Hansa Biopharma AB (publ)

Good day and welcome to the HANSA Biopharma fourth quarter and full year 2025 financial 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 phone. To withdraw your question, please press star then two. We ask that you limit yourself to one question, please. Please note that this event is being recorded. I would now like to turn the conference over to Hansa Biopharma CEO, Renee Aguiar-Lucander. Please go ahead.

Thank you. Good afternoon and good morning. Welcome to the Hansa Biopharma Conference Calls Review Q4 and the results for the full year of 2025. I'm Renee Aguiar-Lucander. CEO of 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, U.S.

Please turn to slide two.

Please allow me to draw your attention to the fact we'll be making forward-looking statements during this presentation, and you should therefore apply appropriate caution. Please turn to slide three and today's agenda. Move on to page four, please. In terms of key achievements in Q4, Q4 saw strong growth over the same quarter last year, with product revenue growth of almost 140% and total revenue growth of 135%. Total revenues for the year amounted to $222.3 million, or about $25 million, a growth of 46% compared to total revenues in 2024. In Q4, we successfully also closed an equity round of 671.5 million Swedish krona, or about 71 million US dollars, which will fund operations into 2027. As planned, we submitted our BLA application to the FDA in December of 2025, and we await their decision to accept the filing and communicate a PDUFA date, which we expect to receive shortly. We also announced the planned development for HANSA 5487, which we plan to take into GBS, Guillain-Barre, in a late-stage trial before the end of this year. Finally, we also reorganized the European Commercial Organization as part of a broader initiative to improve transparency and accountability across the organization. Please turn to slide five. So 2025 really was a year of transformation for the company. Driven by senior leadership changes, several initiatives were successfully implemented to strengthen the organization and make it fit for purpose in a competitive global environment. We renegotiated the existing debt facility, strengthened the senior management team and brought in key expertise, restructured the organization and streamlined reporting lines. We also clarified the positioning of HANSA 5487 and financed the company with two equity capital raises, ensuring runway into 2027. Please turn to slide six. A recent area of focus has been the European Commercial Organization. As I pointed out previously, the launch in Europe was quite unusual as there was very limited clinical data as well as clinical experience in Europe at the time. The challenge of launching a product under these circumstances with a large phase three trial as well ongoing should not be underestimated. I believe that the upcoming European phase we read out in combination with the presentation of the Confidus data and expected real-world data publications from Europe will positively impact this situation. In addition, we launched a number of initiatives which are being rolled out this quarter. I expect this to impact performance to some extent, as all change management implementation tends to do this. I would therefore expect a relatively weak development of revenues in Q1, complemented by a strong second half 2026, as these changes take effect. Please turn to slide seven. In the U.S., we're faced with a very different landscape to that of Europe. We recently read up the very successful CONFIDAS trial, and we're expecting additional data to become available, as I've already covered. We have a well-researched and data-backed plan for our pre-commercial activities, managed by a highly experienced and well-integrated team. Structurally, the U.S. market is quite different from the European market in terms of organ allocation systems, pricing and reimbursement, patient advocacy, and data availability. We believe that we're well-positioned to successfully launch the product into the market later this year, subject to approval. With that, I will hand over to Maria, who will provide some more details on these topics.

