Hansa Biopharma AB (publ)

Good day and welcome to the Hansa Biopharma second quarter and first half year 2026 financial results conference call. 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 then two. Please note this event is being recorded. I would now like to turn the conference over to Hansa Biopharma CEO, Renée Aguirre-Lucander. Please go ahead.

Thank you very much. Good afternoon and good morning, everybody. Welcome to the Hansa Biopharma Conference call to review the Q2 results for 2026. I'm Renée Aguirre-Lucander, CEO for Hansa Biopharma. Joining me today is Adam Cutler, Chief Financial Officer, Richard Philipson, Chief Medical Officer, and Maria Tarnson, Chief Operating Officer and President of the US. Please turn to the next page. Please allow me to draw your attention to the fact that we'll be making forward-looking statements during the presentation, and you should therefore apply appropriate caution. Next slide, please.

This is the brief agenda for today's call.

Next slide, please. So, looking at this quarter, I believe that it was a transformative quarter for HAMSA. By partnering in Europe, we strengthened the commercial support for Idoferix, both in terms of resources and experience, which will enhance patient access and ensure long-term success. In the short term, this can have a somewhat negative impact on financial performance due to the inherent uncertainties, which always comes with change. But strategically and long-term, I strongly believe that this was the right decision for the product, for patients and for Hansa. We also read out positive top-line data from the confirmatory European trial PAS, which paves the way for the conversion from conditional approval to full approval in Europe, which we hope to achieve next year. We also completed the strengthening of the executive team this quarter with the addition of Fredrik Röck as VP Business Development and Adam Cutler, who's making his public debut today as our new CFO. Finally, we attended ATC where the phase three data was presented in the form of an oral presentation and subsequently hosted a very successful Capital Markets Day on June 25th where several leading medical experts provided their insights regarding the existing unmet medical need, clinical use observations, and real-world experience from using Itaferix in Europe. In terms of financial performance, in terms of the Q2 revenues, they were as predicted an improvement over Q1 and amounted to 48.1 million Swedish krona versus 49.1 million Swedish krona in Q2 of 2025. Can we go to the next page, please? So here is a brief overview of the details regarding the recent transaction. A couple of things to highlight here are obviously that post this quarter this transaction was formally closed, and we have now also received the upfront payment. There are presently quite substantial resources focused on the transition process to ensure a smooth and coordinated handover. The collaboration is working very well, and we are now working jointly together towards the next key milestone, which is the transfer of the market authorization holdership to our new partner, CERB Pharmaceuticals. In parallel, we're obviously also working on the filing preparations for EMA, transitional personnel, and information transfer regarding clinical operations, as well as related regulatory quality and pharmacovigilance-related areas. Just a brief reminder of the transaction as such. It was a €115 million out-licensing agreement for Idaferix in EU, the UK, Switzerland, Norway, Liechtenstein, Iceland, and Middle East and North Africa. Our partner is CERB Pharmaceuticals, and there was an initial €110 million upfront payment, which as I mentioned has now been received. The closing took place post this quarter. And upon acceptance by EMA of the filing for full approval, there is an additional payment due of €5 million. Can we go to the next page, please? If we take a brief look at what we plan to focus on for the rest of the year, I've already covered a couple of the key items here, such as the transition work to CERB and filing for full approval in Europe. In addition to that, we plan to explore potential additional collaborations in gene therapy and other geographic outlicensing opportunities. Obviously, there are no guarantees that we ultimately will choose to proceed or conclude any such potential transactions this year, but it is an area of exploration that we plan to undertake starting in the second half of this year. Our key focus as an organization is obviously our ongoing interactions with FDA, related to our BLA filing on lipidase, and the continued work on the comprehensive pre-commercial plan in the US, ensuring that we're ready to launch in Q1, subject to an approval. With that, I will hand over to Maria, who will provide some more details on some of these

