Welcome to Implantica Quality Report 2022. Throughout the call, all participants will be in listen-only mode, and afterwards there will be a question and answer session. If you wish to ask a question, please press zero one on your telephone keypad. Today I'm pleased to present CEO Peter Forsell, CFO Andreas Öhrnberg, and VP Operations. Please begin your meeting. Yes, hello everybody. My name is Peter Forsell, and I will talk about Implantica, which is focused on bringing advanced technology into the body. Myself, for those who is new listeners, I have had a previous successful implant business with a gastric band, and it was sold for lots of money to Johnson & Johnson, and that money has then been reinvested in Implantica. I've invested more than SEK 1 billion in Implantica. Implantica is focusing very much on eHealth. eHealth will revolutionize health care. It will be possible to treat diseases in a better way and even this new way of treating. You will save cost because treatment could be made on distance. The patient doesn't need to stay as much at hospital or go as many visits. The patient will also be more involved and be more engaged in the treatment. Implantica has developed, as probably most of you know, a very advanced eHealth platform. We have been adapting that platform to our different products, and this development is going extremely well. We foresee this to be a milestone for the eHealth development when you can have a platform to change treatment at a distance. We have made a large patent work. Just as a repetition again, we have more than 2,000 patent cases, more than 300 inventions, and we have spent three years to select 40 of them after market analysis, production analysis, and so on. That's why we have a very high vision in this company. We should become the world leader in smart medical implants. We will provide implant solutions to millions of patients with substantial needs and to save cost for society. That's really a vision that is quite bold. If we should then look a little bit into what has happened during this quarter. We have completed our clinical trial of our food sensor for AppetiteControl. You are maybe aware of that we have a product called AppetiteControl that control appetite in the same way as the body's normal control. That's when you feel full, you start to stretch the stomach wall, and then it goes to signal to the brain who says, "Now you are full." We control appetite the same way. We then to be able to do that, we need to know how much are people eating, what are they eating, are they swallow solid food, liquid, and so on. We have then developed a food sensor that keeps control of people's eating. That's what has now been tested with 20 human volunteers who has been testing this sensor. That's of course a really key feature in this appetite control device. Our main product is of course RefluxStop to treat acid reflux because it's already on the market. Just a little bit repetition how this product works here, that this acid reflux is sort of caused by fluid coming up from the stomach into esophagus, and it's burning and causing pain, and it's very unpleasant and also quite risky to have this disease. Most of these existing treatment, they are focusing on the food passageway that you should support the closing of this muscle, the LES muscle here. However, this then affects the food channel here, which means people get difficult to swallow. They could get nothing up. They can't belch. They can't vomit. It's quite lot of side effects with these treatments. In our RefluxStop then find out that there's nothing wrong with this muscle. It's just the position of this closing muscle that is the problem. We place something parallel to the food passageway that in combination with the diaphragm here, we divide the chest from abdomen, a large muscle that keeps a large distance here all the time dynamically and therefore we treat the cause of acid reflux. People get fully normal without affecting the food passageway at all. Our technology has been recognized by quite many by now, and Frost & Sullivan have given us their 2022 European Technology Innovation Leadership Award for our product, RefluxStop. That tells you that it's not only we who believe in this product and this new technology, which is quite interesting, huh. We also have conducted the first meeting with our key opinion leaders. You know, we are selecting and trying to get on board really important surgeons in this treatment field. The really key ones who influence all the others. We had a meeting lately with 11 key opinion leader surgeons, and we discussed everything from the results and also how should we now standardize their technique. It would be a consensus paper written. It's actually already written and will be published, where you see the result of these discussions. It was also full-day meeting. Here you see some of these key surgeons. You know, Dr. Borbély from the University Hospital in Bern. Inselspital is actually the largest hospital in Switzerland. We have Jörg Zehetner from Hirslanden. It's a group of 10 hospitals in Switzerland. Professor Thorsten Lehmann from Germany, very large reflux center, one of the largest in Germany, actually, and also Professor Sebastian Schoppmann, who is one of the top leaders in this treatment field from Austria. Just examples here. The fantastic with this product is that the treatment field is absolutely enormous. It's 1 billion people suffer from acid reflux. 