Xvivo Perfusion — Call Transcript 2026

Welcome to XVIVO Q1 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 #5 on their telephone keypad. Now I will hand the conference over to CEO Christoffer Rosenblad and CFO Kristoffer Nordström. Please go ahead. Thank you so much. Good morning and good afternoon, everyone, and welcome to XVIVO's earnings call for the first quarter of 2026. We can go to slide two, and just today's presenters are me, Christoffer Rosenblad, calling in from the 2026 ISHLT Conference in Toronto, Canada, and Kristoffer Nordström, CFO, calling in from Philadelphia in the United States. With that, we can go to slide three, financial at a glance. 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 a healthy level, resulting in a positive cash flow for the second consecutive quarter. The CFO, Kristoffer Nordström, will get more into the details on sales, gross 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 lung market trend we saw in Q4 last year continued into 2026 with a good lung market with good underlying growth. 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 transplant teams. With that, we can go over to the highlights of the quarter. We can actually jump straight to slide number 5, where we see the highlights. 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 OPO EVLP hub pilot has been very successful and is now up and running. It partly explained the increased lung sales we see in this quarter. So far, the progress is ahead of our internal plan, and we have identified 4-5 more OPOs in the rollout pipeline plan, where the second OPO 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 EVLP partners we see. We also can report that the 60-patient CAP is now fully included during the quarter. We had an extreme high interest from trial centers to use the heart technology. To satisfy their needs to use the XVIVO Heart Assist, we have asked the FDA for an extension of the CAP so they can use it, again, under the IDE we have. If we look at number five, it's a testament to how well the XVIVO Heart Assist perform, and it's best shown with the real-life experience in Australia. 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 XVIVO Heart Assist to become the global gold standard for preservation of all hearts. While we're waiting for the last part of the CE mark for heart, we should mention that both the machine and disposables are already CE marked. More and more European agencies are approving the XVIVO Heart Assist for compassionate use. 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 ten of the largest transplant programs in the U.S. have opted to use FlowHawk since it simplifies the transplant process and reduces overall costs 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 and see an increased interest to use the XVIVO organ recovery service. We had many, many good conversations during this ISHLT, for example. With all those highlights, we can go to the deep dive into the highlights on slide number six. As I said earlier, I'm right now in the middle of the ISHLT conference, which is the biggest lung and heart transplant congress in the world. After spending time here, it is clear that XVIVO is by far the innovation leader in the field of both lung and heart transplantation. For example, the XVIVO heart device was featured in two late-breaking news sessions that was very well attended and increased the interest from clinics who want to use the heart device. I 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 heart symposium, which will be really interesting to see. Already this Wednesday, we had the lung symposium. The XVIVO, industry-sponsored lung symposium, which was a great success, really, had extremely high attendance, created a lot of interest from future customers to start up EVLP program. It was also very clear that with new innovative technology on the market, the field of lung transplantations has improved significantly over the last decade. One example, over the last 5 years, the number of DCD lung transplantations has more than tripled. More so, if we look at the patient outcome, that also improved. 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. There we see that the adoption of EVLP has been key to enable safe use of those extended criteria organs. Let's jump in to the two highlights in the late-breaking news session from XVIVO. We go to next slide, which is number seven, and it was the U.S. PRESERVE trial that was presented. Again, the clinical result from investigational use is positively surprising us on the heart side. The trial was performed at 14 clinics in the U.S., and they enrolled a total of 141 patients. The U.S. study aimed to prove that extended criteria heart, as described on the slide here, could safely be transplanted using the XVIVO Heart Assist. I'm happy to announce that the study met its predefined efficacy and safety endpoint. The sub-analysis or the analysis of the secondary endpoint showed also that severe PGD was only 7.9%. Severe PGD 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. Next step is that we will now finalize the file for submission to the FDA for their review. 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. The trial was a single-arm proof of concept trial. A total of 40 adult heart transplant recipients across four European transplant centers in Belgium and the Netherlands were enrolled. The primary endpoint for patient survival at 30 days was 98%, which is very high. The secondary endpoint of severe PGD was only 5%, again, showing that the right preservation of heart keeps complications 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 costs in the transplant process and simplify for the transplant teams around the world. With that, we can go into the EU trial, which is now in a publication during Q1 this year. I again want to mention this is the first randomized control trial with superior endpoint that was ever performed in the field of heart transplantation. 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 PGD reduction, and reduced one-year mortality. We can see this at the data if you look at the little box of data that both mortality and severe PGD has a clear link, and I will explain that link. In the analysis of the trial data, it was noted that XVIVO group had a reduction of severe PGD by 76%. 20% in the control group and only 5% in the XVIVO group. It was further noted that the mortality after severe PGD was approximately 40% in both groups, leading to an increased survival of 6% in the XVIVO group versus the control group. We can also note here that the primary endpoint showed 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 XVIVO Heart Assist, and those three trials that I just went through that we have recently presented, the body of evidence in favor of the XVIVO Heart Assist is increasing significantly, which is great news. With that, I will go over to the regulatory update on slide 10, and we can actually go straight to the slide 11, which is the usual overview of our regulatory processes. The US heart trial was fully included in record time, and we now passed the 12-month patient follow-up. You saw the result of that during the late breaking news session of ISHLT and the press release we sent. We are now preparing the regulatory file. When ready, we will submit the file to the FDA for their review. The CE marking process in Europe is ongoing, and we are awaiting feedback from one competent authority. Again, as stated earlier, the HeartBox and disposable part of the product are already CE marked. We have passed the EMA consultation, and we're now waiting for the last consultation. Again, I also want to note we are ready to launch when the product is fully approved. We have a launch plan ready, we have staff recruited, and the interest from clinics in Europe is very high. as I stated earlier, we actually saw some sales already from compassionate use this quarter. Unfortunately, the European heart clinics are suffering badly from the lack of alternatives to the XVIVO Heart Assist. We are working really hard with our notified body to get the final CE mark. We are happy to see and hear all the engagement from our heart transplant clinics in Europe who 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 CE marks. We will use that as a base. I will come back to the U.S. liver update in the next slide, actually. We can go straight to that slide. Slide number 12, and the liver regulatory status. We have previously reported that the Liver Assist has been granted breakthrough device designation by the FDA. We have an approved IDE 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 Assist PMA process to investigate the alternative regulatory route. We are right now in preparation for a FDA Q-Sub meeting where the possible regulatory route will be outlined further. The company and I will come back and inform all investors of the next step in the U.S. Liver Assist regulatory investigation and later, so of course when we report the Q2 report in July, I will give an update. With that, I hand over to our CFO for going into the financial performance of XVIVO. Thank you. Thank you, and happy to do so, Christoffer. The financials for the first quarter. This was a record sales quarter with clear signs of growing momentum, as Christoffer 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 SEK 241 million, 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 SEK 7 million in heart 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. Moving over to Thoracic. The Thoracic business area accelerated in Q1 and delivered record sales of SEK 160 million. Organic growth was 27%, and excluding heart trial revenue, 19%. In regard to lung, 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. 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. This is a very exciting initiative that can have a significant impact for lung transplant patients on the waiting list in the U.S. 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 Christoffer mentioned, in the U.S., it included its last patient. Australia, New Zealand continues with extraordinary market penetration under compassionate use. 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 CE mark 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. Overall, thoracic experiencing a good momentum. Moving over to abdominal. Abdominal continues to deliver good quarters. Net sales were SEK 66 million, equaling an organic growth of 24%. Liver sales grew 12% in local currencies to SEK 45 million. Kidney was the shining star of the quarter in abdominal. Sales grew 63% in local currencies. We see a growing interest for Kidney Assist Transport in North America, both in the U.S. 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 SEK 60 million, representing a negative 10% organic growth. The two areas, FlowHawk and organ 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. 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. Organ recovery showed yet another quarter with negative growth, minus 10%. 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. 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. With an increase in cases, our gross margins will improve to more sustainable levels. EBITDA. Profitability was strong for the second consecutive quarter, 21%, and excluding non-recurrent costs, it was 24%. 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. My final slide for the day here, cash flow. We're ending with some positive news here. For the second consecutive quarter, we ended up with a total positive cash flow. Operating cash flow was SEK 65 million, mainly driven by good sales momentum, of course, and the cash flow from investments was -SEK 55 million. All in all, we ended up for the second quarter in a row with a positive total cash flow. We had SEK 308 million at hand when we closed the quarter. With those final remarks, Christoffer, I will give the word over to you again. Good luck with the end of the conference here. Thank you. With that, we go into the outlook and little bit into the future of what will happen this year and also what will happen long term. We can go to slide number 21, really focusing on this year and activities we have for this year. Again, we are going to continue to build sales force, and build new partnerships, especially in the U.S., to enable the OPOs and clinics to recover more lungs by EVLP adoption through combination of a service model and staying 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 closely with competent authorities in Europe to be able to use the Heart Box as much as possible already now, and we are aiming to obtain a CE mark as soon as possible and waiting for the last part there. Another key milestone, now with the data from the U.S. PRESERVE trial presented at ISHLT, we will now submit the regulatory file to the FDA for their review during the summer. 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. Now we want to continue to support clinics in Europe and also give the U.S. 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 want to 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. The demand for transplant is, according to our analysis, approximately 10 x 10 of today's supply. We 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. We see a market opportunity with this almost 100x of what we see today. 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 ISHLT on increasing the number of organs used for transplantation and actually safely increase them, with improving survival rate as well. We also know that we see growing DCD organ pool. In many countries it's about 50%. We know here in the U.S. it's 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. XVIVO, we want to change the paradigm on transplantation by innovation. We want to be very clear that we believe that innovative products and innovative perfusion and preservation solution is the key for the future. We do have a unique, very innovative and world-leading product in the market or under IDE trials. 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. With that, we turn to slide 23 and open up for questions. The next question comes from Simon Larsson from Danske Bank. Please go ahead. Yes. Good afternoon, everyone. Firstly, maybe on the U.S. heart theme. I noted in the press release from Wednesday that you are planning to hand in the file to the FDA later this year. Could you give us any more details on when that might be? Would be helpful. Thank you. Good question. We are sitting with the file right now. I don't have an exact timeline, but it will be somewhere during the summer. I will come back when I have a better timeline, but it's somewhere during the summer. It's not the end of the year, it's earlier than that. Yeah. Understood. Maybe it's a bit speculative at this point, but would you expect the FDA to summon an advisory committee ahead of a potential approval or yeah, what's your thinking around that dynamic? I can't speculate on what the FDA wants. We have to hand in the file and see what the feedback is and follow their process. It will be more or less impossible to speculate on what will happen or not. I know last time we had an expert panel meeting, we fared very well on the lung side with 10, 0, 10, 0, 10, 0. We know how to do this, and we are confident that we can answer any question the FDA might pose to us. Yeah, fair. I know you said in the beginning of the presentation, Christoffer, that you aim to make the Heart Box a standard of care for all hearts, basically. If you could help us understand the scope of the hearts that you will address in the U.S. maybe to begin with. Will you be focusing on the sort of marginalized ECD, DCD hearts, or older donors? Any help slicing the market opportunity and what you will target first will be also interesting to hear. That's a great question. We can only market what we get on the label, and the label will be pending the FDA review process. It's hard to say exactly. If we look at the PRESERVE trial and the inclusion, exclusion criteria there, it is exactly those hearts we're talking about. It's DCD heart, extended criteria hearts, so that's either due to more than 2-hour preservation and a couple of risk factors or more than 4 hours of. We will definitely target those hearts. We see an increasing interest here from U.S. clinicians. We will have a quite broad target when we launch the product to make sure that we can reach all clinics as soon as possible after day one of the launch. Makes sense. Maybe then the final one from my end, turning a bit to the lung part of the business. Obviously, the EVLP part is doing very good here. Could you say anything about the pipeline, how it looks for new accounts, both in terms of new centers, also OPOs, of course, and also if you're happy with the revenue generation from the new XPS accounts that you signed last year? Maybe your visibility for the lungs here in the coming, let's say, couple of quarters as well. What I know here from ISHLT is that there is a growing interest for an EVLP program, and we do see great progress now, both in underlying market growth, where we see that more and more data is getting published showing that using EVLP for extended grafts or DCD grafts has a really positive impact on the overall survival and that we use more organs. In general, there is a good underlying trend for the lung market. The other thing which we are working with is to put the XPS into more hands, so to say, so we can do it, and especially the hub model that one OPO or one center pumps lungs for a larger area, which we have seen has been very successful before. We have a positive outlook, but again, looking into the future, it's impossible. What we can see so far, it looks very good. Especially, I'm really encouraged after all the meetings we had here in both the lung symposium and all the customer interactions from here, from ISHLT. We see positive outlook. Got you. Great. Thanks so much. Thank you. The next question comes from Ulrik Trattner from DNB Carnegie. Please go ahead. Thank you very much. A few on my end, and I'll start off with the abdominal growth margins. Kristoffer, you touched upon this, but I also noticed that the gross margin was kind of equally low in Q4. Is there effects related to this since you moved your manufacturing to Sweden from the Netherlands? Is it just market product mix that we should expect to revert here in the short term? I can start a little bit high level and then, Nordström, if you want to pitch in on this one. If we take high level, there is today in the abdominal field slightly lower gross margins in Europe versus the U.S. It's partly a regional mix that we hope over time we will grow out of. Also, we are moving production right now and have not reached the full scale in production that we want. It's not, let's say, call it a quick fix, but we diligently work to improve the gross margin for our abdominal portfolio in the next quarters and years to come. We see a gradual improvement, is my belief. I can just add as well, Christoffer, that we do expect to see the growing gross margins for abdominal. What will impact that is, of course, when we start to see a stronger ramp-up in the United States. It was a good quarter in North America, abdominal sales this quarter, but it was partly research sales, that over time, of course, will translate into more clinical sales, so to say. It's still very much of a European business with some regions with lower pricing. Okay, great. On to sort of prospects going ahead and the Q-Sub meeting that you have scheduled. What is your ambition going into this? You can obviously go down a few routes here. Are you aiming to use the European data in order to get approval as you did for kidney or 510(k)? What is sort of the most feasible and reasonable pathway forward here? It's a great question. I mean, of course, we're aiming that, but we will have a dialogue with FDA. We had a very positive meeting earlier this year, and we will continue in a more official Q-Sub meeting with them to get a firm route forward. We, of course, aim to leverage as much of the European data as possible. We would also be in listening mode and see what the requirements from the FDA is. That would be a good dialogue that we have started that is very good and positive. We also have to be humble that the FDA is deciding in this case. We will argue our case and see what comes out of it. Just correct me if I'm wrong, but wouldn't it be beneficial on your end to actually generate some U.S. data prior to launching it? Given, in hindsight, what we have seen with the kidney launch, that U.S. data is of high importance in order to reach higher volume. Yeah. Potentially a 510(k) would be the preferred route on your end. Yeah. The good news with the 510(k) route is that the, let's say, burden of proof is lessened. It's more towards safety than efficacy. You're right. In either way, whatever the FDA says, we need to do a trial if it's, let's say, before or after. We will do a clinical trial in the U.S. to make sure that the American users can replicate the European data. That is extremely good for it to be believable. You're right, with the kidney experience, we learned that very fast, that launching a product without U.S. data will not make it