Earnings Call: Q3 2021

Oct 21, 2021

Ladies and gentlemen, welcome to the hands up by our Faramar Q3 Earnings Call. For the first part of this call, all participants will be in listen only mode and afterwards, there will be a question and answer session. Today, I am pleased to present CEO, Soren Teleslope. Speaker, please begin. Thank you. Good afternoon. Good morning. Welcome to the Enter BioPharma conference call on the results from the 1st 9 months of 2021. I'm Soren Tulles, CEO of Hunter Biopharma. With me today, I have our CFO, Donato Spohter as well as our Head of Investor Relations, Claus Sende. Today we'll review the overall progress and highlights of our business in the most recent quarter and provide a preview of our near term milestones. Our presentation should take around 15 to 20 minutes. And after that, we'll take your questions. 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. MSA Biopharma's transformation into a fully integrated commercial stage biopharmaceutical company has become a reality for this year and we are on track to deliver on our key objectives for 2021 as well as on our strategic priorities to build tomorrow's handset. Throughout the year, we made significant progress advancing our clinical, commercial and corporate strategy with solid progress in our efforts to build and advance the pipeline of valuable drug candidates for rare immunologic diseases, while in tandem introducing IDA for X in Europe as a new transformative therapy that brings hope to the thousands of highly sensitized patients across the continent who are currently waiting for compatible kidney transplant. During the Q3, we made good and steady progress with the commercialization of IDeforex in Europe. As we've discussed before, IDeforex represents a paradigm shift in the transportation ecosystem and as such, there is much foundational work to do in establishing it within the system. We made important advancement towards obtaining market access in a number of key markets and funding has now been secured in the first three countries. In total, we have now submitted health technology assessment doses in 10 countries. These doses are an important component of successful product launch as they support pricing and reimbursement, the achievement of which is obviously critically important for current market penetration. The submitted filings include data demonstrating the uniqueness of IDeforex from a clinical perspective, various country specific demographic data sets to define the eligible patient population based on the drug's approved label, as well as proposed pricing based on the overall value proposition. Recent assessments in Sweden and Germany concluded that IDHIFRX would be a cost affected and potentially even a cost saving drug versus standard of care, which is a rare event for orphan drugs. At the end of August, we participated in the 20th edition of the European Society For Organ Transplantation or ESOP Congress, which was held in Milan, Italy. The ESOP Congress was the 1st in person event post COVID and the handset team had a strong presence, which included a sponsored symposium. One of the key outcomes from EASUT was information of a new work stream with leading transplantation key opinion leaders to advance clinical guidelines in transplanting incompatible kidney transplant patients. The new ESAT work stream is expected to be a key driver for harmonization in the approach to transplanting highly sensitized patients and to ensuring positive outcomes for patients and transplant programs. We will later discuss in more detail how we track progress towards commercial success and which metrics to look for as the company advances its commercial launch strategy in taking dispensation. In the U. S, we have now initiated the first site in San Antonio, Texas recruitment of patients to our randomized controlled clinical trial for kidney transplants, the so called CONFIDUS study, and we expect patient enrollment to commence in the Q4. Initiation of Confidus is a significant milestone in our efforts to access the important U. S. Market. The new trial will enroll 64 highly sensitized patients with a CPRA score of 99.9% or above, representing the group of patients with the highest unmet medical need. We expect to enroll patients at 12 to 15 meeting transplantation centers across the U. S. And that the U. S. Trial will generate valuable experience at these key clinics ahead of a potential approval and commercial launch in the United States. Looking beyond transplantation, we now initiated discussions with the FDA on our anti GBM program following the successful completion of Phase 2, which demonstrated very encouraging clinical data in the first area outside transplantation for amlividase. As as previously guided, we aim to achieve alignment with the FDA on the regulatory path forward in anti GBM later this year. In our ongoing Phase 2 programs for GBS and AMR, we've seen patient recruitment accelerate as new centers were initiated during the Q3 we are on track to meet our target of completing enrollment in both studies towards the end of