Ladies and gentlemen, welcome to the Implantica Audiocast Teleconference for Q4 2021. For the first part of this call, all participants will be in listening only mode, and afterwards there will be a question-and-answer session. Today, I am pleased to present CEO Peter Forsell, CFO Andreas Öhrnberg, and VP Operations and IR Nicole Pehrsson. Please begin. Thank you very much. My name is Peter Forsell, and Implantica, as you know, is all about bringing advanced technology into the body. Now the slides doesn't move. Okay. I will try to give you a little bit business update here for Q4 for Implantica. The most important news is of course that FDA has agreed to accept our European CE mark trial for PMA submission in United States. That's absolutely fantastic achievement because we have only done in Europe 50 patients, and in U.S. they never accept anything else than 100 patients. I think we are the second company in history who has succeeded with something similar. This means we don't need, if we get this approved, we don't need to do a U.S. clinical trial, and we could be much quicker on the U.S. market. It's not unrealistic that we can be on the U.S. market in 1.5 years from now if everything goes as planned, of course. This is really fantastic news, really landmark for Implantica. The question is, why is FDA making this exception and accept the European data in a small study like this? The answer is that they understand that RefluxStop is a product that really is needed. One of the reasons for that is that people get cancer from this disease. The acid from the stomach is coming up into lower esophagus, and it do that over and over and over again, and you get precancerous changes to 10%-20% of acid reflux sufferers, which is 17% of European population, they get precancerous changes. 48,000 people die only in Europe and United States from esophageal adenocarcinoma. This is really terrible when you then know that Karolinska Institutet has helped us to do a literature review, and there is no protection from cancer risk by taking the drugs, PPI drugs. It just, of course, is quite logical because the drugs doesn't really stop the regurgitation of fluid. It just reduce the acidity in the fluid, so you have less symptoms, but they don't minimize the cancer risk. Therefore, this product is absolutely needed, especially when you look at the existing surgical methods, where I have here a comparison between Johnson & Johnson's magnetic band or little ring you placed around lower esophagus to help to close. You can see that the surgical results here is like night and day. If you take the column most to the left, there is 42% who still has acid reflux. They still have measurable too low pH over 24 hours measured. It's 10 x more failures. You see that swallowing problems, it's called dysphagia, is 68% in this LINX FDA trial, which we have in this case. We have compared the CE mark trial with the FDA trial because these studies you can trust. They are rigorously controlled, and you know that this is fair data. This method doesn't really work because even if you compress so much with your ring here that 68% get swallowing problems, still 42% are not treated. That tells you that this method is simply not a working method to treat acid reflux. This is why FDA realized that they really want this product on the U.S. market, and that means it's a real endorsement of the RefluxStop product. It will mean something really positive for us. The next thing we have focused on during this quarter is that we have tried to explore all the usabilities in different phases of our eHealth platform. We have been sitting for three days, 20 experts, and going through our eHealth platform step by step. Everything from how a product is introduced into the system, how you get an implant, how you are treated, everything until you finish your treatment, how every usability step should be done. We have done that for three days with all these experts. You know, this system we have created here, this will mean a real landmark. We will be, as it is today, if we can launch this today, we will be in the absolute front lead of the e-health revolution. That's because we can change treatment on distance. We can have a device that treats different functions inside the body, and the doctor can sit at his hospitals, he control his patients, and he can also change the treatment, adapt the treatment on distance. That will also be a fantastic landmark when this will be launched. As you know, e-health will happen whatever people want or not. All these advanced technology that you have outside the body, that will move inside. Miniaturization, all the advancement in technology. If you look 50 years back in time, this is where we still are inside the body. There will be lots of cost saving because you can reduce hospital stay and number of visits to the hospital. Also the patient will be more involved, you know, feel more in charge, and you can be able to treat more complex diseases, more advanced treatment, and also things that previously were seen as unachievable will be possible to treat. As you know, we have quite many products in our pipeline, and that means that when this platform technology will be launched, we can then put easier and quicker and faster product after product on the market. That's why we have this very high vision in this company. We should become the world leader in smart medical implants. We think we have enough on our feet, so to say, to really believe that this actually could happen. We have also during Q4 made a cadaver lab in Kiel, Germany. There we have actually tested a new product. It's a new version of RefluxStop I wanted to talk about. Because it's the same product more or less, it's possible to make a quite quick introduction on the market with this product. I will show you how it works here. Basically, here you see five RefluxStop in a row or in a column. These you