Carmat SA (ALCAR) Earnings Call Transcript & Summary

Good afternoon to everybody, and welcome to the Q1 2025 update. So altogether with me today, on my left, I have Pascale d'Arbonneau, our Deputy General Manager and Chief Financial Officer; and Francesco Arecchi, Director of Global Market Development; and on my right, the Professor Christian Latrémouille, our Chief Medical Officer. So very quickly for people who don't know us very well. So our mission is to address the advanced heart failure crisis driven by the donor organ shortage. So if you run the map very quickly, so the overall need across the world is assessed around 150,000 patients suffering from advanced biventricular heart failure every year. And only between the U.S. and Europe, 7,300 people will get heart transplant. So it means only 95% of patients in need of a transplant are not treated. So very quickly. So Carmat is a fully-fledged company already at commercial stage in Europe, and we are working to become a global leader in heart replacement. So who are we today? So we have 3 strategic pillars: Europe, U.S. and destination therapy. So first of all, in Europe, we're at commercial stage. So we started last year as a full year in 2024, and we commercialized so far or sold product in 5 different countries within the EU. In the U.S., we are still at clinical stage. We'll speak to it in a few minutes. And we are approved for a bridge to transplant, right? In a few years, our objective is obviously to grow to commercial stage and to be present in most of the EU countries and extend to the Middle East countries as well. We work, obviously, to get at commercial stage in the U.S. at certain stage and to get the permanent support, which is the GRAIL, so destination -- so-called destination therapy indication. As of today, Carmat consists of 200 highly skilled people among R&D, medical, sales and marketing, regulatory, quality and manufacturing. Our capacity as we speak in our facility in the south of Paris is around 500 hearts a year. So 2025 is a pivotal year in our commercial journey. So what we did last year, it was really to start to create the commercial platform. So obviously, we are a tiny and small company. So it started building a field team. So we populated Germany and Italy with a field force. So as we stated last year, we are running a study in France, and we picked up the 2 larger geographies in terms of heart failure treatment in Europe, which are Italy and Germany. We started to train more and more hospitals among these countries and more. And we worked to get, obviously, funding and reimbursement to allow the implant of Aeson, which is the commercial name of our product in these countries. So that's for the commercial platform 2024. Really, our focus in 2024 was to work on the recruitment for our French study, and Christian will speak to it in his presentation. So that's a large study about Aeson and we've been working in France very hard to make sure we could enroll as quick as we could to generate the data in order to help the therapy adoption. 2025, so that's the consolidation of the commercial platform. So we train more and more hospitals in Europe. Thanks to the data published, we'll be able to promote the therapy and we'll work as well to generate more evidence through mostly, obviously, EFICAS. We are preparing for the long-term support that's highly needed for decades. I mean everybody wants a destination therapy product. So what do we need to get there? So first of all, obviously, we need to improve the durability of the product. So it's what we've been working on for the last decade, and we are very close to the goal we wanted to achieve. And to get there, you need, obviously, the new CE Mark, the new directive MDR, which we will get hopefully in the coming weeks. This will allow us to change the design in a significant way. 2026, 2027. So 2026 should be really the inflection point for us. So we won't speak about consolidation anymore, but about growth. So we'll be able to leverage more clinical data. We are aiming at getting the reimbursement in France, which is one of the larger countries for biventricular disease treatment in Europe, and build on long-term support. We believe that with the product we will get at the end of the year, we'll be able to convince more and more centers, especially in Germany, where the time to transplant is longer to get a larger adoption. And obviously, thanks to the data we will generate in the U.S., we'll prepare for the U.S. launch. All the things that we are trying to deliver will be accompanied by operational excellence. So we are working. We are focusing a lot on our finance and on process to make sure that our path to profitability will be as quick as possible. So in a nutshell, what happened in Q1 2025? So first, I'm happy to report 16 implants in 1 quarter only, which is a record quarter for us. And if you compare it year-over-year compared to Q1 of last year, we more than doubled the number of implants from 7 to 16. In terms of sales, we multiplied by 2.4 the sales of Q1 2024 to get to EUR 2.4 million. And it means more than 1 implant a week or more than 5 implants a month. When it comes to EFICAS, which is a key project and objective for the growth of the company, we enrolled 13 patients only in 1 quarter. We got to 49 patients enrolled or 94% of the total inclusion of the study. When it comes to strategic and regulatory milestones, first, we are happy to report the publication of 2 studies in peer-reviewed journals in The Journal of Heart and Lung Transplantation and the JACC: Heart Failure. Second, the FDA. So obviously, after Cohort 1 and before starting the commercialization in 2023 in Europe, we changed things on the device. So we had to get the approval for these changes. And we are at the end of the discussion with the FDA, which approved all the changes as we speak. So now we are expecting a positive approval very shortly to start the second cohort of the EFS. As well, we never spoke about it, but we've been working very hard on the MDRC marking. We answered all the questions, which have been cleared. And now the dossier is in peer review at DEKRA, and we expect the approval within the end of quarter 2 of this year. So in a nutshell, we are happy to report that we achieved our Q1 goals, and it's in line with company's operational and strategic objectives. So I will hand over to Christian, who will give an update on the clinical experience with Aeson.

