Xvivo Perfusion AB (publ)

Thank you so much and good morning and good afternoon and welcome to XVivo's earning call for the second quarter of 2025. I go to the first page after the front page. So today's presenters are me, Kristoffer Rosenblatt, CEO of XVivo and Kristoffer Nordström, CFO. And with that, we go to slide two, the Q2 finance at the glance. I am disappointed to report that Q2 shows negative top line growth compared to the same quarter last year. The three main reasons are a slower than expected long market that led to some destocking, lack of hard sales compared to both expectations and last year, and thirdly, a weaker US dollar. The positive news, however, in the quarter two are that where we invest in field force, we see strong growth and a positive momentum. For example, the U.S. lung sales to clinic and opioids grew by 26 percent. Liver in Europe grew by 32 percent and kidney sales in the U.S. grew by 47 percent during the second quarter of this year. The quarter also showed great progress in terms of milestones for future growth. The key event was the ISHLT in April and the reception of the European Heart Study. With one year data now available, we can conclude that the 76% risk reduction in severe PDD led to improved patient survival. This was expected and known by everyone in the heart transplant community, but the clear correlation also in the study strengthened the conviction. I can't remember how many times I got the question during ISHTT, how can I buy this device from surgeons I met during the meeting? We also have seen progress in the heart approval process and the Canadian launch activities for the abdominal portfolio. Last year, we saw that the two largest US transplant clinics grew the program safely by evaluating lungs. During ISHC, the presentation from Cleveland was very, very impressive, where they showed that they could safely transplant lung that was rejected by more than 47 clinics in the United States, if the ex vivo was used. The convincing results from EVLP that was presented during ISHC has led to an increased interest to start an EVP program, both in the US and in Europe. So there is a very mixed picture in the second quarter from the sales figures we see and the interest. On the other hand, the interest we see from clinic and OPOs who want to start an EVP program. We have had four new XPS customers in the US alone in the first six months, and we see continued high interest, which makes us convinced that the market will come back to higher growth rates again. Q2 shows again that Exviva has a scalable business model. In terms of EBITDA, the scalable model leads to lower EBITDA as a percentage of sales this quarter. It is best illustrated by the fact that gross margin as a percentage of sales are stable in the quarter. Cost in Swedish krona is the same as last year's Q2. Hence, the EBITDA effect we see in the quarter is coming from sales. During the second quarter, we enforced a cost-restruction program to invest where we have the best ROI. As I stated earlier, we see great progress where we stay close to customers. So the investment will predominantly be steered to the heart launch in Europe, as well as supporting the U.S. clinician, including patients into the CAP or the Continuous Access Protocol for heart. ramp up the u.s liver trial and lastly increasing the field force since we now see growth where we invest close to the customers with that we can go over to the third slide which is the y2d financial at the glance for the first six months of the year uh And the first six months shows a similar picture to the quarter. Good and stable gross margin. We continued investment into fuel force and scalable production structures. Sales came in at almost 400 million SEK for the first six months. As we stated earlier, we plan to improve abdominal gross margin to 70% at the latest in 2027 or earlier when we reach economies of scale in production. Christopher Nordstrom, our CFO, will get more into the details on sales, gross margin and EBITDA later in the presentation. More on the first half. We are ready to launch the heart products in Europe as soon as the last medical agency give their approval. This together with the cap in the US that is now approved and we are having the first center ready to include patients. We're looking forward to an exciting second half for Heart. We see that we have a few top clinics in the US for Heart and they will hopefully be one by one now able to start including into the cap during the third quarter of 2025. We have seen very high interest. We have seen that in Australia, the heart penetration continued to be approximately 30%. And we have seen very good results on DCD hearts. So this again shows us that the heart technology has the potential to change the paradigm of heart transplantation. The abdominal stage showed continuous strength, and we are now starting to see positive news for European liver reimbursement based on excellent clinical and hospital economic data. I will come back to this later. In the US, we saw cat grew almost, or kidney assist transport grew almost 50%. And if we look at disposable, they actually grew 70%. So the usage is increasing every quarter. short touch on services and and christopher nordstrom will come back more into details but we are not pleased with the progress in the in the us service business the first part of the strategic review is now concluded in june and we see an increased increase for combined procurement and nrp services We also see that this would fit very well into the heart launch in the US. As stated earlier and in earlier calls, the service initiative is strategic and the purpose is to support the future heart business in the United States. Lastly, and most important before we go into the business highlights, are