Thank you very much, Rene. Next slide, please. Our 2026 Q2 results were in line with results in Q2 2025, with a slight decrease of 1 million SEC. However, a significantly better performance, an increase of 39% compared to Q1 2026. Our product sales were 46.8 million SEC. Performance in Q2 was particularly strong in Spain, where we recently secured reimbursement in one of the largest regions, Catalonia. We are very pleased to see that the targeted market access efforts we put in place now has resulted in strong sales from the region. France continued to perform well, and we also saw solid sales in the other three large European countries, Italy, Germany, and the UK. In Germany, We have, as mentioned in previous quarterly calls, faced significant hurdles since the pause of the urotransplant accepted mismatch program. I'm very pleased to report that in Q2, we saw the publication of the much anticipated consensus recommendations in Germany. These recommendations provide a practical guide to German transplant centers in how to transplant highly sensitized patients within the ETGAS program. We also saw an independent article published by a German law firm confirming that desensitization is allowed under German law and highlighting that patients have a right to access the latest treatments. We therefore anticipate that there will be future growth for imlifidase in Germany in the second half of 2026. Let's now turn our attention to the US market. Next slide, please. The US market is a growing market with very high unmet needs. There are approximately 100,000 patients on the waitlist for a kidney transplant, and 7,000 of those have a CPRA over 98%. The waitlist is growing, and each year approximately 45,000 patients are added to the waitlist. Worth noting is that the highly sensitized patients also face significant mortality, as each year thousands of patients die while on the waitlist or they become too sick and therefore are removed from the waitlist. For these patients, having access to a kidney transplant could be life-saving. And while there are 27,000 transplants each year in the US, there are also significant number of kidneys being discarded. According to latest data, each year around 9,000 recovered kidneys are discarded and over 5,000 due to the reason that no recipient could be located. Our estimate is that the US market represents a $2 billion market for HANSA, taking into account the patient population above 98% CPRA. Please turn to the next slide. Today, we are five months away from the PDUFA of December 19th. Our pre-launch efforts are in full motion, and they are led by a very experienced US team. the US leadership team have collectively launched multiple products and have experience from both the transplant market and nephrology. We have over the last few months conducted several market research initiatives. They all point in the same direction that there is a strong clinical need for quick and effective product that can enable a transplant for highly sensitized patients. Patients are also very positive to the product profile as they do not have great options today to enable a transplant. In blinded market research, nearly 9 in 10 patients express strong interest in learning more. While some US transplant centers have tried experimental desensitization approaches, most centers do not offer this to highly sensitized patients as they are not perceived effective for a deceased donor kidney transplantation. In Q2, we saw the presentation of the confidous data at the American Transplant Congress in Boston. We will have further presentations at the upcoming TTS in Sydney, Australia in September, and at ASHI, a conference for HLA directors in Montreal in October. We will also attend the largest nephrology conference, ASN, in October in Denver. We continue to engage with patient advocacy groups through attending their conferences and our field medical and market access team are actively engaging with the top 100 transplant centers in the US to understand their current management of highly sensitized patients and their financial and operational profile. Please turn to the next slide. We've also conducted various market research with financial stakeholders, both to understand their perception of Imblifidase, but also to help guide our pricing decisions for Imblifidase once approved. We know that the majority of transplant patients have Medicare, but commercial plans also play an important role. The prolonged wait on dialysis is not only a significant patient burden, but also a significant cost to payers. Kidney transplants are covered by Medicare using DRG, plus outlier payments and NTAP. As mentioned in previous calls, we will apply for NTAP, new technology add-on payment, later this year, and our field-based market access team will be ready to provide appropriate education to support formulary inclusion by health systems, as well as support coverage decisions by commercial payers. All of our market access team members come with significant experience in reimbursement and a track record of securing access to novel therapies. And while the majority of patients have Medicare, there is a significant number of patients with commercial plans and they will be covered via contracted rates for kidney transplants or single case agreements. From our market research, we believe that our initial uptake will come from centers with clinical experience and knowledge of imlifidase and from large academic centers who perform large volume of kidney transplants. Already today, we have centers who have indicated interest in prescribing imlifidase shortly after potential approval. We also expect volume to scale further post the approval of NTAP. Please turn to the next slide. If approved, we believe that Imblifidase has the potential to change the treatment paradigm for the highly sensitized kidney transplant patients in the U.S. Imblifidase can address one of the most challenging unmet needs in kidney transplantation and enable a transplant which previously was not possible. From clinical data in Confidus, PAES and real world European data, we have seen a consistent and reproducible clinical benefit. Our phase two data also show durable transplant outcomes over five years. And while there are experimental desensitization approaches, which have been tried, we know that these therapies aren't effective in deceased donor transplantation. Imlifidase therefore has the potential to create a new clinical paradigm for desensitization allowing a rapid and reliable reduction of antibodies to enable a transplant. We are very excited for this significant market opportunity, and if approved, we will be launch ready at PDUFA, and we anticipate having imlifidase available in the US in Q1 of 2027. And with that, I will hand it over to our Chief Medical Officer, Richard Philipson. Richard?

