Good evening, ladies and gentlemen, and welcome to this CARMAT web conference on the occasion of the company's half year results. It will be structured, as usual, in two parts. First, a management presentation, given by the team, led by Stéphane Piat, and afterwards, you'll be able to ask your questions. You can ask them in written through the chat system at the bottom of your screen. I now hand over to Stéphane Piat. Sir, please go ahead. Thank you. Good evening, everybody, and thanks for joining this evening. Today I will speak about the activity of the company in the first semester of the year and give some business update. All together with me, I have Pascale, who is the Chief Financial Officer, Francesco Righi, responsible for the development of the therapy, and Dr. Piet Jansen, the CMO of the company. What are the progress made over the first semester of the year? As a reminder, the mission of the company is still to solve the shortage of human organs in the world. As you know, advanced heart failure, heart failure burden is the first cause of death around the world, and our vision is to become the primary alternative to heart transplants. So, very quickly, what we achieved since the inception of the company in 2008. So I know for everybody it's developing a MedTech implant looks very long, and it is. But we believe at CARMAT that we've been progressing consistently and quite quickly compared to all the other projects. As a reminder, in 2008, we were 5 companies on the starting line and 2 went bankrupt, and the 2 other ones are still implanting in animals. And in the meantime, we've been able to initiate a first in man. We've been able to build a manufacturing facility. We got the CE Mark for Bridge to Transplant. We started commercial very briefly in 2021. We experienced some quality issue, and we decided to voluntarily suspend the implants, and now we are back this year, and we've been restoring the manufacturing capacity. So we have performed clearly all the competitive projects to date. So we are ready now for takeoff. We are not a simple startup at the stage we are today. We are a full-fledged organization. We have all the function in-house. So we have a quality assurance in-house, we have regulatory affairs, we have clinical, we have manufacturing, we have R&D, and we have finance, administration, HR, and last but not least, commercial. So we are a complete organization ready for takeoff. So where we are today, between clinical and commercial, we prepared more than 40 centers ready to implant. We've been working all the summer to build a backlog of patients fueling sales momentum for the last part of the year. We've been expanding beyond the first targets, which were Italy, France, and Germany. Advanced heart failure is probably one of the most important disease growing very fast on our aging population worldwide. As you probably know, the number of transplants is limited to 5,000-6,000 a year between U.S. and Europe, and more than 200,000 people are diagnosed with heart failure every year. Unfortunately, only 3% of them will be able to get a heart transplant, and most of the rest will die within a year. Aeson is a pretty unique solution for an unmet need. Our profile is very unique. So we have acquired hemocompatibility that require very low intensity anticoagulation. We have a physiological flow, silent operation, and last but not least, its activity-based output variation. So we are the only device able to change the flow real time according to the level of exercise of patient, which make a an unparalleled safety profile and a superior quality of life. I will hand over right now to Piet Jansen, our CMO, who will tell you what we achieved so far in terms of clinical outcome and what was our experience after the restart. Yes, good evening, everyone. Thank you, Stéphane. Here we show the four requirements that are essential for physiological heart replacement therapy and how these are met by the Aeson artificial heart compared to the other existing therapies. Physiological replacement can only be achieved if all of these characteristics are present in a single product, which is the case for the Aeson device, as you can see on the graphic. Thanks to this acquired hemocompatibility, we have not observed any cerebrovascular accidents and gastrointestinal bleedings in our patients. Unlike the experience with the LVADs, Aeson patients have not had chronic infections at the percutaneous driveline exit site in our current experience. Since the restart in November 2022, seven patients at five hospitals have been treated with the Aeson device. With the increasing experience on the teams, there's also a growing confidence in the performance of the device, which had made it possible to also treat sicker patients while maintaining a consistent safety profile in these cases. As in our overall experience, the success of the procedure remains 100%, with a survival rate of 83% at 30 days in this small cohort of 7 cases. Three of seven patients were transplanted, and in all cases, the procedure was successful. And last but not least, no device failures occurred in this cohort. Our total experience constitutes 38 patients implanted with the Aeson heart. The longest support duration is 25 months, and 13 patients have received a donor heart. The total clinical experience approaches almost 17 patient-years. The objective of the French EFICAS study is to evaluate the safety, effectiveness, and cost of care of the Aeson artificial heart as a bridge to transplantation. We began recruiting patients for the study in Q4 of 2022, and we expect to complete the enrollment in 2025 for a total of 52 patients implanted with the device. In addition to the six hospitals shown on the chart here, we intend to open at least four additional centers in the coming months to further and