Xvivo Perfusion AB (publ)

Thank you so much. Good morning and good afternoon, everyone, and welcome to Exvivo's earnings call for the second quarter of 2026. To get started, we go to slide two, and today's presenters are me, Christoffer Rosenblad, CEO, calling in from Gothenburg, Sweden, and Christoffer Nordstrom, CFO, calling in from Denver in Colorado. And with that, we can go over to slide three, which is the Q2 financials at the glance. The Q2 shows the sales amount in line with the previous quarter, Q1, and with a 36% organic top line growth compared to the same quarter last year. EBITDA was kept at the healthy level, resulting in a good operating cash flow. For the third consecutive quarter, the total cash flow was neutral and hence the cash position stable. Christoffer Nordstrom, our CFO, will get into the details on sales, gross margin, cash flow and EBITDA later in this presentation. If we look into the segments, both the thoracic and abdominal segments are growing rapidly in both regions, North America and Europe. The lung market trend from Q4 last year continued to 2026 with a good lung market growth. I'm also very pleased with the strong kidney cells in the quarter fueled by larger sales footprint in Europe and a growing sales force and most importantly growing interest from clinicians in the United States. We will come back later in the presentation on the progress for the service segment, the actions taken and how we will execute to become the preferred partner in the transplant process. And with that we can go over to the next slide, which is slide number four, which is the same picture but for the first six months of the year. and it shows a similar picture as the quarter. Good stable overall growth comes from strong thoracic growth and healthy abdominal growth. During this year we have continued to invest mainly in sales force, scalable production structures as well as regulatory approval. Sales came in at 480 million Swedish kronor with a 29% organic growth. If we look into the segments, we can see that 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 600 patients now have been successfully transplanted with the heart assist. The best testament to success is Australia where the heart penetration year one was approximately 30%, year two it increased to 40% of DBD hearts in 2025. This year we already see an increase to approximately 50% penetration of all transplanted hearts in Australia. I also want to mention that our projects are progressing according to plan. Regulatory timelines are hard to predict, but clinical trials, submission file and the development progress are progressing according to timelines we have previously agreed internally. The full-scale production of disposables for heart, liver and kidney will be extremely important to capture future growth potential for all three products. With that project coming to an end, we will now focus on reducing cost per disposable, setting up dual production where deemed necessary, as well as improving our machine production setup. This project will also include our lung portfolio. Lastly, and most important to mention, is that this quarter again shows that the business model is scalable. So with increased sales, we see that turn into an improved EBITDA and an improved underlying cash flow. So with that we can go over to slide five and we will come back later to the financial numbers in that section and we can go into the Q2 highlights on slide five and those we will see on the slides six and seven so we can go straight to number six. One key is that we definitely start to see that with a larger sales force we meet more customers and we see an increase in adoption of our technologies across the line. Number two, we mentioned before that the lung market is back and we very importantly are running an OPO EVL-P hub pilot that is successfully now up and running and that explains partly the increased lung sales during the quarter. So far the progress is in line we plan and we have identified 45 OPOs in the rollout pipeline where of the third OPO was on board last week. We are continuously investing in more feet on the ground in the US to enable closer customer relations with a growing number of EVLP partners. If we look three into heart, As I just stated, in Australia we saw a fast pickup of usage early on and it increases year by year. Now we see a similar interest in Europe and it translated into usage under derogation or compassionate use. We hear more and more testimonies from customers who say that the ex vivo heart disease changed not only the ability to transplant more patients with a higher patient survival rate, but it also reduced stress level in the transplant team and increased the confidence in heart transplantation. In the US, the interest in our ex vivo heart technology is equally high and we have recently submitted the extension of the CAP or continuous access protocol to the FDA. I mentioned in the last quarterly call, but I will mention again after spending time at the ICCT 2026 in Toronto, it's clear that ex vivo is by far the innovation leader in the field of both lung and heart transplantation. If we look into number four, we saw increased sales from the Kinesis Transport and we also see an increased interest and momentum from customers using the Kinesis Transport. This is based on more and more clinical evidence being available to the clinicians that support the use of Kinesis Transport, as well as a larger commercial footprint in both regions, Europe and the US. In parallel, we are working hard to develop the product to meet U.S. opioid needs as well as lowering the cost per disposable to increase margins over time. And with that we continue on highlights and slide number seven. Point five, what is very encouraging is to see that where we put commercial capabilities and increase our sales