Welcome to XVIVO Q3 Report for 2025. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answers session, participants are able to ask questions by dialing 5 on their telephone keypad. Now I will hand the conference over to CEO Christoffer Rosenblad and CFO Kristoffer Nordström. Please go ahead.
Thank you so much and good morning and good afternoon everyone and especially welcome to XVIVO's Earnings Call for the Q3 of 2025.
First, a quick introduction of today's presenters. That's me, Christoffer Rosenblad, CEO, calling in from Gothenburg, Sweden, and we also have Kristoffer Nordström, 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 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 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 three out of the four clinics that acquired XPS in the United States during H1 or half year one 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 October at least started better than Q3 in terms of Lung transplants and in terms of EVLPs to support further Lung transplants. If you compare to w hat we saw in Q3.
Going into our abdominal segment, Liver and Europe are now entering the majority market segments with penetrations above 50% in many European countries. The main tasks 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 corpus 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 US 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.
If we go over to services, we have stated it 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 five quarters to become a preferred partner to the transplant teams in the United States.
And I also want to again state, as I said earlier, that the service initiative is 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 Partner presentation.
This slide Q3 shows again that XVIVO has 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 number four, which is the first nine months at a glance, and we chose a similar picture to the Q3 slide, gross margin could have stayed. 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 US OCS revenue.
In terms of gross margins, I said before that we plan to improve abdominal gross margin to 70% at the latest in 2027 or when we reach economies of scale in production. You will hear more about gross margin and 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 the Heart Assist.
The CAP in the U.S. is now up and running and we have six 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 Hearts 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 it's also a great product for DBD Hearts.
And I think with that results coming out hopefully next year and the Australian experience, we see 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 timelines 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 timelines. Agreed. The production capacity projects for example where we invest to scale up volumes and to ramp up the daily volumes for disposables are running in line with communicated timelines. The full-scale production of the perfusion machines for Heart, Liver and kidney will be extremely important to capture future growth potential for all three 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 the opportunity to get a Heart transplant thanks to the innovative ex vivo Heart technology. And that's what we work on every day to make sure that those patients actually survive. 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 action towards, at this stage, one underperforming OPO. I listened into 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 number seven 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%-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 transplants 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 manifold.
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 this year compared to earlier. And we'll also come back to how we want to improve our service strategy to reduce stress and lack of resources at both clinics and OPOs.
With that we can continue to stay in the U.S. but go to Slide 8.
To paint a picture 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 transplants using EVLP with XPS as their solutions.
For Q3, we can start to conclude that we didn't identify any destocking. We continue to see an increasing interest to start EVLP programs with XPS and, as stated earlier, three out of four of the new accounts that bought 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 market and we acknowledge that there is a resource constraint, we entered into partnership during quarter three with a prestigious perfusionist company. By doing so we 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 U.S. 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 we show gradual impact during the next five 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. 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.
Our Lung Masterclass 2025.
It was a great pleasure for us to welcome the best of the best in Lung transplantation to the 2025 edition. 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 takeaways from me was that many clinics have experienced a tough 2025 with the lack of resources and in some cases lower rating matching of donor organ patient 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 wait list looks a lot better going into Q4 than they did up until Q3.
And with that we go over to slide.
Just have a snapshot of the U.S. CAP study.
The PRESERRVE 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 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 their Continued Access Protocol so we can strengthen our regulatory function file that we aim to hand in to the FDA during the next year.
We can also just briefly state on the preserved status that we had last patient in the original trial, so not the Continued Access Protocols. November last year, we will have 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 number 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 three 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 2023, three to end of Q3, six and we expect that end of Q4 will be seven active hubs on the east coast or east of the Mississippi.
As I stated earlier, we closed the 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 has been asked for, and now we can finally deliver on it. Number 3, we had 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 transport 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.
With that, we can go over to Slide 12 and we leave the United States and we go over to Europe, which we have consolidated into one slide. 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.
Continued strong growth for Liver in Europe. Q3, it was similar to the previous quarter but plus 31%. We continue to add new accounts every quarter, we continue to work on reimbursement, etc. 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 you can note as I said earlier, customers that are using the products are pleased with both the performance of the product but especially how the kidney perform after transplant.
But we have a lower market penetration rate, and we're, it's more account-by-account basis where we have to, let's say, fight to increase penetration rates, and we have to convince kidneys by clinic. But once they have tried the Kidney Assist Transport, they are very convinced of the product and actually increase usage over time. The Lung business in Europe grew mainly with EVLP adoption in the UK 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 Assist.
If we benchmark Australia, it's clear that DCD Heart Assist has a very good position in the transplant system and we expect European heart penetrations 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.
Our Lung kidney portfolio has obtained regulatory approval in all key markets.
And Liver Assist is approved in all key markets.