Great. Thank you very much, Renée. Next slide, please. Before I comment on our progress in Europe and international markets, I would like to take a moment to discuss the opportunity in front of us. In Europe, we have up to 11,000 highly sensitized patients waiting for a kidney transplant. Most of these patients have waited for years, sometimes up to as long as 12 years. When Idiferix was conditionally approved a few years ago, it was the first and only treatment approved to a desensitization of highly sensitized patients. This is still the case, and Idiferix has no competition in this space. Over the years since launch, we have more than 200 patients treated with Idiferix across 40 centers. at the same time as the company has been running a large Phase III study with 50 patients, the PAES study. Today, we are in a different position with significant additional data being released for Imblifidase. In September, we released the U.S. Confidus data, which European KOLs are showing great interest in. We have also published our five-year data in November in Transplant International, And we are expecting more data to become available in 2026. In particular, the readout from the PAES study and real-world evidence from European transplant centers, as well as additional data from the U.S. CONFIDEST study. All of these clinical data combined puts us in a good position to continue to progress the commercial adoption across Europe. Please turn to the next slide. As René mentioned, we delivered solid growth in Q4 with 61.1 million Swedish krona product sales and 139% growth versus the same quarter 2024. The sales came from multiple European markets, but it is worth noting that we had sales in all five large European countries, including Germany, where you, as you know, faced some challenges in 2025. I will comment more on the German situation shortly. As mentioned in last quarter's report, we have been working on securing regional reimbursement in some key regions, and one of them being Catalonia in Spain. In December, we received positive news that the temporary funding for Ideferix has been approved by the Catalan pharmacy department. They are currently setting up the logistical and invoicing process, and we expect this to take a couple of months. In the meantime, we know that there are already several IDFERIX requests that have been sent in from hospitals in Catalonia to CatSalut, the Catalan health service. We are, as a result, cautiously optimistic that we will see improved sales from Spain in 2026. From a market access perspective, we also gained reimbursement in Slovakia in Q4, bringing the total number of countries reimbursed to 24. In addition, we learned in November that the French ANSM made the decision to reimburse Adiferix for use in connection with lung transplants. As you know, Adiferix is only approved for use in kidney transplantation, and this decision to reimburse in lung transplantation is a result of the French lung transplant KOL community driving the process, and asking the ANSM to provide special reimbursement for use in this patient population. As I mentioned on the previous slide, having access to clinical data is critical to drive further adoption of Idiferix. In November, we arranged a large scientific event with 72 transplant experts from 17 countries. This meeting created a forum for the KORs to discuss the latest data and facilitate best practice sharing between centers and countries. In Germany, we faced some challenges in 2025, as mentioned in the last couple of quarterly reports. Germany decided to pause the participation in the neurotransplant priority program for highly sensitized patients. We have worked diligently across public affairs and medical affairs to understand how and if and when this program can potentially be reinstated. At this point in time, it is our assessment that it will take some time before the German Bundesärztekammer has decided whether to continue participating in this program or not. We do not believe there is a path for us to speed up this process as it is an administrative process driven by the Bundesärztekammer. At the same time, we also know that the majority, approximately two-thirds of highly sensitized patients are on the normal ETGAS waitlist in Germany. And German transplant centers can transplant patients with imlicidase in this program. In Q4, German KOLs started writing new guidelines for the ETGAS program. We hope that these guidelines will be published in the first half of 2026 to help guide German transplant centers on how to delist highly sensitized patients to enable transplantation with irepherics. The German KOLs believe that this is the best path forward to facilitate future transplants. Finally, we made some operational changes to our European organization in Q4. In December, we appointed Max Sakaya to lead our European and international organization. we've also made some other changes to our operations in Europe, which we believe will in the long term enable the region to perform better. Please turn to the next slide for the U.S. market. Turning to the U.S. market and the opportunity in front of us, assuming FDA approval. We know that there is a high unmet need in the U.S. as there is currently no approved desensitization therapy for highly sensitized patients. And these patients wait for years to have a matching kidney, which may never arrive. In the U.S., there are approximately 15,000 patients who are highly sensitized, meaning they have a CPRA over 80%. In the category above 98% CPRA, there are 7,000 patients. And in the most highly sensitized patients, the population studied in confidants, there are 3,500 patients waiting for a transplant today. Each year, thousands of patients die or become too sick to transplant, and the wait list continues to grow, again, confirming the unmet need that exists in this population. We know this not only from published statistics, but also from both KOLs and patients as they reach out to our medical affairs and patient advocacy team almost on a weekly basis to ask when Imblifidase will be available in the U.S. It is with these patients in mind that we move swiftly to prepare for a potential U.S. launch and bring IMLIFIDES to the U.S. market. Please turn to slide 11. So our launch preparations are ongoing, and we will be launch ready at PDUFA. There are 200 transplant centers in the U.S., and hundreds of these centers drive 80% of the transplant volume, and the 25 centers who participated and confided us represent 25% of the volume. From a launch perspective, our current assumption is that the initial uptake will come from larger centers with clinical experience. And we believe we are in a great position with the clinical knowledge that exists already today in the U.S. From a reimbursement and access perspective, Imblifidase will be an inpatient treatment covered by the patient's medical insurance. Hospitals are reimbursed via DRG payments and outlier payments for kidney transplants. That is something that they are familiar with today. We will apply for NTAP, New Technology Add-on Payment, which, if granted, will provide a separate Medicare payment to hospitals when Inflifidase is used. Most large and academic hospitals have experience in this form of reimbursement from adopting new therapies such as the CAR-T's for the inpatient setting. Our market access leader is very experienced, and he is in the process of bringing in a field access team in Q1. This team will be charged with working with the transplant center's financial stakeholders to ensure access for patients post-approval. We also have US pricing research ongoing, and we are in the process of defining our supply and distribution network. In addition to our access team, we are also expanding our field-based medical team in Q1, Our current team have significant transplant experience, and we are looking to add additional team members with similar expertise. Finally, on the commercial side, we hired a senior vice president in December, and she joined the organization in January. She joined Hansa with transplant and nephrology experience, and she will be charged with building up our commercial team prior to PDUFA. With that, I would like to hand it over to our Chief Medical Officer, Richard Philipson, who will provide an update on our pipeline. Richard?

