Good morning, and welcome to the Hansa Biopharma Interim Report for January to September 2024 conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing Star, then zero on your telephone keypad. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press Star, then one on your telephone keypad. To withdraw your question, please press Star, then two. Please note, this event is being recorded. I would now like to turn the conference over to Søren Tulstrup, President and CEO of Hansa Biopharma. Please go ahead.
Thank you, operator. Good afternoon, good morning, and welcome to the Hansa Biopharma conference call to review the Q3 results for twenty twenty-four. 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. Now, please turn to slide three and an overview of today's agenda. Today, we'll discuss the progress we made during the third quarter, 2024 , and review our near-term priorities. The presentation should take roughly fifteen to twenty minutes, after which there will be an opportunity to ask questions during a Q&A session. Please turn to slide four and an overview of our Q3 performance.
The third quarter of 2024 marks the company's highest ever quarterly end-market Idefirix sales and fourth consecutive quarter of solid sales performance, with total revenue of 78.4 million SEK. Of this, 69.5 million SEK can be attributed to Idefirix sales. Year-to-date sales for Idefirix total 164.2 million SEK. The continued strong Idefirix sales performance can be attributed to an increase in clinical utilization in key EU markets, including Italy, Germany, France, Spain, and the U.K. Additionally, we're seeing more repeat utilization of Idefirix in clinics across major European markets following good outcomes of first transplants. Of note, a provision of 29.7 million SEK was recorded in the third quarter.
This reflects a revised estimate of the one-time retroactive adjustment of cumulative sales since launch in 2020 , based on recent advancement of near-final pricing negotiations in one key market, where Idefirix has benefited from early access under a special program prior to the conclusion of pricing and reimbursement negotiations. We expect to achieve a successful conversion of this program into full reimbursement in Q4. The provision, only SEK 4.9 million, relates to sales in the third quarter of2024 . Evan will cover this in more detail later in today's call. 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. Please turn to slide five for an overview of Q3 highlights. Throughout 2024 , we've made significant scientific advancements.
In May of this year, we announced the completed randomization of all patients in the U.S. CONFIDES phase III trial in kidney transplantation. The trial is on track for data readouts in second half 2025, followed by the expected submission of a BLA to the U.S. FDA under the accelerated approval pathway. As a reminder, a total of 23 sites were involved in the trial and consented over 140 patients. The sites in the trial represent above about 20% of the total transplantation volumes in the U.S. The third quarter also marked steady progress in additional studies, including the Post-Authorization Efficacy and Safety Study, or PAES study, in kidney transplantation and the GOOD-IDES-02 phase III trial in the autoimmune disease, anti-GBM. The PAES study in Europe is 78% enrolled, with 39 out of 50 patients in the trial.
The study is progressing in parallel with the continued commercialization of Idefirix and is part of our obligation to the European Medicines Agency. We believe that the data generated by this study will support the adoption of Idefirix more broadly and allow even more clinics to gain clinical experience. The GOOD-IDES-02 phase III trial in anti-GBM disease also continues to progress, with 86% of patients enrolled in the trial. Completion of enrollment and data readout is expected in 2025, as previously guided. Anti-GBM is a rare, severe autoimmune condition affecting around 1.6 people per million annually. Imlifidase has been granted orphan drug designation for the treatment of anti-GBM disease by both the U.S. FDA and the European Medicines Agency. We also continue to progress scientific exchange to data presentations at key medical conferences and publications in peer-reviewed journals.
This underscores our commitment to advancing the science related to Idefirix. Of note, as mentioned last quarter, a real-world evidence study was initiated in France to evaluate outcomes in nine imlifidase-treated patients. The study was presented at the AST meeting in June and published in Kidney International Reports in July. Through the follow-up period, there was no graft failure and no deaths. These real-life data demonstrate that the use of imlifidase to desensitize highly sensitized patients can have an acceptable short-term efficacy and safety profile in selected patients in a real-world setting.... Hitto will provide a more comprehensive update on the pipeline and clinical development progress later in the presentation. Now, please turn to slide six for an update on the Idefirix launch in Europe. We continue to make solid progress with the launch of Idefirix in Europe. To date, this marks the fourth consecutive quarter of strong commercial sales.