that the projects are progressing according to plan. The heart project is on time and budget, albeit we did not expect a long review time from one of the medical agencies in Europe. The high workload on regulatory bodies and medical agencies has affected the application review time more than we have anticipated. The production capacity project where we invest to scale up volumes times 10 up to day volumes for disposables are running in line with communicated timelines. And the full scale production of disposable heart, liver and kidney will be extremely important to capture future growth potential for all product groups. And with that, we can go into the highlights, which is on slide four. I want to stop here and just remind ourselves why we're all here. And that is to make sure that no one dies waiting for an organ. Here, Alex, on the picture is one of the 400 patients who got the opportunity of a transplant, thanks to the Exvivo Heart Technology. And interestingly, if we look at the results from the European trial, and if that can the result can be fully replicated globally approximately an additional 500 patients would survive to see the one-year anniversary of the transplantation every year and then we are not counting all the donated hearts that can be translated thanks to the ex vivo technology that comes from the extended criteria donor pool but with that we can go to the slide number five and we will start with two slides where we deep dive into lungs and the very mixed picture we see on on lungs we have gotten used to very high growth for especially in the u.s lung market during 23 and 24 with double digit market growth in number lung transplants the growth has been driven by improved allocation and especially evlp which has grown almost at five times that pace. That's almost 50% growth during the two years. EVLP has been driven by ambitious programs who can safely grow the number of lung transplant using lung that was rejected by other centers. In 2025, we still see growth in the market, but at a slower pace than we used to. And EVLP growth has also slowed down in 2025. there are the reasons are manifold but speaking to customers there are three that stand out number one there is some fatigue of the very high growth for for two years two some centers are lacking resources due to change changes in hospital economics there was a reduction in nih grants that has been enforced at the beginning of the year and and sometimes that has skewed economics for some centers and three the most ambitious clinics using evlp have temporarily reduced their waiting list this reduces the ability to match donor recipients and hence the use of evp goes down temporarily at those large clinics until the waiting list is restored again we can turn to slide six where to show this as we stated earlier, we come from two very strong years in terms of lung growth and especially EVLP growth. And as stated in the beginning of the call, we have also seen fantastic results from ambitious lung transplant programs that can safely increase the number using XVP. In 2025, we see some destocking at our largest customer at the same time as we see an increasing interest to start an EVLP program with XPS. To put this in perspective, the last five years we have been acquiring approximately two new accounts per year. But now in 2025, we have already four new accounts in the first six months and the pipeline of as many for the next six to nine months in the United States. So the growth is mainly coming from top lung transplant clinics. and we start to see progress in the south and the west of the us where we earlier didn't have access to the xvivo technology we now have one active customer on the west coast and interest from many more to start xps program in both the south of the united states and the west coast so in conclusion we grow where we increase our field force and we plan to increase investment into investment in tvlp expert to support the growing number of xps clinics given the recent success of the number one and number two clinics growing their programs with the solid xps pro program we are now very excited to support more clinics growing their program safely And with those two slides around lungs, we will go over too hard and deep dive a little bit into the result and interest we have seen so far, especially from the ISHT in Boston end of April this year. There was, in general, very high interest for the heart technology at the IHCT that took place in April this year. A lot of preclinical work was presented where, for example, hearts were functioning after being preserved for 48 hours in the ex vivo heart box. The highest interest, however, was generated from the European study presentation, the presentation of two early experiences from DCD direct procurement with the heart box. by two clinics, one from Europe and one from the US. As mentioned earlier, the European study is the first randomized controlled trial with superiority endpoint that has been conducted for hearts. But we start with the result from the trial that was presented during ISHZT and the severe PDD was reduced with 76% in the Xvivo group. Since severe PDD is the leading cause of one-year mortality, with almost half of the patients diagnosed with severe PDD after heart transplantation not surviving one year. So we could see that the reduction in severe PDD directly led to 92% survival in the ex vivo group versus 86% in the control group. Hence, we saw six patients surviving thanks to ex vivo and improved preservation of hearts. This result is truly remarkable. since it has been achieved in a standard criteria donated heart population. In the preclinical setting, we have shown earlier that the ex vivo box shows even better results or better comparable results when used to extend the