Okay. Thank you, Stephane. Good afternoon, everybody. And first of all, I just want to come back shortly on the situation of our device as compared with what is existing in the market. And first of all, to be able to achieve our goal and to get a full physiologic replacement of the heart, we have Aeson as a biventricular support, which is a case of BiVAD and SynCardia, which are old devices now. And we come back to pulsatility flow of the blood, which is quite important. That's not the case with BiVAD. We deliver a continuous flow with some specific complications. So we come back to pulsatility, which is really, really important for the physiologic situation of each of our calls in body. And third priority is to get autoregulation. The autoregulation is something which is, of course, physiologic to get a complete adaptation of each situation during the day and during the night. And that's something we are the only one device to be able to achieve this goal. And as the fourth one, which is quite important, too, is a high hemocompatibility, which is really important to be able to reduce some drug regimens such as anticoagulation, for example. So in such a way, clearly, we can suggest to get an unparalleled safety profile with no embolic stroke coming from the device, no intestinal bleeding lesions, which usually are due to the continuous flow. So if we come back to pulsatility, we suppress these kind of lesions and some rare percutaneous cable infection in patients who have systemic infection before the surgery. So that means that clearly, a game changer therapy for physicians and, of course, for patients in 3 aspects. And first of all, the safe surgical procedure, and we are working a lot on patient selection, guided by structuring to be able to suggest the therapy for all kind of patients and to be able to deliver a good treatment, I want to say, to come back to a normal quality of life, and that's probably the aim of the medical achievement of any therapy. So pre-implant 3D virtual tool to check anatomic fitting with the engineer working in Carmat to be able to check each CT scan of any patients to be sure that we have no problem of implantation. That's now the case with a huge safety margin without any problem during all the implants that we have performed, and 100% successful surgical procedure which is quite important to in cardiac surgery. It's a heavy cardiac surgical procedure, and it was in our goal to have a reproducible and safe procedure for implant this device. And which is quite important too, that's the first step of the quality of life is the fast recovery of the patient. And notably, we can underline that the majority of our patients are extubated after 24 hours, which is quite a good result for this kind of surgery. In terms of quality of life, the automatic real-time adaptation of blood flow to patient activities is quite important. And that's the first time that we will be able in the MCS world to suggest this kind of device with quite good results and modification of the outflow of the patient during, for example, the day and the activity if you compare to the night rest. The use or the unused, I want to say, with a few drugs, you can suppress all the drugs which are targeted to the heart himself and the reduction of the level of the anticoagulant therapy. So that's something which is really important to suppress the side effect of this kind of treatment. And finally, at the end, that the discharge from hospital and return back to a normal life at home, which is the aim and which is really important to restore quality of life of the patient. Of course, that's sustainable support, not ongoing adjustment needed due to the autoregulation. You have a smooth day-to-day system management by the patient and mainly at the orifice of the driveline site. And we have some unmatched safety profile that's something which is quite important. And finally, patients could be discharged from hospital after 6 to 8 weeks according to the situation of each people. Our clinical experience accumulated since the beginning of the story is 108 patients treated since 2013, including 42 patients in 2024 and 16 in Q1 2025. So it's a huge experience now with the longest support duration exceeded is 25 months. But for the moment, that's not our goal because we're working as a BTT, bridge transplantation. And of course, 25 months could be the beginning for the next coming destination therapy, and it will be for the future. The cumulative experience is more than 40 years of experience. And now that means it's a really good background to be able to understand and to improve the system in all these aspects. For the moment, we still have 32 patients are currently on Aeson support and more than 30 patients have been transplanted after the implantation of the support. That means mean time to ICU discharge is around 2 weeks, median time to hospital discharge 52 days and the average time on Aeson is 166 days because we are working as BTT and that thing to underline. So that means that's a marked increase in Aeson adoption since 2024, and we are improving the number of implantation regularly, which is important, too, is another aspect and that experience allowing management of increasingly complex cases. I don't want to go in detail for the INTERMACS profile classification. But quickly, INTERMACS 1, that's patient who will die within 2 days, that's the so-called CRASH and burn syndrome. And INTERMACS 4 are people who are called frequent flyers. They came to the hospital, they can be discharged and came back due to the end-stage heart failure. That means that at the beginning, we were able to treat this patient, INTERMACS 4, but with the time in the real life, we have to treat all patients in emergency situation in INTERMACS 1 and 2. And of course, we have