Welcome to the Implantica Q3 2024 earnings call. For the first part of the conference call, the participants will be in listen-only mode. During the questions-and-answers session, participants are able to ask questions by dialing star five on their telephone keypad. Now I will hand the conference over to the speakers: CEO Peter Forsell, CFO Andreas Öhrnberg, and IR Nicole Pehrsson. Please go ahead. Good afternoon, everybody. This is Peter Forsell speaking, and I will try to give you a little bit of an update of what is going on in Implantica. Let's see here. So I will start with a little company overview. It's for the new listeners, and it may be a little bit boring for those who have heard this before, but I will go quickly through. So myself, I'm a surgeon, and I'm also the inventor of most of the devices we have in Implantica. And this is the second business journey. We also developed a business with the adjustable gastric band, where we took 28% of the obesity market outside the U.S. And Implantica has a very interesting developed e-health platform. And this is a platform where you'll be able to treat people from a distance, and the focus will be from inside the body. So we will have very nice miniaturized technology where you can control and replace different bodily functions of different kinds, and everything could be controlled from the hospitals, and you can change the treatment from a distance. And that's absolutely key here, which then will enable us to replace and do many nice things in the body. So we have been sitting three years and gone through how could we now improve healthcare. And here you see 40 selected products that we believe we can do and improve and make healthcare better going forward. And this will save lots of costs for society, and as well as it will be making more advanced treatments for the patients. I have one example: people who have a stoma bag, they have a plastic bag collecting fecal matter because they maybe have taken away their large intestine for some reason, some disease like ulcerative colitis or cancer or other things. And it's not so nice. You have a 2- 3 L floating substance coming out in this bag, and you need to change it. It's self-adhesive on the skin all the time, makes it red, irritated. It's very burdensome. And this is the product we get the most requests from patients every day. Basically, we have requests about this product. And in this case, we are then replacing this stoma bag, and we are collecting the intestine down to the anus. And we can create a reservoir, open and close function, and people could get to more normal life. That's the intention with this product. We also have a product, for example, now for people who can't urinate. They may be paraplegic, had an accident of some kind, or multiple sclerosis disease. And they put in a catheter. Every time they should urinate, they put in a catheter in their own bladder, let's say five times per day. And that's quite burdensome life. We have a solution for that, so you can instead urinate with the remote control. This is just examples to show you that Implantica has a fantastic portfolio going forward. However, it's needed lots of resources for that, and we need to get going with the RefluxStop to be able to continue with all these different nice products. But we have a very high vision in this company. We should become the world leader of smart medical implants. Actually, we have the products, we have the patents, we have the competence. It's just about execution and funding. And it's an interesting, fascinating journey, I can promise you. Just a few words about RefluxStop before we go over to the business update. So existing treatment for people who have acid coming up from their stomach into the esophagus, you know, in the stomach has a special inner layer that you can tolerate the acid, but not the esophagus. And therefore, you burn the esophagus, you get small mini ulcers, and it's a very painful, burdensome disease. And though the normal surgical treatment so far has been focusing on that you should close, support the closing of the sphincter here between the stomach and esophagus. And the reason that people believe this was weak, this sphincter. However, this is your food passageway, and that means if you try to compress here, you get swallowing problems. You can't get anything up, you can't belch or vomit, and you get all the gas you swallow with your saliva and so on. It's accumulated, and you get swollen and distended and so on. And people are not so happy with this type of surgery. So we instead find out that there's nothing wrong with the sphincter. The sphincter is perfect. It's all about how you create the correct anatomy in this region. So you need to restore the position, original position, and keep it in that position. And you restore something called Angle of His. That's the angle between the esophagus and the stomach. And our device is then sitting on the outside of the stomach to enable that you get the normal functional anatomy again. And basically, we treat all the three components of the anti-reflux barrier with this disease, not disease, with this device. And here you see how it looks, the instrument and the little device with 2.5 cm large at the end here. And this works astonishingly well, as you will see from this presentation here. And why is it now so important to treat this disease? The answer is you get cancer. So 48,000 people die from esophageal adenocarcinoma. And according to the literature, most of them are coming from acid reflux. And you can compare to breast