Xvivo Perfusion AB (publ)

Thank you so much. Good morning and good afternoon everyone and welcome to Exvivo's earning call for the first quarter of 2026. We can go to slide number two and just today's presenter are me, Kristoffer Rosenblatt, calling in from the 2026 ISHCT conference in Toronto, Canada, and Kristoffer Nordström, CFO, calling in from Philadelphia in the United States. And with that, we can go to slide number three, financial at the glance. So we see that the first quarter of this year showed a 23% organic top line growth. This is equivalent to an 18% organic top line growth if we adjust for the US cap trial revenue compared to the same quarter last year. EBITDA was kept at the healthy level resulting in a positive cashflow for the second consecutive quarter. The CFO, Christopher Nordström, will get more into the details on sales, cross-margin and EBITDA later in this presentation. Short on the segments, both the thoracic and abdominal segments are growing rapidly in both regions, which are North America and Europe. The long market trend we saw in Q4 last year continue into 2026 with a good long market with good underlying growth. And we see that a larger sales footprint supporting more customers is paying off. I'm also very pleased with the strong kidney sales in the quarter, partly fueled by the Canadian launch and a growing interest in the United States. We will come back later in this presentation on the progress for the service segment, the actions we have taken and how we will execute to become the preferred partner to all the Transplan teams. And with that we can go over to the highlights of the quarter and you can actually jump straight to slide number five where we see that the highlight very very busy quarter we took many important steps last year and this quarter and we have passed many important milestones that led to actually another record quarter which is the first highlight secondly we also had the very important OPIO EVLP hub pilot has been very successful and is now up and running. And it partly explained increased lung cells we see in this quarter. So far the progress is ahead of our internal plan and we have identified 45 more OPIOs in the rollout pipeline plan. Whereof the second OPIO in that plan will be onboarded already now in Q2. In parallel, we are continuously investing in more feet on the ground in the United States to enable a closer customer relations with the growing number of EVP partners we see. And we also can report that the 60 patient cap is now fully included during the quarter. We have an extreme high interest from trial centers to use the HART technology. and to satisfy their needs we have to use text viewer heart assist we have asked the fda for an extension of the cap so they can use it again under the id we have And if we look at number five, it's a testament to how well the ex vivo heart assist performed. And it's best shown with the real life experience in Australia. So during Q1, the penetration increased to 52% for DBD heart. And we're happy to announce that we did our first DCD heart in Australia now as well. It's a very important milestone and makes us convinced that we should aim for the ex vivo harvests to become the global gold standard for preservation of all hearts. And while we're waiting for the last part of the C mark for heart, we should mention that both the machine and disposer is or are already C mark. More and more European agencies are approving the ex vivo heart assist for compassionate use. And we actually saw sales in Europe picking up already now in Q1. This is again an indication that the European transplant teams can't wait for the device that optimize heart preservation and enable more hearts to be used for the patients waiting for a new heart. In our service business, we saw good progress in the Flowhawk part of it with high growth and new customers opting to use the communication software. Already now, six out of 10 of the largest transplant program in the US opted to use Flowhawk since it simplifies the transplant process and reduce overall cost in the process. The organ recovery business is now ready for growth and we have a positive outlook for the rest of the year. We offer NRP if needed as an increased interest to use the Xvevo organ recovery service. I had many, many good conversations during this ISHLT, for example. And with all those highlights, we can go to the deep dive into the highlights on slide number six. So as I said earlier, I'm right now in the middle of the ISHLT conference, which is the biggest, Langenhart. Transplant Congress in the world. And after spending time here, it is clear that Exvivo is by far the innovation leader in the field of both lung and heart transplantation. For example, the Exvivo heart disease was featured in two late breaking news session that was very well attended and increased interest from clinics who want to use the heart device. And I kind of go into those. We have some press releases regarding those, but I will go into them later in the next slide. I also want to highlight that very soon after this meeting, we will have our HART symposium, which will be really, really interesting to see. But already this Wednesday, we had the LANG symposium. So the XV were in this response to LANG symposium, which was a great success, really. It had extremely high attendance, created a lot of interest from future customers to start up EVP program. And it was also very clear that with new innovative technology on the market, the field of lung transplantation has improved significantly over the last decade. So one example, over the last five years, the number of DCD lung transplantation has more than tripled. But more so, if we look at the patient outcome, that also improved. And over the last 10 years, the one year survival for ECDs, extended criteria and DCD lungs, has gone