Hansa Biopharma AB (publ)

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 Soren Tolstrup, 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 2024. I'm Soren Tolstrup, President and CEO of Hansa Biopharma. Joining me today is Evan Ballantyne, Chief Financial Officer, and Hito 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 15 to 20 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, 2024, marks the company's highest ever quarterly in-market Ida Creek sales and fourth consecutive quarter of solid sales performance with total revenue of $78.4 million six. Of this, 69.5 million SEC can be attributed to ID4X sales. Year-to-date sales for ID4X total 164.2 million SEC. The continued strong ID4X sales performance can be attributed to an increase in clinical utilization in key EU markets, including Italy, Germany, France, Spain, and the UK. Additionally, we're seeing more repeat utilization of Idafrix in clinics across major European markets following cost of outcomes of first transplants. Of note, the provision of 29.7 million sec 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 IDFRIX 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. With the provision, only 4.9 million SEC relates to sales in the third quarter of 2024. 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 made significant scientific advancement. In May of this year, we announced the completed randomization of all patients in the U.S. Confidus Phase III trial in kidney transplantation. The trial is on track for data readout 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 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 PIE study, in kidney transplantation, and the GUT-ITIS-02 phase three trial in the autoimmune disease anti-GBM. The PIE study in Europe is 78% involved, with 39 out of 50 patients in the trial. The study is progressing in parallel with the continued commercialization of Idiferix 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 Idiferix more broadly and allow even more clinics to gain clinical experience. The GUDIDIS-02 Phase III trial in anti-GBM disease also continues to progress with 86% of patients involved in the trial. Condition 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. Mifidase 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 through data presentations at key medical congresses and publications in peer-reviewed journals. This underscores our commitment to advancing the science related to IDFRX. Of note, as mentioned last quarter, a real-world evidence study was initiated in France to evaluate outcomes in nine inlifidase-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 hemiphidase to desensitize highly sensitized patients can have an acceptable short-term efficacy and safety profile in selected patients in a real-world setting. Peter 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 ID4X launch in Europe. We continue to make solid progress with the launch of ID4X 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 Idifrix. This represents 32 clinics in 11 markets. Of these, 62% have used Idifrix more than once. This reflects clinicians' growing confidence in ID4X and willingness to identify ID4X-appropriate patients. We also saw an increase in utilization in markets within the uro-transplant program. In total, 53 patients have been identified as ID4X-appropriate patients in markets in the uro-transplant program. Uro-transplant 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 IDFRX in local and international organ allocation systems and underscores an increased demand for IDFRX-designated organs. We recognize the innate volatility in the transplantation market as it relates to organ allocations. We're encouraged by the growing number of clinics that are IDFRX-ready to treat and the increase in new and repeat users as we continue to build out opportunities to ensure ongoing expansion of IDFRX, including extensive engagements with KOLs and clinics in key markets. I will now turn over the call to Hitzu for an update on the pipeline and clinical development. Hitzu, please.

