Thank you, Alfredo. Good afternoon, good morning, and welcome to the Hansa Biopharma conference call on 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. After that, we'll take your questions. Please turn to slide two. Please allow me to draw your attention to the fact that I'll be making forward-looking statements during this presentation. You should therefore apply appropriate caution. Please turn to slide three.
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 registered the first commercial sales of Idefirix, and with this, Hansa 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 to get the first 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 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 29th, 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 FcRn 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 12-18 months later. After a 12-month follow-up, we expect the U.S. clinical study could support a potential BLA submission under the Accelerated 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 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 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 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 competencies needed to build a high-performance organization.
In March, we announced the recruitment of Magnus Korsgren, M.D. and Ph.D., as our new head of R&D. Magnus Korsgren 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 am also pleased to see Dr. Hilary Malone, Ph.D. 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 four.
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. 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 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 the new gold standard in desensitization protocols more broadly. 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 mid-year 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 healthcare technology assessment being published in Sweden recently. Healthcare 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 two 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 healthcare system. Both scenarios presented were within the accepted threshold for pharmaceutical treatment costs. The second scenario even concluded that Idefirix 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. 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 NT-rådet in Sweden is expected around mid-year this year before Idefirix is expected to become commercially available in the clinics in Sweden. Please turn to Slide six.
As mentioned earlier, we have entered into a pre-clinical 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, nine patients out of a target of 30 have now been enrolled. Seven out of 11 centers are currently open for enrollment. In the GBS trial, we have eight patients enrolled out of a target of 30, with seven 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 the EMA to discuss a path forward whilst awaiting the complete data set from the phase II study. Please turn to Slide eight 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 pre-clinical projects ongoing in cancer and anti-drug antibodies, as well as in the promising field of gene therapy, where pre-clinical studies with imlifidase work begun last year by our partner, Sarepta Therapeutics, as part of efforts to develop imlifidase as a potential pre-treatment 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- 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 $10 million, or SEK 89 million, received. Please turn to Slide 10.
G&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 Hansa's 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 continued to invest in our clinical and pre-clinical programs across all of 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 is primarily driven by increased activities in ramping up our commercial activities and organization, 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 $150 million. With our solid cash position and projected burn rate, we expect Hansa to be financed into 2023. I 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. We are 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 NiceR program. On the commercial side, our discussions with national reimbursement authorities are progressing as expected. We could reach the first national reimbursement agreement here in the second or third quarter. I stated earlier during this call, subject to near-term alignment with the FDA, we expect to initiate a randomized control 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 12-18 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 two 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. Please turn to slide 13. With this, we are now ready to take your questions, and I hand over to the operator.
Thank you. If you wish to ask a question, please dial zero one on your telephone keypads now to enter the queue. Once your name is announced, you can ask your question. If you find it's answered before it's your turn to speak, you can dial zero two to cancel. Once again, that's zero one to ask a question or zero two if you need to cancel. We have three questions in the queue so far. The first is from the line of Christopher Udy of SEB. Please go ahead. Your line is open.
Sorry. Hi there. 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%? That's my first question. The other question is, have you submitted the study on the three-year follow-up data already, or is that still to be done?
All right. Well, thanks for the questions, Christopher. I'll hand over to Donato to reply to your first one on the gross margin.
Yeah, Christopher. Hi. Obviously, the first quarter is obviously not representative of what we expect going forward. I think it's too early to give you a concrete number here, but we definitely believe that this is going to improve over time as we see sales growing and launch effects then being eliminated from the numbers.
Good. Thanks, Donato. On the second question, Christopher, on whether or not we have already submitted the three-year data to 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 Kapferer of Camden. Please go ahead. Your line is open.
Hi. Good afternoon. Thank you for taking my questions. I have two 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 when we could see some further data presented or published? Yeah. Then after that, I can ask my second question.
