Implantica AG

Yeah good afternoon everybody this is Peter Forssell speaking and as you know Implantica is focused on bringing advanced technology into the body and what is maybe important for newcomers is that this is not the first time that We run a successful business. We have previously done the gastric band as well. And Implantica is a quite interesting company because we have built an e-health platform. And e-health will be the future of healthcare. And with this system, you can then integrate and treat patients on distance, you can have energizing at the patient's home and there is different aspects. So you can basically, you center all the intelligence and the treatment from inside the body. And the doctor can then control the treatment from distance. And that's a very advanced system needed because it can't be hacked, it can't be anything happening. and this is many many years of work and this system will change healthcare and we have many many products in the pipeline however now when we are coming closer here to the really launching reflux stop and also in us this is of course our main focus for the moment So we have wireless power systems and we have the e-help platform designed. And we have patents, many patents for using these platform technologies to be filed, for example, more than 25,000 pages of e-help patent filings. So we are very well protected for very advanced technology, which will come in there going forward. And our vision is very shy. We should become the world leader in smart medical implants. So there we set the tone of the discussion. So let's move over to reflux stop. Looks like this sitting on the instrument where you introduce it. And for eventual new listeners, I just want to try to explain how reflux stop works. So old technology, you try to close. This winter between the stomach and esophagus because you don't want acid coming up because acid is burning esophagus, you get pain, you can get cancer, it's not pleasant. And there is one method from Dr. Nissen, he developed that you wrap around the top part of the stomach, it's like a mountain, you wrap it around to support the closing. And also you have a product from Johnson & Johnson, it's called Lynx, where it's magnets who try to close support closing the problem is that this affects your food passageway it gets more difficult to swallow you can't get something up as easily it's more difficult to get things up belch vomit and you swallow all the time with your saliva or food you swallow gas or air and this is accumulated so you get swollen distended in your abdomen And reflux stopper has a completely different treatment method. We don't affect the food passageway at all. It's completely undisturbed. And that means normally we should not get any swallowing difficulties called dysphagia. And we simply let the body treat. We just restore the normal anatomy, the normal physiology, and thereby the body treats itself. So the previous theory that this ring muscle, the sphincter here, is weak, that's not correct. Nothing wrong with the sphincter. And you see it with the three drawings here, how you actually then restore the functional anatomy and the body just with itself. And that's sort of the key to success here. And that's why we say we treat the cause of acid reflux. And that also means that the result is thereafter. Here you see a little bit how it looks from inside the stomach and from an x-ray. You see the nice device placed in position. And it's one billion people who suffer from acid reflux. That's an absolutely enormous amount of people. And most people take drugs. They are called PPIs, proton pump inhibitors. And the problem with these drugs is that they don't help everybody. Forty percent of sufferers are not helped by the drugs. So we have 400 million people without discussing the complications with the drugs and side effects and the risk of taking the drugs. Just forgetting that for a moment, it's still 400 million people who is not treated today. And the problem, and you have acid coming up in your lower esophagus, is that it happens over and over again. And this is how you create cancer. If you put an endoscope or gastroscope down in a patient who is suffering from acid reflux, 10 to 20 percent have pre-cancerous changes. It's called Barrett's esophagus. And then you have a certain percentage every year who get the fulminant cancer. So in Europe and United States alone, 48,000 people die from the type of cancer you get from this disease. We can't say for 100% that all of them are caused by acid reflux, but most of them are caused by acid reflux. So it's a really serious disease, and you can take these PPI drugs when you are young, it's okay, but of course they get you more atherosclerosis, so you get more cardiovascular disease, and you get older in your blood vessels simply to take it lifelong. Nothing I would never do. And it's increasing, of course, the complication. If you're young, you take this for a few years, it's probably okay. But when this disease is lifelong, you need to take this medicament all the time. So this was a little background that I'm sorry I repeated for those who know this in and out. But it's just to have a little starting point here. And now I come to the real business update of this. So reflux op is currently on a way of great success, I would say. And that's carried by a multitude of published studies with excellent outcomes from leading reflux centers. And it is actually very, very important that center after center, independent, independent research, their own research, they come out and say, hey, reflux stop is fantastic. That is how you quickly build a new standard of care in this treatment field. And that's our goal. Our goal is to become the new standard treatment for acid reflux sufferers. And we are building it