Hansa Biopharma AB (publ)

Good day, and welcome to the HANSA Biopharma interim results and Q1 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please see the 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 your telephone keypad. To withdraw your question, please press star, then two. Please note, this event is being recorded. And now I turn the conference over to Peter Nicklin, Chairman of the Board, Hansa Biopharma. Please go ahead.

Good afternoon and good morning, everybody. Welcome to the Hansa Biopharma conference call to review our Q1 results for 2025. I'm Peter Nicklin, Chairman of the Board of Hansa Biopharma. You'll recollect in June this year, I actually reached my third year anniversary as Chairman of the Board. Joining me today is Adam Ballantyne, Chief Financial Officer, Hito Kaufmann, our Chief R&D Officer, and René Lucander, our newly appointed CEO. Before we turn to the Q1 results, you are most likely aware that earlier today we announced the departure of Sölden Tolstoy, CEO of Hansa Biopharma, effective immediately. Over the course of his tenure with the organization, CERN successfully navigated the company through several key milestones and financial rounds. The board and I certainly appreciate his leadership and commitment to the company and wish him well for any future endeavors. Later in the call, we will hear from Renée, who has been appointed as CEO, effective immediately. Today is her first day at Hanza, and while she is in the room with me here, I trust that you will agree that it would be unfair to ask to host this call with you today. So with that, please turn to slide two. Please allow me to draw your attention to the fact that we will be making forward-looking statements during this presentation, and you should therefore apply appropriate caution. Please turn to page three. Today, we will discuss the progress we have made during Q1 and review the quarterly performance. The presentation will take roughly 15 to 20 minutes, after which there will be an opportunity to ask questions during a Q&A session. Please turn to chart 4. In Q1 2025, total revenue reached 66.3 million SEC, including IDFRAC sales totaling 65.7 million SEC. This represents a 39% product sales increase over the prior quarter. Please remember, Q1 2025 represents the final negotiated lower pricing in certain markets in comparison to the Q1 2024. We are encouraged by the continued growing European market uptake seen in Q1 reflecting the increased number of transplant clinics with initial and repeat usage of Idefrix and growing clinical consensus on the appropriate use of Idefrix as desensitization treatment for highly sensitized patients as demonstrated by consensus and clinical guidelines being published at both the international and local market level. Please turn to slide five. Thank you. We continue to make good progress with the pipeline and are working towards several key catalysts in the second half of 2025. In the quarter, we announced the completion of enrollment of patients in the post-authorization efficacy and safety or phase three study in Europe. As a reminder, the trial is part of our obligation to EMA based on conditional approval of iDeferex in Europe. We'll talk more about the study in a moment. During the quarter, we also had positive regulatory agency interaction with DFAM, the Federal Institute for Drugs and Medical Devices in Germany, and gained alignment on a proposed clinical trial in Myasthenia gravis for HANSA 5487, our next-generation molecule with redosing potential. There is high unmet need for better options to treat acute phases of this disease, and we believe that HANSA 5487 has the potential to address this. Hito will share more on this later on in the presentation. As we look ahead in 2025, we turn our focus to delivering several key catalysts, including data from the Phase III good eaters O2 study in anti-GBM. and the U.S. Phase III CONFIDUS study in kidney transplantation, as well as data from the Phase II EDIS trial with our partner Geniton in Krieger-Nagier syndrome, and presentation of the data from the Phase II 09 trial in Guillain-Barre syndrome, as we call it, GBS. We also expect data from the Phase 1B Sarepta study with our partner, Sarepta, in Dutch knee muscular dystrophy, which has enrolled the first few patients. Currently, several Adidas trials are temporary halted due to the Adidas safety update in March, including the Sarepta 9001-104 study that we are involved in. An independent review committee concurred that overall EDVDA's benefit-risk profile remains favorable, and importantly, no material impacts are anticipated on the timelines of these studies. Before moving to the next slide, I'd like to highlight our ongoing efforts to publish and present our science to the