Thanks very much, Maria. I'd like to take a few minutes today to summarise the outcomes of the company's Phase 3 study in anti-GBM disease, or good pastures disease. I'll also briefly discuss next steps for the project. Next slide, please. As a brief recap, this phase three clinical trial was conducted at 48 centers in 14 countries in Europe, the UK and the US. Enrollment began in the second quarter of 2023 and all patients were enrolled by the fourth quarter of 2024. The study recruited patients aged 18 years or older with a diagnosis of anti-GBM disease based on serological testing of anti-GBM antibody levels. with an EGFR of less than 20 mils per minute calculated using the modified diet and renal disease formula. Patients with a diagnosis of anti-GBM disease made more than 10 days prior to randomization were excluded. So 50 patients were randomized in a one-to-one ratio to one of two treatment arms. Patients randomized to the control arm started treatment with plasma exchange or PLEX within 24 hours of randomization. Subsequent treatment with PLEX was determined based on anti-GBM antibody levels and using a schedule defined in the study protocol. In addition, cyclophosphamide was administered for a minimum of six cycles and a maximum of 10 cycles, and glucocorticoids were also given. For patients randomized to the imlifidase treatment arm, imlifidase was administered as a single intravenous infusion as soon as possible after randomization, along with cyclophosphamide and corticosteroids. After an interval of at least 48 hours, patients started treatment with PLEX, using the same approach as described for the control arm. The primary endpoint in the study is function as evaluated by EGFR at six months, and the key secondary endpoint is the proportion of patients with functioning kidneys at six months, defined as no dialysis events within four weeks prior to the assessment. Next slide, please. And moving on to the results. A total of 50 subjects were randomized to the study. However, one subject was excluded from the efficacy analysis following a diagnosis of hantavirus infection as the primary cause of illness made after randomization. Therefore, 49 subjects were included in the full analysis set for the evaluation of efficacy. And of these, 47 subjects, or 96%, completed the trial. In brief, 49% of subjects were male, 88% were white, and the mean age of the trial population was 59 years. At the time of enrollment, 45% of subjects were dialysis dependent and 57% had a history of smoking. Next slide, please. Turning to the study outcomes, the primary endpoint, which was EGFR at six months, and the key secondary endpoint, which was proportion of patients with functioning kidney at six months, were not statistically significant. There was no difference in treatment arms in the proportion of patients with end-stage kidney disease or death within six months. It is noteworthy that anti-GBM antibodies declined as expected following imlifidase treatment and the safety profiles in previous clinical experience in anti-GBM disease and other patient populations. Next, please. Since the announcement of the results of the study at the end of last year, we've taken time to understand the study outcomes in more detail. That work is ongoing and we're particularly interested in determining whether any particular subsequent patients derive benefit from the treatment. It's clear that the control arm of the study, the design of which reflected back from regulatory authorities, performed much better than anticipated. This likely reflects the rigorous administrative standards including in the study and may not be achievable in real world medical practice. We do not plan any further clinical trials for anti-GBM disease, but we'll of course present the outcomes of the study at a forthcoming conference. With that, I'd now like to hand over to our chief financial officer, Evan Ballantyne.