criteria hearts. For example, older donor, longer transportation time or DCD hearts. So now we see that we can unlock a lot of hearts not used before, but we can also use the ex vivo heart box for the standard criteria. heart that we actually transplant, that are the majority of the transplants today. It should be said that we expect a good result from the heart box based on the preclinical work that has been done. And we are now very pleased to see that the same results can be shown in the clinical setting. The good results will hopefully lead to publication soon, and after that, we can speak more freely on the fantastic results, on the detail on why we think we have seen those great results so far. Secondly, the early results from DCD direct procurement, in other words, not using NRP for DCD lungs, were presented during ICT from two very prominent clinics. If the early result is shown and proved in a larger number of transplants, direct procurement for DCD using the Xvivo Heart Box could be a new gold standard for DCD hearts. And that's something we are striving for, but there is a bit of proof to be collected before we can state that. But we know that we have a European trial including 40 patients at four centers in two countries in Europe. We have now included more than half of the patients, and we hope to conclude patient enrollment at the end of the year, so we can analyze the data. So the presentations, as well as the experience from the many clinics who now use the HeartBox, were translated to an extreme high interest for the extreme heart technology. And we are looking forward to both the continuous access protocol in the U.S. and European launch, and continue the great experience we have from Australia. And with that, we go to the slide number eight, which is liver. I stated earlier that we see good progress in liver in Europe, where the liver assist is approved. And over the past 20 years, we have been working to refine and develop the liver technology and proving clinical studies that the Xvivo liver technology is reducing biliary complication that over time reduce graft loss. In recent clinical trial and hospital economic trial, it has also been shown that ex vivo liver assist increases the use for livers for transplantation, as well as improving hospital economics due to less complication after transplantation. So with the clinical evidence as the base, we start to see strong growth for liver in Europe. During quarter two, we saw growth of 30% and we added six new accounts. The hurdles for growth when we talk to customers are mainly human resources and reimbursement. And we now see country by country that reimbursement is coming into place. And with an increase in customer facing organization, we now have the ability to support clinics better with human resources. with the clinical results from europe as a background we believe that first canadian clinics should get access to liver assist and that is also the reason why we initiated the liver pma trial in order for american clinics to over time get access to this fantastic technology and with that we go over to two slides on regulatory and clinical updates and we can actually go to the Slide number 10, we show an overview of the regulatory approvals we have today in core markets. And our lung and kidney portfolio has obtained regulatory approval in all key markets. As stated earlier, liver is approved in all key markets except the United States. For heart, we are awaiting regulatory approval in all key markets. Hence, to have our portfolio approved in core market, the focus is heart. as well as liver in the United States, which brings us into the update for heart and liver in the US on page number 11 or slide 11. We see constant progress in the four processes you see in front of you, but the key message is the same as the last time we met. So I will partly repeat what I said in April 2025. The USHAR trial was fully included in record time, 13 months. Next milestone is the 12 months patient follow-up. In parallel, we will prepare the technical and preclinical files for submission as well as building the clinical file larger with the help of the continuous access protocol. After the 12-month follow-up that will end in end of November, some time for database lock and preparation of the clinical file and then we will submit that to the fda as mentioned before in europe we have handed in all documentation for review according to our time plan the application consists of four separate approvals by three parties our notified body and two medical agencies as of today we have received approval from our notified body and one european medical agency However, one medical agency is suffering from a very high workload and are still reviewing the file. We are ready to launch when the product is fully approved and the launch process is ready. Staff is recruited and the interest from clinics in Europe is very, very high. We get phone calls almost every day. So we receive a lot of questions from European clinics that want to start it and I can assure everyone that our regulatory team is working both day and night to make sure that all outstanding questions are answered timely and correctly. In Australia and New Zealand, we see a high usage of the product. They deem it unethical to not use it, so it's approximately around 30% usage right now. The regulatory approval will be pending the C-mark in Europe, and the same will apply to Canada. We have previously reported that the liver assist has been granted a breakthrough device designation by the FDA. With an approved ID, we're working hard to get the trial started. And we are aiming for end of Q3 to get the first patient in. And with that, I will hand over to our CFO, Christopher Nordström, who will present the financial performance report.

