Xvivo Perfusion AB (publ) ($XVIVO)

Welcome to XVIVO Q1 Report for 2026. [Operator Instructions] Now I will hand the conference over to CEO, Christoffer Rosenblad; and CFO, Kristoffer Nordstrom. 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 #2 and just -- today's presenters are me, Christoffer Rosenblad calling in from the 2026 ISHLT Conference in Toronto, Canada; and Kristoffer Nordstrom, CFO calling in from Philadelphia in the United States. And with that, we can go to Slide #3, 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 U.S. 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 Nordstrom 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 segment are growing rapidly in both regions, which are North America and Europe. The lung market trend we saw in Q4 last year continues into 2026 with a good lung 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 transplant teams. And with that, we can go over to the highlights of the quarter, and we can actually jump straight to Slide #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. And it partly explains the increased lung sales we see in this quarter. So far, the progress is ahead of our internal plan, and we have identified 4 to 5 more OPOs in the rollout pipeline plan, whereof 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. And 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. And to satisfy their needs, we have -- 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 ID we have. And if we look at #5, it's a testament to how well the XVIVO 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 are 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. And 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. 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 new hearts. 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, 6 out of 10 of the largest transplant program in the U.S. opted to use Flowhawk since it simplifies the transplant process and reduces 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 and we see an increased interest to use the XVIVO 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 #6. So 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. And 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 Assist was featuring 2 late-breaking news sessions 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 heart symposium, which will be really, really interesting to see. But already this Wednesday, we had the lung symposium, so 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. 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 5 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 1-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 EVLP has been key to enable safe use of those extended criteria organs. But let's jump into the 2 highlights in the late-breaking news session from XVIVO. So we go to the next slide, which is #7, 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 endpoints. 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 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 #8, 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 4 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 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 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 a publication during Q1 this year. I again want to mention this is the first randomized controlled trial with superior endpoint 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 PGD reduction and reduced 1-year mortality. And we can see this at the data, if you look at the little box of data that both mortality and severe PGD have a clear link, and I will explain that link. So in the analysis of the trial data, it was noted that the ex vivo group had a reduction of severe PGD by 76%. So 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 ex vivo 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 3 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. And 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. So the U.S. heart trial was fully included in record time, and we now passed the 12-month patient follow-up and 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. And 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. But again, as stated earlier, the heart box and disposable part of the product are already CE-marked, and 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. 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 XVIVO Heart Assist. So we are working really hard with our notified body to get the final CE-mark. But 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-mark. So we will use that as a base. I will come back to the U.S. liver update in the next slide, actually, so we can go straight to that slide. And Slide #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 IDE and the CMS funding approved. We could have started a trial last year, mid last year. We did decide to temporarily post activities for the liver PMA process to investigate the alternative regulatory route. And we are right now in preparation for FDA QSA 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 U.S. liver regulatory investigation and later, so of course, in the -- when we report the Q2 report in July, we will give an update. And with that, I hand over to our CFO for going into the financial performance of XVIVO.

Thank you, and happy to do so, Christoffer. So 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 first -- 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. So 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 were 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, nonrecurring items, which explains the increase in administration costs. Setting this initiative aside, the underlying EBITDA in Q1 was 24% and was 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 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 digits. 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 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. included its last patient. Australia and New Zealand continue with extraordinary market penetration on the 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 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 U.S. dollar. So overall, thoracic experiencing a good momentum. Moving over to abdominal. Abdominal continues to deliver good quarters. Net sales were SEK 66 million and 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 and sales grew 63% in local currencies. We see a growing interest for Kidney Assist Transport in the 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 a larger portion of kidney sales versus liver, but also a larger portion this quarter of sales to lower-priced 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 2 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 CAP for the Flowhawk team, which means the software is now embedded into the day-to-day practice at 6 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. Organ recovery showed yet another quarter with a 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 capacity 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 incurred 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 nonrecurring 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 SEK 65 million, mainly driven by good sales momentum, of course. And the cash flow from investments was minus SEK 55 million. But all in all, we ended up for the second quarter in a row with a positive total cash flow. And we have SEK 308 million on hand when we closed the quarter. And 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. And with that, we go into the outlook and a little bit into the future of what will happen this year and also what will happen in long term. And we can go to Slide #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 U.S. 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 to 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 higher 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 obtaining 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. 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 U.S. clinicians the ability to actually use the Liver Assist and have the same success we have seen in Europe. And 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 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 their waitlist. So the demand for transplant is according to our analysis, approximately 10x 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 10x in terms of value. So we see a market opportunity with this almost 100x 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 ISHLT of increased the number of organs used for transplantation and actually safely increase them with improving survival rate as well. And we also know that we see a growing DCD organ pool. In many countries, it's above 50%. We know here in the U.S., it 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. And XVIVO, we want to change the paradigm on transplantation 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 a 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.