force, we grow typically between 30 and 60%. And with future approvals expected and coming in as well as our product improvement, we will continue to see this leverage of commercial sales force turning into increased sales at the good return on investment. Even though I wish to have 0.6 here, even though I wish to have had great news, we have seen great progress in all our regulatory processes, as well as, as we have stated, we worked hard on the derogation and compassionate use here in Europe, we see take it up in Australia, and now we see that we have what I deem as good progress in the regulatory processes. I will shed more light on where we are on each approval in the next section of the call, the regulatory and clinical update. But I just want to conclude here that we are pleased with what we have seen so far. If we look at point seven, a very important point. To start with, we are very pleased with the growth and the cash flow we saw during the first half of the year. But we invest heavily in future growth. The majority of the investment, of course, goes into regulatory application for heart, global and liver in the US. But besides that, we continue to invest heavily in building commercial capability and the production scale up to enable Higher volumes than we have today. We are also investing in quality capabilities to support the growth we will see that we believe will be 10-10 in volume versus what we see today. and lastly number eight that capture I think the first half year is that we have a scalable business model we do invest to capture that opportunity. And we see increased sales turn into EBITDA that turn into an improved operating cash flow that we then can invest into regulatory approvals of our future sales drivers, which is heart, global and liver in the United States. And with that nice segue, we can go into the regulator update, slide number eight, but we can actually quickly go to slide number nine to go into the regulatory processes we have. And this is the usual overview that we show every quarter on slide nine. We now see more and more evidence for the heart disease globally. In Europe we ran the first randomized controlled trial with superior endpoint that was performed in the field of heart transplantation. The clinical outcome was great with an additional six lives saved per approximately 100 patients. It is also the first clinical trial to establish a link between preservation method, severe PDD reduction and reduced 1-year mortality. In the analysis of the trial data it was noted that the ex vivo group had a reduction of severe PDD by 76%, which is a lot. Incomparable number, the severe PDD was 20% in the control group, which is expected, but only 5% in the ex vivo group. It was further noted that the mortality of the severe PDD was approximately 40% in both groups, leading to an increased survival of 6 percentage points in the ex vivo group versus the control group. The US heart rate was fully included in record time. It showed the same picture. The severe PDD rate there was only 7.9%. and we are now finalizing the submission for the FDA for their review. So the team is working very hard. We are expected to hand in the submission file to the FDA during this quarter after we are waiting for some validation and product aging data before we can finally submit it. In Europe, the CE Mark Process for Europe is ongoing and at the late stage. Now is my best judgment. Stated earlier, the hardbox and disposable part of the product is already C-marked. The solution has passed EMA consultation and we're now waiting for consultation at the submedical agency for the one part of the product. During Q2, we received a few questions of We are now waiting for feedback on that additional information where we unfortunately don't have an exact timeline, but we expect feedback during this Q3. As we stated earlier, the uptake of heart assist is good in Europe under derogation and compassionate use. and we are ready to launch when the product is fully approved. As the launch plan is ready, we have staff recruited and they are meeting customers today under delegation to support them with everything they need. And the interest from Kleenex is very high in Europe as it is in the rest of the world. I still want to mention that even though the use under derogation of compassionate use is increasing and appreciated by our customer, we need to mention that the European heart clinics are suffering badly from lack of alternatives to the ex vivo heart assist. In both the United States and Canada, the regulatory approval will be pending the CMARC in Europe, so we are waiting for that one. until we will seek for approval in those two regions. The last point, liver in the United States, I will come back with an update on the next slide, slide 10. And liver cyst regulatory status in the United States. So we have previously 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 Q3 already last year at this point pretty much one year ago. We did decide to temporarily pause the activities for the liver PMA process to investigate alternative regulatory routes possible and we are preparing for the FDA Q-Sub meeting where the possible regulatory route will be decided by the FDA. We have recently opted to focus the majority of the resources we have on the heart U.S. submission. That being said, we have very high interest from U.S. clinics that are supporting the U.S. liver submission and we are in good dialogue with clinics to prepare ourselves for the Q-sub meeting with the FDA. We will inform All investors of the next steps in the US liver regulatory investigation latest in the Q3 report if we don't feel the need to do it before that. And with that I conclude the first section of the Q2 presentation and I will hand over to our CFO Christoffer Nordstrom who will present the financial performance.

