Hansa Biopharma AB (publ)

Thank you. Good afternoon, and good morning.

Welcome to the Hansa Biopharma conference call to review Q4 and the results for the full-year of 2025. I'm Renee Aguiar-Lucander, CEO of Hansa Biopharma.

Joining me today is Evan Ballantyne, Chief Financial Officer; Richard Philipson, Chief Medical Officer; and Maria Tornsen, Chief Operating Officer and President, U.S. Please turn to Slide 2.

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 3 and today's agenda.

Let's move on to Page 4, 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 SEK 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 SEK 671.5 million or about USD 71 million, 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 HNSA-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, accountability across the organization. Please turn to Slide 5.

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 HNSA-5487 and financed the company with 2 equity capital raises, ensuring runway into 2027.

Please turn to Slide 6. 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 III trial is well ongoing should not be underestimated.

I believe that the upcoming European Phase III readout in combination with the presentation of the ConfIdeS data and expected real-world data publications from Europe will positively impact this situation. In addition, we've 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 7. In the U.S., we're faced with a very different landscape to that of Europe.

We recently read out the very successful ConfIdeS 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, Renee.

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 Idefirix was conditionally approved a few years ago, it was the first and only treatment approved for desensitization of highly sensitized patients. This is still the case, and Idefirix has no competition in this space.

Over the years since launch, we have more than 200 patients treated with Idefirix 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 Idefirix.

In September, we released the U.S. ConfIdeS data, which European KOLs are showing great interest in.

We have also published our 5-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. ConfIdeS 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 Renee mentioned, we delivered solid growth in Q4 with SEK 61.1 million 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 5 large European countries, including Germany, where, 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 Idefirix has been approved by the Catalent 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 Idefirix requests that have been sent in from hospitals in Catalonia to CatSalut, the Catlan 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 Idefirix for use in connection with lung transplants.

As you know, Idefirix 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 Idefirix.

In November, we arranged a large scientific event with 72 transplant experts from 17 countries. This meeting created a forum for the KOLs 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 Eurotransplant 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 Bundesrat [indiscernible] 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 Bundesrat [indiscernible]. At the same time, we also know that the majority, approximately 2/3 of highly sensitized patients are on the normal ECA waitlist in Germany, and German transplant centers can transplant patients with Imlifidase in this program.

In Q4, German KOLs started writing new guidelines for the ECA 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 Idefirix.

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 Sakajja to lead our European and international organization. We have 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. These patients wait for years to have a match in 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.

In the most highly sensitized patients, the population studied in ConfIdeS, there are 3,500 patients waiting for a transplant today. Each year, thousands of patients die or become too sick to transplant and the waitlist 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 Imlifidase 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 Imlifidase to the U.S. market.

Please turn to Slide 11. Our launch preparations are ongoing, and we will be launch ready at PDUFA.

There are 200 transplant centers in the U.S., and 100 of these centers drive 80% of the transplant volume and the 25 centers who participated in ConfIdeS 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, Imlifidase 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 Imlifidase is used.

Most large academic hospitals have experience in this form of reimbursement from adopting new therapies such as the CAR-Ts 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 centers, financial stakeholders to ensure access for patients post approval. We also have U.S.

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 summarize the outcomes of the company's Phase III study in anti-GBM disease or Goodpasture disease.

I'll also briefly discuss next steps for the project. Next slide, please.

As a brief recap, this Phase III clinical trial was conducted at 48 centers in 14 countries in Europe, the U.K. and the U.S.

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 <20 mL/min calculated using the modified diet and renal disease formula.

Patients with a diagnosis of anti-GBM disease more than 10 days prior to randomization were excluded. A total of 50 patients were randomized in a 1:1 ratio to 1 of 2 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 6 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 6 months, and the key secondary endpoint is the proportion of patients functioning kidneys at 6 months, defined as no dialysis events within 4 weeks prior to the assessment.

Next slide, please. Now 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 6 months and the key secondary endpoint, which was proportion of patients with functioning kidney at 6 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 6 months. It is noteworthy that anti-GBM antibodies declined as expected following Imlifidase treatment and the safety profile was in line with previous clinical trial experience in anti-GBM disease and other patient populations.

Next slide, please. Since the announcement of the results of the study at the end of last year, we have taken time to understand the study outcomes in more detail.

That work is ongoing, and we're particularly interested in determining whether any particular subgroup of patients derive benefit from the treatment. It's clear that the control arm of the study, the design of which reflected from regulatory authorities performed much better than [indiscernible].

