Xvivo Perfusion AB (publ)

Welcome to ex vivo q3 report for 2026. 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 five on their telephone keypad. Now I will hand the conference over to CEO Christopher Rosenblad and CFO Christopher Nordstrom. Please go ahead.

Thank you so much. Good morning and good afternoon, everyone, and welcome to Exvivo's earnings call for the third quarter of 2026. And we can go to slide number two. Joining me today are Christoffer Nordstrom, our CFO, calling in from Denver in Colorado, and myself, Christoffer Rosenblad, CEO, joining from Stockholm, Sweden today. And with that, we can go to slide number three. which is the Q3 financials at a glance. We delivered another solid quarter which stays in line with the first half of the year and organic growth of 32% compared with the third quarter of 2025. EBITDA remained strong supporting healthy operating cash flow For the fourth consecutive quarter, total cash flow was close to neutral, resulting in a stable cash position. Our CFO will later in this call provide more details on sales, gross margin and EBITDA later in the presentation. Looking at the business, Teraki continues to perform very well across both North America and Europe. The positive market trends we saw towards the end of last year continue through the quarter, supported by strong growth in the lung market and our expanding commercial presence. Kidney also delivers strong growth driven by increased commercial coverage in Europe and growing interest in the US market. Against this backdrop, sales developed this quarter and over the coming quarters will be impacted by the transition to updated core components. While this creates a temporary headwind, it does not change our positive view on the underlying market opportunity and business momentum. Turning to slide Four, which is the year-to-date performance. The first nine months of the year show a similar picture to the quarter. We continue to deliver strong and consistent growth driven by robust performance and healthy growth in abdominal. Throughout the year, we have continued to invest in our commercial organization, scalable production capabilities, and regulatory approvals to support future growth. Sales amount to 730 million SEK, corresponding to an organic growth of 30%. A key takeaway from the past two years is that we have demonstrated the scalability of our business model. With only a few months remaining of 2026, we are now increasingly focused on the opportunities ahead. The next two years will be important for Xvivos to continue building the company toward our ambition of becoming the preferred partner in the transplant process. Among the most exciting commercial opportunities are the launch of ex vivo heart-assist transport in Europe and our planned expansion into Canada and Australia. In Australia ex vivo heart-assist transport has already established a strong position through compassionate use and has already now become the standard of care which took only three years. With that we move over to the next slide, slide 5 and the key business highlights from the quarter on the next following slide, 6 and 7. So turning to slide 6 and the key highlights from the quarter. Key 3 was an important quarter for Xevo marked by several milestones across our business. First, with EU approval of ex vivo heart assist transport we can now begin supplying this life-saving technology to patients across Europe. The approval covers all heart donated and all heart transplant recipients including all age group as well as both DBD and DCD donors. Clinical data demonstrated a 76% risk reduction in severe PDD, the leading cause of early mortality following heart transplantation. As a result, six additional patients per 100 survived to their one-year follow-up date. This represents a significant benefit for this vulnerable patient population. In addition, Exvivo Heart Assist also has demonstrated the ability to safely extend preservation and transportation times. This gives transplant teams greater flexibility in planning procedures, enabling surgery to be performed under more controlled conditions with rested transplant teams, while also having the potential to reduce the overall cost of the transplant process. Second, we reached another important milestone with the submission of the PMA application for ex vivo heart assist transport in the United States. We are equally committed to patients with end-stage heart failure in the US and to enabling heart transplant teams to perform surgery with rested teams and in a less stressful and more controlled environment. By extending transportation capabilities, Exvivo Heart Assist has the potential to make more donor hearts available for transplantation while reducing transportation costs, ultimately lowering the overall cost of the transplant procedure. Third, our OPIO EVIL-P hub pilot is now successfully up and running, contributing to the strong lung sales development we have seen this year. We are now seeing three distinct EVLP models emerging in the US market, Advanced Transplant Centers, Centralized EVLP Providers and Opioid-Based Programs. Our strategy is to support all three models, helping more donor lungs reach transplantation and ultimately ensure that nobody dies waiting for a lung. To support this development, we continue to invest in our commercial organization and strengthen relationships with an expanding network of EVLP partners across the United States. And finally, despite making significant investments in scalable manufacturing, regulatory initiatives and commercial expansion, we continue to maintain a healthy financial position. We believe this is the right time to invest in long-term growth opportunities ahead of us and continue building Index Vivo for the future. And with that we turn to slide 7, an update on the European heart laws of ex vivo heart disease transport. During the quarter, our primary focus was on preparing the market launch country by country and clinic by clinic across Europe. We are executing a structured three-tier launch strategy. The first phase is now in place, enabling active transplant centers to begin using the XHAT under derogation or compassionate use while local listing