to work in this way. And actually, we can say that around 50% of our patients are very sick patients in an emergency situation. And in such a way, some patients arrived with an extracorporeal life support, which is so-called ECLS or ECMO before the implementation of Aeson device, which could be able to be achieved around 12 days after the ECMO support. So Aeson really offers a solution even to patient at risk of death in the very short term in a couple of days with no other therapeutic options. That's something which is quite important to underline. The other approach is probably steady expansion of the indications and treated patient profile. And in the second part of the implant period, that means since 2 years, we have implemented 77 patients treated. And as you can see on the right, the etiology of the disease, which are the classical one for the heart transplant program such as the dilated cardiomyopathy and the other one is the ischemic heart disease. A specific chapter in ischemic heart disease is the post-myocardial infarct ventricular septal defect, which is something quite important. That's a huge emergency situation. And regularly, all the patients died within 30 days if you don't do anything. If we try to do through interventional cardiology or through regular surgery, the mortality is around 50% at 30 days. And with our experience now, we have huge results with a huge survival rate around 100% after 6 months. That's something quite important to underline. And of course, something to underline in an emergency situation, and that's probably something quite important for the future. That means Aeson provides a solution for a broad range of patient profiles across a wide range of indications, and we try to find new indications such as GUCH patients, for example, which are patients who have in the childhood some congenital heart disease operated on. And when these patients arrive at the adult age, they need to have some complement surgery and cardiac transplantation as well. You can see here a significant and really a rapid and sustained improvement in patients' quality of life and something really important. You can see on the left side, the appearance of the New York Heart Association classification. And of course, from the orange situation of patients before the surgery, we try to move towards the blue one and the dark blue. And you can see the numbers, the improvement over 6 months. So it's quite important to underline that to be able to have a normal quality of life, a normal day life. And you can see here on the 6 minutes walking distance, which is improving each month regularly. And you can see here the patient performing some exercise or taking a cafe. And that's something quite important to come back to a normal life. So Aeson due to self-regulation and hemocompatibility drive really a significant and rapid improvement in patient's quality of life, which is clearly our target with this kind of program. In France, our clinical trial, the EFICAS study is quite important in terms of strategy for the company. And of course, the clinical objectives, security and performance with the primary endpoint, which is a transplantation or support for 6 months without embolic stroke coming from the device. It's the case and something really important to underline if you compare with the other device existing in the market. And the final population is 52 patients to be implanted in France. And with the study result expected at the end of 2025, we are now at the end of this trial. Of course, the economic objectives of the trial are the value proposition, which is quite important too and the opportunity to get a reimbursement in France, that's something quite important for us. And as a strategic objective, we need to have the therapy adoption in other countries in Europe, and of course, PMA filing the U.S. access. So after the end of the EFICAS study, discussions are initiated with the authorities in France to enable patients continued access to Aeson post completion of the EFICAS study through the reimbursement and with an anticipation from the end of 2026. So that's clearly something with strong clinical evidence to support Aeson adoption. And for the moment, we have treated and we have published some papers with patients with pulmonary hypertension, which is a huge situation because that's a classical contraindication to the regular cardiac transplantation. This paper has been accepted in the Journal of Heart and Lung Transplantation and it's published in February. Second paper, which is accepted and published this patient under ECMO. So that means the huge emergency situation. And we have some other papers, some other results with the post-infarct VSD results that are quite interesting, and will be published soon. And of course, before the end of the year, we hope that we could be able to publish the results of our clinical trials, the EFICAS study on 52 patients with now 94% of enrollment completed. So that's probably 3 more important publications expected for this year. And of course, due to the technology of Aeson, it's clearly a new generation of device generating billions of data. And as you can see here, analyzing this data, this big data to be managed, we are able to work on other fields that means, for example, some diagnostic situation of heart degradation detected using Aeson data in such a way to be able to have an effect on the corrective action, which is due to the autoregulation. And you can see here another aspect, which is an example of a diagnosis of the obstructive sleep apnea detected with Aeson data. And probably in the future, we will be able to work with all these billion of big data, and this data could ultimately be used to improve patient's care and, b, in treatment of heart failure, of course. Francesco?

