Carmat SA (ALCAR) Earnings Call Transcript & Summary

Okay. So I see people are connecting right now. So good evening, everybody, and thanks for joining us on this virtual conference held by Carmat, represented by Stéphane Piat, company's CEO. Just to explain you how it will take place. So first, there is -- there'll be a presentation of Stéphane, and then you will have time to ask your questions through the chat system on Zoom. You can use it on the bottom of your screen normally in the Q&A session. So I will now hand over to Stéphane to go on with the presentation.

Okay. Thank you, [ Duchenne ]. So good evening, and good morning, depending where you are on the planet today. And I take advantage of this time of the year to wish you all a happy new year and, for sure, better year than last year. So thanks for joining. And so today, I will give you an update on the company development, following the announcement that we made 2 weeks ago about the CE marking grant. So the agenda today, we start first with the 2020 review, then I will give you more color to the CE mark opportunity for our company. I will speak then about the clinical development. And I will finish with the business strategy and the way we prepare the commercial launch. So 2020 at a glance. So first, I think what was very important because I think 2020 was a very tough year for the world as a whole. And I think we've been able to take advantage of, well, issues of some to really work better and quicker. And that's the reason why I think we've been able to get the CE marking by the end of 2020. So first, we started the year working with the French government to negotiate a fund for innovation in order to conduct a large study of 52 patients. And we've been able to agree with the French Ministry of Health, and they granted the company a EUR 13 million grant to be able to do this study, which will cost overall EUR 20 million. The second achievement was the fact we've been able, despite the COVID situation, to train 3 U.S. centers to start the early feasibility study in the U.S. We've been able to train Louisville, Dallas and Richmond. And so these sites have been initiated as well, and they are waiting for the clearance of the FDA for the last commercial version to be used in the U.S. And last but not least, it was the third point on the agenda for 2020, we've got granted the CE marking for bridge-to-transplant patients in Europe, and I will come back to it in the coming slides. So overall, I think the conclusion is that we showed the resilience and our capacity to execute against plan, and we achieved the key objectives despite the COVID situation. And obviously, while people were working on CE marking and the FDA approval for the EFS, the marketing team all together with the business development team worked actively on the preparation for the commercial launch for 2021. So the CE mark opportunities, so we've been delighted, obviously, to get the CE marking over Christmas time. It was exactly the 22nd of December. The company has been working very hard for many years to get there. So we got, as indication, the CE marking for bridge-to-transplant patient. It's a pretty broad label. I mean for the experts, it covers patients suffering from biventricular heart failure ranging from INTERMACS Class 1 to INTERMACS Class 4, which is the range that is covered today by LVAD patients, and these are for patients for bridge-to-transplant. So obviously, we anticipated the ramp-up of the manufacturing activities, and we've been working very actively in 2020 to work on processes, work on 2 shifts at the manufacturing sites just to make sure we are able now to start the ramp-up of the manufacturing and be able to support the demand, both on the clinical and the commercial side. And all of this -- and we started to discuss as well very actively with our core target customers in Germany to achieve a smooth commercial launch in Q2 of this year. So in a nutshell, the CE mark as is will allow Carmat to access a larger pool of patients. So advanced heart failure. So as you probably know, and I took some data that are pretty similar across the board. So basically, the number of donors for transplants between the U.S. and Europe has been, unfortunately, for patients, pretty flattish over the last 3 years. So we are accounting around 5,500 or 6,000 transplants a year, while the need for patients for treatment in need of transplant is around 130,000, 140,000 a year. So it means that the percentage of patients treated in need of transplants is around 3%. And you all know that when you're diagnosed advanced heart failure, the mortality rate within a year is ranging between 55% and 77%. So it's an unmet need, which is underserved. So when it comes to Carmat and the CE marking, so what is -- what does it mean in terms of total addressable market in EU? So first and foremost, I think if we speak about low-hanging fruit, we should take a look at the active waiting list in the 2 largest regions in Europe, which are Germany and France. So as you can see, there is a large waiting list, which is not served. If we should stop the clock right now, if we should account the number of people between France and Germany needing a transplant and not served, there would be around 1,600 patients needing a