Hansa Biopharma AB (publ)

Hi, everyone, and welcome to the Hansa Bau Farmer interim report for Q1 2024. 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, please press 5-star on your telephone keypad. Speakers, please begin.

Thank you, operator. Good afternoon. Good morning. Welcome to the Hansa Biopharma conference call to review first quarter results for 2024. I'm Sam Tulsdorp, CEO of Hansa Biopharma. Joining me today is our chief commercial officer and U.S. president, Matt Scholes, and our chief scientific officer, Peter Kaufman. I'm also delighted to welcome Evan Ballantyne as our new chief financial officer. With Evan's deep international experience and successful track record as a pro at public and private life science companies, I'm confident that Evan will be a strong addition to our team and will help drive our financial strategy, deliver on key strategic priorities, and help us build shareholder value. As head of investor relations, Klaus Sindel is also with us. Today, we'll discuss the progress we made during the first quarter of 2024 and review our near-term milestones. Presentation should take roughly 15 to 20 minutes, after which there'll be an opportunity to ask questions during a Q&A session. Now 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. Please turn to slide three and an overview of Q1 highlights. I'm very pleased to see a promising start to 2024. In the first quarter, we continue to see strong commercial execution, making it our best performing quarter so far, and the second consecutive quarter with solid product sales. This strong sales performance is a continuation of the traction we saw at the end of last year, where key large markets such as the UK and Germany started to contribute, supported by new and repeated use of IDFRICS at leading transplant centers. Matt will cover the commercial performance in more detail during his section of the call. Last week, we announced that additional financing has been secured, extending our cash runway into 2026 through a $34.6 million directed share issue targeting its national healthcare specialist investors. I'm very pleased to see the strong interest in the Hansa Equity story from leading U.S. and European specialist investors. This transaction will help finance the preparation for a potential U.S. launch of the Nifidation kidney transplantation, strengthen our ongoing product development in autoimmune indications, and allow for the continued clinical development of HANSA5487, our lead candidate from the NYSER program for repeat dosing. On the clinical development side, I'm encouraged to see our progress in kidney transplantation continue to progress as planned. Enrollment and randomization in our U.S. pivotal confidants trial is advancing as expected. During the first quarter of 2024, four new sites were activated and both screening and randomization of eligible patients have recently accelerated. As previously guided, we expect randomization to complete mid-2024. We've also made significant progress in the European post-approval study with more than a doubling of the number of patients treated in trial in the last couple of quarters. As a reminder, the post-approval study is an obligation under the European Conditional Marketing Authorization and will be used to further investigate the long-term graft survival in 50 highly sensitized kidney transplant patients treated with Idafrix. The study will also help generate important clinical experience in leading transplant centers in using Idafrix as a new transformative desensitization therapy in highly sensitized patients. Beyond kidney transplantation, we continue to advance our omnipotent clinical programs in autoimmunity. In our pivotal phase three trial in anti-GBM disease, our lead autoimmune indication, we reached 50% enrollment in the trial and expect completion in 2025 as previously guided. In our phase two study in Guillain-Barré syndrome, we expect to share contextualized efficacy data later this year following promising first high-level data shared in December of last year. Hansa's lead candidate from the NYSA program for repeat dosing, Hansa 5487, continues to progress as planned, with expected further analysis around endpoints to be completed in the second half of this year, as previously guided, including selection of a lead indication. In gene therapy, imifidase is being investigated in a Phase 1b study as a pretreatment to Levitas, also known as SRP9001, served as FDA-approved gene therapy in Duchenne muscular dystrophy. As communicated earlier, Sorexa leads the communication around the progress of this program, and we expect the first high-level data readout towards the end of this year. With this, I'll hand it over to Matt to go through our commercial progress for the quarter. Matt? Thank you, Surin.