this year or first half of next year as previously guided. Further, I'm also pleased to announce a new study in 12 patients in the U. S. To assess whether amyphidase in combination with monotherapies can optimize patient outcomes in highly sensitized patients with donor specific antibodies, rebound and antibody mediated kidney transplant rejection. The study will be run at New York University Longone Transplant Institute and is expected to commence this next year. Lastly, I also want to highlight that Hanse Biopharma was recently awarded certification as a great place to work for the 2nd consecutive year. Certification as a great place to work reflects our successful efforts over the past years to not only build and maintain a high performance team, but also to create a rewarding and stimulating workplace for our employees. Please turn to Slide 4. As I said initially, cancer biopharma's commercial launch activities are progressing as planned. Our goal is to have a positive impact on patients we work closely with the transplant community to reshape the area of desensitization and integrate IDeforex into clinical practice as a new standard of care. With this novel therapy, we're painting a new path in changing the transplantation ecosystem to accommodate transplants for incompatible kidney patients And we do this in a very focused way, clinic by clinic. We're taking this strategic approach as IDeforex is the 1st and only approved drug to enable kidney transplants in highly sensitized patients in the EU, where incompatible with a deceased donor. And the long term market uptake of this innovative product is highly dependent on successful early experiences in key early adopter clinics. We measure launch progress using a set of key commercialization metrics this directly impact future adoption and sales of IdeofRx as a new transformative therapy. Securing appropriate pricing and reimbursement at the right price level and on label is one of the key metrics for the rollout of IDAFRX. We are on track to secure funding market by market in Europe as indicated by the recent successful completion of case GAA assessments and negotiation procedures in the first of the early launch countries, namely Sweden, Finland and the Netherlands. Further to this, we've initiated additional HTA and reimbursement processes across 7 countries, including United Kingdom, Germany, Norway, Denmark and Israel and most recently also in Italy and Scotland. By year end, we expect to have completed HCA filings in all of the 5 largest European markets as HCA doshoes are being prepared for submission in France and Spain during the Q4. I also want to highlight that we have now submitted marketing authorization applications in both Switzerland and Israel and that IDHFA access will see status as a priority medicine in Poland, which potentially will lead to accelerated access. On the clinical side, we've been working with a number of priority centers to ensure and optimize their clinical readiness as a number of incompatible patients are being identified and prioritized for kidney transplantations in the coming period. So far, 9 clinics are considered clinically ready to take on highly sensitized patients for incompatible kidney transplant, and we continue to work closely with an additional nine vendors across Europe on their preparedness through training, key opinion leader engagement, protocol drafting and logistics. In relation to the awareness and interest metric, we have been extensively engaged during the recent quarter, especially after the easing of COVID-nineteen restrictions as exemplified by our significant presence at the European Society of Organ Transportation Congress, which was held in Milan, Italy in August. At this conference, we held a very well attended symposium entitled A Roadmap to Transplant for the Highest Sensitized Patients, hosted more than 30 key opinion leader meetings with our combined commercial and medical teams and had 2 oral presentations in support of IDRIS. We're very pleased with the great interest from key opinion leaders throughout the Congress. And one of the key outcomes from ESOP was the formation of the new work stream, the leading transplantation key opinion leaders to advance clinical guidelines to include incompatible kidney transplant patients. The new ESOP work stream is expected to be a key driver for harmonization in the approach to transplanting highly sensitized patients and to ensure positive outcomes for patients to transplant programs. Now please turn to Slide 5. Turning now to our clinical programs in antibody mediated injection and the embryo syndrome, where patient recruitment in the 2 Phase 2 programs has been accelerated during the Q3, driven by the initiation of additional recruitment centers. In the AMR trial, 7 patients were enrolled during the Q3, which takes the total number of patients up to 19 out of target of 30. Since July, we have increased the number of access sites in AMR from 7 to 12 and expect 2 additional centers to be opened in the Q4. With the current pace for patient enrollment, we're well on track to