Welcome to XVIVO Q2 report for 2023. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. I will hand the conference over to CEO, Christoffer Rosenblad, and CFO, Kristoffer Nordström. Please go ahead. I want to welcome everyone to the earnings call for the second quarter of 2023 in XVIVO. With that, I turn to slide number 2 in the deck, just with pictures of the two presenters. It's me, Christoffer Rosenblad, CEO for XVIVO, and Kristoffer Nordström, CFO for XVIVO, on today's call. First, giving a presentation and then answering questions from all of you. With that, we go over to slide 3, which is the Q2 finances at a glance. To start with, we are pleased with the quarter, with strong sales, strong growth. We continue to see strong growth on the organic side. We are helped by especially the strong U.S. dollar on the currency effect. We continue to see strong EBITDA development. We have said that our financial goal, 2027, is 30%. We are progressing towards that goal. I said it before, and I say it again, we could reach that tomorrow, but we believe we have a market potential being 100 times bigger than the one we see today. We want to invest towards that very big market opportunity. If we look on the right side of the slide, I'm pleased to say that we see continued good progress, especially in all our segments, thorax, abdominal, and services. Good organic growth for disposable products and case revenue in the services case. I especially want to point out that the abdominal disposable gross margin on 70%, which was the goal we set to reach during the strategy period. I'm very pleased and happy to report that already in Q2 2023, we have reached the goal of 70%. We, of course, want to, from now on, improve that also. We see on the thorax side or thoracic side, that the abilities to have higher margins in the market environment we are, is there. So that's definitely good news. I'm also very pleased to inform and report that the integration of our 3 latest acquisitions have progressed according to plan, and that they are significantly contributing to the high growth we see both YTD and in the quarter. We have definitely stabilized the STAR Recovery Services in the U.S.. As we have press released during the quarter, we will now start integration of that service model and our products. We will also investigate a possible perfusionist model similar to the one we see in Italy, and that will be tested in a few clinics to come. I also want to say, once we are talking about high growth, that we are currently building up our production capacity, and we have delivered without back orders, but we see a very fast increase in demand for our products in the market. We have already started a project to build up production capacity for 10 times for disposable products. We have three types of products we supply to our clinics, and one is solutions or fluids, one is machines, and one is the disposable sterile kits. For both machines and fluids, we feel we can scale up fluids definitely by 10, and machines we can scale up over time. However, for disposables, we do feel the need to invest right now to scale up times 10 within for heart and liver within the next 12 months, and then later on, also for Kidney Assist Transport and lung products. We think the cost is pretty limited. It's a maximum investment of SEK 50 million during 24 years, and we see a very good ROI on this investment, not only from scale, but also that we can redesign some of the products to get lower cost per kit. We will be able to do an investment and get the money back in a quick time. If we turn to slide 4, I won't stay on this slide for too long. It's the YTD, Q1, Q2 financing at a glance. Key message is that Q2 is not just one quarter. We see a continued progress according to our strategy with organic growth on 39% and EBITDA level 18, we see growth in all our product areas with improving gross margins. That's the key message and key takeaway here. In terms of numbers and drivers behind the numbers, our CFO will give you further details later in the presentation. We get the ability to ask Kristoffer Nordström all the questions you have on the finance side. We will instead of dwelling on this slide, we will go to slide 5, which is the Q2 highlights, and we will focus on the progress on the Heart Technology and the STAR integration in this quarterly call. We had progress in all our product areas, but we want to focus on those two in the highlights section. We start with slide 6, the European and Australian Heart experience. To start with, I'm very proud and happy to present that we have finalized inclusion of the regulatory study in Europe. It was a very big study with 202 patients, 15 leading transplant hospitals from 8 European countries. Just the logistic of running the trial was immense. I'm happy to say that the feedback we got so far from the leading KOLs in this in the study has been very, very positive. They really love the experience with the Heart Technology. We are now, I'm going to come to that little bit later. We are now targeting definitely that we can launch it next year, hopefully in Q2. Are very pleased to say that we have already started that regulatory work now. It's now at the hands of our regulatory body or notified body. If you look at the Australian, New Zealand experience, I reported last quarter that we are seeing very good market penetration even before regulatory approval. I can report that we see the same picture in Q2, where roughly one quarter of all heart transplants are done with the XVIVO Heart Technology, which is truly impressive considering it's prior to regulatory approval. It means that the users really loved it. We will, just for your information, do the same in Europe. Not in all countries. We will not apply for compassionate use, but in a number of countries, we will do that where we think it makes sense in Europe as well. We have activated four out of five trial sites, and the fifth will come very soon in Australia, New Zealand, and then we have full coverage there. The reason for having high compassionate use is probably the most interesting for this product because it tells most about the future. The main reason is that maybe twofold, but one is that the clinical data is convincing so far, what we have seen. The data we saw from during the ISHLT was