Carmat SA (ALCAR) Earnings Call Transcript & Summary

Good morning, good evening to everybody, and welcome to the business update and outlook about CARMAT tonight. So the speakers, all together with me tonight, are Dr. Anne-Céline Martha, working in Pompidou in Paris, she is a cardiologist. We have Pascale d'Arbonneau, on my left, who is our Chief Financial Officer. We have Dr. Piet Jansen, our Chief Medical Officer; and Francesco Arecchi, the Director of Global Market Development. So let's get started. So first, we'll begin with the CARMAT 2023 achievements. So as a reminder, our mission is really any way to solve the advanced heart failure transplant and destination therapy crisis. A very quick reminder -- as you all know, between U.S. and Europe, there is a need yearly of 200,000 transplants. Unfortunately, there are much lesser implants organs available a year, around 6,000, 7,000. So only 3% of patients needed -- needing a treatment will be treated and most of the rest will die within a year. So very quickly, the journey of CARMAT. So the company was born in 2008, and we've been listed in 2010. Very quickly, the company managed to go to humans in 2013, and that's the 10-year celebration this year. In 2018, we built the first manufacturing facility in Bois d'Arcy close to Paris, to enable us to support clinical implants and now our commercial activity. In 2020, we got the CE marking for bridge to transplant. So it's -- there are 2 indications for transplantation for mechanical circulatory device. So you have bridge and destination. So today, we have bridge to transplant. So as a reminder, it gives the possibility to patient on the waiting list to wait further to get an organ. In 2021, we did the first implant in the U.S. In 2023, we reached the milestone, so in December, of 50 patients in the history of CARMAT. So 2024, we have now a fully fledged company to support commercial activities, and we are the only CE marked product now a day. And obviously, we are still working to prepare for destination therapy indication. I think in a nutshell, the conclusion is that we were many contenders in 2008. We were 5 beyond SynCardia, which was the first Total Artificial Heart commercialized in Europe. We had a German company ReinHeart and OregonHeart went bankrupt, and we have the chance to have -- 2 other projects still running, Realheart in Sweden and BiVACOR in the U.S., and I welcome Tim and Ina, who I know are listening to us. So welcome to the crew. So 2023 achievements. So we reached 50 patient implants, which was very important. I know it doesn't look like a lot, but for a technology like ours, it's a lot compared to stents or valves. We have now 41 centers trained in 12 different countries, ready for implants at the end of this year. We already included 11 patients in EFICAS, our French study as of end of 2023. We extended the manufacturing capacity to 500 hearts a year in Bois d'Arcy facility. We had the financing of EUR 16 million. So it was much lesser than usually, but the markets were very difficult. So it's divided into 2 buckets, EUR 7 million in trade equity from our existing shareholders, which I want to to thank very much for their long-lasting support and the EUR 9 million in non-dilutive financing and sales of EUR 2.8 million, below expectation, including EUR 1.8 million in Q4. And I think that's a very, very important variable. So we were able to generate 60% of the sales in 1 quarter only. So it shows a very strong dynamic. So 2023 was, for sure, a structuring year towards a successful 2024. I think this year was rich as well in learning. So basically, we've known lot about patient selection. That's a disease which is not well known, and we have a new technology. So we had to understand altogether with centers which were the patient who could benefit the most of our technology. So we have a better understanding today. Patient recovery, because when you treat the patient, that's the beginning of the race, you need to make sure they will recover, do well and be transplanted in the second time. And I think we learned a lot in terms of recovery at the ICU. The surgery, I think surgery, I think it's something that CARMAT nailed down very well since day 1, thanks to obviously inventor Alain Carpentier and we have 100% surgical success. So all the patients went out of the OR following the implant of CARMAT. And it's very nominal now. When I joined the company after 5 patients, I used to be in the room or following each implant. Now I'm not even aware of all the steps, and I don't even know what happened to the patient the day after because things go very smoothly now. And then referral pathway because even if it's not intuitively easy to understand, even if you have a huge need on a new therapy which works quite well, it takes time to get strong adoption. So we understand now, which are the key points and road blocks in order to build the referral pathway and get the patient to the treatment. Last but not least, the product because what I said, the technologies that we developed are very complex in MCS. And if you take a look at the landscape after 40 years, you only have one technology which made it, which is Thoratec LVAD. So it's very complex, and we are very happy to get at the level where we are today in terms of reliability. I mean the hardware is improving all the time, but thanks to the fact that we have the only smart technology today. We've been able to use on piggyback the software in order to prevent the product from failing. And I think we are now at a very good rate of reliability at 1 year. What is very important as well, what we noticed is that the WOW effect is quite important because each center have had experience of a first implant. We are willing to keep on going and all the centers that implanted the first patient kept on going. So the name of the game for us is to break the ice where the centers are trained and didn't start yet. So I will hand over to Piet to speak about clinical update.

