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hansa-biopharma-ab-hansa-biopharma-presenterar-vid-td-cowens-46th-annual-health-care-conference

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Hansa Biopharma is a Swedish biotech company with the lead product imlifidase, which is an antibody-cleaving enzyme being developed to enable kidney transplantation in highly sensitized patients. The enzyme may be further developed for use in other types of transplantation, in autoimmune diseases, gene therapy and oncology. So far Idefirix (imlifidase) has been conditionally approved in the EU for highly sensitized kidney transplant patients.

Currently, Hansa is conducting a pivotal randomized contro trial in kidney transplantation in the United States and is expecting to commence a pivotal study across the U.S. and EU in the rare autoimmune disease anti-GBM during 2022. Additionally, Hansa’s research and development program is advancing the enzyme technology to develop the next generation of IgG-cleaving enzymes with potentially lower immunogenicity, suitable for repeat dosing in relapsing autoimmune diseases and oncology.

Let’s post a summary of Q4 2025 here, even if it’s a bit late. For a change, it was actually a pretty good quarter. Revenue was 76 MSEK, of which product sales accounted for 61 MSEK, representing about twenty treated Idefirix patients. Full-year 2025 revenue grew by approximately 30% year-on-year. Q4 cash flow was still 178 MSEK in the red, and the full-year cash flow was -549 MSEK accordingly. Cash on hand was 701 MSEK.  Hansa gave guidance for a weaker Q1 2026 than the quarter just ended, and improvement could come in the latter half of the year. The US launch is planned for the end of the year (Q4), and hope for this was partly bolstered by Hansa reporting that the FDA accepted the BLA (Biologics License Application) for imlifidase on Feb 18. Personally, I only skimmed through this report, although I still have some kind of Hansa position in my portfolio. However, I spotted something in Redeye’s Q&A section, according to which Redeye does not see the shortage of donated kidneys in the US market as a similar constraint as in Europe. According to analyst Richard Ramanius, the target group for imlifidase is prioritized in the US: “Hansa has an advantage in that US decision makers prioritise highly sensitised patients because they want to reduce dialysis dependence.” Redeye has certainly been quite off the mark with its Hansa analysis so far, so it’s hard to say what value this statement holds. At least the analyst has changed now. Expectations still rest mainly on that US launch and the US market potential.            hansabiopharma.com              hnsa--q4-2025-eng-final.pdf    2038.10 KB

Anti-GBM (GOOD-IDES-02) pivotal phase 3 failed, Hansa announced this morning. Quite a big and surprising disappointment for me. This emphasizes that one cannot draw very big conclusions from comparisons to historical cohorts yet in phase 2, no matter how good it looks. The phase 3 primary endpoint (eGFR 6 months) did not differ in the imlifidase+SoC arm from control-SoC. Although imlifidase rapidly removed anti-GBM antibodies and approximately 60% of patients were dialysis-free at 6 months, the control group achieved almost the same level, resulting in no statistical difference. In phase 2, there was talk of a historical control group that achieved only about 20-25% dialysis-free status. A key reason why phase 3 “lost” to phase 2 is the study design: phase 2 was open-label, uncontrolled, and compared results to that (perhaps too loosely) selected historical cohort, whereas in phase 3, the standard of care was defined in the protocol as exceptionally aggressive (immediate and intensive PLEX + cyclophosphamide + steroids). This significantly raised the results of the control group and eroded the incremental benefit of imlifidase, even though the biological effect itself worked as expected. In other words, imlifidase did work, but when the disease was diagnosed quickly and aggressive SoC was started immediately in this experimental setup, there was no additional benefit from imlifidase. In practice, the regulatory pathway for the anti-GBM indication is non-existent after this, and the value of this indication can be set to zero in Excel.                   hansabiopharma.com              Hansa provides update on Pivotal Phase 3 trial in anti-glomerular basement...                                                clinicaltrials.gov              ClinicalTrials.gov

