Good day. Welcome to the Implantica Fourth Quarter 2022 Earnings Conference call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the Star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask questions, you may press Star then one on a touch-tone phone. To withdraw your question, please press star then two. Please note, this event is being recorded. I would now like to turn the conference over to Peter Forsell, CEO. Please go ahead. Good afternoon, everybody. This is the quarter report four from Implantica. As you know, Implantica is all about bringing advanced technology into the body. I will do a little bit introduction. For eventual new listeners, my name is Peter Forsell. I'm the founder and CEO of Implantica, and I've also invested more than SEK 1 billion in Implantica. We also had a successful previous business with the gastric band. That is the foundation for the funds that we have been using here for Implantica. Implantica has two, you can say, platform technologies. To be able to really do smart, attractive implants and replace bodily function inside the body, you need, first of all, to have more energies. You need to have wireless energy supply. You can't cut people open every month to change a battery. You need an eHealth platform. What we have developed is a system where you basically could collect data from the implant. The doctor could sit remotely, look how the treatment is going, and also change the treatment on distance. eHealth will revolutionize healthcare. It has been so much developed outside the body that not yet has reached inside the body. Whatever Implantica is doing, you will see a revolution of healthcare the coming decades. The advantage is now, as I said, you can treat people on distance, and you can treat people with more unmet needs, and society will also save costs. A real milestone in this development is to actually be able to just treat on distance. It actually is not really available today. The doctor should be able to be in the hospital, the patient in his home or work or whatever, and you should be able to change treatment. That's the key to success here, and that's what we have been able to develop in Implantica. We have then gone through the whole body and said, "How could we now improve healthcare with all this nice technology we have developed?" We have then so many patent cases, nearly 2,000 patent cases, 300 inventions or more. We have sit in three years going through everything and selected not more than 40, what we believe viable implant products. That's sort of the background, that's the pipeline you get in Implantica. That's also why we have this very high vision that we should become the world leader in smart medical implants. We believe that we can not only treat millions of people here, patients, but we can also save lots of costs for society. It's actually more than us who believe that Implantica has really advanced technology. We have got an award here from Healthcare & Pharmaceutical Awards 2022, when they say we are the most innovative medtech company in Central Europe. On top of all this, we have RefluxStop, who is really a very promising product. Basically, in our hands here, we have a $ multi-billion opportunity, and I will explain why. First of all, acid reflux, which means that acid is then coming up from your stomach into your lower esophagus and it's burning and causing pain and many ulcers and so on. This also cause cancers. I think you have heard this before, that it's 48,000 people actually die from this type of cancer. It's called esophageal adenocarcinoma. What is new here is that we actually have really carefully looked into the literature how you really get cancer from acid reflux. You find out when you look at the number of sufferers, it's already statistically proven how many get precancerous changes. It's around 15% of the daily sufferers get precancerous changes, and around 0.6% of those get the full-blown cancer every year. The longer you have your disease, the higher the risk. You get to the same number of patients when you calculate backwards. This is not proof, but it's a strong indication that most of these cancers is caused by acid reflux. This is a totally unacceptable situation. You recall every other cancer you do anything to find. You have mammography for breast cancer, for example, you do anything to find these cancers. Here we have 48,000 people who just die every year. That's not acceptable. It has to change. The problem we have is that the drugs, who's the main treatment for this kind of disease, it doesn't help for this cancer risk. There is no proof in the literature that these drugs actually reduce any cancer risk, and it's maybe even the opposite. That is a really big problem here. When you then look at the treatment, if you now go to slide 13, you see that the market is enormous. It's 1 billion people who has acid reflux. 