Good morning, and welcome to the Implantica first quarter 2023 earnings conference call. All participants will be in 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 a question, you may press star then one on your telephone keypad. 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. I will try to present a little update of Q1 for Implantica. As you know, Implantica is all about bringing advanced technology into the body. Myself, I'm a surgeon and have invested substantial amount of money in Implantica. Implantica has developed two platform technologies. To start to give you a little bit overview here. One eHealth platform that could treat, take action from inside the body and control treatment from inside the body, and a wireless energizing platform. You can give all the energy you need to make smart, active implants. eHealth will revolutionize healthcare. That is guaranteed. Treatment will be brought more closer to the patient. They can use their mobile phone, look how the treatment is going. We will save costs for society because you can have less hospital visits, less hospital stay. Implantica's eHealth platform is designed to treat on distance. On slide seven here, you see a schematic how we the doctor could be at the hospital and the patient could be at his or her home or wherever, and we can control treatment and we could change treatment. That will revolutionize healthcare. Implantica has also gone through the whole body, basically treatment field after treatment field, and looking at all with the eyes of these platform technologies, how could we improve healthcare? We have been able to do more than 300 inventions, and we have done three years of market analysis, product analysis, and prototyping, and selected not less than 40, what we believe viable implant pipeline candidates here. That's why Implantica, on slide nine, has a very bold vision that we should become the world leader in smart medical implants. I will try to give you a little bit business update. First, of course, we have our product, RefluxStop. It's treating acid reflux. We're on slide 10 at the moment. RefluxStop actually has a multi-billion dollar opportunity. That's of course, because the market for acid reflux, on slide 12 here, is huge. It's actually 1 billion people have acid reflux, which is enormous treatment fee, actually. What is really sad today is that 50,000 people die from esophageal adenocarcinoma. When you look in the literature, it's basically most of those is caused by acid reflux. Today in society, you do anything to save cancer lives. You have mammography. You do anything to find cancer and reduce the amount of cancer. Here, only in Europe and United States, we have 50,000 people who actually die every year. That's not acceptable, and this need to change. Actually, the potential for a product like RefluxStop is maybe 10 million procedures annually. Suddenly we have made a hard work to have the medical society and the public to understand the seriousness of this disease. On slide 14, you see the existing surgical treatments today where you try to compress the food passageway and thereby try to support the closing. The problem is, however, that this is people's food passageway, which means you get swallowing problems. You can get nothing up, belch and vomit and so on. People get gas bloating. These procedures have diminished and is very low frequency today because it's too much complications. RefluxStop instead treats the cause of acid reflux. We find out that it was nothing wrong. On slide 15, you can see here nothing wrong with the sphincter. It's just the position of the sphincter. It's in the chest. You have breathing variations. You breathe in and out, therefore pressure is coming and going. This is leaking out through the opening in the diaphragm where the esophagus is passing through, and this affects the muscle. With our principle, we more or less treat everybody who is correctly operated. American Foregut Society has written a white paper where they basically confirm the RefluxStop principle. We have come quite far in the medical community to get them to understand the principle, how this works. It's going quite well for Implantica for the moment. We have launched in Spain. We have in Getafe in Madrid, they have made starting with RefluxStop procedure, and we are preparing now for a public tender process. In Spain, you need to have an official public tender. Because we have really no competition, we believe that will be a quite good process. We have launched in Italy. Here is in Napoli hospital, Ospedale. This is a big reflux center, very enthusiastic to do RefluxStop. We have also launched a second center in Italy. Professor Bona and Bonavina, they are really, you know, well-known people in this society of reflux surgeons. Bonavina is actually the president of the European Foregut Society. The organization of RefluxStop surgeons in Europe, he is the president. He's a very important person that he now switched to do this procedure is of course very important. We also have the center in Friedrichshafen, Professor Thorsten Lehmann, who has actually made 100 RefluxStop procedures. He started 1.5 years ago. During this time period, he has been able to do 100 procedures. He will present his data. Actually, we have received for review data from quite a lot of different hospitals now. It will be many articles popping up more and more with fantastic results from several different centers. We also have started another