As of today, we have reimbursement in 15 European markets, including the top five markets, representing approximately 75% of the European transplant market. In the third quarter, we saw a 10% increase in the number of clinics who gained clinical experience with Idefirix. This represents 32 clinics in 11 markets. Of these, 62% have used Idefirix more than once. This reflects clinicians' growing confidence in Idefirix and willingness to identify Idefirix appropriate patients. We also saw an increase in utilization in markets within the Eurotransplant program. In total, 53 patients have been identified as Idefirix appropriate patients in markets in the Eurotransplant program. Eurotransplant is an international allocation system responsible for the allocation of donor organs across eight countries, including Austria, Belgium, Croatia, Germany, Hungary, Luxembourg, the Netherlands, and Slovenia.
This reflects the adoption of Idefirix in local and international organ allocation systems and underscores an increased demand for Idefirix designated organs. We recognize the innate volatility in the transplantation market as it relates to organ allocation. We're encouraged by the growing number of clinics that are Idefirix ready to treat and the increase in new and repeat users as we continue to build out opportunities to ensure ongoing expansion of Idefirix, including extensive engagements with KOLs in clinics and key markets. I will now turn over the call to Hitto for an update on the pipeline to clinical development. Hitto, please.
Please turn to slide seven. Thank you, Søren. Please turn to slide eight for an update on the pipeline and clinical development highlights to date. We continue to make good progress across the pipeline, inclusive of studies in various stages in autoimmune, gene therapy, and transplant. We continue to believe that imlifidase and HNSA-5487, our next generation IgG cleaving molecule, have the potential to address significant unmet need across the spectrum of diseases where IgG plays a role in disease pathology. During the second quarter, we have made solid progress across our three key therapy areas and with all trials. Please turn to slide nine. As Søren mentioned, we have advanced several key clinical trials over the course of the third quarter and 2024 . To date, Hansa has seven ongoing clinical trials, three phase III trials, two phase II trials, and two phase I trials.
We are excited about the imminent commencement of a second phase I trial in gene therapy, broadening our clinical program with regard to vector use and target tissue. In transplantation, we continue to advance enrollment in the post-authorization efficacy and safety study as part of our obligation to the European Medicines Agency. The CONFIDES US pivotal phase III trial was fully randomized in May, as previously mentioned, and we plan to deliver data in the second half of 2025, followed by BLA submission to the US FDA. As mentioned last quarter, pooled five-year data, including data from the 17-HMedIdes-14 and four phase II trials, have been submitted to a peer-reviewed journal for publication. 17-HMedIdes-14 is a prospective, observational, long-term follow-up study of patients treated with imlifidase prior to kidney transplantation to measure long-term graft survival in patients who have undergone kidney transplantation after imlifidase administration.
Patient survival was 90% death-censored, and graft survival was 82% and in line with standard of care outcomes seen at three years post-transplant. This data is an important part of the broader clinical evidence supporting the use of Idefirix as desensitization therapy for highly sensitized kidney transplant patients. In autoimmune, we have also made good progress across all trials. The GOOD-IDES-02 trial in anti-GBM continues to enroll. Currently, the trial is 86% enrolled, which means 43 out of 50 patients are in the study. We look forward to sharing data in 2025. As a reminder, 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.
We believe imlifidase has significant potential in improving the outcome of these patients and address the unmet medical need. Further, I'm pleased to share the 15-HMedIdes-09 phase II trial in Guillain-Barré syndrome remains on track. We plan to share contextualized efficacy data this year based on the comparison between the data of the study and a matched cohort from the International Guillain-Barré Syndrome Outcome Study, called IGOS. IGOS is a large-scale global research initiative that collects extensive clinical and biological data from GBS patients to enhance understanding and treatment of this potentially life-threatening disease. GBS is an acute, rare, paralyzing inflammatory disease of the peripheral nervous system, usually preceded by an infection or other immune stimulation. Two-thirds of patients have severe symptoms, resulting in the inability to walk unaided. Lastly, data from the 16-HMedIdes-12 phase II trial was published in Clinical Transplantation in July.