placed on the outside of the stomach wall. I will try to explain how this works. Today, for obesity surgery, something called gastric sleeve is operated quite a lot. This is the most common surgical method for obesity. It's done around 600,000 every year. You basically divide the stomach. You prolong esophagus in a long tube, basically. The stomach become a long tube, and the rest you put in the trash, basically. This is of course not so pleasant to be damaged for good, so to say. The problem is that 30% of people, when they do this surgery, get acid reflux. For those who remember how RefluxStop actually works and how we have been able to find out why you actually get acid reflux, to treat the cause of acid reflux, you will then understand why these gastric sleeve patient gets acid reflux. It basically works like this, that you in the chest, you know, you have the big diaphragm muscle that divides the chest from abdomen, that moves up and down during breathing. Therefore, you get pressure variations here in the chest who is leaking out through this little opening called the hiatus here. They are affecting this closing muscle here named LES. If this closing muscle comes too close here, you start to get acid reflux. If it goes all the way into the chest, then you call it a hernia, and for sure, you have acid reflux. Our device placed outside of the stomach wall here, that's just parallel to the food passage way, don't affecting the food passage way at all, but by just repositioning the closing muscle on a good distance from the diaphragm and keeping it there, we treat acid reflux. Now you understand why these patients who now sutured the stomach like a long tube, why they get acid reflux. Yeah, because there is nothing to hold it back, so it could just glide up very easily. That's why 30% of the patients, they get acid reflux by this surgery. That's, of course, not so pleasant. What we have done here is a device that both treat acid reflux and obesity. We take our long row of RefluxStop and we place them on the outside of the stomach wall, and we suture the same as RefluxStop in a little pouch. We have a long sausage pouch here on the outside, and that means that all the volume of the stomach disappears. Inside this stomach now is a very small volume, even less we can make than you get when you do this, obesity surgery, gastric sleeve. At the same time, we can then treat acid reflux with the same principle. Here we have a clever device that could be, relatively quickly on the market. What has happened more during this quarter is that we have hired lots of people. We have set the principle in this company that we should try to find the absolutely best and competent people we can find because this is the people who as a group should drive this company forward. We have been really, really looking to find the absolutely best people available for each position. I will give you just one example here, and this is Paul Mead, who is joining as Chief Operating Officer, and he's coming from Medtronic. He had, you know, really high executive positions in Medtronic over a 20-year period. He has, you know, all the experience of cross-functional leadership and he is a super competent person from Medtronic that is coming to us, which we are very happy for. This is just an example how we try to find the best people. Regarding RefluxStop, I will also give you a little update. As understood from the, every time we talk, there is another COVID wave. But for Q4, actually, it was again that all the hospitals just closed down. They couldn't do any elective surgery, but happily enough, you know, we can say that it is actually starting again now. We are really looking forward now to the next year here and hope that we could have a more normal situation. Of course, it will be some, you know, surgeries waiting in queue and so on, but it still seems like the COVID now is not stopping surgeries anymore, which is, of course, fantastic. Here you see a little bit what we are focusing on. Of course, U.K. and Germany, Austria, Switzerland, that's our key markets we are working on. We also have Italy, Spain, and Sweden, where we are incorporating our efforts. We have, because the FDA approval now, a little bit more focus on quality than actually selling quantity because we could not tolerate any bad surgeries for FDA. FDA is very, very sensitive. They ask you to report every single case, every single complication you have. We need to keep up high quality, train people very carefully, only select good surgeons until we have our approval process in U.S. provided and done. It will be a little bit more focused on quality than quantity, but we are still focusing on these countries that we have said before. In terms of the finance, I think I leave the word to our CFO, Andreas. Many thanks, Peter. Let us turn to slide 24. We recognize the format from earlier periods. Numbers are presented in EUR thousands. The top graphs represent Q4. The bottom graphs will show the full year 2021, and I will here focus on the Q4 numbers. Turning to net sales, we've experienced a 312% increase to EUR 107,000 compared to the same period last year. After an initial short window in the beginning of the quarter, practically all elective surgeries came to a halt after fourth COVID wave swept across continental Europe. As a reminder, we are currently only marketing our initial product, RefluxStop. Turning to gross margin. The gross margin levels that we are experiencing and expect to experience for our lead product, RefluxStop, is highly attractive. Adjusted gross margin in the fourth quarter amounted to 91%, one percentage point lower than the same period last year. Turning to EBIT operating loss. Our quarterly loss expanded year-on-year to approximately EUR 4 million, up from EUR 3.4 million the same period last year. Increased OpEx spend is in line with our ambition to continue to build our commercial