Xvivo Perfusion AB (publ)

Thank you so much. Good morning and good afternoon. And most of all, welcome to Exvivo's earning call for the fourth quarter, as well as for the full year of 2025. And with that, we turn over to slide two. It's just the two presenters that were introduced. It's me, Kristoffer Rosenblatt, calling in from Gothenburg, and the company CFO, Kristoffer Nordstrom, calling in from Philly in the United States. And with that, we can go over to slide three, which are the Q4 financial at the glance. The Q4 shows 10% organic top line growth, which is equivalent to a 12% top line organic growth if we adjust for the US 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 track sales were slightly negatively affected by the lower hard study revenue compared to same quarter last year in the United States, but positively affected by a stronger Q4 long market. It's 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 about 50% 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 US, 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, compare to alternatives. And investigators will come out with cleaner data proving this during 2026, which will be most important in the United States. The progress in our US 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 four, which is the year at a glance. year shows a similar picture to the quarter good and stable gross margin with continued investment to field force and scalable production structures sale came in at 812 million sec with a three percent organic growth and which is then equivalent to eight percent organic growth if we just for us hard 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 Nordström will get into the details on sales, gross margin and 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 timelines 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 timelines agreed. For example, the production capacity project where we invest to scale up volumes times 10 of today's volume for disposables are running in line with communicated timelines. The full scale production for our disposables for heart, liver and kidney will be extremely important to capture the future growth potential for all three product groups. And with that, we can go in to slide number five. 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 land market, but also because of lack of resources, especially in the US fuel 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 US field force. As we stated in the Q3 report, we entered into partnership to enable perfusion 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 timelines for innovative and paradigm shifting products can be hard to predict. But we can take action and we directly strengthen the team and we enforced 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 to, during the second half of 25, double both the hub footprint from six to seven hubs and the surgeon roster to enable to stay closer to customers and do more recovers at the lower cost. We also include the NRP into our service offering to enable an offering that all customers actually request or almost all. 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 six and the key message is that the right actions give the right result so with actions taken in the second half of 25 And a recovering land market in the US. We did deliver for the full year of 2025 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. five highlights. The slide seven is a dividing slide and the highlights of the year are in the two following slides, eight and nine. So let's start with slide eight and the part one of highlights. Firstly, the reason we are here, that Exiva 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 1000 patients more than last year. I want to state this is something that I am and the Tyrex Vivo 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 the promising 12 months data follow-up from the European trial at ISHCT. It was the first and so far only superiority trial in thorax transplantation. And more importantly, it was the first drive to show a direct link between perfusion, a device has severe PDD and patient one year survival, which is a milestone within our field and had never been done before. And I was, I never seen earlier in my life or encountered extreme improvement. We saw with a 76% risk reduction of severe PDD 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 ex vivo 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 nine, which is the second part of yearly highlights. In the US, we launched the first of its kind evil POPO model through a perfusion partnerships. 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 five-year follow-up of a randomized controlled trial for DCD livers. During the year another milestone was the launch of Exvivo Insight that enables remote monitoring for both liver assist and kidney assist. And finally when talking about those two 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 on slide 10 it's a dividing slide and then we have four slides digging into the updates 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 US heart trial was fully including record time and we now passed the 12-month patient follow-up. Next milestones are to present the US study at ISHCT in late April and prepare the technical and preclinical files for submission together with the clinical file to the FDA. We estimate to hand in 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 C-marking process continues. As stated earlier, the heart box and the disposable part of the product is already C-marked. The solution has passed the EMA consultation, and we are now waiting for consultation at the submedical agencies 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 timeline than what has previously been communicated by company. But clear is that once approved, fully approved, we are ready to launch the product. Hence, 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 the ex vivo 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 US, we also see an increasing interest to save patient lives. And more and more clinics realize that the liver heart technology is the way to do that. We today have 10 activated clinics of which six are currently enrolled patients. We recently included patient number 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. And 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 US. And as stated earlier, we are working with the PMA process. And most importantly is the presentation during ISHRT of the first 141 patients in the United States. With that, we can go to slide 13 for a status update of the liver regulatory pathway in the US. 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 2025. 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 510K de novo approval in the US for liver perfusion, we will begin a dialogue with FDA on regulatory pathways for liver assist. The aim is to enable patients in the US 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 timelines or possible route forward, but the company will inform the public and all investors of the outcome of our US-level 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 uh 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 US as well. And with that portion, we go over to slide 15, and I hand over to our CFO, Kristoffer Nordström. Thank you, Kristoffer.