solution, okay? And unfortunately, there is no strong alternative for patients not getting a heart transplant because in front of these thousands of patients in waiting list that can't get any heart transplant, you don't have a lot of solutions which are used today by hospitals and doctors in Europe. If you take a look at the data in 2019, which are pretty similar between France and Germany, only 14 BVAD has been performed in Germany and 15 SynCardia. So it means out of thousands of patients outside the heart transplant, only 29 patients have been treated with BVAD and SynCardia. So it means clearly that there is no satisfactory alternative today to a human heart transplant available on the market. So the bridge-to-transplant indication gives access in EU to a minimum of 2,000 patients a year. So the next question is, okay, why Carmat should be able to take that empty space that the others did not manage to do. So it's because we have an unparalleled safety profile. I think thanks to our technology, we are the only device that does not generate any of the following: we never experienced any stroke out of 19 patients; we never experienced any GI bleeding; and we never experienced any infection at cable sites. And we never had any Hemolysis. So it is a heart which has been designed to mimic, as much as we could, the physiological support, which is provided by a native heart. So we strongly believe at Carmat that our technology is a game changer for patients suffering from end-stage biventricular heart failure. Clinical development. So obviously, when you start the development of therapy, you start with a feasibility phase, and then you move to pivo. But pivo is really the first step to get some approval for commercial. But obviously, if you want to drive adoption, support your value proposition and get reimbursement, you need to generate more data. So that's the reason why we've been working on a very full and complete clinical program. So how does it show in Europe? So in Europe, the European studies are as follows. So first, the pivotal study. So the pivotal study was about safety and performance data. We preset the target of 20. I set a target because there was no statistical plan to be transparent because there were no comparator to Carmat. So that's the reason why we had to set some time a target. And we've been lucky enough because of very early promising data to get the CE marking with less patient than 20. But as a company, we are committed to generate a strong body of evidence, and that's the reason why we will close the study at 20. As of now, we are at 15 patients to date. And we are very happy to report that we've been able to treat 2 patients in 2 different centers in France in December. So it's where we are with the pivotal study, and thanks to the pivotal study, we were able to show that we had barely any complication, and our survival rate was pretty high despite the lack of learning curve. Second will be EFICAS, so that's the French study. And the French study will be with assemble size of 52 patients starting in Q2 of this year, and the results will support product adoption, value proposition and get finally the French reimbursement. This study will be a bit different from the pivotal study. So we'll measure the 6-month survival, free of stroke. And on top of this, as a secondary objective, we will collect health economics to make sure we can build the model to show that our product is cost effective. And obviously, following the commercialization of Carmat in Europe, we will have a post-market clinical follow-up PMCS. That will be a prospective registry of 95 patients within the bridge-to-transplant indication, which is obviously enrollment starting in Q2 as we start commercial. What is interesting with this study, it will obviously make larger or body of evidence. But on top of this, because we are convinced that some patients won't be lucky enough to get a heart transplant for whatever reason, and we will collect the long-term data, so all the patients beyond the year to try to put together a registry, trying to support the indication extension for destination therapy on sicker patients. So that's for Europe. So our goal in Europe is really to have 3 studies. When it comes to the U.S., so the U.S., we were happy to report in February of last year a full approval to start the U.S. early feasibility study of 10 patients. We've got the CMS reimbursement for listed 10 patients in May of last year. And the study will be organized as follows. So basically, it's a 10-patient study. It's a 2-step study, like it was the case in Europe. For the pivo study, it was a 10 plus 10. So in this case, that will be a 3 plus 10. So basically, FDA is requiring to see the follow-up at 60 days of the first 3 patients before allowing Carmat to complete the study with the last 7 patients. So the enrollment is expected to begin in Q1 2021. So while we got the full approval in February of last year, as we are intending to use the latest features we filed in March of last year, 9 amendments, we changed a lot of things on the wearable system mostly, and we wanted to use all these features. So we filed 9 amendments, and we had a discussion on one of the 9. And we did the additional test in December, and we will file it in January. So we are