Good afternoon. Welcome everybody. As you know, Implantica is a company focusing on bringing advanced technology into the body. I will start, we should see here, to give a short background of the company before we go into the business update. First of all, myself, I'm the CEO and Founder of Implantica, and I previously made a gastric banding business with an adjustable gastric band. It was quite successful. We took 28% market share in all U.S., and this was sold to Johnson & Johnson, and I've invested around SEK 800 million in Implantica. I'm also a specialist surgeon in the treatment areas we will talk about here today. Implantica has developed two platform technologies. One wireless energizing platform. Because if you should put advanced technology into the body, you need more energy. You need to be able to supply energy for sophisticated solutions inside the body. You also need to be able to communicate with your caregiver, you need a so-called eHealth platform, and you need to be able to reprogram the device on distance. We are really in the forefront of this technology with lots of patents, lots of development, and this is a really exciting future with this transformation of the eHealth market that we'll follow during the coming years. We have also gone through the whole body to see how we can improve healthcare, how we can improve bodily functions if we have these platform technologies, and we have been able to do not less than more than 300 individual inventions. We have been sitting 70 people for three years and gone through with market analysis, product analysis, production analysis, and prototyping. We have selected 40 implants candidates that we really strongly believe could fill a good market position. Therefore, we also have a very high vision in this company. We have the vision that we should become the world leader in smart medical implants. That is actually based on all the platforms and patents that we actually have in this company. Let's then move over to the currently most important product is of course our product RefluxStop, who is already CE marked on the market. This product has a new treatment principle for acid reflux. All in the past, everybody has believed to hinder acid from the stomach coming up into esophagus, you need to compress the food passageway. It was Dr. Nissen who invented this procedure 65 years ago, and also Johnson & Johnson has a more modern product, the LINX, that do the same thing. The problem, however, is that this affects people's food passageway. People get swallowing problems, they can't belch, they can't vomit, and they can't get gas up. You swallow lots of gas all the time with your saliva and food, and this can't come up anymore, and therefore you get so-called gas bloating. You're swollen, distended in your abdomen. We find out what actually cause acid reflux. We have a treatment where you don't need to affect the food passageway at all. What we found out was that in the chest, you have pressure variations because of the breathing. It comes and goes. This pressure variation is leaking out through the hole where esophagus is passing out through the diaphragm wall. The diaphragm is moving up and down when you are breathing. These pressure variations leaks out here, and this closing muscle that should close on top of the stomach can't handle these pressure variations. If you just can ensure that the sphincter, the ring muscle here, is far below the diaphragm, suddenly everybody gets treated. We have a little device that places in the outside of the stomach wall that keep it in place like this. Actually, we have then fantastic clinical results. This slide is just showing that the side effects with drug therapy is rather serious. It's lots of complication. People wipe out their kidney, they die from cancer, and lots of nasty things happen, and that's why you really need a new treatment method. The good thing with this device is then its fantastic clinical three-year results, which I now will show to you when we start with the business update for quarter four. First of all, we have gone through our three-year results. They have been published also in a press release. We actually had no device-related serious adverse event during the whole three-year study. Between one week of the surgery and until the three-year follow-up, there were no procedure-related complication whatsoever of importance, so to say. No device explants, no esophagus dilatation, which they often do with the methods that compress the food passageway. At the three-year results, no one took PPI. We had 47 out of 50 patients still in the study. Three patients had quit the study, but when they quit the study, no one was taking these drugs, PPIs, and all of them took the drugs before surgery. This is a rather extraordinary good result. If you look and compare with our main device competitor from Johnson & Johnson, the LINX, it's the magnetic band I talked about to compress the food passageway. You can see that the difference in safety and efficacy is substantial. If you take the objectively measured pH monitoring results, where you measure how the pH level are in your esophagus over 24 hours, you can see that 42% failed in the LINX FDA trial, 4% failed in our trial. Swallowing problems, 68% had swallowing problems, 4% had swallowing problems in our study. This is a huge improvement compared to existing technology. We are also starting up with regulatory approvals, trying to get regulatory approvals throughout the entire world. We are working on 30 countries currently in parallel. There's a team of six of us who are spearheading this project, and we expect throughout this year to have regulatory clearance in other countries, which we'll be updating the market on as we get them. The most important country is, of course, the United States, and we have already had two different meetings with the FDA. What we could say that within FDA, it's a little bit different opinions. The more formalistic people think that our European study of 50 patients should have been 100 patients. Meanwhile, the surgical side of FDA seems to be willing to approve our device with the European study we have. We don't know yet