Xvivo Perfusion AB (publ)

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 pound key 5 on their telephone keypad. Now I will hand the conference over to CEO Christopher Rosenblatt and CFO Christopher Nordstrom. Please go ahead.

Thank you so much, and good morning and good afternoon, everyone.

And especially welcome to Equivo's earning call for the third quarter of 2025. First, a quick introduction of today's presenters. That's me, Christopher Rosenblatt, CEO, calling in from Gothenburg, Sweden. And we also have Christopher Nordstrom, CFO, calling in from Philadelphia in the United States. And with that, we go to the third slide, which shows Q3 financials at a glance. The Q3 shows plus six top line organic growth if adjusted for the U.S. hot 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 cells 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 an XPS in the United States during age one, or up to one, are up and running now in the beginning of October. And we also held a lung master class. 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 EVLP support for the lung transplants if you compare to what we saw in Q3. Going into our abdominal segment, liver in Europe are now entering the majority market segments with penetrations above 50% in many European countries. The main task for us are now to support with resources for profusion and data for improved reimbursement. Sales growth is improved in many countries by improved reimbursement, which is based on the carpet of excellent clinical data with better patient survival and more liver use, as well as hospital economic data and health economic data. Kidney, on the other hand, is still below 15% penetration in many countries, including the U.S., and the main task for us is to win account by account. What is good to note is that the feedback we get from kidney customers is that they are very pleased with the product and see that the kidneys are in better condition after being confused with the kidneys' transport. compared to the available alternatives on the market today. And if we go over to services, we have stated earlier, and we are not pleased with the progress of the US 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 very strategic, and the purpose is to support the future HART business in the U.S. During the year, a cost and cash reduction initiative was initiated to enable better resource allocation going forward. The CFO will come back to that during the financial part of the presentation. And this slide, Q3, shows again that Exiva has a scalable business model in terms of EBITDA, We can see that the recovery of sales in Q3 versus Q2 also improved the EBITDA as a percentage if you compare to Q2 of this year. And with that, we go over to slide number four, which is the first nine months at a glance. And we chose a similar picture to the Q3 slide. Good and stable gross margin. We continued investment into fuel force and scalable production structures. We saw that sales came in at 586 million Swedish kronor, with again a 6% growth, if we're just for the U.S. hard to find revenue. And we, in terms of gross margins, I said before that we plan to improve abdominal gross margin to 70% at the latest in 27, or when we reach economies of scale in production. You will hear more about gross margin 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. 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 course that we're running a DCD direct procurement study in the Benelux show that we uh it's also a great product for dcd hearts um and i think we 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 heart approval um but In terms of clinical trials and development projects, there are progress according to timelines, agreed. The production capacity projects, for example, where we better scale up volumes times 10 of the day volumes for disposables are running in line with communicated timelines. The full-scale production of disposables 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 five. 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 Exviva Heart technology. And that's why what we work on every day to make sure that those patients actually survive. We can go into the, to slide six, to the Q3 highlights and important information. If we start with the U.S. federal review, so HSS has launched a review of the organ transplant system in the United States and started to take action towards, at this stage, one underperforming opioid. I listened in to the conference, and I think it was best summarized by the quote from the FDA director, Martin Makara, that you see in the middle of the page here. I want to state that Exvivo is aware that many organs go to waste because of bad communication under utilization 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 opioids. 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 valuation opportunities, and a better service model. We hope that we see it 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 for the US lung market, 22 to 24, double-digit market growth. And it has been driven by improved allocation and EVLP at the ambition programs. We could safely grow their number of lung transplant using lungs that were rejected by other centers. In 2025, we still see growth, but at a lower pace than we are used to. The reasons for the slower market growth are manifold. But at least we start to see weightless coming back at the 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 . And with that, we can go continue to stay in the U.S., but go to slide eight to paint the picture what we would do specifically for lungs. As stated earlier, we have seen fantastic results from ambitious lung transplant programs that safely increase the numbers of lung transplant using EVLP with XPS solution. For Q3, we can start to conclude that we didn't identify NAD stocking. We continue to see an increasing interest to start EVP programs with XPS. That stated earlier, three out of four of the new accounts that bought on 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 Landkraft Magnetik, 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 came together with our audio cover business and communication system flow holes, give our customers an improved experience and support them also during shortage of resources. During the summer, we have also developed EVLP product service model to better fit the opioid system. We will run the first pilot during Q4. And lastly, we have also recognized that we need to reorganize the commercial organization, and we have done so during the summer to have a greater footprint in the south of the country and on the west coast of the United States. Our estimation is that the action taken during the summer will show gradual impact during the next 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 master class 2025. And it was a great pleasure for us to welcome the best of the best in lung transplantation to the 2025 edition. So, we have got 100 clinicians from 19 countries that could exchange ideas through collaboration how we can improve lung transplant practices both usage of lungs and patient outcome. The key takeaway 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 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 10, sorry, and just have a snapshot of the U.S. CAP study. and the preserved study status. We have the first patient enrolled into the study during Q3. At the end of the Q3, we had four patients enrolled, still at one clinic. As of yesterday, we actually had nine patients enrolled into the continuous 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 continuous access protocols so we can strengthen our regulatory file that we aim to hand in to the FDA during the next year. We can also just briefly state on the preserved status that we had last patient in the original trial, so not the continuous access protocols November last year. 