Ladies and gentlemen, welcome to the XVIVO Perfusion Interim Report Q2 2022. I will now hand over to Dag Andersson, CEO. Sir, please go ahead.
Thank you very much. Dag Andersson and Kristoffer Nordström here in Gothenburg to present the Q2 numbers and main event. You can see here on the front page of the interim report, you can see a picture actually over Gothenburg with a lady or woman named Frederica who just received a new delivery. She's, of course, very happy of that. She's actually figuring in several of our media and communication right now. We will then start by talking a little bit about Q2 financials at a glance, as we call it. We have delivered a strong quarter, or let's say yet another strong quarter. When I say strong, I refer to both sales, gross margins and profitability.
We are actually getting closer to delivering our Q1 with SEK 100 million sales. We are not far away from that, which is very, very nice. We presented a growth of almost 60% versus same quarter last year. Organic growth of 28% and acquired growth of 16%. If we look at the business areas, we can then present all the numbers. When it comes to thoracic, organic growth of 24% and abdominal 51% in local currencies. Gross margin disposables thoracic of 82%, which is an increase from 79% same quarter last year. Abdominal showing an even stronger increase, 56% versus 60% last year. We also delivered an Adjusted EBITDA margin of 12%. Christofer will talk more about EBITDA later, but rolling 12-month trend continues to show increasing EBITDA.
We are particularly happy about the Abdominal growth in Q2 . Disposables increased by 57%. Limited currency effects since this is mainly European sales as well. A very strong Abdominal quarter and a strong Thoracic quarter. When it comes to see Q2 , I would like to focus a little bit on the EVLP performance. We can here see that we have performed very well when it comes to EVLP disposable sales, both when comparing with last year, but also when comparing with Q1 this year. I'm particularly pleased to see Europe growing at really fast pace. We are talking about 60% growth versus first two quarters last year. This is actually excellent performance by the European sales team.
Two XPS machines were delivered in the quarter, which means that we have actually delivered five so far this year. In Q2 , we delivered XPS machines to Prague and Toulouse. If you might not remember, just to tell you that in Q1 , we also delivered to Cleveland, the second machine, and to Gainesville and Dublin. The challenge for our organization has been to manage all four major congresses in Q2 . For some reason, all major congresses 2022 ended up in the same quarter. All of them in the U.S., actually, with the exception of ILCS, which took place in Istanbul, Turkey. When we look at the long trend of activity in the U.S., we can here see that numbers are rather stable, let's say last three years.
Q2 numbers were a little bit above 2019 and 2020, but slightly below 2021. European data is harder to get, and the only thing I can say right now is that we are still looking at total 2021 data, which actually showed a 12% increase in Europe versus 2020. We don't have any data yet for Q1 or Q2 this year. In May, we released a press release where we informed about the partnership between XVIVO and Cleveland Clinic in the U.S.. The partnership means that data is collected from the EVLP sessions on our XPS machines. The expectation with this partnership is that we will be able to show aggregated data to support decision-making when evaluating the possibility to transport more marginal lungs.
I cannot yet say when we will be able to present this, but, you know, the study and the work is ongoing. Another important event is, of course, the launch of Kidney Assist Transport. As you all know, the kidney is the most transplanted organ in the world. 2/3 of all organs transplanted are kidneys. We have launched in the U.S., and I would call it a soft launch, since we are actually ensuring that the customers are not only happy with the product itself, but also happy with the service and support provided by our U.S. team. This is why we have not delivered too many kidney samples yet. We have a couple of large customers using the device and ordering disposables, Mayo Clinic, Northwestern Medicine, and Renalytix . Several devices will now be placed with customers during July.
For 2022, focus is 99% on the U.S., and Europe to follow in 2023. We have promised to deliver a couple of Kidney Assist Transport to Europe this year, but you know, main focus is U.S.. I also want to talk a little bit about Liver Assist, actually. We haven't talked too much about Liver Assist of course. But we have a great product. You know that Liver Assist was featured in New England Journal of Medicine in February 2021. We have seen exceptionally high sales growth in disposable sales in Europe during the Q2 . We actually talk about 140% versus last year, and 45% versus Q1 this year. I would say that this is an exceptional performance.
