Hansa Biopharma AB (publ) (HNSA) Earnings Call Transcript & Summary

Good day, and welcome to the Hansa Biopharma Second Quarter and First Half Year 2026 Financial Results Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Hansa Biopharma CEO, Renee Aguiar-Lucander. Please go ahead.

Thank you very much. Good afternoon, and good morning, everybody. Welcome to the Hansa Biopharma conference call to review the Q2 results for 2026. The I'm Renee Aguiar-Lucander, CEO for Hansa Biopharma. Joining me today is Adam Cutler, Chief Financial Officer; Richard Philipson, Chief Medical Officer; and Maria Tornsen, Chief Operating Officer and President of the U.S. Please turn to the next page. Please allow me to draw your attention to the fact that we'll be making forward-looking statements during the presentation, and you should therefore apply appropriate caution. Next slide, please. This is the brief agenda for today's call. Next slide, please. So looking at this quarter, I believe that it was a transformative quarter for Hansa, by partnering in Europe, we strengthened the commercial support for Idefirix both in terms of resources and experience, which will enhance patient access and ensure long-term success. In the short term, this can have a somewhat negative impact on financial performance due to the inherent uncertainties, which always comes with change. But strategically, long term, I strongly believe that this was the right decision for the product, for patients and for Hansa. We also read a positive top line data from the confirmatory European trial, PAES, which paves the way for the conversion from conditional approval to full approval in Europe, which we hope to achieve next year. We also completed the strengthening of the executive team this quarter with the addition of Fredrik Röök as VP Business Development; and Adam Cutler, who's making its public debut today as our new CFO. Finally, we attended ATC or the Phase III data was presented in the form of an oral presentation and subsequently hosted a very successful Capital Markets Day on June 25, where several leading medical experts provided their insights regarding the existing unmet medical need, clinical use observations and real-world experience from using Idefirix in Europe. In terms of financial performance, in terms of the Q2 revenues, they were as predicted an improvement over Q1, and it amounted to SEK 48.1 million versus SEK 49.1 million in Q2 of 2025. Can we go to the next page, please? So here is a brief overview of the details regarding the recent transactions. A couple of things to highlight here are obviously that post this quarter, this transaction was formally closed, and we have now also received the upfront payment. There are presently quite substantial resources focused on the transition process to ensure a smooth and coordinated handover. The collaboration is working very well, and we are now working jointly together towards the next key milestone, which is the transfer of the market authorization holdership to our new partner, Serve Pharmaceuticals. In parallel, we're obviously also working on the filing preparation for EMA, transition of personnel and information trends regarding clinical operations as well as related regulatory quality and pharmacovigilance related areas. As a brief reminder of the transaction as such, it was EUR 150 million out-licensing agreement for Idefirix in EU, the U.K., Switzerland, Norway, Liechtenstein, Iceland and Middle East and North Africa. Our partner is SERB Pharmaceuticals, and there was an initial EUR 110 million upfront payment, which, as I mentioned, has now been received. The closing took place post this quarter. And upon acceptance by EMA of the filing for full approval, there is an additional payment due of EUR 5 million. Can we go to the next page, please? If we take a brief look at what we plan to focus on for the rest of the year. I've already covered a couple of the key items here such as the transition work to serve and filing for full approval in Europe. In addition to that, we plan to explore potential additional collaborations in gene therapy and other geographic out-licensing opportunities. Obviously, there are no guarantees that we ultimately will choose to proceed or conclude any such potential transactions this year. But it is an area of exploration that we plan to undertake starting in the second half of this year. Our key focus as an organization is obviously our ongoing interactions with FDA related to our BLA filing on imlifidase and the continued work on the comprehensive precommercial plan in the U.S., ensuring that we're ready to launch in Q1 subject to an approval. With that, I will hand over to Maria, who will provide some more details on some of these topics.

