Hansa Biopharma AB (publ)

Thank you, operator. Good afternoon, good morning, and welcome to the Hansa Biopharma conference call to review the full-year and Q4 results for 2024.

I'm John Tulloch, President and CEO of Hansa Biopharma. Joining me today is Evan Ballanti-ne, Chief Financial Officer and Hitto Kaufmann, Chief R&D Officer.

Please turn to Slide 2. Please allow me to draw your attention to the fact that we will be making forward-looking statements during this presentation, and you should therefore apply appropriate caution.

Please turn to Slide 3 and an overview of today's agenda. Today, we'll discuss the progress we made during the fourth quarter and review the full-year 2024 performance.

The presentation should take roughly 15 to 20 minutes, after which there will be an opportunity to ask questions during a Q&A session. Please turn to Slide 4 and an overview of our Q4 and full-year performance.

Let's first begin with full-year performance. Total revenue for 2024 was SEK 220.9 million and full-year idleric sales totaled SEK 189.7 million set representing an 83% increase over the prior year.

This performance excludes the impact of a provision of SEK 49.6 million taken in 2024 to reflect discounts and a one-time retroactive rebate linked to successful special early access programs since the launch of IDEFIRIX in 2020. Including the impact of the provision, full-year 2024 total revenue was SEK 171.3 million, representing a 28% increase versus prior year.

Additionally, full-year IDEFIRIX sales including the impact of the provision totaled SEK 140.1 representing a 35% increase over the prior year. The solid year-over-year IDEFIRIX sales growth reflects continued strong launch execution in Europe, which has resulted in an increase in clinical utilization in key markets and continued advancement of regional and local clinical guidelines on the appropriate use of IDEFIRIX in highly sensitized kidney transplant patients.

We're especially encouraged not just by the growing number of key clinics with specific IDEFIRIX protocols in place, but also the growing number of clinics with repeat IDEFIRIX usage following successful outcomes of first transplants and we see this as a key driver of expected future growth. Please turn to Slide 5.

I'd also like to highlight the trailing 12-month product sales data that shows performance over the previous year. This underscores the continued launch progress and growing market uptake without quarterly volatility due to variations in the flow of organ offers to specific highly sensitized patients waiting for an organ offer.

The volatility we expect will continue albeit with diminishing effect over time as we expand the ongoing usage of IDEFIRIX and penetrate new markets throughout Europe and beyond.

Additionally, we completed enrollment in our Phase 3 study in anti-GBM and initiated a Phase 2 trial with our partner Genifin in Crichton Najjar Syndrome. This marked our second gene therapy trial to commence last year.

The first trial was a Phase 1b study with our partner SUREPTRA in Duchenne muscular dystrophy. This trial continues to enroll patients.

2024 also marks significant progress with HANSA-5487, our next-generation IgG cleaning enzyme with redosing potential. In October, we shared positive data from our 12-month analysis of the NYSE-one first in human study.

This analysis demonstrated that HANSA-5487 can robustly and rapidly reduce IgG levels, has redosing potential and a favorable safety and tolerability profile. Early in the year, we completed randomization of all patients in the U.S.

Confided Phase 3 trial in kidney transplantation. The trial is on track for data readout in the second half of 2025 followed by the expected submission of a BLA to the U.S.

FDA under the accelerated approval pathway. Hitto will share more details in a few minutes about these trials and our clinical development plans.

Before moving to the next slide, I'd like to highlight our successful efforts to communicate the benefits of ConfideS in scientific publications and presentations at leading medical congresses around the world. Please turn to Slide 7 for an overview of the commercialization of IDEFIRIX in Europe.

We continue to make solid commercial progress with IDEFIRIX in Europe as a desensitization treatment and kidney transplantation. Due to the continued successful launch efforts in the number of centers gaining clinical experience with IDEFIRIX continues to grow with three additional centers added in Q4 and more than half of all clinics utilizing IDEFIRIX more than once after a positive first clinical experience.