confident that we can start the study in Q1 in the U.S. And as I told you, we already have 3 centers fully initiated, able to start patient recruitment as soon as we get the FDA approval. So these results will be used to support the design of the pivo study in order to get FDA approval. So now finally, after many years of work, we finally got the CE marking. So I will discuss now with you the business strategy and the commercial launch, which is pretty basic and straightforward for people who are experienced in the medtech business. But first, I wanted to tell you what is our intention in terms of positioning and branding. So first, Carmat, it's creating a new product category. So we want to move away from TAH, total actual heart. I think we are much more than what is offered today. We are not a firm with a fixed flow that requires a lot of anticoagulation. We've been adopting by design a hydraulic system to avoid the blood to be in contact with metal or plastic and this to avoid an important level of anticoagulation. We've been as well working on the smart pump with an electronic board issued from the materials of Matra Defense. And this allowing us to adapt the blood flow real time, like your native heart is able to do if you accelerate or if you do some activities. So we want to move away from TAH when it comes to us, and we want to create a new product category that we will call PHRT, which means physiological heart replacement therapy. And this -- because we are adding to a standard TAH, autoregulation and higher hemocompatibility to allow an enhanced quality of life. And the product, because Carmat is a company, and when I joined the company a bit more than 4 years ago, we had a very healthy discussion with my team. And we weren't conscious at the time we were sitting on a lot of technology and very important one and a unique ones. And that's the reason why at the time we decided that Carmat, which was born as a company, should stay as a company, and we should name the product created by Carmat. And the name for the product that we will commercialize in the coming months will be Aeson. So Aeson is a character of the Greek mythology who was killed and came back to life younger. So that's about the story behind the branding. So that we call Aeson. So in terms of strategy, so that will be straightforward. We are conscious about our limited resources, even if important. As I said earlier this morning, I did the same when I was working at Abbott or J&J. So we will focus on the 2 most important geographies for mechanical circulatory support. So we work mostly in Germany and France, and we'll have an opportunistic approach when it comes to other countries if we see some interest of other centers. But for 2021, we concentrate resources in Germany and France. So we'll focus on Germany commercially, and Germany represents today 40% of the volumes in mechanical circulatory support. And we will address France through the study. We spoke about a few slides ago for the 52 patients in the EFICAS study. And France today represents 15% of the MCS market. So Germany, together with France, represent more than 50% of the volumes of MCS devices in Europe. So that's what we want to do. Now we have requests of centers outside these 2 geographies, but obviously, we will serve as needed. So we started to work on the commercial launch before we got the CE mark granted. And we've been working very close with the 23 centers doing transplants in Germany. 20 of the 23 expressed strong interest in starting our program. So what will happen in the coming 2 quarters, it is, at first, we will train the most motivated centers, and we already have 2 centers coming to Paris in our animal lab to train in February. And then we will support them in their discussion for reimbursement with their insurances. So as of today, because the team is as well working on building inventory to serve both clinical and commercial needs, so we intend to generate first commercial sales in Q2 of this year. So Carmat is clearly the new opportunity in cardiology. At first, because there is a large market opportunity, we are speaking about over 100,000 patients needing a heart transplant a year between U.S. and Europe. We have a unique product proposition. So we are the first bioprosthetic physiological replacement heart, and the early data were very promising. We had, again, no GI bleeding, no infection, no hemolysis, no stroke with a very high level of survival of 73% on the first human patient of our pivotal study. We have a clear market access strategy. We got granted later last year CE marking for BTT. The early feasibility study is meant to start very soon. And we have a very strong key opinion leader support. So for the people who are following us for many years as investors and the ones we intend to join us very soon, we have very interesting short-term value-creation milestones: first, the start of the U.S. early feasibility study in Q1 of this year; and then of this year, the start of the French study and the first sales in Europe. So that was about the presentation I wanted to share with you today. Again, thanks a lot for your time. And now we open the floor to questions. So what -- the way it will work, I will take your questions, and I will try to answer the best I can.

