Xvivo Perfusion AB (publ) (XVIVO) Earnings Call Transcript & Summary

Ladies and gentlemen, welcome to the XVIVO Group Report on Operations Q4 2021. I will now hand over to Dag Andersson, CEO. Sir, please go ahead.

Thank you very much. So welcome to XVIVO Q4 call. And the presenters today, it's me Dag Andersson; and my CFO, Kristoffer Nordström. And I would like to start by summarizing some of the highlights. During the quarter, we had a very, let's say, interesting quarter, many things happened, positive things. We achieved, I must say, great organic growth in the quarter, 32%; and for the full year, 27%. Earnings growth total amounted to 42% in the quarter, and adjusted EBITDA margin of 11%. The EBITDA number includes certain nonrecurring items amounting to approximately SEK 4 million, which Kristoffer will touch upon later. During fourth quarter and so -- and in connection with the acquisition of the U.S. company STAR Teams early November, we established a third business area, Services. So we now actually have 3 business areas: Thoracic, which still is the largest, then Abdominal and now Services, where sales in November and December were consolidated. We had a strong gross margin development as a result of continued price increases and economies of scale. Early November, as I mentioned, we closed the acquisition of STAR Teams. STAR Teams is a pioneer within organ recovery in the U.S. It was founded in 2019 by Dr. Hasan Tetteh and has doubled the number of organs recovered each year. So in 2021, a total of 403 organs were recovered versus 200 the year before. So far, STAR Teams is solely focusing on recovering thoracic organs, meaning lung and heart, but will enter abdominal later on this year. The acquisition was financed through a new share issue of SEK 250 million. Strong support from existing shareholders, but also from new investors. Other important events in Q4 include the new heart preservation record set in Australia with our heart preservation technology, 7 hours and 18 minutes. We signed a partnership contract with a leading Brazilian distribution company, Contatti Medical, and we strengthened the North American organization by appointing Fredrik Dalborg as Managing Director, North America as per December 15; and Jaya Tiwari, who was appointed Vice President, Clinical and Regulatory Affairs for the U.S. And on January 3, we also opened our new office in Philadelphia, where -- which we serve as a back office for the combined STAR Teams-XVIVO operations. But as you have seen from press releases in -- lately, we have had some exciting development also taking place this month. We received FDA 510(k) clearance for our unique Kidney Assist Transport Device. This is great news. As you might recall, this device was featured in The Lancet magazine in November 2020. U.S. is the largest kidney transplant market in the world, with close to 19,000 transplants from deceased donors in 2021. And what makes this device unique is that it is portable and the only device to offer hypothermic oxygenated perfusion of kidneys. I believe you've all seen the news related to the first successful xenotransplantation of the heart from pig to human taking place in Maryland, U.S. Our technology was used and the transplant would not have been feasible without our technology. The transplant itself took place on January 7. The patient's only other option would have been palliative care at the hospice. The patient's heart today looks good, with no signs of rejection, and though he medically could leave the ICU, they anticipate him to be moved to rehab 30 days post-transplant if all continues -- or continues well as it appears right now. Talking a little bit about transplant activity, and we can start with U.S. And as regards to U.S., a new record was set in 2021, with over 40,000 transplants performed. All organs developed positively with the exception of lungs, which saw small decrease versus 2020. In Europe, lung transplant activity actually increased by 12%, 2021 versus 2020. So what will 2022 bring? I'm not going to look too deep into the crystal ball, but I can sort of share the following view with you. We believe the transplant activity will continue to increase. And as an example here, I mean, there is a clearly communicated target of 50,000 transplants in 2026. It's a clear commitment. And therefore, we believe that transplant activity will continue to increase in the U.S. but also in other parts of the world. We will roll out our new Kidney Assist Transport device in the U.S. initially. We will start selectively with certain customers and then expand the launch program throughout the year. We believe that EVLP penetration, Ex vivo lung perfusion penetration in the U.S. and Europe will continue to increase, supported by XPS installations on both continents in the coming months. We will continue with price increases. In Europe, we increased prices again on January 1 this year, and we will increase again in the U.S. October 1 or November 1, more or less the same increase as previous years. Up to 16% in the U.S. and 5% to 10% in Europe. We will initiate the clinical trials for our groundbreaking heart technology in the U.S. during the summer and STAR Teams will continue to expand and include abdominal organ recovery later in the year. So Kristoffer Nordström will guide the audience when it comes to financial performance, Q4.