what will be the outcome of this. Most likely we to file a supplement to the existing Pre-Submission to find out really how our route will be in the United States. We have been relatively successful also to get more markets to get reimbursement, because it's not only to get regulatory approval, it's also getting the society to pay for the device. In this case, we newly released that we actually are able to start now to sell in U.K., and with a good reimbursement situation. Of course, when now the COVID situation fades out a bit, this will be a quite important market for us. We have third of March, a first training session with nine different surgeons in U.K. who is interested to start, where we go through the surgical technique and the results and so on. Also, we are happy to announce that we have received our own OPS code in Germany, and that means it's a designated operation and procedure system classification. That means now we have our own code, and that means that first of all, the hospital, there is no question they put in our code, and they get their funding. Also the German Ministry of Health are able now to track our device. They can see the fantastic results we actually have with this device. This is a big step forward in Germany. You need to know, of course, that currently it's not so much surgery going on in Germany. They have a vaccine situation who is like Sweden or similar. Meanwhile, in U.K., it's starting to be a little bit more hopeful where at least they have vaccine enough to vaccinate people. Also, we are preparing our registry study, which means that in Germany, Switzerland, and U.K., we will collect data from the RefluxStop procedure. We will give a little bit of discount on the sales price, and we will have all this data collected. It's actually led by the largest university hospital in Switzerland, Dr. Borbély, who's the lead surgeon for this trial. That will allow us to collect rather lots of data. You need to know that in Germany, it's 12,000 surgeries performed with our device. That means if you take 4,000 for a device, that means EUR 48 million. That's the existing German market. However, when we started with our gastric banding business, we realized that markets that is under dimension, the results are not so good for these surgeries. They could grow quite quickly, and you can have five, 10 times growth if you're lucky in the market where it's not so good treatment exists today. We also are focusing on another study. We are also developing a randomized clinical trial. This will be necessary to achieve reimbursement in France. We are hopefully within the next coming months, going to be approaching HAS, which is a French health ministry, and putting in a submission to try to get a Forfait Innovation, which will they allow them to actually pay for the study and pay for the device. We would be targeting probably around 100 patients, following them for one year. We would also intend to include patients in the U.S. to also get reimbursement pathways starting in the U.S. as well. During this quarter, we have of course also focused lots of product development, as you understand, because we have promised the market to bring more products to the market here, and one of these products is our new device for treating and controlling appetite called AppetiteControl. That's, of course, a very exciting product because it's integrating both the wireless energizing platform and the eHealth platform, and will allow, with a very easy, quick procedure, half an hour, that people could control their appetite basically with a remote control or fully automatic system where the doctor could, on distance, reprogram the device. This will be a real landmark. We will be in the absolute frontline of the eHealth transformation when we have this product on the market. We are also working in the urology field. As you know, we have two devices. One is the remote-controlled urinary sphincter. Another one is a device to empty the bladder for people who can't urinate. It could be you have a spinal cord injury, you have a disease called multiple sclerosis, for example, and you can't empty your bladder. You need to put in a catheter five times per day to urinate. That's a very, very burdensome life, and it's around 100 million people we have with this disease worldwide. This is a parallel project to develop also this device. Of course, COVID-19 has impacted us like other people, and things slowed down a little bit, especially, of course, the sales expansion. However, we have tried to use instead the time to have webinar education. We had quite many, I think between 20 and 30 German surgeons have gone through our webinar training, and we have been working very heavily, of course, with the reimbursement and the regulatory approval in more countries. It will come more news about this step by step when we succeed in different regions. I think I will also leave the word here now for our CFO, Andreas Öhrnberg, to continue a little bit about the finances. Thank you very much, Peter. Let us turn to slide number 25. Here we recap some key financial characteristics of our business. Being mindful that existing investors have seen this, we can summarize this slide in three points. Revenue potential. RefluxStop, our lead product, is going after a multi-billion market opportunity. In terms of margins, what we experience today as well as what we forecast for the future, you see elevated gross margins, which you also will see in our P&L. In terms of investments, as communicated in connection with IPO, we invest our capital in two areas. That is commercialization initiatives as well as product development. Let us turn to slide number 26. We have two slides on financials, one P&L summary and one balance sheet summary. We express the P&L in EUR 1,000 and the balance sheet in million euros. Upper graphs you see on the slide, that represents Q4 numbers, and the lower graphs represent 2020 numbers. First look at sales. We are in an early commercialization phase of our lead product, RefluxStop. In 2020, sales increased to EUR 152,000. Looking at our gross margin, we are very encouraged by the exceptionally high margins we are achieving, even