Ladies and gentlemen, welcome to the XVIVO Group interim report Q3 2021. I will now hand over to Dag Andersson, CEO. Sir, please go ahead. Hello everybody. Good morning, good afternoon, good evening, depending on where you are in the world. Today, Kristoffer Nordström, CFO, and myself, Dag Andersson, CEO. We are happy to present the Q3 numbers and report to you, and you will be able to ask questions, and also on the web, there will be possibility to post those questions. If we look at some of the highlights during the third quarter. We have an increase of 31% net sales, acquired growth. As you probably remember, we made an acquisition in the Netherlands, end of September last year when we acquired the Dutch company OrganAssist. We have had a good increase also in terms of machine perfusion, percentage of net sales at 53%. Gross margins continue to be strong. We have a gross margin of 78% for thoracic. For abdominal, 53%, which is actually higher than previous quarters this year. As I have mentioned to you in previous calls, we continuously increase prices, and we are now in the process of increasing prices 1st of November for thoracic U.S. and then Europe will follow in January. We have adjusted EBITDA margin of 10%, which we are also very happy with. Some of the events. We have launched a new strategy plan. I will come back to that, covering the time period 2022 through 2026. We had our first Capital Markets Day here in Gothenburg in September, which I, from what I've heard, was well appreciated, and we had a high number of attendees as well, around 100 persons in total. We participated in a strong way at the ESOT conference in Milan. ESOT stands for the European Society for Organ Transplantation. We have also delivered a fourth XPS, the lung machine, to Lung Bioengineering in the U.S. For those of you who were participating in the Capital Markets Day, the managing director of Lung Bioengineering was participating in our Capital Markets Day, and they have two sites in the U.S., one in Maryland, one in Jacksonville. We now have two machines for lung perfusion in both of these two sites, which is very positive. As regards to the strategy, we have a strategic objective, which is very clear. We want to become the global leader for an organ company. That is our objective. We have also clearly defined our economic engine, which is to measure revenue per installed machine. We have not done this in the past, but this is going to be very important key metric moving forward, because for every machine that we install, we want to maximize the utilization of this machine and hence this key metric that we measure going up. When it comes to our strategy, we define five strategic focus areas which will lead to a global or leading organ company position. The number one focus area here is to become global leader abdominal, meaning global leader liver and kidney with initial focus on the U.S. We have also as a second strategic focus area, to become market leader with our heart preservation system, and talk a little bit more about that later. We will focus on increasing penetration of machine perfusion. We know that the way to increase utilization of organs is through increased penetration of machine perfusion. That is something we focus strongly on. We are working closely with government and in different geographies to secure all instances of reimbursement. Reimbursement for our products or machines and solutions exist in a number of countries, of course, U.S., Netherlands, France, there is also strong movement in this direction now in, for example, U.K. and also in Germany. When there is reimbursement in place, pricing becomes less of an issue when it comes to machine perfusion, machines and solutions for organ preservation and evaluation. Last but not least, we know that China, in the future, at some point in time, will become the largest transplant market in the world. It's not there yet. United States is far bigger than China because China doesn't have reimbursement today, but will have in the future. These are our five strategic focus areas. I will now let my CFO, Kristoffer, talk about a little what is going on in the transplant world with activity level. Yes. Thank you, Dag. I will follow up that with financial information as well for the quarter. I think it would be good to shed some light on the transplant activity, especially in this quarter, where we saw some effects of the Delta on healthcare in general. I think this picture summarizes it very well. During the third quarter, the transplant activity, especially in the U.S., was impacted by the effects that the Delta had on the intensive care at hospitals. As you can see on this slide, the number of COVID patients in hospitals in the U.S. increased dramatically in the beginning of the third quarter. 