from 85% to above 90% and is now on par with what we call normal lungs. And there we see that the adoption of IVLP has been key to enable safe use of those extended criteria organs. But let's jump in to the two highlights in the late breaking news session from ex vivo. So we go to the next slide, which is number seven, and it was the US preserved trial that was presented. Again, the clinical result from investigation use is positively surprising us on the heart side. The trial was performed at 14 clinics in the US and they enrolled a total of 141 patients. The US study aimed to prove that extended criteria heart, as described on the slide here, could safely be transplanted using the ex vivo heart assist. I'm happy to announce that the study methods predefined efficacy and safety endpoints. The sub-analysis or the analysis of the secondary endpoint showed also that severe PDD was only 7.9%. severe PDD is the leading cause for early and late mortality in heart transplantation. I will come back later here on the importance of it when we look over the European data. And next step is that we will now finalize the file for submission to the FDA for their review. And then we can turn to slide number eight, which is the other late breaking news which was a very well received presentation from the European DCD direct procurement experience with DCD heart. So the trial was a single arm proof of concept trial a total of 40 adult heart transplants recipient across four European transplant centers in Belgium and the Netherlands were enrolled. And the primary endpoint for patient survival at 30 days was 98%, which is very high. And the secondary endpoint of severe PDD was only 5%. Again, showing that the right preservation of heart keeps complication after heart transplantation low. I also want to mention looking forward that if the method of direct procurement is widely accepted by the heart transplant community, it would significantly reduce cost in the transplant process and simplify for the transplant teams around the world. And with that, we can go into the EU trial, which is now in the publication during Q1 this year. I again want to mention this is the first randomized control trial with Cipri and Point that was ever performed in the field of heart transplantation. So no one dared to try this before, but we did. It is also the first clinical trial to establish a link between preservation method, severe PDD reduction, and reduced one-year mortality. And you can see this at the data, if you look at the little box of data that both mortality and severe PDD has a clear link. And I will explain that link. So in the analysis of the trial data, it was noted that the Xvivo group had a reduction of severe PDD by 76%. So 20% in the control group and only 5% in the retrieval group. It was further noted that the mortality after CBRPD was approximately 40% in both groups, leading to an increased survival of 6% in the retrieval group versus the control group. We can also note here that the primary endpoint shows statistical significance at day 365, which is good. With the experience we have seen in Australia with more than 50% of all DBD hearts now being preserved on the ex vivo heart assist and those three trials that I just went through and we have recently presented, the body of evidence in favor of the ex vivo heart assist is increasing significantly. Which is great news. And with that I will go over to the regulatory update on slide 10 and we can actually go straight to slide 11 which is the usual overview of our regulatory processes. So the US Heart Trial was fully included in record time and we now passed the 12 months patient follow-up and you saw the result of that during the late breaking news session of ISHRT and the press release we sent. We are now preparing the regulatory file and when ready we will submit the file to the FDA for their review. The C-marking process in Europe is ongoing and we are awaiting feedback from one competent authority. But again, as stated earlier, the hardbox and disposable part of the product are already C-marked. And we have passed EMA consultation and we are now waiting for the last consultation. Again, I also want to note we are ready to launch when the product is fully approved. So we have a launch plan ready. We have staff recruited and the interest from clinics in Europe is very high. And as I stated earlier, we actually saw some sales already from compassionate use this quarter. But unfortunately, the European heart clinics are suffering badly from the lack of alternatives to the ex vivo heart assist. So we are working really hard with our notified body to get the final C mark. But we are happy to see and hear all the engagements from our heart transplant clinics in Europe. We just want to get it up and running. Also to mention, and we mentioned before that the Australian and possible Canadian approval will follow on the CMARCS. We will use that as a base. I will come back to the US liver update in the next slide, actually. So we can go straight to that slide. And slide number 12. And the liver regulatory status. So we have previously reported that the liver assist has been granted breakthrough device designation by the FDA. We have an approved ID and the CMS funding approved. We could have started a trial last year, mid last year. We did decide to temporarily pause activities for the liver PMA process to investigate the alternative regulatory route. And we are right now in preparation for FDA Q-Sub meeting where the possible regulatory route will be outlined further. And the company and I will come back and inform all investors of the next step in the US liver regulatory investigation. And latest, of course, when we report the Q2 report in July, I will give an update. And with that, I hand over to our CFO for going into the financial performance of XViva. Thank you.