Thank you very much, Renee. Next slide, please. Our 2026 Q2 results were in line with results in Q2 2025, with a slight decrease of SEK 1 million. However, a significantly better performance, an increase of 39% compared to Q1 2026. Our product sales were SEK 46.8 million. Performance in Q2 was particularly strong in Spain, where we recently secured reimbursement in one of the largest regions, Catalonia. We are very pleased to see that the targeted market access efforts we put in place now has resulted in strong sales from the region. France continued to perform well, and we also saw solid sales in the other 3 large European countries, Italy, Germany and the U.K. In Germany, we have, as mentioned in previous quarterly calls, faced significant hurdles since the pause of the Eurotransplant accepted mismatch program. I'm very pleased to report that in Q2, we saw the publication of the much anticipated consensus recommendations in Germany. These recommendations provide a practical guide to German transplant centers in how to transplant highly sensitized patients within the ETKAS program. We also saw an independent article published by a German law firm confirming that desensitization is allowed under German law, and highlighting that patients have arrived to access the latest treatments. We, therefore, anticipate that there will be future growth for Imlifidase in Germany in the second half of 2026. Let's now turn our attention to the U.S. market. Next slide, please. The U.S. market is a growing market with very high unmet needs. There are approximately 100,000 patients on the wait list for a kidney transplant and 7,000 of those have a CPRA over 98%. The waitlist is growing, and each year, approximately 45,000 patients are added to the waitlist. Worth noting is that the highly sensitized patients also faced significant mortality, as each year, thousands of patients die while on the waitlist or they become too sick and therefore, are removed from the waitlist. For these patients, having access to a kidney transplant could be life-saving. And while there are 27,000 transplants each year in the U.S., there are also significant number of kidneys being discarded. According to latest data, each year, around 9,000 recovered kidneys are discarded and over 5,000 due to the reason that no recipient could be located. Our estimate is that the U.S. market represents a $2 billion market for Hansa taking into account the patient population above 98% CPRA. Please turn to the next slide. Today, we are 5 months away from the PDUFA of December 19. Our prelaunch efforts are in full motion, and they are led by a very experienced U.S. team. The U.S. leadership team have collectively launched multiple products and have experience from both the transplant market and nephrology. We have, over the last few months, conducted several market research initiatives. They all point in the same direction that there is a strong clinical need for quick and effective product that can enable a transplant for highly sensitized patients. Patients are also very positive to the product profile as they do not have great options today to enable a transplant. In blinded market research, nearly 9 in 10 patients expressed strong interest in learning more. While some U.S. transplant centers have tried experimental desensitization approaches, most centers do not offer this to highly sensitized patients as they are not perceived effective for disease stone or kidney transplantation. In Q2, we saw the presentation of the confines data at the American Transplant Congress in Boston. We will have further presentations at the upcoming TTS in Sydney, Australia in September, and its ACHI, a conference for HLA directors in Montreal in October. We will also attend the largest nephrology conference, ASM in October in Denver. We continue to engage with patient advocacy groups through attending their conferences and our field medical and market access team are actively engaging with the top 100 transplant centers in the U.S. to understand their current management of highly sensitized patients and their financial and operational profile. Please turn to the next slide. We've also conducted various market research with financial stakeholders, both to understand their perception of imlifidase, but also to help guide our pricing decisions for imlifidase once approved. We know that the majority of transplant patients have Medicare but commercial plans also play an important role. The prolonged weight on dialysis is not only a significant patient burden, but also a significant cost to payers. Kidney transplants are covered by Medicare using DRG plus outlier payments and NTAP. As mentioned in previous calls, we will apply for NTAP new technology add-on payment. Later this year, and our field-based market access team will be ready to provide appropriate education to support formulary inclusion by health systems as well as support coverage decisions by commercial payers. All of our market access team members come with significant experience in reimbursement and a track record of securing access to novel therapies. And while the majority of patients have Medicare, there is a significant number of patients with commercial plans, and they will be covered via contracted rates for kidney transplants or single-case agreements. From our market research, we believe that our initial uptake will come from centers with clinical experience and knowledge of imlifidase, and from large academic centers who perform large volume of kidney transplants. Already today, we have centers who have indicated interest in prescribing imlifidase shortly after potential approval. We also expect volume to scale further post the approval of NTAP. Please turn to the next slide. If approved, we believe that imlifidase has the potential to change the treatment paradigm for the highly sensitized kidney transplant patients in the U.S. Imlifidase can address one of the most challenging unmet needs in kidney transplantation and enable a transplant, which previously was not possible. From clinical data in ConfideS PES and real-world European data. We have seen a consistent and reproducible clinical benefit. Our Phase II data also show durable transplant outcomes over 5 years. And while there are experimental de sensor translation approaches, which have been tried, we know that these therapies aren't defected in diseased donor transplantation. Imlifidase therefore, has the potential to create a new clinical paradigm for desensitization, allowing a rapid and reliable reduction of antibodies to enable a transplant. We are very excited for this significant market opportunity. And if approved, we will be launched already at PDUFA, and we anticipate having imlifidase available in the U.S. in Q1 of 2027. And with that, I will hand it over to our Chief Medical Officer, Richard Philipson. Richard?