capabilities, that including sales, market access, and the quality function. R&D activities further intensified over the quarter, both relating to our eHealth platform and pipeline products. Let us turn to slide 25. We have a very solid financial position. End of December, we held EUR 132.7 million of cash and short-term investments. For the short-term investments that relate to term deposits, hence, we are not exposed to any financial market risk. We do not carry any interest-bearing debt on our balance sheet. Let us turn to slide 26. Here we list our top shareholders. In addition to our founder, Peter's shareholding, our investor base is dominated by Swedish and Swiss high-quality institutions. Back to you, Peter. Thank you. Yeah, I think this presentation is coming more or less to its end here. Of course, from our standpoint, the fact that we actually relatively quickly could be on the U.S. market if everything goes as planned, that's of course absolutely fantastic. I leave the question open, so to say, if anyone has any question, they are welcome. Thank you. Ladies and gentlemen, if you do wish to ask a question, please press zero on your telephone keypad. If you wish to withdraw your question, you may do so by pressing zero two to cancel. There will be a brief pause while questions are being registered. Our first question comes from Christian Lee with Pareto Securities. Please go ahead. Yes. Thank you. Hi, Peter, Andreas, and Nicole. Hello Congratulations on the progress with the U.S. PMA submission and the positive feedback from the FDA. I have a couple of questions, please. I was wondering if you could walk us through the revenue development during Q4. You mentioned that you had a window at the beginning of the quarter and that the reflux surgeries came to a halt later in the quarter. Does the revenue of EUR 107,000 represent one month of sales or just some words on that, please. Basically it's one month of surgeries, yes. Okay. Excellent. You also described a new version of RefluxStop. Is this version targeting a different group of patients compared to the conventional RefluxStop? When do you believe that this product could be commercially available? Yeah. To treat acid reflux, we think it could be relatively quickly on the market. We are currently making a time plan to see how quick it could be, and we have to get back to you on that one. But of course, compared to these advanced products, we are doing something that is basically the same as is already approved could much quicker come to the market. That's why we have, you know, looked into this as well. This version is also targeting obesity. Would it be any conflict with your AppetiteControl product, for instance? I mean, if AppetiteControl works as planned, of course, that is a product that has rather exceptional potential because it's so low risk. You don't open anything of the food passageway and it could be a conflict going forward. As you know, the COVID situation has delayed things a little bit and it is still more complex with products that still take some time. If we can get something on the market here, it could be quite attractive. We have tested already with the surgery interviews, and this seems to be a product that people are really longing for because they have all this acid reflux with these patients. All right. Thank you. You also mentioned that, regarding your commercialization strategy, that you're focusing on quality rather than quantity. Will this have an implication on your sales activities in the near term? You know, we have a new market access person, one of the absolutely best you can get. His name is Amit, and he has large experience how you should do this. We have gone through how the successful companies have done it. It's not about having, you know, EUR 1 million, EUR 5 million, EUR 10 million revenue now. We want to build a multi-billion dollar company. We have promised our venture investors to become a really large company, and therefore this must be our main focus to become this really large player we have promised everyone. The lowest risk is to focus on quality until you have your approval and everything. Because the system today works like this, that every single complication you make, that goes to FDA. You have to report it to FDA. For example, we have now decided that we will wait with Middle East, for example. We had already set up to start with Middle East, and we had surgeons waiting and so on. Because it's so complicated to ensure the quality because of the language barriers, the traveling and so on, we feel we should not take the risk to get anyone who is not perfectly trained to do this procedure. That's more important for us because, you know, we are not looking for tomorrow. We are looking how does this company looks three, four years, maybe five years from now, then we want to fulfill what we promised our investors. When you look at all the successful companies, then you see that what they have done, they are focused on a relatively small number of really high quality markets and succeeded to get reimbursement and approval, and they have a fantastic development. We are learning from history and from a very, very qualified lead we now have in our team. We are built out with really high quality people who are health economics analysis persons. Also, you know, we have even sales and marketing people for the payers employed. We are really doing things right and very careful for the moment. Okay. Excellent. Thank you very much. I will jump back to the queue. Thank you. As a reminder, if you do wish to ask a question, please press zero one on your telephone keypad. At this time, we have no further questions. I will now hand back to our speakers for a final remark. Yeah. We just thank you very much everybody for listening, and we wish you a really good day and afternoon and evening. See you.
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