Hansa Biopharma AB (publ)

Good day and welcome to the HANSA Biopharma Quarter 3 2025 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 your touchtone phone. 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, Operator. Good afternoon, good morning. Welcome to the Hansa Biopharma conference called Review Q3 and results for the first nine months of 2025. I'm Renée Aguiar-Lucander, CEO for Hansa Biopharma, and joining me today is Evan Ballantyne, CFO, Richard Philipson, Chief Medical Officer, and Maria Torrenson, Chief Operating Officer and President of the U.S. Please turn to slide two. Please allow me to just quickly draw your attention to the fact that we will be making forward-looking statements during the presentation, and you should therefore apply appropriate caution. Please turn to page three and today's agenda. Today we'll discuss the progress we've made in the nine months of 2025 and review the quarterly performance. I'll also share my reflections and insights based on my first six months in the role. The presentation itself should take roughly 20 minutes, after which there will be an opportunity to ask questions during a Q&A session. Please turn to page four. Over the past several months, Hansa has been through quite a transformation. including a significant reshaping of the capital structure involving debt restructuring and significant strengthening of the cash position through two successful equity raises. In addition, the reporting structure of the company has been changed to provide for enhanced accountability and transparency, as well as result in a simpler and leaner organization. We have in parallel added key competencies to the senior team, which are crucial for a successful BLA filing, review, and pre-launch preparations as well as the requirement for a successful product launch subject to approval in the U.S. I believe that the market opportunity in the U.S. is very substantial, and this brings me to the last but ultimately most important point and key event of this quarter, the successful outcome of the phase three CONFIDAS trial. This trial randomized patients between 2022 and 2024 with a 12-month follow-up period, and we're truly delighted that we could report out such a strong p-value of 0.0001, which I believe reflects the unmet medical need for these highly sensitized patients. And we're now looking forward to submitting the BLA filing before the end of the year. Moving to Europe, this summer quarter reflected lower than expected transplant rates, further impacted by the absence of transplants in Germany due to the situation flagged already in Q2, as well as continued challenges related to local reimbursement. I'll comment further on this shortly. Regarding pipeline developments, we were excited to report the very first clinical data from the gene therapy area, which clearly showed that Lipidase's ability to successfully reduce antibodies related to AAV vectors by over 95% reduction from baseline, and thus enabled dosing of patients who otherwise would have been excluded. These data, in conjunction with further clinical data obtained from our collaboration with Genethon, bolsters our view that gene therapy could become a significant future market opportunity for HANSA. Please turn to page five. As I already stated in my Q2 address, I was expecting Q3 to be a weak quarter for reasons that should not be a surprise to anyone who's actually tried to obtain a hospital appointment during the summer in many European countries. This actually ranges from difficult to close to impossible, except for reasonably acute situations in many regions. However, this was exacerbated by a variety of country-specific factors already mentioned. As we've now had the opportunity to review the situation in Europe somewhat in more detail over the last couple of months, our conviction regarding the significant growth opportunity has not been diminished, but we do believe that there are several areas which can be improved and strengthened to enhance both performance and predictability. We've identified several of these and intend to start rolling them out in this quarter. However, as a backdrop to these initiatives, I'd like to review some of the key situational facts of the European market. So as I've already kind of stated previously, at the time of launch in Europe, there was limited clinical data available. There was only two sites that were actually in Europe which participated in the phase two trial. So very few KOLs had any experience of this procedure in Europe at the time of launch. There was also obviously need for drafting and implementation of guidelines. And as we know, Europe has a long and complex reimbursement process to deal with. Due to the fragmentation of the market, obviously there are different national organ allocation systems, and they do not all kind of operate in the same way. And obviously at the same time, as the company was really challenged with the kind of limited KOL support and experience and clinical data, there was also a large clinical study initiated at 23 of the European sites, many of them very large academic institutions, to recruit 50 patients in a transplant trial. There's also been the strategic decision earlier to go very broad in Europe rather than have a more focused approach. So what we are going to do, since we do believe that there is an extremely large growth potential based on where we are