Hi, 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. I'll give Pål the stage. Thank you very much. Good morning. I would start by mentioning that I'm suffering from a terrible flu. It's not COVID. I've been tested, and I've actually had that quite recently, but I will be coughing quite a lot during this presentation, so my apologies in advance. Apart from that, I'm very happy to present our results and business progress for the first quarter of 2021. I have a short presentation, and I will follow the following agenda. I will speak about COVID-19, the Q1 results. I will provide a business update, and we will wrap up by looking at the key milestones for the coming years and a Q&A. Let's go. This slide, the COVID-19 remarks, this slide is unchanged from the last time we met in middle of February. You might recall that I was very skeptical about the progress given increased restrictions in our markets that we experienced were much tougher than what we experienced in the spring of 2020. Despite that, the quarter actually turned out quite well or even very well. We cannot say that this is over. If we have learned something is that the restrictions change quickly and from one week to another, a region in Germany, for example, can be more or less completely closed. Our customers are operating on far from full capacity. Please remember that. The day this is over for us, make no mistake, I will be the first one to tell you. Looking at the first quarter results, this is our best quarter ever. Our gross order intake amounted to SEK 2.1 million, which represents an increase of 30% year-on-year. No less than 90 EPISEALER implants were ordered during the quarter. That's an increase of 30% year-on-year. 34 surgeons ordered implants. That's an increase of 55% year-on-year. That figure is a figure I am particularly happy about today. Related to that, we actually did business in 11 countries, which represents an increase of 120% year-on-year. Very important for us. I will explain more later. Clinical data with five years follow-up was presented at the World Arthroplasty Congress just at the start of the second quarter. That's a huge achievement. The results were very strong, and they point to the fact that the EPISEALER works for up to five years, and we hope to see more details on this study later on. This is now the second time we see promising early data on five-year follow-ups, and this is extremely encouraging. The loss for the period, slightly better than last year, SEK 16.7 million negative. At the end of the quarter, we had SEK 137 million in the bank. My final comment here relates to strategy execution. When you're early in the commercial phase, it's very important that you identify the key drivers and key indicators, and they all point to the right direction for us in this quarter, and especially this relates to surgeon activity. If we look at how the years 2019, 2020, and 2021 have started, you can easily track that on this slide. Last year started pretty well, but then leveled off quite significantly at the end of Q1. This year, despite even tougher restrictions, the growth has continued, and this creates a stable and strong base to continue to grow from. I mentioned the key ratios, the gross order intake, and the number of EPISEALERs approved increased by 30% year-on-year. Net sales, however, increased only by 9%. I would also like to address the difference between those two figures. Before that, just again, looking at the historical development of the implant portfolio, and as a nice round figure, doesn't mean much in reality, but it's always nice to communicate, we had our 1,000th implantation booked during the quarter. Back to the topic of gross order intake, order book, and net sales. In our business, when a surgeon orders an implant, we account for that as gross order intake, and we send the invoice at the time of surgery, meaning that not until then, it is reflected in the P&L. Surgeries can definitely be spread out over a longer time period these days. They try to find a surgery date later on in the spring maybe, and that's why the net sales doesn't increase as much as the gross order intake. The order book that has been built up now amounts to SEK 1.8 million, and this SEK 1.8 million represents EPISEALERS that will be invoiced in the coming months. That is also an increase of 71% year-on-year. That is a pretty substantial increase of the order book. Previously, we have referred to this as order backlog as well. Going back to our financial and operational targets, I think this slide is very important, and I think I will always bring it to these occasions, and it relates to clinical data, global establishment, reimbursement, and technology. Up to an FDA approval, we have committed to deliver substantial revenue growth. Although we will never be satisfied until the absolute figures are where they should be, significantly higher than today. We are delivering high growth rates, and I would dare to say that without COVID, the growth rate would have been significantly higher. The portfolio of clinical evidence continued to expand, and five-year data is something that's very important to deliver, and that's nothing you should take for granted in a business like this. Full market access in all our markets, you will see an international update on the coming slides, but as you will see, we're making good progress and the industry's best implant technology for population. I think that's best evidenced in quarter by the progress with the EPISEALER Talus, the ankle implant. That's what I would like to focus on today. The market is big. There are well over 2 million knee replacements in our target markets every year. About 350,000 of those, we estimate could be potential EPISEALER patients. In our target markets, there are also more than 20,000 orthopedic surgeons. This is a big market, and knee surgery is prestigious. It's big. It's the biggest segment within orthopedics together with spine. The burden of proof for establishing yourself in the industry and in the treatment algorithm is very high. We are, I dare to say, absolutely on the right way. Patients need this product, surgeons need this product, and the product seems to work now over a very long time. Moving on with the international update. I mentioned that global establishment is a key strategic cornerstone for us. These are all countries that we are working towards in one way or another. U.S., of course, being potentially the last and biggest piece to the puzzle. In Q1 last year, we did business in five countries. We had presence in more countries, but that was what the activity looked like. The relative size of the flags here indicates the relative weight in the gross order intake. Look at the progress in Q1 2021. No less than 11 countries. This is great progress. Looking at how the surgeons behave, we could see that the 22 surgeons that ordered EPISEALER implants a year ago, they had an annualized run rate of 12 implants. That means that they did on average three implants in the quarter, and simply annualizing that figure turns out to 12. This is a very important metric that we are following daily and hourly, and by minute, I dare tell you. We need to see growth in this figure. Now we're adding several surgeons, 34 surgeons, with a slightly lower annualized run rate, easily explained by COVID because consultation hours are far from full capacity, as I mentioned. We also know when an orthopedic surgeon gets confidence in the data, in the procedure, this leads to an increase in usage. We are