Thanks, Maria. Today I'm going to talk about the results of the CONFIDA study that were presented recently at the American Transplant Congress. Next slide. The results of the CONFIDA study evaluating the use of imlicidase in highly sensitized kidney transplant patients were presented by Dr. Robert Montgomery, director of the NYU Langone Transplant Institute, who gave the presentation on behalf of the CONFIDA study group. The abstract was selected to be highlighted at the closing plenary session, What's Hot, What's New?, reflecting the importance of the findings for the field of kidney transplantation in highly sensitized patients. I'd like to present some of the highlights of Dr. Montgomery's presentation at ATC. Next slide. I'll start by briefly reviewing the study design. Patients considered potential candidates for the study were consented and entered a pre-screening period. One or more unacceptable antigens were delisted from the patient's HLA profile to increase the likelihood of the patient receiving an organ offer. When an organ offer was received, patients entered screening and underwent a final evaluation of eligibility. Eligible patients were then randomized to the amlifidase arm or the control arm in a one-to-one ratio. The period of follow-up in the study was 12 months from the time of randomization. Patients randomized to the imlifidase arm accepted the organ offer and were treated with imlifidase. If treatment resulted in cross-match conversion from positive to negative, then patients were transplanted and entered follow-up. Patients randomized to the control arm either accepted the organ offer, were treated with non-approved desensitization, and then proceeded to transplant, or the organ offer was rejected and the patient waited for a more compatible organ offer or offers later in the 12-month follow-up period. Next slide, please. Here we see that the demographic and baseline characteristics were generally balanced between the two arms of the study. It's worth noting the extended period that patients had spent on the wait list for transplantation. The mean time on the wait list was 7.3 years in the illiterate arm and 5.2 years in the control arm. The majority of patients in both arms had had a previous transplant, and there was a higher total level of baseline donor-specific antibodies in the imlifidase treatment arm. Next slide, please. With respect to the primary efficacy outcome, at 12 months, mean EGFR was 51.5 mils per minute in the imlifidase arm compared to 19.3 mils per minute in the control arm. with a statistically significant and clinically meaningful difference between the two groups of patients of 32.2 mls per minute with a p-value less than 0.0001. As can be seen from the graphic, EGFR in patients in the in liquidase arm remains remarkably stable after around day 30 post-randomization, three to 12 months, which suggests favorable longer-term outcomes in these patients. Next slide, please. At 12 months, the key secondary endpoint of dialysis dependency was statistically significant in favor of imlifidase with a p-value equal to 0.0007. A total of five patients with dialysis dependency in the imlifidase arm compared to 17 patients in the control arm. Furthermore, when looking at EGFR categories at 12 months in transplanted patients, it's noteworthy that most patients, 92%, in the imlicidase arm had an EGFR of 30 mils per minute or higher at 12 months, with only 8% of patients having an EGFR less than 30 mils per minute. In contrast, 40% of patients in the control arm had an EGFR less than 30 mils per minute at 12 months, indicative of superior kidney function outcomes in patients transplanted following treatment with imlicidase. Next slide, please. Patient survival was 97% in the amlifidase arm compared to 100% in the control arm. One patient in the amlifidase arm died on study day 72 due to issues unrelated to graft function. Profile of adverse events and serious adverse events likely reflected typical post-transplant complications and adverse effects associated with current post-operative immunosuppressive practice and was in keeping with previous clinical trial experience. No imlifidase infusion was discontinued due to an infusion-related reaction. Next slide, please. As already mentioned, at baseline, patients in the imlifidase treatment column had a higher total DSA compared to the control arm. Nevertheless, these patients achieved a much lower perioperative level of DSA compared to controls, which is maintained at a low level for approximately one week before rebounding to a peak on day 15. thereafter progressively decreasing. Next slide, please. Based on post-transplant biopsies, antibody-mediated rejection was observed in 57% of transplanted patients in the amyloidase arm compared to 46% of patients for whom data are available in the control arm. Mean EGFR both with and without AMR was higher for patients transplanted in the amyloidase arm compared with the control arm throughout the trial period. and evidence of AMR on biopsy did not impact kidney function. Furthermore, and importantly, both early and late AMR were successfully treated with available therapies, and no grafts in the amlifidase arm were lost due to AMR. It's also worth noting that this was discussed with an expert panel at Hamza's recent Capital Markets Day last month, where the consistent view was that the observed antibody-mediated rejection was consistent, predictable, and manageable. Next slide, please. So, in conclusion, at one year post-randomization, desensitization within lipidase was associated with clinically meaningful and statistically significant improvement in kidney function, as measured by EGFR. In the lipidase treated patients, the EGFR was 51.5 mils per minute, which is superior to the EGFR of 19.3 mils per minute observed in the control arm. Mifidase enabled successful transplantation and resulted in higher transplant rates compared with patients in the control group. At one year, five patients were dialysis dependent in the Mifidase arm compared to 17 patients in the control arm. No transplants in the Mifidase arm were lost due to AMR and the Mifidase treatment was well tolerated with a safety profile typical of transplant recipients. I'd now like to hand over to our Chief Financial Officer, Adam Cutler.