important center in Germany, Klinikum Aschaffenburg, who have both decided to join the registry study and started to do RefluxStop. Professor Borbély from Inselspital, you know, Switzerland's largest university hospital. He presented his three-year results at SaGES conference in Canada just recently. His overall conclusion was that outcomes achieved during the CE data study can be replicated in a real-world hospital setting. In real life, our fantastic results we have of our CE mark has been able to be achieved also by this university hospital. Here you can see some of the results he presented. This is a questionnaire. You ask the patients how it's going, and you see the results are really nice. Here you see the different symptoms, how they disappear. The blue color here means they are gone or the light blue improved. You can see that the results are really excellent. Also another large reflux center is doing a RefluxStop now. It's AKH in Vienna, which is actually the largest hospital in Europe. It's a huge university. They presented in a Finnish Gastro Days Congress in Helsinki, the results. Here to the right, you can see a little picture how you see RefluxStop from inside. This is now on slide 26 here. From inside the stomach, you see how it's protruding into the stomach like a little round ball. That's the RefluxStop device here. Slide 27, we have since January been at 12 congresses in different parts of the world that you can see here. Some of these meetings, we had really impactful presentations. These three presentations you see here, that's really powerful presentations that has been taking place. We have also been able to get further on with our registry study on slide 29. The ethics committee have approved in Switzerland and Germany our study. The study is up and running with several centers performing cases, and the study is called ReStore, RefluxStop Registry Study. That will involve many centers and many, many patients, and that will build a platform for proving to the world how good the RefluxStop is. We have several sites lined up. We have two sites in Scandinavia who is willing to join the study. It's Ersta Hospital and Sundsvalls sjukhus, and they have also filed for ethics committee. We have a couple of sites in Germany who has committed, in Austria, in Switzerland, and also it's upcoming in Italy as well. We are also being successful in publishing our very important cost-effectiveness analysis that was made of University of York. Actually, probably the most reputed magazine for this type of information has been publishing our article. And that's of course, extremely important because this shows that RefluxStop is more cost-efficient than our competitors, both the drugs, PPI, medical treatment, and the standard of care, Nissen fundoplication or other fundoplication procedures and the LINX, the magnetic band basically to close. This is really fantastic news, we are then continuing this hard work to be doing tailor-made analysis of cost-effectiveness in every single country, basically. We are focusing now on cost-effectiveness analysis in Sweden, Norway, Switzerland, and budget impact analysis in Italy and Spain. This can't be underestimated how important this is, because today it's more and more about money. It's not always about having the best treatment. We have also successfully completed now our ISO 13485 and MDSAP recertifications, and we are waiting for the final MDR approval, which we preliminary has got as well. It's only the clinical side left. Regarding market access, as you know, we have a complete, very highly professional team working on all the three cornerstones to achieve reimbursement. That means someone needs to pay for the product. When we get approved to sell in Europe, it sounds really nice. The problem is that insurance companies or if it's from the government, governmental bodies need to pay for the device as well. You can have a small business based on private pay, but to really unlock the huge potential that RefluxStop has, we actually need them to create this reimbursement process. This is an admin process. It's not so much if you get reimbursement or not, it's more about when you will get reimbursement. Of course, the pandemic has made life a little bit more complicated. People hold on to their money a little bit more. NHS in U.K., for example, handling healthcare in U.K., they're more or less bankrupt and, you know, lots of restrictions on cost and so on. That has made this process a little bit longer than it normally should have been. We are very, very far and we are continuing with high speed with a really professional team to do this. It's all about the cost effectiveness analysis I talked about, which one team is doing, and it's about the clinical evidence. As you can see, it's more and more articles were coming up. It could be 10-20 articles already this year coming up with data from RefluxStop. Of course, we need to expand the market, both new markets and within the existing markets, of course, to get more data to present. Here you can see a bit how it looks in the different markets. We have started now in quite some countries, most of the important market actually in Europe we are focusing on. Then we are targeted to expand to France, United States, Canada, and Japan. Of course the FDA approval is key and the final FDA submission is targeted to be filed this year. U.S. is of course a very, very important market. It's also important because FDA, they look not