though the business being subscale in most areas. In 2020, gross margins amounted to 97%, up from 90% the prior year. Turning to EBIT. Looking at our operating loss over the period, which amounted to EUR 10.6 million, which was an increase of EUR 6 million. Looking at that and want to make an apple-to-apple comparison in order to understand how the underlying cost base developed over the year, one needs to do two things. One needs to adjust for IPO costs as well as the consolidation of Implantica MediSwiss AG. When one does that exercise, one can see that the underlying OpEx amounted to EUR 5.7 million, which is an increase of EUR 1.5 million over the 12 months period. Hence, the change over the period is materially smaller than the headline number. Turning to slide 27. We closed the year with a very strong balance sheet. At the year-end, we held cash amounting to EUR 97.5 million of cash in the bank. We had an equity ratio in the region of 99%, carrying no interest-bearing debt. With this, I would like to hand it back to Peter. Yeah, we have put forward also a slide here where you can see the main shareholders. We have really powerful shareholders in this company with Handelsbanken, Swedbank, TIN Fonder, Nordea, Skandia, Unionen, If, and so on. We are really, really happy to have so powerful shareholders, and we hope really to be able to cooperate with them in a good way in the future. I think that would be enough from my side, and we can open up to some questions. Thank you. Ladies and gentlemen, if you have a question for the speakers, please press zero one on your telephone keypad now. If you wish to withdraw your question, you may do so by pressing zero two to cancel. Once again, that's zero one if you wish to ask the speaker the questions. Our first question comes from the line of Christian Lee of Pareto Securities. Please go ahead. Your line is now open. Christian, your line is now open. Hi. Did you say my name, Christian Lee of Pareto Securities, perhaps? Yeah. Okay. Please, welcome. Okay, great. Thank you. Thank you for taking my questions. I have a couple of questions here. You mentioned that you have had two meetings with the FDA, and the next step is likely to be a Pre-Submission supplement, leading to a third meeting. I was wondering if you could elaborate what kind of feedback you have got in the first two meetings, and what you need to add in supplement. Yeah. During the first meeting, we should go through the whole submission and discuss with FDA, but we had not less than 10 people from FDA attending, which was much more than expected. The whole meeting, we were not able to finish. We were just not halfway when the hour we get is finished. FDA is a rather precise bureaucratic organization, so you file your submission, you have your hour, and that normally is it. Because we had not finished, we got another meeting, and that was decided that we should have that with the surgical expertise. We then have a meeting with the surgical expertise, and basically, it's all about if our trial in Europe will be accepted as the trial for getting approval in United States or not, or if we need to do a second trial, which then could take a year, for example. It seems like the surgical side are convinced we should have the approval based on our trial. Meanwhile, the more formalistic side of FDA is more concerned. They want their 100 patients, that is standard more, and so on. Now it will be internal discussion within FDA, and we will need to file another supplement submission with our new data. We filed originally with one-year data focus. Now we have three-year data. We even have four-year data coming out. We will file very quickly, and then we will have another meeting to find out finally, hopefully, what pathway we will have. Okay. you're planning to release your four-year data anytime soon, sounds like. We have offered FDA that we should be able to supply the four-year data for them for this approval process. That they were, of course, really happy with that. It's very unusual that you have so long-term data. All right. Okay. When do you expect to release the full four-year data? Oh, that's a hard question to answer. I could not answer that right away. Yeah. Sure. If you would make a more extensive study in the U.S., when do you expect it to start? Do you believe that your current cash position would be enough to finance such a study? Our cash position is definitely enough to finance that study. If you get a lighter and faster approval process instead, you probably then need to make the study to get the reimbursement. It's not so big difference. If you need to do a new study for the approval process, you can do that in a way that it could help you also for the reimbursement and the opposite then. It takes a couple of years in United States, but it's of course a huge, nice market that we are looking forward to. Yeah. You mentioned that you have regulatory processes for reimbursement in 30 countries. In what countries do you expect to receive regulatory clearance during 2021? Yeah. We hope that countries like Australia maybe, Canada maybe, Mexico, Chile, Hong Kong. There is a long list. Step by step, we will get more and more countries. Some are more difficult. Japan, for example, takes longer time with the study. On the other hand, you can probably sell in Japan directly to surgeons beforehand. Every country is different, and it's a complex work. Many people are working on this in parallel here. Okay. Thank you very much. I will jump back to the queue. Thank you. Thank you. Once again, I remind you, if you do have a question for the speakers, please press zero one on your telephone keypad now. We currently have no further questions. I will hand back to the speakers for any final remarks. Okay. Yeah. I would thank you all for listening, and we are trying our best to really build a large company and then try to fulfill what everybody wants. So far, I think everything is going as planned, except a little bit delay because of the COVID situation. That I think everybody is aware of. Yeah. Once again, have a good afternoon, and thank you very much.
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