Yes, Dag, I'm happy to do that. So yes -- so overall, if we start with the big picture here and the underlying fundamentals, it was a great quarter financially. For net sales, we saw a strong recovery from Q3 in all business areas compared with Q4 last year, the growth in local currency was 42%, corresponding to an organic growth of 32%, in line with our ambitions for the year. We continue to see improvements on the overall gross margin for the group. However, an understanding of each business area is important since the gross margins are varying for each business area, and I will have a comment on the business areas later on here. Adjusted EBITDA was 11% and that was in line with Q3 and also Q4 last year. I would like to mention that we took some initiatives strategically in Q4, which led to higher costs than forecasted, especially within marketing and sales, you could see those costs increase a little bit. And it was about investments in sales platforms, but also some onetime costs connected to the organization. And if we would exclude those costs, I would dare to say that we would have had an EBITDA of approaching 15%. Then move over to the next slide. So if we dig in a little bit to the Thoracic business area, we saw a good growth in both U.S. and Europe, which was pleasant, especially in machine perfusion and EVLP, which is, of course, very, very important for us. So here, the increase from Q3, for example, was actually as high as 85% compared to that quarter, which is good. Net sales amounted to SEK 59 million and organic growth was 33% compared to Q4 last year. We placed one of the XPS machine at the clinic in Berlin, Germany and the transplant team there and perfusion team has now been trained. So we hope that they will have their first clinical EVLP very soon, very exciting. Portion of machine perfusion was high, 53%. And as a reference, it was 38% last year -- sorry, in Q3. Gross margins continue to improve. Margins on nondurable goods were 83% in the quarter, which is 3% units higher than last year, and that increase is mainly driven by our continuous price increases, as Dag mentioned earlier here. But we also have some economies of scale, of course, especially from the fixed costs allocated to COGS, which represent a lower portion of sales as net sales is growing. Moving over to Abdominal and some Q4 highlights. Net sales came in at SEK 21 million, which is a record. All of our business areas showed records, by the way. So it's a strong growth compared with SEK 13 million in the second -- in the third quarter and SEK 17 million last year. So organic growth for abdominal was 29%. Gross margins were very good compared to earlier quarters, [ 55% ]. It's a pretty large increase compared to previous year, 50%. So worth mentioning there was that there were some one-offs in our favor in the quarter that had a positive impact on the margin. And I would say that excluding those, the gross margin would have been aligned with Q3, which means 53%, which is still a good improvement from last year, and it will also continue to improve as we are increasing prices as Dag mentioned. So the Services, our new business area of the company, [indiscernible] on STAR Teams. So we had 2 months of sales in November and December. The transaction was closed on November 9. And maybe worth mentioning, it consists of STAR Teams and their organ recovery business. It's only in the U.S.A. Organ recovery refers to organ removal from the donor body, it refers to preservation of organs in cold solutions during the transport. And it also refers to, I mean, the logistic and coordination solutions that they provide to their clinics. So by removing all these tasks and responsibilities from the clinics, they provide a great value to U.S. clinics today. SEK 6 million, they contributed with in the quarter, and they also contributed with an EBITDA of 25%. And as Dag has said, I think, they doubled the number of cases that they did compared to 2021. So over 400 cases, which is fantastic. And they have actually -- they have been a key for some clinics to actually increase their transplant programs, it couldn't be done without them. Next slide is EBITDA overview, some comments for the quarter. So EBITDA adjusted for items affecting comparability was SEK 10 million, and that means a margin of 11% in line with the year-to-date margin as well. What we say are affecting comparability in this case was more or less the costs for our M&A process, so SEK 10 million. And as I said earlier, we took some initiatives in Q4 which led to higher costs for marketing and sales than initially expected, so to say. Cash flow, important. Cash flow from operating activities in Q4 was minus SEK 1 million. In comparison with other KPIs that we have highlighted in this presentation, which were great for the quarter, the cash flow in that [ sentence ] was [ a bit weak ]. But worth mentioning here is the following that, first, in the quarter, we paid for these M&A costs, roughly SEK 10 million. Secondly, we paid off some liabilities for STAR Teams in connection with the -- or actually after the acquisition of SEK 2 million. And also, I think it's important to know that, yes, we had very strong sales in November and December, and the customers will pay us in Q1 according to the normal payment conditions. Total cash flow Q4 was, of course, impacted also by the directed new share issue of SEK 250 million and the initial purchase price paid for STAR Teams of SEK 93 million. So that led us to a total cash flow for the period of plus SEK 111 million for the quarter. In terms of R&D projects, we have invested according to our budget for the year and according to plan. Final slide for me, Financials-full year, just to comment. So to conclude the financial section, some comments on the full year, yes, as I said. Net sales increased 44% compared to last year, organic growth was 27%, acquired growth was 22% and the rest was currency effect. Gross margin in line, roughly 1% lower than last year. But here, we need to keep things apart here. So in this year, 2021, we include a full year of Abdominal, for example. And last year, we only had 1 quarter and that has an impact on the total gross margin since Abdominal at the moment has lower margins than Thoracic. So the underlying gross margins have all improved, very important to note that. And that's very clear to see when we look at the Q4 isolated. EBITDA adjusted 11% for the year, as we have said before. And with that, I leave it over to you, Dag.

