Xvivo Perfusion Aktie

Welcome to XVIVO Q2 Report for 2026. [Operator Instructions] Now I will hand the conference over to CEO, Christoffer Rosenblad; and CFO, Kristoffer Nordstrom. Please go ahead.

Good afternoon, everyone, and welcome to XVIVO's earnings call for the second quarter of 2026.

To get started, we go to Slide 2 and today's presenters are me, Christoffer Rosenblad, CEO, calling in from Gothenburg, Sweden; and Kristoffer Nordstrom, CFO calling in from Denver in Colorado.

And with that, we can go over to Slide 3, which is the Q2 financials at the glance, the Q2 shows the sales amount in line with the previous quarter Q1 and with a 36% organic top line growth compared to the same quarter last year. EBITDA was kept at a healthy level, resulting in a good operating cash flow.

For the third consecutive quarter, the total cash flow was neutral and hence, the cash position stable. Kristoffer Nordstrom, our CFO, will get into the details on sales, gross margin, cash flow and EBITDA later in this presentation.

If we look into the segments, both the track and abdominal segments are growing rapidly in both regions, North America and Europe. The lung market trend from Q4 last year continued into 2026 with a good long market growth. I'm also very pleased with the strong kidney sales in the quarter, fueled by a larger sales spread in Europe and growing sales force and most importantly, the growing interest from clinicians in the United States.

We will come back later in the presentation on the progress for the Service segment. The action has taken and how we will execute to become the preferred partner in the transplant process.

With that, we can go over to next slide, which is Slide #4, which is the same picture but for the first 6 months of the year. And it shows a similar picture as the quarter. Good, stable overall growth come from strong track growth and healthy abdominal growth. During this year, we have continued to invest mainly in sales force, scalable production structures as well as regulatory approval.

Sales came in at SEK 480 million with a 29% organic growth. If we look into the segments, we can see that for part, the main hurdle is regulatory approval. Once the heart assist is used, the feedback is overwhelmingly positive. We continue to build evidence and more than 600 patients now have been successfully translated with artists. The best testament to success is Australia, where the heart penetration in year 1 was approximately 30%. Year 2, it increased to 40% of DBD art in 2025. This year, we already see an increase to approximately 50% penetration of all transplanted heart in Australia.

I also want to mention that our projects are progressing according to plan. regulatory time lines are hard to predict. But clinical trial submission file and the development progress are progressing according to time lines we have previously agreed internally. The full-scale production of disposables for heart, liver and kidney would be extremely important to capture future growth potential for all three products.

With that project coming to an end, we will now focus on reducing cost per disposable, setting up dual production where deem necessary as well as improving our machine production setup. This project will also include our lung portfolio.

Lastly and most important to mention is that this quarter again shows that the business model is scalable. So with increased sales, we see that turning to an improved EBITDA and an improved underlying cash flow.

So with that, we can go over to Slide 5, and we will come back later to the financial numbers in that section, and we can go into the Q2 highlights on Slide 5. And those we will see on the Slide 6 and 7. So we can go straight to #6.

One key is that we definitely start to see that with a larger sales force, we meet more customers, and we see an increased adoption of our technologies across the line.

Number two, we mentioned before that the lung market is back, and we very importantly are running an OPO EVLP hub pilot that is successfully now up and running, and that explains partly the increased lung sales during the quarter. So far, the progress is in line with plan, and we have identified four to five OPOs in the rollout pipeline, whereof the third OPO was onboarded last week. We are continuously investing in more feet on the ground in the U.S. to enable closer customer relations with a growing number of EVLP partners.

If we look three, look into heart, as I just stated, in Australia, we saw a fast pickup of usage early on, and it increases year by year. Now we see a similar interest in Europe, and it translated into usage under derogation or compassionate use. It's interesting. We hear more and more testimony from customers who say that XVIVO heart exchange, not only the ability to translate more patients with higher patient survival rate, but also reduced stress level in the transplant team. and increase the confidence in hard transportation.

In the U.S., the interest in our XVIVO heart technology is equally high, and we have recently submitted the extension of the cap or continuous access protocol to FDA. I mentioned in the last quarterly call that I would mention again at the spending time at the ISHLT 2026 in Toronto, it's clear that XVIVO is by far the innovation leader in the field of both lung and heart transplantation.

If we look into #4, we saw increased sales from the kidney [indiscernible] transport, and we also see an increased interest and momentum from customers using the kidney [indiscernible] transport. This is based on more and more clinical evidence being available to the clinicians that support the use of kidneys [indiscernible] transport, as well as a larger commercial footprint in both regions, Europe and the U.S.

In parallel, we are working hard to develop the product to meet U.S. OPO needs as well as lowering the cost per disposable to increase margins over time.

And with that, we continue on highlights and Slide #7. Point five, what is very encouraging is to see that when we put commercial capabilities and increase our sales force, we grow typically between 30% and 60%. And with future approvals expected and coming in as well as our product improvement, we will continue to see this leverage of commercial sales force turning into increased sales at a good return on investment.

Even though I wish to have point six, even though I wish to have had great news. We have seen great progress in all our regulatory processes as well as -- as we have stated, we worked hard on the derogation and compassionate use here in Europe. We see tick it up in Australia. And now we see that we have what I deem as good progress in the regulatory processes. I will shed more light on where we are on each approval in the next section of the call, the regulatory and clinical update. But I just want to conclude here that we are pleased with what we have seen so far.

If we look at point seven, very important point. To start with, we are very pleased with the growth and the cash flow we saw during the first half of the year. And we but we invest heavily in future growth. The majority of the investment, of course, go into regulatory application for heart globally and liver in the U.S. But besides that, we continue to invest heavily in building commercial capability and the production scale-up to enable higher volume than we have today. We are also investing in quality capabilities to support the growth we will see that we believes will be 10% in volume versus what we see today.

And Lastly, number that capture, I think, the first half year is that we have a scalable business model. We do invest to capture that opportunity, and we see increased sales turn into EBITDA, that turn into an improved operating cash flow that we then can invest into regulatory approvals of our future sales drivers, which is heart globally and liver in the United States.

And with that nice segue, we can go into the regulatory update, Slide #8, but we can actually quickly go to Slide #9 to going to the regulatory processes we have. And this is the usual overview that we show every quarter on Slide 9. We now see more and more evidence for the heart disease globally. In Europe, we ran the first randomized controlled trial with superior endpoint that was performing the field of heart transplantation. The clinical outcome was great with an additional six live save per approximately 100 patients. It is also the first clinical trial to establish a link between preservation method, severe PDD reduction and reduced 1-year mortality. In the analysis of the trial at it was noted that XVIVO group had the reduction of severe PDD by 76%, which is a lot. In comparable number, the severe PDD was 20% in the control growth, which is expected, but only 5% in ex vivo group. It was further noted that the mortality of the severe PDD was approximately 40% in both groups, leading to an increase survival 6 percentage points in the XVIVO group versus the control group.

The U.S. hard drivers will include in a record time. So the same picture. The severe PDD rate there was only 7.9%, and we are now financing the submission for the FDA for their review. So the team is working very hard. We are expected to hand in the submission filed to the during this quarter after there are -- we are waiting for some validation and product aging data before we can finally submit it.

In Europe, the market process for Europe is ongoing and at the late stage. Now is my best judgment. I stated earlier, the hard box and disposable part of the product is already marketed solution has passed EMA consultation we're now waiting for consultation at the South America Agency for the one part of the product.

During Q2, we received a few questions of clarification nature, which we turned around in less than a week. We are now waiting for feedback on that additional information where we unfortunately don't have an exact time line, but we expect feedback during this quarter, Q3. As we stated earlier, the uptake of heart disease is good in Europe under derogation and compassionate use, and we are ready to launch when the product is fully approved. Hence the launch plan is ready. We have staff recruited and they are meeting customers today under derogation to support them with everything they need, and the interest from clinics is very high in Europe as it is in the rest of the world.

I still want to mention that even though the use under derogation compassionate use is increasing and appreciated by our customer, we need to mention that European heart clinics are suffering badly from lack of alternatives to the XVIVO heart assist.

In both United States and Canada, the regulatory approval will be pending the CE Mark in Europe we are waiting for that one for until we will seek for approval in those two regions.

The last point liver in the United States. I will come back with an update on the next slide, Slide 10. And leases regulatory status in the United States. So we have previously reported that the Liver Assist has been granted breakthrough device designation by the FDA with an approved IDE and CMS funding improved. We could have started a trial already last year, this point pretty much 1 year ago. We did decide to temper the post activities for the liver premade process to investigate alternative regulatory routes possible. And we are preparing for the FDA Q-Sub meeting where the possible regulatory route will be decided by the FDA.

We have recently opted to focus the majority of the results we have on the heart U.S. submission. That being said, we have very high interest for us clinics that are supporting the U.S. liver submission. And we are in good dialogue with clinics to prepare ourselves for the Q-Sub meeting with the FDA. We will inform all investors of the next steps in the U.S. liver regulatory investigation latest in the Q3 report, if we don't feel the need to do it before that. And with that, I conclude the first section of the Q2 presentation, and I will hand over to our CFO, Kristoffer Nordstrom, who will present the financial performance.

Yes. Thank you, Kristoffer. Turning to the financial performance for the second quarter then. So this was another strong quarter for XVIVO, the strong momentum we saw in the first quarter continue into Q2, as you have seen, and we delivered net sales of SEK 239 million, which corresponds to an organic growth of 36% in local currencies.

Importantly, growth was broad-based across our portfolio and driven by continued adoption of our technologies in all major organ areas. Pleased to see that.

At the same time, we continue to invest in commercial capabilities, regulatory activities and operational scale-up initiatives while maintaining a solid profitability. EBITDA amounted to SEK 45 million, and that's around 19% in an EBITDA margin. And we believe that this demonstrates both the strength and the scalability of our business model. I will get back to that.

Gross margin was 71% Domestic margins remained strong, while gross margins in abdominal and services continue to impact the overall mix, and I will come back to that as well in a moment here.

Going over to the next slide, which is the largest business area today for XVIVO, Thoracic. So Thoracic delivered a positive quarter with net sales SEK 58 million and an organic growth of 53%. Adjusted for part trial revenue, we're still at 52% organic growth, so very good. The momentum in lung continue to strengthen disposable sales grew 69% in the quarter, and we continue to see expansion beyond our largest customer accounts.

Activity remains strong, both among leading transfer centers, but also within our growing OPO strategy. And during the quarter, as an example, two additional express systems were installed at OPOs in the United States and are expected to become operational in the second half of the year.

Heart, Christoffer touched upon it, we're very pleased, very proud to see that we delivered a particularly strong quarter in half, generating sales of SEK 24 million and primarily from Europe and Australia. We continue to see increasing use under compassionate use and irrigation and wait for our regulatory approvals. With the approximately 600 has transplants with our technology, we continue to build both clinical experience and commercial momentum ahead of our future approvals, which will be very important.

Gross margin on Thoracic 83%, remaining at a very attractive level despite the increase in contribution from hard sales that you should remember, is still at prelaunch pricing.

Moving over to Abdominal. Abdominal delivered another strong quarter and reported net sales of SEK 65 million, corresponding to 26% organic growth. Liver sales grew 11% in local currencies, while kidney contributed and was the primary growth driver with a growth of 72%. We are particularly encouraged by the continued adoption of kidney's transport both in Europe and North America as more centers can experience with the early adoption of this technology.

Gross margin was 57%, so an improvement from Q1, but less than 68% last year. The decrease was primarily driven by product mix with Kidney representing a lot share of sales as well as pricing conditions in certain markets. While this impacts margins in the short term, we remain very confident in the long-term margin opportunity within Abdominal as adoption increases in the U.S. where pricing levels are structurally higher. And as we continue implementing manufacturing and sourcing improvements, we expect margins to improve over time.

So overall, we remain satisfied with the growth trajectory in abdominal and the increasing adoption of both our liver and kidney technologies.

Turning to services. Our third business area. Net sales were SEK 15 million, corresponding to a negative growth of 25%. The development continues to be explained mainly by lower organ recovery volumes, while Flowhawk delivers another strong quarter. Flowhawk grew 48% organically, continues to gain traction among [indiscernible] programs across the United States. And we remain convinced that our digital workflow solutions will become an increasingly important part of transplant infrastructure and customer integration for XVIVO over time.

Within order recovery, volumes remained below our expectations yet in our quarter. However, following the investments we have made into the organization, the talent that we have attracted, we feel that we are getting closer to growing our customer base, and that's our -- we have a firm focus on returning to growth here in the second half of the year. And I think we should still see some results, especially in the back end of the year.

Gross margin was 10%, and that's purely reflecting the lower recovery volumes combined with our investments in capacity, as volumes to recover, the margins should naturally improve.

So switching gears from sales and going into EBITDA and profitability. So despite continued investments, as we talk a lot about in commercial expansion, regulatory activities and scaling the organization for future growth. remains strong at 19% in the quarter and 20% year-to-date. And on a rolling 12-month basis, we -- EBITDA has now improved to 21%.

Many companies can deliver high growth, and many companies can deliver profitability, and we're thinking that delivering 29% organic growth during the first half year of the year while sustaining around 20% EBITDA margins and generating positive cash flow demonstrates the quality of our business model and this already at the very early phase of our growth journey. So we're very proud of that.

As we have said previously, XVIVO's business model is highly scalable. We will continue to invest where we see clear long-term commercial opportunities, particularly in North America. But we will also maintain disciplined cost control across the organization.

My final slide, cash flow. One of the most encouraging aspects of the quarter, we think, was the continued improvement in cash generation. The operating cash flow amounted to SEK 63 million in the quarter and SEK 129 million year-to-date. And this should be compared with a negative operating cash flow during the first half of the year last year. So this reflects both the stronger commercial performance and the continued focus on working capital management. Cash flow from investments amounted to minus SEK 68 million in the quarter and relates primarily to regulatory and product development activities, especially within heart.

And what we think is particularly important is that over the past 3 quarters, we have demonstrated our ability to largely self-fund both our operating investments, but also our growth investments or CapEx. So despite continued investments into future growth, total cash flow for the first half of the year was essentially breakeven, and we ended the cash -- ended the quarter with a strong cash position of SEK 305 million. So with those comments, I will hand over to you again, Christoffer. Thank you.

Thank you, Nordstrom. We will round off this presentation with the outlook for the rest of the year and then a little bit longer-term outlook. We start with Slide 19 in and the outlook for 2026 and our focus areas.

So we will continue to build sales force and build new partnerships in the U.S. to enable OPO and other clinics to recover more lungs by EVLP adoption, through a combination of service models and staying very close to customers.

In parallel, we increased our service offering to better tailor customer needs, especially offering Flowhawk and [ NRP ] from hopefully increased footprint, we have an increased surgical footprint. We should also have an increased contract footprint.

We will continue to work closely with our competent authorities in Europe to -- with the aim of obtaining the CE Mark of Heart, of course. We are aiming to submit the regulatory heart filed to the FDA for their review during this quarter as well as deciding the regulatory pathway for Liver Assist in the United States with aim of given U.S. surge of the same opportunity we now see here in Europe using the Liver Assist where European clinical team saves hundreds of lives every quarter, thanks to Liver Assist.

And if we turn from this year outlook to a little bit longer term, which is, I think, is important to keep in mind what we have is that the demand for transient is still 10x higher than the supply of organs. We should also remember that the sales value for machine perfusion is approximately 10x higher versus what is used today to a large extent, study cold storage or a beer cooler box type with ice.

Machine perfusion and our service model have proven to increase the number of orders to be used for transportation, especially in the fast-growing DCD organ pool, where the main growth drivers are superior clinical results from machine perfusion and the fact that we can reduce complexity and add time for the [ Trampa ] clinic in order to reduce stress.

So in conclusion, we know the machine perfusion and good service models are normal and DCD graph will drive growth in the near and the long-term future.

Lastly, want to change the paradigm for transplantation by innovation. We are convinced and committed to increase increasing patient lives of transplantation, making sure that no one dies waiting for an organ and making sure that we have rested transplant performance surgery at a lower cost than what we see today in the transplant chain.

And we hope that you, dear listener, in the future when you fly, you might be seated near to an XVIVO heart box with the heart being transported to a patient who likely is about to change soon. And if you see that ever device in flight, you should know that it's not just a heart traveling. It's a hope for a new and a better life for the patient and his her family. And I want to thank you for supporting us on this journey to change the transplant system forever through superior innovation.

And with those last words, I also want to thank you for listening today. And with that, we will open up the lines for questions.

[Operator Instructions] The next question comes from Simon Larsson from Danske Bank.

A few questions from me, and I would like to start on the strong Heart print that you mentioned. Would it be fair to assume that sales in this quarter was maybe a bit boosted by a lot of new placement of the boxes or were revenues mainly stemming from existing clients already sort of using consumables and yes, some sort of a basic run rate for the business? Or I mean, just how we should think about the dynamics of the business model here in the beginning of the launch, if you will. And if we should extrapolate anything in the second half?

Thank you, Simon. It's a great question. I mean we are scaling up in Europe. There were limited heat box sales, both in Q1 and Q2. So the main sales from disposables. But we should remember that once you get started, you have a few kits as safety stock. So that has affected half year 1 to some extent. But we see definitely increasing uptake in Europe from [indiscernible] Heart.

Great. Great. And the second question was on EVLP. So I believe you have three OPOs signed now on online as well. it sounds like more also in the pipeline, hopefully, for the remainder of this year. So if you could help us understand the potential of these OPOs when it comes to revenue. I mean, I guess, you have data on your current volumes and growth rates, et cetera. So I'm just trying to understand what free to find OPOs can do for you in the same next fiscal year? What type of -- was the name you'll be talking about?

We are in pilot face. So we do need to come back in probably 6 months to answer that question properly and with more exact data. But what we do see is that the opportunity to evaluate in lungs on the OPO side is vastly at #1 on the clinical side due to their access to extended criteria lines that is there. and also the fact that it simplified the whole process.

So we have seen in one note, we saw a fairly fast uptake. We need to replicate that 3 to 4x more to come back with exact numbers coming into next year. But so far, it looks good. And according to our own plans, it's according to those at least.

Okay. Okay. Makes sense. And the final one was on sort of further recovering investments in sales force when we're approaching a Heart launch, both in Europe and in the U.S., right, into next year? So could you give us any like help or ballpark estimate on like how many more salesperson, support persons do you need to really cater and to meet the demand and to make it a successful launch here for the heat product. So what's the magnitude of investments basically that we should expect here in next year maybe?

Yes. In Europe, we have invested. There will be add-on investments when the more customers come on, the more field force, we need, so to say, ranging from customer support to technical support to clinical support to sales reps. So that is more of a scaling exercise.

In the U.S., we will start to do in next year scale up. We -- depending on a little bit on the timing, but we do believe that we need an approximately 10 to 13 extra commercial head count ranging from sales reps again to customer support, technical support and increased clinical training/support.

The next question comes from Jakob Lembke from SEB. .

Yes. My first question is on the OPO customer channel. So I'm wondering the first deal that you won here earlier in the year, if you can elaborate on how that has sort of developed and ramped up here in the first half of 2026.

I can go on that, yes. So you might -- you got -- we acquired that opioid at the back end of last year, they became active very early this year. And I would say they have a strong ambition at bill and a mutual mission on par with volume-wise for EVLP on par with, let's say, the top 5 centers in the U.S. So you talk about fairly larger volumes.

