- €115 million out-licensing agreement
- Positive data from European confirmatory trial (PAES)
Lund, Sweden, 22 July 2026. Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), today announced its half year report for the period January-June 2026.
Renée Aguiar-Lucander, CEO, Hansa Biopharma said, "This was a defining quarter for Hansa. The announcement of the European out-licensing agreement, positive PAES results supporting application for conversion to full European approval, growing recognition of the strength and clinical relevance of our ConfIdeS Phase 3 data, and continued progress toward a potential US launch of imlifidase mark important milestones in our development. These achievements strengthen our financial foundation, increase our strategic flexibility, and reinforce our confidence in the significant long-term opportunity for imlifidase to transform outcomes for highly sensitized kidney transplant patients."
Business Update
Revenue for the second quarter amounted to 48.1 MSEK, compared with 49.1 MSEK in the corresponding period in 2025. Idefirix product sales reached 46.8 MSEK, compared with 47.8 MSEK in Q2 2025. For the first half of 2026, revenue totalled to 82.7 MSEK, compared with 115.5 MSEK in the corresponding period last year, while Idefirix product sales totalled 80.7 MSEK, compared with 113.5 MSEK in the first half of 2025. The year-on-year development primarily reflects a weaker first quarter.
Commercial execution improved significantly (+39%) over Q1, with continued growth in Spain following the achievement of reimbursement in Catalonia and continued strong performance in France. We also saw solid demand in the other large European markets Germany, Italy and the UK.
On May 19th Hansa entered into a €115 million out-licensing agreement with SERB Pharmaceuticals covering development and commercialization of Idefirix in solid organ transplantation in the European Union, United Kingdom, Switzerland, Norway, Liechtenstein, Iceland and the MENA region. Hansa received an upfront payment of €110 million in the first half of July and will receive additional €5 million payment upon acceptance of the filing for conversion to full marketing authorization l of Idefirix by the European Medicines Agency (EMA).
Successful Confirmatory Trial Outcome
Positive efficacy and safety results from the European post-authorization study (PAES) of Idefirix in kidney transplantation were reported, including a one-year graft failure-free survival rate of 90%, supporting submission to the European Medicines Agency (EMA) for conversion to full marketing authorization.
In addition, further data from the US pivotal Phase 3 ConfIdeS trial was shared as an oral presentation at ATC 2026 and selected for inclusion in the 'What's Hot, What's New' plenary session.
Financial Summary
| Amounts in MSEK, unless otherwise stated | Q2 2026 | Q2 2025 | H1 2026 | H1 2025 |
| Revenue | 48.1 | 49.1 | 82.7 | 115.5 |
| - Including: Product sales | 46.8 | 47.8 | 80.7 | 113.5 |
| SG&A expenses | (118.9) | (90.5) | (224.5) | (166.5) |
| R&D expenses | (67.9) | (95.8) | (125.2) | (160.1) |
| Loss from operations | (174.1) | (154.5) | (316.6) | (247.9) |
| Loss for the period | (260.5) | (197.0) | (456.9) | (235.8) |
| Net cash used in operations | (103.5) | (94.2) | 250.5 | (230.0) |
| Cash and short-term investments | 552.8 | 354.4 | 552.8 | 354.4 |
| EPS before and after dilution (SEK) | (2.56) | (2.78) | (4.49) | (3.42) |
| Number of outstanding shares | 101,763,222 | 84,763,222 | 101,763,222 | 84,763,222 |
| Weighted average number of shares before and after dilution | 101,763,222 | 70,802,763 | 101,763,222 | 68,937,930 |
| Number of employees at period end | 131 | 140 | 131 | 140 |
Conference Call Details
Hansa Biopharma will host a telephone conference today Wednesday, 22 July 2026, at 14:00 CEST / 08:00 EDT.
The event will be hosted by Renée Aguiar-Lucander, CEO, Richard Philipson, CMO, Adam Cutler, CFO, and Maria Törnsén COO and President US. The call will be held in English.
Slides used in the presentation will be live on the webcast during the call and will also be made available online after the call under Financial reports | Hansa Biopharma.
To participate in the telephone conference, please use the dial-in details provided below:
Participant Dial In (USA/Canada 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: Webcast | Hansa Biopharma Half Year Report 2026
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Contacts for more information:
Adam Cutler, Chief Financial Officer
IR@hansabiopharma.com
Kerstin Falck, VP Global Corporate Affairs
media@hansabiopharma.com
Notes to editors
About Hansa Biopharma
Hansa Biopharma AB is a pioneering commercial-stage biopharmaceutical company developing and commercializing novel immunomodulatory therapies to transform care for patients with acute or complex immune disorders. Hansa's proprietary IgG-cleaving enzyme technology platform addresses serious unmet medical needs in transplantation, gene therapy and autoimmune diseases. 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 that will be developed for Guillain-Barré Syndrome (GBS). Hansa Biopharma is based in Lund, Sweden, and has operations in Europe and the US. The company is listed on Nasdaq Stockholm under the ticker HNSA. Find out more at www.hansabiopharma.com and follow us on LinkedIn.
©2026 Hansa Biopharma AB. Hansa Biopharma, the beacon logo, IDEFIRIX, and IDEFIRIX flower logo are trademarks of Hansa Biopharma AB, Lund, Sweden. All rights reserved.