So first question, "What are the 3 centers in the U.S. for the pivot study?" So first, it's feasibility, but that's okay, study. So the 3 centers are there Dallas, Louisville and BC Richmond, right. Good. "You received CE approval. Congratulations. Your confidence and trust in your product is great. Can you do business in India?" As of today, no, because, first, we are not organized to do so. It's not part of our strategic plan for this year. And I guess we'll need more regulatory approval beyond CE mark. "Hello. Could you discuss the commercial organization currently and how that might look through 2021 in Germany?" So thanks for the question. So we already have 3 people on the field in Germany, which will be supported by other people in Europe for the first month. And as we get the CE marking now and we want to attract talents. So I was really waiting for the CE marking to start to chase and recruit the talent in Germany. So we will start to look for the head of Germany in the coming weeks. Okay. "Could you give us an idea about pricing in Europe?" So the pricing in Europe. So basically, we built our value proposition around the service we are providing to centers, and the service we are providing is around the association of 2 LVAD plus service. So that will be beyond the price of 2 LVAD. So in Europe, that will be a price superior to EUR 150,000. Another question. "How does the Aeson device compared to the HeartMate products in the U.S.A." So I think it does not compare, really, obviously, if you don't use 2 HeartMate together because if you use 1 HeartMate, you obviously are using it to support the left ventricle. Aeson will support 2 ventricles. So we are already working on sicker patients with low ejection fraction on both left and right ventricles. So we support both ventricles. Now some doctors, and it's true in the U.S. as well, are using what we call HeartMate 6. So we put together 2 HeartMates, but there are a lot of complication. And it's not designed for it, but in absence of a good biventricular support, they are trying to associate 2 pumps together. So basically, HeartMate was designed to support left ventricle. We designed the 2 ventricle -- we support the 2 ventricles. Okay. "When could a indication be possible?" Very good questions. I think we'll need at least 20 patients beyond a year to get this. And we hope that we are able to collect more than 95 patient in our postmarketing surveyance by the end of 2022. So potentially, if at least 20% of these patients are not able to get transplanted, we could be able to support or file a dossier in 2023. "I realize a huge market opportunity, 2,000 patients. What is your production capacity? And any insights on the COGS?" So 2 very good questions. So as I alluded to earlier, our biggest challenge now, as all the medtech companies, is to ramp up manufacturing. And we are working actively to move first to 10 units a month very quick. And if needed, we'll increase capacity in a linear way. Now the sites that we built in 2018 dedicated to Carmat is able to manufacture max 400 units a year. So as the demand grows as we hope, we'll need to make a decision by the end of 2021 about the future development of our manufacturing site. "Any insight on the COGS?" Well, the COGS today doesn't mean a lot. We did not -- we probably built 60, 70 clinical units so far in all the history of Carmat, and the COG is pretty high. But our goal within 5 to 6 years is really to get to domestic standards in cardiology and to get to a growth margin -- gross margin, sorry, around 70%. "When do you expect to open the other European countries, for example, U.K., Ireland?" As I said, we will focus on Germany, but we will be open to work with centers which are committed to really embrace our program. So it includes, obviously, U.K. and Ireland. And to that note, I was very pleased yesterday to get an e-mail from NICE asking us because we are reviewing the guidance on the use of total artificial heart, and they asked us if we were interested in being listed in U.K. So that's probably something we do. "Any centers expressed interest in the U.K.?" Yes, many, by the way, one in particular, which is really coming back to us very often, but as of now, we don't want to disclose the names because there is really no active discussions. But yes, many centers expressed a strong interest and especially one which is well known for heart failure publications. "Is there a new version, new product from Carmat currently in development?" Yes. Obviously, we work like a normal company. So we have a product road map with cycles of 3 years. So the product which will be used in commercial in the U.S. is really, I would say, a product with a lot of new features. We have a new battery mechanism. We have very nice cables. It's a very comfortable system. And obviously, over the last 5 years, the process is to build the heart. Improved a lot, and we feel very comfortable with the level of reliability we reached now. "How does creating a new product category impact your marketing efforts? Do you believe you will have to educate the market about the differences?" Very good question. We don't think so. Pulsatility, auto regulation have been required by doctors for decades. The only issue is that nobody was able to make it real. And thanks to the vision of Alain Carpenter and the engineers of Carmat, we've been able to build a heart, which is auto regulated and pulsatile and hemocompatible. But yes, we don't have to educate the market. Everybody was looking for it. "I think you started some implants in Saudi Arabia." No, we never started in Middle East. But we know and we are conscious from my past experience as well, where I started the [indiscernible] kit, there is a huge need because of the population profile, diabetes, all that things, in Middle East, and we are pretty interested in starting in Middle East. "Can you elaborate about patient selection? Does