expand recruitment. In addition to the safety and performance data that we will accrue, the results will also include socioeconomic data that will help us obtain reimbursement for the product in France. Finally, the study will also be used to support our efforts in the United States, as I will explain in the next slides. The U.S. feasibility study can be seen as a gateway to commercial approval in the United States. Since the design and conduct of the Early Feasibility Study and the EFICAS study are very similar and encompass the same patient population, it is our intention to employ the results of this EFICAS study in our request for access to the American market, which is planned for 2026. Thank you, Piet. So, I will speak about manufacturing updates. So when you develop a new device, a new cardiac implant, you have two patients to solve. The first one is clinical, and I believe we've been doing a great job regarding clinical outcome with our device. And the second one, which is probably one of the most difficult tasks, is to move from prototyping to manufacturing. And as most of the product developed so far, we've been experiencing the same learning curve. We learned the hard way. We moved from ramping up to the first problems, to resolve these problems, and getting back to manufacturing. So in a nutshell, what we've been doing is that we resolved the supply issues the first part of the year. It took a bit longer than expected. If you remember, for people who followed the January call, our goal was to replenish gradually the supply chain, but unfortunately, it's been a bit longer than expected, and we could restart to build a significant inventory in June only. So summer has been a time for a higher ramp up. And as we speak, we have close to 30 devices on the shelf, and we finally managed these months to go beyond the 10 products a month. So I would say that now we're able to accompany the implants coming next quarter. So manufacturing expansion is on track. So as you will remember, we have, as of today, a capacity at full speed of 250 devices a year. As we anticipate for the coming years a fast growth, we are working as we speak to expand our facilities. So here you see the business park where we are based, close to Paris. So we started our history in BDA1, which was the first building, and as we speak, we're expanding to BDA2, and it should be finished by the end of the year. So BDA1 will become mostly a clean room and BDA2, where will be the place where we assemble the product. And we should get to a capacity of 500 devices by the end of the year. And then, you see on the right side of the picture, a new building called BDA3, where we plan for the future to build a huge clean room, to be able to move up to 1,000 device. Interestingly enough, is 500 devices will roughly take us to EUR 100 million as a first stage, and once we get close to that stage, we probably trigger all the work to build a clean room in BDA3... Commercial development. So I think that's probably the most important piece of our work as we speak. So, in the last 5-6 years, we've been working on evidence-based medicine with clinical. We've been working as well to start to build a manufacturing site on build processes in order to build inventory, and now we are already entering in the commercial phase. So I will hand over to Francesco, who will explain in more detail how we are facing the market. Thank you, Stéphane, and good evening. This slide is very important because it allows us to explain the route to implants. And each we start is never off on process. It implies certain steps, and each step can have a different duration according to the country, the hospital where we want to achieve implants. The first step is communication to customers about the availability of the product. Then hospitals start the screening process, which may be a little complex as it requires consensus on a particular patient from the heart team. So, as you know, every patient is discussed nowadays in our heart teams, and only if you know, everyone agrees on the potential... Let's say, on the fact that a patient could benefit from a certain therapy, then, you know, the patient is referred to that therapy. So once the patient is referred, our experts, together with the clinicians, evaluate the patient, and only when it is confirmed that the actual implant planning phase starts. So what we did since June is the following, and it's important to highlight that, you know, we started really our implant generation process in June, when we had, let's say, enough level of stocks at manufacturing. So since June, the field has started engaging customers to generate demand. Hospitals have started the screening process, which resulted in a backlog of patients. Some of these patients have been confirmed for implants. So that's, they, they, they have been discussed by our experts and the clinicians at the hospitals. And then, you know, the implants already said that the implant phase planning phase has started. So from June until now, CARMAT has been pursuing its efforts in terms of training of medical teams, has been supporting hospitals for therapy funding, and has taken advantage of the first part of the year to reinforce the field team. And I'm referring to the surgical doctors, the field therapy specialists, as well as the commercial team. So what does this mean in terms of numbers? So we have received since June, once again, more than 50 patients. So these 50 patients, more than 50 patients, have been referred to us. We have collected 25 CT scans, that as you know, they are important to assess the eligibility of the patients for the implants. And we have approved 20 patients for implants. So some of these patients have been implanted, some of them are in the implanting phase. And to give you some figures about what is about