1st of July, for example, the number of patients, 13,000. It peaked September 1st with 100,000 patients. Luckily, the decrease in September has been equally dramatic. As we speak, the number of COVID patients are down to 55,000 in the U.S. This has, of course, had an impact on healthcare capacities in general. In Europe, the trend has been more or less the same, but not far as dramatic as you can see. If you look at the lung transplants in the U.S., the number of lung transplants year-to-date is in line with 2020. There actually has been 24 lung transplants more, but it's 6% down against a more normal year like 2019. In 2021, the first two quarters show growth, but the third quarter was down 18% compared to the second quarter. In comparison to 2020, the third quarter was down 9%. However, the trend in October so far has been positive, so we are carefully optimistic. In the first 3 weeks of Q4, the weekly average of lung transplants was 49. This means an increase of five transplants a week compared to Q2 this year. In Europe, as I explained earlier, the COVID impact varies from country to country. There is no quarterly transplant data available actually. Year to date, we can see that the number of lung transplants are the same as 2020. They're actually identical. To the financial of the quarter, starting with a P&L overview and key ratios. As I just mentioned, this was a quarter affected by the Delta virus effect of intensive care. Net sales amounted to SEK 65 million, a growth of 31% compared to last year. The growth was entirely an acquired growth coming from the abdominal business area. Thoracic organic sales growth was overall zero. I guess you could say that what we lost in the U.S. due to Delta was compensated by stronger sales in Europe and the rest of the world. Regarding gross margin, we are pleased with the margins also for this quarter, as Dag mentioned. Total gross margin is 69%. It's a little bit dependent on product mix there. I will dig into the details on the upcoming slides. Adjusted EBITDA was SEK 5 million, corresponding to a margin of 10%. Decent, in my opinion, given the lower sales than expected. Year to date, net sales SEK 173 million, a total gross margin of 73%, and an adjusted EBITDA margin of 12%. If you look into the thoracic business area, net sales amounted to SEK 42 million, and as I said, means a 0% growth against 2020. Non-durable goods was 94% of sales. We had one XPS sale in the quarter, as Dag mentioned, to Lung Bioengineering. Fantastic that they have bought their fourth machine from us. We will place two machines in England and Germany very soon, which is very promising. In terms of regions, the split was basically what we are used to see. North America constitutes about two-thirds of total sales. Machine perfusion represented 38% of sales. That's quite low. For example, if you compare with 2019, the split used to be more like 50/50. Static preservation portion in Q3 was 60%. Strong gross margin, 78%, and in line with previous year. Moving over to abdominal. They showed net sales of SEK 30 million, which is a strong growth compared with SEK 9 million in the second quarter. These SEK 30 million was in line with the OrganAssist sales in Q3 last year. However, they were not a part of XVIVO then. The organic growth year to date for OrganAssist for January to September is +28% compared to 2020, which is good. As you know, abdominal more or less only operates in Europe, therefore 97% of the sales are in Europe, and gross margin, 63%, is the strongest quarter so far. Just some short comments on the EBITDA. Adjusted for one-time costs, it amounted to SEK 5 million, corresponding to a margin of 10%. The item- expecting comparability was SEK 1 million in the quarter and consisted primarily of integration costs with OrganAssist. We are now finalizing the centralization of the warehouse to Netherlands. The rolling 12 adjusted EBITDA is SEK 27 million+, and that means 11%. My final slide for today, financial position and cash flow. Cash flow from operating activities was -SEK 9 million, that was mainly due to a negative change of working capital. For example, we are now strategically building stock. We did it last quarter, we do it this quarter again. Both orthopedic, we are manufacturing XPS to meet future demand, which is good, and we are also, for abdominal, securing products for our upcoming launch since we are moving from one supplier to another. Cash flow from investing activities was - SEK 20 million, mainly attributable to investment in our heart project as usual. Cash position, SEK 285 million by end of Q3, which is in line with our internal expectations and I feel confident that we have a good cash position that is sufficient and that forms a good basis for us to reaching our strategic objectives for the upcoming strategic period. I will now give the word back to Dag Andersson again. Thank you, Kristoffer. I will talk a little bit about the R&D pipeline, let's say the most important projects where interesting progress has been made also since last quarter. I will talk first about the European heart preservation trial project where we are