very convincing with, for example, in Australia, no 30-day mortality. We could prolong the out-of-body time to more than double of the generally accepted four hours, et cetera, which is compared to standard of care, is a very impressive number. The other thing where we see it's the XVIVO Heart Technology, or explanation for the use of the XVIVO Heart Technology even before regulatory approval is that seeing is believing. We hear from almost all our users that they see on the first heartbeat after using our technology, that a heart is in better shape. The first punch the heart takes after transplant is like it never been outside the body. Normally, in a heart transplant, it would take, could take a couple of beats to even long ECMO time to get there. We feel very strong that this product will be a paradigm shifter for the transplant industry as we see it. Also, more important to that, it also when seeing is believing, they see that the heart is performing good, it definitely gives confidence that the technology works and that they want to use it more. One last thing which we have heard, which we don't have data, we will definitely look into this more, is that aftercare, and especially ECMO usage, is less frequent using our technology versus standard of care, which is also another, let's say, not proof, but it's another arrow pointing in the right direction that the heart is in better condition after using the heart technology. We can not fully explain this today, but we have run a study where we can see that one of the reasons are that we have higher cell survival on the endothelium after using our box. That could be an explanation, and more will come, and we are running a couple of studies to try to explain fully why we see those good results from the heart technology. With that, I will go to the next slide, which is the Heart Technology in the U.S. Here I think it's the best news during the quarter I want to highlight, it's that we got the IDE approval from the FDA. That was great news, by the way. The best news is actually that we got a request from the FDA to investigate if we could include the DCD in the study as an inclusion criteria. This is fantastic news for many reasons. One is that the donor pool in the United States in 2022 is roughly one-third of the donors are from the DC pool and two-thirds from DBD. The other reason that is fantastic news is that this will, of course, we would like to attack that pool sooner or later, but this saves us four years in come to market doing that. It will also save us actually a lot of money in not running two separate trials. This was fantastic news from the FDA during the quarter. We expect, and we have said that we expect the study to start enrollment end of Q3. I have to point out now that that's still our goal. We are working really hard towards it. However, the fact that we have to negotiate the DCD inclusion criteria with the FDA might prolong first patient in a month or two. Again, that is really worth it if we can come four hours faster to market with the DCD inclusion, that is already one-third of the American donor pool and is growing double-digit a lot faster than the DBD donor pool. It will soon be at least 50% of the donor pool in the U.S.. It's definitely very good news. I'm also happy to say that when it comes to the U.S. trial, we have really the best transplant center engaged, the best KOLs, high impact center, large center in the U.S.. I'm really looking forward to going to the U.S. and meet sites and see how the trial is progressing over time. With that, we go to the next slide, which is slide number eight, and also some very encouraging and good news. We have press release that we will start integration of Star into XVIVO. We will have one brand, one strength and value proposition, one organization. Everybody wants this, XVIVO, all employed in the Star, and also our customers. We will focus on becoming a preferred partner in the transplant process, and to do that, we need to have a combined service product offering. We see that's we can finally accomplish that. We had also, due to the fact that we had to focus on the processes within STAR Teams, we have prolonged both the integration until now and also the acceptance of new contracts. Now we feel we are in a good shape, fantastic shape with our service offering, and we will now start accepting new contracts and integration, which start immediately. I'm also very happy to present our latest strategic collaboration. It's an aviation company called MTJ Aviation in the U.S., and this collaboration will enable reduced logistic complexity, reduced costs for the transplant teams and hospitals, and a lot easier working environment for our staffing going out and recovering organs. I think I'm very happy for this collaboration. We will have dedicated aircraft for three primary hubs, with an intention to grow that if we see the need for more hubs with an increased service offering and product offering. Again, great progress in our service U.S. operation, and I strongly believe that more to come. There will be one-time cost associated with this, and we have already flagged for and taken SEK 11 million in this quarter, and we believe there will be an estimated another SEK 11 million during second quarter of the year or second half of the year. Good, great. With that, we go over to the clinical pipeline and slide 9, which is the right slide. We step over to the slide 10, and our status in clinical trials and the timelines. If we start with the heart and the U.S., as I said, very, very good news. We expect to get the first patient in very soon. The trial will include, with the current trial design of 100, will include 141 patients. As I said, high impact centers engaged. I met most of them during April, and I feel very positive towards this trial. It will be interesting to follow it. In Europe, as we have stated earlier, it's all included patients. We will now look at the data. We have submitted the technical files to the notified body, et cetera, and we will now work closely with our notified body and competent authorities to enable a regulatory approval and a commercial launch in Q2 next year. I want to point out two things. The first 1 I already said, it's about the DCD that might prolong the start of it, but we shorten time to market for DCD. The