fly. We have to do something either way. We're still aiming to leverage as much as possible of the very positive European data. It's by far the largest body of clinical data we have for short, long-term, all sorts of grafts, which are very positive. That's of course our aim. Great. A question on the CAP program, as you went from four patients in Q3 2022 and now 36 here in Q1, and I would assume that the interest has not come down post ISHLT. How quickly can you get a sort of re-approval or expansion of your CAP program in the U.S.? We're aiming as soon as possible. It is under review from the FDA, and they will come back to us soon, according to what they said. Again, it's hard to speculate on the FDA timeline and the work burden they have. What we can say is that, yeah, the interest is extremely high from U.S. clinicians before the ISHLT and before those two presentations, and it has increased significantly after. That is very clear. Can you give some type of indication on just the penetration per the sites who are actually active in the CAP program? Are they using it on all of their hearts that are being transplanted, or is it just a portion of them, or can you give us any more insight to that? That would be very interesting. Yeah, that's a good question. We should remember right now that this is a scarce resource for them. There is a limited number of patients, so they only use it on the worst grafts and the sickest patients where they see no other use right now. We should remember that. We can see in some CAP centers that it's quite high penetration. The testimonial I get when I'm here from the users is that this is so easy to use, it's really plug and play, and the hearts are in an excellent condition after being in the XVIVO Heart Assist. Some have quite high penetration, but we should remember that it would be higher if we would have an approval or, let's say, it's unlimited use, because now it's capped to number of patients. I think it's more interesting to look to the Australian situation where there is an uncapped continuous access protocol, so to say, similar, but it's uncapped too. There we see that it's 50% for DBDs, and now we're starting with DCD. Sure. Yeah. Just on the data that you have generated here lately and percentage, obviously a positive outcome in the U.S. and four additional patients in Europe on HOPE. Are you adding this to the European regulatory agencies and have this in any way increased your confidence in obtaining approval for the Heart Box here in 2026? The straight answer is yes. The feedback we get from those compassionate use is that, yeah, we don't see any alternative on the market for any grafts, pediatric, adult, DCD or DBD. It's really encouraging to see medical agencies in Europe looking into the file, clearly state there is no alternative. We need compassionate use for this product. Yes, the straight answer is yes, we get more confident the more we talk to medical agencies and the more we talk to clinicians of how important this is. Again, the regulatory process is a regulatory process and it's hard to speculate. Definitely, due to this, we are more confident, yes. Great. Last question on my end. Did you mention that you had found 4-5 OPO targets to sort of be integrated into an EVLP program? If I heard that clearly. Yeah. 4-5 are identified in the pipeline right now. To clarify that, we have done our first installation, very successful ahead of plan. We are doing our second one, I think, yeah, while we speak or at least very soon after ISHLT. There is a rollout plan, which to some extent will be resource limited, but we have a clear plan and we're going to make sure that we are successful in every installation. We're going to make sure that we all get. We are also increasing our internal resources to be able to handle that increased growth and increased interest from OPOs, where, in all honesty, the XPS and the STEEN Solution was developed in the beginning for this target group of OPOs. It's great to be back home again, so to say, and see the OPOs using it. Okay, great. Essentially it's an acceleration, not sort of a maintained pace, even with your sort of limited resources. We will try to accelerate it as fast as possible, but we will be very conscious that we want to have the right quality of people, both from our side, from our partners' sides, and from the OPO side to make sure that each and every OPO program is a successful program, where the clinicians really get the organs they so deserve for the patients on the waiting list. We will be very cautious on keeping a high quality. Great. Well, thanks for taking the question and congrats on the successful data and presentation at ISHLT. Thank you. I'll get back into the queue. The next question comes from Jakob Lemke from SEB. Please go ahead. Yes, hello. My first question is on the strong EVLP sales here in Q1. I'm wondering if you can sort of elaborate a bit more across the different customer groups, sort of your single one large customer, other U.S. customers, as well as ex-U.S. during the quarter? Yes, definitely can do that. It is one, an underlying market growth where we see an increased interest to making more lung transplantations. We see a changing organ pool where more and more organs become extended criteria or DCD. That's the underlying growth we see fueling the interest. We see both a, let's call it an underlying growth from existing customers. We see that we now add new customers as well, which are slowly becoming more up and running. We see, of course, the fast uptake in the pilot of the OPO. Those are, let's say, the three reasons. We also see that with increase in the sales footprint, in other words, number of feet on the ground close to customers, we can see an increased usage. It's a direct link there. Okay. Also, I'm wondering if there was any sort of large orders or timing effects impacting the strong Q1 sales for EVLP? We saw the trend in Q4, and I think that trend continued into Q1. We didn't see any huge, let's call it seasonal effect or upstocking, destocking during either this quarter, this year or Q1 this year or Q1 last year. I guess my question then is it fair to assume then that this is sort of a new baseline for EVLP consumables? Yeah, I think that's a fair assumption. We do see an increasing interest and we do foresee that we will continue to grow both existing and new EVLP programs. Absolutely. Good. I also have a question on heart and the compassionate use in Europe. I'm wondering if you can elaborate a bit on sort of how freely the centers can use the product right now, and also if you can share how many centers that are live and if you have any more that you think will go live soon. Yeah, I think to start with, when we talk about compassionate use, there are, of course, limitations to it. Also this is in Europe, so it's different country by country. Hopefully, soon here it's going to be more Australian-like, and some will be more restricted in terms of when you can use it or not. It's hard to give one answer to that question because it's many countries. We do see that more and more countries are opening up for this opportunity, and that is very positive. That's the key message. We, of course, hope that we don't need this and get the CE mark very soon. We see that we can keep the high interest and continues to save patients where there is no alternative to the XVIVO Heart Assist, which is the case right now. Okay. I'm also wondering if there's been any new or recent dialogue with the notified body or the competent authority regarding EU CE mark, and also if you expect to get the approval done in early summer? We are in dialogue with our notified body. To clarify, we are not in direct contact with competent authorities in this case because they have asked for a consultation, and we are in contact with the notified body. The answer is yes to notified body. There has been contact. From what we heard from them, yes, we should expect something here in early summer or summer. That's the latest we heard. We are crossing our fingers and provide all the information we possibly can to make sure that we can get a good decision. Okay, this final question, sort of a follow-up to the earlier discussion about the potential label of the heart product in the U.S. I'm just thinking that the FDA must surely also include or consider the data you have gathered outside of the U.S., sort of the European randomized two-arm trial and as well the Australian trial. I guess it must be a very broad label because you have the broadest data of any machine perfusion product out there, right? To start with, we're extremely proud of all the data we have. Every time we do something with XVIVO Heart Assist Transport, the clinical outcome is better than we could expect from it. We're very proud of it. It's hard to speculate on the FDA and what they will do. We will of course submit all data for their review. The lowest bar is for safety reasons. We will argue that it should be taken into consideration at least for a future label discussion. It's hard to speculate on the ruling from the FDA, so to say, regarding the label. If we look at the inclusion/exclusion criteria in the United States PRESERVE trial, it will cover the majority of donated hearts as it is already today. That in itself would be an extremely good label. Okay. I understand that. Thank you very much. That's all from me today. Thanks. Thank you. The next question comes from Filip Wiberg from Pareto Securities. Please go ahead. Hi, good afternoon. First, I think I just would like to follow up on a prior question about the strength in EVLP this quarter. I suppose, like the largest customer explains some part of the strength at least. Given that, I'm just trying to get a better sense of the risk of ending up in a similar situation that we had last year with the destock. You said that you don't think there are any stocking effects this quarter, but could you please just talk a little bit about that and the visibility for this largest customer? Oh, yeah. That's a good question. We have very good visibility and very good dialogue with our largest customers, and we could see that they grow actually as much as other customers during Q1. Like we are, they are also depending on the underlying market growth, so to say. We have a very good one-year visibility into what they aim to do. They are, for the same reasons we are, dependent on the underlying market growth. We saw that last year in Q2 last year. It was that we got a dip during one quarter. If the momentum we see now that we believe will continue, we have good visibility. Good. Thanks for that. We talked a little about the gross margins here, but perhaps one on thorax, which was actually okay this quarter. I'm just thinking about it going forward now when EVLP is growing, Perfadex becoming a smaller part. Will you be able to defend the gross margin you've had when EVLP continues to grow and takes a bigger share? How you believe it's going to be affected when you launch heart in both Europe and in the U.S. That is our goal, to defend the thoracic gross margins. You have a point that this quarter was extraordinary when it comes to EVLP portion out of sales, right? We have a lower margin on EVLP than on Perfadex. We also see the growth initiatives in the U.S. We have good prices on those. I'm speaking about the hub model for EVLP. Also we have not yet decided on the heart price in the U.S. as well, which will be a contributor to the gross margins going forward. What we feel for thoracic, that we are in a good spot, and we will work to continue to defend also the abdominal margins here in 2026, of course. I don't know, but the bigger picture is also that for our thorax products or heart and lung, we can have more of a global price list. We don't see any regional differences if you compare, and we're not yet there for our abdominal products. That's something we need to work on, of course. We are more confident. Of course, with heart, when you start up production, there is always slightly lower. I am confident that we very soon can get the heart up and running and reach scale in production. All right, good. Perhaps another one to you, Nordström, about the EBITDA margin. You stated it was 24% excluding used heart activities, but I think you said as well that there was some non-recurring costs this quarter. Could you elaborate a little bit about that? Was it only related now to Q1 and nothing going forward? Thank you. Good question, and perhaps deserves some clarification. This also ties into one of the questions I see here in the chat as well. No, it's the same thing. What I referred to as non-current was the SEK 7 million that we spent on foundational heart logistics preparations consultancy work to prepare for the U.S. heart launch. For us, that was a foundational activity, a bit of a one-time. I think the other investments we will do going forward, which we have touched upon in earlier calls as well, is really to build out the U.S. organization to prepare for the launch. I think that will be more of a linear stepwise growth in OpEx in marketing and sales. Overall, on EBITDA, last time I checked the consensus, I think that's kind of where we are aiming to land for the full year of 2026. Okay, good. Thanks. Just to be clear, admin costs, you expect that to come down from Q1 levels? Yes Increasing the selling expenses going forward? Correct. Okay, good. Just last question. I was curious around the next step in direct procurement DCD, so the study Philip Braga presented. What are going to be the next step in this? I suppose there will be more studies required to get the surgeons confident in using this approach, or what do you have to say about that? Yeah, there will be many steps in this. The first one, we hope that Philip Braga can submit a paper on how to do this, so we get a standardized approach to direct procurement. This was, of course, a very important step to make this data public and also to get the interest up for direct procurement. What we've seen is that the uptake is pretty fast once you got the hang of it and you've done it. The interest to avoid all complicated other processes you would have to do, such as NRP or very expensive machinery, in DCD hearts is avoided. You reduce cost, you reduce complexity, et cetera. The interest to go this route was, during the late breaking news, extremely high. There was unfortunately not enough time for questions, but we will revisit that during our heart symposium today, so hopefully more people can ask questions. Then again, this is a technique that spreads really surgeon to surgeon, so they will talk to each other and train each other and get more and more confident over time. Okay, good. Thank you very much. That was all from me. Thank you. I actually have to leave quite. The next question comes from Ludwig Germunder from Handelsbanken. Please go ahead. Hi, and thank you for taking my questions. I would like to follow up with another question on the EVLP and in line with some questions already asked. I would like to hear if you could say something about how you see the recovery in terms of how much is recovered now on EVLP. Are we back at previous normal levels? You mentioned this is fair to assume as a new baseline in EVLP consumable sales. Do you see any more recovery to do before you're back at some sort of pre-levels, after last year? No, I think not so much recovery. We have to be very aggressive and find new customers and new concepts which satisfy the needs from American surgeons, such as the OPO model. We will continue to build on what we have, so to speak, on the foundation we have now established during Q4 and Q1. I want to mention that last year, there was a tough period for lung transplantation in terms of the numbers flattened out and there was a lack of resources in the system. Again, the system reacted quickly. I think we reacted quickly to give them alternative resources with partnerships. I more look at it as a forward-looking exercise. Okay, I see. Thank you. I have a question. I'm not sure if you mentioned it already. I apologize if you did, but on the CAP study for heart, you filled the 60 hearts that you were allowed to do. You previously mentioned that you could possibly get another 60 hearts. Can you comment anything on the status around that now? No, I can't comment further than I already did. We have applied for another 60, and we do hope that FDA come back as soon as possible. We have to understand, we are under an IDE, and FDA are deciding what we can do and not do during an IDE. I got it. Those are my questions. Thank you for taking my questions. Thank you. Thanks. Should we continue or would you like to end the call? Yeah, continue. If the last two questions, we can keep them short. I know we're over time, and I actually have to leave for another meeting, but I see there are two more analysts who have questions. Okay. I do want to give them the opportunity to ask those questions. I will ask Let's continue. Fairly brief. The next question comes from Oscar Bergman from Redeye. Please go ahead. Hello, Kristoffer. I will be really, really quick. We can talk later on the phone. Just wondering, R&D costs are SEK 37 million, if that should be considered sort of a baseline going forward, or if there are any one-offs that make maybe the last couple of quarters a better baseline? Yeah, good question. I think it could be used as a baseline for the rest of the quarters here this year, but you will see a significantly lower spend on the other type of CapEx, material assets. We're very soon done with investments into increasing the product capacity. I think all in all, you will see lower CapEx in 2026 than you saw in 2025. Which means that we are optimistic that we should be able to end the year on a cash positive level here, which would be first time in XVIVO history. Thanks. When you have the CE marking in place for the heart product, will you be able to implement any price changes in Australia and New Zealand? If yes, roughly how much, and will it be immediately after the CE marking? To start with, the CE mark will be the base for the approval in Australia, but we still need to go through a review process there to start with. Now we have a fixed reimbursement, so with the increasing body of evidence in terms of health and hospital economics, we will of course, improve reimbursement levels, and the chance of doing that is a lot higher after an approval, so to say. Now you get what you get, so to say, during an unapproved product. That's a job that will start. It will not be immediate. You do have to work with reimbursement in each country. Okay. That's good enough for me. Thank you. The next question comes from Edward Hall from Stifel. Please go ahead. Thank you very much, guys, for taking my questions. Just quickly on lung and how we should think about it for the rest of the year. I think you've outlined the underlying existing customers. The new customers are growing, and obviously looking at Q2 and Q3 are weaker comps. Is there anything that you would point out to show anything that I may be missing outside of the trends that you've already outlined? That would just be my first question. Thank you. Thank you, Ed, for that question. I do think that there will, of course, be seasonality like in any business, and also depending on the number of donors going for EVLP. I still state this, we do see an increased interest for lung transplantation in general and for EVLP in particular, based on the body of evidence we see now, for example, there was a presentation here during ISHLT, which show that you get better outcome on both DBD and DCD for EVLP if you standardize your EVLP program and EVLP protocol. If you have a very clear inclusion criteria, you actually get better results from using EVLP than standard of care. I think this growing body of evidence speaks for EVLP increasing as an indication of all lungs. Perfect. No, that makes sense. Just final question from my side. Just want to get your thoughts on how transplant surgeons are thinking about the trade-off between sort of the increased ECMO use that we saw in the PRESERVE data for some of the DCD implants versus what actually came out with lower severe PGD. From your talks that you've had this week at the Congress, is there any initial thoughts you could comment on there? No, I think that everyone was surprised that the data was as good as it was because the donor pool and the patients were very marginal, so to say. This was better than expected from many of the trial centers, so that was really good news. I think that we saw still a low level of severe PGD was really good. I think that would be the leading indicator for us, and that we also could see that we could replicate that in survival data, really strengthen the whole belief for what this product can do once it's on the market. Perfect. Okay. That makes sense. It sounds like actually the lower PGD rate is really the driving force in that trade-off. Yeah. That's how I should think about it. Yeah. Okay, perfect. Thank you very much. Thank you very much, everyone. Sorry for going a little bit over time. We will now end the call and move to the last slide where we want to thank you so much for today, and we meet next time on July 14th.