Carmat require a greater thoracic space?" Great question. And we learned so much over the last 4 years. And I think you know we acquire scans, and we do 3D simulation to try to place our device on the scan and to see if it fit patients. So what I can tell you with the learning we had, the only limitation we see now is the distance between the thoracic cage and the backbone. And we need a minimum of 12 centimeter, right? So I don't know exactly what it means in inches, but I think it will be around 3 inches. So that's really about this. So you're right, I think SynCardia is 10 centimeters. So we need a bit more than this, and we are not sure. So it means we should have about the same anatomic criteria as SynCardia G10, as you call it. "Congratulation. When do you expect FDA approval?" So our internal goal is 2024. We work hard to get there, but it's 4 years from now. So -- but we need to start from the beginning. So we'll try to execute against the EFS, start as soon as we can the pivo and then the file for DMA. We might as well or we may file for a breakthrough designation, but we'll see. "Are you going to commercialize Aeson alone in all geographies?" Yes, we do. It's not a street fight business. We will work direct. I think the name of the game is about building referral flow. It's a heart failure disease. It's a heart failure device. So apart from regions where it's difficult to go direct for many reasons, regulatory reasons mostly, so Middle East or some Eastern Europe countries we'll go through distributors, but we'll go direct in large countries in Europe. "Are you going to plan a collaboration with any centers in Italy?" So we've been contacting, well, the talent centers many years ago. But from a regulatory standpoint, it was very hard to include Italian centers in the pivo study. But yes, indeed, we did work very close to Padova, to Niguarda in Milan. We have contacts with San Raffaele. We went obviously to center for [indiscernible] in Bologna. We went to Federico II in Naples. So Yes, I mean, obviously, Italy is my second home country. So I know very well people there. So yes, we have been discussing with many centers. And we are hopeful that when I was discussing with some doctors over Christmas in Italy, and I'm hopeful we are able to work very soon. When I was working on Cipher in 2002, I've been working with Lombardia region to allow fast access to innovation, funding selected new products at 80% level. So I'm hopeful we are able to use the same system when we come to Italy for Lombardia at least. "When do you forecast profitability of the business?" Well, I mean, today, we won't give any outlook. What I can tell you, we have a long-range plan of 10 years. And obviously, we'll get to breakeven much before the end of the long-range plan. "What is the main reason why you could not enroll more than 5 patients since you resumed pivo 2 years ago, while there is such a huge market, as you highlighted?" Yes, that's a very good question. Well, we are -- and that's the difference with many other products. We have a lot of intelligence in our products. We are generating, you will believe it or not, billions of data points per week. So we know pretty everything about what happened in the device. And so we work on predictive maintenance. And if you followed very closely Carmat, we experienced very early as it is the norm, I would say, for whatever device, we had a lot of products issue. I mean in the feasibility, we had membrane leakage. We had electronic board problems, all that stuff. So what we decided after Cohort 1 because we wanted to improve processes to make the product more reliable, basically, we did a retrospective analysis of all explanted patients and all the product on bench test. So to get CE mark, we had to put 8 product on bench test, but we all studied. And back to the bench, we heard a lot about new processes, and it took more than 1 year to change some processes, which we believe were very important to avoid what happened usually when you ramp up manufacturing and you get commercial. I mean I don't know a device which didn't have any recall after CE mark. I can't swear it won't happen with Carmat, but I believe now we are in a very strong spot when it comes to manufacturing quality levels. So that's the reason why it took long is because we stopped as we did communicate around 1 year, right? Okay. So that was the company interested in working with us. "What is the prognosis of long-term survival with your product until the patient can find an actual donor heart?" Well, that's really -- that's a good question. I really don't have an answer to it. I mean -- and that really depends on the countries. When it comes to BTT experience, we transplanted people after 3 months and some people after 9 months. So I don't really have today the answer. "Will your EFS patient be BTT? And what's the expected wait time for them to get transplant?" So yes, so they will be BTT that's right. And in the U.S., on average, if you get the device such as total artificial heart, you will be very high in a ranking for BTT. So you should get a transplant within 3 months. Yes. "Are you aware of any publication around Aeson in scientific journals, so not called under Aeson, but Carmat?" So yes, we had 2 publications this year, one on the Journal of Journal of offline transplant about our BTT experience and one about autoregulation. And one will be released, I think, in the coming months about steel BTT and autoregulation. Yes. So about the size of Carmat, already answered. We strongly believe that Carmat will fit 95% of Caucasian patients. "Good afternoon. Any threats from 3D printing regarding manufacturing the heart?" Very good questions. I don't see a threat but an opportunity for both sides. I think what is interesting with the 3D printing, so Israel -- the Israel program was very good to publicize their program, but they were not the first. Maybe