Ladies and gentlemen, welcome to the Implantica Audiocast with teleconference, Q1 2022. For the first part of this call, all participants will be in listen only mode, then afterwards there will be a question and answer session. Today, I am pleased to present CEO Peter Forsell, CFO Andreas Öhrnberg, and VP IR and Operations Nicole Pehrsson. Dear speakers, the floor is yours. Yes, good afternoon. My name is Peter Forsell, and I will present for you Implantica, who is all about bringing advanced technology into the body. For those who doesn't know me yet, I'm surgeon and the founder of this company, and I have once developed a very successful business in the gastric banding implant area. Implantica has a very high mission and vision. We believe we should become the world leader in smart medical implants. We believe we have medical implant solutions that will provide to millions of patients with substantial medical needs, and at the same time save costs for society. I will try to give you a little bit business update over this quarter here. The sales for RefluxStop increased 2.4x during Q1 2022 compared to the same quarter last year. That although, as you know, we have had a COVID situation, and we have just been able to restart, basically, our business case in a reasonable way. Acid reflux is actually a huge treatment field. It's maybe the largest medical treatment field in the world today. It affects 1 billion people. It's 1 billion people who at least once per year take one cure of PPI drugs for their disease. It's 17% of the European population has weekly acid reflux. We have an area with a substantial medical need here. If you look at the number of surgeries ongoing today here, you see the small little red dot here. That's the existing number of obesity surgeries. Anti-reflux surgeries, sorry. It's, of course, a huge potential here in all these large number of sufferers, and I will try to explain that later on. We have now restarted, you know, the business again, you can say, after quite a long COVID timeout. Congresses have started again, and it's really fun that finally, you know, we are traveling again and then meet the surgeons more regularly and so on. We see both two sales starting to kick off. The other registry study will start to kick off. It looks a little bit promising going forward. We also, you know, have started surgeries in quite some new hospitals, both in Switzerland, Germany, and U.K. For example, in U.K., we have a very important KOL, Mr. Nick Boyle, who is the founder of RefluxUK and also the Vice President of the European Foregut Society. We are collecting the really important KOLs. We have expanded our territory a bit. You see the blue countries here where we actually now are focusing and have sales organizations. We have started also in Italy, in Spain, Portugal, and so on. We have been able to collect some of the really key KOLs. Really top-class surgeons that is highly respected in this area, which will make other surgeons to follow when they see that these key ones are performing the procedure. Here you can see some of the citations here from these surgeons that people are really believing in this product. For example, in Professor Lehmann here in Friedrichshafen in Germany, they have been operating like, you know, more than 40 procedures, although they started in July last year and although we have had this COVID situation. It looks promising from the KOL's point of view and also from the patient point of view. You know, we have been starting to collect material for social media campaigns. We make interviews with patients who has got the Reflux Stop device. What is apparent for the group who has been supporting us here to take these patients in front of the camera and make these interviews is the absolutely astonishing result we have with this device. People are completely super happy. They could have been sick for 10 years, 15 years, 20 years and have had a horrible life, and suddenly it's all gone, you know. We have quite many of these patients. This is not just one, two, three, four patients. It's a fantastic result, and it brings you some kind of pleasure, you know, to see that this really works, basically. The Reflux, so to say, has two things that makes it much better than the competition. That's we so treats the cause of acid reflux. We do not compress the food passageway as you do in a standard standard of care procedure. They try to get rid of the reflux by compressing the food passageway. Maybe logical, but that cause lots of problems. You get swallowing problems, you cannot binge, you cannot vomit, you get accumulation of gases down in your gut, and you get swollen, distended. Patients in general are quite unhappy with existing surgery. On top of that, RefluxStop also treats acid reflux much better. If you compare, for example, with our main device competitor in their FDA trial, they treated 58% of the patients. If you measure the only really good objective measurement you can make to see if you have acid reflux, you simply measure what the pH is in lower esophagus over a 24-hour period. You simply see if you're leaking up acid and that reduces your pH. In the RefluxStop CE-marked study, 98% of the patients had normal pH. We are treating acid reflux much, much