Thank you, Christian. Good afternoon. As previously mentioned by Stephane, Q1 has been extremely solid, I would say, very convincing and above all, in line with the company's objectives. So a record quarter with 16 implants. The previous record was 13. As already said, we did perform more than 5 implants per month. And in terms of sales, the result is equal to EUR 2.4 million, which is equivalent to 2.4x the results in Q1 of 2024 and plus 10% versus Q4 2024. As you can see on the chart on the right-hand side, every year, we do better in the same quarter. So in Q1 of 2023, we did 1 implant. In Q1 2024, 7. And in Q1 2025, more than double, 16. So you can really appreciate very nice quarterly evolution in terms of implants. So in a nutshell, Q1 2025 has been the best quarter in Carmat's commercial history. So this excellent performance has been driven by an outstanding progress in the EFICAS study. So 13 implants in Q1 carried out by 7 different hospitals. So the total number of implants for the study is now 49. So this means recruitment rate of 94%. So 3 patients to go to complete the enrollment. So we expect to complete it this month, so by the end of April. What is also extremely important is the adoption of the therapy by the hospitals is pretty spread out in the country, 6 hospitals with at least 5 implants and the university hospital in Lille with a record number of implants equal to 10. So we have built in France a very strong customer base with a lot of experience, and their experience will be key in order to accelerate the learning curves of all the other hospitals that are about to start their total artificial heart program. We said several times, and Christian mentioned it already a couple of minutes ago that EFICAS is a strategic pillar for the development of the therapy. And we can also say again that EFICAS predicts the future therapy adoption in other European countries and beyond also Europe. Q1 2025 has been a great occasion to make some important progress in the building of our commercial platform. Results have been a bit below the expectation in Germany. But Nevertheless, we have seen a patient flow comparable to that in France, which is confirmation of the high interest in the therapy in the German market. There are 2 main differences between Germany and France. First of all, we treat in Germany very sick patients, sicker patients than those in France. And then in Germany, there is expectation for long-term bridge. So due to these differences, it's much more, let's say, the route to implantation is much more complicated in Germany. That's why there are certain patients that go out the referral funnel once they are identified. Nevertheless, we have continued to develop the markets. We carried out to implants. We trained hospitals. We have finalized a contract with an important university hospital. We have negotiated successfully reimbursement. So we are still pretty optimistic about what we can achieve in Germany. In Italy, the situation is different. Usually, Q1 is slow because there is the redefinition of the budget at the hospital level. Nevertheless, we have carried out one implant in a new hospital, and we have made very good progress from a budget perspective. So one tender has been awarded. There are 2 others being negotiated. So we are about to create, in Italy, a very nice budget platform that makes us very confident about what we are going to achieve in the coming weeks and months in the country. And then obviously, we should not neglect the other countries where there is a significant potential. For example, in Croatia, we got one national tender awarded. We have recently signed off an agreement with a distribution partner in Hungary. And we have witnessed very high interest on the therapy from several hospitals in Spain. So we count really to develop more this market in the coming months. In terms of communication, so building upon the basis of 2024, thanks to new published data, we have increased our customer engagement efforts, and we also have launched a series of initiatives to increase public awareness on heart failure and total artificial heart. So we did participate with symposia at, at least 2 major congresses in France and in Germany. We have launched a campaign to celebrate the milestone of the 100th patient treated. And we also have prepared the high-risk patients campaign, which is based on the recently published data on ECLS patients. So this campaign has been already launched in the field, so it is getting rolled out by the field team. And then obviously, the lay public, historically, we have been very present in the French media. The news here is that we do communicate more and more above all in Italy, where the therapy has been showcased several times on national TV over the last quarter. We have launched in Italy a very broad awareness campaign in order to educate and inform the lay public on advanced heart failure and the total artificial heart as an optimal therapeutic option. So to conclude my part, I think we can share a promising outlook for the therapy. There is an unmet need. So there are many patients out there in need of transplants that have no solution. Christian has very well explained how valuable and impactful the Aeson total artificial heart is on patients' quality of life. What we have already initiated is the generation and collection of clinical evidence for long-term support. And this will be key in order to broaden indications, increase patient flow, improve market penetration, geographic expansion and above all, also improve financing and reimbursement of the therapy. So what are the growth catalysts? In 2025, we count on the publication on early experience. The restart of the second cohort of the EFS study in United States will be also key in Europe to boost the confidence on the therapy. And then what will also be crucial is the MDR CE marking, which will allow Carmat to introduce substantial product improvements and then to generate and publish additional clinical data to obtain, first of all, a long-term support indication and eventually indication of destination therapy. Thank you, and I'll hand it over to Pascale.