Additionally, I'm pleased to share that following the team's successful engagement with key opinion leaders in Europe and medical societies there, there are now two published international consensus documents providing guidance on desensitization in kidney transplantation. The most recent guidance was published in Transplant International, providing specific guidelines on the appropriate use of Imlifidase in clinical practice to enable kidney transplants in highly sensitized patients.

Finally, thanks to our continued successful market access efforts, we recently secured reimbursement in three additional European markets. HandsOnNow has secured reimbursement in 18 markets, including the five largest European markets.

We recognize the innate volatility in organ transplantation market due to variations in the flow of organ offers, but are encouraged by the growing number of clinics that are ready to treat with IDEFIRIX and the increase in urine repeat users providing a solid foundation for expected continued growth and market uptake. I will now turn it over to Hitto for an update on the pipeline and clinical development.

Please turn to Slide 8.

Thank you, Theron. Please turn to Slide 9 for an update on the pipeline and clinical development highlights to date.

As you can see, we continue to make good progress across the pipeline in all three therapeutic areas. And in the fourth quarter, we shared several updates in both the autoimmune and gene therapy areas.

I'll now walk through some of the specific trials and studies we have ongoing and the clinical development plans we have in place. Please move to Slide 10.

Let me start with the left hand side of this slide and reiterate the continuous focus of Hansa on advancing science in areas where there remains high unmet medical need. I'm pleased to share that over the course of 2024, we have presented at several leading congresses in autoimmune, gene therapy, and transplantation, and published 10 articles in peer reviewed journals.

These efforts underscore our commitment to advancing the understanding of potential applications for our molecules, as well as the science behind complex conditions with very few treatment options. On the right hand of the slide, you can see a summary of the progress we have made in 2024, and specifically, the clinical development of Imlifidase and HNSA-5487.

In autoimmune, we communicated two key pieces of data in Q4. The first is the positive results of the 15H meditis09 Phase 2 study of imlifidase, an indirect treatment analysis of that data to the International Green Bar Syndrome Outcome Study, or IGOS, in Green Barr Syndrome, also known as DBS.

The second is the completed enrollment of GOOD-IDES-02 Phase 2I trial in anti-GBM. The GOOD-IDES-02 trial is a Phase 2I open label controlled randomized multicenter trial across Europe and the US and is evaluating renal function and the need for dialysis at six months in patients with severe anti-GBM disease.

Anti-GBM is a rare severe autoimmune condition affecting around 1.6 people per million annually. Encouraged by our Phase 2 data, we believe imlifidase has significant potential improving the outcome of these patients and address the unmet medical needs.

ELEVIDYS has been granted orphan drug designation for the treatment of anti-GBM disease by both the U.S. Food and Drug Administration and the European Medicines Agency.

Q4 also marks the commencement of our second trial in gene therapy. In December, we announced the initiation of a trial with Genethon, one of our gene therapy partners in Crigler-Najjar syndrome.

The trial, GNT-018 IDIS, is a Phase 2 trial in patients with Crigler-Najjar Syndrome with pre-existing antibodies against adeno-associated virus vectors or AAV. The trial will evaluate the efficacy and safety of single intravenous administration of Genitorm's gene therapy, GNT-003, following pretreatment with HMedIdeS.

Antibodies against ACE vectors remain a major challenge as their presence in patients excludes them from entering clinical studies with potential curative gene therapy treatment and from access to currently marketed and future gene therapies. Crisey Lejeune syndrome is a rare genetic liver disease characterized by abnormally high levels of bilirubin in the blood, which leads to irreversible neurological damage manifested as muscle weakness, lethargy, deafness, intellectual disability, and eye movement paralysis.

At present, patients must undergo phototherapy for up to 12 hours a day to keep the bilirubin levels below the toxicity threshold. Crigler Najjar Syndrome is an ultra-rare disease affecting less than one case per 1 million per year.

