Earnings Call: Q1 2021

Apr 22, 2021

Thank you, operator. Good afternoon, good morning, and welcome to the handset biopharma conference call on the Q1 of 2021. I'm Soren Thunstolm, CEO of Hansebiopharma. With me today, I have our CFO, Donato Spota as well as our Head of Investor Relations, Claus Sende. Today, we'll review the overall progress and highlights of our business in the Q1 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. ANSA'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 Q1, we have registered the 1st commercial sales of IDeforex and with this Enter Biopharma's evolution into a fully integrated commercial stage Biopharmaceutical company is now a reality. Our commercial launch activities are underway as planned and we expect get the 1st national reimbursement agreements in place in early launch countries from mid year this year and onwards. As part of this effort, healthcare technology assessments are being conducted by payers to evaluate the health economic impact of using IDACRX. The first such assessment was recently published in Sweden and this assessment was favorable to the use of IDH4X in scenarios representing both high and low mortality assumptions dialysis patients. On March 29, ANSA entered into a preclinical research collaboration agreement with AgenX to explore the potential of combining inlucidase, antisense IgG antibody cleaving enzyme and ifkatigimod, Argenx's FcRn antagonist. We're pleased to collaborate with REGENX, a leader in the field of CRN inhibition, as they share our commitment to bringing innovative new medicines to patients suffering from autoimmune diseases. A combination of amipidase and ifkatikumab 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, ANSA is currently in productive dialogue with the FDA 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 and 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 twenty twenty one and completion of enrollment 12 to 18 months later. After a 12 month follow-up, we expect the U. S. Clinical study could support a potential BLA submission under the accelerated pool pathway in the first half of twenty twenty four. Furthermore, I'm pleased to announce that our long term follow-up study in highly sensitized Kidney patients continues to show encouraging outcomes after a new PDASE treatment 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 studies during 2020 due to the COVID-nineteen pandemic. Patient enrollment was reinitiated in both studies back in December 2020 under a risk based side by side approach. More details will be shared later on during this presentation. Lastly, I'm also happy to see that we're continuing to attract the Talent and competence is needed to build a high performance organization. In March, we announced the recruitment of Magnus Kolske, MD and PhD as our new Head of R and D. Magnus Carlsgajten will bring extensive international experience in translational medicine and 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 Doctor. Hilary Malone, PhD in Molecular Neuropharmacology being proposed at the next AGM as a new member of the Board of Directors at Hanse Biopharma. Doctor. Malone is based in the U. S, where she currently hosts the position of Executive Vice President and Chief Operating Officer at Valla Health Incorporated in Boston, As she has previously held a range of senior global executive positions at Sanofi, Pfizer, WISE and AstraZeneca among others. Please turn to Slide 4. As I said initially, AntibioPharma's evolution into a Fully integrated commercial stage biopharmaceutical company is now a reality following the company's first commercial sales of IDOFORIX 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 ID4X to leading patient 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 2 studies. The aim is to turn early adopters into centers of reference and over time to make IDH4X the new gold standard in desensitization protocols more broad. We 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, Hansek 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 healthcare technology assessment being published in Sweden recently. Healthcare technology assessments are often being conducted by government organizations or regional Here is to evaluate the health economic impact of using IDAFORIX before a final decision is made whether to recommend or grant national or regional level reimbursement. The HTA assessment by the Swedish TRV presented 2 cost effectiveness scenarios, 1 with high and 1 with low dialysis mortality assumptions to assess the health economic impact of implementing IDHORx in the Swedish healthcare system. Both scenarios presented where within the accepted threshold for pharmaceutical treatment costs and the second scenario even concluded that eye deferrish would 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 TOB, favoring the use of IDePhRx in highly sensitized patients incompatible to a deceased donor. A recommendation by the NC Board in Sweden is expected around midyear this year before IDH4X 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 AgenX, a global leader in the field of FcRn inhibition. This new collaboration sets out to explore the potential of combining enliphidase 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, Hansen Agenics 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 2 programs in AMR and GV has restarted. Both studies were temporarily hold for some time during 2020 due to the