This likely reflects the rigorous administration of standard therapies including PLEX in the study and may not be achievable in real-world medical practice. We do not plan any further clinical trials in 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.

Sales performance. For the fourth quarter, total revenue reached SEK 222.3 million, up 30% or SEK 51 million year-over-year.

Full-year product sales were SEK 204.7 million, representing a 46% increase or SEK 64.6 million compared to the prior year of SEK 104.1 million. Fourth quarter performance was particularly strong with total revenue of SEK 76 million, up 135% or SEK 43.7 million year-over-year.

Idefirix product sales in Q4 were SEK 61.1 million, increasing 139% or SEK 35.5 million compared to the same period last year. Fourth quarter contract sales, primarily from AskBio were SEK 14.9 million.

As we've previously noted, while full-year Idefirix 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 SEK 101.6 million for the fourth quarter compared to SEK 88 million in the fourth quarter of 2024, representing an increase of SEK 14 million or 15%.

On a full-year basis, SG&A expense of SEK 357 million was SEK 13 million or 4% higher compared to the same period a year ago of SEK 344 million. Excluding a SEK 21 million 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 SEK 304.7 million for the full-year compared to SEK 346 million in 2024.

This represents an improvement of approximately SEK 71 million or 19% compared to the prior year. In the fourth quarter of 2025, R&D expense of SEK 74.4 million was SEK 27 million or 26% favorable compared to the fourth quarter in 2024 of SEK 101 million.

With the completion of enrollment for both the ConfIdeS 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 SEK 521 million was an improvement of SEK 116 million or 18% compared to the operating loss of SEK 637 million in 2024. In the fourth quarter, the operating loss of approximately SEK 125 million was an improvement of SEK 49 million or 28% compared to the same period in 2024 of SEK 174 million.

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 SEK 149 million and SEK 149 million for the full-year ended December 31.

As previously mentioned, the company completed a direct share issue of approximately SEK 671.5 million or approximately USD 71.3 million for the fourth quarter. At December 31, 2025, cash and cash equivalents totaled SEK 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.

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 road map with clear strategic imperatives, reflecting the many key inflection points in 2026.

This includes the communication of our PDUFA date, readout of the PAES trial, presentation and publication of ConfIdeS data, agreement with the FDA regarding our development program in GBS and the potential approval of Imlifidase 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 vision and mission, strong expertise and highly integrated cross-functional teams. We value accountability, transparency and strong horizontal communication.

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 Hansa. 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.

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.

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? 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?

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

Sure. Thank you for the question.

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. The concept of getting reimbursed for 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 are 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 the CAR-Ts. The pathway itself is not really an unknown thing for U.S.

for the healthcare system. As part of the pre-launch work, what we are doing is obviously engaging with each hospital's financial stakeholders to understand their particular expertise in doing this.

If they have expertise, as an example, in applying the NTAP from CAR-Ts. That's some of the work that is ongoing currently, but it's not a new reimbursement pathway.

I think that's the best way I can answer it. The work is ongoing at the moment to really understand on the center-by-center, what is their expertise and experience in doing this.

This is Suzanne from Kempen. Looking a bit ahead on the potential launch of Imlifidase 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 CPA subset on the waitlist, 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 face with nation element? Last, how do you believe we should think about the trajectory of sales in the first years of a launch?

I'll start -- 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 [ MFN ], etc.

Sure. 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. We know center-by-center, how many patients are listed for kidney transplant, how many are highly sensitized, their cPRA score, how long they have been on the waitlist.

That is data that is readily available in the U.S. 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 waitlist today above 80% cPRA. As I mentioned, if you go up to 98%, you have 7,000 patients.

In the most sensitized patients, the population we studied in ConfIdeS, there are today 3,500 patients in the U.S. in that group.

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.

Again, we know also center-by-center how many transplants are happening at each center. That goes back to my comment earlier on 100 centers represent 80% of the volume, and we know that from statistics.

I think at the end of the day, 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. I think we'll see when we get the final label.

Again, the market opportunity is significant in the U.S. Renee, do you want to comment on the pricing in MFN maybe?

Yes. I'll certainly take the MFN question and maybe you can address something around kind of the launch expectations.

I guess one of the things I just want to add is obviously that today, as Maria said, there are 100,000 patients on this waiting list, but we also know, obviously, that this particular patient category really quite a few of the 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. I think that there is a gray area there in terms of which we are not going to really 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. Again, you're having a very significant number of additional patients being added.

That is, again, obviously without having a real sense of what that potential gray area looks like today. With regards to MFN, I mean, I guess that the price point in Europe today in terms of list price across most of these countries in Europe is around $350,000 per treatment.

