H2 2025

Negative

• Operating loss of 154.8 MSEK in Q2 2025
• Cash position decreased to 354.4 MSEK from 705.0 MSEK year-over-year
• Remaining debt payments due in 2027-2029
• Additional US $14.9M true-up payment due January 2026

Insights

Biotech Financial Analyst

Hansa secured financing, restructured debt, and showed 76% year-over-year IDEFIRIX sales growth, extending cash runway to Q2 2026 while advancing key trials.

Hansa Biopharma's Q2 2025 results reveal a dual-pronged financial approach combining a 232 MSEK ($24.3M) directed share issue with strategic debt restructuring. The company converted $14.9M of NovaQuest debt to equity, with remaining obligations pushed to 2027-2029 and a $14.9M true-up payment due January 2026 that can be settled in cash or equity.

The standout metric is IDEFIRIX's 76% year-over-year quarterly sales growth, reaching 47.8 MSEK compared to 27.2 MSEK in Q2 2024. First-half 2025 sales reached 113.5 MSEK, a 52% increase over H1 2024 and already representing 80% of full-year 2024 product sales.

Despite this revenue growth, Hansa remains unprofitable with a quarterly operating loss of 154.8 MSEK and net loss of 178.9 MSEK. The loss narrowed compared to Q2 2024's 187.4 MSEK operating loss, suggesting improved financial efficiency. Cash position stands at 354.4 MSEK, down from 705.0 MSEK a year ago, with a cash runway now extending into Q2 2026.

The bolstered financial position supports two crucial Phase 3 readouts expected in H2 2025: the ConfIdeS trial for kidney transplantation (leading to a planned BLA submission) and the GOOD-IDES-02 trial in anti-GBM disease. Additional pipeline progress includes positive Phase 2 data in Guillain-Barré syndrome and ongoing enrollment in gene therapy combination trials with Genethon and Sarepta.

The financial restructuring and extended runway come at a critical juncture with multiple late-stage clinical catalysts approaching, positioning Hansa to potentially bridge from clinical-stage to commercial-stage company with a U.S. market entry if the upcoming BLA submission is successful.

• Hansa secures directed cash share issue of approximately 232 MSEK/US $24.3M and restructures NovaQuest debt.
• As compared to prior year Q2 IDEFIRIX product sales increased 76%.

LUND, Sweden, July 17, 2025 /PRNewswire/ -- Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), today announced its interim report for January-June 2025.

Renée Aguiar-Lucander, CEO, Hansa Biopharma said, "In Q2 2025, the Company successfully secured additional financing and restructured its existing debt agreement with NovaQuest, ensuring the ability to report out data on two key Phase 3 programs in kidney transplantation and anti-GBM. With a cash runway now extending into Q2 2026, we can focus on near term catalysts, strategic pipeline decisions and driving the continued commercialization of IDEFIRIX in Europe."

Financial Performance

In Q2 2025, Hansa completed a successful capital raise with the support of new and existing shareholders. The funding will support two Phase 3 trial readouts in the second half of 2025 including the ConfIdeS US pivotal trial in kidney transplantation and GOOD-IDES-02 trial in anti-GBM.

As part of a directed share issue, Hansa and NovaQuest entered into an amended debt agreement in which the Company offset US $14.9M of outstanding debt through the issue of new shares (equity). The remaining debt will be paid in fixed cash payments in June 2027, June 2028 and June 2029. In addition, a true-up payment of approximately US $14.9M is due on January 31, 2026, which may be settled in cash or equity at the Company's discretion.  

IDEFIRIX Q2 product revenues increased by 76% as compared to the same period last year. In Q2 2025, the Company delivered 47.8 MSEK in IDEFIRIX sales reflecting an increase of 76% as compared to previous year (27.2 MSEK) for the same time period. For the 1H 2025, IDEFIRIX sales amounted to 113.5 MSEK representing a 52% increase in product sales over 1H 2024, which represents approximately 80% of full year product sales for 2024.

Pipeline Progress

The Company remains on track to report data from the 20-HMedIdeS-17 study (ConfIdeS). A Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) is expected in second half 2025, following data readout.

Positive data from the 15-HMedIdeS-09 Phase 2 trial including an indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS) was presented at the Peripheral Nerve Society (PNS) annual meeting in May.

Enrolment is ongoing in GNT-018-IDES, a Phase 2 trial in Crigler Najjar to evaluate the efficacy and safety of Genethon's gene therapy, GNT-0003 following pre-treatment with imlifidase. The Phase 1b trial SRP-9001-104 with Sarepta remains on track for an initial data readout later this year.

Financial Summary

	MSEK, unless otherwise stated – unaudited	Q2 2025	Q2 2024	1H 2025	1H 2024
	Revenue	49.1	34.3	115.5	90.3
	- thereof: Product sales1	47.8	27.2	113.5	74.7
	SG&A expenses	(90.5)	(88.2)	(166.5)	(179.5)
	R&D expenses	(95.8)	(91.7)	(160.1)	(194.6)
	Loss from operations	(154.8)	(187.4)	(248.2)	(346.8)
	Loss for the period	(178.9)	(207.9)	(216.0)	(426.5)
	Net cash used in operations	(111.7)	(189.2)	(263.6)	(378.3)
	Cash and short-term investments	354.4	705.0	354.4	705.0
	EPS before and after dilution (SEK)	(2.53)	(3.30)	(3.13)	(7.38)
	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	70,802,763	62,929,675	68,937,930	57,800,736
	No of employees at the end of the period	140	146	140	146
	1 Product sales in the second quarter 2024 totaled 47.1 MSEK. Sales were offset by a provision totaling 19.9 MSEK for potential credits associated with volume discounts and potential refunds. First half 2024 product sales totaled 94.6 MSEK and were offset by the provision totaling 19.9 MSEK. Net of the provision, first half product sales totaled 74.7 MSEK.

Conference Call Details

Hansa Biopharma will host a telephone conference today Thursday, 17 July 2025, at 14:00 CEST / 8:00 am EDT.

The event will be hosted by Renée Aguiar-Lucander, CEO, Evan Ballantyne, CFO, Hitto Kaufmann, CSTO, and Maria Törnsén COO and President U.S. The call will include a review of the interim results and a business and pipeline update. It will be held in English.

Slides used in the presentation will be live on the company website during the call under Events & Presentations 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: https://event.choruscall.com/mediaframe/webcast.html?webcastid=hUSedAeI

Contacts for more information:
Evan Ballantyne, Chief Financial Officer
IR@hansabiopharma.com

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 Hansa Biopharma's (HNSA) Q2 2025 IDEFIRIX sales?

IDEFIRIX sales reached 47.8 MSEK in Q2 2025, representing a 76% increase compared to Q2 2024 (27.2 MSEK).

How much funding did Hansa Biopharma raise in Q2 2025?

Hansa secured a directed cash share issue of approximately 232 MSEK (US $24.3M) and restructured its NovaQuest debt by converting US $14.9M to equity.

What is Hansa Biopharma's cash runway following the recent financing?

The company's cash runway now extends into Q2 2026, supporting two Phase 3 trial readouts in H2 2025.

When does Hansa Biopharma expect to submit its BLA to the FDA?

Hansa plans to submit a Biologics License Application (BLA) to the FDA in the second half of 2025, following the ConfIdeS trial data readout.

What were Hansa Biopharma's operating results for Q2 2025?

The company reported an operating loss of 154.8 MSEK, with R&D expenses of 95.8 MSEK and SG&A expenses of 90.5 MSEK.