completing recruitment towards the end of this year or by first half of next year at the latest. We expect to announce the 1st data readout for the AMR Phase 2 study in the second half of twenty twenty two as previously guided. In the GBS trial, we have now enrolled 14 patients out of the target of 30 patients. During the Q3, we've added 1 additional center and expect 2 initial centers to be initiated during the Q4. As previously guided, we expect enrollment in the GBS trial to be completed towards the end of this year over half first half next year at the latest with a first data readout in the second half of twenty twenty two. Enrollment into both of these studies is ongoing under a risk based side by side approach. And given the volatility of the situation we're facing related to COVID-nineteen, our guidance assumes no further escalation of the COVID-nineteen pandemic, potentially forcing trial centers to reprioritize patient recruitment or even shut down again. Moving on to our anti GBM program, where dialogue with the FDA has now been initiated regarding the regulatory path forward towards BLA in the U. S. The dialogue with the FDA is expected to conclude later this year as previously guided. Similar in Europe, the construction regulatory advice meeting was recently held for D. Form, Hensa is now preparing for a dialogue with E and A around the regulatory path forward towards a marketing authorization application in Europe in anti GBM. Last year, very encouraging Phase 2 data was presented in anti GBM, demonstrating that 2 thirds of the anti GBM patients enrolled achieve dialysis independence 6 months after treatment. As I mentioned earlier on this call, we've just initiated the 1st center in our new providers trial in kidney transplantations in the U. S. At the San Antonio Methodist Hospital in Texas. The U. S. Trial will target 64 highly sensitized size patients with a CPRA score of 99.9% and above, representing the group of patients with the highest unmet medical need. We expect to initiate additional centers in the coming months, aiming at 12 to 15 leading transportation centers across the U. S. As previously communicated, we expect to complete enrollment in the second half of twenty twenty two with a 12 month follow-up on eGFR completed by second half of twenty twenty three. Results from the trial are expected to support a BLA under the accelerated pull pathway in the first half of twenty twenty four. Please turn to Slide 6 and a summary overview of our pipeline. As depicted on this slide, thanks to continued progress over the past few years, we've developed a broad clinical pipeline in both transplantation and autoimmune diseases. In addition, we have exciting preclinical projects ongoing in cancer and anti drug antibodies, as well as in the very promising field of gene therapy, where our partnership with Sarepta is assessing amitidase as a pretreatment to Sarepta's gene therapy programs in Duchenne and Limb girdle muscular dystrophies. Preclinical development is progressing according to plan and upon successful completion, we expect the new today's to move into the clinic as the next step. Beyond the partnership with Sarepta, Hansel is also engaged in a preclinical collaboration with argenx, which is also moving forward according to plan. The focus of the AgenX collaboration is to assess the potential benefits of combining enlutidase with efgartigimod, AgenX's FcRn inhibitor. With this overview, I will now hand over the call to Ignacio, who will take us through a review of the financials for the 1st 9 months. Ignacio, please? Thank you, Soren. Please turn to Slide 7. As Soren outlined, we are on track to achieve our key 2021 objectives through continued progress across our business and pipeline activities. Revenue for the 1st 9 months of 2021 grew to DKK 18,500,000, including DKK 6,000,000 in product sales and DKK 10,400,000 in revenue recognition under the Sarepta agreement. Please turn to Slide 8. We continue to invest the Ibuproix launch and our pipeline in accordance with our operational and financial plans. For the 1st 12 months of 2021, SG and A expenses amounted to DKK224 1,000,000 compared to DKK 140 1,000,000 for the same period last year. The increase is in full support of our objectives to develop Kamsa into a fully integrated biopharmaceutical company and as such, Premier League reflects our expansion of commercial activities, including investments in the territories, marketing, market access and supply chain activities related to the launch of iDofrix in Europe. Our investments in R and D amounted to SEK163 1,000,000 for the 1st 9 months of 2021, which is about the same level as for previous year. Investing in R and D and our pipeline activities, that was all for concluding areas remains a key priority for Hanse as it supports long term value creation for the company. A net loss for the 1st 9 months of 2021 were DKK 385,000,000 compared to DKK 350,000,000 for the same period last year. The increase is primarily driven an increased activity in ramping up our commercial activities and developing hands on to a