cancer. They do anything to find a breast cancer. They do all these mammographies and programs and anything. Here, 48,000 people just die, and no one is doing anything. It's a disastrous situation, and we believe we have the treatment that could, in the long run, change this. And it's 20% of the population we talk about. It's 17% of the population in Europe and 20% in the United States. They have acid reflux. And if I took a gastroscope and endoscope, and I just put down in the stomach of anyone who has this disease, I will find that 10%-20% has precancerous changes. That's instead of 1%-2% if I do it in the normal population. So this is not to play with this disease. Finally, business update. So far we have done more than 1,000 surgeries in Europe. We have more than 35 hospitals, and it's going very well for Implantica, actually extremely well. And we have submitted our second module in our PMA to FDA to get approval for selling also in the U.S. This is the most important of the three modules we are supplying because it includes all the clinical trial, all the effort we have done, all the results of all the hospitals doing these 1,000 surgeries, everything, all the complications, everything is submitted to FDA. And I will give you a little short recap of the five-year clinical results, which is the one that has been submitted to FDA. And you can see here that everybody took drugs before surgery. There is a drug called PPI who reduces the acid in your stomach. The problem with this drug is it has nasty complications long term. So it's not pleasant to take this drug for the rest of your life. And if you compare before and after surgery, you can see we had one patient out of 50 who took PPI after surgery. At four-year follow-up, we had 44 patients left because we had two people died from COVID, one disabled with long COVID, bedbound, and so on. But anyhow, one single patient needing to take drugs, that's an absolutely extraordinary result. There is no literature, no treatment whatsoever who even comes close to this type of treatment, and here you can see when we compare to standard of care, this is five-year results, and there is published a very, very comprehensive literature review of standard of care Nissen fundoplication, and it's from Karolinska Institute. It's very, very seriously done. They have looked at all the randomized articles, the high-quality articles. They found 63 randomized articles, and here you see the results of that, and then you see in comparison our five-year results. This is like an indirect comparison, which is not super accepted, you know, when you do research and so on. But in this case, because it's such an extensive literature review, you can see this as the platform for this treatment Nissen here. You can see this is like night and day. It's sort of no comparison in outcome here. You see like 40% have difficulties belch and vomit, for example, or 29% have swallowing difficulties after the other Nissen fundoplication, for example. If you compare to our main device competitor, this is now LINX device who is on the market since a long time, since 2012. It's a magnetic band that you place around the esophagus. Here you can see how we compare their FDA trial with our CE mark trial at one year. Because this is the most serious research done on LINX's is their FDA trial because that's rigorously controlled and so on, and you can see it's again like night and day. If you compare pH, so you measure pH in lower esophagus over 24 hours, which is the most objective measurement we have for this disease, you see that 36% still failed this test with our competitor, and you see that 68% had swallowing difficulties called dysphagia, so it's again, we are presenting a revolution in the treatment of acid reflux. We are then starting to do some market entry preparation in the United States because we hope that it will not be too far away until we can enter the U.S. market, and here you see a little bit, we already have a great interest from surgeons. You know, we go to exhibitions. We have had a cadaver training in the U.S. So we had 10-20 centers, and we have already a fantastic interest in the United States. We have more or less done all our marketing we need to do to select 20-30 leading centers in the U.S. to start directly after launch, which is also fantastic. And we have actually decided to develop the United States in six regions. We are preparing, you know, for how we should do this. If we now get the FDA approval, you need to be very careful what you say here because FDA really doesn't want us to talk about any commercial activities before we actually are approved. But here you can see the comparison. I have Great Britain and Germany here as sizes just to compare how huge actually the market is here in the United States. We have also very heavily investigated how our medical devices have succeeded in the United States, how they have done it, how it has gone for them. If you take our main device competitor, they have so far sold 50,000 devices of their device. We have another device here. It's Inspire. It's a device for snoring. It's like a little mini pacemaker you put in so you stimulate so you don't snore anymore. Here you can see how they are developed. It took quite some time. They were a small company. It took some time, but they have, you know, expanded like crazy. They have today a market value of $8 billion. So it's really going well for them, even if it took some time in this case. Here I have another example. This is Axonics, another device. Here you see the expansion went