processes are completed. We now turn to Tier 2 and our current focus is targeting 33 transplant centers across 4 priority markets where reimbursement is already established. These centers together with the first 80% almost 40% of all heart transplant clinics in Europe. Parallel, in tier 3, our commercial and market access teams are working closely together to identify patient segments where the clinical value purpose is particularly strong, including DCD hearts, long-distance organ transplantation, pediatric transplantation, and complex patients with prior LVAD support. With a very strong clinical evidence base already established, the focus is increasingly shifting towards health economics and reimbursement. From our perspective, the question is no longer whether the ex vivo heart assist can become the gold standard of future heart transplantation. The key question is how quickly reimbursement can be established to ensure broader patient access across Europe. Ultimately, our vision is clear. To make this technology available to more patients, enabling more heart transplants and bringing us one step closer to the future where nobody actually dies waiting for a heart. So that was the key milestone of this quarter and as customer we turn to slide 8 and the regulatory and clinical update. As more products receive approval and enter the market the list of ongoing regulatory milestones continues to get shorter and with that we can turn to slide 9 to show that picture. So the CMARC for ex vivo heart assist in Europe serves as a foundation for our regulatory application in both Australia and Canada. In addition to the clinical data generated in Australia, the European clinical trial provides strong supporting evidence. It was the first randomized controlled trial with a superiority endpoint conducted in the field of heart transplantation. Beyond the strong clinical outcome, the trial was also the first to establish a link between preservation method, which is the X-hat, the risk reduction of severe PDD, which was 76%, and the improved one-year survival of six percentage points. For heart in the US and liver in the US, I will return to the more deep dive into the following slides. And with that we turn to slide 10, which is the regulatory status of ex vivo heart assist transport in the United States. The US Heart Trial was fully enrolled in record time, completing enrollment in 13 months compared to the written plan of 30 months, and delivering results consistent with those we've seen in Europe. The study met its predefined safety and efficacy endpoints, while the analysis of secondary endpoints showed a severe PDD rate of only 7.9%. We also reached an important milestone with submission of the PMA application for ex vivo heart disease transport. The submission has been accepted by the FDA in September and the review process is now ongoing. During the quarter, the extension of the Continuous Access Protocol or the CAP was also approved, providing access to this really innovative and life-saving technology for an additional 60 patients at the participating trial centers in the United States. The breakthrough device designation support an efficient PMA review process and we are talking commercial launch in late 2027. This is subject to FDA review process time as well as an approval. It should be mentioned that the breakthrough device designation allow us to have a dialogue with the FDA during the process, so that should facilitate the process. Though I have to mention, as always, FDA review timelines are determined by the agency themselves and remain difficult to predict, we will continue to provide regular updates to the domestic community on the progress of the Exviva HAT review process during quarterly calls. And with that, we turn to slide 11. and the US Liver Regulatory Opportunity. But before I go in there, let me start with an overview of the clinical evidence supporting Xvivo Liver Assist. Exvivo Liver Assist is approaching stand-up care for liver transplantation in several European markets and is supported by one of the largest body of clinical evidence in the transplant field, if not the largest body of evidence we have seen in the transplant field so far. The evidence base includes more than 100 peer-reviewed publications and covers a broad range of outcomes, from improved patient outcomes in both GCD and DPD liver transplantation to meaningful operational and economic benefits for transplant teams. Clinical studies have demonstrated improved utilization of donor levers, improved post-transplant outcome, and reduced complication. At the same time, machine perfusion has enabled transplant centers to work with greater flexibility and predictability, supporting both the teams and the hospital operations. Taken together, we believe XVivo Liver Assist has established one of the strongest clinical health economic evidence bases in transplantation and provides a solid foundation for our regulatory and commercial ambitions in the United States. And with that we go to slide 12 and a more specific update on the US regulatory pathway for the Liver Assist. Following a re-evaluation of our US regulatory strategy last year, interest in the liver assist has continued to grow among transplant centers in the United States. We are increasingly being approached by centers and clinics that would like to get access to liver assist, recognizing both its clinical benefits and its potential to improve workflow and quality of life for transplant teams. There is a clear demand in the United States for cost-efficient solutions that can improve outcomes while supporting a more sustainable transplant practice. Against this backdrop, our regulatory team is actively preparing the submission package for the FDA. We are targeting a 510 submission in the first half of 2027 and subject again to regulatory timelines commercially launched in early 2022. A. We believe the US represents a significant long-term opportunity for liver assist, supported by both the strong clinical evidence base we just showed you and a growing market interest. And with that, I turn over to slide 13 and hand over to our CFO, Christoffer Nordstrom, for the next segment of this quarterly call.