fully integrated company. Please turn to Slide 9. Cash flow from operating activities amounted to minus SEK365 1,000,000 for the 1st 9 months of 2021, which compares to $194,000,000 for the same period last year. The increase should be seen in the context of the US10 $1,000,000 of loan payments received by Sarepta of July last year under our license agreement with Sarepta. As of September 30, 2021, Hamzal's cash position, including short term investments amounted to SEK 1,000,000,000 corresponding to approximately $115,000,000 With our solid cash position and projected earn rate, we expect Hanzah to be financed into 2023 as previously guided. I now hand back to Soren to give his final remarks. Thank you, Donato. Please turn to Slide 10. Enter Biopharma's transformation into a fully integrated commercial stage biopharmaceutical company has become a reality in 2021 and we continue to demonstrate solid progress in our clinical, commercial to corporate strategy, including significant progress in our efforts to build and advance a pipeline of valuable drug candidates for rare and neurologic diseases. Looking at the milestones ahead, we expect to announce the 1st patient enrolled in the U. S. Confitus trial here in the Q4, following the initiation of the 1st recruitment site in Texas. As discussed, results from the trial are expected to support a BLA under the accelerated approval path trade in the first half of twenty twenty four. In addition, as also discussed, we aim to conclude our dialogue with FDA on a regulatory path forward for our NC GBM program later this year as previously guided. In our 2 Phase 2 programs in AMR and GBS, we've seen an acceleration in the enrollment rate in patients following the addition of more centers. At the current pace and assume no further escalation of the COVID-nineteen pandemic, we're well on track to completing recruitment towards the end of this year or by first half next year at the latest as previously guided. Following completion of enrollment, we expect to announce the first data readout from those studies in the second start of 2022 as previously guided. With regards to our NICE program for repeat dosing scenarios, we expect IND enabling tox studies to be completed in 2022. Upon successful completion of these studies, we expect to advance the NICE program into clinical studies. We look forward to keeping you updated on our progress in advancing our mission to bring life saving, life altering therapies to patients with serious rare diseases, while generating long term value for our shareholders and society at large. Please turn to Slide 11. With us, we're now ready to take your questions. Operator, please begin. Thank you, ladies and gentlemen. If you have a question, you have to press 1 on your telephone keypad, it's 0 followed by 1 on your telephone keypad. The first question from Christopher Hood from SEB. Please go ahead. Hi, there. Thanks for taking my questions. So you've been guiding expectations lower For over a year, I guess, giving everybody plenty of time to get used to the idea. But your negative gross margin on IDEPRX, Not only in Q3, but also from obviously but also from before for the whole year. I mean, looks like possible signal that demand has not met internal projections. So would you please comment on how your expectations may have changed in the past 12 months And at what level your assumptions have changed? Is demand a factor here at all or is it just access? And how confident are you that sales will finally start again in Q4? Thanks. Thanks, Christopher, for that question. So no, our internal forecasts have not changed. This is due to the fact that our tests have not changed. This is due to the fact that obviously when you produce, you need to produce pretty big batch sizes and we want to make sure that we have product available in any on any circumstances. The last thing he wants is to not to be able to supply in the market, right? But our internal forecasts are totally consistent over the past year. And so there's been no change in that. And we're confident that as I said earlier in this call that we've had a good start to the launch. We're seeing very, very solid progress versus the key launch metrics. And we certainly expect this to pick up and follow the S shaped launch curve that I've been talking quite a lot about over the past year or 2. Okay, perfect. Thanks. Sort of just another follow-up question. Do You need to add manpower experience to your market access marketing or medical affairs teams to get that pickup to happen. Do you feel that you're adequately staffed there? Well, I'm very pleased with our market access team. That really has done a fantastic job getting our market access programs going. We may need to staff up as we spread out geographically. But at this point in time, we have the capacity we needed to handle the submissions. As I said, we've submitted now in 10 different countries and we have ongoing discussions in many of the key countries. As far as medical and commercial staff is concerned, there will be some additions as we get into specific