step by step, but it has started to bear fruit. And I will give you some examples later on in this presentation. We have again our three pillars. I have showed it many times before, and I start a little bit with the market expansion, regulatory approvals, new centers and so on to give you a little feedback. So first of all, we have filed, as you probably know, most of you, the first module, our PMA, and we have got the feedback from FDA. It was only from the company's perspective, minor things, nothing that we can't answer or correct, which is very, very positive. For strategic reason, we decided that we will file our Module 2 together with the answer. That's what we have been doing right now. And it's not so far away, of course, from filing now the Module 2. It's hard to give an exact date. Many people involved, we have around 10 people working on this PMA. But it will be in the near term. We will file, of course, then Module 2. And Module 2 includes the clinical data, all the clinical results from our now five-year study. And I will give you some insight into that as well. In parallel, UK, NHS, the National Health Service, who stands for the public health care in UK, they have started to investigate reflux doctors to see if it should give it full payment in their healthcare system. And we are starting to operate in more and more NHS hospitals, public healthcare hospitals. And NHS, they have an organization called NICE, National Institute for Health and Care Excellence. And they are defining who should be treated, what should they be treated with, and which products should we approve in our healthcare system. And they give guidelines. And this is what we are actually working on right now. We have a meeting with them in September. We have supplied a big dossier to them. And that's of course quite interesting because these effects, not only UK, they are very influential, this NICE. We have now more than 35 hospitals and more than It says 850. It's more than 900 patients. It will soon reach 1,000, I guess. So it's going step by step. We are still focusing on the countries you have seen before. We have been quite successful in Italy and Spain, as you know. And I can give you some centers that have started, which is quite important. One is University of Southampton. And this is a very interesting hospital because in many treatment areas, they supply healthcare for 4 million people down there in Southampton. So it's a huge, huge hospital. And here we did the surgery. You see the grumpy man there, that's me, together with Dr. Fergus Nobel there. And it was robotic surgery. So what you see to the left of Dr. Nobel there is actually a robotic system. It was completely done with robotic surgery, which is quite interesting. Also in Germany, we have a very important hospital. It's Herzogin Elisabeth Hospital in Braunschweig. And this is nice because it's an INEC reporting hospital. That means they report all their costs for the procedure, which is quite valuable for us when we should have increased reimbursement in Germany. we can refer to these centers who operate. So we are collecting these type of centers for the moment to get more and more surgery done, which is directly reported to the healthcare society. And in Spain, we have Dr. Sanchez started to operate. We have another center in Spain, in Valencia, also started. Of course, not all the centers. I just wanted to give you some feeling. It's nice to see some nice pictures with happy healthcare people. Although in Spain they have decided that they should use this very orange color so people should not steal their dresses, the clothing, because they are so ugly that no one wants them. But it looks very ugly when you see them also. so yeah that's this also we have made some really nice marketing campaigns so we have really start now and especially in uk you know we wanted really to it's come from from the patients up to the surgeons and we need really to create more hospitals and more interest in reflux top so we had a patient story featured on BBC South Today, Breakfast News, and also on ITV, and it was around and started with 8 million viewers. But this ended up in 67 different publication pieces. People took this up from everywhere, everything from TV to press to an incredible reaction. And people who understand this have calculated that the potential reach was 1.17 billion people from this campaign. And Dr. Fergus Nobel at Southampton, he described the incredible number of patients inquiring as just inundated, he called it. It's so many people calling the hospital after this campaign, so it was just incredible. because we have one out of five have this disease. And that's why you get so many patients. We have done a similar in Italy, where we had a TV channel, RAI, to have a 50-minute long patient story, of course, a success story. And this was picked up by five television agencies, six news agencies and 13 online channels. And they calculated the total reach of this campaign to nine million people. So the hospital involved here who started this process, they had to set up a new call center just to handle all the phone calls from patients. So a complete separate person just doing nothing else than answer requests from patients. That's how huge this treatment field is. This is just to give you a feeling of the potential of this product. Problem still we have is that we need to get paid for the product. It's nice to sell a product, but if you don't get paid, it's more difficult. And what we need is the public health care system to pay for the product. And that's what we are working on step by step by step. So let's go to the next pillar in our three key pillar market access profile here. And that's, of course, we need to create superior clinical evidence. And that I would say we have been very successful. So here I wanted just to show you, we have a complete team to support surgeons, help them with different things, to get things, presentations, articles, everything done. And we have so far this year 36 conference abstracts submitted. We have 28 oral posters. We have 20 submitted manuscripts. 