Carmat SA (ALCAR) Earnings Call Transcript & Summary

Joining us for this conference [indiscernible] for the presentation of 2021 half-year results and the corporate strategy. It will be structured in 2 parts. First, a presentation made by the management of the company represented by Stephane Piat, CEO; Pascale d'Arbonneau, CFO; and Christian Latrémouille, Director of Surgical Affairs. [Operator Instructions] I will now hand over to Stephane. Stephane, please go ahead.

Yes. Good morning, everybody. Thanks for your time today. So today, we'll give you an update about half year results and the outlook for the remaining of the year. So today with me, Pascale d'Arbonneau, CFO; and Christian Latrémouille, Director of Surgical Affairs. So the agenda is split in 3 parts, progress made by CARMAT, 2021 half-year results, strategy and outlook to finish with. So progress, first. So obviously, we can't ignore the impact of COVID. It's been limited, but we had some impact. So beginning of the year, we had some disruption because of supply chain. So it delayed the ramp-up of the manufacturing, but now we are okay. And we had some issues to access the hospital. So with the change of the administration in the U.S. in March, there were more stringent rules. So it's been very hard for us to move to the U.S. [indiscernible] personnel until June, but now we have NIE for 1 year. So that's the reason why we've been able to do the 3 patients in the last 6 weeks in the U.S. And as well, we've been delayed for the training of German centers that could not fly to France, but now it's resumed, so it's good. So we had roughly the minor impact of the quarter on the operations. So we had a very strong performance to start with. It's been a very good surprise. Commercially speaking, in 2 months, we treated 6 patients in 4 centers. So it means that 2 centers decided to treat 2 patients in a row. And in the U.S., we've been able to enroll the cohort of 3 patient rather quickly and in 2 centers, Duke and Louisville. So -- which is kind of a revenue of EUR 2 million, roughly, which gives you a good idea about the average price of our device. Even if you have slight differences between Europe and U.S. So overall, that was a very good surprise. We've been able to execute pretty quickly against plan. And we had a very good first impression of centers I think you had the chance to follow some of the conferences of Duke and different press release from the German centers and [ rebuild ] center. And overall, I would say there are 4 main [indiscernible]. So CARMAT support is best-in-class, [indiscernible] is very easy to manage. It trends automatically by itself. Recovery of patients is very impressive. We are able to discharge them rather quickly. And we confirm as well as we used to say for the last year is that the potential patient population is very large. And Carmelo Milano, to quote him said during the call conference after the first in plant at Duke but he was assessing the market around 90,000 patients a year in the U.S. only, and it's about the same in Europe. So I think we had the first good impression, which was very good, and that's the reason why 3 centers out of 7 decided to treat another patient rather quickly after first implant. So I think what was very impressive, it was really the first experience. I think we've been improving case after case. And obviously, centers were very happy. It worked pretty well. I think in terms of execution, I think now, we know to get organized. We are very flexible. It happened twice, but we had an implant in the U.S. and Europe the same week, and we didn't have any problem. So I will hand over right now to Christian. Christian, who is our Director of Surgical Affairs, he used to work with Alain Carpentier. Until last year, he was the head of the Surgical Department as Pompidou in Paris, and he joined us officially in January to take care of the expansion of the therapy and more specifically, for the start of all the centers commercially. So Christian?