Thank you, Christoffer. So turning to the financial performance of the third quarter and this was another stable quarter for Exdebo as Christoffer already mentioned. Net sales reached 253 million SEK corresponding to an organic growth of 32% in local currencies. Growth was led by Thoracic, our largest business area, while also Abdominal continued to show positive momentum. EBITA amounted to 52 million SEK corresponding to a margin of 21% compared with 19 last year and this improvement was supported primarily by the strong sales but also somewhat seasonally lower activity levels on the cost side over the summer months. Gross margin worth a comment. Gross margin was 70% compared with 75% last year. The year-on-year decrease reflected lower margins in services primarily, as well as product mix and some inventory write-down within Thoracic. Excluding services, where we have made deliberate investments over P&L, The net gross margin was 75%, both in the quarter and year-to-date. Moving over to our largest business area, Thoracic. Thoracic delivered a very strong quarter with net sales of 177 million SEK and organic growth of 51%. Lung sales amounted to 155 million SEK and EVLP disposable growth was 67%. We mentioned it in the report, so Thoracic also benefited from approximately 19 million SEK of tailwinds towards the end of the quarter. So we had a 8.5 million SEK adjustment, you can say, based on IFRS and the treatment of lease contracts, and that refers to the 3.0 bill. and that lesson we learned here in the quarter so that's why you see that a bit of a one-time effect in this quarter isolated. And that's how we're going to treat those contracts going forward as well when we onboard new OBOs. There was also approximately 10 million SEK of inventory build-up by our largest customer in the US. Hard sales. Positive amounted to 22 million sec compared with 10 million sec last year. The CAP study has started. I think we had three patients included in Q3, so it contributed with 1 million sec, which means that the rest, the 21 million sec, comes from Europe and it comes from Australia, where we continue to see a very strong interest in good adoption of the technology. Gross margin was 80% compared with 89% last year. And as I mentioned, the decrease is mainly explained by the product mix, hence a larger portion of this XPS revenue and also the inventory write-downs. Excluding these events, the gross margin would have been 85%. Moving over to abdominal, net sales of 62 million SEK corresponding to an organic growth of 12%. Liver sales were 40 million SEK and grew 9% in local currencies. Growth was somewhat lower than last year reflecting temporary implications from the manufacturing transfer that has been going on and somewhat softer activity in a few European markets over the summer. We remain encouraged by the long-term opportunity, supported by continued adoption in our core markets and the broader DCD utilization that continues, but also more long-term reimbursement developments and those opportunities. Kidney sales amounted to 22 million SEK and grew 19% in local currencies. Growth in the quarter was affected by seasonality and implications from the manufacturing We do expect growth at current customers and with the current design to continue to return to higher levels of growth from the beginning of 2027. Gross margin was 61% compared to 60% last year. Turning to services, our final business area. So net sales were 14 million SEK. That means a negative growth of 28%. The decline was again primarily explained by lower organ recovery volumes. We remain optimistic about the pipeline of prospective customers. We have several contract processes currently underway, so that's very encouraging. However, these processes continue to take longer time than we Gross margin was negative, 19%, compared with 37% last year, and the decrease reflects the lower recovery volumes combined with our investment in expanding the surgical team to position us for winning new contracts in new geographies and for building capacity ahead of the US heart launch later on. So as recovery volumes increase and the new capacity is utilized, we expect the gross margins to recover significantly. EBITDA, looking at 52 million SEK in EBITDA in Q3 compared with 36 last year, and the EBITDA margin improved to 21% from 19%. Year-to-date EBITDA was 148 million SEK and the margin was 20% compared to 17 last year, so an improvement there. A rolling 12, we're at 21%. The margin improvement in the quarter was supported by the strong sales, but also the seasonal and lower summer activity. While we continue to invest in commercial expansion, as we talked about, regulatory activities and also the infrastructure to support the future growth. Final slide, cash flow. Cash flow from operating activities was strong, 53 million SEK positive in the quarter compared with 21 last year. The improvement was primarily driven by the strong sales development. And for the first nine months, our operating cash flow amounted to 182 million SEK compared with only 14 last year. So a significant improvement on the cash flow this year, which I am very proud of. Cash flow from investing activities was minus 49 million SEK and 39 of those were invested into our regulatory approval processes and clinical trials, primarily related to HART. So over the past three quarters we have generated positive operating cash flows that has been sufficient to fund both our operating and our investing activities. And we ended the quarter with a cash position of 313 million SEK and in addition we have an unutilized part of our credit facility of 12 million euro. So we believe that we will enter next year with a solid cash position. And with those comments, Christoffer, I will hand over to you again. Thank you.