much faster. We, of course, studied very carefully how they have done their market launch. You see that they sold for $100 million within two years, third year. They have today a market value of $3.6 billion in the United States. This is examples of success stories. I'm not telling you, of course, that we will become such a success story. That's beyond my right to do. I'm just showing you how it could go if you are successful in the United States. We are also doing lots of other activities in the United States. Here you see the American Foregut Society. So Foregut stands for this region where you have reflux. It's a meeting with like 6,000-700,000 doctors from the United States at this meeting. Here you see some people listening to the RefluxStop session here. We have a fantastic, I say it's incredible interest from the U.S. surgeons. And that's, of course, depending on these fantastic results because it's not only these results from the SMW now have been made available for the public. It's also lots of different centers from Europe are presenting the result one after another. And this creates, they have the same fantastic results basically, every center. And that's why the U.S., they are eagerly, eagerly waiting for this product. Here you can see our user meeting, the third global annual RefluxStop user meeting. And here you can see it's more than 100 surgeons are spending one day extra for us. They come and spend one day. They get a full day of training, all the different centers present the results. There is lots of discussion, interaction, and of course a nice dinner. This day they spend here with us just because they are so eagerly interested in this device. We also have, you see on this slide here also to the right, we have developed a new very advanced training program. This is Professor Zehetner who is presenting a little bit the robotic surgery we are making here in this scene. I just wanted to show you how we then have developed a really advanced training program. We are really prepared for training all these surgeons. This will be an online system and lots of videos and other interesting stuff for the surgeons. So I talked about the other clinical data, and that's also what is making it so fantastic with RefluxStop that it's not only the very controlled CE or FDA study, it's also all the other centers who present, and we are then visiting all the big congresses, and the different surgeons are presenting their results, and we have so far this year, 75 conference abstracts presented at these congresses. We have more than 15 published manuscripts, so and lots of things in the pipeline. It's like a snowball effect. You put a little snowball, you know, on top of the mountain, and it's warm weather. That's the little bit the effect we have here with all the research, all the articles coming up for this product, and it's all fantastic results. We have published our four-year results, of course. The five-year is so far only supplied to FDA, but it's presented at the congresses. So if you're interested, you can go in and read about the four-year results in Surgical Endoscopy. This has been published, and it's lots of very, very highly renowned articles or magazines, you know, high reputation. Sorry for my English. It's very highly regarded magazines. So you have Swiss Medical Weekly, for example, that's where Dr. Nissen published his results in 1956. Could you imagine? This magazine has been since 1956, and it's a very regarded magazine. Nature, the same. The Scientific Reports have a very high-ranked article and so on. So it's lots of stuff coming up, all from independent hospital centers who present their own results, independent from Implantica. We also have our studies ongoing, so, you know, we are doing our randomized trials. We have a Pan-American or Pan-European registry study we are doing. We have ethics committees submitted and approved in many, many different countries now. It's all, we are step by step, so to say, working in one direction to prove this is by far the best you can get. The randomized trial between Nissen and RefluxStop will, of course, be very, very interesting because if we can, in a randomized trial, prove that we are the better treatment, that's, of course, going to open many doors for payers and reimbursement and so on. This is Professor Schoppmann in Vienna who is doing this study. He's the central hospital. Then it's, of course, many other hospitals joining. If we then look at cost effectiveness, today's world economy is also very important. Also here, we have been extremely successful. So we have made individual analysis of the cost benefit in all these different countries. You see the map here. And we have published it. And it got published in highly respected magazines as well. So we have proven now that we save so much reoperation and so much complications. So it's worthwhile to invest in a RefluxStop treatment. That's basically what you can say. It's even more cost-effective than drugs. Although the drugs cost very little money because it's so much side effects with the drugs. And that's, of course, very, very important. Then we talk about the market expansion. I will give you some example how fantastic the interest for this product is. So we started one and a half years ago in Italy. And we invited people to come to a user meeting and take one day off and only spend it with us. 21 surgeons came to this meeting. We have in Spain 23 surgeons from 17 hospitals, one and a half years after launch. They spent two days with us, Friday and Saturday. Saturday, it was live