XVIVO.STXVIVO.STSTO
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Operator: Welcome to XVIVO Q4 Report for 2025. [Operator Instructions] Now I will hand the conference over to CEO, Christoffer Rosenblad; and CFO, Kristoffer Nordstrom. Please go ahead.
Christoffer Rosenblad: Thank you so much. Good morning and good afternoon, and most of all, welcome to XVIVO's Earnings Call for the Fourth Quarter as well as for the Full Year of 2025. And with that, we turn over to Slide 2. It's just the 2 presenters that were introduced. It's me, Christoffer Rosenblad calling in from Gothenburg and the company's CFO, Kristoffer Nordstrom, calling in from Philadelphia in the United States. And with that, we can go over to Slide 3, which are the Q4 financials at a glance. The Q4 shows a 10% organic top line growth, which is equivalent to a 12% top line organic growth if we adjust for the U.S. heart trial revenue compared to Q4 last year. With recovering sales, the EBITDA recovered to healthy levels during Q4, again, showing that the revenue model is scalable. In terms of segment growth, the thoracic sales were slightly negatively affected by the lower heart study revenue compared to the same quarter last year in the United States, but positively affected by a stronger Q4 lung market, especially stronger if you compare sequentially to Q3 this year and even more so if you compare to Q2 this year. The abdominal segment shows great progress for both liver and kidney during the quarter. As stated earlier, liver in Europe has entered the majority market segment with penetration above 15% in many countries and up to 25% in core markets. The main task is to support growth with increasing resources for perfusion as well as more data for improved reimbursement level. In parallel, we are increasing the sales force footprint in Europe. While kidney, on the other hand, is still below 15% penetration in many countries, including the U.S., the main task is to win account by account. We are very, very encouraged by the positive feedback we get from our kidney customers. They see that the kidneys are in better condition after being perfused in Kidney Assist Transport compared to alternatives. And investigators will come out with clinical data proving this during 2026, which will be most important in the United States. The progress in our U.S. service business need to be drastically improved. It is a strategic investment to prepare for the heart launch, and therefore, we invest heavily for growth. We will come back later in the presentation on the actions taken and how we will execute to one day become the preferred partner in the transplant process. And with that, we can go to the next Slide 4, which is the year at a glance. The year shows a similar picture to the quarter, good and stable gross margin with continued investment in field force and scalable production structures. Sales came in at SEK 812 million with a 3% organic growth and which is then equivalent to 8% organic growth if we adjust for U.S. heart trial revenue. As we said in the last call, during the end of Q3, a cost and cash restructuring initiative was initiated to enable better resource allocation going forward. And our CFO, Kristoffer Nordstrom, will get into the details on sales, gross margin, EBITDA later in the presentation. For heart, the main hurdle is regulatory approval. Once the Heart Assist is used, the feedback is overwhelmingly positive. We continue to build evidence. We now have more than 500 patients that have been safely transplanted and also, I would say, successfully transplanted with Heart Assist. The CAP or Continuous Access Protocol in the U.S. is up and running, and we just passed the 30-patient mark included in the trial. In Australia, the heart penetration last year was -- or in '24 was approximately 30%. And we saw last year that going up to 40% for DBD heart in Australia during 2025. I'm also proud and happy to present that the Benelux DCD direct procurement study has enrolled all 40 patients. And I'm truly looking forward to another great presentation and publication that will most probably change heart transplantation and heart recovery forever. The high interest, the early very good results on DCD hearts and the Australian experience once again shows that the heart technology has the potential to change the paradigm of heart transplantation forever once it's launched. Lastly and most important to mention is that the projects are still progressing according to plan. Regulatory time line are hard to predict. We saw that this summer with the EU heart approval, especially when we come with groundbreaking innovative new technology that has the potential to change the paradigm. But both the clinical trials and development projects are progressing according to the time line agreed. For example, the production capacity project, where we invest to scale up volumes x10 of today's volume for disposables are running in line with communicated time line. The full-scale production for our disposables for heart, liver and kidney will be extremely important to capture the future growth potential for all 3 product groups. And with that, we can go into Slide #5. Let's be clear, for avoidance of doubt, we are not pleased with the performance in 2025. And that made us take fast and important step for future growth. Firstly, the EVLP business didn't grow as expected. This was partly due to slower lung market, but also