Hansa Biopharma Reports First Quarter and Interim January-March 2025 Financial Results
Rhea-AI Summary
Hansa Biopharma (HNSA) reported strong Q1 2025 financial results with total revenue of 66.3 MSEK, driven by IDEFIRIX® product sales of 65.7 MSEK, representing a 39% increase from Q1 2024. Key operational highlights include:
- Completed enrollment in Post Authorization Efficacy and Safety study
- Secured access in three additional European markets
- Growing repeat utilization of IDEFIRIX® across Europe
- Appointment of Renée Aguiar-Lucander as new CEO
Financial metrics:
- SG&A expenses: 76.0 MSEK
- R&D expenses: 64.3 MSEK
- Operating loss: 93.4 MSEK
- Net loss: 37.1 MSEK
- Cash position: 250.2 MSEK
Multiple pipeline catalysts expected in H2 2025, including data readouts from U.S. ConfIdeS Phase 3 trial in kidney transplantation and anti-GBM Phase 3 trial.
Positive
- 39% year-over-year increase in product sales (65.7 MSEK vs 47.4 MSEK)
- Expanded market access to three additional European markets
- Growing repeat utilization in key European centers
- Reduced operating loss from 159.4 MSEK to 93.4 MSEK YoY
- Decreased R&D expenses from 103.0 MSEK to 64.3 MSEK
Negative
- Cash position decreased to 250.2 MSEK from 541.5 MSEK in Q1 2024
- Continued quarterly sales fluctuations due to unpredictable organ allocation market
- Net cash used in operations of 151.9 MSEK
- Reduction in workforce from 166 to 138 employees YoY
Insights
Hansa delivers 39% product sales growth with narrowed losses while progressing clinical pipeline with multiple upcoming catalysts.
Hansa Biopharma's Q1 2025 performance shows robust commercial momentum with product sales reaching
Operational efficiency has significantly improved, with operating loss narrowing to
The cash position stands at
A leadership transition sees Renée Aguiar-Lucander appointed as CEO, replacing Søren Tulstrup who steps down after seven years. This management change comes at a pivotal time as the company approaches multiple clinical readouts in H2 2025.
The expanded geographic footprint with three additional European markets gaining access and reimbursement approval for IDEFIRIX® strengthens the commercial outlook, while growing repeat utilization indicates building physician confidence in the therapy.
Pivotal milestone achieved with PAES enrollment completion; multiple late-stage data readouts expected H2 2025 across diverse indications.
Hansa's completion of enrollment in the Post Authorization Efficacy and Safety (PAES) study represents a significant regulatory milestone toward potential full marketing authorization in Europe for IDEFIRIX®. This study fulfills obligations following conditional authorization by the European Commission and is expected to read out in H2 2026.
The company has strategically positioned for commercial acceleration, noting that with PAES enrollment complete, they expect increased commercial utilization at key centers that participated in the study. This suggests efficient conversion of clinical sites to commercial prescribers.
The pipeline is advancing with multiple value-inflection points anticipated in H2 2025, including readouts from the U.S. ConfIdeS Phase 3 pivotal trial in kidney transplantation and the anti-GBM Phase 3 pivotal trial. These late-stage data readouts could significantly expand IDEFIRIX®'s addressable markets.
The positive data from the Phase 2 trial in Guillain-Barré Syndrome (GBS) scheduled for presentation at an upcoming medical conference indicates potential expansion into neurological applications. The company specifically notes that this data demonstrated "imlifidase's potential to address significant unmet need in GBS," suggesting clinically meaningful outcomes.
Additionally, the development of next-generation molecule HNSA-5487 for repeat dosing applications remains on track, with recent positive regulatory feedback from BfArM confirming the clinical development plan in myasthenia gravis (MG). This expands the platform technology into autoimmune neurology with a molecule designed for chronic administration.
The ongoing Phase 2 trial in Crigler Najjar syndrome with Genethon demonstrates Hansa's strategy to leverage its technology in enabling gene therapy for patients with pre-existing antibodies against AAV vectors, potentially unlocking access to gene therapies for previously ineligible patients.