to happen and what is happening lately. So we have two cases planned this week. We are working with some of our customers to plan cases next week on already identified individuals. And we already have a patient planned in two weeks. This is the momentum that we have been experiencing. We are really, let's say, seeing all the results of the work that started in summer. We have 25 hospitals trained for commercial implants. We have a brand new experienced CARMAT team in place. We have everything which is needed now in order to achieve our sales objectives by the end of the year. Sales momentum will be further supported by hospitals activation. We have the 25 hospitals already trained, but, you know, the goal that we gave to ourselves at the beginning of the year was 30. We have four. Hospitals already booked for trainings in Q4. We are planning some other initial trainings, so we are pretty confident about, let's say, achieving these results. And we have been also working on market expansion. As you know, we are active in Germany and Italy, but we are also now in the phase of activating some other countries. So we are talking about Greece, Switzerland, Austria, Israel, for example, where the product is already approved. So we believe that we have here, let's say, the right platform in order to achieve our results, sales results short term, but also long term. So now it's time for the finance update, so I will hand it over to Pascale. Thank you. Yes, good afternoon. So, in terms of finance, let's have a look at the PNL first. As you will expect, the PNL reflects our activity in the first half of the year. So we had, as Francesco said, limited sales of 3 devices we have sold in the period, because we started engaging the customer quite late because we didn't have enough devices on shelf. Meanwhile, we've tried to control expenses very tightly, and you see that the level of expenses was pretty similar in 2023 and in 2022 for the first part of the year. As you would know now, we do have some interest associated with bank loans. We've got two loans, one we took back in 2018, the EIB, from the EIB, EUR 30 million, and we also have 2 additional state guaranteeing loans, EUR 10 million in total, that we picked during the COVID period. At the same time, we continue a strong investment in R&D, and most of the R&D activity is based in France. So we do benefit from a Research Tax Credit of EUR 1 million in the period. So net, net, we had a loss of about EUR 26 million, which is broadly similar to the loss we had last year for the same period. Obviously, what's even more important for a company like ours is cash. You'd see that the cash burn from operations and investments was pretty stable versus last year. About 5-5.5 million a month. You will know that, you know, CapEx have picked up a little bit, and this is obviously connected to the manufacturing expansion that we are currently doing. That's, so that's for the business, so to speak. And in terms of financing, during the period, we got a blended financing from the French state under the so-called Plan Santé 2030 healthcare plan. That's a total financing of EUR 13 million, which is split into four tranches, and we got the first tranche in the first half of 2023. So out of the EUR 4.7 million financing that you see on the screen, I mean, 3.3 come from this financing that we got from the French state. All the financing we got during the period is non-dilutive. So we ended up the period with a cash position of EUR 24 million, giving us a cash runway until end of October this year, and the net debt was EUR 33 million as well. So in terms of financial strategy, I think it's we are at a crucial time where, you know, we do expect a strong sales momentum going forward, so starting in Q4. We'll combine that with a very drastic cost reduction, which is really important to sort of get some traction in terms of of financing. And in parallel, the second pillar of the financial architecture, if you will, is really financial discipline. So we'll be very strict in terms of resource allocation and operational excellence, so that every sort of penny which is spent and invested in the business is worth spending and directed towards value creation for the company. So with these two pillars, we will definitely go towards profitable growth as quickly as we can. Now, obviously, with a cash runway of until end of October, you'd expect that we will, you know, have to identify some funding, and we are working very actively to extend this cash runway in the very short term. So you should expect something here very shortly. And going forward, because we'll still need to, you know, raise money for a couple of years, we look at both dilutive and non-dilutive financing, as we said back in January. Now I will hand over to Stéphane again. I will just say before that, we get very strong support from our reference shareholders. So, you know, the main shareholders are Matra, Airbus Group, Matra Défense, and three family offices, which are very loyal and have been supporting us for quite a while, and we will continue to do so. So, Stéphane? Thank you, Pascale. So, before we move to a Q&A section, I will just finish with the outlook. So, well, just as a reminder, well, the market population addressable market is pretty big as you know. Our technology so far is one of the most promising under development. And, obviously, manufacturing scale-up is really what will be one of our main focus for the future, because we anticipate a strong demand. So we are set for growth. So, I think from a product standpoint, well, clinical results were quite impressive so far. And, it looks like we've been working quite well on quality, and we didn't experience any bad results so far. And manufacturing is ramping up. Obviously, we should not forget, we are a new company, so it