Thank you very much, Richard. Next slide, please. For the fourth quarter, total revenue reached 222.3 million SEC, up 30% or 51 million SEC year-over-year. Full-year product sales were 204.7 million SEC, representing a 46% increase, or 64.6 million SEC, compared to the prior year of 104.1 million SEC. Fourth quarter performance was particularly strong, with total revenue of 76 million SEC, up 135%, or 43.7 million SEC, year over year. Idifrix product sales in Q4 were 61.1 million SEC, increasing 139 percent, or 35.5 million sec, compared to the same period last year. Fourth quarter contract sales, primarily from AskBio, were 14.9 million sec. As we previously noted, while full uriodiferic sales were strong, quarterly results can fluctuate due to the inherent variability of the European kidney allocation systems. Next slide, please. SG&A expense. SG&A expense totaled approximately 101.6 million SEC for the fourth quarter, compared to 88 million SEC in the fourth quarter of 2024, representing an increase of 14 million SEC, or 15 percent. On a full-year basis, SG&A expense of 357 million SEC was 13 million SEC or 4% higher compared to the same period a year ago of 344 million SEC. Excluding a 21 million SEC restructuring charge recorded in the second quarter of 2025, SG&A expenses were slightly favorable compared to the full year 2024. R&D expense. 2025 R&D expense totaled approximately 304.7 million SEC for the full year, compared to 346 million SEC in 2024. This represents an improvement of approximately 71 million SEC, or 19 percent compared to the prior year. In the fourth quarter of 2025, R&D expense of 74.4 million SEC was 27 million SEC, or 26 percent favorable compared to the fourth quarter in 2024 of 101 million SEC. With the completion of enrollment for both the CONFIDAS and the PAES clinical trials, R&D expense should continue to decline. Operating loss. For the full year 2025, the company's operating loss of 521 million SEC was an improvement of 116 million SEC or 18% compared to the operating loss of 637 million SEC in 2024. In the fourth quarter, the operating loss of approximately 125 million SEC was an improvement of 49 million SEC or 28% compared to the same period in 2024 of 174 million SEC. The year-over-year improvement in operating results is driven by strong revenue growth and a continued focus on controlling operating expenses. Next slide, please. Cash. Cash used in operations for the fourth quarter totaled $149 million SEC, and $149 million SEC for the full year ended December 31st. As previously mentioned, the company completed a direct share issue of approximately $671.5 million, or approximately $71.3 million for the fourth quarter. At December 31, 2025, cash and cash equivalents totaled $701 million. Now I'd like to turn the call back to Renee for closing remarks and Q&A.

Thank you, Evan. Please turn to the next page. So in summary, during 2025, we have built a strong foundation to capitalize on the strong science, competitive advantage, and deep expertise in HANSA biopharma. We've developed a clear roadmap with clear strategic imperatives reflecting the many key inflection points in 2026. This includes the communication of our PDUFA date, readout of the PAS trial, presentation and publication of Confidus data, agreement with the FDA regarding our development program in GBS, and the potential approval of Enlyphidase in the U.S. and launch into the U.S. market, as well as the filing for full approval in Europe. The entire organization is now highly focused on execution, leveraging the agility, clarity of mission and mission, strong expertise, and highly integrated cross-functional teams. We value accountability, transparency, and strong horizontal communication. And we are driven by our overarching ambition to deliver novel treatment solutions to patients with unmet medical needs. Please turn to the next slide. I cannot emphasize enough the value of the highly experienced team in HMSA. This is only the most senior level on this page, but I can assure you that the level of experience and expertise runs deep in the organization. And I truly believe that the importance and value of highly motivated and clearly aligned human resources cannot be overestimated in this industry. We all look forward to delivering on our hopes and dreams in 2026, and we hope that you will continue to support us on this journey. With that, I will hand over for Q&A.

Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touch-tone phone. If you're using a speaker phone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. If possible, please restrict yourself to one question. At this time, we will pause momentarily to assemble our roster. The first question today comes from Farzen Huck with Jefferies. Please go ahead.

Hi. Thank you for taking my question. For the U.S. launch, you talked about the launch preps underway. It's a bit early, but do you have any initial feedback from payers on what reimbursement policies could potentially look like? And then on EU commercial operations, quickly, you provided some color on the broader impact going forward based on operational changes, but any color on revenue guidance for the year?

So, we are not going to provide any revenue guidance for the year at this stage. But I will hand over to Maria to address the question on reimbursement.

Sure. Thank you for the question. So as I mentioned before, this is a well-established pathway in the U.S. It's an inpatient drug covered by the patient's medical insurance, and we know that the majority of patients are on Medicare in the U.S. So the concept of getting reimbursed for a kidney transplant with the DRG code is well-established. And so is also the outlier payment that the hospitals can apply for anything not covered by the DRG. The other path we're taking is, as I mentioned, the NTAP path. We're going to apply for NTAP. That would allow, if approved, an extra payment for Medicare. That pathway has been well established with Cortese. You know, so the pathway itself is not really an unknown thing for U.S., you know, for the healthcare system. And As part of the prelaunch work, what we are doing is obviously engaging with each hospital's financial stakeholders to understand their particular expertise in doing this, you know, and if they have expertise. as an example in applying the NTAP from CAR-T. So that's some of the work that is ongoing currently, but it's not a new reimbursement pathway. So I think that's the best way I can answer it. And the work is ongoing at the moment to really understand on a center-by-center, what is their sort of expertise and experience in doing this. Perfect. Thank you so much. You're welcome.