We will later in the summer or September take a decision on how to approach the US market with Liver Assist. This is truly a success product in Europe. A few words on Brazil. You will know that we established a legal entity last year. We have also initiated partnership with Contatto Medical, and we have hired a regional business manager in Brazil. What is also very positive now is that we actually have all products, not only Perfadex Plus, but we have all products with regulatory approval, with the exception of STEEN Solution and the perfusion circuits. All other products are regulatory approved. We are actually planning our first machine sales to Brazil in this quarter. A few words on the R&D timeline, and I will focus on the heart project.
The European heart trials are progressing well, actually a little bit better than I would have sort of hoped for. We have included already at least 100 patients, and we are now including 10-15 patients per month, which is a high rate. Therefore we should be done by December with the European trials. The same thing with Australia and New Zealand, where we have three centers activated in this investigator-initiated study in Australia. When it comes to the U.S., we are in constant interaction with the FDA. We have submitted some additional critical data and information to the FDA, and a new call is actually done with the FDA next week. I cannot say anything else regarding the IDE submission or exact dates or anything right now.
This is just to give you an update on this. PrimECC, which we do not talk too much about, but it is an important study, and we now have three centers activated in Sweden, Norway, and Germany, and might also include two more centers. We will in September, October, get some midterm feedback on the performance of PrimECC. I'm looking forward to this. Hopefully I will then be able to talk more about PrimECC in the next quarterly call. I will then hand over to my CFO, Kristoffer Nordström.
Thank you, Dag. Next slide as well.
Yeah.
Hi, everyone. I will talk a little bit about the finances here for a couple of slides. We're very satisfied with this quarter. I'll start with the company as a whole, and then go through the highlights for each business area, which is more important for understanding. XVIVO, we followed up Q1 with a stable Q2 , proving that there is a good momentum for us at the moment for whole organs, actually. Net sales amounted to SEK 94 million, and that's a 59% increase versus a somewhat weak comparison quarter. However, disposable sales, as Dag has mentioned, for both thoracic and abdominal showed strong trend and good growth also versus the Q1 . Organic growth in local currencies was 20% in total.
This is usually 10% price for us, and 20% is all about volume. Acquired growth, meaning STAR Teams, was 16%. Gross margin, 72%. I will comment more on this for each business area because it varies, the margins vary between the business areas. Both EBIT and EBITDA was strengthened versus last year. EBITDA SEK 5 million better and a margin of 12%. In the summary, we are pleased with quarter and we continue to deliver good growth and profitability in, you know, a very turbulent world out there. Next slide, please. Moving over to thoracic. It was a strong quarter. Net sales amounted to SEK 69 million. Organic growth was 24% in local currency.
As we said, since the global transplant activity is rather flat, it means that the growth comes more or less from what's most important, which is our EVLP activity. EVLP grew 32% versus last year. Two machines sold, Prague and Toulouse. We have a good momentum, and we're also looking forward to future placements this year for sales of machines. Very important to mention, gross margin. We continue to see an improvement here driven by our successful price increases that we have implemented now two years in a row. We also have some US dollar effects in here as well, but mostly it's all about the price increases. Next slide, Abdominal. Abdominal was the rising star of the quarter.
Very pleasing was the growth of the disposable. If you looked into the details of the numbers, you could see there were no machine sales in the quarter. That does not mean that we didn't place the machines. We actually had seven machine placements this quarter. As we have communicated before, procurement and transport. That is the strategy that we will have on all markets. We will place machines, and we will have a volume commitment from the customers driving disposable sales. Specific for this quarter, and that is not very usual, is that we also have that model for a couple of liver placements as well. That was one of the drivers for the strong disposable sales.
Over 100% growth on disposables versus last year, but also worth mentioning, a 35% increase against Q1 this year. The trend is very, very good here. Gross margin also very, very content with that, 56% versus 50% last year. Here we don't see any foreign exchange rate effects at all, since it's mostly European sales. Maybe some of it, but mostly it's all about price increases. Next slide, please. Services and STAR Teams. Services, as a recap, consists of STAR Teams and their recovery business in the U.S. solely. They were acquired by us last year in November. This was the Q2 where we can present full sales, so to say, three months per quarter of this business.