Thank you, Richard. Total revenue for Q2 2026 was 48.1 million Swedish krona, representing a 2% decrease compared to Q2 2025 of 49.1 million Swedish krona. Product sales for Q2 2026 were 46.8 million Swedish krona, representing a 2% decrease as compared to Q2 2025 of 47.8 million Swedish krona. Importantly, as Renee noted, Q2 2026 product sales were up 39% over Q1 2026. Next slide, please. For Q2 2026, SG&A expenses totaled approximately 119 million Swedish krona and were up 13 million Swedish krona, or 12%, compared to Q1 2026 of 106 million Swedish krona. Compared to Q2 2025, SG&A expense of approximately 91 million Swedish krona, Q2 2026 expenses were 28 million Swedish krona higher. The variance was driven by increased costs associated with preparation for the expected U.S. market launch, costs associated with the convertible debt and the CERB deal, as well as increased costs for Hansa's long-term incentive programs. R&D expenses in Q2 2026 totaled approximately 68 million Swedish krona and were 29% or 28 million Swedish krona favorable compared to Q2 2025. The decrease in R&D expenses was primarily driven by the wind-down in clinical trial activities and restructuring activities taken in 2025. In Q2, the loss from operations was 174 million Swedish krona compared to 155 million Swedish krona in Q2 2025. Next slide, please. Cash used in operations in Q2 2026 totaled 104 million Swedish Krona compared to 112 million Swedish Krona in Q2 2025. As of Q2 2026, cash and cash equivalents totaled 553 million Swedish Krona or 57 million US dollars. This does not include the 110 million Euro upfront payment received from CERB earlier this month. which would bring pro forma Q2 cash to approximately 1.8 billion Swedish krona or approximately 185 million US dollars. This transaction extends Hansa's cash runway and strengthens the company's balance sheet in advance of FDA approval and subsequent US launch. Headcount for the period totaled 153 compared to 140 in Q2 2025 and 122 in Q1 2026. Q22026 headcount reflects hiring in preparation for expected US market launch, but does not yet reflect the expected transfer of personnel to serve related to the out-licensing transaction. And now I'd like to turn the presentation back to Renee for closing remarks and the Q&A portion of the call.