Thank you, Francesco, and good afternoon. So from a finance point of view, I will touch on sales quite rapidly because Stephane and Francesco already mentioned that. But in the quarter, we delivered sales of EUR 2.4 million, and that has to be compared to the EUR 1 million we delivered in Q1 '24. So a nice increase, actually a multiplication by 2.4, which is absolutely in line with our objective to double sales in '25 versus '24. Obviously, sales is one thing, but our key goal at Carmat is to get to breakeven and drive profitable growth. So in order to do that, we've got a good financial -- articulated financial architecture in place based on 4 things really. First thing is sales momentum. So in the short term, our goal is to develop sales in Europe and actually EMEA. But going forward, we're going to launch a therapy in the U.S. as well, which is the biggest market in the world and we'll build upon long-term indication as well. At some point, we'll get, we think, DT indication. So that will broaden the potential for Aeson. The second pillar is very important, and it is margin enhancement, and we are really working hard and the whole company is working hard on it. We've got 2 things to do. Number one is to reduce COGS dramatically, and we're going to do that progressively over the next few years, and we've got a very good plan for that. And the second point is operational excellence across the board, I would say, in all departments of the organization, in sales, in medical, in manufacturing, everywhere. We try to allocate resources smartly and try to do more with less resources or stable resources at least. So that's the second point. Third point is working capital management with a specific focus on inventory management. As you might know, we tend to have relatively long lead time in manufacturing. We work with an awful lot of subcontractors and suppliers, which might drive inventory up. But now we've got very good experience, and we've identified many levers to optimize that. So we're going to progressively reduce inventory levels as well, which will release cash, obviously. And the fourth thing is financial engineering. With the financial debt restructuring that we achieved in 2024, we had 2 objectives. One was to delay the repayment of the financial debt. And the other one was to reduce the portion of the repayment we had to make in cash by implementing so-called equitization, especially for the loan we picked from EIB, the European Investment Bank. So all that paid off because in 2024, we've managed to reduce our monthly cash burn by 20%. Historically, you might remember, we had a sort of monthly cash burn of about EUR 5 million a month, and we reduced that to EUR 3.7 million in 2024. Obviously, we will continue in 2025 and beyond. And we think that we can hit breakeven with a level of sales, which is about 500 implants a year. So to give you a bit more color on that and explain how we're going to achieve that. So in 2024, we had a pool, so to speak, of 60 trained hospitals who were sort of able to make implants. And we had on average of 0.7 implant in each hospital. Obviously, that's an average. Some had not even started, some had not made much more. But on average, that was 0.7 implants per hospital. In order to achieve 500 implants, we think we can do that in Europe. We don't need the U.S. to do that. And we think we need about 100 trained hospitals. So is it easy to do that? Well, it's not a walk in the park, but it's very doable. Recall that even in '24, we trained 19, almost 20 centers. So reaching 100 hospitals is quite doable. Then the next question is, can they make, on average, 5 implants a year in each of those centers? Well, we think it's very credible as well. Why is that? If you just take France, where we've got 9 hospitals trained for Aeson implants. Even in the quarter, in Q1 '25, 3 of them have made 3 implants each. So you see if 3 centers can do 3 implants in a quarter, it's reasonable to think that on average, the hospital we've trained can make 5 implants every year. Important point is that we've got a production capacity already in place to hit breakeven. We've got a production capacity of 500 hearts a year in our factory in Bois-d'Arcy, in the Paris area. And as I said and as Stephane mentioned as well, we are working hard on operational excellence to drive COGS and expenses down or at least to limit the increase. Obviously, going forward, we will develop sales more in EMEA, sell in the United States and get to DT, which will allow us to get to, hopefully, thousands of implants. Finally, financing, which is obviously critical for a company like us. You very well know that the environment is not an easy one from a political, economical point of view, and we've got some turbulence coming from the U.S. right now as well. But so far, we've been quite successful in funding the company. We've secured about EUR 550 million, which