The next question comes from Suzanne Cam, Corthusian with Kempin. Please go ahead.

Hi, good afternoon. This is Suzanne from Kempin. Looking a bit ahead on the potential launch of a liverase in the U.S., can you elaborate a bit more on the opportunity? One, if you can help drill down the actual addressable patient population on an annual basis. You mentioned a couple of thousand patients in the highest CPRA subset on the wait list. But there's also a certain number of transplantations that occur in any given year at targeted centers. Second, on the pricing, what kind of flexibility you see there for the U.S., noting that there is a price point in Europe and there is, of course, the most favored nation element. And last, how do you believe we should think about the trajectory of sales in the first years of a launch? Thank you.

So why don't you start, Maria, and take the question in terms of the market opportunity, and I will address some of the questions around MSN, et cetera. Sure.

So the big benefit we have in the U.S. is that the data available in terms of how many patients are at each center is remarkable. So we know center by center how many patients are listed for kidney transplant, how many are highly sensitized, their CPRA score, how long they've been on their wait list. That is data that is readily available in the U.S. So that, again, gives us a lot of confidence as we approach the launch. If you want to think about the addressable patients, on a national level, you have 15,000 patients on the wait list today above 80% CPRA. And as I mentioned, if you go up to 98%, you have 7,000 patients. And in the most sensitized patients, the population we studied in confidants, there are today 3,500 patients in the U.S. in that group. And as I mentioned, we know where they are center by center. The other thing I would say that each year in the U.S., there are 27,000 transplants going on. And again, we know also center by center how many are happening at each centre. So that goes back to my comment earlier on, you know, 100 centres represent 80% of the volume. And we know that from statistics. So I think, you know, at the end of the day, you know, we don't know what our label will look like. But if you look at how the product has been used in Europe, where we don't have any cutoff on the CPRA, it's been used down to 80% as well. So, you know, I think we'll see when we get the final label. But, again, the market opportunity is significant in the U.S. So, Renee, did you want to comment on the pricing and MFN maybe?

Yes, I'll certainly take the MFN question, and maybe you can address something around kind of launch, you know, the launch expectations. I guess one of the things I just want to add is obviously that, you know, today, as Maria said, you know, there are 100,000 patients on this waiting list. But we also know, obviously, that this particular kind of patient category, really quite a few of the kind of nephrologists or physicians may not put these patients on the waiting list today at all because they would say, what is the point of putting you on the waiting list? We know already that you're not going to get an organ offer. It's very, very difficult for you to do that. So I think that there is a gray area there in terms of which we are not going to really kind of know much more about until we actually have an approved product and can launch this into the market. But I'd like you to keep that in mind. Secondly, obviously, we know that there are about 45,000 or so patients added to this list every year. And about 20% of those are highly sensitized. So again, you're having a very significant number of kind of additional patients being added. And that is, again, obviously without kind of having a real sense of what that kind of potential gray area looks like today. With regard to MSN, I mean, I guess the price point in Europe today in terms of list price across, you know, most of these countries in Europe is around $350,000 per treatment. These prices are really based on kind of health economic analysis and so are considered to be either kind of cost neutral or cost savings to the system since they are set by the actual kind of countries themselves and not by the company. And knowing obviously the dialysis and comorbidities and other kind of costs in the system in the U.S. are probably higher than what they are in Europe. you know, we would not expect China to have a price or have a price in Europe, in the U.S., that are lower than what it is in Europe. However, as Maria said, we are having price discussions, pricing research is ongoing, and obviously we'll take all of that into account before we actually kind of set a price in the U.S. With regard to MSN, I guess my view would be that I think that, you know, Without kind of getting into any kind of political statements, I do think that MFN is probably not the most kind of, not the thing that I worry about the most in terms of this particular kind of rare disease area with limited kind of patient populations really that have really no alternatives today at all and who face the most severe consequences of not being treated. So I'm sure we'll hear more about this in the future, but again, I don't think that this is the area that would kind of, you know, be initially addressed or even be considered to be relevant to address them in kind of the first or even second or third wave of any kind of future discussions on MFA. Do you want to talk a little bit, Maria, about potential kind of expectations around the launch or what we think? Sure.