And then there is -- this is a new method, and we are -- the parties that needs to collaborate. So it's [indiscernible] and it's [ PSI ], our confusions partner and OPOs. So there are learnings in the making. But we believe that we have a proof of concept just provide some more color. I think they are now close to, let's say, 20 EVLP for the first half year and now their addition is higher than that when they are fully up and running, but we consider that a very strong start and now we want to replicate that on the other OPOs as well. I think you will see a variety of slightly lower volumes than this one, but also perhaps higher for press [indiscernible]. It's a good start.

Okay. And this, let's say, 20 million in the first half, is that a reasonable assumption for the second to year 1 now into for H2 2026.

Yes. So I think you will see, I think the ramp-up time could compare a little bit on these two bills? One is smaller and one is bigger. It's a little bit too early to see to say, I think a lesson is that it takes at least a quarter I think, Q2 to come to speed [indiscernible].

That's [indiscernible]. Then I have a question on the heart sales in Europe here in Q2. If you can elaborate on what countries are contributing to that.

As Christoffer said, we're very, very happy now with the we have in Europe. Naturally -- there is some background noise here. I'm not sure if you could [indiscernible]. Naturally, these are sites that has participated in the European clinical trial. But we talk about France, as we set up the press release this year about the derivation of mayor contributors. You have the Benelux countries, Germany, Sweden and Denmark, if I remember correctly. So we think that's a very good starting point here. Thank you.

Okay. And then on the process for Heart in Europe, I mean, I understand that it's very tough for you and it's hard for you to make predictions, but it sounds based on your commentary that we're unlikely to get it within the sort of 1 year or from the press release you sent out, yes, August last year. .

Yes. Yes, that's our best guesstimate at this moment. Based on where we are in, let's say, level of clarification. That being said, it's hard to predict regulatory time lines, especially during the summer. But yes, that's our best guess to on that.

But it's still I mean reasonable to expect it in 2026, perhaps?

Yes, I certainly hope so.

Okay. It's tough. I get it. Then a question on liver, which had a bit slower growth here for the second quarter in a row. And I'm wondering if there is something that has changed there or any sort of abnormal fluctuations.

I think that we had a fairly strong Liver quarter last year to start with. So we have fairly strong comparables. We do have a good Liver pipeline still in Europe. We believe that the majority of market penetration from hereafter will come from both increased sales in, let's say, newer European countries where we have, for example, really high penetration in Benelux we can see an increased penetration in other countries, so [indiscernible].

But we believe that a large part of the two, besides new countries will also come from improved service models here in Europe as well. So we are -- if we look at the pipeline, it looks possible for liver as well.

Okay. And on liver. I know there is one competitor that is talking about expanding more into Europe and there's another competitor that I know is growing a lot. You're not seeing any sort of increased competition from those, in short term?

We do see increased competition to -- in Europe to absolutely. But we believe we have a strong track record, very strong clinical proof, good customer relations, so to say. So we so far haven't seen that strong competition coming in.

I believe that most of the -- let's say, the -- how successful we are is like in our hands and how successful we are to implement good service models. When I talk to customers in Liver, that applies to aisle, especially, they are looking for supporting reimbursement, but especially in service model due to shortage of staff. So if we can support them with that, I'm sure that we will become the preferred partner to a lot of clinics in Europe over time.

The next question comes from Filip Wiberg from Pareto Securities.

I've got a couple of questions, but I'll take them one by one, I think. So the first one is around the largest customer that you have in line. So you had another strong quarter here. So I'm wondering what your expectations are now for the coming quarters and what kind of visibility that you have there? And like also if your projections have changed at all following their own approval.

Thank you. In general, we stay close to all our customers and especially the large ones. We are part of their approval, and we will continue to see increasing quantities. We're convinced of that. The sales value will, of course, be smaller compared to today. We have visibility approximately 6 months, good visibility and for the 6 months, it looks good for. After that, we have less visibility to say so, and we are in a good dialogue to have a better understanding of how the future will be shaped together. So we need to come back on a more deep [indiscernible] of that question.

Okay. Okay. But so I think in connection with the last report in Q1, you mentioned it was fair to assume that, that was a new baseline for the LP number. So -- and this seems to have been true in Q2. So it sounds like you still have confidence around that statement now looking forward as well.

Yes. We are confident for the next months, so to say. We are also very confident that we together will increase the number of the LP so we can make sure that nobody dies waiting for lung at one point and that we will do together. So we are convinced and committed to increase the volume and the number of bps going forward. Exactly how that will shape in to U.S. dollar, it's something we need to come back with if we look into '27, '28, '29.

That's all right. Then a question on heart. So you now plan for the PMA submission after the summer. So now like how large would you see the uncertainties around the exact time line for that? Like do you have all the clear steps that you need to take now going forward until that submission? And like are you able to provide some more details around what that exactly is and what is remaining before you are ready for the submission.

The main, let's say, hurdle bottleneck is that we have had some changes of components with a product that happens. So we need to verify all product aging for, let's say, the final product. So that is what we're waiting for now during the summer. I mean, it's a large clinical file, a large, let's say, product file and animal file as well that needs to be submission. But that we have a great team on board, I sat with them for a week, the clinical results, fantastic. So I am confident if nothing goes wrong, I'm extremely confident and then I mean with product aging or something out of our control. But if it comes to submission, I am right to define et cetera, I'm 100% convinced that we will do that on time. Then it's more the unknown unknowns for that I'm -- I don't know. But for the rest, I'm 100% confident that we will hit that time line, if nothing out of the ordinary happens.

Okay. Very good. Lastly from me around the cap in the U.S. So you submitted it, I think you said earlier. So how long time does it take before the FDA can grant approval for that? And when can we expect transplants to start again under in the U.S?

The straight answer is I don't know 100% sure, but it's a fairly easy turnaround, so to say, for the FDA to do my best guesstimate would be approximately 30 days turnaround time, hence, it should be able to start in somewhere here in Q3, if everything goes all right.

The next question comes from Ludwig Germunder from Handelsbanken.

Thank you, and good afternoon. So I have two questions, I think. I want to start with going back to what was discussed earlier here with the investment in sales force. So when we think about OpEx and scalability going into next year, is the big driver of higher OpEx, the investments in sales force? Or is there anything else we should have to keep in mind?

Yes, it's a great question. Thank you for asking that one. With a growing company and a growing machine fleet, you also need to scale up quality and taking product management, let's say, the back end of the company to take care of the growing fleet and be able to return assets to customers very fast.

So there are -- but those investments are in comparison to commercial capabilities limited. So that's why we normally talk more about commercial capabilities because that's the where the bulk of investments will be funneled. But you are right, there are -- in general, you also need to scale up, let's say, the back end of the company in order to enable higher growth rates.

In terms of production, we don't see that we need to scale up because we have -- we are relying on the majority on third-party manufacturing, et cetera. So that's more improvement projects, lowering COGS over time, efficient processes. But we have the right people on board doing a fantastic job. So I don't see a large scale up there. But definitely quality side, taking product management side, there is a need. But compared to commercial force, it's smaller and limited.

And just a follow-up on that. I mean, is it fair to expect that to grow in line with sales growth?

That should be -- in the beginning, it will be a larger, so to say, investment, let's say, approximately 6 months before launch and 12 months after launch. But once that has stabilized, it growth will far outpace those type of investments. There's more of a...

Yes. Good. And then a question on Abdominal I guess, you mentioned in the report that you had some pricing conditions in I believe, undisclosed markets. Could you elaborate a bit on this, if possible to say what kind of pricing conditions, what markets are affected? And is that for the entire abdominal segment? Or is it more towards liver or kidney?

I can take that one. So I mean if you look at -- and this is -- relates to Europe primarily. But if you look at certain countries in Europe, you have the East Europe, you have certain South European countries where there simply is not -- basically, there is not enough money in the systems and the pricing has to be lower. And it's at those countries, those markets where we do see competition from competitors implementing lower prices. And we believe that we will need to ask ourselves if those markets are at the moment, attractive for us. if you look at the more important markets and what it historically have been our main markets, you don't see that pricing pressure and you see an increase in utilization, especially DCD and now looking into DBD as well, and we see less of competition today.

That might change. But I would say it's more -- we have in last year, we were very good at coming into those markets, Eastern Europe and certain other countries, but it comes with lower margin. But that's not where you will see the growth either worse going forward. So I'm not worried from that perspective. It's just an effect we have at the moment.

And just to be clear, was there something that started or that you started seeing during Q2?

No. I mean that -- well, the volumes at those markets has picked up for us during this year due to our successful installations of our devices mostly.

If you look Q2 specifically, I would rather say it's the fact that we have been very successful on kidney and kidney sales globally are at lower margins. That's how the market looks today. And with the reimbursement long term, we hope that we can improve that. And also we touched upon it, but I want to mention that one of the good outcomes of the manufacturing project that we have run now for 2 years, moving manufacturing from Netherlands to Sweden, is that we will see a lower cost on especially our abdominal portfolio. I will say, perhaps not this year, but that's starting from mid next year. We should start to see that come in.

And then just a final question for me, please. Also on the COGS. I mean besides what you just mentioned, you've also previously been speaking about for kidney specific that volumes have been too low, and that's why the gross margin has been lower. I mean besides the initiatives and the move of production that you mentioned, how much higher volumes do you think is needed to see higher gross margins for the kidney sales.

I can back to some extent. I mean, we need to see three things. One is a geography mix. It's -- I should also mention it's partly by choice where we choose to gather more DBD data on kidney in countries with a little bit lower margins, but you get very good data it makes economically sense because we don't have to pay for it, so to say, but we pay for it through a slightly lower margin. We think that, that will be very useful data going forward in approximately 1 to 1.5 years. So it's a geography mix where we -- when we grow more in high-margin countries, it will, so to say, by the picture. Then it's definitely cost per kit. And there are two components there to look at.

One is the component cost where we need to reduce that and also get a better process. And then lastly, we have seen that when you come up to, let's say, stable production, it's not exactly a quantity because we don't have a pricing with our production suppliers that is based on how much we purchase. So we don't get lower if you purchase more. It's more that the process get improved over time. And then you year-by-year, reduce a little bit of cost every year because of better processes and higher scale pretty much.

So it's a combination of those three factors that I think we take 1 to 1.5 years to get out of the system. But once we do that, we will have a very healthy margin on our full product line.

The next question comes from Ed Hall from Stifel.

I have a couple here. The first one would just be on lung and the OPOs. And I guess as we look into H2, sort of how much does that do you view that as driving growth? And maybe more specifically in Europe sort of in the EVLP momentum you've seen there, do you see that sort of continuing into the rest of the year?

Yes. Looking into forecast, yes, we do believe that, that momentum will continue. We do see an increasing interest for lungs in general, EVLP, in particular. The donor pool is becoming more and more extended criteria to put it that way. Hence, there is a larger portion of DCD. There is more TRP done, which potentially harm the lungs, et cetera. So there is an increase in security coming from donor lung. So we see an increased interest. And we believe that, that will -- if we are staying close to customers and do our job right, we believe that, that momentum will continue through the rest of the year, both in Europe and the United States. .

Perfect. Perfect. That's really clear. And then maybe just more of a Q3 question, but it's obviously, we've seen the typical seasonality in the U.S. for lung. And I was just wondering to hear your thoughts on it for this year, sort of given dynamics like phasing of revenues and obviously this growing OPO strength. Is there anything to offset that seasonality?

I mean, in general, doing this for 14 years, 3 years typically a bit of a weaker quarter. very much depending on that's where the majority of people take vacation and that applies for to translate as well. We -- last year was a bit of an anomaly, with an extremely weak Q2 and actually July, August, and then we saw volumes picking up in September. But that has more to do with United States and the economy behind in transportation, more resources in the transplant system. So if I look at a normal year, I would say Q3 is seasonally a bit weaker and then Q1 to Q4 is typically a little bit stronger.

Okay. Perfect. So this year, there's nothing to offset the last 14 years that you've experienced?

No, we haven't seen any sign of that so far.

That's really clear. And then just my last question just would obviously be on Flowhawk, and I appreciate it's a small part of your service business, but obviously, it looks like it's growing really well and it's a SaaS, so I assume quite a high gross margin contribution. I just wanted to try and understand sort of how big could this be, both in terms of sort of your revenue I guess who's using it now. I'd just be curious to understand a little bit more about this business.

I agree with you. I mean we have high hopes for Flowhawk, and it's still a very unique communication and transplant administration tool. We -- I mean, we will take this picture more deeply for you guys during the rest of the year here as we move into our strategy work at stable, but -- we want it -- we see it as an air traffic control tower more or less that could be used by all OPOs, all transplant centers. And we believe that in the near future here, you should be able to integrate our technologies with Flowhawk, which will create stickiness at the centers and so on and maybe you can also potentially make us come even closer to the customers that organ offering stage and so on. So -- but it's still very -- in the early evenings, but that's why we're also happy to see that we have this growth now when it comes from both renewals from happy customers, but also additional centers coming on board. So it's definitely a product for the future for us.

I see we have one more question left. We are nearing the end of this call, but of course, we will allow 1 more question. So Elvin, please.

The next question comes from Elvin Rolder from DNB Carnegie.

I appreciate you taking the questions, even though we're pretty much out of time. I will just have two ones and see if you can manage both. Perhaps beginning a bit on the gross margins -- margin dynamics in the Thoracic segment, they're strong, but they're still down a bit year-over-year. And I -- you mentioned mix effects during the quarter, and I guess it's because of the EVLP outgrowing Perfadex year-over-year, but I guess also a bit on Heart. So I guess my question is what is the kind of current gross margin that you're operating with in the heart business? And how would you expect this to kind of evolve from where you are now and the kind of 12 months post a European approval? How should we think of that?

I can take that one. Yes, heart being coming from clinical trial supply chain setup has lower gross margin compared to the rest of the product portfolio. So I think that it will take a couple of years post low until we are, let's say, up and running. But we will see definitely 12 months after European launch where we see improvements and then going further into you need typically those changes since it's the PMA in the United States and Class III device here in Europe. There are quite long regulatory time lines for all production and product improvement projects.

So I would say we need probably a couple of years to get up to both scale and optimize production before we see the really high margins we see on more mature products.

Great. And just one more for me. Looking at cash R&D costs during the quarter, it took quite a noticeable step up in Q2 versus Q1, and I guess also versus Q2 last year. And I appreciate -- I acknowledge, of course, that you have the kind of intensive work with both the PMA submission and the European approval. But are there any kind of sort of extra temporary effects that are specific to Q2 now that will start to abate once we have a potential approval in Europe? Or how should we look at R&D when we include capitalized development as well.

Yes. It's -- I'm glad you asked the question there. It's been a busy quarter as we have talked about with a high focus on our regulatory processes, primarily in the U.S. So naturally, the CapEx and the R&D spend in Q2 was higher. We would see that to go down in the second half of the year. And especially as we -- and what will happen is that when we get the CE Mark, we will start to amortize the capital CapEx tied to the mark, so to say. I've disclosed that before, and it's around SEK 25 million per year in amortization.

But despite this, we still believe that we should be able to end the year sales-wise, and the year being cash positive for 2026 would be -- which will be the first time in the [indiscernible].

And with that, I hope want to conclude this quarterly Q2 report, and I hope to see you all back on October 22 for the Q3 report as well. Thank you very much for good questions, and thank you, everyone, for listening and being part of the journey of making sure that nobody dies for longer.

[Audio Gap] for Nordstrom, please go ahead.

Thank you so much. Good morning and good afternoon, everyone, and welcome to Xvivo earnings call for the first quarter of 2026. We can go to Slide #2 and just -- today's presenter are me, Christoffer Rosenblad calling in from the 2026 ISSD Conference in Toronto, Canada; and Kristoffer Nordstrom, CFO calling in from Philadelphia in the United States. And with that, we can go to Slide #3, financial at the glance. So we see that the first quarter of this year showed a 23% organic top line growth. This is equivalent to an 18% organic top line growth if we adjust for the U.S. cap [indiscernible] revenue compared to the same quarter last year.

EBITDA was kept at a healthy level, resulting in a positive cash flow for the second consecutive quarter. The CFO, Kristoffer Nordstrom will get more into the details on sales, gross margin and EBITDA later in this presentation. Short on the segment, both thoracic and abdominal segment are growing rapidly in both regions, which are North America and Europe.

The lung market trend we saw in Q4 last year continue into 2026 with a good lung market with good underlying growth. And we see that larger sales footprint supporting more customers is paying off. I'm also very pleased with the strong kidney sales in the quarter, partly fueled by the Canadian launch and a growing interest in the United States. We will come back later in this presentation on the progress for the Service segment, the actions we have taken and how we will execute to become the preferred partner to all the transplant teams.

And with that, we can go over to the highlights of the quarter, and you can actually jump straight to Slide #5, where we see the highlights. Very, very busy quarter. We took many important steps last year and this quarter, and we have passed many important milestones that led to actually another record quarter which is the first highlight.

Secondly, we also had the very important OPO ELP hub pilot has been very successful and is now up and running and it partly explained increased lung sales we see in this quarter. So far, the progress is ahead of our internal plan, and we have identified 4 to 5 more OPOs in the rollout pipeline plan. Whereof the second OPO in that plan will be onboarded already now in Q2.

In parallel, we are continuously investing in more feet on the ground in the United States to enable a closer customer relations with the global number of EP partners we see. And we also can report that the 60 patient cap is now fully included during the quarter. We had an extreme high interest from trial centers to use our technology. And to satisfy their needs, we have to use Xvivo Heart assist, we have asked the FDA for an extension of the cap, so they can use it again, under the ID we have.

And if we look at number 5, it's a testament to how well the Xvivo Heart Assist performed and it's best shown with the real-life experience in Australia. So during Q1, the penetration increased to 52% for DBD Heart. And we are happy to announce that we did our first DCD heart in Australia now as well. It's a very important milestone and makes us convinced that we should aim for the Xvivo Heart Assist to become the global gold standard for preservation of all hearts.

And while we're waiting for the last part of the CE Mark for heart, we should mention that both the machine and disposal is -- or are already smart. More and more European agencies are approving the Xvivo Heart Assist for compassionate use. And we actually saw sales in Europe picking up already now in Q1. This is, again, an indication that the European transplant teams can't wait for the device that optimize heart preservation and enable more heart to be used for the patients waiting for new.

In our service business, we saw good progress in the Flow hawk part of it with high growth and new customers opting to use the communication software already now, 6 out of 10 of the larger transplant program in the U.S. opted to use Flow since it simplifies the trasplant process and reduce overall cost in the process. The organ recovery business is now ready for growth, and we have a positive outlook for the rest of the year. We offer NRP if needed and see an increased interest to use Xvivo or recovery service. had many, many good conversations during this IST, for example.

And with all those highlights, we can go to the deep dive into the highlights on Slide #6. So as I said earlier, I'm right now in the middle of the IST conference, which is the biggest Langanhart transplant congress in the world. And after spending time here, it is clear that Xvivo is by far the innovation leader in the field of both lung and heart transportation.

For example, the Xvivo Heart Assist was featured in 2 late-breaking news session that was very well attended and increased interest from clinics I want to use the heart device and I kind of go into those. We have some press releases regarding those we go into later in the next slide. I also want to highlight that very soon at this meeting, we will have our Heart Symposium, which will be really, really interesting to see. But already this Wednesday, we had lung Symposium so the Xvivo industry [indiscernible] to langoustine, which was a great success, really, had extremely high attendance, created a lot of interest from future customers to start up EPP.