markets, currently, we have the core team in place. And overall, it's a low double digit number. They're doing, again, an excellent in the key markets interacting with the clinics. But of course, over time as we get access to additional countries, there will be some additions at the front end. Okay, thanks. Really appreciate that. If I could just ask one more before getting back in the queue. Desensitization with previously available methods has gone Out of favor to some extent over the years. What's the latest feedback you get from across the nephrology community around IDEPRIX being the answer I guess, when it comes to the ESOP's work stream, can you give a little bit more background? How is that related to guidelines? What are the steps you need take to get into guidelines? Thanks. Yes, sure. So you're right. I mean, the sensitization has not really been at At the top of the list in Europe for a number of years for a variety of reasons. So this is also why we're stepping into what is somewhat of a virgin territory here. But overall, I would say the feedback and the reaction to IDEXXRX has been very, very positive I've also interacted with quite a number of key opinion leaders over the past year or 2. And I would say that we definitely see high degree of interest. Obviously, that should not be taken as a signal that you'll we've seen very, very strong uptake immediately, but I'm really, really pleased with the interest that we're seeing. You mentioned the ease of the guidelines. And as I talked to earlier on this call, we're very happy that our work stream, a formal work stream has now been formed within the society to put in place European wide guidelines for desensitization of these highly sensitized patients because that will be Very helpful going forward. It's not necessary short term to get started. We have direct interaction, of course, with key mix and national societies, But it will be helpful to have European wide guidelines. And again, just looking at the discussions that took place at ESET in this the team that has been set up, I was pleased with the degree of consensus that we need to do better in Europe here and that there's much more to be done and that the society has a key role to play. So the next step will be obviously to get this work stream going and then to have the guidelines submitting for the publication at some point in the not too distant future, I would expect. Okay. Thank you very much. I'll get back in the queue. Thanks, Christopher. Thank you. Next question from Dominic Gas from Intran. Please go ahead. Hi, there. This is Dominic from Intron Health. Thanks for taking my question. My first question is, have any of the centers that took on an emlicidase patient this year since taking on a second? And if not, then when would you expect them to? Question 2 is just on the quarterly P and L, I was wondering why the cost of revenues I would say hi this quarter? And finally question 3, just wondering again whether you've received any negative feedback from the first transplant centers that have used on this phase? Thanks. On the first question, I'll hand over to Bonnacio for the second. The first question, whether any centers has taken on a second patient, the answer is no. That is a obviously something that we're looking at to have repeat business. And when I'm talking about repeat business, it's not at the patient level, of course, it's at the center level. We expect some of the most important centers to have hopefully 1st patient this year, and then they will typically wait for a number of months to see the outcome before deciding on potentially doing the second and subsequent patients. On the let me take the third question, which was on negative feedback. And that's At this point in time, we do not receive any of that. So far, really good interest, positive attitudes and most centers are getting ready to transplant their first patient. And then the second question, I'll hand over to you to answer. Yes, sure. So I think your question goes in the same direction as Chris was scratching, at the end of the day, I mean, this is looking at the quarter in isolation, this is regarding accounting then, public mainly. It is in that call we have been delivered additional material. So and then in this case, you have to do certain tests from an accounting perspective to value whether you can show a value amount on the balance sheet and obviously since we don't have a history of sales, you basically do a provision and this is what you see in the accounts on the cost of sales, I think importantly to note, if this context is a few things. A, I think this is completely not unusual if you compare to similar companies like Hanse, which is launching their first product. And secondly, the material, while this is provisioned material has not been discarded or so, this is obviously still fine material and we will if there's sales we will use the material to sell it. So it's really just an accounting topic at this point. Okay. Thank you. That's great. That's very helpful. I suppose longer term thinking about COGS, a product like inlithidate, you would expect the gross margin to be pretty high. I mean are we looking at north of 85% for that? It's not guided exactly on what the gross margin is going to be. But generally speaking, I think whatever your interpretation of pretty high is, but we will have certainly I know if it grows nothing from that product. Yes. Okay. Thanks very much. Thank you. Next question from Frederic Gomes from Finance Securities. Please go ahead. Yes. Thank you guys for taking my questions. 