COVID-nineteen pandemic. In the AMR trial, 9 patients out of a Target of 30 have now been enrolled and 7 of 11 centers are currently open for enrollment. In the GBS trial, we have 8 patients enrolled out of a target 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 2 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 preclinical studies with the newfidase were begun last year by partner, Sarepta Therapeutics, as part of efforts to develop a new database as potential pretreatment and 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, Soren. Please turn to Slide 9. As Soren stated at the beginning of our presentation, Hanza has now transitioned into a new phase of It's live following the company's first commercial sales of iDevRx during the Q1 of 2021. Total revenue In Q1 2021 amounted to DKK9 1,000,000, dollars 6,000,000 of which relates to our first product sales. In addition, the company recognized CAD2.4 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 Hamza fulfills its performance obligations under the contract. Since starting working with Sarepta last year, a total of DKK4 1,000,000 has been recognized from the DKK10 1,000,000 or DKK89 million received. Please turn to Slide 10. SG and A expenses amounted DKK60 1,000,000 for the Q1 of 2021 compared to DKK39 1,000,000 for the same period last year. The increase in expenses mainly reflects Amta's broadened commercial activities and organizational expansion over the past quarters related to the launch of IDOFRx, including the hiring of certain local functions as well as investments in marketing and iChain activities as part of the commercialization of IDOFREX in Europe. R and D expenses for the Q1 of 2021 amounted to DKK47 1,000,000 versus DKK53 1,000,000 last year. We continued to invest in our clinical and preclinical programs across all of and therapeutic areas supporting the long term value generation in Hansa BioPharm. The net loss for the Q1 of 2021 was DKK 104,000,000 compared to DKK94,000,000 last year. The increased net loss This is primarily driven by increased activities and ramping up our commercial activities and organization as outlined before. Please turn to Slide 11. Cash flow from operating activities amounted to minus SEK121 million for the Q1, which is on par with the Q1 last year. At the end of March 2021, our cash position, including short term investments, amounted to approximately SEK1.25 billion, which corresponds to approximately US150 $1,000,000 With our solid cash position and projected burn rate, expect Tamsar to be financed into 2023. I now hand back to Soren to give his final remarks. Thank you, Donato. Please turn to slide 12. Hunter Biopharma's evolution into a fully integrated commercial stage biopharmaceutical company is now a reality, We're off to a good start in 2021. Looking at our milestones for this year, we expect to initiate before summer IND mapping tox For our next generation enzymes for repeat dosing, also known as the NICER program. On the commercial side, our discussions with national reimbursement authorities progressing as expected, and we could reach the 1st national reimbursement agreement here in the 2nd or Q3. 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 twenty twenty four. Pending on the COVID-nineteen situation, we expect to complete enrollment of patients into our 2 Phase 2 clinical programs in AMR and GPS in the second half of the year, with high level data readout in the second half of twenty twenty two. 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. Thank you. We have three questions in the queue so far. The first is from the line of Christa Ooch I just wanted to start by asking about the gross margins. It looks like for IDEXRX itself, it's about 71% or so, where do you see it getting up to? Do you think that it would 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? Thanks for the questions, Christopher. I'll hand over to Donato to reply to your first one on the gross margin. Yes, Christopher, hi. So obviously, the Q1 is obviously not representative of what we expect going forward. I mean, I think it's too early to give you a kind of a concrete number here, but we still 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, a peer reviewed journal, that has not happened at this point in time. We're preparing to do so. All right. Terrific. Thank you. Thanks. Thank you. Our next question comes from the line of Ingrid I have 2 for 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 the meeting with the regulators or is there 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 Antibio GM timeline, We are still working on making sure we have all the data and all information necessary to Formally with both the FDA and GMA. 