better than existing treatments. Why is that so important now? Yes, this is important because 48,000 people die from cancer in this region only in Europe and the United States. Because the acid is simply terrorizing the tissue over and over again until you get cancer. That's really, really bad for these patients. Here you can see, this is a slide I've showed before. I just wanted to see, you know, the difference in results here. The problem with the drug therapy, you know, is not only that it doesn't protect from cancer because it doesn't help you. You still have your reflux. You reduce the acidity in your fluid, but the reflux is still irritating enough to get the cancer. These drugs also have lots of complications. That's why, you know, we believe that RefluxStop has all the attributes to become the standard of care in this area. We now basically can say that we have enough feedback from all these KOLs that shows us that we, with a very high likelihood, could be the standard of care for this treatment. Also, we look at our four-year results from our study, and it also remains excellent results. We also know that FDA, they allowed us to take a small European study of 50 patients to go for a PMA application for approval to sell in U.S. Normally, in U.S., they never accept anything else than 100 patients. They never accept that the study is not done in U.S. For our product, RefluxStop, they made an exception there. That is why we strongly believe that this product has the attributes to become the new standard of care. This, if this will happen, this supports that we have a tremendous multibillion-dollar opportunity within our reach because we talk now about 1 billion sufferers. We hope and believe, you know, we strongly believe in the management actually, that with our first disruptive commercial product now, RefluxStop, we have this multibillion-dollar opportunity in our hands. However, this said, to launch a medical implant takes time. It's not done in a coffee break. The society has set up lots of bureaucratic hurdles. They keep their money in their wallet. They are not willing to pay out unnecessary any funds for new technology. You need to go and prove step by step by starting with the KOLs to have the important surgeons to explain that this really is needed, this is something unique. You need to collect your clinical data, more studies, create the awareness among the patient, medical community, and you will then end up with a reimbursement. That's to say that society finally pays for the product. When you look at other successful medical implants, you can find that all of them who has been successful, they have managed to achieve this reimbursement, that the society really pay for the device. You can create a really, really large business, and that's of course what we are targeting here. As I said, FDA has been willing to accept then a PMA, so we are preparing for that. That's part of the hard work we have been doing during this quarter is really to prepare for the PMA application to file for approval in U.S. We have expanding our presence in United States in our subsidiary, Implantica Inc. It takes time, everything, but it goes forward with high speed. We have also been targeting, you know, to strengthen our organization. If we should be able to build a really large company, very successful company, we need really qualified people. We need really talented people who has, you know, the ability to support this growth and this expansion. That's what we are trying to achieve here. We have been looking everywhere all over the world to find the absolutely best people you can find, and we have been concentrating on the leaders of the team, the really, really key people. We have been able to find fantastic people that really share, you know, our vision here, that we should just achieve this goal of being one of the leading companies in medical implants going forward. This is a very exciting journey, and people have been excited to join this journey to help, you know, patients, to treat patients with severe diseases and using cutting-edge new technology. It's very exciting, you know, to be the CEO of a company with so many talented people that share our vision and values. The second leg in our development work we are doing is of course the eHealth area. I can guarantee you that eHealth will revolutionize healthcare. eHealth will come independent of Implantica. More and more advanced technology that already exists outside the body will be brought into the body. You will be able to treat diseases with unmet need, treat diseases better, treat diseases that was not even possible before. You will save costs because treatment could be controlled from distance, and it would be more effective treatment, and treatment will also be brought closer to the patient. The patient will be feeling more involved in the whole treatment. Here is a little bit our eHealth platform, and I just show you to remind you that it's a quite complex system involving, you know, the caregiver, the patient, and so on. It's extremely advanced and needs lots of work that has been put into this. It's many, many, many years of work behind this platform. We had lately a three-day workshop where we have put together, you know, 20 