Sure. So I would start by saying there's a lot of learnings we can take from Europe in terms of the launch that happened several years ago. But there's also some differences, obviously, in the U.S. market. So let's first look at the number of transplant centers. You have 200 centers, and as I mentioned, 100 of those represent 80% of the volume. Our initial focus with the market access and medical team will be those top 100 centers. And what we will do is, going back to what I mentioned before, we will both sort of understand the reimbursement pathway and their expertise. who are the people in each center that are involved in sort of applying those outlier payments and managing the reimbursement for kidney transplant. And then the other path we'll also obviously examine with our medical team is their clinical knowledge. You know, do they have awareness of desensitization? Are they doing that today? To what extent? So our initial focus will be on those 100 centers. I think the key learning is that having clinical experience will matter. So that's why I made the comment earlier that we believe that the initial uptake will come from high-volume centers that are used to doing many transplants and that have clinical experience. So going back to the fact that we have 25 centers in the U.S. that have participated in Confidus, I would expect those centers to be among the early adopters, but not limited to those 25, obviously. But I think that's the way we're currently looking at the market. It's focused on those 100 centers. And those that have clear knowledge of the reimbursement pathway and clinical knowledge, I think will be the early adopters. And I think what we need to keep in mind also is that we're launching into a new space. There's no other product in the U.S. approved for desensitization that have the same mechanism of action as Inlicidase. They can do the same thing. So there's a lot of interest from KOLs and from the patient community You know, I mentioned it earlier that we get multiple requests already today from the community around when will the drug become available, when can I have access, I have a patient that I'm thinking about. So, you know, I think the potential is clearly there, but as I mentioned, we'll take a very focused approach as we sort of prepare for launch in the U.S.

The next question comes from Douglas Sao with HC Wainwright. Please go ahead.

Hi, good morning. Thanks for taking the questions. I guess just in terms of follow-up on the reimbursement, you mentioned both the opportunity for Medicare patients and the access of both, you know, eventually wanting to get applied for the NTAP. And I agree with you, you know, institutions are generally very familiar with it. I'm just curious, you did note that before the NTAP, that hospitals would be able to access the outlier payments. How much would those or that outlier payment cover the VR or to cover the cost of illicit dates in the early going?

Great question. Sure, sure. Very good question. So first I would say that the concept of outlier payment exists already today. As you know, the DRG codes are like an amount that has a retrospective look back at, you know, the cost for kidney transplant. So hospitals are today applying the outlier payment for anything sort of additional that they may be doing for these patients. Then when it comes to how much will they be covered, that's a quite interesting mathematical exercise that it really depends on multiple factors. You know, where the hospital is based, the cost of living of that state, as an example. And it also depends on what they are submitting to CMS. So a hospital could, in reality, you know, submit a long list of things that they think they need coverage for. and say, I need an outlier payment for this. The CMS then has a mathematical formula that they apply, again, going back to, as an example, in which state the hospital is located, and look at what they determine are the appropriate costs for all of these things that the hospital has submitted for, and then they will do their mathematical calculation, and they will go back to the hospital and say, you know what, this is what we will reimburse you for. So it's hard to say. It's not a precise number. It depends on sort of what they charge CMS for and this mathematical formula. But as I said, that is something hospitals are doing today. They do outlier payments with DRG type, you know, Medicare reimbursements. So I can't answer fully the question, but I hope I gave you something exciting to how it works. No, no, no.

I mean, I guess because it said, you know, so this would be like kidney transplant with complications, but, you know, in terms of the DRG, and they submit a lot. I mean, when you think about the sort of typical DRGs or the outlier payments, because I think the CMS typically kind of buckets them or thinks of them in roughly the same range, you'd be able to cover a fair amount with the misleadase. And then I guess it's just a follow-up. To the extent that there are patients in the early going who maybe reimbursement is not easily accessible, how are you thinking about sort of free goods and just the value of getting clinicians used to using the product and that early clinical experience versus, you know, maybe not having sort of optimizing revenues in the early going? And obviously, you know, free goods would impact your gross to net. Thank you.

Yeah, so I was going to first ask you a question on, you know, on getting outlier payments to cover our drug. And I would say that I'm confident that we will work with the hospitals to ensure that they can use Simplicidase. And as I mentioned, as part of the pre-launch work we're doing right now is sort of to understand what are they doing today? What does their P&T committee look like today? So I would not say that that is going to be something that is going to prevent us from having a successful launch. We will make that work. And I think one of the early learnings is that, you know, that sort of may look different from center to center in terms of how they today manage GRG payments and outlier payments. So I would not say that that is something that is going to prevent us. And then your comment on free goods, we don't have a policy for that right now. I think that is something that we would assess, you know, as we come to launch. You know, I'm obviously aware of the fact that, you know, companies tend to have a sort of policy around access to free drugs when they launch, and we'll have that as well when we have, and if it is hopefully approved in the U.S.

