Implantica AG

Welcome to the Implanica Q2 2026 report presentation. For the first part of the presentation, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now I will hand the conference over to the speakers, CEO Peter Forsel, CFO Andreas Ornberg, and Chief Corporate Affairs Officer Nicole Pearson. Please go ahead.

Thank you. So my name is Peter Forssell, the CEO of the company. And I will try to guide you through today's Q2 presentation. So for those who has not heard this before, I'm a surgeon and I'm also the inventor of the product we have in Implant. and also the CEO and founder of the company. And this is the second journey. So the first journey was Stochastic Band, which I developed, and also a business for six years that successfully was sold to J&J. And that's the funding. Part of that has been used for this new Implantica venture. Oh, the really good news for today is, of course, that Implante has got FDA approval for its product, Reflux Stop. And that's, of course, fantastic news because the United States is the largest market for medical products overall. And it's also a country who is more positive to new technology and also willing to pay for new technology. And the good thing here is that we have 1 billion sufferers, where of 78 million we have in the United States. So it's enormous amount of people that have this disease. It's larger than obesity, basically. So I will come back to the FDA approval because I think today we have quite many new listeners. So I will just give a little bit feedback of Implantica shortly, and then we come back to the FDA and what will happen next and so on. So here you see the device called Reflux Stop and today we are operating at 60 centers in Europe and we have done 1,800 procedures. And we introduced the device with a special instrument that we sell together that you see on the picture here. and existing surgical methods for acid reflux. It's also called GERD, gastroesophageal reflux disease. Dr. Nissen has always been focused on that the sphincter between the stomach and esophagus is weak. It can't close properly, and therefore we need to support its closing. And that Dr. Nissen did already in 1956. He took the top part of the stomach, we stuck it in the mountain, and he wrapped it around so you support the closing. There is another product called LINX. It's a magnetic band that also do the same thing, try to support by applying some kind of pressure or at least hindering expansion in this area here. The problem we have now is that this is people's food passageway. That means you get difficult to swallow. You can't get nothing up. You can't belch. You can't vomit. All the air you swallow with your saliva and food that normally just regulates up is not going up anymore. And you get swollen distended in your abdomen. And people are quite unhappy with this surgery. So therefore, we realized these problems. So we have constructed a device that do not affect the food passageway at all. You have no problems with swallowing and other gas bloating and stuff like that. So what we realized is that this winter is perfect. There's nothing wrong with this winter. It's all about the positioning of this winter. and the reason for that is that in the chest you are breathing and you create then of course pressure in pressure out it's changing direction of the pressure all the time if you are breathing in if you are breathing out and then you have your big muscle called diaphragm who divides the chest from abdomen which moves because you use it for breathing and that means that the esophagus then have a hole or passing through a hole in the diaphragm so it can move freely. And these pressure variations then are leaking out through the opening here. And it's like you have a huge stone wall, you know, at the harbor, for example, to protect the boat from the waves. And then you have an opening where the boats go in and out. And it's always very, very streamy in that opening. And that's exactly what we have here. So when this filter comes closer and closer, www.svinter.com This stance here is always kept. So basically what we are doing, we are just restoring the body's normal anatomy and then the body treat itself. We are not treating acid reflux. We just restore the anatomy and ensure that it maintains in that position. And when this little swinter here goes all the way to the chest, like you see on this picture here, then you call it a hernia. And many of these reflux patients have a hernia. Then it's, of course, even worse then. And you can see the normal anatomy, and when you place reflux up, it's very, very similar. So why do we need reflux? The answer is that we have drugs that try to limit the production of acid. The problem is that you try to change things inside the body with drugs, there is always side effects. And there is a reason why you have the acid in your stomach. The acid is there for killing bacteria and killing parasites and things that you eat with your food. There is always bacteria in your food of some kind. Now they just pass through and they come into the small intestine, who normally is sterile, and you get overgrowth of bacteria. It's called SIBO, swollen distended in the abdomen and so on. and the biggest problem is that one, 40% are not treated. So it's only 60% who has helped by these drugs. And second, it's lots of very, very serious side effects with these drugs. So if you take them long term, in this case, it was a study with 157,000 US veterans. They were followed for 10 years and 7,000 died due to the PPI use. So it's a drug that never should have been approved. It's a terrible drug, actually. And one thing that you didn't know from before was that this drug is sucking out