only on our clinical trial data, they want to know every single complication that has happened all over the world in any case. That means we have been focusing our efforts on high quality centers. Centers that is sort of, yeah, excellence, centers of excellence with really key opinion leaders. In the States we are not drawing, we are not selling to anyone. We select our customers very, very carefully. We only get top class KOLs, key opinion leaders, and these is then bringing the product forward so we can get the massive number of publications and high quality data, outstanding data. The product could further expand to mid-size hospitals and then other part of the world that we are not selling for the moment, like Middle East, for example. This is a process. We have a very defined plan. It's a very good plan. It doesn't go in a coffee break, but the end result may be exceptional. Oh, you can see here a little bit how this process is going on slide 38, where you basically need to develop all these KOLs. You need to train them, you need to ensure patient satisfaction, and you need to reach out to the patients on social media. You need to reach out to the doctors who send the patients as well, so they understand that suddenly it exists, the product that actually works. Then you need to get your reimbursement. You need to get someone to pay for the product. Then the business will really take off. With 1 billion sufferers, you can imagine that when this stage is reached, it will be quite a substantial business. Please, welcome to you in the journey. Implantica also have some pipeline products. We are working continuously on our pipeline products. Due to the pandemic, we moved a few of the resources to RefluxStop, and we have a little bit reduced capacity for the other products, but they are still steadily going forward towards market launch. I just wanted to mention a couple really, really interesting products. We are now on slide 40. This is product that sort of is like humanitarian products. This is products that could be fast-tracked in the U.S. based on that there is no alternatives, and it's actually making people's life quite different. The first thing is people who has a stoma bag. They have actually probably taken away part of their intestine. It could be some kind of disease or colitis or cancer or something. Let's say they take the small intestine, the large intestine is gone, and they move the small intestine out through the abdominal wall, and they collect the fecal matter in a plastic bag. The business just for plastic bags and the self-adhesive little plate that you place this plastic bag on is $3 billion. We talk about enormous amount of money just for plastic bags. These people don't need that anymore because we have developed a specific, unique closing system for the intestine, and we make reservoir, and we make emptying of the reservoir on command. We can connect to anus again. People could be normal again. That, I can tell you, we get so many inquiries. It's more... Although for the moment, investors like to write to us because the, the share price has not been so optimal, but this is the top-of-the-line email we get is about this product. I mean, everyone who has such a stoma would like to have such a product. This is something we are really working on. We also have a similar humanitarian type of device for people who can't urinate. They maybe have a spinal cord injury. It could be some kind of accident or could have a multiple sclerosis disease. Their bladder doesn't function, and they put in a catheter in their own bladder 5 times per day. Every time they need to urinate, they put in a catheter that you can see on slide 41 here. This is a burdensome life. I mean, Stephan Siegenthaler and myself, we visit a hospital here in Switzerland. It's a hospital who is only for young people with spinal cord injury. It's enormous hospital. It's 100 million people worldwide we talk about here. We have then created a system so we can empty the bladder from inside the body. You can have a remote control and empty your bladder. Every single one of these patients would do anything on earth to get such a device. I'm sure we can get a very fast-track approval on this device in U.S. here. So we have a few really top interesting product. It's just we had a little pandemic in between who has delayed us a bit. Implantica has a potential, and it's hard to beat, I would say. I wanted to give the word over to our CFO, Andreas Öhrnberg, to talk a bit about the finances. Thank you very much, Peter. Good afternoon or good morning. We should now be on slide 43. Figures on this slide are expressed in EUR thousands. We reported net sales of EUR 307,000 for the quarter, an increase of 55% compared to Q1 2022. We are currently solely marketing our lead product, RefluxStop, and only selectively engaging with key opinion leaders to build a strong reimbursement platform. This to lay the foundation for broad commercial scale-up. 