Good day, and welcome to the Hansa Biopharma year-end and fourth quarter 2024 report. 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 and then two. Please note this event is being recorded. I would now like to turn the conference over to Søren Tulstrup, President and CEO. Please go ahead.
Thank you, Albrecht. Good afternoon, good morning, and welcome to the Hansa Biopharma conference call to review the full year and Q4 results for 2024. I'm Søren Tulstrup, President and CEO of Hansa Biopharma. Joining me today is Evan Ballantyne, Chief Financial Officer, and Hitto Kaufmann, Chief R&D Officer. Please turn to slide two. Please allow me to draw your attention to the fact that we'll be making forward-looking statements during this presentation, and you should therefore apply appropriate caution. Please turn to slide three and an overview of 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. Now, please turn to slide four 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 IDEFIRIX sales totaled SEK 189.7 million, 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 million, 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 five. 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, a 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. Please turn to slide six. 2024 saw much progress in our pipeline projects, and we're very pleased with the delivery of several key pipeline catalysts and advancement of scientific exchange. Of note, we announced positive results from our phase II trial in GBS and results of an indirect treatment comparison to the International Guillain-Barré Syndrome Outcome Study, or IGOS, demonstrating the potential of Imlifidase, our first-generation IgG cleaving molecule, to address a significant unmet need in GBS.
Additionally, we completed enrollment in our phase III study in anti-GBM and initiated a phase II trial with our partner Genethon in Crigler-Najjar syndrome. This marked our second gene therapy trial to commence last year. The first trial was a phase I- B study with our partner Sarepta in Duchenne Muscular Dystrophy. This trial continues to enroll patients. 2024 also marked significant progress with HNSA -5487, our next-generation IgG cleaving enzyme with redosing potential. In October, we shared positive data from our 12-month analysis of the NICE-01 first-in-human study. This analysis demonstrated that HNSA-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. ConfideS phase III 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 Imlifidase in scientific publications and presentations at leading medical congresses around the world. Please turn to slide seven 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 in kidney transplantation.
Due to the continued successful launch efforts and 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 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. Hansa now 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 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 eight.
Thank you, Søren. Please turn to slide nine 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 will 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 the slide and reiterate the continuous focus of Hansa on advancing science in areas where there remains high unmet medical need. I am 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 result of the 15-HMEDIDES-09 phase II study of imlifidase and indirect treatment analysis of that data to the International Guillain-Barré Outcome Study, or IGOS, in Guillain-Barré Syndrome, also known as GBS. The second is the completed enrollment of GOOD-IDES-02 phase III trial in anti-GBM.
The GOOD-IDES-02 trial is a phase III open-label controlled randomized multicenter trial across Europe and the U.S. 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 II data, we believe Imlifidase has significant potential in improving the outcome of these patients and addressing the unmet medical needs. Imlifidase 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-IDAS, is a phase II 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 Genethon's gene therapy, GNT-0003, following pretreatment with imlifidase. Antibodies against AAV vectors remain a major challenge as their presence in patients excludes them from entering clinical studies with potential curative gene therapy treatments and from access to currently marketed and future gene therapies. Crigler-Najjar 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 one million per year. GNT-0003 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-9001-104 phase I-B trial continues. As a reminder, the trial is evaluating the use of Imlifidase as a pretreatment to Sarepta Therapeutics' Elevidys gene therapy in Duchenne Muscular 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 a 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. The ConfideS U.S. pivotal trial in phase III 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 HNSA-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 12-month analysis of that data. The analysis demonstrated that HNSA-5487 can robustly and very rapidly reduce IgG levels, has redosing potential, and a favorable safety and tolerability profile. We believe HNSA-5487 has a highly differentiated profile compared to published data from studies with other IgG targeted therapies.
