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

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July 17, 2025 1:43 AM EDT

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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
[email protected]

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.