Moving on to gene therapy. Enrollment in the Sarepta 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. We expect to share preliminary data from the trial in 2025. With both AskBio and Genethon, we continue to progress preclinical efforts. As previously shared, we have plans to commence a study this year with Genethon, evaluating imlifidase as pretreatment to its GNT-0003 for patients with Crigler-Najjar syndrome. 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.
Finally, just a week ago, we announced positive results for the NICE-01 trial and a 12 month follow-up analysis of HNSA-5487, the company's next-generation IgG cleaving molecule. This analysis demonstrates that HNSA-5487 can robustly and very rapidly reduce IgG levels, has redosing potential, and a favorable safety and tolerability profile. HNSA-5487 has a highly differentiated profile compared to published data from studies with other IgG-targeted therapies. HNSA-5487 has transformational potential to address significant unmet needs 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. The company will focus the initial clinical development on HNSA-5487 in neuro autoimmune disease, with well-characterized role of specific autoantibodies in disease pathology and acute phases.
Initial clinical development of HNSA-5487, which will focus on neuromyelitis optica, NMO, myelin oligodendrocyte glycoprotein antibody disease, MOGAD, and myasthenia gravis. 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. It's also important to note that we are advancing the science of imlifidase through medical congress presentations and publications in peer-reviewed journals. To date, in 2024, we have published in seven peer-reviewed journals, and there have been eight presentations of data at key medical congresses. I will now turn it over to Evan to cover financial performance.
Thank you very much, Hitto. Next slide, please. Let's walk through the company's financial performance in Q3. Revenue for the third quarter of 2024 totaled SEK 78.4 million, including SEK 69.5 million of in-market Idefirix product sales and SEK 8.9 million in contract revenue, mainly from the agreement with Sarepta. Third quarter product sales represented a 321% increase compared to the same period a year ago. This represents the fourth consecutive quarter of strong Idefirix product sales and underscores the continued solid sales launch and execution Søren referred to earlier, and the ongoing clinical utilizations of Idefirix across major European markets. Year-to-date revenue of Idefirix totaled SEK 164.1 million, representing a 171% increase over the prior year.
Total year-to-date revenue, including contract revenue, was SEK 188.1 million. In the third quarter, the company recorded a provision of SEK 29.7 million to reflect discounts and a one-time retroactive rebate on cumulative sales since the launch in one market, where Idefirix has benefited from a special early access program. Of the total Q3 provision, only SEK 4.9 million relates to Idefirix sales in Q3 2024. Net of the provision, Q3 2024 Idefirix sales were SEK 39.8 million, and total year-to-date Idefirix sales were SEK 114.5 million. In Q2, the company recorded a SEK 19.9 million provision, of which only SEK 2 million related to sales in Q2 2024.
Of the total provision amount taken during the last two quarters, 42.7 million SEK related to product sales prior to Q2 2024 and since its launch in 2020. The Q3 provision is based on an updated best estimate of the one-time effect of an expected imminent successful conversion of a special early access program into full reimbursement in markets where Idefirix has been made available through that same special early access program since its launch in 2020. We are currently finalizing negotiations, and as mentioned earlier, expect to successfully convert the early access program to full reimbursement in the very near future. Please turn to slide 12. Thank you. SG&A expense totaled 76 million SEK in the third quarter of 2024, and 255 million SEK year-to-date.
As previously mentioned, SG&A expense has been affected by a restructuring reserve of approximately SEK 3.5 million. Restructuring activities have reduced total SG&A expense compared to prior quarters. Non-cash expense for the company's long-term incentive program was included in SG&A costs and totaled SEK 24 million for the first nine months of 2024. Additionally, R&D expense for the third quarter of 2024 totaled SEK 79.6 million and SEK 274.3 million year-to-date in 2024. Year-to-date, R&D expense also included a restructuring reserve of SEK 6.6 million. Compared to the same period in 2023, the decrease in expense was primarily driven by restructuring activities. Non-cash expenses for the company's LTIP program were included in R&D expense and totaled approximately SEK 7.9 million for the first nine months of 2024.