scientific and clinical community. Importantly, there have been several new international and market-specific clinical consensus guidelines recently published on the appropriate use of amlifidase as a desensitization strategy in highly sensitized kidney transplant patients. This underscores the increasing awareness and belief by the clinical community in the benefits of amlifidase in desensitization. I'll ask you to turn to slide six, please, the next slide. Thank you. In Q1 of 2025, we completed enrollment of patients in the test study in Europe. The study is part of the company's obligation under the European Conditional Marketing Authorization following conditional approval of Ediferix in 2020 by EMA. The study remains on track to read out in the second half of 2026 and is intended to support full marketing authorization in Europe at that time. 22 transplant centers were part of the trial, with 14 centers having treated a total of 50 transplant patients. This is important because it means that participating centers now have both the clinical experience and protocols in place to treat highly sensitized kidney transplant patients in future. We believe these key participating centers will continue to utilize Adiferix to desensitize appropriate patients, now converting to commercial product, and thus contributing significantly to continued product sales growth, and most importantly, ensuring even more patients will have access to this innovative desensitization therapy and a potential life-saving kidney transplant. Just this week, a center in Italy that participated in the PEDS study transferred its first patient to commercial ediferics. As indicated on the slide, the next step is to complete the 12-month follow-up in 2026, followed by submission to EMA to enable full approval. I would ask you to turn to the next slide, please. As stated previously, we continue to make solid progress with the commercialization of Ediferix in Europe. In the quarter, we saw four additional transplant clinics gaining an initial experience with Ediferix. And the number of clinics with repeat usage following a successful first experience continues to grow. Our engagement with European key opinion leaders and medical societies is underscored by the continued publication of new consensus and clinical guidelines on the appropriate use of amlifidase in desensitization of highly sensitized kidney transplant patients. Just this quarter, we saw new international consensus guidelines published in the journal Transplantation Direct and also new national guidelines issued in Spain. Finally, during the quarter, we secured access in three additional European markets, and the DEFREX is now reimbursed in a total of 18 countries, including the five largest European markets. Yesterday, we also learned that we now have reimbursement in Switzerland, underscoring continued advancement of reimbursement in markets throughout Europe. I would now like to turn to Hito. for an update on the progress that we've made with our pipeline projects. Peter, over to you.

Thank you, Peter. Please turn to slide nine for an update on the pipeline and clinical development highlights to date. As you can see, we continue to make good progress across the pipeline in all three therapeutic areas. And in the fourth quarter, we shared several updates in both the autoimmune and gene therapy areas. I'll now walk you through some of the specific trials and studies we have been going, and the clinical development plans we have in place. Please turn to slide 10. I'm pleased to share that we continue to make good progress across all eight active clinical trials, and as you can see on the right, and as Peter has mentioned previously, we have several key catalysts in the second half of the year. In 2025, there have been six peer-reviewed journal articles on illicit AIDS, including two on the 17-H-Med-IDIS-S14 study, which is the five-year data we have shared previously. Of note, we had a positive regulatory agency meeting with development path for HMSA 5487, our next-generation molecule with redosing potential. The meeting confirmed the suggested clinical trial design in myasthenia gravis, an indication with a new reminology. We aligned on investigating the safety and efficacy of HMSA 5487 in myasthenia gravis patients utilizing short and long interval redosing at two dose levels. This approach will facilitate reliable and fast recruiting. Furthermore, we received confirmation on meaningful efficacy endpoints, including patient-reported outcomes such as the MG-specific Activity of Daily Living Scale, MG-ADL, and physician-reported outcomes like the Quantitative MG Scale, QMG. I'm incredibly pleased with the team's work to get us to this point and look forward to sharing more in due course. We