HNSA-5487 has the potential to address significant unmet need across a 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 newer autoimmune diseases with a well-characterized role of specific autoantibodies 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 crises 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 the phase II study, the 15-HMEDIDES-09, and the indirect treatment comparison to IGOS. As a reminder, 15-HMEDIDES-09 is an open-label single-arm multicenter study across the U.K., 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 immunoglobulin 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 mean improvement 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 IGOS Reward Comparator group, 754 severe GBS patients treated with IVIg, patients in the 15-HMEDIDES-09 study, which included 27 severe GBS patients treated with Imlifidase in combination with IVIg, experienced statistically significant improvements across several clinically meaningful measures. The indirect treatment comparison concluded that patients in the 15-HMEDIDES-09 study treated with Imlifidase 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-HMEDIDES-09 study experienced statistically significant improvement across several clinically meaningful measures at multiple time points. At week one, patients were 6.4 times more likely to walk independently compared to the IGOS Reward 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 GBS disability score is important because it directly affects the clinical outcomes, recovery, and quality of 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 healthcare costs, and improve overall patient well-being. We believe these results demonstrate the significant role that Imlifidase may play in the treatment of GBS in combination with the standard of care IVIg. Unlike other molecules, Imlifidase can effectively and very rapidly cleave IgG, potentially halting the progression of nerve 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 to slides.
Can 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 IDEFIRIX, 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. Oops, 15. SG&A expenses totaled approximately SEK 88.5 million for Q4 and SEK 343.8 million for the full year 2024. Full-year SG&A expense was SEK 106.7 million, or 24% favorable compared to the prior year. Restructuring activities helped reduce total year-over-year SG&A expense. 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 SEK 166.3 million compared to SEK 42.3 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 U.S. 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 Biopharma'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 675 million for the full year ended December 31, 2023. As previously mentioned, the company completed a 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 Søren. Please turn to slide 17.
Thank you, Evan.
With this overview, our presentation is now concluded, and we'd like to open the call for questions. Operator, please begin.
We will begin the question and answer session. To ask a question, you may press star, then one on your touch-tone phone. If you're using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you'd like to withdraw your question, please press star and then two. Our first question comes from Suzanne van Voorthuizen with Kempen. Please go ahead.
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 candidates 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? In a similar fashion, you've had the phase II comparison data for GBS. What are next steps for this program, or when should we hear more on advancing the program into a phase III? I have a follow-up as well.
Thank you, Suzanne, for those two questions. First, on the planned interaction with regulatory agencies on the next step for HNSA-5487. As we have communicated, it is our intent to move into myasthenia gravis here. The plan for this interaction is to consult and get feedback on the proposed clinical trial design.
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, Søren. Just to add a little bit of flavor here, very specifically, we are planning for a phase I-B study in patients. We have, as you can imagine, detailed the protocol, and we'll discuss that with health authorities, especially since in my senior grammars, 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. Thank you. For GBS?
Yeah, and for GBS, again, Hitto, do you want to take this?
Sure. Our refined thinking on GBS is clearly to commence with a phase III 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. That is what we've disclosed so far. Again, we're in continuous dialogue there as well.
Got it. Thank you. Maybe with regards to the phase II 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 endpoint or not, or will you also report the kidney function result itself and perhaps some more? Thank you.
Thanks for that additional question, Suzanne.
We expect that the first readout essentially would be the overall conclusion right on primary endpoint. I think these two trials have been very carefully designed to be able to make a conclusion on that. Of course, subsequently, there will be more full disclosure of additional results.
All right. Thank you.
Thanks, Suzanne.
The next question comes from Alexander Krämer with ABG. Please go ahead.
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 finalization of the PAES study? Is it the Eurotransplant or is there some other component which I'm missing here? I have a second question.
Thanks, Alexander, for that question. We are quite optimistic for 2025. We have 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 a 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. 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.
We are seeing large opportunities becoming available for sales this year. That is 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 are 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 the past. When the study is fully enrolled, we expect that these key centers that now have significant experience actually transplanting patients using IDEFIRIX to desensitize ahead of the transplant will be converted to commercial sales. They have even lined up patients as part of participating in this trial. That is clearly also going to be a growth driver in 2025.