GNT-003 is currently being evaluated in a pivotal clinical study in France, Italy and The Netherlands and has received prime status from the European Medicines Agency. Of note, enrollment in SRP-9001104 Phase 1b trial continues.

As a reminder, the trial is evaluating the use of HMedIdeS as a pretreatment to SURECTA therapeutics and Levitus gene therapy in Duchenne muscle dystrophy. In transplantation, we continue to progress enrollment of patients in the Post Authorization Efficacy and Safety Study, PAES, as part of our obligation to the European Medicines Agency.

As mentioned, we are now at 96% enrollment rate with 48 out of 50 patients enrolled. This study will support the adoption of IDEFIRIX more broadly and allow even more clinics to gain clinical experience.

Once completed, centers are expected to commence or increase usage of commercial product. And the confided U.S.

Pivotal trial three in Phase 3 was fully randomized in May, and we plan to deliver data in the second half of 2025, followed by a BLA submission to the U.S. FDA.

Moving to HANSA-5487, our next-generation IgG cleaving enzyme. In October of 2024, we announced positive results of the Nice-01 first in human trial and findings from a twelve month analysis of that data.

The analysis demonstrated that HANSA-5487 can robustly and very rapidly reduce IgG levels, has redosing potential and a favorable safety and tolerability profile. We believe HANSA-5487 has a highly differentiated profile compared to published data from studies with other IgG-targeted therapies.

HANSA-5487 has the potential to address significant unmet need across the spectrum of chronic autoimmune diseases, where IgG plays a role in disease pathology, including autoimmune conditions, and where the need for management of repeat acute immune system attacks is crucial. We will focus initial clinical development in neuroautoimmune diseases with a well-characterized role of specific auto antibodies in disease pathology and recurring acute phases, specifically myasthenia gravis or MG.

A significant number of patients with chronic neurological autoimmune diseases face exacerbations and even severe crisis leading to hospitalization demonstrating the high unmet medical need today. In the first half of 2025, we plan to align with regulatory agencies on the clinical development path of HNSA-5487 in myasthenia gravis.

Please turn to Slide 11 for a summary of the data from 15-HMedIdeS-09 study in GBS. I want to spend just a few minutes providing a bit more context on Phase 2, the 15 H METIDIS-9 and the indirect treatment comparison to IGOS.

As a reminder, 15-HMedIdeS-09 is an open label, single arm, multicenter study across The UK, France and The Netherlands. Patients with severe GBS included all patients with a disability score at and above three.

The study evaluated safety, tolerability and efficacy of single dose imlifidase in combination with intravenous hemoglobin or IVIg in ‘27 adult GBS patients. Data from the study demonstrated that severe GBS patients treated with imlifidase plus IVIG had rapid overall improvement in functional status, including expedited recovery of muscle strength, rapid return to independently walking and a median time to improve by at least one grade in the GBS study at six days.

The key results from the study are one week after treatment, 37% of patients were able to independently walk, and the median treatment in muscle strength was 10.7 points as assessed by Medical Research Council or MRC sum score. Additionally, the median time to independently walk for patients treated in the study was 16 days.

Finally, at week eight, 67% of patients were able to walk independently, 41% of patients had regained the ability to run, and 37% of patients had improved by at least three points in the GBS disability score. Finally, at six months, 63%of patients were able to run or had no functional disability.

Please turn to Slide 12. When compared to the IGEL's real world comparative group, 754 severe GBS patients treated with IVIg, patients in the 15-HMedIdeS study, which included 27 severe GBS patients treated with imlifidase in combination with IVIg experienced statistically significant improvement across several clinical meaningful measures.

The indirect treatment comparison concluded that patients in the 15-HMedIdeS-09 study treated with amlica data plus IVIg returned to independently walking six weeks sooner when compared to severe GBS patients in the IGOS reward comparator group treated with IVIg alone. Additionally, patients in the 15 HVAD iosinone study experienced statistically significant improvement across several clinically meaningful measures at multiple time points.