Thank you. Good morning, ladies and gentlemen, and I'm very proud to be here and to present you where we are in terms of clinic and CARMAT support. And as you can see on the slide, which is specific for the approach of our strategy for the moment in terms of clinics is to give to all new center a real assistance. We just -- we don't just give a device and just help them to implant it and that's it. But we are a complete assistance with a real team and these assistance with -- is due for at least 3 implantation and if necessary, up to 5, and as requested by the center. This assistance team is composed from a surgical proctor for the moment, myself. But in the future, we want to enlarge probably this team, this approach. A device management, specifically to prepare the device before the surgical implantation and general clinical support to be in contact with all the teams inside the operating room. I mean, the surgeon and the anesthesiologist, epothysionists, nurses, scrum nurses and so on, and the supervisor to be according to the regulatory offer [indiscernible] or during the procedure. That's probably something which is very uncommon for a new company to have such number of people to start the program. And clearly, our objective is to provide a unique level of service in order to ensure optimal care for the patient, which is clearly our goal to take the patient in the general entity and to work with before the surgery, during the surgery and just after the surgery during the recovery period in the intensive care unit. So that's something which is really appreciated by all the centers. And of course, with the new technology and technical rupture, technological rupture. That's important to make the first step. And that's not always so easy for our team to check that, and that's why we offer this complete assistance. If I come back on the device and the main properties of the device, if I want to resume the device, we have to keep in mind that, first of all, that the very good hemo compatibility, and that means the consequence of the contact between the [indiscernible] and the device. And in all the cardiac assist device, which are on the market, the contact is between the blood and metallic portion of the device. And here, in this case, there is no more contact with metallic portion, also contact as with biological tissue such as bovine, petroleum, treating specifically -- treated to absolutely no immunologic response. And we know perfectly this material, which is used since more than 50 years with the tissue valve or bioprosthesis. And we have a huge experience with that and we have very good tolerance by the patient. That's the first thing, the hemo compatibility of the device. The second one is probably something very important is a so-called auto regulation. The auto regulation is what you are doing just for the moment with your heart. That means if you need to perform an exercise [indiscernible], your heart will increase the cardiac output and to give -- and to assume the blood supply and the supply in energy for all your organs and specifically for all the muscles during the exercise leading to an improvement in term of oxygenation of the tissue. And that's something quite important because in this device, at the first time that the device is completely auto regulated. That means due to some sensors, which has implemented inside the [indiscernible] wall, and you have a transmission of the acute situation in terms of volume and pressure in size of [indiscernible]. Its data are transmitted to a software, which analyzes and modified the cardiac output adapted to all the situations. That's very important, not only for exercise, but for example, during the everyday life, you don't have the same [indiscernible] and blood [indiscernible] pressure during the night and the day. And that's the first time that we can give and show some curve of this modification of the cardiac output and the pressure in the frequency during the day and during the night. And of course, very interesting too during the recovery period after the surgical implantation. The surgical implantation is always a kind of trauma for the organism and for the body. And so the -- just after this step you will have some unbalanced period during the first hours in the ICU. And here, the auto regulation of the device permit to have a perfect adaptation of any hemodynamic or situation of the patient and that's probably a very important step in this new approach from the modern devices. And the third property is probably the pulsatility. The pulsatility in something which is completely natural, and you can take your own pulse to see this situation. And due to mechanical consideration, all the devices used until now are more or less not delivery perceptive flow, but the continuous flow. And of course, in the body, all the cells and the tissue are not -- are limited in term of function where they have a continuous flow, give much more work with a pulsatile flow. That's something very important. And to summarize these 3 properties, hemocompatibility, autoguration and versatility are probably the 3 main properties of this device. The consequences are shown here in the table -- That's not true scientific tables with significant results, but that some orientation in terms of the main concern of all this device in terms of cardiac assist device. First of all, the risk of reoperation [indiscernible] and mainly due to the fact that in all the devices existing actually, the contact between the metallic portion of the blood need to use high level of anticoagulation drugs and leading, of course, to the risk of hemorrhage as a surgery. And in other [indiscernible], if you are not enough efficient, the risk is to make some clot inside the vessels and the risk is to get some stroke or peripheric emboli. And here, in this case, we reduced drastically the level of [ reoperational bleeding ]. And I want to say for the future that probably we can decrease this 20% because since now a couple of months. And after discussion with Francisco Rabia, who was in charge of the main program in SynCardia in Cedar-Sinai in Los Angeles, we keep the patient open to just open during at least 24 hours, which permit to remove some clots and to reduce the risk in general bleeding and consequences in terms of compression inside the chest, that's probably a very important step. As you can see, we have some 0%, which is very uncommon. And in terms of stroke according to the situation of the hemo compatibility, as I mentioned