Hi, and welcome to Episurf Medical's webcast. Pål Ryfors, the CEO, will be presenting today. My name is Martin Westerlund, and I'm from Finwire TV. If you have any questions to Pål, you can ask them in the form on our website that is located to the right. If you're watching this on YouTube, you can find that form in the description. With that said, I'll give Pål the stage. Thank you very much, Martin. Good morning, everyone. My name is Pål Ryfors, and I am the CEO of Episurf Medical. We have a relatively short agenda today, but some important information. I would like to speak about COVID, unfortunately, and we should, of course, talk about the full year results for 2020. I would like to provide you with an update about the international expansion and very exciting news this morning, the Episealer Patellofemoral System is something that we will address a little bit later. I will round this off by highlighting some of the key milestones that we foresee in the next year and years. With that, I move on. First of all, the boring slide. Why I bring this up today is because we had a tremendously positive trend during the third quarter of 2020. In many ways, that trend was stopped during the middle of Q4 2020 due to new restrictions that often were tougher than the restrictions we saw during the spring of 2020. Unfortunately, this impacted our business. It's in no way a full stop. Our current customers, many of them are still ordering Episealers, but the consultation hours are obviously decreased. In the hospitals and clinics where we constitute a new treatment alternative, obviously, it's tougher to continue to grow during this pandemic. We expect high growth rates once we are out of this. The year ended with a gross order intake of SEK 5.6 million. That was up 11%. That growth rate, we of course, saw a great volatility in that during the year, and let me focus on that for a second. We want to deliver high double-digit growth rates, and the year started very well. In Q1, we were even above 100% growth. Obviously, at the end of Q1, when the outbreak of COVID-19 started, growth leveled off quite significantly. During, as I mentioned, the third quarter, we were seeing signs of the society getting back to normal, and with that, also elective surgery volumes. As I mentioned, in the middle of Q4, that was in many ways stopped. This was a bit of a roller coaster last year, but I am happy that we could offset some of the shortfall created by COVID-19 with licensing income of SEK 1.5 million in the last quarter of 2020. Total income actually ended up 30% during the year. If we look at the number of Episealer orders and implants ordered, we ended the year up 29%, and that is higher than the gross order intake. The difference therein is explained by the fact that many or some cases are still done within studies where we can't charge the full price. We also talked about the growth in the number of double implants in one knee, and that's something that's very, very interesting. This simply means that the surgeon is using two Episealers in one knee. We are not really able to charge full price for that, so the price has been a little bit lower for those situations. That is something that we are addressing. I would like to remind everyone about the fact that reimbursement work for us is something that you really can focus on and drive when you have clinical data, something that we have now. The loss for the year amounted to SEK 63.9 million, and at the end of the year, we had SEK 155 million in cash. Rounding this section off with focusing on the fourth quarter, we can see that the total income grew by 118% in Q4 versus Q4 2019, obviously driven by the licensing income. If you look at the graphs to your right, you see the gross order intake, and compared to 2019, we were growing in Q4, not as much as we would like to, but compared to Q3, we had a negative growth in many ways than explained by COVID-19 restrictions. A little bit of a historical perspective on this slide. The darker blue area illustrates the implantations that have been deferred. Again, this is COVID-19 restrictions leading to surgeries being postponed. These surgeries will take place, and they will be invoiced once they take place. Right now, the activity is lower. The very important information here is, first of all, that we are quickly approaching 1,000 implantations. That is very encouraging. At the bottom here, you can see some key numbers. Just to make a very simple and straightforward illustration. When we entered 2020, we had 11 patients in published studies. Today, we have well over 120 patients in studies with comprehensive clinical scores, and close to 700 patients were included in an implant survival follow-up that was published at the end of last year. We are in a totally different situation today than where we were when we entered 2020. We had business in 13 countries last year. That was essentially 100% up from the year before. We now have four products. We were adding the Episealer Talus product during 2020. All in all, we are a much stronger company today than about 12 months ago. Obviously, we are investing in our U.S. clinical trial, which is the PMA pathway to a U.S. FDA approval. If you look at the cash flow in our business, and you exclude what we invest in the United States, you can clearly see a trend of increasing discipline and lower expenses. I think this is very important. We