running a clinical trials in Europe. We have six centers including patients. We just added another German center not long ago, we are also going to add a number of new centers as well during November and December. The plan as has been communicated from the very beginning is to have the last patient in by Q4 next year and commercial launch Q1 2024. So far, we have included close to 50 patients in the European study. We also have the preservation trial in Australia, New Zealand, and two days ago we actually released a press release. I'm sure that some of you have seen it. The title of that press release is that "XVIVO has set a record for a donor heart outside the body using our groundbreaking technology." What is unique here is that the donor heart was preserved in Australia using non-ischemic heart preservation technology for seven hours and 80 minutes before successful transplantation in a 55-year-old man. By pushing the ideal time limit from less than four hours for traditional storage using ice to more than seven hours using XVIVO technology, more lives will be saved. This was a fantastic accomplishment. We are working or making progress when it comes to the U.S. heart preservation trial, and we have the ongoing discussions with FDA and the trials will start in the U.S. next year. We also have PrimECC, which has been running as critical some time. We have so far only had one site included, that is Sahlgrenska Hospital here in Gothenburg. We expect now also Oslo and Copenhagen to include patients. Hopefully also very soon to German high-volume centers. The target period is to have the clinical study report finalized by second quarter next year. That is for PrimECC. Liver Assist, which is a perfusion machine which came with the acquisition of OrganAssist in the Netherlands end of September last year. We are selling this device or this machine in Europe. We are discussing and working with FDA to define the route forward for us to be able to commercialize the machine in the U.S. The FDA routes will be concluded during this quarter. You might remember that there was a publication in the New England Journal of Medicine, which demonstrate that two hours of 2.5 hypothermic oxygenated perfusion has great sort of clinical medical advantages for the recipient of the liver organ. This is the Liver Assist project, the machine. When it comes to the outlook for the rest of this year, we are now in the final stage of preparing for the launch of the Kidney Assist Transport in the U.S. We are expecting 510 approval in the coming weeks, and we are ready to launch. We have already customers waiting for the device. We will know exactly, I think even by next week, probably the date when we will have the FDA 510(k) approval. As Kristoffer mentioned before, we are now actually installing the XPS machine in the U.K. and Germany. What's very exciting is that U.K. will, little bit not copy, but they will follow the Lung Bioengineering model. There will be one hospital, Harefield, which will be producing lungs, not only for the Harefield Hospital, but also for a few other hospitals. We expect quite good volumes in being there from this. We are also installing a machine in Berlin, in Germany, and will start a lung evaluation program there as well. As I mentioned before, we are going to have a conclusion on the U.S. regulatory pathway for Liver Assist, and we are speeding up the heart preservation and PrimECC clinical trials. At the end of the day, we will know that our vision is no one should die waiting for a new organ. This concludes the presentation by me and by Kristoffer Nordström, and I would then like to open up the floor for questions, and we will try to answer as well as we can. Just feel free to ask any questions that you might have. Thank you. Ladies and gentlemen, if you have a question for the speakers, please press zero, one on your telephone keypad. Just to remind you, for those on the web, you can also submit questions via the Q&A box on the screen. Our first question is from Ulrik Trattner of Carnegie. Please go ahead. Your line is open. Thank you very much. Good afternoon, both Dag Andersson and Kristoffer Nordström. I have a few questions. Start off, some interesting graphs you showed on the development of COVID and the transplantation numbers for lung in the U.S. It looks like we're not back to the level of when we were in Q1, Q2. How is this trend progressing? Should we interpret this that Q4 should look fairly similar to that of Q1 and Q2? To follow up on that one, these are obviously elected procedures. To what extent can you actually defer these procedures? Could this even relate to a pent-up demand? Will these organs that have not been transplanted during this period be discarded? I think if I answer the second one, then Kristoffer can talk about the Q4. When it comes to deferring transplantation, it is quite difficult to do so. You have people on the waiting list, and we know that a high percentage of the