is quite a high number. And we think that about 75% of our financing journey is now complete. So the heavy lifting is sort of behind us, but still we need to finance the company because our cash runway is quite short. And just for the next 12 months, we've got a funding gap of about EUR 35 million. So we are obviously targeting long-term financing. We'll be agile. So we need to adapt to the environment. That's why in the last 18 months, we did several equity raises, relatively small ones, but that was the only way to fund the company. Obviously, as I said, our target is still to have long-term financing. We are targeting a cash runway above 12 months, but we'll be agile. So we've got ongoing discussions with financial investors. And our primary way of finance is the company will still be and will continue to be capital increases and if applicable, nonrepayable funding, but in addition to that, and that's why we implemented recently a flexible equity line with IRIS. We need to bring additional room for maneuver to the company if and when required. And that's why we put in place such a flexible equity line, which we fully control in terms of volumes and exercise price, which means that we can really control the pressure that might happen from such tool. And with that, I will hand over to Stephane for the outlook.

Thank you, Pascale. So I think the first question is it's pretty obvious that there is a need. I mean, that's a matter of fact. And -- but why have total artificial heart been under use over the last 20 years. That's the real question. And we learned the other way, and there are mainly 3 buckets. First, the experience showed like a lot of questions about the clinical complications. So people were not really satisfied with the outcome of technologies used so far. Then the poor quality of life as well. And insufficient product durability. So because of these 3 factors, despite 20 years of existence, the level of activity in that field is still very limited. So we believe, and that's the reason why Aeson is a game changer inertial heart technology. So addressing clinical complications. So first of all, as Christian said, and I think it's really per design, not the design of the technology, but the design of the company. Very often when you start the development, the journey of a medical device development, while you work with technologies, you know, you master and then you try to get to a decent or acceptable clinical outcomes. Well, the way this company was born at the inception was very different. Our founder, Alain Carpentier, was a well-renowned maybe one of the most prominent surgeon of the history, well was -- is very demanding and he said, I don't care about the solution and don't speak about the solution. I want something that mimics the human heart. So that was what he asked to the team. And because he didn't want to experience clinical complications. And I think on that first part, we overachieved is expectation, and we are very happy to report after 44 years of cumulative experience of support with Aeson, while we never generated any embolic stock, that's the first thing. And second thing, as Christian said, we never had any gastrointestinal bleeding, which can be fatal in many ways beyond all the primes it can obviously create to the patient. And well, because we can't say 0 anymore, but out of 108 patients and 44 years of support with support up to 25 amounts while we experienced very limited, it's a low digit single-digit number where [indiscernible] infections, and they are not generated by the product. they were due to systemic infection of the patient before treatment. So we are very happy to report that we have unparalleled safety profile, which is very promising for the adoption of total artificial heart for the future. So that's for the first thing. Second thing is quality of life. And when I started that journey, I was shocked because these people will die and speaking with my colleagues of other companies and I was surprised that, well, the patients are dying, but doctors don't want to use it. And very often, it was due to the profile of this product. And I was surprised because the first thing was noise and noise was really a big thing for the doctors. So we have no noise or barely any noise. There are a lot of new projects with Aeson, and they will experience on the experience vibrations on that as well. when it's for a long support, that's a prime as well. Self-regulation is very important for quality of life as well because self-regulation, allow patient to do a lot of stuff. I mean we have patient biking, going on e-scooter, doing a lot of staff. So self-regulation is very important. Right/left balance is not a detail because right/left balance allows to deal with lung barriers and hypertension, and we are the only divisible to do this. Because I think what we understood, thanks to [indiscernible] to pump