Thanks, Maria. Today I'm going to talk about the results of the ConfideS study that were presented recently at the American Transplant Congress. Next slide. The results of the ConfideS study evaluating the use of imlifidase in highly sensitized kidney transplant patients represented by Dr. Robert Montgomery, Director of the NYU Langone Transplant Institute who gave the presentation on behalf of the ConfideS Study Group. The abstract was selected to be highlighted at the closing plenary recession, what's hot, what's new, reflecting the importance of the findings for the field of kidney plantation in highly sensitized patients. I'd like to present some of the highlights of Dr. Montgomery's presentation at ATC. Next slide. I'll start by briefly reviewing the study design. Patients considered potential candidates for the study were consented and entered a prescreening period. One or more unacceptable antigens were delisted from the patient's HLA profile to increase the likelihood of the patient receiving an organ offer. When an organ offer was received, patients entered screening and underweight final evaluation of eligibility. Eligible patients were then randomized to the imlifidase arm or the control arm in a 1:1 ratio. The period of follow-up in the study was 12 months from the time of randomization. Patients randomized to the imlifidase arm accepted the organ offer and were treated with imlifidase. This treatment resulted in cross-match converting from positive to negative, and patients with transplants is then follow-up. Patients randomized to the control arm either accepted the organ offer were treated with non-approved desensitization and then proceeded to transplant or the organ offer was rejected and the patient waited for a more compatible organ offer or offer later in the 12-month follow-up period. Next slide, please. Here we see that the demographic and baseline characteristics were generally balanced between the 2 arms of the study. It's worth noting the extended period that patients have spent on the waitlist for transplantation. The meantime on the waitlist is 7.3 years in the imlifidase arm and 5.2 years in the control arm. The majority of patients in both arms that had a previous transplant, and there was a higher total level on the baseline donor-specific antibodies in the imlifidase treatment arm. Next slide, please. With respect to the primary efficacy outcome for 12 months, EGFR was 51.5 million per minute in the imlifidase arm compared to 19.3 mL/min in the control arm with a statistically significant and clinically meaningful difference between the 2 groups of patients of 32.2 mL per minute with a p-value less than 0.0001. As can be seen from the graphic eGFR in patients in the imlifidase arm remains remarkably stable after around day 30 post randomization 3 to 12 months, which suggests favorable longer-term outcomes in these patients. Next slide, please. At 12 months, the key secondary endpoint of dialysis dependency was statistically significant in favor of imlifidase with a p value equal to 0.0007. A total of 5 patients for dialysis dependent in the imlifidase arm compared to 17 patients in the control arm, Furthermore, when looking at EGFR categories at 12 months in transplanted patients. It's noteworthy that most patients, 92% in the imlifidase arm had an eGFR of 30 mL/minute or higher at 12 months, with only 8% of patients having an eGFR less than 30 mL per minute. In contrast, 40% of patients in the control arm at an eGFR less than 30 ml per minute at 12 months indicative of superior kidney function outcomes in patients transplanted following treatment with imlifidase. Next slide, please. Patient survival was 97% in the imlifidase arm compared to 100% in control arm. One patient in the imlifidase died on day 72 due to issues unrelated to graft function. Profile of adverse events and serious events spent likely reflected typical post-transplant complications and adverse effects associated with current post operative immunosuppressive practice and wasn't keeping the previous clinical trial experience. Knowing imlifidase infusion was discontinued due to an infusion-related reaction. Next slide, please. As already mentioned, at baseline patients in the imlifidase treatment arm had a higher total DSA compared to the control arm. Nevertheless, these patients achieved a much lower perioperative level of DSA compared to controls, which is maintained at a low level for approximately 1 week before rebounding to peak on day 15, thereafter progressively decreasing. Next slide, please. Based on post-transplant biopsies, antibody-mediated rejection was observed in 57% of transplanted patients in the imlifidase arm compared to 46% of patients for whom data are available in the control arm. Mean eGFR, both with and without AMRs higher for patients transplanted in the imlifidase arm compared with the control arm throughout the trial period and evidence of AMR on biopsy did not impact kidney function. Furthermore, and importantly, both early and late AMR were successfully treated with available therapies and low grafts in the imlifidase arm were lost due to AMR. It's also worth noting that this was discussed with an expert panel at Hansa's recent Capital Markets Day last month. Where the consistent view was that the observed antibody-mediated rejection was consistent, predictable and manageable. Next slide, please. So in conclusion, at 1 year post randomization, desensitization within imlifidase was associated with clinically meaningful and statistically significant improvement in kidney function as measured by eGFR. Imlifidase patients, the eGFR was 51.5 mL/min, which is superior to eGFR of 19.3 mL per minute observed in the control arm. Imlifidase enabled successful transplantation and resulted in higher transplant rate compared with patients in the control group. At 1 year, 5 patients with dialysis dependent in the imlifidase days compared to 17 patients in the control arm. No transplant in the imlifidase arm were lost due to AMR. Imlifidase treatment was well tolerated with a safety profile typical of transplant recipient. I'd now like to hand over to our Chief Financial Officer, Adam Cutler.