Thank you. I'm happy to do so, Kristoffer. So financials for the first quarter. This was a record sales quarter with clear signs of growing momentum, as Kristoffer mentioned, especially in our core business and across all main markets. For the second quarter in a row, the strong sales momentum translated into a positive net cash flow, despite continued investments into our clinical and regulatory processes. We're very happy about that. Net sales in Q1 were 241 million SEC and organic growth was 23% and 18% excluding the heart trial revenue from the cap. Gross margins were 71%. While thoracic margins remained strong, the gross margins in abdominal and services was softer, which will be explained when I go through each business area here in a little while. Our continued focus on cost consciousness continues to translate into healthy EBIT and EBITDA levels. EBIT was 13% and EBITDA 21%. The quarter was impacted by 7 million SEK in hard to go to market preparations, non-recurring items, which explains the increase in administration costs. Setting this initiative aside, the underlying EBITDA in Q1 was 24% and more in line with what we saw in Q4 last year. So moving over to Thoracic. So the Thoracic business area accelerated in Q1 and delivered record sales of 160 million sick. Organic growth was 27% and excluding heart trial revenue, 19%. In regard to LAN, the momentum for EVLP continues to evolve positively. EVLP disposables grew 56% in Q1 and the main customer segments, the centralized perfusion hubs and larger key accounts grew double-digit. And we're very satisfied with the early phase of the perfusion partnership that we launched in Q4 with PSI, as we now have proof of concept from the first OPO EVLP hub. 10 EVLPs have been performed since the introduction of this program with good learnings and great collaboration. We also have a second OPO that was onboarded in early April, and we are hopeful that this partnership will be equally successful, of course. So this is a very exciting initiative that can have a significant impact for lung transplant patients on the waiting list in the US and can have a strong impact on the EVLP adoption over time. In regard to heart, Q1 was a very good quarter. The CAP trial, as Kristoffer mentioned, in the US, it included its last patient. Australia and New Zealand continues with extraordinary market penetration under compassionate use. And finally, what is very encouraging is that we now have a handful of countries in Europe as well, where hospitals have worked hard to get the temporary special permits in place to be able to use the technology. All this in wait for the CMR approval, of course. Gross margin, 83%. in line with last year. And this means that we have successfully increased prices to offset impacts from tariffs and also from a weakened US dollar. So overall, Thoracic experiencing a good momentum. Moving over to Abdominal. Abdominal continues to deliver good quarters. Net sales were 66 million sec and equalling an organic growth of 24%. Liver sales grew 12% in local currencies to 45 million SEK. Kidney was the shining star of the quarter in abdominal and sales grew 63% in local currencies. We see a growing interest for kidney assist transport in the North America, both in the US and Canada, and Q1 brought new accounts, both for clinical and research use. With a few important congresses coming up here in Q2, we are optimistic that the good traction for abdominal will continue as the year progresses. When it comes to gross margin in Q1, the gross margin was 54% versus 63% last year. The decrease was mainly a result of larger portion of kidney sales versus liver. but also a larger portion this quarter of sales to lower price markets such as Asia, South America and Eastern Europe. Once again, a solid quarter for abdominal as we continue to build the market for liver and continue to take market share in kidney. Moving over to services, our last business area, net sales were 60 million sec, representing a negative 10% organic growth. The two areas, Flowhawk and Organic Recovery Services, showed mixed results. Flowhawk showed an impressive growth of 62% as a result from both new customer acquisitions and upgrades and renewals. In Q1, the largest transplant program in the United States decided to implement Flowhawk. That's a true feather in the hat for the Flowhawk team, which means the software is now embedded into the day-to-day practice at six out of the 10 largest transplant programs in the country. And with continued investments into Flowhawk, we believe it truly has the potential to become the future golden standard of transplant workflows and secure communication in the field. Organic recovery showed yet another quarter with negative growth, minus 10%. And as I stated during the Q4 earnings call, We last year put a surgical organization in place that will enable us to return to growth in 2026 and beyond. Today, we have surgical capacities to significantly increase the case