surgeries going on. They could see the operation live. Incredible. It's absolutely incredible interest for this new treatment. Also, we, as I showed you last time, we have made really some nice marketing campaigns in the UK and Italy. Here is an example from Spain, Madrid. It's one out of five persons who have this disease. Imagine one out of five. When you manage like this to get press and radio and magazines and all these things writing about this, it's so many patients who contact the hospitals. It's just incredible. You can imagine one out of five have this disease. The conclusion of all this is that RefluxStop is unstoppable. I will then give the floor to Andreas, our CFO. Many thanks, Peter. Good afternoon or good morning. Could we go to the next slide, Peter? Thank you. We reported net sales of EUR 344,000 for the Q3 2024, an increase of 41% compared to the same period last year. We currently only market our lead product, RefluxStop, to European key opinion leaders to build a strong reimbursement platform. The business consistently delivers exceptional gross margins. As discussed in earlier calls, this being explained by a combination of a simple product delivering best-in-class patient outcomes, as highlighted by the five-year CE trial data that Peter outlined earlier in the call, and being protected by a significant moat thanks to its strong IP. Adjusted Gross Margin for the Q3 amounted to 97%, up from 94% the same period last year. Our Q3 operating loss amounted to EUR 5.3 million, a 7% year-on-year decrease. For the nine months, we experienced a 23% increase in our operating loss, primarily driven by costs related to the preparations of the FDA submission, including a usability trial. Costs relating to the e-health platform development have been managed down in a significant way over the year. Let us turn to the next slide. We have a solid financial position. End of September, we held EUR 69.3 million cash and cash equivalents. We do not carry any interest-bearing debt on our books. The quarterly operating cash outflow amounted to EUR 4.8 million. Total net cash outflow for the period also equaled EUR 4.8 million. Let us turn to the next slide. In addition to our CEO and main shareholder, Dr. Peter Forsell, and other senior leaders in the organization, our investor base is dominated by Swedish and Swiss high-quality institutions. We are grateful for the trust and the support we are receiving to build a commercial platform to address a massive unmet patient need. Back to you, Peter. Thank you very much. Then I think it's time to go to the question and answer section. If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Qianshen Li from Pareto Securities. Please go ahead. Hi, good afternoon, and thanks for the update. So I see there's a dip in revenues compared to Q2. I guess it's because of summer months. But since you have shown great five-year study results and you seem to get more and more traction among the top European surgeons, just trying to understand, is there a potential hurdle you see for switching from Nissen fundoplication to RefluxStop? And in other words, what do you plan to do as a next step in order to further accelerate the sales uptake in Europe? Thank you. Yeah, so the answer to this is very simple. For the surgeons to do a larger number of our devices, they need to get paid. And today, we are starting to get reimbursement in some hospitals in Italy and Spain. And we have some part reimbursement in the U.K., and we have an own code and registration of the operation. So in Germany, but very limited money given. So that's what it's all about, that the hospitals, most of these who do this now, they would only do RefluxStop if it would be paid like a normal part of the healthcare system. And that's why we are doing all this research, all these studies, all these things. That's all to prove we should be part of the healthcare system and be fully paid for. And when we achieve that, it's likely that RefluxStop will be dominating the whole market, and it will be a dramatic increase in sales. Now we are building more and more centers, more and more centers that want to do this. So when that reimbursement situation comes and people get paid, suddenly they can do much more per center. Okay, thank you very much. And maybe a follow-up question. So since you are doing all this campaign and studies, so what is a critical factor, you think, in order to get the reimbursement from these countries? The most critical is the research we are doing, the studies, or more and more articles from more and more centers and our own high-quality studies, the five-year study. All this, of course, is very important. Then, of course, the pressure from the patient also affects. If you suddenly have in NHS, for example, 20 hospitals doing this type of surgery, they need to reconsider. So it's many aspects that you work on in parallel here. But the problem to do too much marketing with patients is that it gets like calls. As I said, in Italy, for example, they made a campaign who, I think it was nine million Italians that got this message, basically. In the whole south of Italy, they are calling into this poor hospital there in Naples, and they need to employ a full-time person just to handle all the requests. I see it's so many patients that you need to be a bit careful. You need to balance it. We are building this step by step by step. After COVID, it takes a little bit longer time, but it's just a matter of time. It's a bureaucratic process. It takes time. Normally, of course, in a perfect working