And it was also very clear that with new innovative technology on the market, the field of lung trustontages has improved significantly over the last decade. So one example over the last years the number of CD lung transplantation has more than tripled. But more so, if we look at the patient outcome, that also improved. And over the last 10 years, the 1-year survival for ECD, extended criteria and DCD lungs, has gone from 85% to above 90% and is now on par with what we call normal lungs. And there, we see that the adoption of [indiscernible] has been key to enable safe use of those extended criteria organs.

But let's jump into the -- 2 highlights in the late-breaking news session from Xvivo. So we go to the next slide, which is #7. And it was the U.S. Preserved trial that was presented. Again, the clinical results from investigation use is positively surprising us on the heart side. The trial was performed at clinics in the U.S., and they enrolled a total of 141 patients. The U.S. study aim to prove that extended criteria heart as described on the slide here, could safely be transplant used in the Xvivo Heart Assist. I'm happy to announce that the study met is predefined efficacy and safety endpoints. The sub-analysis or the analysis of the secular endpoint showed also that severe PDD was only 7.9%.

[indiscernible] is the leading cause for early late mortality in heart transplantation. I will come back later here on the importance of it when you go with the European data. And next step, is that we will now finalize the file for submission to the FDA for their review.

And then we can turn to Slide #8, which is the other late breaking news, which was a very well-received presentation from the European DCD direct procurement experience with DCD Heart. So the trial was a single-arm, proof-of-concept trial, a total of 40 adults had transplants recipients across 4 European transplant centers in Belgium and the Netherlands were enrolled. And the primary endpoint for patients survived, but 30 days was 98%, which is very high. And the secondary endpoint of severe PDD was only 5%, again showing that the right preservation of heart keeps complication after heart transportation low.

I also want to mention looking forward that if the method of direct procurement is widely accepted by the hartalcommunity. It would significantly reduce cost in the transplant process and simplify for the [indiscernible] teams around the world.

And with that, we can go into the EU trial, which is now in a publication during Q1 this year. I again want to mention this is the first randomized control trial endpoint that was ever performed in the field of our transportation. So no 1 there to try this before, but we did. It is also the first clinical trial to establish a link between preservation method, severe PDD reduction and reduced 1-year mortality. And you can see this at the data, if you look at the little box of data that both mortality and severe PDD as a clear link. And I will explain that link.

So in the analysis of the trial daily, it was noted that the Xvivo group had a reduction of severe PDT by 76%. So 20% in the control group and only 5% in DexivoGroup. It was further noted that the mortality after [indiscernible] was approximately 40%. In both groups, leading to an increased survival of 6% in the [indiscernible] group versus the control group. We can also note here that the primary end posture statistical significance at the day 365, which is good.

With the experience we have seen in Australia with more than 50% of all DBD hearts now being preserved on Xvivo Heart Assist and those 3 trials that I just went through, we have recently presented. The body of evidence in favor of the exits is increasing significantly, which is great news.

And with that, I will go over to the regulatory update on Slide 10, and we can actually go straight to Slide 11, which is the usual overview of our regulatory processes. So the U.S. heart trial was fully included in record time, and we'll now pass the 12-month patient follow-up and you saw the result of that during the late-breaking news session of ISHLT in the press release we set. We are now preparing the regulatory file, and when ready, we will submit the file to the FDA for their review.

The [indiscernible] marketing process in Europe is ongoing, and we are awaiting feedback from one competent authority. But again, as stated earlier, the box and disposable part of the product are already [indiscernible]. -- and we have passed in my consultation, and we're now waiting for that last consultation. Again, I also want to note we are ready to launch when the product is fully approved -- so we have a launch plan ready. We have staff recruited and the interest from clinics in Europe is very high. And as I stated earlier, we actually saw some sales already from compassionate use this quarter.

But unfortunately, the European heart clinics are suffering badly from the lack of alternatives to the Xvivo Heart Assist. So we are working really hard with our notified body to get the final C market. but we are happy to see and hear all the engagement from our heart transplant clinics in Europe we just want to get it up and running. Also to mention, and we mentioned before that Australian and possible Canadian approval will follow on the [indiscernible] you will use that as a base. I will come back to the U.S. liver update in next slide, actually, so we can go straight to that slide.

And Slide 12 and the liver regulatory status. So we have previously reported that the lives has been granted breakthrough device designation by the FDA. We have an approved [indiscernible] and this MS funding proved. We could have started a trial last year, mid last year. We did decide to temporary post activities for the Liver PMA process to investigate the alternative regulatory route. And we are right now in preparation for FDA QSR meeting where the possible regulatory route would be outlined further. And the company, and I will come back and inform all investors of the next step in the U.S. ever regulatory investigation and later, of course, in the -- when we report the Q2 report in July, we gave an update.

And with that, I hand over to our CFO for going into the financial performance of [indiscernible].

Thank you, and happy to do so, Christopher. So the financials for the first quarter. This was a record sales quarter with clear signs of growing momentum, as Christoffer mentioned, especially in our core business and across all main markets. For the first -- for the second quarter in a row, the strong sales momentum translated into a positive net cash flow despite continued investments into our clinical and regulatory processes. So we're very happy about that. Net sales in Q1 were SEK 241 million, and organic growth was 23%. And and 18% excluding the hot trial revenue from the cap. Gross margins were 71% and while thoracic margins remained strong, the gross margins in abdominal and services was softer, which will be explained when I go through each business area here in a little while. .

Our continued focus on cost consciousness continues to translate into healthy EBIT and EBITDA levels. EBIT was 13% and EBITDA up 21%. The quarter was impacted by SEK 7 million in Heart go-to-market preparations -- nonrecurring items, which explains the increase in administration costs. Setting this initiative aside, the underlying EBITDA in Q1 was 24% and more in line with what we saw in Q4 last year.

So moving over to thoracic. So the thoracic business area accelerated in Q1 and delivered record sales of SEK 160 million. Organic growth was 27%, and excluding heart trial revenue, 19%. In regard to lung, the momentum for EVLP continues to evolve positively. EVLP disposables grew 56% in Q1 and the main customer segments, the centralized perfusion hubs and larger key accounts grew double digits. And we're very satisfied with the early phase of the perfusion partnership that we launched in Q4 with PSI as we now have proof of concept from the first OPEB hub.

10 EVLPs have been performed since the introduction of this program with good learnings and great collaboration. We also have a second that was onboarded in early April, and we are hopeful that this partnership will be equally successful, of course. So this is a very exciting initiative that can have a significant impact for lung transplant patients on the waiting list in the U.S. and can have a strong impact on the EVLP adoption over time. In regard to heart, Q1 was a very good quarter. The CAP trial, as Christophe mentioned, in the U.S., it included its last patient. Australia, New Zealand continues with extraordinary market penetration under compassionate use. And finally, what is very encouraging is that we now have a handful of countries in Europe as well where hospitals have worked hard to get the temporary special permits in place to be able to use the technology. All this in wait for the CMR approval, of course.

Gross margin, 83%, in line with last year, and this means that we have successfully increased prices to offset impacts from tariffs and also from a weakened U.S. dollar. So overall, thoracic experiencing a good momentum.

Moving over to abdominal. Abdominal continues to deliver good quarters. Net sales were SEK 66 million and equaling an organic growth of 24% and Liver sales grew 12% in local currencies to SEK 45 million. Kidney was the shining star of the quarter in abdominal and sales grew 63% in local currencies. We see a growing interest for [indiscernible] transport in the North America, both in the U.S. and Canada, and [indiscernible] brought new accounts both for clinical and research use.

With a few important congresses coming up here in Q2, we are optimistic that the good traction for abdominal will continue as the year progresses. When it comes to gross margin in Q1, the gross margin was 54% versus 63% last year. The decrease was mainly a result of larger portion of kidney sales versus liver, but also a larger portion this quarter of sales to lower-priced markets such as Asia, South America and Eastern Europe. Once again, a solid quarter for abdominal as we continue to build the market for liver and continue to take market share in kidney.

Moving over to services. Our last business area. Net sales were SEK 60 million, representing a negative 10% organic growth. The 2 areas, Flowhawk and organ Recovery Services showed mixed results. Flowhawk showed an impressive growth of 62% as a result from both new customer acquisitions and upgrades and renewals. In Q1, the largest transplant program in the United States decided to implement Flowhawk, that's a true feather in the head for the Flowhawk team, which means the software is now embedded into the day-to-day practice at 6 out of the 10 largest transplant programs in the country.

And with continued investments into Flowhawk, we believe it truly has the potential to become the future -- the future gold standard of transplant workflows and secure communication in the field. Organ recovery showed yet another quarter with negative growth, minus 10%. And as I stated during the Q4 earnings call, we last year put a surgical organization in place that will enable us to return to growth in 2026 and beyond. Today, we have surgical capacity to significantly increase the case volume. And with ISHLT this month as a starting point, our focus from now on will lie heavily on marketing and sales execution.

Gross margin decreased to 18% and this was purely due to the lower case volumes for organ recovery at the same time as we incur fixed operational costs, keeping our surgical teams on call 24/7. But with an increase in cases, our gross margins will improve to more sustainable levels.

EBITDA. So profitability was strong for the second consecutive quarter, 21%. And excluding nonrecurring costs, it was 24%. So rolling 12, we're at 20%, and we are on a positive trajectory on the rolling 12 KPI. In the following quarters, we will continue to manage our operating expenses with discipline and ensure resources are directed toward initiatives with clear commercial returns. Investments will mainly be directed to sales and clinical field force to capture the significant market opportunity that lies ahead of us being an all-organ company.

And my final slide for the day here, cash flow, and we are ending with some positive news here. So for the second consecutive quarter, we ended up with a total positive cash flow. Operating cash flow was SEK 65 million, mainly driven by good sales momentum, of course, and the cash flow from investments was minus SEK 55 million. But all in all, we ended up for the second quarter in a row with a positive total cash flow. And we had SEK 38 million at hand when we closed the quarter.

And with those final remarks, Christopher, I will give the word over to you again, good luck with the end of the conference here.

Thank you. And with that, we go into the outlook and a little bit into the future of what will happen this year and also what will happen long term. And we can go to Slide #21, really focusing on this year and activities we have for this year. And again, we are going to continue to build sales force and build new partnerships, especially in the U.S. to enable the OPOs and clinics to recover more lungs by EBP adoption through a combination of a service model and staying very, very close to customers.

In parallel, we just heard from our CFO that we will increase our service offering and better tailor customer needs, now we are offering NRP procurement from an increased footprint of surgical teams that can stay close to customers and recover organs with high quality. We will continue to work closely with competent authorities in Europe to be able to use the heart box as much as possible already now. And we are aiming to obtaining [indiscernible] mark as soon as possible and waiting for the last part there.

Another key milestone now with the data from the U.S. PRESERtrial presented at ISST, we will now submit the regulatory file to the FDA for their review during the summer. And we also talked about the liver assist. We'll come back with more information on the regulatory route, but we know that it's soon becoming liver gold standard in Europe, and we save 100 of lives every quarter used in Liverssist. And now we want to continue to support clinics in Europe and also give the U.S. clinician stability to actually use the liver assist and have the same success we have seen in Europe.

And -- we go to the next slide, 22 and a little bit longer-term outlook. And I want to state this recall for this is the reason here. We know that a lot of patients with end-stage organ failure are dying every day. Some of them are on the wait list and -- but the majority never even make the wait list. So -- the demand for transplant is according to our analysis, approximately x10 of today's supply.

We also see that the sales value of machine perfusion that improves patient outcomes and safely increase the usage of donated organ versus cold storage is also approximately x10 in terms of value. So we see a market opportunity with this almost 100x what we see today.

And we know that the machine perfusion and the service model have a proven track record, and that's really been clear here when we [indiscernible] increased the number of organs used for transplantation and actually safely increase them with improving survival rates as well. And we also know that we see growing DCD organ pool in many countries. It's about 50%. We know here in the U.S. is now hitting the 50% mark, and we have clear evidence that machine perfusion is you need to use them to safely address the DCD organs . So and Xvivo, we want to change the paradigm of transportation by innovation. And -- we want to be very clear that we believe that innovative products and innovative perfusion and preservation solution is the key for the future. And we do have a unique very innovative and world-leading products in the market or under IDE trials. So we believe in the longer term that we will lead this market due to innovation over time, enable lower cost of contrasted process, and we think that, that will be very important going forward.

And with that, we turn to Slide 23 and open up for questions.

[Operator Instructions] The next question comes from Simon Larson from Danske Bank.

Yes. Firstly, maybe on the U.S. heart fame, I noted in the press release from Wednesday that you are planning to hand in the file to the FDA later this year. But could you give us any more details on when that might be would be helpful.

Thank you. Good question. We are sitting with the file right now. We don't -- I don't have an exact time line, but it will be somewhere during the summer. So I will come back when I have a better time line, but it's somewhere during the summer. So it's not the end of the year, it's earlier than that. .

Yes. Understood. And maybe it's a bit sort of speculative at this point, but would you expect the FDA to sort of some an advisory committee ahead of a potential approval? Or what's your thinking around that dynamic?

I can't speculate on what the FDA wants. We have to hand in the file and see what the feedback is and follow there, their process, it will be more or less impossible to speculate on what will happen or not. But I know last time we had an expert panel meeting, we fared very well on the lung side with Tencent. So we know how to do this, and we are confident that we can answer any questions the FDA might post to us.

No, fair. Fair. And I know you said in the beginning of the presentation, Christopher, that you aim to make the hard box standard of care for all hearts basically. But if you could help us understand the scope of the hearts that you will address in the U.S. maybe to begin with? Will you be focusing on the sort of marginalized ECD, DCD hearts or older owners? I mean any help slicing the market opportunity and what you will target first would be also interesting to hear.

That's a great question. I mean we can only market what we get on the label and the label will be pending the FDA review process. So it's hard to say exactly. But if we look at the PRESERVE trial and the inclusion/exclusion criteria there, it is exactly those hearts we're talking about. It's DCD heart extended criteria heart. So that's either due to more than 2-hour preservation and a couple of factors -- a couple of risk factors or more than 4 hours of. So we will definitely target those, those hearts. .

We will also -- we see an increasing interest here from U.S. clinicians. So we will have a quite broad target when we launch the product to make sure that we can reach all clinics as soon as possible after day 1 of the launch.

Makes sense. And maybe then the final one from my end. Turning a bit to the land part of the business. Obviously, the EVLP park is doing very good here. Could you say anything about the pipeline, how it looks for new accounts, both in terms of new centers, also OPOs, of course. And also if you're happy with the revenue generation from the new [indiscernible] accounts that you signed last year, and also maybe your visibility for the lungs here in the coming, let's say, couple of quarters as well?

What I know we have from IST is that there is a growing interest for an ELP program, and we do see great progress now, both an underlying market growth where we see that -- more and more data is getting published showing that using EPP for extended grafts or DCD graft has a really positive impact on the overall survival and that we use more organs.

So in general, there is a good underlying trend for the lung market. The other thing which we are working with is to put experience into more hands, so to say, so we can do it and especially the hub model that [indiscernible] 1 center pump lungs for a larger area, which we have seen has been very successful for.

So we have a positive outlook. But again, looking into the future, it's impossible. But what we can see so far it looks very good. And especially, I'm really encouraged after all the meetings we had here in both the lung [indiscernible] and all the customer interactions from here from ISHLT, we see positive [indiscernible].

The next question comes from Ulrik Trattner from DNB Carnegie.

Thank you very much and a few on my end. And I'll start off with the abdominal gross margins. And Christopher, you touched upon this. But I also note that the gross margin was kind of equally low in Q4. So is there FX related to this since you moved your manufacturing to Sweden from the Netherlands? Or is it just market product mix that we should expect to revert here in the short term?

I can start a little bit high level and then Nordstrom, if you want to pitch in on this one. But if we take high level, it is there is today in the at least the abdominal fee, slightly lower gross margins in Europe versus the U.S. So it's partly a regional mix that we hope over time grow out of.

Also, we are moving production right now and have not reached full scale in production that we want. So it's not let's say, call it, a quick fix, but we diligently work to improve the gross margin for our dominant portfolio in the next quarters and years to come. So we see a gradual improvement is my belief.

I'll just add as well, Christopher, -- we do expect to see the growing gross margins for abdominal what what will impact that is, of course, when we start to see a stronger ramp-up in the United States. It was a good quarter in North America abdominal sales this quarter, but it was partly research sales that over time, of course, will translate into more clinical sales, so to say. But it's still very much of our European business with some regions with lower pricing.

Okay. Great. And on to sort of prospects going ahead and the subcu meeting that you have schedules. So what is your ambition going into this? You can obviously go down a few routes here. But are you aiming to use the European data in order to get approval as it did for kidney or 510(k)? What is sort of the most feasible and reasonable pathway forward here?

It's a great question. I mean, of course, we're aiming that, but we will have a dialogue with FDA. We had a very positive meeting earlier this year, and we will continue in a more official [indiscernible] meeting with them to get a firm route forward. .

We, of course, aim to leverage as much of the European data as possible. But we would also be in listening mode and see what the requirements from the FDA is. So there would be good dialogue that we have started that is very good and positive, but we also have to be humble that the FDA is deciding in this case. So we will argue our case and see what comes out of it.

And just correct me if I'm wrong, but wouldn't it be beneficial in your end to actually generate some U.S. data prior to launching it, given sort of the -- in hindsight, what we have seen with the kidney launch that U.S. data is of high importance in order to reach higher volume. Potentially a 510(k) would be the preferred route on your end?

Yes. I mean the good news with the 510(k) route is that the, let's say, burden of proof is lessened. It's more towards safety than efficacy, but you're right. In any way, whatever the FDA says we need to do a trial, if it's, let's say, before or after. So -- we will do a clinical trial in the U.S. to make sure that the American users can replicate the European data that is extremely good for it to be believable.

And you're right, with the kid experience, we learned that very fast at launching a product without U.S. data will not make it fly. So we have to do something either way. But we're still aiming to leverage as much as possible of the very positive European data. It's is by far the largest body of clinical data we have for short, long term, all sorts of graphs, which are very positive. So that's, of course, our aim.

Great. And a question on the CAP program. If you went from 4 patients in Q3 '22 and now 46% here in Q1. And I would assume that the interest has not come down post ISH peak. So how quickly can you get a sort of reapproval or expansion of your CAP program in the U.S.

We're aiming as soon as possible. So it is under review from the FDA, and they will come back to us as soon according to what they said. So -- but again, it's hard to speculate on the FDA time line and the work burden they have. But what we can say is that, yes, the interest is extremely high from U.S. clinicians before the IST and before those 2 presentations, and it has increased significantly after. So that is very clear.

And can you give some type of indication on just the penetration per decides who are actually active in the Cat program? Are they using it on all of their parts that are being transplanted? Or is it just a portion of them? Or can you give us any more sort of insight on that would be very interesting. .

Yes. That's a good question. We should remember right now that this is a scarce resource for them. There is a limited number of patients. So they only use it on the worst graphs and the sickest patients where they see no other use right now. So we should remember that. But we can see in some -- some cap centers that is quite high penetration. And then the testimonial I get when I'm here from the users is that this is so easy to use, it's really plug-and-play, and the hearts are in an excellent condition after being in Xvivo Heart Assit. So it's -- some have quite high penetration, but we should remember that it would be higher if we would have an approval or let's say, it's an unlimited use because now it's cap to number of patients. And I think it's more interesting to look to the Australia situation where there is an uncapped continuous access protocols would say similar, but it's uncapped. And there, we see that it's 50% for DBDs. -- and now we're starting with DCG.