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 the footprint of our commercial team in the United States. We have also taken action on the service side. To start, we've taken mainly 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 3 to end of 6, end of Q3. And we expect that end of Q4 will be seven active hubs on the east coast or east of the Mississippi. We, as I stated earlier, we close the partnership with a great partner, not only to improve our EVLP capabilities with Perfusionist, but also to support clinics with NLP services. which is nowadays in the United States a must to grow our service business. It has been asked for, and now we can finally deliver on it. Number three, we have partnership with numerous both aviation and ground transport partners to enable a full-service offering, if the clinics want that offering. Some have their own transportation partnering, and we're happy with that, but if they don't, we can offer a great network of transportation to simplify for the 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, especially then east of the Mississippi. We are aware of the fact that we need to also grow our hubs and service offering west of the Mississippi, and we will come back to that, both the progress on the actions taken and the future plan in the next quarters to come. And with that, we can go over to slide 12. And we leave the United States, and we go over to Europe. which we have concluded into one slide. And the reason is that it's slightly shorter is that the business is progressing very well. We have a stable field force. We have very good clinical data, long and strong customer relations, and great interactions. But what we've seen so far in Q3 is continued strong growth for liver. In Europe, Q3 was similar to the previous quarter, but plus 31%. We continue to add new accounts every quarter. We continue to work on reimbursement, et cetera. The main hurdle for growth in liver is mainly human resources and reimbursement, which we're working on. And country by country, we now see that reimbursement is coming into place. And with an increasing customer-facing organization, we now have the ability to support clinics better with also resources and especially human resources that support the profusion 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 and, but especially how the kidney performed after transplant. So we have a lower market penetration rate, and we are, it's more account by account base where we have to, let's say, fight to fight to increase penetration rates, and we have to convince clinic by clinic. But once they have tried the kidney assist transport, they are very convinced of the product, and it actually increases usage over time. The lung business in Europe grew mainly with EVLP adoption in the UK and higher perpadex uses per case as the last one as a result of evidence that if you flush more with perpadex, you actually improve the lungs before transplantation, which potentially improve outcome after lung transplantation. And if we look into next year and strategic areas for our European business, we are, as we stated earlier, of course, awaiting the regulatory approval for heart. If we benchmark with Australia, it's clear that Dexvivo Heart Assist has a very good position in the transplant system. And we expect European heart penetrations over time in 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. We can start with just the standard slide of slide 14, which shows an overview of regulatory approvals we have. So our lung and kidney portfolio has obtained regulatory approval in all key markets, and liver is approved in all key markets. For heart, we are awaiting, as we know. approval 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. And in U.S., we are working very hard to make sure that the file is approval ready as soon as possible. For the liver, we have now obtained everything we need, but I will come back later to the decision we have taken during the quarter regarding the liver US trial. And we can turn to 16, which is, a little bit of repetition, but it's good to clarify here the heart and the strong evidence we see in heart. The heart trial in Europe is not the only, not only the first trial to aiming for showing superiority, it's also the first trial to show superiority for heart. But more importantly, it's also the first trial ever to show a direct link between perfusion of the heart and patient outcome. And we can see that by using the heart assist, we can reduce severe PDD, 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 PDD, 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. So, and 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 transplants using the X-View Heart Assist. either if it's long distances or extended criteria hearts, et cetera. And with those great results, we go over to slide 17, where we are looking into more how we want to change the paradigm of heart preservation. And as I stated, we know that we now can increase both patient outcome and we can increase transportation time for hearts. To strengthen the evidence and simplify the DCD process, we have, as I said, the Benelux DCD direct procurement study that we are now under inclusion of patients. And it's progressing fine. The study aims to include 40 patients, and it is estimated to be fully included end of this year, 2025. And we are really looking forward to the results of this study. With a positive outcome of this study, the ex vivo heart assist would fully transformed the process for DCD hearts, 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 DBD heart. With the successful outcome here, we will 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 the liver assist has been granted breakthrough device designation by the FDA. We have an approved IV and can start the trial. We have CMS funding approved, et cetera, and we could have started the trial in Q3. However, the company has decided to temporarily pause the activities for the liver PMA post, to investigate if alternative regulatory route is possible. We hope to, as soon as possible, come back with a 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. better product than what is currently available on the U.S. market, approved faster, and hence, we can see the fantastic results we have seen in Europe, also in the U.S. And with that, I go to slide 19 and hand over to our CFO, Christopher Nordstrom, who will present the financial performance of the year and the quarter.