Xvivo Perfusion AB (publ)

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

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

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

If you wish to ask a question, please dial pound key five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. The next question comes from Simon Larson from Danske Bank. Please go ahead.

Yes, good afternoon everyone. Firstly, maybe on the US heart theme. I know that in the press release from Wednesday that you are planning to hand in the file to the FDA later this year, but could you give us any more details on when that might 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 due in the summer. So I will come back when I have a when I have a better timeline, but it's somewhere during the summer, so it's not the end of the year, it's earlier than that.

Yeah, understood. And maybe it's a bit sort of speculative at this point, but would you expect the FDA to sort of 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. But 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. So we know how to do this, and we are confident that we can answer any question the FDA might pose to us.

Yeah, fair, fair. And I know you said in the beginning of the presentation, Kristoffer, that you aim to make a heart box. standard of care for all hearts, basically. But if you could help us understand the scope of the hearts that you will address in the US, maybe to begin with, will you be focusing on the sort of marginalized ECD, DCD hearts or older donors? I mean, and any help slicing the market opportunity and what you will target first would be also interesting to hear.

That's a great question. I mean, we can only market what we get on the label and the label will be pending the FDA review process. So it's hard to say exactly. But if we look at the preserved trial and the inclusion-exclusion criteria there, it is exactly those hearts we're talking about. It's DCD heart, extended criteria heart. So that's either due to... more than two hour preservation and a couple of factors, a couple of risk factors or more than four hours. So we will definitely target those, those hearts. We will also, we see an increasing interest here from US clinicians. So 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 long 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, and also 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 EWLP 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 opioid over one center pump lungs for a larger area, which we have seen has been very successful before. So we have a positive outlook, but again, looking into the future, it's impossible. But what we can see so far, it looks very good. And especially, I'm really encouraged after all the meetings we had here in both the Lange Symposium and all the customer interactions from here, from ISHIT. So we see a positive outlook.

Gotcha. Great. Thanks so much.

Thank you.

The next question comes from Ulrich Trattner from DNB Carnegie. Please go ahead.

Thank you very much, and a few on my end. And I'll start off with the abdominal gross margins. And Christopher, you touched upon this. But I also note that the gross margin was kind of equally low in Q4. So is there aspects related to this since you moved your manufacturing to Sweden from the Netherlands or 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 Nordstrom if you want to pitch in on this one, but if we take high level it is There is today in the, at least the abdominal field, slightly lower gross margins in Europe versus the US. So it's partly a regional mix that we hope over time we will grow out of. also we are moving production right now and and uh have not reached the full scale in production that we want uh so it's it's not uh let's say call it a quick fix but we diligently work to to improve the gross margin for our government portfolio um in the next quarters and and years to come so we see a gradual improvement is my belief

I can just add as well, Christopher, 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. But it's still very much about European business with some regions with lower pricing. Okay, great.

And on to sort of prospects going ahead and the sub-Q meeting that you have scheduled. So what is your ambition going into this? You can obviously go down a few routes here, but are you aiming to use the European data in order to get approval as you did for kidney or 510K? 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. But we would also be in listening mode and see what the requirements from the FDA is. So that would be a good dialogue that we have started that is very good and positive. But we also have to be humble that the FDA is deciding in this case. So we will argue our case and see what comes out of it.

And just correct me if I'm wrong, but wouldn't it be beneficial on your end to actually generate some US data prior to launching it, giving sort of the, in hindsight, what we have seen with the kidney launch, that US data is of high importance in order to reach higher volume? Yeah. Potentially a 510K would be the preferred route on your end.

Yeah, I mean, the good news with the 510k route is that the burden of proof is lessened. It's more towards safety than efficacy. But you're right in either way, whatever the FDA says, we need to do a trial. It's, let's say before or after. So We will do a clinical trial in the US to make sure that the American users can replicate the European data. That is extremely good for it to be believable. And you're right, with the kidney experience, we learned that very fast that launching a product without US data will not make it fly. So we have to do something either way. But 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 graphs, which are very positive. So that's of course our aim.

Great. And a question on the CAP program. If you went from four patients in Q3 22 and now 36 here in Q1, and I would assume that the interest has not gone down post ISHLP. So how quickly can you get a sort of re-approval or expansion of your CAP program in the US?

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

And 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 parts that are being transplanted or is it just the portion of them? Or can you give us any more insight 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, you know, worst grafts and the sickest patients where they see no other use right now. So we should remember that. But we can see in some cap centers that it's quite high penetration. And the testimonial I get when I'm here from the users is that uh you know this is so easy to use it's really plug and play and the hearts are in an excellent condition um after being in index view heart assist so so it's it's 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 a number of patients. And I think it's more interesting to look to the Australian situation where there is an uncapped continuous access protocols would say similar, but it's uncapped too. And there we see that it's 50% for DBDs and now we're starting with DCD.