because of lack of resources, especially in the U.S. field force. So now we have taken swift actions both to enable service models with partnerships and entering the OPOs as well as a larger investment into the U.S. field force. As we stated in the Q3 report, we entered into partnership for -- to enable perfusionist services. During Q4, we secured our first OPO contract. And as I stated, we have decided to invest in more feet on the ground during 2026 to enable closer customer relations with a growing number of EVLP partners. I just said that regular time line for innovative and paradigm-shifting products can be hard to predict and -- but we can take action. And we directly strengthened the team and reinforced a cost cash saving program to enable at least a healthy cash flow and at the same time, increase the focus on the heart project. For the organ recovery business, we have during the second half of '25, doubled both the hub footprint from 6 to 7 hubs and the surgeon roster to enable -- to stay closer to customers and do more recoveries at a lower cost. We also include NRP into our service offering to enable an offering that all customers actually request or almost all. We expect the fruit of this work to start to kick in during Q2 2026. And with that, we can go over to the next slide, Slide 6. And the key message is that the right actions give the right result. So with actions taken in the second half of '25 and the recovering lung market in the U.S., we did deliver for the full year of '25 organic growth, a stable EBITDA and actually the first ever positive cash flow in a quarter during Q4. And with that, we leave the introduction and we go into 2025 highlights. The Slide 7 is a dividing slide and the highlights of the year are in the two following Slides 8 and 9. So let's start with Slide 8 and the part 1 of highlights. Firstly, the reason we are here that XVIVO has enabled approximately 13,000 life-saving transplants during 2025, giving patients a chance to better life and in many cases, a new life. This is approximately 1,000 patients more than last year. I want to state this is something that I am and the entire XVIVO team are very proud of. And I want to thank you as investors that has enabled investment into truly innovative life-saving technology that has the potential to, in the future, change the life for hundreds of thousands of patients. And turning into our heart technology and the milestone we passed, early in the year, we presented a promising 12-month data follow-up from the European trial at ISHLT. It was the first and so far only superiority trial in thorax transplantation. And more importantly, it was the first trial to show a direct link between perfusion device and severe PGD and patient 1-year survival, which is a milestone within our field and it had never been done before. And I also never seen earlier in my life or encountered the extreme improvement we saw with a 76% risk reduction of severe PGD with very, very high statistical significance. And looking back at the year, we achieved several important milestones for heart, the European DCD trial completed, the CAP study up and running. And as I stated, 40% of DBD hearts in Australia has been preserved with XVIVO Heart Assist during 2025, showing that this is a technology that solves a real problem for patients and doctors in transplantation. And with that, we can go over to Slide 9, which is the second part of yearly highlights. In the U.S., we launched the first of its kind EVLP-OPO model through a perfusion partnership. Through the same partnership, we can now also offer NRP through our Organ Recovery service. For our liver technology, where we are European market leaders, we now have reached 25% penetration in core EU markets. Very, very encouraging results were also published from a 5-year follow-up of a randomized controlled trial for DHOPE DCD Liver. During the year, we -- another milestone was the launch of XVIVO Insight that enables remote monitoring for both Liver Assist and Kidney Assist. And finally, when talking about those 2 products, Liver Assist and Kidney Assist Transport are now regulatory approved in Canada. And with that, we go over to the regulatory and clinical updates. Slide 10 is a dividing slide, and then we have 4 slides taking into the update. We can turn to Slide 11, and we start with the usual overview of the status for the regulatory processes on Slide 11, as I said. The U.S. heart trial was fully included in record time, and we now passed the 12-month patient follow-up. Next milestones are to present the U.S. study at ISHLT in late April and prepare the technical and preclinical files for submission together with the clinical file to the FDA. We estimate to handing the files to the FDA during Q2. In parallel, we continue to build the clinical file with the help of the continuous access protocol in the United States. In Europe, the CE marking process continues. As stated earlier, the Heart Box and disposable part of the product is already CE marked. The solution has passed the EMA consultation, and we are now waiting for consultation at the sub-medical agency in Europe. It is estimated that we will complement the file and hand in for consultation by our notified body at the end of February this year. At this moment, we have no other update on the time line than what has previously been communicated by a company. But clear is that once approved, fully