Hansa Biopharma AB (publ)

Hello everyone and welcome to the Hansa Biopharma Q2 2024 conference call. Today's call is being recorded. For the first part of this call, all participants will be in a listen-only mode. Afterwards, there will be a question and answer session. To ask a question during the Q&A, please press 5 star on your telephone keypad. I'll now hand the call over to CEO Søren Tulsvold. Please begin.

Thank you, Albreida. Good afternoon, good morning, and welcome to the Hansa Biopharma conference call to review the first half and Q2 results for 2024. I'm Sean Hulsvogt, President and CEO of Hansa Biopharma. Joining me today is Evan Ballantyne, Chief Financial Officer, Matt Chollis, Chief Commercial Officer and US President, and Hitzel Kauffman, Chief R&D Officer. Please turn to slide two. Please allow me to draw your attention to the fact that we'll be making forward-looking statements during this presentation, and you should therefore apply appropriate caution. Now, please turn to slide three and an overview of today's agenda. Today, we'll discuss the progress we made during the first half of 2024 and review our near-term priorities. The presentation should take roughly 15 to 20 minutes, after which there will be an opportunity to ask questions during a Q&A session. Please turn to slide four and then we'll give you our Q2 highlights. I'm pleased to announce we have delivered our third consecutive quarter of solid sales with total revenue of 54.2 million SEC. Of this, 47.1 million SEC can be attributed to IDECORIC sales. The strong sales performance we saw in the second quarter is a result of the team's successful efforts to expand access to IDECORICs for highly sensitized kidney patients across Europe. During the quarter, we secured our first commercial sales in Italy, following achievement of reimbursement status in key regions. To date, we've had commercial sales of Ida breaks in all of the top five European markets. We're also seeing strong momentum in our pipeline and clinical development efforts. In May, we announced that confidus, our pivotal phase three U.S. trial in kidney transplantation, had been fully randomized. This marks an important milestone for Hansa, And following data readout in the second half of 2025, we expect to submit a biologics license application to the U.S. FDA seeking accelerated approval. Matt will cover the status and next steps for the trial in more detail during this section of the call. Our post-authorization efficacy study in Europe is progressing at a good pace in parallel with the continued commercialization of itabrix and as part of our obligation to EMA. data that could further support the adoption of Idafrix as desensitization therapy to enable incompatible kidney transplants, this study offers additional opportunities for important transplant centers to gain experience with Idafrix. Data readout is expected in 2025. Looking beyond kidney transplantation, we have advanced several trials in autoimmune diseases. Our phase three anti-DBM disease trial continues with more than 70% of patients enrolled in the trial. Completion of enrollment expected in 2025 as previously guided, and based on the strong momentum in enrolling patients, we now also expect data from the study in 2025. Our phase two trial in Guillain-Barré syndrome also remains on track, and we expect to share additional efficacy data later this year, following promising high-level data communicated in 2023. Our efforts to advance HANSA 5487, the deep candidate from our Next Generation Enzyme Program, continue as planned, and we look forward to sharing further analysis on endpoints of the phase one trial and the development path forward during the second half of this year. Finally, I'd like to congratulate our partner Surepta on the recent achievement of FDA full approval and expanded label for Elevitus in Duchenne Muscular Dystrophy. While this approval enables more patients the opportunity to benefit from the therapy, Some patients remain ineligible due to anti-AV antibodies, and we're excited to continue our collaboration with Surepta to determine the potential for imifidase to enable gene therapy in these patients. With this, I'll hand it over to Matt for a business and operational update. Please turn to slide five.