the substance from your blood vessel, which means that you get extra prone to get atherosclerosis. So when you are 40 years old, you have a 60 years old blood vessels. And that's why you have lots of extra deaths of cardiovascular deaths. and that it's not like you, oh, this patient died from heart attack. It was because he take PPI. That's not the first thing you think about. But now people understand that this is actually complication by the drug. People get cancer from this disease. They get cancer likely from the drug, but it's very difficult to prove these things. You remember how long time it takes to prove that smoking was dangerous, although everybody understands smoking was dangerous. And it's the same here. We know that if we put down an endoscope, a gastroscope endoscope down in your stomach and you have this disease, 10 to 20% have pre-cancerous changes. If you do that in the normal population, it's one to two percent. And they are mainly the reflux patients we talk about. So it's clear you this disease plus this drug give you cancer. But what is what is difficult to separate. Reflex stop them has now been tested for the first patient in is nearly 10 years away. More than nine years since the first patient was operated. And we have presented for FDA our five-year results. And I will just show you a bit the results FDA got. So everybody took drugs before surgery. At five years, one patient took drug and likely not for acid reflux because it was a patient with pain and a kidney disease. If you do the objective measurement, you put down, you put a little capsule who send wirelessly the pH over 24 hours from your lower esophagus. You see here that the results before surgery is much higher here. Then it goes down nicely at six months. It's completely stable at five years. So the outcome is stable for five years here. And here you see the results outcome from every single patient. and this was many lines here in the line of zeros here. And if you use the same definition as the links used for their FDA trial in their SSED memorandum, then everybody was treated, objectively treated patients. So if you then look in the literature, and we found a huge literature review of Nissen fundoplication, which is the standard of care RAP I talked about before, and you can see the comparison in outcome here. So if you look at inability to belch and vomit, 40% had this. We have 0%. 29% have severe swallowing difficulties. We had one patient who had temporary swallowing difficulties. and so on. All these are a little bit like night and day. 52% has gas bloating, although it's not on this slide here. And I think we had around 4%, 4.6%. So it's like night and day, the outcome. And today we have 38 articles. So we have done a really good job systematically doing everything we can. Every surgeon who do this procedure is publishing the results, go to Congress, is present. We have been going to United States for four years, lots of presentation. Every Congress we are there, we are presenting. and that's why we have convinced the surgical society and surgical surgeons in US that this is a fantastic thing. You can read yourself. It's published in Surgical Endoscopy, both the food passageway related events and the total complications. There are two articles you can find in Surgical Endoscopy. We also have a fantastic study where 22 centers from Europe put together all the results. And it's 602 patients from... is it nine countries or six countries? Nine or six countries, maybe six countries. And it's showing that it's a very, very safe device. Much, much, much lower complication rates than standard of care. So finally, we come to the business update and the FDA approval. This is, of course, a really We have been working four and a half years to get this approval. It's so much work, so much effort, so much tests, so much things to do. I would say I can take my full, if we had a paper system, I can take a full wall and I have full files. So huge is this project. It's hard to understand, but it's a very, very rigorous process. So FDA, they come and check all your data. They go to the hospitals. They look at every paper at the hospitals. They look at your quality system. They go to all your manufacturers to check that they do by refracting properly and so on. and this is a huge quality stamp. You know, someone, a company who can pass an FDA PMA like this, this is a quality stamp. Implantica is approved and that is a fantastic milestone achievement. So we will have a kickoff. in September, when the American Forgot Society have their meeting in Washington. So we have already prepared. So we have a huge room and we will have a symposium and speeches and it's a big, big event. And we have lots of key surgeons involved here. Some of them are here. So you are mainly European surgeons below and you have US surgeons on top here. So this is the perfect opportunity to make the first step now in the United States. Now we launch. And very exciting times. Here you see the previous meeting. at the AFS meeting. The same meeting. And here you see, here you actually see the slide of the pH measurement for reflux stop. So this was a presentation for data of reflux stop. And you see it's tons of surgeons here. And this was our symposium. And it was even more than 120 surgeons here. People were standing. It's an enormous event. Just... to describe about reflux stoppers. We are the absolutely hottest topic in the United States. It's like SMS is standing like, you know, hagel. It's really, really top, top, top for the moment. So we have more than 100 surgeons who have told us they are interested to start with reflux stoppers. So we don't really need to do any sales work at this moment. It's