1 billion people take PPI drugs at least once per year. Number of surgeries is less than 1%. Less than 1% of these people actually are treated and have any chance of reducing their cancer risk. That's really serious, that's why RefluxStop has an enormous potential to become a really new standard of care in this treatment field. Before I go into a little bit the other updates, I just wanted to explain how it really works here. In the past, everybody believes that the closing muscle you see on slide 14, that close between the stomach and esophagus, that's weak, it's not strong enough, therefore there have been different surgeries to try to support and close. Dr. Nissen developed his first method already in 1956, where he wrapped around the top part of the stomach to compress the lower esophagus. Johnson & Johnson has a more modern system called LINX, a magnetic band that also compress. The problem now is that this is people's food passageway, and this gives, of course, swallowing problems if someone is trying to close your food passageway. You can't belch, you can't vomit, you get so-called gas bloating because you swallow gas with your food and saliva, and nothing come up any longer. Next slide 15, you see a bit the principle instead of RefluxStop, where you actually don't affect the food passageway at all because we realize the cause of acid reflux. The others treat the symptoms, but we actually treat the cause. The reason why you get acid reflux is the following. You have a chest where you breathe, the lungs come and go, fills with air, and then you get pressure variations in the chest. These pressure variations, they are coming out through the opening where the esophagus is passing through the diaphragm, and they are leaking out here, and they affect this closing muscle, this lower esophageal sphincter. It has not power enough to close anymore because it comes too close to the diaphragm or even up in the chest when they call hernia. If we just can restore this large distance between this closing muscle and the diaphragm and place our device to keep it in that position. We place our device on the outside of the stomach, on the top part of the stomach to reinforce it, so it interacts with the diaphragm, so you always will have this large healthy distance. Since then, people get treated for their acid reflux, and that without the side effects with the previous technologies. What is really exciting news for us is that the American Foregut Society, so Foregut Society is an association mainly of doctors, medical doctors, surgeons who treat acid reflux. That's the main group of the Foregut Society. They have now come out with new guidelines. They have published a white paper in September 2022, where they basically describe how you get acid reflux and obviously then how you should treat it. When you look at this, you realize this is an exact description of the RefluxStop methodology here. We have a clear acceptance that our theory, our principle, that's the one who really counts here. That's, of course, a fantastic, you know, fantastic thing that the big organization here is really believing in what we are doing. I will give you a little bit more updates from the quarter here and maybe a little bit even before the quarter. Let's start human resources because we have previously talked quite a lot of human resources and how we try to really find the absolutely best talent in Implantica. We need people who really work in the same direction and really super competent people. We have actually employed 31 new members of the team here during the last year. That's quite a lot. You will see coming forward here that we have some really fantastic people in this, in this group here. Together, we are really targeting to build the success story we everybody expect from Implantica. I will give you a little bit update on RefluxStop. Here, for example, you have Inselspital, that's the largest university hospital in Switzerland. Professor Borbély, he was presenting at the EFS, as a Foregut Society in Europe, the big conference, the results and outcomes from the operation with RefluxStop. He has been operating RefluxStop since 2018. His conclusion from his presentation here was that they have proven now that in a real normal hospital setting, you can achieve the same fantastic results that we had in our CE study. You can see a little bit his results here. This is a questionnaire you use to find out if people are acid reflux, it's called GERD-HRQL, Health Related Quality of Life questions. You can see that people get fantastic, much better, and treated by the RefluxStop operation. Here you can see some of the symptoms, the heartburn, regurgitation, dysphagia, pain, everything gets much, much better or mostly disappear, in nearly all patients disappear. If we go to slide 26, you see that we have another center in Vienna, Professor Schoppmann, who has been presented his results. This was for Gastro Congress in Helsinki. The good thing here is that Professor Schoppmann, he is the president of the European Foregut Society. The association of anti-reflux medical doctors and surgeons, he is the president of that association. He presented his excellent results on the first 25 patients. You even have a really nice picture he has taken from inside the stomach, how you see how RefluxStop is sitting here like a little round ball. We have all in all, the last quarter, six top-class presentations from surgical experts holding presentation for us. One of them is Professor Zehetner. I will show you also his results. He also has excellent results. You can see here, these columns here, the first one is this questionnaire I talked about. It's the total score, how much people then get much better. You see the symptom heartburn nearly disappears, regurgitation, dysphagia, all things you get fully treated, basically. If you really ask if people are satisfied, you can see here on the ring on page 29 here, besides the woman here with the stomach, you see that all patients, no patient were dissatisfied. One were neutral. It's a scale of three: satisfied, dissatisfied, neutral. The rest are satisfied. This is absolutely incredible results in relation to what you see in standard care. We have been in not less than 18 congresses during the last four months. 