Net sales were SEK 11 million, and that was a growth of 40% versus last year, but also a growth of 13% versus Q1 this year. The number of cases continued to grow, this time at 2% versus last year's quarter. We had one new contract secured this quarter, and that will come to effect in beginning of Q4. There's also a handful of other leads being discussed at the moment. In parallel, we also focus on investing in the organization in order to secure the future growth, of course. Gross margin for the quarter was 55%, a bit of an increase there as well. Next slide. Thank you. EBITDA, P&L, we continue to see an improved EBITDA on a rolling 12-month number basis, SEK 41 million now. The trend is positive.
For the quarter, we ended up on 12%. That's some percent this unit is lower than the last quarter. One of the main reasons here was that we had a very intense quarter in terms of commercial activities, as Dag mentioned. All these congresses that we invested heavily in will of course lead to future opportunities for us in the next quarters and years here. These are costs that we will not see in the next quarter. As other companies, we do experience higher costs in general. For us, it's mostly about, you know, we are a traveling company. It's important to visit customers. Of course, we're seeing increased travel costs. It's about freight, since we ship our goods.
We have a strong US dollar leading to increased costs. However, we do believe that we will be able to handle this in a good way. For example, we talk about freight. The majority of our freight costs are passed on to our customers. We're in a quite good position there, I would say. We also have a very good possibility to continue with our price increases. Dag will touch upon that a little bit in the end here as well. Overall, I think we will come out very good here, and we will be able to strengthen our profitability, even though there is a high inflation, as everyone knows. Next slide, please. That's a slide from my side here.
The operating cash flow for the quarter was minus, SEK 2 million. This was affected by a bonus payment for employees outside of Sweden participating in our award program. That's a little bit of an abnormal transaction I would say, which we have to be very clear about. Excluding this item, the operating cash flow was actually positive, SEK 3 million. Also good to communicate, I think from my side, is that this was the last quarter where you will see this effect. In the future, the incentive programs that we have does not have this component disturbing the analysis for you guys. There was a significant increase in our accounts receivable this quarter, but that was more of a timing effect. No worries there.
We have a very healthy accounts receivable ledger, and we already see some big payments there in the Q3 . Free cash flow was SEK 37 million, and that's mainly due to our investment in our capitalized project and of course primarily our heart projects. That's what I had to share here today. I'll hand over to you again.
Thank you, Kristoffer. Let's talk a little bit about the outlook for the remainder of the year. When I say the remainder of the year, we actually have less than half the year left now. We are in the middle of July. I would just like to talk about a couple of things here. One is that we see a very strong momentum when it comes to machine perfusion. Everyone is talking about machine perfusion, and everybody knows and understands that for organ transplantation and evaluation, you know, this is the way forward. We are well-placed here since we are focusing on machine perfusion with our devices.
We will continue to date Kidney Assist Transport with keep leading Kidney Assist Transport studies in the U.S. and prepare for the commercial launch in Europe 2023. As I've said, I don't want to rush Kidney Assist Transport. There is no need to rush it. We want to learn because this is a new area for us in the U.S., and we have to make sure that the organization is sort of teamed up for it. We also, we will increase the organization by, you know, one or two individuals as volumes increase in the U.S. during the second half of this year. When it comes to price increases, we have so far increased prices in the U.S. on October or November 1st with up to 15%.
In Europe, list prices have increased January 1 , by 5%-10%, sometimes a little bit more. We will continue the price increases, and we might actually aim for higher increases, possibly. I haven't sort of thought that through yet exactly how or higher means. There is no point in asking the question about what exactly does high price increase mean. We will ensure that gross margins continue to increase. We are committed to that, and we will continue therefore to raise prices enough for margins to increase. The work with the heart trials continues. As I've mentioned before, great momentum in Europe and Australia, New Zealand. The hospitals are filing our Like they are very happy.
I was in Munich last October and talked to the Klinikum Großhadern in south of Munich, which is one of the trial sites. They really want to continue using the HeartPulse after the trials are finished. Their view is that the HeartPulse should be used for all hearts in all heart recovery situations, as long as the donor and recipient are not in the same hospital. Otherwise, they want to use the HeartPulse for every recovery. That was quite interesting to hear. We are, as I said, also in continuous discussions with FDA to secure the IDE submission needed to start US trials eventually. Yeah, looking forward to an exciting autumn and of course an exciting future at XVIVO as Mahatma Gandhi, who is a very I think you all know, he was an Indian lawyer and politician.