Thank you, Kristoffer. So I would just end by showing you 2 slides, 1 related to R&D. And here, really focusing on the heart preservation trial, which is ongoing. And just to give you a status update, in Europe, we have now activated 9 centers and we will activate a couple of more centers so that we still plan to get our -- have our last patient included by the end 2022, and commercial launch is still planned for Q1 2024. And as I mentioned earlier, we set a new record with 7 hours and 18 minutes of nonischemic preservation time, which was announced in Q3. And in Australia and New Zealand, we have 2 centers now fully activated. And we are now in discussions with FDA to start the trials in the U.S. by summer this year. And when it comes to PrimECC, we don't talk too much about PrimECC, but it's potentially a very interesting project. We have so far included 1 center, which is Sahlgrenska Hospital, here in Gothenburg. And we are now including also Dresden in Germany, which was fully activated in January. And we are also in discussions now with Oslo and Copenhagen and a few more German centers. And the plan is still to have a clinical study before finalized second quarter 2023 to support the MDR submission. So just summarizing. Yes, we ended the year on a high. We had a strong Q4 with growth in all business areas, and we also had a new business area. Good momentum for EVLP, Kidney Assist Transport U.S. launch is now happening in first quarter. Continued focus on price increases. I mean, price increases took place 1st of November last year in the U.S., 1st of January this year in Europe and will happen again in the autumn in the U.S. STAR Team doubled the number of organ recoveries, more than 400 recoveries in 2021. It's a great achievement by the team. And then, of course, as I showed to you, continued progress in the clinical trials, both related to Heart and PrimECC. And management team reinforced with 2 new U.S.-based members of the XVIVO management team. So this is everything from me and Kristoffer. And yes, the stage is now open for any questions or comments by the audience.

[Operator Instructions] Our first question is from Ulrik Trattner of Carnegie.

And I'll start off with what you're referring to as this -- your efforts being put into place in sales and marketing of around SEK 3 million, SEK 4 million. Could you please shed some more light on what that entails in terms of what efforts have been put into place in Q4 and why we should consider those as one-offs?

Absolutely, Ulrik. I leave that's you, Kristoffer [indiscernible].

Yes. Thank you, Dag. No, but it has been a quarter where we have taken some strategic decisions of, how should I say, putting our efforts together with Abdominal and Thoracic sales force. And that has -- one of the key things here is that we have implemented a completely new sales tools for our sales forces out there on the field with a lot of education, a lot of new strategies taken with also -- with some external help. We have also done some -- also taken some initiatives on modifying the organization a bit, which also led to some costs. And there has also been some costs related to onetime events. And overall, I think these are costs that, yes, did not really qualify to be put in -- to be adjusted for in the adjusted EBITDA, but worth mentioning because there are costs that we will not have next year and it's costs that will increase the efficiency and make us have a good foundation for future growth in 2022.

Great. And a few questions on the durable goods side. Looking at your Thoracic segment, are you seeing sort of improved momentum for XPS sales in the U.S. or as well as for the U.K. given the NICE recommendation? And we have seen -- you mentioned that 1 system was placed in Berlin, but how does the current momentum look like and the outlook and the short term? As well as durable sales in Abdominal, it looks really impressive. And given that there is pure European sales, is there any underlying reason for the strong momentum in Europe?