18 congresses. It's, we are really increase our activity to spread RefluxStop over the world. I will give you a little bit more meat on the bone on the market access process. I think I have showed you this slide before. It's all about building superior health economics. We need to prove that our product is more cost efficient than the others. We need to create clinical evidence to show our results, that we have fantastic results, and we need to expand our market. We need to get into new market, like United States, for example. If we look at the health economic side, as you may be aware of, we have the University of York, who is the most prominent university in the world for health economic analysis. They have helped us to make an analysis and compare RefluxStop with all the other treatment, both drugs, fundoplication, LINX. They came to that RefluxStop is superior to all other therapies in quality of life outcome in cost effectiveness. That's of course, fantastic when we should try to get this product further on the market. What we are doing now is that we actually are repeating this. We are doing this for all the other countries now. We're doing it for Sweden, Norway, Italy, Spain. All this cost effectiveness and budget impact analysis will be repeated in country after country to convince each society that they actually should pay for the device, because that's what really matters, is that society or insurance company, they say, "Yes, RefluxStop, that's a fantastic treatment. We of course need to pay for that." That's when the business really takes off. If we talk about clinical evidence generation, you know, we are trying to both do register studies, randomized trials, and we have several surgeons now starting to write more and more articles. It will be a large number of articles that we published during 2023. We are really building the evidence together with our surgeons to create a platform that is unquestionable for the clinical evidence of this treatment. I can mention something special here about the register study, because that's now ongoing, and we have quite many sites, and it's especially interesting because we have two sites in Sweden, Ersta and Sundsvall, who has now committed to join this trial. We have several sites in Austria, Germany, Switzerland. We have ethical approval for a couple of hospitals and so on. It will be more and more patients collected to show how fantastic RefluxStop really treats acid reflux. The last part is, of course, market expansion. We are, of course, focusing on FDA and it's clear that U.S. market is a very important market. Currently we are just in the process now of filing a large supplement to our pre-submission. It's some issues, it's very delicate to do this absolutely right, so we get an approval right away when we actually file. We are then asking FDA a few more questions about a few more outstanding things. We have also been discussing in France, they support randomized trials. We have been discussing and should go to HAS, the Association for Healthcare in France. They actually then support trials like this funding-wise, so to say. We had a meeting with one expert surgeon related to HAS, who has looked at our protocol, and we have got feedback and so on. This is an ongoing process. We are also putting together the file for Canada. We are quite far with that to try to get approval in Canada. We are also discussing the best pathway in Japan. We got the government of Japan to approve that, it's a company called JETRO, who is a government-owned company who supports special technologies, extra special things that need support, and we have been selected for such support in Japan to get regulatory approval. Here you can see a little bit the markets we are expanding in Europe, of course. We, of course, not only are trying to reach new markets, of course we are expanding the business in the existing ones. You see here some of the countries you see also on the map. We are expanding the markets step by step. We have made our first two surgeries in Spain. We have got a hospital in U.K. who is called Spire Manchester, who is actually part of a group of not less than 39 hospitals and eight clinics across the U.K. It's a private group. We of course hope that that will lead us to more of the hospitals in that group going forward. Also in Italy now, we are starting up here with the new centers. It's overall looking quite good for the expansion of the business. What you need to keep in mind is that before someone pays for the product, the most important is to find the absolutely key