He once said that, "The future depends on what we do today." I actually believe that we have created and we are creating, you know, daily the foundation for future success. We have great products, we have strong R&D and commercial teams, and we have people who are prepared, you know, to walk the extra mile to deliver great results. I think this is all from Kristoffer and my side. I leave over to the audience to ask questions, and we'll try to answer as well as we can. Thank you.
Thank you. Ladies and gentlemen, if you have a question for our speakers, please press zero one on your telephone keypad. Please pause until we have the first question. The first question is coming from Ulrik Trattner at Carnegie. Your line is now open.
Great. Thank you very much, and good afternoon to both of you. I know the strong development, and you mentioned it in Europe, and it looks quite exceptional. Can you shed some more color on what's driving the current sales for Liver Assist? There must be something that has changed year-over-year, or at least over Q1 to Q2, that explains sort of the strong development for Liver in the quarter.
Absolutely, Ulrik. It's so nice to hear your voice, and you're always, for some reason, able to ask the first question, which we almost expected that would come from you. Ulrik, when it comes to Liver Assist, as you said, you know, remarkably good performance in Q2. I would say you know, there are several reasons for it. One reason is that we had some machine installations in the Q1 that sort of paid off in the Q2 . That's, I think, one explanation for it. I would also say that if you look at the European sales team, we have reorganized a little bit in Europe. We have a new head of Europe, and she has a great team, you know, working together with her.
We have changed the European organization and clarified, you know, roles and responsibilities between, you know, the business managers and the clinic specialists. I think we have a very good team, and we have many Liver Assist devices in stores, which of course leads to more disposable sales. There have also been some changes in reimbursement in certain countries, more generous reimbursement in Netherlands in machine perfusion, and also in Belgium, and also great momentum in Italy, which is a big Abdominal market in Europe, where we have a fantastic distributor performing very well with Liver Assist. Liver is actually a big organ in Italy, significantly bigger than kidney for some reason. That's another reason for that success, Ulrik. I hope that sort of partly answers your question.
Yeah, absolutely. If we stay on the Abdominal segment and what you mentioned, the soft launch of Kidney Assist Transport, what does that sort of entail, and when should we expect a broader launch for the transport system, as well as what has been the initial feedback? If you can give us some more color on that, then what remains before we see a high replacement of the ORS system versus the Kidney Assist Transport? Is there something lacking that, or holding back sales, or is it just?
No, no.
Sort of a gradual step up towards.
Okay.
The clinics.
There are certain different angles here in this. If you look at the overall interest, it is definitely huge. I mean, at the latest congress in Boston in June, I was in Boston myself. I mean, there were customers who just came up and said, "How can we get hold of this device? Can we please buy it?" So we sort of prepared a list of customers who desperately want to buy the device. So that's on the positive side. On the, you know, when it comes to reality check, I mean, there is a certain capacity we have this year. We have talked about being able to produce one per week and then stepping up to two per week.
There has been a little bit of a delay in sort of increasing, you know, capacity. That's one part of us being a little bit more cautious. We are also the oxygen cylinders that are used when the device is actually transported. Today, the customers are buying the Kidney Transport are using them in the hospital where there is oxygen in the wall system, in the wall, so to say. The oxygen cylinders will not be delivered until September, October for, you know, supply reasons. We have also focused on customers who are actually using the Kidney Transport device more stationary for the time being. There are a number of factors linked to capacity, how they are used, prioritizing certain customers who are very big and influential.
Ulrik, it is important, as I said in my presentation, that if you just sell, sell, and you don't have the, you know, the ops, the back office structure, you know, the support, I mean, there is also the whole issue around, you know, service people servicing the machines. You know, we need to build the infrastructure. We are doing that, but that doesn't sort of happen overnight. We have never planned for 2022 to be a massive year for kidney transport. It's always been the device that, yes, it's launched, we are selling it, we will increase sales, you know, each month this year, but we are not going to flood the market with devices, this year.
You will see it in the numbers, but 2023 will be, I would call it the year of the Kidney Assist Transport, because then we have, you know, the right sort of capacity level. We have, you know, the service organization, and we have also launched it in the U.S. at that point in time. I hope that answers your question, Ulrik.
