(AGENPARL) – Thu 17 July 2025 7.00 AM CEST / 17-Jul-2025 / Hansa Biopharma AB (STO:HNSA)
· 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, 17 July 2025. 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 Q2 2025 Q2 2024 1H 2025 1H
2024
– unaudited
90.3
: Product
sales[1
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 354.4 705.0 354.4
705.0
investments
EPS before and after dilution (2.53) (3.30) (3.13)
(7.38)
(SEK)
Number of outstanding shares 84,763,222 67,814,241 84,763,222
67,814,241
Weighted average number of 70,802,763 62,929,675 68,937,930
57,800,736
shares before and after
dilution
the period
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 (https://www.hansabiopharma.com/investors/presentations-events/)
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
— ENDS —
Contacts for more information:
Evan Ballantyne, Chief Financial Officer
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 http://www.hansabiopharma.com and follow us on
LinkedIn (https://www.linkedin.com/company/hansa-medical-ab/).
©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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