other 1 is that, with regulatory approval in Europe and the MDR, and with notified body, we can affect our timeline, and we all have met all of the timelines for submissions. It's hard to affect the notified body. They are under a lot of stress due to MDR. It's hard to promise anything in terms of regulatory approval. As I stated earlier, we will investigate compassionate use, et cetera, so we believe that we will have commercial product on the market, being used, gathering more data and more experience, anyway. Australia, I think I said most of it. We have a very good results, encouraging results from that study, really pushing the limit of what we can do in heart transplantation. To point out in terms of go-to-market strategy, the Australian regulatory approval will be pending CE mark. I think we expect that to come shortly after we expect the CE mark. We have the last piece of regulatory approval and clinical trial, and that's the liver and the U.S., or access to the U.S. market. We have a very good product. Liver is probably our fastest-growing product right now in Europe. We have very good clinical results, and more and more clinical, and convincing clinical data is coming out every quarter. Of course, we want the U.S. market to also have access to this product. We are granted Breakthrough Device designation by the FDA. We are in a trial design and planning phase. We will start to actually investigate or investing towards that liver organization already now in 2023, 2024. We are investigating the possibility of having a U.S. heart PMA trial parallel to a liver PMA trial and to accelerate the time to market, I will come back as soon as I have more information on that investigation. That would definitely be great in terms of time to market for both the liver and the heart DCD products. On the next slide 11, we have PrimECC, as you know, last night, we sent a press release that we will stop patient inclusion, look into the data to evaluate strategic options we have. The reason for this is partly that we saw a quite slow patient inclusion, and we want to know why. The other reason is that we are getting more and more focused by the day. I said earlier that we have an opportunity, that it's a market opportunity that's 100 times bigger than we see today, which is roughly 10 times more in volume and 10 times more in value for machine perfusion versus standard care today. We see that we need to focus in order to capture that opportunity, so that's partly it. We have, PrimECC is a fantastic product. What we have seen so far, it's used to prime heart-lung machines. It's a CE mark patented solution, and we would look at it, the data, to analyze it, and then after we have looked at the data from this, the patients we have, we will evaluate next step going forward. We have decided that we should do that before the end of the year, and we hope that we can come back before the end of the year with strategic options for this product. I also want to make sure it has no impact on 2027 financial targets or any day-to-day business in terms of XVIVO, just to be clear on that. With that, I turn to slide 12. I hand over the word to our CFO, Kristoffer Nordström, that is actually on the picture. I see right now. Thank you. I come back the last two slides again, and for questions. Thank you for clarifying the picture, Kristoffer. Good. Yeah, no, Kristoffer has given a very good overview of this great quarter so far, I will spend a few minutes here on discussing the numbers further, in many aspects, this was a record quarter. I mean, it was record sales for the business areas. We achieved the milestone of 70% gross margin on abdominal, EBITDA was strong, et cetera. Overall, we are very content and satisfied with the quarter, and the trend that we see at the moment. A little bit about numbers. Net sales came in for the quarter of SEK 155 million. That's a 64% increase year-on-year. Most importantly, the organic growth was strong, 46% in the quarter. Gross profit increased SEK 48 million to SEK 115 million. That's a big jump up. We delivered a strengthened total gross margin of 75% versus 72% last year. Both EBIT and EBITDA were strengthened significantly versus last year, and we also achieved a sequential improvement versus Q2, which is great. EBIT margin 10%, EBITDA at 19%. The adjustments that we present when we talk about adjusted EBIT, EBITDA margin, that is related to the integration costs in the U.S. as previously announced. Year to date, sales amount to SEK 295 million, a growth of 58%, whereof 40% organic. Year to date, EBIT 9% and EBITDA 18%. I will move to the next slide and go into the business areas. Thoracic performed well again this quarter and continues to deliver growth sequentially. Net sales amounted to SEK 105 million. Organic growth for disposables was 47% in local currencies. The main driver for this growth is EVLP, that is, of course, what we want to be the main driver, right? In Q2, EVLP activity was especially good in the U.S., where volume growth versus the first quarter was significant. If we stay on the lung side, we sold one XPS machine in the quarter, our first machine to a country in the Middle East, which is exciting. We expect that the next quarter will be a little bit more busy, especially in Europe, in terms of XPS placements, it's always a little bit uncertain, you know, quarter to quarter. As we have described, or Kristoffer has described, we continue to sell our heart products in Australia for under special permit. The sales was SEK 7 million in Q1, and this quarter was SEK 5 million. We continue on a very good trend in Australia, which is exciting. Gross margin disposables was good, 84%. We have presented gross margins at the mid-80 level for a few quarters now, which is strong, given, you know, inflation and cost pressure overall. To further improve our margins, we will continue to focus on price increases year-on-year. That we always do, we will also, as Kristoffer mentioned, we will invest in supply chain and manufacturing improvements over the next two years, that will also be beneficial to our margins, also long term. This goes for all our, you know, all our organs and our full portfolio. If we move over to abdominal, net sales came in on SEK 30 million, in line with Q1, which was an all-time high quarter, that is a