For Heart we are awaiting, as we know, approval for CE mark for all core markets.
And the timeline has. There are some shifts and I'll come back to those later in the presentation, but the main timeline has not changed. Besides the pending CE mark in Europe, which we press released during the quarter.
In U.S. we are working very hard to make sure that the filing is approval-ready as soon as possible for the Liver we have now.
Obtain everything we need, but I will come back later to the decision we have taken during the quarter regarding the Liver U.S. trial.
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.
Heart trial in Europe is not only the first trial 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 one year. If you compare that to if you don't have severe PGD, you have only a 5% mortality risk during the first year.
This was in our trial directly translated to six patients more saved or life saved during up to one year.
Which is the first time we can see those direct links between actually perfusion of an organ and better outcome within one year. And if we would extrapolate this to the transplants we are doing on standard criteria Heart today in the world, it would translate into more than 400 lives saved every year. Only for the standard criteria Heart, 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, etc.
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 Hearts.
To strengthen the evidence and simplify the DCD process, we have, as I said, the Benelux DCD Direct Procurement Study progress study that we are now under inclusion of patients and it's progressing fine. The study aims include for the patient, 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 ex vivo 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 can not only, as we have seen in Australia, change the paradigm for DCD 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. And as you know, we previously reported that LiverAssist has been granted Breakthrough Device designation by the FDA. We have an approved IB and can start a trial, we have CMS funding approved etc. And we could have started the trial in Q3. However, the company has decided to temporarily pause activities for Liver PMA process, investigate if 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.
Approve faster and hence we can see the fantastic results we have seen in Europe, also in the U.S.
With that I go to Slide 19 and hand over to our CFO Kristoffer Nordström, 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 represent a gradual improvement from Q2 organic growth -1% but in reality organic growth was +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 these 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 2025 we have maintained a strong focus on operating expenses. Although the organization has grown with new talent and further recruitments, the associated costs were offset by 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 Flowhawk trial revenue the organic growth was minus 4%.
There are two main reasons for the drop in organic growth this quarter. 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 five quarters.
Gross margin in Q3 was phenomenal, 89% positively impacted by product mix. As an example, our global solution 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 four patients were transplanted by one center and the majority of Q3 Heart sales came from Australia. Very strong SEK eight million sales. I get some reports, operator, that there are some issues with the sound, especially if you are viewing this conference from the webcast.
Could you please look into that.
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% machine sales and we saw double digit growth in both Europe and the U.S.
So, once again, a very strong quarter for XVIVO.
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 the focus to EBITDA and cash.
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 toward 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 120 million available under our credit facility, bringing total available funds to 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 about outlook, and we turn to Page 27, so that's the outlook for this next year.
To start with, we continue to work closely with competent authorities in Europe with 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 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 tailor 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 times 10 of today's supply. We also see a sales value of machine perfusion that is approximately times 10 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 from 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 DBD growth will drive growth in the near future, and so in conclusion we see a long-term case that is intact.
Ex vivo 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.
If you wish to ask a question.
Please dial key five on your telephone keypad to enter the queue.
If you wish to withdraw your question.
Please dial on your telephone keypad.
The next question comes from Simon Larsen from Danske Bank.
Please go ahead.
Good afternoon gentlemen. First question from my end on the Lung business and the sequential dynamic that you're describing here, if I'm understanding 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 three hubs that just went live here or is it something else that you're seeing for Q4 Lung particularly? Thank you.
Thank you so much for your question, Simon. To start with, I would say normalize the stock level is probably a better word regarding what we know is that we saw no signs of destocking this quarter. What we've heard, it's normalized stock levels. That conclusion in terms of going into Q4 is anecdotal, but it's not the full picture, but what we have seen is that wait lists have started to build up and those high-performing clinics which we've seen a higher activity in the first three weeks in October in some clinics than we have seen in all of September, but we feel that.
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 whether market growth will go, to be truly honest. That's something we have to see at the end of Q4.
Yeah.
Oh yeah, makes sense, makes sense. Maybe staying online for one more question. Do you expect any 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 quite a big scope Lungs and row that they are aiming for anyways. So have you sort of what do you hear from your customers in the U.S. or are they going to participate, et cetera, what do you hear?
To be truly honest, we heard very little from customers regarding the trial. We heard more on.
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 would be speculative, but I haven't heard from one land 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 provided 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?
Yeah. I mean there are three main pathways to enter the U.S. market is 510(k), PMA and typically so we really 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 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 barge ahead.
Yeah.
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.
Okay.
Okay. Very good.
Thank you so much.
The next question comes from Ulrik Trattner from Carnegie. Please go ahead.
Thank you very much.
And a few questions on my end and potentially starting off where we ended last question. They're on Liver. And just assuming, now just assuming, a 510(k) route which would be faster obviously for you going to market. This is the 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, giving 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 matter pathway, we need solid U.S. data to be able to convince.