Yes, thank you, Christoffer. Turning to the financial performance for the second quarter then. So this was another strong quarter for XBivo. The strong momentum we saw in the first quarter continued into Q2, as you have seen, and we delivered net sales of SEK 239 million, which corresponds to an organic growth of 36% in local currencies. Importantly, growth was broad-based across our portfolio and driven by continued adoption of our technologies in all major organ areas. At the same time, we continued to invest in commercial capabilities, Mark Reade, Christoffer Rosenblad, Johan Holmstrom, Ylva Vihoj, Magnus Nilsson Thoracic margins remain strong while gross margins in abdominal and services continue to impact the overall mix. And I will come back to that as well in a moment here. Going over to the next slide, which is the largest business area today for Xdevo, Thoracic. So Thoracic delivered a positive quarter with net sales of 158 million SEK and an organic growth of 53%. Adjusted for part trial revenue, we're still at 52% organic growth, so very good. The momentum in Lung continued to strengthen. EBLP disposable sales grew 60%. and the largest customer accounts. Activity remains strong, both among leading transplant centers, but also within our growing Opioid strategy. And during the quarter, as an example, two additional XPS systems were installed at Opioids in the United States and are expected to become operational in the second half of the year. Heart, Christoffer touched upon it. We're very pleased, very proud to see that we delivered a particularly strong We continue to see increasing use under compassionate use and derogation in wait for our regulatory approvals. With the approximately 600 hearts transplants with our technology, we continue to build both clinical experience and commercial momentum ahead of Abdominal Abdominal delivered another strong quarter and reported net sales of 65 million SEK, corresponding to 26% organic growth. Liber Sales grew 11% in local currencies while Kidney contributed and was the primary growth driver with a growth of 72%. We are particularly encouraged by the continued adoption of Kidney Assist Transport both in Europe and North America as more centers gain experience with the early adoption of this technology. Gross margin was 57% but less than 68% last year. The decrease was primarily driven by product mix, with kidney representing a larger share of sales, as well as pricing conditions in certain markets. While this impacts margins in the short term, we remained very confident in the long-term margin opportunity within abdominal. As adoption increases in the US, where pricing levels are structured Overall, we remain satisfied with the growth trajectory in abdominal and the increasing adoption of both our liver and kidney technologies. Turning to services, our third business area. Net sales were 15 million SEK, corresponding to negative growth of 25%. The development continues to be explained, mainly by lower organ recovery volumes, while FlowHawk delivers a and continues to gain traction among transplant programs across the United States. And we remain convinced that digital workflow solutions will become an increasingly important part of transplant infrastructure and customer integration for Exdeva over time. Within organ recovery, volumes remain below our expectations yet another quarter. However, following the investments we have made into the organization, the talent that we have attracted, we feel that we are getting closer to growing our customer base. And that's our, we have a firm focus on returning to growth here in the second half of the year. And I think we should still see some results, especially in the back end of the year. Gross margin was 10% and that's purely reflecting the lower or recovery volumes combined with our investments in capacity. As volumes recover, the margins should naturally improve. So switching gear from sales and going into EBITDA and profitability. So despite continued investments, as we talk a lot about, Ebitda remains strong at 19% in the quarter and 20% year-to-date. On a rolling 12-month basis, Ebitda has now improved to 21%. Many companies can deliver high growth and many companies can deliver profitability. We're thinking that delivering 29% organic growth during the first half year of the year while sustaining around 20% EBITDA margins and generating positive cash flow demonstrates the quality of our business model and this already at the very early phase of our growth journey, so we're very proud of that. in North America, but we will also maintain discipline and cost control across the organization. My final slide, cash flow. One of the most encouraging aspects of the quarter, we think, was the continued improvement in cash generation. Operating cash flow amounted to 63 million SEK in the quarter and 129 million SEK year to date. and this should be compared with a negative operating cash flow during the first half of the year last year. So this reflects both the stronger commercial performance and the continued focus on working capital management. Cash flow from investments amounted to minus 68 million SEK in the quarter and relates primarily to regulatory and product And what we think is particularly important is that over the past three quarters, we have demonstrated our ability to largely self-fund both our operating investments, but also our growth investments, our COPEX. So despite continued investments into future growth, total cash flow for the first half of the year was essentially break-even, and we ended the quarter with a strong cash position of 305 million SEK. So with those comments, I will hand it over to you again, Christoffer. Thank you.

Thank you, Nordstrom. We will round off this presentation with outlook for the rest of the year and then a little bit longer term outlook. We start with slide. and the outlook for 2026 and our focus areas. So we will continue to build Salesforce and build new partnerships in the US to enable OPO and other clinics to recover more lungs by EVLP adoption through a combination of service models and staying very close to customers. In parallel, we increase our service offering to better tailor customer needs, especially offering Flohawk and NRP from a hopefully increased footprint. We have an increased surgical footprint. We should also have an increased contract footprint. We will continue to work closely with our competent authorities in Europe with the aim of obtaining the C mark of heart, of course. We are aiming to submit the regulatory heart Thank you very much. Thank you very much. And if we turn from this year outlook to a little bit longer term, which I think is important to keep in mind while we're here, is that the demand for transplant is still 10 times higher than the supply of organs. We should also remember that the sales value for machine perfusion is approximately 10 times higher versus what is used today, to a large extent static cold storage. or a beer cooler box type with ice. Machine perfusion and our service model have proven to increase the number of organs to be used for transplantation, especially in the fast-growing DCD organ pool where the main growth drivers are superior clinical results from machine perfusion and the fact that we can reduce complexity and add time for the transplant clinic in order to reduce stress. So, in conclusion, we know that machine perfusion and good service models on normal and DCD graph will drive growth in the near and the long term future. Lastly, XVivos want to change the paradigm for transplantation by innovation. We are convinced and committed to increasing patient lives after transplantation, making sure that no one dies waiting for an organ, and making sure that we have rested transplant teams performing surgery at a lower cost than what we see today in the transplant chain. And we hope that you, dear listener, in the future when you fly, you might be seated near to an ex vivo heart box with a heart being transported to a patient whose life is about to change soon. And if you see that ex vivo heart device on your flight, you should know that it's not just a heart traveling. It's a hope for a new and a better life for the patient and his or her family. And I want to thank you for supporting us on this journey to change the transplant system forever through superior innovation. And with those last words, I also want to thank you for listening today. And with that, we will open up the lines for questions.