It does. Thank you very much. Just on the service side of the business, 40% growth, and it sounds like you're investing in that organization. 40%, it is solid growth, but it's quite a lot below what they've done historically. Can you give us some more sort of insight to what to expect from that segment? Given that you're investing, what are you specifically investing in? Is it to be expected that the margin side of STAR Teams or the service business, which was rather high last year, is that to come down in 2022?
I mean, when it comes to STAR Teams, of course, growth 2021 and 2020 were higher numbers. You know, the larger you become, then of course it's hard to keep on, you know, doubling the numbers all the time. STAR Teams depends very much on the surgeons that are employed in STAR Teams. They have some excellent surgeons. Unfortunately, they have issues with, you know, one surgeon being in hospital for a long time, one surgeon down with COVID for a very long time, which means that they have actually had to say, "No, thank you," or no to even customers asking them to recover organs. It's very much down to organization or let's say, capacity in the organization, which has been a little bit frustrating.
The problem is that if a surgeon, you know, has an accident, you don't have a surgeon waiting to be in next day. I mean, it is quite a long process to hire surgeons. I just got a message from Åsa that yesterday they employed a new chief surgeon. Surgeons are coming in, but it takes time to compensate for surgeons or sick or have had accidents. I think that is one of the reasons why we are not growing faster, Ulrik. We need to solve, you know, the surgical or the surgeon capacity issue. I cannot tell you exactly how that will impact second half of this year. We have a new contract. It will start in November. We are revising old contracts.
We are changing the prices of some contracts. There is a lot of activity going on within STAR Teams. I think what is also interesting with STAR Teams is that we haven't really used them yet to push our products in the US. I mean, you can imagine during the day they move into Abdominal. I mean, today they are focusing on heart and lung. I mean, when they move into Abdominal, then we can combine STAR Teams with kidney transplant, for example, or later on with the heart box. These opportunities will come, you know, further down the road. I see STAR Teams as it's a long-term investment and something that will get, you know, better and better over time as we integrate STAR Teams closer with XVIVO. Did that answer your question, Ulrik?
Yeah. Yeah, it did. It sounds like main bottleneck is in terms of number of surgeons.
Absolutely.
Could you give us some information on how the number of surgeons have changed as sort of net effects if we were to talk about the ones active during Q2 versus Q2 last year?
Kristoffer, you might know more since you are based in the U.S. nowadays. Have you heard the exact numbers?
Not specifically on that comparison, so to say, but I would say they are today full-time employees. There's also a difference between full-time employees and part-time employees. I would say there are four surgeons today, full-time employees. They have a handful of surgeons that either step in case by case or are on part-time contract. I can't really say exactly how it looked one year ago before we came.
Okay. No, I was just trying to decipher.
Mm-hmm.
the growth versus sort of the retainer fee that you received so far. So last question on my end, then I will let you guys go. It is on the cost side and SG&A. And as you mentioned, quite a lot of trade activities during Q2, which is always a good thing. But could you help us give us some more numbers on this? Because I'm guessing the SG&A ramp-up is also related to the Kidney Assist Transport in the U.S.. Just.
Yeah, I mean it's.
What level to expect and.
No, no.
I'm not trying to extrapolate Q2.
No, no. Kristoffer will talk a little bit about it, but it's related to, you know, the congresses. It is related to certain, I mean, for example, investing in Brazilian regional business manager. It is also related to some additional freight and distribution costs linked to shipping the Kidney Assist Transport. As soon as they have been produced, we have shipped them across to customers in the U.S. All this, you know, amounts together to higher costs. Kristoffer, do you want to shed some light on?
No, no. I think you can be transparent to say that I think we had a budget of around SEK 4 million or actual cost of around SEK 4 million on our conferences this quarter. That cost that we will not see, of course, in the upcoming quarters. We do not foresee any major investments in terms of headcount in the upcoming quarters. Maybe one or two persons to secure the Abdominal growth. I think you will be able to do your calculations based on that.
Yeah, that's great. Well, thank you very much, and congratulations on a great quarter.
Thank you.
Thank you, Ulrik. Thank you.
The next question is coming from Johan Unnérus at Redeye. Your line is now open.
Excellent. Thank you. Again, congratulations. Can you hear me okay?