surgeons, the important surgeons, the quality centers, get them to start and collect more and more high quality centers. It's not useful to sell to creative and creative. That's not the target for the moment because it's all about selecting the evidence that creates the governmental bodies or insurance companies to say, "Yes, we pay for your device." The business will be enormously much higher when you finally get someone to pay for the product. All we are doing now is collecting evidence, so we actually The hospitals will be financed for doing our procedure. You see the little rocket here. This is of the reimbursement. It still plays in the rocket for your information. If we go to slide four to six, there's a little bit about the pipeline update. I will just give you a few things. I think I mentioned before that we are working on something we call RefluxStop II, which actually is a RefluxStop treatment for acid reflux that also will treat obesity. We are basically creating a little sources of our RefluxStop devices here, and we are suiting over it. You basically take out most of the stomach volume. You have a little stomach volume left only. Thereby, you can treat both obesity and acid reflux in the same product. You can see a little bit on these drawings. It's maybe not the most fabulous drawings, but you see the principle, and you see that it will stabilize severe reflux and obesity. We also have for people that's been operated on already with obesity surgery. There is one method called gastric sleeve. It's many tens of millions of people has been operated with gastric sleeve for obesity. The problem is that they create a long prolongation, you can say, of esophagus. The stomach and the intestine, everything is like a long tube. That of course make it much easier to glide up. Because you now know that if something glide up, you get acid reflux. 30% of these patients get this surgically induced acid reflux. We have a solution for that. We just place an arm for our RefluxStop device, and that we call RefluxStop III. We of course are working also on our key products. You know, we have an treatment for obesity called AppetiteControl. Actually, we are quite proud to say that we have solved the food sensor issue, which has been the most tricky part of this product because this is all about creating satiety by sort of expanding your stomach wall the same way that the normal body makes when you eat and you are full, you start to stretch the stomach wall because you expand it. This we have solved, but we also then need to know how much people are eating and when they are eating. That we have done with this food sensor that has been tested on 20 students, and it works really well. This is of course a milestone achievement for this product. We are working on UriRestore. As you know, it's many people who can't urinate. They maybe have a spinal cord injury or multiple sclerosis, they put a catheter into their own bladder every time they should urinate. That's a quite burdensome life. We have the solution here, so we can empty the bladder. We actually have on cadaver lab been showing now that we can fully empty the bladder, and we only have, like, 10 milliliter residual urine left, which is a really good achievement. This product has also taken fundamental steps in its development. Yeah. I would like to give the word over to our CFO, Andreas Öhrnberg, to talk a bit about the capital market. Thank you very much, Peter. Good afternoon or good morning. I'll walk through a brief financial update, and let us turn to slide 53. Figures on this slide are expressed in EUR thousands. I'll comment on the upper graphs showing our financial performance for Q4 2022. Let us start with sales. We reported net sales of EUR 242,000 for the quarter, an increase of 126% compared to Q4 2021. As a reminder, we are currently solely marketing our lead product, RefluxStop, and still selectively engaging with key opinion leaders and their clinics as part of our market access strategy as outlined by Peter. Moving to gross margin. The gross margin levels we see the business delivering are highly attractive. The high gross margin can be explained by the RefluxStop product characteristics. We produce a very simple product while we sell superior patient outcomes. Adjusted gross margin for the quarter amounted to 96%, 5 percentage points higher than Q4 2021. The combination of an exceptional gross margin, no limitations to scaling RefluxStop production underpins the opportunity to generate long-term future profitable growth and free cash flows. Coming to EBIT. Our quarterly operating loss expanded to EUR 5.1 million, up from EUR 4 million Q4 2021. The year-on-year OpEx increase reflects the continued investment into commercial capabilities with a focus on market access. We are committed to invest in the commercial platform that will allow us to address the reflux treatment gap at scale. Let us turn to slide 54. We are fortunate to have a very solid financial position. End of December, we held EUR 109 million cash. We do not carry any interest-bearing debt on our balance sheet. Finally, let's turn to slide 55. In addition to our founder and main shareholder, Dr. Peter Forsell, our investor base is dominated by Swedish and