Speaker 7: Welcome to XVIVO Q1 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 #5 on their telephone keypad. Now I will hand the conference over to CEO Christoffer Rosenblad and CFO Kristoffer Nordström. Please go ahead. Welcome to XVIVO Q1 report for 2026. welcome to xvivo q1 report for 2026 For the first part of the conference call, the participants will be in listen-only mode. 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 #5 on their telephone keypad. during the questions and answers session participants are able to ask questions by dialing #5 on their telephone keypad Now I will hand the conference over to CEO Christoffer Rosenblad and CFO Kristoffer Nordström. now i will hand the conference over to ceo christoffer rosenblad and cfo kristoffer nordström Please go ahead. please go ahead

Speaker 1: Thank you so much. Good morning and good afternoon, everyone, and welcome to XVIVO's earnings call for the first quarter of 2026. We can go to slide two, and just today's presenters are me, Christoffer Rosenblad, calling in from the 2026 ISHLT Conference in Toronto, Canada, and Kristoffer Nordström, CFO, calling in from Philadelphia in the United States. With that, we can go to slide three, financial at a glance. 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 a healthy level, resulting in a positive cash flow for the second consecutive quarter. Thank you so much. thank you so much Good morning and good afternoon, everyone, and welcome to XVIVO's earnings call for the first quarter of 2026. good morning and good afternoon everyone and welcome to xvivo's earnings call for the first quarter of 2026 We can go to slide two, and just today's presenters are me, Christoffer Rosenblad, calling in from the 2026 ISHLT Conference in Toronto, Canada, and Kristoffer Nordström, CFO, calling in from Philadelphia in the United States. we can go to slide two and just today's presenters are me christoffer rosenblad calling in from the 2026 ishlt conference in toronto canada and kristoffer nordström cfo calling in from philadelphia in the united states With that, we can go to slide three, financial at a glance. with that we can go to slide three financial at a glance We see that the first quarter of this year showed a 23% organic top-line growth. 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. 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 a healthy level, resulting in a positive cash flow for the second consecutive quarter. ebitda was kept at a healthy level resulting in a positive cash flow for the second consecutive quarter The CFO, Kristoffer Nordström, will get more into the details on sales, gross 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 lung market trend we saw in Q4 last year continued into 2026 with a good lung market with good underlying growth. 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 transplant teams. The CFO, Kristoffer Nordström, will get more into the details on sales, gross margin, and EBITDA later in this presentation. the cfo kristoffer nordström will get more into the details on sales gross margin and ebitda later in this presentation Short on the segments. short on the segments Both the thoracic and abdominal segments are growing rapidly in both regions, which are North America and Europe. both the thoracic and abdominal segments are growing rapidly in both regions which are north america and europe The lung market trend we saw in Q4 last year continued into 2026 with a good lung market with good underlying growth. the lung market trend we saw in q4 last year continued into 2026 with a good lung market with good underlying growth We see that a larger sales footprint supporting more customers is paying off. 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. 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 transplant teams. 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 transplant teams With that, we can go over to the highlights of the quarter. We can actually jump straight to slide number 5, where we see the highlights. 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 OPO EVLP hub pilot has been very successful and is now up and running. It partly explained the increased lung sales we see in this quarter. So far, the progress is ahead of our internal plan, and we have identified 4-5 more OPOs in the rollout pipeline plan, where the second OPO in that plan will be onboarded already now in Q2. With that, we can go over to the highlights of the quarter. with that we can go over to the highlights of the quarter We can actually jump straight to slide number 5, where we see the highlights. we can actually jump straight to slide number 5 where we see the highlights Very, very busy quarter. 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. 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 OPO EVLP hub pilot has been very successful and is now up and running. secondly we also had the very important opo evlp hub pilot has been very successful and is now up and running It partly explained the increased lung sales we see in this quarter. it partly explained the increased lung sales we see in this quarter So far, the progress is ahead of our internal plan, and we have identified 4-5 more OPOs in the rollout pipeline plan, where the second OPO in that plan will be onboarded already now in Q2. so far the progress is ahead of our internal plan and we have identified 4-5 more opos in the rollout pipeline plan where the second opo 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 EVLP partners we see. We also can report that the 60-patient CAP is now fully included during the quarter. We had an extreme high interest from trial centers to use the heart technology. To satisfy their needs to use the XVIVO Heart Assist, we have asked the FDA for an extension of the CAP so they can use it, again, under the IDE we have. If we look at number five, it's a testament to how well the XVIVO Heart Assist perform, and it's best shown with the real-life experience in Australia. 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. 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 EVLP partners we see. 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 evlp partners we see We also can report that the 60-patient CAP is now fully included during the quarter. we also can report that the 60-patient cap is now fully included during the quarter We had an extreme high interest from trial centers to use the heart technology. we had an extreme high interest from trial centers to use the heart technology To satisfy their needs to use the XVIVO Heart Assist, we have asked the FDA for an extension of the CAP so they can use it, again, under the IDE we have. to satisfy their needs to use the xvivo heart assist we have asked the fda for an extension of the cap so they can use it again under the ide we have If we look at number five, it's a testament to how well the XVIVO Heart Assist perform, and it's best shown with the real-life experience in Australia. if we look at number five it's a testament to how well the xvivo heart assist perform and it's best shown with the real-life experience in australia 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. 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 XVIVO Heart Assist to become the global gold standard for preservation of all hearts. While we're waiting for the last part of the CE mark for heart, we should mention that both the machine and disposables are already CE marked. More and more European agencies are approving the XVIVO Heart Assist for compassionate use. 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. It's a very important milestone and makes us convinced that we should aim for the XVIVO Heart Assist to become the global gold standard for preservation of all hearts. it's a very important milestone and makes us convinced that we should aim for the xvivo heart assist to become the global gold standard for preservation of all hearts While we're waiting for the last part of the CE mark for heart, we should mention that both the machine and disposables are already CE marked. while we're waiting for the last part of the ce mark for heart we should mention that both the machine and disposables are already ce marked More and more European agencies are approving the XVIVO Heart Assist for compassionate use. more and more european agencies are approving the xvivo heart assist for compassionate use We actually saw sales in Europe picking up already now in Q1. 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. 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. 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 ten of the largest transplant programs in the U.S. have opted to use FlowHawk since it simplifies the transplant process and reduces overall costs 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 and see an increased interest to use the XVIVO organ recovery service. We had many, many good conversations during this ISHLT, for example. With all those highlights, we can go to the deep dive into the highlights on slide number six. As I said earlier, I'm right now in the middle of the ISHLT conference, which is the biggest lung and heart transplant congress in the world. After spending time here, it is clear that XVIVO is by far the innovation leader in the field of both lung and heart transplantation. Already now, six out of ten of the largest transplant programs in the U.S. have opted to use FlowHawk since it simplifies the transplant process and reduces overall costs in the process. already now six out of ten of the largest transplant programs in the u.s. have opted to use flowhawk since it simplifies the transplant process and reduces overall costs in the process The organ recovery business is now ready for growth, and we have a positive outlook for the rest of the year. 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 and see an increased interest to use the XVIVO organ recovery service. We had many, many good conversations during this ISHLT, for example. we offer nrp if needed and see an increased interest to use the xvivo organ recovery service. we had many many good conversations during this ishlt for example With all those highlights, we can go to the deep dive into the highlights on slide number six. with all those highlights we can go to the deep dive into the highlights on slide number six As I said earlier, I'm right now in the middle of the ISHLT conference, which is the biggest lung and heart transplant congress in the world. as i said earlier i'm right now in the middle of the ishlt conference which is the biggest lung and heart transplant congress in the world After spending time here, it is clear that XVIVO is by far the innovation leader in the field of both lung and heart transplantation. after spending time here it is clear that xvivo is by far the innovation leader in the field of both lung and heart transplantation For example, the XVIVO heart device was featured in two late-breaking news sessions that was very well attended and increased the interest from clinics who want to use the heart device. I 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 heart symposium, which will be really interesting to see. Already this Wednesday, we had the lung symposium. The XVIVO, industry-sponsored lung symposium, which was a great success, really, had extremely high attendance, created a lot of interest from future customers to start up EVLP program. It was also very clear that with new innovative technology on the market, the field of lung transplantations has improved significantly over the last decade. For example, the XVIVO heart device was featured in two late-breaking news sessions that was very well attended and increased the interest from clinics who want to use the heart device. for example the xvivo heart device was featured in two late-breaking news sessions that was very well attended and increased the interest from clinics who want to use the heart device I go into those. i go into those We have some press releases regarding those, but I will go into them later in the next slide. 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 heart symposium, which will be really interesting to see. i also want to highlight that very soon after this meeting we will have our heart symposium which will be really interesting to see Already this Wednesday, we had the lung symposium. already this wednesday we had the lung symposium The XVIVO , industry-sponsored lung symposium, which was a great success, really, had extremely high attendance, created a lot of interest from future customers to start up EVLP program. the xvivo industry-sponsored lung symposium which was a great success really had extremely high attendance created a lot of interest from future customers to start up evlp program It was also very clear that with new innovative technology on the market, the field of lung transplantations has improved significantly over the last decade. it was also very clear that with new innovative technology on the market the field of lung transplantations has improved significantly over the last decade One example, over the last 5 years, the number of DCD lung transplantations has more than tripled. More so, if we look at the patient outcome, that also improved. 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. There we see that the adoption of EVLP has been key to enable safe use of those extended criteria organs. Let's jump in to the two highlights in the late-breaking news session from XVIVO. We go to next slide, which is number seven, and it was the U.S. PRESERVE trial that was presented. Again, the clinical result from investigational use is positively surprising us on the heart side. One example, over the last 5 years, the number of DCD lung transplantations has more than tripled. one example over the last 5 years the number of dcd lung transplantations has more than tripled More so, if we look at the patient outcome, that also improved. more so if we look at the patient outcome that also improved 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. 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 There we see that the adoption of EVLP has been key to enable safe use of those extended criteria organs. there we see that the adoption of evlp has been key to enable safe use of those extended criteria organs Let's jump in to the two highlights in the late-breaking news session from XVIVO. let's jump in to the two highlights in the late-breaking news session from xvivo We go to next slide, which is number seven, and it was the U.S. we go to next slide which is number seven and it was the u.s PRESERVE trial that was presented. preserve trial that was presented Again, the clinical result from investigational use is positively surprising us on the heart side. again the clinical result from investigational use is positively surprising us on the heart side The trial was performed at 14 clinics in the U.S., and they enrolled a total of 141 patients. The U.S. study aimed to prove that extended criteria heart, as described on the slide here, could safely be transplanted using the XVIVO Heart Assist. I'm happy to announce that the study met its predefined efficacy and safety endpoint. The sub-analysis or the analysis of the secondary endpoint showed also that severe PGD was only 7.9%. Severe PGD 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. Next step is that we will now finalize the file for submission to the FDA for their review. The trial was performed at 14 clinics in the U.S., and they enrolled a total of 141 patients. the trial was performed at 14 clinics in the u.s and they enrolled a total of 141 patients The U.S. study aimed to prove that extended criteria heart, as described on the slide here, could safely be transplanted using the XVIVO Heart Assist. the u.s study aimed to prove that extended criteria heart as described on the slide here could safely be transplanted using the xvivo heart assist I'm happy to announce that the study met its predefined efficacy and safety endpoint. i'm happy to announce that the study met its predefined efficacy and safety endpoint The sub-analysis or the analysis of the secondary endpoint showed also that severe PGD was only 7.9%. the sub-analysis or the analysis of the secondary endpoint showed also that severe pgd was only 7.9% Severe PGD is the leading cause for early and late mortality in heart transplantation. severe pgd 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. i will come back later here on the importance of it when we look over the european data Next step is that we will now finalize the file for submission to the FDA for their review. next step is that we will now finalize the file for submission to the fda for their review 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. The trial was a single-arm proof of concept trial. A total of 40 adult heart transplant recipients across four European transplant centers in Belgium and the Netherlands were enrolled. The primary endpoint for patient survival at 30 days was 98%, which is very high. The secondary endpoint of severe PGD was only 5%, again, showing that the right preservation of heart keeps complications 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 costs in the transplant process and simplify for the transplant teams around the world. 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. 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 The trial was a single-arm proof of concept trial. the trial was a single-arm proof of concept trial A total of 40 adult heart transplant recipients across four European transplant centers in Belgium and the Netherlands were enrolled. a total of 40 adult heart transplant recipients across four european transplant centers in belgium and the netherlands were enrolled The primary endpoint for patient survival at 30 days was 98%, which is very high. the primary endpoint for patient survival at 30 days was 98% which is very high The secondary endpoint of severe PGD was only 5%, again, showing that the right preservation of heart keeps complications after heart transplantation low. the secondary endpoint of severe pgd was only 5% again showing that the right preservation of heart keeps complications 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 costs in the transplant process and simplify for the transplant teams around the world. 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 costs in the transplant process and simplify for the transplant teams around the world With that, we can go into the EU trial, which is now in a publication during Q1 this year. I again want to mention this is the first randomized control trial with superior endpoint that was ever performed in the field of heart transplantation. 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 PGD reduction, and reduced one-year mortality. We can see this at the data if you look at the little box of data that both mortality and severe PGD has a clear link, and I will explain that link. In the analysis of the trial data, it was noted that XVIVO group had a reduction of severe PGD by 76%. 20% in the control group and only 5% in the XVIVO group. With that, we can go into the EU trial, which is now in a publication during Q1 this year. with that we can go into the eu trial which is now in a publication during q1 this year I again want to mention this is the first randomized control trial with superior endpoint that was ever performed in the field of heart transplantation. i again want to mention this is the first randomized control trial with superior endpoint that was ever performed in the field of heart transplantation No one dared to try this before, but we did. 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 PGD reduction, and reduced one-year mortality. it is also the first clinical trial to establish a link between preservation method severe pgd reduction and reduced one-year mortality We can see this at the data if you look at the little box of data that both mortality and severe PGD has a clear link, and I will explain that link. we can see this at the data if you look at the little box of data that both mortality and severe pgd has a clear link and i will explain that link In the analysis of the trial data, it was noted that XVIVO group had a reduction of severe PGD by 76%. 20% in the control group and only 5% in the XVIVO group. in the analysis of the trial data it was noted that xvivo group had a reduction of severe pgd by 76% 20% in the control group and only 5% in the xvivo group It was further noted that the mortality after severe PGD was approximately 40% in both groups, leading to an increased survival of 6% in the XVIVO group versus the control group. We can also note here that the primary endpoint showed 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 XVIVO Heart Assist, and those three trials that I just went through that we have recently presented, the body of evidence in favor of the XVIVO Heart Assist is increasing significantly, which is great news. With that, I will go over to the regulatory update on slide 10, and we can actually go straight to the slide 11, which is the usual overview of our regulatory processes. It was further noted that the mortality after severe PGD was approximately 40% in both groups, leading to an increased survival of 6% in the XVIVO group versus the control group. it was further noted that the mortality after severe pgd was approximately 40% in both groups leading to an increased survival of 6% in the xvivo group versus the control group We can also note here that the primary endpoint showed statistical significance at day 365, which is good. we can also note here that the primary endpoint showed 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 XVIVO Heart Assist, and those three trials that I just went through that we have recently presented, the body of evidence in favor of the XVIVO Heart Assist is increasing significantly, which is great news. with the experience we have seen in australia with more than 50% of all dbd hearts now being preserved on the xvivo heart assist and those three trials that i just went through that we have recently presented the body of evidence in favor of the xvivo heart assist is increasing significantly which is great news With that, I will go over to the regulatory update on slide 10, and we can actually go straight to the slide 11, which is the usual overview of our regulatory processes. with that i will go over to the regulatory update on slide 10 and we can actually go straight to the slide 11 which is the usual overview of our regulatory processes The US heart trial was fully included in record time, and we now passed the 12-month patient follow-up. You saw the result of that during the late breaking news session of ISHLT and the press release we sent. We are now preparing the regulatory file. When ready, we will submit the file to the FDA for their review. The CE marking process in Europe is ongoing, and we are awaiting feedback from one competent authority. Again, as stated earlier, the HeartBox and disposable part of the product are already CE marked. We have passed the EMA consultation, and we're now waiting for the last consultation. Again, I also want to note we are ready to launch when the product is fully approved. We have a launch plan ready, we have staff recruited, and the interest from clinics in Europe is very high. The US heart trial was fully included in record time, and we now passed the 12-month patient follow-up. the us heart trial was fully included in record time and we now passed the 12-month patient follow-up You saw the result of that during the late breaking news session of ISHLT and the press release we sent. you saw the result of that during the late breaking news session of ishlt and the press release we sent We are now preparing the regulatory file. we are now preparing the regulatory file When ready, we will submit the file to the FDA for their review. when ready we will submit the file to the fda for their review The CE marking process in Europe is ongoing, and we are awaiting feedback from one competent authority. the ce marking process in europe is ongoing and we are awaiting feedback from one competent authority Again, as stated earlier, the HeartBox and disposable part of the product are already CE marked. again as stated earlier the heartbox and disposable part of the product are already ce marked We have passed the EMA consultation, and we're now waiting for the last consultation. we have passed the ema consultation and we're now waiting for the last consultation Again, I also want to note we are ready to launch when the product is fully approved. again i also want to note we are ready to launch when the product is fully approved We have a launch plan ready, we have staff recruited, and the interest from clinics in Europe is very high. we have a launch plan ready we have staff recruited and the interest from clinics in europe is very high as I stated earlier, we actually saw some sales already from compassionate use this quarter. Unfortunately, the European heart clinics are suffering badly from the lack of alternatives to the XVIVO Heart Assist. We are working really hard with our notified body to get the final CE mark. We are happy to see and hear all the engagement from our heart transplant clinics in Europe who 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 CE marks. We will use that as a base. I will come back to the U.S. liver update in the next slide, actually. We can go straight to that slide. Slide number 12, and the liver regulatory status. as I stated earlier, we actually saw some sales already from compassionate use this quarter. as i stated earlier we actually saw some sales already from compassionate use this quarter Unfortunately, the European heart clinics are suffering badly from the lack of alternatives to the XVIVO Heart Assist. unfortunately the european heart clinics are suffering badly from the lack of alternatives to the xvivo heart assist We are working really hard with our notified body to get the final CE mark. we are working really hard with our notified body to get the final ce mark We are happy to see and hear all the engagement from our heart transplant clinics in Europe who just want to get it up and running. we are happy to see and hear all the engagement from our heart transplant clinics in europe who 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 CE marks. also to mention and we mentioned before that the australian and possible canadian approval will follow on the ce marks We will use that as a base. we will use that as a base I will come back to the U.S. liver update in the next slide, actually. i will come back to the u.s liver update in the next slide actually We can go straight to that slide. we can go straight to that slide Slide number 12, and the liver regulatory status. slide number 12 and the liver regulatory status We have previously reported that the Liver Assist has been granted breakthrough device designation by the FDA. We have an approved IDE 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 Assist PMA process to investigate the alternative regulatory route. We are right now in preparation for a FDA Q-Sub meeting where the possible regulatory route will be outlined further. The company and I will come back and inform all investors of the next step in the U.S. Liver Assist regulatory investigation and later, so of course when we report the Q2 report in July, I will give an update. With that, I hand over to our CFO for going into the financial performance of XVIVO. Thank you. We have previously reported that the Liver Assist has been granted breakthrough device designation by the FDA. we have previously reported that the liver assist has been granted breakthrough device designation by the fda We have an approved IDE and the CMS funding approved. we have an approved ide and the cms funding approved We could have started a trial last year, mid last year. we could have started a trial last year mid last year We did decide to temporarily pause activities for the Liver Assist PMA process to investigate the alternative regulatory route. we did decide to temporarily pause activities for the liver assist pma process to investigate the alternative regulatory route We are right now in preparation for a FDA Q-Sub meeting where the possible regulatory route will be outlined further. we are right now in preparation for a fda q-sub meeting where the possible regulatory route will be outlined further The company and I will come back and inform all investors of the next step in the U.S. the company and i will come back and inform all investors of the next step in the u.s Liver Assist regulatory investigation and later, so of course when we report the Q2 report in July, I will give an update. liver assist regulatory investigation and later so of course when we report the q2 report in july i will give an update With that, I hand over to our CFO for going into the financial performance of XVIVO. with that i hand over to our cfo for going into the financial performance of xvivo Thank you. thank you