Strong product sales and key progress in pipeline catalysts
Peter Nicklin, Chairman of the Board, Hansa Biopharma said, "In Q1, the Company delivered strong growth with total revenue of 66.3 MSEK and products sales of 65.7 MSEK. This represents a 39 percent increase as compared to Q1 2024 (47.4 MSEK). While the organ allocation market remains unpredictable and directly impacts our quarterly sales, we remain confident in our ability to significantly increase revenue year on year. In Q1, we completed enrollment in the Post Authorization Efficacy and Safety (PAES) study, secured access and reimbursement in three additional European markets, and saw growing repeat utilization of IDEFIRIX® (imlifidase) in key centers across
"Also, of note, following the positive full results from the 15-HMedIdeS-09 single arm Phase 2 study in Guillain Barre Syndrome (GBS) shared in December 2024, the data is set to be presented at an upcoming medical congress. Finally, the development of the Company's next generation molecule for repeat dosing, HNSA-5487, remains on track. We recently had very positive interaction with BfArM confirming the clinical development plan for HNSA-5487 in myasthenia gravis (MG)."
The Company also announced Renée Aguiar-Lucander has been appointed Chief Executive Officer effective immediately. Søren Tulstrup has stepped down from his position of CEO by mutual agreement after seven years of dedicated service to the Company.
Financial Performance
Q1 2025 product sales of IDEFIRIX® totaled 65.7 MSEK representing a 39 percent increase over Q1 2024 (47.4 MSEK). Revenue for the first quarter 2025 totaled 66.3 MSEK. The addition of new sites using IDEFIRIX combined with growing repeat utilization contributed to the performance. Hansa expects to see continued strong year-on-year product sales growth despite continued quarterly product sales fluctuation due to variations in European kidney allocation systems, which impacts the availability of organs for patients.
Pipeline Progress
During the first quarter of 2025, Hansa completed enrolment of the 20-HMedIdeS-19 Post Authorization Efficacy and Safety (PAES) study. The PAES study is part of the Company's obligation following conditional authorization by the European Commission for IDEFIRIX. The study is expected to read out in the second half of 2026 and is intended to support full marketing authorization in
Following positive data from the 15-HMedIdeS-09 Phase 2 trial and indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study (IGOS), the data has been accepted for oral presentation at an upcoming medical conference in 2025. The trial and indirect treatment comparison demonstrated imlifidase's potential to address significant unmet need in GBS.
The Phase 2 trial GNT-018-IDES in collaboration with Genethon in patients with Crigler Najjar syndrome with pre-existing antibodies against adeno-associated vectors (AAV) continues to progress with enrolment currently ongoing.
The 20-HMedIdeS-17 study (ConfIdeS) remains on track for a data readout in the second half of 2025. This pivotal Phase 3 trial is evaluating imlifidase as a potential desensitization therapy, compared to standard of care, to enable kidney transplantation in highly sensitized patients.
Financial Summary
MSEK, unless otherwise stated – unaudited | Q1 2025 | Q1 2024 | FY 2024 | |
Total Revenue | 66.3 | 56.0 | 220.9 | |
-thereof: Product sales | 65.7 | 47.4 | 189.7 | |
Provision1 | – | – | (49.6) | |
Net revenue after provision | 66.3 | 56.0 | 171.3 | |
SG&A expenses | (76.0) | (91.3) | (344.3) | |
R&D expenses | (64.3) | (103.0) | (375.7) | |
Loss from operations | (93.4) | (159.4) | (637.9) | |
Loss for the period | (37.1) | (218.6) | (807.2) | |
Net cash used in operations | (151.9) | (189.1) | (674.9) | |
Cash and short-term investments | 250.2 | 541.5 | 405.3 | |
EPS before and after dilution (SEK) | (0.55) | (4.15) | (12.85) | |
Number of outstanding shares | 67,814,241 | 52,671,796 | 67,814,241 | |
Weighted average number of shares before and after dilution | 67,814,241 | 52,671,796 | 62,834,848 | |
No of employees at the end of the period | 138 | 166 | 135 | |
1 Actual product sales for the full year 2024 totaled 189.7 MSEK. Sales were offset by a provision totaling 49.6 MSEK associated with volume discounts and rebates. Including the provision, year to date product sales totaled 140.1 MSEK. | ||||
Conference Call Details
Hansa Biopharma will host a telephone conference today Thursday, 24 April, 2025, at 14:00 CEST / 8:00 am EDT.
The event will be hosted by Peter Nicklin, Chairman of the Board, Evan Ballantyne, CFO, and Hitto Kaufmann, CR&DO and Renée Aguiar-Lucander. 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=gvTS9Iuw
For the full financial calendar and list of events in 2025 please visit https://www.hansabiopharma.com/investors/calendar/
Contacts for more information:
Evan Ballantyne, Chief Financial Officer
IR@hansabiopharma.com
Stephanie Kenney, 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
©2025 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB,
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20250423 HNSA - Q1 2025 Quarterly Report ENG |
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SOURCE Hansa Biopharma AB
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