approved, we are ready to launch the product as we have a launch plan, it's ready to go, staff is recruited and the interest is, to say the least, extremely high from clinics in Europe. The European heart clinics are suffering badly from lack of alternatives to XVIVO Heart Assist. And for that reason, and in parallel, we are working with local agency to obtain compassionate use in chosen European markets prior to approval. And in Australia, New Zealand, the product is soon becoming gold standard, now at 40%. I believe that number will increase over time. But the regulatory approval will mark in Europe and to be clear, the same will apply to Canada. Regarding liver, I will come back to an update in the following slides. And with that, we can -- before we go into liver, we just have a short recap of heart on Slide 12. In the U.S., we also see an increasing interest to save patient lives and more and more clinics realize that the XVIVO Heart technology is the way to do that. We today have 10 activated clinics, of which 6 are currently enrolled patients. We recently included patient #13 to the continuous access protocol. And we are working hard to turn all activated centers into enrolling centers, and we also want to activate more centers into the trial. Right before we have included the 60th patient, we will apply with the FDA for an extension of another 60 patients to strengthen the clinical file in the U.S. And as stated earlier, we are working with the PMA process and most importantly is the presentation in -- during ISHLT of the first 141 patients in the United States. And with that, we can go to Slide 13 for a status update of the liver regulatory pathway in the U.S. We have earlier reported that the Liver Assist has been granted breakthrough device designation by the FDA. With an approved IDE and CMS funding approved, we could have started a trial in early Q3 '25. However, the company decided to temporarily pause activities for the liver PMA process to investigate if an alternative regulatory route is possible. With the recent 510(k) DeNovo approval in the U.S. for liver perfusion, we will begin a dialogue with FDA on regulatory pathways for Liver Assist. The aim is to enable patients in the U.S. a better product than what is currently approved faster than otherwise would be possible. Since we haven't had the meeting with the FDA, we don't have more information today on time line or possible route forward, but the company will inform the public and all investors of the outcome of our U.S. liver regulatory investigations latest in the Q1 report and earlier if needed. And with that, we can go to Slide 14, which is the last slide in this segment. XVIVO is the clear liver market leader in Europe with, as I stated, 25% penetration in the important markets. This success is built on excellent patient outcome, positive and documented health and hospital economics as well as the Liver Assist enabling the transplant team to have a work-life balance. Hence, they can plan liver surgery better than they could do before. In 2026, we will continue to expand the sales organization to increase penetration in Europe. In parallel, we will increase our efforts to educate the American transplant clinics on the benefits we have seen in Europe using the Liver Assist and where needed, replicate small-scale clinical trials to prove that it applies to the U.S. as well. And with that portion, we go over to Slide 15, and I hand over to our CFO, Kristoffer Nordstrom.
Kristoffer Nordstrom: Thank you, Christoffer. Yes, an overview on the P&L. So net sales in Q4, as you know, came in at SEK 226 million. The organic growth was 10% and 12%, excluding heart trial revenue in total. Sales for the full year came in at SEK 812 million, representing 3% organic growth and 8% excluding heart trial revenue. The total gross margin in Q4 decreased to 73%, primarily due to inventory write-offs related to some R&D projects where we had some overproduction, so more of an anomaly. For the full year, gross margin was more or less in line with last year, 74% versus 75%. And this was despite the unfavorable exchange rate development from a weakened U.S. dollar, as you all are aware of. Throughout the second half of 2025, we maintained a strong focus, as Christoffer mentioned, on the operating expenses. And as a result, the adjusted EBIT in Q4 was 16% and adjusted EBITDA was 25%, which is a new quarterly record for XVIVO. Full year EBIT 11% and EBITDA 20%. I will come back to our view on EBITDA in 2026 in a later slide, so bear with me. Moving over to Thoracic, our largest business area at the moment. Q4 sales were SEK 147 million. Organic growth was 9% and excluding heart trial revenue, 12%. This means that thoracic return to growth again in Q4, and the main reason was the increased EVLP sales volumes, primarily in the U.S. The EVLP disposable sales in the quarter grew 33% versus last year. Perfadex Plus sales were flat, but this was after a strong Q3 where Perfadex grew 17%. And all in all, globally, 8% Perfadex Plus growth for the full year, which means we are maintaining our market position and marketing leading position of this very profitable part of our business. The highlight of the quarter was the installation of the first XPS system to an OPO in the U.S. in collaboration with PSI, and we look forward to expand this first-of-its-kind EVLP service model to more OPOs in 2026. Another highlight was the