takes time, but we believe now the level of process is very satisfying, obviously. We started manufacturing. We built a facility in 2018 only. We should remind that, and I think that's incredible progress we've been able to make over the last five years. Now we are commercial ready, and we are as usual, when you launch a new implant, well, we are learning. Clearly, times have changed, and it's pretty slow to introduce a new therapy, which is so disruptive as our product in hospitals nowadays. So sales forecast, we'll do our best to meet at least EUR 4 million, and we expect, as Francesco said, a strong momentum in Q4. The strategic roadmaps of the midterm objectives, our goal is to prepare for 1,000 devices per annum by 2027. As I showed earlier, the facility is there, so just about tracking sales progress and, at the right time, it is about hiring the right amount of people and buy the machines and build a larger clean room. We keep on working on financing reimbursement in key geographies. Obviously, the price is what it is, and we don't expect a price increase or price decrease. So our way to break even will be a drastic reduction of cost of goods sold. That will pass through the strengthening of manufacturing supplier, and we are still aiming for a PMA submission by 2026. Long-term objectives, well, our goal is still to be a frontline treatment for heart replacement. Obviously, we will work actively to make sure we can evolve and move the indication from bridge to transplant to destination. Our vision is to have a CARMAT as a mainstream treatment, like it is the case for CRT today. And obviously, that means that we need to change the technology over time, and a cable-less device is clearly one of the major progress we could bring to the market. Maybe earlier, as you know, we really generate billion of data points every week. And today, the only way to get access to it, it's really to retrieve the SD card and the controller. And, the solution is already ready. It's about, financing, but we want to have real-time data monitoring to optimize patient treatment, and we want to increase the worldwide footprint to build a multi-billion market cap company. So the ultimate objective is to become the first artificial heart approved for destination therapy. So thank you very much, and, I will answer a few questions if there are some in the queue. So, I have a question from the U.S., so a couple of questions. So the pricing. So the pricing is very transparent. The price in Europe is one, and it's really what we applied when I was at Abbott with MitraClip, so it's one price. So it's 205,000 EUR across Europe. And so one of the seven of the restart plus the three Q4 screens in Q4? Yes, it's right. If H2 implants are in 15-25 range, what could be 2024? That's a pretty good question. So obviously, we are waiting for the end of the year to build the forecast for next year, even if we already have a plan in mind. But we need to use the actual Q4 to build a more precise plan if possible. Because as you know, when you launch a new technology, it's exponential, and it's very hard to predict, and to be honest-... I never worked on a new technology which we managed to predict precisely. So what I know, based on my experience, that takes always longer to get to the inflection point. But on the other side of the coin, is once you pass the inflection point, it's over, it's usually going faster than you expect. So I think the real question is, when do you think you'll get to the inflection point? And I believe we are getting closer to the inflection point as we speak. So numbers for 2024, 50, 100, 115 implants. As we speak, we would think much more about 100+ implants, but more to say in January. On behalf of... So it's another analyst. When do you expect the FDA to allow to resume early feasibility study? So, well, it's been a very long discussions, and, and I will pause there, and, I won't give personal point of view. But, I think that, as we speak, we are a tiny company, and as we said, and as Pascale said, what we will do right now is to move from a growth financing strategy to a quick path to profitability. You know, things are longer than expected. The harsh reality over the last 10-15 years is that the world has changed. Doctors are not as, I would say, engaged as they used to be. I mean, honestly speaking, it would take longer today to have a stent on the market. It would take longer to have valves. It is what it is. Things have changed. People have changed. It's true for competent authorities. So that's the reason why we decided to be more real and to use the money to build a path to profitability before thinking about a huge expansion. So what does it mean concretely? It means that we will do what we need to do to resume EFS. So, I mean, we won't resume EFS this year probably. We won't. We were not pushing with centers. I think we want to respect the FDA timing, so we expect to restart next year. We will build more evidence. And EFICAS, so EFICAS is starting now. So we have six centers. We will extend to 10 centers, and we will treat two patients this week. So it looks like the momentum with EFICAS is starting now. We really restarted, as we tried to explain, hopefully, it's been understood. We've been able to start to build inventory in June only because of supply. So we've been starting to promote the restart of EFICAS and commercial really this summer, and I'm happy to see that the patients are coming now. So the status of EFICAS is that our goal is to complete the enrollment still mid-2025, to have the read of the data end of 2025, early 2026. Probably the change in strategy is that instead of building a lot of evidence in the U.S., we'll try to discuss with the FDA to piggyback on the huge European experience we will build in the meantime. How much time does it take from