Other operating income and expense consists primarily of gains and losses on foreign exchange rates in the company's operations. Other operating income for the third quarter of 2024 was SEK 1.2 million , compared to an expense in Q3 of SEK 1 million . Q3 2024 other expense was SEK 565,000 , as compared to income of SEK 386,000 for the same period in 2023. This change in other expense was primarily driven by the U.S. dollar exchange rate changes against the Swedish krona associated with deferred revenue, accounts payable, and accounts receivable balances. Next slide, please. Cash used in operations for the third quarter of 2024 totaled 149 million SEK and 527 million SEK for the nine months ended September 30, 2024.
The decrease in Hansa's operating loss compared to the same period in 2023 was driven by increased sales as well as an overall reduction in expense. As a reminder, the company completed a direct share issue of approximately SEK 372 million , or $34.6 million in the second quarter. At September 30, 2024, cash and cash equivalents totaled SEK 554 million , compared to SEK 908 million in the same period in 2023. And now I'd like to return the Q&A, the presentation back to Søren. Søren?
Thank you, Evan. Please turn to slide 14. With this overview, our presentation is now concluded and we'd like to open the call for questions. Operator, please begin.
We will now begin the question-and-answer session. To ask a question, you may press star then one on your telephone keypad. 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 then two. At this time, we will pause momentarily to assemble our roster. The first question comes from Laetitia Wehry with Van Lanschot Kempen. Please go ahead.
Yes, thank you so much for the call. It seems like the GBS phase II data for the matched cohort got delayed a bit. Previously, this update was guided for the middle of the year. What is behind that? And can you elaborate what you would like to see in the readout at year-end to move the program towards a registrational phase III? Thank you.
So we have guided for readout, you know, the second part in the second half of this year, and so this is in accordance with the guidance given. What we hope to see, obviously, is that there is going to be speedy recovery, looking at key functional parameters. The overall endpoint is a functional score, and there are sub-parameters here, versus those patients that have been treated with IVIG only. Evans, I don't know if you want to add to this.
That's absolutely correct, Søren. Nothing to add.
Did you have a follow-up, Ms. Wehry?
Thank you. Just a bit more on maybe a different question. The GBM phase III recruitment is progressing well, with the primary endpoint being eGFR at six months.
... Seems like we could expect the study to read out in the second half of 2025. How should we think about the next steps, assuming you can file for approval thereafter? And considering this timeline lines up with the U.S. trial and kidney transplantation, are you comfortable with readout, comfortable with the company's bandwidth to do two filings and commercial launches at the same time?
We're certainly excited that there is a possibility that we can, you know, submit a BLA for this indication. You know, clearly we're moving forward at speed with the enrollment, aiming to fully enroll it as quickly as possible. As you said, it's a six-month study. The timeline is not too dissimilar to the kidney transplant indication. Obviously, we'll make sure that we have the resources to move forward with prioritized indications.
Okay, thank you.
The next question comes from Alexander Krämer with ABGSC. Please go ahead.
Yes, good afternoon. Alexander Krämer on the line. I have two questions. One question related to finance. Could you comment on your R&D OpEx or your R&D spend going forward into 2025, 2026? Looking at the high clinical activity which you have at the moment, and also potential future plans with the 5487 program. Like, do you expect this to rise again after it goes down this year? And then I have a second question.
Yeah. Thanks, Alex, for this question. I think I'll hand over to you, Hitto, for this one.
Yeah, it is true. I mean, obviously, we want to initiate the next clinical trial with HNSA-5487. At the same time, what we will also see next year, we will conclude two phase III trials that we're currently running and operating, the CONFIDES trial in kidney transplantation and the phase III trial in anti-GBM. So that has to sort of be fleshed out a bit more in terms of planning, but there will be new technical activities, but there will also be clinical activities that will be concluded.
Yeah. And Evan, do you want to add to this?
No, I was going to just agree with what Hitto said. Look, we're wrapping up trials now, and we'd like to start HNSA-5487 trials. So, I'm going to tell you, if we start that HNSA-5487 trial in the near term, I view that increase in R&D expense as a good thing.
Okay, thanks. And my second question is about a potential competitor. So actually, there was a poster from a company called Seismic Therapeutic. They have a candidate which I would say, I mean, it has some similarities with HNSA-5487 NiceR in terms of the design and the efficacy profile. And additionally, which is interesting to note here is, I mean, NiceR is focused on the acute setting, while at Seismic Therapeutic, they mentioned that it might be worthwhile investigating both in the acute and chronic treatment settings in autoimmune disease, and they're also targeting myasthenia gravis. What's your view on that, and would you sort that in somehow with what you are doing?