previously. And due to the pulsatility we have no more gastrointestinal bleeding in this kind of patient because we can reduce the level of the anticoagulation and the pulsatility flow has some consequences, normal and natural consequences on the hemostatic biochemical situation, and that's probably a main progress for this kind of device. The [indiscernible] is 0% with infection of [indiscernible]. That's always a great concern for all these patients. For the moment, we don't have the exact reason why we have 0% at this level, but probability pulsatility is still a very important point. and by reducing the risk of stasis in subcutaneous tissue and some states in subcutaneous tissue is a bed of the risk of infection. That's probably how it works. But that's something very interesting. And as you can see here, we just compare with SynCardia, which is still used today since the 1885 to 1985. And of course, due to the anticoagulation therapy at a high level, we have a huge risk or reoperation for bleeding. The risk of stroke is due to the imbalance and very fragile situation between the risk of hemorrhage and the risk of thrombosis inside the device and inside on vessels. The risk of gastrointestinal bleeding to an infection of driving for the same reason. That's our baseline and the data that we compare to SynCardia. Probably very approach to our results, and that's probably very interesting for us to see the great difference of generation between these 2 kind of devices. The 2 other lines BVAD biventricular assist device and LVAD left ventricular assist device. I just want to start by the LVAD, left ventricular device because the left ventricular is always as the main area in the heart, which is important in terms of functionality. And usually, all the disease which are huge concerns start with left ventricular failure. And usually, the right ventricle failure is in the second step, which is adverse functional and then when the patient have the 2 ventricular's in a failure of the 2 ventricular, you need to have 2 ventricular assist device, 1 on the left and 1 on the right. So the LVAD is very important. That's probably the new generation since 2005, which is at the origin of the development of all the cardiac assist program everywhere in the world. But you can see that we still have some consequences in terms of stroke, gastrointestinal breathing and [indiscernible]. And biventricular assist device are used when you implant VAD on the left side and another one on the right side, that's only due to the fact that for the moment, we don't have any device to support the biventricular failure. And that's probably the reason why CARMAT is clearly a new solution for this kind of patient. And of course, with all the complications as you can see, that probably is a very promising device and promising technology for the future. So if we look at the situation of our commercial experience now, that's a very positive first commercial implant and we've clearly since the beginning of the story and the first implant in 2013 in Paris. We have continuous improvement of the procedure. And in term of compensability and understanding, I want to say that after every implantation, we improve and we give more tricks to improve and reduce the outcome the mobilities or the co-morbidity or complication of the processor. That means that as a result, we obtained 100% success rate for surgical implantation that quite important. And that's something which is very important because I always insist on that, we need at first to keep the confidence from all the teams medical and surgical team of every center, working in the world of heart failure and in transplant program and then something very important. Very important in terms of success rate for surgical implantation, but not only the patients who receive the device are now in recovery period, which is quite impressive. For all the physicians working in the ICU, they are really surprised by the speed of recovery of the patients. And probably, that as the original success in some patients are now still discharge from the hospital and come back home. And in all this program for government, we are working as -- implementation as a bridge to transplantation and to prepare for the future, probably and a definitive implantation therapy. So that's probably something which is quite important. And actually, the feedback from all the teams and after more than 9 implementation in the 2 last months we give an answer to a very large clinical need and which actually is without satisfying solution, as BVAD, as I mentioned previously, is not a satisfying solution such as because we have nothing for the moment. And probably CARMAT could be a very good answer and solution for this kind of patient. And that means we probably go on with a very rapid expansion and all inclusion parameters. That means that we have the classical indication -- inclusion indication for cardiac transplantation, generally that the cardiomyopathy, which is so-called dilated cardiomyopathy and the other half is the ischemic disease, and this means patient who have more myocardial [indiscernible] or repetitive myocardial [indiscernible]. And for the moment in terms of target population, we probably improve and enlarge this target population due to enlarged criteria of clinical -- anatomic fitting, which is based on the morphology of each patient from a CT scan, we are able to have a software in morphology to remove the [indiscernible] and to replace it by the device to be sure that there is absolutely no conflict with the ribs or with the sternum. And clearly, we improved our selection criteria, which permit us actually to enlarge all clinical inclusion parameters. And as requested by all the centers, we are working more and more with new indication. That means, for example, the [ redo ] surgery, [ redo ] surgery is for patients who were operated on cardiac surgery for example, for the implantation of LVAD or for example, for mitral surgery. And then after the evolution, they need to have the opportunity to get a device like CARMAT, and that's reduced surgery and reduced surgery is always much more difficult than the primary surgery due to the fact that there is more and more adherence inside the chest with an increased risk of bidding in the postoperative period and sometimes with some technical difficulties. And clearly, since 2 months, we made great steps to go on and to find new indications for all these kind of patients. And now I will leave to Pascale to take -- to follow me.