continued progress in heart sales. So not only did we include 18% in the CAP study, but we also saw continued adoption in Australia and New Zealand, further compassionate use cases in Europe, leading to a Q4 heart sales of SEK 60 million in line with last year. Finally, gross margin, solid 85% in Q4, and this was in line with last year. Moving over to Abdominal. Here, we had yet another record quarter, proud to say we're showing strong performance in both liver and kidney. Net sales were SEK 61 million translated to an organic growth of 30% in the quarter and also 30% for the full year. Liver sales grew 36% in Q4 and 31% full year. Kidney sales grew 20% in Q4 in local currencies and 29% for the full year. So good traction here. Gross margin, as I alluded to before, in Q4 was 56% lower than last year's 67%. And the main reason for this was some year-end write-offs of R&D inventory, and we hope to see the margin return to the plus 60% levels again in 2026. So once again, a solid quarter and another strong year for XVIVO Abdominal. Our last business area, Services. Financially, it was a disappointing quarter in Q4 with sales of 18%, which was in line with Q3, representing a negative organic growth of 21%. As I stated during the last earnings call, the second half of '25 has been transitional. Over the past 6 months, we have put fundamental pieces in place that will drive growth in 2026 and be of strategic importance as we prepare for the U.S. heart launch in 2027. So with a strengthened organization and with the introduction of TA-NRP in Q1, we foresee meaningful growth in 2026. And I think we will develop more -- a better understanding of what the meaningful growth means quarter-by-quarter next year. Gross margin decreased to 25%, and this is a direct result of our investments into the surgical capacity in the second half of last year. And as we acquire new customers in 2026, this margin should improve quarter-by-quarter. Our focus for 2026 is clear and worth repetition. So for organ recovery, it's everything about returning to growth, leveraging our strength in surgical capacity and the NRP offering. And at the same time, we will prepare for the U.S. heart launch. For FlowHawk, our digital software, it's about investing in further commercial excellence, broadening our team, work on the scalability of the product and prepare for integration with XVIVO product portfolio over time. I'm very pleased about our EBITDA in Q4. We hit a new record with an EBITDA margin of 25%. And at the rolling 12 months EBITDA, we're at 20%. The main reason for this achievement was not surprisingly, the increased sales in Q4, but also the stricter cost focus that we implemented during the second half of the year. In the following quarters, we will continue to manage our operating expenses, of course, with discipline and ensure that resources are directed towards areas with the best ROIs. However, with 25% that we delivered now in Q4, that is not what we expect out of the full year in 2026 to be transparent, sorry. I mean the baseline going into 2026 is the annual EBITDA of 20%. And that -- it's from that level that we are growing for next year. And as Christoffer said, 2026, it will be a year where we will invest heavily, primarily into the U.S. commercial organization to prepare for our launches and to accelerate the momentum we see now in EVLP. I would also before we move over to cash flow, which is my last slide, I also want to comment a little bit on the challenging environment we have at the moment when it comes to the currency that is not working in our favor. So overall, if you look at XVIVO and our operations, we have an operational hedge in the fact that we -- where we foresee the majority of our growth in the short midterm is in United States, and that's also where we foresee that we will invest the larger portion of our investments over time. So however, of course, this will translate into SEK eventually in our P&L as well. So that risk we are living with today. We do not have any hedging instruments in place today, but this is something we could implement if we decide that it's the right thing to do. In 2025, the sales in U.S. dollars constituted around 55% of total sales, approximately SEK 450 million. I think the average SEK-USD ratio in '25 was 9.8%. So if we assume a 10% decrease in USD versus SEK to 8.8 in 2026, that would translate into U.S. sales equaling SEK 405 million, hence, a reduction of SEK 45 million, which is roughly 5% decrease of total sales for XVIVO versus last year. So a 10% decrease of USD would roughly translate into a 5% decrease in the global sales for next year. Roughly best estimate that would lead to a decrease of EBITDA of 2% units. So that's a risk to bear in mind when looking into 2026 that the impact of a decrease in EU will be slightly less. Final slide before I hand over to Christoffer again. I'm very proud of our cash flow in Q4. We ended the third quarter with SEK 280 million in cash. We also have our credit facility of SEK 120 million roughly. So that brings total available funds to SEK 400 million. Operating cash flow was strong, SEK 87 million. And for the first time in XVIVO history, we had a total positive cash flow of plus SEK 18 million. So we feel that we enter 2026 with a cost base well aligned with both our financial resources and our growth outlook. And with those final remarks, I will hand over to you again, Christoffer. Thank you.
