Hansa Biopharma AB (publ) (HNSA) Earnings Call Transcript & Summary

Welcome to the Hansa Biopharma Interim Report for Q1 2021. [Operator Instructions] Today, I am pleased to present CEO, Søren Tulstrup. Speakers, please begin.

Thank you, operator. Good afternoon. Good morning and welcome to the Hansa Biopharma conference call in the first quarter of 2021. I'm Søren Tulstrup, CEO of Hansa Biopharma. With me today, I have our CFO, Donato Spota; as well as our Head of Investor Relations, Klaus Sindahl. Today, we'll review the overall progress and highlights of our business in the first quarter of 2021 as well as the near-term milestones. Our presentation should take 15 minutes. And after that, we'll take your questions. Now please turn to Slide 2. Please allow me to draw your attention to the fact that I'll be making forward-looking statements during this presentation, and you should therefore apply appropriate caution. Please turn to Slide 3. Hansa's long-term objective is to build the company into a recognized global leader in rare diseases across multiple broad therapeutic areas through the development of new transformative medicines for patients suffering from rare immunologic diseases. In order to do so, we need to successfully execute on our strategic priorities, and I'm happy to report clear progress across our business already this early in the year. During the first quarter, we have registered the first commercial sales of Idefirix. And with this, Hansa Biopharma's evolution into a fully integrated commercial space biopharmaceutical company is now a reality. Our commercial launch activities are underway as planned, and we expect to get the first national reimbursement agreements in place in early launch countries from midyear this year and onwards. As part of this effort, health care technology assessments are being conducted by payers to evaluate the health economic impact of using Idefirix. The first such assessment was recently published in Sweden, and this assessment was favorable to the use of Idefirix in scenarios representing both high and low mortality assumptions for dialysis patients. On March 29, Hansa entered into a preclinical research collaboration agreement with argenx to explore the potential of combining imlifidase, Hansa's IgG antibody-cleaving enzyme, and efgartigimod, argenx’s FcRn antagonist. We're pleased to collaborate with argenx, a leader in the field of the FcRn inhibitor -- inhibition as they share our commitment to bringing innovative new medicines to patients suffering from autoimmune diseases. A combination of imlifidase and efgartigimod could potentially be used in both the acute and chronic setting of autoimmune diseases and transplantation and may potentially unlock additional therapeutic value. In the U.S., Hansa is currently in productive dialogue with the FDA, and we expect to finalize an agreement with the agency near term on a protocol for a randomized controlled trial in the U.S. Preparatory work to initiate the trial has started, and we're encouraged by the strong interest shown by leading U.S. transplant centers to participate in the trial. Subject to the expected agreement with the FDA on the study protocol near term, we expect study initiation in the U.S. over the summer with the first patient to be enrolled in the second half of 2021 and completion of enrollment 12 to 18 months later. After a 12-month follow-up, we expect the U.S. clinical study could support potential BLA submission under the accelerated approval pathway in the first half of 2024. Furthermore, I'm pleased to announce that our long-term follow-up study in highly sensitized kidney patients continues to show encouraging outcomes after imlifidase and transplantation. We now have 3-year data available, demonstrating follow-up outcomes in line with expectations compared to outcomes in patients undergoing HLA-incompatible transplantation. More details are expected to be shared later this year following submission of a manuscript to a peer-reviewed journal. In our ongoing Phase II programs, GBS and AMR, we see patient enrollment progressing again following a temporary halt of the studies during 2020 due to the COVID-19 pandemic. Patient enrollment was reinitiated in both studies back in December 2020 under a risk-based, site-by-site approach. More details will be shared later on during this presentation. Lastly, I'm also happy to see that we are continuing to attract the talent and competencies needed to build a high-performance organization. In March, we announced the recruitment of Magnus Korsgren, MD and PhD, as our new Head of R&D. Magnus Korsgren will bring extensive international experience in translational medicine, drug development to Hansa as we continue our efforts to build a highly valuable pipeline of drug candidates within transplantation, autoimmune diseases and beyond. I'm also pleased to see Dr. Hilary Malone, PhD in Molecular Neuropharmacology, being proposed at the next AGM as a new member of the Board of Directors at Hansa Biopharma. Dr. Malone is based in the U.S. where she currently holds the position of Executive Vice President