searching a patient to implanting Aeson? That's probably something we underestimated when we restarted. It takes, I would say, between three to four months to start a center, identify a patient, and find room in the planning of the implanting center. It's, you know, we have a patient tomorrow, we have a patient the day after tomorrow, and it took more than one month to get him from selection to the OR. So obviously, there are many different reasons for this. You know, you need to convince all the OR team, and once you get there, everybody needs to confirm, and then you need to find room in the planning. So I would say between three to four months. We hope and we believe that once we break the ice with the first patient in the center, we can treat new patients quicker. Which are the barriers you will face that prevent you from selling 500 hearts in 2024? Well, I think that's simply what I call the market. So, it's not us, even if I don't think we are able to get suppliers to help us to go to 500 by the end of next year. But, I think it's really about the time it takes to get all the centers treating more patients in a year. So now, from a math standpoint, if we have 10 centers next year in France, we restart EFS, and we have 30 centers commercially. But let's focus now on France and commercial. So let's assume we have 40 centers at the end of the year. So 40 centers, it would mean to get to 500, one patient a month per center, which is unrealistic next year. I think back of the envelope calculation for next year, we would think much more about between 2-4 patients a center. So if you run the math, 2-4 a center, so it's at least 100+ to potentially 150, a bit more. So that's the time it takes to get the therapy full speed. When can you activate the program in Lebanon? So that's a good question. We are a pretty small company, and we've been working with the distributor there, and now he's frustrated. We are as well, so we need to choose our battles. And I'm hopeful that we can activate the program very soon. So, you know, the distributor, if he comes with a patient, we'll do all what we can to treat it as soon as we can. But, you know, the world is made of promises, right? And we can't afford anymore to follow all promises, and we got promised with a lot of patients everywhere, starting in France and Germany and Italy. So, you know, we'll focus on main countries today and, but, you know, Lebanon, Israel, other countries, if we have a patient, which is real, we'll make all what we can to do it as quick as we can, because we need to treat patients, but we are open. Are you not quite behind in announcing financing if you have only cash on way about amounts? Well, you know, I don't know where you are based. You're probably not based out of France. Unfortunately, it's a matter of fact that, in healthcare, the company in France, are really waiting for the last minute to, gather as much money as they can to fund companies. And I had a start-up in California as well, and it's what I'm doing with my start-up. So, you know, what we are doing basically is to gather as much information as we can to, to build around, which is as big as, as we can. So, that's what... That's the way it is nowadays, and, but, all that I can say, as of now is that we know for sure we can count on our existing shareholder to be the, the next round. Obviously, as we speak, we are working on it. Do you think it's reasonable to assume you will need EUR 200 million from here to 2027 to get to break even? So I think if you run the math on, if you see our burn, I think, yeah, that's a, that's a good assumption, and, hopefully, it will be less as well. So if you think that this company raised in excess of around EUR 500 million since inception, I believe we raised more than two-thirds of what we needed. So I think from a financing standpoint, in the history of the company, we made the hard work. So, hopefully now we are able to show data reassuring people and helping us to get there. But I think, Filippo, your assumption is, hopefully the right one. You talk about searching for new fundings and said we should expect something soon. Are you in talks and close to signing a deal? Where are you? When are you expecting the new funding? Well, you know, if you follow the company, we've been working like this for the last two years. It's not unusual. Unfortunately, in France, it's pretty hard to get people around the table, so I think with what we have in our hands now, we are able to close a new round, and you should expect news very soon. Are you considering a business continuity plan? Yes. I mean, when you work in a start-up, and it's true for all companies because you never know. I mean, so you know, as a manager, you need to plan for the worst, and I've been doing that for the last seven years. So every time we prepare for a raise, we have a continuity plan as well. So it's nothing new under the sun. You know, I was watching my TV last night, and I was following Elon Musk, and, you know, Tesla died nearly 10 times. That's the start-up life. Has the supplying issue been completely solved now? So if I would say yes, I would be a liar, and I don't want to lie to people. What we said is we stabilized the supply chain, and we improved it to get to 10 products beyond a month. So clearly, there are still tiny open issues we are solving. New ones will come, and we are solving older ones, but as we speak, clearly, we have a better grasp on the supply, the supply chain. That's no question. It's improving every day, and we are very confident by the end of the year, we can ramp up in a easier way, if you will. So, there are no other question, if I'm not wrong. So, thanks for your time, and thanks for your support and your trust, and see you very soon for additional news. Thank you very much. Have a good evening. Bye.