good trend and a good level at the moment. Growth of disposables was specifically good, 79% in local currencies year-over-year, where 40% was organic, 39% was acquired, that's represented by the additional Perfusion Service revenue that we have in Italy at the moment. Sales were mostly comprised by European sales, approximately 86% of total sales, and the lion part of this is liver. As we said, worth mentioning again, gross margin disposables reached 70%, and this is a milestone for us, and it's a significant jump up from last year's 56%. It's a result primarily of two aspects. First of all, as I mentioned, the added margin from our Perfusion Service in Italy, but also, secondly, we see a good progress also on our ASP development on liver in Europe at the moment. To our third and last business area, services. As Kristoffer said, great momentum, a lot of, you know, positive initiatives within this business area, the procurement service division that we have in the U.S.. We have seen in the quarter the interesting collaboration with MTJ Aviation. We are having great discussions with customers. We are currently renegotiating the many of the current contracts with good outcomes, and we're also hoping to bring in some new prominent transplant centers towards the end of the year here as well. Sales were SEK 20 million, in line with the last quarter. That's a 79% growth versus last year. The number of cases in Q2 was 150, and we showed a strong growth in lung volumes, which is very interesting and very good. Lung recoveries are a bit more complex than heart recoveries. This growth in lung volumes is a true quality stamp for our organization and will fit perfectly well also when we enter the new phases of integration here in the future. We performed close to 500 cases last year, which is a significant number, our rolling 12 number now is 564, and we expect to reach about 600 cases for the full year of 2023. I would say key for future growth here is to continue to invest in this organization in both surgical capacity, also infrastructure, and we should also not forget the quality insurance and the quality part. By leveraging XVIVO's brand and reputation, we are very optimistic that, you know, we will be able to attract more surgeons in the future and also win more customer contracts as well. Overall, now when we enter into the new integration phase here, this organization is in a very good shape and ready to grasp the big opportunity that we all see in the U.S. in this area. A little bit about profitability and EBITDA. Q2 was a good quarter also from a profitability point of view. EBITDA, adjusted for integration cost, was SEK 29 million, corresponding to a margin of 90%. Rolling 12 months EBITDA, 60%, representing SEK 83 million. The positive development is primarily a result of increased sales and the gross profit. To Christoffer's point, we are continuing to also, you know, invest in the organization, and we will continue to do so for the rest of the year. My final slide for today, cash flow. Here as well, Q2 was good, so we had a positive cash flow from operating activities, SEK 16 million, a big improvement from last year. Our rolling 12 months operating cash flow is SEK 43 million. We continue to invest, primarily in our R&D projects, where heart is the biggest one, SEK 47 million in total, but in these numbers, we also had some one-offs, if you may, because we made some final payments in connection to the acquisitions of Avionord and STAR Teams that amounted to SEK 18 million out of this 47. The cash position at the end of the period was SEK 171 million. That was everything from me, and I will leave the word over to you again, Christoffer. Thank you. As always, I will end the presentation with the outlook, we start with a long-term outlook, some of you have heard this before, repetition is the mother of learning. We're still looking at a demand that is 10 times the supply of organs and number of transplants today. This is something we have in our vision that we will need to adjust in order to make sure that nobody dies waiting for lung. The sales value for machine perfusion versus static cold storage is roughly times 10. We're looking at the market that is 100 times bigger than the one we see today. Machine perfusion has proven to increase the number of organs to be used for transplantation, especially in the fast-growing DCD pool, but also in a lot of DBD organs, which is called marginal or extended criteria DBD. Machine perfusion on normal and DCD grafts will drive growth in the future. We will continue to invest in this market opportunity with service models, improved machine perfusion, et cetera. Lastly, I would say XVIVO has a unique, innovative, and world-leading products that are second to none on the market today or in clinical trials for regulatory approval in the world. This put us in a unique position to capture this opportunity. We are now getting more and more ready day by day to deliver on this promise. If we look into the little bit shorter term, what we do during 2023, we said that we have four focus areas, and the first one is definitely to we see continued momentum for machine perfusion. I think it's more and more proven that this enables more transplants, higher survival rates, and it's getting used more and more. To drive this, we believe in hub models and service models, so this is what we market and drive towards, and so far has been successful. Number two, we have the Kidney Assist Transport, with a continued introduction in both U.S. and Europe. We have very good results, and customer feedback so far, and we are tweaking the product to fully meet the American market needs and scaling up our production to meet the full market need. So far, very good initial thought. We already talked about the production scale-up times 10, very important project that we already started, and we will continue to invest in this in order to meet the increasing market need. The heart products is, we have already now prepared for the commercial launch in Europe and Australia, and we are definitely in the start of the PMA trial in the U.S. As I said earlier, we are negotiating with the FDA how to include DCD, and that's the last part of the puzzle before start. In liver, we are prepared for trial application and submission in the U.S. Those are the