Absolutely, Johan.
Excellent. Yes, on price increases, that's clearly supporting. You are clear that you are considering perhaps increasing prices at a slightly higher rate, which perhaps would be surprising given the general inflation. Could you please remind us about your earlier expected timing? Can we expect around the same as the last 12 months, U.S. in the fall and Europe early 2023?
I mean, Johan, in general, my answer will be the sooner the better, but in the U.S. you always have to give customers one month pre-notice when you increase prices. So, you know, I'm not saying that it will not. It could be a little bit earlier than first of October, but depends on how quickly we are ready well to inform the customers about this, because we are already in the middle of July and if we are going to increase it, let's say months earlier, we also have to send out this notice a month earlier. I think Europe probably not before 1st of January, but we might look at the magnitude rather of price increases.
I cannot give you any numbers because I haven't thought through yet how to address it, and how much, you know, the price increase possibly could increase with. I haven't given that enough thought yet, so I'm not going to answer that.
Yes, of course. Just out of clarity, this one-month notice, would that also include the exact price increase, whenever it comes?
Yes. Yes.
Yeah. Very good. Also some support. You clearly, you said earlier, you gave a pretty positive view about Brazil and that's been repeated, and also you had some progress in China. Could you give us any flavor of what to expect? It's clearly going to be visible anyway already in the second half of the year.
Yeah, I mean, in Brazil, I mean, Brazil is the third largest Abdominal market in the world. We are planning now to ship first device or devices in Q3 to Brazil. We have orders from our distributors on it and we will, you will see Brazil in the numbers. We have earlier sold to Brazil, I think, because of a little Perfadex Plus, but now we will start selling devices as well to Brazil. I am positive to Brazil. I think it is a very interesting market, and I have sort of good experience from Brazil. When it comes to China, we have still not finalized the registration of XPS. We have Perfadex Plus registered in China.
We have employed or actually the second member of the China team has started. We have two people now working in China. The focus right now is to finalize the registration of, you know, XPS with, you know, the STEEN Solution and everything. We thought that would be done by Q2, which has not happened. If you ask me, Johan, when do you think it will happen? I would probably answer Q3, but I cannot swear on anything right now when it comes to to China and, you know, the current sort of COVID lockdown situation in China doesn't help when it comes to speeding things up either. Did that answer your question, Johan?
Yes, indeed. Thank you. Remind us, you mentioned the capacity on an Abdominal kidney transport. Was it one or two per week or?
Yeah. I mean, we have produced one per week, and now it's a little bit more in certain weeks. The problem is that it takes time to increase capacity. We had planned to produce a certain number this year, and we are getting quite close to that number, I think, by the end of this year. Of course, we have to look at, you know, how do we manage capacity in the future. Do we bring in a second supplier? We are evaluating that.
A lot of time is spent now on supply chain and manufacturing, because as we become much bigger and start delivering many more devices, I mean, don't forget, Johan, that if you go back two years, we were solely a, you know, an XPS manufacturer and we had nothing else. Now we are suddenly, you know, selling hundreds of devices across the world. We need to have a little bit more of a professional outlook on manufacturing, I would say. That will, I think, a little bit impact also how we work in the organization in the coming months.
Thank you. That's useful. Approaching the end of the year, you should have the cylinders in place and obviously placed some more solutions. What do you expect time-wise between installation and disposables?
No, but if you look at the.
What about it?
Yeah, if you look at the customers who have, you know, like Mayo Clinic, Northwestern, and Vivid because they bought disposables quite quickly.
It's part of the.
And Johan did the.
Part of the placement deal. I haven't heard that they are not moving forward with the program immediately. I haven't heard that they do not do that. Yes, that's good. To go back to the OpEx, not that it's extremely important, but it's anyway useful. We should clearly expect sales and marketing to come down a bit, second half of the year. Admin and R&D was rather modest. What should we expect first half year compared to second half the year? Should we expect an increase or flat overall OpEx?
I think when the R&D, of course, when we start the U.S. trials, Kristoffer, then R&D will increase. Yeah. So that is a little dependent on the exact timing of that one, which I cannot give you any more information on today. When it comes to sales and marketing, as we talked about before, Kristoffer and I, we explained it quite well that there were certain costs in this quarter or in the Q2 that will not be repeated in the third or Q4 . How much exactly it will differ, we cannot really answer.