2 on my side. First on Ediferic, can you maybe clarify a little bit the way you're going to take in France, will you go through the normal process to submit the dossier with DHS? Would you try to take advantage of the new early access scheme that has been set up in July, maybe to go faster? And another one on the current Phase 2 in AMR. Just curious about the 30 patients. Will you do a kind of stratification between patients having pre existing GSA and patients who will develop de novo GSA? And one kind of analysis you will perform in this population, just maybe to understand better the data that you could get and the next path after the result of the turbines in the Phase 2. Thanks. Well, thanks Frederic. On your first question, the approach to France, you're right, I mean, nurses' new early access program pathway available in France, which certainly is something that we are looking at. At the same time, the normal route also exists. So We will certainly move forward in France. And I can't say specifically to what extent we'll make the early access program pathway, an option that we'll exploit at this point in time. But certainly, it's a possibility, yes. As far as the AMR study is concerned, we will discuss it in more detail when we get into next year, I will go and so on. So if you will have a little patience, I think you'll get more insights. Was that okay? Operator? I can hear you still, sir. Can you hear me? Yeah, I can hear you. I don't know. We just lost Russ. Yeah, I think we lost the conference. It looks as if we talked about the conference. I mean, not just, I mean, that's probably a more general problem. Yeah, that's probably a problem. We'll go to the next question. Yes? Okay. Next question from Zoe Kara Monee from RBC Capital Markets. Please go ahead. Hi. Thank you for taking my questions. Apologies if these questions were asked before, but I've I missed the start. Two questions from me please. The first one on the clinical readiness, you mentioned 9 centers are ready. Can you elaborate a little more what this means exactly? Is that Infiniti is not even put in the clinical guidelines and physicians are we're unwilling to use the drug. So the centers basically are ready for eligible patients. And then the second question, based on your discussion so far with the centers, how much of hurdle or need for education is to convince to include the desensitization with the new PDAs. And can you give us an estimate of what you think is the current desensitization rate? And what is your aspiration of how much this can increase in the next 2 to 3 years. Thank you. I'll probably need to have you repeat your second question. But in the meantime, let me just So I'll answer the first question, which is on what does clinical readiness mean as far as the centers are concerned. And that really means that the centers, key employees, key staff have been ongoing training that we certainly have been involved in very deep dialogue with the staff around how to treat these patients, how to identify appropriate patients, etcetera. So that is a pretty extensive interaction that needs to take place upfront because obviously, we are As interested in successful outcomes as are the centers and the patients clearly. Second, we also want a specific or not we, but certainly the hospitals, a specific protocol to be drafted and put in place for how to approach all of this. And then there are obviously specific logistics around how to get the product in and handle the product in a transplant situation. So those are some of the key steps, but we really have a very, very granular protocol overall, if you will, for our own sake, to move forward in our interaction with these centers and make sure that they're ready to transplant. So this is really managed at a very detailed level on our end. The second question, if you can just repeat it, it was around how we expected desensitization rates to increase and can you because the audio was a little bit bad, so I didn't get out of it. Yes, sure. Sir, so I'm wondering if the desensitization, because the desensitization is part of using Envucidase. And I wonder So far with the discussion with the centers that we're trying to include it in the clinical guidelines, how much of a hurdle our education centers need to use it. And if you have enough of the rate of desensitization so far As a baseline and where do you expect this rate to increase in the next 2, 3 years with the education that you're going to In the clinical awareness. So reality in Europe is that right now, there is very little desensitization taking place Looking at these very highly