Xvivo Perfusion AB (publ)

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.

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.

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.

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.

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.

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.