and Chief Operating Officer at Valo Health Inc. in Boston. And she has previously held a range of senior global executive positions at Sanofi, Pfizer, Wyeth and AstraZeneca, among others. Please turn to Slide 4. As I said initially, Hansa Biopharma's evolution into a fully integrated, commercial-stage biopharmaceutical company is now a reality following the company's first commercial sales of Idefirix in Europe. Our commercial launch activities are underway as planned in the first early launch countries and initial pharmacy-level pricing is now available in the Nordics, Benelux, Germany and the U.K. In parallel to our commercial efforts, the supply chain has been established for the initial distribution of Idefirix to leading transplantation centers in Europe. Our team is in close contact with these targeted centers to help prepare the centers to implement protocols and select the first patient and ensure a replication of the positive experiences seen in our Phase II studies. The aim is to turn early adopters into centers of reference and over time to make Idefirix new gold standard in desensitization protocols more broadly. We're also engaged in close interaction with national reimbursement authorities to access the necessary funding. As previously guided, decisions by authorities can be expected from midyear and onwards in early launch countries. In parallel with reimbursement negotiation processes, Hansa continues to work with select key centers that potentially have the ability to access funds outside the national reimbursement system for individual patients. Now please turn to Slide 5. As highlighted in the beginning of this call, we saw the first health care technology assessment being published in Sweden recently. Health care technology assessments are often being conducted by government organizations or regional payers to evaluate the health economic impact of using Idefirix before a final decision is made whether to recommend or grant national or regional-level reimbursement. The HTA assessment by the Swedish TLV presented 2 cost-effectiveness scenarios, one with high and one with low dialysis mortality assumptions to assess the health economic impact of implementing Idefirix in the Swedish health care system. Both scenarios presented were within the accepted threshold for pharmaceutical treatment costs and the second scenario even concluded that Idefirix will be a cost-saving drug, which is a rare event for orphan drugs. Assumptions and assessments may, of course, vary from country to country, but we are very encouraged by the first assessment from the Swedish TLV, favoring the use of Idefirix in highly sensitized patients incompatible to a deceased donor. A recommendation by the agency Board in Sweden is expected around midyear this year before Idefirix is expected to become commercially available in the clinics in Sweden. Please turn to Slide 6. As mentioned earlier, we have entered into a preclinical collaboration agreement with argenx, a global leader in the field of FcRn-inhibition. This new collaboration sets out to explore the potential of combining imlifidase and efgartigimod. This combination could potentially be used in both the acute and chronic setting of autoimmune diseases and transplantation and may potentially unlock additional therapeutic value. Under the agreement, Hansa and argenx will contribute equally in terms of resource allocation and will share all IP and data developed through the collaboration while each company will maintain exclusive rights to their respective technologies and products. Please turn to Slide 7. As mentioned in the beginning of this call, patient recruitment in our Phase II programs in AMR and GBS has restarted. Both studies were temporarily halted for some time during 2020 due to the COVID-19 pandemic. In the AMR trial, 9 patients out of a target of 30 have now been enrolled and 7 out of 11 centers are currently open for enrollment. In the GBS trial, we have 8 patients enrolled out of a target of 30 with 7 out of 10 centers currently open for recruitment. Depending on the potential impact of the pandemic, enrollment into both studies is expected to be completed towards the end of 2021, as previously guided. In anti-GBM, we have started preparations for upcoming engagements with the FDA and EMA to discuss the path forward whilst awaiting the complete data set from the Phase II study. Please turn to Slide 8 and a summary overview of our pipeline. As depicted on this slide, thanks to continued progress over the past years, we have developed a broad clinical pipeline in both transplantation and autoimmune diseases, in addition, we have exciting preclinical projects ongoing in cancer and antidrug antibodies as well as in the promising field of gene therapy where our preclinical studies with imlifidase were begun last year by our partner, Sarepta Therapeutics, as part of efforts to develop imlifidase as the potential pretreatment ahead of gene therapy in Limb-Girdle and Duchenne muscular dystrophy. I'll now hand over the call to Donato, who will take us through a detailed review of the financials. Donato, please?