I mean if we start with XPS, Ulrik, I mean we have -- we are sometimes [ replacing ] an XPS and sometimes selling the XPS, depending a little bit on the, let's say, call it, the customer commitment. For example, we have placed an XPS in Berlin, and Berlin has a commitment on achieving a certain number of EVLP. So we use a little different strategy depending on the customer side. So in Berlin, we now have an XPS and we have started EVLP. U.K. has actually done 1 EVLP, but they have not yet installed a machine. It's going to happen now any day or week. But they are sort of -- have started with the EVLP program. We are already -- we have orders now for XPS in the next 2, 3 months, which are very positive, both in the U.S. and in Europe. And also in new sites, which are highly interesting. But I cannot yet talk about the geography here. That will come a little later. When it comes to Abdominal, I mean we have had success with Liver Assist, there is high demand for this machine. And as we all know, I mean, Liver Assist was featured in the New England Journal of Medicine last year. And we have had good sales in Europe. We also believe that we will be selling outside Europe actually this year. We are still debating how to apply for a U.S. regulatory approval, there are different pathways here to purpose depending on what kind of scope we want to include in the application. But we see very good momentum on the Abdominal side, Ulrik, and XPS machines will -- there will be several machines placed or sold during the next couple of months in Europe and in the U.S.

Great. And 2 follow-up questions on that, perhaps you could start off with Liver Assist. And as you mentioned, there are different pathways going forward here. Is it likely that you can deviate from a PMA route for the Liver Assist in the U.S.? And thus then that would entail that it wouldn't be on the market until next year.

No, no. I mean, we believe that it would be a PMA route, Ulrik. That is our, let's say, main assumption today. And that also involves certain number of clinical trials depending on what's -- let's say, what kind of scope we want to have in that sort of PMA route. So that's most likely to be the case for Liver Assist in U.S.

Okay. Great. And on XPS, is there any increased interest from lung bioengineering? Or have they sort of filled up their capacity of number of XPS being used?

Yes, let's answer it the following way: I mean there are -- today, lung bioengineering is working on 2 sites, they have Maryland and they have Jacksonville, Florida. And we now have 2 XPSs in both Maryland and in Jacksonville. But of course, if there is a decision to invest in a third perfusion center, then of course, we will be involved in that discussion and decision as well, Ulrik, with lung bioengineering.

Great. A few more questions. Big opportunity in Brazil for Abdominal, it's really nice seeing you expanding your footprint here with Contatti. But should we expect to see some material sales from Brazil in 2022? And what reached does Contatti have? Do you have any numbers on sort of market share, of number of transplantations performed by Contatti or something similar for us to delve our understanding around your opportunity in Brazil?

I mean, I have never -- I have not yet met Contatti myself. I've had several colleagues who have been to Brazil, and we have also reinforced business development organization with the person who will be supporting Brazil very actively. I mean, Contatti Medical is the leading company this year to working with transplant centers in Brazil. So the most famous transplant center is the Albert Einstein Hospital in Sao Paulo, and they are working very closely with this transplant center. So we believe that 2022 can see -- we can achieve some good sales numbers in Brazil. There is the plan that we have agreed on together with Contatti, and we are most likely also going to employ in our person in place in -- Brazilian person who will then be working actively supporting Contatti but employed by XVIVO. So I cannot give you any numbers in terms of what we [indiscernible].

That's fine. But if we were to move direction then to China, are we to expect any news during the year on expanding into China, some progress on reimbursement or at least grow coverage for transplantation?

Absolutely. I think China, the good news is that we have achieved, what we call it, regulatory approval for Perfadex Plus in China. So that's ticked. And we are in the process now of working with regulatory approval for XPS in China as well, Ulrik. So I think these are the, let's say, priorities right now. We will also -- if sales sort of develops, we will also recruit possibly 2 to 3 persons more throughout the year in China. But we all know that regulatory approval can take some time in China, but at least it's done for Perfadex Plus, and we believe that XPS will follow in the not-too-distant future.

Great. One last question on my end. STAR Teams is reporting an EBITDA margin of 25% out of [indiscernible] that was brought into Q4. They reported 31% for rolling 12 months up until mid-year. Is there any seasonality that goes into these costs? Or any reason for why the profitability should be lower than 30%?

Kristoffer, would you respond to that?

I would not say any seasonal effect in here. What they have done is that they have done a very good job in recruiting surgeons, which has -- they do that a little bit in front of the curve and that gives some impact on the gross margin and also then, of course, on the EBITDA. So that is also the reason why the gross margin was a little lower than when we looked at the company and the pro forma in the beginning. So -- but they will have very good economic scale once they add a few customers.