will continue to work with great discipline also going forward. However, we will, of course, invest in the U.S. trial, something we have to. On that topic, let's have a quick look on an international update, starting with Europe. Germany is our key market. In Germany, there are about 2,000 knee surgeons that we can target, and we are only working with a small number of that today. The activity levels with those surgeons is, I would like to say, very, very encouraging. Now it's all about getting out to a broader group of surgeons, something you can do with clinical evidence, something we have today. In Germany, we are continuing the expansion. In the U.K., today, I can happily confirm that the NICE process has started, and the NICE process is our key goal for the U.K. market. Being included in the NICE guidelines is somewhat of a national approval in the U.K., meaning that we can penetrate the NHS system as well as the private market in a much, much better way than what we've been able to do so far. Would like to mention France, where we are starting with the Episealer Talus and the first surgery, we announced that last year, and it's been postponed two times, I believe. It's actually taking place today, and I believe it is as we speak, so very interesting. Italy and Poland, two very interesting countries for us, and we've had a promising start, and you should look forward to more updates about those countries. Portugal is also on our radar. The launch in Portugal is somewhat delayed, and for the final time today, I hope I would like to blame COVID-19 for that, but we're moving on there. In the Asia- Pacific region, and if you exclude India for a second, we are focusing on Hong Kong, Singapore, Malaysia, Australia, New Zealand, and we have distributors signed in all of those countries, and we expect regulatory clearances in all of those countries during this year and next year. We are also focusing on reimbursement in those markets, and we have done surgeries in Hong Kong. Again, more news also from this region. India, personally, this is something I think is extremely interesting. We have a key opinion leader signed up who has an extensive network in India, and we're starting with a KOL strategy in India. Later on, the sales strategy will probably be built up by a network of distributors and also some direct sales managers in the country. We need to start with a few specialist centers and grow from there together then with our key opinion leader. We have completed the regulatory filings in India. We also have an Episurf company in India. There's been a fair amount of work in the background. This is a very attractive orthopedic market. As I mentioned, I think this is highly interesting. The Middle East, we're focusing on Israel, Saudi, and United Arab Emirates. In UAE, we actually had the first patient. It was turned down by the insurance company because we didn't have any clinical evidence or enough clinical evidence to show at that point in time. There is interest from surgeons and patients. We have some activity in Israel, again, focusing on Episealer Talus in the first instance. In those markets, we are targeting reimbursement in the private health insurance sector. United States, focus one, two, and three is patient recruitment in the IDE clinical trial. It's ongoing. We're scanning a lot of patients. We have recruited more patients than last time, and we spoke, but you will also see more updates going forward. We've taken the time to focus on a few amendments in the clinical protocol, which should ease up the patient recruitment. That process, the patient recruitment process, has been tough during 2020. We have to admit that. The changes we're making, the network we have of sites already signed for the trial, et cetera, provides a good basis for really speeding this up during 2021, and that's a priority for Episurf, of course. This morning, we also announced that we intend to file a 510(k) application later this year already for something called the Episealer Patellofemoral System, focusing then on the U.S. market. Let's spend a minute on that. Just after I have recap our financial and operational targets. You know we're focusing on clinical data, global establishment, reimbursement, and making sure we have the best technology out there, something evidenced today by the Episealer Patellofemoral System, I think. Pre-FDA approval, we are focusing on substantial growth, significant expansion of the portfolio of clinical evidence, full market access in all our markets. That is the situation where our sales rep can sit down with the surgeon and discuss nothing but the patient. We have achieved that. Again, focusing on having the best technology for these lesions. Post FDA approval, we want to achieve a 30% market share in all of our target markets. The market is big, and as we communicated at our Capital Markets Day in September 2020, this market is worth about $1 billion, so it's a significant market, and that is the market we are targeting. Talking about the Episealer Patellofemoral System. The patella in Swedish, that's the knäskålen. You can all feel it if you feel on your knee. These lesions on the patella, they're common, and they are severe. What you often have is a lesion in the trochlear area, the opposing area in the knee. MRI is a very good tool to use for analyzing these lesions. As you can see here, the patella cartilage is