blood is not end per se. You need to pump blood properly, like your human heart does, and we do. Then a few drugs. So we are not on AV anticoagulation drags. We have low molecular [indiscernible], so which is very low drug management compared to the others. I mean quality of life measured with questioners like the VAS, 6 minute walk test, I mean, are showing very strong improvement in quality of life. So that's the second thing. Last but not least, because obviously, we have to perform very quickly on the clinical side and quality of life, but the drawback was product durability. So we started from very far. I mean, many years ago, we first demand. We approved in the pivotal study in Europe and the contemporary court after the quality hold has improved drastically. So we've been working very hard for the last 15 years on continuous improvement, thanks to bench testing. But bench testing doesn't show you everything. And thanks to the last cohort of 70-plus patients, we learn a lot in real life experience. So the elephant in the room for us and that was the reason for the quality all was enhanced electronics. And we fixed it. So that's very good news, that was a tough one. And thanks to real life experience, we learned about compliance bag interaction with some specific anatomy in isolated cases. So we worked on it. And thanks to the CE mark MDR, we'll be able to enhance the compliance bag and get what we call internally destination therapy product. And this version will be available to the market by end of 2025. So thanks to superior clinical outcomes, thanks to enhanced quality of life and thanks to a long-term support product, we will provide an answer to all actual heart challenges. So now if we speak about the vision of our founder, Alain Carpentier, well, we are really now on our way to permanent support or so-called destination therapy. So we are best positioned device for long-term patient support. I think it's been clear and obvious since day 1, I mean, we had super clinical results since first patient treated. Same for quality of life. Now we will learn the hard way regarding durability. I think we've been working very hard, and I'm very happy to report that -- we strongly believe that by Q4, we get a product which will be very long-lasting. So we have a clear road map for permanent use of Aeson as we speak. So the U.S., I will speak specifically about bridge to transplant today. So our strategy to the U.S., so that's -- you know that's iterated process. So we spoke about the FDA last month, I think, about our strategy. Obviously, it's early for them to position themselves. But the way we are working on is first, to start the second cohort of EFS. So we are well advanced in our discussion. We approved all the major changes of which the electronic -- and now we're waiting for formal approval to restart -- hopefully very, very soon. And our goal is to couple U.S.-generated data with EFICAS, which will be a very large study for TAH52 patients. And our goal is to be ready by the end of 2027 for submission. Obviously, in the meantime, we've been working continuously to work on the technical file. So it's to clear all the question on the product -- we did most of it. So obviously, there is still a list of question and answer that we will work on in the coming months. But our goal is to be ready for submission of PMA preparation filing by 2027 to get approved for BTT in the U.S. by 2027 or 2028. So as I said a few seconds ago, we are well advanced in our discussion to restart Cohort 2 in the coming months in the U.S., as I said, declared the major changes on the product. So, just to give you an idea about the potential of the product and that will be with limited data years ago, 3 to 4 years ago, with independent studies run by specialized companies. So if you add up BTT on DT, the sales at peak of Carmat could be around 5% of the addressable market. So it's very reasonable, and it would range between $1.3 billion a year to $2 billion a year. So Carmat is poised to lead the heart replacement segment. So our priorities. So first of all, we need to walk before we run. So we're working very hard to develop the sales in Europe Second, we keep on working on generation and publication of clinical data, which will be very important to help the adoption of the product. We are preparing for long-term use of Aeson with a product, which we plan to release as early as Q4 of this year, preparing the launch of Aeson in the U.S. and continued journey towards profitability. Our ultimate goal stays becoming the first total artificial heart approved for destination therapy. So that's about our priorities. So I'm very happy all the time to show that picture of one episode of the Simpsons. They are visionary people, and I'm happy they picked up in their series, the Carmat heart. So now the presentation is over, and I will move to the question-and-answer session.