Thank you, Adam. Next slide, please. So, in summary, HANSA is now in a strong position to realize its strategic objectives as set out. It is well-capitalized, has a clear roadmap, and has an experienced team leading all critical activities. Our clinical data has consistently been strong, and we believe strongly support the risk-benefit thesis laid out for imlifidase. We are clearly an execution focus at this point in time, looking forward to the value inflection point in Q4. This quarter really marks a new strategy and journey for HANSA. We look forward to sharing the future milestones of this journey with all of you over the next several quarters, and we are very excited about the future. Next slide, please. And with that, we're going to turn the call over to Q&A.

Thank you. We will now begin the question and answer session. To ask a question, you may press star then 1 on your touchtone 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 would like to withdraw your question, please press star then 2. At this time, we will pause momentarily to assemble our roster. Our first question comes from Farzin Haque with Jefferies. Please go ahead.

Good morning. Congrats on the progress and thank you for taking my question. Maybe for Rene, now that you're roughly five months from the December PDUFA, can you characterize the pace of information requests, like any signals from the mid-cycle communication or on the TMC front with site inspections that you have received so far?

So I would say that the experience of our kind of interaction with FDA to date have been very normal as expected. I don't think that we have received anything that would cause me to be concerned or have any issues in terms of how the review is going. We are, as you can expect, receiving you know, consistent kind of queries and answering them in a timely manner.

And then one more, like you have been adding field-based market access and market and medical affairs personnel, but are there any specific things that you can do at the transplant centers ahead of approvals, essentially, you know, to activate them and be launch ready?

That is exactly the purpose of hiring the staff. Maria, do you want to kind of take and explain some of the details of what these teams are actively doing in the field today and how that will assist them to be launch ready?

Yes, happy to take the question. So yes, we have hired a field-based market access team, a medical team, so we are covering the entire United States right now. If you look at the number of transplant centers in the US, as you know, there are 200 centers, and roughly 100 of those represent 80% of our volume. So the people we've hired, they are now targeted with going out to these 100 centers and basically doing two things. The first one is what we call transplant center profiling, basically understanding who are the different stakeholders in each center, from the surgeon to the nephrologist to the transplant coordinator, to financial stakeholders, who are the people that are going to sit around the table and make clinical, financial, and operational decisions. That is part of the profiling, getting to know all of these customers and also understanding who will be the champion, who is going to be the person who is going to take this on board when the product is new and sort of bring those discussions to the broader cross-functional team. So that's the site profiling. The other aspect they're doing is what we call sort of site readiness. So understanding where do they stand today in terms of their readiness to treat patients. As an example, how many patients do they potentially have that are highly sensitized? Understanding how do they treat highly sensitized patients today? How often do they see these patients? Understanding the clinical knowledge. Do they have all the people there that will be part of this? So that is part of the sort of site readiness. And the goal is obviously to see that how many do we think will be ready shortly after approval in Q1, and who do we think is going to take maybe a quarter or two quarter longer to be ready. So that is part of what they're doing right now.

Super helpful. Congress in the progress. Thank you. Thank you.

Thank you. The next question comes from Matt Phipps with William Blair. Please go ahead.

Thanks for taking my questions. Adam, I was wondering if you could help us on if the upfront payment from CERB will be recognized on the P&L in the third quarter. And then just curious on what we will hear on the trial design for 5487 is Do you need to wait for that IND submission to kind of figure out some more of that trial design, or do you think you'd have an update sometime here in the second half before we get to your end? Thank you.