[Operator Instructions] The next question comes from Simon Larsson from Danske Bank.

Yes. 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. But 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. We don't -- I don't have an exact time line, but it will be somewhere during the summer. So I will come back when I have a better time line, but it's somewhere during the summer. So it's not the end of the year, it's earlier than that.

Yes. 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 yes, 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 questions the FDA might pose to us.

Yes, fair. Fair. And I know you said in the beginning of the presentation, Christoffer, that you aim to make the 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 U.S. maybe to begin with? Will you be focusing on the sort of marginalized ECD, DCD hearts or older donors? I mean 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 PRESERVE 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 2-hour preservation and a couple of factors -- a couple of risk factors or more than 4 hours. So we will definitely target those hearts. We will also -- we see an increasing interest here from U.S. 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 1 of the launch.

Makes sense. And 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, 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 EVLP program, and we do see great progress now, both an underlying market growth where we see that more and more data is getting published showing that using EVLP for extended grafts or DCD graft has a really positive impact on the overall survival and that we use more organs. So in general, there is a good underlying trend for the lung market. The other thing which we are working with is to put XPS into more hands, so to say, so we can do it and especially the hub model that 1 OPO with 1 center pumps lungs for a larger area, which we have seen has been very successful for. 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 lung symposium and all the customer interactions from here from ISHLT, so we see positive outlook.

The next question comes from Ulrik Trattner from DNB Carnegie.

Thank you very much and a few on my end. And I'll start off with the abdominal gross margins. And Christoffer, you touched upon this. But I also note that the gross margin was kind of equally low in Q4. So is there FX 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 [ fees ], slightly lower gross margins in Europe versus the U.S. 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 have not reached full scale in production that we want. So 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. So we see a gradual improvement, is my belief.

I'll 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. But it's still very much of a 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 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 QSUB 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 there would be 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 U.S. data prior to launching it, given sort of the -- I mean, hindsight, what we have seen with the kidney launch that U.S. data is of high importance in order to reach higher volume. Potentially a 510(k) would be the preferred route on your end?

Yes. I mean 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, but 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. So 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. And you're right, with the kid experience, we learned that very fast that launching a product without U.S. 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 is 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. As you went from 4 patients in Q3 '22 and now further 6 here in Q1. And I would assume that the interest has not come down post ISHLT. So how quickly can you get a sort of reapproval or expansion of your CAP program in the U.S.

We're aiming as soon as possible. So yes, it is under review from the FDA, and they will come back to us soon, according to what they said. So -- but again, it's hard to speculate on the FDA time line and the work burden they have. But what we can say is that, yes, the interest is extremely high from U.S. clinicians before the ISHLT and before those 2 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 a portion of them? Or can you give us any more sort of insight that would be very interesting.

Yes. 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. So we should remember that. But we can see in some CAP centers that is quite high penetration. And then 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 Xvivo Heart Assist. So 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 an unlimited use because now it's capped to number of patients. And I think it's more interesting to look to the Australian situation where there is an uncapped continuous access protocol. So it is similar, but it is uncapped. And there, we see that it's 50% for DBDs and now we're starting with DCD.

Sure. Yes. And just on the data that you have generated here lately and presented. Obviously, a positive outcome in the U.S. and 4 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 heart box here in 2026.

The straight answer is yes. I mean, the feedback we get from those compassionate use is that, yes, we don't see any alternative on the market for any graft, pediatric, adult, DCD or DBD. So 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. And so 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. And -- but again, the regulatory process is a regulatory process. And it's hard to speculate. But definitely, we are -- due to this, we are more confident, yes.

Great. And last question on my end. Did you mention that you had found 4 to 5 OPO targets to sort of be integrated into an EVLP program. I just too -- if I heard that clearly.

Yes, 4 to 5 are identified in the pipeline right now, to clarify that. So we have done our first installment, very successful ahead of plan. We are doing our second one. I think while we speak or at least very soon after ISHLT. And then there is a rollout plan, which is, 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. So we're going to make sure that we are there. And we are also increasing our internal resources to be able to handle an 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. 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 at sort of a maintained pace even with your sort of limited resources.

Yes. 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 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 audience they so deserve for the patients on the waiting list. So we'll be very cautious on keeping a high quality.

The next question comes from Jakob Lembke from SEB.

So 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 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. 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 OPO that was -- so those are let's say, the 3 reasons. We also see that we're increasing the sales footprint. In other words, number of feet on the -- close to 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 Q1 sales for EVLP?

I think it was fairly -- 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 up stocking, destocking during either this quarter this year or Q1 this year or Q1 last year.

So I guess my question then is it fair to assume then that this is sort of a new base line for the EVLP consumables?