all about selecting the key centers. We need to do this step by step. It's not like you run 2,000 centers in the same time because we need to ensure the quality. We need to train the surgeons. We need to make a legal agreement with every hospital. In the United States, everything is legal. It's very, very serious. It's not like in a coffee break, you go to the hospital and one day later you have a signed contract with the hospital. No, no, no, no. The hospital, they have legal committees, they have medical committees, they have ethical committees. All these need to be passed step by step. And then you need to negotiate the agreement with every single hospital. And then you need to train the surgeon. So we will have a fantastic outcome in the United States, but it will be step by step. You can't, you know, run around and take several hundreds at the same time. It will be a step by step. Nicely, safe, very seriously growth, long-term sustained growth, build on high quality. 20 surgeons already trained. They have been traveling to Europe and they have seen lots of different surgeries here. They have the cadaver surgeries in Chicago. So 20, we have already reasonable trade. And here you see a little bit this process. So, you know, the hospital, they have certain process when they start with new technology. So first you have a sort of hospital sign off of the technology. Then you have the ethics committee sign off. and then you have activation of the center. It will take some time. It will go quicker to start to train than to start to sell something. If we are generous when we do the training, we can start training in a couple of months or a few months. That's approximately the time frame we have here to get going. Of course, very exciting times and We will then, together with the European Foregold Society meeting, we will bring lots of American people over and also see surgeries here in the US. Then, of course, we will be training centers in the US. So we are targeting 10 training centers in the US who should receive extra effort of training. So our main device competitor, which is this magnetic band I talked about, they have already decided to withdraw from all markets outside U.S. And I would not be surprised if they also will withdraw from the U.S. market in the near term as well. So that, of course, opens up a new market for us. Good things also that we have made cost-benefit analysis in the United States. And we have concluded that we are much more cost-effective than any other treatment. And that is very important that you both have the best treatment, but you also are the most cost-effective alternative that people love when you are most cost-effective as well. We of course have lined up and more people to employ. We already have nine people in the US, but we are now targeting to make a quite heavy expansion. And we have several of those coming from leagues, really competent people who know this treatment field and so on. So we have had many interviews and we have many more to come. And why is it now so important to have all this clinical evidence? Yeah, the answer is that if you come like a normal standard US company, you do your PMA in US, you come out with one year data, and people doesn't accept that to start to make a new treatment and operate like crazy. They do it very carefully. They want to know that data works long term. It's the five-year data. That's a completely different animal. People know that this product really works long term. And therefore, when you come with five-year data and make a launch, It's a completely different launch. It goes much faster, much quicker than you would expect a normal US company to do their launch in the United States. We have produced and are producing in total 13,000 products to be prepared for the launch in the US market. We have done a special tool for the United States as well, so we can produce in the US. and we are sort of prepared for a splash in the market. That's what we really target here. The good thing with Driflagstop is that our market is approximately 10 times larger than the existing surgical market. And now you wonder how could that be the case that your market is 10 times larger and the answer is the following. Half of the patients today, they are not operated. because they have so much swallowing difficulties, so it doesn't work. You can imagine that you have this sphincter here, and then you try to operate with the old techniques where you try to compress and close, and then you come with your esophagus has been damaged by the acid. The acid damaged the nerve ends, it damaged the muscles, so you have very weak food transportation. It's difficult to swallow. and then you come with this weak food transportation and then you try to close down here. That doesn't work. Impossible. So therefore, half of all sufferers, they are not treated. And that's what we try to show here. You have two halves. This half is the one who is operated today. The other half is those who has no treatment today. They are completely without treatment. And this half... They are all the severe sufferers, all the long term sufferers. In this group here, you have 10 times higher surgical need because they are all the really terrible patients. And that's the one who get damaged in the esophagus by the acid because they have so much acid coming up. They have it so long term. and that's why we have a much, much larger market because we don't close down. We can operate these people with severe swallowing difficulties and damages over us. It doesn't matter for us. And NHS is the public hospitals organization in UK and they have an organization called NICE. This is the most respected organization in the world