Sure. Thanks, Ingrid. On the GBM timeline, we are still working on making sure we have all the data and all information necessary to engage formally with both the FDA and EMA. That will happen, and as we've said, this will happen in the course of the rest of the year. 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 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 Idefirix in Europe. I think going forward, should we expect you to give us an actual sales guidance at some point? Are you planning to start sharing some more granularity on how sales is going, like 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 early days. 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 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. 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. There's a lot of things that need to fall in place. 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. Those reasons include regulatory reasons. You will 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.
That's very clear. Thank you.
Thanks, Ingrid.
Bye.
Thank you. Our next question comes from the line of Charles Weston at RBC. Please go ahead.
Hello. Thanks for taking my questions, and congratulations on the first commercial sale milestone. Three questions, please. First of all, you mentioned that Idefirix's pharmacy pricing has been agreed in seven countries. What is the range, minimum and maximum and average of those, please?
Just to correct you, it's not that we have agreed the pharmacy-level pricing. This is in free pricing type of countries where you can put the price out there, which we've done in these countries. That is the pharmacy-level pricing, and it's around EUR 300,000 per patient.
Okay. Thank you. 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. I'll let Donato speak to that in a little bit more detail.
Hi, Charles. Well, obviously, as we've guided, we're in the process of preparing a number of studies which we plan to initiate in the course of this year. 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. Going forward, obviously that will also mean that 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.
Thank you. 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. RCT study and also the post-approval study in Europe, which I think we mentioned before that both studies we plan to initiate in the second half. Essentially 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. 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- 48 months. Obviously even in that case, we'd expect them to grow from the SEK 2.5 million. Again, is there a way to predict how that's going to be booked or will it be a bit lumpy depending on your activity?
As you may be aware, Charles, that this is obviously the recognition of the SEK 10 million that we got into our P&L is very much dependent on our contribution into the activities that are ongoing. Obviously this is not necessarily steadily. If there's more activities on our side that will result in a higher recognition in a quarter. If there's less activities at our end, that would result in a lower recognition for us as a quarter. I guess taking the overall amount for your modeling, 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 Waite at Intune Health . Please go ahead. Your line is open.
Hi, this is Dominic Waite from Intune Health. Thanks for taking my questions. I have two. Question one concerns your collaboration with argenx. I was hoping you could explain a bit of the thinking behind combining efgartigimod within Idefirix. It looks to me like both mechanisms of action achieve similar things, which is deplete IgG. What's the thinking behind that? 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. 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. Let me take your questions in order, and I think maybe on the third one, Donato can chime in as well. As far as the rationale behind the argenx collaboration, you're right, both companies' products are targeting IgG. The approach is different, and the outcome is also somewhat different. Imlifidase, as you may know, essentially cleaves IgG immediately. Within a couple of hours from a 15-minute infusion, you'll have IgG levels dropping down below detectable, and they stay down there for approximately seven days before bouncing back, and then within a month, they're 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. Obviously that's a different profile, which is great in many settings.
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. Where we see imlifidase potentially acting in a complementary way with FcRn inhibitors is as induction therapy or when you have, for instance, flare. You have specific situations in certain chronic autoimmune diseases where you need efficacy beyond the maintenance therapy. Those are the types of settings that certainly from our perspective, could be highly relevant for a combination of efgartigimod and imlifidase. As we've said, we've started pre-clinical work now, and we're very excited to see that progressing. 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 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. 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. That obviously may trigger sales even before there's a national level reimbursement, which is essentially also what we've seen here. The third question, I'll hand over to Donato.
Thanks.
Yeah, Dominic, on your question with regard to the revenue, if you look at Q1 revenue, you can see two major components. One is the Sarepta revenue recognition, one 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. There will be certainly a certain amount recognized from the SEK 10 million into the P&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 Idefirix. As soon as the patient is treated, the revenue is basically recognized, can't give you an outlook to that.
As I said, depends really on the number of patients that we treat. 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. Our next question comes from the line of Caroline Lanner 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 Idefirix. Another question, how pricing was received, and have any discounts been applied?
On your first question there, what I can say is that all the sales is from one country, and that country is Germany.
All right.
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 anything. Well, he doesn't, so that's good. We will not comment on that.
All right. It is much for that. Thought I might ask anyway.
Thanks, Caroline.
All right. Thank you.