Please turn to slide four. As Surin mentioned in his introduction, we saw strong commercial performance in the first quarter. with $47 million in product sales, which is the second consecutive quarter of strong sales and, as Surin highlighted, our best-performing quarter so far. Growth this first quarter was driven by product sales in our largest European markets, including France, UK, and Germany, as well as initial sales in Belgium. At Hansa, we are launching a transformative new therapy in kidney transplantation, It is a paradigm change rather than a product for a well-established use, as it enables the treatment of cross-match positive patients. Generating successful early experiences in key early adopter clinics will be highly critical for the long-term market uptake of this innovative product. So, ultimately, we must win the acceptance battle, both for treatment of the patient type and the subsequent adoption of the product. To measure our progress, we're using a set of key launch metrics, which we introduced back in the fall of last year. These metrics will directly or indirectly impact future adoption and sales of Idaferix as a new transformative therapy. We will continue to revisit these on a regular basis to demonstrate our progress. These metrics include market building and market access activities, patient identification, and transplant center readiness and use. Looking at our market access and market building activities first, we have seen atmospheric specific guidelines being implemented on a national level in seven key markets so far, including Germany and Italy more recently. These guidelines provide a new clinical practice framework for healthcare professionals on a management pathway for highly sensitized patients, and our medical teams are supporting further country-level guideline development in other European countries. In addition, we have now secured pricing and reimbursement in 75% of the European kidney transplant market, including all of the largest five markets, and expect to see utilization in new centers, which will support increasing sales growth in 2024 and in the years to come. HTA processes continue to run in several other markets. In fact, we have 11 processes ongoing, including markets such as Portugal and Switzerland, and a dossier was submitted in Ireland during the first quarter. Third, let's look at patient identification. Following the conditional market authorization in Europe, HANSA is running a mandatory post-approval study in Europe in parallel with the commercialization. The post-approval study helps clinicians generate valuable experience in treating and managing patients. as we build the foundation for Iodiferics to become a new standard of care and desensitization. While, in the short term, this study may affect commercial sales and patient uptake, long term, the experiences from this study will positively impact sales growth. During the last six months, we have seen more than a doubling of the number of patients treated in the trial, and we have now completed approximately 72% of the post-approval study. The post-approval study is on track to complete treatment in 50 patients by the end of 2025 and will support full marketing authorization in Europe. Ongoing patient identification through organ allocation systems, such as neurotransplant, is another critical factor, since increased access to organs is critical to equitable care for highly sensitized patients. On that note, we're pleased to say that the first two patients were treated in neurotransplant new desensitization program during the first quarter of this year, following increased patient identification and selection at the end of last year, where both the first and second wave patient assessment took place on a large number of patients for treatment with this new desensitization program. The new pilot program under the acceptable mismatch program is intended to transform desensitization across eight European member countries, including Germany, the Benelux, and select Eastern European countries. Fourth, scaling up the base of transplant centers with clinical experience is a key commercial metric. And while uptake will remain volatile from quarter to quarter, even with a growing base, due to the unpredictability of organ allocation to highly sensitized patients on waiting lists, we are pleased with the continued progress in establishing new centers that use Idaferix. Today, approximately 50 clinics qualify as Idaferix-ready-to-treat patients, while the number of clinics that have treated patients commercially or through our post-approval study has grown steadily. When we received EMA authorization in 2020, only two centers had clinical experience with Itiferix. And by the end of the first quarter of 2023, that number of centers had grown to 15. Today, more than 25 centers across both clinical studies and commercial sales have experience with Itiferix. Furthermore, by the end of the first quarter, the number of centers with repeat usage had grown to 17. We obviously are very pleased that we achieved two consecutive quarters that each represent our best product sales quarters so far. And in addition to continued sales in France, we anticipate further growth to come from the U.K., Germany, Spain, and Italy as our efforts continue to have impact into 2024. We also have to reemphasize that as the base of centers grows, We will continue to see more patients identified on the wait list at these centers for idaferyx, but there will be some volatility in sales from quarter to quarter, as the timing and number of organs allocated are basically determined by factors that are out of our control. Please turn to slide five. With regard to our pivotal U.S. confidus trial in kidney transplantation, enrollment and randomization continue to advance as expected. During the first quarter of 2024, four new sites were activated, taking our total number of activated sites from 17 to 21. Similarly, both consenting and randomization of eligible patients have recently accelerated to 122 patients consented and 49 patients randomized out of a target of 64. The confided study is designed to evaluate amlifidase as a potential disruptive therapy for highly sensitized patients waiting for a deceased donor kidney through the U.S. kidney allocation system. Approximately 2,500 highly sensitized patients in the U.S. with a CPRA score of 99.9% and above fit into this category, yet they are not transplanted today, despite prioritization points on the kidney allocation system. As we have previously noted, we expect randomization of this study to be complete by mid-2024, with a BLA submission expected 2025 under the accelerated approval path. And now I will hand over the call to Hito, who will walk us through the progress of our exciting pipeline projects.