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 characteristics. We produce a very simple product while we sell best in class patient outcomes. Adjusted gross margin for the quarter amounted to 95%, which is flat year-on-year. The combination of an exceptional gross margin, no limitations to scaling RefluxStop production underpins opportunity to generate future long-term profitable growth and free cash flows. Our quarterly operating loss expanded to EUR 4.9 million, up from EUR 4.4 million Q1 2022. The year-over-year OpEx increase reflects the continued investment into building 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. Please turn to slide 44. We are fortunate to have a very solid financial position. End of March, we held EUR 102 million of cash, and we do not carry any interest bearing debt on our books. Let us turn to slide 45. In addition to our CEO, 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 support we're receiving to build a commercial organization to address a huge unmet patient need. Back to you, Peter. Thank you. Yeah, basically, this was the end of the slide presentation. I just wanted to show you that Implantica has been selected as one of the 50 Most Admired Companies to Watch for 2023 by CIO Bulletin. With that, I leave, give over for any questions. We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press star then two. At this time, we will pause momentarily to assemble our roster. Again, if you have a question, please press star then one. Our first question will come from Christian Lee with Pareto Securities. You may now go ahead. Thank you, and good afternoon. I have a couple of questions, please. Could you please give us an update regarding your discussions with the FDA? Are there any further supplements required? What are the data points they are looking for? Do you still believe you could file the PMA submission before the year-end? Yes, I believe we should file for year-end. What people need to understand that, an application to FDA, that's like a wall of papers if it would have been in the good old days. Now everything is digital, but it's still quite substantial work, and therefore you can't for 100% predict the exact day you will be able to do this. We would be very disappointed if we can't file this year. That's absolutely what we are working for. With FDA, we could have probably maybe filed earlier for FDA, but we also when you do this big application, you want to clear questions with FDA. If you have done your package of biocompatibility in a certain way, you ask them in advance in a pre-submission supplement and say, "Do you think our biocompatibility test is good here?" "We have done this bench testing here. Is this package of bench testing, do you think this is okay?" By doing that and getting this answer in advance, if it's something that is then not correct, you have the chance to redo some test or correct or do take some kind of action. Therefore, our consultant judged that you gain time. Even if FDA takes three months to answer, it's still valid to do that route, to clear all the different issues. That's what we have been doing. It looks very good. As you know that FDA accept our European trial is an absolutely unique decision. I mean, it's that they accept 50 patients operated in Europe when they want 100 patients operated in U.S., that's totally unique. For example, I can mention we were at an American Congress here in Chicago just recently now. One of the FDA people came up to the booth and talk to Juanita, our marketing responsible person. She says, "Oh, RefluxStop. Peter Forsell. Oh, I remember. Yeah, this was a fantastic product. We have been waiting for your application." FDA is really positive to our device. Okay, great. In the latest round of discussions with the FDA, did they request for any more clearance of any issues? We are waiting now for the last questions from FDA. It will take still some time before we know the final outcome, if we need to do anything more or not. Okay, excellent. On the theme of the U.S. market launch, have you started to work with the KOLs in the U.S., besides those you are already working with in Europe as part of your market access strategy? Absolutely. Because we have, you know, quite a few U.S. employees by now. We have Amit, who is the market access expert. We have Juanita, the payer advocacy expert. We have been running around, and it has been key European doctors holding speeches in U.S. at different conferences. We have been doing quite a good marketing job overall. For example, Professor Lipham, who is maybe the most respected surgeon in this treatment area in the world, also fantastic, experienced surgeon. He was the president of the American Foregut Society, the association who handles this type of surgeries in United States. He says to us, "I have every week people wanting RefluxStop to my center." This, you know, already we, you know, we have just started, so to say. There's been an explosion in knowledge about RefluxStop. Everything seems to understand that this is the new upcoming treatment, and both patients and surgeons realize this. The surgeons are eagerly waiting that we should be able to launch this in United States. Thank you. My third question. You, I know that you are planning to start a randomized controlled trial this summer, just to access France. How many patients do you hope to include in this trial? When do you think you can publish the data? This is of course a very good question. However, not fully so easy to answer. When you do, sorry, a randomized trial, it's all about showing statistical significance. When you compare with the standard of care treatment, we must be able to select so many patient that is needed to show that we statistically are the superior product. That's what we have been working on. Otherwise, we are ready to launch actually maybe even two randomized trials. That will happen in the near term. I would guess the first data collection point will be eight months, where