Christoffer Rosenblad: Thank you so much. And with that, I will round off with the outlook for 2026 and then the longer-term outlook as I normally want to end the presentation. And if we start with the focus on 2026 on Slide 23. The key message that we will continue to build the sales force and to build on the new partnership in the U.S. to enable OPOs and clinics to recover more lungs by EVLP adoption through a combined service model and staying closer to customers. In parallel, we will increase our service offering to better tailoring customer needs, especially offering NRP procurement from an increased footprint with more available surgeons. We continue to work close with competent authorities in Europe with the aim of obtaining a CE mark for Hawk. And I'm, of course, looking forward to the presentation or many presentations on heart, but especially the U.S. heart study during ISHLT and that we -- after that, hand in the regulatory file to the FDA for submission. And lastly, in Europe, Liver Assist saves hundreds of lives every quarter, and we will support clinicians to increase that number through larger sales force, better reimbursement and more data to support them. And in many cases, service models to enable a better work-life balance for the teams. And with that, we can go over to the last slide or second to last slide 24, and it's a longer-term outlook. And I want to state this and I want to state it again that we are looking at a demand that is 10x higher than the available donated and used organs for transplantation today. And the sales value of machine perfusion is approximately 10x static cold perfusion. So the market opportunities there is approximately 100x bigger than what we see today. Machine perfusion and service models has proven to increase the number of organs to be used for transplantation, especially in the fast-growing DCD organ pool. The main growth drivers are superior clinical results for machine perfusion and the fact that service model reduced complexity and time for the transplant clinic. XVIVO has unique truly paradigm-shifting technology that are on the brink to becoming a gold standard in many fields. And I want to end this presentation with a look into the future. And you will, in the future, find yourself on an airplane. You might be seated next to the XVIVO Heart Box with a heart being transported to a patient whose life is about to change. And this patient has likely been on the waiting list for a long time with limited to no quality of life at all. And by having innovative paradigm-changing technology on the market, we will not only save this patients' life, we will also reduce the cost for the healthcare system dramatically as well as more importantly, we often forgotten in the field we are. At the same time, we have to remember there is a donor family who in their darkest moment, chooses the gift of life to someone in need. And that is what XVIVO Heart device can enable, and that is why XVIVO is here. So I hope that one day, if we continue to invest in innovation, in field force close to customers, that we can make our vision come true that nobody should die waiting for an organ. And with that, we turn to Slide 25 and open up for questions.
Operator: [Operator Instructions] The next question comes from Simon Larsson from Danske Bank.
Simon Larsson: My first question relates to the investments that you're planning [indiscernible] and at the U.S. launch of the Heart Box in '27 and the effect on profitability. So, yes, so I got it right from you, Kristoffer, we should not expect the EBITDA profitability level in a 25% range for the full year '26. Is that the correct way of viewing this?
Kristoffer Nordstrom: Exactly. So I mean, the baseline from 2025 is 20% EBITDA. And we, of course, have an ambition to grow our top line next year, but we will make very deliberate decisions on how to use that money and growth is more important than profitability, it's that way.
Simon Larsson: Yes. Okay. That makes sense. And I was also a bit curious about the lung performance here in Q4. Obviously, a strong bounce back from earlier quarters. Should we view this as some kind of baseline from which you can grow here going into '26? Or should we continue to expect some volatility maybe in sales here in the quarters ahead? Any dynamics that we should know about as we enter '26, would be helpful?
Christoffer Rosenblad: Thank you, Simon. Great question. I wish I could give a clear answer. The clear answer is when we plan into 2026, this is, yes, the baseline we plan for. When we talk to customers in the U.S., there is a sentiment that we need to grow the number of lung transplants, partly due to the OPO dynamics where the rating could improve if they improve allocation of lungs and partly because of the TA-NRP opportunity where we actually throw a lot of lungs today away unnecessarily after TA-NRP when they could go through EVLP and be used for transplantation. That being said, it's always hard looking into the future because you don't know the volatility that comes with the future. But with the knowledge we have today, that is the best expectation we can give you.
Simon Larsson: Yes. Very good. On the U.S. CAP study, just to confirm now as you're recruiting very fast, is it certain that you can extend the CAP to another 60 patients once you have recruited the first 60?
Christoffer Rosenblad: I mean nothing is certain, so to say, because it's always up to the FDA and it's their decision. What is in dialogue, we have been told that we should be able to extend it if the safety data looks encouraging. So that's what we know. But this is solely the decision of the FDA and not our decision. I just want to clarify that.
Simon Larsson: Okay. Okay. Yes. Okay. Makes sense. Final one from my end on the potential EU Heart Box approval. Do you think it could be the case that the notified body would want to see the U.S. heart data in April before making any final decisions? Or could an approval come earlier than that, that makes sense?