At week one, patients were 6.4x more likely to walk independently compared to the IGOR's real world comparator group. In GBS, IgG is a key driver of inflammatory attacks on peripheral nerves and has been clinically linked to the severity and progression of the disease.

Rapid reduction of IgG levels has the potential to benefit GBS patients by depleting pathological IgG antibodies, thereby halting disease progression resulting in faster recovery and less severe disease. Improvement in GBF disability score is important because it directly affects the clinical outcomes, recovery and quality of the life for patients.

Better management of disease severity can help reduce the risk of life threatening complications, shorten recovery time, prevent long term disability, lower health care costs and improve overall patient well-being. We believe these results demonstrate the significant role that ELEVIDYS may play in the treatment of GBS in combination with the standard of care IVIg.

Unlike other molecules, ELEVIDYS can effectively and very rapidly cleave IgG, potentially halting the progression of MRF damage associated with GBS and stopping the progression of the disease. I will now turn it over to Evan to cover financial performance.

Please turn the slide. Could we advance one more slide?

Thank you, Hitto. Let's walk through the company's financial performance for Q4 and the full-year.

Revenue for the full-year totaled SEK 171.3 million, representing a 28% increase from the previous year of SEK 134.1 million. Q4 revenue totaled SEK 32.3 million, including IDEFIRIX product sales of SEK 25.6 million.

Excluding the impact of the aforementioned provision, product sales for the full-year were SEK 189.7 million, representing an increase of 83% or SEK 86 million compared to the prior year product sales of SEK 103.7 million. It is important to recognize that despite strong full-year 2024 sales of IDIFRX, quarterly sales continue to fluctuate as a direct result of variations in the European kidney allocation systems.

As mentioned in previous quarters, the company recorded a provision totaling SEK 49.6 million to reflect discounts and a one-time retroactive rebate on cumulative sales since the launch of IDEFIRIX in 2020. At this time, the company does not expect any further provisions will be necessary.

Next slide please, 15. SG&A expenses totaled approximately SEK 88.5 million for Q4 and SEK 343.8 million for the full-year of 2024.

Full-year SG&A expense was SEK 106.7 million or 24% favorable compared to the prior year. Restructuring activities help reduce total year-over-year SG&A expense and as previously mentioned, SG&A expenses included a restructuring reserve of approximately SEK 3.5 million.

For the full-year 2024, SG&A expense included a SEK 24 million non-cash charge related to the company's long term incentive programs or LTIP. R&D expenses totaled approximately SEK 101.4 million for Q4 and approximately SEK 375.7 million for the full-year.

Full-year R&D expense was SEK 36 million or 9% favorable compared to the prior year. The favorable decrease in R&D expense was primarily driven by restructuring actions.

Full-year R&D expense included approximately SEK 7.9 million of non-cash charges related to the company's LTIP program and a restructuring reserve of SEK 6.6 million. For the full-year, net financial income and expense resulted in total expense of approximately SE166.3 million compared to SE42.3 million in Q3 or in 2024 or 2023.

In Q4, net financial income and expense represented an expense of approximately SEK 100 million in contrast to income of SEK 51.3 million in Q4 of 2023. Changes in financial income and expense are primarily driven by non-cash expense related to the NovaQuest note and changes in the US Dollar exchange rate against the Swedish krona.

The full-year operating loss of SEK 641.4 million was SEK 147.3 million or 19% favorable compared to the operating loss of SEK 788.5 million in 2023. The Q4 operating loss of approximately SEK 173.6 million was essentially flat compared to the prior year.

The improvement in Hansa's operating loss compared to the prior year was driven by increased sales as well as an overall reduction in expense. Please turn to the next slide.