Thank you. We can move over to the next slide. And I will try to speed this up because I understand there would be great discussions in the Q&A afterwards. But we, of course, also need to dig into the numbers here, especially on the thoracic side. But overall, net sales in Q2, 178 million SEC, and the organic growth was lower than we expected, minus 11%. This is a quarter where we see a mixed picture with areas of negative growth, but also areas with good growth and progress in line with our expectations. I will get into that as we move on here. Overall gross margin in the second quarter was almost in line with last year, 74%, and year-to-date identical, also 74%, which we are very happy about. This was the first quarter where we saw some effects from the weakened US dollar versus SEC. And that translated into a negative 6% currency effect on sales. And that is expected to continue to have an impact at these currency levels. But that said, we're pleased to see that the gross margins remained intact in the second quarter. Adjusted EBITDA was 13%. As we have a scalable business model, profitability will increase again when sales pick up. Next slide, please. So moving over to the thoracic business area. The sales in Q2 were 105 million with an organic growth that was negative 19%. As you know, thoracic sales consists of both lung and heart revenue. And for this quarter specifically, it is important that we dissect the different pockets of sales. So if we start with lungs, lung sales, the growth was negative minus 10% in local curses. And this was mainly due to the destocking and software EVLP activity at our largest customer in the US, to whom sales were reduced roughly 40% versus Q2 last year. In 2024, this customer stood for about 50% of the US EVLP volumes. So obviously, any movements up or down currently gives large impacts. To the positive, so outside this customer in the US, lung sales grew 26% and sales of EVFP kits grew 21%. This tells that we continue to deliver on our strategy to become the preferred partner with the lung transplantation. And it was further demonstrated in Q2 by the acquisition of these two additional XPS customers in the US. One of them is a brand new high ambition lung transplant program. And over the summer, one of the customers that we acquired late Q1 will be activated. And this is a top five lung transplant program in the US. The outlook for additional XPS sales in the second half of the year looks equally good as the first half of the year where we sold six XPS systems globally. And that said, the interest of starting an in-house program has actually never been bigger. And we now have the capacity to meet the demand here for the rest of the year. Looking ahead, we expect that we will continue to grow our EVP customer base, both in the US and in Europe, and we will invest in resources, as Kristoffer mentioned, to stay even closer to these customers. From a total growth perspective, though, the EVP activity at our largest customer will continue to have a large impact on the total sales growth. In terms of Perfadex, sales grew 18% in the US and 8% in Europe, so it was a good quarter. Let's move over to Heart. Sales were 3 million SEK in Q2 versus 19 million SEK last year. As you know and communicated earlier last year included trial revenue which makes comparables tough this quarter and it will be even tougher in Q3 and Q4 as we had 30 million SEK in trial revenue last year in those two quarters. So Heart sales compared to Q2 will grow in the quarters to come though. We have the upcoming US CAP protocol and it's scheduled to start here over the summer. And that is allowed to include up to 60 patients. And as said, we hope to have the CMR in Europe soon, of course. Heart sales in Australia, Kristoffer touched upon it. If you look into the details, yeah, it was a softer quarter from a sales perspective in Q1, but there's no reason to draw conclusions from that as the enthusiasm in Australia remains very, very solid. Gross margin was very strong, 86% and 1% units better than last year, which is delighting. So let's move over to abdominal. Abdominal, the sales came in at 52 million SEK, translating to an organic growth of 19%. And the role in 12 growth is at 25%. Similar split on revenue as previous quarters, you have liver on 74% and kidney on 26%. Liver sales grew 28% in local currencies and on the main markets in Europe, we had a higher growth, 32%. So we definitely are making a solid progress in liver and continue to do so. Christopher mentioned six additional liver assist devices have been installed in Western Europe year to date. And we also start to see a growing interest in the Eastern parts of Europe, which is a little bit of a new market for us. So that's exciting. We work hard on reimbursement as always for HOPE, hypothermic oxygenized perfusion, and we believe we will have a new country coming on board with reimbursement here in the beginning of 2026. Kidney sales declined 2% primarily due to high machine sales last year of 