Thank you, Søren. Please turn to Slide 9. As Søren stated at the beginning of our presentation, Hansa has now transitioned into a new phase of its life following the company's first commercial sales of Idefirix during the first quarter of 2021. Total revenue in first quarter 2021 amounted to SEK 9 million, SEK 6 million of which relates to our first product sales. In addition, the company recognized SEK 2.4 million in revenue from the upfront payment received in July 2020 under the Sarepta agreement. Sarepta upfront payment is expected to be recognized over a period of approximately 36 to 48 months as Hansa fulfills its performance obligations under the contract. Since starting working with Sarepta last year, a total of SEK 4 million has been recognized from the USD 10 million or SEK 89 million received. Please turn to Slide 10. SG&A expenses amounted to SEK 60 million for the first quarter of 2021 compared to SEK 39 million for the same period last year. The increase in expenses mainly reflects and just broadened commercial activities and organizational expansion over the past quarters related to the launch of Idefirix, including the hiring of certain local functions as well as investments in marketing and supply chain activities as part of the commercialization of Idefirix in Europe. R&D expenses for the first quarter of 2021 amounted to SEK 47 million versus SEK 53 million last year. We continue to invest in our clinical and preclinical programs across all of our therapeutic areas, supporting the long-term value generation in Hansa Biopharma. The net loss for the first quarter of 2021 was SEK 104 million compared to SEK 94 million last year. The increased net loss was primarily driven by increased activities and ramping up our commercial activities and organizations, as outlined before. Please turn to Slide 11. Cash flow from operating activities amounted to minus SEK 121 million for the first quarter, which is on par with the first quarter last year. At the end of March 2021, our cash position, including short-term investments, amounted to approximately SEK 1.25 billion, which corresponds to approximately USD 150 million. With our solid cash position and projected burn rate, we expect Hansa to be financed into 2023. I'll now hand back to Søren to give his final remarks.

Thank you, Donato. Please turn to Slide 12. Hansa Biopharma's evolution into a fully integrated commercial-stage biopharmaceutical company is now a reality, and we're off to a good start in 2021. Looking at our milestones for this year, we expect to initiate before summer IND-enabling tox studies for our next-generation enzymes for repeat dosing, also known as the NiceR program. On the commercial side, our discussions with national reimbursement authorities are progressing as expected, and we could reach the first national reimbursement agreement here in the second or third quarter. As stated earlier during this call, subject to near-term alignment with the FDA, we expect to initiate a randomized controlled trial in the U.S. over the summer with the first patient to be enrolled in the second half of the year and completion of enrollment 12 to 18 months later. This could support a potential BLA submission under the accelerated approval pathway in the first half of 2024. Depending on the COVID-19 situation, we expect to complete enrollment of patients into our 2 Phase II clinical programs in AMR and GBS in the second half of the year with high level data readout in the second half of 2022. We look forward to keeping you updated on our progress in advancing our mission to bring life-saving and life-altering therapies to patients with rare diseases while generating long-term value to our shareholders and society at large. Now please turn to Slide 13. With this, we're now ready to take your questions, and I hand over to the operator.

[Operator Instructions] We have three questions in the queue so far. The first is from the line of Christopher Uhde of SEB.

I just wanted to start by asking about the gross margins. It looks like for Idefirix itself is about 71% or so. Where do you see it getting up to? Do you think that it could get as high as 90%? Or -- that's my first question. And the other question is, have you submitted the study on the 3-year follow-up data already? Or is that still to be done?