Cash used in operations for Q4 totaled SEK 148 million and SEK 665 million for the full-year ended December 31, 2024 or December 31. As previously mentioned, the company completed the direct share issue of approximately SEK 372 million or approximately 35 million in the second quarter.

In Q4, cash and cash equivalents totaled SEK 405 million. I'd like to turn the presentation back to Soren.

Please turn to Slide 17.

Thank you, Evan. With this overview, our presentation has now concluded and we would like to open the call for questions.

Operator, please begin.

Hi, team. This is Suzanne from Kempen.

Thanks for taking my questions. Could you elaborate a bit more on your planned regulatory interactions on the repeat dose candidate in MG?

Like what type of meeting is it that you plan with the FDA and what should we expect in terms of an update on next steps for this program in the first half of this year? And in a similar fashion, you've had the Phase 2 comparison data for GBS.

What are next steps for this program or when should we hear more on advancing the program into a Phase 3? And then I have a follow-up as well.

Well, thank you, Suzanne, for those two questions. So first on the planned interaction with regulatory agencies on the next step for 6487.

As we have communicated, it is our intent to move into myasthenia gravis here. And so the plan for this interaction is to consult and get feedback on the proposed clinical trial design and we said earlier during this call, we expect this interaction to happen in the coming months essentially.

I don't know, Hitto, do you want to add anything to this?

Sure. Thank you, sir.

And just to add a little bit of flavor here, very specifically, we are planning for a Phase 1b study in patients and we have, as you can imagine, detailed the protocol and we'll discuss that we'll have authorities, especially since in myasthenia gravis, it's important to carefully consider the subpopulation of patients that you want to target in an early study. You could also safely assume that there will be some dose-finding elements in there.

However, we will only post conversation with health authorities detail out the study plan, and that's what you can expect at some point in time.

Got it. And for TBS?

Yes. And for us with TBS, again, Hitto, do you want to take this?

Sure. So our refined thinking on GBS is clear to commence with a Phase 3 study that would have a control arm that reflects the current either standard of care or practice of medicine, depending on which country you look at, which is essentially IVIG.

So that's what we've disclosed so far. And again, we're in continuous dialogue there as well.

Got it. Thank you.

And maybe with regards to the Phase 3 readouts for the U.S. Kidney trial and the study in anti-GBM in particular, what amount of data disclosure can we expect in the top line release?

Will this be primarily qualitative in nature of meeting the endpoints or not or will you also report the kidney function result itself and perhaps some more? Thank you.

Well, thanks for that additional question, Suzanne. So we expect that the first readout essentially would be the overall conclusion right on primary endpoint and I think these two trials have been very carefully designed to be able to make a conclusion on that and then of course subsequently there will be more full disclosure of additional results.

Yes. Good afternoon.

I have two questions. Maybe to start with looking at the outlook into 2025, what are the key triggers that could drive and improve the EU sales?

Is it a high definition of the PEAS study? Is it the urotransplant or cell system other component which I'm missing here?

And then I have a second question.

Well, thanks Alexander for that question. So we're quite optimistic for 2025.

We've seen solid growth in 2024. If we look at all of the indicators of a successful launch, i.e., number of clinics with protocols in place, number of clinics that have tried the product, number of clinics that have tried the product successfully and have used it in the second and third patient and so on.

All of the lights there are on green. We are also expanding the footprint, the reimbursement footprint in Europe.

Towards the end of the year, we got reimbursement at the national level in Spain and Italy. Two very important kidney transplant markets in Europe.

It's being translated from the national level to regional level in Italy, I think we're at north of 90% of regions. And in Spain, we now have reimbursement in the second very important region.

We got the first Catalonia very recently. That's the most important region in Spain.

And so we are seeing large opportunities becoming available for sales this year. So that's certainly one part of it, impacting our thinking around the growth opportunities in 2025.

Another is, as you mentioned the completion of enrollment in the post-approval efficacy study. We're very, very close to having this fully enrolled.