Speaker 5: Thank you, and happy to do so, Christoffer. The financials for the first quarter. This was a record sales quarter with clear signs of growing momentum, as Christoffer 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 SEK 241 million, 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. Thank you, and happy to do so, Christoffer. thank you and happy to do so christoffer The financials for the first quarter. the financials for the first quarter This was a record sales quarter with clear signs of growing momentum, as Christoffer mentioned, especially in our core business and across all main markets. this was a record sales quarter with clear signs of growing momentum as christoffer 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. 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. we're very happy about that Net sales in Q1 were SEK 241 million, and organic growth was 23%, and 18% excluding the heart trial revenue from the CAP. net sales in q1 were sek 241 million and organic growth was 23% and 18% excluding the heart trial revenue from the cap Gross margins were 71%. 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. 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. 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 SEK 7 million in heart 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. Moving over to Thoracic. The Thoracic business area accelerated in Q1 and delivered record sales of SEK 160 million. Organic growth was 27%, and excluding heart trial revenue, 19%. In regard to lung, 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. 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. EBIT was 13% and EBITDA 21%. ebit was 13% and ebitda 21% The quarter was impacted by SEK 7 million in heart go-to-market preparations, non-recurring items, which explains the increase in administration costs. the quarter was impacted by sek 7 million in heart 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. setting this initiative aside the underlying ebitda in q1 was 24% and more in line with what we saw in q4 last year Moving over to Thoracic. moving over to thoracic The Thoracic business area accelerated in Q1 and delivered record sales of SEK 160 million. the thoracic business area accelerated in q1 and delivered record sales of sek 160 million Organic growth was 27%, and excluding heart trial revenue, 19%. organic growth was 27% and excluding heart trial revenue 19% In regard to lung, the momentum for EVLP continues to evolve positively. in regard to lung 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. evlp disposables grew 56% in q1 and the main customer segments the centralized perfusion hubs and larger key accounts grew double digit 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. 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. This is a very exciting initiative that can have a significant impact for lung transplant patients on the waiting list in the U.S. 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 Christoffer mentioned, in the U.S., it included its last patient. Australia, New Zealand continues with extraordinary market penetration under compassionate use. 10 EVLPs have been performed since the introduction of this program with good learnings and great collaboration. 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. 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 This is a very exciting initiative that can have a significant impact for lung transplant patients on the waiting list in the U.S. and can have a strong impact on the EVLP adoption over time. this is a very exciting initiative that can have a significant impact for lung transplant patients on the waiting list in the u.s and can have a strong impact on the evlp adoption over time In regard to heart, Q1 was a very good quarter. in regard to heart q1 was a very good quarter The CAP trial, as Christoffer mentioned, in the U.S., it included its last patient. the cap trial as christoffer mentioned in the u.s it included its last patient Australia, New Zealand continues with extraordinary market penetration under compassionate use. australia new zealand continues with extraordinary market penetration under compassionate use 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 CE mark 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. Overall, thoracic experiencing a good momentum. Moving over to abdominal. Abdominal continues to deliver good quarters. Net sales were SEK 66 million, equaling an organic growth of 24%. Liver sales grew 12% in local currencies to SEK 45 million. Kidney was the shining star of the quarter in abdominal. Sales grew 63% in local currencies. 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. 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 CE mark approval, of course. all this in wait for the ce mark 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. 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 Overall, thoracic experiencing a good momentum. overall thoracic experiencing a good momentum Moving over to abdominal. moving over to abdominal Abdominal continues to deliver good quarters. abdominal continues to deliver good quarters Net sales were SEK 66 million, equaling an organic growth of 24%. net sales were sek 66 million equaling an organic growth of 24% Liver sales grew 12% in local currencies to SEK 45 million. liver sales grew 12% in local currencies to sek 45 million Kidney was the shining star of the quarter in abdominal. kidney was the shining star of the quarter in abdominal Sales grew 63% in local currencies. sales grew 63% in local currencies We see a growing interest for Kidney Assist Transport in North America, both in the U.S. 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. We see a growing interest for Kidney Assist Transport in North America, both in the U.S. and Canada, and Q1 brought new accounts both for clinical and research use. we see a growing interest for kidney assist transport in north america both in the u.s 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. 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. 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. 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. 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. moving over to services our last business area Net sales were SEK 60 million, representing a negative 10% organic growth. The two areas, FlowHawk and organ 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. 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. Organ recovery showed yet another quarter with negative growth, minus 10%. Net sales were SEK 60 million, representing a negative 10% organic growth. net sales were sek 60 million representing a negative 10% organic growth The two areas, FlowHawk and organ recovery services, showed mixed results. the two areas flowhawk and organ recovery services showed mixed results FlowHawk showed an impressive growth of 62% as a result from both new customer acquisitions and upgrades and renewals. 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. 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. 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 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. 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 Organ recovery showed yet another quarter with negative growth, minus 10%. organ recovery showed yet another quarter with negative growth minus 10% 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. 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. With an increase in cases, our gross margins will improve to more sustainable levels. EBITDA. Profitability was strong for the second consecutive quarter, 21%, and excluding non-recurrent costs, it was 24%. Rolling 12, we're at 20%, and we are on a positive trajectory on the rolling 12 KPI. 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. 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. today we have surgical capacities to significantly increase the case volume With ISHLT this month as a starting point, our focus from now on will lie heavily on marketing and sales execution. 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. 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 With an increase in cases, our gross margins will improve to more sustainable levels. with an increase in cases our gross margins will improve to more sustainable levels EBITDA. ebitda Profitability was strong for the second consecutive quarter, 21%, and excluding non-recurrent costs, it was 24%. profitability was strong for the second consecutive quarter 21% and excluding non-recurrent costs it was 24% Rolling 12, we're at 20%, and we are on a positive trajectory on the rolling 12 KPI. 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. My final slide for the day here, cash flow. We're ending with some positive news here. For the second consecutive quarter, we ended up with a total positive cash flow. Operating cash flow was SEK 65 million, mainly driven by good sales momentum, of course, and the cash flow from investments was -SEK 55 million. All in all, we ended up for the second quarter in a row with a positive total cash flow. We had SEK 308 million at hand when we closed the quarter. 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. 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. 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 My final slide for the day here, cash flow. my final slide for the day here cash flow We're ending with some positive news here. we're ending with some positive news here For the second consecutive quarter, we ended up with a total positive cash flow. for the second consecutive quarter we ended up with a total positive cash flow Operating cash flow was SEK 65 million, mainly driven by good sales momentum, of course, and the cash flow from investments was -SEK 55 million. operating cash flow was sek 65 million mainly driven by good sales momentum of course and the cash flow from investments was -sek 55 million All in all, we ended up for the second quarter in a row with a positive total cash flow. all in all we ended up for the second quarter in a row with a positive total cash flow We had SEK 308 million at hand when we closed the quarter. we had sek 308 million at hand when we closed the quarter With those final remarks, Christoffer, I will give the word over to you again. Good luck with the end of the conference here. With those final remarks, Christoffer, I will give the word over to you again. with those final remarks christoffer i will give the word over to you again Good luck with the end of the conference here. good luck with the end of the conference here

Speaker 1: Thank you. With that, we go into the outlook and little bit into the future of what will happen this year and also what will happen long term. We can go to slide number 21, really focusing on this year and activities we have for this year. Again, we are going to continue to build sales force, and build new partnerships, especially in the U.S., to enable the OPOs and clinics to recover more lungs by EVLP adoption through combination of a service model and staying 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. Thank you. thank you With that, we go into the outlook and little bit into the future of what will happen this year and also what will happen long term. with that we go into the outlook and little bit into the future of what will happen this year and also what will happen long term We can go to slide number 21, really focusing on this year and activities we have for this year. we can go to slide number 21 really focusing on this year and activities we have for this year Again, we are going to continue to build sales force, and build new partnerships, especially in the U.S., to enable the OPOs and clinics to recover more lungs by EVLP adoption through combination of a service model and staying very close to customers. again we are going to continue to build sales force and build new partnerships especially in the u.s to enable the opos and clinics to recover more lungs by evlp adoption through combination of a service model and staying very close to customers In parallel, we just heard from our CFO that we will increase our service offering and better tailor customer needs. 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. 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 closely with competent authorities in Europe to be able to use the Heart Box as much as possible already now, and we are aiming to obtain a CE mark as soon as possible and waiting for the last part there. Another key milestone, now with the data from the U.S. PRESERVE trial presented at ISHLT, we will now submit the regulatory file to the FDA for their review during the summer. 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. Now we want to continue to support clinics in Europe and also give the U.S. clinicians the ability to actually use the Liver Assist and have the same success we have seen in Europe. We will continue to work closely with competent authorities in Europe to be able to use the Heart Box as much as possible already now, and we are aiming to obtain a CE mark as soon as possible and waiting for the last part there. we will continue to work closely with competent authorities in europe to be able to use the heart box as much as possible already now and we are aiming to obtain a ce mark as soon as possible and waiting for the last part there Another key milestone, now with the data from the U.S. another key milestone now with the data from the u.s PRESERVE trial presented at ISHLT, we will now submit the regulatory file to the FDA for their review during the summer. preserve trial presented at ishlt we will now submit the regulatory file to the fda for their review during the summer We also talked about the Liver Assist. 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. 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 Now we want to continue to support clinics in Europe and also give the U.S. clinicians the ability to actually use the Liver Assist and have the same success we have seen in Europe. now we want to continue to support clinics in europe and also give the u.s 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 want to 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. The demand for transplant is, according to our analysis, approximately 10 x 10 of today's supply. We 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. We see a market opportunity with this almost 100x of what we see today. We go to the next slide 22, and a little bit longer-term outlook, and I want to state this every call, for this is the reason we're here. we go to the next slide 22 and a little bit longer-term outlook and i want to 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. 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. some of them are on the wait list but the majority never even make the wait list The demand for transplant is, according to our analysis, approximately 10 x 10 of today's supply. the demand for transplant is according to our analysis approximately 10 x 10 of today's supply We 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. we 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 We see a market opportunity with this almost 100x of what we see today. we see a market opportunity with this almost 100x of what we see today 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 ISHLT on increasing the number of organs used for transplantation and actually safely increase them, with improving survival rate as well. We also know that we see growing DCD organ pool. In many countries it's about 50%. We know here in the U.S. it's 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. XVIVO, we want to change the paradigm on transplantation by innovation. We want to be very clear that we believe that innovative products and innovative perfusion and preservation solution is the key for the future. 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 ISHLT on increasing the number of organs used for transplantation and actually safely increase them, with improving survival rate as well. 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 ishlt on increasing the number of organs used for transplantation and actually safely increase them with improving survival rate as well We also know that we see growing DCD organ pool. we also know that we see growing dcd organ pool In many countries it's about 50%. in many countries it's about 50% We know here in the U.S. it's now hitting the 50% mark, and we have clear evidence that machine perfusion is. we know here in the u.s it's 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. you need to use them to safely address the dcd organs XVIVO, we want to change the paradigm on transplantation by innovation. xvivo we want to change the paradigm on transplantation by innovation We want to be very clear that we believe that innovative products and innovative perfusion and preservation solution is the key for the future. we want to be very clear that we believe that innovative products and innovative perfusion and preservation solution is the key for the future We do have a unique, very innovative and world-leading product in the market or under IDE trials. 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. With that, we turn to slide 23 and open up for questions. We do have a unique, very innovative and world-leading product in the market or under IDE trials. we do have a unique very innovative and world-leading product in the market or under ide trials 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. 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 With that, we turn to slide 23 and open up for questions. with that we turn to slide 23 and open up for questions

Speaker 7: The next question comes from Simon Larsson from Danske Bank. Please go ahead. The next question comes from Simon Larsson from Danske Bank. the next question comes from simon larsson from danske bank Please go ahead. please go ahead