All right. Well, thanks for the question, Christopher. I'll hand over to Donato to reply to your first one on the gross margin.

Yes, Chris. So obviously, the first quarter is obviously not that representative of what we expect going forward. I mean I think it's too early to give you kind of a concrete number here, but we do definitely believe that this is going to improve over time as we see sales growing and launch effects and being eliminated from the numbers.

Good. Thanks, Donato. On the second question, Christopher, on whether or not we have already submitted the 3-year data to a journal, peer-reviewed journal, that has not happened at this point in time. We are preparing to do so.

Our next question comes from the line of Ingrid Gafanhão of Kempen.

I have two from me. I think first of all, I was wondering regarding your plans in GBM. Are you going to provide any clarity on the timing that you're going to have with meeting with the regulators or when we could see some further data presented or published? Yes. And then after that, I can ask my second question.

Sure. Thanks, Ingrid. So on the anti-GBM time line, we are still working on making sure we have all the data and all the information necessary to engage formally with both the FDA and EMA. So that will happen. And as we've said, this will happen in the course of the rest of the year. And certainly, the aim is to reach an agreement before the end of the year on the path forward. As far as making additional data available, beyond the data that we already published, the high-level data, I cannot give you a precise kind of date, but it will hopefully happen at some point during this year.

All right. No. Got it. That's clear. And my second question is, I recognize it's still a little bit early in the sales trajectory for Idefirix in Europe. But I think going forward, should we expect you to give us an actual sales guidance at some point? And are you planning to start sharing some more granularity on how sales is going by, for example, informing us about the number of patients that are treated in a certain period of time? How should we prepare for this going forward?

Yes. You're right. It's still very, very early days. And I think as we've discussed a number of times, this is really a transformative therapy and a lot of things need to fall in line. It's very, very difficult to predict the precise slope of the uptake other than what we have said for a number times, which is that we expect it to be an S-shaped launch curve where initially, you'll have to invest a lot of time and resources in working with the key centers in Europe to make sure that they're optimally prepared to select the right patients and have good first experiences in those patients. So our aim for this year really is not a high number of patients. It is to have a number of the leading centers that we expect to be early adopters across Europe to have a first positive experience. They need to put in place local protocols and a lot of different things need to be put in place also, how the work and allocation system should work and so on in the region or in the country. So there's a lot of things that need to fall in place. So we will certainly not provide that kind of guidance short term is what I can say. I also want to say that you should not expect guidance on a patient level. For a variety of reasons, we will not discuss individual patients or clinics or in specific treatment circumstances and so on. And those reasons include regulatory reasons. So it will be you'll see, obviously, the sales, and you'll have some assumptions around what that means in terms of patients, and that's all we can do at this point in time.

And our next question comes from the line of Charles Weston at RBC.

Congratulations on the first commercial sale milestone. Three questions, please. First of all, you mentioned that Idefirix pharmacy pricing has been agreed in 7 countries. What is the range, minimum and maximum and average, of those, please?

So just to correct you, it's not that we have agreed the pharmacy-level pricing. This is a free-pricing-type countries where you can put the price out there, which we've done in these countries. So that is the pharmacy-level pricing. And it's around EUR 300,000 per patient.

Okay. And then just in terms of the costs, this is more of a modeling question, really. How should we be thinking about R&D phasing through 2021?

The phasing through 2021, well, I'll let Donato speak to that in a little bit more detail.

Charles, well, obviously, as we've guided, I mean we're in the process of preparing a number of studies, which we initiate with -- which we plan to initiate in the course of this year. So I think overall, you can expect that R&D expenses will start to pick up during the remainder of the year. Our overall guidance, as you're aware of, is that with the current cash position that we're going to be able to finance -- expect to be able to finance our operations into 2023. So going forward, obviously, that will also mean that we would -- we are expecting some accelerated expenses over the months and quarters to come not only this year, but on also 2022 as we continue to invest in our pipeline and broaden the pipeline and the activities.