Sure, yeah. And just on the data that you have generated here lately and presented, obviously positive outcome in the US and four additional patients in Europe on hope. Are you adding this to the European regulatory agencies and have this in any way sort of increased your confidence in obtaining approval for the hard box here in 2026?

um the straight answer is yes i mean the feedback we get from those compassionate uses that yeah we don't see any alternative on the market uh for for any grafts pediatric adult dcd or dvd so it's really encouraging to see medical agencies in europe looking into the file uh clearly state there is no alternative we need compassionate use for this uh this product and uh So, yes, the straight answer is yes, we get more confident the more we talk to medical agencies, the more we talk to clinicians of how important this is. But again, the regulatory process is a regulatory process, and it's hard to speculate. But definitely, due to this, we are more confident, yes.

Great. And last question on my end. Did you mention that you had found 45 OPIO targets to sort of be integrated into an EVLP program? I just tuned to if I heard that clear.

Yeah, four to five are identified in the pipeline right now. clarify that uh so we have we have our done our first installment very successful ahead of of our plan uh we are doing our second one i think yeah while we speak or at least very soon after isht and then there is a rollout plan which is uh to some extent will be uh resource limited but to uh but we have a clear plan and we're gonna make sure that we are successful in every installation So we're going to make sure that we are that. And we are also increasing our internal resources to be able to handle that and increase growth and increase interest from OPOs. Where, in all honesty, the XPS and the Sten solution was developed in the beginning for this target group of OPOs. So it's great to be back home again, so to say, and see the OPOs using it.

Okay, great. And essentially it's an acceleration, not sort of a maintained pace, even with your sort of limited resources.

Yeah, so we will try to accelerate 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 partner's side, 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. So we'll be very conscious of keeping a high quality.

Great. Well, thanks for taking the question and congrats on the successful data and presentation at IFH-LT. I'll get back into the queue.

The next question comes from Jakob Lemke from SEB. Please go ahead.

My first question is on the strong EVLP sales here in Q1. So 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 US customers as well as ex-US during the quarter.

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

Okay. And then also I'm wondering if there was any sort of large orders or timing effects impacting the strong QA cells for EDLC?

I think it was fairly, we saw the trend in Q4 and I think that trend continuing to 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.

So I guess my question then is, 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. I mean, we do see an increasing interest and we do foresee that we will continue to grow both existing and new EVLP programs, absolutely.

Good, then I also have a question on HAARC 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 and also this is being Europe so it's different country by country some are are more hopefully soon here is going to be more Australian like and some will be more restricted in terms of of when you can use it or not. So it's hard to give one answer to that question because it's many countries, but we do see that more and more countries are opening up for this opportunity. And that is very, very positive. That's the key message. And then we, of course, hope that we don't need this and get this e-mark very soon, but we see that we can keep the high interest and continues to save patients where there is no alternative to the ex vivo heart assist which is the case right now.

Okay and then I'm also wondering if there's been any new or recent dialogue with the notified body or the competent authority regarding the EUC mark and also if you expect to get the approval then 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 consultation and we are in contact with notified body. So 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. So 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, and then it's a final question, sort of a follow-up to the earlier discussion about the potential label of the hard product in the US. 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 randomized two-armed trial and as well the Australian trial. So 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. And every time we do something with extrema heart assist, the clinical outcome is better than we could expect from it. So 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 the review. I mean, the lowest bar is for safety reasons. And we will argue that it should be taken into consideration at least for a future label discussion. But it's hard to speculate on the ruling from the FDA, so to say, regarding the label. But if we... If we look at the inclusion exclusionary in the United States preserve trial, it will cover the majority of of donated hearts as it is already today. So so that would be that in itself will be an extremely good label.

I understand that. Thank you very much. Thanks. Thank you.

The next question comes from Philip Weiberg from Pareto Securities. Please go ahead.

All right, good afternoon. First, I think I just would like to follow up on a prior question about the strength in EVLT this quarter. So 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 D-Stock. And 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?

Yeah, that's a good question. I mean, 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. But like like we are, they are also depending on the underlying market growth, so to say. But we have a very good one year visibility into what they aim to do. But they are for the same reasons we are dependent on the underlying market growth. And we saw that last year in Q2 last year, it was that we got a dip during one quarter. So 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. But I'm just thinking about it going forward now, when EDLP is growing, Perfidex is becoming a smaller part. So will you be able to defend the gross margin you've had when EDLP continues to grow and takes a bigger share. And then also how you believe it's going to be affected when you launch HART in both Europe and in the US.