A rather weak Q3 from Hansa. One can probably already conclude that there simply isn’t a proper market for Idefirix in Europe for the kidney transplant indication. Revenue 30.8 MSEK, significantly less than a year ago. This corresponds to about ten treated patients. Sales in Germany are in trouble after Germany suspended its participation in the Eurotransplant prioritization program, and there are also problems in Spain. This also indicates weak future quarters. The “launch,” if the sales effort can still be called that, is thus going in the wrong direction in Europe. The cash situation is, of course, good after a directed issue made at a surprisingly good price. The issue raised 671.5 MSEK (71.5 MUSD) at the beginning of October, with a subscription price of almost SEK 40. The dilution with these issues is quite significant.  Quote from the Q3 report:  As mentioned in the Q2 report, the German Eurotransplant Prioritized Program has been paused, and as a result no product sales were reported in Germany during Q3. While physicians in Germany can continue prescribing IDEFIRIX under the standard Eurotransplant Kidney Allocation System (ETKAS), we expect that the pause of the prioritized program will continue to have a negative impact in the near- to mid-term.  This situation in Germany was explained in the Q2 Q&A session mainly by concerns in Germany about patient equality:  When it comes to these highly sensitized patients, you – they end up in this priority program for specific reasons. Let’s say, they’ve had a previous transplant, they have been pregnant, they’ve had a blood transfusions. You know the reason why they’re highly sensitized. And in Germany, what they have really been discussing is this health equity. That certain patients end up in this program.  Here, it seems to be implied that at least some patients are sensitized “due to their own reasons,” meaning they might not have properly managed their immunosuppressive medication with the first transplant or otherwise cause problems with their lifestyle. At least such a comment came from a German doctor earlier. Since kidneys are a very limited resource, they are preferably given to a non-sensitized recipient without the cost of Idefirix. This perspective is quite bad for Hansa. And there are also problems with Idefirix reimbursement in Spain. The story relies increasingly on the USA and, of course, on future indications in the development pipeline. Unfortunately, the FDA is also currently closed, which is unlikely to speed up the project… Fortunately, I realized at some point to start trading this – buying below SEK 30 and selling above SEK 35 has been a significantly better strategy than ‘hodling’ in recent years. At some point, this might still take off if the USA succeeds, and before that, it would be good to be involved if one believes in the story. After the Q3 report, we are at least back at buying prices. Of course, there is a lot of optimism in the report about the future and indications in the development pipeline, but in the short term, it left a rather melancholic feeling nonetheless.            hansabiopharma.com              hnsa--q3-2025-eng-final-1.pdf    2.07 MB

It’s not entirely uncommon. The FDA looks at things a bit differently when approving a study and later when evaluating a drug for approval. According to the protocol, if a transplant is not received, the GFR is set to zero. The control group’s GFR is so low that either 1. The control group’s transplants have, on average, failed, or 2. (which I consider likely) there are only a few transplants in the control group. If 2. is true, this leads to the conclusion that the endpoint GFR does not actually measure the improvement in the probability of transplant success with imlifidase, but rather the kidney function of those who received a transplant versus those who did not. The risk of bias in the study is also increased by the fact that both the “local desensitization regime” and how conclusions are drawn from it regarding the probability of transplant success are not precisely defined and probably vary between centers. It could be, for example, that the post-desensitization protocol for predicting transplant success is “too strict,” meaning it leaves patients without a transplant who could still receive a functioning transplant with modern immunosuppression. I wouldn’t be surprised if this were the case, because as long as there are fewer transplants than those who need them, the probability of success is desired to be set high. But the situation will become clear when Hansa publishes the figures. However, I will now follow the company more closely; for now, I decide to be without a position and might strike if the FDA requests further clarifications.

Very good points and questions. This thread has indeed needed some life! I’ll answer how I see the matter. I am not a medical professional, as a disclaimer. It is true that a ≥99.9% cut-off restricts the patient population very strictly – it concerns the most difficult-to-transplant patients. Behind this is perhaps at least the idea that the biggest bottleneck in this indication is the scarcity of donor kidneys. In practice, every kidney transplanted with the help of imlifidase is taken from another patient awaiting a transplant. In this sense, it might be advisable to strictly limit the potential patient group only to those who have an extremely low probability of receiving a functional kidney when operating according to SOC (Standard of Care). In this case, it is certainly an unmet need. Could one also think that approval for this group could also open the door for broader use in the future? According to my understanding, 1-2% of those on the transplant list belong to this patient group, meaning perhaps a few hundred patients per year in the USA. For example, Erik Penser Bank estimated in its somewhat older comprehensive analysis that with 86% penetration in this cPRA ≥99.9% patient group, 550 patients from the transplant waiting list would be treated in the USA in 2031. Based on European experiences, that penetration assumption is likely clearly too high, even though the market is different, and faster sales development can reasonably be expected in the USA than in Europe.  I myself wouldn’t be particularly concerned about the study protocol, even though the criticism itself is relevant; some comparators in this setup are left without a transplant, which pushes the eGFR result down because eGFR remains low in dialysis patients. However, this is precisely the reality: without imlifidase, no transplant can be found for these patients. The control thus corresponds to standard of care: Waiting, some form of off-label desensitization, or a very unlikely chance of receiving a suitable organ. Furthermore, as I understand it, the FDA has approved this specific study protocol and endpoints, so it would probably be strange to start complaining about the study design after the study? Moreover, the eGFR difference between the control groups was so large that it is unlikely to be explained solely by this “imbalance,” even though this goes strongly beyond my own expertise… Perhaps more detailed data will be available when the full results are published next year. In any case, the efficacy and safety of imlifidase have now been demonstrated so many times on different continents that I would be surprised if further studies were still required. I still consider the biggest problem and question mark to be the same old theme: the scarcity of donated kidneys. Every expensive imlifidase kidney is practically taken from another “easier” patient. There is already data showing that these organs transplanted with imlifidase practically last similarly to “normal” grafts, but one might still think it’s unnecessary to spend an additional 300k+ EUR, and perhaps even more in USD, per patient if there were a cheaper use for the kidney. However, the FDA does not take a stance on these cost issues, so I cannot consider this an obstacle to BLA approval either. Instead, the market potential remains a question. In summary: the clinical evidence is convincing, and the FDA has been involved in approving the setup, so I believe the regulatory risk is small. The biggest question from an investor’s perspective still relates to market size and realized penetration. Good news nonetheless.