And just to clarify, could we be modeling therefore a smooth ramp up through the year? Or could we expect perhaps another quarter of more modest R&D and then stepping up more in the second half?

Well, I think one of the key drivers for this year is certainly then the initiation of the U.S. strategic body and also the post-approval study in Europe, which we mentioned before, both studies we plan to initiate in the second half. So potentially, that means that there will be more expense in the second half to be expected than in the first half of this year.

And my last question was, unfortunately, another boring modeling question. I'm not going to go around the Sarepta milestones. Can I just clarify, you said that they would be booked over 36 to 48 months. And obviously, even in that case, we'd expect to grow from the SEK 2.5 million. So again, is there a way to predict how that's going be booked? Or would it be a bit lumpy depending on your activity?

Well, as you may be aware, Charles, that this is obviously the recognition of the USD 10 million that we got into our P&L is very much dependent on our contribution into the activities that are ongoing and obviously, this is not necessarily steadily. So if there's more activities on our side that will result in a higher recognition in the quarter, if there's less activities at our end, then that would result in a lower recognition for a specific quarter. But I guess taking the overall amount for your modeling, I'm not so sure that -- I'm not sure that it's too much off if you just apply a linear recognition.

Our next question comes from the line of Dominic Rose at Intron Health.

This is Dominic Rose from Intron Health. I have two. Question one concerns your collaboration with argenx. I was hoping you could explain a bit the thinking behind combining efgartigimod with imlifidase. It looks to me like both mechanisms of action issue similar things, which is targeting IgG. So what's the thinking behind that? And then on question two, I was hoping you could provide a bit more color on which markets you hope to win reimbursement for this year and roughly how many patients that would correspond to. And as a follow-on to that, the revenues that you reported in Q1, just to confirm, weren't those private market sales? Does that mean without winning market reimbursement until midyear, we should expect Q2 product revenues to be at a fairly similar run rate to Q1?

Okay. So let's take your questions in order, and I think maybe on the third one, Donato can chime in as well. So as far as the rationale behind the argenx collaboration, you're right, both companies' products are targeting IgG. But the approach is different and the outcome is also somewhat different. So imlifidase, as you may know, essentially increased IgG immediately. And so within a couple of hours from a 15-minute infusion, you have IgG levels dropping down below detectable, and they stay down there for approximately 7 days before bouncing back and then within a month, they are back to normal. Efgartigimod, on the other hand, it takes down IgG but not to the level that imlifidase does. And it takes a little bit longer. So obviously, that's a different profile, which is great in many settings. So imlifidase is not something that we're developing for, let's say, maintenance therapy because you don't want to have your IgG levels down below detectable for a sustained period of time. So where we see imlifidase potentially acting in a complementary way with FcRn inhibitors is as induction therapy or when you have, for instance, flare, so you have specific situations in certain autoimmune -- chronic autoimmune diseases where you need efficacy beyond the maintenance therapy. So those are the types of settings that certainly from our perspective could be highly relevant for a combination of efgartigimod and imlifidase. And as we've said, we've started preclinical work now, and we're very excited to see that progressing. Then your second question was on which markets we expect to have reimbursement in this year. That is a little bit, as you'll appreciate, difficult to predict. Clearly, what you do see in Europe is that the certain markets tend to be faster than others. You need to go through less comprehensive reimbursement negotiation processes and so on. Those countries are typically Germany, the Nordics, Benelux, to a certain extent, the U.K. and a few other countries. So we would expect that some of these countries would also be represented in the first countries to make a national level positive decision, hopefully, on granting reimbursement. In addition to that, we are also working with local clinics to see if we can help them access specific funding locally available outside of the national reimbursement system and then obviously, may trigger sales before -- even before there is a national level reimbursement, which is essentially also what you've seen here. And then the third question, I'll hand over to Donato. Thanks.