really expert in this area to go through all the usability areas of our eHealth platform to check, you know, how could we proceed in the different scenarios from early stage until the end of the treatment. This has been very effective way of trying to improve and adapt our eHealth platform to our pipeline products. We have also done lots and lots of patent work relating to this eHealth platform, and actually we have filed patent application with more than 25,000 pages about this eHealth area. This sounds quite a lot, but this is sort of necessary to protect our invention and to build long-term really high value. Our value, you know, is based on these platform technologies and our unique product pipeline, but it also needs the third leg on this is the patent protection. We don't want the big, huge American companies to copy everything we do. We want to stand there alone on our extraordinary technology. I think it's time then to give the word to our CFO, Andreas Öhrnberg. Thank you very much, Peter. I'll provide you with a brief financial performance snapshot. Let us turn to slide 25. The figures on this slide are presented in euro thousands. We reported net sales of EUR 198 thousand for Q1 2022, an increase of 141% compared to Q1 2021. As indicated by Peter, over January and February, the team faced headwinds in our active markets due to the Omicron variant. As a reminder, we are currently solely marketing our initial product, RefluxStop, and still only selectively partnering with key opinion leaders and their clinics. Moving to gross margin. The gross margin level that our lead product, RefluxStop, can deliver is highly attractive. This we experience at subscale volumes already. Adjusted gross margin for the quarter amounted to 95%, 4 percentage points higher compared to Q1 2021. EBIT. Our quarterly operating loss expanded to EUR 4.4 million, up from EUR 2.3 million the same period last year. The year-on-year OpEx increase reflects the transformation we have gone through over the last 12 months. Where the company has been focusing on capability building in the areas of commercial development as well as quality and regulatory. We see these capabilities as key for our successfully scaling the business. We have continued to invest in R&D, both for our pipeline products and eHealth platform that Peter just went through, which we see reflected in both our OpEx and CapEx spend for the period. Let us turn to slide 26. We are in the fortunate position to have a very solid financial position. End of March, we held EUR 125.7 million cash and short-term investments. Short-term investments relate to term deposits, hence we are not exposed to any financial market risk, and we do not carry any interest-bearing debt on our books. Let us turn to slide 27, looking at our shareholders. In addition to our founder and main shareholder, Peter, our investor base is dominated by Swedish and Swiss high-quality institutions. Thanks to our strong shareholder base, strategic decision-making is underpinned by creating value for patients and investors in the medium to long term rather than focusing on the next quarter. We thank all our shareholders for their commitment and continued trust and support. With that, I will hand it back to you, Peter. Thank you. Don't know if we have any questions. Ladies and gentlemen, if you wish to ask a question, please press zero-one on your telephone keypad. Thank you for holding until we have our first question. Our first question comes from Christian Lee, Pareto Securities. Please go ahead. Thank you, and good afternoon. It is quite exciting to see that your commercialization strategy is moving forward, after a slow start due to the pandemic. I have a couple of questions for you. Could you please comment on the geographical sales split in the quarter? Were sales mostly related to the U.K. or the DACH region? Our main sales is created in Germany and Switzerland. Okay. Nothing from the U.K. in the quarter. There is sales in the U.K. from the quarter, but you asked who was the largest territories, you know. U.K. we are starting to build up now. Okay. We have started, you know, with the president of the European Foregut Society, you know, the most respected surgeon in U.K. He has started with RefluxStop, Mr. Nick Boyle, in something called RefluxUK. You can go into the homepage, RefluxUK, and see how they promote, you know, RefluxStop. That will then follow now, we hope, a series of new hospitals. It's lots of ongoing discussions. You know, it's an admin process for these hospitals to get started, and that could take, you know, three months or four months. It's quite many hospitals lined up, so it looks quite promising now and the pandemic finally seems to be over. Okay. Thank you. Could you please give us an update on the total number of patients that have been treated with RefluxStop so far? I think you mentioned that there have been 40 procedures in Germany by Dr. Lehmann, for instance, since July last year. Yeah. I mean, I honestly can't the exact number, of course, but we talking about, you know, soon reaching 200-300, 300 maybe surgeries, something like that. We have mainly been focusing, you know, on these key centers. When you have a new key center, they always start, and they do maybe