Yeah, thanks, Alex, for this second question. What is good to see is that there are additional players stepping into this space, right? I mean, obviously, we're well ahead, and it's great to see that others see that there are opportunities here, and as far as the acute versus chronic use or let's say, maintenance use, I think that there are opportunities in both spaces, and so this is certainly something that could be pursued. We're initially focusing on the acute phases, but certainly there is potential outside of that as well.
Thank you.
The next question comes from Douglas Tsao with H.C. Wainwright. Please go ahead.
Hi. Thanks for taking the questions. Just first question on the provision that was taken for Austria. I guess I know that was for sort of past periods. You know, we saw a second quarter. So what does that necessarily mean? I mean, does that imply that the negotiations sort of have necessitated larger discounts, and does that sort of have an impact on the pricing going forward? And I believe that this is largely confined to just one market. Thank you.
Yeah, thanks for that, question, Doug. So, you know, as we discussed and as you mentioned here, this is related primarily to this conversion of an early access program into full reimbursement, which obviously is a positive outcome. Overall, we're you know, in line with the expectations around pricing going forward. But then there is this element of your repayment of you know, certain charges since the launch in 2020. So that's a one-time event, essentially. But overall, certainly very, very positive outcome that we expect in the very near future. That will lead to full reimbursement, you know, at a price point that we think fully reflects the value proposition that we're bringing to the table.
Okay, great. And then just on anti-GBM, the recruitment has gone, I mean, certainly, I think, faster than our expectations. Do you have a sense, is it that there's greater enthusiasm for imlifidase, and therefore, you know, investigators are sort of putting a higher proportion of their patients onto therapy? Or is it that, while it continues to be a very rare condition, that perhaps there are more, there's greater incidence than was previously expected? Thank you.
... Yeah, thanks for this follow-up question, Doc. So, clearly, we're encouraged by the fact that we've been able to relatively rapidly enroll patients in this trial. I think that reflects a couple of things. Certainly it could be that the you know, prevalence incidence is higher than expected. But we're also really seeing this as something that kind of mirrors the fact that it's a very severe condition and that there's high desire from the centers to participate and enroll patients. Remember, two out of three patients in this disease lose their kidney function and end up in dialysis, and it's a very, very serious disease with very bad outcomes overall.
Clearly, we're very encouraged by the progress here, and we look very much forward to the readout next year, which again, as I said, can lead to full approval.
Okay, great. Thank you so much.
Thanks, Doug.
The next question comes from Matt Phipps with William Blair. Please go ahead.
Hi, thanks for taking my question, and congrats on continued commercial success in Europe here at growth. Does the setting of a final reimbursement price in this market have read through to reference pricing in other countries that might cause other provisions to be needed, or is that also taken into account? And then, Evan, I guess, when do you think you need to start building the U.S. commercialization ahead of expansion there? When should we expect kind of some growth in SG&A from that?
Thanks, Matt. So as far as the implications on other markets is concerned, we're essentially fully within the range that we have expected and want to within, and this is a very stable range, you know, also in the wake of the preceding pricing and reimbursement approvals in other countries. So we're very pleased with not only the extent of coverage that we have now throughout Europe, but also the level that we've been able to negotiate with payers. So that's your first question. As far as the U.S. launch is concerned, clearly we will want to and are planning to build up additional infrastructure, launch infrastructure ahead of the expected launch in the U.S.
We do believe it's a very, very significant opportunity. Again, recall we have north of 20 clinics, representing a very large proportion of kidney transplant patients in the U.S., active in our U.S. CONFIDES trial, and so there's gonna be a high level of experience at the time of launch. So obviously we want to be fully ready for that launch, and that entails also, you know, investing at a reasonable level. Evan, do you want to comment further on this?
No, I think you nailed it, Søren.
Thanks.
The next question comes from Christopher Uhde with SEB. Please go ahead.