Yes, Dominic, on your question with regard to the revenue, I mean if you look at Q1 revenue, you can see 2 major components. One is the Sarepta revenue recognition and one is product sales. And the Sarepta revenue recognition, that's a piece of revenue, which obviously will be coming the next quarter as well. I can't give you the exact level of revenue that we're going to be recognizing, it depends on the activities that are going to be performed and the progress that is made there. But -- so -- but there will be certainly a certain amount recognized from the SEK 10 million into the P&L also in second quarter. When it comes to product sales, that very much depends on the number of patients that are going to be treated with imlifidase. As soon as the patient is treated, the revenue is basically recognized. And so I can't give you an outlook to that. As I said, it depends really on the number of patients that we treat, but it is an immediate recognition of the sale as soon as the patient has been treated.

Thanks for that. Did that answer your questions, Dominic?

Yes. That's very helpful.

And our next question comes from the line of Caroline Van Feltz of Danske Bank.

I was just wondering if you could provide any additional information on from which countries the Q1 revenues were generated from Idefirix. And also another question, how pricing was received and have any discounts been applied?

So on your first question there, what I can say is that all the sales is from one country and that country is Germany. And in Germany, we don't have national-level reimbursement at this point in time. We have submitted a dossier to AMNOG. So that process is ongoing. As far as pricing, discounts and so on, that's not something we will comment on. I'm looking at Donato if he volunteers and he doesn't. So that's good. We do not comment on that.

And we have a follow-up from Christopher Uhde at SEB.

So one of your comments on the efgartigimod collaboration rationale just provokes a question. I just wanted to double check about the NiceR rationale because -- so basically, you said a moment ago, you wouldn't necessarily want patients to have no antibodies chronically. And obviously, I wouldn't want to give up mine. But I guess there might be some situations where you would, would you not? And I guess when you think about NiceR, are you thinking about it ever being used sort of on a sort of chronic repetitive basis with a view to maintaining 0 level or undetectable antibodies? Or are you thinking about it more for intermittent use?

Yes. It's really the latter. So it's not for kind of ongoing maintenance therapy where for a very long period you would have these IgG levels down below detectable. So -- but clearly, we are developing NiceR as therapies that can be used intermittently when you need specific additional impact, if you will, or prior to initiating maintenance therapy. By then, that can be dosed in the gene therapy space to deal with, for instance, neutralizing antibodies current -- post dosing of the AAV gene therapy, which may be multiple dosing scenarios. It can be autoimmune diseases where, again, we have these players that occur in many IgG-driven autoimmune diseases several times a year. And it can be in the oncology setting, again, where, hopefully, we will have a proof of mechanism for our approach there, which is to try to increase efficacy of immuno-oncology therapies. And there, of course, almost by default, this is repeat dosing scenarios, right? We're still not certain, of course. We still don't have the full data set, how frequent you would want to dose and what is optimal, but that will be coming out of our development programs.

Okay. But I mean I guess you wouldn't necessarily say you've completely ruled out the possibility of certain situations arising when you might want to do that.

Nothing is ruled out. But to me, it's unlikely that we would try to develop, at this point in time, at least, with the profile we have, looking at our lead candidate, which is a very efficacious one, diseases or disease scenarios where we would offer therapies that would keep IgG levels down below detectable for years. So it's more like -- it's more intermittent therapy, right? And what frequency and what kind of intervals, it's impossible to say at this point in time. I'll say that we're fairly comfortable that we can, again, generate and develop enzymes that are very efficacious and that can be dosed repeatedly and can be kind of build to target specific diseases where there's a high degree of unmet medical need.

I mean is the immunogenicity a factor here?

Immunogenicity is always a factor. But again, as you know, our aim through the NiceR program is really to significantly decrease the immunogenicity of what we see immune today, right?