Hi, good morning, everyone. So a few words about our sort of half year financial results. As we -- as Stephane described, we had an intense first of 2021. We were very busy on different fronts. Production ramp-up is a key one, but also continued activities to secure supplies, prepare for commercial launch and prepare for the initiation of 2 key clinical studies. So including the EFS study in the United States and the FICA clinical trial in France. So that led to a higher level of activity compared to last year and to a higher level of operating expenses as well, as you can see on the screen. In terms of financial results, obviously, that relates to the interest that we carry on the loans, the different loans that we have. So the EIB loans of EUR 20 million, and this [indiscernible] loans of EUR 10 million that we contracted last year. And on the positive side of things, we got a research and credit research and innovation tax credit of EUR 0.7 million, which is broadly in line with the one we had last year as well. So net-net, obviously, as we didn't generate any revenues in the first part of '21, we recorded a loss of EUR 26 million. Obviously, for a company like ours, which is just starting marketing its product, cash is everything, is really important. So as you can see as well, the cash burn was in the first half of this year was about EUR 30 million, again, which is higher than what you could see last year. Obviously, this is a direct impact of the high level of activity that we had and a direct consequence of -- especially building up inventory ahead of commercial launch and the initiation of the EFS and [ FCAS ] studies. The sort of 30 million-ish cash burn is a good indication of what we're going to burn in the future over the next sort of 12 months. But obviously, in the first half of this year, very importantly, we also did an equity raise of about EUR 56 million. So net-net, our cash position was strong at the end of the semester. So EUR 58 million above the level of EUR 36 million that we had at the end of 2020. That leads us nicely to our cash run rate. So if you add up the cash that we had in hand at the end of June this year. And the last tranche of EUR 10 million of the EIB loan that we're going to draw down in Q4, that will be enough to finance our activities through to mid-2022. So this is a confirmation that we are funded until mid-2022 without any additional resources that might come. Obviously, what that means is that by that deadline, so to speak, we'll have to raise money again or find other sources of funding. Very importantly, in terms of communication because we had some questions about that. So we'd like to confirm that we'll obviously communicate when significant milestones are reached. And obviously, when we publish and comment our financial results, but we will not communicate on each individual implant or sell whether it's part of commercial activity or part of clinical trials. And obviously, in line with good practices, we will not comment on patients as status either. And obviously, other principles are subject to regulatory requirements or special circumstances. So we will comply with all regulatory requirements in terms of communication, especially applicable in France. And then a final point on sort of share price performance. So obviously, it's not up to us, the management team of the company to comment on the performance, but you will note that our share price increased by 20 -- sorry, 62% over the last 12 months, which is higher than relevant indexes in our sector. And we now have a market cap which is usually about EUR 450 million. Remember, we are listed on Euronext Growth in Paris. In terms of shareholders, I will just confirm that Airbus is still our main shareholders and has been supporting us for quite a few years. And we also have 3 very loyal family offices which have been supporting us for a few years now and which are sort of 3 key shareholders for the company. And on that, I will hand over to Stephane, again, who will update you on our strategy and outlook.