then damaged on both sides. The Episealer Trochlea implant, for example, doesn't have an opposing component. It's just an implant in the trochlear area. When we are analyzing potential patients, if they have a patella lesion, depending on the severity of that particular lesion, it can constitute what we call a contraindication for using an Episealer. Today in the market, there are no individualized patella buttons, as they are referred to. When you perform a total knee arthroplasty, maybe not in Sweden, but internationally, you always use a patella button or in most cases. These lesions are common, as I mentioned. For example, in one study of over 900 knees, 51% of those had knee pain, and 40% of the 900 had lesions in patella. Sometimes we have to reject patients due to the fact that the patella lesion is too severe. During 2020, we started to look at this, and we analyzed our technology, and we looked at what can we do to expand the indications for the Episealer and also what other benefits are there. We realized that we can expand to a significantly larger geographic area because the U.S. market, we foresee a 510(k) process, and we could also then quite significantly expand the indication. We can also then shorten the time to the U.S. market significantly. We are aiming at filing a 510(k) already this year with the aim of having that approved and ready for marketing on the U.S. market 2022. This will be a two-component system with an Episealer implant or very, very similar to the current Episealer implant in the trochlear area and a patella implant in the patella made out of polymer. Both of these will be based on the Episealer technology as is today. They will be individualized. The fixation will be cement, that's a difference from what we're doing today. Similar to today, we will use a toolkit and the surgical guides, et cetera, for achieving the correct positioning and depth, et cetera. Something we have been talking about many times before. Rounding this off, this project is ongoing, and we have now taken a decision to aim at the 510(k) submission later 2021. Final comments. In Q4, we executed a directed issue of SEK 66 million, and we had a very strong institutional participation in that issue. As you can see, we communicated that we are funded until the middle of 2023, and that a lot of the focus right now is on marketing, regulatory work, and reimbursement, which are the key steps in the early commercialization. If you look at the shareholder list as of December 2020, I would like to say a couple of things. First of all, this is based on the Euroclear shareholder list. We make some adjustments we think are appropriate. For example, aggregated pension accounts, et cetera, where there are hundreds of thousands of shareholders. We remove those, and we make certain other adjustments where we know that someone is behind a custody account or something, and they have said okay to use the name. If you ask us today, this is the best view of the shareholders in Episurf. Why we are focusing on this for a second is that historically, we think this has been a problem. The institutional shareholding in Episurf was not at a sufficient level, but we think it is today. We have also gotten very firm feedback from our shareholders to fix that problem, and I think during 2020 we fixed it. We also have close to 10,000 shareholders now, and we are very grateful for the support that we have seen. My last slide for today. First of all, in the very near future, there are three clinical papers in the very final stages before publication in medical journals. We had hoped to have these published last year. You never know exactly when things happen, but I can confidently say that they are in the final steps. We are also this year looking forward to additional studies on mid to long-term. As you saw a few days ago, it was announced that the five-year data was to be presented at the World Arthroplasty Congress in April. That is something that we expect to see more of, and I've elaborated a bit on that in my CEO statement in the report. The EPIC-Knee study will continue, and you will hear more about the patient recruitment updates during the year. The global expansion continues. We are focusing on the regions I just mentioned, so expect news from those. On the strategic milestones, I would like to highlight the fact that the NICE process now formally has started for us, which is very encouraging. We're moving on at full speed. Thank you very much for listening. Now it's time for some Q&A. Thank you, Pål. Like you said, now it's time for the Q&A. If you have any questions to Pål, you can ask him in the form on our website, and I'll ask them if time allows. If you're watching this afterwards or we don't have time to answer your questions, I'll make sure to send them over to Pål and his team. The first question is: visiting hospitals is difficult now as a result of COVID-19. Once the restrictions are lifted, what can we expect to be the first order of business for Episurf? Thank you. The answer to that question is more of the same, and continue to expand with new clinics, not only in our home markets in Europe, but also in the other countries I mentioned where we have regulatory clearance. Yeah, we need to do more of that and continue where we left off in Q3. Thank you for that answer. The second question is: you're mentioning that your long-term target is 30% market