sensitized patients and trying to make them eligible for potentially life saving kidney that just doesn't really happen because you don't have any approved product and you don't have non approved products that are able to get the kind of decreasing in donor specific antibodies rapidly to enable patients undergoing a kidney transplant when a deceased donor organ becomes available with a positive cross match. So essentially, as I said, we're walking into virgin territory here. And this is also why we need to talk not just about our own product, but the whole field of desensitization. And that is a process which has started. And as I said, we are very comfortable and happy with the progress that we've seen, the action within the medical societies, including the European Society of Organ Transplantation, where they have now created this very focused work stream that will specifically look at guidelines for desensitizing, highly sensitized patients. And this is all in the back of the emergence and the availability of IDH4X as a transformative therapy, right. So So this is what is happening at this point in time. Okay. Thank you. Thanks. Thank you. Next question from Christopher Hurd from DCEV. Please go ahead. Yes. Hi there. Thanks. So What's the status of the confirmatory trial that you need for the EU for kidney transplantation? And how important is it to your Marketing strategy. That's my first follow-up. And then the next one is, so how much influence coming out to the broader pipeline, How much influence do you have on recruitment rates in the IISs? You've talked about potentially starting a trial for stem cell transplantation and potentially other indications. Given that IIS have so far proven to be a slow way to go, how do you think about what your development strategy would be for any new indications? Thanks. Good questions. Thanks, Chris. So first on the post approval efficacy study, which is a study one has a confirmatory trial in Europe. We are finalizing the last steps, and we expect is to be ready to be initiated by the end of the year essentially. As far as the importance of this study, obviously, we need to run it, it's a significant on our side, but it's also a good way to develop experience in some of the countries in Europe, where it will take a little bit longer to gain access, right? So then we have the second way of generating hopefully positive experiences in key centers. So that's where we stand with that trial. Your Second question is also a good one. You're right, the investigator initiated trials tend to be a little bit slower in recruitment rates and so on, obviously, as a company, you have less influence there. So going forward, we will aim to run few trials ourselves, but they will be complemented by some of these investigator initiated studies for certain indications. So it will be a combination going forward. Okay. Thanks very much. And just to be clear, the post approval efficacy study That will be separate from the FDA, the study for the FDA? Yes, that's a separate study. That's a European protocol only. The FDA study is again a separate U. S. Trial that we're initiating following good interaction with the FDA. We're aligned on the start a protocol and the pathway forward. So that's a U. S. Scoring trial, the CUFIRE trial. Okay. Thanks. And do you have a rough indication of how many patients you need for the European one? For the European one, we expect over the years to include approximately 100 patients. Okay. Thanks so much. Thank you. Thank you. We have a new question once again from Zoey Kiramalole from RBC Capital Markets. Please go ahead. Thank you. Just a follow-up question, hopefully quick and very specific. You have so far for the U. S. Trial, one side active And the intention is to have between 12 to 15 sites active. Can you tell us how many more sites you expect Have active by the year end and by when we should expect to see all sites up and running? Thank you. Yes. So you're right. We expect 12 to 15 centers. It's a little bit tricky to give you a hard number for how many centers we would expect by the end of the year. Obviously, this is an ongoing process. I would expect a couple of more centers to get active in the near future. And that's obviously relatively soon into or earnings will be the following year that we'll have the bulk of the centers up and running. There is Very strong interest from these key centers to participate. And so I don't think it's certainly not a question of motivating them, but there's obviously a number that she needs to take them through. So that's what I can say at this point in time. Okay. Thank you. So we'll wait for more updates. Thank you. Thanks. Thank you. We have a new question from Adam Carlson from ABG Sundal Courier. Please go ahead. Hi, thank you for taking my question. Just one from me, if I could. Just on the work with the ESAT work stream that you were mentioning and in regards to developing clinical guidelines for emphytase in the renal transplantation indication. You were saying you hope to kind of complete that work during 2021 as I understand. I'm