you sort of compare the two products. The study maybe will go on, let's say, to two years as a randomized trial, to compare again. Of course, the study will go on for longer, maybe up to five years. The randomized trial will be the endpoint will be the six months and the two years and one year. Okay, thank you very much. I will jump back to the queue. Thank you. Thank you. Okay. If you have a question, please press star then one. Our next question will come from Filippo Puccioni with Kepler. You may now go ahead. Hello, good evening. Thank you for taking my question. I was wondering, you were mentioning during the call about the broad market buildup. I was wondering if you would share your expectation on when will your broad market buildup start, say? This of course is then not 100% in our hands. For the moment, we are in a phase where we only focus on the really key centers. We select the key centers in each country to build up very solid data and surgeons who is really competent in this field. We are trying to expand the market to Canada, Japan and United States. United States is here a key market, not only because it's a huge market, but it's also a bit easier to get a business even before you get your full reimbursement. In U.S., you can expect a faster take-up of the business. I would say if we file FDA this year, the average handling time is 10-12 months, and we don't know if FDA are intending to give us some kind of extra high speed or not. They seems to be quite favorable to get RefluxStop on the market. There you can say you have then one and a half year approximately down the line. When you get your FDA approval, then you can also start to spread in Europe to a little bit more centers. You of course, have the huge U.S. market, so it will be starting to take off. Thank you. Can you share with us the time by which you expect to be breakeven? I think it's more a question for our CFO. We have, you know, since the pandemic in general been very reluctant to give hardly any timelines or any forecast or anything because we were so, you know. It's hard to work when suddenly, you know, you have a world where you can't even buy electronic components, and the healthcare system is not working because there's no money anymore. You know, it's so many parameters that is not in our hand. What we could say is, of course, that now it looks much brighter than ever, so to say. It looks like the world is recovering and we are starting to expand, and it looks very promising. The key is to achieve this reimbursement. U.S. approval, one cornerstone, and then to get reimbursement. This is a process that you can expect take a couple of years. Different in different countries. You know, some countries could take longer. It could take 4 years in some countries. Other countries could go quicker. It's a step-by-step approach. For the moment, I would prefer to not fully answer your question more than in principle terms like this. Thank you very much. I really do understand. Maybe one last question, if I may? Could you give us an idea, ballpark of what would the selling price be of RefluxStop, the average selling price? For the moment, we are selling the product in Europe for EUR 5,900. As a principle, we don't sell with discount. We support some hospitals with a bit of research and so on, depending. We of course support people when they're doing our trials because it's lots of work for them. For the price of the product, we try to avoid discount because when you get your reimbursement, you don't want to sell with discount, and suddenly your reimbursed price also is heavily discounted. Okay. I don't know if you understand that. Thank you very much. Yeah. Thank you. By the way, in U.S. of course the price will be higher. You know, it will be substantially higher in U.S. because you have all these risks and insurances and all this, the price level in general is much higher in U.S. Our next question will be a follow-up from Christian Lee with Pareto Securities. You may now go ahead. Pardon me, Christian Lee, you're now open for follow-up. Yes. Thank you. A question for Andreas, perhaps. Considering your market activities, you haven't increased your operating expenses that much, compared to last year. It would be helpful if you could guide us on the cost level going forward. Is this the level we should expect, or do you plan to increase in the coming quarters? If so, by how much? Thank you for the question, Christian. I mean, as you say, right, I mean, since the IPO, we have seen cost expanding fairly rapidly quarter on quarter. We have invested in building up our commercial muscles. Looking forward, it will be more about how do we efficiently use those muscles. If you look at, you know, last, I mean, Q4, we had a bit more of OpEx, which also was due to one-offs, as we discussed on the last earnings call. I mean, I think it came down 4% to this quarter. Looking forward, looking forward to 2023, I mean, we will bring on additional talent. However, as the core capabilities have been built within the firm, hiring will be very selective. The general trend we foresee is OpEx continuing to increase but at a much slower pace than we have seen over the last 12 months. All right. Thank you very much. This concludes our question and answer session. I would like to turn the conference back over to Peter Forsell for any closing remarks. Yeah. Thank you very much. Thank you for listening. Thank you for supporting Implantica. Have a really good evening.