announced positives results in October 24 regarding NICE-01, the first in-human trial, and findings from a 12-month analysis of that data for HANSA 5487. The analysis demonstrated that HANSA 5487 can robustly and very rapidly reduce IgG levels, has redosing potential, and a favorable safety and tolerability profile in study subjects. We continue to believe HANSA 5047 has a highly differentiated profile compared to published data from studies with other IgG-targeted therapies. Additionally, I'm pleased to share that data from the 15-H-Met-IDIS-09-phase-2 study of amlifidase in Guillain-Barre syndrome, also known as GBS, has been accepted for presentation in the upcoming medical congress. We look forward to sharing this data with the clinical community. It's worth mentioning that we are hosting a virtual science deep dive discussion on June 16th at 2 p.m. Central European time and 8 a.m. Eastern time on GBS. This is part of a larger series of deep dives who plan to hold throughout the year. The intention is to discuss the current diagnosis and treatment of GBS, as well as the existing unmet need that exists for patients and clinicians. I'm thrilled to be joining my colleague, Elizabeth Sonneson, Global Franchise Lead Autoimmune at Hunter, as well as two key opinion leaders, Dr. David Arakomba, Andy with Johns Hopkins University, and Simon Rinaldi, MRCP, PhD with the University of Oxford. Registration is required for this event and can be found on our website. We hope you can join us. We anticipate that we will also have data from the good IDIS02 phase 3 trial in anti-GBM, As a reminder, the GUT-IDIS-02 trial is a Phase III open-label, controlled, randomized, multicenter trial across Europe and the U.S., and is evaluating renal function and the need for analysis at six months in patients with severe anti-GBM disease. Encouraged by our Phase II data, we believe amlifidase has significant potential in improving the outcome of these patients and address the unmet medical need. Imlicidase has been granted orphan drug designation for the treatment of MTGBM disease by both the U.S. Food and Drug Administration and the European Medicines Agency. Later this year, we anticipate that from GNT-018-IDIS, a Phase II trial in patients with Klick-Namajar syndrome, with the pre-existing antibodies against adenoaccessory-aided virus vectors, or AEVs, The trial will evaluate the efficacy and safety of a single intravenous administration of genitome gene therapy, GMT-0003, following pretreatment with imbifidase. GMT-0003 is currently being evaluated in a pivotal clinical study in France, Italy, and the Netherlands, and has received prime status from the European Medicines Agency. As Peter mentioned, several elevator studies have been temporarily halted due to a safety update provided in March. We look forward to continuing our collaboration with Sirepta on SRP 9001-104. Importantly, Sirepta does not expect a material impact on the timeline for these studies. And based on the findings from an independent data review committee, the benefit-risk profile remains favorable to continue dosing in the PORS trials without changes to study protocols. Finally, the confided U.S. Pivotal Phase III trial was fully randomized in May 2004, and we plan to deliver data in the second half of 2025, followed by a BLA submission to the U.S. FDA. Please turn to slide 11 for a summary of long-term data and various publications. The 17-H MED-IDAS-14 study is a prospective observational long-term follow-up study of patients treated with amifidase prior to kidney transplantation to measure long-term graft survival in patients who have undergone kidney transplantation after amifidase administration. Importantly, trial data was pooled with data from four Phase II trials and showed sustained positive outcomes out to five years in most highly sensitized patients who received an amlifidase-enabled kidney transplant. The five-year extended pooled analysis is a continuation of the analysis at three years of cross-match positive-only patients. The pooled analysis showed sustainable positive outcomes out to five years in most highly sensitized patients who received an amylifidase-enabled kidney transplant. After five years, patient survival rate was 90%, and graft survival was 82%, in line with outcomes seen at three years post-transplant. At five years, mean estimated glomerular filtration rate, EGFR, was 50 ml per minute per square meter. EGFR is a measure of how well the kidneys are working in the body. The extended pooled analysis has been published in several key journals and presented at key medical congress. We continue to look for ways to share this important long-term data with the community. I will now turn the presentation over to Evan to cover financial performance.