five or 10, and then they wait to see. Then when they see that this really works well, you know, everybody wants to see with their own hands that it works as good as we say in our clinical trial results, and then they start doing procedures. I can take, for example, we have Friedrichshafen in Germany, for example. They started July last year, so it's a little bit more than half a year ago. They started a bit slowly, but although the pandemic and everything, they have made more than 40 surgeries, you know, up until now, so to say. It's all about that they have this admin process first, 3-4 months, that they should have the decision at the hospital administration. Then the surgeon should do and follow his patient for some time. You have for these hospitals, you can have up to a year delay before it sort of start to really take off for the hospital. We of course have started now after the pandemic, so we are a good bit into that. You know, we have continued in a good way since January, basically. It's a process. I think we will see during the autumn quite a lot of hospitals who takes off a bit here now. It looks a bit promising right now. It's just a hope that we have no more viruses coming flying, huh? Yeah, sure. Thank you. Could you please also give us an update regarding the status of the PMA applications to the FDA? When do you plan to submit the application? You know, this is such a PMA application that's a huge application, so to say. We talk about hundreds of documents and many tests and different things that need to be outlined. Actually, you know, we are a large team of the magnitude of 5-10 people who is working full-time on this project. The problem we have with FDA, you know, is that sometimes it's a bit hard to know what they actually want, and what do they actually want to see and how do they want us to do the test and so on. That's what we are figuring out, you know. We are currently filing a little supplement to our previous discussions with FDA to get some clarity of some issues, you know. I can give you some example. In Europe, for example, you have one approval for the product, you have another approval from the surgical instrument, and then we tell people when they mount together, if. Basically, you're planning to file before the year end, if that's right? Yeah. That, that's our hope. Yeah, absolutely. Yeah. Okay. Okay, great. Thank you very much. Yeah. You know, the U.S. is because we as you know, we have employed a fantastic market access team. We have now health economics expert. We have someone based in U.S. who is an expert on payer communication and to reach the payers in good order, you know, and before we get the reimbursement approval. We are really focusing now to do everything with maximum effort and do the really right thing in U.S. Because if we can get this approved in U.S. and if we can get it reimbursed, then suddenly you will see why this has such a potential, this device, you know, because it just you need to build. Everything here is built step by step. It's a long bureaucratic process that is outlined, you know, by the societies. We just have to live in that environment. That means although we have the product who is the best treatment, we have the product that normally should be done in millions of procedures, this is not happening because someone needs to pay for the product. That's the process we are doing. This long process doesn't change the final endpoint. It doesn't change the potential of this device. It's just a question of time. Okay. Thank you. Excellent. My final question is, we have seen many other medical companies having issues with the supply chain and sourcing of electronic and other components. Is this something you are concerned about as well? Yeah, I mean, I must be very honest and say that this COVID, you know, has not only affected that people doesn't do surgeries or it has, as you know, it's waiting list everywhere for surgeries because people didn't get operated for such a long time, and then they have lots of lined up surgeries and so on. That makes this a little bit slow start. It's not. You press the button and say, "Now COVID is over, and now you can start." No, it's a process, you know, to get back to normality again. One of these areas where it is actually quite hard is the electronic component. You know, we have been, you know, developing our products, our eHealth platform, adapted everything, but it's difficult to build the products because we have had delays in delivery of components. This is something now that starts to get better, you know. Today you maybe have, I don't know, you can have one year delivery time maybe on a modern chip. Before it has been, you know, hopeless to do anything with this stuff at all, you know. It's just the whole world has been, you know, put down for some time here in a big timeout. It's improving more and more, and we have then tried to go around that finding chips, you know, that is not so commonly used or find some chips that people have in stock. We have been able to quite well prepare us and get to a reasonable good situation. It's clear that we are delayed and that's. I think it's for every company like this. We have got a delay, but that doesn't change that the potential is very high