Christoffer Rosenblad: It's a great question. I don't have a definite answer to the question. My gut feeling is that they want to see the U.S. data beforehand. That's what I guess. Hence, I would not expect anything before presentation end of April. And also moreover, so hard to predict time line. But we work hard on our end to make sure that we can get the highest attention from notified body, et cetera. And just to clarify, actually, the Heart Box and the Heart Disposable is CE marked, so we can sell those. It's a solution that means consultation for pharmaceutical ingredients that we are waiting for.
Operator: The next question comes from Jakob Lembke from SEB.
Jakob Lembke: My first question is on EVLP development in the U.S. And I'm wondering if you could sort of elaborate on the development among different customer segments, your lodged key customer, other core customers and new customers you won recently.
Christoffer Rosenblad: Yes. We see a positive development on all customer segments in Q4, if you compare to Q3 and Q2. But we see a stronger from main customers and existing customers, so to say, who have EVLP practice up and running from the ones setting up programs, we see an increased interest, so to say, and a slight increase in sales, but we see the main impact coming from, let's say, the heavy users on EVLP. We also see an increased interest for more service components in the EVLP segment and hence, that's the partnership. So that's why we're working hard on strengthening both the partnership, but also our field force to enable it.
Jakob Lembke: Okay. And then on the opportunity to deliver or do EVLP through the OPOs, my question is, do you have any ongoing discussions with other OPOs and sort of yes, how many could you have, let's say, in a couple of years, you think?
Christoffer Rosenblad: Yes, we have ongoing discussions and high interest from OPOs for starting OPO programs. I would like to come back in later calls on the exact number once we have proved our first 2 to 3 OPO models, so to say, then we will have a clearer view on both the pipeline. We will have the right resource on the field to collect the interest, et cetera. But what is clear today is that reach for EVLP is not -- in the United States is not as strong as it should be to enable a higher usage of donated lungs in the United States today. And we need to increase that reach to enable a higher usage to be clear.
Jakob Lembke: Okay. And then also, I'm wondering if you had any lung machine sales here in the quarter?
Kristoffer Nordstrom: Yes, in the Q4, we had no sales per se, but we had this placement at this OPO that we just discussed. I think there was another placement as well in Europe, which takes the year -- the full year total XPS new accounts to 6 or 7. The pipeline for Q1 is promising, and we hope to have a few more, 2, 3 more, I think, in Q1. There is still a discussion whether we will sell these or if we will place them, but that says something about the underlying health of the EVLP business [indiscernible].
Jakob Lembke: Okay. That's very helpful. Then I have a question on Liver in Europe, which, as you said here on the call, has developed quite well. My question is if you could elaborate a bit on what markets are driving this?
Christoffer Rosenblad: It's the core markets in Europe. I would say the main driver is where we have a service model in Italy, which is really driving highest penetration rates in Europe. We see strong growth in Benelux as well. We see Germany growing very fast from a slightly lower level. And then, of course, we have the other core markets in European, France and U.K., where we see a strong uptake as well.
Jakob Lembke: Okay. Sounds very promising. And then just a final question on the -- what expectations we should have on capitalized development going forward?
Christoffer Rosenblad: We will focus on -- the main money we spend right now is going into the heart trial. So it's partly pending approvals, how much we need to invest into heart trials. But we should expect that level to continue for -- up until approval for both in Europe and then later in the U.S.
Jakob Lembke: Okay. But let's say you get a European approval here mid-2026, should we expect some of that to come down then after that?
Kristoffer Nordstrom: Yes. I think the majority of the spending, and that was also the case in Q4 is directed towards the U.S. trial and the regulatory process over there. So that should come down slightly, I think.
Operator: The next question comes from Ulrik Trattner from DNB Carnegie.
Ulrik Trattner: First off, on the European regulatory pathway here for the [indiscernible]. It sounds like you are increasingly becoming more confident in what's needed on your end to be achieved in order to obtain approval versus your previous communication. Is there anything you can add to that if that is true?
Christoffer Rosenblad: Yes, I can confirm it's true. We had encouraging meetings both with our notified body and with medical agencies to clarify what we need to do. And we do have a higher confidence today that we are -- let's say, know what is needed.
Ulrik Trattner: Great. And if we were to also sort of look at liver here and your upcoming meeting with the FDA regarding a 510(k) and I guess this will be for a HOPE device and not a DHOPE device. But can you give any type of outline here in terms of a time line if you have a positive meeting with the FDA in February?
Christoffer Rosenblad: I would choose to not speculate on the time line at this point, though it would be premature. So I would wait for the FDA meeting to have a clear picture on time line going forward and what we need to do to achieve them and then we come back.