Thank you, Sarin. Please turn to slide six for an update on Itasferix launch in Europe. As mentioned, this marks the third quarter of strong commercial sales for Idaferix. We attribute the continued commercial utilization of Idaferix to several things. The first is that we have seen additional centers come on board throughout Europe and continue to progress reimbursement in key European markets. As Surin mentioned, we secured our first commercial sale in Italy in Q2. As of today, we have reimbursement in 14 European markets, including the top five markets. And we have access to approximately 75% of the European transplant market. By Q2, 28 centers gained clinical experience with Itiferix. This is an increase from last quarter, with three additional centers gaining experience with Itiferix. Importantly, 60% of those centers have used Itiferix more than once. And there are over 50 transplant centers in Europe that have the capability to perform kidney transplants in highly sensitized patients. Repeat utilization underscores the growing clinical confidence in Itiferix and clinicians' ability and willingness to identify Itiferix-appropriate patients. Given that we see increased uptake in new clinics in new markets, we believe that repeat utilization could happen at several clinics in the remainder of 2024. While we have full confidence that our strategy is the right one, we recognize the volatility of the transplantation market, particularly with respect to organ allocation. And therefore, we'll continue to broaden our base of opportunity, including the progression of health technology assessment processes in several countries to ensure ongoing expansion of itinerary availability and reimbursement to even more markets and patients. The second reason we believe we are seeing good progress in Europe is that desensitization strategies within the clinical community continue to advance. In fact, the European Society of Transplantation, ESOT, published a consensus paper in April entitled European Consensus on the Management of Synthetized Kidney Transplant Recipients, a Delphi Study. The paper recommends imlifidase as a desensitization strategy for these kidney transplantations in selected patients for whom no other treatment options are available. This follows the organization's publication of the first-ever guidelines on desensitization in 2022, which resulted in idaferic-specific guideline implementation at the national level in key European markets. And finally, Eurotransplant's Desensitization Program is helping identify patients eligible for idaferics. To date, the program has identified and treated five patients with idapherics, including in Germany, the largest market in urotransplant footprint. This validates that participating transplant centers are now receiving idapherics-designated kidneys. Urotransplant is an international allocation system responsible for the allocation of donor organs across eight countries, including Austria, Belgium, Croatia, Germany, Hungary, Luxembourg, the Netherlands, and Slovenia. Please turn to slide seven. Advancing the science of amlifidase in kidney transplantation is also important. To that end, there are two key studies we continue to progress, including a long-term follow-up study, the 17 H. meditis 14 study and the post-authorization efficacy study, PAES. As we have communicated previously, The long-term study has demonstrated that for important endpoints, such as graft survival and overall survival, in lipidase-treated, highly sensitized patients achieve similar outcomes as non-sensitized patients. Both studies are on track, and Hito will share more about them in just a moment. Additionally, a real-world evidence study has been initiated in France to evaluate outcomes in nine in lipidase-treated patients. Through the initial follow-up period, there has been no graft failure and no death, and these real-life data demonstrate that the use of amlipidase to desensitize highly sensitized patients can have an accessible short-term efficacy and safety profile in selected patients. Please turn to slide eight. Finally, we are happy to announce that, confided, the pivotal US Phase III trial is now fully randomized. As a reminder, The CONFIDA study is evaluating amlifidase as a potential desensitization therapy compared to treatment according to standard of care to enable kidney transplantation in highly sensitized patients waiting for a deceased donor kidney. A total of 64 highly sensitized patients on the wait list for kidney transplantation were randomized on a one-to-one basis to either desensitization with amlifidase or standard of care. What's important to know about the study? is the total of 23 sites were enrolled in the trial and can send over 140 patients. Approximately half of these sites, about 11, were responsible for randomizing two or more patients. The sites in the trial represent about 20% of the total transplantation volumes in the U.S. Currently, 13 sites have treated patients within lipidase thus far, which is very encouraging, and we believe further validates that clinicians are recognizing the clinical value and patient-benefit amlifidase in highly sensitized patients. Following full randomization, all patients will be followed for 12 months per the study protocol, and we expect data readout in second half 2025, and followed by submission of a BLA to the US FDA to seek accelerated approval. I will now turn to Hito for an update on the pipeline. Please turn to slide nine.