things you should expect more information on during 2023. With that, I close the presentation part of this call and open up for question. If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Ulrik Trattner from Carnegie. Please go ahead. Thank you very much, good afternoon, and perhaps good morning to you, Mr. Nordström. A few questions on my end, I hope you can hear me all right. I'll start off with some broader questions, then perhaps going in with a few regarding the quarter. If we could start off with STAR and integration and the new collaboration with MTJ. Kristoffer, you touched upon this briefly throughout the presentation, that you were seeing a situation where you can expand the service offering in the U.S. on the base of this, sort of similar to that you have in Italy. What does this mean in practice? Are we to expect here in the medium term that XVIVO will operate service, Perfusion Service, centers in the U.S., or what should we expect? Yeah, Kristoffer will also about here. I mean, right now we are trialing that, if we call it the Italian model, in limited number of clinics to see so we learn more from Italy. It took them quite a long time to learn it, so we are currently trialing it. Over time, we see when I go meeting customers, that gives us both Europe and the U.S., they very often tell me that, "Yes, yes, we are convinced about the clinical need. We understand it. That's not it. It's like it's a resource issue." I believe this will be a key for success, growing our machine perfusion offering in the future. We will start with, let's say, trials to see, to make sure if there are learnings. We know a lot from Italy, we know that there's always tweaks country by country, clinic by clinic, in order to make it really good. I hope that answered the question? Sure. Absolutely. A follow-up question on STAR Teams. STAR Teams currently have around 9% of all lungs and hearts, sort of transportation out of all recovery, of all sort of lungs and hearts currently. With this sort of new collaboration and expansion to having plan, what is a reasonable number in terms of market share for STAR Teams in the medium term? Is it in the teens, is it around 20%, 30%? What is feasible here? To be truly honest, we have not had a target market share for the number of recoveries. The main reason being that we want to be a customer's true friend, so we will be there for them. To paint that in a bit of color, right now, for six months, we said no to a lot of contracts because we want to get the logistics right, we want to get everything right. If you put it, nail it before we scale it. I do believe there is a huge opportunity to grow this market share, absolutely. We are targeting having a, let's say, perfected customer offering rather than a market share target for our STAR services. That's the one thing. Secondly, on the MTJ Aviation contract, it will be better for us, for our employees. It will also be a lot better for the customers. We will drive down costs in the, in the transplant system, where additional flights might increase the legs and with increased costs for the transplant center. This is something requested by our current customers to have a better service provider, which we now have that on board. We can drive down cost per transplant for the transplant center. I think this will be a great piece of the puzzle, not the only one, but one piece of the puzzle for a great product service offering. Great. If we were to jump to the IDE and for heart, and as you mentioned, it's great news that you may also include DCD hearts in the U.S. study. Just, and you allude to some uncertainty when the study can start, but call it out to be in the second half of this year. How fast do you expect to enroll patients? Now, when you if we were to reason that DCDs were to be included, how fast would it take for you to include all these patients? That's a great question. We have said before we include a DCD, but it will take roughly 18 months. If we include the DCD patients, we will almost or we will double the pool of possible organs, so we should be able to do it faster for sure. I don't think that just because the first patient, it might be a little bit delayed due to negotiation with the FDA, I'm not sure that the last patient then will be affected in any major way. We are now spending all our time on getting that negotiation with the FDA finalized as soon as possible. All the clinician knows what protocol to follow. Great. On regulatory pathway for heart in Europe. I know the MDR is a new framework, and it's a lot of work that needs to be done. Where are you in the process with the notified body? Have you submitted the technical file for the heart machine yet? Yes, we have. I hope I was clear during the call. We have really met all our deadlines, but I'm always very humble when it comes to regulatory bodies, such as notified body or the FDA, et cetera, that we can, of course, affect some of the time by sending in good quality reports, et cetera, and answering questions fast. We can never affect their working burden, so to say, that could be high during some periods of the year, et cetera. I'm always a bit humble, but we have kept our lines. We have handed in the technical file for the heart box. That is done and waiting for review. There will be questions, of course, and we will turn around them in a fast and correct manner. That I can promise. Last question on heart, before moving on. Since you've been participating in a lot of conferences, and you have a lot of now user feedback. Because you're seeing and saying that seeing is believing in heart, what is the key aspects of the heart machine? What are they the most impressed about? Is it the avoiding primary graft dysfunction, or is it the prolonged transportation time, or is it both? It's actually a combination of both, but I think the most mind-blowing to all of us was when McGiffin presented during ISHLT. you know, pushing the time limit so far with so many hearts going way beyond what was normally accepted in terms of ischemic time, and showing up that low 30-day mortality, I think that was because he compared it to the ISHLT average, which is 8% already at five hours, and most of the hearts in Australia were going beyond that time limit at 0%. I think that was mind-blowing for all of us. That's one part