That is our goal to defend the thoracic gross margins. You have a point that, I mean, this quarter was extraordinary when it comes to EVLP portion out of sales, right? So we have a lower margin on EVLP than on Perfodex. But we also see the growth initiatives in the US. We have good prices on those, speaking about the hub model for EVLP. And also we have not yet decided on the heart price in the US as well, which will be a contributor to the gross margins going forward. So 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.

And I don't know, but the bigger picture is also that for our Thorax products, so heart and lung, we can have more of a global price list. So we don't see any regional differences if you compare, and we're not yet there for our Domna products. So that's something we need to work on, of course, but we are more confident. And of course, with heart, there is always, when you start up production, there's always a slightly lower, but 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 EBTA margin. You stated it was 24% excluding use heart activities, but I think you said as well that there was some non-recurring cost this quarter. So 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. And this also ties into one of the questions I see here in the chat as well. So, no, it's the same thing. So what I referred to as non-current was the 7 million SEC that we spent on foundational heart loss preparations, consultancy work to prepare for the US heart launch. So 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 early calls as well, is really to build out the US organization to prepare for the launch. And I think that will be more of a linear stepwise growth in OPEX in marketing and sales. But overall on EBITDA, I mean, 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. So just to be clear, admin costs, you expect that to come down from Q1 levels, but that's 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 Rega presented, like 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 Filip and Erika can submit a paper on how to do this so we get a standardized approach to direct procurement. then this was of course a very important step to make this data public and also to get the interest up for direct procurement. But what we've seen is that the uptake is pretty fast once you got the hang of it and you've done it. And the interest to avoid all complicated other processes you would have to do such as NRP or very expensive machinery, uh in in dcd hearts is avoided so you reduce cost you reduce complexity etc so the interest to go this go this route was was during the late breaking news was extremely high and uh there was unfortunately not enough time for questions but we will uh revisit that during our heart symposium today so hopefully more people can can ask questions um and then again it's it's um 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.

The next question comes from Ludwig Germunder from Handelsbanken. Please go ahead.

Hi, and thank you for taking my questions. I would like to All up with another question on the EVLP and in line with some questions already asked, but 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 consumer sales, but do you see any more recovery to do before you're back at some sort of three 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 opioid model. So we will continue to build on what we have, so to say, on the foundation we have now established during Q4. Sorry, Q4 and Q1. I want to mention that last year there was a tough period for lung transplantation in terms of the number flattened out and there was a lack of resource in the system. But again, the system reacted quickly. I think we reacted quickly to give them alternatives, alternative resources with partnerships. So I more look at it as a forward-looking exercise.

Thank you. And then 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?

I can't comment further than I already did. We have applied for another 60 and we do hope that if they come back as soon as possible, but it's it's we have to understand we are under an ID and FDA are deciding what we can do and not do do during an ID.

Okay, I got it. That was my question. Thanks 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, if 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, so I do want to give them the opportunity to ask those questions. But I will ask them fairly brief.

The next question comes from Oscar Bergman from Red Eye. Please go ahead.

Hello, Christoffers. I will be really, really quick. We can talk later on the phone. Just wondering, R&D costs at 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 COPX, material assets, we're building out the We're very soon done with investments into our, you know, increasing the product capacity. So I think all in all, you will see lower COPEX in 2026 than you saw in 2025, which means that we are optimistic that we should be able to to to to end the year on a cash positive level here, which would be the first time in XTV history.

Thanks. And then, when you have the CE marking in place for the whole product, will you be able to implement any price changes in Australia and New Zealand? And if yes, roughly how much and will it be immediately after the CE marking?

To start with, the CE marking 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 an unapproved product. So that's a job that will start. It will not be immediate. So you do have to work with reimbursement in each country.

Okay, that's good enough for me. Thank you.

The next question comes from Ed Hall from Stifel. Please go ahead.

Thank you very much, guys, for taking my questions. Just quickly on Lung and how we think about it for the rest of the year. So I think you've outlined that underlying existing customers and new customers are growing and obviously looking at Q2 and Q3 or 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? And that would just be my first question.

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

Perfect. No, that makes sense. And then just final question from my side. I just want to get your thoughts on how transplant surgeons are thinking about the tradeoff between sort of the increased ECMO use that we saw in the preserved 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, but I think that everyone was surprised that the data was as good as it was because both the donor pool and the patients were very marginal, so to say. So 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 PDD 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.

Okay, so that makes sense. So it sounds like actually the lower PGD rate is really the driving force in that trade-off. That's how I should think about it.

Yeah. 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.