Thank you, Pascale. So back to business. So the 3 areas of focus for the coming months will be 3. So manufacturing, I mean, that's paramount for all device companies, even the bigger, larger companies. That's a very critical point to move from prototyping to ramping up manufacturing, obviously, clinical studies, the future of a therapy, it's really about clinical evidence, expansion of indications and last but not least, commercial, obviously, and all the strategic projects here above cited are progressing well at the point. So manufacturing. So as of today, we are able now to assemble 10 products months, and the goal is to get to 20 by the end of the year and so on. We are increasing consistency reliability. We are improving more and more processes, we are building up a real manufacturing state-of-the-art site now to allow a better fluidity of manufacturing. And obviously, as we said, our main area of focus may be regarding manufacturing suppliers. Obviously, we need to work with people who are able to accompany us in a strong growth setting and to ensure production continuity. So the objective is to, as I just said, assemble at least 20 products a month by year-end and growing even more next year. in order to be able to support both clinical and commercial demand in 2022. In terms of clinical programs, so it's pretty rich. We have 4 clinical studies ongoing. So we have the pivotal studies, which have been used in order to support the [ CE ] marking for [ bisutransplant ]. We had an internal target of 20. So we've been stuck at 15 because, obviously, we got [ CE Mark ] and we were prioritizing obviously, commercial for the last 2 months that we'll get started again next week or the week after in order to [indiscernible] as quick as we can and close the pivotal study. Then we will start probably next month, a very large study in France of 52 patients aimed at -- to driving product adoption, support value proposition and get [indiscernible] reimbursement that will be a very large study. About health economics, the goal is really to show that using Carmat, you can make the same -- save money. And the study will start probably next quarter. So it's 52 patients for 2 years. We'll be funded at 70% by the French government, and we already have 6 centers starting very soon. And obviously, that's a commitment from our side, which is now a prerequisite when you have a CE Mark. So we will capture the 95 first commercial patient in the registry in order to make sure that the experience in real life is at least as good as in the clinical pivotal study. We have 5 patients to date, probably some patients [indiscernible] candidancy won't be able to get in a timely manner a human heart, and we will capture obviously the patient that will go beyond the year. But as I said earlier, and Christian as well, the vision of [indiscernible] Carmat 30 years ago was to get the first bivent technology for destination therapy, which is still our goal. So we will -- in the coming weeks, we'll work on the plan to make sure that now that we have a product, which we believe is very strong. We tackle that task of indication, expansion. I don't know, not only with the PMcF, but probably with a dedicated registry. But as I said, well, we had patients so far that went to 25 months that died from cancer and we had to stop the [indiscernible]. But on bench test, we have products that went beyond 5 years. So we're pretty confident that it's the right time for starting such a study. Then the U.S., obviously, for a medical device company, as of now, it may change with EFS and easier access to the U.S. But until now the first step for a device company was to get CE Mark, win in Germany and then get access to the U.S. as soon as possible. So we got approved earlier this year, an early feasibility study of 10 patients in -- it's a 2-step study. It's 3 plus 7. So we had a first cohort of 3 patients and FDA wanted to see or wants to see the 60-day follow-up before we can keep on going with Cohort B. So as we just said, we completed Cohort A. So we will wait for the patient to get to 60 day, and then we will submit the follow-up to FDA to be able to keep on going with Cohort B. We are very excited to have been able to work with these 2 very important centers in the U.S., Duke University in Durham, which has been the first U.S. center to implant a Carmat. I guess you see very often news from the patient in the news. And Louisville, which performed 2 implants so far with Mark Slaughter, who is one of the pioneer in MCS field. Just as a reminder, they celebrated a few weeks ago, the first implant of AbioCor 20 years ago. And the study results will be used to support the design of a pivotal study for potential FDA approval. So the goal with Carmat, as Christian said, it's really to come with a new generation device. So we will move from TAH, total artificial heart, to what we will call PHRT, physiological heart replacement therapy because as Christian explained very well in detail compared to the technology available today, we are adding self-regulation and higher biocompatibility to allow a better quality of life. And the commercial name for the product is called Aeson. It's been disclosed earlier this year in January. So in Europe, everybody is calling it Aeson. But for other reasons in the U.S., when you read the press release, both Duke and Louisville are speaking about Carmat because we submitted the EFS more than 2 years ago. And at the time, the commercial name did not exist, but I guess, in the near future, that