48 out of 50 patients have been enrolled. Obviously these patients have kind of been cannibalizing sales in in the past and when the study is fully enrolled, we expect that these key centers that now have significant experience actually transplanti-ng patients using IDIFIRIX to desensitize ahead of the transplant, will be converted to commercial sales.

And they have even lined up patients as part of participating in this trial. So that's clearly also going to be a growth driver in 2025.

And then you mentioned the Euro transplant program, which covers, Germany, BENELUX, Croatia, Hungary, Slovenia, a few other countries and that is moving forward as well. So as that progresses and data becomes, you know, available throughout the participating clinics and they gain experience, we expect a positive impact also on transplants taking place outside of this specific program.

So there's really a number of reasons why we think, 2025 is going to be another year with significant growth.

Okay, thank you. And second question on the Sarepta.

Maybe it's a mistake, but in the report, I think you do not write anymore that the initial data readout in 2025, but I think you had it on the slides. Could you elaborate a little bit, like what are the, the bottlenecks with that trial?

I mean, I know Sarepta is running it, but maybe you could look shed a little bit more light on what this means in terms of like also the milestone payments and the collaboration revenue you expect from Sarepta into 2025 is something that is going to increase compared to ‘24 levels.

So as you said, this study is being run by partner Sarepta. We have a very good collaboration with them and we are excited to see the trial progress.

It's still enrolling patients and so patients are being lined up and enrolled and we do expect data to be available this year. This is what Sarepta has also communicated in the public domain.

So as I said, moving forward as planned and we're really excited about that. We are also very excited about the second clinical stage trial we have ongoing in the gene therapy space with our French partner Genethon in Crigler-Najjar where we have started the trial and we have enrolled the first patient.

This is a group of patients where there's a very high proportion of them that have two high titus of neutralizing antibodies against the vector used in the gene therapy. And therefore there's a significant unmet medical need and a very serious disease to enable administration of hopefully, successful gene therapy in these patients.

So moving forward as well and we're certainly hoping to get data this year as well.in that disease. And that will be then in different tissue than the Sarepta trial in Duchenne.

In Duchenne, it's muscle tissue. In Crigler-Najjar, it's liver tissue.

So 'twenty five, we hope, is going to be very, very exciting, an important year for our efforts in the gene therapy space.

Great. And maybe just on the financial aspect of Sarepta, please?

A - Soren Tulstrup Yes, well, there is a number of milestones as you know, significant amount of milestones potentially ahead trial, just shy of $400 million, we have not communicated the specifics around timing and so on of these milestones, but obviously as the program progresses, this is becoming more near term.

Hi. Can you hear me?

A - Soren Tulstrup Yes. Good morning, Doug.

Hey, good morning, Soren. Just maybe just to start with the performance in the fourth quarter, was there any particular markets that maybe were sort of came in below sort of your current expectations?

I know there's always some variability, but just were there any sort of specific markets, in particular, I'm thinking about France that may have been a little slower than had been the prior trend. A – Soren Tulstrup I cannot offer that level of granularity.

What I do want to say overall is as we've discussed and as you know very well Doug, sales is volatile, right, whether a number of patients are transplanted this side of the quarter or the other side really depends on availability of organs and acceptance of organs and the value of one single transplant versus the total sales is significant and material, right? So I'm not surprised that we see a quarter that is not on a par with the previous quarter, which was our best quarter ever, right?

So that's what I can say. I would say on France, France really continues to be a growth driver.

We're very, very encouraged by what we've seen in France. And again, France is the one major market in Europe where we've had access for a number of years through the early access program and it is a country where there was a little bit of experience early on that we've been able to leverage and spread throughout the country.

So we're looking really to emulate what has happened in France and some of the other key markets and certainly a promising one is Spain, which is really one of the most sophisticated kidney transplant markets in Europe. So, we're encouraged by what we've seen so far.