Yes, 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 new -- both existing and new EVLP programs, absolutely.

Good. Then 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.

Yes. 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 more hopefully soon here is going to be more Australian like and some will be more restricted in terms 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 the CE Mark very soon, but we see that we can keep the high interest and continue to save patients where there is no alternative to the XVIVO 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 CE Mark? And also, if you expect to get the approval then in the 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 notified body. So the answer is yes, to the notified body. There has been contact. We -- from what we heard from them, yes, we should expect something here in early summer or summer. So that's the latest we heard. So 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 as a 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 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 2-arm trial and as well as the Australian trial. So I guess it must be a very broad label because you have, I mean, the most broad -- 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 XVIVO 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 their review -- I mean, the lowest bar is for safety reasons. And we do -- 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 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. So that would be -- that in itself will be an extremely good label.

The next question comes from Filip Wiberg from Pareto Securities.

First, I think I just would like to follow up on a prior question about the strength in EVLP 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 destock. 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?

Yes, 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 we are, they are also depending on the underlying market growth, so to say, but we have a very good 1 year visibility into what they aim to do. And -- but they are for the same reason, as 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 1 quarter. So if the momentum we see now that we believe will continue, we have good visibility.

Good. We talked a little bit 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 EVLP is growing, Perfadex becoming a smaller part. So will you be able to defend the gross margin you've had when EVLP continues to grow and takes a bigger share and then also 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 I mean this quarter was extraordinary when it comes to EVLP portion out of sales, right? So -- and we have a lower margin on EVLP than on Perfadex. But we also see the growing -- the growth initiatives in the U.S., we have good prices on those and speaking about the hub model for EVLP. And 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. 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.

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 abdominal products. So that's something we need to work on, of course. But we are more confident. And of course, with the heart, there is always when you start up production, there is always 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 Nordstrom about the EBITDA margin, you stated it was 24%, excluding U.S. heart activities. But I think you said as well that there was a nonrecurring 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 noncurrent was the SEK 7 million that we spent on foundational heart launch preparations consultancy work to prepare for the U.S. heart launch. So for us, that was a foundational activity, a bit of a onetime. 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 U.S. organization to prepare for the launch. And I think that will be more of a linear step-wise 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 2026.

Okay. Good. So just to be clear, admin costs, do you expect that to come down from Q1 levels, but that 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 Filip 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?

Yes, there will be many steps in this. The first one, we hope that Filip Rega 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 process you would have to do, such as NRP or very expensive machinery in DCD hearts is avoided. So you reduce cost, you reduce complexity, et cetera. So the interest to go this route was during the late-breaking news was extremely high. And 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. And 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.

The next question comes from Ludwig Germunder from Handelsbanken.

I would like to follow 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 or you see the recovery in terms of how much is recovered now in EVLP. Are we back at previous normal levels? You mentioned this is fair to assume as a new baseline in EVLP consumable sales. But do you see any more recovery to do before you're back at some sort of [ pre ] levels after last year?

No, I think we -- 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. So we will continue to build on what we have, so to say, on the foundation we have now established during Q4, Q3 -- sorry, Q4 and Q1. I want to mention that last year, there was a tough period for lung transplantation in terms of the number flattening 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.

Okay. I see. And then I have a question. I'm not sure if you mentioned it, 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 FDA come back as soon as possible, but it's -- we have to understand, we are under an IDE and the FDA are deciding what we can do and not do, during an IDE.

Should we continue? Or would you like to end the call?

Continue. If the last few 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 2 more analysts who have questions. So I do want to give them the opportunity to ask those questions. But I will be very brief.

The next question comes from Oscar Bergman from Redeye.

Just wondering, R&D costs of SEK 37 million, if that should be considered sort of a baseline going forward? Or are there any one-offs that make maybe the last couple of quarters a better baseline?

Yes. Good question. Yes. 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 building out the -- we are very soon done with investments into our -- increasing the product capacity. So 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 the first time in Xvivo history.

And then when you have the CE Mark in place for the heart 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 fixed reimbursement. So with 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. So that's a job that will start. It will not be immediate. So you do have to work with reimbursement in each country.

The next question comes from Ed Hall from Stifel.

Just quickly on lung and how we should think about it for the rest of the year. So I think you've outlined the underlying existing customers, the new customers are growing and obviously, looking at Q2 and Q3 or weaker comps? Or 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, Ed, for that question. I do think that there will, of course, be seasonality like in any business depending. And we're also depending on the number of donors going for EVLP, but we do see -- and I still state that 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 that we -- for example, it was the presentation here during ISHLT, which show that you can 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 a final question from my side. Just wanted 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, 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.

Perfect. 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.

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 thank you so much for today and we meet next time on July 14.