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. My second question is, I recognize it's still a little bit early in the sales trajectory for Adafruit 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 of times, which is that we expect it to be an S shaped launch curve, where initially we'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 working allocation system should to 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 specific treatment circumstances and so on. And those reasons include regulatory reasons. So it will be you will see obviously the sales and you will have some assumptions around what that means in terms of patients, and that's all we can do at this point in time. That's very clear. Thank you. Thanks, Igor. Thank you. And our next question comes from the line of Charles Weston at RBC. Please go ahead. Your line is open. Hello. Thanks for taking my questions and congratulations on the first commercial sale milestone. Three questions, please. First of all, you mentioned that Ediferic's 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 in 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 €3,000 per patient. Okay. Thank you. And then just in terms of the costs, this is more of a modeling question really. How should we be thinking about R and D phasing through 2021? The phasing in 2021. I'll let Donato speak to that in a little bit more detail. Hi, Charles. Well, obviously, as we've guided, I mean, We're in the process of preparing a number of studies, which we initiate which we plan to initiate in the course of this year. So I think overall, you can expect that R and 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 thank you, and just to clarify, could we be modeling, therefore, a smooth ramp up through the year? Or Could we expect perhaps another quarter more modest R and D and then stepping up or in the second half? Well, I think one of the key drivers for this year is certainly then the initiation of the U. S. RCT study and also The post approval study in Europe, which we mentioned before, the post studies we plan to initiate in the second half. So Andrew, that means that there will be more expenses in the second half to be expected than in the first half of this year. Thank you. And my last question is unfortunately another boring modeling question, and that is 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 them to grow from the DKK 2,500,000. So again, is there a way to predict how that's going to be built? Or would it Be a bit lumpy depending on your activity. Well, it's as you may be aware, Charles, that this is obviously the recognition of the $1,000,000 that we got into our P and 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 we address activities at our end, then that would result in a lower recognition for us this quarter. But I guess taking the overall And for your modeling, I'm not so sure that although I'm not sure that it's too much off if you just apply a linear recognition. Thank you very much. Very clear. Thanks, Charles. Thank you. Our next question comes from the line of Dominic Rose at Interim Health. Please go ahead. Your line is open. Hi. This is Dominic Rose from Interim Health. Thanks for taking my questions. I have 2. Question 1 concerns your collaboration with Argenx. I was hoping you could explain a bit of the thinking behind combining efgartigimod within Lithia Days. It looks to me like both mechanisms of action achieved similar things, which is toplete IgG. So what's the thinking behind that? And then on question 2, I was hoping you could provide a bit more color on which markets you had 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, were those private market sales? Does that mean without winning market reimbursements until mid year, we should expect Q2 product revenues to be at a fairly similar run rate to Q1? Thanks. Okay. So let me take your questions in order and I think maybe on the third one, Nathan Arto can chime in as well. As far as the rationale behind the AgenX collaboration, you're right, both companies' products are targeting IgG, But the approach is different and the outcome is also somewhat different. So amyloidase, as you may know, essentially cleaves 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. Ifkatikuma, on the other hand, takes down IgG, but not to the level that amikidase does, And it takes a little bit longer. So obviously, that's a different profile, which is great in many settings. So inizudase is not something that we're developing for, let's say, maintenance therapy because you don't want to have your That was down below detectable for a sustained period of time. So where we see Envisudase potentially acting in a complementary way with if shear inhibitors is as induction therapy or When you have, for instance, flares, 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 Tecumut and leukulase. And as we've said, we've started preclinical work now and we're very excited to see that Then your second question was on which markets we expect to have reimbursement in this year. That is a little bit, as you will appreciate, difficult to predict. Clearly, what you do see in Europe is that the shirk new artists tend to be faster than others. We 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 we've seen here. And then the third question, I'll hand over to Tomatsu. Thanks. And yes, Dominik, on your question with regard to the revenue, I mean, if you look at Q1 revenue, You can see 2 major components. 1 is the Sarepta revenue recognition and 1 is product sales. 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 depends on the activities that are going to be performed and the progress that is made there. But there will be certainly a certain amount recognized from the $10,000,000 into the P and L also in the second quarter. When it comes to product sales, that very much depends on the number of patients that are going to be treated. With Ameluzidase, as soon as the patient 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 as 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. Thanks. That's very helpful. Thanks. Thank you. And our next question comes from the line of Caroline Manna of Danske Bank. Please go ahead. Your line is open. Yes, good afternoon. Thank you for taking my questions. I was just wondering if you could provide any additional information on From which countries, the Q1 revenues were generated from Ideophirix? 