Hansa Biopharma AB (publ)

Good day and welcome to the Hansa Biopharma first quarter 2026 earnings results conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on a touch-tone telephone. To withdraw your question, please press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to Hansa Biopharma CEO, Renée Aguiar-Lucander. Please go ahead.

Thank you very much. Good afternoon. Good morning, everybody. And welcome to the Hansa Biopharma conference call to review the Q1 results for 2026. I'm Renee Aguilar-Lukander, CEO for HANSA Biopharma. And joining me today is Evan Ballantyne, Chief Financial Officer, Richard Phillipson, Chief Medical Officer, and Maria Thornson, Chief Operating Officer and President of the U.S. Please, next slide, please. Please allow me to draw your attention to the fact that we'll be making forward-looking statements during the presentation. You should therefore apply appropriate caution. Next slide, please. This is the agenda for today's call. And these are the people who will, as I just mentioned, who will be covering the different sections. Next slide, please. So let me start by taking you through an overview of the quarter. As I mentioned in the Q4 report, we expected Q1 to be impacted by the significant number of initiatives which we rolled out during the quarter, which I'll cover in some more detail later in the presentation. This is intended also that what, This is indeed also will be observed, with revenues amounting to 34.6 million Swedish crowns, slightly above Q3 of 2025. We know that there will continue to be significant variability between quarters, and I do not expect this to change over the medium term due to the structural issues related to organ allocations in Europe. During the quarter, we raised $30 million in a convertible note, significantly extending our runway. We also pay down the NovaQuest debt by almost $15 million in January as per the restructuring agreement, and we now do not have another payment due until the middle of 2027. We also spent significant time and resources during the quarter compiling the briefing pack to the FDA related to GBS, which we submitted in early April. We're very excited about the fact that our abstract of the CONFIDUS study was accepted for oral presentation at ATC in June. In the quarter, we continued to build out our U.S. leadership team and also initiated our BLA review with the FDA. Next slide, please. In December of 2025, we announced the leadership change of the European Commercial Organization and initiated a significant reorganization, in combination with a rollout of new system support and ways of working. We believe that this was necessary in order to be appropriately prepared for the role of a significant amount of data, which we'll be able to share with the physician and patient community, starting in Q2 and continuing for the remainder of 2026. I want to thank all of my colleagues in the commercial organization for their leadership, collaboration, and ability to adapt quickly, as we all know that change is not easy, and especially not when it comes in high concentration over a short period of time. However, we have achieved a lot over the last three months, and we can now start to see some of the benefits, though it will still take a couple of months for everything to truly get better down. Next page, please. I am not planning to provide any detailed guidance for this year, but I would like to share some fundamental components with which we will leverage to successfully navigate 2026. One year into my CEO role at HAMSA, I'm glad to announce, and I'm sure that the organization is happy to hear, that the changes which were necessary to stabilize the business and position it for growth have more or less been completed. This included the restructuring induction in force, the renegotiation of the debt facility, raising of equity capital to ensure sufficient runway to read out key clinical data and obtain a potential US approval, strengthening the internal expertise and experience required to successfully build an international and sustainable life science business, clarify and focus the pipeline strategy, and last but certainly not least, review, reorganize, and adapt the European Commercial Organization to improve transparency, performance, and ensure the effective delivery of key clinical data to the physician and patient community. I believe that the company now is well-positioned to benefit from the key events coming up this year, and we look forward to sharing them with you as the year progresses. Q1 was, as I said in my report, a transition quarter, but there is no new or different information fundamentally impacting our market, and we have no reason to believe that the performance was primarily impacted by the many changes that we rolled out during the quarter. We're also encouraged by the strong start to Q2, which we hope is the beginning of a consistent trend of improvement, which will be further strengthened by the data coming out in Q2. With this, I will hand over to Maria, who will provide some more details on several of these topics.