Yeah, an overview on the P&L. So, net sales in Q4, as you know, came in at 226 million SEK. The organic growth was 10% and 12%, excluding hard trial revenue in total. Sales for the full year came in at 812, representing 3% organic growth and 8% excluding hard 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 US dollar, as you all are aware of. Throughout the second half of 2025, we maintained a strong focus, as Christophe 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 Xebo. 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 147 million SEC. Organic growth was 9% and excluding hot trial revenue, 12%. This means that Thoracic returned to growth again in Q4. And the main reason was the increased EVLP sales volumes, primarily in the US. The EVLP disposable sales in the quarter grew 33% versus last year. PerfectX Plus sales were flat, but this was after a strong Q3 where PerfectX grew 17%. And all in all, globally, 8% PerfectX 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 express system to an OPO. in the US in collaboration with PSI. And we look forward to expand this first of its kind EVLP service model to more opioids 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, New Zealand, further compassionate use cases in Europe, leading to a Q4 heart sales of 60 million SEK 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 61 million SEK, 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, solid quarter and another strong year for Exvivo Domino. 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 six months, we have put fundamental pieces in place that will drive growth in 2026 and be of strategic importance as we prepare for the US heart launch in 2027. So with a strengthened organization and with the introduction of TANRP in Q1, we foresee meaningful growth in 2026. And I think of what the meaningful growth means quarter by quarter next year. Gross margin decreased to 25%, and this is a direct result of all 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. Our focus for 2026 is clear and worth repetition. So for organ recovery, it's everything about returning to growth, leveraging our strength and surgical capacity and the NRP offering. And at the same time, we will prepare for the US 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 role in 12 months, EBITDA were 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, the 25% that we deliver now in Q4, that is not what we expect out of the full year in 2026 to be transparent. I mean, the baseline going into 2026 is the annual EBITDA of 20%. And that's It's from that level that we are growing for next year. And as Christopher 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, 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 Xevo and our operations, we have an operational hedge in the fact that we, you know, where we foresee the majority of our growth in the short, mid-term is in the United States. And that's also where we foresee that we will invest um the larger portion of our investments over time so however of course this will translate into see it eventually in our pnl as well so that risk we're 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 um In 2025, the sales in US dollars constituted around 55% of total sales, approximately 450 million SEK. I think the average SEK-USD ratio in 2025 was 9%. 10% decrease in USD versus SEK to 8.8 in 2026. That would translate into US sales equaling 405 million SEK, hence a reduction of 45 million SEK, which is roughly 5% decrease of total sales for TiVo 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 Euro will be slightly less. Final slide before I hand over to Kristoffer 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 120 million SEK roughly. So that brings total available funds to SEK 400 million. Operating cash flow was strong, 87 million SEK. And for the first time in Exvivo history, we had a total positive cash flow of plus 18 million SEK. So we feel that we entered 2026 with a cost base well aligned with both our financial resources and our growth outlook. And with those final remarks, I will hand over to you again, Christoffer. Thank you.

Thank you so much. And with that, I will round off with the outlook for 2026 and then the longer term outlook as I normally want to end the presentation. And 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 US to enable opioids and clinics to recover more lungs by EVLP adoption through a combined service model and stay close to the 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. continue to work close with competent authorities in europe with the aim of obtaining a c mark for heart and i'm of course looking forward to the presentation or many presentation on on heart but especially the the us heart study during ishtt and that we after that hand in the regulatory file to the fda for submission And lastly, in Europe, liver assist saves 100 of lives every quarter. And we will support clinicians to increase that number through larger Salesforce, 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 10 times higher than the available donated and used organs for transplantation today. And the sales value of machine perfusion is approximately 10 times that of cold perfusion. So the market opportunities there is approximately 100 times 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 from machine perfusion and the fact that service model reduce complexity and time for the transplant clinic. Exvivo has unique truly paradigm shifting technology that are or are on the brink to becoming gold standard in many fields. I want to end this presentation with a look into the future. You will in the future find yourself on an airplane. You might be seated next to the XVIVO heart box with the heart being transported to a patient whose life is about to change. This patient has likely been on the waiting list for a long time with limited to no quality of life at all. By having innovative paradigm-changing technology on the market, we will not only save this patient's life, we will also reduce the cost for the healthcare system dramatically. As well as, more importantly, which is 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.