Speaker 9: Yes. Good afternoon, everyone. Firstly, maybe on the U.S. heart theme. I noted in the press release from Wednesday that you are planning to hand in the file to the FDA later this year. Could you give us any more details on when that might be? Would be helpful. Yes. yes Good afternoon, everyone. good afternoon everyone Firstly, maybe on the U.S. heart theme. firstly maybe on the u.s heart theme I noted in the press release from Wednesday that you are planning to hand in the file to the FDA later this year. i noted in the press release from wednesday that you are planning to hand in the file to the fda later this year Could you give us any more details on when that might be? could you give us any more details on when that might be Would be helpful. would be helpful

Speaker 1: Thank you. Good question. We are sitting with the file right now. I don't have an exact timeline, but it will be somewhere during the summer. I will come back when I have a better timeline, but it's somewhere during the summer. It's not the end of the year, it's earlier than that. Thank you. thank you Good question. good question We are sitting with the file right now. we are sitting with the file right now I don't have an exact timeline, but it will be somewhere during the summer. i don't have an exact timeline but it will be somewhere during the summer I will come back when I have a better timeline, but it's somewhere during the summer. i will come back when i have a better timeline but it's somewhere during the summer It's not the end of the year, it's earlier than that. it's not the end of the year it's earlier than that

Speaker 9: Yeah. Understood. Maybe it's a bit speculative at this point, but would you expect the FDA to summon an advisory committee ahead of a potential approval or yeah, what's your thinking around that dynamic? Yeah. yeah Understood. understood Maybe it's a bit speculative at this point, but would you expect the FDA to summon an advisory committee ahead of a potential approval or yeah, what's your thinking around that dynamic? maybe it's a bit speculative at this point but would you expect the fda to summon an advisory committee ahead of a potential approval or yeah what's your thinking around that dynamic

Speaker 1: I can't speculate on what the FDA wants. We have to hand in the file and see what the feedback is and follow their process. It will be more or less impossible to speculate on what will happen or not. I know last time we had an expert panel meeting, we fared very well on the lung side with 10, 0, 10, 0, 10, 0. We know how to do this, and we are confident that we can answer any question the FDA might pose to us. I can't speculate on what the FDA wants. i can't speculate on what the fda wants We have to hand in the file and see what the feedback is and follow their process. we have to hand in the file and see what the feedback is and follow their process It will be more or less impossible to speculate on what will happen or not. it will be more or less impossible to speculate on what will happen or not I know last time we had an expert panel meeting, we fared very well on the lung side with 10, 0, 10, 0, 10, 0. i know last time we had an expert panel meeting we fared very well on the lung side with 10 0 10 0 10 0 We know how to do this, and we are confident that we can answer any question the FDA might pose to us. we know how to do this and we are confident that we can answer any question the fda might pose to us

Speaker 9: Yeah, fair. I know you said in the beginning of the presentation, Christoffer, that you aim to make the Heart Box a standard of care for all hearts, basically. If you could help us understand the scope of the hearts that you will address in the U.S. maybe to begin with. Will you be focusing on the sort of marginalized ECD, DCD hearts, or older donors? Any help slicing the market opportunity and what you will target first will be also interesting to hear. Yeah, fair. yeah fair I know you said in the beginning of the presentation, Christoffer, that you aim to make the Heart Box a standard of care for all hearts, basically. i know you said in the beginning of the presentation christoffer that you aim to make the heart box a standard of care for all hearts basically If you could help us understand the scope of the hearts that you will address in the U.S. maybe to begin with. if you could help us understand the scope of the hearts that you will address in the u.s maybe to begin with Will you be focusing on the sort of marginalized ECD, DCD hearts, or older donors? will you be focusing on the sort of marginalized ecd dcd hearts or older donors Any help slicing the market opportunity and what you will target first will be also interesting to hear. any help slicing the market opportunity and what you will target first will be also interesting to hear

Speaker 1: That's a great question. We can only market what we get on the label, and the label will be pending the FDA review process. It's hard to say exactly. If we look at the PRESERVE trial and the inclusion, exclusion criteria there, it is exactly those hearts we're talking about. It's DCD heart, extended criteria hearts, so that's either due to more than 2-hour preservation and a couple of risk factors or more than 4 hours of. We will definitely target those hearts. We see an increasing interest here from U.S. clinicians. We will have a quite broad target when we launch the product to make sure that we can reach all clinics as soon as possible after day one of the launch. That's a great question. that's a great question We can only market what we get on the label, and the label will be pending the FDA review process. we can only market what we get on the label and the label will be pending the fda review process It's hard to say exactly. it's hard to say exactly If we look at the PRESERVE trial and the inclusion, exclusion criteria there, it is exactly those hearts we're talking about. if we look at the preserve trial and the inclusion exclusion criteria there it is exactly those hearts we're talking about It's DCD heart, extended criteria hearts, so that's either due to more than 2-hour preservation and a couple of risk factors or more than 4 hours of. it's dcd heart extended criteria hearts so that's either due to more than 2-hour preservation and a couple of risk factors or more than 4 hours of We will definitely target those hearts. we will definitely target those hearts We see an increasing interest here from U.S. clinicians. we see an increasing interest here from u.s clinicians We will have a quite broad target when we launch the product to make sure that we can reach all clinics as soon as possible after day one of the launch. we will have a quite broad target when we launch the product to make sure that we can reach all clinics as soon as possible after day one of the launch

Speaker 9: Makes sense. Maybe then the final one from my end, turning a bit to the lung part of the business. Obviously, the EVLP part is doing very good here. Could you say anything about the pipeline, how it looks for new accounts, both in terms of new centers, also OPOs, of course, and also if you're happy with the revenue generation from the new XPS accounts that you signed last year? Maybe your visibility for the lungs here in the coming, let's say, couple of quarters as well. Makes sense. makes sense Maybe then the final one from my end, turning a bit to the lung part of the business. maybe then the final one from my end turning a bit to the lung part of the business Obviously, the EVLP part is doing very good here. obviously the evlp part is doing very good here Could you say anything about the pipeline, how it looks for new accounts, both in terms of new centers, also OPOs, of course, and also if you're happy with the revenue generation from the new XPS accounts that you signed last year? could you say anything about the pipeline how it looks for new accounts both in terms of new centers also opos of course and also if you're happy with the revenue generation from the new xps accounts that you signed last year Maybe your visibility for the lungs here in the coming, let's say, couple of quarters as well. maybe your visibility for the lungs here in the coming let's say couple of quarters as well

Speaker 1: What I know here from ISHLT is that there is a growing interest for an EVLP program, and we do see great progress now, both in underlying market growth, where we see that more and more data is getting published showing that using EVLP for extended grafts or DCD grafts has a really positive impact on the overall survival and that we use more organs. In general, there is a good underlying trend for the lung market. The other thing which we are working with is to put the XPS into more hands, so to say, so we can do it, and especially the hub model that one OPO or one center pumps lungs for a larger area, which we have seen has been very successful before. We have a positive outlook, but again, looking into the future, it's impossible. What I know here from ISHLT is that there is a growing interest for an EVLP program, and we do see great progress now, both in underlying market growth, where we see that more and more data is getting published showing that using EVLP for extended grafts or DCD grafts has a really positive impact on the overall survival and that we use more organs. what i know here from ishlt is that there is a growing interest for an evlp program and we do see great progress now both in underlying market growth where we see that more and more data is getting published showing that using evlp for extended grafts or dcd grafts has a really positive impact on the overall survival and that we use more organs In general, there is a good underlying trend for the lung market. in general there is a good underlying trend for the lung market The other thing which we are working with is to put the XPS into more hands, so to say, so we can do it, and especially the hub model that one OPO or one center pumps lungs for a larger area, which we have seen has been very successful before. the other thing which we are working with is to put the xps into more hands so to say so we can do it and especially the hub model that one opo or one center pumps lungs for a larger area which we have seen has been very successful before We have a positive outlook, but again, looking into the future, it's impossible. we have a positive outlook but again looking into the future it's impossible What we can see so far, it looks very good. Especially, I'm really encouraged after all the meetings we had here in both the lung symposium and all the customer interactions from here, from ISHLT. We see positive outlook. What we can see so far, it looks very good. what we can see so far it looks very good Especially, I'm really encouraged after all the meetings we had here in both the lung symposium and all the customer interactions from here, from ISHLT. especially i'm really encouraged after all the meetings we had here in both the lung symposium and all the customer interactions from here from ishlt We see positive outlook. we see positive outlook

Speaker 9: Got you. Great. Thanks so much. Got you. got you Great. great Thanks so much. thanks so much

Speaker 1: Thank you. Thank you. thank you

Speaker 7: The next question comes from Ulrik Trattner from DNB Carnegie. Please go ahead. The next question comes from Ulrik Trattner from DNB Carnegie. the next question comes from ulrik trattner from dnb carnegie Please go ahead. please go ahead

Speaker 10: Thank you very much. A few on my end, and I'll start off with the abdominal growth margins. Kristoffer, you touched upon this, but I also noticed that the gross margin was kind of equally low in Q4. Is there effects related to this since you moved your manufacturing to Sweden from the Netherlands? Is it just market product mix that we should expect to revert here in the short term? Thank you very much. thank you very much A few on my end, and I'll start off with the abdominal growth margins. a few on my end and i'll start off with the abdominal growth margins Kristoffer, you touched upon this, but I also noticed that the gross margin was kind of equally low in Q4. kristoffer you touched upon this but i also noticed that the gross margin was kind of equally low in q4 Is there effects related to this since you moved your manufacturing to Sweden from the Netherlands? is there effects related to this since you moved your manufacturing to sweden from the netherlands Is it just market product mix that we should expect to revert here in the short term? is it just market product mix that we should expect to revert here in the short term

Speaker 1: I can start a little bit high level and then, Nordström, if you want to pitch in on this one. If we take high level, there is today in the abdominal field slightly lower gross margins in Europe versus the U.S. It's partly a regional mix that we hope over time we will grow out of. Also, we are moving production right now and have not reached the full scale in production that we want. It's not, let's say, call it a quick fix, but we diligently work to improve the gross margin for our abdominal portfolio in the next quarters and years to come. We see a gradual improvement, is my belief. I can start a little bit high level and then, Nordström, if you want to pitch in on this one. i can start a little bit high level and then nordström if you want to pitch in on this one If we take high level, there is today in the abdominal field slightly lower gross margins in Europe versus the U.S. if we take high level there is today in the abdominal field slightly lower gross margins in europe versus the u.s It's partly a regional mix that we hope over time we will grow out of. it's partly a regional mix that we hope over time we will grow out of Also, we are moving production right now and have not reached the full scale in production that we want. also we are moving production right now and have not reached the full scale in production that we want It's not, let's say, call it a quick fix, but we diligently work to improve the gross margin for our abdominal portfolio in the next quarters and years to come. it's not let's say call it a quick fix but we diligently work to improve the gross margin for our abdominal portfolio in the next quarters and years to come We see a gradual improvement, is my belief. we see a gradual improvement is my belief

Speaker 5: I can just add as well, Christoffer, that we do expect to see the growing gross margins for abdominal. What will impact that is, of course, when we start to see a stronger ramp-up in the United States. It was a good quarter in North America, abdominal sales this quarter, but it was partly research sales, that over time, of course, will translate into more clinical sales, so to say. It's still very much of a European business with some regions with lower pricing. I can just add as well, Christoffer, that we do expect to see the growing gross margins for abdominal. i can just add as well christoffer that we do expect to see the growing gross margins for abdominal What will impact that is, of course, when we start to see a stronger ramp-up in the United States. what will impact that is of course when we start to see a stronger ramp-up in the united states It was a good quarter in North America, abdominal sales this quarter, but it was partly research sales, that over time, of course, will translate into more clinical sales, so to say. it was a good quarter in north america abdominal sales this quarter but it was partly research sales that over time of course will translate into more clinical sales so to say It's still very much of a European business with some regions with lower pricing. it's still very much of a european business with some regions with lower pricing

Speaker 10: Okay, great. On to sort of prospects going ahead and the Q-Sub meeting that you have scheduled. What is your ambition going into this? You can obviously go down a few routes here. Are you aiming to use the European data in order to get approval as you did for kidney or 510(k)? What is sort of the most feasible and reasonable pathway forward here? Okay, great. okay great On to sort of prospects going ahead and the Q-Sub meeting that you have scheduled. on to sort of prospects going ahead and the q-sub meeting that you have scheduled What is your ambition going into this? what is your ambition going into this You can obviously go down a few routes here. you can obviously go down a few routes here Are you aiming to use the European data in order to get approval as you did for kidney or 510(k)? are you aiming to use the european data in order to get approval as you did for kidney or 510(k) What is sort of the most feasible and reasonable pathway forward here? what is sort of the most feasible and reasonable pathway forward here

Speaker 1: It's a great question. I mean, of course, we're aiming that, but we will have a dialogue with FDA. We had a very positive meeting earlier this year, and we will continue in a more official Q-Sub meeting with them to get a firm route forward. We, of course, aim to leverage as much of the European data as possible. We would also be in listening mode and see what the requirements from the FDA is. That would be a good dialogue that we have started that is very good and positive. We also have to be humble that the FDA is deciding in this case. We will argue our case and see what comes out of it. It's a great question. it's a great question I mean, of course, we're aiming that, but we will have a dialogue with FDA. i mean of course we're aiming that but we will have a dialogue with fda We had a very positive meeting earlier this year, and we will continue in a more official Q-Sub meeting with them to get a firm route forward. we had a very positive meeting earlier this year and we will continue in a more official q-sub meeting with them to get a firm route forward We, of course, aim to leverage as much of the European data as possible. we of course aim to leverage as much of the european data as possible We would also be in listening mode and see what the requirements from the FDA is. we would also be in listening mode and see what the requirements from the fda is That would be a good dialogue that we have started that is very good and positive. that would be a good dialogue that we have started that is very good and positive We also have to be humble that the FDA is deciding in this case. we also have to be humble that the fda is deciding in this case We will argue our case and see what comes out of it. we will argue our case and see what comes out of it

Speaker 10: Just correct me if I'm wrong, but wouldn't it be beneficial on your end to actually generate some U.S. data prior to launching it? Given, in hindsight, what we have seen with the kidney launch, that U.S. data is of high importance in order to reach higher volume. Just correct me if I'm wrong, but wouldn't it be beneficial on your end to actually generate some U.S. data prior to launching it? just correct me if i'm wrong but wouldn't it be beneficial on your end to actually generate some u.s data prior to launching it Given, in hindsight, what we have seen with the kidney launch, that U.S. data is of high importance in order to reach higher volume. given in hindsight what we have seen with the kidney launch that u.s data is of high importance in order to reach higher volume

Speaker 1: Yeah. Yeah. yeah

Speaker 10: Potentially a 510(k) would be the preferred route on your end. Potentially a 510(k) would be the preferred route on your end. potentially a 510(k) would be the preferred route on your end

Speaker 1: Yeah. The good news with the 510(k) route is that the, let's say, burden of proof is lessened. It's more towards safety than efficacy. You're right. In either way, whatever the FDA says, we need to do a trial if it's, let's say, before or after. We will do a clinical trial in the U.S. to make sure that the American users can replicate the European data. That is extremely good for it to be believable. You're right, with the kidney experience, we learned that very fast, that launching a product without U.S. data will not make it fly. We have to do something either way. We're still aiming to leverage as much as possible of the very positive European data. It's by far the largest body of clinical data we have for short, long-term, all sorts of grafts, which are very positive. Yeah. yeah The good news with the 510(k) route is that the, let's say, burden of proof is lessened. the good news with the 510(k) route is that the let's say burden of proof is lessened It's more towards safety than efficacy. it's more towards safety than efficacy You're right. you're right In either way, whatever the FDA says, we need to do a trial if it's, let's say, before or after. in either way whatever the fda says we need to do a trial if it's let's say before or after We will do a clinical trial in the U.S. to make sure that the American users can replicate the European data. we will do a clinical trial in the u.s to make sure that the american users can replicate the european data That is extremely good for it to be believable. that is extremely good for it to be believable You're right, with the kidney experience, we learned that very fast, that launching a product without U.S. data will not make it fly. you're right with the kidney experience we learned that very fast that launching a product without u.s data will not make it fly We have to do something either way. we have to do something either way We're still aiming to leverage as much as possible of the very positive European data. we're still aiming to leverage as much as possible of the very positive european data It's by far the largest body of clinical data we have for short, long-term, all sorts of grafts, which are very positive. it's by far the largest body of clinical data we have for short long-term all sorts of grafts which are very positive That's of course our aim. That's of course our aim. that's of course our aim