Please turn to slide seven. Thank you, Cern. 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 imifidate and HANSA-5487, or next-generation IgG cleaving molecules, 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 Sirin mentioned, we have advanced several key clinical trials over the course of the third quarter and 2024. To date, Hunter has seven ongoing clinical trials, three phase three trials, two phase two trials, and two phase one trials. We are excited about the imminent commencement of a second phase one 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 CONFIDAS 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 MED-IDIS-14 and 4 Phase II trials have been submitted to a peer-reviewed journal for publication. 70H MED-IDIS-14 is a prospective observational long-term follow-up study of patients treated with emicidase prior to kidney transplantation to measure long-term graft survival in patients who have undergone kidney transplantation after emicidase administration. Patient survival was 90% death-centered, 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 imifidase as desensitization therapy for highly sensitized kidney transplant patients. In autumn, we have also made good progress across all trials. The Good Ideas 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 Ideas 02 trial is a Phase III open-label controlled, randomized, multicenter trial across Europe and the U.S., and it's evaluating renal function and the need for dialysis at six months in patients with severe anti-GBM disease. We believe amlifidase has significant potential in improving the outcome of these patients and address the unmet medical need. Further, I'm pleased to share that the 15-age metitis O9 phase 2 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. Data from the 16 MED-IDIS 12 Phase 2 trial was published in Clinical Transplantation in July. Moving on to gene therapy. Enrollment in the Sarepta 9001-104 Phase 1B trial continues. As a reminder, the trial is evaluating the use of imbitidase as a pretreatment to Sarepta Therapeutics' Alevitis gene therapy in Duchenne muscle dystrophy. We expect to share preliminary data from the trial in 2025. With both Aspio and Genitome, we continue to progress preclinical efforts. As previously shared, we have plans to commence a study this year with Genitome evaluating imlifidase as pre-treatment to its GNT0003 for patients with Kregler-Majard syndrome. GNT0003 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. And finally, just a week ago, we announced positive results for the NICE-01 trial and a 12-month follow-up analysis of HANZA5487, the company's next-generation IgG-cleaning molecule. This analysis demonstrates that HANZA5487 can robustly and very rapidly reduce IgG levels, has redosing potential and a favorable safety and tolerability profile. 154.87 has a highly differentiated profile compared to published data from studies with other IgG targeted therapies. 154.87 has transformational 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. The company will focus initial clinical development on HANZA5487 in neuro-autoimmune disease with well-characterized role of specific autoantibodies in disease pathology and acute phases. Initial clinical development of HANZA5487 will focus on neuromyelitis optica, NMO, myelin oligodendrocyte glycoprotein antibody disease, MOGARD, 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 imifidase 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, Guido. Next slide, please. Let's walk through the company's financial performance in Q3. Revenue for the third quarter of 2024 totaled 78.4 million SEC, including 69.5 million SEC of in-market Adiferex product sales and 8.9 million SEC 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 Idifrex product sales and underscores the continued solid sales launch and execution Soren referred to earlier, and the ongoing clinical utilization of Idifrex across major European markets. Year-to-date revenue of iDiferex totaled 164.1 million SEC, representing a 171% increase over the prior year. Total year-to-date revenue, including contract revenue, was 188.1 million SEC. In the third quarter, the company recorded a provision of 29.7 million SEC to reflect discounts, and a one-time retroactive rebate on cumulative sales since the launch in one market where iDifference has benefited from a special early access program. Of the total Q3 provision, only 4.9 million SEC relates to iDifference sales in Q3 2024. Net of the provision, Q3 2024 iDifference sales were 39.8 million SEC. and total year-to-date GIF-REx sales were 114.5 million SEC. In Q2, the company recorded a 19.9 million SEC provision, of which only 2 million SEC related to sales in Q2 2024. Of the total provision amount taken during the last two quarters, 42.7 million SEC 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 Idifrex 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 SEC in the third quarter of 2024 and 255 million SEC year-to-date. As previously mentioned, SG&A expense has been affected by a restructuring reserve of approximately 3.5 million SEC. 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 24 million SEC for the first nine months of 2024. Additionally, R&D expense for the third quarter of 2024 totaled 79.6 million SEC and 274.3 million SEC year-to-date in 2024. Year-to-date R&D expense also included a restructuring reserve of 6.6 million SEC. 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 7.9 million SEC 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 1.2 million SEC compared to an expense in Q3 of 1 million SEC. Q3 2024 other expense was 565,000 SEC as compared to income of 386,000 SEC 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 SEC and $527 million SEC 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 direct sales issue of approximately 372 million SEC or 34.6 million US dollars in the second quarter. At September 30th, 2024, cash and cash equivalents totaled 554 million SEC compared to 908 million SEC in the same period in 2023. And now I'd like to return the presentation back to Soren. Soren?

Thank you, Evan. Please turn to slide 14. With this overview, our presentation is now concluded. I would 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 1 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 Leticia Wherry with Van Lenshot Kempen. Please go ahead.

Yes, thank you so much for the call. It seems like the GBS Phase 2 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 3? Thank you.

But we have guided for readout 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 subparameters here versus those patients that have been treated with IVIG only. So I don't know if you want to add to this.

That's absolutely correct, sir.

Nothing to add.

Did you have a follow-up, Ms. Weary?

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. It 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 US trial in kidney transplantation, are you comfortable with the company's bandwidth to do two filings and commercial lunches at the same time?

Well, we're certainly excited that there is a possibility that we can submit a BLA for this indication. So, you know, clearly, we're moving forward at speed with the enrollment, aiming to fully enroll it as quickly as possible. And as you said, it's a six-month study. So the timeline is not too dissimilar to the kidney transplant indication. And 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 Kramer with ABGSC. Please go ahead.

Yes, good afternoon. Alexander Kramer 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, Hitzu, for this one.

Yeah, it is true. I mean, obviously, we want to initiate the next clinical trial with 50487. At the same time, what we will also see next year we will conclude to phase three trials that we're currently running and operating, the confidants trial and kidney transplantation and the phase three trial and anti-GBM. So that has to sort of be fleshed out a bit more in terms of planning, but there will be new clinical 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 Hito said. Look, we're wrapping up trials now, and we'd like to start a 5487 trial. So I'm going to tell you, if we start that 5487 trial in the near term, I view that increase in RD 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 it has some similarities with 5487 NICER in terms of the design and efficacy profile and additionally which is interesting to note here is 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 in autoimmune disease, and they're also targeting myasthenia gravis. What's your view on that, and could you sort that in somehow with what you are doing?

Thanks, Alex, for this second question. So 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. As far as the acute versus chronic use or 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 Sal with HC Wainwright. Please go ahead.

Hi, thanks for taking the questions. Just first question on the provision that was taken for ID4X. 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 this is largely confirmed to just one market. Thank you.

Yeah, thanks for that question, Doc. So 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 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 a very, very positive outcome that we expect in the very near future that would lead to a 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 amyloidase, 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, you know, 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 there is a high desire from the centers to participate and enroll patients. I remember two out of three patients in this deceased lose their kidney function and end up in dialysis. It's a very, very serious disease with very bad outcomes overall. So 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, Doc. The next question comes from Matt Phipps with William Blair. Please go ahead.