I'll take that 5487 briefly before I hand over to Adam. I think that's the shorter answer. So we are kind of in ongoing kind of conversations with the FDA on that. And so, yes, we do hope to be able to provide some more information hopefully when we report the next quarter. and there's clearly a target for us to file an IND before the year end to initiate clinical studies in DBS. Sorry, Adam, over to you.

No, no, no problem at all. So to answer your question, we're still sorting through the exact accounting treatment of that. It will at least start to be recognized. in Q3 of this year, but it may be that the recognition of that upfront payment is spread over a longer period of time. So obviously from a cash point of view, we have the cash. It will be on our balance sheet as of Q3, but as far as the revenue recognition, it may be spread over a longer period of time due to certain elements of the agreement with CERB.

Thank you. And maybe just real quick, should we expect any updates from the Genethon or Sarepta collaborations in the second half of this year?

In terms of the Geneson collaboration, I know that they had as a target themselves to complete a recruitment before the end of the year. And so that would be potentially something that could be communicated in the second half, depending on how they progress against that milestone that they have set for themselves. But otherwise, I think it's more, I think it's unlikely that we'll hear anything more on the third agreement this second half.

I think you've taken the questions.

Thank you. The next question comes from Thomas Smith with Lyric Partners. Please go ahead.

Hey, Tien, good morning. Thanks for taking the questions and congrats on all the progress here. Two questions, if I could. You mentioned that you're actively exploring some additional collaboration opportunities, particularly on the gene therapy side. Just wondering if you could elaborate a bit on the types of collaborations you're looking for and any learnings you're able to incorporate from your existing collaborations with Genethon and Sarepta. And then a second question. Just at the Capital Markets Day last month, you mentioned that the results from the investigator-initiated autoimmune ANCA study within lipidase would be evaluated over the next few weeks. Just wondering if there's any update on this front with respect to timing or expectations. Thanks so much.

Great. I'll let Richard take the second part of that question. With regards to the gene therapy and licensing, so one of the kind of new members of the team that will be joining us now next month is obviously a VP of Business Development. And this is obviously an area where we have been lacking in terms of having senior resources dedicated to that task. So with the arrival of Frederick we actually intend, we will have the resources that's required to kind of a little bit more systematically and professionally kind of pursue and follow up on quite a lot of the inquiries and questions and inbound interest that we receive and have received on an ongoing basis. So it's in the light of that new resource that I am hopeful that we'll be able to, from a kind of resource and focus perspective, be able to address some of that kind of inbound interest that we have been seeing and continue to see. So in terms of any details of that, I think we'll probably be able to kind of speak to that a little bit more at the next kind of quarterly update. Richard, do you want to take the second part of that?

Sure, yeah. As you mentioned, we did say that we've completed enrollment into the study evaluating lipidase in anchor-associated vasculitis. It's an investigative-sponsored study being run in Germany. So all 10 patients have been enrolled. Pharmacodynamic effects that we saw in response to imifibase treatment were as expected, but we want to collect the relevant and protocol-defined follow-up data before we can really draw any firm conclusions from that study in terms of clinical outcomes. That's going to take, patients have followed up for six months, so it's going to take some extra time to gather that information for all of the patients. So we'd expect to be able to be able to update on that later in the year.

Got it. That's helpful. Thank you, guys. I appreciate you taking the questions.

Thank you. The next question comes from Douglas Zhao with HC Wainwright. Please go ahead.

Hi. Good morning. Thanks for taking the questions. Quickly, in terms of the U.S. opportunity, Maria, you sort of touched on the fact that this is mostly a Medicare market. I am just curious, though, do you think that sort of you might have a little more flexibility from a reimbursement standpoint early on to penetrate with the commercial patient population? and if you had sort of discussions around how the mechanism or the mechanics of how amiflidase would be reimbursed in the commercial setting.