1 billion. It's just absolutely enormous amount of people. If you look, the current number of surgeries down here is like, I think we said maybe 250,000, but 550,000. It's nothing. It's absolutely nothing. The problem is that the existing surgery is simply not good enough. The medical doctors doesn't send patients. The general practitioner doesn't send patients for surgery because the outcome is not satisfactory. That is now what we change here. To release the commercial potential, which is huge for this product, it's a step-by-step approach. You know, you need to take different steps to achieve that someone actually is paying your product. It's nice to be able to sell a product, but if no one is paying, it doesn't really help you. You need to have the insurance companies and the healthcare systems, governmental bodies to say, "Wow, this product we of course need to pay for." That's what we are doing right now. Let me guide you a little bit through the three key pillars in this establishment of RefluxStop, as we believe it, the new standard of care in this treatment area. RefluxStop has actually all the attributes to become the new standard of care. First of all, of course, we need to look at the cost-benefit analysis. Today, you know, the healthcare systems, they are more and more cost observant, and they really want to see that the benefits is higher than the costs. We have then, together, or actually it's not together, it's actually University of York. They have done a health economic analysis for us. This is a very, very solid comparison between RefluxStop, and it also has been comparing, you know, the competition. We have the magnetic sphincter augmentation device, for example, who is our main device competitor and also fundoplication is sort of the standard of care treatment today. We have medical treatment and PPI. All these three have been compared with RefluxStop from a cost benefit economic and healthcare cost perspective. The good news is that RefluxStop is superior to all the other therapies in quality of life outcomes. This is excellent news for RefluxStop because that report, which is now being published, we have been accepted to present this at one of the larger conferences here for payers. This will influence all over the world, you know, to show that this is really value for money, this device. The second pillar here, that is to generate more evidence that this is a successful treatment. It's more and more result-oriented, the approval to pay for a device, that it actually works nicely and preferable, of course, is better than the competition, but at least as good. In our case, we are then collecting and trying to support. We are making new studies. We have a national register study, which is started. We have six centers lined up so far in three countries, but that will follow quite a lot of centers in the near term. A huge study with many patients. We have a randomized control study, where you have a control group with Nissen. All this will build more evidence that we are actually much better than the competition. We have many surgeons today who has experience both long and short term, and they are all writing different articles about RefluxStop. That's sort of the second pillar to build this reimbursement case. You can see, for example, here is a comparison to our main device competitor on their FDA trial with our CE mark trial. You can see in green here, RefluxStop, it's outstanding. I mean, the comparison here is it's really huge differences. We, as I said, we have all the attributes to become the new standard of care and release a multi-billion dollar opportunity here. That's what we are working on in this step-by-step approach. What maybe is important to know also is that this disease cause cancer, and actually nearly 50,000 people die from this type of cancer caused by acid reflux. Maybe not all of the cases is caused by acid reflux, but the majority for sure is caused by this disease. That means that in all other cancer types, it's lots of efforts so to save life and do all the treatment to control this cancer. Here we have a disease that is totally terrible and have no good treatment so far. We really believe that in the long run, this could be an absolutely exceptional opportunity. The third pillar in this process of gaining full market access for RefluxStop is of course to expand the territories where we can sell. In this case, of course, United States is a very important market. We are currently preparing the so-called PMA application, that's a pre-market approval application for United States. We had several meetings with FDA, and they have approved to accept such an application based on our European trial. We don't need to do any more trial if everything goes as planned. That's of course very exciting. From the application is filed, you can expect, I think the average time is 8-10 or maybe up to 12 months handling time by FDA, but it's not a huge timeline we talk about here. This is of course a very interesting market for Implantica. In Europe, we have expanded and especially in Italy, we are working very hard, and we have many new centers lined up. Of course, U.K., Spain, Germany, of course, also Norway. We have a new center now in Norway. As you know, the COVID situation caused some delay, and after the COVID, people had a lot of waiting lists, and it was a bit, you know, slow. It's starting now to really take off. I would say when we come to the fourth quarter this year, we hope that it should start to take off, this commercialization process. If we then go to capital market and finances, I will leave the floor to our CFO here, Andreas Öhrnberg. Many thanks, Peter. Similar to earlier periods, we share two slides summarizing the financial performance. Let us turn to slide 24. Figures on this slide are presented in EUR thousands. I will comment on the upper graphs exhibiting our Q2 performance. We reported net sales of EUR 207,000 for Q2 2022, an increase of 80% compared to Q2 2021. As a reminder, we are currently solely marketing our lead product, RefluxStop, and still only selectively engaging with key opinion leaders and their clinics as part of our market access strategy. Moving to gross margin. The gross margin levels that our lead product RefluxStop has delivered quarter after quarter are highly attractive. Adjusted gross margin for the quarter amounted to 97%, 3 percentage points higher than Q2 2021. The exceptional gross margins experienced and no limitations to scaling RefluxStop production underpin the opportunity to generate long-term future profitable growth and free cash flows. EBIT. Our quarterly operating loss expanded to EUR 4.3 million, up from EUR 3 million Q2 2021. 