Okay, great. Thank you so much. One of the things I would just add is obviously just the, you know, the Medicare reimbursement received for hospital training is not tapped at DRG, right? DRG is a guaranteed kind of base payment that the hospital can expect to receive. And if you actually look at something like CAR-T, which I think is a fairly good analog here, if you look at Tamaraya, it was launched with a price of, I believe, just under $500,000 per treatment, and the assigned DRG had a base payment rate of $36,000 at that time. And so there was a pretty robust uptake of that, and I think, you know, certainly even hospitals were reporting that that they were kind of profitable when they were providing CAR T treatments. So, again, I think that there is certainly kind of familiarity with the hospitals around these situations. And I don't think that, you know, one should get too kind of carried away with kind of the actual kind of DRG number per se, because it is more of a kind of guaranteed minimum, I would say, than a kind of this is the amount that the hospital actually receives. Because I would probably bet you that that is probably not what a lot of the hospitals receive at the end of the day, depending on the patient, what they have to use, and again, as Maria said, the way that CMS looks at this. But I mean, hopefully we've covered that for you.

Okay, great. That's very helpful.

The next question comes from Thomas Smith with Liebering Partners. Please go ahead.

Hey, guys. Good morning. Congrats on the progress, and thanks for taking our questions. Just on the U.S. commercial launch preparations, you referred to some work you're doing refining the supply and distribution plans for Idaferix in the U.S. And just elaborate on that and update us on the manufacturing and how you're thinking about distribution of the drug product in the States. And then as a follow-up, I was hoping you could elaborate a bit on this interesting decision in France to expand reimbursement to include lung transplant. Are you expecting that we could see similar decisions in other European countries? And when it comes to the U.S., how are you thinking about potential adoption in other solid organ settings beyond kidney transplant? Thanks so much.

Do you want to start off, Maria? Sure. Sure. Sure. So some more details about supply and distribution. So our drug, Inglifidase, is manufactured in Europe. And the work that we're doing now is selecting our 3PL and also deciding on our specialty distributors and what the network is going to look like. So really... The question that we are solving for is how do we get the drug into the U.S.? And then when it comes into the U.S., the 3PL, what is the distribution network going to look like? Which specialty distributors are we going to use? And then how are the hospitals going to purchase the drug from the SD? So that's a very typical U.S. sort of launch prep that we're doing. When it comes to France and the lung transplant program program, There is a KOL in France that has, I think a few years ago, used imlicidase in a compassionate use in a lung transplant patient. That is really how it started, but obviously saw the benefit of using this, despite the fact that we don't have an indication in lung transplant. And this KOL and the other KOLs in the lung transplant community in France they went to ANSM in France and asked them to consider a special reimbursement for lung transplant. And I would say that that particular pathway has happened for other drugs in France as well. So ANSM has this pathway to, if a drug is approved in one indication, they can approve special reimbursement in other indications. That's what happened. Obviously, this is not an approved indication for us, so we haven't generated any clinical data. But that is sort of the pathway that has been established in France since November. And you asked also about U.S. adoption across other transplants. I think that is a bit too early to say. I think if you, René, may want to comment on it, but if you look at the mechanism of action, you can understand why the French KOL decided to try imlifidase. I think it's... you know, something that is hard to tell at this point in time in the U.S. There is another publication from a center in the U.S. that used imlicidase in a heart and liver transplant. That is a published case study. But it's sort of hard to judge at this point in time how and if, you know, it will be used. I don't know, Renee, if you want to comment anything further on that sort of other organ transplant.

Sure. Yes. I mean, as Maria said, I mean, this is a, you know, this is kind of tricky to kind of discuss off-label use when we don't really have a true product at this point in time. But I would say in subsequent to potential approval, obviously, it would make sense for us to kind of, you know, revisit this, you know, this whole area of potential label broadening with the FDA in terms of understanding what would they like to see? How do they look at this? And, you know, is there anything that we, you know, should do, could do to try and facilitate some of this? So I think it will depend a lot on what regulatory advice we get regarding this potentially. But I think, you know, for now, we're really kind of just focused on the, you know, on getting the approval and launching in kidney, which is a very, very substantial opportunity. We are aware, obviously, of that there are, there's a lot of, you know, proceeds, you know, unmet medical need in all of these kind of transplant settings. But I think we will kind of take one step at a time at this point.

The next question comes from David Nearingarden with Wedbush Securities. Please go ahead.