Speaker 10: Great. A question on the CAP program, as you went from four patients in Q3 2022 and now 36 here in Q1, and I would assume that the interest has not come down post ISHLT. How quickly can you get a sort of re-approval or expansion of your CAP program in the U.S.? Great. great A question on the CAP program, as you went from four patients in Q3 2022 and now 36 here in Q1, and I would assume that the interest has not come down post ISHLT. a question on the cap program as you went from four patients in q3 2022 and now 36 here in q1 and i would assume that the interest has not come down post ishlt How quickly can you get a sort of re-approval or expansion of your CAP program in the U.S.? how quickly can you get a sort of re-approval or expansion of your cap program in the u.s

Speaker 1: We're aiming as soon as possible. It is under review from the FDA, and they will come back to us soon, according to what they said. Again, it's hard to speculate on the FDA timeline and the work burden they have. What we can say is that, yeah, the interest is extremely high from U.S. clinicians before the ISHLT and before those two presentations, and it has increased significantly after. That is very clear. We're aiming as soon as possible. we're aiming as soon as possible It is under review from the FDA, and they will come back to us soon, according to what they said. it is under review from the fda and they will come back to us soon according to what they said Again, it's hard to speculate on the FDA timeline and the work burden they have. again it's hard to speculate on the fda timeline and the work burden they have What we can say is that, yeah, the interest is extremely high from U.S. clinicians before the ISHLT and before those two presentations, and it has increased significantly after. what we can say is that yeah the interest is extremely high from u.s clinicians before the ishlt and before those two presentations and it has increased significantly after That is very clear. that is very clear

Speaker 10: Can you give some type of indication on just the penetration per the sites who are actually active in the CAP program? Are they using it on all of their hearts that are being transplanted, or is it just a portion of them, or can you give us any more insight to that? That would be very interesting. Can you give some type of indication on just the penetration per the sites who are actually active in the CAP program? can you give some type of indication on just the penetration per the sites who are actually active in the cap program Are they using it on all of their hearts that are being transplanted, or is it just a portion of them, or can you give us any more insight to that? are they using it on all of their hearts that are being transplanted or is it just a portion of them or can you give us any more insight to that That would be very interesting. that would be very interesting

Speaker 1: Yeah, that's a good question. We should remember right now that this is a scarce resource for them. There is a limited number of patients, so they only use it on the worst grafts and the sickest patients where they see no other use right now. We should remember that. We can see in some CAP centers that it's quite high penetration. The testimonial I get when I'm here from the users is that this is so easy to use, it's really plug and play, and the hearts are in an excellent condition after being in the XVIVO Heart Assist. Some have quite high penetration, but we should remember that it would be higher if we would have an approval or, let's say, it's unlimited use, because now it's capped to number of patients. Yeah, that's a good question. yeah that's a good question We should remember right now that this is a scarce resource for them. we should remember right now that this is a scarce resource for them There is a limited number of patients, so they only use it on the worst grafts and the sickest patients where they see no other use right now. there is a limited number of patients so they only use it on the worst grafts and the sickest patients where they see no other use right now We should remember that. we should remember that We can see in some CAP centers that it's quite high penetration. we can see in some cap centers that it's quite high penetration The testimonial I get when I'm here from the users is that this is so easy to use, it's really plug and play, and the hearts are in an excellent condition after being in the XVIVO Heart Assist. the testimonial i get when i'm here from the users is that this is so easy to use it's really plug and play and the hearts are in an excellent condition after being in the xvivo heart assist Some have quite high penetration, but we should remember that it would be higher if we would have an approval or, let's say, it's unlimited use, because now it's capped to number of patients. some have quite high penetration but we should remember that it would be higher if we would have an approval or let's say it's unlimited use because now it's capped to number of patients I think it's more interesting to look to the Australian situation where there is an uncapped continuous access protocol, so to say, similar, but it's uncapped too. There we see that it's 50% for DBDs, and now we're starting with DCD. I think it's more interesting to look to the Australian situation where there is an uncapped continuous access protocol, so to say, similar, but it's uncapped too. i think it's more interesting to look to the australian situation where there is an uncapped continuous access protocol so to say similar but it's uncapped too There we see that it's 50% for DBDs, and now we're starting with DCD. there we see that it's 50% for dbds and now we're starting with dcd

Speaker 10: Sure. Yeah. Just on the data that you have generated here lately and percentage, obviously a positive outcome in the U.S. and four additional patients in Europe on HOPE. Are you adding this to the European regulatory agencies and have this in any way increased your confidence in obtaining approval for the Heart Box here in 2026? Sure. sure Yeah. yeah Just on the data that you have generated here lately and percentage, obviously a positive outcome in the U.S. and four additional patients in Europe on HOPE. just on the data that you have generated here lately and percentage obviously a positive outcome in the u.s and four additional patients in europe on hope Are you adding this to the European regulatory agencies and have this in any way increased your confidence in obtaining approval for the Heart Box here in 2026? are you adding this to the european regulatory agencies and have this in any way increased your confidence in obtaining approval for the heart box here in 2026

Speaker 1: The straight answer is yes. The feedback we get from those compassionate use is that, yeah, we don't see any alternative on the market for any grafts, pediatric, adult, DCD or DBD. It's really encouraging to see medical agencies in Europe looking into the file, clearly state there is no alternative. We need compassionate use for this product. Yes, the straight answer is yes, we get more confident the more we talk to medical agencies and the more we talk to clinicians of how important this is. Again, the regulatory process is a regulatory process and it's hard to speculate. Definitely, due to this, we are more confident, yes. The straight answer is yes. the straight answer is yes The feedback we get from those compassionate use is that, yeah, we don't see any alternative on the market for any grafts, pediatric, adult, DCD or DBD. the feedback we get from those compassionate use is that yeah we don't see any alternative on the market for any grafts pediatric adult dcd or dbd It's really encouraging to see medical agencies in Europe looking into the file, clearly state there is no alternative. it's really encouraging to see medical agencies in europe looking into the file clearly state there is no alternative We need compassionate use for this product. we need compassionate use for this product Yes, the straight answer is yes, we get more confident the more we talk to medical agencies and the more we talk to clinicians of how important this is. yes the straight answer is yes we get more confident the more we talk to medical agencies and the more we talk to clinicians of how important this is Again, the regulatory process is a regulatory process and it's hard to speculate. again the regulatory process is a regulatory process and it's hard to speculate Definitely, due to this, we are more confident, yes. definitely due to this we are more confident yes

Speaker 10: Great. Last question on my end. Did you mention that you had found 4-5 OPO targets to sort of be integrated into an EVLP program? If I heard that clearly. Great. great Last question on my end. last question on my end Did you mention that you had found 4-5 OPO targets to sort of be integrated into an EVLP program? did you mention that you had found 4-5 opo targets to sort of be integrated into an evlp program If I heard that clearly. if i heard that clearly

Speaker 1: Yeah. 4-5 are identified in the pipeline right now. To clarify that, we have done our first installation, very successful ahead of plan. We are doing our second one, I think, yeah, while we speak or at least very soon after ISHLT. There is a rollout plan, which to some extent will be resource limited, but we have a clear plan and we're going to make sure that we are successful in every installation. We're going to make sure that we all get. We are also increasing our internal resources to be able to handle that increased growth and increased interest from OPOs, where, in all honesty, the XPS and the STEEN Solution was developed in the beginning for this target group of OPOs. It's great to be back home again, so to say, and see the OPOs using it. Yeah. 4-5 are identified in the pipeline right now. To clarify that, we have done our first installation, very successful ahead of plan. yeah 4-5 are identified in the pipeline right now. to clarify that we have done our first installation very successful ahead of plan We are doing our second one, I think, yeah, while we speak or at least very soon after ISHLT. we are doing our second one i think yeah while we speak or at least very soon after ishlt There is a rollout plan, which to some extent will be resource limited, but we have a clear plan and we're going to make sure that we are successful in every installation. there is a rollout plan which to some extent will be resource limited but we have a clear plan and we're going to make sure that we are successful in every installation We're going to make sure that we all get. we're going to make sure that we all get We are also increasing our internal resources to be able to handle that increased growth and increased interest from OPOs, where, in all honesty, the XPS and the STEEN Solution was developed in the beginning for this target group of OPOs. we are also increasing our internal resources to be able to handle that increased growth and increased interest from opos where in all honesty the xps and the steen solution was developed in the beginning for this target group of opos It's great to be back home again, so to say, and see the OPOs using it. it's great to be back home again so to say and see the opos using it

Speaker 10: Okay, great. Essentially it's an acceleration, not sort of a maintained pace, even with your sort of limited resources. Okay, great. okay great Essentially it's an acceleration, not sort of a maintained pace, even with your sort of limited resources. essentially it's an acceleration not sort of a maintained pace even with your sort of limited resources

Speaker 1: We will try to accelerate it as fast as possible, but we will be very conscious that we want to have the right quality of people, both from our side, from our partners' sides, and from the OPO side to make sure that each and every OPO program is a successful program, where the clinicians really get the organs they so deserve for the patients on the waiting list. We will be very cautious on keeping a high quality. We will try to accelerate it as fast as possible, but we will be very conscious that we want to have the right quality of people, both from our side, from our partners' sides, and from the OPO side to make sure that each and every OPO program is a successful program, where the clinicians really get the organs they so deserve for the patients on the waiting list. we will try to accelerate it as fast as possible but we will be very conscious that we want to have the right quality of people both from our side from our partners' sides and from the opo side to make sure that each and every opo program is a successful program where the clinicians really get the organs they so deserve for the patients on the waiting list We will be very cautious on keeping a high quality. we will be very cautious on keeping a high quality

Speaker 10: Great. Well, thanks for taking the question and congrats on the successful data and presentation at ISHLT. Great. great Well, thanks for taking the question and congrats on the successful data and presentation at ISHLT. well thanks for taking the question and congrats on the successful data and presentation at ishlt

Speaker 1: Thank you. Thank you. thank you

Speaker 10: I'll get back into the queue. I'll get back into the queue. i'll get back into the queue

Speaker 7: The next question comes from Jakob Lemke from SEB. Please go ahead. The next question comes from Jakob Lemke from SEB. the next question comes from jakob lemke from seb Please go ahead. please go ahead

Speaker 4: Yes, hello. My first question is on the strong EVLP sales here in Q1. I'm wondering if you can sort of elaborate a bit more across the different customer groups, sort of your single one large customer, other U.S. customers, as well as ex-U.S. during the quarter? Yes, hello. yes hello My first question is on the strong EVLP sales here in Q1. my first question is on the strong evlp sales here in q1 I'm wondering if you can sort of elaborate a bit more across the different customer groups, sort of your single one large customer, other U.S. customers, as well as ex-U.S. during the quarter? i'm wondering if you can sort of elaborate a bit more across the different customer groups sort of your single one large customer other u.s customers as well as ex-u.s during the quarter

Speaker 1: Yes, definitely can do that. It is one, an underlying market growth where we see an increased interest to making more lung transplantations. We see a changing organ pool where more and more organs become extended criteria or DCD. That's the underlying growth we see fueling the interest. We see both a, let's call it an underlying growth from existing customers. We see that we now add new customers as well, which are slowly becoming more up and running. We see, of course, the fast uptake in the pilot of the OPO. Those are, let's say, the three reasons. We also see that with increase in the sales footprint, in other words, number of feet on the ground close to customers, we can see an increased usage. It's a direct link there. Yes, definitely can do that. yes definitely can do that It is one, an underlying market growth where we see an increased interest to making more lung transplantations. it is one an underlying market growth where we see an increased interest to making more lung transplantations We see a changing organ pool where more and more organs become extended criteria or DCD. we see a changing organ pool where more and more organs become extended criteria or dcd That's the underlying growth we see fueling the interest. that's the underlying growth we see fueling the interest We see both a, let's call it an underlying growth from existing customers. we see both a let's call it an underlying growth from existing customers We see that we now add new customers as well, which are slowly becoming more up and running. we see that we now add new customers as well which are slowly becoming more up and running We see, of course, the fast uptake in the pilot of the OPO. we see of course the fast uptake in the pilot of the opo Those are, let's say, the three reasons. those are let's say the three reasons We also see that with increase in the sales footprint, in other words, number of feet on the ground close to customers, we can see an increased usage. we also see that with increase in the sales footprint in other words number of feet on the ground close to customers we can see an increased usage It's a direct link there. it's a direct link there

Speaker 4: Okay. Also, I'm wondering if there was any sort of large orders or timing effects impacting the strong Q1 sales for EVLP? Okay. okay Also, I'm wondering if there was any sort of large orders or timing effects impacting the strong Q1 sales for EVLP? also i'm wondering if there was any sort of large orders or timing effects impacting the strong q1 sales for evlp

Speaker 5: We saw the trend in Q4, and I think that trend continued into Q1. We didn't see any huge, let's call it seasonal effect or upstocking, destocking during either this quarter, this year or Q1 this year or Q1 last year. We saw the trend in Q4, and I think that trend continued into Q1. we saw the trend in q4 and i think that trend continued into q1 We didn't see any huge, let's call it seasonal effect or upstocking, destocking during either this quarter, this year or Q1 this year or Q1 last year. we didn't see any huge let's call it seasonal effect or upstocking destocking during either this quarter this year or q1 this year or q1 last year

Speaker 4: I guess my question then is it fair to assume then that this is sort of a new baseline for EVLP consumables? I guess my question then is it fair to assume then that this is sort of a new baseline for EVLP consumables? i guess my question then is it fair to assume then that this is sort of a new baseline for evlp consumables

Speaker 1: Yeah, I think that's a fair assumption. We do see an increasing interest and we do foresee that we will continue to grow both existing and new EVLP programs. Absolutely. Yeah, I think that's a fair assumption. yeah i think that's a fair assumption We do see an increasing interest and we do foresee that we will continue to grow both existing and new EVLP programs. we do see an increasing interest and we do foresee that we will continue to grow both existing and new evlp programs Absolutely. absolutely

Speaker 4: Good. I also have a question on heart and the compassionate use in Europe. I'm wondering if you can elaborate a bit on sort of how freely the centers can use the product right now, and also if you can share how many centers that are live and if you have any more that you think will go live soon. Good. good I also have a question on heart and the compassionate use in Europe. i also have a question on heart and the compassionate use in europe I'm wondering if you can elaborate a bit on sort of how freely the centers can use the product right now, and also if you can share how many centers that are live and if you have any more that you think will go live soon. i'm wondering if you can elaborate a bit on sort of how freely the centers can use the product right now and also if you can share how many centers that are live and if you have any more that you think will go live soon