U.S. clinicians and opioids.
So that's correct. Okay, great.
And if we were to move to the next regulatory filing, Heart study results could be announced Q2 2026 and I assume you then aim to file directly and then a 90-day sort of filing process for 510(k) 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.
We don't know for sure, but I would expect it being first of kind and the groundbreaking technology.
We are putting into our regular timelines that there will be.
The plan and review from.
For the Heart technology, so there will probably be a longer timeline than you said, due to this reason.
Okay, great.
Yes.
So similar to that of the XPS system.
Yes, which is also groundbreaking and change the paradigm of Lung transplantation and now we aim to change the paradigm of Heart so then we assume that.
If they want to take an opinion, we'll come back when we know more.
And just on the continued access program update 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 three quarters or how should we view that? Or is there some misinterpretation on my end there?
We see 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 nine in a very short time frame.
But our estimation is that we will get more clinics in to be active in the Continued Access Protocol and that will hence lead to fairly fast inclusion. We knew from the original PRESERVE study that it took nine 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 Continued Access Protocol, but seeing the interest from our clinicians, I hope that the FDA won't accommodate.
But I want to be clear that.
It's their choice and not our choice.
Sure.
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 run on your Heart device?
The estimation we see now is no. I mean 60 patients.
And hopefully prolong our 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 Continued 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 Assist with NRP?
Yes, we were allowed also in the original preserve study, including 141 patients, we were allowed to include any extended criteria Heart versus 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.
Okay, great.
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? It is 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 transplant 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.
Yeah, great, great. No, it's not really language. Engineering having a fantastic service is not a replication of that. Just to be clear. But two things have happened this year. One is the reduction of NIH grants in the beginning of the year which has. There is a 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 two 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 NRP or otherwise being marginal or extended criteria. And we also see an increasing interest from OPOs that they have got contact from their.
Nearby clinics and said, "Can you perform EVLP on all those Lungs?" Now we are really happy with the Hearts when we do NRP, but the Lungs are potentially destroyed and we don't know. So those things have happened in parallel. We have gotten more and more questions from our organ recovery service that, you know, we like you but can you please include NRP into 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. 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 OPO 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. 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 promised 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 the most pressing service here going forward will most likely be in Heart in order to expand your footprint in the U.S.
Terumo, 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 speak, training as many as possible on EVLP.
We have.
Everyone should also be trained on EVLP.
Okay, great.
I will get back into the queue.
Thanks for taking my questions.
Thank you so much.
The next question comes from Jakob Lembke from SEB. Please go ahead.
Yes, hi. 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 it both in your?
Court, or what can you say?
Right now, we are in, let's call it, dialogue phase to fully understand what need to be.
Amended.
Improved in terms of evidence. So we are trying to fully understand together.
With regulatory authorities in Europe. That's where we are right now.
Okay, but you still feel fine about the previously communicated timeline?
Yeah, that has not changed. Until further knowledge, it has not changed.
Okay.
And then, if you can also give some more details about the U.S. approval process for Heart?
What are the milestones or sort?
Of key dates we need to submit to the FDA and so on in order to sort of receive the time that we are approved in the beginning of 2027?
I think we, to start with, we need to find out 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 timeline will be harder to predict from our side and we need to come back with an update on more expected timelines 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, etc. 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.
At this stage it is our estimation and not something the FDA has told us. I want to be clear with that.
Okay, but you will hand everything in to them by Q2 2026.
Yeah, that is our aim. And I will come back if there's any change to that timeline. But I will come back with.
More guidance if we change that. But that's our internal time at this moment.
Okay.
And then just a final question on Lung in the episodes in the quarter, if you 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 the rest of the.
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 two that drag down the overall number.
As I said earlier, going forward, we see.
More customers coming on board, especially the new ones from the first half of the year, are now trained and at least three out of four are fully trained and running.
We see that from.
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.
Okay, that's all for me today. Thank you very much.
Thank you so much.
I see we are one minute past three, so I don't know how many questions we have.
The next question comes from Maria Vara from Stifel. Please go ahead.
Hi, good afternoon. I'll be very quick considering. Yeah, it's already a long call, so maybe just a quick follow up on the rate of enrollment and activation of the centers within the CAP program. You know, you mentioned that it took nine 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 previous 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.
Thank you.
Great question. I mean, many of them, yeah, they were part of the PRESERVE trial, so that is correct. I think, unfortunately, the Continued 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 Continued Access Protocol.
Okay, yeah, 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.
I mean, as far as Continued Access Protocol.
Let's say the one-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.
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 2027. 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 timeline, but we will do our best from our side at least.
Okay, thank you. That's all from my side.
Thank you so much.
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 would 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 27th, 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 and thank you for good questions and see you in approximately three months.