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 Amnok, 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 in what he does and so that's good. We will not comment on that. All right. Thought as much for that. Thought I might ask anyway. Thanks, Caroline. All right. Thank you. Thank you. And we have a follow-up from Christopher Udi at 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? Thanks. 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 the 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, either that can be dosed in gene therapy space to deal with, for instance, neutralizing antibodies occurring post dosing of the gene therapy, which may be multiple dosing scenarios. It can be in autoimmune diseases where again you have these flares, they 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 are, 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. Well, I mean, I guess you wouldn't necessarily say you've completely ruled out The possibility of certain situations arising that 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 candidate, which is a very efficacious one, diseases or diseases in ions where we would offer therapies that will keep IgG levels down below detectable for years. So it's more like a 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 would say that we're fairly comfortable that we can, Again, generate we can develop enzymes that are very efficacious and that can be dosed repeatedly and can be kind of built to target It's a disease where there's a high degree of unmet medical need. I mean, is immunogenicity a factor here? Neogenicity is always a factor. But again, as you know, our aim through the NYSER program is really to significantly decrease the immunogenicity of what we see in the weaker days, right? Okay, terrific. Thank you. Thanks. Thank you. Currently, we've got one further question in the queue. 1 now. And the last question so far is from a follow-up from the line of Charles Weston, RBC. Please go ahead. Your line is open. Just a quick follow-up. How many patients have been treated with Ediferix 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 or rights of reason. 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 the commercial sales at least in level data and we'll not report on that going forward either. Okay. Thank you. Worth trying. Thanks, Charles. We've had a couple more questions coming through. The next This is from the line of Johan Enyruz of Redeye. Please go ahead. Your line is open. Thank you. Thanks for taking my question. Mainly, a follow-up and clarification on the earlier question. The Sarepta partnership, the NICE That is included in that, is that correct? No, that's not correct. So the Sarepta agreement is focused on amifidase And it's specifically focused on existing neutralizing antibodies, just to be clear. Yes. So could nycer be included? It's not included in the current setup. So can NICE will be included, obviously, something that we're also looking to develop for the gene therapy space. So that certainly is a possibility. Yes. And when Could NICE be ready to be included in that partnership or another partnership in gene therapy? Specifically, where we stand with NICE 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 preclinical work with the NISTR molecules in the gene therapy space or even earlier, that certainly is a possibility. And what about the Agenk collaboration, is that subject nicer? That collaboration is focused on Immutidase specifically and efgartigimod, so these 2 specific molecules. So that's a similar situation. Okay. Thank you very much. Welcome, Yuan. Thank you. And we've got another question from Ingrid Caffano of Kempen. Please go ahead. Your line is open. Hi. Thank you for having me back. I think just given that it's a bit of a quiet year ahead in terms of useful Regarding clinical trials, I was wondering, is there any color that you can give to us or that you can share if we should be expecting or at least on the lookout Or any additional news on business development front? I can't predict that. Obviously, I can tell you we're very busy 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 new nucleotides 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. We'll have to see, right? So that's what I can say at this point. All right. This has to try. Thank you, sorry. You're welcome. Thank you. And we have one further question in the queue at this time, and that's from the line of Chris Tewariuti of SEB again. Please go ahead. 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 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 You say that these are were all of these uses sort of following 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? Thanks. 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. 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, right? So that's what I can say. I wouldn't say that this is something that you are used to 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. Okay. Thanks much. Appreciate it. Bye. Thanks, Okay. There seems to be no further questions at this time. So I'll hand back to our speakers for the 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.