3 million SEK. The utilization of Kindersys transport disposables increases though and as an example in the US we saw a growth of 47%. Last business area, services. Sales amounted to 21 million SEK. The organ recovery part of services decreased by 19% due to lower activity volume. During the year, we have seen that customers both existing but also potentially new customers begin to express more and more interest in NRP as a procurement technique for hearts. And that is currently not a service that we offer broadly. We have, however, set up a pilot program with one customer to define how this could look, how a partnership could look, and nrp is one of the topics that we will address in the strategic review of our service offering that is currently taking place as the market opportunity is for these type of services of is very very high of course the acquisition of flow hook contributed positively positively with a growth of 13 similar to last quarter Moving over to EBITDA profitability, as mentioned, EBITDA came in at 13% and rolling 12 months, we're currently at 19%. In terms of OPEX, the outlook for second half of the year, our focus will be on further investments into our commercial organization and markets where we see the highest return on investment. We believe that our back-end organizations such as operations, R&D, administration are right-sized for what we want to achieve near term, so no significant investments are needed there. Not affecting EBITDA, but definitely worth mentioning related to OPEX is that once we obtain our C mark for hard technology, we will start to amortize the development and trial costs of approximately 200 million SEK. That amortization will be spread out over 10 years, which means 20 million SEK per year and 5 million SEK per quarter. And as stated before, and Kristoffer mentioned it, our ambition is to continue to improve EBITDA year on year, but have a healthy relationship between growth and sustainable profitability development. And my final slide before I hand the word over to Kristoffer again. So cash flow financial position Q2 operating cash flow was positive 9 million SEK. We continue to invest in inventory and will continue to do so, primarily to be able to meet the demand for heart once the approval is obtained. Investments amounted to 72 million, primarily spent on the US clinical trials and perfusion devices to be placed at customers. And in alignment with our announcements in connection to Q1, we have financed the increase in working capital with utilizing our revolving credit facility, 8 million euros utilized in Q2. And that was all for me. Over to you, Kristoffer.

Thank you so much. We go to the outlook for the year and we can go start with the 2025 outlook. We will, as stated earlier, restructure our cost base to be able to invest more close to customers on Fieldforce. And key focus will be to invest in EVLP expertise close to customers to activate the growing number of new customers. For HART, we are preparing for the launch in Europe and in the Pacific. We continue to build the US regulatory clinical file and support US clinics during CAP. For liver, the excellent clinical data published, we will continue to invest in commercial capabilities and capture the opportunity we see in Europe. And we aim, as stated earlier, to start a liver clinical trial in the United States during 2025. We have met Canadian customers and we see a great interest for both the liver and kidney products. We are staying very close to those customers when prepared, both for reimbursement because they need financing to start the program and also our launch activities. And lastly, we will continue to prepare ourselves for the US art launch by strategically building a service offering in the US with the aim to become a preferred partner. And as always, I will end with a long-term outlook. There will always be better quarter and worse quarters, but the long-term outlook is very important to keep in mind. when we invest towards a future market that is not fully there yet. So we see a demand for transplants that are 10 times higher than today's supply. The sales value of machine perfusion versus cold static storage is approximately times 10. We have seen and we see in more trials that machine perfusion have proven to increase the number of organs to be used for transplantation and, as we saw in the heart case, also improve patient survival. We know that the DCD organ pool is growing very fast, and especially in this segment, machine perfusion will play a vital role. And hence, machine perfusion service model on normal and DCD graphs will drive growth in the near and the long future. So in conclusion, this quarter is very disappointing, but the long-term case remains the same. Exviva has a unique and proven product platform we are committed to execute on our strategy and we will in order to one day accomplish that nobody should die waiting for an organ so with that thank you for listening to us today and we will open up the lines for questions