volume. And with ISHLT this month as a starting point, our focus from now on will lie heavily on marketing and sales execution. Gross margin decreased to 18%, and this was purely due to the lower case volumes for organ recovery at the same time as we incur fixed operational costs, keeping our surgical teams on call 24-7. But with an increase in cases, our gross margins will improve to more sustainable levels. EBITDA. So profitability was strong for the second consecutive quarter, 21% and excluding non-recurrent costs, it was 24%. So rolling 12, we're at 20% and we are on a positive trajectory on the rolling 12 KPI. In the following quarters, we will continue to manage our operating expenses with discipline and ensure resources are directed toward initiatives with clear commercial returns. Investments will mainly be directed to sales and clinical field force to capture the significant market opportunity that lies ahead of us being an all organ company. And my final slide for the day here, cash flow. And we're ending with a positive, some positive news here. So for the second consecutive quarter, we ended up with a total positive cash flow. Operating cash flow was 65 million SEKs, mainly driven by good sales momentum, of course. And the cash flow from investments was minus 55 million SEKs. But all in all, we ended up for the second quarter in a row with a positive total cash flow. And we had 308 million SEKs at hand when we closed the quarter. And with those final remarks, Christopher, I will give the word over to you again. Good luck with the end of the conference here.

Thank you. And with that, we're going to go into the outlook and look a bit into the future of what will happen this year and also what will happen long term. And we can. go to slide number 21, really focusing on this year and activities we have for this year. And again, we are going to continue to build Salesforce and build new partnerships, especially in the US to enable the OPOs and clinics to recover more lungs by EVLP adoption through a combination of a service model and staying very, very close to customers. In parallel, we just heard from our CFO that we will increase our service offering and better tailor customer needs. Now we are offering NRP procurement from an increased footprint of surgical teams that can stay close to customers and recover organs with high quality. We will continue to work close with competent authorities in Europe. to be able to use the heart box as much as possible already now. And we are aiming to obtaining a C-mark as soon as possible. I'm waiting for the last part there. Another key milestone now with the data from the U.S. Preserve Trial presented at ISFTT, we will now submit the regulatory file to the FDA for their review during the summer. And we also talked about the liver assist. We come back with more information on the regulatory route, but we know that it's soon becoming the liver gold standard in Europe. And we save hundreds of lives every quarter using liver assist. And now we want to continue to support clinics in Europe and also give the US clinicians the ability to actually use the liver assist and have the same success we have seen in Europe. We go to the next slide, 22 and a little bit longer term outlook. And I wanna state this every call for this is the reason we're here. We know that a lot of patients with end-stage organ failure are dying every day. Some of them are on the wait list, but the majority never even make the wait list. So the demand for transplant is, according to our analysis, approximately 10 times 10 of today's supply. also see that the sales value of machine perfusion that improves patient outcomes and safely increase the usage of donated organ versus cold storage is also approximately times 10 in terms of value so we see market opportunity with this almost 100 times of what we see today And we know that the machine perfusion and the service model have a proven track record and that's really been clear here when we were in ISH-AT of increased the number of organs used for transplantation and actually safely increased them with improving survival rate as well. And We also know that we see growing DCD organ pool in in many countries, it's about 50%. We know here in the US is now hitting the 50% mark. And we have clear evidence that machine perfusion is you need to use them to safely address the DCD organs. So and Xvivo, we want to change the paradigm on transportation by innovation. And we want to be very clear that we believe that innovative products and innovative perfusion and preservation solution is the key for the future. And we do have an unique, very innovative and world leading product. in the market or under IDE trials. So we believe in the longer term that we will lead this market due to innovation over time, enable lower cost in the transplant process. And we think that that will be very important going forward. And with that, we turn to slide 23 and open up for questions.