Thanks for taking my question. Congrats on continued commercial success in Europe here at Growth. Does the setting of 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 be within, and this is a very stable trend. range 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. confidants trial, and so there's going to 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 investing at a reasonable level. Evan, do you want to comment further on this? No, I think you nailed it, Thorne. Thanks.

The next question comes from Christopher Udy with SEB. Please go ahead.

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 toleration. 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 a little bit in more detail about 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 H126? Thank you.

Thanks, Christopher, for those two questions. So first on the chronic versus acute opportunity. So clearly, as we communicated at the NICER 5487 call, we want to initially prioritize moving into these chronic neuroimmune diseases where you have recurrent attacks, and we will focus on the attacks for 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 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. And as you will recall, we have also looked at, you know, how 5487 and glyphidase potentially could could be part of that management program. So clearly there is an opportunity, we think, in both spaces, but initially we're focusing on the acute attack themselves. And we will provide further updates as we complete interactions with the regulatory authorities on the path forward here. On the second question, Christopher, SG&A, on 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 up that, you know, gradually as we get closer to the potential launch in the U.S. Evan, I don't know if you want to add some comments to this.

Look, as Soren 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 Salesforce and MSLs as well.

Yep, thanks. Thank you. The next question comes from Johan Oneros with Redeye. Please go ahead.

Excellent. Thanks for the question. Can you hear me?

Yeah.

Excellent. Yeah. Follow-up and a 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 two millions and three millions in a bit or something like that um and it also seems to be a result of negotiations and reviews of a specific market then 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 the main historic provisions or views, 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 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, Nicole, 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 someone mentioned, at the end of negotiations, really, I'm going to say across Europe. You know, obviously, I think you know this, 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 brokers like Portugal, Switzerland, for instance, Hungary, just to mention a few folks. 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 example of where we have additional negotiations ongoing.

So in terms of sort of the reference for future sort of normal pricing options, 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 on a payer-by-payer basis, there may be volume discounts and so on that apply. And then there might be some other parameters. But those are to be more or less known within the existing quarters. So this is a very unique situation where there is a negotiation that has taken place over several years, reflecting what it normally takes. And then there are special parameters where there will be some retroactive effect, which may not be and certainly not expected to be the case going forward. So this is a unique situation.

Excellent. And shortly, there is an item refund liabilities of 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. 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.

So this position will stay a bit higher, or is this something we should expect to come through in the working capital for the next?

I don't think we're going to be establishing the 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 26, 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. Is there something to be said about potential partnerships that might be even targets for NYSER that you could consider sort of partnering with? And yeah, can you add some flavor into that?

But thanks for that additional question, Yuan. 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, 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, Juan. The next question comes from Natalia Davies from Intron Health. Please go ahead.

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 three trial? So a bit more color and that would be great. And the second is just on the run up of the idaferric cells. Is that primarily attributable to re-treatment of existing patients or is it new clinics coming on board? And if there are any specific regions where you see more scope for growth, it would 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 statistically significant benefit in the Mifidase-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 critical situations where a kidney transplant patient has an acute episode of antibody-mediated rejection. And the data set has been published now and certainly is something that is being discussed 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 a phase three trial in the very near future, but there's certainly a very encouraging data set as far as the primary endpoint is concerned. Even though we've looked at the secondary endpoints where you look at more hard 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 Idaferix 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 going to be repeat usage in the same patient. a sender will typically, for the first time, try it in a patient, wait six to 10, maybe even more months before determining whether the sender feels that it's comfortable moving into using it more broadly in second and third and 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're 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 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 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. So we expect Spain to contribute materially next year. The same goes for Italy, where we now have access to, I think, 90% of patients by the regions as well. Um, and so that's looking very encouraging. We have strong support from, uh, key clinics and, and, uh, patient associations and so on. So also promising a country there. And then of course your transplant program where currently 53 patients have been identified. Um, there's ample opportunity for, for expansion in those countries that are part of the, your transplant program as well. The UK is typically as, 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 UK, 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 inlifitase patients, So very positive around 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 we, 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.

And we have a follow-up from Leticia Leary with Van Lenshot Kempen. Please go ahead.

Yes, thank you for making time for a second question. Regarding the repeat dose candidates, another call took place recently, but any update on what 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 as quickly as possible. Also, continuing dialogues with some leading players in the 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 Sao with H.C. Wainwright. Please go ahead. Mr. Sowell, did you have a follow-up?

Sorry about that.

Go ahead, please.

Sorry, I was on mute. Can you hear me now?

Please go ahead.

Sorry, I was on mute. In terms of current use, Soren, and I apologize if I missed it, I'm just curious, between the fifth 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, Doc. 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. And essentially, we were encouraged by both, right? We want to see increasing repeat usage, reflecting positive early experiences, and also new centers coming online, right? So as I mentioned, we have now 113 centers in Europe that are ready to use in a few days. 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.

And 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 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 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, Doc.

This concludes our question and answer session. I would like to turn the conference back over to Sirin Toolstrip for any closing remarks.

So thank you, Aubrey, 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 programs as we move forward. Thank you very much.

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