Ulrik Trattner: Sure. But if you can clarify here on this potentially then being a HOPE product and not a DHOPE product. And you obviously achieved a lot of success in Europe on a DHOPE device. And I guess you would see more logic combining a DHOPE device with NRP, for example. So how would a HOPE device fit into the current landscape in the U.S. right now?
Christoffer Rosenblad: In discussion with U.S. customers, we see that a HOPE device would fit very well into an NRP setting, absolutely. So we don't see any change there in application to use. We also see that in -- if we're going to -- if we will go from hyperthermia or HOPE up to normothermia and warm evaluation, then dual would be needed. But we believe for a setting where we only need to either time shift or improve outcome or combined with NRP, we believe that current hope would be sufficient enough for at least the customer segment. And we have to evaluate if we need further on to also look into hope. But at this stage, time to market is prioritized over especially normothermia.
Ulrik Trattner: Okay. So is it fair for one to assume that you will look at DHOPE as a sort of sequential development process into the U.S., starting off with HOPE, building your customer base and then doing a PMA study for DHOPE?
Christoffer Rosenblad: Where no decisions are taken today regarding the regulatory full strategy, that could be a possible way forward, absolutely. But that's something we need to go back to when we have a clear picture after meeting the FDA.
Ulrik Trattner: And next question would be on the Kidney Assist Transport ramp-up in the U.S. throughout 2026. I know that you comment that full-scale commercial launch, and I guess that entails you're done with the tweaking of the box and the adapter for the dual arteries and the sizing of the box by sort of end of the year. But you have signed up OPO contracts. So just can you give us some rough guidance on how the commercial interests ahead of the sort of broader commercial launch?
Christoffer Rosenblad: I mean it's interesting because it's -- once a clinic start to use it, they are very pleased with it, so to say. So key in '26 will be to add more clinics to get a greater or more clinics with a greater user experience as well as going into the OPOs to have them also experience what a great product it is. So that is the main task we see. We see a great interest from many counterparties in the field, and we want to continue with a slightly limited sales force we have now, but we still want to cater that interest to make sure that more kidneys can be used for transplantation. And when they get used, they will have a higher survival rate. And as I said in the presentation, we're also looking forward to investigator-driven studies coming out with -- showing that on the American transplant system as well.
Ulrik Trattner: Great. And last question on my end. You successfully historically implemented quite significant price increases year-over-year. So what's the plan here for 2026? And also if that could offset potential tariff impact?
Kristoffer Nordstrom: Yes. That's correct, Ulrik. We've been fortunate in the last years, been able to implement quite high price increases. We took a decision in the fall to push our price increases in the U.S. a little bit earlier. Usually, that's a January thing. So we increased prices in the U.S. around 5%. I think it was across the board in November to manage the tariffs. Europe, normally, there is a similar price increase in the beginning of the year as well. However, here, we have longer contracts due to tender, et cetera. So you don't really see the immediate effect there. But we -- overall, we believe that we have handled this in a good way and in a similar path as we have done in the past.
Operator: The next question comes from Filip Wiberg from Pareto Securities.
Filip Wiberg: I've got just a couple of follow-up questions here. So first is on the CAP. So 10 centers now up and running. You did 18 transplants in the quarter and I think you said they're up at 30 in total now, right? So my question is mostly in terms of their total heart volumes, like sort of a penetration rate. So what percentage of their total volumes have they used the heart box in, if you get the question?
Christoffer Rosenblad: Got it. Got it. We probably need a longer-term view of that to come with a better question, but we can see that -- in the original trial, we could see that some centers had up to 20%, 25% of their volume going on the Heart Box. So the indication for use in the trial were extended criteria or it’s typically DCD more than 4 hours, about 50 years, more than 2 hours, et cetera. So fulfill that criteria. So we could see fairly high, let's say, clinic penetration in some centers during the original trial. And we need to come back after we -- after this trial is more up and running with a better view on the continuous access protocol and how that translates.
Filip Wiberg: Okay. Yes, I was just trying to get a feeling around the potential after an approval just in these centers, which I suppose now are used to using device, but okay. But another one, you're planning to extend it right like after you or close to reaching the 60 patients, so will that -- will there be sort of a delay after the first 60 patients are done? Or can it start just right away after that?
Christoffer Rosenblad: We plan to interact with FDA, so there is no delay on -- by request from our users. So it will follow the same protocol, same IRB, et cetera. So there should be a possibility to have no delays.