will be Aeson for everybody. So the commercial plan. So as we said earlier this year, we'll focus mostly on Germany, but we will extend as well to other countries, which has been the case in Italy, and we'll open very quickly as well in the Netherlands. So just to show you the ramp-up. So we trained 4 centers in Q2, which implanted already commercially. We trained 3 new centers in Q3, which should start very soon. And we have a plan today to train at least 6 centers in Q4 and probably 7. So which will be at least an amount of 13, 14 ready to keep ongoing in January next year. And obviously, we will start as well to fill the program for Q1 and Q2 of next year to make sure that we have a large base of customers in Europe. So my last slide for today, and I will answer your questions. Well, Carmat has a strong growth potential. So when you take a look at the analysis of broader forces, first of all, if you take a look at the environment, it's very positive for Carmat because the demographics, while we have aging population, today, because of the difficulty to develop such a device, I would like to remain but obviously, you have one competitor today, SynCardia, and you had 5 other programs in 2008 when we started. And today, out of these 5 competitors that started in 2008, you see I'm excluding SynCardia, which has been used very largely in the last 20 years. The other competitors in development are still at bench test level or animal level, and we're the only one that managed after 12 years to get to a commercial and U.S. study. So on top of the low rivalry, I would say, among existing competitors, you have a low threat of new entrants. That would be pretty slow. You need a lot of money and you need to do a lot of experiments, low threat of substitute. I'm thinking about gene therapies, it will take time. Pretty sure it will work a day, but it's not prime time today for them. You have a low bargaining power of buyers because you don't have a lot of offering, and you have a low bargaining power of suppliers. So basically, I think Carmat is in a very good spot now. I mean it's a technology with a great potential, thanks to its unique value proposition. So thanks for your time today. We don't have a lot of questions, but I will answer the question.

So I have question from H.C. Wainwright. So is the pace of commercial rollout in Europe meeting your expectations? Yes, it does. It's even -- well, we are not speaking about obviously large numbers, but it's been quicker than expected. So hopefully, it keeps on going this way. Do you expect the frequency of commercial implants to increase significantly in the coming quarters? Yes, I think, obviously. When you launch a therapy, which you believe will be successful. I mean the goal is to double volumes very, very quickly. So yes, we intend to -- or we expect to increase the frequency very quickly. What does the FDA need to confirm from the first 3 patients in the U.S. EFS study? So obviously, the feasibility, it's name -- I mean, they want to check if it's feasible. So at that stage, they won't really check the efficacy and the secondary endpoint, that will be much more about the device behavior first. So if we have technical issues as we had in the first event in Europe in 2013, that's the first thing. And the second thing as well because we still are -- we are a large start-up, but we don't have operation in the U.S. And I think one question mark for them is, are you able to replicate what you're doing in commercial in Europe, in U.S. hospitals. And so far, it's been the case. Obviously, we don't use the same -- it's the same setting, but not the same people. So we don't fly everybody all the time. We have as well a U.S. surgical proctor in the U.S. So basically, the last case performed a few days ago in the U.S. was not performed with Christian Latremouille, who was focusing on commercial and animal training in Europe, but by U.S. surgical proctor. And then last question from H.C. Wainwright. When do you expect to complete enrollment of the rest 7 patients in the U.S. EFS study? So obviously, now we need to wait for 60 days and submit the dossier. So we hope that we can get clearance by December and restart in December. So I think we have the product on the shelf of the U.S. study. So hopefully, if we keep on going at that pace, we should be down by the end of quarter 1, but that's ballpark would be end of quarter 1, early quarter 2. Another question, does the current material shortness of components like chips impact the production of the Aeson? So well, we are using the electronic board of [indiscernible]. So as you can imagine, that's a quite complex electronic board made of tons of components. So you're right, that's a good point. So probably, you have a huge shortage of components today in the world. So very often, it ends up in auctions. And very often the price of the component that is usually sold at 1 is sold 20x the price. So it's a problem for people like Sony, which are building consumer goods such as PS5. That's the reason why you don't have any PS5 around the world for the last months because they can't afford for a product sold $250 to buy components, $20 to [indiscernible] $1 or less. It's not the case for us because as of now, the manufacturing cost for Carmat is pretty high, as you can imagine. And the cost of components is not even 0.01% of the overall cost. So we don't suffer from chip impact today because we're able to pay the price. And we order components. I think the only impact we used to order