of it, the clinical results. The, I would say the other one, which I hear over and over again, and this is what I mean with seeing is believing, is that it's easy to use product, but especially for a heart surgeon to see the first punch being really like it's never been outside of the body, for that gives a lot of confidence. I think that means more than we think, because once you have transplanted a heart, you're really looking for those early signs. Was this a good heart? Was this a good transplant? Will this be successful over time? Those early signs from the surgeons will actually mean something because you see that when the chest is still open. I think that is definitely so important. Lastly, I think a lot of... If I talk to a lot of surgeons and they ask, I ask them: What can I do for you? Many of them tell me, "If you can make this a daytime procedure, I would be thankful, because it is exhausting over time to always go up 2:00 A.M. in the morning for a transplant, and before that, being active for 24 hours in the organ procurement or allocation process. If we can simplify that and do it schedule 6:00 A.M. in the morning, that would be great." I think this is one step in that direction, where you enable the logistics at the hospital to be better. You also enable, you take away a lot of insecurities because once you don't know how long time it will take to explant the heart from the patient either. That's an insecurity every heart transplant surgeon have, is that it could take, it could go quick, but it could take hours. You know, every hour counts. With our box, they know that they have that time. They can do it correctly, the explant of the old heart as well, so they don't destroy any blood vessels or anything. So it takes down stress, et cetera. It's a multifaceted reasons I think. It's not a silver bullet, but it attacks a lot of the worries from the transplant surgeon team. Great. Since we're talking about, seeing is believing, what's holding back Kidney Assist in the U.S.? sorry, which one in the U.S.? Kidney Assist Transport. It's not the market this time, it's more us. We are, when we launched it pre or pre-launched it in the U.S., we got early feedback from the U.S. market. We decided to address that. Long story short, the Kidney Assist Transport is designed for European market. The OPO system in the U.S. has different demands on the product, so we adjusted those. We are in the progress of that. So that's one thing we are addressing right now and improving while we talking, actually. The other thing is the production capacity, where we have decided that the big scale up times 10 will be the big reason or the big solution to scale up of production capacity. We had some, let's say, early child diseases in terms of production ramp-up with the current supply chain, where we are addressing that now, and hopefully in a year or less than one year, we will have addressed it fully. That's the. It's more us than the market, because when I talk to our sales reps in Europe and the U.S., their interest for the product is there, and they really like to use it. It's easy to use, they like the product, they love the clinical results they have seen in clinical trials, and they have done small scale testing themselves with standard of care, and they see that it's performing accordingly. It's more us than the market. Okay, great. Last question on my end. Short one might be for Nordström. I note that R&D in percentage of sales did a jump in this quarter. Is that something that we should extrapolate going forward, or were there some sort of exceptional cost here in the second quarter? Thank you, Ulrik. I would not quote a specific, but specific to this year to date is that we have taken a strategic decision to allocate less internal resources to some of our capitalized projects that has led to those costs being taken over P&L instead. That put for the year to date, to talk about SEK 5, SEK 6 million, that will continue. I would say the quarter was pretty busy in terms of audits. I can't remember the exact number here, but I would say that broader answer, yes, you should continue to see this type of spend on the R&D. Okay, great. Thank you, Kristoffer and Kristoffer, and I'll get back into the queue. Thank you, Ulrik. The next question comes from Jakob Lembke from SEB. Please go ahead. Hi, good afternoon. I have a few questions, and I hope you have time for them. I'll take them one by one. My first question is, relating to EVLP in the U.S., which seems to be accelerating. I'm wondering if there's, like, any new hubs that has been established or anything else in particular that is driving the strong growth? Thank you for that question. I would say in general, there are in the U.S., there are definitely a hub around Cleveland that start to deliver. In general, what we can say is that the hub model does deliver, and we can see the same pattern in Europe and in the U.S., that it works. Not unexpectedly, it's always good to get proof that what you thought would work, that it actually works. It's not right now, it's not so much... Yeah, it's maybe one more hub in the U.S., but it's more that the hub model works that we see. Moving on to the heart products. I mean, obviously, I guess it's, you know, facilitating more transplants in Australia and New Zealand right now. Do you have any sense of, I mean, how much of the growth is driven, or how much of the volumes are driven by new transplants, vis-à-vis, you know, existing transplant that otherwise would have been, you know, you're able to do? I actually have asked the team the same question, but I did not get an answer yet from Australia. In the U.S., you have really good statistics on number of transplants. You don't actually have the same transparency or easy access to data in Australia. I'm waiting for that answer because I do hope and believe that many of those transplants are new, that would never happen. We know that definitely all the transplants going beyond five hours are new. That we know, but we don't know the exact number in percentage or number of transplants right now. I will hopefully come back during the next call in October with a better answer. Okay, on heart in Europe, do you have a sense for when, you know, the first compassionate use approval could come? We actually have in one country