Thank you. We have a follow-up from Christopher Udy at SEB. Please go ahead, your line is open.
Thanks. One of your comments on the efgartigimod collaboration rationale just provokes a question I just wanted to double-check about the NiceR rationale, because 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 you not? I guess, when you think about NiceR, are you thinking about it ever being used on a sort of chronic repetitive basis with a view to maintaining zero level or undetectable antibodies? Or are you thinking about it more for intermittent use? Thanks.
Yeah, it's really the latter. It's not for kind of ongoing maintenance therapy where for very long periods you would have the IgG levels down below detectable. 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. Right? That can be both in the 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. 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 the efficacy of immuno-oncology therapies.
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. I guess you wouldn't necessarily say you've completely ruled out the possibility of certain situations arising where 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. It's more like a, there's more intermittent therapy, right? What frequency, and with 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 and develop enzymes that are very efficacious and that can be dosed repeatedly and can be kind of built to target specific diseases where there's a high degree of unmet medical need. Mm-hmm.
Is immunogenicity a factor here?
Immunogenicity is always a factor. Again, as you know, our aim through the NiceR program is really to significantly decrease the immunogenicity of what we see in imlifidase, right?
Okay, perfect. Thank you.
Thanks.
Thank you. Currently, we've got one further question in the queue. Just as a reminder to participants, if you do wish to ask a question, please dial zero one now. The last question so far is a follow-up from the line of Charles Weston at RBC. Please go ahead. Your line is open.
Hello. Just a quick follow-up. How many patients have been treated with Idefirix so far in April, please?
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 recent. This I can't tell you. Obviously, you're aware of how many patients have been treated over the phase II trials. We're not going to give you the commercial sales patient-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 come through. The next is from the line of Johan Unnérus of Redeye. Please go ahead. Your line is open.
Thank you. Thank you for taking my question. It's mainly a follow-up and clarification on the earlier question. The Sarepta partnership, the NiceR is included in that, is that correct?
No, that's not correct. The Sarepta agreement is focused on imlifidase, and it's specifically focused on existing neutralizing antibodies, just to be clear.
Yeah. Could NiceR be included?
It's not included in the current setup.
Yeah.
Can NiceR be included? Obviously something that we're also looking to develop for the gene therapy space, so that certainly is a possibility.
Yeah. 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. We expect to do so before summer or over summer, essentially around summer. 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 pre-clinical work with the NiceR molecules in the gene therapy space even earlier. That certainly is a possibility.
What about the argenx collaboration? Is that subject NiceR?
That collaboration is focused on imlifidase specifically and efgartigimod. These two specific molecules.
That's a similar situation. Okay. Thank you very much.
Welcome, Johan.
Thank you. We've got another question from Ingrid Kapferer 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 news flow 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 for any additional news on business development front? Potential partnerships?
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 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. Can that lead to additional news? Absolutely. Will it? I don't know. When? I don't know. We'll have to see, right? That's what I can say at this point.
All right. Just had to try. Thank you, sorry.
You're welcome.
Thank you. We have one further question in the queue at this time, and that's from the line of Christopher Udy of SEB again. Please go ahead. Your line is open.
Hi, thanks again for taking my question. To follow up on the comment about Germany, I think my sense from your comments previously was that obviously you'd be tightly trying to choreograph the launch. 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 where all of these uses sort of following the careful choreographing of the launch that you talked about? Should we see then this German opportunity as maybe a little bit of an upside to what you had discussed previously? Thanks.
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. For that reason, there is some infrastructure building, infrastructure being a term for a range of issues to be implemented in Germany that we're certainly hard at work doing. That's what I can say. I wouldn't say that this is something that we should use to say that this is an upside for anyone, including ourselves. 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.
That's what I can say in general.
Okay. Thanks much. Appreciate it. Bye.
Thanks, Christopher.
Thank you. Once again, if there are any final questions, please dial zero one on your telephone keypads now. Okay. There seems to be no further questions at this time. I'll hand back to our speakers for the closing comments.
Thanks very much, Albright, 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. With this, thanks so much, and have a nice day.