Yes. Thank you, Stephane. So here you see a brief overview of the devices that are currently used for biventricular support. The first device is the pneumatically driven SynCardia Total Artificial Heart, which provides pulsatile flow and then there is the use of LVADs in both left and right assist support where the natural sick heart is still in place. In those devices, although they provide biventricular support, there's very little pulsatility and hemocompatibility is also quite poor. And then for the Aeson device, the 2 outstanding peculiarities of this system is the autoregulation. There's no other device on the market, not even in the LVAD market, which relies on information from the patient's well-being and behavior to adjust the flow. And we use a technology that's based on pressure sensors to adapt the flow to the need of the patient. What's also very important to achieve physiological heart replacement therapy is the way blood cells are treated. So in our system, we have a very low stress on blood cells, and we also use biological materials in contact with blood. And those 2 elements will allow for the patient to use a very low level of anticoagulation to prevent the clots, which also reduces the risks of complications related to poor hemocompatibility. So on a current experience, even though we treat the patients that are much sicker than in our early experience, we still have an unparalleled safety profile where we've observed no disabling strokes and no intestinal bleeding issues, which are well known for the continued flow devices. So if you look at our overall experience, and I've been participating in this adventure since the very first patient, so we've treated 50 patients since 2013. We started very carefully with patients that are depending on medication. But if we look at the last 10 patients that we implanted, all of those patients were already on support with temporary support devices. So we've gained a lot of experience, thanks to our clinicians who are very close to us these days. And with these 50 patients, we have a total of close to 20 years of patient support. The longest support duration is over 2 years. And in our recent experience, we have transplanted successfully 14 patients to receive a donor heart and there are still a large number of patients currently on support who are waiting for a donor because that's the indication for which we are approved in Europe. Now, if you look back at those 10 years and then use it for our future presence in the market. I think we initiated a game-changing therapy by partnering with clinicians, with engineers and do this step by step. So for example, for the surgical procedure to achieve 100% success, you need really to work with the clinicians to have the right patient selection and use your own experience as proctors to choose the right patient at right moment. We also have a virtual implant tool where we use a digital twin, so to speak, to already do the implant before the patient is touched to increase the level of confidence with the surgical team. And all that has contributed to a 100% success for procedure even though, as I also mentioned, we're treating much sicker patients. So the fact that we use this autoregulated flow means that the physiological blood pressures and flows are restored immediately, which gives the opportunity to the clinician to focus on patient recovery. So there's a fast recovery in the intensive care than in general ward and the fact that we have a hemocompatible system will allow the physicians to start with anticoagulation when they feel that it's necessary. So there's no urgency to do that. And last but not least, for the patient, it's very important that the external components such as batteries and bags are easy to handle. So with all of that, our experience is growing. We've seen this WOW effect, notably in the new centers who have always been reluctant to step into this field of artificial heart and ventricular replacement therapy, but once they're on board, they don't want to leave and they want to keep part of this project. So now we'll pass the microphone to Dr. Martin, who will share with you some clinical experience.