Swiss high-quality institutions. We are grateful for the trust and the support we receive from our investors to scale the business to address the huge unmet patient need. Back to you, Peter. Thank you. I then just wanted to say with this nice picture here that RefluxStop is unstoppable. We are fighting against bureaucracy and administration processes, but our results shows that this is a product that you really need, and it will take over this market. It just will take some time. Questions. We will now begin the question-and-answer session. To ask a question, you may press star then one on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. If at any time your question has been addressed and you would like to withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. The first question today comes from Christian Lee with Pareto Securities. Please go ahead. Thank you. Good afternoon. The commercialization of RefluxStop has so far been focusing on sales in key markets, that building a network of top KOLs. Do you plan to continue this strategy in 2023, or are you considering going out more broadly based on the positive validated clinical data that has been gathered so far and the published health economic analysis? We are trying to stay with the strategy we have for the moment. We are not selling everywhere. We are, for example, not selling in the Middle East, although we can get a good business there right now. We are focusing on quality, the absolutely important key centers that will build a fundament for a future expansion when we get the reimbursement. To collect all the data we need to convince insurance companies and, you know, governmental bodies or healthcare bodies that they actually, here we have a treatment they have to pay for. When we achieve that, then we can go out broader. Got it. My second question is regarding the PMA application. If you could, please provide us an update, both in terms of, the additional supplement you are preparing and also the timeline when you expect to submit the final application. Thank you. Yeah. You know, an application to FDA, a PMA application, you can say that's more like a full wall of documents. It's a really heavy process. It's big work, and we are very far in that work. It's also a complicated process with many aspects to think about. To really not make any mistakes, we are asking FDA some last questions. We have four different question areas. We are asking them some final questions. This is a process that will take approximately three months to get an answer. Before that, we can't file to do the final application. Of course, depending on the results of these questions, this need to then to be integrated into the big PMA application, or maybe we need to do some updates or maybe some new tests we have not thought about, we don't know. In the near future, so to say, we, of course, hope to file this. If you say like this, our, we should be very disappointed if we don't file this application during this year. Exactly what months, we can't predict because we need the answer from FDA first to know. Okay, thank you. My final question is perhaps for Andreas. OpEx in Q4 increased by 33% year-over-year. Should we expect this current level of OpEx on a quarterly basis in 2023, or could you perhaps guide us on the level you're looking for giving all the commercial and re-regulatory activities you're planning? Hello, Christian, thank you for the question. How we allocate resources in a disciplined way is very important for us. The OpEx that we run currently, as you can imagine, is primarily not to support current activities and current sales. It's all about investing in a platform to scale sales in the future. I mean, since IPO, we have been seeing an OpEx, kind of, growing OpEx quarter-on-quarter fairly rapidly. At the same time, over the last 12 months, we have seen that rate coming down, except of Q4, where we saw that rate going up. I would not read in too much into that given that we had some one-off expenses that we took, kind of non-cash expenses in Q4. We will continue to see OpEx going up based on selective hires. All the fundamental capabilities and departments have been built, so we will not see an expansion in a similar rate, just to focus on getting those additional talent on board. I hope that give you some background. I will not give any specific guidance in terms of numbers, but, hopefully, that helps you to think about, you know, how the dynamics will play out over the year. Okay. Thank you very much, Andreas. That's all from me. Thank you. As a reminder, if you have a question, please press star then one to be joined into the question queue. There is no more questions, I would like to turn the conference back over to Peter Forsell for any closing remarks. I would just say thank you very much to everybody for listening, and I hope to see you soon. We are targeting to maybe make a capital market day for Implantica, where we may all carefully go through all our strategy and what we are doing during half a day, maybe. We will come back with that, so you can get a bit even more meat on the bone than you can get on a short meeting like this. Thank you very much for listening. The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.