Sure. Yes. And just on the data that you have generated here lately and presented a positive outcome in the U.S. and 4 additional patients in Europe on hope. Are you adding this to the European regulatory agencies and have this in any way or increase your confidence in obtaining approval for the hard box here in 2026.

The straight answer is yes. I mean, the feedback we get from those compassionate use is that, yes, we don't see any alternative on the market for engraft, pediatric, adult, DCD or DVD. So it's really encouraging to see medical agencies in Europe, looking into the file, clearly, this state, there is no alternative. We need compassionate use for this product. And so yes, the straight answer is, yes, we get more confident the more we talk to medical agencies as the more we talk to clinicians of how important this is. And -- but again, the regulatory process is a regulatory process. And and it's hard to speculate. But definitely, we are -- due to this, we are more confident, yes.

Great. And last question on my end. Did you mention that you had down [indiscernible] OPO targets to sort of be integrated into an EVLP program. I just to, if that [indiscernible].

Yes. 425 are identified in the pipeline right now to clarify that. So we have done our first installment, very successful ahead of plan. We are doing our second one. I think while we speak or at least very soon after [indiscernible]. And then there is a rollout plan, which is, to some extent, will be resource limited but to but we have a clear plan, and we're going to make sure that we are successful in every installation. .

So we're going to make sure that we all -- and we are also increasing our internal resources to be able to handle an increased growth and increased interest from OPOs, where, in all honesty the XPS and the [indiscernible] solution was developed in the beginning for the target group of Ops. So it's great to be back home again, so to say, and see the OPOs using it.

Okay. Great. And essentially, it's an acceleration at sort of a maintained pace even with your sort of limited resources.

Yes. So we will try to accurate as fast as possible, but we will be very conscious that we want to have the right quality of people both from our side, from our partner side and from the OPO side to make sure that it's each and every OPO program is a successful program where the clinicians really get -- they will get stay so deserved for their -- the patients on the waiting list. So we will be very cautious on keeping a high quality.

The next question comes from Jakob Lembke from SEB. .

So my first question is on the strong [indiscernible] here in Q1. So I'm wondering if you can sort of elaborate a bit more different customer group, sort of your single one large customer -- other U.S. customers as well as ex U.S. during the quarter?

Yes, definitely can do that. It is and underlying market growth where we see an increased interest to making more lung crampentations. And we see a changing organ pool where more and more organs become extended criteria or DCD. So that's the underlying growth we see fueling the interest. So we see both a, let's call it, an underlying growth from existing customers, and we see that we now add new customers as well, which are are slowly becoming more up and running. And we see, of course, the fast uptake in the pilot of Loop that was -- so those are let's say, the 3 reasons.

We also see that we're increasing the sales footprint. In other words, number of feet on the close to customers. We can see an increased usage. So it's a direct link there.

Okay. And then also, I'm wondering if there was any sort of large orders or timing effects impacting the strong Q1 sales for [indiscernible].

I think it was fairly -- we saw the trend in Q4, and I think that trend continued into Q1. We didn't see any huge, let's call it, seasonal effect or or upstocking destocking during either this quarter this year or Q1 this year or Q1 last year.

So I guess my question then is it fair to assume then that this is sort of a new base line for the LTE consumables? .

Yes, I think that's a fair assumption. I mean we do see an increasing interest, and we do foresee that we will continue to grow new -- both existing and new EVP programs, absolutely.

Good. Then I also have a question on heart and the compassionate use in Europe. I'm wondering if you can elaborate a bit on sort of how freely the centers can use the product right now? And also if you can share how many centers that are live and if you have any more that you think will go live [indiscernible].

Yes. I think to start with when we talk about compassionate use, there are, of course, limitations to it. And also, this is being Europe, so it's different country by country. Some are more hopefully soon here is going to be more Australian like and some will be more restricted in terms of when you can use it or not. So it's hard to give one asset to that question because it's many countries, but we do see that more and more countries are opening up for this opportunity, and that is very, very positive. That's the key message.

And then we, of course, hope that we don't need this and get the CMA very soon, but we see that we can keep the high interest and continues to save patients where there is no alternative to the Xvivo Heart assist, which is the case right now.

Okay. And then I'm also wondering if there's been any new or recent dialogue with the notified body or the competent authority regarding mark? And also, if you expect to get the approval then in the early summer.

We are in dialogue with our [indiscernible] body. To clarify, we are not in direct contact with competent authorities in this case because they have asked for a consultation, and we are in contact with notably. So the is yes to [indiscernible]. There has been contact. We -- from what we heard from them, yes, we should expect something here in early summer or summer so that's the latest we heard. So we are crossing our figures and provide all the information we possibly can to make sure that we can get a good decision. .

Okay. And then just a final question, sort of a follow-up to the earlier discussion about the potential level of the hot product in the U.S. I'm thinking that the FDA must surely also include or consider the data you have gather outside of the U.S. sort of [indiscernible] randomized 2-arm trial and as well the [indiscernible]. So I guess it must be a very broad label because you have, I mean, the most broad the broader data of [indiscernible] product out there, right?

To start with, we're extremely proud of all the data we have. And every time we do something with Xvivo Heart Assit, the clinic outcome is better than we could could expect from it. So we're very proud of it. It's hard to speculate on the FDA and what they will do. We will, of course, submit all data for the review -- I mean, the lowest bar is for safety reasons. And we do -- we will argue that it should be taken into consideration at least for future label discussion. But it's hard to speculate on the ruling from the FDA, so to say, regarding the label.

But if we -- if we look at the inclusion/exclusion material in the United States serve trial, it will cover the majority of donated hearts as it is already today. So that would be -- that in itself will be an extremely good labor.

The next question comes from Filip Wiberg from Pareto Securities.

First, I think I just would like to follow up on a prior question about the strength in EVLP this quarter. So I suppose like the largest customer and some part of the strength at least. Given that, I'm just trying to get a better sense of the risk of ending up in a similar situation that we had last year with the destock. And you said the you don't think there are any stocking effects this quarter, but could you please just talk a little bit about that and the visibility for this largest customer?

Yes, that's a good question. I mean we have very good visibility and very good dialogue with our largest customers, and we could see that they grow actually as much as other customers during Q1. But like we are -- they are also depending on the underlying market growth, so to say, but we have a very good 1 year visibility into what they aim to do. And -- but they are for the same reason as we are dependent on the underlying market growth. And we saw that last year in Q2 last year, it was that we got a dip during 1 quarter. So if the momentum we see now that we believe will continue, we have good visibility.

Good. We talked a little bit about the gross margins here, but perhaps one on Torex, which was actually okay this quarter. But I'm just thinking about it going forward now when Editis growing -- perfect becoming a smaller part. So will you be able to defend the gross margin you've had when the LC continues to grow and take a bigger share and then also how you believe it's going to be affected when you launch heart in both Europe and in the U.S.

That is our goal to defend the thoracic gross margins. You have a point that I mean this quarter was extraordinary when it comes to EVLP portion out of sales, right? So -- and we have a lower margin on EVLP to [indiscernible]. But we also see the growing -- the growth initiatives in the U.S., we have good prices on those and speaking about the hub model for EVLP. And also, we have not yet decided on the heart price in the U.S. as well, which will be a contributor to the gross margins going forward. So we feel for thoracic that we are in in a good spot. And we worked to continue to defend also the abdominal margins here in 2026, of course. .

I don't know what the bigger picture is also that for our Toro products, so heart and lung, we can have more of a global price list. So we don't see any regional differences if you compare, and we're not yet there for our dominant products. So that's something we need to work on, of course. But we we are more confident. And of course, with the heart, there is always when you start up production, there is always slightly lower, but I am confident that we very soon can get the heart up and running and reach scale in production.

All right. Good. Perhaps another one you Nordstrom about the EBITA margin, stated it was 24%, excluding used heart activities. But I think you said as well that there was a nonrecurring cost this quarter. So could you elaborate a little bit about that. Was it only related now to Q1 and nothing going forward?

Thank you. Good question and perhaps deserve some clarification, and this also ties into one of the questions I see here in the chat as well. So no, it's the same thing. So what I referred to as noncurrent was the SEK 7 million that we spent on foundational heart lost preparations consultancy work to prepare for the U.S. heart launch. So for us, that was a foundational activity, a bit of a onetime. I think the other investments we will do going forward, which we have touched upon in early calls as well is really to build out the U.S. organization to prepare for the launch.

And I think that will be more of a linear step-wise growth in OpEx in marketing and sales. But overall, on EBITDA, I mean, last time I checked the consensus, I think that kind of where we are aiming to land for the full year 2026.

Okay. Good. So just to be clear, admin costs, do you expect that to come down from Q1 levels, but that increasing the selling expenses going forward?

Correct.

Okay. Good. Just last question. I was curious around the next step in direct procurement DCD. So the study Philippe presented, like what are going to be the next step in this. I suppose there will be more studies required to get the surgeons confident in using this approach? Or what do you have to say about that?

Yes, there will be many steps in this. The first one, we hope that [indiscernible] can submit a paper on how to do this. So we get a standardized approach to direct procurement. Then this was, of course, a very important step to make this data public and also to get the interest up for direct procurement. But what we've seen is that the uptake is pretty fast once you got a hang of it, and you've done it. And the interest to avoid all complicated other process you would have to do, such as NRP or very expensive machinery in DCD hearts is avoided. So you reduce cost, you reduce complexity, et cetera.

So the interest to go this route was during the late-breaking news was extremely high. and there was, unfortunately, not enough time for questions, but we will revisit that during our hearts [indiscernible] today. So hopefully, more people can ask questions. And then again, this is a technique that spreads really surgeon to surgeon, so they will talk to each other and train each other and get more and more confident over time.

The next question comes from Ludwig Germunder from Handelsbanken.

I would like to follow up with another question on the EVLP and in line with some questions already asked, but I would like to hear if you could say something about or you see the recovery in terms of how much is recovered now in EDLP are back at previous normal levels. You mentioned this is fair to assume as a new baseline in EVLP consumer sales. But do you see any more recovery to do before you're back at some sort of [indiscernible] levels after last year?

No, I think we -- not so much recovery. We have to be very aggressive and find new customers and new concepts, which satisfy the needs from American surgeons, such as the OBO model. So we will continue to build on what we have, so to say, on the foundation we have now established during Q4, Q3 -- sorry, Q4 and Q1.

I want to mention that last year, there was a tough period for lung transplantation in terms of the number flatten out, and there was a lack of resource in the system. But -- we again, the system reacted quickly. I think we reacted quickly to give them alternatives, alternative resources with partnerships. So I more look at it as a forward-looking exercise.

Okay. I see. And then I have a question. I'm not sure if you mentioned it all apologize if you did. But on the cap study for hard to fill the 60 hearts that you were allowed to do. You previously mentioned that you could possibly get another 60 hearts. Can you comment anything on the status around that now?

I can't comment further than I already did. We have applied for another 6, and we do hope that if they come back as soon as possible, but it's -- we have to understand, we are under an ID and the FDA are deciding what we can do and not do doing [indiscernible].

Should we continue? Or would you like to end the call?

Continue if the last 2 questions, if we can keep them short. I know we, over time, and I actually have to leave for another meeting. But I see there are 2 more analysts have questions, so I want to give them the opportunity to ask those questions.

The next question comes from Oscar Bergman from Redeye.

Just wondering, R&D costs of SEK 37 million, if that should be considered sort of a baseline going forward? Or are there any one-offs that make maybe the last couple of quarters a better baseline?

Yes. Good question. Yes. I think it could be used as a baseline for the rest of the quarters here this year, but you will see a significantly lower spend on the other type of CapEx, material assets. We're building out the -- we are very soon done with investments into our increasing their product capacity. So I think all in all, you will see lower CapEx in 2026 than you saw in 2025, which means that we are optimistic that we should be able to end the year on a cash positive level here, which would be the first time in Xvivo history. .

And then when you have the C market in place for the for product? Will you be able to implement any price changes in Australia and New Zealand -- and yes, roughly how much? And will it be immediately after the [indiscernible].

To start with the [indiscernible] will be the base for the approval in Australia, but we still need to go through a review process there to start with. Now we have fixed reimbursement. So increasing body of evidence in terms of health and hospital economics, we will, of course, improve reimbursement levels, and the chance of doing that is a lot higher after an improve I say. Now you get what you get, so to say, during an unapproved product. So that's a drop that will start. It will not be immediate. So you do have to work with reimbursement in each country. .

The next question comes from Ed Hall from Stifel.

Just quickly on lung and how we should think about it for the rest of the year. So I think you've outlined the underlying existing customers, the new customers are growing and obviously, looking at Q2 and Q3 or weaker comps? Or is there anything that you would point out to show anything that I may be missing outside of the trends that you've already outlined? And that would just be my first question.

Thank you for that question. I do think that there will, of course, be seasonality like in any business depending. And we're also depending on the number of donors going for [indiscernible] -- but we do see -- and I still state that we do see an increased interest for lung transplantation in general and for EVLP, in particular, based on the body where as we see now that we -- for example, it was the presentation here during IST, which show that you can better outcome on both DBD and DCD for EVLP if you standardize your EVLP program and EVLP protocol. So if you have a very clear inclusion criteria, you actually get better results from using EVLP than standard of care. So I think this growing [indiscernible] evidence speaks for EVLP increasing as an indication of all lungs. .

Perfect. No, that makes sense. And then just a final question from my side. Just wanted to get your thoughts on how transplant surgeons are thinking about the trade-off between sort of the increased ecmo use that we saw in the preserve data for some of the DCD implants versus what actually came out with lower severe PGD. From your talks that you've had this week at the Congress, is there any initial thoughts you could comment on there?

No, but I think that everyone was surprised that the data was as good as it was because both the donor pool and the patients were very marginal, so to say, -- so this was better than expected from many of the trial centers. So that was really good news. I think that we saw still a low level of severe [indiscernible] was really good. I think that would be the leading indicator for for us and that we also could see that we could replicate that in survival data, really strengthen the whole belief for what this product can do once it's on the market. .

Perfect. Okay. So that makes sense. So it sounds like actually the lower PGD rate is really the driving force in that trade-off. That's how I should think about it.

Yes. thank you very much, everyone. Sorry for going a little bit over time. We will now end the call and move to the last slide where we want thank you so much for today and we meet next time on July 14.

Welcome to XVIVO Q4 Report for 2025. [Operator Instructions]

Now I will hand the conference over to CEO, Christoffer Rosenblad; and CFO, Kristoffer Nordstrom. Please go ahead.

Thank you so much. Good morning and good afternoon, and most of all, welcome to XVIVO's Earnings Call for the Fourth Quarter as well as for the Full Year of 2025. And with that, we turn over to Slide 2. It's just the 2 presenters that were introduced. It's me, Christoffer Rosenblad calling in from Gothenburg and the company's CFO, Kristoffer Nordstrom, calling in from Philadelphia in the United States.

And with that, we can go over to Slide 3, which are the Q4 financials at a glance. The Q4 shows a 10% organic top line growth, which is equivalent to a 12% top line organic growth if we adjust for the U.S. heart trial revenue compared to Q4 last year. With recovering sales, the EBITDA recovered to healthy levels during Q4, again, showing that the revenue model is scalable. In terms of segment growth, the thoracic sales were slightly negatively affected by the lower heart study revenue compared to the same quarter last year in the United States, but positively affected by a stronger Q4 lung market, especially stronger if you compare sequentially to Q3 this year and even more so if you compare to Q2 this year.

The abdominal segment shows great progress for both liver and kidney during the quarter. As stated earlier, liver in Europe has entered the majority market segment with penetration above 15% in many countries and up to 25% in core markets. The main task is to support growth with increasing resources for perfusion as well as more data for improved reimbursement level. In parallel, we are increasing the sales force footprint in Europe.

While kidney, on the other hand, is still below 15% penetration in many countries, including the U.S., the main task is to win account by account. We are very, very encouraged by the positive feedback we get from our kidney customers. They see that the kidneys are in better condition after being perfused in Kidney Assist Transport compared to alternatives. And investigators will come out with clinical data proving this during 2026, which will be most important in the United States. The progress in our U.S. service business need to be drastically improved. It is a strategic investment to prepare for the heart launch, and therefore, we invest heavily for growth. We will come back later in the presentation on the actions taken and how we will execute to one day become the preferred partner in the transplant process.

And with that, we can go to the next Slide 4, which is the year at a glance. The year shows a similar picture to the quarter, good and stable gross margin with continued investment in field force and scalable production structures. Sales came in at SEK 812 million with a 3% organic growth and which is then equivalent to 8% organic growth if we adjust for U.S. heart trial revenue. As we said in the last call, during the end of Q3, a cost and cash restructuring initiative was initiated to enable better resource allocation going forward. And our CFO, Kristoffer Nordstrom, will get into the details on sales, gross margin, EBITDA later in the presentation.

For heart, the main hurdle is regulatory approval. Once the Heart Assist is used, the feedback is overwhelmingly positive. We continue to build evidence. We now have more than 500 patients that have been safely transplanted and also, I would say, successfully transplanted with Heart Assist. The CAP or Continuous Access Protocol in the U.S. is up and running, and we just passed the 30-patient mark included in the trial. In Australia, the heart penetration last year was -- or in '24 was approximately 30%. And we saw last year that going up to 40% for DBD heart in Australia during 2025.

I'm also proud and happy to present that the Benelux DCD direct procurement study has enrolled all 40 patients. And I'm truly looking forward to another great presentation and publication that will most probably change heart transplantation and heart recovery forever. The high interest, the early very good results on DCD hearts and the Australian experience once again shows that the heart technology has the potential to change the paradigm of heart transplantation forever once it's launched.

Lastly and most important to mention is that the projects are still progressing according to plan. Regulatory time line are hard to predict. We saw that this summer with the EU heart approval, especially when we come with groundbreaking innovative new technology that has the potential to change the paradigm. But both the clinical trials and development projects are progressing according to the time line agreed. For example, the production capacity project, where we invest to scale up volumes x10 of today's volume for disposables are running in line with communicated time line. The full-scale production for our disposables for heart, liver and kidney will be extremely important to capture the future growth potential for all 3 product groups.

And with that, we can go into Slide #5. Let's be clear, for avoidance of doubt, we are not pleased with the performance in 2025. And that made us take fast and important step for future growth. Firstly, the EVLP business didn't grow as expected. This was partly due to slower lung market, but also because of lack of resources, especially in the U.S. field force. So now we have taken swift actions both to enable service models with partnerships and entering the OPOs as well as a larger investment into the U.S. field force. As we stated in the Q3 report, we entered into partnership for -- to enable perfusionist services.

During Q4, we secured our first OPO contract. And as I stated, we have decided to invest in more feet on the ground during 2026 to enable closer customer relations with a growing number of EVLP partners. I just said that regular time line for innovative and paradigm-shifting products can be hard to predict and -- but we can take action. And we directly strengthened the team and reinforced a cost cash saving program to enable at least a healthy cash flow and at the same time, increase the focus on the heart project.

For the organ recovery business, we have during the second half of '25, doubled both the hub footprint from 6 to 7 hubs and the surgeon roster to enable -- to stay closer to customers and do more recoveries at a lower cost. We also include NRP into our service offering to enable an offering that all customers actually request or almost all. We expect the fruit of this work to start to kick in during Q2 2026.