I should mention that we are also looking at some markets outside of Europe like Australia where we got approval with a label even including living donor situations that's obviously a way to expand the market and be less exposed to the challenge of competing for available deceased donor organs and so hopefully we're negotiating with the Australian authorities, but that's a market where also right now there is actually material significant experience. I think it's around eight patients that have been transplanted and quite a number of those living donor transplants.

So we have good hopes there and clearly ahead of us are other very important markets, not just in Europe, Middle East, Asia, Latin America, but also importantly the U.S. Of course.

And maybe as a follow-up question, in terms of GBS, there has been some other clinical development activity by competitors. I'm just curious, does that influence in any way how you are thinking about sort of moving into a pivotal study design?

Yes, you're right. There has been recent clinical activity in that space, and actually we've been encouraged by the attention that this has attracted.

Clearly, there is a high unmet medical need for these patients. It's a very serious disease.

It just hits you very, very suddenly. These patients are hospitalized in ICUs and it's extremely important to have very fast, very rapid and significant impact on the disease and so we are very encouraged by the data that we've been able to generate looking at also patients in the, I guess database and that kind of confirms our intent to, you know, move forward in this market.

We have not changed our plans for, let's say, the sign of Phase 3 trial or anything based on newly available data from other trials. We think this is a great way to demonstrate a benefit versus standard of care, which really in the US and in Europe is IVIG.

So we think we have a really, really good starting point to generate the data that the market will value, and will guide their prescription pattern.

Hi, this is Eric on for Matt Phipps. Thanks for taking the question.

Just two questions. So, first, after the seasonality impact in the fourth quarter, can you comment on all, about how the transplant rates have started in the 2025 year?

And secondly, can you characterize or provide any additional granularity on how much benefit completing the post-authorization efficacy study will provide to revenue in Europe in 2025?

Thanks, Eric for those two questions. So as far as seasonality is concerned, I think it's too early to say that there's specific seasonality here.

Like I explained, you know, we have expected from the start that there would be significant volatility quarter on quarter, just depending on the organ offer flow and whether specific organs are accepted by specific clinics for specific patients. And I'm not going to comment on how this year has started and so on, other than saying that, clearly we expect for the reasons that I discussed just before, we expect continued strong growth in Europe.

Then you asked about the benefits, specific benefits of the post-approval efficacy study and really of course are two benefits. Well, three, sorry.

First, as I discussed earlier, the fact that all patients soon will be enrolled means that there will be no cannibalization going forward, right? We are talking about 50 patients that have been transplanted in this trial, in parallel with us actually marketing commercial products in the same region.

So that effect is going to stop. Then you will have centers that will be ready to use commercial products, and who will have actual experience and even protocols in place in these clinics.

So that's going to be helpful as well. And then of course, first we are looking forward, of course, to getting the data.

We believe that the data will reinforce the, let's say the positive position of IDEFIRIX in the market. We have generated now quite some data also on commercially transplanted patients or data has been generated in various markets and has been reflected also in guidelines and so on.

We believe that additional data obviously will be helpful. And of course, in the end, we're looking to get full approval in Europe based on the totality of data generated also from this post approval study.

Yes, first moving into then 2025, what about the ability to see patients that are about both, call it pipeline of patients, patients being ready at centers, what's your level of visibility as you move into 2025?

Yes, great question. So what we've seen over the past 12 to 18 months is actually an increase in the pipeline of patients, right?

They're being identified by the centers and by specific programs like the Euro transplant program, which screens a large number of patients and then identify quite a number and so on. So there is a growing pipeline of patients and that again confirms the unmet medical need and also the desire by the clinics and the medical community to actually do something.

Clearly, what you also want to see at some point is that patients start to become active, right, because there is a competition for available deceased donor organs, particularly again through my experience with previous launches that is going to come at some point. There is increasing awareness of the fact that some patients really don't have access to life-saving kidney transplants and I don't think that that's going to be accepted for many years into the future.

So we're also looking for patient growth at some point.

