- PDUFA target date set for December 19 by the FDA
- Runway significantly extended
Lund, Sweden, 23 April 2026. Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), today announced its interim report January-March 2026.
Renée Aguiar-Lucander, CEO, Hansa Biopharma said, "In the first quarter of 2026, we continued to execute against our strategic priorities as we advanced imlifidase toward a potential U.S. approval of our Biologics License Application (BLA) with an assigned December 19 PDUFA[*] target date. Preparations for a potential U.S. launch progressed in parallel, while in Europe we saw the expected short term impact of the commercial reorganization and related initiatives. Quarterly revenues remain inherently variable due to structural issues related to organ allocation and as previously communicated we do not expect this to change in the medium term. Consequently, Q2 has had a strong start, and we believe that the benefits of the reorganization will support improved performance from the second quarter onward. During the quarter, we strengthened our financial position through a USD 30.0 million convertible note financing, significantly extending our runway and reinforcing our focus on disciplined financial and operational execution as we approach multiple near term value driving milestones."
Financial Performance
First-quarter Revenue totalled 34.6 MSEK compared to 66.3 MSEK in Q1 in 2025. IDEFIRIX product sales reached 33.9 MSEK, compared to 65.7 MSEK in Q1 2025.
Business Update
Imlifidase Biologics License Application (BLA) was accepted for review by the FDA and PDUFA* action date for the BLA is set for December 19, 2026.
On March 19, 2026, the Company entered into a USD 30.0 million convertible note purchase agreement with Athyrium Capital Management. The convertible note has a fixed interest rate of 3.0% payable semi-annually in cash beginning September 15, 2026, and a conversion premium of 25%. This transaction extends Hansa's cash runway and strengthens the company's balance sheet in advance of the planned U.S. launch. Including the convertible note, Hansa's cash and cash equivalents on March 31, 2026, totalled 676.5 MSEK or approximately USD 73.2 million.
Pipeline Progress
The results from ConfIdeS pivotal U.S. Phase 3 Trial (20-HMedIdeS-17) have been accepted as an oral presentation at the American Transplant Congress (ATC) in Boston in June 2026.
Financial Summary
| Amounts in MSEK, unless otherwise stated | Q1 2026 | Q1 2025 | 12M 2025 |
| Revenue | 34.6 | 66.3 | 222.3 |
| - Including: Product sales | 33.9 | 65.7 | 204.7 |
| SG&A expenses | (105.6) | (76.0) | (356.6) |
| R&D expenses | (57.3) | (64.3) | (304.7) |
| Loss from operations | (142.5) | (93.4) | (520.7) |
| Loss for the period | (196.3) | (38.8) | (534.1) |
| Net cash used in operations | (157.0) | (151.9) | (549.2) |
| Cash and short-term investments | 676.5 | 250.2 | 701.1 |
| EPS before and after dilution (SEK) | (1.93) | (0.57) | (6.58) |
| Number of outstanding shares | 101,763,222 | 67,814,241 | 101,763,222 |
| Weighted average number of shares before and after dilution | 101,763,222 | 67,814,241 | 81,200,543 |
| Number of employees at period end | 122 | 138 | 125 |
Conference Call Details
Hansa Biopharma will host a telephone conference today Thursday, 23 April 2026, at 14:00 CEST / 8:00 am EDT.
The event will be hosted by Renée Aguiar-Lucander, CEO, Richard Philipson, CMO, Evan Ballantyne, CFO, and Maria Törnsén COO and President U.S. 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 First Quarter 2026 Earnings
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Contacts for more information:
Evan Ballantyne, 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 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.
©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.
[*] PDUFA date - the target date by which the FDA issues a decision on a new drug or biologic application.