system, we would already be approved. Everybody should understand that this new treatment is needed and should be paid. That's not how bureaucracy works. It's an effort we need to do. Be sure, it's just a matter of time. Okay, thank you very much. I guess this randomized controlled trial will be part of it. It will be critical. So now you are expecting first patient to be enrolled in Q125. What is the reason of this delay? And may I say how many patients do you plan to enroll in total? And when can you expect the top line result? Thank you. We are involving 200 patients, 100 with Nissen and 100 with RefluxStop. And it's hard to say exactly how long time the enrollment will be. They will be followed. The first results will come half a year after everybody is enrolled. And if that takes half a year, then it's one year. If it takes one year to enroll them, it's one and a half year. But it's not that far away. And that, of course, will be a heavy study. Okay, thank you very much. Thanks for taking my questions. Thank you. As a reminder, if you wish to ask a question, please dial pound key five on your telephone keypad. I also have some nice written question here, depending if no one else is calling. There are no more phone questions at this time. So I hand the conference back to the speakers for any written questions. Yeah, so maybe I can start to look at some questions here. Someone is asking here how it's going for RefluxStop in Sweden. And the answer is quite well. So in Ersta in Stockholm, they have operated the three first patients. And they are now trying to get resources so they can continue to operate. And the interest among the surgeons is high. They want to do this. It's just an economical question. So we have to wait how it's the administrative part who will decide how it goes. But hopefully, they will soon start to operate more regularly. And it will be more hospital centers in Sweden who will follow. We have already a few more centers lined up to start. Then someone asked, can you go from a Nissen to RefluxStop? And the answer is yes. You can redo a Nissen and place a RefluxStop. It's always when you do second surgery, a little bit more risk for side effects. But overall, it's many procedures done, and it has worked well. How big is the market in the U.S. once you get reimbursement? Yeah, so the answer to that is that the number of surgeries today is not enormous. However, the market is enormous. That's because when you have something that works so well and people go through lots of side effects, they don't operate. So the medical doctors don't send the patient for surgery. If you send a patient and he comes back and has so much following problems that it's worse than the reflux before they made the surgery, when you get five such patients back, you don't send more patients. And that's a little bit the situation. So the market itself is extremely large to answer that question. So how many RefluxStop surgeries can surgeons do per week? And the answer to that is that the larger centers, they do like 400 per year, maybe realistic. So something like in the U.S., many centers do like 400 surgeries per year. Excuse me, what do we have more for question here? How big is the chances of the FDA approval? Oh, that's a dangerous question to answer. I mean, if I put it this way, I would be extremely surprised if the FDA has not allowed us to submit this study here in Europe as in our PMA. And the results are over any expectations. I think the chances must be seen as very large. And what have we more here? Regarding the U.S. PMA, when do you think module three will be sent in? In three months later or can you send it in? Okay. So the timing schedule is three months, as you say here. And then, of course, it could differ a little bit, plus and minus. But I don't think we will supply the answer to module two together with module three. It depends if it's very easy to do that answer. But it took a little bit long to perform the answers here we had now this time. So it's a little bit depends. But hopefully, we talk about the magnitude of these three months. But it depends a little bit the strategy we select when we get the answer of module two. Yeah, that's another question of module three. Are there any long-term plans for large medical technology company to carry your stake in Implantica? No such plans or we have no such plans. We are trying to be that large company to answer your question. We should be a new large med tech company. No sound. That's above my competence to answer. Good luck. What have we here? That's the same question about the module three. We have several such questions. I think I have answered them all. Now, have I missed something? How is it going in France? I have a question here also. Yeah, so in France, they have a little bit strange system. So to get reimbursement, you need to do another trial in the U.S. So we are trying to integrate that together with our randomized trial to see how we can get reimbursement in France. We have a few centers who are started in France, and the interest is high. It's just how they get paid because they have a very rigorous DRG system. So they have no extra money or anything like they have in Spain and Italy, where it's a little bit more flexible. I think thereby, if I have not missed anything, I hope I have answered them all, and I thank you very, very much for listening. Sorry, it took a little bit of time this time, but it's a very exciting period now for Implantica, actually. It's going really well, and we are really excited. Thank you very much. Bye-bye.