So with methodology, do you implement to improve your product quality and avoid escaping defects. So yes, that's a very good question. So as I said, it's a mix of bench test on real-life testing. So what we are doing is quite unusual, and I'm very excited that center's accepted to do it. I've been working in that field for 30 years, developing stents, valves that stuff. So to learn much more than what we could get from bench test, we asked the centers when they expand the device to send it back to Carmat. So what happened is that we analyze 360 degrees all the explants at Carmat. So we have a real life experience which is very important in terms of information. So it happened that we transplanted a patient today after Carmat in Germany, and we will get the product back to our offices in 1 or 2 days from now, and we'll be able to analyze everything. So thanks to this, we've been able to identify all the improvement we had to bring to the product. So that's a mix between bench test and obviously, real life experience. So we expand all the devices that we analyze all the time. What do you think by the core latest advances. So I won't comment. What I can say is that it's very early stage, very limited experience I think like we did on our friends of SynCardia, they will learn the hard way. It's a tough space. It takes time. So it's very different from us that it's probably less more compatible for sure, you should expect the complication of VADs, perhaps more, I mean, the reported vibration, obviously, 1 to 3 weeks or even 3 months support is not enough for patients. So it's early. I wish they succeed. There is room for everybody, and we need to be more contenders to grow that market, which is humongous. Can you please develop on your market share versus your competitors? Well, I mean we can't speak about the market because you know -- and my friend, I think Patrick CEO of SynCardia I'm not sure because I don't have this, but he was on the list to attend so you can write if it's true or not. But I read the news and based on Renaissance Capital, all friends of SynCardia generated $4 million last year. We did $8 million. So it's what I said after 20 years, is very disappointing. So it's $12 million. So I don't think we can speak about market share. I mean it's a new market to be developed further. And as I said, there is place -- room for many people to grow that market. What will Trump taxes effect on your business in the coming years in the U.S. That's a damn good question. I think nobody has the answer. You see the stock market. Everybody is freaking out. So we are not concerned about this to be real. I mean we need to sell product in Europe and restart the cohort 2. So I think I don't know if Trump will be still there in 3 years from now, first. And I don't know even if these taxes will take effect really. So I don't know. Do you expect any delay in FDA decision given the recent turmoil in the agency? Is Carmat able to achieve cash flow breakeven from sales in Europe alone. So first, yes, as Pascale said, our goal is to achieve breakeven in Europe. So we have enough sectors in Europe, and we have the capacity to do it without further investments in terms of manufacturing. So that's our goal. U.S. is key and paramount to obviously increase growth. So that's the first question. Second question is about the FDA. So we've been lucky enough to be far advanced in the process to restart cohort 2. So as we speak, they cleared all the technical file, and we are waiting for the letter for approval, but it's not obviously discounted, but we don't expect bad news. Hello. So I will read everything. So the name will be disclosed Jeff of Ladenburg. How many centers do you expect in the U.S. second quarter of 7 implants, any overlap with Cohort 1. So obviously, we'll start with the cohort 1 centers, RVAD and Duke. We have 10 centers. We're interested, but 7 patients is not enough for 10 centers. That's pretty obvious. So maybe how many centers did we train already in the U.S. 9 and among the larger ones where I -- maybe you can remind the names.

We have Cedar-Sinai, we have Emory, we have VCU, we have UPMC [indiscernible].

So many more that when we need unfortunately. But hopefully, we can get until an extension very quick as well. But let's start the cohort 2 -- go over it and then we'll be able to satisfy all the other ones. Can you share how many implants you are targeting for 2025, excluding EFICAS implant. So I mean, the goal is to double the sales. EFICAS is now at the end, we ask for an extension, but it's a small part of it. So it's clearly more than 40-50 commercial. But I would not discount EFICAS because I think it would be very wrong because we really don't care where the sales come from. I mean, the important thing is to generate experience in sales. So if we are lucky enough and we get a good extension. If EFICAS runs quicker than commercial, that's good enough. As Pascale and Francesco said, at the end of the day, it's experience, and I think it's a good predictor of success for the future. Taking the example of [lille] which has the highest volume of implants, what is their experience curve in terms of patient selection, duration of surgery, patient discharge is the number of medical staff needed to perform the entire process smaller optimized. So now I will let Christian speak to it. But clearly, that's a very -- that was probably the first center able to do the cases without the proctor but only one person on our site to prepare device. So Christian, you have the question in front of your eyes.

Yes. I think that's a really interesting question because, of course, our goal for us is that all the centers become independent. That means not only for the surgeon, but independent in selection of patients, so screening of patients and conditioning the patient before the surgery to, of course, the surgical procedures and the period in the ICU is quite important too. That means you need to have a convergence of all the competencies of people of many teams. And that's probably the case in [lille], and that's probably the reason why are able to perform such a highest volume of implant. And I think that's something quite important in any center to be able to have these conversions of competency, and that's quite important. And the duration of surgery and patient discharge, according to this situation, of course, you decrease the duration of surgery each time and the decrease the bypass time, for example, patient discharge patient could be discharged with a shorter and shorter period of time and so on. So that the learning curve, which is classical for that.