Yeah, hi there. Thanks for taking my questions. I wanted to circle back to a subject that I raised on the NiceR call. Not to say anything bad about this call. But so, in terms of chronic versus acute, you know, feedback we're getting from the investors we've spoken to is that there's a lot of enthusiasm for adding a chronic angle to the program, you know, along the lines of tolerization. And so I wondered if you could talk about what would it make-- what would it take for you to consider expanding to add that angle to what you've already talked about doing? And, you know, let's say if you were to consider adding it, how quickly could you move ahead on that?
And perhaps you could kind of talk about, you know, a little bit in more detail about why you don't, why you haven't decided to go with that right out of the gate, or if you were perhaps just not prepared to speak about it at that first call. And then maybe if I could just try to pull a little bit on the thread there with the earlier question on SG&A. Would the timing of the ramp-up be reasonable to be expected to be around mid-2025, given you'd probably be launching in H1-26? Thank you.
Thanks, Christopher, for those two questions. So first on the chronic versus acute opportunity. Clearly, as we communicated at the HNSA-5487 call, we want to initially prioritize moving into these chronic neuro autoimmune diseases, where you have recurrent attacks, and we will focus on the attacks, so the acute setting. Because we think that there is a very, very high level of unmet medical need, as also validated by our extensive consultations with KOLs and clinics. And we have a very, very unique profile that same people essentially are extremely excited about and feel that we have an opportunity to move in relatively fast to demonstrate a benefit in these situations.
Now, that does not mean that we don't see that there is also potentially an opportunity for more participation, let's say, in the maintenance part of managing these diseases. As you will recall, we have also looked at, you know, how HNSA-5487 and imlifidase potentially could be part of that management program. Clearly, there is an opportunity, we think, in both spaces, but initially we're focusing on the acute attacks themselves. We will provide further updates, you know, as we complete interactions with the regulatory authorities on the path forward here. On the second question, Christopher, SGNA, you know, the ramp up and so on, ahead of the U.S. launch.
So already we have boots on the ground in the U.S., as you know, not just global boots, but also local U.S. boots. And so it's a question of building out that, you know, gradually as we get closer to the potential launch in the U.S. Evan, I don't know if you wanna add some comments to this.
No, look, we have, as Søren mentioned, we started building up a presence in the U.S. in advance of the submission of the BLA, but we'd like to be completely ready to launch in the U.S. with a full sales force and MSLs as well.
Yeah. Thanks.
Thank you.
The next question comes from Johan Unnérus with Redeye. Please go ahead.
Excellent. Thanks for the question. Can you hear, can you hear me?
Yeah.
Yep. Yeah.
Excellent. Yeah, follow up on the clarification to begin with, on the provisions and discounts and rebates. It's reassuring, of course, that it seems to be a modest part of this, referring to both Q3 and the previous Q2, SEK 2 million and SEK 3 million and a bit, or something like that. And it also seems to be a result of negotiations and reviews of a specific market than in Q3. What should we think of the risk of having other sort of reviews referring to other markets historically? Is this sort of the end of the main historic provisions and reviews, or is there a concern that we could see some more historic reviews?
Yeah, thanks, Johan, for that question. So clearly, this is related to a very unique situation where a special early access program that has been extremely successful is converted, we hope, very soon to, you know, full reimbursement. And so this is a unique kind of retroactive application of the consequences of that. And we certainly don't expect that, you know, given where we stand right now, where we have, you know, like I said earlier in the call, access to the vast majority of kidney transplant patients in Europe at a price point that we think fully reflects the value that we bring to the table. So it's certainly not something that is expected.
But I'll hand over to you, Evan, to potentially add some comments to this.
Yeah, I mean, look, negotiations for pricing, as you're certainly aware, across Europe and the rest of the world, have become more difficult for pharmaceutical companies, large and small. I think we've done a very good job negotiating prices, and I think we're, as Søren mentioned, at the end of negotiations, really. I'm going to say, across Europe. You know, obviously, I think you notice we're selling in Germany, France, Italy, Spain, Belgium, just right across Europe. And so these negotiations have been going on for years, for the better part of two years, and we're seeing the end of them right now.
There are still a few outstanding good progress like Portugal, Switzerland, for instance, Hungary, just to mention a few. So... and then there are, of course, also efforts outside of Europe, like in Australia, where we're quite excited that we got approval recently. There is a very material opportunity in Australia, and we're currently in the process of negotiating with the Australian payer authority, so that's just one, you know, example of where we have additional negotiations ongoing.