people on the waiting list, they die because it takes too long to get a new organ. I think it's not like with elective care that you can just move forward the surgery and everything will work out. People actually die on the waiting list. I think that is probably the way to answer it. If you can push, there are, of course, different categories of patients on the waiting list as well. I'm sure the most acute cases are getting a new organ. If you can defer it sometimes, then you would do it. I think you will not see an enormous pent-up demand, suddenly there will be 15% more transplantations after a few weeks. It doesn't really work like that. We can see the activity there picking up again in Q4. Kristoffer, you can elaborate on that number that you showed before as well. Yes. It's hard for us to predict as well, but the trend so far, as I said, in October, has showed an increase of the weekly average of lung transplants, three weeks, which is good, from 44 in average in Q3 to 49 in these first two weeks. I also think that if you look at the first graph I showed, the number of COVID-19 patients in hospital, it doesn't correlate to 100%, but the peak that we saw in Q3 of 100, I think could be compared with the peak that we saw in the beginning of the year of almost 130,000 patients. That is less. Hopefully that means also that the recovery can come back again. Have we seen any effects on the waiting list expanding over this time period? The problem with the waiting list is that you don't typically add patients to the waiting list unless you know that there is a realistic chance. There's no real waiting list explosion. It all depends on who is added and how you add people to the waiting list. There are always waiting lists, we know that the potential waiting list is always much higher than real waiting lists. If you look at waiting list data, there has been two weeks of decline in activations. There is a correlation between waiting list numbers and, let's say the ability and access to intensive care. I'm sure that you will see the waiting list increase as there is more access again to transplant programs with COVID cases coming down again. Okay, great. Second question relates to gross margin development. Should we not be able to see the price increases sort of affecting gross margin positively? I don't believe we have really seen that or is it too early to call out? No, it's a good question. If you take abdominal, for example, we cannot compare it with last year because we did not own OrganAssist or the abdominal product range last year. That's new. We can only compare abdominal with quarter one and with quarter two. We have seen an improvement in gross margin comparing quarter three this year with quarter two and quarter one. When it comes to thoracic, the 78%, there is a little bit different product mix this year compared to the same quarter last year. Price increases have taken place. There are also differences in gross margin if you compare, for example, our PERFADEX preservation solution compared with the EVLP offering. Product mix do actually play in here as well. That's the reason why you don't see an increase of 78% versus last year. It's also, if you compare to the same quarter last year where we had the same gross margin of 78% for thoracic and other goods. We have also invested in the organization with people also working in operations with manufacturing and so the cost base is a little bit higher, and at the same time we see the same revenue level. That's temporarily an effect as well. Okay, that's great. Two more questions, if I may, starting off with OrganAssist and its potential earn-outs. Does it look like they will reach these earn-outs in 2021? I do believe one was related to sales, right? One was related to clinical achievements and registrations. Given the progress- Yes of clinical activity, it looks like they most likely would have hit that earn-out. How sort of will this play out and what type of earn-outs are we talking about? There is an earn-out of plus EUR 2 million. EUR 2 million is paid out if we do achieve the 510(k) approval for the pediatric transport before December 31st. That we feel confident that we will get. That means an earn-out of EUR 2 million. When it comes to sales, we had quite an aggressive target for this year. The year is not over yet, but it's probably going to be challenging to reach the earn-out for sales as we see it right now, because we also know that earlier in the year, there was the impact also from COVID in Europe, even if that is less so now. I would say with certainty, certain you can never be, but with a high level of certainty that they will get the earn-out on the 510(k) approval, yes, but less likely that they will get the earn-out on the sales revenue targets. Does that answer your question? Absolutely. Thank you, Dag. Will that be booked over the P&L? Yes, it will be. We are having discussions with the auditors, actually. It will most likely be a financial