12 are published. And seven additional manuscripts completed and ready for submission. This is a heavy work. And this means that it's more and more of these centers now who have started with reflux stop some years back. Now it's started to bear fruit. They come out with their own results. Everybody says, oh, reflux stop. That's fantastic. That's selling surgeons to surgeons. That is 100 times more effective. than sales people selling any product. We are of course doing our RCTs. I think I have a special little slide on that. So I will come back to our studies, which is also very important. And yeah, here is the slide. Sorry. So we have got at the committee approval in Vienna, Austria, because it's Professor Schopman, At AKH, it's the largest university hospital in Europe, actually, in Vienna here. They are the leading hospital in this randomized trial comparing standard of care and missing fund application. And they got the approval. In Austria, though, it's some kind of competent authority that also need to say, give sort of say the okay. So it's another application file, and that is said that you should be maximum one month. And I think some weeks has already passed of that. So we are very close now to finally get started with this RCT. And we have more in Frankfurt. It's also in Germany. There was a visit by Dr. Mustafa. to the committee and they basically have said that they will approve also in Germany. Switzerland is already filed. It's quicker handling. I think it also very soon will be ready to start so we can really get going with this first very important RCT randomized trial where you basically have lottery which you should operate the reflux stop or standard of care. And we also have then many superior articles coming out, and I will guide you a little bit through that. So first of all, we have our excellent four-year results. And this is the results but five years that we are using for our FDA. We have not told you yet about the five-year results. I can't say so much. They are also excellent, but we have presented the four-year results. And you have a link in our press releases. I think I didn't put it here. have in our press release we have given you a link if you want to read yourself this is published in surgical endoscopy which is a very interesting journal because it's the official journal of sages the american gi and endoscopic surgeon society and it's also the european association for endoscopic surgery so this is a very influential magazine they are involved in the guidelines to the payers to you know, society to tell what should be used and not used. It's a very important magazine here. And the results, of course, is, I mean, I should be objective and say fantastic. You can say nothing less than fantastic to be objective here. It's incredible results, basically. So here you see regurgitation, that's how much is coming up, you know, As the reflux is basically often called by regular rotation, it's coming up stomach fluid in your esophagus. And here you can see how it has developed over the years. And you see that it's stable. It's nothing. All this, we have four years. The outcome is stable. And if you look at swallowing problems, which is one serious difficulty with standard of care, you know, you have between 30 and 50 percent of the patients. with five-year results have swallowing difficulties with standard of care. And here you can see we have one patient, one single patient with swallowing problems. This is what you call night and day to have half of the patients or one patient. That's really different. And basically no patient takes any drug PPI due to acid reflux. It's actually two patients who took drugs, but not for acid reflux. They have something called gastritis, or some in Swedish. And then there is other reasons, you know, that patient could not be happy. But the key is, is it because of acid reflux? Because that's what we treat. We don't treat, you know, other problems. We have also another very interesting magazine. This is also a very, very highly respected magazine. It's called Swiss Medical Weekly. And this is the magazine where Dr. Nissen, you know, the one who invented the Nissen for duplication, the current standard of care has been used all the way since 1956. He published his results in this magazine back in 1956. So this is a really top of the line press here. And then we have Dr. Sethner who published his first results. And that's very interesting. because he has operated patients who doesn't have any good treatment today. So he had operated patients, we call them ineffective esophageal motility. And that means that your nerves and muscles in lower esophagus, that doesn't work like they should. You don't transport food as you should. You are very weak at transporting the food down. So these patients often have swallowing difficulties. And you can imagine if you then put in a circle something around the esophagus and try to press to close, they have really get difficulties to swallow. So these patients, according to the NICE guidelines I talked about before, they are not recommended for surgery. These patients have no good treatment today. And also the large hernia patients with existing treatment, they have like 50% recurrence rate in five years. So 50% of the patients need to be re-operated. So neither of these two groups has really any good treatment today. And I would say the IEM patients, that's one-third of the sufferers. And large hernia is another third of the sufferers. So we talk about here