today, is to really review the organizational structure overall. We're looking for accountability, focus, and efficiencies, and we've identified some areas that we think would benefit to be strengthened We're also going to invest in Europe in terms of systems, clarifying KPIs, reporting lines, and provide additional education and training. We will obviously focus on dissemination of the clinical data that we now have in terms of the phase three. I do think that this kind of phase three trial and the clinical data that stems from that will become extremely important in conversations with European KOLs and transplant surgeons. and we'll focus on all of that in terms of best practice and peer-to-peer interactions. So, in summary, we will be refining and implementing these activities over the next three months, and we'll keep you updated as we move through this process. Please turn to the next page. Following the strong phase three data, I just wanted to provide a brief overview of the U.S. market opportunity, where there are several key differentiating factors from Europe, which we believe will impact both the potential size of the overall opportunity, as well as the adoption rate compared to what we've experienced in Europe. A significant differential is obviously that we have a large and robust clinical trial that just read out, with data that's going to be available to the community pre-launch. As part of that, we also have a lot of KOL engagement and experience as part of the very large trial that's being conducted in the U.S. In terms of pricing, if we look at kind of reimbursement, obviously the price can be managed by the company. It will be based on research and the clinical and payer setting. There is a national organ allocation system which is centralized with clear guidelines for how these matches are being made. and with also a specific kind of focus on highly sensitized patients. In terms of this, we're going to focus on the 25 sites. We were part of the phase three, which represent about 25% of all transplants in the U.S., where these transplant surgeons will be familiar with the procedure, and we'll have a subsequent rollout plan with an initial target of about 100 clinics. In addition, the data that we'll read out from the European-based PAS study will also be available, as will real-world data from Europe, which we hope will also, in the near future, we will see in form of some publications. We have a well-researched, externally validated and structured launch plan, and we have very strong market analytics capabilities internally. There is an active patient advocacy in the US, strong kidney organizations, and a clear physician demand for the product. So in conclusion, we're extremely excited about the upcoming regulatory process and look forward to engaging with the FDA with a purpose and focus of bringing illicit AIDS to patients in the US. With that, I'll hand it over to Maria, who will provide some more details on these topics. Thank you very much, Rene.

Next slide, please. Our Q3 performance was, as Rene mentioned just earlier, impacted by the seasonality and the pause of the German prioritized program for highly sensitized patients. As mentioned in our Q2 report, Germany paused participation in the urotransplant prioritized program earlier in the year. And as a result, we did not recognize any sales in Germany in Q3. the prioritized program continues in the other smaller countries in the eurotransplant zone. While German physicians can still use Idiferix in the normal ETGAS program, it will require publication and adaptation of new guidelines for broad adoption. And we therefore expect this to continue to have a negative impact in the near to mid-term on our sales performance in Germany. We continue to work with physicians to understand the timing of these new guidelines and we have also initiated various public affairs efforts to better understand how and when the prioritized program can be reinstated in Germany. In addition to Germany, our sales were also negatively impacted by regional dynamics in the Spanish market, where the lack of transparent protocols in the region of Andalusia is limiting usage of idiferics. From a market access perspective, we have been very successful in gaining national reimbursement in 21 European and international markets. Over 90% of the European population are covered by national reimbursement. However, in some European markets, we also need regional reimbursement to enable idferics usage. We still have some key regions in Europe where this reimbursement is lacking. And one such example is the Catalonia region in Spain, where the overall healthcare budget has been blocked at the regional level, impacting Idiferix negatively. As Catalonia and Andalusia are two of the largest regions in Spain, our Spanish sales were lower than expected in Q3. Despite some of these market challenges, we have a strong support in many European and international markets, with one example being France, a country where there are clear guidelines for Idiferix usage, strong support from key opinion leaders, significant positive clinical experience over several years, and a clear path to reimbursement. We are building on these positive experiences as we look at how we can optimize performance across Europe. As René mentioned earlier, Europe represents a significant growth opportunity, and as such, we are implementing