And just by curiosity, how many partner clinics do they have currently? And is it feasible for them to -- now they doubled the number of organs recovered during 2021, is it possible for them to do the same in 2022?

I mean, Ulrik, that is possibly [indiscernible] leading question, [indiscernible] in a good way. Yes, they are adding new contracts all the time and they are approaching 15 sort of customer where there are sort of clear contracts in place. And the way starting -- how it works is that they have a subscription model, where you pay a monthly fee for having access to STAR Teams, and then there is a recovery fee per organ sort of recovered. And when it comes to number of organs recovered in 2022. I cannot give you exactly the number that we have planned for, but it will be higher than last year, yes.

Great to hear. That was all on my end and congratulations on a good quarter.

Thank you. Thank you. You had some good questions as well.

Our next question is from Johan Ernest of [indiscernible].

And once again, congratulations, it a very solid -- a really solid quarter. Can we start off with Thoracic? It came in very strong, especially it seems to be a good contributor from the U.S. market as well despite that lung transactions -- transplants flat overall. Is there any pent-up demand here or any other things underlying?

No. I think you are [indiscernible] when it comes to U.S. and especially in Q4, we have gained market share in the U.S. So that's one part of it. And then, of course, price increases also have an impact on the Thoracic performance in the U.S. But we have gained market share. We also have new customers in the U.S.

That's positive, of course. What's the [indiscernible] can we expect you to gain -- continue to gain market share? And what to expect from the contribution for your customers?

I mean, as I mentioned to Ulrik as well, we are -- there will be XPS, new XPS machines sold both in the U.S. and Europe in the coming months and months. And whenever you install a new XPS machine, of course, it leads to more actually the lung perfusion execution. So yes, I cannot give you any sort of numbers as you can understand when it comes to this year. But we see good momentum as we ended the year on a high. And yes, we do our best to continue to take market share.

And the experience of the price increase is obviously positive given the numbers, but it also seems to be positive that you alluded to another increase in the coming autumn.

Absolutely. Absolutely. We will continue to increase prices. I mean we have unique products. We have unique technology. If we look at customers sort of comparisons, we are still priced below our main competitor in the U.S., and there is no reason why we should be priced too low. At the same time, it's hard to increase prices more than, I think, 15% increase is quite a large increase. It's hard to do more in one go in the U.S. Europe is a little bit more sensitive, because in Europe it depends a little bit on contractual arrangement, reimbursement model. I mean even if reimbursement is now increasing in countries like Netherlands, for example, and being introduced in Belgium and [indiscernible], we are not able to increase that much in Europe as in the U.S. But we plan to continue with the price increases for the future.

Then can you remind us of the price [indiscernible] for Kidney Assist transport in the U.S., the launch is supposed to take off pretty soon, of course?

Kristoffer, do you have the price number in your head?

For the Kidney Assist transport launch in the U.S. ?

Yes.

Yes, I think our initial assessment was somewhere north of $4,000 per procedure. The strategy for the machine itself, the device itself, varies a little bit, but we lean towards [ of ] placing those machines to a certain volume commitment, of course. But the pricing point is also something we will learn along the way. I mean it's a new product, it's a new market and investment for us. So we will know more further on during the year.

Excellent. And what sort of objectives could we have for 2022? Not that we expect any specific guidance, of course. But it's a specialist market, you have the centers, surely some of these centers will have a higher rate of deceased donors of these [ client ] targets?

So can you repeat the question? I was a little bit uncertain what you actually wanted to ask to answer there, Johan. If you can just...

Can we expect you to address most of the centers that have a higher portion of deceased circle through [indiscernible] some communities are one of the prime targets?

You mean for Lungs in general or for Lungs or for which...

[indiscernible] Kidney Assist [indiscernible].

With the Kidney Assist Transport, I mean, of course, I mean we know that there is an increasing, how do you say, utilization of the donors, of organs from deceased -- dying -- patients dying for coronary death, and that is naturally something that we will be targeting on, of course.

And it's also very useful to hear about the powerful Liver Assist. And when can we expect more clarity in terms of the pathway that seems to be perhaps more obvious, but also the clinical -- level of clinical trials that will be involved?

I cannot give you a date for that yet. But as soon as we are ready, and we see that we have taken the right decision and also anchored it with the Board, then we will also communicate this to be in connected with the quarterly report communication or something else. But I -- it will come, but not today.