two-thirds of the sufferers who really doesn't have any good treatment. At least not the IEM patients. The other one you get to re-operate over and over again. We had a little statement from Dr. Sethner here, professor of UFC. No, USC, yes. Based on 150 reflux cases I've performed over the past four years, it's clear reflux stop has the potential to reform how we treat severe GERD patients, especially with ineffective esophageal dysmotility, where reflux stop is turning out to be the best available treatment option. so we have been from this perspective very successful here you see his results you can see that after surgery all patients were satisfied except maybe a couple of patients of these 40 who was neutral no one was dissatisfied after surgery here you see the swallowing problems they are fading out also after this surgery that the patient had before surgery And you can see you have a questionnaire here when you ask questions before and after surgery. The very long ones are when you ask the questions before surgery. The non-existing or very low ones, they are after surgery. And in this case, we have separated questions for heartburn. And you see they go down to zero. You see regurgitation goes down to zero, and the total score is improving dramatically from 35 to two in median IQR scale here. So it's just absolutely astonishing results, not matched by any other technology Anything I'm aware of in the literature can match this. We have also Professor Schopman, which is leading the RCT study. He has done another study of just IEM patients, these with defect motility. And his conclusion is, you know, this is excellent result in this group of patients with IEM who have no optimal treatment available until now. And this is published in Nature Scientific Reports. This is one of the most highest respected and rated magazines in the world here we talk about. So he got it immediately published because this is such a great news. Here you see a little bit his results, his score goes down and a little bit also the different things. I would say we are carried on a way of success in terms of publications and convincing the healthcare society here. We extremely well, nothing less you can say. Then we have the cost effectiveness, you know, and that we have again published more articles. So we go through country after country to conclude that reflux stop is the most cost-effective anti-reflux treatment. That's very important for the payers. And this we have been doing now in many more countries. So we have Sweden, Norway, Switzerland, Italy. So we have a couple of articles published also here. So we have cost-effectiveness published in Journal of Medical Economics, also a very respected journal. we have in italy published in in pharmaco economics also very influential magazine so it's it's all about building blocks it's like you're building a house we are building it from the ground and up and we do it professionally we do it methodically step by step Yes, that's time then for Andreas to say something about the capital market and finance. Andreas, the world is yours.

Thank you very much, Peter. Good afternoon or good morning. We reported net sales of 554,000 euro for the quarter, an increase of 59% compared to the same period last year. This is driven by a combination of new centers and higher activity levels at existing centers. As a reminder, in Europe, we are only selectively engaging with key opinion leaders to build a strong reimbursement platform. In the US, we are not commercial as we are currently in the FDA approval process as outlined earlier. Let us turn to gross margin. We continue to deliver industry-leading gross margins Adjusted gross margins for the quarter amounted to 91% compared to 94% in the same period last year. We expect to continue to see quarter-on-quarter volatility in the gross margin levels. This provided the subscale nature of the current operation. The combination of superior gross margins and no limitations to scaling reflux stop production underpins the operating leverage we can expect. as the business scales and matures. Let us look at earnings before interest and tax, EBIT. The operating loss expanded to €5.9 million, up from €4.3 million in the same period last year. Looking at the quarter-on-quarter development, we saw OPEX decreasing by €1.3 million from the elevated cost levels we experienced in the connection with the FDA filing preparations over Q1 this year. The quarterly GA cost remained roughly flat year-on-year. We experienced an increase in R&D spending, where R&D expense for the quarter came in at €3 million versus €1.2 million the same period last year. A key difference compared to the same period last year was the 1.1 million euro capitalization of development expenses in Q2 2023. For Q2 2024, this number was close to zero as all R&D was expensed in the P&L. As communicated earlier, we are continuing to reduce investments in e-health and pipeline product as we redeploy resources to commercialization or reflux stock, including the randomized clinical trials that were discussed. These trials are reflected as R&D expense in our financial statements. Let us turn to slide 52. We are fortunate to have a robust financial position. Over the quarter, the total net cash outflow amounted to 6.3 million euro. End of June, we held 74 million euro of cash, and we do not carry any interest bearing debt on our books. And with that, let us turn to slide 53. In addition to our CEO and main shareholder, Dr. Peter Purcell, and other senior leaders in the organization, our investor base is dominated by Swedish and Swiss high-quality institutions, And we are grateful for the trust and support we are receiving to build a commercial organization to address a massive unmet patient need. Back to you, Peter.

Thank you very much.