So in terms of sort of the reference for future, sort of normal pricing, of course, you stated that, you're well within the boundaries of, what you hope or expected to establish. But, is it a fair view to take that, there could be some changes still, but, those should be minor compared to what we've seen earlier?
Well, as you know, when you negotiate, you know, on a payer by payer basis, there may be, you know, volume discounts and so on, that apply, and then there might be some other parameters. But those are to be, more or less, you know, known within the existing quarter. This is a very unique situation where there is a negotiation that has taken place over several years, you know, reflecting what it normally takes. And then there are special parameters, where there will be some retroactive effect, which may not be, and certainly are expected to be, the case going forward. So this is a unique situation.
Excellent. And, shortly, there's an item, Refund Liabilities of SEK 132 million, then is that something that should go through fairly soon? And what should we think about that line going forward?
... Evan, do you want to take this?
Yeah, sure. Well, look, we've got the provision on our financial statements, and as far as making the retroactive rebates or payments, that will come in future years.
This position will stay a bit higher, or is there something we should expect to come through in the working capital for the next, let's see-
I don't think we're gonna be, I don't think we're gonna be establishing provisions of this size anymore. In fact, as I said earlier, I believe that we're substantially done with pricing negotiations.
Yeah. Good. And finally, you also secured sort of financial situation into 2026, but it's probably fair to take the view that you will sort of need some additional firepower to support the growth and opportunities. The way you're advancing, you're also increasing your opportunities. You said something to decide about potential partnerships, and you could, that might be even targets for NiceR, that you could consider sort of partnering with, and, and, yeah. Can you add some flavor into that?
Thanks for that additional question, Johan. So clearly, partnering is part of our strategy, right? And you've seen that play out within the gene therapy space, where currently we have three partnerships with leading players in that space, and they're quite successful. Going forward, there certainly are other opportunities to partner, not just within the gene therapy space, where we continue to have a number of dialogues, but also around other assets and areas. So clearly, that's something that we're also pursuing. I think a successful biotech company like ours, that has a versatile and flexible technology platform and multiple programs, only benefits from partnering, and partnering in a smart way, as we've done in the past.
Excellent. Thank you. That's all from us.
Thanks, Johan.
The next question comes from Natalya Davies, from Intron Health. Please go ahead.
Hi, thank you for taking my questions, just a couple from me. The first one, what are the next steps with the AMR program, following the phase two data? Are you actively searching for partnerships to fund a phase III trial? So a bit more color on that would be great. And the second is just, on the revenue, the Idefirix sales. Is that primarily attributable to retreatment of existing patients, or with the new clinics coming on board? And if there are any specific regions where you see more scope for growth, it'd be great if you could answer those. Thanks.
So as far as the AMR program is concerned, we're obviously very thrilled that we saw this, you know, statistically significant benefits in the imlifidase treated patients compared to standard of care in terms of the ability to rapidly and very robustly knock down donor-specific antibodies in these very, you know, critical situations, where a kidney transplant patient has an acute episode of antibody-mediated rejection. And the data set has been, you know, published now and certainly is something that is being discussed, you know, broadly. We have not yet determined the specific next steps here for this indication, but certainly this is something that is being looked at.
We do not anticipate to start a phase III trial in the very near future, but there's certainly you know a very encouraging data set as far as the primary endpoint is concerned. Even though if you look at the secondary endpoints, where you look at more heart you know endpoints, as we've seen in other AMR trials, given the fact that the patients are so heterogeneous, it is difficult in relatively small trials to get very clear outcomes. So running a phase three trial would entail a relatively large trial, so that should be said.
Then as far as Idefirix uptake is concerned, so it is really a mixture of new utilization in new patients, and then reuse by the clinic in other new patients, right? So remember, there's not gonna be repeat usage in the same patient. A center will typically, for the first time, try it in a patient, wait 6-10 , maybe even more months, before determining whether the center feels that it's comfortable, moving into using it, you know, more broadly in second and third and you know, succeeding patients.