Speaker 5: Yeah, I think to start with, when we talk about compassionate use, there are, of course, limitations to it. Also this is in Europe, so it's different country by country. Hopefully, soon here it's going to be more Australian-like, and some will be more restricted in terms of when you can use it or not. It's hard to give one answer to that question because it's many countries. We do see that more and more countries are opening up for this opportunity, and that is very positive. That's the key message. We, of course, hope that we don't need this and get the CE mark very soon. We see that we can keep the high interest and continues to save patients where there is no alternative to the XVIVO Heart Assist, which is the case right now. Yeah, I think to start with, when we talk about compassionate use, there are, of course, limitations to it. yeah i think to start with when we talk about compassionate use there are of course limitations to it Also this is in Europe, so it's different country by country. also this is in europe so it's different country by country Hopefully, soon here it's going to be more Australian-like, and some will be more restricted in terms of when you can use it or not. hopefully soon here it's going to be more australian-like and some will be more restricted in terms of when you can use it or not It's hard to give one answer to that question because it's many countries. it's hard to give one answer to that question because it's many countries We do see that more and more countries are opening up for this opportunity, and that is very positive. we do see that more and more countries are opening up for this opportunity and that is very positive That's the key message. that's the key message We, of course, hope that we don't need this and get the CE mark very soon. we of course hope that we don't need this and get the ce mark very soon We see that we can keep the high interest and continues to save patients where there is no alternative to the XVIVO Heart Assist, which is the case right now. we see that we can keep the high interest and continues to save patients where there is no alternative to the xvivo heart assist which is the case right now

Speaker 4: Okay. I'm also wondering if there's been any new or recent dialogue with the notified body or the competent authority regarding EU CE mark, and also if you expect to get the approval done in early summer? Okay. okay I'm also wondering if there's been any new or recent dialogue with the notified body or the competent authority regarding EU CE mark, and also if you expect to get the approval done in early summer? i'm also wondering if there's been any new or recent dialogue with the notified body or the competent authority regarding eu ce mark and also if you expect to get the approval done in early summer

Speaker 1: We are in dialogue with our notified body. To clarify, we are not in direct contact with competent authorities in this case because they have asked for a consultation, and we are in contact with the notified body. The answer is yes to notified body. There has been contact. From what we heard from them, yes, we should expect something here in early summer or summer. That's the latest we heard. We are crossing our fingers and provide all the information we possibly can to make sure that we can get a good decision. We are in dialogue with our notified body. we are in dialogue with our notified body To clarify, we are not in direct contact with competent authorities in this case because they have asked for a consultation, and we are in contact with the notified body. to clarify we are not in direct contact with competent authorities in this case because they have asked for a consultation and we are in contact with the notified body The answer is yes to notified body. the answer is yes to notified body There has been contact. there has been contact From what we heard from them, yes, we should expect something here in early summer or summer. from what we heard from them yes we should expect something here in early summer or summer That's the latest we heard. that's the latest we heard We are crossing our fingers and provide all the information we possibly can to make sure that we can get a good decision. we are crossing our fingers and provide all the information we possibly can to make sure that we can get a good decision

Speaker 4: Okay, this final question, sort of a follow-up to the earlier discussion about the potential label of the heart product in the U.S. I'm just thinking that the FDA must surely also include or consider the data you have gathered outside of the U.S., sort of the European randomized two-arm trial and as well the Australian trial. I guess it must be a very broad label because you have the broadest data of any machine perfusion product out there, right? Okay, this final question, sort of a follow-up to the earlier discussion about the potential label of the heart product in the U.S. okay this final question sort of a follow-up to the earlier discussion about the potential label of the heart product in the u.s I'm just thinking that the FDA must surely also include or consider the data you have gathered outside of the U.S., sort of the European randomized two-arm trial and as well the Australian trial. i'm just thinking that the fda must surely also include or consider the data you have gathered outside of the u.s sort of the european randomized two-arm trial and as well the australian trial I guess it must be a very broad label because you have the broadest data of any machine perfusion product out there, right? i guess it must be a very broad label because you have the broadest data of any machine perfusion product out there right

Speaker 1: To start with, we're extremely proud of all the data we have. Every time we do something with XVIVO Heart Assist Transport, the clinical outcome is better than we could expect from it. We're very proud of it. It's hard to speculate on the FDA and what they will do. We will of course submit all data for their review. The lowest bar is for safety reasons. We will argue that it should be taken into consideration at least for a future label discussion. It's hard to speculate on the ruling from the FDA, so to say, regarding the label. If we look at the inclusion/exclusion criteria in the United States PRESERVE trial, it will cover the majority of donated hearts as it is already today. That in itself would be an extremely good label. To start with, we're extremely proud of all the data we have. to start with we're extremely proud of all the data we have Every time we do something with XVIVO Heart Assist Transport, the clinical outcome is better than we could expect from it. every time we do something with xvivo heart assist transport the clinical outcome is better than we could expect from it We're very proud of it. we're very proud of it It's hard to speculate on the FDA and what they will do. it's hard to speculate on the fda and what they will do We will of course submit all data for their review. we will of course submit all data for their review The lowest bar is for safety reasons. the lowest bar is for safety reasons We will argue that it should be taken into consideration at least for a future label discussion. we will argue that it should be taken into consideration at least for a future label discussion It's hard to speculate on the ruling from the FDA, so to say, regarding the label. it's hard to speculate on the ruling from the fda so to say regarding the label If we look at the inclusion/exclusion criteria in the United States PRESERVE trial, it will cover the majority of donated hearts as it is already today. if we look at the inclusion/exclusion criteria in the united states preserve trial it will cover the majority of donated hearts as it is already today That in itself would be an extremely good label. that in itself would be an extremely good label

Speaker 4: Okay. I understand that. Thank you very much. That's all from me today. Thanks. Okay. okay I understand that. i understand that Thank you very much. thank you very much That's all from me today. that's all from me today Thanks. thanks

Speaker 1: Thank you. Thank you. thank you

Speaker 7: The next question comes from Filip Wiberg from Pareto Securities. Please go ahead. The next question comes from Filip Wiberg from Pareto Securities. the next question comes from filip wiberg from pareto securities Please go ahead. please go ahead

Speaker 3: Hi, good afternoon. First, I think I just would like to follow up on a prior question about the strength in EVLP this quarter. I suppose, like the largest customer explains some part of the strength at least. Given that, I'm just trying to get a better sense of the risk of ending up in a similar situation that we had last year with the destock. You said that you don't think there are any stocking effects this quarter, but could you please just talk a little bit about that and the visibility for this largest customer? Hi, good afternoon. hi good afternoon First, I think I just would like to follow up on a prior question about the strength in EVLP this quarter. first i think i just would like to follow up on a prior question about the strength in evlp this quarter I suppose, like the largest customer explains some part of the strength at least. i suppose like the largest customer explains some part of the strength at least Given that, I'm just trying to get a better sense of the risk of ending up in a similar situation that we had last year with the destock. given that i'm just trying to get a better sense of the risk of ending up in a similar situation that we had last year with the destock You said that you don't think there are any stocking effects this quarter, but could you please just talk a little bit about that and the visibility for this largest customer? you said that you don't think there are any stocking effects this quarter but could you please just talk a little bit about that and the visibility for this largest customer

Speaker 1: Oh, yeah. That's a good question. We have very good visibility and very good dialogue with our largest customers, and we could see that they grow actually as much as other customers during Q1. Like we are, they are also depending on the underlying market growth, so to say. We have a very good one-year visibility into what they aim to do. They are, for the same reasons we are, dependent on the underlying market growth. We saw that last year in Q2 last year. It was that we got a dip during one quarter. If the momentum we see now that we believe will continue, we have good visibility. Oh, yeah. oh yeah That's a good question. that's a good question We have very good visibility and very good dialogue with our largest customers, and we could see that they grow actually as much as other customers during Q1. we have very good visibility and very good dialogue with our largest customers and we could see that they grow actually as much as other customers during q1 Like we are, they are also depending on the underlying market growth, so to say. like we are they are also depending on the underlying market growth so to say We have a very good one-year visibility into what they aim to do. we have a very good one-year visibility into what they aim to do They are, for the same reasons we are, dependent on the underlying market growth. they are for the same reasons we are dependent on the underlying market growth We saw that last year in Q2 last year. we saw that last year in q2 last year It was that we got a dip during one quarter. it was that we got a dip during one quarter If the momentum we see now that we believe will continue, we have good visibility. if the momentum we see now that we believe will continue we have good visibility

Speaker 3: Good. Thanks for that. We talked a little about the gross margins here, but perhaps one on thorax, which was actually okay this quarter. I'm just thinking about it going forward now when EVLP is growing, Perfadex becoming a smaller part. Will you be able to defend the gross margin you've had when EVLP continues to grow and takes a bigger share? How you believe it's going to be affected when you launch heart in both Europe and in the U.S. Good. good Thanks for that. thanks for that We talked a little about the gross margins here, but perhaps one on thorax, which was actually okay this quarter. we talked a little about the gross margins here but perhaps one on thorax which was actually okay this quarter I'm just thinking about it going forward now when EVLP is growing, Perfadex becoming a smaller part. i'm just thinking about it going forward now when evlp is growing perfadex becoming a smaller part Will you be able to defend the gross margin you've had when EVLP continues to grow and takes a bigger share? will you be able to defend the gross margin you've had when evlp continues to grow and takes a bigger share How you believe it's going to be affected when you launch heart in both Europe and in the U.S. how you believe it's going to be affected when you launch heart in both europe and in the u.s

Speaker 5: That is our goal, to defend the thoracic gross margins. You have a point that this quarter was extraordinary when it comes to EVLP portion out of sales, right? We have a lower margin on EVLP than on Perfadex. We also see the growth initiatives in the U.S. We have good prices on those. I'm speaking about the hub model for EVLP. Also we have not yet decided on the heart price in the U.S. as well, which will be a contributor to the gross margins going forward. What we feel for thoracic, that we are in a good spot, and we will work to continue to defend also the abdominal margins here in 2026, of course. That is our goal, to defend the thoracic gross margins. that is our goal to defend the thoracic gross margins You have a point that this quarter was extraordinary when it comes to EVLP portion out of sales, right? you have a point that this quarter was extraordinary when it comes to evlp portion out of sales right We have a lower margin on EVLP than on Perfadex. we have a lower margin on evlp than on perfadex We also see the growth initiatives in the U.S. we also see the growth initiatives in the u.s We have good prices on those. we have good prices on those I'm speaking about the hub model for EVLP. i'm speaking about the hub model for evlp Also we have not yet decided on the heart price in the U.S. as well, which will be a contributor to the gross margins going forward. also we have not yet decided on the heart price in the u.s as well which will be a contributor to the gross margins going forward What we feel for thoracic, that we are in a good spot, and we will work to continue to defend also the abdominal margins here in 2026, of course. what we feel for thoracic that we are in a good spot and we will work to continue to defend also the abdominal margins here in 2026 of course

Speaker 1: I don't know, but the bigger picture is also that for our thorax products or heart and lung, we can have more of a global price list. We don't see any regional differences if you compare, and we're not yet there for our abdominal products. That's something we need to work on, of course. We are more confident. Of course, with heart, when you start up production, there is always slightly lower. I am confident that we very soon can get the heart up and running and reach scale in production. I don't know, but the bigger picture is also that for our thorax products or heart and lung, we can have more of a global price list. i don't know but the bigger picture is also that for our thorax products or heart and lung we can have more of a global price list We don't see any regional differences if you compare, and we're not yet there for our abdominal products. we don't see any regional differences if you compare and we're not yet there for our abdominal products That's something we need to work on, of course. that's something we need to work on of course We are more confident. we are more confident Of course, with heart, when you start up production, there is always slightly lower. of course with heart when you start up production there is always slightly lower I am confident that we very soon can get the heart up and running and reach scale in production. i am confident that we very soon can get the heart up and running and reach scale in production

Speaker 3: All right, good. Perhaps another one to you, Nordström, about the EBITDA margin. You stated it was 24% excluding used heart activities, but I think you said as well that there was some non-recurring costs this quarter. Could you elaborate a little bit about that? Was it only related now to Q1 and nothing going forward? All right, good. all right good Perhaps another one to you, Nordström, about the EBITDA margin. perhaps another one to you nordström about the ebitda margin You stated it was 24% excluding used heart activities, but I think you said as well that there was some non-recurring costs this quarter. you stated it was 24% excluding used heart activities but i think you said as well that there was some non-recurring costs this quarter Could you elaborate a little bit about that? could you elaborate a little bit about that Was it only related now to Q1 and nothing going forward? was it only related now to q1 and nothing going forward

Speaker 5: Thank you. Good question, and perhaps deserves some clarification. This also ties into one of the questions I see here in the chat as well. No, it's the same thing. What I referred to as non-current was the SEK 7 million that we spent on foundational heart logistics preparations consultancy work to prepare for the U.S. heart launch. For us, that was a foundational activity, a bit of a one-time. I think the other investments we will do going forward, which we have touched upon in earlier calls as well, is really to build out the U.S. organization to prepare for the launch. I think that will be more of a linear stepwise growth in OpEx in marketing and sales. Thank you. thank you Good question, and perhaps deserves some clarification. good question and perhaps deserves some clarification This also ties into one of the questions I see here in the chat as well. this also ties into one of the questions i see here in the chat as well No, it's the same thing. no it's the same thing What I referred to as non-current was the SEK 7 million that we spent on foundational heart logistics preparations consultancy work to prepare for the U.S. heart launch. what i referred to as non-current was the sek 7 million that we spent on foundational heart logistics preparations consultancy work to prepare for the u.s heart launch For us, that was a foundational activity, a bit of a one-time. for us that was a foundational activity a bit of a one-time I think the other investments we will do going forward, which we have touched upon in earlier calls as well, is really to build out the U.S. organization to prepare for the launch. i think the other investments we will do going forward which we have touched upon in earlier calls as well is really to build out the u.s organization to prepare for the launch I think that will be more of a linear stepwise growth in OpEx in marketing and sales. i think that will be more of a linear stepwise growth in opex in marketing and sales Overall, on EBITDA, last time I checked the consensus, I think that's kind of where we are aiming to land for the full year of 2026. Overall, on EBITDA, last time I checked the consensus, I think that's kind of where we are aiming to land for the full year of 2026. overall on ebitda last time i checked the consensus i think that's kind of where we are aiming to land for the full year of 2026

Speaker 3: Okay, good. Thanks. Just to be clear, admin costs, you expect that to come down from Q1 levels? Okay, good. okay good Thanks. thanks Just to be clear, admin costs, you expect that to come down from Q1 levels? just to be clear admin costs you expect that to come down from q1 levels

Speaker 5: Yes Yes yes

Speaker 3: Increasing the selling expenses going forward? Increasing the selling expenses going forward? increasing the selling expenses going forward

Speaker 5: Correct. Correct. correct

Speaker 3: Okay, good. Just last question. I was curious around the next step in direct procurement DCD, so the study Philip Braga presented. What are going to be the next step in this? I suppose there will be more studies required to get the surgeons confident in using this approach, or what do you have to say about that? Okay, good. okay good Just last question. just last question I was curious around the next step in direct procurement DCD, so the study Philip Braga presented. i was curious around the next step in direct procurement dcd so the study philip braga presented What are going to be the next step in this? what are going to be the next step in this I suppose there will be more studies required to get the surgeons confident in using this approach, or what do you have to say about that? i suppose there will be more studies required to get the surgeons confident in using this approach or what do you have to say about that

Speaker 1: Yeah, there will be many steps in this. The first one, we hope that Philip Braga can submit a paper on how to do this, so we get a standardized approach to direct procurement. This was, of course, a very important step to make this data public and also to get the interest up for direct procurement. What we've seen is that the uptake is pretty fast once you got the hang of it and you've done it. The interest to avoid all complicated other processes you would have to do, such as NRP or very expensive machinery, in DCD hearts is avoided. You reduce cost, you reduce complexity, et cetera. The interest to go this route was, during the late breaking news, extremely high. Yeah, there will be many steps in this. yeah there will be many steps in this The first one, we hope that Philip Braga can submit a paper on how to do this, so we get a standardized approach to direct procurement. the first one we hope that philip braga can submit a paper on how to do this so we get a standardized approach to direct procurement This was, of course, a very important step to make this data public and also to get the interest up for direct procurement. this was of course a very important step to make this data public and also to get the interest up for direct procurement What we've seen is that the uptake is pretty fast once you got the hang of it and you've done it. what we've seen is that the uptake is pretty fast once you got the hang of it and you've done it The interest to avoid all complicated other processes you would have to do, such as NRP or very expensive machinery, in DCD hearts is avoided. the interest to avoid all complicated other processes you would have to do such as nrp or very expensive machinery in dcd hearts is avoided You reduce cost, you reduce complexity, et cetera. you reduce cost you reduce complexity et cetera The interest to go this route was, during the late breaking news, extremely high. the interest to go this route was during the late breaking news extremely high There was unfortunately not enough time for questions, but we will revisit that during our heart symposium today, so hopefully more people can ask questions. Then again, this is a technique that spreads really surgeon to surgeon, so they will talk to each other and train each other and get more and more confident over time. There was unfortunately not enough time for questions, but we will revisit that during our heart symposium today, so hopefully more people can ask questions. there was unfortunately not enough time for questions but we will revisit that during our heart symposium today so hopefully more people can ask questions Then again, this is a technique that spreads really surgeon to surgeon, so they will talk to each other and train each other and get more and more confident over time. then again this is a technique that spreads really surgeon to surgeon so they will talk to each other and train each other and get more and more confident over time