item asset over the P&L, according to IFRS. Perfect. Last question on my end before I get back into the queue. It relates to your quite positive comments, Dag, Lung Bioengineering's business model on perfusion services. Obviously you have Lung Bioengineering in the U.S. Should we interpret your positive comments as that is something that you're looking into Europe as something that we should see as a potential over the next 12 months that you establish, or is there any limitation in terms of reimbursement for each geography in Europe as well as organ allocation program that limits your opportunity to do a similar type of perfusion service model? I think it is difficult, as I see it now at least, to work sort of cross-border in Europe. It is not that easy because of the difference in a model. Some countries have reimbursement, others don't. As I mentioned, Harefield Hospital in the U.K. is going to adopt, let's say, a mini model of Lung Bioengineering, where they will be perfusing lungs also for other transplant hospitals. I know that also in France, I've talked to Foch in Paris, which is the big lung transplant center. They have also expressed an interest in perfusing lungs for other French hospitals. The problem in France is that the surgeons are not that willing to give up on this, and there has to be financial incentive as well connected to this. If you look at Lung Bioengineering, they have a fantastic model in place where they only charge the transplant center if they are successfully delivering, if there is a successful transplantation of the lung that they are actually delivering to the hospitals. That is fantastic. That works in the U.S., but I think you will see national examples of centralized sort of perfusion models, not only for lungs, but also for other organs over time. That I think will grow. I see and view that very positively. Does that answer your question? It does. Thank you very much, Dag. I'll get back into the queue. Congratulations on the heart transplantation patients, by the way. Thank you. I just see here that there is a question from Johan Unnerus on the U.K., where he says that, yeah, this is an important dynamic market for XVIVO. Is Delta a concern for XVIVO over the next few months? We have regular contact with Harefield, we are installing the machine now as planned. There is a budget allocated for a certain number of XVIVO lung perfusion sessions in that hospital. We have not heard anything yet that there will be any impact from Delta on our business potential with Harefield for the time being. I think in the case of the U.K., if you centralize the perfusion to 1 big transplant hospital, it might actually make it even easier, considering the Delta variant as well, that you are doing it in 1 sort of site. The answer is that there's no concern or there is no information saying that there will be any delay in this activity or launch program. I hope that answered Johan's question. Thank you. Our next question on the audio lines is from Caroline Banér of Danske Bank. Please go ahead. Your line is open. Hello, gentlemen. Thank you very much for taking my question. On the abdominal segment, you have a very ambitious goal for 2026 of sales from abdominal being kind of at thoracic level. Could you give some color on how you plan to get there? Thanks. You want to start, Kristoffer, a little bit, how we have sort of thought about the modeling? This is one of our strategic objectives for the strategy period, to be the global leader actually of abdominal, and to initially put our strongest focus on the U.S. market. The key here will be the launches of our products, starting with the Kidney Assist. We need to ensure that we have a strong organization in U.S. that can handle the products, and we have taken steps there. We also have products that are supported by very strong clinical data that we believe very much in. It will also be important for us to continue to think of how we can make lives easier for the transplant teams. Look how we can broaden our business as well. We will have very good machines. We will have a very strong sales force, but we're also looking to if there are other things that we can provide the transplant teams with in the abdominal field. I think that is important for us. Yeah. Absolutely. I think at the end of the day, to have the best technology on the market, which in The Lancet publication and also The New England Journal of Medicine have shown when it comes to kidney and liver, and we have a commercial team with sales people in the U.S. dedicated to abdominal. I think the rest of the world we will actually share the same sales team we said, I think, for the time being, both thoracic and abdominal. We will make a big push in the U.S., which today is the biggest abdominal market in the world. We have a launch plan ready. We have customers lined up. We have done everything on pricing, and everything is ready to go. As soon as we get the type and pay approval