multiple activities to address the European performance. We are reinforcing our peer-to-peer education on guidelines and delisting practices, and we are arranging multiple educational events, with one example being a large scientific event in November with around 80 European key opinion leaders. We're also, as mentioned earlier, reinforcing our public affairs efforts to address some of the systemic barriers we are observing in some key regions and markets. And finally, our market access team are working on addressing the regional access challenges mentioned earlier. Please turn to slide nine. Let's now turn our focus to the U.S. market, which represents a significant opportunity for Hansa. As Rene mentioned, a few weeks ago, we presented positive top-line data from Confidus, our phase three trial in highly sensitized kidney transplant patients. When we look at the U.S. market, it is important to remember that these highly sensitized patients have no approved desensitization therapy available today, and the unmet need is therefore significant. There are approximately 15,000 highly sensitized patients with a CPRA over 80% in the U.S. today, and more than 7,000 with a CPRA over 98%. and 3,500 patients in the most sensitized group with the CPRA at 99.9% or above. In total, 100,000 patients are on the U.S. transplant wait list. And each year, 45,000 patients are added to the wait list with highly sensitized patients representing 20%. Unfortunately, due to the long wait list, each year there are 10,000 patients who pass away or become too sick to transplant while waiting for an organ. And the median wait time for an organ for these highly sensitized patients is seven years. Please turn to the next slide. With the recent announcement of the positive Phase III confidants data, our U.S. organization is focused on preparing for a potential launch in the second half of 2026, subject to FDA approval. As mentioned, the U.S. market represents a significant opportunity, and while there are important learnings from the European launch, there are also obvious reasons why the U.S. launch will be different. The market opportunity is significantly larger than in Europe. As you saw in the previous slide, there are today 15,000 highly sensitized patients on the U.S. wait list, and this list is growing each year. Unfortunately, 2,500 highly sensitized patients pass away while waiting for a matching organ, or they become too sick to transplant each year. If we look strictly at the confidants criteria, CPRA over 99.9%, there are today 3,500 patients on this wait list. Half of them have waited over seven years for a suitable organ, which is a sign of the tremendous unmet need that exists for these patients. The burden of being on dialysis should also not be underestimated. These patients need to undergo dialysis for several hours, multiple times a week, and the cost for Medicare is approximately $100,000 per patient per year for dialysis. For those patients who are fortunate to find a matching transplant, they will have a significantly better outcome with more than 80% being alive after five years compared to 40% on dialysis. A recent patient preference study also shows that these patients are waiting for an approved desensitization therapy, with 61% of US patients today practically discussing this with their physician. While a European launch has been impacted by the regional market dynamics described earlier, the US market is vastly different, and we should therefore expect a stronger launch. In the U.S., there is a national organ allocation system where highly sensitized patients are prioritized. As you heard earlier, this is one of the challenges we're facing in some European markets. There's also significant efforts from the current U.S. administration to improve transplant care and ensure better outcomes for patients and better usage of organs. From a market access perspective, we know that kidney transplants are covered by Medicare, Our market access team will work with various stakeholders to ensure adequate reimbursement for both outlier payments and NTAP, new technology add-on payment. It is also worth noting that Hansa will enter the U.S. market with significantly more clinical experience and data compared to the situation we're launching in Europe. The confided centers are collectively responsible for 25% of all transplants taking place in the U.S. each year. This puts us in a much better situation compared to the European launch, as these centers already have clinical experience using emblifidase and have seen the benefit of desensitizing their highly sensitized patients with emblifidase. As the U.S. market is highly concentrated, with 200 adult kidney transplant centers and hundreds of these representing 80% of the transplant volume, this is a launch we can manage successfully ourselves with a small footprint. We expect to hire around 20 field-based key account managers who will be responsible for the sales of Inblifidase. Finally, already today we have a very experienced team leading this exciting launch. Current team members all bring significant therapeutic area experience and launch experience. Over the coming 12 months, we will also add to this team to ensure we are ready to launch Inblifidase successfully, assuming FDA approval. And with that, I would like to hand it over to our Chief Medical Officer, Richard Phillipson, to discuss our pipeline. Richard.