But it will come this year, certainly?

Yes, of course, we will communicate this year, yes. But I cannot be thinking you the date for this year.

Our next question is from Caroline Baner of Danske Bank.

Congrats gentlemen on the report and, of course, on the FDA approval. Really good news. So just a question on -- related to the rollout of Kidney Assist in the U.S. Do you see any additional sales costs related to that rollout? How should we think about that going forward?

I mean, we have plans Caroline to -- I mean, we have today one person who is dedicated to Kidney Assist transport in the U.S. One very good sales person. I mean the plan is, of course, to add a few resources as the year goes by and the volume sort of build up. And -- so we will -- but very good plan for and budgeted for and has been in our plans for some time. But that is also why we want to take it a little bit carefully in the first weeks or months, not to push too hard because we also want to gain insights and competence because we are entering a totally new market in the U.S. where we have never been before. And we know that we have a fantastic product, but we also want to ensure that the organization is capable of handling the volumes as they grow and also that we can hire the right person or persons over the year. Before -- also, we've seen with Kidney Assist transport, we are talking about machine numbers, which we've been much higher than XPS over time. So we need to learn [indiscernible] how we are going to service the machines, what kind of resources do we need for that. So we don't have the answer to everything yet, Caroline, we don't. So that is why I have said that we will start by launching selectively so that we really give the best customer service possible and not to overpromise. Does that make sense?

Absolutely. Fair enough. I definitely don't expect you to have all the answers. So -- but when you say launching selectively, could you give us some more color on what the perfect customer would look like to you in Kidney Assist, for example?

Yes. I mean we have made a launch plan and the plans for 2022. And we know which centers are the ones to target first. And we are already -- we've had discussions with several centers. And there are centers today who are using the competitive product. There is one competitor in the market. And there are centers today who are using old technology, meaning an [indiscernible], yes, nothing else. So we have the target date. We have already had discussions with centers. Most of the big kidney centers in the U.S. are in the Southeast or Eastern part of the country. And those are the ones that we have built relationships with. And there are certain centers, which are actually very large, Caroline. I mean there are centers making -- doing a lot of transplants, and those are the ones we are also primarily sort of discussing with. I can't go into more detail on specific names right now.

That's fair. And I was kind of hoping you'd say that, that you were looking at the ones with a larger volume. So I'm pretty happy with that answer. So looking at heart -- at the heart device in the future, could you give any guidance on what share of Thoracic you expect that to be or it could be? I understand that it's looking into your crystal ball and all that, but any guidance there?

No, Caroline. I love the question, but I can't really answer it. I mean we have made, of course, internal plans already when it comes to how we will price it and so on. But if you look at heart holistically, I mean, the number of heart transplants, it's a little bit more than lung. I think lung is around 4% of all transplants in the world and the hears is 6%. So it is a more transplanted organ than lungs. But I think our heart device will also enable more transplants to take place because one of the limiting factors is the ischemic time, 3 to 4 hours outside the body, and after that, the heart not function in a new body. So I think you can make your own assumptions around it, but I can't give -- I can't be more specific right now and give you any volume indications. That would also be a little bit premature.

All right. Understood. I have plenty of assumptions. I'm just trying to bounce them off you, I think.

I know you make your assumptions every quarter.

Yes. But okay -- but let's go back to kidney. So what kind of capacity do you have to meet the potential demand in the U.S. in terms of...

You mean manufacturing -- you need manufacturing of those machines?

That's right. Yes, that's right. Yes.

Yes. I mean we are using external manufacturer in the Netherlands. One company is producing the shell and one is sort of assembling the device itself. So it's 2 well-known, well-reputed Dutch companies. And there is a production ramp-up, of course. We are starting since a couple of weeks with, it's one -- we're producing one device per week and that will then increase over time. But it's like with everything, Caroline, you have to be a little bit carefully in the beginning, you have to gain experience, you have to make sure that the supply of components, that everything works. So we don't see any rush to flood the market quickly with this device. But we need to work very closely with the external manufacturer and make sure that capacity is built up in a good and logical way. So right now, it's sort of one device per week, that's what we are doing. That's all the information I can give you right now.

[Operator Instructions] Our next question is from Peter Ostling of Pareto Securities.