Good evening. I am really happy to be here to share our clinical experience and then some thoughts about ease on implantation. I am heart failure specialist, taking care of patients with life threatening heart disease, I mean, that advanced heart failure and refer some of them to project, so surgical project like assist device implantation or transplantation. And to be honest, the Aeson heart is a true revolution in our medical and surgical practice. First of all, is a revolution in the management of advanced heart failure. In the therapeutic strategies, for the first time, we have -- we can fill the gap of an unmet need, having a true alternative to heart transplantation. It is useful and necessary for patients who are not -- who have a limited access to transplantation or patients with temporary contradiction to heart transplantation. The second revolution is the technical revolution of course with the concept unique in the world. I mean that machine is able to beat at the rhythm of the normal heart and with the flow, which is increased if we need to climb steep stairs, for example. So thanks of hemocompatibility, pulsatility and self-regulation, the patient can have a normal rhythm of life. And then it's true philosophical revolution as well and mean that we have to integrate that humans can live with the machine, and it is a step necessary to go to destination therapy. We implanted 3 patients in our institution in the EFICAS study. All of them are men, around 50 years old, and they have 3 different medical and cardiologic history, 3 different lives. Here, the example of the first patient we implanted is 55 years old, and he was admitted at the hospital for a first heart failure decompensation revealing the heart disease immediately, severe and life threatening -- both sides of the heart were affected, the right and the left. And because the pump was very weak, the patient had very low blood pressure, renal failure, liver failure. And after 3 weeks of intensive medical management, the patient has kept to all that we can propose. And then we proposed to implant Aeson heart. He was discussed with all the team, validated by the national expert and validated as well for the anatomic compatibility and we could -- and this is a real advantage to schedule the implantation for the next day. The intervention was really uneventful. I mean, the surgical technique is now mastered. So no problem during the surgery. The patient could be extubated the next day and then can be discharged from the intensive care after 10 days. The main thing in this pathway is the very favorable clinical course of the patient. During the phase in the ward, he could benefit from accelerated rehabilitation, but the most precious time was for education and to be able to get -- to know the device and to make Aeson his own. So it was really a precious and important time. And then he was discharged to the rehab center where all the job is to make body building to renutrition and to make performance for all the effort of the daily life. And he has been transplanted after 139 days and having, during this time, really precious time with his family and social time. So we had a really rich experience of all these patients, the 3 we implanted in our institution and the 11th patient included in the EFICAS study -- and we could identify some limits to have the true and total addition of the all community, medical and surgical community. We could identify that we have to trust the device. Aeson is doing the job. So you have a restoration of flow, restoration of pressure. I mean that patient has normal blood pressure, normal liver, normal kidney. It's technically reliable and it's really easy to use for doctors, for nurse and for the patient and all are true advantages. Then we identified that the crucial point is to select the right patient and more importantly, at the right time. We have to take advantage of all we have learned with our experience with other assist device. And we have to implant patient early, when they are not too sick, to take all the benefit of this implantation. And last but not least, we have now to change our mindset and to integrate Aeson in the therapeutic arsenal, making this therapy of exception available for all and this is all the more easy than we have all the support at any time from CARMAT at any stage of the implantation. And then go back to the heart of the matter. I mean that patient's life and patient's quality of life. The challenge is met. The patients are talking about a new lease in life. They know -- they know that they are survivors, and they know that they were riskiest escape and are back to life. The second point is that patients are back to freedom with no more symptoms of heart failure. They are able to walk, to run, to have -- to make functional -- and to restore functional capacity and more importantly, to be discharged to home. And the last point is that it is truly a winning bet on future. For today, of course, with inpatient bridge to transplantation to maximize all the chance to get -- to go to heart transplantation in the best condition. And for tomorrow, if destination therapy is validated, ultimately, be able to save more lives.