Thank you, Richard. Total revenue for Q2 2026 was SEK 48.1 million, representing a 2% decrease compared to Q2 2025 of SEK 49.1 million. Product sales for Q2 2026 were SEK 46.8 million, representing a 2% decrease as compared to Q2 2025 of SEK 47.8 million. Importantly, as Renee noted, Q2 2026 product sales were up 39% over Q1 2026. Next slide, please. For Q2 2026, SG&A expenses totaled approximately SEK 119 million and were up SEK 13 million or 12% compared to Q1 2026 SEK 106 million. Compared to Q2 2025, SG&A expense of approximately SEK 91 million, Q2 2026 expenses were SEK 28 million higher. The variance was driven by increased costs associated with preparation for the expected U.S. market launch, costs associated with the convertible debt and the SERB deal as well as increased costs for Hansa's long-term incentive programs. R&D expenses in Q2 2026 totaled approximately SEK 68 million and were 29% or SEK 28 million favorable compared to Q2 2025. The decrease in R&D expenses was primarily driven by the wind down in clinical trial activities and restructuring activities taken in 2025. In Q2, the loss from operations was SEK 174 million compared to SEK 155 million in Q2 2025. Next slide, please. Cash used in operations in Q2 2026 totaled SEK 104 million compared to SEK 112 million in Q2 2025. As of Q2 2026, cash and cash equivalents totaled SEK 553 million or USD 57 million. This does not include the EUR 110 million upfront payment received from SERB earlier this month. which would bring pro forma Q2 cash to approximately SEK 1.8 billion or approximately USD 185 million. This transaction extends Hansa's cash runway and strengthens the company's balance sheet in advance of FDA approval and subsequent U.S. launch. Headcount for the period totaled 153 compared to 140 in Q2 2025 and 122 in Q1 2026. Q2 2026 reflect -- headcount reflects hiring in preparation for expected U.S. market launch but does not yet reflect the expected transfer of personnel to SERB related to the out-licensing transaction. And now I'd like to turn the presentation back to Renee for closing remarks and the Q&A portion of the call.

Thank you, Adam. Next slide, please. So in summary, Hansa is now in a strong position to realize its strategic objectives as set out. It is well capitalized, has a clear road map and has an experienced team leading all critical activities. Our clinical data has consistently been strong, and we believe strongly support the risk-benefit thesis laid out for imlifidase. We are clearly in execution focus at this point in time looking forward to the value inflection point in Q4. This quarter really marks a new strategy and journey for Hansa. We look forward to sharing the future milestones of this journey with all of you over the next several quarters. and we are very excited about the future. Next slide, please. And with that, we're going to turn the call over to Q&A.

Thank you. We will now begin the question-and-answer session. [Operator Instructions] Our first question comes from Farzin Haque with Jefferies.

Congrats on the progress. Maybe for Renee. Now that you're roughly 5 months from the December PDUFA, can you characterize the pace of information request like any signals from the mid-cycle communication or on the CMC front beside the inspections that you have received so far? .

So I would say that the experience of our current interaction with the FDA to date have been very normal as expected. I don't think that we have received anything that would cause me to be concerned or have any issues in terms of how the review is going. We are, as you can expect, receiving consistent time of queries and answering them in a timely manner.

And then 1 more, you have been adding field-based market access and market and medical affairs personnel. But are there any specific things that you can do at the transplant centers ahead of approval essentially activate them and be launch-ready?