seeing that our top surgeons, if you so like, the guys that have used the EPISEALER for quite some time who are really comfortable, they are beyond the point of where they need more data, et cetera. They're comfortable with this. They use this every quarter. They have a steady patient flow, and we need to deliver more and more surgeons and customers globally into that group. We think we will be very successful in those efforts. Again, rounding off with this very important slide, which illustrates that we have gone into something that's hard and it takes time, but today I can really say that we are on our way. Moving on to the shareholder list. If you look at the shareholder list on our website, for example, you can often see custody accounts and difficult-to-identify names on the shareholder list. Where we can and when we are allowed to clarify that list and be transparent about the names behind various accounts, we try to do that. This is what the list looked like at the end of Q1 to the best of our knowledge. I'm very happy to conclude that at the end of Q1, we actually had well over 10,000 shareholders. Thank you very much for your support. Looking ahead, just as we prioritized last year, the milestones that are closest to materialize relates to clinical milestones. We have several papers that we expect to be published very soon. I've said that before. I know that. Nevertheless, these processes are difficult to estimate in terms of timing, but we know that they are in the very final stages. We have added a tick mark to the slide in this quarter with the early data from the European CPL study with the five year follow-up, and we hope to see much more of that later this year or potentially early next year. The patella project, the EPISEALER Patellofemoral System that we announced at the time of the Q4 report is going on well, and we are committed to our goal of submitting a 510(k) application later this year for a full approval potentially mid next year. On the global expansion, as you've seen today, we are taking steps there. We're doing great progress, and we are working through the regulatory timetables in a great number of countries, and we think that's the right thing to do because when this takes on and this becomes a well-known and in many ways standardized alternative in the treatment algorithm, we want to grow in as many countries as possible. That was actually it for today, and I will invite the Q&A session. Thank you very much. Thank you, Pål. Like you said, now it's time for the Q&A. If you have any questions to Pål, you can ask them in the form on our website. I'll ask them if time allows. If you're watching this afterwards or that 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: "Can you elaborate on the new patents that's been approved in Hong Kong and in the U.S.? Yes, I can, but that's actually potentially the question within Episurf that is very far away from my knowledge. We have worked with our IP portfolio on patents for consistently since the beginning actually, so about 10 years. We have had a strategy of filing a broad patent portfolio globally, and it also must cover several parts of our technology, meaning not only the implant, but very much so the instruments and the software. I actually can't comment on these patents specifically. I simply don't have that in front of me. It all relates to a greater strategy that follows the commercial strategy, which focuses on global establishment. The IP is something that we have worked with, I would like to say, very well from the start in Episurf. Thank you, Pål. Moving on to the next question: "You have reached a significant milestone of 1,000 implants. What does that mean for Episurf? It doesn't change anything. It's a nice round figure to use in marketing. The important thing is that many of those patients are included in clinical trials, and many of them have now had the implant for quite some time. Although we cannot with 100% certainty say that we know exactly the status of each and every patient, regardless if a patient is in a clinical study or not, a surgeon who sees a great outcome for his or her patient two, three, four, five years up, that creates that confidence I just spoke about for that particular surgeon. The 1,000 figure actually says that we have a lot of happy customers out there and a lot of happy patients out there. I think that's the most important thing. Thank you for that answer. The next question: "Can you elaborate on the distribution agreement you have with Australia and New Zealand? Yes. The distribution agreement, I won't provide any details, but what is very important is a company like us, as you've seen, we haven't expanded our cost base in many years and the number of employees I think is flat now since many years. We are trying to find efficient ways of working internationally. The distributors, in our case, they play a very important role when it comes to regulatory filings in various countries. When we find a reliable, credible, trustworthy distributor, that is a partner many, many months and often years before any commercial activity takes place. I would say that is the key, the point that is very important for us. We would never choose a distributor that we don't believe in. We have full confidence in all of our distributors, and I believe that we could potentially launch in New Zealand before Australia. The latest these filings should be concluded, completed next year. Thank you, Pål. The next question: "What's your hope and vision for the remainder of 2021? As I mentioned in the Q1 statement that was released about four or five minutes ago, we need to expand our marketing activities as much as we can. It is difficult to be out there physically, but we're doing what we can, and we will take every opportunity we can. Now, please remember that clinical data in any size or form, we didn't have that until late last year. Before that, we had an excellent study, but it was smaller, and we needed more volume. Now we are in a totally different position. We must be out there and market and be visible to surgeons and I mentioned our cooperation with ESSKA in the report, which is a very important organization. We will work together with them, and we will do everything we can when it comes to pure sales activities, webinars, congresses, whether they are digital or not, and market our results because they are good. We have nothing to excuse ourselves for anymore in quite some time. Thank you, Pål. The next question: "Your cash reserve looks to be quite significant as of now. Are you planning on allocating your money on something other than patents? Oh, in terms of cash funding, I don't expect any significant reallocation of what we have seen in the last quarters. The U.S. clinical trial, the EPIC-Knee Study is a big project for us obviously. It is also costly, of course, very important. The marketing activities I mentioned in Europe, we will expand. The most important factor there is our sales reps, and that's the sales force we have had now for a couple of years. In terms of financial capital allocation, I wouldn't expect that to increase significantly during the year. A bit of a boring answer, a little bit more of the same, but I think that's okay to say when things are actually going in the right direction. Okay. Thank you, Pål, for your presentation and your good answers for this Q&A. Thank you to all you who have followed today's webcast. I hope that we see each other soon again. Bye-bye. Thank you.
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