You mentioned the Eurotransplant Program, which covers Germany, Benelux, Croatia, Hungary, Slovenia, a few other countries. That is moving forward as well. As that progresses and data becomes available throughout the participating clinics and they gain experience, we expect a positive impact also on transplants taking place outside of this specific program. There are really a number of reasons why we think 2025 is going to be another year with significant growth.
Thank you. Second question on the rep. Maybe it's a mistake, but in the report, I think you do not write anymore the initial data readout in 2025, but I think you had it on the slides. Could you elaborate a little bit? What are the bottlenecks with that trial?
I mean, I know Sarepta is running it, but maybe you could shed a little bit more light on what this means in terms of also the milestone payments and the collaboration revenue you expect from Sarepta into 2025. Is this something that is going to increase compared to 2024 levels?
As you said, this study is being run by partners Sarepta. We have a very good collaboration with them, and we are excited to see the trial progress. It's still enrolling patients, and patients are being lined up and enrolled. We do expect data to be available this year. This is what Sarepta has also communicated in the public domain. As I said, moving forward as planned, and we're really excited about that.
We're 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 too high titers of neutralizing antibodies against the vector used in the gene therapy. Therefore, there's a significant unmet medical need in a very serious disease to enable administration of hopefully successful gene therapy in these patients. Moving forward as well, we're certainly hoping to get data this year as well in that disease. 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.
2025, we hope, is going to be a very, very exciting and important year for our efforts in the gene therapy space.
Great. Maybe just on the financial aspect of the Sarepta, please.
Yeah. There is a number of milestones, as you know, significant amount of milestones potentially ahead, right, up to just shy of $400 million. We have not communicated the specifics around timing and so on of these milestones. Obviously, as the program progresses, this is becoming more near term.
Okay. All right. Great. Thank you very much.
Thanks, Alexander.
The next question comes from Douglas Tsao with H.C. Wainwright. Please go ahead.
Hi. Can you hear me?
Yes. Good morning, Doug.
Hey, good morning, Søren. Maybe just to start with the performance in the fourth quarter, was there any particular markets that maybe came in below y our current expectations?
I know there's always some variability, but just were there any specific markets in particular, I'm thinking about France, that may have been a little slower than had been the prior trend?
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. The value of one single transplant versus the total sales is significant and material, right? 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? That's what I can say. I would say on France, that France really continues to be a growth driver.
We're very, very encouraged by what we've seen in France. France is the one major market in Europe where we've had access for a number of years through the early access program. 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, right? We're looking really to emulate what has happened in France and some of the other key markets. Certainly, a promising one is Spain, which is really one of the most sophisticated kidney transplant markets in Europe. We're encouraged by what we've seen so far. I should mention that we're 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. Hopefully, we're negotiating with the Australian authorities. 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, quite a number of those living donor transplants. We have good hopes there. 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.
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're thinking about moving into a pivotal study design? Thank you.
Yes, you're right. There has been recent clinical activity in that space.
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. It's extremely important to have very fast, very rapid, and significant impact on the disease. We're very encouraged by the data that we've been able to generate, looking at also patients in the IGOS database. That kind of confirms our intent to move forward in this market. We have not changed our plans for, let's say, the design of phase III 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 U.S. and in Europe is IVIg.
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.
Okay. Great. Thank you so much.
Thanks, Doug. The next question comes from Eric Yeung with William Blair. Please go ahead.
Hi. This is Eric on for Matt Phipps. Thanks for taking the question. Just two questions. First, after the seasonality impact in the fourth quarter, can you comment at all about how the transplant rates have started in the 2025 year? 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. As far as seasonality is concerned, I think it's too early to say that there's specific seasonality here.
Like I explained, 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. I am 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. You asked about the specific benefit of the post-approval efficacy study. Really, of course, our true benefits, well, three, I should say. 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.