That is exactly the purpose of hiring the staff. Maria, do you want to kind of take and explain some of the details of what these teams are actively doing in the field today and how that will assist them to be launch-ready?

Yes. Happy to take the question. So yes, we have hired a field-based market access team, a medical team, so we're covering the entire United States right now. If you look at the number of transplant centers in the U.S., as you know, there are 200 centers and roughly 100 of those represent 80% of our volume. The people we've hired, they are now targeted with going out to these 100 centers and basically doing 2 things. The first 1 is what we call transplant center profiling, basically understanding who are the different stakeholders in each center from the surgeon to the nephrologist to the transplant coordinator, to financial stakeholders, who are the people that are going to sit around the table and make clinical financial and operational decisions. That is part of the profile in getting to know all of these customers and also understanding who will be the champion. Who is going to be the person who's going to take this on board when the product is new and sort of bring those discussions to the broader cost functional team, so that's a side profiling. The other aspect they are doing is what we call sort of site readiness. So understanding where do they stand today in terms of their readiness to treat patients. As an example, how many patients do they potentially have that are highly sensitized, understanding how do they treat highly sensitized patients today? How often do they see these patients? Understanding their clinical knowledge, do they have all the people there that will be part of this. So that is part of the sort of site readiness. And the goal is obviously to see that how many do we think will be ready shortly after approval in Q1 and who do we think is going to take maybe a quarter or 2 quarters longer to be ready. So that is part of what they're doing right now.

The next question comes from Matt Phipps with William Blair.

Adam, I was wondering if you could help us on if the upfront payment from SERB will be recognized on the P&L in the third quarter? And then just curious on what we will hear on the trial design for 647 is -- do you need to wait for that IND submission to kind of figure out some more of that trial design? Or do you think you'd have an update sometime here in the second half before we get to year-end?

I'll take that briefly before I hand over to Adam, I think the shorter answer, so we are kind of an ongoing kind of conversations with the FDA on that. And so yes, we do hope to be able to provide some more information, hopefully, when we report the next quarter. And there's clearly a target for us to file an IND before the year-end to initiate clinical studies in CBS. Sorry, Adam, over to you.

No, no problem at all. So to answer your question, we're still sorting through the exact accounting treatment of that. It will at least start to be recognized in Q3 of this year, but it may be that the recognition of that upfront payment is spread over a longer period of time. So obviously, from a cash point of view, we have the cash will be on our balance sheet as of Q3. But as far as the revenue recognition, it may be spread over a longer period of time due to certain elements of the agreement with served.

And maybe just real quick, should we expect any updates from the Genethon or Sarepta collaborations in the second half of this year?

In terms of Genethon collaboration, I know that they had as a target themselves to complete recruitment before the end of the year. And so that would be potentially something that could be communicated in the second half, depending on how they progress against that milestone that they have set for themselves. But otherwise, I think it's more -- I think it's unlikely that we'll hear anything more in the Sarepta agreement this second half.

The next question comes from Thomas Smith with Leerink Partners.

Congrats on all the progress here. Two questions, if I could. You mentioned that you're actively exploring some additional collaboration opportunities, particularly on the gene therapy side. Just wondering if you could elaborate a bit on the types of collaborations you're looking for and any learnings you're able to incorporate from your existing collaborations with Genethon and Sarepta. And then a second question, just at the Capital Markets Day last month, you mentioned that the results from the investigator-initiated autoimmune ANCA study with imlifidase would be evaluated over the next few weeks. Just wondering if there's any update on this front with respect to timing or expectations.

Great. I'll let Richard take the second part of that question. With regards to the gene therapy and licensing, so 1 of the kind of new members of the team that will be joining us now next month is obviously a VP of Business Development. And this is obviously an area where we've been lacking in terms of having senior resources dedicated to that task. So with the arrival of Fredrik we actually intend -- we will have the resources that's required to kind of a little bit more systematically and professionally kind of pursue and follow up on quite a lot of the inquiries and questions and inbound interest that we receive and have received on an ongoing basis. So it's in the light of that new resource that I am hopeful that we'll be able to from a kind of resource and focus perspective, be able to address some of that kind of inbound interest that we have been seeing and continue to see. So in terms of any details of that, I think we'll probably be able to kind of speak to that a little bit more at the next kind of quarterly update. Richard, do you want to take the second part of that?