And with that, we can go over to the next slide, Slide 6. And the key message is that the right actions give the right result. So with actions taken in the second half of '25 and the recovering lung market in the U.S., we did deliver for the full year of '25 organic growth, a stable EBITDA and actually the first ever positive cash flow in a quarter during Q4.

And with that, we leave the introduction and we go into 2025 highlights. The Slide 7 is a dividing slide and the highlights of the year are in the two following Slides 8 and 9. So let's start with Slide 8 and the part 1 of highlights. Firstly, the reason we are here that XVIVO has enabled approximately 13,000 life-saving transplants during 2025, giving patients a chance to better life and in many cases, a new life. This is approximately 1,000 patients more than last year. I want to state this is something that I am and the entire XVIVO team are very proud of. And I want to thank you as investors that has enabled investment into truly innovative life-saving technology that has the potential to, in the future, change the life for hundreds of thousands of patients.

And turning into our heart technology and the milestone we passed, early in the year, we presented a promising 12-month data follow-up from the European trial at ISHLT. It was the first and so far only superiority trial in thorax transplantation. And more importantly, it was the first trial to show a direct link between perfusion device and severe PGD and patient 1-year survival, which is a milestone within our field and it had never been done before. And I also never seen earlier in my life or encountered the extreme improvement we saw with a 76% risk reduction of severe PGD with very, very high statistical significance.

And looking back at the year, we achieved several important milestones for heart, the European DCD trial completed, the CAP study up and running. And as I stated, 40% of DBD hearts in Australia has been preserved with XVIVO Heart Assist during 2025, showing that this is a technology that solves a real problem for patients and doctors in transplantation.

And with that, we can go over to Slide 9, which is the second part of yearly highlights. In the U.S., we launched the first of its kind EVLP-OPO model through a perfusion partnership. Through the same partnership, we can now also offer NRP through our Organ Recovery service. For our liver technology, where we are European market leaders, we now have reached 25% penetration in core EU markets. Very, very encouraging results were also published from a 5-year follow-up of a randomized controlled trial for DHOPE DCD Liver. During the year, we -- another milestone was the launch of XVIVO Insight that enables remote monitoring for both Liver Assist and Kidney Assist. And finally, when talking about those 2 products, Liver Assist and Kidney Assist Transport are now regulatory approved in Canada.

And with that, we go over to the regulatory and clinical updates. Slide 10 is a dividing slide, and then we have 4 slides taking into the update.

We can turn to Slide 11, and we start with the usual overview of the status for the regulatory processes on Slide 11, as I said. The U.S. heart trial was fully included in record time, and we now passed the 12-month patient follow-up. Next milestones are to present the U.S. study at ISHLT in late April and prepare the technical and preclinical files for submission together with the clinical file to the FDA. We estimate to handing the files to the FDA during Q2. In parallel, we continue to build the clinical file with the help of the continuous access protocol in the United States.

In Europe, the CE marking process continues. As stated earlier, the Heart Box and disposable part of the product is already CE marked. The solution has passed the EMA consultation, and we are now waiting for consultation at the sub-medical agency in Europe. It is estimated that we will complement the file and hand in for consultation by our notified body at the end of February this year. At this moment, we have no other update on the time line than what has previously been communicated by a company. But clear is that once approved, fully approved, we are ready to launch the product as we have a launch plan, it's ready to go, staff is recruited and the interest is, to say the least, extremely high from clinics in Europe.

The European heart clinics are suffering badly from lack of alternatives to XVIVO Heart Assist. And for that reason, and in parallel, we are working with local agency to obtain compassionate use in chosen European markets prior to approval. And in Australia, New Zealand, the product is soon becoming gold standard, now at 40%. I believe that number will increase over time. But the regulatory approval will mark in Europe and to be clear, the same will apply to Canada.

Regarding liver, I will come back to an update in the following slides. And with that, we can -- before we go into liver, we just have a short recap of heart on Slide 12. In the U.S., we also see an increasing interest to save patient lives and more and more clinics realize that the XVIVO Heart technology is the way to do that. We today have 10 activated clinics, of which 6 are currently enrolled patients. We recently included patient #13 to the continuous access protocol. And we are working hard to turn all activated centers into enrolling centers, and we also want to activate more centers into the trial.

Right before we have included the 60th patient, we will apply with the FDA for an extension of another 60 patients to strengthen the clinical file in the U.S. And as stated earlier, we are working with the PMA process and most importantly is the presentation in -- during ISHLT of the first 141 patients in the United States.

And with that, we can go to Slide 13 for a status update of the liver regulatory pathway in the U.S. We have earlier reported that the Liver Assist has been granted breakthrough device designation by the FDA. With an approved IDE and CMS funding approved, we could have started a trial in early Q3 '25. However, the company decided to temporarily pause activities for the liver PMA process to investigate if an alternative regulatory route is possible. With the recent 510(k) DeNovo approval in the U.S. for liver perfusion, we will begin a dialogue with FDA on regulatory pathways for Liver Assist. The aim is to enable patients in the U.S. a better product than what is currently approved faster than otherwise would be possible. Since we haven't had the meeting with the FDA, we don't have more information today on time line or possible route forward, but the company will inform the public and all investors of the outcome of our U.S. liver regulatory investigations latest in the Q1 report and earlier if needed.

And with that, we can go to Slide 14, which is the last slide in this segment. XVIVO is the clear liver market leader in Europe with, as I stated, 25% penetration in the important markets. This success is built on excellent patient outcome, positive and documented health and hospital economics as well as the Liver Assist enabling the transplant team to have a work-life balance. Hence, they can plan liver surgery better than they could do before. In 2026, we will continue to expand the sales organization to increase penetration in Europe. In parallel, we will increase our efforts to educate the American transplant clinics on the benefits we have seen in Europe using the Liver Assist and where needed, replicate small-scale clinical trials to prove that it applies to the U.S. as well.

And with that portion, we go over to Slide 15, and I hand over to our CFO, Kristoffer Nordstrom.

Thank you, Christoffer. Yes, an overview on the P&L. So net sales in Q4, as you know, came in at SEK 226 million. The organic growth was 10% and 12%, excluding heart trial revenue in total. Sales for the full year came in at SEK 812 million, representing 3% organic growth and 8% excluding heart trial revenue. The total gross margin in Q4 decreased to 73%, primarily due to inventory write-offs related to some R&D projects where we had some overproduction, so more of an anomaly. For the full year, gross margin was more or less in line with last year, 74% versus 75%. And this was despite the unfavorable exchange rate development from a weakened U.S. dollar, as you all are aware of. Throughout the second half of 2025, we maintained a strong focus, as Christoffer mentioned, on the operating expenses. And as a result, the adjusted EBIT in Q4 was 16% and adjusted EBITDA was 25%, which is a new quarterly record for XVIVO. Full year EBIT 11% and EBITDA 20%. I will come back to our view on EBITDA in 2026 in a later slide, so bear with me.

Moving over to Thoracic, our largest business area at the moment. Q4 sales were SEK 147 million. Organic growth was 9% and excluding heart trial revenue, 12%. This means that thoracic return to growth again in Q4, and the main reason was the increased EVLP sales volumes, primarily in the U.S. The EVLP disposable sales in the quarter grew 33% versus last year. Perfadex Plus sales were flat, but this was after a strong Q3 where Perfadex grew 17%. And all in all, globally, 8% Perfadex Plus growth for the full year, which means we are maintaining our market position and marketing leading position of this very profitable part of our business. The highlight of the quarter was the installation of the first XPS system to an OPO in the U.S. in collaboration with PSI, and we look forward to expand this first-of-its-kind EVLP service model to more OPOs in 2026.

Another highlight was the continued progress in heart sales. So not only did we include 18% in the CAP study, but we also saw continued adoption in Australia and New Zealand, further compassionate use cases in Europe, leading to a Q4 heart sales of SEK 60 million in line with last year. Finally, gross margin, solid 85% in Q4, and this was in line with last year.

Moving over to Abdominal. Here, we had yet another record quarter, proud to say we're showing strong performance in both liver and kidney. Net sales were SEK 61 million translated to an organic growth of 30% in the quarter and also 30% for the full year. Liver sales grew 36% in Q4 and 31% full year. Kidney sales grew 20% in Q4 in local currencies and 29% for the full year. So good traction here. Gross margin, as I alluded to before, in Q4 was 56% lower than last year's 67%. And the main reason for this was some year-end write-offs of R&D inventory, and we hope to see the margin return to the plus 60% levels again in 2026. So once again, a solid quarter and another strong year for XVIVO Abdominal.

Our last business area, Services. Financially, it was a disappointing quarter in Q4 with sales of 18%, which was in line with Q3, representing a negative organic growth of 21%. As I stated during the last earnings call, the second half of '25 has been transitional. Over the past 6 months, we have put fundamental pieces in place that will drive growth in 2026 and be of strategic importance as we prepare for the U.S. heart launch in 2027. So with a strengthened organization and with the introduction of TA-NRP in Q1, we foresee meaningful growth in 2026. And I think we will develop more -- a better understanding of what the meaningful growth means quarter-by-quarter next year.

Gross margin decreased to 25%, and this is a direct result of our investments into the surgical capacity in the second half of last year. And as we acquire new customers in 2026, this margin should improve quarter-by-quarter. Our focus for 2026 is clear and worth repetition. So for organ recovery, it's everything about returning to growth, leveraging our strength in surgical capacity and the NRP offering. And at the same time, we will prepare for the U.S. heart launch. For FlowHawk, our digital software, it's about investing in further commercial excellence, broadening our team, work on the scalability of the product and prepare for integration with XVIVO product portfolio over time.

I'm very pleased about our EBITDA in Q4. We hit a new record with an EBITDA margin of 25%. And at the rolling 12 months EBITDA, we're at 20%. The main reason for this achievement was not surprisingly, the increased sales in Q4, but also the stricter cost focus that we implemented during the second half of the year. In the following quarters, we will continue to manage our operating expenses, of course, with discipline and ensure that resources are directed towards areas with the best ROIs. However, with 25% that we delivered now in Q4, that is not what we expect out of the full year in 2026 to be transparent, sorry. I mean the baseline going into 2026 is the annual EBITDA of 20%. And that -- it's from that level that we are growing for next year. And as Christoffer said, 2026, it will be a year where we will invest heavily, primarily into the U.S. commercial organization to prepare for our launches and to accelerate the momentum we see now in EVLP.

I would also before we move over to cash flow, which is my last slide, I also want to comment a little bit on the challenging environment we have at the moment when it comes to the currency that is not working in our favor. So overall, if you look at XVIVO and our operations, we have an operational hedge in the fact that we -- where we foresee the majority of our growth in the short midterm is in United States, and that's also where we foresee that we will invest the larger portion of our investments over time. So however, of course, this will translate into SEK eventually in our P&L as well. So that risk we are living with today. We do not have any hedging instruments in place today, but this is something we could implement if we decide that it's the right thing to do.

In 2025, the sales in U.S. dollars constituted around 55% of total sales, approximately SEK 450 million. I think the average SEK-USD ratio in '25 was 9.8%. So if we assume a 10% decrease in USD versus SEK to 8.8 in 2026, that would translate into U.S. sales equaling SEK 405 million, hence, a reduction of SEK 45 million, which is roughly 5% decrease of total sales for XVIVO versus last year. So a 10% decrease of USD would roughly translate into a 5% decrease in the global sales for next year. Roughly best estimate that would lead to a decrease of EBITDA of 2% units. So that's a risk to bear in mind when looking into 2026 that the impact of a decrease in EU will be slightly less.

Final slide before I hand over to Christoffer again. I'm very proud of our cash flow in Q4. We ended the third quarter with SEK 280 million in cash. We also have our credit facility of SEK 120 million roughly. So that brings total available funds to SEK 400 million. Operating cash flow was strong, SEK 87 million. And for the first time in XVIVO history, we had a total positive cash flow of plus SEK 18 million. So we feel that we enter 2026 with a cost base well aligned with both our financial resources and our growth outlook.

And with those final remarks, I will hand over to you again, Christoffer. Thank you.

Thank you so much. And with that, I will round off with the outlook for 2026 and then the longer-term outlook as I normally want to end the presentation. And if we start with the focus on 2026 on Slide 23. The key message that we will continue to build the sales force and to build on the new partnership in the U.S. to enable OPOs and clinics to recover more lungs by EVLP adoption through a combined service model and staying closer to customers. In parallel, we will increase our service offering to better tailoring customer needs, especially offering NRP procurement from an increased footprint with more available surgeons. We continue to work close with competent authorities in Europe with the aim of obtaining a CE mark for Hawk. And I'm, of course, looking forward to the presentation or many presentations on heart, but especially the U.S. heart study during ISHLT and that we -- after that, hand in the regulatory file to the FDA for submission.

And lastly, in Europe, Liver Assist saves hundreds of lives every quarter, and we will support clinicians to increase that number through larger sales force, better reimbursement and more data to support them. And in many cases, service models to enable a better work-life balance for the teams. And with that, we can go over to the last slide or second to last slide 24, and it's a longer-term outlook. And I want to state this and I want to state it again that we are looking at a demand that is 10x higher than the available donated and used organs for transplantation today. And the sales value of machine perfusion is approximately 10x static cold perfusion. So the market opportunities there is approximately 100x bigger than what we see today.

Machine perfusion and service models has proven to increase the number of organs to be used for transplantation, especially in the fast-growing DCD organ pool. The main growth drivers are superior clinical results for machine perfusion and the fact that service model reduced complexity and time for the transplant clinic. XVIVO has unique truly paradigm-shifting technology that are on the brink to becoming a gold standard in many fields. And I want to end this presentation with a look into the future. And you will, in the future, find yourself on an airplane. You might be seated next to the XVIVO Heart Box with a heart being transported to a patient whose life is about to change. And this patient has likely been on the waiting list for a long time with limited to no quality of life at all.

And by having innovative paradigm-changing technology on the market, we will not only save this patients' life, we will also reduce the cost for the healthcare system dramatically as well as more importantly, we often forgotten in the field we are. At the same time, we have to remember there is a donor family who in their darkest moment, chooses the gift of life to someone in need. And that is what XVIVO Heart device can enable, and that is why XVIVO is here.

So I hope that one day, if we continue to invest in innovation, in field force close to customers, that we can make our vision come true that nobody should die waiting for an organ.

And with that, we turn to Slide 25 and open up for questions.

[Operator Instructions] The next question comes from Simon Larsson from Danske Bank.

My first question relates to the investments that you're planning [indiscernible] and at the U.S. launch of the Heart Box in '27 and the effect on profitability. So, yes, so I got it right from you, Kristoffer, we should not expect the EBITDA profitability level in a 25% range for the full year '26. Is that the correct way of viewing this?

Exactly. So I mean, the baseline from 2025 is 20% EBITDA. And we, of course, have an ambition to grow our top line next year, but we will make very deliberate decisions on how to use that money and growth is more important than profitability, it's that way.

Yes. Okay. That makes sense. And I was also a bit curious about the lung performance here in Q4. Obviously, a strong bounce back from earlier quarters. Should we view this as some kind of baseline from which you can grow here going into '26? Or should we continue to expect some volatility maybe in sales here in the quarters ahead? Any dynamics that we should know about as we enter '26, would be helpful?

Thank you, Simon. Great question. I wish I could give a clear answer. The clear answer is when we plan into 2026, this is, yes, the baseline we plan for. When we talk to customers in the U.S., there is a sentiment that we need to grow the number of lung transplants, partly due to the OPO dynamics where the rating could improve if they improve allocation of lungs and partly because of the TA-NRP opportunity where we actually throw a lot of lungs today away unnecessarily after TA-NRP when they could go through EVLP and be used for transplantation. That being said, it's always hard looking into the future because you don't know the volatility that comes with the future. But with the knowledge we have today, that is the best expectation we can give you.

Yes. Very good. On the U.S. CAP study, just to confirm now as you're recruiting very fast, is it certain that you can extend the CAP to another 60 patients once you have recruited the first 60?

I mean nothing is certain, so to say, because it's always up to the FDA and it's their decision. What is in dialogue, we have been told that we should be able to extend it if the safety data looks encouraging. So that's what we know. But this is solely the decision of the FDA and not our decision. I just want to clarify that.

Okay. Okay. Yes. Okay. Makes sense. Final one from my end on the potential EU Heart Box approval. Do you think it could be the case that the notified body would want to see the U.S. heart data in April before making any final decisions? Or could an approval come earlier than that, that makes sense?

It's a great question. I don't have a definite answer to the question. My gut feeling is that they want to see the U.S. data beforehand. That's what I guess. Hence, I would not expect anything before presentation end of April. And also moreover, so hard to predict time line. But we work hard on our end to make sure that we can get the highest attention from notified body, et cetera. And just to clarify, actually, the Heart Box and the Heart Disposable is CE marked, so we can sell those. It's a solution that means consultation for pharmaceutical ingredients that we are waiting for.

The next question comes from Jakob Lembke from SEB.

My first question is on EVLP development in the U.S. And I'm wondering if you could sort of elaborate on the development among different customer segments, your lodged key customer, other core customers and new customers you won recently.

Yes. We see a positive development on all customer segments in Q4, if you compare to Q3 and Q2. But we see a stronger from main customers and existing customers, so to say, who have EVLP practice up and running from the ones setting up programs, we see an increased interest, so to say, and a slight increase in sales, but we see the main impact coming from, let's say, the heavy users on EVLP. We also see an increased interest for more service components in the EVLP segment and hence, that's the partnership. So that's why we're working hard on strengthening both the partnership, but also our field force to enable it.

Okay. And then on the opportunity to deliver or do EVLP through the OPOs, my question is, do you have any ongoing discussions with other OPOs and sort of yes, how many could you have, let's say, in a couple of years, you think?

Yes, we have ongoing discussions and high interest from OPOs for starting OPO programs. I would like to come back in later calls on the exact number once we have proved our first 2 to 3 OPO models, so to say, then we will have a clearer view on both the pipeline. We will have the right resource on the field to collect the interest, et cetera. But what is clear today is that reach for EVLP is not -- in the United States is not as strong as it should be to enable a higher usage of donated lungs in the United States today. And we need to increase that reach to enable a higher usage to be clear.

Okay. And then also, I'm wondering if you had any lung machine sales here in the quarter?

Yes, in the Q4, we had no sales per se, but we had this placement at this OPO that we just discussed. I think there was another placement as well in Europe, which takes the year -- the full year total XPS new accounts to 6 or 7. The pipeline for Q1 is promising, and we hope to have a few more, 2, 3 more, I think, in Q1. There is still a discussion whether we will sell these or if we will place them, but that says something about the underlying health of the EVLP business [indiscernible].

Okay. That's very helpful. Then I have a question on Liver in Europe, which, as you said here on the call, has developed quite well. My question is if you could elaborate a bit on what markets are driving this?

It's the core markets in Europe. I would say the main driver is where we have a service model in Italy, which is really driving highest penetration rates in Europe. We see strong growth in Benelux as well. We see Germany growing very fast from a slightly lower level. And then, of course, we have the other core markets in European, France and U.K., where we see a strong uptake as well.

Okay. Sounds very promising. And then just a final question on the -- what expectations we should have on capitalized development going forward?

We will focus on -- the main money we spend right now is going into the heart trial. So it's partly pending approvals, how much we need to invest into heart trials. But we should expect that level to continue for -- up until approval for both in Europe and then later in the U.S.

Okay. But let's say you get a European approval here mid-2026, should we expect some of that to come down then after that?