Thank you very much, Rene. Next slide, please. Let me first turn your attention to the European and international markets. In Europe, Idiferix has maintained a unique position since launch. There is no other approved therapy on the European market which can do what Idiferix does. enabling a life-saving kidney transplant for highly sensitized patients. Across Europe, there are up to 11,000 highly sensitized patients waiting for a kidney transplant today. These patients need to navigate the complexities of finding an organ, and in some cases, that can take up to 12 years. In Europe, we launched with very limited data from only phase 2 studies. And over the years, we have built on that clinical experience and now have over 200 patients treated with Idiferix in Europe. 2026 is a very exciting year for our European business, as we will finally gain access to additional clinical data, which we know European KOLs are eagerly awaiting. Our Phase 2 data was published last year, and in 2026, we look forward to releasing additional data from our U.S. Phase 3 study, Confidus, and most importantly, from our European Phase III trial, PAES. This data will allow us not only to communicate additional data to European transplant centers, but it will also enable us to seek full approval in Europe. In addition, we know that European KOLs are anticipating publishing their own real-world evidence, and we look forward to seeing these data published. Next slide, please. Our Q1 performance was, as Rene mentioned, impacted by the changes we made to our European business. We made those changes as we felt they would be necessary to drive growth in the second half of this year and in future years. Our Q1 product sales was 33.9 million SEK. The performance was mainly driven by France and our international markets. We do not believe this performance is a reflection of IDFERIC's potential but rather a short-term impact based on the decisions we made. We have in previous calls talked about the challenges we have faced in Germany with the pause of the Eurotransplant program and in the region of Catalonia, Spain, with regional reimbursement. I'm very pleased to report that our targeted efforts have resulted in positive changes. In Germany, the KORs have submitted new consensus recommendations for publication in an international journal. These recommendations, which will enable German transplant centers to transplant patients within the ETKAS program, where the majority of highly sensitized patients are listed, have been rolled out to German transplant centers in a webinar, and we anticipate the recommendations will be published in mid-2026. In Spain, we secured reimbursement in the region of Catalonia after months of targeted efforts. The new reimbursement pathway went into effect as of April 1st. And post Q1 close, we have seen our first sale in Catalonia with this new reimbursement pathway. Catalonia is a very important region for irepherics. In our PAES trial, one third of all enrolled patients came from three centers in the Catalonia region. As such, we have significant clinical experience already and we anticipate this region will be a strong contributor to future sales. In addition to these positive accomplishments, we have also made targeted investments in new systems and activities to drive further growth of Idiferix in the coming years. Let's now turn our attention to the US market. Next slide. We are excited about the potential of bringing Imblicidase to the US market. Today, there are approximately 15,000 highly sensitized patients on the wait list for a kidney transplant in the U.S., and 7,000 of those have a CPRA over 98%, making it very difficult to find a matching organ. For the patients with the highest CPRA, they may never receive an organ offer or have to wait over seven years before they can have a transplant. Unfortunately, approximately 10,000 patients die or become too sick to transplant while waiting, and a higher proportion of those patients are highly sensitized. This is where amblifidase can play an important role in reducing the wait time and enabling more patients to have access to a life-changing transplant. Next slide, please. We have recently conducted several market research projects in the U.S. which all confirm the unmet needs for patients and the potential place for amlifidase in their treatment journey. Today, there are no approved treatments for the desensitization of highly sensitized kidney transplant patients, and the off-label treatments used are not seen as great options for patients. The burden of dialysis is also very real. Patients who wait for a kidney transplant need to undergo dialysis three times a week for several hours each time, That creates an extreme burden on the patient, impacting the patient's quality of life, and also contributing to significant costs for the healthcare system. When preparing for a potential launch in the U.S., we know that we need to engage with several stakeholders within the transplant centers, from surgeons to transplant coordinators, pharmacists, and HLA directors. In particular, the HLA director will play an important role with amlifidase, as they are responsible for the delisting protocols and managing the antigen profile of the patient. PNT approval will be critical to ensure access at hospital level, and in our initial research, financial decision makers and clinical experts believe imlifidase will gain PNT approval given the strong clinical profile of imlifidase. Finally, we believe our initial launch drivers and uptake will likely come from centers with prior clinical experience of imblifidence and from high-volume kidney transplant centers. So let's turn to the next slide and look at our launch preparations. Our launch preparations are in full motion, and we are focusing our efforts on two critical areas, site of care strategy and market access. As I mentioned in the previous slide, We believe our initial uptake will come from centers with clinical experience and from centers who are performing high volume of kidney transplants. We are therefore focusing our efforts on the top 100 centers initially in the U.S. Those centers represent approximately 80% of the volume, and among those centers, we have 25 confided centers who are accounting for 25% of the volumes. These centers have clinical experience, which we believe will be a differentiating factor compared to the European launch, where we only had two centers with clinical experience prior to European approval. Our market access activities have been focused on completing our market research and gaining a better understanding of transplant centers' financials. The majority of transplants are paid by Medicare, and in particular those patients who have waited for a long time for a transplant tend to a larger extent to have Medicare insurance. When speaking with financial decision makers in the transplant centers, they all recognize the significant burden for these patients and the strong value proposition of imlifidase. Our efforts are focused on enabling speed of access at launch and breadth of adoption across multiple transplant centers. As mentioned in previous calls, we know that NTAP, New Technology Add-on Payment, and outlier payments will be important for transplant center economics. And prior CAR-T launches are good launch analogs that we are using to model our center engagements. Finally, we have also focused on identifying our distribution partner and other aspects of the supply chain to ensure we can deliver the product to the U.S. shortly after approval. Other activities in the quarter have been focused on building out our U.S. team with a particular focus on market access and medical affairs Our full commercial build is expected in Q4, shortly before PDUFA. Our medical team are focused on engaging with KOLs and transplant center stakeholders at medical conferences. And we are in particular looking forward to the American Transplant Congress in Boston in June, where we will present our full confidants data, have a HANSA symposium and other KOL engagements. Finally, across the U.S. organization, we are focused on our site of care strategy. As I mentioned earlier, in each transplant center, there are multiple stakeholders we need to engage with, from market access to medical affairs and commercial, to ensure we have a successful launch. We have developed a strong strategy for how to engage these centers to ensure we know the stakeholders and can best support the incorporation of imlifidase into their treatment workflow once approved. With that, I will hand it over to our Chief Medical Officer, Richard Philipson, for an overview of our pipelines. Richard?