Yes, so you are correct. The majority of patients are Medicare, but there is roughly a third of patients that have a commercial plan, and those patients will sort of either be covered by the contracted rates with those plans, or single case agreements. And I think if you look at historical launches in this space, you know, if you look at drugs that have been launched with DRG, Outlaw Repayment and NCAP, if you analyze those sort of claims, you see more commercial claims earlier on. So I think that is an area that we continue to sort of explore and we will have in the next month or so we'll have a meeting with some representatives from commercial plants and advisory board to sort of gather their feedback on how that would work. So, but you are correct that that is a potential sort of early launch, you know, revenue generating stream.

And Maria, just as a follow-up along those lines, because I think And I'd be curious if you've gotten feedback where it sounds like maybe you're in the early stages that commercial patients don't or commercial insurers often are paying much higher rates for dialysis. And so I think there might be some greater urgency on the part of those payers to get patients ultimately transplanted.

Yeah, you are correct. I mean, they do pay a higher yearly cost for dialysis for patients. So I think exactly what you say is we want to have a dialogue with those stakeholders or representatives to sort of understand their perspective because you could see a potentially, you know, a quicker sort of cost saving, you know, if they have patients that are highly sensitized that we today know the median wait time is seven years. You know, we've also heard that there are patients waiting 10, 15 years on dialysis and obviously that will increase the cost, not only for Medicare, but also for commercial payers. So that is a discussion we'll have with those representatives to sort of better understand their perception of dialysis versus sort of a transplant with Inglifidase.

Okay, great. Thank you very much.

You're welcome.

Thank you. The next question comes from David Nierengarten with Wedbush Securities. Please go ahead.

Thanks for taking the question. Just another one on maybe some reimbursement dynamics or other reasons that the centers that you have spoken with might not adopt in lipidase immediately. Is it largely reimbursement concerns? When you look ahead, is it maybe not enough transplants to think about bringing in Muthu Desai on board. What are you hearing when you talk with centers on reasons why they might not adopt it immediately?

Thanks. I would first say that we do have a lot of interest from centers. Centers that have participated in confidants and also large centers where they've made pretty strong statements that they have patients waiting. From our perspective, what we're really trying to understand is, I think there are two aspects. The center needs to be clinically ready, and they need to be ready from an operational and financial perspective. So that is exactly why we have our medical team being out now trying to understand whether they stand from a clinical perspective. And things we're looking for are, do they have a transplant surgeon, a nephrologist? How does the team work? Do they have the clinical knowledge of highly sensitized patients? And things like that. And from an operational financial perspective, we're trying to understand how do they today handle DRG and outlier payments? And who are the people involved? Who sits on the P&T committee at the hospital? And so sort of getting those two aspects ready. And I think from my perspective is if you're not ready on the clinical perspective or the financial and operational, I don't think that you will be ready to use them later days. But we're doing that work right now with the top 100 centers, as I said, to sort of understand where they stand. And I would anticipate that you will have a group of those centers that are ready pretty quickly. And then as typically as part of launch, some of these centers may be later on in that process, maybe because they need further education on the product, which we can't give until it's approved. So those are some of the things that we're looking for.

Great. Thanks. Thank you. The next question comes from Georg De Galenov Bjorki with ABG. Please go ahead.

Hi, this is from ABG. Thank you for taking my questions. I am wondering, now that the CERB deal has formally been closed, if perhaps you're able to provide some details on the terms in the supply agreement of IDF-ERICs, please. And then are there any significant accrued on-sales or base production level of cost of goods sold we should account for in Q3. Thank you.

So in terms of kind of details of the agreement, I don't think that we're in a position to share any kind of significant details. I think that the agreement just simply states that we will continue to supply the licensed regions as we have kind of previously been supplying the region. But obviously, as part of that, there is a certain kind of cost sharing, obviously, that's going to go on going forward, considering that, obviously, we no longer benefit from the revenues. Obviously, there is a portion of the cost of goods, obviously, that will also be allocated along with those revenues. But otherwise, it's really kind of business as usual, I would say, from a supply standpoint. You know, we've been, this drug, as you know, has been kind of commercially available for several years in Europe and, you know, supply chains are, I would say, reasonably kind of well established.