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 successfully scaling the business. Investing in R&D, both pipeline products and the eHealth platform, as reflected in our OpEx and CapEx spend, remain a key priority as it underpins the company's long-term value creation strategy. Let us turn to slide 25. We are fortunate to have a very solid financial position. End of March, we held EUR 121.5 million of cash and short-term investments. Short-term investments relates to term deposits with a tier one Swiss bank, hence what we book as short-term investment is not exposed to financial market risk. We don't carry any interest-bearing debt on our books. Let us turn to slide 26. In addition to our founder and main shareholder, Dr. Peter Forsell, our investor base is dominated by Swedish and Swiss high-quality institutions. We would like to thank our strong shareholder base and for their continued trust and support. With that, I will hand it back to you, Peter. Thank you. I would say that we go to questions and answers. Thank you. If you wish to ask a question, please press zero one on your telephone keypad. If you wish to withdraw your question, you may do so by pressing zero two at the console. Our first question comes from Christian Lee, Pareto Securities. Please go ahead. Your line is now open. Yes. Thank you for taking my questions. My first question is related to the health economic analysis from University of York. When do you expect to present the data from the analysis? And would it be possible to comment on the level of cost savings that the analysis have found when using RefluxStop compared to the other treatments? We have got two abstracts accepted for conference that is held. November sixth November sixth is the conference. Then it will be presented and thereafter published. Then after that, we can release the information. Now, this is sort of pure research done, you know, but this is a professional center for economic analysis. York is famous all over the world for these activities, so to say. It's a bit difficult to release in advance, but what you can say is that we have shown compared to all other treatments that we provide for increased cost benefit. We also have, you know, the quality of life is superior. You compare the outcome of the device and make a health economic analysis. It's absolutely incredible news for our treatment. Okay. Excellent. Based on the analysis, do you consider any changes to your pricing strategy of RefluxStop, perhaps set at a higher price point? I mean, we actually have increased the price a little bit for RefluxStop. The list price currently is EUR 5,900. To some extent, a little bit this was the original price we set, but then we had a little bit period when we lowered the price a bit. We will try to keep the price level. As you know, we have a strategy where our priority now is strictly to get the payers to pay, to get the healthcare system, insurance company, to get everybody to pay for RefluxStop. That's our priority. We are not maximazing sales in any other way than to get the key opinion leaders to support the approval and the reimbursement. That's our main focus. We are building the ground for a long-term, very successful device. This has gone through many iterations and discussions. As you know, we have improved our team with the top-class individuals who's capable of doing the right thing. We have looked at how all the successful companies have done it, and we are learning from others that this is the way we should do it to maximize the likelihood that we can release this really, really large potential that we have in this product. The list price for the European countries is EUR 5,900. Would it be fair to assume that you can get a higher price in the U.S.? Absolutely. The U.S. in general has much, much higher price levels, for sure. Gotcha. Yes. Yeah. I would, my final third question is regarding AppetiteControl. When do you expect to present the evaluation of the clinical trial? Yeah, this will hopefully be quite soon. They are, you know, this is computerized data with all the input. When you have this food sensor, this food sensor is recognizing, you know, how much you are eating and what you are eating and if it's solid food or liquid and so on. This analysis is then, you know, influenced by movements by the patient or the patient talking or, you know, other parameters who need to be filtered away. With this is made special, you know, filtering systems to analyze the data, so therefore it's a little bit of computer work. I don't expect this to be more than a few weeks, you know, and then we will have the results. Already know, preliminary we know that we have no problem, you know, to differentiate if the patients are doing other activities or if they are swallowing liquid or if they're swallowing solid food, for example. So this we have already find. So it looks very, very promising and this will then of course be a key feature for the appetite control device. So when you combine these two, then you have a real system that could have the eHealth platform. You know, suddenly the doctor could sit by his hospital and the patient are at home or somewhere else, and he can look at his patients every second month, for example, and he can adjust how much a patient could eat. Doctor can completely control the weight and say, "Yeah, I think for lunch you have to eat a little bit less." It's all adjusted on distance, you know, fully automatic system. The combination of this food sensor, the eHealth platform and the product, that will bring something totally new to the market. That's great. Thank you very much. Thank you. Thank you. A reminder, if you wish to ask a question, please press zero one on your telephone keypad. There are no further questions at this time. I hand over to the speakers for any closing remarks. Yeah, we would like to say thank you very much to all the investors for the patience and support for our company and our products and we will try to give something back if they just have some patience with us. I wish to thank everybody. Thank you. Bye-bye.
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