Thank you, Anne-Céline, Dr. Martha. Good afternoon, good evening. As Stephane said a couple of minutes ago, '23 has been a structuring year for our commercial efforts. -- CARMAT laid a robust foundation for its commercial ambitions in 2024. In 2023, we have continued investing in hospitals, education and training. We have now 33 commercial hospitals in different countries trained. These hospitals will be key for our commercial expansion in 2024. Last year, our field force witnessed substantial scaling. This has allowed the organization to increase the capacity in terms of sales coverage while providing consistently a best-in-class clinical support, which is highly appreciated by each hospital we work with across Europe. For the first time, at CARMAT, during the second half of last year, we did have alignment between a product supply and ambitions in terms of implantations. This allowed us to promote the therapy without any restriction. This will continue in 2024. So we can say that product supply issues are definitely behind us. We did not only deepen our understanding of the patient referral pathway, but we have also broadened patient selection, pushing the therapies boundaries without compromising clinical [indiscernible]. By enlarging patient selection, we have identified and engaged new clinical stakeholders, which is positioning us in a way that we can reach a broader patient pool. The EFICAS study has been one of the most important achievements for CARMAT in 2023, thanks to the dedication, involvement and trust in the therapy of the French hospitals. In total, 11 patients have been enrolled in the main arm of the study, 7 only in Q4 of last year. All the hospitals have been actively involved in recruitment of patients. And this year, we are going to add 3 extra institutions in order to continue ensuring robust patient recruitment to end the study as foreseen in 2025. It's important not to overlook the strategic importance of the EFICAS study for the development of the Aeson Total Artificial Heart. This study supports the therapy's value proposition. It will help CARMAT achieve French reimbursement and also post market approval in the United States. In brief, the EFICAS study is an important catalyzer of driving product adoption. It will help medical community adoption and anticipates all the dynamics that we are going to see in the coming weeks, months in the other countries in Europe. In 2023, our journey has witnessed promising dynamics. If the first part of the year has been challenged by supply chain issues, the second part of the year has been witnessed with an incredible growth in terms of implantations. 60% of trained hospitals referred patients, 30% of trained hospitals started the therapy with their first implantation, 9 new hospitals performed their first implant. And this element is extremely important because it showcases our ability to start the therapy in new hospitals in different countries, and it fuels our confidence for a promising 2024. Among these 9 hospitals, who have important and prestigious institutions, the hospital Niguarda in Milano, which is among the sites of reference for advanced heart failure in Italy or, for example, the university hospital in Dusseldorf which is the second largest heart transplant center in Germany. The chart on the right shows the impressive trajectory of devices sold in 2023. We moved from 1 patient a month in Q3 to 4 patients a month in Q4. So we did experience a strong momentum in Q4 2023, which fuels our confidence and ambitions for 2024. This year will be simply a year of commercial execution based on 3 strategic pillars. Market development, reimbursement and customer engagement. Germany and Italy will remain the key focus areas. Here, the objective is clear. Convert the trained hospitals into implanting sites. At the same time, we will increase our presence in Europe and in Middle East by continuing establishing our distribution network. In these countries, in this area, the objective will be to start implanting. Reimbursement will stay fundamental key for the development of the therapy. On the basis of the success of 2023, we are committed to keep our excellent track record in the negotiations between hospitals and seek funds in Germany. In collaboration with hospitals and our partners, we are going to leverage budget pockets dedicated to innovation in order to fund the therapy. Customer engagement will take the main stage. We've already started to increase our marketing and scientific communication over the end of last year. This year, we are going to amplify this effort in order to share customer experience, clinical evidence developed around the Aeson Total Artificial Heart and to continue gaining key opinion leaders support. Last and not least, these initiatives will help us build the referral pathway for our patients, referral pathway that is often not established when a new therapy is launched. On this slide -- on this specific slide, you can see some examples of the activities that we have carried out over the last months of 2023. We created in the past a surgical experts group. This year, we are going to form a group of anesthesiologists, intensivists, a group dedicated to ICU treatment. This strategic action is extremely important because it will allow us to better identify and manage sicker patients resulting into a broader pool of possible patients. As last year, we are going to encourage our experts to write case reports, publications and at CARMAT, we are going to continue organizing webinars, local symposia and presentations during the major local and international congresses. In 2024, the objectives are clear. We have to reach as many patients as possible and we are willing to create, develop a medical and scientific community around the Aeson Total Artificial Heart in order to drive wider adoption of the therapy. Thank you, and I pass it along to Pascale.