here. I mean, you know, the eHealth platform we have will most likely, if it will be launched today, would bring us to the absolutely front line of the eHealth revolution. We will be in the absolutely top front of this to bring advanced technology into the body. Then that there is some year, couple of years delay because of this COVID, we just have to accept, you know. Luckily enough, we have a solid balance sheet, and we have enough funding to do this, and we don't need to care about any additional funding for a long time. You know, we can do our work, and we can continue. The investors who stay with us, they will probably get highly rewarded. That's our goal. Okay. Thank you very much. What about the input materials for RefluxStop? Do you have any issues with sourcing these materials? No. Here we have been smart. Yeah. Do you feel confident to, you know, continue your commercialization strategy for this product this year? Yeah. Here we were a bit smart, so we bought well ahead, you know, so there we should be in a good shape for RefluxStop. There we don't see any additional delay now. We just see going forward. Excellent. Thank you very much. I will jump into the queue. Thank you. Thank you. Thank you. Our next question comes from Johan Hussein, private investor. Please go ahead. Hi. I wonder about future implants that you have mentioned before that may be adjusted remotely by the doctor. Of course, you have to take into account that hackers might want to hack the system. Perhaps it might be just for fun or more severe to hurt or kill the patient. I'm sure you have taken this into account. I wonder, since this is new, have you had any discussions with the regulatory authorities so they have the same opinion as you on what is needed to be done? Can you elaborate a little about how you see this potential problem? You are absolutely right. That's sort of one of the absolutely key issues to develop a system like this. How do we ensure that no one really could hack the system? Because we need a safe system. You know, you maybe saw on the presentation it's a rather complex system. You know, the patient could have, for example, a remote control, and this could be to open and close his urethra. Let's say the patient are leaking urine as an example. You know, I want to urinate, I press my remote, or I press my remote to close. Of course, this remote doesn't need to have connection to internet, for example. It is. It's when you have a connection to internet, you start to get problem, and people is coming and hacking you. If you have an independent unit that is not controlled, is not connected to internet, then you have less problems. There is lots of ways. You know, we have been working on this for many years. I mean, it's a huge work, and we have involved all the experts regarding safety and the regulatory process and what is allowed and not allowed. When you should reach a higher level than has been achieved before. I mean, we are targeting a system that doesn't exist today. We will have a system that improves. We actually will be able to control the treatment on distance. It's even more important. That's why all this work has been done, all these efforts, all these experts and so on. Everybody is convinced that we have a system that actually will change this. This world of eHealth will be changed with our platform. The only problem we have is that we also need to launch our products. All this COVID and all this, you know, has put a little bit of a hiccup or a pause or, you know. It's not in our hands, this. We have not been able to, but we have been able to refine the eHealth system, the wireless system, and all this. You will see if you just are a bit patient. This is not done in a coffee break. You know, the whole treatment area here, you need to be patient. You will see something that actually will change the whole way you can treat people. Okay. Suppose there's a patient who is worried that their implant might be hacked. Can they turn off the possibility to use it remotely, turn it off, just to make sure that no one will do anything that harms them? Or can it be possible to set up limits so a doctor can only change the device within certain limits that won't hurt the patient? All your proposal is good proposal, has been taken into account. I can assure you that we have managed to take all these things into account. If you look, you know, how it works today with the BankID and you know how it's way to solve issues like this today also, you know. Your concern is absolutely well-founded, you know. I said thank you for raising the issue, but it has been in the forefront of our whole development, what you just raised. Okay. Thank you very much. Thank you. Thank you. Ladies and gentlemen, as a reminder, if you wish to ask a question, please press zero one on the telephone keypad. Ladies and gentlemen, as a final reminder, if you wish to ask a question, please press zero one on the telephone keypad. We have no further questions. Dear speakers, back to you. Yeah. We just would like to say thank you to everybody listening, and we really wish you a good afternoon. Thank you. Thank you. Bye-bye. Ladies and gentlemen, this concludes today's conference call. Thank you all for attending. You may now disconnect.