from FDA, we just push the button and then we start selling. Thanks. That sounds like a well-thought-out plan. A follow-up question on that in terms of the planned price increases. Are you getting any pushback from clients that being in Europe, of course? What do you expect from U.S. clients and also potential competition over there? I can tell you, to start with U.S., we have not had any pushback at all when we did last year. We have not had any pushback now. We are actually implementing it on 1st of November because you have to give 30 days notice. For some reason, with all the contracts, we postponed the pricing increase from 1st of October to 1st of November. We are doing it now, and there's no pushback. In the U.S., we know that there is one competitor called TransMedics. They don't have an EVLP solution like we have, but they have a preservation solution for lungs, and they are charging nearly twice our price in consumables. I don't see any issue in the U.S. to continue to increase prices. In Europe, it varies a little from country to country, depending, again, on the reimbursement model in the country. For example, in the Netherlands, they are now introducing a more generous reimbursement model from 1st of January, and they are also actually going to make it compulsory to use machine perfusion for marginal organs. We see that we can increase prices in certain European countries in a good way, and also, of course, get higher volumes. Whereas in countries where there is no reimbursement, of course, depending on who is the budget holder and how the budget for machines versus consumables and solutions is managed, there needs to be a little bit of a different discussion. We are also preparing a lot of support material showing that raw materials are actually going up a little bit in price, and we are building a story around our price increases in an even better way this year, I would say, Kristoffer, than we've done in the past. So far so good. All right. That's all from me. Thanks, guys. Thank you. Thank you. Just as a reminder, if you wish to ask a question, please press zero, one on your telephone keypad. Our next question is from Dylan van Haaften of Bryan, Garnier & Co. Please go ahead. Your line is open. Excellent. Thank you very much. Hi, Kristoffer. Just two questions from my side. 1st one is on EVLP trends. If I understand correctly, there is sort of a negative mix towards warm perfusion. I was also wondering if you could perhaps characterize a bit sort of the OPTN weekly trends, where I can't really sort of see the COVID impact in terms of volumes, but maybe there's a difference in how that data is reported. That's my 1st question, and the 2nd one would be if you've actually encountered TransMedics, their device in tenders in the 3rd quarter, and perhaps so far this month. Okay. Kristoffer, do you want to start with the first part there? Which is a little bit the relative warm versus cold. That was really your question, Dylan, if I could. Yeah, basically. Yeah. In terms of EVLP, it varies from client to client, I think. For smaller clients, they, in general, have had much harder to focus on having their EVLP programs running rather than the big ones. We do know, for example, however, that one of our biggest companies, the UHN in Canada, that they have seen a quite significant decrease in their EVLP program of about 50% compared to last year. I guess it varies a lot between the clinics. We are far from the 2019 levels still, which was more of a normal year. What was the second question again, Dylan? About TransMedics in tenders. Let me take that one, yeah. We have not seen TransMedics. You mean in lung? Yeah. No, we have not seen them because they are not evaluating lungs, Dylan, in our way. They have a lung transplantation device, they don't have any sort of unique solution. They don't have any sort of PMA for it. No, I have not seen them in any tenders. You know that since we have sort of 90% market share when it comes to cold preservation of lungs, with the PERFADEX Plus solutions, we can very easily also monitor transplantation volumes in different geographies based on our sales of PERFADEX Plus. There is nothing that we have seen from TransMedics in any sort of tenders and discussions we have had with customers at all. Excellent. That's very clear. I was just wondering if you saw them around because they're guiding- No aggressively. Yeah. Yes. That is good. We don't see them. Excellent. Thank you very much, guys. Thank you. Thank you. Thank you. There are no further questions at this time, so I'll hand back to our speakers. okay. Were there no more questions? No more questions. Okay. I don't see any questions from the web either. I think we have answered all the questions there are, and I would like to thank you all for listening in. It's much appreciated that you take your time to listen to our reports. We talk again in a couple of months' time. Thank you all, and thank you for organizing this.