Hey, thanks for taking the question. I just had one on the future GBS study. Just if if there were similarities or differences or other guidelines you could point to with other trials in the field like Nexons and GBS, and just if there were key differences or similarities you were looking for when you talk with the FDA about that design.

Thanks. So I guess I'll have Richard comment on this shortly, but I guess that we are we're kind of internally at the stage when we are looking at a variety of different options they're trying to bring to the FDA, and we will very shortly decide upon which way we're going to take this forward. And obviously, in all of these kind of conversations with KOLs, you know, various kind of trials have come up. But also, like most drugs and most trials, they all have their benefits and drawbacks. And, you know, we should all learn from each other in terms of how to best kind of optimize for the benefit of the patient. But Richard, I don't know if you have any specific comments on that.

Sure. You know, I think there clearly are opportunities to learn. You know, other people, development programs, other clinical trials that are being conducted in the field, as Rene says. I mean, we're still at the stage of looking at different development program options, different clinical trial options. But I think it's also important that we do have evidence from our mechanism from a previous study that we did. I think that's very useful information that we can use when we are designing our program our molecule 5487 so i think that's that's an equally important area of information that we're using along with as as renee said uh uh and you have indicated learning from what other companies have done i think the critical step really is to um take our preferred design option which we will very shortly identify and and take that for discussion with regulatory authorities, in particular the FDA. I think that that feedback will be critical in terms of determining the whole way forward.

The next question comes from Richard Ramius with Red Eye. Please go ahead.

Hello. Good afternoon. I have one question. When do you recognize revenue and how long on average does cash conversion take from the time of the sale?

I'm sorry, you're breaking up a little bit. Can you repeat that question? Sorry.

When do you recognize revenue and how long on average does it take to convert the conversion from into cash?

Evan, do you want to take that question?

Yeah, sure. So great question. We recognize revenue, as you would guess, under IFRS 15. So we recognize revenue when the product ownership has been transferred from HANSA to the hospital. As you're probably aware, some of the hospitals – pay us based on an actual transplant, and some hospitals pay us in terms that could be 30, 60, or 90 days later. So there is sometimes a timing difference between revenue recognition and the collection of cash in accounts receivable.

The next question comes from Eric Holcard with Carnegie. Please go ahead.

Yes, hi, congrats on the quarter. Two quick questions, if I may. First, on the Sarepta collaboration, you say in the report that you are actively reviewing the data and discussing the next steps. When will you expect to communicate the outcome of these discussions? Then a short one for Evan on the annual cost for the full U.S. organization when reps have been onboarded. What's the rough number for that full organization? Thanks.

Thanks for that. So in terms of the Sarepta collaboration, as I'm sure you're aware, Sarepta is having quite a lot of regulatory interactions at the moment with regards to their core business. And so that's really kind of where their focus is at the moment. And I think that the only thing that I can say is that, you know, we are continuing to have very constructive and good interactions, but we're also mindful of the fact that this program is probably not at the very top of the list at the moment for Sarepta. And so it's difficult for me to give you an exact timing. of when, you know, we'll be able to kind of, you know, fully communicate exactly what the next steps are going to look like. That really is not, unfortunately, not really under my control at the moment. But I can assure you as soon as we do, we will communicate it. And, you know, we are, as I said, we're kind of in ongoing kind of discussions and communication and conversation, but it is hard to kind of give an exact time at this point. And that has nothing to do with the interest in the program or any kind of anything else. I think it's just really a matter of priorities at SREPTA at this point in time. Evan, do you want to take the second part?

Yes, sorry, you broke up on that second part. Could you repeat that question? The second question.

Yeah, my second question related to the annual costs for the full U.S. organization when the 20 reps have been onboarded.

Oh, sorry. Yeah, so we baked that into our budget. And as Rene mentioned earlier, we have cash into 2027. So we've anticipated those costs. We haven't reported them or broke them out specifically. But the U.S. is a very, very large market, and I think to address that market with 18 to 20 different reps is a really good use of capital.

So, Evan, my question was more about sort of how we should model costs on an annual basis when you have the full organization in place.

Yes, so you should model them. I think including the sort of 15 to 20 different reps we'll have on the commercial team under Maria, we'll probably have an equal number of support staff, including some SG&A and MSLs in the organization. And then I would take an average salary and wage for a U.S. employee.

All right.

This concludes our question and answer session. I would like to turn the conference back over to CEO Renee Aguiar-Lukinder for any closing remarks.

Thank you very much. Thank everybody for listening in to this presentation, and we hope to see you again soon. Thank you.

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.