Yes. I think the majority of the spending, and that was also the case in Q4 is directed towards the U.S. trial and the regulatory process over there. So that should come down slightly, I think.

The next question comes from Ulrik Trattner from DNB Carnegie.

First off, on the European regulatory pathway here for the [indiscernible]. It sounds like you are increasingly becoming more confident in what's needed on your end to be achieved in order to obtain approval versus your previous communication. Is there anything you can add to that if that is true?

Yes, I can confirm it's true. We had encouraging meetings both with our notified body and with medical agencies to clarify what we need to do. And we do have a higher confidence today that we are -- let's say, know what is needed.

Great. And if we were to also sort of look at liver here and your upcoming meeting with the FDA regarding a 510(k) and I guess this will be for a HOPE device and not a DHOPE device. But can you give any type of outline here in terms of a time line if you have a positive meeting with the FDA in February?

I would choose to not speculate on the time line at this point, though it would be premature. So I would wait for the FDA meeting to have a clear picture on time line going forward and what we need to do to achieve them and then we come back.

Sure. But if you can clarify here on this potentially then being a HOPE product and not a DHOPE product. And you obviously achieved a lot of success in Europe on a DHOPE device. And I guess you would see more logic combining a DHOPE device with NRP, for example. So how would a HOPE device fit into the current landscape in the U.S. right now?

In discussion with U.S. customers, we see that a HOPE device would fit very well into an NRP setting, absolutely. So we don't see any change there in application to use. We also see that in -- if we're going to -- if we will go from hyperthermia or HOPE up to normothermia and warm evaluation, then dual would be needed. But we believe for a setting where we only need to either time shift or improve outcome or combined with NRP, we believe that current hope would be sufficient enough for at least the customer segment. And we have to evaluate if we need further on to also look into hope. But at this stage, time to market is prioritized over especially normothermia.

Okay. So is it fair for one to assume that you will look at DHOPE as a sort of sequential development process into the U.S., starting off with HOPE, building your customer base and then doing a PMA study for DHOPE?

Where no decisions are taken today regarding the regulatory full strategy, that could be a possible way forward, absolutely. But that's something we need to go back to when we have a clear picture after meeting the FDA.

And next question would be on the Kidney Assist Transport ramp-up in the U.S. throughout 2026. I know that you comment that full-scale commercial launch, and I guess that entails you're done with the tweaking of the box and the adapter for the dual arteries and the sizing of the box by sort of end of the year. But you have signed up OPO contracts. So just can you give us some rough guidance on how the commercial interests ahead of the sort of broader commercial launch?

I mean it's interesting because it's -- once a clinic start to use it, they are very pleased with it, so to say. So key in '26 will be to add more clinics to get a greater or more clinics with a greater user experience as well as going into the OPOs to have them also experience what a great product it is. So that is the main task we see. We see a great interest from many counterparties in the field, and we want to continue with a slightly limited sales force we have now, but we still want to cater that interest to make sure that more kidneys can be used for transplantation. And when they get used, they will have a higher survival rate. And as I said in the presentation, we're also looking forward to investigator-driven studies coming out with -- showing that on the American transplant system as well.

Great. And last question on my end. You successfully historically implemented quite significant price increases year-over-year. So what's the plan here for 2026? And also if that could offset potential tariff impact?

Yes. That's correct, Ulrik. We've been fortunate in the last years, been able to implement quite high price increases. We took a decision in the fall to push our price increases in the U.S. a little bit earlier. Usually, that's a January thing. So we increased prices in the U.S. around 5%. I think it was across the board in November to manage the tariffs. Europe, normally, there is a similar price increase in the beginning of the year as well. However, here, we have longer contracts due to tender, et cetera. So you don't really see the immediate effect there. But we -- overall, we believe that we have handled this in a good way and in a similar path as we have done in the past.

The next question comes from Filip Wiberg from Pareto Securities.

I've got just a couple of follow-up questions here. So first is on the CAP. So 10 centers now up and running. You did 18 transplants in the quarter and I think you said they're up at 30 in total now, right? So my question is mostly in terms of their total heart volumes, like sort of a penetration rate. So what percentage of their total volumes have they used the heart box in, if you get the question?

Got it. Got it. We probably need a longer-term view of that to come with a better question, but we can see that -- in the original trial, we could see that some centers had up to 20%, 25% of their volume going on the Heart Box. So the indication for use in the trial were extended criteria or it’s typically DCD more than 4 hours, about 50 years, more than 2 hours, et cetera. So fulfill that criteria. So we could see fairly high, let's say, clinic penetration in some centers during the original trial. And we need to come back after we -- after this trial is more up and running with a better view on the continuous access protocol and how that translates.

Okay. Yes, I was just trying to get a feeling around the potential after an approval just in these centers, which I suppose now are used to using device, but okay. But another one, you're planning to extend it right like after you or close to reaching the 60 patients, so will that -- will there be sort of a delay after the first 60 patients are done? Or can it start just right away after that?

We plan to interact with FDA, so there is no delay on -- by request from our users. So it will follow the same protocol, same IRB, et cetera. So there should be a possibility to have no delays.

Okay. Very good. And then just last question, if you can talk a little more broadly on the market in the U.S. with some prior questions have been around lung here and if there have been some one-off effects or so. But are you seeing a continued improvement in like general market in the beginning of 2026 with then a continued improvement? Or what's the situation now?

Yes. I must say, since October, we see a better sentiment in lung, which is the market we know the best, so to say. And we do see an increased usage of our products. And we have no reason -- I mean, we're just a couple of days into '26. So we have no -- we haven't seen any change so far on that sentiment that we saw in Q4, not turning -- continuing into '26. Again, in discussions with clinics, they share the same positive sentiment as they did in October when we met during the global EVLP Masterclass or Lung Masterclass.

The next question comes from Ludwig Germunder from Handelsbanken.

I have only two questions, please. The first one would be on EVLP, which is kind of a follow-up on the previous question. Could you comment anything about the new customers that you signed last year and how they have been developing during -- since they signed [indiscernible]?

Yes, great. Absolutely, we can -- they have developed well. It takes a while to set up a good internal EVLP program. We see that in 6 to 9 months, they were up and running, and we see an increasing activity that we are now investing sales force to make sure that, that continues and accelerate during 2026.

Okay. Great. And then on the -- you mentioned the move of production capacity and that is running according to plan. Could you just remind us, please, what that time line is?

Yes, great. We plan to have to finalize the majority of the setup this coming summer to be ready, let's say, with all investments for the x10 ability to produce. We can already see in many products that we have that ability already for disposables, for example, for liver and kidney.

The next question comes from Oscar Bergman from Redeye.

I got a quick couple of questions from my end. You mentioned that you have up to 25% market share for delivery in some core European markets. I remember the figure being 30% in Italy. I'm just wondering if this has come down. And if you can just comment some on TransMedics entrants in this market?

Great. Thank you. Very good question. No, other way around in Italy, it's growing every day actually. We have a fantastic team in Italy, one of the best teams I ever met, very dedicated, customer-centric. They're always there. The customer call in the middle of the night, they're actually there. So it's a great team, great customer interaction. So it's constantly growing. Hard to comment on what other people are doing in Italy or elsewhere. We haven't seen anything so far.

Okay. And then on the kidney product, you did some redesigning for the U.S. market. Just wondering where you stand today in terms of this process and when you will be able to scale up commercially?

The project is ongoing, and we are working on a couple of avenues commercially in parallel. One of them being acquiring more clinical data, which we are doing together with investigators; two, getting into more hands, so we get more clinics up and running and three, pilot into some OPOs who knows that it will come -- the improved product will come early next year in around a year's time to pilot in an OPO setting. So that's what we are doing in parallel, so to say.

Okay. And then if we assume that the Heart Box with a CE mark sometime during the summer, then how quickly will you be able to sort of hit the pedal to the metal and then start accelerating commercially?

It's a great question. The answer is very fast within some limits, so to say, it needs to get listed, reimbursement, et cetera. Through the year, I mean, in the next couple of months, we will have a better view on that because we are working in parallel with reimbursement in some markets. But judging from customer interest, it will be a very instant uptake in many markets in Europe. So -- but we have high, high, high interest in France, Germany, Italy, U.K., et cetera. But there might be administrative delays. But from a clinical side, there will be no delay at all.

Okay. And just a final question, Christoffer. You mentioned that you do some restructuring of the Service segment in the U.S. Can you just elaborate more practically what this means?

In terms of Organ Recovery service, what we've practically done and if you go back and listen to the Q3 report, we described it or the conference call described a little bit more in detail there. But we have restructured the service to also enable NRP with the partnership as can now recover TA-NRP in our organ recovery. More importantly, we have educated everyone in our team, et cetera, to be able to do it. And we also doubled the number of hubs where we travel from to reduce cost, and we also doubled the footprint on -- or let's call it, surgical footprint to enable fast growth in this segment. So those are the main items we have done to gear up for growth.

Thank you so much, everyone. I see that we now are over time and need to conclude this conference. And if I turn to the last slide with a reminder that we will meet in the future next time is April 22 to listen to the interim report January to March ‘26, which we will actually broadcast most probably from ISHLT.

Thank you for today, and see you next time.

Hi, everyone. Hope you're enjoying day 3 of the JPMorgan Healthcare Conference. My name is Vidhushi Taduri, and I'm an associate in the health care team here at JPM. It's my pleasure to introduce XVIVO's CEO, Christoffer Rosenblad, who will be presenting to you today. Over to you.

Thank you so much, and welcome to XVIVO's presentation. XVIVO is a company that scientifically pushed the boundaries of organ care prior to transplantation. And since you so amicably introduced me, I would jump to the XVIVO's vision. Today, organ failure is the most common cause of mortality. XVIVO is determined to change this and one day make sure that our vision come true, which is that nobody should die waiting for an organ.

Alex, on this picture used to live in Perth, Australia, which is a very remote town in Australia. Before XVIVO, Alex would have died due to organ shortage or too far distances to recover new heart. Now she got enrolled in the XVIVO Australian study for the Heart Assist Transport device, and she did receive a heart from across the country. And this would have been impossible without XVIVO's technology. And I actually met her in Europe. Today, she's living her fullest life. She's taking her PhD in Amsterdam in the Netherlands and living a normal life like the rest of us going to the gym every day.

So what do we do in XVIVO? This is an overview. If we start with the company's XVIVO, it actually means outside the body. And that is exactly where we operate in the transplant process. We are between the organ donation and the transplantation. And our job is to optimize organ care and evaluation of organs to enable more organs and better organs to be transplanted.

This is a snapshot of XVIVO. Basically, XVIVO's products are based on almost 30 years of intensive research. It's hundreds of thousands of man-hours that go into basic research to come to where we are today. And we started in thoracic region, hearts and lungs. And we started with lungs and later actually intensified our research into heart technology. Now we come back to this technology later in the presentation.

In 2020, we acquired the abdominal portfolio, so that's liver and kidney and became the first global all-organ company within transplantation. In the following years after 2020, we acquired service modules, so we can enhance our go-to-market strategy and be a true partner to our customers.

In terms of financials, we always had very healthy financials and in the past years, healthy growth rate as well, especially in the years when we started to commercialize our paradigm shift in technology. We look -- pretty much in terms of market, we look like a lot of med tech companies with 60% in the Americas, 35% in EMEA and 5% in APAC. Then we can jump into the transplant market and the problem we are facing today for later on in the presentation, explain how we want to solve this problem.

Today, we know that approximately 2 million people are in need of a transplant every year. However, in the year of 2024, only 170,000 transplants were performed. Hence, we are now meeting 10% of the global need for transplantation. And to explain a little bit more, for sure, to fill that gap of 1 to 10, we need to have more donors. But to be very clear, the key problem is that we need to use -- that we're using too few of the actually donated organ as you see in this picture.

To increase the use rate of the donated organs we have today, we need machine perfusion. The other challenges we are facing is a change in dynamic of the donor population. There are 2 types of donation. It's either DBD, donation of the brain death. And the other one is DCD, which is donation of the circulatory death. During the past 10 years, we've seen a shift of a typical donor. From 10 years ago, it was typically a young DBD donor. And now it's typically an older DCD donor.

Both DCD and age, donor age introduces uncertainty into the organ quality. And this is where machine perfusion come in, both in terms of keeping the organ in good condition and evaluation tools to determine what is a good or bad organ. And the best impact, where the impact that is best shown is the introduction of our lung technology. Even though we have seen overall a fairly low number in growth of donors with low single digits in the last 5 years, the number of lung transplants where we have commercialized our portfolio has grown 11% in the same period.

So this is where we see that technology can shift how we actually -- how many organs we can use. So coming back more into how do we actually solve the problem. For decades, XVIVO has been in the forefront of saving lives. Today, we have the best innovation in the market. This is great, but not enough. We also need to provide the best-in-class services to help OPOs and transplant programs to grow.

And our goal is to become the preferred partner in the transplant process in the next couple of years. And this is the offering of the best-in-class products we are providing to the market. XVIVO -- a few things to point out, XVIVO is the only company that develops perfusion sets that are the bags and the bottles you see in the picture. XVIVO is also the global leader in both lung preservation, transportation, preservation and in lung evaluation today. We are the European #1 in livers. But the most interesting technology is the XVIVO Heart technology. It's really the crown jewel of the product portfolio.

Today, it's not commercialized yet. It's awaiting approval in Europe, but it has the potential to change transplantation forever. And we will come into that a little bit later. On the right-hand side of the slide, you can also see the service offering. This is under buildup to be fully built up during late 2027.

We look at Slide 14, the regulatory approval status in the core market. It's -- a few things are clear. And one thing that strikes me is that we see that we have the majority of our growth in front of us. Today, the main share of revenue come from our lung products. And we see that we have approval -- global approval on kidney as well as European and Australian approval of liver.

And the most innovative product, the heart is not even approved yet. But all regulatory trials are completed, and we are on the brink now to launch those products and change the paradigm for heart in the world. And if we look at the liver, we are investigating our regulatory pathway for the U.S. market for liver as well. The impact XVIVO will have to the transplant industry is mainly 4, and this is how we want to reshape transplantation. The first 2 points are patient-centric and the last 2 points are more transplant and society-centric. But the first and more important, which is completely linked to our vision is that we need to make more organs available for transplant.

And with our technology, we can do that. The other thing we see in all clinical trials is that by using XVIVO, we can improve the patient's life by better outcome and longer survival. But this is not enough. We also need to support our partners, the transplant clinic and the OPOs. And we're going to do that by reducing cost and increasing efficiency in the transplant system so we can enable more transplant for the same U.S. dollar amount. But it's also -- what we also want to do is to reshaping how transplant are perform and making it a plannable procedure. And we can see that already on liver in Europe, for example, it's now a plannable procedure versus before it was something you did in the middle of the night. So we are in the process to do that already.

I started to say that we spent 3 decades on research, and this is something that makes us completely unique in the field we are. We have really tried to optimize organ care with best-in-class perfusate solutions. And we -- as I said, we are the only company who actually brought those solutions to market. The third point which makes us unique is that we have spearheaded and have a large body of evidence for HOPE, which stands for Hyptherermic Oxygenated Perfusion.

And that has proven to be the best way of transporting an organ between the donor side and the transplant hospital. You keep them in the best condition possible with the lowest risk and with the best patient outcome. It has also been proven that with HOPE, we can increase the out-of-body time more than you could before.

The last part of the presentation will go more into the future and the outlook. We start with a little bit shorter-term outlook. And since the U.S. is our largest market and also has the greatest growth potential, both short and long term, the catalysts for next year are to drive lung evaluation adoption where we are already leaders today, and we're going to grow that market. We also will implement NRP into our service offering on customer request.

The most important milestone next year will be to file the heart file to the FDA. And we will invest heavily into our commercial organization, both to drive growth from existing products we have today, but also to prepare for the heart launch that will come in '27. In Europe, we have a very strong position, and we are looking forward to the CE mark also for heart in Europe that will drive growth for the next decade in Europe as well.

And we will enable customers to use the best-in-class products. And it's a question I get every day from European clinics is when can I buy your heart products, so I can start recovering more heart and get better patient outcome, and I can also make heart a plannable procedure versus today, an extremely stressed procedure. We have approximately 4 hours out of body time.

If we look a little bit further into the future and how we want to change the paradigm of especially heart, I promise to come back to heart. And if I want to highlight one thing, is the transatlantic flight that was performed. It's the first time ever a heart flew across the Atlantic Ocean. And not only it was unprecedented due to distance, it was also the longest out-of-body time ever recorded with more than 12 hours. And it's amazing.

But typically, today, you use -- even for short distances, you use private airplanes. This was done on a commercial airline or an Air France in commercial. And as you see on the picture here, this is an actual picture from that recovery. It's on economic -- economy seat, which is -- so it's unprecedented for 3 things. What is even more striking with this case, there have been many more after this. But what is striking with this case is that Professor Lebreton, he really pushed the boundary because the donor was very old.

And more so, the patient was older patient and too sick to transplant. So he was delisted from the transplant list. But thanks to Professor Lebreton's hard work and XVIVO's heart box, the patient got a second chance to live and actually had a very good recovery after transplantation. And to sum up, why you should invest into XVIVO. As I started, the market potential is huge. In terms of number of transplant is 10x larger than what standard of care can accomplish today.

XVIVO is the only global company that can offer a portfolio for all organs that increases availability and improve patient outcome. We have similar to the previous presenter here, we have a history of continuous profitable growth. And last point I want to point out that spending those 3 decades of heavy research has paid off, that the portfolio we have now is truly innovative. And when we go into next generation of organs such as xeno organs or printable organs, that's when XVIVO products really needs to be used.

So for example, there has been 2 xeno hearts made here in the U.S. Both were made possible with XVIVO technology. Without it, those would have not been possible to make -- to have been done at all.

And with that, I want to end the presentation with a little bit longer look into the future. When you fly, you might be seated next to one of those heart boxes. That is a heart donated that is transported to a patient. This patient has likely been on the waiting list for a long time, hoping for a donated heart. At the same time, there is a donor family. And in the darkest of moments, choose to give the gift of life to someone else they don't know.

And I invite you today to be part of this journey and share this vision that one day, nobody should die waiting for a new organ. Thank you for listening.

I think we can move on to Q&A if there's any questions from the floor and any that are coming through online. To kick things off, it will be really interesting to hear what makes XVIVO really unique to your competitors and versus your peers in the market?

Yes. Thank you for that question. I think the 3 decades of ground research into how do you actually keep the cells alive, how do you optimize organ preservation, how do you optimize organ evaluation, what type of perfusate liquids do you actually need to accomplish this makes us truly unique in a couple of ways.

But the most striking way is that we have -- we're the only company who brings perfusates to market in the transplant industry today. And the perfusate is the blood substitutes, and that is so important to keep cells alive. And that's why we see in clinical trial superior outcome over and over again when we run clinical trial. So that makes us truly unique. We're the only one in the world doing this today.

And secondly, I would say we have spearheaded the HOPE, way of transporting organ. And that is by finding the right temperature, which is hypothermic, but not ice and oxygenated and perfuse it both during transport, but also for making implantable surgery in a safe way. And HOPE offers a lot of benefits. it will prolong out-of-body time, but it will also be the safest way of actually transporting an organ.

For example, if something goes wrong with the device or if anything happens during flight, there is no -- the organ will be in good shape no matter what because it will be kept at optimal temperature. It will be far better than ice, which are -- is the standard of care today. So even in the worst-case scenario, it's still better than what we actually do today.