Thank you. So obviously, manufacturing for us is really, really key because before selling the product, you need to produce them, to manufacture them, and this is what we do at our manufacturing site in Bois d'Arcy in Paris area, in France. So in 2023, we had set ourselves the objective to increase capacity to actually double capacity to reach a number of 500 hearts a year. We did that by mostly opening a new -- a second building in our site, which is now certified and active. So we now have routinely about 15 to 20 products on shelf, which obviously supports the sales trajectory that Francesco mentioned and we forecast a manufacturing output of about 100 devices in 2024. Now this was the first step to reach 500 hearts -- a capacity of 500 hearts a year. As a second step, by 2027, we'd like to increase that capacity to 1,000, and we are already reviewing options to do this. So on this pictures, you can see the yellow buildings, which are ours. So Building 1 is the historical building. This is where we used to manufacture all the products in the past, well, actually until the end of 2023. Now we produce the devices in both BDA 1 and BDA 2, so 2 buildings next to each other. And going forward, we've also rented a third building, BDA 3, which is used mostly for storage right now, which we might use in the future to increase the capacity and to go to step 2 that I mentioned a few seconds ago. So financial guidance. So I think we've got much more visibility on production and actually sales trajectory as well. So we now forecast annual sales for next -- for this year, 2024, of EUR 14 million to EUR 20 million. You might recall that we generate sales both as part of the EFICAS study in France and in a pure commercial setup, mostly currently in Germany and Italy. So the sales forecast is underpinned by basically 3 things: the right level of inventory. So supply issues are behind us, as mentioned by Francesco. We think it's reasonable to forecast about 30 implants as part of the EFICAS study in 2024. We did 7 in Q4 2023. So if you run the math, 30 for the full year -- on a full year basis, looks or sounds reasonable. And we've already trained 33 hospitals for a commercial setup. We plan to train about 20 more. So if we want to hit the sales forecast that you can see on the screen, we need roughly to make 1 to 1.5 implants in each of those centers, which, again, is not a done deal, but looks reasonable. If you project yourself in 2027. This is where we think we're going to hit breakeven, which is very important for a company like us. So this will be based on very strong sales momentum in -- mostly in Europe. And in 2027, we also plan to launch Aeson in the U.S., which is, as you know, the biggest market in the world. Meanwhile, we'll have to reduce our cost of goods dramatically, obviously. At the minute, obviously, we produce a small number of devices, so the COGS is still high. But when we hit a bigger scale, the cost of goods would reduce very importantly. Now financing. So obviously, for a company like us, which will not reach breakeven until 2027, we need to get some funding. So we currently have a fairly short cash runway until the end of January. We raised EUR 16 million in '23, which is a decent number, but not sufficient, obviously. So what's the plan to navigate the road to breakeven? So a, we will reduce cash burn progressively. We have a plan to reduce cash burn by 20% between '23 and '24, that's the first step. And we'll implement a very strong financial discipline to make sure every dollar which is spent or invested is invested in the right way for the company and contributes to reaching our key objectives. The second lever is really important as well. You might remember that we had contracted a significant financial debt with the EIB, European Bank. So now comes the time to reimburse that loan. The first tranche is due to be reimbursed at the end of January. So we've managed to negotiate this with the EIB. So instead of repay in '24, '25 and '26 -- we've pushed that and we now repay -- we'll start repaying in '26, only in July '26 -- so we'll do the repayment in '26, '28 and '29, which is -- '26, '27 and '28, sorry, which is obviously much better for the company because this is when we will start generating some cash. At the same time, we'll equitize that debt, which means that instead of reimbursing in cash, we'll translate that into shares so that we don't have to use the cash we would raise to reimburse the loan. And that's really, really important for the company. Still, we need to raise funds. So I'll get back to that in a minute. So we today launched an equity raise. You should expect further equity raises even this year. And then going forward, until 2027, we'll consider all options, obviously, dilutive and non-dilutive. So what have we announced tonight? So we've announced that we would launch a capital increase tomorrow. So the subscription period will extend until the 25th of January. The price will be EUR 3.99, which means roughly a 30% discount versus the 5 previous days of trading. And this is a capital increase, which is available to all, individuals and institutional investors. So a broad reach, obviously, for that equity raise. The initial amount is about EUR 15 million with a minimum of EUR 11 million. If we don't hit EUR 11 million, we won't do the capital increase. But we could get up to EUR 20 million thanks to the extension close and the greenshoe close that we might use if the demand is there. And obviously, we already have subscriptions of about EUR 9 million, which gives us confidence that we'll manage obviously to do that capital equity raise of EUR 15 million. So how are we going to use the money we're going to raise? Well, that would help us in the very short term. We've got financial needs of about EUR 50 million for full year 2024. So this capital increase will basically cover our needs until about May. And then we are already working on other options in terms of financing to extend the cash runway beyond that period. And on this, I will hand over to Stephane.