That effect is going to stop. 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. That is going to be helpful as well. Of course, third, we are looking forward, of course, to getting the data. We believe that the data will reinforce, 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 that has been reflected also in guidelines and so on. We believe that additional data obviously will be helpful. 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.
Got it. Thank you.
Thanks, Eric.
The next question comes from (Johan Amiram) with Redeye. Please go ahead.
Thank you for taking a question. Do you want to end the interview? Yes. First, moving into then 2025, what about the ability to see patients that are about, well, calling pipeline of patients, patients being ready at centers, what's your level of visibility as you move into 2025?
Yeah. Great question. 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. They're being identified by the centers and by specific programs like the Eurotransplant Program, which screens a large number of patients and then identifies quite a number and so on. There is a growing pipeline of patients. 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. Typically, 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 do not have access to life-saving kidney transplants. I do not think that that is going to be accepted for many years into the future. We are also looking for patient calls at some point.
Thanks. That is very useful. Related to that, of course, you are not in the 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 are some considering using your products also for less extremely sensitized patients?
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? 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 systems. That's the overall judgment that's been used by the centers and other decision-makers here.
Interesting. Finally, then on the compliance study, is it possible to give a sense of how many new centers that have not been, that are naive to IDEFIRIX earlier, that will sort of be added to the network with the prior study? Also, the same question for the Eurotransplant Program.
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 our phase II trials. Therefore, the compliance trial is important not just in generating data, but also in generating experience in what are really the key centers for kidney transplantation in the U.S. As you know, we have involved a large number, almost 20 centers here. The situation in the U.S. is going to be very, very unlike the situation in Europe in that we're going to have at least 10 times as many key clinics with experience at the time of launch. We've seen in France what that means, right? We've essentially done the most perfect pre-marketing job you can do, namely run this, say, three trial against the U.S. kidney allocation system.
The centers have also learned how to operate within that system. We are really encouraged by the progress there, the engagement by the trial sites. Also, broadly in the U.S., we have been in contact, of course, with HRSA and other key stakeholders and decision-makers in this space. The current administration is also very, let's say, I would not say optimistic, but they are 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 U.S. I have heard numbers as high as north of 60,000 transplants. Now there are 20-something thousand. That is really good tailwind as well.
We think that there are a lot of indicators showing that the U.S. opportunity is very, very material and that we're able to, we'll be able to explore and exploit that much faster than what has happened in Europe.
Excellent. That's very useful. I'll think about Europe then and the Eurotransplant Program. That program is also adding centers, presumably, and also the confirmatory study in Europe.
Yes. Absolutely. Again, the Eurotransplant study is obviously a, let's say, regulated planned way of generating experience in these particular patients in Europe and in participating countries. That's also great. 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. That's important. I mean, say a country like Netherlands, for instance, which has a number of centers participating.
It's going to be very important for that country that now the study is fully enrolled soon and, of course, with hopefully supporting data.
Excellent. Is it possible to ask a question regarding OpEx and especially R&D?
Yeah. You can have one last question, Johan. You choose.
Thank you. Yeah. R&D side, it was a step up in Q4. What sort of level of trending should we expect moving into 2025? 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 U.S. is winding down. As Hitto discussed, he's meeting with the FDA and regulatory bodies in Europe and the U.S. to launch additional trials for HNSA-5487.
My expectation is that in the latter half of the year, we will see R&D expense go up as we enter those clinical trials, but come down as we complete the PAES trial, which, as Søren mentioned, is almost fully enrolled. As we complete the ConfideS U.S. phase III trial,
it sounds like we should expect a bit lower in the first half and then perhaps trending upwards afterwards.
Yep.
Excellent. Thank you.
This concludes our question and answer session. I would like to turn the conference back over to Søren Tulstrup for any closing remarks.
Thank you, Albert, and thank you, everyone who called in. We appreciate your interest. At Hansa, we have got an exciting year ahead of us and look forward to keeping you updated. Thank you.
The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.