As you also know, obviously, these prices are really based on health economic analysis and are considered to be either cost neutral or cost savings to the systems since they are set by the actual countries themselves and not by the company. Knowing obviously that dialysis and comorbidities and other costs in the system in the U.S.

are probably higher than what they are in Europe. We would not expect to have a price or have a price 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.

Obviously, we'll take all of that into account before we actually set a price in the U.S. With regards to MFN, I guess my view would be that I think that without getting into any political statements, I do think that MFN is probably not the thing that I worry about the most in terms of this particular rare disease area with limited patient populations really that have really no alternatives today at all and who face the most severe consequences of not being treated.

I'm sure, we'll hear more about this in the future. Again, I don't think that this is the area that would be initially addressed or even be considered to be relevant to address them in the first or even second or third wave of any kind of future discussions on MFN.

Do you want to talk a little bit, Maria, about potential expectations around the launch or what we think.

Sure. 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. Let's first look at the number of transplant centers.

You have 200 centers. 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. What we will do is going back to what I mentioned before, we will both understand the reimbursement pathway and their expertise, who are the people in each center that are involved in applying those outlier payments and managing the reimbursement for kidney transplant.

Then the other path we will also obviously examine with our medical team is their clinical knowledge. Do they have awareness of desensitization?

Are they doing that today to what extent? Our initial focus will be on those 100 centers.

I think the key learning is that having clinical experience will matter. That's why I made a 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.

Going back to the fact that we have 25 centers in the U.S. that have participated in ConfIdeS, I would expect those centers to be among the early adopters, but not limited to those 25, obviously.

I think that's the way we're currently looking at the market is focused on those 100 centers and those that have a clear knowledge of the reimbursement pathway and clinical knowledge, I think, will be the early adopters. I think what we need to keep in mind also is that we are launching into a new space.

There is no other product in the U.S. approved for desensitization that have the same mechanism of action as Imlifidase and can do the same thing.

There's a lot of interest from KOLs and from the patient community. 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. I think the potential is clearly there, but as I mentioned, we'll take a very focused approach as we prepare for launch in the U.S.

I guess just in terms of following up on the reimbursement, Maria, you mentioned both the opportunity -- this will obviously largely be reimbursement in DRG for Medicare patients and the access of both eventually wanted to get applied from the NTAP. I agree with you, institutions are generally very familiar with it.

I'm just curious, you did note that before the NTAP that hospitals will be able to access the outlier payments. How much would those or that outlier payment cover the DRG -- or cover the cost of Imlifidase early go?

A very good question. 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 the cost for kidney transplant. Hospitals are today applying the outlier payment for anything 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, where the hospital is based, the cost of living of that state as an example. It also depends on what they are submitting to CMS.

A hospital could, in reality, 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 have submitted for.

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." It's hard to say, it's not a precise number.

It depends on what they charge CMS for, and this mathematical formula. As I said, that is something hospitals are doing today.

They do outlier payments for the DRG type Medicare reimbursements. I can't answer fully the question, but I hope I gave you some insight into how it works.

No. I mean, because this is a kidney transplant with complication from in terms of the DRG and they submit a lot.

I mean when you think about the typical DRGs or the outlier payments because I think the CMS typically buckets them or think of them roughly in the same range, do you think you'd be able to cover a fair amount with Imlifidase? Then I guess just as 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 free goods and just the value of getting clinicians used to using the product in that early clinical experience versus maybe not having optimizing revenues in the early going?

Obviously, free goods would impact your gross to net.

Yes. I was the first answer your question on getting outlier payments to cover our drug.

I would say that I'm confident that we will work with the hospitals to ensure that they can use Imlifidase. As I mentioned, as part of the pre-launch work we're doing right now is to understand what are they doing today, what does their P&T committee look like today.

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.

I think one of the early learnings is that, that may look different from center-to-center in terms of how they today manage DRG payments and outlier payments. I would not say that, that is something that is going to prevent us.

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 as we come to launch.

I'm obviously aware of the fact that companies tend to have a policy around access to free drugs when they launch, and we'll have that as well when we have Imlifidase hopefully approved in the U.S.

One of the things I would just add is obviously just the Medicare reimbursement received for hospital is not tapped at DRG, right? DRG is a guaranteed base payment that the hospital can expect to receive.

If you actually look at something like CAR-T, which I think is a fairly good analog here, if you look at [indiscernible], 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. There was a pretty robust uptake of that.

I think certainly, even hospitals were reporting that they were profitable when they were providing CAR-T treatment. Again, I think that there is certainly familiarity with the hospitals around these situations.