to analyze new technology and do that for NHS. They spent nine months to analyze reflux stop. And their conclusion was, yes, we think you should let them operate for these patients here in the UK. So we are approved in the public NHS hospital to operate this half. They didn't even give us this half because at that time we didn't have so much data like we have today. But they gave us this half and say, okay, they have no treatment. You have a good treatment. Please go ahead. And because this is 10 times larger market than this, it's super fine for the moment. So this is, of course, fantastic when we now go to United States. And as you can see, it's 30,000 procedures only done in United States today, but we see our market as 300,000. and that you can compare to obesity surgery who had the market before the injections came. You know, it was 300,000. Today it's 200,000 or maybe even less. So, but it's the same magnitude. It's the same magnitude of treatment. One out of five Americans have acid reflux. One out of five. Here you see a little bit summarizing this. So if we just look at those who is not treated by the drugs, forget now that this disease give you cancer, forget that the drugs is terrible complications. So we just say the drugs are fine. 60% take drugs. We still have 40% to operate. And if we do that, we have 31 million people. And if we then take 0.1% of that, we have a 250 million revenue. calculated for some kind of estimated first imaginary initial price in U.S. of the product. So 1% market, which is quite realistic, 300,000 surgeries, very realistic for this huge shipping field. Then you have $2.5 billion in revenue. This is sort of long-term goals, of course. It's not a coffee break here we talk about. And you never know in life, but it just gives you a potential. Update for Europe. 66% growth this quarter, quite nice. Total revenue for the first half, 1.6 million. Some really good hospital centers we have started in different countries, of course, including one big U.S. group actually who is spread all over the world called Andersen in Madrid. Here is some examples how we have made this cost-benefit analysis I talked about in the United States. We have made them in country after country after country. Of course, a huge work, but very well spent time and money. And here is one example. It was published in an article in Italy. They said that you save money by operating with Reflex Stop. It's not only that you have the best treatment, you also save money by operating with Reflex Stop. And what happens then? Tender win, tender win, tender win, tender win. So the total we have now 2.3 million secured in public healthcare funding in Italy. This is just the beginning, and this is how it works in the budget system. You step by step by step, you get more and more real business, so to say. We have in Germany, A very good situation. We have our own code, a specific code just for the reflux spot procedure. The problem we experienced is that there is a healthcare body in Germany called INEC, and they should decide how much money you should get, and that's based on real cost. and the real cost is calculated for so-called INEC reporting hospitals. So it's a smaller group of hospitals in Germany who report every cost they have for every procedure and they get paid for that as in from INEC to do that. and they had no big reflux surgery center in that group. They didn't do reflux surgery. So we had to start from scratch and educate and train and convince people to start with reflux surgery. So now we finally have seven of these ENIC reporting hospitals who perform reflux top surgery. So now we can get going to do the surgeries that Inek Need, so they can finally say, yes, we see the cost of your procedure is this. Okay, you get reimbursed for this. 12,000 procedures in Germany, so that would be fantastic, of course. UK, I already explained for you how we are into the NHS hospitals. Spain is a nice example of what happens when you have a healthcare system who listen to the surgeons. So if you take the Swedish healthcare system, it's the admin people who decides. They don't care if the surgeon wants to do a new treatment. They just look at cost. And that means that the Swedish healthcare system is going the elevator down to the basement because no new treatment gets approved. No one pays for anything because they just try to save cost. In Spain, it's completely different. They don't have lots of money in Spain or big budgets and so on. But then the surgeon says, I want to use Reflex Stop. They say, OK, you can do that. But this budget this year, you can only do one per month. And then they do that. They do 12 per first year. The next year, they can maybe get 36, for example. And that's how it works in the budget system. You need to go step by step by step. But you see, we have 20 centers in Spain because they listen to the surgeons and patients. And this is just showing you what potential we have in our treatment. U.S. approval opens up many doors. Canada, for example, say, yes, okay, we want to be, we take the U.S. approval right away. You get approved. We have many other regions like Japan or Australia who actually take seriously with the U.S. And now we can start to operate in the Middle East that we didn't do before. South America, and so on and so on. So it opens up much more markets here now that we have been taking calmly before. We also have a new treatment area, and that's obesity, where those who operate for obesity today, they do something called gastric sleeve, which means that they cut away a big portion of the stomach, put in the trash, so the stomach gets like a proliferation of esophagus, like a tube. So you have a long, long