Currently, we've got one further question in the queue. [Operator Instructions] And the last question so far is a follow-up from the line of Charles Weston, RBC.

Just a quick follow-up. How many patients have been treated with Idefirix so far in April, please?

So as I said, I think in response to Ingrid's question, we're not going to comment on specific patient-level sales data. We will only communicate and report out the overall sales for a variety of reasons. So this I can't tell you. Obviously, you're aware of how many patients have been treated over the Phase II trials, but we're not going to give you the commercial sales patient-level data, and we'll not report on that going forward either.

We've had a couple more questions coming through. The next is from the line of [ Johan Inuris ] of Redeye.

Maybe a follow-up and clarification on the earlier question. The Sarepta partnership, NiceR is included in that. Is that correct?

No. That's not correct. So the Sarepta agreement is focused on imlifidase. And it's specifically focused on the existing neutralizing antibodies, just to be clear.

Yes. So could NiceR be included?

It's not included in the current setup. So can NiceR be included? Obviously, it's something that we're also looking to develop for the gene therapy space. So that certainly is a possibility.

Yes. And when could NiceR be ready to be included in that partnership or another partnership in gene therapy?

Well, specifically, where we stand with NiceR right now is that we are preparing to initiate IND-enabling tox studies, and we expect to do so before summer or over summer since around summer. So obviously, we need to complete that. And then at some point next year, we could potentially be ready to go into the clinic. Again, you could, of course, initiate a preclinical work with the NiceR molecules in the gene therapy space even earlier. That certainly is a possibility.

And what about the -- again, collaboration is that probably to NiceR?

That collaboration is focused on imlifidase specifically and efgartigimod. So these 2 specific molecules.

So that's a similar situation.

Yes.

We've got another question from Ingrid Gafanhão with Kempen.

I think just given that it's a bit of a quiet year ahead in terms of news for -- regarding clinical trials. I was wondering, is there any color that you can give to us that you can share if we should be expecting or at least be on a lookout for any additional news on business development front?

I can't predict that. Obviously, I can tell you, we're very busy. And I'm talking to a very broad range of players in various fields. Certainly, in the gene therapy field, there is a lot of interest for the approach using imlifidase to deal with pre-existing neutralizing antibodies, which really is a major challenge for quite a large number of gene therapy companies, depending on their specific vectors and what specific diseases they're targeting. So can that lead to additional news? Absolutely. Will it? I don't know. When? I don't know, but we'll have to see, right? So that's what I can say at this point.

And we have one further question in the queue at this time. And that's from the line of Christopher Uhde of SEB again.

Just to follow up on the comment about Germany because I think my sense from your comments previously was that obviously, you'd be tightly trying to choreograph the launch. Is it -- but -- and yet, I think you mentioned that you expected it to be probably in countries other than Germany that the first patients would be treated, if I remember correctly. Can you just comment on -- do you say that these are -- were all of these uses sort of calling the careful choreographing of the launch that you talked about? And should we see then this, I mean, German opportunity as maybe a little bit of an upside to what you had discussed previously?

So the situation in Germany is -- and the reason why we've said that Germany is a little bit of a special case is the fact that, as you may recall, they had some issues quite some years back with liver transplants, and it was a bit of a scandal in Germany. And for that reason, there is some infrastructure building, infrastructure being a term for range of issues to be implemented in Germany that we're certainly hard at work doing it, right? So that's what I can say. I wouldn't say that this is something that you should say that this is an upside for anyone, including ourselves. I mean things are moving ahead as planned. Clearly, a lot of work has to be done to enable the centers to, again, select the right patients and make sure that they have access to funds and to organs and all of this. So that's what I can say in general.

[Operator Instructions] Okay. There seems to be no further questions at this time. So I'll hand back to our speakers for their closing comments.

Thanks very much, operator, and thank you, everyone, for your interest in our Q1 results. It's been a pleasure to update you, and I look very much forward to keeping you updated as we move forward. So with this, thanks so much and have a nice day.