just looking for a bit of clarification whether that Which would mean kind of completion of drafting of a potential clinical guidelines or kind of how what work needs to be done post completion of this EASL work stream before there could be kind of clinical guidelines in place that would be implementable broadly in Europe, I guess? Yes. So the task force has now been set up as I said, And they're getting going as we speak. Obviously, the next step will be to produce a draft that will need to be circulated within the played it within the wider community and with the usual review and so on. I expect this to take months And I really can't predict obviously when this will be completed, but if there are not too many discussions and so on, it shouldn't necessarily take very long upon completion of this internal peer review and agreement on the final version, it will need to be submitted for publication and so on. Again, I can't give you a hard date or I think kind of status by end of the year, but I expect this to take some months. And As I said, the good thing is that there is clearly alignment within the society that they need to produce these guidelines that they would be helpful. And my reading of the situation is that there is not too much disagreement around how they would look like. But This is a scientific society and as ever it's impossible to predict what will come out of it, but we are certainly encouraged by what we've seen so far. Great. Thank you. Maybe just a second question if I could. Perhaps a difficult one for you to comment on just now. It was an update that came here during the call that another Swedish company, Genovis, has entered into a licensing agreement with selected by science to develop IgG proteases for use in gene therapy in autoimmune diseases. And I was wondering whether you have any kind of sense of how similar their approach is to what you're hoping to do with immunoaffidase in gene therapy and immunoimmune diseases and then whether you can kind of comment on potential similarities or differences between those programs, if you're able to at this early stage. No, I'm not able to comment on that and general won't, but I would say that there are obviously a number of different approaches in this space. And we're very comfortable with the unique approach that we're taking. So that's what I can say in general. Great. Thank you. Thank you. We don't have any more questions for the moment, ladies and gentlemen. If you wish to ask a question, please press 1 on the telephone keypad. Once again, 0 and 1 on your telephone keypad. Looks like we have no more questions by phone. Let's wait a few more seconds. We have a new question from Douglas Tsao from please go ahead. Hi, good morning. Thanks for taking the questions. And I apologize if it was already asked for the drop. But just in terms of the targeted centers that you're in, what's your sort of overall target in terms of the percentage Of transplant taking place in Europe over time and certainly in the key markets. I mean, are you going to be covering 90% of the overall transplant volume or is that sort of or the target can be a little bit lower? Thank you. Well, I mean, as we've discussed in the past, this is a very, very concentrated target audience. So in some countries, you only have one clinic essentially doing all the kidney transplants like in Norway, for instance, where there In Austria, there's one center only in Finland. In some of the larger countries, the top 5 or so represent 70% to 80% of kidney transplants. And certainly, we would target the key centers. So we do target centers representing the bulk of the kidney transplants through our efforts, but it's a low number overall. Okay. Great. Thank you. And then just, Soren, the timeline for actually bringing a center online and fully training them, how long does that typically take from when you first show up to, when they're able to use iPad? It's difficult to say at this point in time because most of the clinics that we've gotten or I would say all of the clinics that we've gotten online, if you will, Our clinics have been interacting with quite extensively over the past couple of years, obviously, in various settings. That does not mean that it takes several years obviously to put them online. This is a very concentrated target audience and we interact for many reasons And have an ongoing dialogue. So but it is a process that takes A while because you need to get consensus within the center. And as I said, you need to take them through training and so on and so forth. So it doesn't happen from 1 month to the next, let me put it that way. Okay, great. Thank you. Thanks, Douglas. Thank you. We don't have any more questions for the moment. 0 followed by 1 on your telephone keypad. Seems that there is no more questions by the phone. Okay. In that case, thank you so much for your interest. It's been a pleasure to update you on our progress so far and we look forward to continuing our dialogue. Thanks so much and have a nice day. Thank you. Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect your line.