I guess larger cost on the US study would be very positive if that would happen in second half the year. But perhaps you would incur some related cost even if the actual study wouldn't start by the end of the year.
To clarify on that type of cost, a US IDE trial in the U.S., that is a project and with associated costs that would be capitalized as on our balance sheet. That will not affect EBITDA, although it will be a, of course, in the end, a significant spend for us. I think one of the reasons for the also in my view, a bit modest R&D costs in the P&L is that we have people who, for example, previous years worked with maintenance of products. They have more focused on certain development projects this year and also been capitalized. It's not that we have decreased our manpower, so to say, in R&D. It's more a shift of allocation on what the projects they are working with.
Yeah. I think it's important to note that even if you know, R&D costs are capitalized, you know, once you start working trials in the U.S., there will also be need for medical people to fly to the U.S.. There will be more time spent from, you know, the, let's say, different parts of the organization. Of course, starting trials in the U.S. will have certain cost implications, but we cannot say how much that will be well at this point in time.
Yes, of course. Thank you. Finally, on more perhaps value-driving aspects, the gross margin on disposable and especially Abdominal, it's increasing as you have set up your goal to be in. You seem to deliver on that. What about the outlook? It partly relates to the price increase, which you haven't really decided on fully, but.
Yeah.
You are making good progress.
Yeah, it's price increases, but it's also the mix between U.S. and Europe. As we sell more in U.S. over time, you know, the price level in the U.S. is higher, significantly higher than in Europe. When Kidney Assist Transport becomes, let's say, a paid product, then of course it will also impact, you know, the gross margin in a very positive direction.
If I may, are you still confident that you can match the two business lines, well you have a third as well in services, by 2026? As a recollection from the capital market day, that seems very, very positive.
Yeah. I mean, Johan, let's see. You will hear more again in September. We are meeting now in August again to look at the strategy. I think it has a little to do with what we plan when it comes to Liver Assist and the US go-to-market strategy for Liver Assist, which we will also talk a little bit about in September, not today. We're, you know, whether it could be 50-50 or 40-60 or 45-65, hard to say anything else right now. We come back to that in September at the Capital Markets Day.
Any of these figures would be highly significant, I think. Thank you very much.
Welcome. Thank you.
The next question comes from Peter Östling at Pareto Securities. Your line is now open.
Thank you very much. A couple of questions. Just a clarification. I believe that Kristoffer said that of the around 30% organic growth, 10% was price and 20% was volume. Did I hear you right, Kristoffer?
Yes. Yes.
Yeah. For thoracic, the 24% was mainly related to price increases. Well, maybe 15% price and the rest was could be volume.
For Thoracic organic growth, 24% in local currencies. Yes, that's correct. That also—I mean, that also applies to what I just said. Around 10% is price and the rest is volume. It looks a little bit different on the different pockets.
Can you say anything about how the pipeline for XPS deliveries look for the remainder of 2022?
No. I mean, we cannot talk about specific customers, but there will be further deliveries of XPS. We have done five so far, and there will be a few more this year, Peter, but I cannot name the customers. I know where they will be going, but I can't name the quantity or the customer names.
Yeah. Okay. I didn't want the name of the customer, just a ballpark figure if there will be.
Just say couple of XPS.
Okay. Now in hindsight, when you have been facing this problem with the gas cylinder in the U.S., was this something that you could foresee?
No, we could not have foreseen that.
Finally, on the capacity and the production side, what is the main problem there when it comes to scaling up capacity and.
The main issue for scaling up is the housing manufacturer. You know, when we produce the Kidney Assist Transport, we have two contract manufacturers. One is producing the housing, you know, the shell of the box, and one is producing the actual, you know, box with the components. And it's really the housing that is the limiting factor. We are starting a second supplier in the Q4 this year for housing, and that will improve capacity. I cannot give you any numbers on exactly how much it will improve capacity, but that is the limiting factor, the housing manufacturer.
Okay. Thank you.
Thank you, Peter.
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Okay. I would like to thank all of you for listening, for participating, and for asking some excellent questions and look forward to presenting next quarter numbers or this quarter numbers to you in October, this year. Thank you for listening, and have a great summer. Bye.