And so what is very, very encouraging to see is that not only are we seeing an increase in the number of clinics that are using it in the first patient, we are also seeing an increase in the number of clinics that are happy with the outcome in the first patient and have decided to move ahead, and do it in second and third patients and so on. So, that's on the clinic and patient side. As far as regions is concerned, what we've seen recently is that we have gained, you know, market access, reimbursement in key countries like Italy and Spain. And especially Spain probably has one of the, if not the best organ allocation system in Europe, potentially in the world.
We have lots of support from, you know, key clinics in Spain. It will take a little while before they materially contribute, so they haven't done this so far, because even though we have reimbursement at the national level, that reimbursement needs to push, to be pushed down to the regions. But we're getting, again, reimbursement at the regional level. Very recently, we got it in Catalonia, a key region representing one third of all transplants in Spain. And so, we're seeing very good progress that then also needs to be reflected in hospital budgets and so on. We expect Spain to contribute materially next year. The same goes for Italy, where we now have access to, I think, 90% of patients via the regions as well.
And so that's looking very encouraging. We have strong support from key clinics and patient associations and so on. So also a promising country there. And then, of course, the EuroTransplant program, where currently 53 patients have been identified. There is ample opportunity for expansion in those countries that are part of the EuroTransplant program as well. The U.K. is typically, as we see across many indications and therapies, relatively conservative country as far as early uptake is concerned. But clearly looking at the volume of kidney transplants in the U.K., there's also significant potential there. And then France, which has been our leading country so far, and where we've seen great uptake.
We definitely think that this will continue, again, based on very, very positive outcome in the first treated patients, and we talked about the paper on the nine imlifidase patients, so very, very positive around, you know, opportunities for further growth in France as well, and then we hope to see a mirroring of what we've seen in France in some of the other large countries in Europe. In addition, I should mention that, as I said earlier, we are looking at Australia, for instance, and there are significant other opportunities across the globe. There are certain in the Middle East, for instance, as well, and South America over time, so clearly lots of opportunities for continued growth here.
We have a follow-up from Laetitia Wehry with Van Lanschot Kempen. Please go ahead.
Yes, thank you for, for making time for a second question. Regarding the repeat dose candidate, no call took place recently, but any update on when we could expect to hear more on the next development plans in autoimmune indications?
So the next step here is to, you know, complete interactions with regulatory authorities. And once that has happened, we expect to provide an update there. Obviously, we're doing what we can to complete this, you know, as quickly as possible. Also, continuing dialogues with some leading players in this space. So I can't give you a specific time point, but certainly this is a key priority for us, so we expect that to come in the near future.
Okay, perfect. Thank you so much.
And we have a follow-up from Douglas Tsao with H.C. Wainwright. Please go ahead. Mr. Tsao, did you have a follow-up?
Oh, sorry about that.
Go ahead, please.
Sorry, I was on mute. Can you hear me now?
Please go ahead again.
Sorry for that. I was on mute. Just in terms of current use, Søren, and I apologize if I missed it. I'm just curious, between this quarter sales, what percent were in new centers versus repeat use, at centers that had previous experience?
Well, I can't give you, top of mind, an exact distribution there, Doug, but like I said, I mean, the growth is coming and the sales overall is coming from a mixture of repeat use and new clinics. Essentially, we're encouraged by both, right? We wanna see increasing repeat usage, reflecting positive early experiences and also new centers coming online, right? As I mentioned, we have now 113 centers in Europe that are ready to use imlifidase. That is a significant increase from the last quarter. Again, reflecting the positive almost snowball effect of the early experiences being then kind of given to additional centers as well.
Another just one final quick follow-up. I mean, do you have any centers that are now using it regularly, meaning that you're recording sales in them and on, you know, pretty much every quarter? Thank you.
We have certain centers that are regular users, right? So once they become repeat users and again, that's based on positive early experiences, typically, they have, you know, positive experiences going forward, and they will even increase their ability to manage these patients. So I can't give you a specific number on a quarter-by-quarter basis, but we're encouraged by the overall progress.
Okay, great. Thank you, and congrats on the progress.
Thanks, Doug.
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, Albright, and thank you, everyone, for calling in here. We're very excited about the progress in the preceding quarter, and we look forward to updating you on continued progress as we move forward. Thank you very much.
The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.