share in all target markets. What would you say is the most significant obstacle for Episurf in order to achieve that? Yeah, that question can trigger a rather long answer, but we are always internally discussing and reviewing what phase we are in, and it's important that we understand who we are and where we are and how far we have come and so on. If you look at our technology, we are confident that it works. That confidence precedes sort of the scientific evidence, which will come. We know that this works, and mini metal implants for this kind of knee lesions, that's not an established treatment alternative today. What we are betting on, the big bet here for us, it's not the clinical performance because we think this works now. We are betting on do surgeons want to do this or not, and we're confident they will, but it will take some time and drive that kind of clinical acceptance is probably the hardest task we have. The good thing is that it's getting easier day by day as more surgeons talk to their peers, speaking about this technology on clinical congresses now supported by proper clinical evidence and later this year or early next year, maybe publish five-year data, et cetera. The obstacle, I would say, is an accepted treatment algorithm, and we are changing that algorithm. In that, you have our greatest challenge, but I would also like to say the big opportunity. Thank you for that answer. The next question is: can you quantify how far behind you are in terms of patient recruitment in EPIC-Knee versus plan? Yes. We still have an opportunity to perform all the surgeries during 2021. Obviously, that's a very optimistic target. I would say we had a little bit of, how would you say, air in the planning already from the beginning. We are definitely a few months behind, but I wouldn't draw any bigger conclusion than that today. Okay. Thank you. How do you expect the sales will develop when you get access to the U.S. market? We think that this will be a brilliant product for the U.S. market. If you look at the Episealer Patellofemoral System, that's in the first instance, is a very strategic product because we get access to U.S. surgeons. They use the damage markings, the visualization tools we have. We can start build a network and prepare for a proper launch once we have the PMA approval for the full knee portfolio. There are 10,000, 15,000 knee surgeons in the U.S. The Episealer surgeries are often performed as day surgery in Europe today. That's an extremely attractive feature of our technology because the ambulatory surgical centers in the United States are growing in importance. This is a quick procedure. It brings people back to living life, which is our vision, and that's just a few of the reasons why we think they will appreciate this in the United States. Thank you for that answer. The next question is: could you elaborate on the news that you released this morning regarding the Episealer? Yeah, I think that's exactly a little bit what I just mentioned, that it's a great product in the sense that it's widening the indications for the Episealer. If you look at our target markets, you take very big numbers, and you make adjustments, and you work your way down to a potential patient group for us through literature reviews, et cetera. That group is growing with this product. We will always be a niche indication if you compare it to a total knee replacement. Every surgeon, they see these patients. Some see five, some see 25, some see 50, some see 100. They see them. Now they can treat more. That's very important for us. Secondly, the strategic value of getting to the United States and being able to start to penetrate that market, that's very important for us and of great value for many obvious reasons. Thank you for that answer. The next question is, could you talk more about the software leg of Episurf? Yes. First of all, we have a tremendous visualization tool, which are being used in the implant business today, and surgeons like that. Historically, there's been quite a lot of buzz around the software tool, and if you look at the orthopedic industry as such, computer-assisted surgery planning tools, et cetera, that's an extremely hot topic. We have taken down the expectations on a separate commercialization of that because what we could do is visualize something that you otherwise would see in a knee arthroscopy, which is an invasive procedure. That could be a great market. We are not 100% sure how we should commercialize that. We have not taken that off the table, and we are discussing it with key opinion leaders. Every surgeon we're working with are using the software, so they're getting used to it. We are showing not only the bone structure of the knee, we're also showing the cartilage, which is maybe a bit unique given that we're using MRIs. We have to come back to how we can capitalize on that separately. We had an opportunity to out-license a part of our software last year, and we took that opportunity, and I'm sure that there will be more opportunities in the future. I would like us for us to focus on the knee and the ankle products we have right now. We have to get back to anything we can do with the imaging technology. That was a long answer. Sorry for that. Thank you very much. Thank you, Pål, for today, and thank you to all of you who have followed today's webcast. I hope that we see each other soon again. Bye-bye. Thank you.