Thank you, Pascale. So now we'll move to the outlook for 2024 and beyond. So first of all, well, that's a huge business potential, heart failure, that's the leading cause of death now a day, the market is obviously quite huge. In terms of technology, when you screen the landscape, we have, we believe a superior technology versus alternatives, and we are using components, which make us think that we will lead for a long time, the crew. Hospital capacity, but as Francesco said, that's always the challenge. I build mitral transcatheter market on tricuspid and even if the need is important, it takes always time to install a therapy. So it's about therapy development. And I think now we are ready for prime time. And last but not least, is the manufacturing scale up, maintaining a higher quality standard. In terms of strategy, so the 2024 objectives. First is to really have a successful commercial uptake in Europe, reach at least 75% of the French study, to have 50 centers trained commercially. So it means add at least 17 new centers to the 33. As Pascale said, we had to postpone some projects because it's -- well, times are pretty tough on the market. So we diminish seriously the cash burn. Last but not least, we are hopeful to get -- well, the resumption of the cohort 2 in the U.S. by the end of the year. Mid-term objectives, so increase manufacturing beyond the 500 to 1,000 by 2027, achieve reimbursement in all geographies. In order to get to profitability, we need to reduce the COGS, strengthening the manufacturing supplier base and launch -- plan at least to launch in the U.S. in 2027 which means that for this year, the outlook will be between EUR 14 million and EUR 20 million and still aiming at reaching breakeven in 2027. So our ultimate objective become -- is to become the first total artificial heart approved for destination therapy to address the donor organ shortage. Regarding the U.S., obviously, that's iterative process. So it's not something we share with FDA at that stage, but we found it's the best solution that would allow the introduction of the product Aeson in the U.S. So it's to complete the EFS and add the 52 patients of EFICAS altogether with the registry that we are collecting in Europe with commercial patients, which will make more than 100 patients to offer for a PMA submission. The horizon is still destination therapy that was the vision -- it's the vision of our founder, Alain Carpentier, and we believe we are the best positioned device for 3 simple reasons. So first, performance. Obviously, I think it's quite unique. Out of 50 patients, we never had any disabling stroke or GI bleeding. On that, we believe it will be very hard to match as performance. Second is better quality of life. Obviously, we are the only technology autoregulated, but more importantly, managing the balance, right/left, which is a huge challenge in these patients, which will enhance quality of life. And then durability on time is helping us because obviously, we started -- from where we started, so with a high level of failure as usual, and we have been learning -- now we have a very interesting level of reliability at 1 year. And what happened at the end of the year was very important because we've been able, thanks to the software, to mitigate the risk of the hardware, and we are still working on continuous improvement, and we are very positive about the fact that this year the hardware will have significant improvements, again, to get to a very high level of reliability. So in a nutshell, why invest in CARMAT now? Well, first of all, the market is important. Technology is very unique. It's a proven leadership team, and we have a fully fledged company. We are really doing everything at home. So regulatory, manufacturing, commercial, R&D, everything. So that's a commercial stage company, and now it's all about execution. Thanks for listening. And now we'll move to the session for question and answers. Thank you very much.

First question, I will try to read it as clear as I can. It's been a long day. So hi team, any recent info on -- so several questions in one. So any recent info on market battery and power development. So first of all, obviously, we have a cable like everybody does today. Others are already thinking about induction -- so we are not in a hurry because, obviously, to have a fully implantable battery for a few months for bridge to transplant is not really ideal, I believe, but that will be a real question once we move to destination. So there are many aspects to that. First of all, we need to lower, obviously, the power consumption of our device. And we can do that with the software because our device is super precise and super fast, and we really don't need that. So we will work on lowering the power. That's for sure. And we are doing a lot of technology scouting about, well, induction. We are aware of a lot of technologies which are not public yet, which will become public hopefully within 4 to 5 years. You have very interesting ideas, but not very sexy as I call it, and which I don't think is the solution for the future. I mean if you want to move with no cable, you need to have something very good, like, if you will, pace makers today. So we are doing technology scouting. And when time comes, we'll move to it. Thoughts on continued miniaturization of the product. Well, I think that was self-inflicted because when I joined, people told me, well, it doesn't fit anybody but cows. It's not the case. That's a good news. So I think today, if you take a look at the recent experience, we are rejecting only 10% of patients. I think we can still push a bit the boundaries, but we don't want to run risk not to be able of closing the [indiscernible]. But anyway, -- there is not in the short term any plan. I think we have enough to [indiscernible] for the time. But I think, obviously, if it happens, but we are really very successful very quickly, we will address the point. When do you expect to start to work on the extension of mentioned capacity to reach 1,000 in 2027? Well, we already have the solution. It doesn't mean we will pursue that solution, but we already rent, as Pascale showed, a third building, which is used for storage right now, which is pretty big on which we could potentially move all the clean room and move from 500-plus square meter to 1,000 plus. So it would be pretty easy and no disruption. But as of today, that's option 1. Should we expect some delays this year due to the recent software update? That's a very good question. So no. So all the patients which are under CARMAT as we speak, there are 13. They've been updated. So that's good news and all the new patients that will be treated in the near future, starting next week, will have the new software on the prosthesis. Where are long-term feedbacks from patients still under Aeson support. So I will hand over to Anne-Céline Martha, maybe it's not very long term, but what is the feedback?

The feedback of the patient -- they know that they are the survivors and that they were suffering for life threatening condition, and they have a real good feedback of this support. They are able to go back home and it is the main advantage of all the strategy we can propose. So it's -- people are going back to life and with freedom and it's a really advantage of the strategy. So they feel well. And more importantly, they can go to the heart transplantation in very good conditions.