Hansa Biopharma Reports Second Quarter and Interim January-June 2025 Financial Results
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.
Hansa Biopharma (NASDAQ:HNSA) ha comunicato i risultati finanziari del secondo trimestre 2025, evidenziando un aumento del 76% su base annua nelle vendite del prodotto IDEFIRIX, che hanno raggiunto 47,8 milioni di SEK. L'azienda ha ottenuto un aumento di capitale tramite un'emissione azionaria diretta di 232 milioni di SEK (24,3 milioni di dollari USA) e ha ristrutturato il debito con NovaQuest, convertendo in equity 14,9 milioni di dollari USA di debito residuo.
Le vendite di IDEFIRIX nella prima met脿 del 2025 hanno raggiunto 113,5 milioni di SEK, segnando un incremento del 52% rispetto al primo semestre 2024. I progressi nel pipeline includono prossime comunicazioni di dati da due programmi di Fase 3 nel trapianto renale e nella glomerulonefrite anti-GBM, con una prevista presentazione della BLA alla FDA nella seconda met脿 del 2025. Il finanziamento ottenuto estende la liquidit脿 fino al secondo trimestre del 2026.
Hansa Biopharma (NASDAQ:HNSA) inform贸 los resultados financieros del segundo trimestre de 2025, destacando un aumento interanual del 76% en las ventas del producto IDEFIRIX, que alcanzaron los 47,8 millones de SEK. La compa帽铆a asegur贸 una emisi贸n de acciones dirigida por valor de 232 millones de SEK (24,3 millones de d贸lares estadounidenses) y reestructur贸 su deuda con NovaQuest, convirtiendo en acciones 14,9 millones de d贸lares de deuda pendiente.
Las ventas de IDEFIRIX en la primera mitad de 2025 alcanzaron los 113,5 millones de SEK, lo que representa un incremento del 52% respecto al primer semestre de 2024. Los avances en la cartera incluyen pr贸ximas publicaciones de datos de dos programas de Fase 3 en trasplante renal y anti-GBM, con una presentaci贸n planificada de la BLA a la FDA en la segunda mitad de 2025. La financiaci贸n asegurada extiende la liquidez hasta el segundo trimestre de 2026.
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2025雲� 靸侂皹旮� IDEFIRIX 毵れ稖鞚� 1鞏� 1350毵� SEK搿� 2024雲� 靸侂皹旮� 雽�牍� 52% 歃濌皜頄堧嫟. 韺岇澊頂勲澕鞚� 歆勴枆 靸來櫓鞙茧電� 鞁犾灔 鞚挫嫕瓿� 頃�-GBM鞐� 甏�頃� 霊� 臧滌潣 3靸� 頂勲攴鸽灗鞐愳劀 瓿� 雿办澊韯� 氚滍憸臧� 鞓堨爼霅橃柎 鞛堨溂氅�, 2025雲� 頃橂皹旮办棎 FDA鞐� BLA 鞝滌稖 瓿勴殟鞚� 鞛堧嫟. 頇曤炒霅� 鞛愱笀鞚� 2026雲� 2攵勱赴旯岇 順勱笀 鞙犽彊靹膘潉 鞐办灔頃滊嫟.
Hansa Biopharma (NASDAQ:HNSA) a annonc茅 ses r茅sultats financiers du deuxi猫me trimestre 2025, mettant en avant une augmentation de 76 % des ventes du produit IDEFIRIX par rapport 脿 l'ann茅e pr茅c茅dente, atteignant 47,8 millions de SEK. La soci茅t茅 a s茅curis茅 une augmentation de capital par 茅mission d'actions dirig茅e de 232 millions de SEK (24,3 millions de dollars US) et a restructur茅 sa dette NovaQuest, convertissant 14,9 millions de dollars de dette en actions.
Les ventes d'IDEFIRIX au premier semestre 2025 ont atteint 113,5 millions de SEK, soit une hausse de 52 % par rapport au premier semestre 2024. Les avanc茅es du pipeline incluent des r茅sultats 脿 venir de deux programmes de Phase 3 en transplantation r茅nale et anti-GBM, avec une soumission BLA pr茅vue aupr猫s de la FDA au second semestre 2025. Le financement s茅curis茅 prolonge la tr茅sorerie jusqu'au deuxi猫me trimestre 2026.
Hansa Biopharma (NASDAQ:HNSA) ver枚ffentlichte die Finanzergebnisse f眉r das zweite Quartal 2025 und hob einen 76%igen Umsatzanstieg bei IDEFIRIX im Jahresvergleich auf 47,8 Mio. SEK hervor. Das Unternehmen sicherte sich eine gezielte Kapitalerh枚hung in H枚he von 232 Mio. SEK (24,3 Mio. USD) und restrukturierte seine NovaQuest-Schulden, wobei 14,9 Mio. USD der ausstehenden Schulden in Eigenkapital umgewandelt wurden.
Die IDEFIRIX-Verk盲ufe im ersten Halbjahr 2025 erreichten 113,5 Mio. SEK, was einem Anstieg von 52% gegen眉ber dem ersten Halbjahr 2024 entspricht. Fortschritte in der Pipeline umfassen bevorstehende Datenver枚ffentlichungen aus zwei Phase-3-Programmen zur Nierentransplantation und Anti-GBM, mit einer geplanten BLA-Einreichung bei der FDA in der zweiten H盲lfte 2025. Die gesicherte Finanzierung verl盲ngert den Cash-Runway bis zum zweiten Quartal 2026.
- 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
- 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
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
The standout metric is IDEFIRIX's
Despite this revenue growth, Hansa remains unprofitable with a quarterly operating loss of
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-Barr茅 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 - As compared to prior year Q2 IDEFIRIX product sales increased
76% .
Ren茅e 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
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
IDEFIRIX Q2 product revenues increased by
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
Positive data from the 15-HMedIdeS-09 Phase 2 trial including an indirect treatment comparison to the International Guillain-Barr茅 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 鈥� 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听 听 听听 | 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 | ||||||
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 Ren茅e Aguiar-Lucander, CEO, Evan Ballantyne, CFO, Hitto Kaufmann, CSTO, and Maria T枚rns茅n COO and President
Slides used in the presentation will be live on the company website during the call under 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:
Contacts for more information:
Evan Ballantyne,听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
漏2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB,
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