Thanks. That's very useful.

And related to that, of course, you're not in a position or nobody is to promote off-label use, but perhaps there is a sense or if you notice that there are centers keeping very strict to the label or is it are some considering using your products also for less extremely sensitized patients?

Well, I mean, let's say the rules, the guidelines, instructions for what patients qualify and what patients don't qualify vary from country to country and sometimes from center to center, right? But in general, of course, it's on label in the sense that they're transplanting highly sensitized patients that are unlikely to be transplanted given local organ allocation system.

So that's the overall judgment that's been used by the centers and other decision-makers here.

Interesting, and finally then on the COMPANYA studio study, is it possible to give a sense of how many new centers that are naive to IDEFIRIX earlier that it will sort of be added towards the network with the Bayer study? And also the same question for the Euro transplant program?

Well, I mean, of course from the start, all of the centers have been more or less naive, right? We had a limited number of centers involved in Phase 2 trials.

And therefore the Confides trial is important not just in generating data, but also in generating experience in what are the really the key centers for kidney transplantation in the US. And as you know, we have involved a large number, north of 20 centers here.

And so the situation in the US is going to be very, very unlike the situation in Europe in that we're going to have at least 10 times as many, you know, key clinics with experience at the time of launch. And we've seen in France what that means, right?

So we've essentially done the most perfect pre-marketing job you can do and mainly run this Phase 3 trial against the US Kidney Allocation System. So the centers have also learned how to operate within that system.

So we're really encouraged by the progress there, the engagement by the trial sites. And also broadly in the US we've been in contact, of course, with hearsay and other key, you know, stakeholders and decision makers in this space.

The current administration, is also very, let's say, I wouldn't say optimistic, but they're really pushing for an improvement in the transplant rate. When they were last in power, they set a target of doubling the transplant rate in the US.

And I've heard numbers as high as, you know, north of 60,000 transplants. Now there are 20 something thousand.

So that's really good tailwind as well. So we think that there are a lot of indicators showing that the US opportunity is very, very material and that we're able to, we will be able to, explore and exploit that, you know, much faster than what has happened in Europe.

Excellent. That's very useful.

I always think about Europe then the Euro transplant program, that program is also adding centers, presumably, and also the confirmatory study in Europe.

Yes. Yeah, absolutely.

So again the Euro transplant study is obviously a, let's say regulated planned way of generating experience and in these particular patients in Europe and participating countries. And so that's also great.

And then the post-approval efficacy study clearly involves centers also that from the start, didn't have experience, and now they have experience and even protocols in place, as I said. So that's important.

I mean, say a country like Mellons, for instance, which, has a number of centers participating, it's going to be very important, for that country that, you know, now this study is fully enrolled soon. And of course we're hopefully supporting data.

Excellent. Is it possible to ask questions regarding OpEx and especially R&D?

Yeah, you can have one last question you want to ask.

Thank you. Yeah, R&D side, it was a step up in Q4.

What sort of level of trending should we expect moving into ‘25? Is, is Q4 level we should be familiar with or is this a bit on the high side?

I’ll turn it over to…

Yeah, Evan here. I think it's a bit on the high side right now, but, look, the Confides trial in the US is winding down.

As Hitto discussed. He's meeting with the FDA and regulatory bodies in Europe and the US to launch trials, additional trials for 5487.

So my expectation is that in the latter half of the year, we'll see, R&D expense go up as we enter those clinical trials, but come down as we complete the PAES, uh, trial, which is, Soren mentioned is almost fully enrolled. And as we complete the confides, uh, U.S.

Phase 3 trial.

So, it sounds like we should expect a bit lower and the first half and then perhaps trending upwards afterwards.

Yeah.

Excellent. Thank you.

Well, thank you Aubrey, and thank you everyone who called in. We appreciate your, your interest in Hansa, I've got an exciting year ahead of us and look forward to keeping you updated.

Thank you.