tube now, esophagus and the stomach, and because you know that you get reflux because the sphincter glides up, of course it glides up and everything is lost a long tube. There's nothing to stop it from gliding up at all anymore. So 68% long-term get acid reflux, surgically induced acid reflux. And already after one year, 40 to 50% of these patients have acid reflux. So we are starting directly now after the summer, a combination of reflux stop and gastric sleeve. So it will be a European study here with four centers to test this. Finally, then before we start with questions, as you know, we have two fantastic platform technologies. So we have a wireless energizing platform and an e-health platform. and these is extremely advanced. It's a decade of development and it's We have 25,000 pages of patents for this ER platform. And this allows you to, we can control people's health from inside the body, and we can look at it from distance. We can have super smart implants, ultra smart implants, and we can change the treatment remotely. The doctor could be in this hospital, the patient in this home, and you can change the treatment. And we have then gone through the whole body to say, how could we now improve healthcare with these technologies? And we ended up with 300 inventions, 300. And we have then gone through them all with market analysis, product analysis, production analysis. And we have ended up with 40, what we believe, completely viable, really good, long-term, really... Perfect Implant Products. And out of these, I can tell you, we have around 10 reflux stop caliber products. So we have something in the background that could create a new Medtronic. It's the same number of products like Medtronic. It's just not done in the coffee break and it's not our priority right now. And it costs lots of money and it's lots of execution, but still... In the future, long-term, Implantica may be someone who is really attractive to own charging. and I will just give you shortly two examples of what you can do. In this case, it's people who has taken away the large intestine. They may have ulcerative colitis or some other disease, cancer or whatever, and they collect the fecal matter in a plastic bag outside abdominal wall. And it's of course not like we are running on the beach, super happy with this plastic bag with your stuff in. However, The business for plastic bags is $3.9 billion. So only these plastic bags have a business of $3.9 billion. and we can solve that. They need our device and a remote control. When I was a young surgeon, we made experimental surgery with this. We sutured the small intestine down to the anus, those who had the sphincter left, and we tried to do a little rest of our bedding and suture together, but this didn't work because in the small intestine, you have two, three liters of fluid because all the fluid is sucked up in the large intestine. And it's like you have the worst diarrhea you can imagine and no swinter could handle it. And the reservoir made it just stand there full and just overflowing. There was nothing to empty. All this is sold now. We can make a reservoir. We can empty the reservoir on command. We have a swinter who is artificial so we can handle it open and close. And people don't need any swinter. They can take away their wholly inflamed large intestine with the swinter and everything. and they fix it anyhow and they don't need this plastic bag anymore. Another example, people can't urinate. 1.7% of the US population can't urinate. They have a spinal cord injury, multiple sclerosis disease. They put in a catheter in their own bladder five times per day. Every time they urinate, they put in a catheter. If you manage to put in a catheter in your own bladder once, you have done an achievement. It's not fun. They don't need this anymore. They need our device and the remote control. Finance update. I give the word to Andreas, our CFO.

Thank you very much, Peter. I'll walk through the financial highlights for the second quarter of 2026 with a focus on revenues, margins, operating costs and our balance sheet position. Overall, We are pleased with the continued commercial progress during the quarter. Net sales came in at €717,000, up 66% compared with the second quarter of 2025. Growth was mainly driven by accelerating reflux stop adoption in the Italian and the Spanish markets. Turning to profitability, our gross margin remained best in class, This underpins the attractive economics of our business model as we scale the business. Adjusted gross margin amounted to 94% in the quarter, compared with 90% in the same period last year. So even at this early stage of commercialization, we continue to see very attractive margins. on operating expenses. The operating loss for the quarter amounted to 4.2 million euro that represented 7% improvement year on year. This improvement was achieved despite a 6% increase in R&D expenses, mainly related to the finalization of the FDA application. That increase was more than offset by lower general admin expenses, which demonstrates that we continue to manage costs in a very disciplined manner. Let me turn to the next slide to look at cash flow and balance sheet. Operating cash outflow for the quarter amounted to 3.9 million euro, broadly unchanged from the second quarter of 2025. At the end of June, we held €41.7 million in cash and cash equivalents and no interest-bearing debt. Finally, on our shareholder base, on the next page, We continue to benefit from the support of long-term institutional investors. We greatly value the continued support as we focus on making reflux stop available to GERD patients at scale in the US and worldwide. With that, let me hand it back to you, Peter.