Okay, thank you.

Thank you. The next question comes from Christopher Lude with SEB. Please go ahead.

Hi there, Christopher Udy from ICB. Thank you for taking my questions. Just was wondering really on what you're going to do with the cash from the CERB transaction. Obviously, you know, you've talked about using some of it for the launch, which makes sense, but do you need all of it for that? I mean, how much flexibility does this give you for M&A? And if you could talk about maybe, you know, the breadth of therapeutic areas and given your balance sheet, the stages of development that make most sense and how creative one can be in terms of deal structures. Thank you.

Thank you for that. I would say that in general, obviously, at this point in time, we don't know exactly what the world is going to look like in January. But I would say that on the basis of the cash that we have, I would say that obviously we're very confident that we'll be able to kind of really have a robust and successful launch. You are correct, obviously, depending on the uptake commercially kind of in the U.S., we may very well end up in a situation where we still will have kind of surplus cash or have a strong balance sheet. And I think if that is the case, I think that, you know, personally I want to kind of probably wait and see and know exactly kind of what I have in terms of my cash reserve. I think until then I think we'll continue to kind of spend cash wisely and appropriately. But you are right that obviously it can potentially open up a situation where we can explore opportunities to in-license either kind of complementary commercial products that are consistent with our footprint and our call point or that's kind of not either financially possible or we can't find anything that we find is, you know, find truly attractive commercially, then obviously we could also consider in licensing or partnering in terms of a late stage clinical stage product. So I think that these are things that, you know, we have now kind of, I would say, the luxury to potentially kind of explore and look at. But I will say that we will probably, you know, most likely not kind of go forward and kind of agree or sign up anything until it's clear to us exactly what the situation is in terms of the launch and the uptake curve in the U.S. But it certainly kind of gives us, you know, a lot more optionality and opportunities going forward to kind of build a, I would say, kind of whether that is a kind of a, you know, we're always going to stick, I would think, within kind of limited commercial opportunities. So we're not going to go into any GP kind of related situations or things that require a very, very broad commercial infrastructure. I think that we're going to definitely focus on rare, orphan, you know, specialty products, whether that then becomes kind of rare autoimmune products or whether that is kind of more kind of, you know, towards the hospital products. I guess that is something that we have now the opportunity and the time to really kind of look into, map out, and ultimately kind of set a strategy for that we can kind of then pursue next year. So I think it does, I think it is, you know, again, it's a luxury to be in this situation as a kind of biotech company. It's exciting, but as I said, we're going to be very disciplined and wise in terms of how we spend this cash for now.

Okay, thank you very much.

Thank you. Again, if you have a question, please press star, then 1. The next question comes from Suzanne Van Virtheisen with Van Linschot-Keppen. Please go ahead.

Hi, this is on a man for Suzanne. Thank you for taking our question. So you've indicated that you're in discussions with the FDA for 5487. To clarify, what are still some outstanding topics or next steps before reaching an agreement? And is there anything you could potentially share on any preliminary design?

So it is really kind of continued interactions and discussions around kind of the design And so we've had some initial kind of feedback, and we've taken part of that feedback that's been kind of quite clear. Some of it's been a little bit more complex to kind of maybe interpret and identify. And so we have some additional questions, want to go back to the FDA and clarify some of those points. So until we have kind of full clarity and understanding as to kind of what they're, you know, what they would like to see and what implications that might have for the design, I'd rather not get into any details in terms of the design. But I think that we're kind of, you know, we're certainly kind of continuing to operate and prepare everything and certainly targeting kind of opening an IND before the beginning of the year. But I think this is something that will require, you know, a little bit more kind of clarification and discussion with the FDA before we are ready to kind of completely share the design of that trial.

Okay, thank you.

Thank you. This concludes our question and answer session. I would like to turn the conference back over to CEO Rene Aguiar-Lucender for any closing remarks.

Thank you very much. Thank you, everybody, for listening to this Q2 report, and we look forward to sharing our Q3 report in due time.

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