they were the first to print a heart with coronaries. But in Italy, they printed much before a larger heart but with no coronaries. So now the first challenge is to be able to print a large heart because, well, if you remember the Israeli heart was like this. There is a different building a heart like this. But I see really like has a strong opportunity for both of us because they have a nice envelope, but they don't have a mechanism of action, right? We have a mechanism of action, and our envelope is a rigid one, is a body made of polymer. So we might, in the future, see an opportunity together. "A major problem with that are the driver infection. What measures did you take to get rid of the infections?" Yes. So that's a very good point. So it's only today, obviously, hypothesis on our side, but we strongly believe, because we are pulsatile, that's the reason why we don't get infections. Because what I can tell you is we are working in the same centers as for LVADs. And so we have the same protocols. The only difference, we never get any infection, and we have more than 9 years of support under Carmat on the cable side. So we believe it's because of pulsatility. "You mentioned CMS reimbursement during the U.S. feasibility. Will this fall under DRG 1 designation?" It's too much from -- unfortunately, I'm not with my expert, but we will answer that if you send us your e-mail on our site. "Is there any capital equipment components required for implantation, patient support?" No, I think the beauty of our system and like -- well, SynCardia, for example, you move directly as you are in the operating room on your portable system. So there is no time for transfer from the big base to portable system. So basically, the patient gets out of the operating room to the ICU with the portable system. And the only equipment that we give to the center is an iPad, which allows the center to connect the patient on -- and get the data in continuous way if they want to, to monitor the patient during the first days. "You touched upon the number of patients on waiting list. So could you also talk a bit about the capacity of the current hospitals that perform this transplant? How many surgeons are currently in your initial markets, Germany and France?" So first of all, and that's a very good question, but I will answer it differently to start with. I will start with my answer, and then I will answer your questions, if you allow. So basically, the waiting list is the very starting point. As you know, you don't want to create false hope. And that's the reason why the waiting list is pretty small. It's 2 to 3x the capacity for centers to get donors because if they don't want to create false hope when you are on the waiting list. Now when you speak about potential, so in Germany, you have 23 centers and, I would say, around 60 or 70 surgeons able to do it. And in France, it will be similar, a bit less. "So after being used for a patient, the device is refurbished." No, it's not because, obviously, you have tissues growing on the pericardium in our products. So we would not clean it and use it on a new patient. "Life expectancy of Aeson itself." So a very good question. So we come from the aerospace industry. So we've been testing the product the way you do in aerospace industry. So you can't fly for bench test. Your plane 10x the nominal speed. So you overstress all the spare parts. It's what we did. So stressing the spare parts such as pumps, we've been demonstrating that it can last for decades. But altogether, that's different. And that was clearly the question of the FDA. And basically, what I can tell you today, we've been beyond 5 years on bench test, but the bench test is not real life. And in real life, we went to 25 months where we had to stop the product because the patient was getting other comorbidities, and the family didn't want the patient to keep on going. So we had to stop the product. So bench test more than 5 years, and on patients, we reached already 25 months. "Unlike patients directly transplanted, your patients are much less sicker. Does it mean we should avoid patient very sick such [indiscernible]?" No, I don' believe. It's not a problem of sick or not sick patients. We treated mostly INTERMACS 3 to 2, it's because we strongly believe, as everybody should, that the earlier the better. And it's not true only for TAH. It's true for valves. It's true for a lot of heart failure patients. When you are regurg, you need to fix it as quick as you can. You can't wait the nonreturn point. So that's the reason why we're insisting with doctors to select and pick up the patient early in the disease development. But we could -- and it's in the protocol in the U.S., we will allow patient under ECMO, obviously, I think with less than 1 week under ECMO, if I'm not wrong. "Has the device been CE marked under INDD or MDR?" So under INDD. And "How long has a patient survived using Carmat heart?" So I told you 25 months, and we were required to stop the device for other products. Last question, if no other question comes. "So if the heart works as well as planned, what would be the biggest hurdle to its commercial development?" Well, I think I told you already, I think my expectation, and that's only in my view, based on the early discussions we had with centers, I believe our biggest hurdle will be to be able to supply the demand. So that's the reason why, as a company, we are focusing now all our efforts on the manufacturing side. So I don't see new questions coming my way. So I wanted to thank you all for your time today. If you have any question we are allowed to answer, well, feel free to rally, I would say, go to our site and write to us, and I will be more than happy to answer your questions. And that's pretty everything. So thanks lot for following us. I hope you will come as well new supporters. And I wish you again a happy new year 2021. Thank you very much.