Yes. First, nice quarter, guys. First, I just wanted to -- when you say -- when you talk about market share in the U.S. within Lungs, how do you define that market? I guess it's not just the EVLP market and you divide it by yourself and TransMedics. So how do you define the market? And how do you look at specific market share when you talk about that in the U.S. for EVLP?

It's a good question, Peter. I mean if you look at the total market, I mean, what we have done -- it all depends on what you include in the potential market. And the way we see it is that we include the Consumer Goods, STEEN Solution and Perfadex Plus at a certain price level. That becomes, let's say, the quality revenue per -- potential revenue per lung transplants performed. So that's only one part of this. Now with the acquisition of STAR Teams, you can actually expand the definition of market potential as we expand the value chain. But we take the number of transplants and we apply it by a number -- or multiply it by a certain called value per transplant according to our definition of what is then included in this -- in the transplant activity from our side. And then we make assumptions on how much could actually be EVLP or how much would not be sort of EVLP programs. And then we make certain market share assumptions. And we have talked through the prospect about EVLP having a penetration of -- globally of 5%, 6%. And in the U.S., it's a little bit higher. And of course, we have an ambition to gain market share every year, and we have that in our plans up to 2026, where we have set the revenue targets per year and also, of course, profit target. So that is a little bit how we define. I don't know, Kristoffer, if you want to be more specific about the market size calculation model that we apply.

No. I wouldn't.

Okay. But one way of seeing it is that, as you probably know, that OPTN started to collect EVLP data for transplant recipients a couple of years ago. And I think the last number I've seen was that EVLP was used at around 6% of the recipients. Have you -- and that -- I think it's a couple of years old. I don't know if you have any later number. Maybe it's [indiscernible] a little bit during the pandemic.

Yes. I think so. I haven't seen -- I don't know, Kristoffer, if you have any recall of the latest numbers.

No, I don't. I don't. What we -- it's always a little tricky to gain data from -- regarding EVLP, a lot of that collection needs to be done by [ STAR specialist ]. So -- but we do know, I mean, based on the Q4 that we sold a lot of high volumes, a lot of EVLP goods. And we also know that the major clinics, for example, the Cleveland Clinics, have actually grown their programs during COVID. That, I think, is what I can comment.

Okay. Liver Assist seemed to have had a very good quarter. I was just a little bit curious, I mean, both the Liver Assist and the Kidney Assist is rather flexible, so you can use it both as hypothermic perfusion and normal thermic perfusion. I was just wondering when it comes to Liver Assist, is the main use actually the way it was used in the New England Journal of Medical article? Or is it also extensively used for normothermic evaluation of livers?

I mean we believe that hyperthermic, which is what was used in the article is the main way sort of forward. But we have -- flexibility can be used normothermically, but it's nothing that we sort of promote, Peter, if I may say so. I think that's how I can sort of comment it.

Okay. When you say that EVLP as -- sorry.

I just want to say with [ Liver Assist ], the good thing is there is flexibility. And I think not every device has that feature. And I think that's -- it's sort of -- yes, and some institutions or hospitals have a different view on normothermic versus hypothermic, and I think it's good to be flexible. I think that's also worth commenting from my side.

I mean in my view, they are quite complementary in order to expand the pool of available organs in the lungs.

Absolutely. Absolutely.

I guess that when you go to -- maybe it's a little bit early to say, but when you talk to the FDA about the future routes in the U.S., is it mainly the hypothermic use that you discussed? Or will you still have that flexibility in the U.S. also?

We will come back on that.

I think that is what they -- yes, that is what one of the things that we are discussing with FDA at the moment since there are different routes. But we haven't concluded yet.

Okay. Okay. And finally, when will you start to give more numerical guidance for the full year? Your main competitor does that, so when will you start to provide a range of top line expectations for the full year?

Yes, I mean, it's a good question. I know that you would like us to do this, Peter. I think we should, at some point, do it. I think the more matured projects we have and, let's say, the wider the assortment and assortment range we have, which is sort of happening as time goes by, I think we will come to a point when we can give this guidance. But once again, let us come back when we feel comfortable of doing so. But you have a point and I support your thinking and which -- we should be able to do it, but I cannot tell you exactly what date we will do it on.

There are no more questions on the audio line. So I'll hand back over to the speakers.

Perfect. Then I think we can conclude here unless -- yes, if there are no further questions. And thank you for excellent questions, by the way, good discussion. And I hope to see you all again in one quarter's time when we report first quarter '22. So thank you from Kristoffer and myself to all of you. Thank you. Bye.