In your presentation, you often referred to the paradigm shift when describing your heart technology. What do you mean by that? Would you mind expanding a little bit further?

Yes, absolutely. Thank you for the question. We believe that heart has the potential to become the gold standard in heart transplantation and heart preservation transportation. The reasons are manyfold. But one, patient outcome is better. If we compare normal hearts that we did in Europe, we saw that we got an improved patient outcome using this. And this is normal hearts below 4 hours, DBDs that are -- they are improved.

We can also see that not only can we improve patient's life, we can also make more organs available because of matching. Today, matching is limited or opportunity of matching is limited due to the short out-of-body time which is approximately 4 hours, which doesn't allow for optimum matching. But with the heart box in the market, you could go for national allocation in Europe, in United States, in large areas.

And we can already see one example of this is Australia, which is prior to approval. So we don't -- we can't market the product, we can't sell the product. But in DBD heart, we have a 40% market penetration already without actually selling the product or promoting it. So I think that's a hint to why I think it will change the paradigm and lastly, the heart product and the heart box you see in the picture here, it allows for reducing huge amounts of cost into transplant system, where you before had to pay hundreds of thousands in U.S. dollar in transportation costs, you can today go on a commercial airline there or for shorter distance opt for car instead of private airplanes, which is the -- what we use today.

So we're driving down costs, we will enable more transplants to be made and hence, more patient lives to be saved. So this is why we believe this should be the gold standard going forward and once approved.

Yes. That's great. Any questions from the audience? Okay. I think a final question from my side. I think when we look forward into 2026 and the years forward, what should investors keep an eye on? And what should we be excited about?

I hope the same things as I am looking forward to, and I'm excited. Number one, we are looking forward to the biggest heart and lung transplant congress. It will be held in April. We will have some -- hopefully, some great presentations there. We hope for U.S. data to be presented or U.S. data will be presented during the conference. We also run a direct procurement DCD trial in Europe that we hope to be presented, which is fantastic, 40 patients, which will make the DCD recovery process so much easier than we do today, and we will drive, again, drive down cost by using this simple device.

Besides that, we are obviously looking forward to handing in our application to the FDA for the heart box and the CE mark, hopefully this year for -- in Europe. So we can start selling it and start marketing in Europe. And besides that, I will keep my eye on the -- what we have seen in the last couple of years, the increase in penetration of existing technologies we have on the market. So that's, of course, something to keep an eye on. We have a great lung product approved everywhere in the world and the liver technology in Europe to see that continued market penetration.

That's great. I think we've got one question in the audience.

[indiscernible]

We are still investigating and there is no update today on the regulatory process for the United States. That was the question. But as soon as we have an update, we will come back in a quarterly investor call.

One question. Once your cardiac device is approved, and it seems to be a lot simpler to use and more easy to transport, how do you -- how does XVIVO plan to really expand that and potentially compete with the NOP system from the -- one of your biggest competitors?

I mean, I think in Europe, there is fairly limited competition from NOP today. In the United States, there will be a need for a service component for some clinics. So the feedback I get today is that this is so easy to use, so we don't need any service. We can do this ourselves, a lot of clinics. But there will be some clinics due to size or lack of recovery surgeons that want to have an additional service component to enable the use of XVIVO heart box.

Thank you very much.

Thank you.

Welcome to XVIVO Q3 Report for 2025. [Operator Instructions]

Now I will hand the conference over to CEO, Christoffer Rosenblad; and CFO, Kristoffer Nordstrom. Please go ahead.

Thank you so much, and good morning and good afternoon, everyone, and especially welcome to XVIVO's earnings call for the third quarter of 2025.

First, a quick introduction of today's presenters. This is me, Christoffer Rosenblad, CEO, calling in from Gothenburg, Sweden. And we also have Kristoffer Nordstrom, CFO, calling in from Philadelphia in the United States.

And with that we go to the third slide, which shows Q3 financials at a glance. The Q3 shows a plus 6% top line organic growth if adjusted for the U.S. heart trial revenue compared to the same quarter last year. We can note that there was no destocking during Q3 and hence the EBITDA recovered to expected levels during the quarter.

In terms of segment growth, the Thoracic sales were affected by lower heart study revenue in the U.S. and a softer Q3 lung market. The Abdominal segment shows great progress for both liver and kidney.

Looking a little bit into the future. In the beginning of October, the 3 out of the 4 clinics that acquired an XPS in the United States during H1 or half year 1 are up and running now in the beginning of October, and we also held a Lung Masterclass. I will come back to that later. Yesterday, where it was noted that, that October at least started better than Q3 in terms of lung transplant and in terms of EVLPs to support for the lung transplant if you compare to what we saw in Q3.

Going into our Abdominal segment, liver in Europe are now entering the majority market segments with penetrations above 15% in many European countries. The main task for us are now to support with resources for perfusion and data for improved reimbursement.

Sales growth is improved in many countries by improved reimbursement, which is based on the carpet of excellent clinical data with better patient survival and more livers used, as well as hospital economic data and health economic data.

Kidney, on the other hand, is still below 15% penetration in many countries, including the U.S., and the main task for us is to win account by account. What is good to note is that the feedback we get from kidney customers is that they are very pleased with the product and see that the kidneys are in better condition after being perfused with the Kidney Assist Transport compared to the available alternatives on the market today.

And if we go over to Services, we have stated earlier, and we are not pleased with the progress of the U.S. service business. And we reported in the last Q2 report that the analysis was finalized for an action plan and that we see an increased interest for combined procurement and NRP service model.

This would fit very well into the heart launch. During the summer it was decided to execute on this plan and invest into service segment, and I will come back later in this presentation with the actions we have taken and how we will execute during the next 5 quarters to become a preferred partner to the transplant teams in the United States.

And I also want to again state, as we have said earlier that the service initiative is very strategic and the purpose is to support the future heart business in the U.S.

During the year, a cost and cash reduction initiative was initiated to enable better resource allocation going forward. The CFO will come back to that during the financial part of the presentation.

And to end this slide, Q3 shows again that XVIVO has a scalable business model in terms of EBITDA. We can see that the recovery of sales in Q3 versus Q2 also improved the EBITDA as a percentage if you compare to Q2 of this year.

And with that, we go over to Slide #4, which is the first 9 months at a glance. And it shows a similar picture to the Q3 slide. A good and stable gross margin. We continued investing into field force and scalable production structures. We saw that sales came in at SEK 586 million with again a 6% growth if we adjust for the U.S. heart trial revenue.

In terms of gross margins, I said before that we plan to improve Abdominal gross margin to 70% at the latest in '27 or when we reach economies of scale in production. You will hear more about gross margin or EBITDA levels later in the presentation.

For heart the main hurdle is regulatory approval. Once the Heart Assist is used the feedback is overwhelmingly positive. We continue to build evidence and more than 500 patients have now been transplanted successfully with Heart Assist.

The CAP in the U.S. is now up and running, and we have 6 patients included as of yesterday. I will come into later a little bit more on heart, but we can also see that in Australia, the heart penetration rate last year was approximately 30% and we now see that this year it has increased to 40% for DBD heart, which shows again that the need for this product in the market.

We have also stated in early calls that we're running a DCD direct procurement study in the Benelux to show that we -- it's also a great product for DCD hearts. And I think with that results coming out, hopefully next year and the Australian experience, we see a great potential to truly shift the paradigm of heart transplantation.

Lastly, and also important to mention is that the projects are progressing according to plan. Regulatory time lines are hard to predict, which we saw this summer for the EU heart approval. But in terms of clinical trials and development projects, they are progressing according to time lines agreed.

The production capacity projects, for example, where we invest to scale up volumes 10x of the day volumes for disposables are running in line with communicated time lines. The full-scale production of disposables for heart, liver and kidney will be extremely important to capture future growth potential for all 3 products.

And with that, we can go to Slide 5. And I want to remind everybody why we are here. It's a picture in front of us reminds us that Alex is one of the 500 patients that got opportunity to get a heart transplant, thanks to the innovative XVIVO heart technology. And that's why what we work on every day to make sure that those patients actually survive.

If we can go into Slide 6 to the Q3 highlights and important information. If we start with the U.S. federal review, so HHS has launched a review of the organ transplant system in the United States and started to take actions towards at this stage, one, underperforming OPO, listening to the conference.

And I think it was best summarized by the quote from the FDA Director, Marty Makary, that you see in the middle of the page here. I want to state that XVIVO is aware that many organs go to waste because of bad communication, underutilization of technology that improves organ utilization, patient outcome, et cetera. And this is why we work day and night to improve the situation for both transplant teams and OPOs.

Our products and services correctly used will enable more organs to be used and less stress on the transplant system, which we do acknowledge there is a high level of stress right now. But we hope with longer transportation times, more evaluation opportunities and a better service model, we hope that we see us as part of the solution to release that stress and less mistakes will be made.

And we can stay in the U.S. and go to Slide #7 and just have a brief view of the U.S. lung market. And as we said earlier, and you can see it also in the slide, we have gotten used to very high growth in the U.S. lung market '22 to '24, double-digit market growth. And it has been driven by improved allocation and EVLP at the ambitious programs who could safely grow their number of lung transplant using lungs that were rejected by other centers.

In 2025, we still see growth, but at a lower pace than we are used to. The reasons for the slower market growth are manyfold. But at least we start to see waitlist coming back at a few of the ambitious clinics I talked to. And we have also acknowledged that the lack of resources has impacted growth rate this year compared to earlier. And I will also come back to how we want to improve our service strategy to reduce stress and lack of resources at both clinics and OPOs.

And with that, we can go -- continue to stay in the U.S., but go to Slide 8 to paint the picture of what we will do specifically for lungs. As stated earlier, we have seen fantastic results from ambitious lung transplant programs that safely increased the numbers of lung transplant using EVLP with XPS system solution.

For Q3, we can start to conclude that we didn't identify any destocking. We continued to see an increasing interest to start EVLP programs with XPS. And as stated earlier, 3 out of 4 of the new accounts that bought an XPS in the first half of the year is now up and running, unfortunately, not in Q3, but in early October, at least.

To improve our service to lung transplant clinic and we acknowledge that there is a resource constraint, we entered into a partnership during quarter 3 with a prestigious perfusionist company. By doing so, we've got access to 175 perfusionists and we can together with our organ recovery business and communication system FlowHawk, give our customers an improved experience and support them also during shortage of resources.

During the summer, we have also developed an EVLP product service model to better fit the OPO system. We will run the first pilot during Q4.

And lastly, we have also recognized that we need to reorganize the commercial organization, and we have done so during the summer to have a greater footprint in the south of the country and on the West Coast of the United States.

Our estimation is that the action taken during the summer will show gradual impact during the next 5 quarters. The interest for starting an EVLP program with XPS is extremely high by the most successful lung transplant clinics in the U.S., has proved that that's the way to safely increase lung transplant volumes. And we believe by increasing our support level, we will be able to better realize this interest from customers.

And with that we can go over to -- I came home yesterday still running, but I came home yesterday from the -- our Lung Masterclass 2025. And it was a great pleasure for us to welcome the best of the best in lung transplantation to the 2025 edition. So we have got 100 clinicians from 19 countries that could exchange ideas through collaboration, how we can improve lung transplant practices and improve both usage of lungs and patient outcome.

The key takeaway for me was that many clinics has experienced a -- or had experienced a tough 2025 with the lack of resources and in some cases lower waiting list, making matching of donor organ patients a lot harder. We see that we need to support our clinicians better. And so far, what I could -- in the conversations I had, we could see that at least the waitlist looks a lot better going into Q4 than they did up until Q3.

And with that we go over to Slide 10, sorry, and just have a snapshot of the U.S. CAP study and the PRESERVE study status. We have the first patient enrolled into the study during Q3. At the end of the Q3, we had four patients enrolled still at one clinic. As of yesterday, we actually had nine patients enrolled into the continuous (sic) [ Continued ] Access Protocol still at one clinic.

At the end of Q3, we activated five centers that are able to enroll patients. And the focus for Q4 will be to activate more clinics. There is a need for the product, and also support them as much as we can so they can restart enrolling patients into the continuous access protocol so we can strengthen our regulatory file that we aim to hand in to the FDA during the next year.

We can also just briefly state on the PRESERVE status that we had last patient in the original trial, so not the continuous access protocol as November last year. We will have the -- go through the data analysis Q1 in 2026, and the study result is expected to be announced in Q2 2026.

And with that we can go over to Slide #11 that I said earlier we should deep dive a little bit into the actions taken during the summer. Besides the footprint of our commercial team in the United States we have also taken action on the service side.

To start, we've taken mainly 3 actions. One, we have doubled the surgical capacity both in terms of number of surgeons and in terms of active locations. So we've gone from end of Q2 3 to end of -- 6 end of Q3. And we expect that end of Q4 will be 7 active hubs in the -- on the East Coast or east of the Mississippi.

As I stated earlier, we closed a partnership with a great partner not only to improve our EVLP capabilities with perfusionist, but also to support clinics with NRP services, which is nowadays in the United States a must to grow our service business that has been asked for and now we can finally deliver on it.

At number 3, we have partnership with numerous both aviation and ground transport partners to enable a full-service offering if the clinics want that offering. Some have their own transportation partnering, and we're happy with that. But if they don't, we can offer a great network of transportation to simplify for the transplant teams.

So with those actions we will improve our services. We had already best-in-class service in terms of quality, but now we can offer service tailored to customer needs as well. So we hope that we have laid the foundation for growth within this segment, and -- especially then east of the Mississippi. We are aware of the fact that we need to also grow our hubs and service offering west of the Mississippi, and we will come back to that both the progress on the actions taken and the future plan in the next quarters to come.

And with that, we can go over to Slide 12, and we leave the United States and we go over to Europe, which we have concluded into one slide. And the reason is that it's slightly shorter is that the business is progressing very well. We have a stable field force. We have very good clinical data, long and strong customer relations and great interactions.

But what we've seen so far in Q3 is a continued strong growth for liver in Europe. Q3 it was similar to previous quarter by plus 31%. And we continue to add new accounts every quarter. We continue to work on reimbursement, et cetera.

The main hurdle for growth in liver is mainly human resources and reimbursement, which we're working on. And country-by-country, we now see that reimbursement is coming into place. And with an increasing customer-facing organization, we now have the ability to support clinics better with also resources, and especially human resources that support with perfusion services.

Kidney is showing growth, 54% in Q3, and that is great. What we can note, as I said earlier, customers that are using the products are pleased with both the performance of the product and -- but especially how the kidney performed after transplant. So we -- but we have a lower market penetration rate, and we are -- it's more account-by-account base where we have to, let's say, fight a fight to increase penetration rates, and we have to convince clinic-by-clinic. But once they had tried the Kidney Assist Transport, they are very convinced of the product and actually increased usage over time.

The lung business in Europe grew mainly with EVLP adoption in the U.K. and higher PERFADEX usage per case as -- the last one as a result of evidence that if you flush more with PERFADEX, you actually improve the lungs before transplantation, which potentially improve outcome after lung transplantation.

And if we look going into next year and strategic areas for our European business, we are, as we stated earlier, of course, awaiting the regulatory approval for heart. If we benchmark Australia, it's clear that XVIVO Heart Assist has a very good position in the transplant system. And we expect European heart penetration to over time mimic what we have seen in Australia.

We're also awaiting the -- as I said earlier, the DCD to have a full coverage in Europe once we launch. We have also acknowledged that in the U.S. as well as in Europe, there is a constraint on resources. So we have a very successful model in Italy, and we will launch that model into a few test markets where rules and legislation allows for that.

And with that, we can move over to our regulatory, clinical update. It's a little bit longer than normal this time, but we can start with just the standard slide of Slide 14, which shows an overview of regulatory approval we have. So our lung and kidney portfolio has obtained regulatory approval in all key market, and liver is approved in all key markets. For heart, we are awaiting, as we know, approval for all core markets.

And the time line has -- there are some shifts, and I'll come back to those later in the presentation. But the main time line has not changed besides the pending CE-mark in Europe, which we press released during the quarter. And in U.S., we are working very hard to make sure that the file is approval ready as soon as possible.

For the liver, we have now obtained everything we need, but I will come back later to the decision we have taken during the quarter regarding the liver U.S. trial.

And we can turn to 16, which is a little bit of a repetition, but it's good to clarify here the heart and the strong evidence we see in heart. The heart trial in Europe is not the -- not only the first trial to aiming for showing superiority, it's also the first trial to show superiority for heart. But more importantly, it's also the first trial ever to show a direct link between perfusion of a heart and patient outcome. And we can see that by using XVIVO Heart Assist, we can reduce severe PGD, which is the leading cause of early and late mortality with 76%.

And what we know from before and what we've seen in the trial is that, if you get the diagnosis of severe PGD, you have approximately 40% mortality risk within 1 year. If you compare that to -- if you don't have severe PGD, you have only 5% mortality risk during the first year.

So -- and this was in our trial directly translated to 6 patients more safe or life saved during -- up to 1 year, which is the first time we can see those direct links between actually perfusion of an organ and better outcome within 1 year.

And if we would extrapolate this to the transplants we are doing on standard criteria heart today in the world, it will translate into more than 400 lives saved every year only for the standard criteria heart. And then we're not counting all the extra hearts that we can actually get available for heart transplant using the XVIVO Heart Assist, either if it's long distances or extended criteria heart, et cetera.

And with those great results, we go over to Slide 17, where we are looking into more how we want to change the paradigm of heart preservation. And as I stated, we know that we now can increase both patient outcome and we can increase transportation time for heart. To strengthen the evidence and simplify the DCD process, we have, as I said, the Benelux DCD direct procurement study that we are now under inclusion of patients, and it's progressing fine. The study aim to include 40 patients, and it is estimated to be fully included end of this year 2025. And we are really looking forward to the result of this study.

With a positive outcome of this study, the XVIVO Heart Assist would fully transform the process for DCD heart, making it safer, easier, less resource-intensive and with improved patient outcome. So then we cannot only, as we have seen in Australia, change the paradigm for DBD heart with a successful outcome, here we would also change the paradigm for DCD hearts and hence the full heart transplant process.

And with that, we go over to the last slide of the clinical and regulatory update on Slide 11 or Page 11 (sic) [ Slide 18 or Page 18 ]. And as you know, we previously reported that the Liver Assist has been granted Breakthrough Device Designation by the FDA. We have an approved ID and can start the trial. We have CMS funding approved, et cetera, and we could have started the trial in Q3. However, the company has decided to temporarily pause the activities for the liver PMA process to investigate if an alternative regulatory route is possible.

We hope to, as soon as possible, come back with the result from that investigation. The aim of the investigation is to see if we can get a faster route and hence enable patients in the U.S. a better product than what is currently available on the U.S. market, approved faster. And hence, we can see the fantastic results we have seen in Europe also in the U.S.

And with that, I go to Slide 19 and hand over to our CFO, Kristoffer Nordstrom, who will present the financial performance of the year and the quarter.

Thank you, Christoffer. Yes. So net sales in Q3 were SEK 189 million, which represents a gradual improvement from Q2. Organic growth, minus 1%. But in reality, organic growth was plus 6% if we set aside heart trial revenue. Besides heart trial revenue, organic growth was again impacted by soft market conditions in the U.S. and lower EVLP activity among a few larger customers.

As our CEO has mentioned before in this call, we do see signs of EVLP activity recovery as we have entered into the fourth quarter.