I don't think that we should get too carried away with the actual DRG number per se, because it is more of a 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 the CMS looks at this. Hopefully, we've covered that for you.

Congrats on the progress. Just on the U.S.

commercial launch preparations, you referred to some work you're doing refining the supply and distribution plans for Idefirix in the U.S. Can you just elaborate on that?

Update us on the manufacturing and how you're thinking about distribution of the drug product in the states? 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? When it comes to the U.S., how are you thinking about potential adoption in other solid organ settings beyond kidney transplant?

You want to start off, Maria, on supply?

Sure. Some more details on supply and distribution.

Our drug, Imlifidase is manufactured in Europe. 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.

Really, the question that we're solving for is how do we get the drug into the U.S. Then when it comes into the U.S.

to 3PL, what is the distribution network going to look like, which specialty distributors are we going to use? Then how are they going to purchase -- the hospitals are going to purchase the drug from the SD.

That's a very typical U.S. launch prep that we're doing.

When it comes to France, and the lung transplant program, there is a KOL in France that has, I think, a few years ago used Imlifidase in a compassionate use in a lung transplant patient. That is really how it started that obviously saw the benefit of using this despite the fact that we don't have an indication in lung transplant.

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. I would say that, that particular pathway is has happened for other drugs in France as well.

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. We haven't generated any clinical data, but that is the pathway that has been established in France since November.

You asked also about U.S. adoption across other transplants.

I think that is a bit too early to say. I think if you -- Renee 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 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 Imlifidase in heart and liver transplant that is a published case study. It's hard to judge at this point in time how and if it will be used.

I don't know, Renee, if you want to comment anything further on that other organ transplant.

Sure. Yes.

I mean, as Maria said, I mean, this is tricky to discuss off-label use when we don't really have an approved product at this point in time. I would say, subsequent to potential approval, obviously, it would make sense for us to revisit 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?

Is there anything that we should do, could do to try and facilitate some of this. I think it will depend a lot on what regulatory advice we get regarding this potentially.

I think for now, we're really just focused on getting the approval and launching in kidney, which is a very, very substantial opportunity. We are aware, obviously, that there's a lot of can perceive unmet medical need in all of these transplant settings.

I think we will take one step at a time at this point.

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

I guess I'll have Richard comment on this shortly. I guess that we're internally at this stage, we are looking at a variety of different options to bring to the FDA, and we will very shortly decide upon which way we're going to take this forward.

Obviously, in all of these conversations with KOLs, various trials have come up. Also, most drugs and most trials, they all have their benefits and drawbacks.

We should all learn from each other in terms of how to best optimize for the benefit of the patient. Richard, I don't know if you have any specific comments on that.

Sure. I think there clearly are opportunities to learn other development programs, other clinical trials that are being conducted in the field, as Renee says.

I mean, we're still at the stage of looking at different development options, different clinical trial options. 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 provides us with useful information that we can use when we are designing our program molecule 5487. I think that's an equally important area of information that we're using along with, as Renee said, and you have indicated learning from what other companies have done.

I think the critical step really is to take our preferred design option, which we will very shortly identify and take that for discussion with regulatory authorities, in particular, the FDA. I think that feedback will be critical in terms of determining the way forward.

I have one question. When do you recognize revenue?

How long on average does it take to convert the conversion from into cash?

Evan, do you want to take that question?

Yes. Sure.

Great question. We recognize revenue, as you would guess, under IFRS 15.

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 could be 30, 60 or 90 days later.

There is sometimes a timing difference between revenue recognition and the collection of cash in accounts receivable.

Congrats on the quarter. Two quick questions, if I may.

First, on the Sarepta collaboration, you say in the report that you're 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 for that. In terms of the Sarepta collaboration, as I'm sure you're aware, I mean, Sarepta is having quite a lot of regulatory interactions at the moment with regards to their core business.

That's really where their focus is at the moment. I think that the only thing that I can say is that 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.

It's difficult for me to give you an exact timing of when we'll be able to 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.

I can assure you as soon as we do, we will communicate it. As I said, I mean, we're in ongoing discussions and communication and conversation.

It is hard to give an exact time at this point in time. 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 Sarepta 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?

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

Yes. We baked that into our budget.

As Renee mentioned earlier, we have cash into 2027. We've anticipated those costs.

We haven't reported them or broken them out specifically, but the U.S. is a very, very large market.

I think to address that work with 18 to 20 different reps is a really good use of capital.

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

Yes. You should model them.

I think including the 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. Then I would take an average salary and wage for U.S.

employee.

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

Thank you.