Speaker 3: Okay, good. Thank you very much. That was all from me. Okay, good. okay good Thank you very much. thank you very much That was all from me. that was all from me

Speaker 1: Thank you. I actually have to leave quite. Thank you. thank you I actually have to leave quite. i actually have to leave quite

Speaker 7: The next question comes from Ludwig Germunder from Handelsbanken. Please go ahead. The next question comes from Ludwig Germunder from Handelsbanken. the next question comes from ludwig germunder from handelsbanken Please go ahead. please go ahead

Speaker 6: Hi, and thank you for taking my questions. I would like to follow up with another question on the EVLP and in line with some questions already asked. I would like to hear if you could say something about how you see the recovery in terms of how much is recovered now on EVLP. Are we back at previous normal levels? You mentioned this is fair to assume as a new baseline in EVLP consumable sales. Do you see any more recovery to do before you're back at some sort of pre-levels, after last year? Hi, and thank you for taking my questions. hi and thank you for taking my questions I would like to follow up with another question on the EVLP and in line with some questions already asked. i would like to follow up with another question on the evlp and in line with some questions already asked I would like to hear if you could say something about how you see the recovery in terms of how much is recovered now on EVLP. i would like to hear if you could say something about how you see the recovery in terms of how much is recovered now on evlp Are we back at previous normal levels? are we back at previous normal levels You mentioned this is fair to assume as a new baseline in EVLP consumable sales. you mentioned this is fair to assume as a new baseline in evlp consumable sales Do you see any more recovery to do before you're back at some sort of pre-levels, after last year? do you see any more recovery to do before you're back at some sort of pre-levels after last year

Speaker 1: No, I think not so much recovery. We have to be very aggressive and find new customers and new concepts which satisfy the needs from American surgeons, such as the OPO model. We will continue to build on what we have, so to speak, on the foundation we have now established during Q4 and Q1. I want to mention that last year, there was a tough period for lung transplantation in terms of the numbers flattened out and there was a lack of resources in the system. Again, the system reacted quickly. I think we reacted quickly to give them alternative resources with partnerships. I more look at it as a forward-looking exercise. No, I think not so much recovery. no i think not so much recovery We have to be very aggressive and find new customers and new concepts which satisfy the needs from American surgeons, such as the OPO model. we have to be very aggressive and find new customers and new concepts which satisfy the needs from american surgeons such as the opo model We will continue to build on what we have, so to speak, on the foundation we have now established during Q4 and Q1. we will continue to build on what we have so to speak on the foundation we have now established during q4 and q1 I want to mention that last year, there was a tough period for lung transplantation in terms of the numbers flattened out and there was a lack of resources in the system. i want to mention that last year there was a tough period for lung transplantation in terms of the numbers flattened out and there was a lack of resources in the system Again, the system reacted quickly. again the system reacted quickly I think we reacted quickly to give them alternative resources with partnerships. i think we reacted quickly to give them alternative resources with partnerships I more look at it as a forward-looking exercise. i more look at it as a forward-looking exercise

Speaker 6: Okay, I see. Thank you. I have a question. I'm not sure if you mentioned it already. I apologize if you did, but on the CAP study for heart, you filled the 60 hearts that you were allowed to do. You previously mentioned that you could possibly get another 60 hearts. Can you comment anything on the status around that now? Okay, I see. okay i see Thank you. thank you I have a question. i have a question I'm not sure if you mentioned it already. i'm not sure if you mentioned it already I apologize if you did, but on the CAP study for heart, you filled the 60 hearts that you were allowed to do. i apologize if you did but on the cap study for heart you filled the 60 hearts that you were allowed to do You previously mentioned that you could possibly get another 60 hearts. you previously mentioned that you could possibly get another 60 hearts Can you comment anything on the status around that now? can you comment anything on the status around that now

Speaker 1: No, I can't comment further than I already did. We have applied for another 60, and we do hope that FDA come back as soon as possible. We have to understand, we are under an IDE, and FDA are deciding what we can do and not do during an IDE. No, I can't comment further than I already did. no i can't comment further than i already did We have applied for another 60, and we do hope that FDA come back as soon as possible. we have applied for another 60 and we do hope that fda come back as soon as possible We have to understand, we are under an IDE, and FDA are deciding what we can do and not do during an IDE. we have to understand we are under an ide and fda are deciding what we can do and not do during an ide

Speaker 6: I got it. Those are my questions. Thank you for taking my questions. I got it. i got it Those are my questions. those are my questions Thank you for taking my questions. thank you for taking my questions

Speaker 1: Thank you. Thank you. thank you

Speaker 6: Thanks. Thanks. thanks

Speaker 5: Should we continue or would you like to end the call? Should we continue or would you like to end the call? should we continue or would you like to end the call

Speaker 1: Yeah, continue. If the last two questions, we can keep them short. I know we're over time, and I actually have to leave for another meeting, but I see there are two more analysts who have questions. Yeah, continue. yeah continue If the last two questions, we can keep them short. if the last two questions we can keep them short I know we're over time, and I actually have to leave for another meeting, but I see there are two more analysts who have questions. i know we're over time and i actually have to leave for another meeting but i see there are two more analysts who have questions

Speaker 5: Okay. Okay. okay

Speaker 1: I do want to give them the opportunity to ask those questions. I will ask I do want to give them the opportunity to ask those questions. i do want to give them the opportunity to ask those questions I will ask i will ask

Speaker 5: Let's continue. Let's continue. let's continue

Speaker 1: Fairly brief. Fairly brief. fairly brief

Speaker 7: The next question comes from Oscar Bergman from Redeye. Please go ahead. The next question comes from Oscar Bergman from Redeye. the next question comes from oscar bergman from redeye Please go ahead. please go ahead

Speaker 8: Hello, Kristoffer. I will be really, really quick. We can talk later on the phone. Just wondering, R&D costs are SEK 37 million, if that should be considered sort of a baseline going forward, or if there are any one-offs that make maybe the last couple of quarters a better baseline? Hello, Kristoffer. hello kristoffer I will be really, really quick. i will be really really quick We can talk later on the phone. we can talk later on the phone Just wondering, R&D costs are SEK 37 million, if that should be considered sort of a baseline going forward, or if there are any one-offs that make maybe the last couple of quarters a better baseline? just wondering r&d costs are sek 37 million if that should be considered sort of a baseline going forward or if there are any one-offs that make maybe the last couple of quarters a better baseline

Speaker 5: Yeah, good question. I think it could be used as a baseline for the rest of the quarters here this year, but you will see a significantly lower spend on the other type of CapEx, material assets. We're very soon done with investments into increasing the product capacity. I think all in all, you will see lower CapEx in 2026 than you saw in 2025. Which means that we are optimistic that we should be able to end the year on a cash positive level here, which would be first time in XVIVO history. Yeah, good question. yeah good question I think it could be used as a baseline for the rest of the quarters here this year, but you will see a significantly lower spend on the other type of CapEx, material assets. i think it could be used as a baseline for the rest of the quarters here this year but you will see a significantly lower spend on the other type of capex material assets We're very soon done with investments into increasing the product capacity. we're very soon done with investments into increasing the product capacity I think all in all, you will see lower CapEx in 2026 than you saw in 2025. i think all in all you will see lower capex in 2026 than you saw in 2025 Which means that we are optimistic that we should be able to end the year on a cash positive level here, which would be first time in XVIVO history. which means that we are optimistic that we should be able to end the year on a cash positive level here which would be first time in xvivo history

Speaker 8: Thanks. When you have the CE marking in place for the heart product, will you be able to implement any price changes in Australia and New Zealand? If yes, roughly how much, and will it be immediately after the CE marking? Thanks. thanks When you have the CE marking in place for the heart product, will you be able to implement any price changes in Australia and New Zealand? when you have the ce marking in place for the heart product will you be able to implement any price changes in australia and new zealand If yes, roughly how much, and will it be immediately after the CE marking? if yes roughly how much and will it be immediately after the ce marking

Speaker 1: To start with, the CE mark will be the base for the approval in Australia, but we still need to go through a review process there to start with. Now we have a fixed reimbursement, so with the increasing body of evidence in terms of health and hospital economics, we will of course, improve reimbursement levels, and the chance of doing that is a lot higher after an approval, so to say. Now you get what you get, so to say, during an unapproved product. That's a job that will start. It will not be immediate. You do have to work with reimbursement in each country. To start with, the CE mark will be the base for the approval in Australia, but we still need to go through a review process there to start with. to start with the ce mark will be the base for the approval in australia but we still need to go through a review process there to start with Now we have a fixed reimbursement, so with the increasing body of evidence in terms of health and hospital economics, we will of course, improve reimbursement levels, and the chance of doing that is a lot higher after an approval, so to say. now we have a fixed reimbursement so with the increasing body of evidence in terms of health and hospital economics we will of course improve reimbursement levels and the chance of doing that is a lot higher after an approval so to say Now you get what you get, so to say, during an unapproved product. now you get what you get so to say during an unapproved product That's a job that will start. that's a job that will start It will not be immediate. it will not be immediate You do have to work with reimbursement in each country. you do have to work with reimbursement in each country

Speaker 8: Okay. That's good enough for me. Thank you. Okay. okay That's good enough for me. that's good enough for me Thank you. thank you

Speaker 7: The next question comes from Edward Hall from Stifel. Please go ahead. The next question comes from Edward Hall from Stifel. the next question comes from edward hall from stifel Please go ahead. please go ahead

Speaker 2: Thank you very much, guys, for taking my questions. Just quickly on lung and how we should think about it for the rest of the year. I think you've outlined the underlying existing customers. The new customers are growing, and obviously looking at Q2 and Q3 are weaker comps. Is there anything that you would point out to show anything that I may be missing outside of the trends that you've already outlined? That would just be my first question. Thank you very much, guys, for taking my questions. thank you very much guys for taking my questions Just quickly on lung and how we should think about it for the rest of the year. just quickly on lung and how we should think about it for the rest of the year I think you've outlined the underlying existing customers. i think you've outlined the underlying existing customers The new customers are growing, and obviously looking at Q2 and Q3 are weaker comps. the new customers are growing and obviously looking at q2 and q3 are weaker comps Is there anything that you would point out to show anything that I may be missing outside of the trends that you've already outlined? is there anything that you would point out to show anything that i may be missing outside of the trends that you've already outlined That would just be my first question. that would just be my first question

Speaker 1: Thank you. Thank you, Ed, for that question. I do think that there will, of course, be seasonality like in any business, and also depending on the number of donors going for EVLP. I still state this, we do see an increased interest for lung transplantation in general and for EVLP in particular, based on the body of evidence we see now, for example, there was a presentation here during ISHLT, which show that you get better outcome on both DBD and DCD for EVLP if you standardize your EVLP program and EVLP protocol. If you have a very clear inclusion criteria, you actually get better results from using EVLP than standard of care. I think this growing body of evidence speaks for EVLP increasing as an indication of all lungs. Thank you. thank you Thank you, Ed, for that question. thank you ed for that question I do think that there will, of course, be seasonality like in any business, and also depending on the number of donors going for EVLP. i do think that there will of course be seasonality like in any business and also depending on the number of donors going for evlp I still state this, we do see an increased interest for lung transplantation in general and for EVLP in particular, based on the body of evidence we see now, for example, there was a presentation here during ISHLT, which show that you get better outcome on both DBD and DCD for EVLP if you standardize your EVLP program and EVLP protocol. i still state this we do see an increased interest for lung transplantation in general and for evlp in particular based on the body of evidence we see now for example there was a presentation here during ishlt which show that you get better outcome on both dbd and dcd for evlp if you standardize your evlp program and evlp protocol If you have a very clear inclusion criteria, you actually get better results from using EVLP than standard of care. if you have a very clear inclusion criteria you actually get better results from using evlp than standard of care I think this growing body of evidence speaks for EVLP increasing as an indication of all lungs. i think this growing body of evidence speaks for evlp increasing as an indication of all lungs

Speaker 2: Perfect. No, that makes sense. Just final question from my side. Just want to get your thoughts on how transplant surgeons are thinking about the trade-off between sort of the increased ECMO use that we saw in the PRESERVE data for some of the DCD implants versus what actually came out with lower severe PGD. From your talks that you've had this week at the Congress, is there any initial thoughts you could comment on there? Perfect. perfect No, that makes sense. no that makes sense Just final question from my side. just final question from my side Just want to get your thoughts on how transplant surgeons are thinking about the trade-off between sort of the increased ECMO use that we saw in the PRESERVE data for some of the DCD implants versus what actually came out with lower severe PGD. just want to get your thoughts on how transplant surgeons are thinking about the trade-off between sort of the increased ecmo use that we saw in the preserve data for some of the dcd implants versus what actually came out with lower severe pgd From your talks that you've had this week at the Congress, is there any initial thoughts you could comment on there? from your talks that you've had this week at the congress is there any initial thoughts you could comment on there

Speaker 1: No, I think that everyone was surprised that the data was as good as it was because the donor pool and the patients were very marginal, so to say. This was better than expected from many of the trial centers, so that was really good news. I think that we saw still a low level of severe PGD was really good. I think that would be the leading indicator for us, and that we also could see that we could replicate that in survival data, really strengthen the whole belief for what this product can do once it's on the market. No, I think that everyone was surprised that the data was as good as it was because the donor pool and the patients were very marginal, so to say. no i think that everyone was surprised that the data was as good as it was because the donor pool and the patients were very marginal so to say This was better than expected from many of the trial centers, so that was really good news. this was better than expected from many of the trial centers so that was really good news I think that we saw still a low level of severe PGD was really good. i think that we saw still a low level of severe pgd was really good I think that would be the leading indicator for us, and that we also could see that we could replicate that in survival data, really strengthen the whole belief for what this product can do once it's on the market. i think that would be the leading indicator for us and that we also could see that we could replicate that in survival data really strengthen the whole belief for what this product can do once it's on the market

Speaker 2: Perfect. Okay. That makes sense. It sounds like actually the lower PGD rate is really the driving force in that trade-off. Perfect. perfect Okay. okay That makes sense. that makes sense It sounds like actually the lower PGD rate is really the driving force in that trade-off. it sounds like actually the lower pgd rate is really the driving force in that trade-off

Speaker 1: Yeah. Yeah. yeah

Speaker 2: That's how I should think about it. That's how I should think about it. that's how i should think about it

Speaker 1: Yeah. Yeah. yeah

Speaker 2: Okay, perfect. Thank you very much. Okay, perfect. okay perfect Thank you very much. thank you very much

Speaker 1: Thank you very much, everyone. Sorry for going a little bit over time. We will now end the call and move to the last slide where we want to thank you so much for today, and we meet next time on July 14th. Thank you very much, everyone. thank you very much everyone Sorry for going a little bit over time. sorry for going a little bit over time We will now end the call and move to the last slide where we want to thank you so much for today, and we meet next time on July 14th. we will now end the call and move to the last slide where we want to thank you so much for today and we meet next time on july 14th