Interesting. What kind of market size estimates have been presented? That cPRA>=99.9% is quite a strict cut-off. Does that mean at most a few percent of all transplant candidates? Another thing that concerns me is the study protocol. If a patient is randomized to the control group but screening predicts an unfavorable outcome for the graft, the patient does not receive a transplant but remains on dialysis and stays among the controls. I wouldn’t be surprised if the FDA takes issue with this because some control patients do not receive active treatment (transplant). And local protocols in different centers may vary. But it is a difficult setup.

Finally, research results from Hansa. Let’s see how much of it was already priced in. A positive result is no surprise, of course. Imlifidase successfully meets primary endpoint in pivotal US Phase 3 ConfIdeS trial in kidney transplantation | Hansa Biopharma

Hansa Biopharma

Lund, 23 februari 2026. Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), meddelade idag att Renée Aguiar-Lucander, VD, Hansa Biopharma, kommer att presentera vid DNB Carnegie's 16th Annual...

Lund, 23 februari 2026. Hansa Biopharma AB, "Hansa" (Nasdaq Stockholm: HNSA), meddelade idag att Renée Aguiar-Lucander, VD, Hansa Biopharma, kommer att presentera vid DNB Carnegie's 16th Annual Nordic Healthcare Conference i Boston, måndagen den 2 mars 2026. Hansa Biopharma CFO Evan Ballantyne, och COO och President U.S. Maria Törnsén kommer också att delta i evenemanget.Om du är intresserad av att boka enskilda möten med Hansas ledning, vänligen kontakta Hansa Biopharma på&nbsp;<a href="mailto:ir@hansabiopharma.com">ir@hansabiopharma.com</a>.Evenemang:&nbsp;TD Cowen 46th Annual Health Care Conference, Hansa Biopharma Corporate PresentationDatum, tid och plats:&nbsp;Måndag den 3 mars , 11:10-11:40 AM EST, Boston Marriott Copley Place, Boston MA.Talare:&nbsp;Renée Aguiar-Lucander, VD, Hansa Biopharma--- SLUT PÅ PRESSMEDDELANDET ---Kontaktpersoner för mer informationEvan Ballantyne,&nbsp;Chief Financial Officer IR@hansabiopharma.comKerstin Falck,&nbsp;VP Global Corporate Affairs media@hansabiopharma.comBakgrundsinformationOm Hansa BiopharmaHansa Biopharma AB är ett banbrytande biofarmabolag i kommersiell fas som utvecklar och kommersialiserar nya immunmodulerande terapier för att transformera vården för patienter med akuta eller komplexa immunrelaterade sjukdomar. Hansas egenutvecklade plattformsteknologi baserad på IgG-klyvande enzymer syftar till att adressera betydande otillfredsställda medicinska behov inom transplantation, genterapi och autoimmuna sjukdomar. Företagets portfölj omfattar imlifidase, en förstklassig enzymterapi som klyver immunoglobulin G (IgG)-antikroppar och som har visat sig möjliggöra njur­transplantation hos högsensitiserade patienter, samt HNSA-5487, en nästa generationens IgG-klyvande molekyl som kommer att utvecklas för Guillain-Barrés syndrom (GBS). Hansa Biopharma är baserat i Lund och har verksamhet i Europa och USA. Bolaget är noterat på Nasdaq Stockholm under kortnamnet HNSA. Läs mer på &nbsp;<a href="http://www.hansabiopharma.com">www.hansabiopharma.com</a> och följ oss på <a href="https://www.linkedin.com/company/hansa-medical-ab/">LinkedIn</a>.©2026 Hansa Biopharma AB. Hansa Biopharma, ledljuslogotyp, IDEFIRIX, och IDEFIRIX blomlogotyp är varumärken som tillhör Hansa Biopharma AB, Lund. Alla rättigheter förbehållna.<div></div>