Filip Wiberg: Okay. Very good. And then just last question, if you can talk a little more broadly on the market in the U.S. with some prior questions have been around lung here and if there have been some one-off effects or so. But are you seeing a continued improvement in like general market in the beginning of 2026 with then a continued improvement? Or what's the situation now?
Christoffer Rosenblad: Yes. I must say, since October, we see a better sentiment in lung, which is the market we know the best, so to say. And we do see an increased usage of our products. And we have no reason -- I mean, we're just a couple of days into '26. So we have no -- we haven't seen any change so far on that sentiment that we saw in Q4, not turning -- continuing into '26. Again, in discussions with clinics, they share the same positive sentiment as they did in October when we met during the global EVLP Masterclass or Lung Masterclass.
Operator: The next question comes from Ludwig Germunder from Handelsbanken.
Ludwig Germunder: I have only two questions, please. The first one would be on EVLP, which is kind of a follow-up on the previous question. Could you comment anything about the new customers that you signed last year and how they have been developing during -- since they signed [indiscernible]?
Christoffer Rosenblad: Yes, great. Absolutely, we can -- they have developed well. It takes a while to set up a good internal EVLP program. We see that in 6 to 9 months, they were up and running, and we see an increasing activity that we are now investing sales force to make sure that, that continues and accelerate during 2026.
Ludwig Germunder: Okay. Great. And then on the -- you mentioned the move of production capacity and that is running according to plan. Could you just remind us, please, what that time line is?
Christoffer Rosenblad: Yes, great. We plan to have to finalize the majority of the setup this coming summer to be ready, let's say, with all investments for the x10 ability to produce. We can already see in many products that we have that ability already for disposables, for example, for liver and kidney.
Operator: The next question comes from Oscar Bergman from Redeye.
Oscar Bergman: I got a quick couple of questions from my end. You mentioned that you have up to 25% market share for delivery in some core European markets. I remember the figure being 30% in Italy. I'm just wondering if this has come down. And if you can just comment some on TransMedics entrants in this market?
Christoffer Rosenblad: Great. Thank you. Very good question. No, other way around in Italy, it's growing every day actually. We have a fantastic team in Italy, one of the best teams I ever met, very dedicated, customer-centric. They're always there. The customer call in the middle of the night, they're actually there. So it's a great team, great customer interaction. So it's constantly growing. Hard to comment on what other people are doing in Italy or elsewhere. We haven't seen anything so far.
Oscar Bergman: Okay. And then on the kidney product, you did some redesigning for the U.S. market. Just wondering where you stand today in terms of this process and when you will be able to scale up commercially?
Christoffer Rosenblad: The project is ongoing, and we are working on a couple of avenues commercially in parallel. One of them being acquiring more clinical data, which we are doing together with investigators; two, getting into more hands, so we get more clinics up and running and three, pilot into some OPOs who knows that it will come -- the improved product will come early next year in around a year's time to pilot in an OPO setting. So that's what we are doing in parallel, so to say.
Oscar Bergman: Okay. And then if we assume that the Heart Box with a CE mark sometime during the summer, then how quickly will you be able to sort of hit the pedal to the metal and then start accelerating commercially?
Christoffer Rosenblad: It's a great question. The answer is very fast within some limits, so to say, it needs to get listed, reimbursement, et cetera. Through the year, I mean, in the next couple of months, we will have a better view on that because we are working in parallel with reimbursement in some markets. But judging from customer interest, it will be a very instant uptake in many markets in Europe. So -- but we have high, high, high interest in France, Germany, Italy, U.K., et cetera. But there might be administrative delays. But from a clinical side, there will be no delay at all.
Oscar Bergman: Okay. And just a final question, Christoffer. You mentioned that you do some restructuring of the Service segment in the U.S. Can you just elaborate more practically what this means?
Christoffer Rosenblad: In terms of Organ Recovery service, what we've practically done and if you go back and listen to the Q3 report, we described it or the conference call described a little bit more in detail there. But we have restructured the service to also enable NRP with the partnership as can now recover TA-NRP in our organ recovery. More importantly, we have educated everyone in our team, et cetera, to be able to do it. And we also doubled the number of hubs where we travel from to reduce cost, and we also doubled the footprint on -- or let's call it, surgical footprint to enable fast growth in this segment. So those are the main items we have done to gear up for growth. Thank you so much, everyone. I see that we now are over time and need to conclude this conference. And if I turn to the last slide with a reminder that we will meet in the future next time is April 22 to listen to the interim report January to March ‘26, which we will actually broadcast most probably from ISHLT. Thank you for today, and see you next time.