approval for it. I don't know if there have been any transplants under it. We are working with a, with less than a handful, but it's three or four countries in Europe for compassionate use cases. I know in one country we have approval. We hope that that will come soon. I know that the interest is high from the clinician side, so we are doing our utmost to facilitate this, of course. Okay. Moving on to the investment in production capacity. Do you see any risk of any bottlenecks before you're up and running with the new investment? T here are always risks. I mean, the operation team is working day and night to make sure that we have no back order. I mean, we have a vision that nobody should die waiting for an organ. We should definitely not be a reason for with non-delivery. We do believe that if we don't make this investment, there will be a high risk. We believe with this investment, we have lowered it significantly as far as we possibly can. Okay. Is the final question relating to the news on PrimECC. If you can share how many patients that have been recruited in the trial to this date, and if you think that will be enough to draw any new conclusions? We soon will be able to do that. This information has obviously gone out to all the trial members, et cetera, and we will gather the data, both on number of patients and the results from it, and we will come back with more informed. We are at, is it roughly 50 patient-ish? We don't know if we can draw any conclusion based on that today, but we hope, at before we meet in October again, that we have some initial idea based on the data, when we have seen it. Right today, I mean, the decision was taken last night, so it's hard to say anything right now. Yeah. Okay, understood. That was all the questions from my end. Congratulations on the good quarter. Thank you so much. The next question comes from Johan Unnerus from Redeye. Please go ahead. Thank you for taking our question, and I hope we can hear us pretty well. Yes. Thank you. Just some short questions. On the heart and the U.S. opportunity, the DCD segment is, of course, very interesting, to say the least. How, what sort of time frame should we expect to get a clarification if this is included, and how confident or optimistic are you that this could be included? Great question. I will start that with saying that when it comes to regulatory bodies, I always have a large portion of humility, and I always try to be humble. They can always choose. We should remember this time they've asked us to include it. We did not ask them. Hence, I believe there is a high chance of inclusion. Otherwise, I don't see why they would actually ask. It was by request by the FDA. That's number one. Number two, I know that we have handed in our proposal already, we've done our part. I do hope and believe for the same reason that they have requested that we have a fast turnaround time, because they also see the need from American users and the American market to have a good technology, helping take care of more organs and making sure that more transplants are available, increasing patient survival and reducing healthcare costs in the U.S. I believe they have a motivation for doing this as well. Again, I mean, the you should always be humble. They set the rules, and we apply to them. That's how it works in our industry. I do have high confidence that it will be included and that it will happen in a short time frame, and we are still working towards first place in the end of September, but I do realize that if there will be a need of a negotiation, that could be postponed with a couple of months. Thank you. That's very useful. Sort of a more overall question, of course, there is always scope for economies of scales on the OpEx side, given the sort of growth that you are experiencing. On the gross margin side, the improvement has been rather significant in a short period of time. Should we expect more of a sort of steady state or more mature improvement going forward? I mean, we are still in early days in terms of scaling, and many of our products are almost, let's call it, R&D type of products that we now set up into large scale production. I do believe, and that's why we can make this type of investment and get really quick ROI, is because we can be quite easy redesign of the products, make them producible in a fast way. I think definitely we can expect over time, improving gross margins and reducing costs, for sure. Also wise from experience, it looks like a lot happened now and nothing happened before. I know it's a work that been ongoing for many quarters and years. It's just that sometimes you see it more in the numbers than you've seen previously. It looks more than step change than the reality, which is more of a everyday hard work type of improvements, where you improve a little bit here, a little bit there. Definitely. I believe after this two-year period, we will see improvements in the costs, I do believe that. There are huge opportunities for improving the cost structure and the design of the products to make them scalable. It's more of a gradual journey. Yes. Going forward. Yes. Yes. Finally, you managed to reorganize and integrate the service offer considerably, and in a short period of time, and at the same time, keeping up the strong organic growth and also improving margins at the same time. That's rather impressive, and you alluded to that the whole hub model is accepted and liked, and it works in Italy. You're rolling out in the U.S. Should we expect this to continue in other big markets? Yes. We should expect that. There is a true underlying need that driving this change, one is definitely capacity, and the other one is the work burden on the transplant team, where if a transplant 24 hours, that is too long time to scale up the number of transplants. There will be a high burnout ratio in the transplant community if we don't do anything about it. When the transplant team really adds value is during the taking the right organ to the right patient and being rested and do the implant itself. The rest of it, we should be able to support the transplant industry with solutions and services and good product, for better evaluation, better transportation, better recovery services, et cetera, et cetera. They are spending their time where they truly make a