components fit -- 42 weeks upfront. Now we are doing it 62 weeks upfront. So we need to start earlier as well. Can you tell me about the progress of new production facilities? So the production facility, as I said, well, we moved from a few months to 10 now, hopefully 20 by the end of the year. Obviously, we'll see -- next year will be very important because we see if the demand takes off as per plan. And if it does, we probably will need to think already about manufacturing expansion. So we already have a plan, and we should get started on this new plan of expansion because it will take at least 2 years, as you will understand, to get a brand-new facility, which -- with a clean room today, our clean room is around 300 square meter, and we'll probably move to a clean room of 1,000 square meters. So it's where we are today. But yes, we have a plan and we should move very fast now. How many devices do you expect to sell in 2022? So obviously, it was the first year, and we wanted to see how it goes. So it would have been very [indiscernible] from our side to give some numbers already beginning of this year. But for next year, we will give some outlook like you do usually. Obviously, the outlook will have a range, and the range will be pretty large because we are not a mature business. We're not Abbott or J&J. So you will have probably an outlook with a large range of targets. Any sales plan you can share for the next years to come? Not at that stage. Last question. When do you expect the [indiscernible] study to conclude? So I'm not sure [indiscernible] what you mean, but -- so let's go back to the study. So I said the U.S. study. That will be probably end of Q1, early Q2. The pivot study, obviously it in competition with commercial, but we should be able to finish well, first semester next year. And I don't know if ETD was meant for EFICAS, the French study, but we think it will take roughly 2 years to enroll the 52 patients in France or a bit more. So it will be end of 2023 or early 2024. Another question. Yes, the French study. Okay. So it was EFICAS. So EFICAS, the plan -- we will initiate centers because we will -- we are waiting for a final approval. We were already approved. But as I said earlier, we are changing many things on the product all the time. as you can imagine. So we submitted before summer, new, minor changes. And we got the ruling. I think we should get the ruling this week. So we should be able to disclose the approval for the latest version in the coming days, hopefully. So we'll initiate French centers by the end of the month, early next month. So we'll start the study in Q4. So I think probably we are over with the study up for the end of 2023. Another question. What would the production capability of the new plan be? So obviously, today, with the plant we have, with the processes we have today, we believe that we could reach eventually stretching all the angles, 350 to 400 a year. So the new plant will be at least 3x larger. And hopefully, we are able to make the processes better. So it will be at least, well, I would say, 1,000-plus, 1,200 implant products a year at least. So I don't see additional questions. So maybe I wait -- I pose for 30 seconds, if somebody wants to shoot the last question. But overall, I think strategically, obviously, that's a very important field. That's a very complex one, I think if you're following MCS. We used to have a lot of contenders, barriers at entry are very high. It's a very complex business. Now in TAH, we have only one competitor for now, SynCardia, which has been doing a great job. And for LVAD, we used to have 2 very important players, Abbott, which acquired [indiscernible] and Medtronic, which acquired HeartMate. And as you probably read, Medtronic earlier this year, decided to discontinue HeartMate. So today, you have only 1 LVAD and 1 TAH. Another question. Do you consider further share emission or can you work with short-term loans? Well, I think we had some loans, but the preferred option, not for everybody, but the safer option when you can raise money with a capital increase at good condition is always the best thing. It protects better, the company. So our first preferred solution is always capital increase. So that will probably the strategy again. So to finish on what I was saying, so a very difficult field. But I think it's a very promising field, and we truly believe that we have a game changer. I think we have a line of 0s in stroke, in infection, in bleeding. It's been confirmed as well in commercial in the U.S. So I think we are very bold on the technology that we are offering today to hospitals and patients. And we truly believe that we have the right strategy on hand, and that will be really about execution and to take back the last question that will be about, as usual, money and the way you use it. And I think the company has a great management as great people. We have a very strong strategy. We have strong financial partners. We have strong industrial partners, and we have strong clinical partners. So I think we are set for success. Obviously, MCS is a bumpy road. So as I usually say, expect the unexpected, but I think we are equipped to succeed. So I wanted to thank you all for your time today. If you will, you will be able anywhere to review that presentation, another presentation on our site that will be posted very shortly. Obviously, you can follow the site, address some questions and we'll answer. And thanks for your time again, and I wish you a very good day. Thanks a lot. Bye.