Year-to-date, net sales are SEK 586 million, representing also 6% in organic growth, excluding heart trial revenue. And in the following quarters, we will continue to emphasize the impact of this trial related revenue to provide a clearer picture of the progress of our current business for you all.

Total gross margin in Q3 and year-to-date were in line with last year, 75% and 74%, respectively, which we are pleased with given the unfavorable currency effect on sales in 2025 from the weakened U.S. dollar.

Throughout '25, we have maintained a strong focus on operating expenses, although the organization has grown with new talent and further recruitment, the associated costs were offset by disciplined cost management. And as a result, OpEx was in Q3 this year, 2% less than last year, as an example. Adjusted EBIT in Q3 was 9% and adjusted EBITDA was 19%.

Moving over to the respective business areas, starting off with Thoracic. So sales were SEK 115 million. Organic growth was negative, minus 12%, and excluding heart trial revenue, the organic growth was minus 4%.

There are two main reasons for the drop in organic growth this quarter. So first of all, less machine sales, XPS sales versus last year and also lower EVLP activity, as I've mentioned, at a few higher volume customers.

We have started to see signs of increased EVLP activity in September-October, and we believe in a gradual ramp-up at current customers over the next 5 quarters.

Gross margin in Q3 was phenomenal, 89%, positively impacted by product mix. As an example, our global PERFADEX sales grew 17%, and this is the product with our highest margin. And we also have the positive effect of not having any XPS machine sales this year.

When it comes to heart, sales were SEK 10 million in Q3 versus SEK 19 million last year. Worth repeating, last year included significant trial revenue, which makes the comparable numbers irrelevant. We will start to see more and more revenue from the CAP study as patient enrollment continues. In Q3, 4 patients were transplanted by one center, and the majority of Q3 heart sales came from Australia, very strong, SEK 8 million.

I get some reports, operator, that there are some issues with the sound, especially if you are viewing this conference from the webcast. So could you please look into that? And I will continue in the meantime.

Abdominal. So Abdominal performed a record quarter. It was the best quarter in history for us, showing strong performance both in liver and kidney. Net sales, SEK 55 million, translating to an organic growth of 47%. Year-to-date, the organic growth is 31%.

Liver sales grew 34% in local currencies, and we're pleased to see that throughout the year, we have successfully expanded and grown our business in larger markets such as Italy, DACH and U.K., which are big markets and will be very important for us in the future. Kidney sales increased 79% versus last year and 49% excluding machine sales, and we saw double-digit growth in both Europe and the U.S. So once again, a very strong quarter for Abdominal.

Services. I think most importantly, Christoffer has already shared what we have done, what actions we have taken in the quarter that will lead us to growth in 2026. But from a financial perspective, the quarter was soft. We see good contribution from FlowHawk, our latest acquisition, who added 17% of growth in the quarter. But in terms of the recovery business, we expect to see improvements starting next year.

So let's switch to focus to EBITDA and cash flow. EBITDA came in at 19% in Q3 and rolling 12 months we're currently at 19% as well. As mentioned, throughout 2025 we maintained a strong focus on operating expenses. And in the following quarters, we will continue to manage our operating expenses with discipline, ensuring resources are directed towards initiatives that drive clear commercial returns in the short term.

Our operations, R&D and administrative functions are well scaled for current ambitions, allowing us to invest selectively. We are a growth company. We're built on a scalable business model and strong gross margins. And as we grow, increased profitability will follow.

And my final slide, cash flow, so we ended the third quarter with SEK 280 million in cash and an additional SEK 120 million available under our credit facility, bringing total available funds to SEK 400 million.

Operating cash flow was positive SEK 21 million, which is encouraging given the ongoing buildup of inventory during the transition of our new Sweden-based supply chain. While our revolving credit facility remains in place to support working capital needs, our positive operating cash flow meant no additional drawdowns were needed in Q3.

Cash flow from investments amounted to minus SEK 61 million, resulting in a total cash flow of SEK 44 million for the quarter.

As Christoffer alluded to, during the summer, we implemented strict cost discipline in response to the temporary slowdown in lung sales and the delayed heart regulatory approval. Combined with the completion of important CapEx investments made in 2025, we now approach '26 with a cost base well in line with both our financial resources and our growth outlook.

And with those final remarks on cash flow, I will hand back over to you again, Christoffer. Thank you.

Thank you so much. I don't know if people hear me. I will try to continue to talk on outlook, and we turn to Page 27. So that's the outlook for this and next year. To start with, we continue to work close to competent authorities in Europe with the aim to obtain a CE-mark for heart, that is priority number one.

We will also have a clear priority on -- with the recent reorganization and new partnerships in the United States, we will focus on increasing EVLP adoption through a combination of service models and staying close to customers. In parallel, we will increase our service offering to better tail customer needs, especially offering NRP procurement from an increased footprint in the United States.

Liver Assist in Europe saves hundreds of lives every quarter. We will support clinicians to increase that number through this year and next year. And lastly, in the U.S., we will prepare the heart regulatory file for submission to the FDA. And in parallel, we will strengthen the U.S. field force to enable a successful heart launch and enable a strong lung and kidney business until we see that heart launch.

And going over to Slide 28, which is the long-term outlook, and it's a repetition from all the quarterly calls. But we have seen a demand of 10x of today's supply. We also see a sales value of machine perfusion that is approximately 10x versus static cold perfusion.

Machine perfusion and service model have proven to increase the number of organs to be used for transplantation, especially in the fast-growing DCD pool; and the main growth driver of superior clinical result for machine perfusion. And the fact that service model reduce complexity and time for the transplant clinics.

Hence, machine perfusion and service models on normal and DCD growth will drive growth in the near future. And so in conclusion, we see a long-term case that is intact.

XVIVO has a unique and proven product platform. We are committed to execute our strategy to one day accomplish that no one will die waiting for an organ.

And with that, we turn to Page 29. We hope that you still hear us and that we can hear your question. Thank you for listening. And with that, we open up the lines for questions.

[Operator Instructions] The next question comes from Simon Larsson from Danske Bank.

First question from my end on the lung business and the sequential dynamic that you're describing here. If I'm understand you correctly, there was no destocking in the quarter. Should we view that as customers having fully burned through their stock at this point? That's the first question.

And then the second one relates sort of to the communication around your confidence in a stronger Q4. Is this growth coming predominantly from the 3 new accounts that just went live here? Or is it something else that you're seeing for Q4 lung particularly?

Thank you so much for your questions, Simon. To start with, I would say, normalized stock level is probably a better word regarding what we know is that we saw no signs of destocking this quarter. So -- and what from we heard, it's normalized stock levels that's -- that all we can conclude.

In terms of going into Q4, it's anecdotal, but we -- and it's not the full picture, but what we have seen is that waitlists have started to build up and those high-performing clinics, which we've seen a higher activity in the first 3 weeks in October in some clinics than we have seen in all of September. So it's anecdotal.

But we feel that it's talking to larger clinics in the U.S., we feel that they are more positive now than we have seen at the beginning or especially Q3-Q4. But we don't know where the market growth will go to be truly honest, that's something we have to see at the end of Q4.

Makes sense. Maybe staying on lung for one more question. Do you expect any type of impact on the U.S. EVLP business from TransMedics and their next-generation OCS lung trial? From what I understand, the recruitment will potentially start here in Q4, and it's a pretty big scope of lungs enroll that they are aiming for anyways. So what do you hear from your customers in the U.S., are they going to participate, et cetera? And what do you hear?

To be truly honest, we heard very little from customers regarding the trial. We heard more on the heart side, to be truly honest. It might have an impact. It is to be seen. We don't know that yet.

Typically, what we have seen earlier is that an increased interest in machine perfusion will hopefully also lead or has historically at least led to an increased activity as well. So the market has grown further. So it's to be seen. It would be speculative. But we haven't heard -- I haven't heard from one lung customer that they will participate at this stage.

Okay. Sounds reassuring. The final one from my end on liver. Obviously, you're taking sort of a strategic review here of the go-to sort of pathway forward for the liver trial in the U.S. Maybe sort of provide -- and, of course, you can't really maybe comment at this point, but maybe a 510(k) pathway could be sort of, something that you're looking into. Is that correct way of thinking about this?

Yes. I mean there are three main pathways to enter the U.S. market is 510(k) -- 510(k), de novo, PMA and -- typically. So we will investigate and have a dialogue together with the FDA what is the best pathway forward, also talking to our customers what is the most preferred. If we will find that a faster process is possible, we would, in dialogue with customers, decide on way forward. We'll have to come back later when we know more. So we decided today that we owe it to ourselves, we owe it to our patients and our customers to at least investigate this before we walk ahead.

Yes. So it's not possible at this point to say anything about how this could affect sort of time to market or potential pricing? It's too early, I assume.

Correct. It's too early at this stage to know that.

The next question comes from Ulrik Trattner from DNB Carnegie.

And a few questions on my end and potentially starting off where we ended last question there on liver. And just assuming -- now just assuming a 510(k) route, which would be faster, obviously, for you going to market. This is a similar route of you in kidney. But are you seeing a pitfall of going down such a route with not having a sort of U.S. clinical data on the product given sort of the anecdotal evidence that patients or clinics have been reluctant to adopt your device prior to having real U.S. data?

Yes. I mean the straight answer to that question is yes. I mean, we learned through experience that we need U.S. data either way. So no another pathway. We need solid U.S. data to be able to convince U.S. clinicians and OPOs. So that's correct.

And if we were to move to the next regulatory filing of heart study results could be announced Q2 '26. And I assume you then aim to file directly and then a 90-day sort of filing process for 510 -- for approval. So that would assume the heart product on the U.S. market by Q4 of next year. Is that a fair assumption?

No. And the reason is I expect there to be an expert panel meeting that would add at least 180 days because they have to call for the panel, et cetera. That is our expectation. But this is what I expect. So we don't know for sure. But I would expect this being first of kind and the groundbreaking technology we are putting into our regulatory timelines that there will be expert the panel review from -- for the heart technology. So there will probably be a longer time line than you said due to this reason.

So similar to that of the XPS system, sort of.

Yes. Which is also groundbreaking and changed the paradigm of lung transplantation and now we aim to change the paradigm of heart. So then we assume that the FDA want the second opinion. But we'll come back when we know more, Ulrik.

And just on the Continued Access Program updates where you have activated a few centers. Just to clarify, you have approval for 60 transplantations to be performed and then you can renew that. Is your estimation that you will do 60 transplants over -- like including Q3, the next 3 quarters? Or how should we view that? Or is there some misinterpretation on my end there?

We see that, that once they get started they get easily used and addicted to the heart technology. So that estimation would depend, of course, how many we get from activated to actually including patients, and we saw that we have one clinic now doing 9 in a very short time frame. But our estimation is that we will get more clinics in to be active in the continuous access protocol, and that will hence lead to a fairly fast inclusion.

We knew from the original PRESERVE study that it took 9 months for the study to be up and running and fully up and running, so to say. So we don't know. And also to be clear, it's always up to the FDA if they want to prolong a continuous access protocol. But seeing the interest from our clinicians, I hope that the FDA want to accommodate, but I want to be clear that it's their choice and not our choice.

Sure. And on TransMedics running another sort of U.S. clinical heart trial, is there any sort of competition among patients or this potentially would slow down number of patients that are actually running your heart device?

The estimation we see now is no. I mean, 60 patients and hopefully prolonged are very few patients considering the potential of the XVIVO heart technology. So I would say that the cap on the number of patients will be the defining factor on how many we can include into the continuous access protocol and not so much what competition are doing or anything else.

And just to clarify as well, are you allowed under the CAP program to combine your heart device with NRP?

Yes, we were allowed also in the original PRESERVE study, including 141 patients, we were allowed to include any extended criteria heart, which is the DCD heart. So we included direct procurement, we included NRP from DCD and long preservation time and other reasons for any heart to be extended criteria.

And last question on my end and potentially the most exciting one, at least what I think. These perfusion technicians, 170-plus, can you give us some more granularity on what this means? Where are they located? Is this a replication of what Lung Bioengineering is doing? How will you support clinics?

And we've also heard comments here in the last few quarters on a lot of transplantation clinics taking the XPS program in-house and kind of builds to your comment on high interest of starting up new EVLP programs. But if you can provide us some more granularity on this, that would be great.

Yes. Great. Great. No, it's not really Lung Bioengineering having a fantastic service, is not a replication of that just to be clear. But 2 things have happened this year. One is the reduction of NIH grants in the beginning of the year, which has -- there is a resource -- lack of resources in many clinics, especially academic larger hospitals. That has happened.

The other thing is that TA-NRP has grown significantly this year compared to previous year, which has damaged a lot of lungs. So this has led to 2 things. One, the interest for clinicians or bigger clinics to start their own EVLP program to actually take care of those lungs that are coming from TNRP or otherwise being marginal or extended criteria.

And we also see an increasing interest from OPOs that they have got the contact from their -- yes, nearby clinics and said, can you perform EVLP on all those lungs. Now we are really happy with the hearts when we do TA-NRP, but the lungs are potentially destroyed that we don't know. So those things have happened.

In parallel, we have got more and more questions from our organ recovery service that we like you, but can you please include NRP into your service model? So for that reason, we scanned the market and wanted to find a great partner. And I think we found the best of the best with -- they have 175 perfusionists on the roster strategically placed, very much in line with what you saw on one of the slides when we increased our footprint from our organ recovery service.

And they saw the same need as we did, but from the other side that they saw an increasing need for EVLP, they saw an increased need for NRP. But they were lacking products and surgeons. So it's really a great marriage if we get this to work. It's a perfect match where we can fulfill our customer needs with a high level of quality and a high level of customized service.

So we can support both OPOs who are in need of improving their program and improving the number of allocated lungs, and we can support clinicians with NRP going out, so they don't have to take their really, really good surgeons that should actually do transplants. They don't need to send them out in the middle of the night to do NRP, et cetera.

So we hope that this will be -- this is the start of something that can become great, and we hope that it will become as good as it promise right now to be over time.

And just one follow-up there. Are these 175 perfusionists, are they lung specialized? Or are these agnostic to both Thoracic and Abdominal? Because I know sort of the most sort of pressing service here going forward will most likely be in heart in order to expand your footprint in the U.S.

True. No, they are typically agnostic to organ. I mean, they are specialized in perfusion and very good in perfusion of all organs, so to say. It should be mentioned that today out of 175, I think it's 75 are fully trained on NRP. And we are, as we speaking, training as many as possible on EVLP. So we have -- so everyone should also be trained on EVLP.

The next question comes from Jakob Lembke from SEB.

Yes. First question on heart and the process to get it approved in Europe. If you can give an update sort of is the file at review anywhere right now or is the ball in your court or what can you say?

Right now, we are in, let's call it dialogue phase to fully understand what needs to be amended/improved in terms of evidence. So we are trying to fully understand together with regulatory authorities in Europe. So that's where we are right now.

But you still feel fine about the previously communicated time line?

Yes. That has not changed. Until further knowledge it has not changed.

And then if you can also give some more details about the U.S. approval process for heart, sort of what are the milestones or sort of key dates where you need to submit to the FDA and so on in order to sort of assume the time line where you are approved in the beginning of 2027?

I think we -- to start with, we need to finalize the clinical file, which will be important. In parallel, we are preparing the animal file and product file to hand in aiming in Q2 next year. Then the time line will be harder to predict from our side, and we need to come back with an update on more expected time lines after that because it depends very much on the route forward that the FDA chooses. So it's partly out of our hands.

But they need to review the documents and make sure that they are on par for calling to an expert panel meeting, then they need to call for expert panel meeting and it has to go through that, et cetera. So we estimate from handing in the file that there are at least 12 months process, but that is an estimate from our side, and we need to come back with more granular data when we hear more back from the expectation on process forward from the FDA. But at this stage, it is our estimation and not something the FDA has told us. I want to be clear with that.

But you will hand everything in to them by Q2 2026?

Yes. That is our aim. And I will come back if there's any change to that time line, but I will come back with more guidance if we change that. But that's our internal time line at this moment.

And then just a final question on lung and the EVLP sales in the quarter. If you just could elaborate sort of the trends across the different parts of the business, speaking of the large U.S. customer, other U.S. customers and rest of world?

Especially for Q3 or more overall?

Yes. What you saw here in Q3?

In Q3, we saw, in general, a quite weak quarter. We saw a few customers who had lower EVLP activities, very few of them, so to say. I think it's only 2 that dragged down the overall number. As I said earlier, going forward, we see more customers coming on board with especially the new ones from the first half of the year are now trained and at least 3 out of 4 are fully trained and up and running. So we see -- and we see that from a few that were a little bit lower in Q3, we can see that they have come back now in early October. So that's the picture we see right now at least.

I see we are 1 minute past 3:00, so I don't know how many questions we have.

The next question comes from Maria Vara from Stifel.

I'll be very quick considering, yes, it's already a long call. All right, so maybe just a quick follow-up on the rate of enrollment and activation of the centers within the CAP program. You mentioned that it took 9 months to get up and running all the centers involved in the pivotal study. But I was wondering why it's taking in a way some time to activate the centers from the CAP? My feeling is like some of them should be part of the PRESERVE study. Could you maybe clarify if that's not the case? And if there is any hurdles that you're seeing in terms of the activation, whether these centers already have, for example, TransMedics technology? And what is the overall demand there? What's happening?

Thank you. Great question. I mean many of them, yes, they were part of the PRESERVE trial. So that is correct. I think, unfortunately, the continuous access protocol is viewed as a completely new trial. And what has taken time is mainly after reduction of resources, especially going into research at the beginning of the year, it has taken longer time than we earlier anticipated to get through the red tape in each and every clinic. And everybody has been -- when I talk to surgeons, they are really eager to start. But, let's say, hospital system behind them has had a challenging time adjusting to the new level of resources, especially when it comes to research, which has hampered the uptakes, so to say.

But we do expect that -- we do feel there is a great interest, and we do expect that, that will translate over time into -- everybody has to be retrained and recertified, et cetera. But over time that will translate into more and more clinics coming up and running also into the continuous access protocol.

Okay. That makes sense. And in terms of the clinical data, do you plan to use this data from the CAP program into the filing of the FDA? Or that's something that is not on your mind at this moment?

Yes. I mean, as far as continuous access protocol, let's say, the 1-year follow-up will not be that easy to accommodate to the FDA, but the data will absolutely be used from a safety data point. So it will be used as confirming what we saw in the original trial PRESERVE.

All right, that's clear. And maybe just a last question on the liver and redesigning the regulatory pathway. I'm aware that there hasn't been any specific guidance on time to market, but obviously, this will shift things. And based on my estimates, we could have expected some kind of launch maybe in '27. However, that might seem unlikely, even though you could have another route, which could be quicker. Any thoughts here that you could share on time to market for liver?

I think to start with, yes, that sounds ambitious. I agree with that. At this stage we don't know, to be very clear and honest. But as soon as we do know, we will communicate with everyone, preferably during one of those calls. And hopefully, we can conclude with the FDA or at least get some guidance from the FDA before the Q4 report in end of January when we release that one. Of course, with the U.S. administration being in shutdown mode, it's hard to predict if we can accommodate that time line, but we will do our best from our side at least.

I hand the conference back to the speakers for any closing comments.

Thank you so much for listening in to us today during the Q3 report, and I will just quickly go through to the last page, yes. And I hope to see you for the year-end report 2025 that we will have the conference call on January 27, 2026, and you also see the other interim reports for next year on your screen in front of you.

But thank you very much for listening in. Thank you for good questions, and see you in approximately 3 months.