difference for the patient's life. Okay, thank you. The next question comes from Peter Östling, from Pareto. Please go ahead. Yes, thank you good afternoon, gents. I have yeah, I have a couple of questions. I will take them one by one. First of all, I will, I, notice that you, I think it's the first time officially, that you have stated that you may contemplate running the heart and liver projects in parallel for the U.S.. Do you expect your current financial position to be suffice to cover doing that, or do you, are you looking at some kind of financial arrangements in order to go ahead with that plan? Very good question, Peter. That, I, yes, that is one of the cornerstones, is that if we do this, we want to go full force ahead and not do it sequential, but do it in parallel, and to do full force ahead with 2 PMAs. My judgment today is that we need more capital. I have to be honest, that is obviously the board's decision, but I propose that that could be one way forward. The other item we need to contemplate is definitely on the resource side, our own resources running 2 PMAs at the same time. It could be quite burdensome for a handful of people who are having key competencies in, especially, running PMAs and dealing with the FDA, et cetera. Those are the two questions we are currently contemplating to do that. I think the business case of getting early to market with liver, it holds. We see that it's, I think, our fastest-growing product right now, and the user experience is great. We believe we cracked the code with the Italian service model, and we finally see that we have reached those high penetration ratios we always wanted, and we actually see growing from there. I said before, we are roughly at 25% penetration on the liver product in the Italian market, versus comparable other European countries are down at 5%. We see that we have cracked a lot of, or straightened out a question mark, I should say, regarding, both heart and liver in the past six months, that has brought this question to the table. Okay, great. The SEK 50 million in the capacity enhancing investment that you are planning for the next 24 months, is that spread evenly over that period, or is more at the beginning or at the end? Also, are there any specific disposables that needs a boost in capacity, or is it more broad-based all over the, your product assortment? I would say the one that we don't have, we don't need it now, now we can wait a little bit, is lung. But I would say for heart, liver, and kidney, I think we do need to do it ASAP. What we will do is we will start with heart and liver, scale them up. That will leave a lot of free capacity for kidney, since kidney and liver today are sharing one supply chain through the way. That's where we focus the most on, and then we will bring in the Kidney Assist Transport disposable, right after we did liver and heart. That's the plan, after that, we will do lung. In terms of investment, I, it's always hard to predict, but according to the plan the team put forward, we are at a pretty even pace during this time period. Okay, great. Thank you. I think it's good that you postponed the start of the U.S. heart trial by including DCD donors instead of excluding them. I think you are taking the right decision to go after that. I was just wondering, how does it look in Europe and Australia? There, it's a different kind of approval process there. Would you be able to use the heart product for DCD donors in those geographies? It depends on the label. We don't know exactly the label right now. I would expect, speculating and talking from experience, that we would need to do some additional small scale confirmatory studies to include it in the label. That's my expectation, and that's what we're working towards right now. We have already started and seen positive results from preclinical trials, and if we could then transfer those into clinical settings, I would believe that that is sufficient, and that's what we have seen before in both Europe and Australia. Okay, great. Thank you. Let's see here. You mentioned the launch of the Kidney Assist Transport has been rather slow due to some logistical problems and the tailor-making that you needed to do for the U.S. market. Maybe I heard you wrong when you said, I think I heard you say that all these problems will be solved within one year. Did I hear you correct, or will you be more active in the launch process later this year? Thank you for clarifying that. Yes. What I meant with one year is that we will scale up production a lot in one year when we with the scale up project. In one year we will have definitely solved all the issues. I would say already now, while we're speaking, we are solving the issues, and we are launching customer by customer right now. We see progress over time, for sure. Okay. It's improving every day, so it's more of a gradual. In terms of production capacity, especially on the disposable side, I would say when we can release the whole current production set up to kidney, that we now are doing kidney and liver, that will be the game changer in terms of disposables. Okay. Thank you for that question. By the way, I don't want to be impolite, but I see I have another meeting in 1 minute, I have just a short final question for Kristoffer Nordström, regarding the financial income and expenses. They have been rather high. I guess it's revaluation of assets and liabilities. In the P&L, you mean, the financial items? Exactly. I think it was five in the Q1, now it's seven, almost eight. Yeah, exactly. It's mostly currency related, you know, with a strong dollar and revaluating assets and liabilities, so it's nothing spectacular. No. You, do you expect them to be at this level in, for the rest of the year, or would it depends, or? I mean, that is very hard to answer, given, since it's exchange rate related, mostly. Okay. If, if you, if they are staying at the current levels? Yeah. There would be no big differences in the future, I would say. Okay. Thank you. That was all for me. Thank you. Thank you so much. With that last question, I would like to thank you all for participating in this call, and I wish you all to come back in the Q3 earnings call in October. Looking forward to that. Before that, I hope that you all get a great summer, talk to you soon again. Thank you so much.